Project BioShield II Act of 2005 - Establishes: (1) the Terrorism and Infectious Disease Countermeasure Purchase Fund; (2) procurement pools for qualified countermeasures and security countermeasures; (3) the International Public Health Advisory Committee to develop strategies for establishing such pools; (4) the Office of Public Health Countermeasure Development within the Department of Health and Human Services (HHS) ; (5) the Office of Medical Readiness within the Office of the Secretary of the Department of Homeland Security (DHS) to assume functions of the National Disaster Medical System and the Metropolitan Medical Response System; (6) the National Emergency Medical Readiness and Response Board within DHS to oversee emergency medical response plans; (7) the National Center for Healthcare Technology Development to manage NIH intellectual property; (8) the Millennium Medicine Discovery Award; (9) the Office of the Deputy Commissioner for Biological, Chemical, Nuclear, Radiological and Infectious Disease Products; and (10) the Global Disease Detection Trust Fund.
Creates incentives for the development of countermeasures, including: (1) payments to manufacturers; (2) accelerated approval of countermeasures; (3) patent term restoration and extension; (4) exclusive marketing; (5) federal tax incentives; (6) reimbursements for production costs; (7) expedited processing of visa applications; (8) grants and contracts for the construction and management of biosafety level 3-4 facilities; and (9) grants and scholarships for personnel to conduct biodefense and infectious disease research.
Sets forth provisions regarding necessary research for countermeasure development, including research regarding: (1) diagnostics; (2) detection technology; (3) infectious diseases; (4) accurate animal models; (5) biologics; (6) vaccine adjuvants; (7) the production of cell culture; (8) vaccines; (9) zoonotic disease surveillance; and (10) agroterrorism research.
Bioshield Export Priority Act - Requires the Secretary of Commerce or the Secretary of Health and Human Services to expedite the processing of requests to export restricted items necessary to procure countermeasures.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 975 Introduced in Senate (IS)]
1st Session
S. 975
To provide incentives to increase research by private sector entities
to develop medical countermeasures to prevent, detect, identify,
contain, and treat illnesses, including those associated with a
biological, chemical, nuclear, or radiological weapons attack or an
infectious disease outbreak, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 29 (legislative day, April 28), 2005
Mr. Lieberman (for himself, Mr. Hatch, and Mr. Brownback) introduced
the following bill; which was read the first time
_______________________________________________________________________
A BILL
To provide incentives to increase research by private sector entities
to develop medical countermeasures to prevent, detect, identify,
contain, and treat illnesses, including those associated with a
biological, chemical, nuclear, or radiological weapons attack or an
infectious disease outbreak, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
(a) Short Title.--This Act may be cited as the ``Project BioShield
II Act of 2005''.
(b) In Honor.--This Act is enacted in honor of Robert Stevens,
Thomas Morris, Jr., Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and
Lisa J. Raines, victims of terrorist attacks in the United States in
2001.
(c) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title.
TITLE I--AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 2004 REGARDING
TERROR COUNTERMEASURES
Sec. 101. Procurement of certain drugs, detection technology,
diagnostics, and research tools.
Sec. 102. Additional authority under project bioshield.
Sec. 103. Request of agency.
TITLE II--AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 2004 REGARDING
INFECTIOUS DISEASE COUNTERMEASURES; ADDITIONAL PROVISIONS
Sec. 201. Amendments to the Project Bioshield Act of 2004 regarding
infectious disease countermeasures.
Sec. 202. Procurement pools; additional incentives under Project
Bioshield.
Sec. 203. Annual report.
Sec. 204. Use of funds; requirements of manufacturers.
TITLE III--AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 2004 REGARDING
INCENTIVES TO ESTABLISH BIODEFENSE, INFECTIOUS DISEASE, VACCINE, AND
RESEARCH TOOL INDUSTRIES.
Subtitle A--Certification of Successful Development
Sec. 301. Certification of successful development.
Subtitle B--Federal Tax Incentives
Sec. 311. General provisions.
Sec. 312. Tax credits.
Subtitle C--Patent Protections
Sec. 331. Patent term restoration and extension and exclusive
marketing.
Sec. 332. International protection for bioshield intellectual property.
Subtitle D--Liability Protections
Sec. 341. Liability and compensation for injured parties.
TITLE IV--VALLEY OF DEATH FOR SMALL COMPANIES
Sec. 401. Purpose.
Sec. 402. Valley of death for small companies.
TITLE V--BIOSHIELD ANTITRUST EXEMPTION
Sec. 501. Limited antitrust exemption.
TITLE VI--BIOSHIELD IMMIGRATION PRIORITY
Sec. 601. H1B visa exemption.
Sec. 602. Visa processing.
TITLE VII--BIOSHIELD EXPORT PRIORITY
Sec. 701. Short title.
Sec. 702. Requirement to expedite export applications.
Sec. 703. Preservation of foreign sales markets for qualified and
security countermeasures.
TITLE VIII--OFFICE OF PUBLIC HEALTH COUNTERMEASURE DEVELOPMENT
Sec. 801. Office of Public Health Countermeasure Development.
Sec. 802. Bioterror, chemical, nuclear, radiological, and infectious
disease countermeasure development
strategy.
TITLE IX--OFFICE OF MEDICAL READINESS AND RESPONSE OF THE DEPARTMENT OF
HOMELAND SECURITY
Sec. 901. Office of Medical Readiness and Response of the Department of
Homeland Security.
TITLE X--NATIONAL EMERGENCY MEDICAL READINESS AND RESPONSE BOARD
Sec. 1001. National Emergency Medical Readiness and Response Board.
TITLE XI--ENCOURAGING GREATER COORDINATION WITH FORMER SOVIET
SCIENTISTS AND TRANSFER OF COUNTERMEASURES
Sec. 1101. Purpose; report to Congress.
TITLE XII--EMERGENCY CONTINUITY OF NATIONAL HEALTHCARE; REIMBURSEMENT
OF INFECTIOUS DISEASE PHYSICIANS FOR COMMUNITY EMERGENCY PREPAREDNESS
ACTIVITIES; MEDICAL LICENSE RECIPROCITY
Sec. 1201. Continuity of national healthcare system in an emergency.
Sec. 1202. Reimbursement of infectious disease physicians for community
emergency preparedness activities.
Sec. 1203. Medical license reciprocity.
Sec. 1204. Liability protection for healthcare volunteers and
hospitals.
TITLE XIII--ADEQUACY OF EMERGENCY MEDICAL RESPONSE ASSETS FOR HOMELAND
SECURITY MISSIONS
Sec. 1301. Adequacy of emergency medical response assets for homeland
security missions.
TITLE XIV--CONSTRUCTION OF SPECIALIZED RESEARCH FACILITIES FOR THE
DEVELOPMENT OF COUNTERMEASURES
Sec. 1401. Construction of specialized research facilities for the
development of countermeasures.
TITLE XV--BIODEFENSE AND INFECTIOUS DISEASE RESEARCH AND SCIENTIFIC AND
TECHNICAL PERSONNEL
Sec. 1501. Establishment of grant program.
TITLE XVI--NATIONAL INSTITUTES OF HEALTH
Subtitle A--National Center for Healthcare Technology Development
Sec. 1601. Purpose.
Sec. 1602. National Center for Healthcare Technology Development.
Sec. 1603. Technology development opportunities assessments.
Sec. 1604. Resources for the National Center for Healthcare Technology
Development.
Sec. 1605. Biennial report of the Director of the National Institutes
of Health to the President and Congress.
Sec. 1606. Authority of the Directors of the National Research
Institutes; biennial report.
Sec. 1607. Commercial research and investigations.
Sec. 1608. SBIR/STTR program consultation with the Director of the
Center of Healthcare Technology
Development.
Sec. 1609. Purpose of the National Research Institutes.
Sec. 1610. Conforming amendment.
Sec. 1611. Effective date.
Subtitle B--Protecting Government Investment in Basic Biomedical
Research
Sec. 1621. Findings.
Sec. 1622. Utilization and availability.
Sec. 1623. Restoration of term of unexploited patents on Government
sponsored inventions relating to
countermeasures.
Sec. 1624. Encouraging the patenting of research tools.
Sec. 1625. Effective date.
Subtitle C--Partnership Challenge Grants
Sec. 1631. Partnership challenge grants.
TITLE XVII--DEVELOPMENT OF COUNTERMEASURE RESEARCH AT THE DEPARTMENT OF
DEFENSE
Sec. 1701. Development of countermeasure research at the Department of
Defense.
Sec. 1702. Request by the department of defense.
Sec. 1703. Expanded public-private partnership agreements for research
and development.
TITLE XVIII--MILLENNIUM MEDICINE DISCOVERY AWARD
Sec. 1801. Millennium Medicine Discovery Award.
TITLE XIX--FOOD AND DRUG ADMINISTRATION
Sec. 1901. Other incentives.
Sec. 1902. Systems biology.
Sec. 1903. Bioterror and infectious disease provisions.
Sec. 1904. Approvals of certain drugs based on animal trials.
Sec. 1905. Clinical trial guidelines for anti-infectives.
Sec. 1906. Authorization of appropriations for FDA purchase of
microbiological data.
Sec. 1907. Authorization of appropriations to implement Public Health
Service action plan to combat antimicrobial
resistance.
TITLE XX--ANIMAL MODELS
Sec. 2001. Animal models for certain diseases.
Sec. 2002. Animal models five-year initiative.
TITLE XXI--STRENGTHENING OF THE VACCINE INDUSTRY
Subtitle A--Biologics, Adjuvants, and Cell Culture Development
Sec. 2101. Biologics manufacturing capacity incentives.
Sec. 2102. Biologics manufacturing efficiency incentives.
Sec. 2103. Development of vaccine adjuvants.
Sec. 2104. Cell culture or recombinant vaccines.
Subtitle B--Influenza Vaccine
Chapter 1--Influenza Vaccine Awareness Campaign
Sec. 2111. Awareness campaign and education and outreach efforts.
Chapter 2--Encouraging Vaccine Production Capacity
Sec. 2121. Incentives for the construction of vaccine manufacturing
facilities.
Chapter 3--Ensuring Sufficient Flu Vaccine Supply
Sec. 2131. Vaccine supply.
Chapter 4--Preparing For a Pandemic or Epidemic
Sec. 2141. Preparation for influenza pandemic or epidemic; anti-virals
supply.
Chapter 5--Report And Administration
Sec. 2151. Report to Congress.
Sec. 2152. Simplified administration of vaccine supply.
Sec. 2153. Medicare coverage of vaccines and prophylaxis as
countermeasures.
TITLE XXII--GAAP ACCOUNTING FOR VACCINE REVENUE RECOGNITION
Sec. 2201. GAAP accounting for vaccine procurement.
TITLE XXIII--HUMAN CLINICAL TRIALS AND DRUGS FOR RARE DISEASES AND
CONDITIONS
Sec. 2301. Expanded human clinical trials qualifying for orphan drug
credit.
TITLE XXIV--HEALTHCARE SYSTEM COLLECTION OF CLINICAL DATA REGARDING
SAFETY AND EFFECTIVENESS OF COUNTERMEASURES
Sec. 2401. Findings; definitions.
Sec. 2402. Certification of clinical countermeasures delivery centers.
Sec. 2403. Eligibility criteria.
Sec. 2404. Policies, procedures, and protocols for the delivery of
clinical countermeasures.
Sec. 2405. Incentives for qualified clinical countermeasures delivery
centers.
Sec. 2406. Authorization of appropriations.
TITLE XXV--CENTERS FOR DISEASE CONTROL AND PREVENTION
Sec. 2501. Global Disease Detection Trust Fund.
Sec. 2502. Environmental microbiology facility study and report.
Sec. 2503. Enforcement of quarantines.
Sec. 2504. Educational campaign at the Centers for Disease Control and
Prevention.
TITLE XXVI--ZOONOTIC DISEASE SURVEILLANCE
Sec. 2601. Zoonotic disease surveillance.
TITLE XXVII--COUNTERMEASURES AGAINST AGROTERRORISM
Sec. 2701. Findings.
Sec. 2702. Definitions.
Sec. 2703. Establishment of working group.
Sec. 2704. Duties.
Sec. 2705. State and local assistance.
Sec. 2706. Interagency coordination.
Sec. 2707. Regional, State, and local preparedness.
Sec. 2708. International activities.
Sec. 2709. Review of legal authority.
TITLE XXVIII--GLOBAL DISTRIBUTION OF MEDICAL COUNTERMEASURES.
Sec. 2801. Findings.
Sec. 2802. Report by USAID.
TITLE XXIX--ENVIRONMENTAL PROTECTION AGENCY; DECONTAMINATION AND
REMEDIATION
Sec. 2901. Findings.
Sec. 2902. Report on capabilities.
TITLE I--AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 2004 REGARDING
TERROR COUNTERMEASURES
SEC. 101. PROCUREMENT OF CERTAIN DRUGS, DETECTION TECHNOLOGY,
DIAGNOSTICS, AND RESEARCH TOOLS.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.) is amended--
(1) in section 319F-1(a)--
(A) by redesignating paragraphs (3), (4), and (5)
as paragraphs (4), (5), and (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Inclusion.--The term `qualified countermeasure'
includes detection technology, diagnostics, and research tools,
as those terms are defined in section 319F-3.''; and
(2) in section 319F-2(c)(1)(B), in the matter preceding
clause (i), by striking ``means a'' and inserting ``means
detection technology, diagnostics, and research tools, as those
terms are defined in 319F-3, a''.
(b) Purchase Funds.--Title V of the Homeland Security Act of 2002
(6 U.S.C. 311 et seq.) is amended by adding at the end the following:
``SEC. 512. COUNTERMEASURE PURCHASE FUND AT THE DEPARTMENT OF HOMELAND
SECURITY.
``(a) Purchase Fund.--
``(1) Establishment of fund.--There is established in the
Department a fund to be known as the `Terrorism and Infectious
Disease Countermeasure Purchase Fund' (referred to in this
subsection as the `Fund') consisting of amounts appropriated
for expenditure by the Secretary under paragraph (4). This fund
shall be separate from the special reserve fund established
under section 510.
``(2) Investment of fund.--Amounts in the Fund shall be
invested in accordance with section 9702 of title 31, United
States Code, and any interest on, and proceeds from, any such
investment shall be credited to and become part of the Fund.
``(3) Use of fund.--
``(A) In general.--The Secretary shall expend
amounts in the Fund--
``(i) for the purchase of countermeasures;
and
``(ii) to provide advance, partial,
progress or other payments, in accordance with
subparagraph (E), to manufacturers of
countermeasures.
``(B) Purchase.--Countermeasures shall be purchased
by the Fund at the price and under the terms negotiated
by the Secretary and the manufacturer or at a
commercial price, if applicable.
``(C) Coordination with the department of health
and human services.--The Secretary may delegate
authority to the Secretary of Health and Human Services
to purchase countermeasures using the Fund. Any such
purchases by the Secretary of Health and Human Services
shall be conducted as if made by the Secretary under
this section.
``(D) Conditions for purchase.--
``(i) In general.--Payments for purchases
under subparagraph (A)(i) shall be made under
such terms and conditions as are set forth in
the contract between the parties.
``(ii) Determinations.--The determinations
required under section 319F-2(c) of the Public
Health Service Act shall not be required with
respect to a contract, grant, or other
transaction funded by the Fund under this
section.
``(E) Advance, partial, progress, or other
payments.--
``(i) In general.--The Secretary may make
payments under subparagraph (A)(ii) to
manufacturers of countermeasures prior to the
final purchase of such countermeasure.
``(ii) Basis for payments.--Payments under
this subparagraph shall be based on--
``(I) the performance of the
manufacturer involved as measured by
the Secretary using objective,
quantifiable methods (such as delivery
of acceptable items, work measurement,
or statistical process controls)
established by the Secretary;
``(II) the accomplishment of events
or milestones as defined in a program
management plan that is developed by
the manufacturer and submitted to the
Secretary; or
``(III) other quantifiable measures
of results determined appropriate by
the Secretary.
``(iii) Number, time, and amount of
payments.--
``(I) In general.--The Secretary
shall, with respect to a manufacturer
of a countermeasure, determine the
number of payments to be made, the
timing of such payments, and subject to
subclause (II), the amount of each such
payment.
``(II) Limitation.--The amount of a
partial payment made to a manufacturer
under this subparagraph shall not
exceed the portion of the total
purchase price (described in
subparagraph (B)) for the
countermeasure that remains unpaid as
of the date of the payment involved.
``(iv) Conditions for payment.--The
Secretary shall ensure that any payment to
which this subparagraph applies is commensurate
with the actions taken by the manufacturer and
the progress made in achieving the performance
measures under clause (ii)(I) through the time
of such payment. The manufacturer shall provide
such information and evidence as such Secretary
determines necessary to determine compliance
with the preceding sentence.
``(v) Independent research and development
costs.--The payment amount under this
subparagraph may include the costs associated
with independent research and development
undertaken by the manufacturer prior to
entering into a contract or other agreement
with the Secretary under this section.
``(4) Authority to contract.--
``(A) In general.--For purposes of a procurement
under this subsection, the Secretary shall have
responsibilities described in subparagraphs (B) and
(C).
``(B) Procurement.--
``(i) In general.--The Secretary shall be
responsible for--
``(I) arranging for procurement of
a countermeasure, including negotiating
terms (including quantity, production
schedule, and price) of, and entering
into contracts, cooperative agreements,
or other transactions, and for carrying
out such other activities as may
reasonably be required; and
``(II) promulgating such
regulations as the Secretary determines
necessary to implement the provisions
of this subsection.
``(ii) Other transaction authority,
additional authority for research projects.--
The Secretary shall have the authority to enter
into transactions (other than procurement
contracts, grants, and cooperative agreements),
including transactions for prototypes, to the
same extent as provided to the Secretary of
Defense under section 2371 of title 10, United
States Code, for purposes of carrying out the
objectives of the Project BioShield II Act of
2005.
``(iii) Contract terms.--
``(I) Mandatory terms.--A contract
for procurement under this subsection
shall include the following terms:
``(aa) Contract duration.--
The contract shall be for a
period not to exceed 10 years,
except that, in first awarding
the contract, the Secretary may
provide for a longer duration,
not exceeding a total of 18
years, if the Secretary
determines that complexities or
other difficulties in
performance under the contract
justify such an extended
period. The contract shall be
renewable for additional
periods, none of which shall
exceed 5 years.
``(bb) Product approval.--
The contract shall provide that
the vendor seek approval,
clearance, or licensing or
validating of the product from
the Secretary or other
appropriate Federal agency and
for a timetable for the
development of data and other
information to support such
approval, clearance, or
licensing, and that the
Secretary may waive part or all
of such contract term on
request of the vendor or on the
initiative of the Secretary.
``(II) Storage by vendor.--A
contract for procurement under this
subsection may provide that the vendor
provide storage for stocks of a product
delivered to the ownership of the
Federal Government under the contract,
for such period and under such terms
and conditions as the Secretary may
specify, and in such case amounts from
the purchase fund under subsection (a)
shall be available for costs of
shipping, handling, storage, and
related costs for such product.
``(III) Warm industrial base fee.--
A contract for procurement under this
section may provide that the vendor
receive a fee for establishing and
maintaining manufacturing capacity in
excess of the initial requirement of
purchase of the countermeasure, in
order to ensure that the Secretary has
available a warm industrial base in the
event of the need to increase purchases
of countermeasures. To the extent
practicable, the Secretary shall modify
contracts in existence on the date of
enactment of this Act to have available
a warm industrial base. The cost of
maintaining a warm industrial base
shall be an allowable and allocable
direct cost to the contract.
``(IV) Purchase of fda licensed
products.--Nothing in this section
shall be construed to prevent the
Secretary from purchasing
countermeasures that are licensed by
the Food and Drug Administration for
the indicated use or, in the event of a
countermeasure that is established to
be safe and effective for uses other
than those indicated on the label of
such countermeasure, a use for which
the vendor may be approved under
emergency use authorities or approval
by the Food and Drug Administration
subsequent to purchase.
``(V) Other contract
requirements.--
``(aa) Cost accounting
standard.--Notwithstanding any
other provision of law, the
cost accounting standards set
forth under chapter 99 of title
48, Code of Federal
Regulations, the cost
principles set forth under part
31 of title 48, Code of Federal
Regulations, and the
requirement for submission of
certified cost and pricing data
under section 304A of the
Federal Property and
Administrative Services Act of
1949 (41 U.S.C. 254b) shall not
apply to any contract, grant,
or cooperative agreement
entered into under the Project
BioShield Act of 2004 (or the
amendments made to such Act by
the Project BioShield II Act of
2005.).
``(bb) Single
transaction.--The Secretary
shall, to the extent
practicable, enter into a
single transaction with each
contractor for the procurement
of countermeasures, even if
additional research and
development of such
countermeasures may be
required, so long as the
Secretary determines that
sufficient and satisfactory
clinical experience or research
data supports a reasonable
conclusion that such security
countermeasures will qualify
for approval or licensing by
the Food and Drug
Administration within 8 years
from the date of entering into
the procurement transaction.
``(iv) Procurement of multiple product and
technologies.--Notwithstanding any other
provision of law, the Secretary shall, to the
maximum extent practicable, enter into multiple
transactions for the procurement of multiple
technologies and products from multiple
manufacturers of countermeasures in order to
mitigate the risks associated with dependence
on a single supplier or technology.
``(v) Single transaction.--The Secretary
shall, to the extent practicable, enter into a
single transaction for the procurement of
countermeasures, even if additional research
and development of such countermeasures may be
required, so long as the Secretary determines
that sufficient and satisfactory clinical
experience or research data supports a
reasonable conclusion that such security
countermeasures will qualify for approval or
licensing by the Food and Drug Administration
within 8 years from the date of entering into
the procurement transaction. The fact that an
entity has not filed for investigational new
drug status with the Food and Drug
Administration, or has filed for such status
but has not yet been approved, shall not be the
sole basis for a determination by the Secretary
with respect to whether a countermeasure
qualifies for approval or licensing by the Food
and Drug Administration not more than 8 years
from the date of the procurement transaction.
``(vi) Availability of simplified
acquisition procedures.--
``(I) In general.--If the Secretary
determines that there is a pressing
need for a procurement of a specific
countermeasure, the amount of the
procurement under this subsection shall
be deemed to be below the threshold
amount specified in section 4(11) of
the Office of Federal Procurement
Policy Act (41 U.S.C. 403(11)), for
purposes of application to such
procurement, pursuant to section
302A(a) of the Federal Property and
Administrative Services Act of 1949 (41
U.S.C. 252a(a)), of--
``(aa) section 303(g)(1)(A)
of the Federal Property and
Administrative Services Act of
1949 (41 U.S.C. 253(g)(1)(A))
and its implementing
regulations; and
``(bb) section 302A(b) of
such Act (41 U.S.C. 252a(b))
and its implementing
regulations.
``(II) Application of certain
provisions.--Notwithstanding subclause
(I) and the provisions of law and
regulations referred to in such clause,
each of the following provisions shall
apply to procurements described in this
clause to the same extent that such
provisions would apply to such
procurements in the absence of
subclause (I):
``(aa) Chapter 37 of title
40, United States Code
(relating to contract work
hours and safety standards).
``(bb) Subsections (a) and
(b) of section 7 of the Anti-
Kickback Act of 1986 (41 U.S.C.
57 (a) and (b)).
``(cc) Section 304C of the
Federal Property and
Administrative Services Act of
1949 (41 U.S.C. 254d) (relating
to the examination of
contractor records).
``(dd) Section 3131 of
title 40, United States Code
(relating to bonds of
contractors of public buildings
or works).
``(ee) Subsection (a) of
section 304 of the Federal
Property and Administrative
Services Act of 1949 (41 U.S.C.
254(a)) (relating to contingent
fees to middlemen).
``(ff) Section 6002 of the
Solid Waste Disposal Act (42
U.S.C. 6962).
``(gg) Section 1354 of
title 31, United States Code
(relating to the limitation on
the use of appropriated funds
for contracts with entities not
meeting veterans employment
reporting requirements).
``(III) Internal controls to be
established.--The Secretary shall
establish appropriate internal controls
for procurements made under this
clause, including requirements with
respect to documentation of the
justification for the use of the
authority provided under this paragraph
with respect to the procurement
involved.
``(IV) Authority to limit
competition.--In conducting a
procurement under this subparagraph,
the Secretary may not use the authority
provided for under subclause (I) to
conduct a procurement on a basis other
than full and open competition unless
the Secretary determines that the
mission of the BioShield Program under
the Project BioShield II Act of 2005
would be seriously impaired without
such a limitation.
``(vii) Procedures other than full and open
competition.--
``(I) In general.--In using the
authority provided in section 303(c)(1)
of the Federal Property and
Administrative Services Act of 1949 (41
U.S.C. 253(c)(1)) to use procedures
other than competitive procedures in
the case of a procurement under this
subsection, the phrase `available from
only one responsible source' in such
section 303(c)(1) shall be deemed to
mean `available from only one
responsible source or only from a
limited number of responsible sources'.
``(II) Relation to other
authorities.--The authority under
subclause (I) is in addition to any
other authority to use procedures other
than competitive procedures.
``(III) Applicable government wide
regulations.--The Secretary shall
implement this clause in accordance
with regulations implementing such
section 303(c)(1) (including
requirements that offers be solicited
from as many potential sources as is
practicable under the circumstances,
that required notices be published, and
that submitted offers be considered),
as such regulations apply to
procurements for which an agency has
authority to use procedures other than
competitive procedures when the
property or services needed by the
agency are available from only one
responsible source or only from a
limited number of responsible sources
and no other type of property or
services will satisfy the needs of the
agency.
``(viii) Premium provision in multiple
award contracts.--
``(I) In general.--If, under this
subsection, the Secretary enters into
contracts with more than one vendor to
procure a countermeasure, such
Secretary may, notwithstanding any
other provision of law, include in each
of such contracts a provision that
identifies an increment of the total
quantity of countermeasure required,
whether by percentage or by numbers of
units.
``(II) Determination of
government's requirement not
reviewable.--If the Secretary includes
in each of a set of contracts a
provision as described in subclause
(I), such Secretary's determination of
the total quantity of countermeasures
required, and any amendment of such
determination, is committed to agency
discretion.
``(ix) Extension of closing date; receipt
of proposals not reviewable.--A decision by the
Secretary to extend the closing date for
receipt of proposals for a procurement under
this subsection is committed to agency
discretion.
``(x) Limiting competition to sources
responding to request for information.--In
conducting a procurement under this subsection,
the Secretary may exclude a source that has not
responded to a request for information under
section 303A(a)(l)(B) of the Federal Property
and Administrative Services Act of 1949 (41
U.S.C. 253a(a)(1)(B)) if such request has given
notice that the Secretary may so exclude such a
source.
``(C) Countermeasures purchased.--Any stockpiles of
countermeasures purchased under this section may be
held in the strategic national stockpile under section
319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b).
``(5) Requirements for manufacturers.--The Secretary, or
the Secretary of Health and Human Services under delegated
authority, shall provide to manufacturers to the extent
feasible the logistical and operational requirements of
countermeasures prior to their development and acquisition. The
logistical and operational requirements will consider public
health needs as well as requirements for storage, maintenance,
security, rotation, and transport of any countermeasures
purchased through the Countermeasure Purchase Fund.
``(6) Coordination.--Consistent with the provisions of
section 319F-2(c)(2)(B) of the Public Health Service Act, the
Secretary shall coordinate with the Secretary of Health and
Human Services to store, maintain, secure, rotate, and
transport any materiel purchased through the Countermeasure
Purchase Fund and designated for use in the Strategic National
Stockpile under such section 319F-2.
``(7) Appropriation.--
``(A) In general.--The total appropriations made
available for both the Fund under section 512 and the
special reserve fund under section 510 may be used to
provide funding for activities conducted by the
Secretary and, where appropriate, the Secretary of
Health and Human Services, in accordance with the
Project BioShield Act of 2004 and the Project BioShield
II Act of 2005 (and the amendments made by such Acts).
``(B) Use of funds.--The Secretary, or the
Secretary of Health and Human Services under delegated
authority, may use the funds under this section to
cover the costs of storage, maintenance, security,
rotation, and transport of any material purchased
through the Countermeasure Purchase Fund.''.
``(b) Definition.--In this section, the term `countermeasure' has
the meaning given such term in section 319F-3 of the Public Health
Service Act.''.
SEC. 102. ADDITIONAL AUTHORITY UNDER PROJECT BIOSHIELD.
(a) Additional Authority for Research Projects.--Section 319F-1 of
the Public Health Service Act (42 U.S.C. 247d-6a) is amended by--
(1) redesignating subsection (f) as subsection (g); and
(2) inserting after subsection (e) the following:
``(f) Other Transaction Authority.--The Secretary shall have the
authority to enter into transactions (other than procurement contracts,
grants, and cooperative agreements), including transactions for
prototypes, to the same extent as provided to the Secretary of Defense
under section 2371 of title 10, United States Code, for purposes of
carrying out the objectives of the Project BioShield Act of 2004.''.
(b) Encouragement of Technology Transfer and Commercialization.--
Section 319F-2(c)(5)(B)(iii) of the Public Health Service Act (42
U.S.C. 247d-6b(c)(5)(B)(iii)) is amended to read as follows:
``(iii) Where there is a potential to
transfer the technology developed as a security
countermeasure to the commercial market, either
as a countermeasure to be sold in foreign
markets or, if the countermeasure has
beneficial use and utility for indications
other than chemical, biological, radiological,
or nuclear protection, for use as other than a
countermeasure in commercial markets thus
meriting Federal funding to stimulate and
encourage such commercialization and technology
transfer, and demonstrating a potential return
on such Federal investment.''.
(c) Procurement of Certain Countermeasures.--Section 319F-2 of the
Public Health Service Act (42 U.S.C. 247d-6b) is amended by--
(1) redesignating subsections (e) and (f) as subsections
(l) and (m), respectively; and
(2) by inserting after subsection (d) the following:
``(e) Procurement of Certain Countermeasures.--
``(1) In general.--The Secretary shall, to the extent
practicable, enter into transactions for the procurement of
security countermeasures, even if additional research and
development of such security countermeasures may be required,
so long as the Secretary determines that sufficient and
satisfactory clinical experience or research data supports a
reasonable conclusion that such security countermeasures will
qualify for approval or licensing by the Food and Drug
Administration within 8 years from the date of entering into
the procurement transaction.
``(2) Basis for determination.--The fact that an entity has
not filed for Investigational New Drug status with the Food and
Drug Administration, or has filed for such status but has not
yet been approved, shall not be the sole basis for a
determination by the Secretary with respect to whether a
security countermeasure qualifies for approval or licensing by
the Food and Drug Administration within 8 years from the date
of entering into the procurement transaction.
``(f) Effect of Section.--Notwithstanding any other provision of
law, the cost accounting standards set forth under chapter 99 of title
48, Code of Federal Regulations, the cost principles set forth under
part 31 of title 48, Code of Federal Regulations, and the requirement
of the submission of certified cost and pricing information under
section 254b of title 41, United States Code, shall not apply to any
contract, grant, or cooperative agreement entered into under the
Project BioShield Act of 2004 (or the amendments made to such Act by
the Project BioShield II Act of 2005).
``(g) Accelerated Approval.--An entity that enters into an
agreement under this section, section 319F-1, or section 512 of the
Homeland Security Act of 2002 shall be eligible for accelerated
approval of a countermeasure in accordance with section 573 of the
Federal Food, Drug, and Cosmetic Act.
``(h) Procurement of Multiple Product and Technologies.--
Notwithstanding any other provision of law, the Secretary shall, to the
extent practicable, enter into multiple transactions for the
procurement of multiple technologies and products from multiple
manufacturers of qualified and security countermeasures (as defined by
this section and section 319F-1) in order to mitigate the risks
associated with dependence on a single supplier or technology.
``(i) Warm Industrial Base Fee.--A contract for procurement under
this section may provide that the vendor receive a fee for establishing
and maintaining manufacturing capacity in excess of the initial
requirement of purchase of the countermeasure, in order to ensure that
the Secretary has available a warm industrial base in the event of the
need to increase purchases of countermeasures. To the extent
practicable, the Secretary shall modify contracts in existence on the
date of enactment of this subsection to have available a warm
industrial base. The Secretary shall deem the cost of such fee
allowable and allocable as a direct cost to the contract.
``(j) Purchase of FDA Licensed Products.--Nothing in this section
shall be construed to prevent the Secretary from purchasing
countermeasures that are licensed by the Food and Drug Administration
for the indicated use or, in the event of a countermeasure that is
established to be safe and effective for uses other than those
indicated on the label of such countermeasure, a use for which the
vendor may be approved under emergency use authorities or approval by
the Food and Drug Administration subsequent to purchase.''.
(d) Technical Amendments.--Section 319F-2 of the Public Health
Service Act (42 U.S.C. 247d-6b) is amended by--
(1) in the section heading, inserting ``and Security
Countermeasure Procurements'' after ``Stockpile''; and
(2) in subsection (c)--
(A) in the heading, by deleting ``biomedical'';
(B) in paragraph (5)--
(i) by amending subparagraph (A) to read as
follows:
``(A) In general.--The Secretary, in accordance
with the provisions of this paragraph, shall identify
specific security countermeasures that the Secretary
determines, in consultation with the Homeland Security
Secretary, to be appropriate for inclusion in the
stockpile under subsection (a) or acquisition for other
purposes pursuant to procurements made with amounts in
the special reserve fund under paragraph (10) (referred
to in this subsection individually as a ``procurement
under this subsection'').''; and
(ii) in subparagraph (B)(ii), by deleting
the word ``stockpile'' and inserting
``government'';
(C) by amending paragraph (6)(D) to read as
follows:
``(D) Subsequent specific countermeasures.--
Procurement under this subsection of a security
countermeasure for a particular purpose does not
preclude the subsequent procurement under this
subsection of any other security countermeasure for
such purpose if the Secretary has determined under
paragraph (5)(A) that such countermeasure is
appropriate for inclusion in the stockpile or
acquisition for other purposes and if, as determined by
the Secretary, such countermeasure provides improved
safety or effectiveness, or for other reasons enhances
preparedness to respond to threats of use of a
biological, chemical, radiological, or nuclear agent.
Such a determination by the Secretary is committed to
agency discretion.''; and
(D) in paragraph (8)--
(i) in subparagraph (A)--
(I) by striking ``Cooperation.--''
and all that follows through ``out''
and inserting ``Cooperation.--In
carrying out''; and
(II) by striking ``, subject to
subparagraph (B),''; and
(ii) by striking subparagraph (B).
SEC. 103. REQUEST OF AGENCY.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
(as amended by section 102) is further amended by inserting after
subsection (j) the following:
``(k) Request of Agency To Use BioShield I and BioShield II
Authority and Incentives.--
``(1) In general.--Upon request by a Federal agency, the
Secretary may establish interagency agreements, under terms
acceptable to the Secretary, in which such agency may order
countermeasures under procurement contracts or procurement
pools established by the Secretary.
``(2) Processing of orders.--The ordering of a
countermeasure under an agreement under paragraph (1)
(including transfers of appropriated funds between an agency
and the Department to pay for such orders) may be conducted
pursuant to section 1535 of title 31, United States Code, if
such order is processed under the terms established--
``(A)(1) in the interagency agreement required by
subsection (c)(7)(B), for orders of detection
technology and decontamination technology placed by the
Department of Homeland Security; or
``(2) by the Secretary in the interagency agreement
described under paragraph (1) for all other orders; and
``(B) in the Project BioShield Act of 2004 and the
Project BioShield II Act of 2005 (and the amendments
made by such Acts) with respect to the procurement of
countermeasures under this section and section 319F-
1.''.
TITLE II--AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 2004 REGARDING
INFECTIOUS DISEASE COUNTERMEASURES; ADDITIONAL PROVISIONS
SEC. 201. AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 2004 REGARDING
INFECTIOUS DISEASE COUNTERMEASURES.
(a) Countermeasures To Detect, Diagnose, Prevent, or Treat an
Infectious Disease.--
(1) Procurement authority.--Section 319F-1(a)(2) of the
Public Health Service Act (42 U.S.C. 247d-6a) is amended--
(A) in subparagraph (A), by striking ``; or'' and
inserting a semicolon;
(B) in subparagraph (B), by striking the period and
inserting ``; or''; and
(C) by adding after subparagraph (B) the following:
``(C) detect, diagnose, treat, or prevent an
infectious disease (as defined in section 319F-3(a)(6))
adversely affecting public health.''.
(2) Strategic national stockpile.--Section 319F-2(c)(1)(B)
of the Public Health Service Act is amended--
(A) in clause (i)(III)(bb), by striking ``; or''
and inserting a semicolon;
(B) in clause (ii), by striking the period and
inserting ``; or''; and
(C) by adding at the end the following:
``(iii) is intended to detect, diagnose,
prevent, or treat an infectious disease (as
defined in section 319-3(a)(6)).''.
SEC. 202. PROCUREMENT POOLS; ADDITIONAL INCENTIVES UNDER PROJECT
BIOSHIELD.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.), as amended by section 101, is amended by
inserting after section 319F-2 the following:
``SEC. 319F-3. PROCUREMENT OF CERTAIN DRUGS, DETECTION TECHNOLOGY,
DIAGNOSTICS, AND RESEARCH TOOLS.
``(a) Definitions.--For purposes of this part:
``(1) Biological or chemical agent; toxin; nuclear or
radiological material; terror weapon.--The term--
``(A) `biological agent', `biological toxin', or
`chemical agent', or any variation of any such term,
includes any microorganism, virus, infectious
substance, toxic biological product, or toxic or
poisonous chemical, that may be used in a manner that
may cause widespread death or serious bodily injury,
including biological agents and toxins described in
paragraphs (1) and (2) of section 178 of title 18,
United States Code;
``(B) `nuclear or radiological material' means any
radioactive material that may be used in a manner that
may cause widespread death or serious bodily injury;
and
``(C) `terror weapon' or `weapon of mass
destruction' mean any matter described in subparagraph
(A) or (B) that may be used in a manner that may cause
widespread death or serious bodily injury.
``(2) Countermeasure.--The term `countermeasure' means--
``(A) a vaccine and related delivery system, anti-
infective, antibiotic or combinations thereof, therapy,
microbicide, diagnostic technology, drug, biological
product, chemical, or other technology that is subject
to applicable provisions of this Act, the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or the
Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.), and that
prevents infection with, or the spread of, or the
directly diagnose, treat, or prevent the pathological
effects of infection with, bodily harm from, or the
spread of, a biological or chemical agent or toxin on
the list described in subsection (f), including
treatments for addressing excessive bleeding and other
trauma following a terrorist attack;
``(B) a therapy, diagnostic, or piece of equipment
that may be used to detect, treat, or prevent bodily
harm that may be caused by the use of biological,
chemical, nuclear, or radiological material as a terror
weapon or by an infectious disease;
``(C) a qualified countermeasure, as defined in
section 319F-1; or
``(D) a security countermeasure, as defined in
section 319F-2.
``(3) Decontamination technology.--The term
`decontamination technology' means a product or service used
for the decontamination of property following a terrorist
attack.
``(4) Detection Technology.--The term `detection
technology' means scientific instruments, consumables (such as
reagents or assays, including reagents or assays using
polymerase chain reaction (PCR) or Real Time PCR), software, or
services for the detection of the presence, concentration,
characteristics, or identification of a biological, chemical,
nuclear, radiological agent, or infectious disease in
environmental or field samples.
``(5) Development.--The term `development' or `to develop'
includes research leading to the identification and isolation
of suitable compounds or biological materials, the engineering,
modification (including research leading to the expanded use of
currently approved drugs or biological products), evaluation,
production, and formulation of such compounds or materials, the
conduct of preclinical and clinical studies, the preparation of
an application for marketing approval, and preparation of test
methods, with respect to countermeasures regulated by the Food
and Drug Administration, and other actions prior to approval of
a countermeasure by the Food and Drug Administration or when it
is procured as an unlicensed countermeasure under section 319F-
2(e).
``(6) Diagnostics.--
``(A) In general.--The term `diagnostics' includes
products, devices, and technologies to detect,
identify, or analyze the potential presence of, or
exposure to, 1 or more biological, nuclear,
radiological, or chemical agent or toxin in potentially
exposed individuals through means to enable effective
medical intervention through the administration of
appropriate countermeasures.
``(B) Inclusion.--The term `diagnostics' includes
technologies that diagnose or screen for the health and
safety of potentially exposed individuals and products
that serve as contraindicators for vaccines or drugs.
``(7) Infectious disease.--
``(A) In general.--The term `infectious disease'
means a disease in humans caused by--
``(i) a microbe (including a bacteria,
virus, fungus, or parasite) that is acquired by
a person and that reproduces in that person;
``(ii) microbial products (such as
botulinum toxin); or
``(iii) a prion.
``(B) Inclusion.--The term `infectious disease'
includes--
``(i) a disease in humans caused by a
microorganism, whether or not--
``(I) such microorganism is
acquired by an individual through
human-to-human contact; or
``(II) if the individual is
initially symptomatic of the disease;
and
``(ii) zoonotic diseases that may find
hosts in animal and human populations.
``(8) Manufacturer.--
``(A) In general.--The term `manufacturer' means an
entity responsible for research, evaluation,
development, or production of a countermeasure and,
except for a countermeasure that is not subject to
review and approval by the Food and Drug Administration
prior to marketing (such as research tools), the
potential or actual holder of the approved new drug
application, biologic license application, or product
license application or equivalent for such
countermeasure.
``(B) Limitation.--The term `manufacturer' does not
require that a manufacturer conduct the actual
research, evaluation, development, or production in its
own facilities, but may enter into arrangements with
third parties for the research, evaluation,
development, or production of the countermeasure.
``(9) Research tool.--The term `research tool' includes the
full range of tools and systems that accelerate the discovery,
development, and manufacture of countermeasures, including
animal disease models, cell lines, cell line cultures for the
production of biologics, de novo DNA synthesis, monoclonal and
polyclonal antibodies, reagents or assays (such as those
utilizing the polymerase chain reaction (PCR) or Real Time PCR
processes), drug delivery technologies, vaccine adjuvants,
antibiotic sensitivity screens, laboratory animals, large
animals including nonhuman primates (and other such animals
used or intended to be used for drug production), growth
factors, combinatorial chemistry and DNA libraries, vaccine
antigen libraries, clones and cloning tools (such as PCR or
Real Time PCR), methods, laboratory equipment and machines,
databases, and other technologies that enable the rapid and
effective development of countermeasures, including
diagnostics, vaccines, drugs, antibiotics, non-laboratory
tools, and tools systems that directly assist such
countermeasure development efforts.
``(b) Procurement Pools.--
``(1) In general.--Notwithstanding any other provision of
law, the Secretary shall establish, and make payments from,
procurement pools with respect to the procurement of a
qualified countermeasure under section 319F-1 or a security
countermeasure under section 319F-2.
``(2) Role of other organizations.--In organizing the
procurement pools under paragraph (1), the Secretary may accept
contributions and guarantees from--
``(A) non-governmental organizations;
``(B) international health agencies;
``(C) the United Nations;
``(D) the Global Vaccine Acquisition Initiative;
and
``(E) private nonprofit organizations that are
organized to support international public health
research and programs.
``(3) Consultation.--The Secretary shall--
``(A) consult with the organizations described
under paragraph (2) regarding the terms and management
of procurement contracts that exceed $25,000,000 in
value under this section and sections 319F-1 and 319F-2
that receive payment from the procurement pool
established under paragraph (1); and
``(B) provide information to such organizations
regarding such procurement contracts.
``(4) Limitation.--Nothing in this part shall be construed
to prohibit the Secretary or the Secretary of Homeland Security
(with respect to procurement agreements under section 512 of
the Homeland Security Act of 2002) from accepting contributions
and guarantees from organizations that receive funding from the
Federal Government.
``(5) Contribution to other pools.--The Secretary and the
Secretary of Homeland Security (with respect to procurement
agreements under section 512 of the Homeland Security Act of
2002) may contribute funds to procurement pools organized by
other entities, such as foreign governments, the United
Nations, or nonprofit or non-governmental entities for
procurement of qualified and security countermeasures.
``(c) Advisory Committee.--
``(1) Establishment.--The Secretary shall establish an
advisory committee to be known as the International Public
Health Advisory Committee (referred to in this section as the
`Advisory Committee').
``(2) Membership.--
``(A) In general.--The Advisory Committee shall be
composed of representatives, to be appointed by the
Secretary, from organizations, including the Centers
for Disease Control and Prevention and the
organizations described in subparagraph (B), with
expertise and resources regarding the development and
distribution of countermeasures against biological,
chemical, nuclear, or radiological agents or infectious
diseases.
``(B) Organizations described.--The organizations
described under this subparagraph are--
``(i) non-governmental organizations;
``(ii) international health agencies;
``(iii) the United Nations;
``(iv) the Global Vaccine Acquisition
Initiative; and
``(v) private nonprofit organizations that
are organized to support international public
health research and programs.
``(3) Duties of advisory committee.--The Advisory
Committee, through a public process, shall--
``(A) develop an international, multifaceted, and
coordinated strategy, that, with respect to
countermeasures against biological, chemical,
radiological, and nuclear agents or infectious
disease--
``(i) develops strategies for establishing
procurement pools;
``(ii) develops strategies to facilitate
partnerships between the government and private
sector;
``(iii) makes recommendations for
strengthening the infrastructure necessary for
researching, creating, and stockpiling critical
therapeutics;
``(iv) recommends ways in which the
countermeasure development process may be
shortened; and
``(v) makes recommendations for priority
areas for developing research and discovery
programs necessary to develop countermeasures;
``(B) develop criteria for determining which
countermeasures against biological, chemical, nuclear,
and radiological agents or infectious disease should be
developed and procured;
``(C) explore priority broad spectrum therapeutics
and ways in which the countermeasure development
process may be accelerated to facilitate rapid
development of new drugs in the event of an attack with
a previously unknown biological agent or pathogen; and
``(D) recognize the importance and the need for
advancement in the field of bioinformatics which will
accelerate the discovery or development of all types of
countermeasures by promoting the use of advanced
mathematical, computing, or image processing
technologies, including pattern recognition methods,
lossless digital data compression for storage and
transmission of biomedical images, and the ability to
analyze massive amounts of data, in order to solve
complex research and development problems.
``(d) Diagnostics Incentives.--
``(1) Identification.--Not later than 180 days after the
date of enactment of the Project BioShield II Act of 2005, the
Secretary shall develop and make available to potential
manufacturers, a list of the diagnostics that need to be
developed to prepare the United States for a terrorist attack
using a biological or chemical agent, infectious disease,
toxin, or nuclear or radiological materials, or to counter a
naturally occurring infectious disease outbreak. The Secretary
shall provide such information as the Secretary determines to
be necessary to enable such potential manufacturers to
structure and focus their research and development programs for
the development of such research tools.
``(2) Revisions.--The Secretary shall revise the list
developed under paragraph (1) not less often than annually, and
make such list available to potential manufacturers of
diagnostics under terms and conditions consistent with the
security interests of the United States.
``(3) Development of Certain Diagnostics.--
``(A) In general.--The Secretary, acting through
the Assistant Secretary for Public Health
Countermeasure Development, shall develop and
implement, in consultation with State and local public
health officials and private sector entities, a
strategy for the development of infectious disease
multiplexed molecular level diagnostic screening
technologies and the building of an integrated and
standardized information system linking the Federal,
State, and local public health systems for reporting
automated laboratory results for all toxicology and
infectious diseases. The strategy shall address the
integration, correlation, and analysis from laboratory
results with data generated from environmental
monitoring using detection technology.
``(B) Strategy.--The strategy developed and
implemented pursuant to subparagraph (A) shall--
``(i) include the development of
confirmatory laboratory tests to validate
presumptive results available from initial
screening;
``(ii) complement the development of
therapeutics where appropriate; and
``(iii) promote the advancement of
bioinformatics through the use of incentives,
the procurement and rapid development of new
devices, and the development of a robust and
standardized information infrastructure for
carrying out medical surveillance tasks.
``(C) Technology.--
``(i) In general.--The specific screening
and diagnostics technology used to implement
the strategy described in subparagraph (A) may
consist of multiplexed devices that screen for
routinely encountered common infectious
diseases and have biothreat agent detection
algorithms embedded in the devices with
automatic reporting features.
``(ii) Dissemination and evaluation.--The
Secretary shall develop--
``(I) the methods by which the
results from such detection devices may
be rapidly disseminated to the
appropriate domestic and international
health care systems; and
``(II) a system by which the
utility of such results, and the
efficacy of such dissemination system,
may be evaluated and improved, as
necessary.
``(4) Utilization of diagnostics by health care
providers.--
``(A) In general.--The Secretary shall develop and
implement a strategy that recognizes the need to
provide the right incentives to the health care
industry, including the qualified clinical
countermeasures delivery centers under the Project
Bioshield II Act of 2005, to allow the industry to
utilize the new diagnostic tools that will be made
available through research and allow for screening for
infectious diseases and other biological, chemical,
nuclear, radiological, and emerging terrorist threats.
``(B) Reimbursement.--The strategy shall include
appropriate incentives to allow for reimbursement to
State and local governments, hospitals, clinics, and
other providers who perform laboratory screening
utilizing newer molecular level tests that rapidly
detect infectious diseases and other biological,
chemical, nuclear, radiological, and emerging terrorist
threats.
``(C) Strategies.--The Secretary shall establish
similar strategies for States and local governments to
utilize to promote biological, chemical, nuclear,
radiological, and other emerging terrorist threats and
infectious diseases screening, including testing for
the rapid identification of potential biothreat agents.
``(5) No judicial review.--Notwithstanding any other
provision of law, there shall be no judicial review of the
list, or revised list, developed by the Secretary under this
subsection.
``(e) Research Tools Incentives.--
``(1) Identification.--Not later than 180 days after the
date of enactment of the Project BioShield II Act of 2005, the
Secretary shall develop and make available to potential
entities and manufacturers, a list of the research tools and
the systems to aid in the development of such tools that need
to be developed to prepare the United States for a terrorist
attack, with a biological or chemical agent or toxin or nuclear
or radiological materials, or to counter a naturally occurring
infectious disease outbreak. The list developed by the
Secretary shall include research tools for which there is a
need for development in order to understand why certain
countermeasures may cause adverse events, how to minimize such
adverse events, and how to treat such adverse events. The
Secretary shall provide such information as the Secretary
determines to be necessary to enable such potential
manufacturers to structure and focus their research and
development programs for the development of research tools.
``(2) Revisions.--The Secretary shall revise the list
developed under paragraph (1) not less often than annually, and
make such list available to potential manufacturers of research
tools under terms and conditions consistent with the security
interests of the United States.
``(3) No judicial review.--Notwithstanding any other
provision of law, there shall be no judicial review of the
list, or revised list, developed by the Secretary under this
subsection.
``(4) Utilization and availability.--
``(A) In general.--Entities that enter into a
contract for procurement of a qualified countermeasure
under section 319F-1 or of a security countermeasure
under section 319F-2, or under section 512 of the
Homeland Security Act of 2002 shall maximize the
utilization of the research tools involved for the
development of countermeasures. In addition, such
entities shall promote the advancement of
bioinformatics through the use of incentives for the
development and procurement of bioinformatics research
tools.
``(B) Rule of construction.--Nothing in this
section or chapter 18 of title 35, United States Code,
shall be construed to restrict the right of an entity
described in subparagraph (A) to--
``(i) secure and enforce patents with
regard to research tools;
``(ii) enter into exclusive, revocable, and
nontransferable licenses of such research
tools; or
``(iii) impose limits on royalty- or
product-reach-through or downstream rights or
agreements on future countermeasures or
products, or option rights with respect to a
research tool.
``(f) Initial List.--Not later than 180 days after the date of
enactment of the Project BioShield II Act of 2005, the Secretary, in
consultation with the Secretary of Defense and the Secretary of
Homeland Security, shall develop, publish in the Federal Register, and
make available to potential manufacturers of terror weapons and
infectious disease countermeasures, except as provided in subsection
(i), a list of biological and chemical agents, toxins, and nuclear and
radiological materials that may be used as weapons of mass destruction
or that are infectious diseases with respect the which the Secretary
finds that research to develop new and improved countermeasures is in
the national interest of the United States. Such initial list may, at
the discretion of the Secretary, contain the following:
``(1) Variola major (confluent, flat, and hemorrhagic
smallpox).
``(2) Bacillus anthracis (anthrax) or near-neighbor
pathogenic Bacillus spp.
``(3) Clostridium botulinum (botulism) or botulism toxins.
``(4) Francisella tularensis (tularemia).
``(5) Yersina pestis (Black Death: bubonic plague,
pneumonic plague).
``(6) Pathogenic Haemophilus spp.
``(7) Ebolavirus spp. (Ebola hemorrhagic fever).
``(8) Marburgvirus spp. (Marburg hemorrhagic fever).
``(9) Arenavirus Lassa Virus (Lassa fever).
``(10) Arenavirus Junin Virus (Argentine hemmorrhagic
fever).
``(11) Nairovirus Crimean-Congo hemorrhagic fever virus
(Crimean-Congo hemmorrhagic fever).
``(12) Coxiella burnetti (Q fever).
``(13) Coccidioidomycosis immitis (Coccidioidomycosis, San
Joaquin Valley, or desert fever).
``(14) Clostridium perfringens (gas gangrene, necrotizing
enteritis).
``(15) Treponema spp.
``(16) Borrelia spp.
``(17) Chlamydia psittaci (parrot fever).
``(18) Phlebovirus Rift Valley fever virus (Rift Valley
fever).
``(19) Rickettsia rickettsii (Rocky Mountain Spotted
Fever).
``(20) Brucella spp. (brucellosis).
``(21) Burkholderia mallei (glanders).
``(22) Alphavirus Venezuelan equine encephalitis virus
(Venezuelan equine encephalomyelitis).
``(23) Alphavirus Eastern equine encephalitis virus
(Eastern equine encephalomyelitis) and Alphavirus Western
equine encephalitis virus (Western equine encephalomyelitis).
``(24) Ricin toxin (castor bean toxin).
``(25) Trichothecene Mycotoxins.
``(26) Dinoflagellate neurotoxin (Paralytic Shellfish
Toxin).
``(27) Aflatoxins.
``(28) Epsilon toxin of clostridium perfringens.
``(29) Staphylococcus enterotoxin B (Staphylococcus
entertoxin B intoxication).
``(30) Methicillin-resistant staphylococcus aureus.
``(31) Influenza.
``(32) Avian influenza.
``(33) Pathogenic Salmonella spp. (gastrointestinal upset,
enteric fever).
``(34) Salmonella Typhi (typhoid fever).
``(35) Shigella dysenteriae (dysentery, hemolytic-uremic
syndrome).
``(36) Escherichia coli 0157:H7 (severe diarrhea,
hemolytic-uremic syndrome) and other Escherichia coli
pathotypes.
``(37) Vibrio species (cholera).
``(38) Toxoplasma gondii.
``(39) Cryptosporidium parvum.
``(40) Henipavirus Nipah virus (Nipa encephalitis).
``(41) Hantavirus spp. (Hantavirus Pulmonary Syndrome).
``(42) Tickborne hemorrhagic fever viruses.
``(43) Tickborne encephalitis virus.
``(44) Flavivirus Yellow Fever virus (Yellow fever, West
Nile virus, Dengue).
``(45) Human Immunodeficiency Virus (HIV), Acquired Immune
Deficiency Syndrome (AIDS)
``(46) Plasmodium falciparum, P. ovale, P. vivax, P.
malariae (Malaria).
``(47) Rickettsia typhi (typhus).
``(48) Antibiotic-resistant Mycobacterium tuberculosis.
``(49) Entamoeba histolytica (amebiasis).
``(50) Pathogenic Shigella spp. (bacillary dysentery,
Shigellosis).
``(51) Giardia lamblia (giardiasis).
``(52) Orthopox virus spp. (monkey pox infection).
``(53) Trypanosoma brucei gambiense or rhodesiense
(trypanosomiasis, sleeping sickness).
``(54) Leishmania donovane (visceral leishmaniasis, black
fever, Kala Azar).
``(55) Schistosoma mansoni, S. haematobium, S. japonicum
(schistosomiasis or bilharzia).
``(56) Necator Americanus and Ancylostoma duodenale
(hookworm).
``(57) Ascaris lumbricoides (roundworm).
``(58) Trichuris trichiura (whipworm).
``(59) Onchocerca volvulus (river blindness).
``(60) Drancunculus medianensis (guinea worm).
``(61) Wuchereria bancrofti and Brugia malayi (lymphatic
filariasis or elephantiasis).
``(62) Mycobacterium ulcerans (Burulu Ulcer).
``(63) Mycobacterium leprea (leprosy).
``(64) Chlamydia trachomitis (Trachoma).
``(65) Pathogenic Streptococcus spp.
``(66) Nerve agents (including Tabun, Sarin, Soman, GF, VX,
V-gas, third generation nerve agents organophosphate pesticides
add carbamate insecticides).
``(67) Blood agents (including hydrogen cyanide and
cyanogen chloride).
``(68) Blister agents (including Lewisite, nitrogen and
sulfur mustards).
``(69) Heavy metals (including arsenic, lead, and mercury).
``(70) Volatile toxins (including benzene, chloroform, and
trihalomethanes).
``(71) Pulmonary agents (including phosgene and chlorine
vinyl chloride).
``(72) Incapacitating agents (including BZ).
``(73) Nuclear and radiological materials.
``(74) Exotic agents including hybrid organisms,
genetically modified organisms, antibiotic-induced toxins,
autoimmune peptides, immune mimicry agents, binary bioweapons,
stealth viruses, and bioregulators and biomodulators.
``(75) Innovative treatments and measures to address
trauma, including excessive bleeding, resulting from an act of
terrorism.
``(76) Any other new and emerging natural infectious
disease threats.
``(g) Revisions.--The Secretary shall revise the list developed
under subsection (f) on at least an annual basis, and make such list
available, under the terms and limitations described in this section,
to potential manufacturers of terror weapons countermeasures,
infectious disease countermeasures, or weapons of mass destruction
countermeasures, or to holders of approved certifications. Such terms
and conditions shall be consistent with the security interests of the
United States.
``(h) No Judicial Review.--Notwithstanding any other provision of
law, there shall be no judicial review of the Secretary's
determinations regarding which agents, toxins, or materials to include
on the list, or revised list, developed under this section or of a
determination to exempt information from public distribution under this
section.
``(i) Exemption.--
``(1) In general.--The Secretary may exempt certain
information concerning weapons of mass destruction from
publication if the Secretary determines that such publication
would be detrimental to the security of the United States. In
providing an exemption under the preceding sentence, the
Secretary shall develop procedures for making such list or
information available on a confidential basis to potential
manufacturers of countermeasures.
``(2) Sufficiency of information.--In developing the
procedures described in paragraph (1), the Secretary shall
ensure that the information provided to potential manufacturers
of countermeasures is sufficient to enable the Federal
Government and the manufacturer to determine when such a
manufacturer has successfully developed a countermeasure and
therefore becomes entitled to the procurement, intellectual
property, and liability provisions of title III of the Project
BioShield II Act of 2005 (and the amendments made by such
title).''.
(b) Detection Technology Incentives.--Section 512 of the Homeland
Security Act of 2002 (as added by section 101), is amended by--
(1) redesignating subsection (b) as subsection (d); and
(2) inserting after subsection (a) the following:
``(b) Detectors Technology Incentives.--
``(1) Identification.--
``(A) In general.--Not later than 180 days after
the date of enactment of the Project BioShield II Act
of 2005, the Secretary shall develop and make available
to potential manufacturers, a list of the infectious
disease, biological, chemical, radiological, or nuclear
agents to be detected as well as the name and seller of
the detection technology furnished to the Government
and whether the Secretary has certified such detection
technology under section 301(b)(4) of the Project
BioShield II Act of 2005. The detection targets shall
include chemical or biological agents or toxins or
nuclear or radiological materials.
``(B) Availability of information.--The Secretary
shall provide such information as the Secretary
determines to be necessary to enable the potential
manufacturers of terror weapons and infectious disease
detection technology to structure and focus their
research and development programs for the development
of such technology.
``(C) Revisions.--The Secretary shall revise the
list developed under subparagraph (A) not less often
than annually, and make such list available to
potential manufacturers of terror weapons and
infectious disease detections equipment under terms and
conditions consistent with the security interests of
the United States.
``(D) No judicial review.--Notwithstanding any
other provision of law, there shall be no judicial
review of the determinations by the Secretary regarding
which agents, toxins, or materials are to be included
on the list, or revised list, developed under this
subsection.
``(E) Consultation.--In developing and revising the
list described under subparagraph (A), the Secretary
shall consult with the Secretary of Health and Human
Services and the Secretary of Defense.
``(F) Exemption.--
``(i) In general.--The Secretary may exempt
certain information concerning weapons of mass
destruction from publication under this
subsection if the Secretary determines that
such publication would be detrimental to the
security of the United States. In providing an
exemption under the preceding sentence, the
Secretary shall develop procedures for making
such list or information available on a
confidential basis to potential manufacturers
of countermeasures.
``(ii) Sufficiency of information.--In
developing the procedures described in clause
(i), the Secretary shall ensure that the
information provided to potential manufacturers
of countermeasures is sufficient to enable the
Federal Government and the manufacturer to
determine when such a manufacturer has
successfully developed a countermeasure and
therefore becomes entitled to the procurement,
intellectual property, and liability provisions
of title III of the Project BioShield II Act of
2005 (and the amendments made by such title).
``(2) Other detection technology incentives.--
``(A) In general.--In furnishing the list to
potential vendors of detection technology, the
Secretary shall promote the advancement of
bioinformatics through the use of incentives for
bioinformatics research tools to develop detection
technology.
``(B) Cooperation.--The Secretary shall cooperate
with the Secretary of the Department of Homeland
Security and in consultation with the appropriate
Advisory Committees, in the course of DHS certification
of detection technology countermeasures, to generate
performance measures or performance standards (such as
`time to result', `sensitivity', or `specificity' with
respect to a target pathogen) for such detection
technology countermeasures.
``(c) Decontamination Technology Incentives.--
``(1) Identification.--
``(A) In general.--Not later than 180 days after
the date of enactment of the Project BioShield II Act
of 2005, the Secretary shall develop and make available
to potential manufacturers, a list of the infectious
disease, biological, chemical, radiological, or nuclear
agents for which decontamination technology is
necessary as well as the name and seller of the
decontamination technology furnished to the Government
and whether the Secretary has certified such
decontamination technology under section 301(b)(4) of
the Project BioShield II Act of 2005. The
decontamination targets shall include chemical or
biological agents or toxins or nuclear or radiological
materials.
``(B) Availability of information.--The Secretary
shall provide such information as the Secretary
determines to be necessary to enable the potential
manufacturers of terror weapons and infectious disease
decontamination technology to structure and focus their
research and development programs for the development
of such technology.
``(C) Revisions.--The Secretary shall revise the
list developed under subparagraph (A) not less often
than annually, and make such list available to
potential manufacturers of terror weapons and
infectious disease decontamination equipment under
terms and conditions consistent with the security
interests of the United States.
``(D) No judicial review.--Notwithstanding any
other provision of law, there shall be no judicial
review of the determinations by the Secretary regarding
which agents, toxins, or materials are to be included
on the list, or revised list, developed under this
subsection.
``(E) Consultation.--In developing and revising the
list described under subparagraph (A), the Secretary
shall consult with the Secretary of Health and Human
Services and the Secretary of Defense.
``(F) Exemption.--
``(i) In general.--The Secretary may exempt
certain information concerning weapons of mass
destruction from publication under this
subsection if the Secretary determines that
such publication would be detrimental to the
security of the United States. In providing an
exemption under the preceding sentence, the
Secretary shall develop procedures for making
such list or information available on a
confidential basis to potential manufacturers
of countermeasures.
``(ii) Sufficiency of information.--In
developing the procedures described in clause
(i), the Secretary shall ensure that the
information provided to potential manufacturers
of countermeasures is sufficient to enable the
Federal Government and the manufacturer to
determine when such a manufacturer has
successfully developed a countermeasure and
therefore becomes entitled to the procurement,
intellectual property, and liability provisions
of title III of the Project BioShield II Act of
2005 (and the amendments made by such
title).''.
(d) Negotiations With Foreign Governments.--The Secretary of
Homeland Security shall enter into negotiations with foreign
governments and organizations to secure coordination and reciprocity
among the applicable regulatory agencies responsible for approving and
licensing countermeasures, including diagnostics, vaccines, and drugs
to prevent, treat, detect, or identify, an infectious disease.
SEC. 203. ANNUAL REPORT.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) (as amended by sections 202, 1401, 1631, 1901, 2101, and 2102)
is amended by inserting after section 319F-8 (as added by section 1631)
the following:
``SEC. 319F-9. ANNUAL REPORT.
``(a) In General.--
``(1) Submission of report.--Not later than January 1,
2006, and each January 1 thereafter, the Secretary shall submit
to the appropriate committees of Congress, and make available
to the public, a report concerning the implementation of
sections 319F-4 through 319F-8 and the amendments made by title
III of the Project BioShield II Act of 2005.
``(2) Content of report.--Reports under paragraph (1) shall
include--
``(A) an assessment of whether the incentives
provided for under sections 319F-4 through 319F-8 and
such amendments are sufficient, as determined by the
Secretary, to induce the biotechnology, pharmaceutical,
device, and research tool industries to modify their
ongoing research priorities and devote management and
scientific talent to researching the development of
priority countermeasures, detections equipment,
diagnostics, research tools, or drugs intended to
directly prevent or treat the pathological and
physiological effects of exposures to biological,
chemical, nuclear, radiological, and other emerging
bioterrorist threats and infectious diseases;
``(B) an assessment of whether such incentives are
sufficient, as determined by the Secretary, to address
the sensitivity of such industries to the possibility
of challenges to their prices and patents and the terms
of sales that may arise when the Federal Government is
an oligopoly or monopoly purchaser;
``(C) an assessment of whether such incentives are
likely to lead to the development of countermeasures
and implementation through the qualified clinical
countermeasures delivery centers to prepare the United
States in the event of the use by terrorists and others
of biological, chemical, nuclear, or radiological
weapons against military or intelligence, Government,
and civilian population of the United States;
``(D) an assessment of whether such incentives will
lead to the development of research tools;
``(E) an assessment of whether such provisions are
achieving the goal of securing the United States from
bioterror attacks and infectious disease outbreaks;
``(F) an assessment of whether the incentivies of
the Project BioShield II Act of 2005 are being abused
by sponsors seeking expanded market protection for non-
countermeasure products based on the development of
countermeasures that are marginally useful or that
require minimal research and development efforts;
``(G) an accounting of the additional healthcare
costs to consumers, healthcare providers, and
government payors due to the application of the
marketing protection incentivies of such Act;
``(H) a description of how such incentives for
private sector research relate to the provision of
public funding for the development of countermeasures;
and
``(I) recommendations to increase or decrease the
effectiveness of such incentives.
``(b) Limitation on Publication.--The Secretary may exempt
information from disclosure to the public under subsection (a) if the
Secretary determines that such publication may be detrimental to the
security of the United States. Such determinations by the Secretary
shall not be subject to judicial review.''.
SEC. 204. USE OF FUNDS; REQUIREMENTS OF MANUFACTURERS.
(a) In General.--The Secretary of Health and Human Services may use
funds appropriated for the Strategic National Stockpile under section
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) or under
any other provision of law for the storage, maintenance, security,
rotation, and transport of any material purchased for such stockpile.
(b) Requirements of Manufacturers.--The Secretary of Health and
Humans Services shall provide to manufacturers, to the extent
practicable, the logistical and operational requirements of
countermeasures prior to their development and acquisition. The
logistical and operational requirements shall consider public health
needs as well as requirements for storage, maintenance, security,
rotation, and transport of any countermeasures purchased under the
authority of the Project BioShield Act of 2004.
TITLE III--AMENDMENTS TO THE PROJECT BIOSHIELD ACT OF 2004 REGARDING
INCENTIVES TO ESTABLISH BIODEFENSE, INFECTIOUS DISEASE, VACCINE, AND
RESEARCH TOOL INDUSTRIES
Subtitle A--Certification of Successful Development
SEC. 301. CERTIFICATION OF SUCCESSFUL DEVELOPMENT.
(a) Definitions.--For purposes of this title, the term
``countermeasure'' has the meaning given that term in section 319F-3 of
the Public Health Service Act (as added by section 101), and the terms
``countermeasure product'', ``eligible patent'' and ``designated
product'' have the meanings given such terms in section 156(a) of title
35, United States Code (as added by section 331).
(b) Certification Requirements.--
(1) In general.--An entity described in paragraph (2) may
submit to the Secretary of Health and Human Services (referred
to in this subtitle as the ``Secretary'') with respect to
agreements for procurement entered into under section 319F-1 or
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a or
247d-6b), or to the Secretary of Homeland Security with respect
to agreements for procurement entered into under section 512 of
the Homeland Security Act of 2002 (as added by section 202), an
application for certification that--
(A) the entity may receive a patent term extension
under the provisions of section 158 of title 35, United
States Code (as added by section 331), and the duration
of any such extension; and
(B) the entity has successfully developed a
countermeasure under an agreement described in
paragraph (2)(C).
(2) Entity described.--An entity described under this
paragraph is an entity that--
(A) operates a private sector establishment;
(B) is engaged in the conduct of research to
develop a countermeasure; and
(C) enters into an agreement for procurement with
the Secretary under the authority provided in section
319F-1 or 319F-2 of the Public Health Service Act (42
U.S.C. 247d-6a or 247d-6b), or with the Secretary of
Homeland Security under section 512 of the Homeland
Security Act of 2002 (as added by section 101).
(3) Successful development of a countermeasure.--For the
purposes of this section, an entity shall be deemed to have
successfully developed a countermeasure if, after the date the
entity enters into an agreement for procurement with the
Secretary under the authority provided in section 319F-1 or
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a or
247d-6b), or with the Secretary of Homeland Security under
section 512 of the Homeland Security Act of 2002 as added by
section 101, either--
(A) the entity has met the requirements specified
in the contract for procurement under section 319F-1 or
319F-2 of the Public Health Service Act (42 U.S.C.
247d-6a or 247d-6b)) or under section 512 of the
Homeland Security Act of 2002; or
(B) the countermeasure has been approved under
sections 505 or 513 of the Federal Food Drug and
Cosmetic Act (21 U.S.C. 355) or section 351 of the
Public Health Service Act; (42 U.S.C. 262), as
appropriate.
(4) Certifications by secretary.--
(A) Certification as to eligibility for special
patent term extension.--
(i) In general.--An entity, prior to the
date it has successfully developed a
countermeasure product, may request that the
Secretary determine if the entity is entitled
to receive an extension of the term of an
eligible patent under section 158 of title 35,
United States Code (as added by section 331),
and the duration of any such extension.
(ii) Factors considered.--The Secretary
shall consider the following factors in making
the determinations specified in clause (i)--
(I) the nature of the terror
threats to be countered and the
importance of developing the
countermeasures in question to respond
to such threat;
(II) the difficulty, risk, and
expense likely to be associated with
the development of such countermeasure;
(III) the existence or non-
existence of practical alternatives to
the countermeasure to be developed;
(IV) whether review of the safety
and effectiveness of the countermeasure
product will require reports from
clinical investigations of the
countermeasure product; and
(V) the impact of the patent
extension on consumers and healthcare
providers.
(iii) Limitation.--The Secretary may
determine that an extension under this section
is available only if the countermeasure product
involved--
(I) contains an active ingredient
(including any ester or salt of the
active ingredient) which has not been
approved in another application under
section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(b)); and
(II) is superior to a previously
available drug, antibiotic drug,
biological product, device, detection
technology, or research tool.
(iv) Limitation on extensions.--Any
extension authorized by the Secretary shall not
exceed 2 years, and shall not be less than 6
months, in duration.
(v) Written determination.--The Secretary
shall provide an entity that requests a
determination under clause (i) with a written
determination on the eligibility of that entity
for a patent term extension under section 158
of title 35, United States Code (as added by
section 331), and the duration of any such
extension.
(vi) Effect of section.--The Secretary
shall promulgate regulations to give effect to
this section.
(B) Written notice of entity developing
countermeasure.--
(i) In general.--Not later than 180 days
after entering a contract with the Secretary of
Health and Human Services under section 319F-1
or 319F-2 of the Public Health Service Act (42
U.S.C. 247d-6a or 247d-6b) or with the
Secretary of Homeland Security under section
512 of the Homeland Security Act of 2002 (as
added by section 101) for the procurement of a
countermeasure for which the Secretary of
Health and Human Services or the Secretary of
Homeland Security, as appropriate, has
determined that a patent extension is available
under section 158 of title 35, United States
Code (as added by section 331), the entity that
enters such contract shall notify such
appropriate Secretary of the patent that would
be extended if such entity received a
certification under section 301(b)(4)(A).
(ii) Publication of information.--The
Secretary of Health and Human Services, with
respect to a contract under such section 319F-1
or 319F-2 of the Public Health Service Act, or
the Secretary of Homeland Security, with
respect to a contract under such section 512 of
the Homeland Security Act of 2002, shall
publish in the Federal Register the information
provided in a notification received under
clause (i).
(iii) Irrevocable election.--An submission
of a notification by an entity under clause (i)
shall constitute an irrevocable election of the
patent extended under section 158 of title 35,
United States Code, except that such entity may
elect to restore the term of the eligible
patent under section 156a of title 35, United
States Code, instead of extending the term of
the patent under such section 158 on the basis
of the successful development of the
countermeasure.
(C) Certification as to successful development.--
With respect to an application for certification
submitted by an entity in accordance with the terms of
the agreement for procurement described under paragraph
(2)(C), the Secretary or the Secretary of Homeland
Security, as appropriate, shall--
(i) determine if the entity has
successfully developed the countermeasure
involved;
(ii) provide the notice required under
subparagraph (B);
(iii) approve or deny the application for
certification; and
(iv) notify such entity of and publish such
approval or denial, and the reasons therefore.
(D) Effects of certification.--If the Secretary or
Secretary of Homeland Security certifies the
application of an entity under paragraph (3)(A), such
entity--
(i) shall receive payment under the
contract described in paragraph (2)(C);
(ii) may utilize the patent restoration and
extension protection under section 156a and 158
of title 35, United States Code (as added by
section 331);
(iii) may utilize the marketing exclusivity
provisions of section 505(c)(3)(E) and
505(j)(5)(F) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(c)(3)(E) and 21
U.S.C. 355(j)(5)(E)); and
(iv) may utilize the liability protections
described under this title (and the amendments
made by this title).
(c) Rule of Construction.--Nothing in this section shall be
construed to restrict the authority of the Secretary (with respect to
procurement agreements under section 319F-1 or 319F-2 of the Public
Health Service Act (42 U.S.C. 247d-6a or 247d-6b)) or the Secretary of
Homeland Security (with respect to procurement agreements under section
512 of the Homeland Security Act of 2002 (as added by section 101) to
permit an entity to utilize the liability protections described under
this title (and the amendments made by this title) or to receive
payment under the agreement described in subsection (b)(2)(C) prior to
the approval of the application for certification submitted by the
entity pursuant to the terms of such agreement.
(d) Judicial Review.--A determination by the Secretary or the
Secretary of Homeland Security, as appropriate, under subsection (b)
shall constitute final agency action subject to judicial review. A
prevailing plaintiff in an action challenging an adverse determination
by the Secretary or Secretary of Homeland Security under such
subsection may be awarded reasonable attorneys fees under section 2412
of title 28, United States Code.
Subtitle B--Federal Tax Incentives
SEC. 311. GENERAL PROVISIONS.
(a) In General.--Any entity which enters into a contract for
procurement with the Secretary under the authority provided in section
319F-1 or 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a or
247d-6b) or under section 512 of the Homeland Security Act of 2002 (as
added by section 101) may irrevocably elect 1 of the following Federal
tax incentives to fund research with respect to each contract to
develop countermeasures (as that term is defined in section 319F-3 of
the Public Health Service Act (as added by section 202)):
(1) Research and development limited partnerships to fund
countermeasure research.--The entity may establish a limited
partnership for the countermeasures, but only if such entity is
a qualified small business as determined under section 1202(d)
of the Internal Revenue Code of 1986, by substituting
``$750,000,000'' for ``$50,000,000'' each place it appears. For
purposes of the Internal Revenue Code of 1986, section 469 of
such Code shall not apply with respect to a limited partnership
established under this paragraph.
(2) Capital gains exclusion for investors to fund
countermeasure research.--The entity may issue a class of stock
for the countermeasures under section 1202 of the Internal
Revenue Code of 1986 with the following modifications:
(A) Increased exclusion for noncorporate
taxpayers.--Subsection (a) of section 1202 of such Code
shall be applied by substituting ``100 percent'' for
``50 percent''.
(B) Application to corporate taxpayers.--Subsection
(a) of section 1202 of such Code shall be applied
without regard to the phrase ``other than a
corporation''.
(C) Stock of larger businesses eligible for
exclusion.--Paragraph (1) of section 1202(d) of such
Code (defining qualified small business) shall be
applied by substituting ``$750,000,000'' for
``$50,000,000'' each place it appears.
(D) Reduction in holding period.--Subsection (a) of
section 1202 of such Code shall be applied by
substituting ``3 years'' for ``5 years''.
(E) Nonapplication of per-issuer limitation.--
Section 1202 of such Code shall be applied without
regard to subsection (b) (relating to per-issuer
limitations on taxpayer's eligible gain).
(F) Modification of working capital limitation.--
Section 1202(e)(6) of such Code shall be applied--
(i) in subparagraph (B), by substituting
``5 years'' for ``2 years'', and
(ii) without regard to the last sentence.
(G) Nonapplication of minimum tax preference.--
Section 57(a) of such Code shall be applied without
regard to paragraph (7).
(3) Tax credits to fund countermeasure research.--The
entity may be eligible for the tax credits provided for in
section 312.
(b) Reporting; Recapture.--
(1) Reporting.--Each entity described in subsection (a)
shall submit to the Secretary and the Secretary of the Treasury
such information regarding its election of any tax incentive
under this section with respect to any contract described in
subsection (a) as the Director of the National Institutes of
Health and the Secretary of Health and Human Services determine
necessary to carry out the enforcement provisions prescribed
under paragraph (2).
(2) Recapture.--The Secretary of the Treasury, in
consultation with the Director of the National Institutes of
Health and the Secretary of Health and Human Services, shall
provide for the recapture of any tax benefits resulting from
any elected tax incentive under this section if the resulting
research is for a purpose other than that specified in such
contract.
(c) Effective Date.--The provisions of this section shall apply to
taxable years beginning after December 31, 2004.
SEC. 312. TAX CREDITS.
(a) Amendments to the Internal Revenue Code.--
(1) Tax credit to fund countermeasure research.--
(A) In general.--Subpart D of part IV of subchapter
A of chapter 1 of the Internal Revenue Code of 1986
(relating to business-related credits) is amended by
adding at the end the following new section:
``SEC. 45J. CREDIT FOR MEDICAL RESEARCH RELATED TO DEVELOPING
COUNTERMEASURES.
``(a) General Rule.--For purposes of section 38, in the case of any
entity described in section 311(a) of the Project BioShield II Act of
2005 which makes an election under such section to apply this section,
the countermeasures research credit determined under this section for
the taxable year is an amount equal to 35 percent of the eligible
countermeasures research expenses for the taxable year.
``(b) Eligible Countermeasures Research Expenses.--For purposes of
this section--
``(1) Eligible countermeasures research expenses.--
``(A) In general.--Except as otherwise provided in
this paragraph, the term `eligible countermeasures
research expenses' means the amounts which are paid or
incurred by the taxpayer during the taxable year with
respect to any contract described in section 311(a) of
the Project BioShield II Act of 2005 which would be
described in subsection (b) of section 41 if such
subsection were applied with the modifications set
forth in subparagraph (B).
``(B) Modifications; increased incentive for
contract research payments.--For purposes of
subparagraph (A), subsection (b) of section 41 shall be
applied--
``(i) by substituting `eligible
countermeasures research' for `qualified
research' each place it appears in paragraphs
(2) and (3) of such subsection, and
``(ii) by substituting `100 percent' for
`65 percent' in paragraph (3)(A) of such
subsection.
``(C) Exclusion for amounts funded by grants,
etc.--The term `eligible countermeasures research
expenses' shall not include any amount to the extent
such amount is funded by any grant, contract, or
otherwise by another person (or any governmental
entity).
``(2) Countermeasures research.--The term `countermeasures
research' means research conducted by an entity with respect to
the development of countermeasures (as defined in section 319F-
3 of the Public Health Service Act).
``(c) Coordination With Credit for Increasing Research
Expenditures.--
``(1) In general.--Except as provided in paragraph (2), any
eligible countermeasures research expenses for a taxable year
to which an election under this section applies shall not be
taken into account for purposes of determining the credit
allowable under section 41 for such taxable year.
``(2) Expenses included in determining base period research
expenses.--Any eligible countermeasures research expenses for
any taxable year which are qualified research expenses (within
the meaning of section 41(b)) shall be taken into account in
determining base period research expenses for purposes of
applying section 41 to subsequent taxable years.
``(d) Coordination With Credit for Clinical Testing Expenses for
Certain Drugs for Rare Diseases.--Any eligible countermeasures research
expense for a taxable year shall not be taken into account for purposes
of determining the credit allowable under section 45C for such taxable
year.
``(e) Special Rules.--
``(1) Pre-clinical research.--No credit shall be allowed
under this section for pre-clinical research unless such
research is pursuant to a research plan an abstract of which
has been filed with the Food and Drug Administration before the
beginning of such year. This paragraph shall be waived for any
research that is pursuant to a research plan or abstract that
has been filed with the Food and Drug Administration not later
than 270 days after the date of enactment of this section. The
Secretary of Health and Human Services shall prescribe
regulations specifying the requirements for such plans and
procedures for filing under this paragraph.
``(2) Certain rules made applicable.--Rules similar to the
rules of paragraphs (1) and (2) of section 41(f) shall apply
for purposes of this section.''.
(B) Inclusion in general business credit.--Section
38(b) of such Code is amended by striking ``plus'' at
the end of paragraph (18), by striking the period at
the end of paragraph (19) and inserting ``, plus'', and
by adding at the end the following new paragraph:
``(20) the countermeasures research credit determined under
section 45J.''.
(C) Denial of double benefit.--Section 280C of such
Code is amended by adding at the end the following new
subsection:
``(e) Credit for Eligible Countermeasures Research Expenses.--
``(1) In general.--No deduction shall be allowed for that
portion of the eligible countermeasures research expenses (as
defined in section 45J(b)) otherwise allowable as a deduction
for the taxable year which is equal to the amount of the credit
determined for such taxable year under section 45J(a).
``(2) Certain rules to apply.--Rules similar to the rules
of paragraphs (2), (3), and (4) of subsection (c) shall apply
for purposes of this subsection.''.
(D) Deduction for unused portion of credit.--
Section 196(c) of such Code (defining qualified
business credits) is amended by striking ``and'' at the
end of paragraph (11), by striking the period at the
end of paragraph (12) and inserting ``, and'', and by
adding at the end the following new paragraph:
``(13) the countermeasures research credit determined under
section 45J(a) (other than such credit determined under the
rules of section 280C(e)(2)).''.
(E) Technical amendment.--The table of sections for
subpart D of part IV of subchapter A of chapter 1 of
such Code is amended by adding at the end the following
new item:
``Sec. 45J. Credit for medical research
related to developing
countermeasures.''.
(2) Tax credit to fund countermeasure research at certain
qualified non-profit and academic institutions including
teaching hospitals.--
(A) In general.--Subpart D of part IV of subchapter
A of chapter 1 of the Internal Revenue Code of 1986
(relating to business related credits) is amended by
inserting after section 41 the following:
``SEC. 41A. CREDIT FOR COUNTERMEASURES RESEARCH EXPENSES.
``(a) General Rule.--For purposes of section 38, in the case of any
entity described in section 311(a) of the Project BioShield II Act of
2005 which makes an election under such section to apply this section,
the countermeasures research credit determined under this section for
the taxable year shall be an amount equal to 35 percent of the excess
(if any) of--
``(1) the eligible countermeasures research expenses for
the taxable year, over
``(2) the countermeasures base period amount.
``(b) Eligible Countermeasures Research Expenses.--For purposes of
this section--
``(1) In general.--The term `eligible countermeasures
research expenses' means the amounts which are paid or incurred
by the taxpayer during the taxable year directly or indirectly
to any qualified nonprofit or academic institution for
countermeasures research activities with respect to any
contract described in section 311(a) of the Project BioShield
II Act of 2005.
``(2) Countermeasures research activities.--
``(A) In general.--The term `countermeasures
research activities' means research conducted by an
entity with respect to the development of
countermeasures (as defined in section 319F-3 of the
Public Health Service Act), conducted at any qualified
nonprofit or academic institution in the development of
any product, which occurs before--
``(i) the date on which an application with
respect to such product is approved under
section 505(b), 506, or 507 of the Federal
Food, Drug, and Cosmetic Act,
``(ii) the date on which a license for such
product is issued under section 351 of the
Public Health Service Act, or
``(iii) the date classification or approval
of such product which is a device intended for
human use is given under section 513, 514, or
515 of the Federal Food, Drug, and Cosmetic
Act.
``(B) Product.--The term `product' means any drug,
biologic, medical device, or research tool.
``(3) Qualified nonprofit or academic institution.--The
term `qualified nonprofit or academic institution' means any of
the following institutions:
``(A) Educational institution.--A qualified
organization described in section 170(b)(1)(A)(iii)
which is owned or affiliated with an institution of
higher education as described in section 3304(f).
``(B) Teaching hospital.--A teaching hospital
which--
``(i) is publicly supported or owned by an
organization described in section 501(c)(3),
and
``(ii) is affiliated with an organization
meeting the requirements of subparagraph (A).
``(C) Foundation.--A medical research organization
described in section 501(c)(3) (other than a private
foundation) which is affiliated with, or owned by--
``(i) an organization meeting the
requirements of subparagraph (A), or
``(ii) a teaching hospital meeting the
requirements of subparagraph (B).
``(D) Charitable research hospital.--A hospital
that is designated as a cancer center by the National
Cancer Institute.
``(E) Other institutions.--A qualified organization
(as defined in section 41(e)(6)).
``(4) Exclusion for amounts funded by grants, etc.--The
term `eligible countermeasures research expenses' shall not
include any amount to the extent such amount is funded by any
grant, contract, or otherwise by another person (or any
governmental entity).
``(c) Countermeasures Research Base Period Amount.--For purposes of
this section, the term `countermeasures research base period amount'
means the average annual eligible countermeasures research expenses
paid by the taxpayer during the 3-taxable year period ending with the
taxable year immediately preceding the first taxable year of the
taxpayer beginning after December 31, 2004.
``(d) Special Rules.--
``(1) Certain rules made applicable.--Rules similar to the
rules of subsections (f) and (g) of section 41 shall apply for
purposes of this section.
``(2) Coordination with credit for increasing research
expenditures and with credit for clinical testing expenses for
certain drugs for rare diseases.--Any eligible countermeasures
research expense for a taxable year shall not be taken into
account for purposes of determining the credit allowable under
section 41 or 45C for such taxable year.
``(3) Eligible countermeasures research expenses not
treated as unrelated business taxable income.--For purposes of
section 511, eligible countermeasures research expenses paid or
incurred by the taxpayer directly or indirectly to any
qualified non-profit or academic institution shall not be
considered unrelated business taxable income of such
institution.''.
(B) Credit to be part of general business credit.--
Section 38(b) of such Code (relating to current year
business credits), as amended by this section, is
amended by striking ``plus'' at the end of paragraph
(19), by striking the period at the end of paragraph
(20) and inserting ``, plus'', and by adding at the end
the following:
``(21) the countermeasures research credit determined under
section 41A(a).''.
(C) Denial of double benefit.--Section 280C of such
Code, as amended by this section, is amended by adding
at the end the following new subsection:
``(f) Credit for Countermeasures Research Expenses.--
``(1) In general.--No deduction shall be allowed for that
portion of the eligible countermeasures research expenses (as
defined in section 41A(b)) otherwise allowable as a deduction
for the taxable year which is equal to the amount of the credit
determined for such taxable year under section 41A(a).
``(2) Certain rules to apply.--Rules similar to the rules
of paragraphs (2), (3), and (4) of subsection (c) shall apply
for purposes of this subsection.''.
(D) Deduction for unused portion of credit.--
Section 196(c) of such Code (defining qualified
business credits), as amended by this section, is
amended by striking ``and'' at the end of paragraph
(12), by striking the period at the end of paragraph
(13) and inserting ``, and'', and by adding at the end
the following new paragraph:
``(14) the countermeasures research expenses credit
determined under section 41A(a) (other than such credit
determined under the rules of section 280C(f)(2)),''.
(E) Clerical amendment.--The table of sections for
subpart D of part IV of subchapter A of chapter 1 of
such Code is amended by adding after the item relating
to section 41 the following:
``Sec. 41A. Credit for countermeasures
research expenses.''.
(3) Countermeasures equity tax credit.--
(A) In general.--Subpart D of part IV of subchapter
A of chapter 1 of the Internal Revenue Code of 1986
(relating to business-related credits), as amended by
this section, is amended by adding at the end the
following new section:
``SEC. 45K. COUNTERMEASURES EQUITY TAX CREDIT.
``(a) Allowance of Credit.--
``(1) General rule.--For purposes of section 38, in the
case of a taxpayer who holds a qualified countermeasures equity
investment on a credit allowance date of such investment which
occurs during the taxable year, the countermeasures equity tax
credit determined under this section for such taxable year is
an amount equal to the applicable percentage of the amount paid
to the qualified countermeasures company solely in exchange for
its stock at original issue.
``(2) Applicable percentage.--For purposes of paragraph
(1), the applicable percentage is 40 percent.
``(3) Credit allowance date.--For purposes of paragraph
(1), the term `credit allowance date' means, with respect to
any qualified countermeasures equity investment--
``(A) the date on which such investment is
initially made, and
``(B) each of the 3 anniversary dates of such date
thereafter.
``(b) Qualified Countermeasures Equity Investment.--For purposes of
this section--
``(1) In general.--The term `qualified countermeasures
equity investment' means any equity investment in a qualified
countermeasures company if--
``(A) such investment is acquired by the taxpayer
at its original issue (directly or through an
underwriter) solely in exchange for cash,
``(B) not less than \1/2\ of such cash is used by
the qualified countermeasures company with respect to
any contract described in section 311(a) of the Project
BioShield II Act of 2005 or efforts reasonably leading
to such contract (such as generation of preliminary
data or prototype development), and
``(C) such investment is designated for purposes of
this section by the qualified countermeasures company.
Such term shall not include any equity investment issued by a
qualified countermeasures company more than 5 years after the
date that such company receives an allocation under subsection
(d). Any allocation not used within such 5-year period may be
reallocated by the Secretary under subsection (d).
``(2) Limitation.--The maximum amount of equity investments
issued by a qualified countermeasures company which may be
designated under paragraph (1)(C) by such company shall not
exceed the portion of the limitation amount allocated under
subsection (f) to such company.
``(3) Treatment of subsequent purchasers.--The term
`qualified equity investment' includes any equity investment
which would (but for paragraph (1)(A)) be a qualified equity
investment in the hands of the taxpayer if such investment was
a qualified equity investment in the hands of a prior holder.
``(4) Redemptions.--A rule similar to the rule of section
1202(c)(3) shall apply for purposes of this subsection.
``(5) Equity investment.--The term `equity investment'
means any stock (other than nonqualified preferred stock as
defined in section 351(g)(2)) in an entity which is a
corporation.
``(c) Qualified Countermeasures Company.--For purposes of this
section the term `qualified countermeasures company' means any domestic
corporation subject to tax under subchapter C of this chapter if such
company has entered into a procurement contract with the Secretary of
Health and Human Services under section 319F-1 or 319F-2 of the Public
Health Service Act (42 U.S.C. 247d-6a or 247d-6b) or with the Secretary
of Homeland Security under section 512 of the Homeland Security Act of
2002.
``(d) National Limitation on Amount of Investments Designated.--
``(1) In general.--There is a qualified countermeasures
equity tax credit limitation for each calendar year. Such
limitation is $100,000,000 for each calendar year 2005 through
2009.
``(2) Allocation of limitation.--The limitation under
paragraph (1) shall be allocated by the Secretary among
qualified countermeasures companies selected by the Secretary.
In making allocations under the preceding sentence, the
Secretary shall give priority to the extent to which it is
reasonably anticipated that a qualified countermeasures company
would have insufficient taxable income and tax liability to
utilize research tax credits and other tax incentives provided
by sections 311 and 312 of the Project BioShield II Act of
2005.
``(3) Carryover of unused limitation.--If the qualified
countermeasures equity tax credit limitation for any calendar
year exceeds the aggregate amount allocated under paragraph (2)
for such year, such limitation for the succeeding calendar year
shall be increased by the amount of such excess. No amount may
be carried under the preceding sentence to any calendar year
after 2014.
``(e) Recapture of Credit in Certain Cases.--
``(1) In general.--If, at any time during the 4-year period
beginning on the date of the original issue of a qualified
countermeasures equity investment in a qualified
countermeasures company, there is a recapture event with
respect to such investment, then the tax imposed by this
chapter for the taxable year in which such event occurs shall
be increased by the credit recapture amount.
``(2) Credit recapture amount.--For purposes of paragraph
(1), the credit recapture amount is an amount equal to the sum
of--
``(A) the aggregate decrease in the credits allowed
to the taxpayer under section 38 for all prior taxable
years which would have resulted if no credit had been
determined under this section with respect to such
investment, plus
``(B) interest at the underpayment rate established
under section 6621 on the amount determined under
subparagraph (A) for each prior taxable year for the
period beginning on the due date for filing the return
for the prior taxable year involved.
No deduction shall be allowed under this chapter for interest
described in subparagraph (B).
``(3) Recapture event.--For purposes of paragraph (1),
there is a recapture event with respect to a qualified
countermeasures equity investment in a qualified
countermeasures company if--
``(A) such company ceases to be a qualified
countermeasures company, or
``(B) such investment is redeemed by such company.
``(4) Special rules.--
``(A) Tax benefit rule.--The tax for the taxable
year shall be increased under paragraph (1) only with
respect to credits allowed by reason of this section
which were used to reduce tax liability. In the case of
credits not so used to reduce tax liability, the
carryforwards and carrybacks under section 39 shall be
appropriately adjusted.
``(B) No credits against tax.--Any increase in tax
under this subsection shall not be treated as a tax
imposed by this chapter for purposes of determining the
amount of any credit under this chapter or for purposes
of section 55.
``(f) Basis Reduction.--The basis of any qualified countermeasures
equity investment shall be reduced by the amount of any credit
determined under this section with respect to such investment. This
subsection shall not apply for purposes of sections 1202, 1400B, and
1400F.
``(g) Regulations.--The Secretary shall prescribe such regulations
as may be appropriate to carry out this section, including regulations
which--
``(1) prevent the abuse of the purposes of this section,
``(2) impose appropriate reporting requirements, and
``(3) apply the provisions of this section to newly formed
entities.''.
(B) Credit to be part of general business credit.--
Section 38(b) of such Code (relating to current year
business credits), as amended by this section, is
amended by striking ``plus'' at the end of paragraph
(20), by striking the period at the end of paragraph
(21) and inserting ``, plus'', and by adding at the end
the following:
``(22) the countermeasures equity investment credit
determined under section 45K(a).''.
(C) Deduction for unused portion of credit.--
Section 196(c) of such Code (defining qualified
business credits), as amended by this section, is
amended by striking ``and'' at the end of paragraph
(13), by striking the period at the end of paragraph
(14) and inserting ``, and'', and by adding at the end
the following new paragraph:
``(15) the countermeasures equity investment credit
determined under section 45K(a),''.
(D) Clerical amendment.--The table of sections for
subpart D of part IV of subchapter A of chapter 1 of
such Code is amended by adding after the item relating
to section 41 the following:
``Sec. 45K. Countermeasures equity tax
credit.''.
(b) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2004.
Subtitle C--Patent Protections
SEC. 331. PATENT TERM RESTORATION AND EXTENSION AND EXCLUSIVE
MARKETING.
(a) Limitation.--A private entity may utilize the patent term
restoration and extension and exclusive marketing provisions described
in this subtitle if such private entity--
(1) is an entity described under section 301(b)(2);
(2) has had an application for certification approved by
the Secretary of Health and Human Services or the Secretary of
Homeland Security, as appropriate, under section 301(b)(4)(C);
and
(3)(A) has received approval of the countermeasure by the
Food and Drug Administration; or
(B) section 319F-2(e) applies.
(b) Restoration of Patent Terms Relating to Countermeasures.--
(1) In general.--Chapter 14 of title 35, United States
Code, is amended by inserting after section 156 the following:
``Sec. 156a. Restoration of patent terms relating to countermeasure
products
``(a) Definitions.--In this section, the term--
``(1) `countermeasure product' means a countermeasure, as
that term is defined in section 319F-3(a)(2) of the Public
Health Service Act, that is a--
``(A) new drug, antibiotic drug, or device, as
those terms are defined in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321); or
``(B) biological product, as such term is defined
in section 351 of the Public Health Service Act (42
U.S.C. 262);
``(2) `regulatory review period' means the period of time
that--
``(A) starts on the date that is the later of--
``(i) the date that an eligible patent
sought to be extended under this section is
filed;
``(ii) if the countermeasure product is a
drug, antibiotic drug, or biological product,
the date that an exemption under section 505(i)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)) became effective for the
product; or
``(iii) if the countermeasure product is a
device, the date that an investigational device
exception is approved under section 520(g) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j(g)) became effective for the
product; and
``(B) ends on the date that is--
``(i) in the case of a drug or antibiotic
drug, the date on which an application
submitted for the drug or antibiotic drug under
section 505(b)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b)(1)) is
approved;
``(ii) in the case of a biological product,
the date on which an application submitted for
the biological product under section 351 of the
Public Health Service Act (42 U.S.C. 262) is
approved;
``(iii) in the case of a device, the date
on which an application submitted for the
device under section 513 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c) is
approved; or
``(iv) if an application is submitted under
subsection (c)(3) prior to any of the dates
specified in clauses (i) through (iii), the
date that the countermeasure product became
eligible for purchase under a contract for
procurement under section 319F-1 or 319F-2 of
the Public Health Service Act (42 U.S.C. 247d-
6a or 247d-6b)) or under section 512 of the
Homeland Security Act of 2002;
``(3) `eligible patent' means a patent that--
``(A) claims a countermeasure product that has been
successfully developed as specified in section
301(b)(3) of the Research Act, or an active ingredient
of such product, or a process of making or method of
using such product or the active ingredient of such
product for the countermeasure use that has been
approved by the Food and Drug Administration; and
``(B) is owned by, or licensed to, an entity that
has been certified as having successfully developed the
countermeasure section 301(b)(4)(C) of the Research
Act; and
``(4) `Research Act' means the Project BioShield II Act of
2005.
``(b) Patent Term Restoration.--The term of an eligible patent
shall be restored by a period equal to the number of days in the
regulatory review period if, with respect to the patent that is the
basis of the application--
``(1) an application under subsection (c) is submitted to
the Director by either the owner of record of the patent, or
its agent, on or before the later of--
``(A) the date specified in subsection (c)(3); or
``(B) 45 days after the date of issuance of the
patent;
``(2) the patent has not been previously restored under
this section, or extended under section 156 or 158;
``(3) the term of the patent has not expired before the
date that the application is submitted to the Director; and
``(4) the regulatory review period for the countermeasure
product--
``(A) has not been relied upon to support an
application to extend the term of another patent under
this section or under section 156; and
``(B) did not commence before the date of enactment
of the Research Act.
``(c) Administrative Provisions.--
``(1) In general.--To obtain a restoration of the term of a
patent under this section, the owner of record of the patent or
the agent of the owner shall submit an application to the
Director.
``(2) Content.--The application shall contain--
``(A) a description of the approved countermeasure
product and the Federal statute under which regulatory
review occurred;
``(B) the identity of the patent for which a
restoration is sought; and
``(C) such other information as the Director may
require.
``(3) Submission of application.--An application under this
section shall be submitted to the Director not later than 60
days after the last of the following dates:
``(A) The date that the product became eligible for
purchase under a contract for procurement under section
319F-1 or 319F-2 of the Public Health Service Act (42
U.S.C. 247d-6a or 247d-6b)) or under section 512 of the
Homeland Security Act of 2002.
``(B) The date that an application under section
505 of the Federal Food Drug and Cosmetic Act was
approved for the drug or antibiotic drug.
``(C) The date that an application under section
351 of the Public Health Service Act was approved for
the biological product.
``(D) The date that an application under section
513 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360c) was approved for the device.
``(4) Publication of applications by the secretary.--
Immediately under receipt of an application for patent
restoration under this subsection, the Director shall publish
the application and provide a reasonable period of time for
interested parties to submit comments with respect to the
application.
``(5) Irrevocable election.--The submission of an
application under this section is an irrevocable election of
the application of this section to the patent that is the basis
of the application. A patent that has been the basis of an
application made under this section may not be the subject of
an application made under section 156 or 158.
``(d) Limitations.--A patent that is the subject of an application
filed under subsection (c) may not be restored under this section if--
``(1) the regulatory review period for the countermeasure
product was commenced before the date of enactment of the
Research Act;
``(2) the patent that is the basis of the application under
this section expired before the date of enactment of the
Research Act; or
``(3) a patent which has been extended under section 156 of
this title prior to the date of enactment of the Research Act
claims the countermeasure product, an active ingredient of the
countermeasure product, a method of using the countermeasure
product, a method of using an active ingredient of the
countermeasure product, or making the countermeasure.''.
(2) Technical and conforming amendment.--The table of
sections for chapter 14 of title 35, United States Code, is
amended by inserting after the item relating to section 156 the
following:
``156a. Restoration of patent terms relating to countermeasure
products.''.
(c) Extension of Patent Terms Relating to Countermeasure
Products.--
(1) In general.--Chapter 14 of title 35, United States
Code, is amended by adding at the end the following:
``Sec. 158. Extension of patent terms relating to countermeasure
products
``(a) Definitions.--In this section, the term--
``(1) `countermeasure product' means a countermeasure, as
that term is defined in 319F-3(a)(2) of the Public Health
Service Act, that is a--
``(A) new drug or antibiotic drug, as those terms
are defined in section 201 in the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321), containing an active
ingredient (including any ester or salt of the active
ingredient) which has not been approved in another
application under section 505(b) of that Act (21 U.S.C.
355(b));
``(B) device, as that term is defined in section
201 in the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321); or
``(C) biological product, as that term is defined
in section 351 of the Public Health Service Act (42
U.S.C. 262);
``(2) `designated product' means a drug, antibiotic drug,
or device, as those terms are defined in section 201 of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 321), or a
biological product, as that term is defined in section 351 of
the Public Health Service Act;
``(3) `eligible patent' means a patent that at the time the
eligible entity entered into the contract to develop such
countermeasure product, was owned by or licensed to that
eligible entity, and claims a designated product, an active
ingredient of a designated product, a method of making or using
a designated product or a method of making or using an active
ingredient of a designated product;
``(4) `eligible entity' means a natural or legal person
that has--
``(A) successfully developed a countermeasure
product;
``(B) been certified as being eligible to receive a
patent term extension under this section by section
301(b)(4)(A)(i) of the Research Act;
``(C) been certified as having successfully
developed a countermeasure under section 301(b)(4)(C)
of the Research Act; and
``(D) entered into a contract for the sale of the
countermeasure product under section 319F-1 or 319F-2
of the Public Health Service Act (42 U.S.C. 247d-6a or
247d-6b) or section 512 of the Homeland Security Act of
2002; and
``(5) `Research Act' means the Project BioShield II Act of
2005.
``(b) Patent Term Extension.--The term of an eligible patent shall
be extended for the period determined by the Secretary of Health and
Human Services in a certification under section 301(b)(4)(A)(i) of the
Research Act, in addition to the term which would otherwise apply
except for this section, if--
``(1) an application under subsection (c) is submitted to
the Director by either the owner of record of the patent or its
agent on or before the date specified in subsection (c)(3);
``(2) the patent has not been previously extended under
this section, or under section 156 or 156a;
``(3) the applicant has provided written notice and the
Secretary has published such information as required under
section 301(b)(4)(B) of the Project BioShield II Act of 2005;
``(4) the patent has not expired before the date that the
application is submitted;
``(5) the term of no other patent has been extended based
on the certification being relied upon by the eligible entity
to request extension of the patent; and
``(6) no other patent that claims the designated product,
an active ingredient of the designated product, a method of
making or using a designated product or a method of making or
using an active ingredient of a designated product has been
extended under this section or under section 156a.
``(c) Administrative Provisions.--
``(1) In general.--To obtain an extension of the term of a
patent under this section, the owner of record of the patent or
the agent of the owner shall submit an application to the
Director.
``(2) Content.--An application filed under this section
shall contain--
``(A) a description of the approved countermeasure
product and the Federal statute under which regulatory
review occurred;
``(B) the identity of the eligible patent for which
an extension is sought under this section;
``(C) the identity of the eligible entity and the
applicant (if different from the eligible entity);
``(D) the identity of the designated product to
which the eligible patent relates;
``(E) information concerning the certification
specified in section 301(b)(4)(A)(i) of the Research
Act being relied upon as the basis of the extension
being requested;
``(F) information indicating that the entity owned
or licensed the eligible patent at the time it entered
into the contract to develop the countermeaure product;
and
``(G) such other information as the Director may
require including to establish that the applicant meets
the requirements of this section.
``(3) Submission of application.--An application under this
section shall be submitted to the Director within 60 days after
the date of the certification specified in section 301(b)(4)(C)
of the Research Act that is being relied upon to request
extension of the patent that is the subject of the application.
``(d) Irrevocable Election.--The submission of an application under
this section is an irrevocable election of the application of this
section to the patent that is the basis of the application. A patent
that has been the basis of an application made under this section may
not be the subject of an application made under sections 156 or
156a.''.
(2) Technical and conforming amendment.--The table of
sections for chapter 14 of title 35, United States Code, is
amended by adding at the end the following:
``158. Extension of patent terms relating to countermeasure
products.''.
(d) Discretionary Waiver of March-In Rights and Exclusive
Licensing.--
(1) Discretion to waive march-in rights.--
(A) In general.--The owner of a patent over which
the Government has rights under chapter 18 of title 35,
United States Code, may request that a Federal agency
under whose funding a subject invention was made may
waive rights the Government has under sections 200,
203, and 209 of title 35, United States Code, if--
(i) such entity holds a certification under
section 301(b)(4)(C) of the Research Act; and
(ii) the subject invention is related to or
will be used to discover, evaluate, produce,
manufacture or use the countermeasure,
detection equipment, diagnostic, research tool,
drug, antibiotic drug, biological product or a
device that is the subject of the
certification.
(B) Requests.--If a request under subparagraph (A)
is made within 90 days after the date of the
certification under section 301(b)(4)(C) of the
Research Act or the date that the entity obtained title
to the patent, the Federal agency shall grant the
request.
(2) Federally owned inventions.--Section 209 of title 35,
United States Code, is amended--
(A) by redesignating subsections (e) and (f) as
subsections (f) and (g), respectively; and
(B) by inserting after subsection (d) the
following:
``(e) Terms and Conditions of Exclusive License.--Each exclusive
license granted under section 207(a)(2) shall include a provision that,
at the discretion of the licensee, the licensee may act as the agent
for the licensor with respect to any patent for the licensed invention
for purposes of extending a patent under section 156a or 158.''.
(3) Cooperative research and development agreements.--
Section 12(b) of the Stevenson-Wydler Technology Innovation Act
of 1980 (15 U.S.C. 3710a(b)) is amended by adding at the end
the following:
``(7) Each exclusive license for a patent granted under an
agreement entered into under subsection (a)(1) shall include a
provision that, at the discretion of the licensee, the licensee
may act as the agent for the licensor with respect to that
patent for purposes of extending a patent under section 156a or
158 of title 35, United States Code.''.
(4) Applicable licenses.--The amendments made by paragraphs
(2) and (3) shall apply only to exclusive licenses granted
after 60 days after the date of enactment of this Act.
(e) Exclusive Marketing.--Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 505B, the following:
``SEC. 505C. MARKET EXCLUSIVITY FOR COUNTERMEASURE PRODUCTS.
``(a) In General.--Subsection (b) shall apply if the Secretary
determines that a new drug is a countermeasure product, as that term is
defined in section 156a(a)(1) of title 35, United States Code, that has
been successfully developed by an entity that has been certified under
section 301(b)(4)(A) of the Project BioShield II Act of 2005.
``(b) Exclusivity.--With respect to a new drug described in
subsection (a)--
``(1)(A)(i) the period referred to in subsection
(c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii)
of such section, shall be 10 years instead of 5 years, and the
periods of 4 years, to 48 months, and to 7 and one-half years
referred to in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of
such section shall be 9 years, 108 months, and 9 years,
respectively; or
``(ii) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(E) of such section, and in clauses (iii) and
(iv) of subsection (j)(5)(F) of such section, shall be 6 years
instead of 3 years; and
``(B) if the drug is designated under section 526 for a
rare disease or condition, the period referred to in section
527(a) shall be 10 years instead of 7 years.
``(c) Special Rule for Unexploited Countermeasures.--If, as of the
date that is 45 days before the date on which the periods specified in
paragraph (1) or (2) of section 505B expire, there has been no
substantial commercial exploitation of the drug, including
insubstantial sales of the drug following its approval for marketing,
the periods specified in such sections shall be extended by a period of
3 years.''.
SEC. 332. INTERNATIONAL PROTECTION FOR BIOSHIELD INTELLECTUAL PROPERTY.
The Secretary of Commerce, the United States Trade Representative,
and the Commissioner of Patents shall ensure in international,
bilateral, and multilateral negotiations and agreements, and
proceedings before agencies of the World Trade Organization, that--
(1) intellectual property for which restoration of a patent
term is granted under section 156a of title 35, United States
Code (as added by section 331), or for which an extension of a
patent term is granted under section 158 of title 35, United
States Code, (as added by section 331) under this Act is not
impaired;
(2) substantially similar intellectual property rights
granted to the same or related entities as those that qualify
for restoration or an extension under such sections are not
impaired; and
(3) vigorous enforcement actions and sanctions are taken
and imposed with respect to infringement of such intellectual
property.
Subtitle D--Liability Protections
SEC. 341. LIABILITY AND COMPENSATION FOR INJURED PARTIES.
(a) The Public Health Service Act Amendments.--Section 224 of the
Public Health Service Act (42 U.S.C. 233) is amended--
(1) in subsection (a), by inserting ``or the manufacture or
distribution of a covered countermeasure as defined in
subsection (p)'' after ``including the conduct of clinical
studies or investigation'';
(2) in the heading of subsection (p), by striking
``Administration of Smallpox Countermeasures by Health
Professionals'' and inserting ``Manufacture, Distribution, and
Administration of Covered Countermeasures'';
(3) in subsection (p)(1)--
(A) by inserting ``manufacture, distribution, or''
after ``liability arising out of'';
(B) by striking ``against smallpox to an
individual''; and
(C) by inserting before the period at the end
``notwithstanding the applicability of the SAFETY Act
(6 U.S.C. 441 et seq.)'';
(4) in subsection (p)(2)--
(A) in the heading, by striking ``countermeasure
against smallpox'' and inserting ``covered
countermeasures'';
(B) in subparagraph (A)(i)--
(i) by inserting ``(I)'' after ``makes
advisable''; and
(ii) by inserting before the period at the
end ``; or (II) the manufacture or distribution
of a covered countermeasure for possible future
administration to a category or categories of
individuals'';
(C) in subparagraph (A)(ii) by inserting--
(i) ``, or product or products'' after ``or
substances''; and
(ii) before the period at the end ``and any
conditions governing the manufacture or
distribution of such covered countermeasures'';
(D) in subparagraph (A)(iv), by adding at the end
before the period ``. Notwithstanding clause (iii),
such declaration or amendment shall take effect
immediately upon publication and shall not be subject
to the provisions of section 553 of title 5, United
States code, concerning prior notice and opportunity
for comment''.
(E) in subparagraph (A), by adding at the end the
following:
``(v) Recommended declaration.--Any person may
recommend to the Secretary at any time the declaration
of a countermeasure under this paragraph and may
provide data and information to support such
recommendation.'';
(F) in subparagraph (B)(i), by striking ``, for a
purpose stated in paragraph (7)(A)(i),''; and
(G) by adding at the end the following:
``(E) Liability of the united states.--The United
States shall be liable under this subsection with
respect to a claim arising out of the manufacture,
distribution, or administration of a covered
countermeasure regardless of whether--
``(i) the cause of action seeking
compensation for harm caused by such
countermeasure is alleged as negligence, strict
liability, breach of warranty, failure to warn,
or other action; or
``(ii) the covered countermeasure is
designated or certified as a qualified anti-
terrorism technology under the SAFETY Act (6
U.S.C. 441 et seq.).
The United States shall be liable under this subsection
for claims for injury or loss arising out of
administration of a covered countermeausre during a
human clinical investigation on a covered
countermeasure whether or not the certification for
successful development of the countermeausre is made
under section 301(b)(3) of the Project BioShield II Act
of 2005.
``(F) Liability of the united states for
manufacture or distribution within the scope of
declaration.--
``(i) In general.--Except as provided in
paragraph (5)(B)(ii), the United States shall
be liable under this subsection with respect to
a claim arising out of the manufacture or
distribution of a covered countermeasure if--
``(I) the manufacturer was covered
by a declaration by the Secretary under
subparagraph (A) with respect to such
countermeasure; and
``(II) the countermeasure was
manufactured and distributed in
accordance with, and during, the
relevant period of such declaration.
``(ii) Effect of section.--For purposes of
this section, any activity reasonably related
to the manufacture, distribution, or
administration of a covered countermeasure
shall be considered to be a medical, surgical,
dental, or related function within the scope of
the covered person's employment by the Public
Health Service.'';
(5) in subsection (p)(4)(A), by inserting ``manufacture,
distribution, or'' after ``arising out of the''; and
(6) in subsection (p)(7)--
(A) by striking subparagraph (A) and inserting the
following:
``(A) Covered countermeasure.--
``(i) Before publication of list.--Until
the date that the Secretary publishes the list
described under section 319F-3(f), the term
``covered countermeasure'' means a substance or
product that is specified in a declaration
under paragraph (2).
``(ii) After publication of list. After the
date that the Secretary publishes the list
described under section 319F-3(f), the term
``covered countermeasure'' means a substance or
product that is--
``(I) specified in a declaration
under paragraph (2); and
``(II)(aa) a countermeasure, as
such term is defined is section 319F-3;
or
``(bb) designed, developed,
modified, used, or procured for the
purpose of preventing, detecting,
identifying, or treating pandemic
influenza or limiting the harm such
influenza might otherwise cause.'';
(B) in subparagraph (B)--
(i) in the matter preceding clause (i), by
inserting ``manufacture, distribution, or''
after ``with respect to the''; and
(ii) in clause (iv), by inserting ``or
distribution'' after ``with respect to
administration''; and
(C) in subparagraph (D)--
(i) in the heading, by inserting
``manufacture, distribution, or'' after
``arising out of'';
(ii) in the matter preceding clause (i)
by--
(I) striking ``administration of a
covered countermeasure''; and
(II) by inserting ``relating to the
manufacture, distribution, or
administration of a covered
countermeasure'' after ``with respect
to a claim or liability'';
(iii) in clause (iii), by striking ``; or''
and inserting a semicolon;
(iv) in clause (iv) by striking the period
and inserting ``; or''; and
(v) by adding at the end the following:
``(v) the manufacture or distribution of a
covered countermeasure and administration of a
covered countermeasure in the course of a human
clinical investigation.
For purposes of this subsection, the term
`administration' includes administration in the
course of a human clinical investigation.''.
(b) Amendments to the SAFETY Act.--The SAFETY Act (6 U.S.C. 441 et
seq.) is amended--
(1) in section 863, in subsections (a)(1), (a)(2), (d)(1),
and (d)(2), by inserting ``, or potential threat of such act,''
after ``from such act'';
(2) in section 864--
(A) in subsections (a)(1), (b), and (c), by
inserting ``or potential threat of such act'' after
``from such act''; and
(B) in subsection (a)(3), by inserting ``or
potential threat of such act'' after ``act of
terrorism''; and
(3) in section 865(1)--
(A) by inserting ``(including a vaccine,
therapeutic or other biological product, drug,
antimicrobial or combination thereof, detection
technology, or device)'' after ``product'';
(B) by inserting ``, biotechnology, detection
technology, or a pharmacological product'' after
``information technology''; and
(C) by inserting ``treating,'' after
``preventing,''.
(c) Limitation.--A private entity may utilize the liability
protections described in this section (and the amendments made by this
section) if such entity--
(1)(A) is described under section 301(b)(2); and
(B) has been certified by the Secretary of Health and Human
Services or the Secretary of Homeland Security, as appropriate,
under section 301(b)(4); or
(2) without regard to the requirements of sections
301(b)(2) and 301(b)(4), has developed a product (including a
drug, vaccine, or other biologic), equipment, service
(including support service), device, or technology (including
information technology) designed, developed, modified, used, or
procured for the specific purpose of preventing, detecting,
identifying, or treating pandemic influenza or limiting the
harm such pandemic might cause.
(d) Effect of Section.--Notwithstanding any other provision of law,
an entity shall not be required to apply for and receive designation or
certification by the Secretary of Homeland Security of a product or
service as a Qualified Anti-Terror Technology under the SAFETY Act (6
U.S.C. 441 et seq.) in order to receive indemnification under Public
Law 85-804.
(e) Effect on Pending Actions.--Nothing in this Act (or the
amendments made by this Act) shall be construed to apply to a legal
action pending or filed on or before the date of enactment of this Act
against a manufacturer or other entity with respect to a diagnostic,
therapeutic, detection technology, or research that was not conducted
pursuant to a contract under the amendments made by this Act or the
Project BioShield Act of 2004 (Public Law 108-276).
TITLE IV--VALLEY OF DEATH FOR SMALL COMPANIES
SEC. 401. PURPOSE.
It is the purpose of this title to enable small companies to fund
the initial research and development necessary so that such small
companies may be able to participate in the procurement process for
countermeasures, and become part of a national biodefense, infectious
disease, and research tool industry.
SEC. 402. VALLEY OF DEATH FOR SMALL COMPANIES.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-
6b), as amended by section 103, is amended by--
(1) redesignating subsections (l) and (m) as subsections
(r) and (s), respectively; and
(2) inserting after subsection (k) the following:
``(l) Reimbursement.--The Secretary may reimburse an entity for
costs associated with improvement, increase, or production of a
countermeasure necessary for testing (including a clinical trial)
conducted on humans or animals from funds appropriated to fund the
Project BioShield Act of 2004 and the Project BioShield II Act of 2005.
``(m) Grants to Certain Entities.--The Secretary may award grants
to State or local government agencies, small businesses, university
technology partnership offices, and other entities to conduct
preliminary screening of compounds and to develop of business plans
related to such preliminary screenings.
``(n) Security Funding.--The Secretary shall provide funding for an
entity that enters into an agreement under the amendments made by the
Project BioShield Act of 2004 or the Project BioShield II Act of 2005
(and the amendments made by such Act) to provide security for the
personnel and facilities of such entity that develop, produce,
distribute, or store countermeasures under section 319K.
``(o) Priority Access to Certain Research Results.--An entity that
enters into an agreement under this section, section 319F-2, or section
512 of the Homeland Security Act of 2002 shall be given priority access
to the results of research related to the epidemiology and pathogenesis
of agents, the genomes and other DNA analysis, or other comparative
analysis of agents relevant to research conducted under subparagraphs
(A), (B), and (C) of section 319F(h)(1).
``(p) Translational Development for Biodefense Drug and Vaccine
Candidates.--
``(1) In general.--An entity that enters into an agreement
under this section, section 319F-2, or section 512 of the
Homeland Security Act of 2002 shall be eligible for
translational development for biodefense drug and infectious
disease countermeasure candidates. For purposes of this
section, such entities may include universities, small
businesses, for-profit, and nonprofit entities.
``(2) Translational development.--In this subsection, the
term `translational development' shall include the following:
``(A) Triage screening of applications for
promising drug and biological candidates.
``(B) Plans to outline the tasks, timelines, and
costs required to complete the development process for
promising drug and biological candidates.
``(C) Implementation of the recommended development
steps for key therapeutics.
``(D) Project management to implement the
recommended development steps.
``(E) Regulatory consultants to interface with the
Food and Drug Administration and the entity to devise a
plan that rapidly brings new biodefense candidates to
approval and stockpiling.
``(q) Rule of Construction.--Nothing in this section shall be
construed to limit the authority of the Secretary or the Secretary of
Homeland Security to distribute countermeasures from the Strategic
National Stockpile to foreign countries or foreign entities if it is
determined by such Secretaries that such a deployment would protect the
interests and safety of citizens of the United States, living in the
United States or abroad, from the event of a bioterrorist attack or
other public health emergency.''.
TITLE V--BIOSHIELD ANTITRUST EXEMPTION
SEC. 501. LIMITED ANTITRUST EXEMPTION.
Section 2 of the Clayton Act (15 U.S.C. 13) is amended by adding at
the end the following:
``(g) Limited Antitrust Exemption.--
``(1) Countermeasures development meetings.--
``(A) Countermeasures development meetings and
consultations.--The Secretary may conduct meetings and
consultations with parties involved in the development
of countermeasures for the purpose of the development,
manufacture, distribution, purchase, or sale of
countermeasures consistent with the purposes of this
title. The Secretary shall give notice of such meetings
and consultations to the Attorney General and the
Chairperson of the Federal Trade Commission (referred to in this
subsection as the `Chairperson').
``(B) Meeting and consultation conditions.--A
meeting or consultation conducted under subparagraph
(A) shall--
``(i) be chaired or, in the case of a
consultation, facilitated by the Secretary;
``(ii) be open to parties involved in the
development, manufacture, distribution,
purchase, or sale of countermeasures, as
determined by the Secretary;
``(iii) be open to the Attorney General and
the Chairperson;
``(iv) be limited to discussions involving
the development, manufacture, distribution, or
sale of countermeasures, consistent with the
purposes of this title; and
``(v) be conducted in such manner as to
ensure that national security, confidential,
and proprietary information is not disclosed
outside the meeting or consultation.
``(C) Minutes.--The Secretary shall maintain
minutes of meetings and consultations under this
subsection, which shall not be disclosed under section
552 of title 5, United States Code.
``(D) Exemption.--The antitrust laws shall not
apply to meetings and consultations under this
paragraph, except that any agreement or conduct that
results from a meeting or consultation and that does
not receive an exemption pursuant to this subsection
shall be subject to the antitrust laws.
``(2) Written agreements.--The Secretary shall file a
written agreement regarding covered activities, made pursuant
to meetings or consultations conducted under paragraph (1) and
that is consistent with this paragraph, with the Attorney
General and the Chairperson for a determination of the
compliance of such agreement with antitrust laws. In addition
to the proposed agreement itself, any such filing shall
include--
``(A) an explanation of the intended purpose of the
agreement;
``(B) a specific statement of the substance of the
agreement;
``(C) a description of the methods that will be
utilized to achieve the objectives of the agreement;
``(D) an explanation of the necessity of a
cooperative effort among the particular participating
parties to achieve the objectives of the agreement; and
``(E) any other relevant information determined
necessary by the Secretary in consultation with the
Attorney General and the Chairperson.
``(3) Determination.--The Attorney General, in consultation
with the Chairperson, shall determine whether an agreement
regarding covered activities referred to in paragraph (2) would
likely--
``(A) be in compliance with the antitrust laws, and
so inform the Secretary and the participating parties;
or
``(B) violate the antitrust laws, in which case,
the filing shall be deemed to be a request for an
exemption from the antitrust laws, limited to the
performance of the agreement consistent with the
purposes of this title.
``(4) Action on request for exemption.--
``(A) In general.--The Attorney General, in
consultation with the Chairperson, shall grant, deny,
grant in part and deny in part, or propose
modifications to a request for exemption from the
antitrust laws under paragraph (3) within 15 days of
the receipt of such request.
``(B) Extension.--The Attorney General may extend
the 15-day period referred to in subparagraph (A) for
an additional period of not to exceed 10 days. Such
additional period may be further extended only by the
United States district court, upon an application by
the Attorney General after notice to the Secretary and
the parties involved.
``(C) Determination.--In granting an exemption
under this paragraph, the Attorney General, in
consultation with the Chairperson and the Secretary--
``(i) must find--
``(I) that the agreement involved
is necessary to ensure the availability
of countermeasures;
``(II) that the exemption from the
antitrust laws would promote the public
interest; and
``(III) that there is no
substantial competitive impact to areas
not directly related to the purposes of
the agreement; and
``(ii) may consider any other factors
determined relevant by the Attorney General and
the Chairperson.
``(5) Limitation on and renewal of exemptions.--An
exemption granted under paragraph (4) shall be limited to
covered activities, and shall expire on the date that is 3
years after the date on which the exemption becomes effective
(and at 3-year intervals thereafter, if renewed) unless the
Attorney General in consultation with the Chairperson
determines that the exemption should be renewed (with
modifications, as appropriate) considering the factors
described in paragraph (4).
``(6) Limitation on parties.--The use of any information
acquired under an exempted agreement by the parties to such an
agreement for any purposes other than those specified in the
antitrust exemption granted by the Attorney General shall be
subject to the antitrust laws and any other applicable laws.
``(7) Guidelines.--The Attorney General and the Chairperson
may develop and issue guidelines to implement this subsection.
``(8) Report.--Not later than 1 year after the date of
enactment of the Project BioShield II Act of 2005, and annually
thereafter, the Attorney General and the Chairperson shall
report to Congress on the use and continuing need for the
exemption from the antitrust laws provided by this subsection.
``(9) Sunset.--The authority of the Attorney General to
grant or renew a limited antitrust exemption under this
subsection shall expire at the end of the 10-year period that
begins on the date of enactment of the Project BioShield II Act
of 2005.
``(h) Definitions.--In this section:
``(1) Antitrust laws.--The term `antitrust laws'--
``(A) has the meaning given such term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12(a)), except that such term includes the Act of June
19, 1936 (15 U.S.C. 13 et seq.) commonly known as the
Robinson-Patman Act), and section 5 of the Federal
Trade Commission Act (15 U.S.C. 45) to the extent such
section 5 applies to unfair methods of competition; and
``(B) includes any State law similar to the laws
referred to in subparagraph (A).
``(2) Countermeasure.--The term `countermeasure' has the
meaning given that term in section 319F-3 of the Public Health
Service Act.
``(3) Covered activities.--
``(A) In general.--Except as provided in
subparagraph (B), the term `covered activities' means
any group of activities or conduct, including
attempting to make, making, or performing a contract or
agreement or engaging in other conduct, for the purpose
of--
``(i) theoretical analysis,
experimentation, or the systematic study of
phenomena or observable facts necessary to the
development of countermeasures;
``(ii) the development or testing of basic
engineering techniques necessary to the
development of countermeasures;
``(iii) the extension of investigative
findings or theory of a scientific or technical
nature into practical application for
experimental and demonstration purposes,
including the experimental production and
testing of models, prototypes, equipment,
materials, and processes necessary to the
development of countermeasures;
``(iv) the production, distribution, or
marketing of a product, process, or service
that is a countermeasures;
``(v) the testing in connection with the
production of a product, process, or services
necessary to the development of
countermeasures;
``(vi) the collection, exchange, and
analysis of research or production information
necessary to the development of
countermeasures; or
``(vii) any combination of the purposes
described in clauses (i) through (vi);
and such term may include the establishment and
operation of facilities for the conduct of covered
activities described in clauses (i) through (vi), the
conduct of such covered activities on a protracted and
proprietary basis, and the processing of applications
for patents and the granting of licenses for the
results of such covered activities.
``(B) Exception.--The term `covered activities'
shall not include the following activities involving 2
or more persons:
``(i) Exchanging information among
competitors relating to costs, sales,
profitability, prices, marketing, or
distribution of any product, process, or
service if such information is not reasonably
necessary to carry out the purposes of covered
activities.
``(ii) Entering into any agreement or
engaging in any other conduct--
``(I) to restrict or require the
sale, licensing, or sharing of
inventions, developments, products,
processes, or services not developed
through, produced by, or distributed or
sold through such covered activities;
or
``(II) to restrict or require
participation by any person who is a
party to such covered activities in
other research and development
activities, that is not reasonably
necessary to prevent the
misappropriation of proprietary
information contributed by any person
who is a party to such covered
activities or of the results of such
covered activities.
``(iii) Entering into any agreement or
engaging in any other conduct allocating a
market with a competitor that is not expressly
exempted from the antitrust laws by a
determination under subsection (i)(4).
``(iv) Exchanging information among
competitors relating to production (other than
production by such covered activities) of a
product, process, or service if such
information is not reasonably necessary to
carry out the purpose of such covered
activities.
``(v) Entering into any agreement or
engaging in any other conduct restricting,
requiring, or otherwise involving the
production of a product, process, or service
that is not so expressly exempted from the
antitrust laws by a determination under
subsection (i)(4).
``(vi) Except as otherwise provided in this
subsection, entering into any agreement or
engaging in any other conduct to restrict or
require participation by any person who is a
party to such activities, in any unilateral or
joint activity that is not reasonably necessary
to carry out the purpose of such covered
activities.
``(4) Development.--The term `development' includes the
identification of suitable compounds or biological materials,
the conduct of preclinical and clinical studies, the
preparation of an application for marketing approval, and any
other actions related to preparation of a countermeasure.
``(5) Person.--The term `person' has the meaning given such
term in subsection (a) of the first section of this Act.
``(6) Secretary.--The term `Secretary' means the Secretary
of Health and Human Services.''.
TITLE VI--BIOSHIELD IMMIGRATION PRIORITY
SEC. 601. H1B VISA EXEMPTION.
Section 214(g) of the Immigration and Nationality Act (8 U.S.C.
1184(g)) is amended by adding at the end the following new paragraph:
``(9)(A) The numerical limitations contained in paragraph (1)(A)
shall not apply to any nonimmigrant alien issued a visa or otherwise
provided status under section 101(a)(15)(H)(i)(b) who--
``(i) is employed by a person that has entered into a
contract for procurement with the Secretary of Health and Human
Services under the authority provided in section 319F-1 or
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a and
247d-6b) or with the Secretary of Homeland Security under
section 512 of the Homeland Security Act of 2002; and
``(ii) provides services related to the research,
development, or production of a qualified countermeasure or a
security countermeasure under such contract.
``(B) In this paragraph:
``(i) The term `qualified countermeasure' has the meaning
given that term in section 319F-1 of the Public Health Service
Act.
``(ii) The term `security countermeasure' has the meaning
given that term in section 319F-2 of the Public Health Service
Act.''.
SEC. 602. VISA PROCESSING.
(a) Requirement To Expedite.--The Secretary of Homeland Security
and the Secretary of State shall expedite the processing of an
application of an alien seeking a visa under section
101(a)(15)(H)(i)(b) of the Immigration and Nationality Act (8 U.S.C.
1101(a)(15)(H)(i)(b)) if such alien--
(1) is employed by a person that has entered into a
contract for procurement with the Secretary of Health and Human
Services under the authority provided in section 319F-1 or
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a and
247d-6b) or with the Secretary of Homeland Security under
section 512 of the Homeland Security Act of 2002; and
(2) provides services related to the research, development,
or production of a qualified countermeasure or a security
countermeasure under such contract.
(b) Definitions.--In this section:
(1) Qualified countermeasure.--The term ``qualified
countermeasure'' has the meaning given that term in section
319F-1 of the Public Health Service Act.
(2) Security countermeasure.--The term ``security
countermeasure'' has the meaning given that term in section
319F-2 of the Public Health Service Act.
TITLE VII--BIOSHIELD EXPORT PRIORITY
SEC. 701. SHORT TITLE.
This title may be cited as the ``Bioshield Export Priority Act''.
SEC. 702. REQUIREMENT TO EXPEDITE EXPORT APPLICATIONS.
(a) In General.--The Secretary of Commerce or the Secretary of
Health and Human Services, whichever is applicable, shall expedite the
processing of a request to export a drug, medical device, diagnostic
test, etiological agent, biological product, or any item the export of
which is restricted pursuant to section 5 or 6 of the Export
Administration Act of 1979 (as in effect pursuant to the International
Emergency Economic Powers Act; 50 U.S.C. 1701 et seq.), if the export
of that drug, medical device, diagnostic test, etiological agent,
biological product, or other item is necessary to carry out a
procurement contract entered into by the Secretary of Health and Human
Services under the authority provided in section 319F-1 or section
319F-2 of the Public Health Service Act (42 U.S.C. 247d-6a and 247d-
6b), or by the Secretary of Homeland Security under section 512 of the
Homeland Security Act of 2002, with respect to a qualified
countermeasure or security countermeasure under such contract.
(b) Qualified and Security Countermeasures Defined.--In this
section:
(1) the term ``qualified countermeasure'' has the meaning
given that term in section 319F-1 of the Public Health Service
Act (42 U.S.C. 247d-6a); and
(2) the term ``security countermeasure'' has the meaning
given that term in section 319F-2 of the Public Health Service
Act (42 U.S.C. 247d-6b).
SEC. 703. PRESERVATION OF FOREIGN SALES MARKETS FOR QUALIFIED AND
SECURITY COUNTERMEASURES.
Notwithstanding any other provision of law, no Federal agency shall
sell, barter, trade, or transfer a qualified countermeasure or a
security countermeasure to a foreign government, or to any other
foreign entity or purchaser outside the United States where an entity
that has successfully developed a countermeasure under this Act or the
Project BioShield Act of 2004 (Public Law 108-276) (and the amendments
made by such Acts) is able to sell, barter, trade, or transfer such
countermeasure to such foreign government or entity, unless the
President makes a determination that such sale, barter, trade, or
transfer is necessary for protecting the national security or national
defense of the United States.
TITLE VIII--OFFICE OF PUBLIC HEALTH COUNTERMEASURE DEVELOPMENT
SEC. 801. OFFICE OF PUBLIC HEALTH COUNTERMEASURE DEVELOPMENT.
Section 2811(a) of the Public Health Service Act (42 U.S.C. 300hh-
11(a)) is amended to read as follows:
``(a) Assistant Secretary for Public Health Countermeasure
Development.--
``(1) In general.--There is established within the
Department of Health and Human Services the Office of Public
Health Countermeasure Development (referred to in this
subsection as the `Office'). Such Office shall be headed by an
Assistant Secretary for Public Health Countermeasure
Development, who shall be appointed by the President and shall
report to the Secretary.
``(2) Deputy director.--There is established within the
Department of Health and Human Services the position of Deputy
Director for Medical Countermeasure Development.
``(3) Duties.--The Assistant Secretary for Public Health
Countermeasure Development shall ensure that research supported
by the Department of Health and Human Services--
``(A) is consistent with the national preparedness
plan developed under section 2812 with respect to--
``(i) identifying priorities, goals,
objectives, and policies for identifying,
developing, delivering, and evaluating medical
and other countermeasures to biological,
chemical, radiological, nuclear, and other
emerging natural and terrorists threats and
infectious diseases and research tools and
countermeasures should include containment and
decontamination strategies for human and animal
remains; and
``(ii) coordinating the civilian efforts of
the Federal Government to identify and rapidly
develop such countermeasures; and
``(B) is conducted pursuant to a comprehensive,
research-based strategy for--
``(i) the conduct of basic and applied
research;
``(ii) the development of the
countermeasures described under subparagraph
(A)(i); and
``(iii) the development of standards by
which the goals of such strategy may be
accomplished and evaluated.''.
SEC. 802. BIOTERROR, CHEMICAL, NUCLEAR, RADIOLOGICAL, AND INFECTIOUS
DISEASE COUNTERMEASURE DEVELOPMENT STRATEGY.
Subtitle B of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh-11 et seq.) is amended by adding at the end the following:
``SEC. 2812. BIOTERROR, CHEMICAL, NUCLEAR, RADIOLOGICAL, AND INFECTIOUS
DISEASE COUNTERMEASURE DEVELOPMENT STRATEGY.
``(a) Plan for Countermeasure Research.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Defense and the Secretary of Homeland Security,
shall develop a comprehensive, long-term plan for engaging
State and local public health officials, medical examiners, and
other non-Federal entities, including private for-profit
entities, in the research, development, production, delivery,
and evaluation of countermeasures for biological, chemical,
radiological, and nuclear weapons and infectious diseases.
``(2) Contents.--The plan described under paragraph (1)
shall include a plan for the development of countermeasures for
exotic pathogens (including vaccine resistant bacterial or
viral strains, antibiotic resistant organisms, genetically
modified organisms, hybrid organisms, synthetic organisms,
autoimmune peptides, antibiotic-induced toxins, ethnic and
racial specific pathogens, and bioregulators and biomodulators)
and measures for containment and safe handling of contaminated
human and animal remains.
``(3) Other duties.--The Secretary, in consultation with
the Secretary of Defense and the Secretary of Homeland
Security, shall--
``(A) develop a plan and strategy for engaging
pharmaceutical and biotechnology companies,
universities, small businesses, and nonprofit
institutions, including entities that are under-
resourced and not able to advance beyond preclinical
development to clinical trials, in order to create a
multi-dimensional biodefense, infectious disease,
vaccine, and research tool industry; and
``(B) provide joint oversight of translational
development for biodefense drug and vaccine candidates,
as provided in section 319F-2(o).
``(4) Coordination; purpose.--In developing the plan
described under paragraph (1), the Secretary, in consultation
with the Secretary of Defense and the Secretary of Homeland
Security, shall--
``(A) consult with--
``(i) other Federal agencies with expertise
in research, development, and production of the
countermeasures described under paragraph (1);
``(ii) private, for-profit entities, State
and local public health officials, medical
examiners, and entrepreneurs with expertise and
technology with respect to such
countermeasures, research tools, and the
systems for developing such research tools;
``(iii) investors that fund the entities
described under clause (ii);
``(iv) nonprofit research universities and
institutions;
``(v) professional organizations
representing infectious disease physicians and
scientists;
``(vi) local public health and hospital
organizations; and
``(vii) national and international
healthcare delivery and public health entities,
and other interested private and public
entities;
``(B) evaluate proposals to ensure that--
``(i) Federal efforts assist and
incentivize private sector development of
systems to facilitate and expedite the
development and diffusion of research tools,
and research tool systems, to aid in the
development and deployment of countermeasures;
``(ii) research and development of such
countermeasures by non-Federal entities is
likely to yield countermeasures that may be
procured and deployed with respect to the
homeland security in the United States and
against an infectious diseases;
``(iii) ample investor capital is available
to fund such research and development, and non-
Federal entities are not dependent on grants
from the Federal Government;
``(iv) the terms of procurement of such
countermeasures are defined in advance so that
entities may accurately and reliably assess--
``(I) the potential countermeasures
market;
``(II) the potential rate of
return; and
``(III) that the terms of the
procurement are comparable to the
procurement of other medicines and
biological products from other markets;
``(v) appropriate intellectual property,
risk protection, and Government approval
standards are applicable to such
countermeasures;
``(vi) federally funded research is
conducted and prioritized to address the
highest priority countermeasure detection tools
and transfer or license those technologies, as
appropriate, to non-Federal entities for
production; and
``(vii) universities, State and local
government laboratories, and research
institutions play a vital role as partners in
research, development, and technology transfer,
with appropriate progress benchmarks for such
activities, with for-profit entities; and
``(C) provide the private sector with sufficient
advance notice of the procurement priorities of the
Federal Government with respect to countermeasures.
``(5) Plan details.--
``(A) In general.--The plan described under
paragraph (1) shall, on an annual basis--
``(i) designate, in 5 year increments,
specific countermeasures for which contracts
under the Project BioShield Act of 2004 and the
Project BioShield II Act of 2005 will be
awarded;
``(ii) estimate the date on which request
for proposals will be published;
``(iii) provide information regarding the
qualifications of the entities with which it
may enter into an agreement; and
``(iv) list the projected schedule for the
completion of the development of such
countermeasures.
``(B) Designation of countermeasures.--
``(i) In general.--The plan described in
paragraph (1) shall, on an annual basis,
designate specific countermeasures to be
developed against terror weapons or weapons of
mass destruction.
``(ii) Infectious disease countermeasures
in the united states.--For every 5 such
countermeasures designated under clause (i),
not less than 2 additional countermeasures
shall be designated for development against an
infectious disease that--
``(I) is not a terror weapon or
weapon of mass destruction; and
``(II) has or may have substantial
incidence in the United States.
``(iii) Global infectious disease
countermeasures in developing countries.--For
every 5 such countermeasures designated under
clause (i), not less than 2 additional
countermeasures shall be designated for
development against an infectious disease
that--
``(I) is not a terror weapon or
weapon of mass destruction; and
``(II) has or may have substantial
incidence largely in developing
countries.
``(C) Designation of research tools; purchase
pools; estimation.--The plan described in paragraph (1)
shall--
``(i) designate research tools, including
research tool systems, to be developed;
``(ii) identify purchase pools with which
the Secretary shall seek to negotiate for the
development of countermeasures; and
``(iii) estimate the amount of
appropriations necessary to procure the
development of such countermeasures and
research tools.
``(D) Public availability.--The plan described in
paragraph (1) shall be published in the Federal
Register.
``(6) Performance measure system.--
``(A) In general.--Not later than 180 days after
the development of the plan described in paragraph (1),
the Secretary shall implement a performance measure
system to evaluate the progress toward the goals of the
Project BioShield II Act of 2005, which shall include a
list of clear, measurable benchmarks by which progress
may be evaluated, including--
``(i) a list of threats for which
countermeasures are necessary;
``(ii) a list of research and research tool
systems necessary for the development of
countermeasures;
``(iii) systems to develop and deliver
countermeasures for at-risk populations;
``(iv) an annual accounting of the number
of outbreaks, including incidence numbers and
case fatality rates, in the United States of
influenza and other such diseases that such Act
addresses;
``(v) a list of any new threats that either
emerged from nature, or that were engineered
and released during the previous year; and
``(vi) an accounting of the time that it
took to detect, analyze, and respond to any
instance of a threat.
``(B) Evaluation.--Not later than 1 year after the
publication of the benchmarks described in subparagraph
(A), and on annual basis thereafter, the Secretary
shall publish and submit to Congress an evaluation of
the progress made with respect to such benchmarks
during the preceding year.
``(7) Submission of plan; reporting.--
``(A) Submission of plan.--Not later than 270 days
after the date of enactment of the Project BioShield II
Act of 2005, the Secretary shall submit to Congress the
plan developed under paragraph (1) and recommendations
for the enactment of supporting or enabling legislation
with respect to such plan. The Secretary shall submit
to Congress an updated version of such plan and such
recommendations on an annual basis.
``(B) Reporting.--The Secretary shall report
periodically to Congress on the status of the
countermeasure research, development, and production of
non-Federal entities, and submit recommendations for
legislation as determined necessary by the Secretary.
``(b) Advisory Committee.--
``(1) Establishment of committee.--The Secretary, in
consultation with the Secretary of Defense and the Secretary of
Homeland Security, shall establish an advisory committee to be
known as the Public Health Countermeasure Development Advisory
Committee (referred to in this section as the `Advisory
Committee').
``(2) Duties.--The Advisory Committee shall advise the
Secretary, the Secretary of Defense, and the Secretary of
Homeland Security with respect to the establishment of a
biodefense, an infectious disease, vaccine, and a research tool
industry to supply the Federal Government and other public
entities with the medical countermeasures necessary to protect
the public from biological, chemical, radiological, and nuclear
attacks, or infectious diseases.
``(3) Membership.--The Secretary, Secretary of Defense, and
the Secretary of Homeland Security shall appoint the members of
the Advisory Committee, which shall be composed of--
``(A) representatives of the for-profit and
nonprofit research sectors, and State and local
governments, including representatives of the small
business industry and infectious disease medical,
research, biotechnology, and pharmaceutical
communities; and
``(B) experts on the terms and impact of the
incentives provided under the Project BioShield Act of
2004 or the Project BioShield II Act of 2005 (and the
amendments made by such Acts).
``(4) Vacancies.--Any vacancy in the Advisory Committee
shall not affect its powers, but shall be filled in the same
manner as the original appointment.
``(5) Meetings.--The Advisory Committee shall meet at the
call of the co-chairpersons.
``(6) Co-chairpersons.--The Secretary, the Secretary of
Defense, and the Secretary of Health and Human Services shall
serve as the co-chairpersons of the Advisory Committee.
``(7) Powers.--
``(A) Hearings.--The Advisory Committee may hold
such hearings, sit and act at such times and places,
take such testimony, and receive such evidence as the
Advisory Committee considers advisable to carry out
this section.
``(B) Information from federal agencies.--
``(i) In general.--The Advisory Committee
may secure directly from any Federal department
or agency such information as the Advisory
Committee considers necessary to carry out the
provisions of this section. Upon request of the
Advisory Committee, the head of such department
or agency shall furnish such information to the
Advisory Committee.
``(ii) Limitation.--Nothing in this
subsection shall be construed to allow the
Advisory Committee to secure information that
is exempt from disclosure under section 552 of
title 5, United States Code (commonly referred
to as the Freedom of Information Act).
``(C) Postal services.--The Advisory Committee may
use the United States mails in the same manner and
under the same conditions as other departments and
agencies of the Federal Government.
``(8) Personnel.--
``(A) Travel expenses.--The members of the Advisory
Committee shall not receive compensation for the
performance of services for the Advisory Committee, but
shall be allowed travel expenses, including per diem in
lieu of subsistence, at rates authorized for employees
of agencies under subchapter I of chapter 57 of title
5, United States Code, while away from their homes or
regular places of business in the performance of
services for the Advisory Committee. Notwithstanding
section 1342 of title 31, United States Code, the
Secretary may accept the voluntary and uncompensated
services of members of the Advisory Committee.
``(B) Detail of government employees.--Any Federal
Government employee may be detailed to the Advisory
Committee without reimbursement, and such detail shall
be without interruption or loss of civil service status
or privilege.''.
TITLE IX--OFFICE OF MEDICAL READINESS AND RESPONSE OF THE DEPARTMENT OF
HOMELAND SECURITY
SEC. 901. OFFICE OF MEDICAL READINESS AND RESPONSE OF THE DEPARTMENT OF
HOMELAND SECURITY.
(a) In General.--Title VIII of the Homeland Security Act of 2002 (6
U.S.C. 361 et seq.) is amended by inserting after section 879 the
following:
``SEC. 879A. OFFICE OF MEDICAL READINESS AND RESPONSE.
``(a) Establishment.--There is established within the Office of the
Secretary an Office of Medical Readiness and Response.
``(b) Assistant Secretary.--The Office established under subsection
(a) shall be headed by an Assistant Secretary for Medical Readiness and
Response, who shall be appointed by the President by and with the
advice and consent of the Senate.
``(c) Duties of the Assistant Secretary.--The Assistant Secretary
for Medical Readiness and Response shall--
``(1) serve as the principal advisor to the Secretary on
all matters related to emergency medical preparedness and
response;
``(2) develop Federal strategy, training (including
exercises), coordination, funding, and implementation of
emergency medical response to mass casualty events for Federal,
State, and local public health agencies and private sector
entities in support of homeland security;
``(3) serve as the primary Federal official with respect to
overseeing the identification and development, in consultation
with nonprofit health and public health departments and medical
centers, of medical preparedness centers and deployable medical
care units designed to meet the demands of a terrorist event or
other incident requiring mass casualty care and containment of
infectious disease;
``(4) serve as the primary official of the Department
relating to and overseeing medical emergencies, including
emergencies incident to a terrorist attack or naturally
occurring infectious disease outbreak;
``(5) in coordination with the Secretary of Health and
Human Services, have the authority to deploy the Strategic
National Stockpile and the Commissioned Corps of the Public
Health Service;
``(6) report directly to the Secretary; and
``(7) evaluate and report to Congress on the preparedness
of Federal, State, and local agencies to respond to major
medical disaster.
``(d) Functions.--There shall be transferred to the Office of
Medical Readiness and Response the following functions, personnel,
assets, and liabilities of the following:
``(1) The National Disaster Medical System (transferred to
the Department pursuant to section 503(5)).
``(2) The Metropolitan Medical Response System (transferred
to the Department pursuant to section 503(5)).
``(3) The emergency medical response functions of the
Office of Emergency Preparedness (transferred to the Department
pursuant to section 503(5)).
``(4) Other resources and offices of the Department as
designated by the Secretary.''.
(b) Conforming amendments.--Section 502(3) of the Homeland Security
Act of 2002 (6 U.S.C. 312(3)) is amended--
(1) in subparagraph (B)--
(A) by striking ``, the National Disaster Medical
System,''; and
(B) by striking the semicolon and inserting ``;
and'';
(2) by striking subparagraph (C); and
(3) by redesignating subparagraph (D) as subparagraph (C).
TITLE X--NATIONAL EMERGENCY MEDICAL READINESS AND RESPONSE BOARD
SEC. 1001. NATIONAL EMERGENCY MEDICAL READINESS AND RESPONSE BOARD.
(a) In General.--Title VIII of the Homeland Security Act of 2002 (6
U.S.C. 361 et seq.), as amended by section 901, is further amended by
inserting after section 879A (as added by section 901) the following:
``SEC. 879B. NATIONAL EMERGENCY MEDICAL READINESS AND RESPONSE BOARD.
``(a) Establishment of Board.--
``(1) In general.--There is established in the Department
the National Emergency Medical Readiness and Response Board
(referred to in this section as the `Board').
``(2) Chairperson.--The Assistant Secretary for Medical
Readiness and Response shall serve as the chairperson of the
Board.
``(3) Composition.--The Board shall be composed of the
following members (or their designees):
``(A) The Assistant Secretary for Medical Readiness
and Response.
``(B) The United States Surgeon General.
``(C) The Assistant Secretary for Public Health
Countermeasure Development.
``(D) The Director of the National Institutes of
Health.
``(E) The Director of the Centers for Disease
Control and Prevention.
``(F) The Director of National Bioterrorism and
Hospital Readiness of the Health Resources and Services
Administration.
``(G) The Deputy Assistant to the Secretary of
Defense for Chemical and Biological Defense.
``(H) The Commanding General, Army Medical Research
and Materiel Command.
``(I) The Assistant Secretary for Health of the
Department of Veterans Affairs.
``(J) The Deputy Commander, United States Northern
Command.
``(K) The Commissioner of Food and Drugs.
``(L) The Secretary of Agriculture.
``(M) The Postmaster General.
``(N) Any other individual appointed by the
President to the Board.
``(4) Meetings.--The Board shall meet at the call of the
chairperson.
``(b) Duties and Powers.--
``(1) Duties.--The Board shall oversee the following
activities:
``(A) The development, assessment, and validation
of national, interagency, emergency medical response
plans, in coordination with State and local public
health officials, for bioterrorism (including
agroterrorism), chemical attack, radiological attack,
nuclear attack, infectious disease, and high explosives
attack.
``(B) In cooperation with State and local public
health agencies, the development, testing, and
implementation of a plan for the necessary training
related to, and the assessment and evaluation of, the
Federal emergency medical response plans described in
subparagraph (A).
``(C) The coordination of the Federal emergency
medical response plans described in subparagraph (A)
among all the Federal departments and agencies
represented on the Board through joint exercises that
shall be observed and evaluated by the members of the
Board (or their designees).
``(D) Defining, and determining when and how to
implement, national level emergency medical response
plans to medical disasters.
``(2) Powers.--The Board may secure directly from any
Federal department or agency such information as the Board
considers necessary to carry out this subsection. Upon request
of the chairperson of the Board, the head of such department or
agency shall furnish such information to the Board.
``(c) Board Personnel Matters.--
``(1) Detail of government employees.--Any Federal
Government employee may be detailed to the Board without
reimbursement, and such detail shall be without interruption or
loss of civil service status or privilege.
``(2) Procurement of temporary and intermittent services.--
The chairperson of the Board may procure temporary and
intermittent services under section 3109(b) of title 5, United
States Code, at rates for individuals which do not exceed the
daily equivalent of the annual rate of basic pay prescribed for
level V of the Executive Schedule under section 5316 of such
title.
``(d) Advisory Committee.--
``(1) Establishment.--Not later than 180 days after the
date of enactment of the Project BioShield II Act of 2005, the
Assistant Secretary for Medical Readiness and Response shall
establish an advisory committee that shall provide assistance
and oversight to the Board and to the Assistant Secretary for
Medical Readiness and Response.
``(2) Composition.--The advisory committee established
pursuant to paragraph (1) shall consist of representatives,
appointed by the Assistant Secretary for Medical Readiness and
Response, of--
``(A) designees of State and local public health
and emergency management agencies;
``(B) State and local emergency managers or
adjutant generals and State emergency medical services
directors;
``(C) physicians and first responders (including
nurses, police, and paramedics);
``(D) academic medical research institutions;
``(E) the World Health Organization;
``(F) the International Committee of the Red Cross;
``(G) the International Federation of Red Cross and
Red Crescent Societies;
``(H) the American Red Cross;
``(I) the Infectious Disease Society of America;
``(J) professional medical and clinical societies,
as appropriate;
``(K) local hospitals and hospital districts;
``(L) medical care delivery facilities (hospital
outpatient centers);
``(M) pharmacies;
``(N) accredited schools of public health;
``(O) pathologists, coroners, and chief medical
examiners; and
``(P) other individuals and representatives of
entities appointed by the Assistant Secretary for
Medical Readiness and Response to the advisory
committee.''.
(b) Conforming Amendments.--The table of contents in section 1(b)
of the Homeland Security Act of 2002 (6 U.S.C. 101 note) is amended
by--
(1) inserting after the item relating to section 511 the
following:
``Sec. 510. Countermeasure Purchase Fund at the Department of Homeland
Security.'';
and
(2) inserting after the item relating to section 879 the
following:
``Sec. 879A. Office of Medical Readiness and Response.
``Sec. 879B. National Emergency Medical Readiness and Response
Board.''.
TITLE XI--ENCOURAGING GREATER COORDINATION WITH FORMER SOVIET
SCIENTISTS AND TRANSFER OF COUNTERMEASURES
SEC. 1101. PURPOSE; REPORT TO CONGRESS.
(a) Purpose.--The purpose of this section is to direct the
Department of State and the Department of Commerce to develop and
implement a program to secure the access to, and transfer of,
compounds, culture collections, devices, scientific methods, and
research tools to the United States to further the protection of the
United States and its allies against biological, chemical, nuclear, and
radiological agents or infectious diseases. Such an effort must address
the state of intellectual property of such items and ensure the
security of such intellectual property to allow for and encourage
commercialization.
(b) Report.--
(1) In general.--Not later than 180 days after the date of
enactment of the Project BioShield II Act of 2005, the
Secretary of State, in cooperation with the Secretary of
Homeland Security and Secretary of Commerce, shall report to
the Committee on Foreign Relations of the Senate and the
Committee on International Relations of the House of
Representatives on the existence and adequacy of all United
States Government-sponsored programs or organizations
responsible for encouraging commercialization of
countermeasures developed by former-Soviet scientists and
current scientists working within the Commonwealth of
Independent States (referred to in this section as ``CIS'').
(2) Content of report.--The report described under
paragraph (1) shall identify any known legal prohibitions and
practical challenges in the United States or CIS to the
purposes of this section, including laws governing intellectual
property, export controls, and classification of information
restricting or inhibiting private-sector exchange and
development of such countermeasures. The Secretary of State
shall provide such information as the Secretary determines to
be necessary to enable such potential commercialization and
cooperation.
TITLE XII--EMERGENCY CONTINUITY OF NATIONAL HEALTHCARE; REIMBURSEMENT
OF INFECTIOUS DISEASE PHYSICIANS FOR COMMUNITY EMERGENCY PREPAREDNESS
ACTIVITIES; MEDICAL LICENSE RECIPROCITY
SEC. 1201. CONTINUITY OF NATIONAL HEALTHCARE SYSTEM IN AN EMERGENCY.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
amended by adding at the end the following:
``(e) Continuity of National Healthcare System in an Emergency.--
``(1) Emergency health insurance reimbursement.--In the
event of a public health emergency determined pursuant to
subsection (a), the Secretary may guarantee reimbursement to
public and private healthcare providers (which shall include
nurses and non-clinical staff) for care related to the public
health emergency provided to individuals by such providers to
the extent that the public or private health insurance
reimbursement (as the case may be) to such providers is not
applicable because of war or terrorism coverage exclusions at
one of the following rates:
``(A) The applicable rates under the Medicare and
Medicaid programs.
``(B) A per diem rate determined by the Secretary.
``(2) Guarantee of payments.--During a closure of the
United States mails due to a public health emergency determined
pursuant to subsection (a), the Secretary may provide a
guarantee of payment to private healthcare providers to enable
such providers to maintain services and continuity in response
to such emergency.''.
SEC. 1202. REIMBURSEMENT OF INFECTIOUS DISEASE PHYSICIANS FOR COMMUNITY
EMERGENCY PREPAREDNESS ACTIVITIES.
Section 319 of the Public Health Service Act (as amended by section
1201) is further amended by adding at the end the following:
``(f) Reimbursement of Infectious Disease Physicians for Community
Emergency Preparedness Activities.--The Secretary shall reimburse
board-certified infectious disease and public health specialists for
services provided during a public health emergency under subsection (a)
at applicable rates under the Medicare program, to the extent that such
services are not otherwise wholly reimbursed by other public or private
insurance.''.
SEC. 1203. MEDICAL LICENSE RECIPROCITY.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) (as
amended by section 1202) is further amended by adding at the end the
following:
``(g) Medical License Reciprocity.--The Secretary may issue
regulations requiring the establishment of reciprocity of medical
licensing and certification between or among States during a national
or local public health emergency determined pursuant to subsection (a).
``(h) Minimum Standards.--Medical licensing for the purposes of
subsection (g) shall include the licensing of allopathic and
osteopathic physicians, registered nurses, nurse practitioners,
physician assistants, pharmacists, paramedics, respiratory therapists,
and other first responders or allied health professionals.
``(i) PSA.--The Secretary may issue regulations requiring or
providing appropriate liability and workman's compensation coverage for
healthcare professionals and others responding to a public health
emergency, as determined under subsection (a).''.
SEC. 1204. LIABILITY PROTECTION FOR HEALTHCARE VOLUNTEERS AND
HOSPITALS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) (as amended by sections 202, 1402, 1631, 1901, 2101, 2102, and
1631) is amended by inserting after section 319F-9 (as added by section
203) the following:
``SEC. 319F-10. LIABILITY PROTECTION FOR HEALTHCARE VOLUNTEERS AND
HOSPITALS LITIGATION MANAGEMENT.
``(a) Federal Cause of Action.--
``(1) In general.--There shall exist an exclusive Federal
cause of action for claims arising out of, related to, or
resulting from care delivered by any person or entity at any
location in the United States if the governor of that State has
declared a state of emergency, or the Secretary of Health and
Human Services declares that a public health emergency is in
effect in that State, or the President signs a disaster
declaration for that State. Such Federal cause of action shall
be brought in the United States district court for the District
of Columbia and shall be only for injuries that are caused by
willful or wanton misconduct.
``(2) Limitations.--Healthcare personnel, volunteers, and
other workers providing emergency medical or triage care in
field settings, alternative treatment facilities, and in
vaccination or medication distribution settings shall be immune
from claim for loss of property (including business
interruption or other types of indirect losses), personal
injury, or death.
``(b) Special Rules.--
``(1) In general.--When a hospital is providing care under
emergency conditions as described in this section and such care
is not administered for or in expectation of compensation, then
the maximum liability to the Federal Government on behalf of
the hospital (or its employees, volunteers, officers, and
directors) is $250,000 for each claimant.
``(2) Punitive damages.--No punitive damages intended to
punish or deter, exemplary damages, or other damages not
intended to compensate a plaintiff for actual medical expenses
or lost wages may be awarded in an action under this section,
nor shall any party in such action be liable for interest prior
to the judgment.
``(3) Noneconomic damages.--No noneconomic damages may be
awarded for claims under this section.
``(4) Limitations.--Hospitals and other health care
organizations shall be immune from vicarious liability for the
actions of volunteers providing care under emergency conditions
described in this section, even if the hospital or health care
organization is considered the employer for worker'
compensation purposes.
``(5) Attorney fees.--Attorney fees in an action under this
section shall be calculated on a reasonable amount of work
performed on behalf of the plaintiff.''.
TITLE XIII--ADEQUACY OF EMERGENCY MEDICAL RESPONSE ASSETS FOR HOMELAND
SECURITY MISSIONS
SEC. 1301. ADEQUACY OF EMERGENCY MEDICAL RESPONSE ASSETS FOR HOMELAND
SECURITY MISSIONS.
(a) Study.--The Assistant Secretary for Medical Readiness and
Response of the Department of Homeland Security shall perform a study
and prepare a report assessing the state of medical and health
readiness and response capability to respond to large-scale medical
emergencies, such as terrorist actions. The study will evaluate the
following aspects of medical and health readiness and response:
(1) The nature and extent of emergency medical and health
resources needed to respond to and mitigate a biological,
chemical, radiological, or nuclear attack or an infectious
disease outbreak.
(2) The assets and resources currently available from the
Federal, State, and local governments, private sector entities,
industry, hospitals, and academia to meet the homeland security
mission.
(3) The deficiencies in assets and resources needed to
respond to such an attack or outbreak.
(4) Recommendations regarding the types and extent of
assets and resources needed to be secured to respond to such an
attack or outbreak, including those requested from State and
local public health agencies and their volunteer responders.
(b) Content.--The report described in subsection (a) shall assess
and make recommendations with regard to--
(1) the appropriate roles and responsibilities in
responding to a medical emergency of--
(A) full-time government employees;
(B) part-time personnel; and
(C) volunteer personnel;
(2) the appropriate skills and skilled workers needed,
including physicians (including infectious diseases
specialists), other health care personnel, and first
responders;
(3) the appropriate planning and training needed prior to
an attack or outbreak;
(4) the appropriate contingency plans for responding to a
novel or catastrophic incident; and
(5) mechanisms to--
(A) develop and pilot test strategies to be used to
reduce disease transmission in a bioterrorism incident,
a public health emergency, or an epidemic or pandemic;
(B) develop and validate meaningful national
standards for Federal, State, and local public health
agencies and for nongovernmental healthcare delivery
institutions in preparedness for and response to
epidemics, pandemics, and mass casualty incidents;
(C) test these methods in State, local, and multi-
State proof-of-concept tests; and
(D) develop public risk communication tools that
support the widespread use of such activities.
(c) Consultation.--In preparing this report, the Assistant
Secretary for Medical Readiness and Response of the Department of
Homeland Security shall consult with the members of the National
Emergency Preparedness and Response Board.
(d) Submission Date.--The report shall be submitted to Congress not
later than 1 year after the date of enactment of this Act.
TITLE XIV--CONSTRUCTION OF SPECIALIZED RESEARCH FACILITIES FOR THE
DEVELOPMENT OF COUNTERMEASURES
SEC. 1401. CONSTRUCTION OF SPECIALIZED RESEARCH FACILITIES FOR THE
DEVELOPMENT OF COUNTERMEASURES.
(a) In General.--Part B of title III of the Public Health Service
Act (42 U.S.C. 243 et seq.) (as amended by sections 202, 1901, 2101,
and 2102) is amended by inserting after section 319F-6 (as added by
section 2102) the following:
``SEC. 319F-7. CONSTRUCTION OF BIOSAFETY LEVEL 3-4 RESEARCH FACILITIES.
``(a) Findings.--Congress finds that--
``(1) research to develop countermeasures requires the use
of special facilities where biological and chemical agents can
be handled safely both for laboratory research and efficacy
testing in animal models;
``(2) very few companies and very few State and local
public health laboratories have sufficient funds for the
construction of these special facilities; and
``(3) the Federal Government can facilitate research and
development of countermeasures by financing the construction of
these special facilities.
``(b) Grants Authorized.--
``(1) In general.--The Secretary is authorized to award
grants and contracts to grantees to construct, maintain, and
manage (including funding for staff and staff training)
biosafety level 3-4 facilities.
``(2) Requirements.--To be eligible for a grant under
paragraph (1) an entity shall--
``(A) allow use of the facility involved by only
those researchers who meet qualifications set by the
Secretary;
``(B) give priority for the use of the facility
involved to those entities that have been registered
and certified by the Secretary to develop
countermeasures; and
``(C) allow the National Institutes of Health and
the Centers for Disease Control and Prevention to
inspect the facility involved at any time.
``(3) Number of grants.--The Secretary of Homeland Security
shall determine the number of facilities that need to be
constructed under this section, not to exceed 10 such
facilities nationwide, and the Secretary shall award grants
based on such determination.
``(c) Application.--
``(1) In general.--To be eligible to receive a grant under
this section, an entity shall submit to the Secretary an
application at such time, in such form, and containing such
information as the Secretary may require.
``(2) Contents.--Each application submitted pursuant to
paragraph (1) shall--
``(A) provide detailed information on the technical
specifications of proposed facilities;
``(B) propose a design that includes offices for
personnel, visiting researchers, and facilities for
research and laboratory materials; and
``(C) provide assurances that--
``(i) the facilities shall be available on
a fee-for-service or other basis to companies
and academic researchers;
``(ii) such services offered to companies
and academic researchers shall include testing
and validation studies for all types of
countermeasures, including detection
technology;
``(iii) such facilities shall utilize the
research tools identified by the Secretary in
section 319F-3 of this Act or certified under
section 301(b)(4) of the Project BioShield II
Act of 2005; and
``(iv) that the facilities will be
constructed as secure facilities.
``(d) Definitions.--For the purposes of this section--
``(1) unless otherwise specifically identified, the term
`Director' means the Director of the National Institutes of
Health;
``(2) the term `biosafety level 3 facility' means a
facility described in section 627.15 of title 32, Code of
Federal Regulations (or any successor regulation); and
``(3) the term `biosafety level 4 facility' means a
facility described in section 627.16 of title 32, Code of
Federal Regulation (or any successor regulation).
``(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this
section.''.
(b) Needs Assessment.--The Secretary of Health and Human Services
shall conduct a study of regional and national laboratory capacities
with respect to the laboratories described in section 319F-7 of the
Public Health Service Act (as added by this title) before implementing
such section.
TITLE XV--BIODEFENSE AND INFECTIOUS DISEASE RESEARCH AND SCIENTIFIC AND
TECHNICAL PERSONNEL
SEC. 1501. ESTABLISHMENT OF GRANT PROGRAM.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended by adding at the end the following:
``SEC. 409J. GRANTS FOR BIODEFENSE AND INFECTIOUS DISEASE RESEARCH.
``(a) In General.--The Director of the Centers for Disease Control
and Prevention (referred in this section as the `Director'), in
consultation with the Assistant Secretary for Medical Readiness and
Response of the Department of Homeland Security, and the Secretary of
Defense shall establish a program to award grants and scholarships to
eligible entities to ensure that sufficient scientific and technical
personnel are available to conduct biodefense and infectious disease
research.
``(b) Eligibility.--To be eligible to receive a grant or
scholarship under subsection (a), an entity shall--
``(1) be--
``(A) an individual who desires to acquire a
scientific or technical skill identified and listed by
the Director under subsection (c)(1)(A); or
``(B) a facility or institution that is designated
as a scientific or technical skills facility under
subsection (c)(1)(B); and
``(2) submit to the Director an application, at such time,
in such manner, and containing such information as the Director
may require.
``(c) Identification of Scientific and Technical Skills
Shortages.--
``(1) Assessment and designation.--
``(A) In general.--Not later than 1 year after the
date of enactment of this section, and annually
thereafter, the Director shall, for purposes of this
section, assess the science and technical skills that
are needed for the development of medical
countermeasures to biological, chemical, nuclear,
radiological, and other emerging natural and terrorists
threats and infectious diseases, including the
expertise needed concerning the identification of
drugs, detection equipment, diagnostics, and research
tools with respect to such countermeasures. Upon
completion of such assessment, the Director shall
publish a list of the scientific and technical skills
so identified and for which there exists a shortage of
qualified individuals.
``(B) Facilities.--Not later than 1 year after the
date of enactment of this section, and annually
thereafter, the Director shall designate public or
nonprofit private facilities or institutions that the
Director determines provides education or training with
respect to a scientific or technical skill identified
and published on the list under subparagraph (A).
``(2) Limitation on removal from list or designation.--The
Director shall not remove a skill from the list under paragraph
(1)(A) or a designation with respect to a facility or
institution under paragraph (1)(B) unless the Director has
afforded interested persons and groups an opportunity to
provide data and information in support of the listing or
designation involved, and has made a determination on the basis
of the data and information submitted by such persons and
groups and other data and information available to the
Director.
``(3) Criteria.--The Director shall establish by regulation
criteria for the listing of skills or designation of facilities
and institutions under paragraph (1).
``(4) Notice.--The Director shall give written notice of
the listing of a skill or designation of a facility or
institution not later than 60 days from the date of such
designation, to--
``(A) the Governor of each State and official of
each local city or town in which the facility or
institution so designated is in whole or part located;
and
``(B) appropriate public or nonprofit private
entities which provide education or training in the
skills so listed.
``(5) Recommended designation.--Any person may recommend to
the Director the listing or a skill or designation of a
facility or other institution under paragraph (1).
``(6) Dissemination of criteria.--The Director shall
disseminate information concerning the criteria described in
paragraph (3) to--
``(A) the Governor of each State;
``(B) the representative of any facility selected
by any such Governor to receive such information;
``(C) the representative of any facility that
requests such information; and
``(D) the representative of any facility determined
by the Director to be likely to meet such criteria.
``(d) Use of Funds.--
``(1) Scholarships.--
``(A) In general.--Amounts provided to an
individual under a scholarship under subsection (a)
shall be used to obtain education leading to a degree
or postdoctoral training at a nonprofit institution
determined appropriate by the Secretary to further the
development of medical countermeasures to biological,
chemical, nuclear, radiological, and other emerging
terrorists threats and infectious diseases, including
the expertise needed concerning the identification and
development of drugs, detection equipment, human and
animal remains handling and containment equipment and
methods, diagnostics, and research tools with respect
to such countermeasures.
``(B) Agreement to serve.--To be eligible to
receive a scholarship described in subparagraph (A), an
individual shall agree to enter into contract with the
Director for obligated service as provided for in
subparagraph (C).
``(C) Obligated service.--An individual who has
entered into a written contract with the Director under
subparagraph (B) shall conduct countermeasures research
on a full-time basis in an area determined appropriate
by the Director for the period of obligated service
provided for in such contract.
``(D) Period of service.--The period of obligated
service under a contract under subparagraph (B) shall
be equal to the greater of--
``(i) 1 year for each school year for which
the individual was provided a scholarship under
subsection (a); or
``(ii) 2 years.
``(E) Breach of contract.--The provisions of
section 338E shall apply to a breach of contract under
this paragraph to the same extent that such provisions
apply to a breach of a scholarship contract under such
section.
``(2) Transition to workforce.--The Director is authorized
to provide assistance to Federal agencies to incorporate the
individuals who receive a grant under this section into the
Federal workforce, including non-tenured positions that could
transition into permanent positions at the end of the payback
period.
``(3) Grants.--Amounts awarded under a grant under
subsection (a) shall be used for activities that facilitate the
conduct of countermeasures research.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, such sums as may be
necessary.''.
TITLE XVI--NATIONAL INSTITUTES OF HEALTH
Subtitle A--National Center for Healthcare Technology Development
SEC. 1601. PURPOSE.
The purpose of this subtitle is to enhance the licensing of
research, and protect the value of intellectual property, funded by the
National Institutes of Health to companies to develop healthcare
technologies for the benefit of patients.
SEC. 1602. NATIONAL CENTER FOR HEALTHCARE TECHNOLOGY DEVELOPMENT.
(a) In General.--Part E of title IV of the Public Health Service
Act (42 U.S.C. 287 et seq.) is amended by adding at the end the
following:
``Subpart 7--National Center for Healthcare Technology Development
``SEC. 485K. NATIONAL CENTER FOR HEALTH CARE TECHNOLOGY DEVELOPMENT.
``(a) Definition.--In this subpart, the term `healthcare technology
development program' means a program designed to--
``(1) maximize the technology development opportunities and
the return on the investment of the Federal Government in
research related to the development of human diagnostics,
therapeutics, anti-microbials, vaccines, and research tools so
that this investment provides clinical benefits to individuals;
``(2) ensure that research supported by the Federal
Government is complimentary to, and not duplicative of or
competitive with, private sector research;
``(3) speed the development of biomedical research enabling
human diagnostics, therapeutics, vaccines, and research tools;
and
``(4) reduce the time and cost necessary for the
development of human diagnostics, therapeutics, vaccines, and
research tools.
``(b) Establishment; Purpose.--
``(1) Establishment.--There is established within the
National Institutes of Health a National Center for Healthcare
Technology Development (referred to in this subpart as the
`Center').
``(2) Purpose.--The purpose of the Center is to increase
and support healthcare technology development, which includes--
``(A) maximizing the technology development
opportunities and the return on the investment of the
Federal Government in research related to the
development of human diagnostics, therapeutics,
vaccines, and research tools so that this investment
provides clinical benefits to individuals;
``(B) ensuring that research supported by the
Federal Government is complimentary to, and not
duplicative of or competitive with, private sector
research;
``(C) speeding the development of biomedical
research enabling human diagnostics, therapeutics,
vaccines, and research tools; and
``(D) reducing the cost and time necessary for the
development of human diagnostics, therapeutics,
vaccines, and research tools.
``(c) Director.--
``(1) In general.--The Center shall be headed by a Center
Director (referred to in this section as the `Center Director')
appointed by the President by and with the advice and consent
of the Senate.
``(2) Compensation.--The Center Director shall be
compensated at a rate that is the greater of--
``(A) the average total compensation of the
directors of the national research institutes; or
``(B) level IV of the Executive Schedule.
``(3) Duties of the center director.--The Center Director
shall perform functions as described under this subpart and as
the Secretary and the Director of NIH determine appropriate.
``(d) Associate Director.--
``(1) In general.--There shall be in the Center an
Associate Director for Biological, Chemical, Radiological, and
Infectious Disease Countermeasure Development (referred to in
this section as the `Associate Director'), who shall be
appointed by the Center Director.
``(2) Duties of the associate director.--The Associate
Director shall--
``(A) serve as a liaison between the Department of
Health and Human Services, the National Institutes of
Health, the Department of Homeland Security, and the
Department of Defense on matters relating to the
development of biomedical technologies that enable
effective countermeasures to bioterror, chemical, and
radiological agents and infectious diseases;
``(B) ensure that the National Institutes of Health
supports research that is consistent with, and
supportive of, the joint strategy for the development
of countermeasures for bioterror, chemical, and
radiological agents and infectious diseases of the
Department of Homeland Security, the Department of
Health and Human Services, and the Department of
Defense; and
``(C) annually review the effectiveness of the
technology transfer policies and practices of the
National Institutes of Health with respect to the
development of countermeasures for bioterror, chemical,
and radiological agents and infectious diseases to
ensure that the policies and practices are consistent
with the joint countermeasure development strategy of
the Department of Homeland Security, the Department of
Health and Human Services, and the Department of
Defense.
``(e) Duties of the Center.--The Center shall--
``(1) manage the technology transfer, partnership, and
healthcare technology development programs at the National
Institutes of Health;
``(2) oversee the healthcare technology development
programs of the grantees of the National Institutes of Health;
``(3) secure and license intellectual property for research
performed at the National Institutes of Health;
``(4) prepare, on an annual basis, the National Healthcare
Technology Development Strategy regarding the technology
transfer, partnership, and healthcare technology development
programs of the National Institutes of Health and the grantees
of the National Institutes of Health;
``(5) with regard to the Healthcare Technology Development
Opportunities Assessments under section 492A--
``(A) establish criteria for the contents of the
assessments;
``(B) assist National Institutes of Health
applicants in preparing the assessments;
``(C) assist the Directors of the national research
institutes in reviewing the assessments;
``(D) prepare periodic analyses of the contents of
the assessments; and
``(E) prepare periodic analyses of the extent to
which the opportunities were realized;
``(6) in consultation with the Directors of the national
research institutes, the National Advisory Council under
subsection (f) and the Institute Advisory Councils under
subsection (g), prepare a research agenda for the National
Institutes of Health, and for each national research institute,
that describes--
``(A) the technology development opportunities and
the research that would be most beneficial to enhancing
the return on the investment of the Federal Government
in developing human diagnostics, therapeutics,
vaccines, and research tools, so that this investment
provides clinical benefits to individuals;
``(B) the research supported by the Federal
Government that is complimentary to, and not
duplicative of or competitive with, private sector
research;
``(C) proposed measures designed to speed the
development of human diagnostics, therapeutics,
vaccines, and research tools; and
``(D) proposed measures designed to reduce the cost
and time necessary to develop human diagnostics,
therapeutics, vaccines, and research tools;
``(7) publish a technology transfer, partnership, and
healthcare technology development manual that describes the
most effective healthcare technology development policies and
practices for the National Institutes of Health and its
grantees that maximize the technology development opportunities
and the return on the investment of the Federal Government in
research to the development of healthcare technology;
``(8) collect and analyze comprehensive data regarding the
effectiveness of the technology transfer, partnerships, and
healthcare technology development programs of the National
Institutes of Health and its grantees that maximize the
technology development opportunities and the return on the
investment of the Federal Government in research to the
development of healthcare technology, including data
regarding--
``(A) intellectual property;
``(B) licensing and commercialization of inventions
sponsored by the National Institutes of Health;
``(C) cooperative research and development
agreements; and
``(D) technology development opportunities
assessments under section 492A(a);
``(9) develop guidelines that enable the National
Institutes of Health to accept and divest economic interests in
commercial entities that enter into technology transfer,
licensing, and partnership relationships with the National
Institutes of Health;
``(10) accept payment for services, use of equipment,
materials, or laboratory personnel, and retain or transfer
those funds to the appropriate laboratories;
``(11) ensure that Small Business Innovative Research
(SBIR) and Small Business Technology Transfer Program (STTR)
grants under section 9 of the Small Business Act (15 U.S.C.
638) are awarded to entities that have the greatest capacity to
develop healthcare technology that provides clinical benefits
to individuals;
``(12) oversee the review of SBIR and STTR grants;
``(13) annually award the `Birch Bayh and Robert Dole Award
for Healthcare Partnerships' to the individual and to the
organization that has made the most significant contribution
with regard to--
``(A) maximizing the technology development
opportunities and the return on the investment of the
Federal Government in research related to the
development of human diagnostics, therapeutics,
vaccines, and research tools so that this investment
provides clinical benefits to individuals;
``(B) ensuring that research supported by the
Federal Government is complimentary to, and not
duplicative of or competitive with, private sector
research;
``(C) speeding the development of biomedical
research enabling human diagnostics, therapeutics,
vaccines, and research tools; and
``(D) reducing the time and cost necessary to
develop human diagnostics, therapeutics, vaccines, and
research tools;
``(14) annually award the `Ronald Reagan and Morris Udall
Award for Healthcare Technology Development' to the individual
scientist supported by the National Institutes of Health that
has made the most significant contribution to the development
of healthcare technology that provides clinical benefits to
individuals;
``(15) provide grants to private organizations with
expertise in technology transfer, partnerships, and healthcare
technology development programs;
``(16) manage an education program for National Institutes
of Health and private sector entity employees and grantees on
the role of the National Institutes of Health concerning the
development of healthcare technology; and
``(17) manage the advisory councils under subsections (f)
and (g).
``(f) National Advisory Council.--
``(1) Establishment.--The Secretary shall establish in the
Center an advisory council to be known as the National
Healthcare Technology Development Advisory Council (referred to
in this subsection as the `National Advisory Council').
``(2) Composition.--
``(A) In general.--The National Advisory Council
shall be composed of 13 members to be appointed in
accordance with subparagraph (B) and subject to
subparagraphs (C), (D), (E), and (F).
``(B) Appointment; background.--
``(i) Appointment.--Not later than 180 days
after the effective date of the Project
BioShield II Act of 2005, the Director of NIH
shall appoint the members of the National
Advisory Council.
``(ii) Background.--Of the members
appointed under clause (i)--
``(I) not less than 9 members shall
be executive officers of biotechnology,
pharmaceutical, diagnostic, and
research tool companies that are
currently developing or commercializing
healthcare technology;
``(II) not less than 3 members
shall be executive offices of small
business interests; and
``(III) the remaining members may
include investors and investment
company executives, securities
analysts, experts in the economics of
biomedical research and development,
experts in intellectual property and
technology transfer, Food and Drug
Administration regulations, licenses,
partnerships, and technology transfer
officers of grantees of the National
Institutes of Health.
``(C) Institute advisory councils.--A member of the
National Advisory Council shall not serve as a member
of an Institute Advisory Council under subsection (g).
``(D) Ex officio members.--
``(i) In general.--The Secretary of
Commerce, the Director of the National Science
Foundation, and the Director of the National
Institute of Standards and Technology shall
serve as ex officio members of the National
Advisory Council.
``(ii) Designees.--The officers listed in
clause (i) may appoint a designee to perform
their functions on the National Advisory
Council.
``(E) Chairperson.--The Director of NIH shall
appoint a chairperson of the National Advisory Council
from among the council members.
``(F) Vacancy.--Any vacancy in the National
Advisory Council shall not affect the powers of the
Council and shall be filled in the same manner as the
original appointment.
``(3) Duties of the national advisory council.--The
National Advisory Council shall advise the Center Director
regarding policies and procedures that will--
``(A) maximize the technology development
opportunities and the return on the investment of the
Federal Government in research related to the
development of human diagnostics, therapeutics,
vaccines, and research tools so that this investment
provides clinical benefits to individuals;
``(B) ensure that research supported by the Federal
Government is complimentary to, and not duplicative of
or competitive with, private sector research;
``(C) speed the development of biomedical research
into effective human diagnostics, therapeutics,
vaccines, and research tools; and
``(D) reduce the cost and time needed for the
development of human diagnostics, therapeutics,
vaccines, and research tools.
``(4) Powers.--
``(A) Hearings.--The National Advisory Council may
hold such hearings, sit and act at such times and
places, take such testimony, and receive such evidence
as the National Advisory Council considers advisable to
carry out this section.
``(B) Information from federal agencies.--The
National Advisory Council may secure directly from any
Federal department or agency such information as the
National Advisory Council considers necessary to carry
out the provisions of this section. Upon request of the
National Advisory Council, the head of such department
or agency shall furnish such information to the
National Advisory Council.
``(C) Postal services.--The National Advisory
Council may use the United States mails in the same
manner and under the same conditions as other
departments and agencies of the Federal Government.
``(5) Personnel.--
``(A) Travel expenses.--The members of the National
Advisory Council shall not receive compensation for the
performance of services for the National Advisory
Council, but shall be allowed travel expenses,
including per diem in lieu of subsistence, at rates
authorized for employees of agencies under subchapter I
of chapter 57 of title 5, United States Code, while
away from their homes or regular places of business in
the performance of services for the National Advisory
Council. Notwithstanding section 1342 of title 31,
United States Code, the Secretary may accept the
voluntary and uncompensated services of members of the
National Advisory Council.
``(B) Detail of government employees.--Any Federal
Government employee may be detailed to the National
Advisory Council without reimbursement, and such detail
shall be without interruption or loss of civil service
status or privilege.
``(g) Institute Advisory Councils.--
``(1) Establishment.--The Secretary shall establish in the
Center the National Center for Healthcare Technology
Development Institute Advisory Councils (referred to in this
subsection as the `Institute Advisory Councils').
``(2) Composition.--
``(A) In general.--Each Institute Advisory Council
shall be composed of 13 members appointed in accordance
with subparagraph (B) and subject to subparagraphs (C),
(D), (E), and (F).
``(B) Appointment; background.--
``(i) Appointment.--Not later than 180 days
after the effective date of the Project
BioShield II Act of 2005, the appropriate
Institute Director shall appoint the members of
the respective Institute Advisory Council.
``(ii) Background.--Of the members
appointed under clause (i)--
``(I) at least 9 members shall be
executive officers of biotechnology,
pharmaceutical, diagnostic, and
research tool companies that are
currently developing or commercializing
healthcare technology; and
``(II) the remaining members shall
include investors and investment
company executives, securities
analysts, experts in the economics of
biomedical research and development,
experts in intellectual property and
technology transfer, Food and Drug
Administration regulations, licenses,
partnerships, and technology transfer
officers of grantees of the National
Institutes of Health.
``(C) National advisory council.--A member of an
Institute Advisory Council shall not serve as a member
of the National Advisory Council under subsection (f).
``(D) Ex officio member.--The Center Director, or
his or her designee, shall serve as an ex officio
member of the Institute Advisory Councils.
``(E) Chairperson.--The appropriate Institute
Director shall appoint a chairperson of the respective
Institute Advisory Council from among the council
members.
``(F) Vacancies.--Any vacancy in an Institute
Advisory Council shall not affect the powers of the
Council and shall be filled in the same manner as the
original appointment.
``(3) Duties of the institute advisory council.--The
Institute Advisory Councils shall advise the Center Director
regarding policies and procedures that will--
``(A) maximize the technology development
opportunities and the return on the investment of the
Federal Government in research related to the
development of human diagnostics, therapeutics,
vaccines, and research tools so that this investment
provides clinical benefits to individuals;
``(B) ensure that research supported by the Federal
Government is complimentary to, and not duplicative of
or competitive with, private sector research;
``(C) speed the development of biomedical research
into human diagnostics, therapeutics, vaccines, and
research tools; and
``(D) reduce the cost and time needed for the
development of human diagnostics, therapeutics,
vaccines, and research tools.
``(4) Powers.--
``(A) Hearings.--The Institute Advisory Councils
may hold such hearings, sit and act at such times and
places, take such testimony, and receive such evidence
as the Institute Advisory Council considers advisable
to carry out this section.
``(B) Information from federal agencies.--The
Institute Advisory Councils may secure directly from
any Federal department or agency such information as
the Institute Advisory Council considers necessary to
carry out the provisions of this section. Upon request
of an Institute Advisory Council, the head of such
department or agency shall furnish such information to
the Institute Advisory Council.
``(C) Postal services.--The Institute Advisory
Councils may use the United States mails in the same
manner and under the same conditions as other
departments and agencies of the Federal Government.
``(5) Personnel.--
``(A) Travel expenses.--The members of the
Institute Advisory Councils shall not receive
compensation for the performance of services for the
Institute Advisory Councils, but shall be allowed
travel expenses, including per diem in lieu of
subsistence, at rates authorized for employees of
agencies under subchapter I of chapter 57 of title 5,
United States Code, while away from their homes or
regular places of business in the performance of
services for the Institute Advisory Councils.
Notwithstanding section 1342 of title 31, United States
Code, the Secretary may accept the voluntary and
uncompensated services of members of the Institute
Advisory Council.
``(B) Detail of government employees.--Any Federal
Government employee may be detailed to an Institute
Advisory Council without reimbursement, and such detail
shall be without interruption or loss of civil service
status or privilege.
``(h) Traineeships; Fellowships.--
``(1) In general.--The Secretary, acting through the Center
Director, may--
``(A) provide research training and instruction in
technology transfer and healthcare commercialization
transfer, licenses, partnerships, and healthcare
technology development; and
``(B) establish research traineeships and
fellowships in technology transfer and healthcare
commercialization.
``(2) Stipends and allowances.--The Secretary may provide
individuals receiving instruction, a traineeship, or fellowship
under paragraph (1) with such stipends and allowances,
including amounts for travel, subsistence, and dependents, as
the Secretary determines necessary.
``(3) Employee detail.--The Secretary shall establish
guidelines for the temporary leave, for a period of not to
exceed 3 years, of not more than 220 employees of the National
Institutes of Health, to appropriate for-profit organizations
that are in the business of developing human therapeutics,
vaccines, devices, or diagnostics and research tools.
``(i) Grants.--
``(1) In general.--The Secretary, acting through the Center
Director, shall award grants to eligible nonprofit institutions
to provide training, instruction, traineeships, and fellowships
under subsection (h).
``(2) Use of funds.--A nonprofit institution that receives
funds under this subsection shall use the amounts provided
through the grant to provide training, instruction,
traineeships, and fellowships to individuals under subsection
(h) with regard to technology transfer and healthcare
development.
``(3) Eligibility.--To be eligible for a grant under this
subsection, a nonprofit institution shall submit an application
to the Secretary in such form, in such manner, and containing
such information as the Secretary may require.
``(j) Authorization of Appropriations.--There is authorized to be
appropriated an amount equal to 0.3 percent of the amount obligated by
the National Institutes of Health in fiscal year 2004 for each fiscal
year to carry out this section.''.
(b) Government Discount.--The Secretary of Health and Human
Services and the Secretary of Veterans Affairs shall ensure that the
price that the Federal Government pays for a drug, biological product,
human therapeutic, vaccine, or diagnostic developed using technology
licensed by the National Institutes of Health does not include
reimbursement for any royalty rate previously paid by the technology
partner or its assign.
SEC. 1603. TECHNOLOGY DEVELOPMENT OPPORTUNITIES ASSESSMENTS.
Section 492A(a) of the Public Health Service Act (42 U.S.C. 289a-
1(a)) is amended by adding at the end the following:
``(3) Technology development opportunities assessment.--
Each proposal submitted to the National Institutes of Health
shall include an assessment, prepared in compliance with the
guidelines developed by the National Center for Healthcare
Technology Development, of technology development
opportunities, including opportunities that may exist for the
proposed research to--
``(A) maximize the technology development
opportunities and the return on the investment of the
Federal Government in research related to the
development of human diagnostics, therapeutics,
vaccines, and research tools so that this investment
provides clinical benefits to individuals;
``(B) ensure that research supported by the Federal
Government is complimentary to, and not duplicative of
or competitive with, private sector research;
``(C) speed the development of biomedical research
into human diagnostics, therapeutics, vaccines, and
research tools; and
``(D) reduce the cost and time necessary for the
development of human diagnostics, therapeutics,
vaccines, and research tools.''.
SEC. 1604. RESOURCES FOR THE NATIONAL CENTER FOR HEALTHCARE TECHNOLOGY
DEVELOPMENT.
Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b))
is amended--
(1) in paragraph (13)(B), by striking ``and'';
(2) in paragraph (14), by striking ``title 38, United
States Code.'' and inserting ``title 38, United States Code;
and''; and
(3) inserting after paragraph (14) the following:
``(15) after consultation with the Director of the National
Center for Healthcare Technology Development, shall develop
programs designed to--
``(A) maximize the technology development
opportunities and the return on the investment of the
Federal Government in research related to the
development of human diagnostics, therapeutics,
vaccines, and research tools so that this investment
provides clinical benefits to individuals;
``(B) ensure that research supported by the Federal
Government is complimentary to, and not duplicative of
or competitive with, private sector research;
``(C) speed the development of biomedical research
into human diagnostics, therapeutics, vaccines, and
research tools; and
``(D) reduce the time and cost necessary for the
development of human diagnostics, therapeutics,
vaccines, and research tools.''.
SEC. 1605. BIENNIAL REPORT OF THE DIRECTOR OF THE NATIONAL INSTITUTES
OF HEALTH TO THE PRESIDENT AND CONGRESS.
Section 403 of the Public Health Service Act (42 U.S.C. 283) is
amended--
(1) in paragraph (4), by striking ``area; and'' and
inserting ``area;'';
(2) in paragraph (5), by striking ``Nursing Research.'' and
inserting ``Nursing Research; and''; and
(3) by inserting after (5) the following:
``(6) a description of the healthcare technology that has
been developed for the clinical benefit of individuals with
support by the National Institutes of Health in the preceding
2-year period and the specific contribution of research
supported by the National Institutes of Health to this
technology.''.
SEC. 1606. AUTHORITY OF THE DIRECTORS OF THE NATIONAL RESEARCH
INSTITUTES; BIENNIAL REPORT.
(a) Authority of the Directors of the National Research
Institutes.--Section 405(b)(1)(A) of the Public Health Service Act (42
U.S.C. 284(b)(1)(A)) is amended--
(1) in clause (iii), by striking ``disabilities, and'' and
inserting ``disabilities,'';
(2) in clause (iv), by striking ``the environment;'' and
inserting ``the environment, and''; and
(3) by inserting after clause (iv) the following:
``(v) the expansion of knowledge of the creation,
manufacture, or administration of treatments of
patients suffering from diseases, disorders, or
disabilities; and''.
(b) Biennial Report.--Section 407 of the Public Health Service Act
(42 U.S.C. 284b) is amended to read as follows:
``SEC. 407. INSTITUTE BIENNIAL REPORT.
``(a) In General.--The Director of each national research
institute, after consultation with the advisory council for the
institute, shall include in the biennial report made under section
403--
``(1) a description of the research areas identified as
most relevant to the development of technology by the National
Center for Healthcare Technology Development Advisory Council;
``(2) a description of the activities of the institute;
``(3) a description of technology that has been developed
and licensed for the clinical benefit of individuals from all
research supported by the institute; and
``(4) a description of program policies of the Director of
the institute.
``(b) Additional Reports.--The Director of each national research
institute may prepare such additional reports as the Director
determines appropriate.
``(c) Opportunity for Written Comments.--The Director of each
national research institute shall provide the advisory council for the
institute an opportunity for the submission of the written comments
described under section 406(g).''.
SEC. 1607. COMMERCIAL RESEARCH AND INVESTIGATIONS.
Section 301(a) of the Public Health Service Act (42 U.S.C. 241(a))
is amended in the matter following paragraph (8) by striking ``for
biomedical and behavioral research, substances and living organisms''
and inserting ``for commercial, biomedical, and behavioral research,
substances, resources, rights to intellectual property, and living
organisms''.
SEC. 1608. SBIR/STTR PROGRAM CONSULTATION WITH THE DIRECTOR OF THE
CENTER OF HEALTHCARE TECHNOLOGY DEVELOPMENT.
Section 9 of the Small Business Act (15 U.S.C. 638) is amended--
(1) in subsection (g)(3)--
(A) in subparagraph (A), by striking ``; or'' and
inserting a semicolon;
(B) in subparagraph (B), by inserting ``or'' after
the semicolon; and
(C) by adding after subparagraph (B) the following:
``(C) the Director of the National Center for
Healthcare Technology Development under section 485K of
the Public Health Service Act;''; and
(2) in subsection (o)(3)--
(A) in subparagraph (A), by striking ``; or'' and
inserting a semicolon;
(B) in subparagraph (B), by inserting ``or'' after
the semicolon; and
(C) by inserting after subparagraph (B) the
following:
``(C) by the Director of the National Center for
Healthcare Technology Development under section 485K of
the Public Health Service Act;''.
SEC. 1609. PURPOSE OF THE NATIONAL RESEARCH INSTITUTES.
Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.)
is amended--
(1) in section 410 (42 U.S.C. 285), by inserting before the
period the following: ``, and the conduct and support of the
development of healthcare technologies'';
(2) in section 418 (42 U.S.C. 285b), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(3) in section 426 (42 U.S.C. 285c), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(4) in section 435 (42 U.S.C. 285d), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(5) in section 443 (42 U.S.C. 285e), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(6) in section 446 (42 U.S.C. 285f), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(7) in section 448 (42 U.S.C. 285g), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(8) in section 453 (42 U.S.C. 285h), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(9) in section 455 (42 U.S.C. 285i), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(10) in section 457 (42 U.S.C. 285j), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(11) in section 461 (42 U.S.C. 285k), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(12) in section 463 (42 U.S.C. 285l), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(13) in section 464 (42 U.S.C. 285m), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(14) in section 464H (42 U.S.C. 284n), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(15) in section 464L (42 U.S.C. 285o), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(16) in section 464R (42 U.S.C. 285p), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies'';
(17) in section 464V (42 U.S.C. 285q), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies''; and
(18) in section 464Z (42 U.S.C. 285r), by inserting before
the period the following: ``, and the conduct and support of
the development of healthcare technologies''.
SEC. 1610. CONFORMING AMENDMENT.
Section 401(b)(1) of the Public Health Service Act (42 U.S.C.
281(b)(1)) is amended by adding at the end the following:
``(S) The National Center for Healthcare Technology
Development.''.
SEC. 1611. EFFECTIVE DATE.
This title shall take effect on October 1, 2005, or upon the date
of enactment of this title, whichever occurs later.
Subtitle B--Protecting Government Investment in Basic Biomedical
Research
SEC. 1621. FINDINGS.
Congress finds that--
(1) the rate of return on the Federal Government's
investment in basic biomedical research is maximized when the
intellectual property for that research is effectively
transferred to commercial entities for development into
healthcare products for the benefit of patients;
(2) intellectual property for research supported by the
National Institutes of Health is often not competitive with
intellectual property for research supported by private
investors due to inefficiencies of the technology transfer
process and the consequent erosion of the term of the patents
for the technology; and
(3) to protect the Federal Government's investment in basic
biomedical research and to maximize the likelihood that
technology will be developed into healthcare products, a patent
that is not affected by the inefficiencies in the technology
transfer process should be granted.
SEC. 1622. UTILIZATION AND AVAILABILITY.
(a) In General.--An entity with respect to which an affirmative
determination is made under section 301(b)(4) shall maximize the
utilization of a research tool involved for the development of
countermeasures, including making the research tool available on
commercially reasonable terms to other entities certified under section
301(b)(4) to develop countermeasures.
(b) Rule of Construction.--Nothing in this title or chapter 18 of
title 35, United States Code, shall be construed to restrict the right
of an entity described in subsection (a) to--
(1) secure and enforce a patent regarding a research tool;
(2) enter into exclusive, revocable, and nontransferable
licenses of a research tool; or
(3) impose limits on royalty- or product- reach-through or
downstream rights or agreements on future countermeasures, or
option rights with respect to a research tool.
SEC. 1623. RESTORATION OF TERM OF UNEXPLOITED PATENTS ON GOVERNMENT
SPONSORED INVENTIONS RELATING TO COUNTERMEASURES.
(a) In General.--Chapter 14 of title 35, United States Code, is
amended by adding at the end the following:
``Sec. 159. Patent term restoration for unexploited patents on
Government sponsored inventions
``(a) Definitions.--In this section:
``(1) Eligible government-sponsored invention.--The term
`eligible Government-supported invention' means an invention
supported in part by funds appropriated to the National
Institutes of Health that may be used to produce a
countermeasure to a terror agent, infectious disease or other
disease or condition or is subject to the provisions of chapter
18 of title 35, United States Code.
``(2) Eligible government patent.--The term `eligible
Government patent' means a patent that--
``(A) claims an eligible Government-supported
invention;
``(B) has not been extended or restored under
section 156, 156a, or 158; and
``(C) has not been licensed prior to a date that is
2 years before the date the patent will expire.
``(3) Effective exploitation of date of the patent.--The
term `effective exploitation date of the patent' means the date
that is the later of--
``(A) the date that the patent is licensed to an
entity that is not a Federal agency, as that term is
defined in section 201(a), for purposes of development
or commercialization of the patented invention; or
``(B) if the patent claims a product, a method of
using a product or a method of using a product as
defined in section 156(a), the date that such product
is approved under section 505(b)(1) of the Federal Food
Drug and Cosmetic Act (21 U.S.C. 355(b)(1)) or under
section 351 of the Public Health Service Act (42 U.S.C.
262).
``(b) Patent Term Restoration for Eligible Government Patents.--
``(1) In general.--Notwithstanding the provisions of
section 154, the term of an eligible Government patent shall be
restored by a period equal to the number of days starting on
the date that the patent is issued and ending on the date of
effective exploitation date of the patent.
``(2) Limitation.--No eligible Government patent shall be
restored under this section unless--
``(A) the Director of the National Institutes of
Health (referred to in this section as the `Director of
NIH') determines that the licensing of such patent will
assist in the development of countermeasures,
medicines, vaccines, and other technology potentially
beneficial to patients; and
``(B) prior to the expiration of the patent, the
Director of NIH submits an application to the Director
to restore the term of the patent under subsection (c).
``(c) Procedure for Restoring Term of Eligible Government Patent.--
``(1) In general.--The Director of NIH shall request
restoration of an eligible Government patent by submitting a
written application to the Director.
``(2) Contents of application.--An application under this
section shall--
``(A) be sent to the Director prior to the date
that is 45 days before the patent expires;
``(B) set forth the period of the restoration
requested; and
``(C) provide an explanation of the basis of the
conclusion of the Director of NIH that the requirements
of subparagraph (A) are met with respect to the patent
being restored.
``(3) Effect of section.--The Director of NIH shall
promulgate regulations to give effect to this section,
including procedures that permit the restoration of patents in
respect of which title has been transferred under section 202.
``(d) Deferral of Payment of Patent Issue Fees for Eligible
Government Patents.--The Federal agency that has rights in an invention
subject to a patent application under chapter 18 may defer the payment
of fees under section 41 due for issuance of an eligible Government
patent until the date that is 90 days after the date that the patent
been licensed to an entity that is not a Federal agency as that term is
defined in section 201(a). Not later than 30 days after the date a
notice of allowance of the patent application is mailed by the
Director, the applicant shall inform the Director that it is invoking
this section with respect to the application. The Director shall issue
the patent for the National Institutes of Health-supported technology
notwithstanding the non-payment of the issue fee, subject to the
provisions of this section.
``(e) Procedures Applicable to Patent Term Restoration
Applications.--The Director has the authority to accept an application
submitted under this section and sections 156, 156a, and 158 after the
date specified in such sections in exceptional circumstances or where
good cause is shown for the delay in submitting the application, except
no application may be accepted under any of these sections more than 30
days after the date specified in such section.
``(f) Rules of Construction Regarding Research Tools.--Nothing in
this section or chapter 18 of title 35, United States Code, shall be
construed to restrict the right of an entity to--
``(i) secure and enforce patents with
regard to research tools;
``(ii) enter into exclusive, revocable, and
nontransferable licenses of such research
tools; or
``(iii) impose limits on royalty- or
product-reach-through or downstream rights or
agreements on future countermeasures or
products, or option rights with respect to a
research tool.''.
(d) Discretionary Waiver of March-In Rights and Exclusive
Licensing.--
(1) In general.--The owner of a patent over which the
Government has rights under chapter 18 of title 35, United
States Code, may request that a Federal agency under whose
funding a subject invention was made may waive rights the
Government has under sections 200, 203, and 209 of title 35,
United States Code.
(2) Requests.--If a request under paragraph (1) is made
within 90 days after the date that the entity obtained title to
the patent, the Federal agency shall grant the request.
(c) Federally owned inventions.--Section 209 of title 35,
United States Code, (as amended by section 301) is amended--
(A) by redesignating subsections (f) and (g) as
subsections (g) and (h), respectively; and
(B) by inserting after subsection (e) the
following:
``(f) Terms and Conditions of Exclusive License.--Each exclusive
license granted shall include a provision that, at the discretion of
the licensee, the licensee may act as the agent for the licensor with
respect to any patent for the licensed invention for purposes of
extending a patent under section 156a or 158.''.
(d) Technical and Conforming Amendment.--The table of sections for
chapter 14 of title 35, United States Code, is amended by adding after
the item relating to section 158 the following:
``159. Patent term restoration for unexploited patents on
Government sponsored inventions.''.
SEC. 1624. ENCOURAGING THE PATENTING OF RESEARCH TOOLS.
Section 200 of title 35, United States Code, is amended by striking
``enterprise without unduly encumbering future research and discovery''
and inserting ``enterprise''.
SEC. 1625. EFFECTIVE DATE.
This title takes effect on October 1, 2005, or upon the date of
enactment of this title, whichever occurs later.
Subtitle C--Partnership Challenge Grants
SEC. 1631. PARTNERSHIP CHALLENGE GRANTS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) (as amended by sections 202, 1901, 2101, 2102, and 1401) is
amended by inserting after section 319F-7 (as added by section 1401)
the following:
``SEC. 319F-8. NATIONAL INSTITUTES OF HEALTH COUNTERMEASURES
PARTNERSHIP CHALLENGE GRANTS.
``(a) Grants Authorized.--The Director of the National Institutes
of Health (in this section referred to as the `Director'), in
consultation with the Director of the Centers for Disease Control and
Prevention, is authorized to award, in consultation with the Foundation
for the National Institutes of Health, partnership challenge grants to
promote joint ventures between the National Institutes of Health, the
Foundation for the National Institutes of Health, its grantees,
qualified clinical countermeasures delivery centers, and for-profit
biotechnology, pharmaceutical, and medical device industries for the
development of countermeasures and research tools.
``(b) Regulations.--The Director shall issue regulations within 90
days of the date of enactment of this section to implement the awarding
of grants under subsection (a).
``(c) Rule of Construction.--Nothing in this section shall be
construed to preclude an entity that receives a partnership challenge
grant under this section from also being certified as being eligible
for the tax, procurement, intellectual property, and liability
incentives provided for under the amendments made by subtitle A of
title III of the Project BioShield II Act of 2005.
``(d) Safety Training Program.--The Director of NIH, in
consultation with the Director of the Centers for Disease Control and
Prevention, shall establish a safety training program for researchers
working in biosafety level 3 or 4 facilities.
``(e) Transfer of Funds.--The Director is authorized to transfer
funds to the Foundation for the National Institutes of Health to be
used for partnership grants and other costs associated with
administering this section.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for each of fiscal years
2004, 2005, 2006, 2007, and 2008 for the purpose of carrying out this
section.''
TITLE XVII--DEVELOPMENT OF COUNTERMEASURE RESEARCH AT THE DEPARTMENT OF
DEFENSE
SEC. 1701. DEVELOPMENT OF COUNTERMEASURE RESEARCH AT THE DEPARTMENT OF
DEFENSE.
There are authorized to be appropriated to the Department of Health
and Human Services, including funds appropriated under the Project
BioShield Act of 2004 and this Act, such sums as may be necessary to
secure and facilitate the development of countermeasures, as defined in
section 319F-3 of the Public Health Service Act (as added by section
202), and infectious disease research at the Department of Defense.
SEC. 1702. REQUEST BY THE DEPARTMENT OF DEFENSE.
(a) In General.--Upon request by the Secretary of Defense, the
Secretary of Health and Human Services may establish interagency
agreements, under terms acceptable to the Secretary of Health and Human
Services, in which the Department of Defense may order countermeasures
under procurement contracts or procurement pools established by the
Secretary of Health and Human Services.
(b) Processing of Orders.--The ordering of a countermeasure under
an agreement under subsection (a) (including transfers of appropriated
funds between the Department of Defense and the Department of Health
and Human Services to pay for such orders) may be conducted pursuant to
section 1535 of title 31, United States Code, if such order is
processed under the terms established--
(1) by the Secretary in the interagency agreement described
under subsection (a) for all other orders; and
(2) in the Project BioShield Act of 2004 and the Project
BioShield II Act of 2005 (and the amendments made by such Acts)
with respect to the procurement of countermeasures under
section 319F-2 and section 319F-1 of the Public Health Service
Act.
SEC. 1703. EXPANDED PUBLIC-PRIVATE PARTNERSHIP AGREEMENTS FOR RESEARCH
AND DEVELOPMENT.
(a) Cooperative Research and Development Agreements.--
(1) Authority.--In order to develop countermeasures and
research tools, the Secretary of Defense may--
(A) authorize the directors or commanders of
laboratories and technical activities to enter into
agreements under section 3710a of title 15, United
States Code; and
(B) subject to requirements analogous to those
governing the licensing of federally owned inventions
under section 209 of title 35, United States Code,
grant nonexclusive, exclusive, or partially exclusive
licenses, royalty-free or for royalties or other
consideration, for computer software developed at a
laboratory or technical activity that would, if the
information involved were obtained from a non-Federal
source, constitute a trade secret or commercial or
financial information that is privileged or
confidential under the meaning of section 552(b)(4) of
title 5, United States Code.
(2) Protection of software.--The Secretary of Defense shall
provide appropriate precautions against the unlicensed
dissemination of any software licensed under paragraph (1)(B),
including exemption from subchapter II of chapter 5 of title 5,
United States Code (commonly known as the Administrative
Procedure Act), for a period of up to 5 years after the
development of the software by the laboratory or technical
activity.
(b) Royalties.--
(1) In general.--Except as provided in paragraph (2), any
royalties or other payments received by the Department of
Defense from licensing computer software under subsection
(a)(1)(B) shall be disposed of as follows:
(A) The Department may provide appropriate
incentives, from royalties or other payments, to
laboratory and technical activity employees who are not
developers of such computer software but who
substantially increased the technical value of the
software.
(B) The Department shall retain the royalties and
other payments received until the Department or the
laboratory or technical activity involved makes
payments to employees of a laboratory or technical
activity under subparagraph (A).
(C) The balance of the royalties or other payments
shall be transferred by the Department of Defense to
the accounts of any of its laboratories and technical
activities, with the majority share of the royalties or
other payments from any invention going to the account
of the laboratory or technical activity responsible for
the invention. The royalties or other payments so
transferred may be used or obligated by a laboratory or
technical activity during the fiscal year in which they
are received or during the 2 succeeding fiscal years--
(i) to reward scientific, engineering, and
technical employees of the laboratory or
technical activity, including developers of
sensitive or classified technology, regardless
of whether the technology has commercial
applications;
(ii) to further scientific exchange among
the laboratories and technical activities of
the Department;
(iii) for education and training of
employees consistent with the research and
development missions and objectives of the
Department or the laboratory or technical
activity, and for other activities that
increase the potential for transfer of the
technology of the laboratories and technical
activities;
(iv) for payment of expenses incidental to
the administration and licensing of computer
software or other intellectual property made at
that laboratory or technical activity,
including the fees or other costs for the
services of other agencies, persons, or
organizations for intellectual property
management and licensing services; or
(v) for scientific research and development
consistent with the research and development
missions and objectives of the laboratory or
technical activity.
(D) All royalties or other payments retained by the
Department or laboratory or technical activity after
payments have been made pursuant to subparagraphs (A),
(B), and (C) that are unobligated and unexpended at the
end of the second fiscal year succeeding the fiscal
year in which the royalties and other payments were
received shall be paid into the Treasury of the United
States.
(2) Excess payments.--If, after payments to employee-
developers under paragraph (1), the royalties or other payments
received by the Department of Defense in any fiscal year exceed
5 percent of the budget of the Department for that year, 75
percent of such excess shall be paid to the Treasury of the
United States and the remaining 25 percent may be used or
obligated as described in paragraph (1)(C). Any funds not so
used or obligated shall be paid into the Treasury of the United
States.
(3) Treatment of payments.--Any payment made to an employee
under this subsection shall be in addition to the regular pay
of the employee and to any other awards made to the employee,
and shall not affect the entitlement of the employee to any
regular pay, annuity, or award to which such employee is
otherwise entitled or for which such employee is otherwise
eligible or limit the amount thereof. Any such payment made to
an employee-developer shall continue after the developer leaves
the laboratory or technical activity or the Department.
Payments made under this section shall not exceed $150,000 per
year to any one person, unless the President approves a larger
award (with the amount in excess of $150,000 being treated as a
Presidential award under section 4504 of title 5, United States
Code).
(c) Regulations.--The Secretary of Defense shall promulgate
regulations implementing this section.
(d) Information in Report.--The report required under section
2515(d) of title 10, United States Code, shall include information
regarding the implementation and effectiveness of this section.
(e) Laboratory and Technical Activity Defined.--As used in this
section, the terms ``laboratory'' and ``technical activity'' mean any
facility or group of facilities that is owned, leased, operated, or
otherwise used by the Department of Defense to perform research,
development, engineering, testing, or evaluation. The term includes
Department of Defense universities, depots, logistics centers, test
centers, shipyards, arsenals, or similar organizations that perform
these activities in any capacity consistent with their missions,
regardless of whether such activities are a primary or substantial
element of such missions. This definition also shall be used by
Department of Defense entities when entering into cooperative research
and development agreements under section 3710a of title 15, United
States Code.
(f) Effective Date and Expiration.--The authority provided for in
this section is for a pilot program to test the effectiveness of this
authority and shall expire on December 31, 2009.
TITLE XVIII--MILLENNIUM MEDICINE DISCOVERY AWARD
SEC. 1801. MILLENNIUM MEDICINE DISCOVERY AWARD.
Part P of title III of the Public Health Service Act (42 U.S.C. 280
et seq.) is amended by adding at the end the following:
``SEC. 3990. MILLENNIUM MEDICINE DISCOVERY AWARD.
``(a) Establishment of Award.--There is established an award to be
known as the Millennium Medicine Discovery Award (referred to in the
section as the `Award').
``(b) Purpose of Award.--The Secretary shall present the Award to
an individual, institution of higher learning (as defined in section
101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)), or
commercial entity that--
``(1) discovers a vaccine or therapeutic that cures or
prevents AIDS;
``(2) discovers a vaccine or therapeutics that prevents
infection from malaria;
``(3) discovers a new class of anti-microbials; or
``(4) attains another achievement in infectious disease
research as determined by the Secretary.
``(c) Regulations.--
``(1) In general.--The Secretary shall by regulation
establish the medical discoveries for which the Award may be
conferred, the amount of the award, and the application process
for the Award.
``(2) Limitation.--The amount of an Award under this
section, which shall be in the form of cash, shall not exceed
$100,000,000 per discovery.
``(d) Examples of Discoveries.--Discoveries that may qualify for an
Award under this section may include 1 of the following:
``(1) An oral vaccine delivery system, or needle-free
system, that provides primary immunization against bioterrorism
agents, infectious disease, or significant diseases of the
developing world.
``(2) A new adjuvant for vectored or recombinant DNA
vaccines that induce and sustain both cellular and humeral
responses in humans that is directed at bioterrorism agents,
infectious diseases, or significant diseases of the developing
world.
``(3) A vaccine that provides lifelong protection against
HIV-1 infection, or a vaccine that lessens the viral load in
those immunized people who become infected or that delays the
clinical progression of disease and decreases transmission of
the virus through the immunized population.
``(4) A microbicide that prevents or significantly reduces
HIV transmission and other infections. In this paragraph, the
term `microbicide' means a range of products, including those
products in gel, cream, film, ring, or suppository form that,
when applied topically, prevent HIV transmission and other
sexually transmitted diseases.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this section.
The Secretary shall secure \1/2\ of the funding for the Awards under
this section from other entities, including nonprofit institutions.''.
TITLE XIX--FOOD AND DRUG ADMINISTRATION
SEC. 1901. OTHER INCENTIVES.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 319F-3 (as added by
section 202) the following:
``SEC. 319F-4. ACCELERATED APPROVAL OF COUNTERMEASURES.
``(a) In General.--The Secretary may designate a countermeasure as
a fast-track product pursuant to section 506 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356) or as a device granted priority review
pursuant to section 515(d)(5) of such Act (21 U.S.C. 366e(d)(5)). Such
a designation may be made prior to the submission of--
``(1) a request for designation by the sponsor or
applicant; or
``(2) an application for the investigation of the drug
under section 505(i) (21 U.S.C. 355(i)) of such Act or section
351(a)(3).
Nothing in this subsection shall be construed to prohibit a sponsor
or applicant from declining such a designation.
``(b) Use of Animal Trials.--A drug for which approval is sought
under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(d)) or section 351 on the basis of evidence of effectiveness
that is derived from animal studies may be designated as a fast-track
product for purposes of this section.
``(c) Priority Review.--
``(1) In general.--A countermeasure that is a drug or
biological product shall be subject to the performance goals
established by the Commissioner of Food and Drugs for priority
drugs or biological products.
``(2) Definition.--In this subsection, the term `priority
drugs or biological products' means a drug or biological
product that is the subject of a drug application referred to
in section 101(4) of the Food and Drug Administration
Modernization Act of 1997.''.
SEC. 1902. SYSTEMS BIOLOGY.
(a) Findings.--Congress makes the following findings:
(1) Systems biology, the application of computational tools
to understand the dynamic behavior of biological networks as
integrated systems rather than isolated parts, is an emerging
field of research.
(2) Open-source systems biology can play a role in
accelerating understanding of complex biological systems,
increasing confidence in the analysis and prioritization of
drug targets, enabling predictive toxicology, and other
emerging capabilities.
(3) Such capabilities can lead to shorter drug development
times, speeding the delivery of needed medication to address
public health concerns, and may help decrease or manage the
high risks associated with the entire drug development system,
resulting in a reduction of the mounting costs of drug
development and an increase in the number of new entities
brought to market to improve public health.
(b) Implementation of Biology Research Programs.--The Secretary of
Health and Human Services shall promulgate regulations implementing--
(1) systems biology research programs, including systems
biology tool development, model development, and integration of
such research into experimental frameworks validating and
exploiting research results;
(2) research efforts, including systems biology approaches,
directed to address the detection of biothreat agents through
blood samples; and
(3) such programs described in the Food and Drug Report of
March 2004 entitled ``Critical Path Initiative'' that enable
the development of tools and methods for the rapid approval of
safe medications for the treatment of anticipated biohazards.
SEC. 1903. BIOTERROR AND INFECTIOUS DISEASE PROVISIONS.
(a) Bioterror and Infectious Disease Provisions.--Chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended
by adding at the end the following:
``Subchapter F--Bioterror and Infectious Disease Products
``SEC. 571. DEFINITIONS.
``In this subchapter:
``(1) Biological agent.--The term `biological agent',
`biological toxin', or any variation of any such term, means
any microorganism, virus, infectious substance, or biological
product, that may be used in a manner that is intended to cause
widespread death or serious bodily injury, including biological
agents and toxins described in paragraphs (1) and (2) of
section 178 of title 18, United States Code.
``(2) Bioterror or infectious disease product.--The term
`bioterror or infectious disease product' means a
countermeasure against a biological agent.
``(3) Countermeasure.--The term `countermeasure' means--
``(A) a vaccine and related delivery system, anti-
infective, microbicide, diagnostic technology, drug,
biological product, or other technology that can be
used to diagnose, treat, or prevent infection with or
bodily harm from, or the spread of, a biological or
chemical agent or toxin on the list described in
section 319F-3(f) of the Public Health Service Act, and
that is subject to applicable provisions of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
the Public Health Service Act (42 U.S.C. 201 et seq.),
or the Virus-Serum-Toxin Act (21 U.S.C. 151 et seq.);
``(B) a therapy, diagnostic, or piece of equipment
that may be used to detect, treat, or prevent bodily
harm that may be caused by the use of nuclear or
radiological material as a terror weapon;
``(C) a qualified countermeasure, as defined in
section 319F-1 of the Public Health Service Act (42
U.S.C. 247d-6a); and
``(D) a security countermeasure, as defined in
section 319F-2 (42 U.S.C. 246d-6b).
``(4) Infectious disease.--
``(A) In general.--The term `infectious disease'
means a disease in humans caused by--
``(i) a microbe (including a bacteria,
virus, fungus, or parasite) that is acquired by
a person that reproduces in that person;
``(ii) microbial products (such as
botulinum toxin); or
``(iii) a prion.
``(B) Inclusion.--
``(i) a disease in humans caused by a
microorganism, whether or not--
``(I) such microorganism is
acquired by an individual through
human-to-human contact; or
``(II) if the individual is
initially symptomatic of the disease;
and
``(ii) zoonotic diseases that may find
hosts in animal and human populations.
``SEC. 572. DEPUTY COMMISSIONER FOR BIOLOGICAL, CHEMICAL, NUCLEAR,
RADIOLOGICAL, AND INFECTIOUS DISEASE PRODUCTS.
``(a) Establishment of Office.--There is established within the
Office of Counterterrorism of the Office of the Commissioner of the
Food and Drug Administration an Office of the Deputy Commissioner for
Biological, Chemical, Nuclear, Radiological, and Infectious Disease
Products (referred to in this section as the `Deputy Commissioner').
``(b) Duties.--The Deputy Commissioner shall--
``(1) oversee, plan, and direct resources and personnel of
the Center for Biologics Evaluation and Research, the Center
for Drug Evaluation and Research, and other relevant offices
within the Food and Drug Administration, toward the evaluation
of products for the prevention, surveillance, diagnosis, and
treatment of biological, chemical, nuclear, radiological, and
emerging infectious disease threats;
``(2) review not less than annually, the progress of such
offices with respect to the functions described under paragraph
(1); and
``(3) consult with the Commissioner of Food and Drugs with
respect to carrying out the duties described under paragraph
(1).
``(c) Authority.--The Deputy Commissioner shall have the
authority to address staffing needs and compensation for
shortfalls resulting from any waiver of user fees under section
574.
``SEC. 573. ACCELERATED APPROVAL FOR CERTAIN PRODUCTS.
``The Secretary shall, at the request of the sponsor of a new
bioterror or infectious disease product, deem such countermeasure a
fast track product under section 506 if--
``(1) there is no other countermeasure product approved by
the Food and Drug Administration sufficient to respond to the
bioterror or pathogen threat addressed by such new product; and
``(2) the bioterror or pathogen threat addressed by such
new product is eminent, as determined by the Secretary, in
consultation with the Secretary of Homeland Security and the
Director of the Centers for Disease Control and Prevention.
``SEC. 574. WAIVER OF USER FEES.
``(a) In General.--The Secretary shall waive the assessment of a
user fee under chapter VII to the application and approval of a
bioterror or infectious disease product. Such waivers shall not result
in a reduction of funds available to the Secretary for conducting
review of such applications and approvals.
``(b) Limitation.--The Secretary shall not waive an assessment of a
user fee under subsection (a) for an applicant more than once.''.
SEC. 1904. APPROVALS OF CERTAIN DRUGS BASED ON ANIMAL TRIALS.
(a) Federal Food, Drug, and Cosmetic Act.--Section 505(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended by
adding at the end the following: ``In the case of drugs and diagnostic
devices for use against infectious disease or lethal or permanently
disabling toxic biological, chemical, radiological, nuclear, or other
substances, when adequate and well-controlled studies of effectiveness
in humans cannot ethically be conducted because the studies would
involve administering a potentially lethal or permanently disabling
toxic substance or organism to healthy human volunteers, and when
adequate field trials assessing use of the drug or diagnostic device
(in situations such as after accidental or hostile exposure to the
substance) have not been feasible or where adequate volumes of human
samples for diagnosis from previous exposures is not available, the
Secretary may grant approval based on evidence of effectiveness derived
from appropriate studies in animals. The Secretary may promulgate
regulations establishing standards, criteria, and procedures for use of
the authority contained in the preceding sentence.''.
(b) Public Health Service Act.--Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(k) Approval of Certain Products and Diagnostic Devices Based on
Animal Trials.--In the case of biological products and diagnostic
devices for use against infectious disease, or lethal or permanently
disabling toxic biological, chemical, radiological, nuclear, or other
substances, when definitive human effectiveness studies in humans
cannot ethically be conducted because the studies would involve
administering a potentially lethal or permanently disabling toxic
substance or organism to healthy human volunteers, and when adequate
field trials assessing use of the drug (in situations such as after
accidental or hostile exposure to the substance) have not been
feasible, the Secretary may grant approval based on evidence of
effectiveness derived from appropriate studies in animals. The
Secretary may promulgate regulations establishing standards, criteria,
and procedures for use of the authority provided under this
subsection.''.
(c) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this section
(and the amendments made by this section).
SEC. 1905. CLINICAL TRIAL GUIDELINES FOR ANTI-INFECTIVES.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 510 the following:
``SEC. 511. CLINICAL TRIAL GUIDELINES FOR ANTI-INFECTIVES.
``(a) In General.--Not later than 1 year after the date of
enactment of the Project BioShield II Act of 2005, the Secretary,
acting through the Commissioner of Food and Drugs, shall issue
guidelines for the conduct of clinical trials with respect to anti-
microbials, including anti-microbials to treat resistant pathogens,
bacterial meningitis, acute bacterial sinusitis, acute bacterial otitis
media, and acute exacerbation of chronic bronchitis. Such guidelines
shall indicate the appropriate animal models of infection, in vitro
techniques, and valid microbiologic surrogate markers.
``(b) Review.--Not later than 5 years after the date of enactment
of the Project BioShield II Act of 2005, the Secretary, acting through
the Commissioner of Food and Drugs, shall review and update the
guidelines described under subsection (a) to reflect developments in
scientific and medical information and technology.''.
SEC. 1906. AUTHORIZATION OF APPROPRIATIONS FOR FDA PURCHASE OF
MICROBIOLOGICAL DATA.
(a) In General.--There are authorized to be appropriated $3,000,000
for fiscal year 2007 for the purpose of strengthening the ability of
the Food and Drug Administration to evaluate antibiotics for the
treatment of targeted pathogens.
(b) Sole purpose.--Such funds shall be used solely for the purpose
of contracting with entities that the Secretary of Health and Human
Services determines capable of providing national, real-time
microbiological data relevant to antibiotic sensitivity of all
clinically relevant strains of bacterial pathogens.
SEC. 1907. AUTHORIZATION OF APPROPRIATIONS TO IMPLEMENT PUBLIC HEALTH
SERVICE ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE.
To implement the Public Health Service action plan to combat
antimicrobial resistance (Public Health Action Plan to Combat
Antimicrobial Resistance, Part 1: Domestic Issues (January 18, 2001))
as developed by the Interagency Antimicrobial Resistance Task Force
authorized under section 319E of the Public Health Service Act (42
U.S.C. 247d-5), there are authorized to be appropriated $25,000,000 for
fiscal year 2007.
TITLE XX--ANIMAL MODELS
SEC. 2001. ANIMAL MODELS FOR CERTAIN DISEASES.
(a) Finding.--Congress finds that the development of well-
characterized animal models for identified threat agents is crucial for
testing the efficacy of medical countermeasures, and that data is
crucial for licensure of products to protect the Nation, particularly
those animals genetically designed and bred to mimic the disease or
toxic response of humans to a particular biological insult.
(b) Establishment of Working Group; Grants To Study Animal
Responses.--Subpart 6 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285f et seq.) is amended by adding at the end
the following:
``SEC. 447C. ESTABLISHMENT OF WORKING GROUP.
``(a) In General.--The Director of the Institute, in consultation
with the Assistant Secretary for Medical Readiness and Response of the
Department of Homeland Security and the Director of the Centers for
Disease Control and Prevention, shall establish a working group to
carry out the duties described in subsection (b) (referred to in this
section as the `Working Group').
``(b) Duties.--The Working Group shall determine the most pressing
scientific gaps in understanding that must be addressed to create
accurate animal models used to determine disease processes for agents
that threaten humans.
``(c) Membership.--The Working Group shall include not less than
one Director of a center in the National Private Research Program.
``SEC. 447D. GRANTS TO STUDY ANIMAL RESPONSES.
``(a) In General.--The Secretary, in consultation with the
Commissioner of Food and Drugs and the Secretary of Homeland Security,
shall--
``(1) establish and award grants under this section to
eligible entities to study the physiological responses of
certain animal species to bioterrorism agents and other
infectious agents; and
``(2) coordinate efforts to identify and develop well-
characterized animal models, including correlates of
protection, when feasible, for categories of infectious
diseases, and classes of toxins considered the most likely
threats to human populations, as identified as bioterror agents
by the Office of Emergency Preparedness and Response of the
Centers for Disease Control and Prevention.
``(b) Eligibility; Application.--To be eligible to receive a grant
under this section, an entity shall--
``(1) provide assurances to the Secretary that the entity
has a biosafety level 3 or 4 facility that is approved by the
Centers for Disease Control and Prevention or has a contractual
relationship with such a facility; and
``(2) with respect to an animal biosafety lab, provide
assurances that such lab is in compliance with the Guide for
the Care and Use of Laboratory Animals and the Animal Welfare
Act (7 U.S.C. 2131 note); and
``(3) submit to the Secretary an application at such time,
in such manner, and containing such information as the
Secretary may require.
``(c) Benefits Under Project BioShield.--
``(1) In general.--If the Secretary determines that an
entity receiving a grant under this section has successfully
and thoroughly created an animal model for the purpose of
testing and regulating novel countermeasures, such animal model
shall be considered a research tool for purposes of receiving
the benefits under the amendments made by the Project BioShield
II Act of 2005.
``(2) Clarification.--An animal model may be developed, and
subsequently recommended by the Food and Drug Administration,
separately from a countermeasure application so that such
animal model is regarded as a research tool for the
countermeasure and such Administration may require such
recommended animal model in clinical trials to fulfill
regulatory requirements.
``(d) Definitions.--
``(1) Biosafety level 3 facility.--The term `biosafety
level 3 facility' means a facility described in section 627.15
of title 32, Code of Federal Regulations (or any successor
regulation).
``(2) Biosafety level 4 facility.--The term `biosafety
level 4 facility' means a facility described in section 627.16
of title 32, Code of Federal Regulations (or any successor
regulation).
``(3) Research tool.--The term `research tool' includes the
full range of tools that scientists may use in the laboratory,
including animal disease models, cell lines, cell line cultures
for the production of biologics, monoclonal and polyclonal
antibodies, reagents, drug delivery technologies, vaccine
adjuvants, laboratory animals, large animals including nonhuman
primates and large animals used for drug production, growth
factors, combinatorial chemistry and DNA libraries, antigen
libraries, clones and cloning tools (such as PCR or Real Time
PCR), methods, laboratory equipment and machines, databases,
and other technologies that enable the rapid and effective
development of countermeasures, including diagnostics,
vaccines, and drugs.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for the development of
animals models described under subsection (a)(2).''.
SEC. 2002. ANIMAL MODELS FIVE-YEAR INITIATIVE.
(a) Findings.--Congress finds the following:
(1) The United States Government has made an unprecedented
commitment to expanding and advancing the biomedical research
program at the National Institutes of Health, and the success
of the Government's efforts is contingent upon the availability
of quality resources that will enable and enhance all research
endeavors ranging from the most basic and fundamental to the
most highly innovative.
(2) Biomedical research has relied on such quality
resource, the National Primate Research Centers Program, for
more than 40 years, for research models and expertise with non-
human primates.
(3) The National Primate Research Centers Program is
comprised of a network of 8 National Primate Research Centers
(referred to in this section ``NPRCs'') that provide
centralized housing and care for non-human primates, as well as
the facilities and support necessary for research conducted
with such primates. Scientists from almost every State use the
resources of the NPRCs for a vast array of studies.
(4) As a result of expanded investment in biomedical
research from 2000 to 2005, the demand for the resources of the
NPRCs has increased significantly, but several important
impediments have become barriers to successful non-human
primate research, including the limited number of such primates
available, the lack of infrastructure to breed and house
animals for research, and the need for trained staff for
handling and sophisticated care.
(5) In order to remedy such problems, the National
Institutes of Health needs to support a Federal advancement
initiative for the NPRCs that addresses the necessary upgrades
and program capacity expansions.
(b) Five-year Initiative for Primate Centers.--
Subpart 1 of Part E of title IV of the Public Health Service Act
(42 U.S.C. 287 et seq.) is amended by--
(1) redesignating the section 481C as added by Public Law
106-505 as section 481D; and
(2) by adding at the end the following:
``SEC. 481E. FIVE-YEAR INITIATIVE FOR PRIMATE CENTERS.
``(a) In General.--The Secretary shall provide additional sums to
the base grants provided to the National Primate Research Centers by
the National Center for Research Resources in order to--
``(1) increase domestic breeding capabilities;
``(2) develop bridging programs to effectively utilize
additional primate species;
``(3) increase the quality and capacity of primate housing
and breeding facilities and the availability of related state-
of-the-art diagnostic and clinical support equipment for
primates; and
``(4) increase the number of personnel trained in primate
care and management at the National Primate Research Centers.
``(b) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this
section.''.
TITLE XXI--STRENGTHENING OF THE VACCINE INDUSTRY
Subtitle A--Biologics, Adjuvants, and Cell Culture Development
SEC. 2101. BIOLOGICS MANUFACTURING CAPACITY INCENTIVES.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) (as amended by sections 202 and 1901) is amended by inserting
after section 319F-4 (as added by section 1901) the following:
``SEC. 319F-5. BIOLOGICS MANUFACTURING CAPACITY INCENTIVES.
``(a) Survey and Plan.--Not later than 90 days after the date of
enactment of the Project BioShield II Act of 2005, the Secretary
shall--
``(1) conduct a survey of the biologics manufacturing and
filling facilities, including those for the production of
antibiotics, vaccines, monoclonal and polyclonal antibodies,
recombinant proteins, and plant compounds using cell culture
methods, recombinant technology or other techniques, as well as
those for the production of antibodies and other blood products
from human and animal blood, operating in the United States and
determine whether additional manufacturing facilities that will
be needed (and if so the number of such facilities) to
manufacture and stockpile biologically active materials for
bioterrorist attacks or infectious disease outbreaks; and
``(2) develop a plan to ensure that sufficient biologics
manufacturing and filling facilities are available in the
United States, Canada, Mexico, Europe, and Japan, when they are
needed, including an analysis of the feasibility of the Federal
Government contracting for the construction and maintenance of
such facilities or of providing tax and other incentives for
the construction and maintenance of such facilities by private
sector entities.
``(b) Submission to Congress.--The Secretary shall submit the plan
developed under subsection (a)(2) to Congress together with
recommendations concerning the manner in which to ensure that the
needed biologics manufacturing facilities available for the production
of countermeasures under this title are constructed and available,
including the siting, design and certification costs, costs of training
and recruitment of expert staff, and other costs associated with such
facilities.
``(c) Incentives for the Construction of Biologics Manufacturing
Facilities Available for the Production of Countermeasures.--The
Secretary shall issue regulations regarding the selection of an entity
that agrees to operate as a biologics manufacturing facility available
for the production of countermeasures under this title in accordance
with the plan developed under subsection (a)(2) for the investment tax
credit provided under the amendments made by title III of the Project
BioShield II Act of 2005. Such regulations shall state when such an
entity shall be available and the terms for the use for the production
of such countermeasures. If an entity is constructed to produce such
countermeasures, such entity shall provide notice that such entity is
available to produce such countermeasures.''.
SEC. 2102. BIOLOGICS MANUFACTURING EFFICIENCY INCENTIVES.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) (as amended by sections 202, 1901, and 2101) is amended by
inserting after section 319F-5 (as added by section 2101) the
following:
``SEC. 319F-6. BIOLOGICS MANUFACTURING EFFICIENCY INCENTIVES.
``(a) Findings.--Congress finds that--
``(1) the manufacturing of biologics, which are derived
from living organisms, is an art as well as a science;
``(2) the efficiency of the biologics manufacturing process
determines the output capacity, purity, and manufacturing cost
of antibiotics, vaccines, recombinant proteins, plant
compounds, antibodies, and blood products;
``(3) technical advances in manufacturing sciences for
biologics can increase the capacity of the Federal Government
to ensure that antibiotics, vaccines, recombinant proteins,
plant compounds, antibodies, and blood products are available
as part of a bioterror or infectious disease plan and to reduce
the cost of manufacturing and stockpiling these vaccines,
recombinant proteins, plant compounds, antibodies, and blood
products; and
``(4) the subjects of research relating to the
manufacturing of biologics may include the development of--
``(A) additional well-characterized cell lines or
host strains for antibiotics, vaccines, recombinant
proteins, plant compounds, and monoclonal and
polyclonal antibody production;
``(B) new biologic and chemical standards for use
in product testing, including testing of potency and
purity;
``(C) improved preservatives for vaccines or other
biologics to prolong shelf-life;
``(D) adjuvants that enhance the immune response;
``(E) tests to determine contamination with human
or animal viruses or prions;
``(F) improved tests of potency and purity during
the manufacturing process, not just for the final
product;
``(G) improved characterization of biologics at the
macro-molecular level;
``(H) processes that enhance the yield and quality
of biologics;
``(I) improved methods that enhance disinfection
and sterilization of material and facilities;
``(J) new methods to improve output, manufacturing
costs, and product quality with a particular emphasis
on downstream processing (separation and purification)
where particular bottlenecks occur with much lost
product, complexity, and very high costs; and
``(K) improved methods for decontamination of
production facilities to enable switching from one
product to another.
``(b) Survey and Plan.--Not later than 180 days after the date of
enactment of the Project BioShield II Act of 2005, the Secretary
shall--
``(1) conduct a survey of existing biologics manufacturing
sciences and determine whether technical advances in such
sciences might increase the biologics output capacity and
purity, and lower the manufacturing cost of antibiotics,
vaccines, recombinant proteins, plant compounds, antibodies,
and blood products; and
``(2) develop a plan to provide incentives to enhance
scientific research to develop new technologies identified
under the survey conducted under paragraph (1), including a
list of the possible technologies that may be developed and the
possible incentives that may lead to their development.
``(c) Submission to Congress.--The Secretary shall submit the plan
developed under subsection (b)(2) to Congress together with
recommendations concerning the provision of funding or incentives for
the conduct of scientific research to develop new technologies relating
to biologics manufacturing sciences.
``(d) Incentives.--The Secretary shall establish a program under
which entities that agree to develop new technologies, or improve
existing technologies, in accordance with the plan developed under
subsection (b)(2) are eligible for the tax incentives provided for
under the amendments made by section 312 of the Project BioShield II
Act of 2005.''.
SEC. 2103. DEVELOPMENT OF VACCINE ADJUVANTS.
(a) Findings.--Congress finds the following:
(1) New vaccines are under development and testing for the
control of infectious diseases including human immunodeficiency
virus infection, anthrax, avian flu, and many others, and
additional infectious diseases can be anticipated with advanced
rapid, along with advanced rapid production of vaccine
technologies.
(2) Most new vaccines are composed of synthetic,
recombinant, or highly purified subunit antigens that are safer
than those in use as of the date of enactment of this Act, but
their purity can result in a weaker protective response from
the vaccine recipient.
(3) Vaccines are administered to protect a healthy
population, and any complications with vaccines result in swift
and severe public and legal responses.
(4) Adjuvants are chemicals that enhance the specific
protective immune response of vaccines.
(5) As of 2005, there is one aluminum salt-based adjuvant
used in vaccines licensed in the United States.
(6) Standardized methods to evaluate new vaccine adjuvant
safety must be implemented for human vaccines that are to be
formulated with novel adjuvants.
(7) Vaccine adjuvants should receive highest priority by
the Food and Drug Administration and the National Institute of
Allergy and Infectious Diseases, as the failure to develop and
approve them will result in the inability to deploy effective
countermeasures against bioterrorism or naturally occurring
infectious diseases, even when vaccine development is achieved.
(b) Vaccine Adjuvant Priority.--The Secretary of Health and Human
Services shall promulgate regulations that establish--
(1) priority handling procedures, which may included
expedited review and fee waivers, at the Food and Drug
Administration with respect to vaccine adjuvants; and
(2) methods for evaluating the safety of--
(A) adjuvants, separate from the methods used to
evaluate the safety and effectiveness of adjuvants with
vaccine agents; and
(B) adjuvants used in conjunction with one or more
vaccine agent.
(c) Incentives for Vaccine Adjuvant Producers.--
(1) In general.--Persons that produce adjuvants shall be
entitled to receive the incentives under title III (and the
amendments made by that title).
(2) Defense of certain malpractice and negligence suits.--
Section 224 of the Public Health Service Act (42 U.S.C. 233)
(as amended by title III of this Act) shall apply to vaccine
adjuvants developed for use in bioterrorism countermeasures or
to treat or prevent infectious disease in the same manner as
such section applies to covered countermeasures (as defined by
such section).
(d) Requests for Proposals.--The Secretary of Health and Human
Services shall develop and publish in the Federal Register a request
for proposals with respect to adjuvant development and production.
(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary carry out this section.
SEC. 2104. CELL CULTURE OR RECOMBINANT VACCINES.
(a) Grants.--The Director of the National Institutes of Health, in
consultation with the Commissioner of Food and Drugs and the Director
of the Centers of Disease Control and Prevention, may award grants to
eligible entities for the development of cell-culture and other vaccine
production technologies.
(b) Eligibility.--To be eligible to receive a grant under this
section an entity shall--
(1) be a public or private entity determined appropriate by
the Director of the National Institutes of Health; and
(2) prepare and submit to the Director an application at
such time, in such manner, and containing such information as
the Director may require.
(c) Use of Funds.--An entity shall use amounts received under a
grant under this section to carry out activities leading to the
development of cell-culture and other vaccine production technology,
including the retooling of outdated plants and the construction of new
manufacturing plants.
(d) Activities of the Food and Drug Administration.--To further the
goal of increasing the production of cell culture and other vaccines,
the Food and Drug Administration shall--
(1) develop updated regulations relating to the approval of
cell culture and other vaccines; and
(2) as part of such regulations, provide for priority to be
given to the inspection and evaluation of cell culture and
other vaccine manufacturing plants.
(e) Activities of the Secretary.--To further the goal of increasing
the production of cell culture and other vaccines, the Secretary of
Health and Human Services shall--
(1) develop a strategic plan for the distribution of
biologicals developed at facilities constructed under a grant
under this section in the case of an infectious disease
outbreak; and
(2) not later than 6 months after the date of enactment of
this Act, submit to the appropriate committees of Congress a
report on the strategy developed under paragraph (1) and on the
status and use of previous vaccine development grants.
(f) Authorization of Appropriations.--There is authorized to be
appropriated such sums as may be necessary to carry out this section.
Subtitle B--Influenza Vaccine
CHAPTER 1--INFLUENZA VACCINE AWARENESS CAMPAIGN
SEC. 2111. AWARENESS CAMPAIGN AND EDUCATION AND OUTREACH EFFORTS.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399O. AWARENESS CAMPAIGN AND EDUCATION AND OUTREACH EFFORTS.
``(a) Campaign.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention (in this section referred to
as the `Director'), shall conduct a public awareness campaign and
education and outreach efforts each year during the time period
preceding the influenza season on each of the following:
``(1) The importance of receiving the influenza vaccine.
``(2) Which populations the Director recommends to receive
the influenza vaccine to prevent health complications
associated with influenza, including health care workers and
household contacts.
``(3) Professional medical education of physicians, nurses,
pharmacists, and other health care providers and such
providers' associated organizations.
``(4) Information that emphasizes the safety and benefit of
recommended vaccines for the public good.
``(b) Outreach to Medicare Recipients.--
``(1) In general.--The Administrator of the Centers for
Medicare & Medicaid Services shall, at the earliest possible
time in the influenza vaccine planning and production process,
reach out to providers of medicare services, including managed
care providers, nursing homes, hospitals, and physician offices
to urge early and full preordering of the influenza vaccine so
that production levels can accommodate the needs for the
influenza vaccine.
``(2) Rates of immunization among medicare recipients.--The
Director shall work with the Administrator of the Centers for
Medicare & Medicaid Services to publish the rates of influenza
immunization among individuals receiving assistance under the
medicare program under title XVIII of the Social Security Act
(42 U.S.C. 1395 et seq.).
``(c) State and Public Health Adult Immunization Activities.--The
Director shall support the development of State adult immunization
programs that place emphasis on improving influenza vaccine delivery to
high-risk populations and the general population, including the
exploration of improving access to the influenza vaccine.
``(d) Efficacy of Vaccine.--The Director shall work with
appropriate agencies in conducting a study to assess the efficacy of
the influenza vaccine.
``(e) Existing Modes of Communication.--In carrying out the public
awareness campaign and education and outreach efforts under subsections
(a) and (b), the Director may use existing websites or structures for
communication.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $10,000,000 for each of fiscal
years 2005 through 2009.''.
CHAPTER 2--ENCOURAGING VACCINE PRODUCTION CAPACITY
SEC. 2121. INCENTIVES FOR THE CONSTRUCTION OF VACCINE MANUFACTURING
FACILITIES.
(a) Vaccine Manufacturing Facilities Investment Tax Credit.--
(1) Allowance of credit.--Section 46 of the Internal
Revenue Code of 1986 (relating to amount of investment credit)
is amended by striking ``and'' at the end of paragraph (1), by
striking the period at the end of paragraph (2) and inserting
``, and'', and by adding at the end the following new
paragraph:
``(3) the vaccine manufacturing facilities investment
credit.''.
(2) Amount of credit.--Subpart E of part IV of subchapter A
of chapter 1 of such Code (relating to rules for computing
investment credit) is amended by inserting after section 48 the
following new section:
``SEC. 48A. VACCINE MANUFACTURING FACILITIES CREDIT.
``(a) In General.--For purposes of section 46, the influenza
vaccine manufacturing facilities investment credit for any taxable year
is an amount equal to 20 percent of the qualified investment for such
taxable year.
``(b) Qualified Investment.--
``(1) In general.--For purposes of subsection (a), the
qualified investment for any taxable year is the basis of each
influenza vaccine manufacturing facilities property placed in
service by the taxpayer during such taxable year.
``(2) Vaccine manufacturing facilities property.--For
purposes of this section, the term `influenza vaccine
manufacturing facilities property' means real and tangible
personal property--
``(A)(i) the original use of which commences with
the taxpayer, or
``(ii) which is acquired through purchase (as
defined by section 179(d)(2)),
``(B) which is depreciable under section 167,
``(C) which is used for the manufacture,
distribution, or research and development of vaccines,
and
``(D) which is in compliance with any standards and
regulations which are promulgated by the Food and Drug
Administration, the Occupational Safety and Health
Administration, or the Environmental Protection Agency
and which are applicable to such property.
``(c) Certain Progress Expenditure Rules Made Applicable.--Rules
similar to rules of subsections (c)(4) and (d) of section 46 (as in
effect on the day before the date of the enactment of the Revenue
Reconciliation Act of 1990) shall apply for purposes of this
subsection.
``(d) Termination.--This subsection shall not apply to any property
placed in service after December 31, 2009.''.
(b) Technical Amendments.--
(1) Clause (iii) of section 49(a)(1)(C) of such Code is
amended to read as follows:
``(iii) the basis of any vaccine
manufacturing facilities property.''.
(2) Subparagraph (E) of section 50(a)(2) of such Code is
amended by inserting ``or 48A(c)'' before the period.
(3) The table of sections for subpart E of part IV of
subchapter A of chapter 1 of such Code is amended by inserting
after the item relating to section 48 the following:
``Sec. 48A. Vaccine manufacturing facilities credit.''.
(c) Effective Date.--The amendments made by this section shall
apply to property placed in service after December 31, 2004, under
rules similar to the rules of section 48(m) of the Internal Revenue
Code of 1986 (as in effect on the day before the date of enactment of
the Revenue Reconciliation Act of 1990).
CHAPTER 3--ENSURING SUFFICIENT FLU VACCINE SUPPLY
SEC. 2131. VACCINE SUPPLY.
Title XXI of the Public Health Service Act (42 U.S.C. 300aa-1 et
seq.) is amended by adding at the end the following:
``Subtitle 3--Influenza Vaccine
``vaccine supply
``Sec. 2141. (a) Requests for More Doses.--
``(1) In general.--Not later than March 15 of each year,
the Secretary shall enter into contracts with manufacturers to
produce such additional doses of the influenza vaccine as
determined necessary by the Secretary.
``(2) Content of contract.--A contract for additional doses
shall provide that the manufacturer will be compensated by the
Secretary at an equitable rate negotiated by the Secretary and
the manufacturer for any doses that--
``(A) were not sold by the manufacturer through
routine market mechanisms at the end of the influenza
season for that year; and
``(B) were requested by the Secretary to be
produced by such manufacturer.
``(3) When such vaccine purchases should take place.--The
Secretary may purchase from the manufacturer the doses for
which it has contracted at any time after which it is
determined by the Secretary, in consultation with the
manufacturer, that the doses will likely not be absorbed by the
private market.
``(b) Contingency Plan.--The Secretary shall encourage States to
develop a contingency plan, in coordination with the Department of
Health and Human Services, for maximizing influenza immunization for
high-risk populations in the event of a delay or shortage of the
influenza vaccine.
``(c) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be
necessary.''.
CHAPTER 4--PREPARING FOR A PANDEMIC OR EPIDEMIC
SEC. 2141. PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC; ANTI-VIRALS
SUPPLY.
Subtitle 3 of title XXI of the Public Health Service Act, as added
by section 2131, is amended by adding at the end the following:
``preparation for influenza pandemic or epidemic
``Sec. 2142. (a) Establishment of a Protocol.--The Secretary,
acting through the Director of the National Vaccine Program (referred
to in this section as the `Director of the Program'), shall continue
progress on the pandemic preparedness plan and, in consultation with
the Director of the Centers for Disease Control and Prevention,
establish a protocol to attempt to prevent, prepare for, and respond to
an influenza pandemic or epidemic. Such protocol shall be updated as
determined appropriate by the Director of the Program.
``(b) Contents of Protocol.--The protocol established under
subsection (a) shall--
``(1) improve upon the current influenza vaccines and
production and dissemination methods; and
``(2) address--
``(A) methods to coordinate dissemination of the
influenza vaccine to key populations in the event of an
influenza pandemic or epidemic;
``(B) expansion of influenza vaccine manufacturing
capacity (including making advance arrangements for
ensuring the availability of raw materials) to respond
to the needs of the United States during an influenza
pandemic or epidemic;
``(C) alternative ways to manufacture or produce
the influenza vaccine;
``(D) alternative methods to prevent the spread of,
and complications associated with, influenza, including
anti-viral medications;
``(E) vaccine manufacturing capacity, production,
and dissemination to improve preparedness for immediate
pandemic threats, which may include avian influenza;
``(F) a tracking method for publicly and privately
sold doses of the influenza vaccine to enable the
Director of the Program to determine, after
consultation with manufacturers of the influenza
vaccine, how much supply is in circulation in the case
of an influenza pandemic or epidemic; and
``(G) other issues determined by the Director of
the Program to be appropriate.
``(c) Coordination; Preparation; Prevention.--In establishing the
protocol under subsection (a), the Director of the Program shall--
``(1) coordinate with health care providers, manufacturers,
research institutions, health care organizations, and other
expert stakeholders;
``(2) continue building international and national
surveillance capacity;
``(3) continue to engage in epidemiological studies and
research on novel influenza viruses; and
``(4) assist States with preparedness activities for a
rapid State and local response to an influenza pandemic,
including exploring methods of making the influenza vaccine
more accessible to the general population.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $150,000,000 for each of fiscal
years 2005 through 2009.
``SEC. 2143. INFLUENZA ANTI-VIRALS SUPPLY.
``(a) In General.--The Secretary shall establish a stockpile of
anti-virals to use for rapid response to an influenza outbreak.
``(b) Amount.--The stockpile established under subsection (a) shall
be of sufficient quantity to treat not less than 2 percent of the
population of the United States.''.
CHAPTER 5--REPORT AND ADMINISTRATION
SEC. 2151. REPORT TO CONGRESS.
Not later than 180 days after the date of enactment of this Act,
the Director of the Centers for Disease Control and Prevention, in
consultation with the Assistant Secretary for Medical Readiness and
Response of the Department of Homeland Security and the Director of the
National Institute for Allergy and Infectious Disease of the National
Institutes of Health, shall submit a report to Congress that describes
alternatives to traditional vaccines and anti-viral therapeutics for
viral diseases, including negative immunomodulation compounds that
partially suppress a macrophage-dependent innate immune response of an
individual to viral pathogens, in order to decrease morbidity and
mortality from an excessive immune response.
SEC. 2152. SIMPLIFIED ADMINISTRATION OF VACCINE SUPPLY.
Section 1928(d)(6) of the Social Security Act (42 U.S.C.
1396s(d)(6)) is amended by inserting before the last sentence the
following: ``The Secretary may sell such quantities of vaccines from
such supply as the Secretary determines appropriate. Proceeds received
from such sales shall be available to the Secretary solely for the
purposes of this section and shall remain available until expended.
SEC. 2153. MEDICARE COVERAGE OF VACCINES AND PROPHYLAXIS AS
COUNTERMEASURES.
(a) Findings.--Congress finds the following:
(1) In the event of a bioterrorism attack or infectious
disease outbreak, it is in the public interest to ensure
appropriate and timely voluntary utilization of critical
vaccines and other prophylaxis against these pathogens.
(2) Such voluntary utilization in such emergency will be
increased if the vaccines and other prophylaxis are covered
under Medicare Part B.
(3) Such voluntary utilization reduces adverse impacts on
the public health infrastructure and assists in containing the
pathogen without the need to impose quarantines.
(4) Coverage and reimbursement for most vaccines and other
prophylaxis currently is not available under Medicare Part B.
(5) Medicare Part B does cover diagnostic services as well
as drugs and biological products that are administered incident
to a physician's services that are not usually self-
administered by the patient as long as they are ``reasonable
and necessary for the diagnosis or treatment of illness or
injury or to improve the function of a malformed body member''.
(6) The public interest would be served best by extending
Medicare Part B coverage and reimbursement to vaccines and
prophylaxis that would combat a wide variety of chemical and
biological agents, toxins, nuclear and radiological materials,
and emerging infectious diseases.
(b) Amendment to the Social Security Act to Extend Coverage.--
Section 1861(s)(10)(A) of the Social Security Act (42 U.S.C.
1396x(s)(10)(A)) is amended by inserting ``, a vaccine or prophylaxis
against any of the agents, toxins, or materials on the list developed
by the Secretary under section 319F-3(f) of the Public Health Service
Act and its administration'' after ``pneumococcal vaccine and its
administration''.
(c) Effective Date.--The amendment made by subsection (b) shall
apply to items furnished on or after the date of enactment of this Act.
TITLE XXII--GAAP ACCOUNTING FOR VACCINE REVENUE RECOGNITION
SEC. 2201. GAAP ACCOUNTING FOR VACCINE PROCUREMENT.
Not later than 180 days after the date of enactment of this Act,
the Secretary of Health and Human Services and the Secretary of
Homeland Security, in consultation with appropriate representatives
from the Securities and Exchange Commission (as determined by such
Secretaries) shall meet to determine--
(1) how contracts entered into under the Project BioShield
Act of 2004 and the Project BioShield II Act of 2005 (and the
amendments made by such Acts) may be structured so that a
person that enters such a contract can recognized revenue under
General Acceptable Accounting Principles accounting rules; or
(2) how the Securities and Exchange Commission may
interpret its Staff Accounting Bulletin Number 104 of December
17, 2003, to achieve the result described under paragraph (1).
TITLE XXIII--HUMAN CLINICAL TRIALS AND DRUGS FOR RARE DISEASES AND
CONDITIONS
SEC. 2301. EXPANDED HUMAN CLINICAL TRIALS QUALIFYING FOR ORPHAN DRUG
CREDIT.
(a) Expanded Human Clinical Trials Qualifying for Orphan Drug
Credit.--
(1) In general.--Subclause (I) of section 45C(b)(2)(A)(ii)
of the Internal Revenue Code of 1986 is amended to read as
follows:
``(I) after the date that the
application is filed for designation
under such section 526, and''.
(2) Conforming amendments.--Clause (i) of section
45C(b)(2)(A) of the Internal Revenue Code of 1986 is amended by
inserting ``which is'' before ``being'' and by inserting before
the comma at the end ``and which is designated under section
526 of such Act''.
(3) Effective date.--The amendments made by this subsection
shall apply to amounts paid or incurred after December 31,
2003.
(b) Publication of Filing and Approval of Requests for Designation
of Drugs for Rare Diseases or Conditions.--Subsection (c) of section
526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) is
amended to read as follows:
``(c) Not less than monthly, the Secretary shall publish in the
Federal Register, and otherwise make available to the public, notice of
requests for designation of a drug under subsection (a) and approvals
of such requests. Such notice shall include--
``(1) the name and address of the manufacturer and the
sponsor;
``(2) the date of the request for designation or of the
approval of such request;
``(3) the nonproprietary name of the drug and the name of
the drug under which an application is filed under section
505(b) of this Act or section 351 of the Public Health Service
Act;
``(4) the rare disease or condition for which the
designation is requested or approved; and
``(5) the proposed indication for use of the product.''.
TITLE XXIV--HEALTHCARE SYSTEM COLLECTION OF CLINICAL DATA REGARDING
SAFETY AND EFFECTIVENESS OF COUNTERMEASURES
SEC. 2401. FINDINGS; DEFINITIONS.
(a) Purpose.--The purpose of this title is to provide necessary
protocols and funding to ensure that real time clinical data about a
countermeasure, as it is utilized, may be extracted in order to assess
the appropriate role of such countermeasure in responding to a terror
attack or outbreak of infectious disease.
(b) Definitions.--In this title:
(1) Clinical countermeasures delivery.--The term ``clinical
countermeasures delivery'' refers to the coordinated
development, implementation, and evaluation of consistent
clinical countermeasures policies, diagnostic procedures and
protocols, education and training, and necessary medical
capacities (such as administrative support, infrastructure
including healthcare epidemiology, laboratories, information
systems, leadership and expert personnel, research capability,
equipment and supplies) for the healthcare delivery and
response community within a defined geographic area that takes
into account populations at risk and vulnerabilities to
pathogens and agents.
(2) Clinical countermeasures delivery center.--The term
``clinical countermeasures delivery center'' means a nonprofit
health or public health, medical center, or public hospital,
including an academic health center or other similar
organization, that dedicates a significant percentage of its
resources for the coordination of healthcare delivery,
research, education, and integrated community services, as
determined by the Assistant Secretary for Medical Readiness and
Response of the Department of Homeland Security.
(3) Emergency situation.--The term ``emergency situation''
means a natural or man-made event that requires an emergency
response and is designated as an emergency by the President, a
Governor through an appropriate State emergency management
coordinator, local government executive, or a county emergency
manager (only with respect to a condition for a period not to
exceed 24 hours pending review and approval by a Governor) in
which clinical countermeasures may or will be utilized.
(4) Healthcare delivery and response community.--The term
``healthcare delivery and response community'' means
individuals, entities, and institutions that provide--
(A) direct patient healthcare, public health, or
community health; or
(B) emergency medical care, such as emergency
medical, fire, and police services.
(5) Qualified clinical countermeasures delivery center.--
The term ``qualified clinical countermeasures delivery center''
means a clinical countermeasures delivery center that has been
certified under section 2402 as in compliance with the
requirements of section 2403.
(6) Assistant secretary.--The term ``Assistant Secretary''
means the Assistant Secretary for Medical Readiness and
Response of the Department of Homeland Security.
SEC. 2402. CERTIFICATION OF CLINICAL COUNTERMEASURES DELIVERY CENTERS.
(a) Establishment of Program.--The Assistant Secretary shall
establish and administer a program to certify clinical countermeasures
delivery centers as qualified clinical countermeasures delivery centers
for purposes of ensuring that--
(1) the coordinated development, implementation, and
evaluation of clinical countermeasures will precede and follow
the utilization of the clinical countermeasures developed under
this Act (or the amendments made by this Act) or otherwise
available to respond to a biological, chemical, nuclear,
radiological, or explosive event or other emergency situation;
and
(2) such countermeasures are delivered to affected and at-
risk populations within a therapeutically effective time
period.
(b) Application.--
(1) In general.--To be certified as a qualified clinical
countermeasures delivery center, a clinical countermeasures
delivery center shall submit to the Assistant Secretary an
application at such time, in such manner, and containing such
information as the Assistant Secretary shall require.
(2) Approval.--In determining whether to approve an
application under paragraph (1), the Assistant Secretary shall
ensure that the clinical countermeasures delivery center is in
compliance with the criteria developed pursuant to section
2403.
(c) Requirements.--Upon approval of an application under subsection
(b), a qualified clinical countermeasures delivery center within a
specified geographic area and representing an affected or at risk
population, shall--
(1) during the pre-event phase, develop, test (through
exercises), and have in place plans for clinical
countermeasures delivery, in accordance with section 2404;
(2) during the pre-event phase, prepare, test, and have in
place plans to develop new, and to maintain existing,
collaborations with members of the healthcare delivery and
response community;
(3) during the event phase, deliver clinical
countermeasures to affected and at-risk populations in a
therapeutically effective time period and provide medical
management and treatment of adverse events arising from
utilization of clinical countermeasures developed in response
to an emergency situation;
(4) during the event phase, communicate preliminary
findings regarding the delivery and efficacy of clinical
countermeasures to appropriate Federal, State, and local public
health authorities;
(5) during the post event phase, have in place a validated
process of metrics and measures for evaluating the
effectiveness of clinical countermeasures through clinical
research, including external evaluation, quality assurance and
mitigation, and an evaluation of the clinical countermeasures
delivery center's capability to respond to the needs of
populations at risk and address potential hazard
vulnerabilities; and
(6) during the post-even phase, share information about the
effectiveness of countermeasures and the capability of the
countermeasure delivery centers to respond to the event to
appropriate Federal, State, and local public health
authorities.
(d) Standards.--The Assistant Secretary shall set standards to
ensure that qualified clinical countermeasures delivery centers remain
prepared to fulfill the functions described under this section in the
event of an emergency situation.
SEC. 2403. ELIGIBILITY CRITERIA.
(a) In General.--The Assistant Secretary shall establish by
regulation criteria for the certification of clinical countermeasures
delivery centers as qualified clinical countermeasures delivery centers
for purposes of this title.
(b) Minimum Qualifications.--The criteria developed under
subsection (a) shall require that a qualified clinical countermeasures
delivery center--
(1) be a nonprofit healthcare provider that is directly
affiliated with an accredited medical teaching institution,
accredited school of public health, or an institution of higher
education (as defined by section 101(a) of the Higher Education
Act of 1965 (20 U.S.C. 1001(a))); and
(2) have in place--
(A) plans for clinical countermeasures delivery in
accordance with section 2404;
(B) collaborating agreements with members of its
healthcare delivery and response community;
(C) plans to participate annually in at least 1
major exercise of plans and systems demonstrating
coordination among representatives of its healthcare
delivery and response community, as evaluated by the
Secretary;
(D) operating and managing clinical plans to
deliver healthcare to affected and at risk populations
in response to an emergency situation; and
(E) a validated process--
(i) of metrics and measures for evaluating
the effectiveness of the delivery center's
capability to meet the needs of affected and at
risk populations and address potential
vulnerabilities to hazards; and
(ii) for sharing the results and data from
the plans and activities required under this
subsection.
SEC. 2404. POLICIES, PROCEDURES, AND PROTOCOLS FOR THE DELIVERY OF
CLINICAL COUNTERMEASURES.
(a) In General.--The Assistant Secretary, in consultation with the
Commissioner of the Food and Drug Administration, the Director of the
Centers for Disease Control and Prevention, the Health Resources
Services Administration, the Commissioner of Medicare and Medicaid, and
other regulatory and accreditation agencies, as appropriate, shall
establish policies, procedures, and protocols to ensure the coordinated
delivery of clinical countermeasures as described in section 2402(c).
(b) Description.--The policies, procedures, and protocols
established under subsection (a) shall be designed to--
(1) foster cooperation and coordination among qualified
clinical countermeasures delivery centers;
(2) ensure the implementation, delivery and evaluation of
clinical countermeasures among the healthcare delivery and
response community; and
(3) identify and address the clinical, operational,
ethical, and legal issues that may arise during an emergency
situation.
(c) Duties of Centers.--The qualified clinical countermeasures
delivery centers shall--
(1) meet the requirements described in subparagraphs (A)
and (B) of section 2403(b)(2);
(2) participate annually in at least 1 major exercise of
plans and systems demonstrating the coordination of clinical
countermeasures among representatives of its healthcare
delivery and response community;
(3) have in place operating and clinical plans--
(A) to deliver clinical countermeasures within a
therapeutically effective time period to affected and
at risk populations in response to an emergency
situation; and
(B) for the medical management and treatment of
adverse events arising from utilization of clinical
countermeasures developed in response to an emergency
situation; and
(4) have in place a validated process--
(A) of metrics and measures for--
(i) evaluating the effectiveness of
clinical countermeasures, including external
evaluation, quality assurance, and mitigation;
and
(ii) evaluating the clinical
countermeasures delivery center's capability to
meet the needs of affected and at risk
populations and address potential
vulnerabilities to hazards; and
(B) for sharing the results and data from the plans
and activities required under this subsection.
SEC. 2405. INCENTIVES FOR QUALIFIED CLINICAL COUNTERMEASURES DELIVERY
CENTERS.
A clinical countermeasures delivery center that is certified by the
Assistant Secretary as a qualified clinical countermeasures delivery
center--
(1) shall be entitled to reimbursement--
(A) for the costs associated with preparedness for
clinical countermeasures delivery and maintaining
readiness for a healthcare emergency requiring the use
of clinical countermeasures, including training
exercises and educational programs;
(B) for costs associated with the implementation,
delivery, and evaluation of clinical countermeasures in
the event of a healthcare emergency in which clinical
countermeasures, including those developed under this
Act (or the amendments made by this Act), are utilized;
and
(C) for costs associated with the post-event
initiatives involved with the delivery of clinical
countermeasures in the event of a healthcare emergency
in which clinical countermeasures, including those
developed under this Act (or the amendments made by
this Act), are utilized; and
(2) at the discretion of the Assistant Secretary, may
receive 1 or more of the following:
(A) Bonus payment under the Medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.) for the reimbursement of expenditures incurred
in connection with the implementation of activities
under this title.
(B) Increased graduate medical education
reimbursement for expenditures incurred in connection
with the implementation of activities under this title.
(C) The application and receipt of surcharges with
respect to reimbursements under the Medicare or
Medicaid programs under title XVIII or XIX of the
Social Security Act (42 U.S.C. 1395 or 1396 et seq.)
paid to the qualified clinical countermeasures delivery
centers.
(D) Participation in a program to receive temporary
personnel replacements, salary reimbursements, and
training cost reimbursement, to be applied to the
personnel of qualified clinical countermeasures
delivery centers that choose to obtain specialized
training in emergency preparedness or that want to
obtain special certifications.
(E) Malpractice and tort liability indemnification
for the qualified clinical countermeasures delivery
centers and the personnel supporting such centers for
legal fees and judgments incurred in connection with
the implementation of activities under this title.
(F) Worker's compensation indemnification with
respect to qualified clinical countermeasures delivery
centers' personnel in connection with the
implementation of programs under this title during
periods of training and emergency situations.
(G) Notwithstanding the requirements of section
1867 of the Social Security Act (42 U.S.C. 1395dd),
commonly known as the Emergency Medical Treatment and
Active Labor Act, the ability of qualified clinical
countermeasures delivery centers to pre-triage patients
during an emergency situation, including triaging based
on nonemergent conditions to other hospitals,
ambulatory facilities, or other appropriate healthcare
entities.
(H) Indemnification by the Federal Government for
legal fees incurred by the qualified clinical
countermeasures delivery centers during an emergency
situations, as well as worker's compensation and
overall liability coverage during such a situation and
during periods of training.
(I) The assistance of Federal personnel or armed
forces personnel for the planning and support of
training and training exercises for the personnel of
the qualified clinical countermeasures delivery
centers.
(J) The provision of family support services for
workers, including emergency management and public
health agencies personnel, supporting the center during
an emergency situation to allow for communication
access to such workers during such situation, priority
standing for access to vaccines and other recommended
interventions, and other services to help workers
function effectively in such a situation.
SEC. 2406. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as may be
necessary to carry out this title.
TITLE XXV--CENTERS FOR DISEASE CONTROL AND PREVENTION
SEC. 2501. GLOBAL DISEASE DETECTION TRUST FUND.
(a) In General.--
(1) Establishment of fund.--There is established within the
Centers for Disease Control and Prevention a Global Disease
Detection Trust Fund (referred to in this title as the
``Detection Trust Fund'').
(2) Administration.--The Detection Trust Fund shall be
administered by the Director of the Centers for Disease Control
and Prevention.
(3) Purposes.--The purposes of the Detection Trust Fund are
to--
(A) detect, verify, and respond to infectious
disease outbreaks around the world more quickly,
including threats such as avian influenza and the
development of antimicrobial resistance that emerge
outside the United States;
(B) control intentional or naturally occurring
health threats at their origin and prevent
international spread;
(C) protect the health and safety of United States
citizens and officials traveling or living abroad; and
(D) protect the economic interests of the United
States and its partners from threats to health.
(b) Use of Fund.--
(1) In general.--The Director of the Centers for Disease
Control and Prevention may expend not more than $250,000,000 in
each fiscal year from the Detection Trust Fund on global
disease detection activities, which may include--
(A) conducting--
(i) disease surveillance activities;
(ii) field investigations;
(iii) training and development activities;
and
(iv) research on methods and approaches for
detection and control of threats to health
described in subsection (a)(3);
(B) developing information and communications
technology;
(C) improving infectious disease epidemiology;
(D) providing technical assistance for disease
prevention and control programs;
(E) ensuring the capacity to prepare for and
respond to emerging and unknown public health threats
and emergencies; and
(F) developing and maintaining of laboratory
capacity.
(2) Limitation.--Amounts expended from the Detection Trust
Fund shall not be funded through reductions in the annual
appropriations for related activities of the Centers for
Disease Control and Prevention.
(c) Authorization of Appropriations.--There are authorized to be
appropriated $1,250,000,000 to the Detection Trust Fund to carry out
this section.
SEC. 2502. ENVIRONMENTAL MICROBIOLOGY FACILITY STUDY AND REPORT.
Not later than 6 months after the date of enactment of this Act,
the Director of the Centers for Disease Control and Prevention shall--
(1) conduct a study on the feasibility of developing an
environmental microbiology facility as part of the National
Interagency Biodefense Campus at Fort Detrick, Maryland; and
(2) submit to Congress a report that describes the findings
of the study under paragraph (1), including--
(A) the need for such a facility and the potential
benefits of developing such a facility as part of the
Interagency campus;
(B) the feasibility of constructing such a
facility, and
(C) the projected cost and timetable for the
construction of such a facility.
SEC. 2503. ENFORCEMENT OF QUARANTINES.
(a) Penalties.--Section 368 (42 U.S.C. 271) is amended--
(1) in subsection (a), by striking ``$1,000 or by
imprisonment for not more than one year'' and inserting
``$250,000 or by imprisonment for not more than 10 years''; and
(2) in subsection (b), by striking ``$5,000'' and inserting
``$1,000,000''.
(b) Panel Physician Quality Control.--Section 361 of the Public
Health Service Act (42 U.S.C. 264) is amended by adding at the end the
following:
``(f) Where the United States enters into agreements, contracts, or
other arrangements with physicians or other healthcare providers and
laboratories in foreign countries for the purpose of conducting health
screening on aliens seeking temporary or permanent residence in the
United States, the Secretary shall evaluate each such physician or
provider on an annual basis to certify that the physician or provider
adequately complies with applicable regulations governing the medical
screening of applicants for entry into the United States. The Secretary
may assess certification or user fees to support the annual evaluation,
quality control, and certification of panel physicians performing such
foreign medical screenings.''.
SEC. 2504. EDUCATIONAL CAMPAIGN AT THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
(a) In General.--The Director of the Centers for Disease Control
and Prevention shall, in consultation with relevant stakeholders, carry
out a 2-phase, national educational campaign to make available
information about the possible public health measures that might be
implemented in the event of a pandemic outbreak or a bioterror attack
involving an infectious disease.
(b) Campaign Content.--
(1) In general.--The campaign established under subsection
(a) may include information regarding--
(A) the circumstances under which a range of public
health measures might be implemented;
(B) the concepts of person-to-person spread,
quarantine, isolation, and movement restriction;
(C) mass pre- and post-exposure prophylaxis, the
use of off-label drugs, and other extraordinary
measures to protect the public health;
(D) the rationale and benefits to the public of
implementing such public health measures; and
(E) the legal rights of citizens in the event such
public health measures are implemented.
(2) Campaign phase 1.--
(A) In general.--In Phase 1 of the campaign
established under subsection (a), the Director of the
Centers for Disease Control and Prevention shall
consult with a diverse advisory panel in the
preparation of nationally standardized messages and
guidance about the range of medical and nonmedical
interventions to interrupt disease transmission.
(B) Composition of advisory panel.--The advisory
panel consulted under subparagraph (A) shall include--
(i) representatives of State and local
governments and nongovernmental public health
agencies;
(ii) public health experts and medical
practitioners who have real-world experience in
crisis management and risk communication;
(iii) business leaders;
(iv) members of the lay public; and
(v) subject matter experts in bioethics,
risk communication, health education, community
organization, advertising, and public
relations.
(C) Collection of information.--To direct the
deliberations of the advisory panel, the Director of
the Centers for Disease Control and Prevention shall
collect and synthesize extant information regarding
community-level disease containment measures, including
assessment of interventions during the SARS outbreak.
(3) Campaign phase 2.--
(A) Purpose.--The purpose of Phase 2 of the
campaign established under subsection (a) shall be to
augment at the State and local level nationally
standardized messages to address specific community
needs and concerns.
(B) Establishment of grant.--
(i) In general.--The Director of the
Centers for Disease Control and Prevention
shall award grants to 5 local health
departments (that are regionally and
demographically diverse) to design and deliver
educational campaigns targeted for their
community with respect to the plans of the
health departments for implementing a range of
public health interventions in the context of a
pandemic outbreak or biological attack.
(ii) Application.--Local public health
departments shall submit to the Secretary an
application to receive a grant under clause (i)
at such time, in such manner, and containing
such information as the Secretary may require.
(c) Authorization of Appropriations.--There are authorized to be
appropriated $20,000,000 for each of fiscal years 2006 through 2010 to
carry out this section.
TITLE XXVI--ZOONOTIC DISEASE SURVEILLANCE
SEC. 2601. ZOONOTIC DISEASE SURVEILLANCE.
(a) Findings.--Congress makes the following findings:
(1) Seventy percent of the known bioterrorist agents are
zoonotic.
(2) Emerging infectious diseases such as SARS, monkeypox,
and West Nile virus have emerged from animal origins.
(2) Early warning of impending zoonotic disease outbreaks
has failed in sentinel animal populations during zoonotic
outbreaks such as SARS, monkeypox, and West Nile virus.
(3) There is no way to predict what species might serve as
sentinels in emerging infectious diseases or bioterrorist
events.
(4) Many animals, such as dogs, cats, and exotic pets, do
not fall under the jurisdiction of any Federal agency.
(5) There is a lack of focus on the detection of zoonotic
threats in sentinel or reservoir animal populations prior to
human involvement.
(6) There is a continued inability to share real-time data
across the human and veterinary agencies on zoonotic threats.
(b) Establishment of Working Group.--The Secretary of Homeland
Security, in consultation with the Secretary of Health and Human
Services, the Secretary of Agriculture, the Secretary of the Interior,
and the Secretary of Defense shall establish a Zoonotic Disease Working
Group within the Department of Homeland Security (referred to in this
section as the ``Working Group'').
(c) Duties of Working Group.--
(1) In general.--The Working Group shall conduct a study of
all matters relating to the creation of an integrated (human
and animal) real-time zoonotic disease surveillance network and
make recommendations that address gaps in surveillance
activities.
(2) Matters studied.--The Working Group shall--
(A) evaluate the status of zoonotic disease
surveillance by Federal agencies and the private sector
as of the date of enactment of this Act;
(B) identify--
(i) existing bioterrorism funds in Federal
and State agencies;
(ii) budgets that could be redirected
toward improving the ability to detect and
report zoonotic threats across species handled
by veterinary and wildlife institutions; and
(iii) existing laboratory facilities for
zoo animals, pets, and exotic collections that
could be networked, equipped, and funded for
such purpose; and
(C) consult private sector representatives,
including those with expertise on non-agricultural
species, exotic pets, and zoo animals, representatives
of State and local public health agencies, and
representatives from veterinarians and laboratories.
(3) Submission of report.--Not later than 8 months after
the date of enactment of this Act, the Working Group shall
submit a report to the Secretary of Homeland Security with
respect to its findings and recommendations under this section.
TITLE XXVII--COUNTERMEASURES AGAINST AGROTERRORISM
SEC. 2701. FINDINGS.
Congress finds that--
(1) agriculture is important to the social and economic
stability of the United States;
(2) in 2001, food production constituted 9.7 percent of the
gross domestic product of the United States, generating cash
receipts in excess of $991,000,000,000;
(3) the agriculture production and food industries are
vulnerable to deliberate agroterrorist acts and naturally
occurring disease disruption;
(4) practices that heighten this vulnerability include--
(A) the highly intensive and concentrated nature of
agribusiness in the United States, which increases the
potential speed with which a disease can spread;
(B) the insufficiency of agricultural security
methods and biosurveillance technologies;
(C) the hesitancy of producers to report disease
outbreaks for fear of uncompensated culling or
quarantine;
(D) the declining pool of veterinarians and
diagnosticians trained to recognize foreign animal
diseases;
(E) larger breeding herds, which reduce individual
animal health observations and may cause illnesses to
remain undetected; and
(F) inadequate laboratory diagnostic capability at
the national and local levels;
(5)(A) countermeasures should be developed to both prevent
and control agroterrorism;
(B) incentives under title III (and amendments made by that
title) should be made available to persons who develop and
manufacture those countermeasures;
(C) threats to biosecurity should be identified through
cooperative decisions made by the Secretary and the Secretary
of Homeland Security;
(D) the Secretary regulates and approves biological and
chemical agents and toxins under the Virus-Serum-Toxin Act (21
U.S.C. 151 et seq.); and
(E) the Secretary of Health and Human Services, acting
through the Center for Veterinary Medicine of the Food and Drug
Administration, regulates and approves new animal drugs under
section 512 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b);
(6) preventative countermeasures (including all equipment,
materials, drugs, personnel, and training necessary to
interdict the spread of animal and plant diseases efficiently
and effectively) should include--
(A) increased funding for the Animal and Plant
Health Inspection Service to increase training and
better protect the borders of the United States;
(B) increased funding for exotic animal and plant
disease research conducted in countries in which exotic
diseases are endemic;
(C) improved use, by persons under contract with
the Federal Government to develop countermeasures, of
appropriate containment facilities controlled by the
Federal Government (such as the National Veterinary
Disease Laboratory in Ames, Iowa or Plum Island, New
York); and
(D) increased funding for vaccine and antibiotic
research;
(7) control countermeasures should include--
(A) recruiting, training, and equipping field
personnel;
(B) developing rapid and specific diagnostic tests;
(C) developing a stockpile of countermeasures to
biological and chemical agents and toxins of
consequence to the agricultural community, as
determined by the Secretary, with adequate funding for
the development of the stockpile;
(D) researching and stockpiling of antiviral,
antifungal, antibacterial, and vector control agents;
and
(E) a national system of livestock identification
and movement surveillance; and
(8) an effective system of countermeasures against
agroterrorism will require initial centralization followed by
dissemination of policies and practices to a local level.
SEC. 2702. DEFINITIONS.
In this Act:
(1) Agricultural disease.--The term ``agricultural
disease'' means an outbreak of a plant or animal disease, or a
pest infestation, that requires prompt action in order to
prevent injury or damage to people, plants, livestock,
property, the economy, or the environment.
(2) Agricultural disease emergency.--The term
``agricultural disease emergency'' means an agricultural
disease that the Secretary determines to be an emergency
under--
(A) section 415 of the Plant Protection Act (7
U.S.C. 7715); or
(B) section 10407(b) of the Animal Health
Protection Act (7 U.S.C. 8306(b)).
(3) Agriculture.--The term ``agriculture'' includes--
(A) the science and practice of activities relating
to food, feed, and fiber production, processing,
marketing, distribution, use, and trade;
(B) family and consumer science, nutrition, food
science and engineering, agricultural economics, and
other social sciences; and
(C) forestry, wildlife science, fishery science,
aquaculture, floraculture, veterinary medicine, and
other environmental and natural resource sciences.
(4) Agroterrorism.--The term ``agroterrorism'' means the
commission of an agroterrorist act.
(5) Agroterrorist act.--The term ``agroterrorist act''
means a criminal act consisting of causing or attempting to
cause damage or harm to, or destruction or contamination of, a
crop, livestock, farm or ranch equipment, material or property
associated with agriculture, or a person engaged in
agricultural activity, that is committed with the intent--
(A) to intimidate or coerce a civilian population;
or
(B) to influence the policy of a government by
intimidation or coercion.
(6) Biosecurity.--
(A) In general.--The term ``biosecurity'' means
protection from the risks posed by biological,
chemical, or radiological agents to--
(i) plant or animal health;
(ii) the agricultural economy;
(iii) the environment; or
(iv) human health.
(B) Inclusions.--The term ``biosecurity'' includes
the exclusion, eradication, and control of biological
agents that cause plant or animal diseases.
(7) Countermeasure.--The term ``countermeasure'' has the
meaning given that term in section 319F-3 of the Public Health
Service Act (as added by section 202).
(8) Indian tribe.--The term ``Indian tribe'' has the
meaning given the term in section 4 of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b).
(9) Secretary.--The term ``Secretary'' means the Secretary
of Agriculture.
(10) Tribal government.--The term ``tribal government''
means the governing body of an Indian tribe.
SEC. 2703. ESTABLISHMENT OF WORKING GROUP.
The Secretary, in consultation with the Secretary of Health and
Human Services and the Secretary of Homeland Security, shall establish
a working group (referred to in this title as the ``Working Group'')
that shall include representatives of--
(1) appropriate agencies of the Department of Agriculture,
appointed by the Secretary;
(2) the Centers for Disease Control and Prevention,
appointed by the Secretary of Health and Human Services;
(3) the Center for Veterinary Medicine of the Food and Drug
Administration, appointed by the Secretary of Health and Human
Services, in consultation with the Secretary of Defense and the
Secretary of Homeland Security;
(4) the Department of Homeland Security, appointed by the
Secretary of Homeland Security; and
(5) the Animal Health Institute.
SEC. 2704. DUTIES.
(a) Study.--
(1) In general.--The Working Group shall conduct a study of
all matters relating to developing countermeasures against
agroterrorism in the United States.
(2) Matters to be studied.--The matters to be studied by
the Working Group shall include--
(A) the nature of United States preparedness for
agroterrorism threats to crops and livestock in the
United States, including an evaluation of the progress
of ongoing research, studies, and programs;
(B) the availability of countermeasures against
agroterrorism threats;
(C) the strategy used to develop such qualified
countermeasures to both prevent and control an
agroterrorism threat;
(D) the appropriateness of adapting the incentives
established by the amendments made by the Project
BioShield Act of 2004 (118 Stat. 835) and by this Act
(including amendments made by this Act), to such
countermeasures against agroterrorism;
(E) whether technological innovation is required to
complete the identification, border security, and
transit surveillance of livestock;
(F) the appropriateness of entering into bilateral
agreements with countries in which exotic animal
disease vaccines that are approved by the Department of
Agriculture are produced in order to provide for the
use of the vaccines by the United States in the case of
an emergency;
(G) the feasibility of producing certain vaccines,
especially vaccines for foot and mouth disease, in the
continental United States;
(H) the feasibility of leasing Plum Island, New
York, for use as a commercial vaccine production
facility; and
(I) the provision of funds for the Agency for
International Development to establish an office of
animal and plant health, the mission of which is to
assist countries in controlling and eradicating
diseases that pose a threat to agriculture in the
United States.
(b) Recommendations.--The Working Group shall develop
recommendations on--
(1) specific requirements needed to accelerate the
development of countermeasures against agroterrorism, including
research tools, biologics, and therapeutics; and
(2) if the Working Group determines that the commercial
agricultural industry is incapable or has inadequate resources
to fulfill the biosecurity needs of the United States, adapting
the incentives described in subparagraph (D) of subsection
(a)(2).
(c) Report.--Not later than 1 year after the date of enactment of
this Act, the Working Group shall submit to the appropriate committees
of Congress a report that contains--
(1) a detailed statement of the findings and conclusions of
the Working Group; and
(2) the recommendations of the Working Group for such
legislation and administrative actions as the Working Group
considers appropriate.
SEC. 2705. STATE AND LOCAL ASSISTANCE.
(a) Study.--
(1) In general.--In consultation with the steering
committee of the National Animal Health Emergency Management
System and other stakeholders, the Secretary shall conduct a
study to--
(A) determine the best use of epidemiologists,
animal and plant pathologists, computer modelers, and
statisticians as members of emergency response task
forces that handle foreign or emerging agricultural
disease emergencies; and
(B) identify the types of data that are necessary
for proper modeling and analysis of agricultural
disease emergencies.
(2) Report.--Not later than 180 days after the date of
enactment of this Act, the Secretary shall submit a report that
describes the results of the study under paragraph (1) to--
(A) the Secretary of Homeland Security; and
(B) the head of any other agency involved in
response planning for agricultural disease emergencies.
(b) Geographic Information System Grants.--
(1) In general.--The Secretary, in consultation with the
Secretary of Homeland Security and the Secretary of the
Interior, shall establish a program under which the Secretary
shall provide grants to States and local governments to develop
capabilities to use a geographic information system or
statistical model for an epidemiological assessment in the
event of an agricultural disease emergency.
(2) Authorization of appropriations.--There are authorized
to be appropriated such sums as may be necessary to carry out
this subsection.
(c) Grants To Facilitate Participation of State and Local Animal
and Plant Healthcare Officials.--
(1) In general.--The Secretary of Homeland Security, in
coordination with the Secretary, shall establish a program
under which the Secretary of Homeland Security shall provide
grants to communities to facilitate the participation of State
and local animal and plant healthcare officials in community
emergency planning efforts.
(2) Authorization of appropriations.--There is authorized
to be appropriated such sums as may be necessary to carry out
this subsection.
(d) Biosecurity Awareness and Programs.--
(1) In general.--The Secretary shall implement a public
awareness campaign for farmers, ranchers, and other
agricultural producers that emphasizes--
(A) the need for heightened biosecurity on farms;
and
(B) reporting to the Department of Agriculture any
agricultural disease anomaly.
(2) On-farm biosecurity.--
(A) In general.--Not later than 240 days after the
date of enactment of this Act, the Secretary, in
consultation with associations of agricultural
producers and taking into consideration research
conducted under the National Agricultural Research,
Extension, and Teaching Policy Act of 1977 (7 U.S.C.
3101 et seq.), shall--
(i) develop guidelines--
(I) to improve monitoring of
vehicles and materials entering or
leaving farm or ranch operations; and
(II) to control human traffic
entering or leaving farm or ranch
operations; and
(ii) distribute the guidelines developed
under clause (i) to agricultural producers
through agricultural informational seminars and
biosecurity training sessions.
(B) Authorization of appropriations.--
(i) In general.--There are authorized to be
appropriated such sums as may be necessary to
carry out this paragraph.
(ii) Information program.--Of the amounts
made available under clause (i), the Secretary
may use such sums as are necessary to establish
in each State an information program to
distribute the biosecurity guidelines developed
under subparagraph (A)(i).
(3) Biosecurity grant pilot program.--
(A) Incentives.--
(i) In general.--Not later than 240 days
after the date of enactment of this Act, the
Secretary shall develop a pilot program to
provide incentives, in the form of grants or
low-interest loans, to agricultural producers
to restructure farm and ranch operations (based
on the biosecurity guidelines developed under
paragraph (2)(A)(i)) to achieve the goals
described in clause (ii).
(ii) Goals.--The goals referred to in
clause (i) are--
(I) to control access to farms and
ranches by persons intending to commit
agroterrorist acts;
(II) to prevent the introduction
and spread of agricultural diseases;
and
(III) to take other measures to
ensure biosecurity.
(iii) Limitation.--The amount of a grant or
low-interest loan provided under this paragraph
shall not exceed $10,000.
(B) Report.--Not later than 3 years after the date
of enactment of this Act, the Secretary shall submit to
Congress a report that--
(i) describes the implementation of the
pilot program; and
(ii) makes recommendations for expanding
the pilot program.
(C) Authorization of appropriations.--There are
authorized to be appropriated such sums as may be
necessary to carry out this paragraph.
SEC. 2706. INTERAGENCY COORDINATION.
(a) Agricultural Disease Liaisons.--
(1) Agricultural disease management liaison.--The Secretary
of Homeland Security shall establish a senior level position
within the Federal Emergency Management Agency the primary
responsibility of which is to serve as a liaison for
agricultural disease management between--
(A) the Department of Homeland Security; and
(B)(i) the Federal Emergency Management Agency;
(ii) the Department of Agriculture;
(iii) other Federal agencies responsible for a
response to an emergency relating to an agriculture
disease;
(iv) the emergency management community;
(v) State emergency and agricultural officials;
(vi) tribal governments; and
(vii) industries affected by agricultural disease.
(2) Animal health care liaison.--The Secretary of Health
and Human Services shall establish within the Department of
Health and Human Services a senior level position the primary
responsibility of which is to serve as a liaison between--
(A) the Department of Health and Human Services;
and
(B)(i) the Department of Agriculture;
(ii) the animal health community;
(iii) the emergency management community;
(iv) tribal governments; and
(v) industries affected by agricultural disease.
(b) Transportation.--
(1) In general.--The Secretary of Transportation, in
consultation with the Secretary and the Secretary of Homeland
Security, shall--
(A) publish in the Federal Register proposed
guidelines for restrictions on interstate
transportation of an agricultural commodity or product
in response to an agricultural disease;
(B) provide for a comment period of not less than
90 days for the proposed guidelines; and
(C) establish final guidelines, taking into
consideration any comment received under subparagraph
(B); and
(2) provide the guidelines described in paragraph (1) to
officers and employees of--
(A) the Department of Agriculture;
(B) the Department of Transportation; and
(C) the Department of Homeland Security.
SEC. 2707. REGIONAL, STATE, AND LOCAL PREPAREDNESS.
(a) Environmental Protection Agency.--The Administrator of the
Environmental Protection Agency, in consultation with the Secretary,
shall cooperate with regional, State, and local disaster preparedness
officials to include consideration of the potential environmental
effects of a response activity in planning a response to an
agricultural disease.
(b) Department of Agriculture.--The Secretary, in consultation with
the Secretary of Homeland Security, shall--
(1) develop and implement procedures to provide information
to, and share information among, Federal, regional, State,
tribal, and local officials regarding agricultural threats,
risks, and vulnerabilities; and
(2) cooperate with State agricultural officials, State and
local emergency managers, representatives from State land grant
colleges and research universities, agricultural producers, and
agricultural trade associations to establish local response
plans for agricultural diseases.
(c) Federal Emergency Management Agency.--The Director of the
Federal Emergency Management Agency, in consultation with the
Secretary, shall--
(1) establish a task force consisting of agricultural
producers and State and local emergency response officials to
identify the best practices for regional and State agricultural
disease programs;
(2) distribute to States, tribal governments, and
localities a report that describes the best practices
identified under paragraph (1); and
(3) design packages containing exercises for training,
based on the identified best practices, in the form of printed
materials and electronic media, for distribution to State and
local emergency managers, State agricultural officials, and
tribal government officials.
SEC. 2708. INTERNATIONAL ACTIVITIES.
(a) International Agricultural Disease Surveillance.--Not later
than 1 year after the date of enactment of this Act, the Secretary, in
consultation with the Secretary of State and the Administrator of the
Agency for International Development, shall submit to Congress a report
that describes measures taken by the Secretary to--
(1) streamline the process of notification by the Secretary
to Federal agencies in the event of an agricultural disease in
a foreign country; and
(2) cooperate with representatives of foreign countries,
international organizations, and industry to develop and
implement methods of sharing information relating to
international agricultural diseases and unusual agricultural
activities.
(b) Inspections of Imported Agricultural Products.--The Secretary
of Homeland Security shall--
(1) cooperate with the Secretary and any appropriate
Federal intelligence official to improve the ability of the
Department of Agriculture to identify agricultural commodities
and products, livestock, and other goods imported from suspect
locations that are recognized by the intelligence community
as--
(A) having experienced an agricultural terrorist
activity or an unusual agricultural disease; or
(B) harboring or having harbored an agroterrorist;
and
(2) use the information described in paragraph (1) to
establish priorities for inspecting imported agricultural
products.
(c) Bilateral Mutual Assistance Agreements.--The Secretary of
State, in coordination with the Secretary and the Secretary of Homeland
Security, shall--
(1) enter into mutual assistance agreements with other
countries to provide and receive assistance in the event of an
agricultural disease, including--
(A) training for veterinarians and agriculture
specialists of the United States in the identification,
diagnosis, and control of foreign agricultural
diseases;
(B) providing resources and personnel to a foreign
government with limited resources to respond to an
agricultural disease; and
(C) bilateral training programs and exercises
relating to assistance provided under this paragraph;
and
(2) provide funding for a program or exercise described in
paragraph (1)(C).
SEC. 2709. REVIEW OF LEGAL AUTHORITY.
(a) In General.--The Attorney General, in consultation with the
Secretary, shall conduct a review of State and local laws relating to
agroterrorism and biosecurity to determine--
(1) the extent to which the laws facilitate or impede the
implementation of a current or proposed response plan relating
to an agricultural disease;
(2) whether an injunction issued by a State court could--
(A) delay the implementation of a Federal response
plan described in paragraph (1); or
(B) affect the extent to which an agricultural
disease spreads; and
(3) the types and extent of legal evidence that may be
required by a State court before a response plan described in
paragraph (1) may be implemented.
(b) Report.--Not later than 180 days after the date of enactment of
this Act, the Attorney General shall submit to Congress a report that
describes the results of the review under subsection (a) (including any
recommendations of the Attorney General).
TITLE XXVIII--GLOBAL DISTRIBUTION OF MEDICAL COUNTERMEASURES
SEC. 2801. FINDINGS.
Congress finds the following:
(1) Experience with infections diseases like HIV and
malaria in developing countries illustrate that the United
States must work with developing countries to plan for the
delivery of products developed under this Act (and the
amendments made by this Act).
(2) For patients to benefit from these new medical
interventions, there must be health care providers to prescribe
and administer such interventions and assistance to purchase
the treatments.
(3) The United States Agency for International Development
(referred to in this title as ``USAID'') should work with its
counterparts in other highly industrialized nations to gain
assistance in supplying such products. The Department of Health
and Human Services and USAID should undertake preapproval
planning and multilateral consensus building to assure optimal
outcomes for use of such products.
SEC. 2802. REPORT BY USAID.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Administrator of the United States Agency for
International Development (referred to in this section as the
``Administrator of USAID''), in consultation with the entities
described under subsection (b), shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives the report
described under subsection (c).
(b) Consulting Entities.--In preparing the report under subsection
(a), the Administrator of USAID shall consult with the following
entities:
(1) The Secretary of State.
(2) The United States Global AIDS Coordinator and Office of
International Health Affairs.
(3) The Director of the Centers for Disease Control and
Prevention.
(4) The Commissioner of Food and Drugs.
(5) The Surgeon General.
(6) The Secretary of Homeland Security.
(7) The Secretary of Defense.
(8) The Director of the United States Peace Corps.
(9) The World Health Organization.
(10) The United Nations Children's Fund (UNICEF).
(11) The United Nations Human Commissioner for Refugees
(UNHCR).
(12) The Global Fund to fight HIV/AIDS, TB and Malaria.
(13) The Global Alliance for Vaccines and Immunizations
(GAVI).
(14) The International Committee of the Red Cross, the
International Federation of Red Cross and Red Crescent
Societies, and the American Red Cross.
(15) Other non-profit non-government organizations and
foundations with expertise in the distribution of infectious
disease countermeasures.
(c) Report.--
(1) In general.--The report under subsection (a) shall
address--
(A) the global distribution of countermeasures
procured under the Project BioShield Act of 2004
(Public Law 108-276) and this Act (and the amendments
made by such Acts), particularly countermeasures to
infectious diseases that are not terror weapons and
that have a substantial incidence in developing
countries;
(B) the existing infrastructure with respect to
ensuring global distribution of such countermeasures;
and
(C) plans for strengthening the infrastructure
described under subparagraph (B) to ensure the
effective global distribution of such countermeasures.
(2) Content of report.--The report under subsection (a)
shall include an analysis with respect to--
(A) the procedures by which the appropriate
officials at the Office of Public Health Countermeasure
Development of the Department of Health and Human
Services will notify USAID and other agencies of the
types, characteristics, quantity, and timing of the
countermeasures that may become available under the
Project BioShield Act of 2004 (Public Law 108-276) and
this Act (and the amendments made by such Acts);
(B) the types and sources of data upon which the
Government will rely in determining the numbers and
locations of specific populations that might benefit
from such countermeasures;
(C) the means for ensuring that such
countermeasures will be distributed in developing
countries that cannot purchase the countermeasures;
(D) the trade and regulatory barriers to the global
distribution of such countermeasures and
recommendations for removing such barriers;
(E) the appropriate--
(i) priorities for national and regional
distribution of such countermeasures based on
public health, medical, and other criteria;
(ii) terms for the transfer and sale of
such countermeasures by the United States and
other entities participating in a procurement
pool established under section 319F-3 of the
Public Health Service Act (as added by section
202) to other governments or nongovernment
organizations and individuals;
(iii) labels and information provided to
public health officials and individuals
regarding such countermeasures;
(iv) protocols for licensing of
countermeasures distributed globally, and
policies for distribution of unlicensed
investigational countermeasures;
(v) protocols for assessing the safety and
effectiveness of such countermeasures and any
contraindications for the utilization of such
countermeasures;
(vi) pre- and post-licensing clinical
testing of such countermeasures;
(vii) strategy for minimizing the
development of natural resistance to such
countermeasures;
(viii) liability and indemnification
policies associated with global distribution of
countermeasures; and
(ix) protections for intellectual property
associated with such countermeasures; and
(F) the appropriate protocols for ongoing
assessment of the effectiveness of the global
distribution strategy, including independent
assessments.
(d) Assessment by the Director of the Centers for Disease Control
and Prevention.--The Director of the Centers for Disease Control and
Prevention shall submit as part of the report under subsection (a), an
assessment of--
(1) the existing public health infrastructure available to
participate in the global distribution of the countermeasures
described under subsection (c)(1) and the appropriate strategy
for strengthening the public health infrastructure necessary
for the global distribution of such countermeasures;
(2) the capacity of international public health agencies to
respond to a pandemic or other public health emergency,
including distribution of such countermeasures and other
medical countermeasures and recommendations for strengthening
such capacity;
(3) the existing information reporting and diagnostic and
detection systems regarding global infectious disease and
recommendations for strengthening such systems;
(4) the capacity of international public health agencies to
establish and maintain quarantines or other isolation
strategies to contain outbreaks of infectious diseases and
recommendations for strengthening such capacity;
(5) the long-term impact on health and chronic disease of
distributing such countermeasures;
(6) the ability of the United States to provide long-term
medical and supportive care for victims of an infectious
disease, or adverse effects of a countermeasures;
(7) the feasibility of creating a Strategic Global
Stockpile of countermeasures; and
(8) the feasibility of initiating a global preparedness
fund for a global response to outbreaks of infectious diseases.
TITLE XXIX--ENVIRONMENTAL PROTECTION AGENCY; DECONTAMINATION AND
REMEDIATION
SEC. 2901. FINDINGS.
Congress finds the following:
(1) Nuclear, biological, and chemical decontamination
present different challenges for homeland security. Nuclear
contamination can be detected easily but can only be remediated
by removal of radioactive material.
(2) Chemical contamination is relatively easy to detect,
dissipates rapidly in warm weather, and inactivates under the
right circumstances.
(3) Biological contamination presents the biggest
challenge, in part, because very large indoor and outdoor areas
may become contaminated (hundreds of square miles) and, in
part, because detection methods and decontamination
technologies are not optimally effective.
(4) Indoor biological decontamination can be more
challenging than outdoor decontamination due to the absence of
weathering processes and environmental decay.
(5) Current indoor biological decontamination methods have
emerged from ad hoc emergency responses to the Fall 2001
anthrax letter attacks.
(6) Opening one letter containing several grams of Bacillus
anthracis spores in the Daschle Suite of the Hart Senate Office
Building initiated a 3-month remediation and restoration effort
that ultimately involved 26 Federal buildings at a cost of
approximately $26,000,000.
(7) The transit of several other anthrax-laden letters
through the Brentwood and Trenton United States Postal Service
Processing and Distribution Centers led to an unprecedented 3
and \1/2\ year remediation effort involving tens of thousands
of environmental samples and on-site construction of
specialized chlorine dioxide decontamination facilities at a
total cost of more than $200,000,000.
(8) It is not practical to scale up these operations to
handle 1 or more wide-area anthrax releases.
SEC. 2902. REPORT ON CAPABILITIES.
(a) In General.--Not later than one year after the date of
enactment of this Act, the Administrator of the Environmental
Protection Agency (referred to in this section as the
``Administrator''), in consultation with the Secretary of Defense, the
Secretary of Health and Human Services, the Secretary of Homeland
Security, and other Federal agencies as determined appropriated by the
Administrator, shall submit to the Committees on Health, Education,
Labor, and Pensions, Armed Services, Homeland Security and Governmental
Affairs, and Environment and Public Works of the Senate and the
Committees on Energy and Commerce, Armed Services, Homeland Security,
and Resources of the House of Representatives, a report that--
(1) describes--
(A) the state of technology for the detection and
monitoring of nuclear, biological, and chemical
contamination;
(B) the technologies and operational concepts for
indoor and outdoor environmental remediation of such
contamination;
(C) training and doctrine for decontamination;
(D) the safety and environmental consequences
associated with such remediation and decontamination
procedures;
(E) the financial costs and timelines associated
with such procedures;
(F) the number of available decontamination
companies and personnel, along with plans for
augmenting such workforce in an emergency;
(G) the health and safety standards used to
determine efficacy of clean up procedures, and the
state of efforts to define such standards;
(H) an assessment of Federal assets to coordinate
and implement decontamination responses; and
(I) the ability of the Environmental Protection
Agency and other agencies to train, equip, and field a
dedicated homeland defense decontamination capability;
and
(2) makes recommendations with respect to--
(A) defining different contamination events and
scenarios;
(B) research, technologies, and technology
infrastructure, needed to fill technology deficiencies;
(C) development of doctrine, training, and
certification methods for decontamination;
(D) methods of enhancing the Federal, as well as
industrial, response capability;
(E) dual use technologies and programs;
(F) methods for coordination among the Department
of Defense, the Department of Health and Human
Services, the Technology Safety Working Group of the
United States Army, the Defense Advanced Research
Projects Agency, and the Defense Threat Reduction
Agency;
(G) development of standards for decontamination
(both health and environmental); and
(H) a joint decontamination research, development,
and operational program.
(b) Request by Administrator.--
(1) In general.--The Administrator may request that the
Secretary of Health and Human Services enter into an
interagency agreement, under terms acceptable to the Secretary,
in which the Environmental Protection Agency may order
countermeasures under procurement contracts or procurement
pools established by the Secretary.
(2) Processing of orders.--The ordering of a countermeasure
under an agreement under paragraph (1) (including transfers of
appropriated funds between the Environmental Protection Agency
and the Department of Health and Human Services to pay for such
order) may be conducted pursuant to section 1535 of title 31,
United States Code, if such order is processed under the terms
established--
(A) by the Secretary of Health and Human Services
in the interagency agreement described under paragraph
(1); and
(B) in the Project BioShield Act of 2004 and this
Act (and the amendments made by such Acts) with respect
to the procurement of countermeasures under sections
319F-1 and 319F-2 of the Public Health Service Act (42
U.S.C. 247d-6a and 247d-6b) (as amended by this Act).
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S4590-4595)
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 97.
Committee on Health, Education, Labor, and Pensions Subcommittee on Bioterrorism and Public Health Preparedness. Hearings held. With printed Hearing: S.Hrg. 109-210.
Committee on Health, Education, Labor, and Pensions. Held a roundtable discussion of the bill.
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