Authorizes the Secretary to enter into contracts and provide assistance for product development, including good manufacturing practices and facility security.
Requires the Secretary to ensure that medical supplies from the National Pharmaceutical Stockpile are located in appropriate proximity to the site of special events.
Amends the Federal Food, Drug, and Cosmetic Act to permit: (1) fast-track designation and priority review for unapproved countermeasure products; and (2) the use of animal trials for drugs useful against lethal or disabling agents.
Requires the Secretary to: (1) prohibit the unauthorized transportation of biological agents; (2) establish and maintain a list of each biological agent and toxin potentially threatening to public health and another list of those agents and toxins potentially threatening to national security; and (3) establish safety procedures for the transfer of such agents and toxins.
Requires the Secretaries of Health and Human Services and Defense to coordinate the creation of a government-owned, contractor-operated vaccine production facility on a military installation.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3457 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 3457
To ensure the prompt research, development, manufacture, and
distribution of new lifesaving drugs, biologics, and medical devices
that prevent or mitigate the consequences of a bioterrorist attack, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 11, 2001
Mr. Schrock (for himself and Mr. Bartlett of Maryland) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on the Judiciary, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To ensure the prompt research, development, manufacture, and
distribution of new lifesaving drugs, biologics, and medical devices
that prevent or mitigate the consequences of a bioterrorist attack, 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.
This Act may be cited as the ``Pathogen Research, Emergency
Preparedness, and Response Efforts Act of 2001'' or the ``PREPARE
Act''.
SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by
adding at the end the following:
``TITLE XXVIII--DEVELOPING NEW COUNTERMEASURES AND PROTECTING EXISTING
COUNTERMEASURES AGAINST BIOTERRORISM
``SEC. 2801. DEVELOPMENT OF DRUGS, BIOLOGICAL PRODUCTS, AND MEDICAL
DEVICES TO COMBAT BIOTERRORISM.
``(a) Identification of Biological Agents or Toxins.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Defense and the Attorney General, shall identify
biological agents or toxins that may be identified, prevented,
or treated through--
``(A) the development of new covered products;
``(B) the development of new uses, including
pediatric uses, for approved covered products; or
``(C) the manufacture or distribution of covered
products that would otherwise not be manufactured or
distributed in sufficient quantities.
``(2) Publication and availability.--Not later than 180
days after the date of enactment of this title, and annually
thereafter, the Secretary shall publish in the Federal
Register, or otherwise make available to manufacturers or
potential manufacturers of covered products, a list of the
biological agents and toxins identified under paragraph (1) for
which the Secretary desires to encourage the development of, or
new uses for, covered products or the manufacture or
distribution of such covered products.
``(b) Consultation.--In carrying out this section, the Secretary
shall consult with experts in the pharmaceutical, biotechnology, and
medical device industries, academic medical centers, and research
institutions, including those with pediatric expertise.
``(c) Limited Antitrust Exemption.--
``(1) Countermeasures development meetings.--
``(A) Scheduling countermeasures development
meetings.--The antitrust laws shall not apply to
meetings or consultations conducted by the Secretary
with parties involved in the development of
countermeasures for the purpose of the development,
manufacture, distribution, and sale of countermeasures
that are prioritized under section 2801(a), consistent
with the purposes of this title. The Secretary shall
give notice to the Assistant Attorney General of
Antitrust of meetings scheduled pursuant to this
subsection.
``(B) Meeting conditions.--Any meeting under
subparagraph (A)--
``(i) shall be chaired by the Secretary;
``(ii) shall be open to parties involved in
the development of countermeasures, as
determined by the Secretary;
``(iii) shall be open to the Attorney
General and the Federal Trade Commission;
``(iv) shall be limited to discussions
involving the development, manufacture,
distribution, or sale of countermeasures that
are prioritized under section 2801(a); and
``(v) shall be conducted in such manner as
to ensure that national security, confidential,
and proprietary information is not disclosed
outside the meeting.
``(C) Minutes.--The Secretary shall ensure that
minutes of the meeting are maintained.
``(2) Applying for limited exemption.--
``(A) Filing procedures.--As a result of meetings
under paragraph (1), the Secretary and participating
parties may file a written request with the Attorney
General for a limited exemption from the antitrust laws
to allow appropriate parties to enter into agreements
or engage in conduct relating to the development,
manufacture, distribution, or sale of countermeasures
prioritized under section 2801(a). Any such request
shall set forth the intended purpose of the agreement,
including an explanation as to why a cooperative effort
among potential competitors is necessary to achieve the
objective of the agreement. The request shall state
with specificity the substance of the agreement, the
methods that will be utilized to achieve the objectives
of the agreement, and any other relevant information
relating to the development and production of
countermeasures that are prioritized under section
2801(a).
``(B) Grant of exemption.--Not later than 60 days
after receipt of a request filed pursuant to
subparagraph (A), the Attorney General, in consultation
with the Chairman of the Federal Trade Commission shall
make a determination to grant, deny, grant in part and
deny in part, or propose modifications to any request
made pursuant to subparagraph (A) for exemption from
the antitrust laws. In making the determination, the
Attorney General shall consider factors including the
following:
``(i) Whether such agreement would promote
the purposes of this title.
``(ii) Whether the exemption from the
antitrust laws would promote the public
interest.
``(iii) The competitive impact to areas not
directly related to the development and
production of countermeasures prioritized under
section 2801(a).
``(C) Sunset.--The authority of the Attorney
General to grant a limited antitrust exemption under
this section expires at the end of the 2-year period
beginning on the date of enactment of the Pathogen
Research, Emergency Preparedness, and Response Efforts
Act of 2001.
``SEC. 2802. CONTRACTS FOR DEVELOPMENT OF COVERED PRODUCTS.
``(a) Authority.--The Secretary may enter into contracts and
cooperative research and development agreements pursuant to section
11(a) of the Stevenson-Wydler Technology Innovation Act of 1980 (15
U.S.C. 3710(a)), material transfer agreements, or other agreements, or
agree to the amendment or modification of existing or future contracts
or agreements, for the development, manufacture or distribution of
covered products for uses or new uses identified by the Secretary
pursuant to section 2801(a). A contract or agreement entered into, or
amended or modified, under this subsection may address 1 or more
aspects of the development, manufacture, or distribution of 1 or more
uses of 1 or more covered products. Such contracts or agreements may
set forth guaranteed minimum quantities of products and negotiated unit
prices.
``(b) Timing of Contract.--Notwithstanding any other provision of
law, the Secretary may enter into a contract or agreement under
subsection (a) even before the development, approval, or clearance of
the covered product that is the subject of the contract or agreement.
Such contract or agreement may provide for the termination of the
contract or agreement for the convenience of the Government if the
contractor fails to develop the covered product involved.
``(c) Payments.--Payments under a contract or agreement under
subsection (a) may be made from--
``(1) funds obligated for the performance of the contract
or agreement involved;
``(2) funds available for the development, manufacture,
distribution, or purchase of covered products for uses referred
to in section 2801(a); or
``(3) any other funds available to the Secretary.
``(d) Contracts.--In administering the provisions of this section,
the Secretary may enter into contracts in advance of appropriations and
incur obligations without regard to provisions of law relating to
contracts, including sections 1341, 1342, 1349, 1350, and 1351, and
subchapter II of chapter 15, of title 31, United States Code.
``SEC. 2803. INDEMNIFICATION.
``The Secretary shall, in any contract or agreement for the
manufacture, development, distribution, or the purchase of a covered
product intended for a use identified by the Secretary pursuant to
section 2801(a), indemnify and hold harmless the contractor consistent
with the following principles:
``(1) Uses covered.--Indemnification only extends to uses
of the covered product pursuant to a contract entered into by
the Secretary under section 2802.
``(2) Entities covered.--The Secretary may indemnify
contractors, subcontractors, distributors, persons who
administer covered products, or other parties as determined
appropriate by the Secretary pursuant to contracts entered into
under section 2802.
``(3) Limits.--No indemnification shall be provided for
intentional torts by the contractor or torts by the contractor
involving gross negligence or recklessness.
``SEC. 2804. HIGH QUALITY PRODUCTION.
``The Secretary may, with the agreement of the manufacturer of a
drug, biological product, or medical device that is approved, licensed,
or cleared (or awaiting approval, licensure, or clearance) under
section 505, 510, 513, or 515 of the Federal Food, Drug, and Cosmetic
Act, or section 351 of this Act, and is a covered product, provide
intensive assistance, including on-site assistance, when necessary, in
order to facilitate prompt compliance with good manufacturing practice
regulations under sections 210, 211, 225, 226, 600, 601, 606, or 820 of
title 21, Code of Federal Regulations, in the manufacturing,
processing, packing, or holding of the drug, biological product, or
medical device.
``SEC. 2805. SECURITY FOR RESEARCH AND PRODUCTION.
``(a) In General.--The Secretary, in consultation with the Attorney
General and the Secretary of Defense, may award grants and contracts,
enter into cooperative agreements, and provide technical or nonmonetary
assistance, to provide security to facilities that conduct research and
development, production, distribution, and storage of covered products.
``(b) Best Practices.--The Secretary shall develop guidelines and
best practices to enable entities eligible for funding under this
section to secure their facilities against potential bioterrorist
attack.
``SEC. 2806. MOBILITY OF STOCKPILE.
``(a) Special Events.--In managing the National Pharmaceutical
Stockpile, the Secretary, in consultation with State and local
government officials, shall take into consideration the timing and
location of special events, including designated national security
events.
``(b) Location of Certain Stocks.--In carrying out subsection (a),
the Secretary shall ensure that medical supplies from the National
Pharmaceutical Stockpile are located in appropriate proximity to the
site of the special event.
``SEC. 2807. DEFINITIONS.
``In this title:
``(1) Antitrust laws.--The term `antitrust laws'--
``(A) has the meaning given such term in subsection
(a) of section 1 of the Clayton Act (15 U.S.C. 12(a)),
except that such term includes 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) Biological agents or toxins.--The terms `biological
agent' and `toxin' have the meanings given such terms in
section 178 of title 18, United States Code.
``(3) Covered products.--The term `covered products'
includes drugs, biological products including vaccines, and
medical devices including in vitro diagnostics, that may be
developed or produced to identify, prevent, or treat disease or
harm in humans, including children and other vulnerable
populations, resulting from an attack or threatened attack
using biological agents or toxins.
``(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 or
clearance, the conduct of postmarket or postapproval studies,
and any other actions related to preparation of a covered
product.''.
SEC. 3. EXPEDITING FDA REVIEW AND APPROVAL.
(a) Amendment.--Section 506 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356) is amended by adding at the end the following:
``(e) Biological Agents or Toxins.--
``(1) In general.--The Secretary may designate an
unapproved covered product identified pursuant to section
2801(a) of the Public Health Service Act as a fast-track
product pursuant to this section. Such a designation may be
made before the submission of--
``(A) a request for designation by the sponsor; or
``(B) an application for the investigation of the
drug under section 505(i) or section 351(a)(3) of the
Public Health Service Act.
``(2) Use of animal trials.--An application for a drug for
which approval is sought on the basis of evidence of
effectiveness that is derived from animal studies under the
last sentence of section 505(d) or section 351(a)(1) of the
Public Health Service Act may be designated as a fast-track
product for purposes of this section.''.
(b) Review.--The Secretary shall grant priority review to a
submission for a covered product, unless the sponsor has filed an
application for review of the product under section 506 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356).
SEC. 4. USE OF ANIMAL TRIALS IN THE APPROVAL OF COVERED PRODUCTS.
(a) New Drugs.--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 for use against a potentially lethal
or permanently disabling toxic biological agent or toxin, when adequate
and well-controlled studies in humans cannot ethically be conducted
because the studies would involve administering such an agent or toxin
to healthy human volunteers without a proven treatment, and when
adequate field trials assessing the 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, including approval for
pediatric populations, based on evidence derived from appropriate
studies in animals or other information. The Secretary may use
authority under section 506 or other relevant provisions to order
postmarketing approval studies. Drugs approved solely under the
authority of the preceding two sentences shall be for purposes of
identifying, treating, or preventing infection, disease, injury, or
other health condition or consequence resulting from a disabling toxic
chemical, biological, radiological, or nuclear attack or potential
attack, or other significant disease emergency as the Secretary may
determine appropriate.''.
(b) New Biological Products.--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 Based on Animal Trials.--
``(1) In general.--In the case of biological products for
use against a potentially lethal or permanently disabling toxic
chemical, biological, radiological, nuclear, or other agent or
toxins, when adequate and well-controlled studies in humans
cannot ethically be conducted because the studies would involve
administering such an agent or toxin to human volunteers
without a proven treatment, and when adequate field trials
assessing the use of the biological product (in situations such
as after accidental or hostile exposure to the substance) have
not been feasible, the Secretary may grant approval, including
approval for pediatric populations, based on evidence derived
from appropriate studies in animals or other information.
``(2) Postmarketing approval studies.--With respect to
products described in paragraph (1), the Secretary may use
authority under section 506 of the Federal Food, Drug, and
Cosmetic Act to order postmarketing approval studies.
``(3) Limitations.--Biological products approved solely
under the authority of this subsection shall be for purposes of
identifying, treating, or preventing infection, disease,
injury, or other health condition or consequence resulting from
a potentially disabling toxic chemical, biological,
radiological, or nuclear attack or potential attack, or other
significant disease emergency as the Secretary may determine
appropriate.''.
(c) Final Rule.--Not later than 60 days after the date of enactment
of the Pathogen Research, Emergency Preparedness, and Response Efforts
Act of 2001, the Secretary shall finalize the proposed rule published
on October 5, 1999, regarding the use of animal trials in the approval
of products.
SEC. 5. BIOLOGICAL AGENTS AND TOXINS.
(a) In General.--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 E--Biological Agents and Toxins
``SEC. 570. AUTHORITY TO RESTRICT TRANSPORTATION AND USE.
``(a) In General.--The Secretary shall undertake a program that,
through inspections and other containment procedures, will prohibit the
unauthorized shipment or transportation in interstate or foreign
commerce, the possession or other use in or affecting commerce, or
assistance to another person in such transportation, shipment, or other
use by any person of biological agents or toxins, or the receipt of
biological agents or toxins so shipped or transported.
``(b) Definitions.--In this section:
``(1) Biological agents and toxins.--The terms `biological
agent' and `toxin' have the meanings given such terms in
section 2807 of the Public Health Service Act and refer to a
biological agent or toxin listed as a `select agent' in section
72.6(j) of title 42, Code of Federal Regulations, which is not
exempt under section 72.6(h) or appendix A of such title and
which does not include any such biological agent or toxin that
is in its naturally occurring environment and that has not been
cultivated, collected, or otherwise extracted from its natural
source.
``(2) Person.--The term `person' includes an alien (other
than an alien admitted for permanent residence) who is a
national of a country as to which the Secretary of State has
made a determination (that is in effect) that such country has
repeatedly provided support for acts of international
terrorism.''.
(b) Enforcement.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(bb) The shipment, transportation, possession, or other use,
assistance with respect to, or receipt of a biological agent or toxin
in violation of section 570.''.
SEC. 6. REGULATION OF BIOLOGICAL AGENTS AND TOXINS POSING POTENTIAL
NATIONAL SECURITY THREAT.
(a) Redesignation and Clarification of Biological Agents;
Regulatory Provisions of Antiterrorism and Effective Death Penalty Act
of 1996.--
(1) In general.--Part F of title III of the Public Health
Service Act (42 U.S.C. 262 et seq.) is amended by inserting
after section 351, the following:
``SEC. 351A. ENHANCED CONTROL OF BIOLOGICAL AGENTS AND TOXINS.
``(a) Regulatory Control of Biological Agents and Toxins.--
``(1) List of biological agents and toxins.--The Secretary
shall, through regulations promulgated under subsection (c),
establish and maintain a list of each biological agent and each
toxin that has the potential to pose a severe threat to public
health and safety.
``(2) Criteria.--In determining whether to include an agent
or toxin on the list under subsection (a), the Secretary
shall--
``(A) consider--
``(i) the effect on human health of
exposure to the agent or toxin;
``(ii) the degree of contagiousness of the
agent or toxin and the methods by which the
agent or toxin is transferred to humans;
``(iii) the availability and effectiveness
of pharmacotherapies and immunizations to treat
or prevent any illness resulting from infection
by the agent or toxin; and
``(iv) any other criteria that the
Secretary considers appropriate; and
``(B) consult with scientific experts representing
appropriate professional groups.
``(b) Regulation of Transfers of Listed Biological Agents and
Toxins.--The Secretary shall, through regulations promulgated under
subsection (c), provide for--
``(1) the establishment and enforcement of safety
procedures for the transfer of biological agents and toxins
listed pursuant to subsection (a)(1), including measures to
ensure--
``(A) proper training and appropriate skills to
handle such agents and toxins; and
``(B) proper laboratory facilities to contain and
dispose of such agents and toxins;
``(2) the establishment of safeguards to prevent access to
such agents and toxins for use in domestic or international
terrorism or for any other criminal purpose;
``(3) the establishment of procedures to protect the public
in the event of a transfer or potential transfer of a
biological agent or toxin in violation of the safety procedures
established under paragraph (1) or the safeguards established
under paragraph (2); and
``(4) appropriate availability of biological agents and
toxins for research, education, and other legitimate purposes.
``(c) Regulations.--The Secretary shall promulgate regulations to
carry out this section.
``(d) Definitions.--For purposes of this section and section 351B,
the terms `biological agent' and `toxin' have the meanings given such
term in section 2807.''.
(2) Conforming amendment.--Subsections (d), (e), (f), and
(g) of section 511 of the Antiterrorism and Effective Death
Penalty Act of 1996 (42 U.S.C. 262 note) are repealed.
(3) Effective date.--The amendments made by this subsection
shall take effect as if incorporated in the Antiterrorism and
Effective Death Penalty Act of 1996.
(b) Regulation of Biological Agents and Toxins Posing Potential
National Security Threat.--
(1) In general.--Part F of title III of the Public Health
Service Act (42 U.S.C. 262 et seq.), as amended by subsection
(a)(1), is further amended by inserting after section 351A the
following:
``SEC. 351B. REGULATION OF BIOLOGICAL AGENTS AND TOXINS POSING
POTENTIAL NATIONAL SECURITY THREAT.
``(a) In General.--
``(1) List of biological agents and toxins posing national
security threat.--The Secretary shall, through regulations
promulgated under subsection (d), establish and maintain a list
of those biological agents and toxins listed pursuant to
section 351A(a)(1) that the Secretary determines to be a
potential national security threat.
``(2) Criteria.--In determining whether to include an agent
or toxin on the list under subsection (a), the Secretary
shall--
``(A) consider the criteria specified in section
351A(a)(2)(A), and any other criteria that the
Secretary considers appropriate; and
``(B) consult with scientific, intelligence, and
military experts representing appropriate professional
groups.
``(b) Regulation of Transfers of Listed Biological Agents and
Toxins.--The Secretary shall, through regulations promulgated under
subsection (d), provide for the establishment and enforcement of
standards and procedures governing the possession, use, and transfer of
biological agents and toxins listed pursuant to subsection (a)(1) that
are designed to protect public safety and national security, including
safeguards to prevent access to such agents and toxins for use in
domestic or international terrorism or for any other criminal purpose.
``(c) Civil Money Penalties.--A violation of a requirement imposed
by a regulation promulgated under this section shall be subject, in
addition to any other applicable civil or criminal sanctions, to a
civil money penalty in an amount not to exceed $250,000.
``(d) Regulations.--The Secretary shall promulgate regulations to
carry out this section.
``(e) Freedom of Information Act Exemption.--Any information
provided to the Secretary pursuant to regulations issued under
subsection (d) or under section 351A(c) shall not be disclosed under
section 552 of title 5, United States Code.''.
(2) Effective date.--The amendment made by this subsection
shall take effect as if incorporated in the Antiterrorism and
Effective Death Penalty Act of 1996.
SEC. 7. ADMINISTRATION.
In administering the provisions of this Act, the Secretary of
Health and Human Services shall--
(1) continue to recognize and honor rights relating to
patents, data, and copyrights; and
(2) comply with all applicable provisions of the
regulations relating to Federal acquisition, the Federal Trade
Secrets Act, and all other laws protecting confidential
commercial information, trade secrets, and intellectual
property rights, and patent and nonpatent market exclusivity
rights.
SEC. 8. COORDINATION OF EFFORTS TO PROTECT AGAINST BIOTERRORISM.
The Secretary of Health and Human Services and the Secretary of
Defense shall coordinate in the planning, design, and construction of a
Department of Defense Government-owned, contractor-operated vaccine
production facility on a military installation, as appropriate.
SEC. 9. ENHANCEMENT OF PENALTIES FOR ANIMAL ENTERPRISE TERRORISM.
Section 43 of title 18, United States Code, is amended--
(1) in subsection (a), by striking ``one year'' and
inserting ``5 years'';
(2) in subsection (b)--
(A) by redesignating paragraph (2) as paragraph
(3);
(B) by inserting after paragraph (1) the following:
``(2) Explosives or arson.--Whoever in the course of a
violation of subsection (a) maliciously damages or destroys, or
attempts to damage or destroy, by means of fire or an
explosive, any building, vehicle, or other real or personal
property used by the animal enterprise shall be imprisoned for
not less than 5 years and not more than 20 years, fined under
this title, or both.''; and
(C) in paragraph (3), as so redesignated, by
striking ``under this title and'' and all that follows
through the period and inserting ``under this title and
imprisoned for life or for any term of years.''; and
(3) in subsection (c)--
(A) by striking ``and'' at the end of paragraph
(1);
(B) by striking the period at the end of paragraph
(2) and inserting ``; and''; and
(C) by adding at the end the following:
``(3) for any other economic damage resulting from the
violation of this section.''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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