Infectious Diseases Research and Development Act of 2005 - Limits the liability of manufacturers of qualified infectious disease products by limiting: (1) punitive damages unless the manufacturer acted with malicious intent to injure the individual or deliberately failed to avoid unnecessary injury that the manufacturer knew the individual was substantially certain to suffer; and (2) non-economic damages to $250,000.
Sets forth circumstances under which the term of a patent may be extended for qualified infectious disease products.
Requires the Secretary of Health and Human Services to designate qualified infectious disease products as fast-track products for approval.
Amends the Public Health Service Act to require the Director of the National Institute of Allergy and Infectious Diseases to expand and intensify efforts to assist small manufacturers to conduct end-stage clinical trials on qualified infectious disease products.
Amends the Internal Revenue Code to establish an infectious disease research credit and a qualified infectious disease products manufacturing facilities investment credit.
Authorizes appropriations for activities related to antimicrobial resistance.
Establishes the Commission on Infectious Diseases Product Development to identify infectious pathogens that are a significant threat to public health and make recommendations to the Secretary on how best to address such pathogens.
Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary, acting through the Commissioner of Food and Drugs, to issue guidelines for the conduct of clinical trials with respect to antibiotic drugs.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3154 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 3154
To provide incentives for pharmaceutical companies, biotechnology
companies, and medical device companies to invest in research and
development with respect to antibiotic drugs, antivirals, diagnostic
tests, and vaccines that may be used to identify, treat, or prevent an
infectious disease, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 30, 2005
Mrs. Cubin (for herself, Mr. Baird, Mr. Matheson, Mr. Baker, Mr.
LaHood, Mr. Bonner, Mr. Davis of Alabama, Mr. Gingrey, and Mr. Weldon
of Florida) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
the Judiciary and Ways and Means, 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 provide incentives for pharmaceutical companies, biotechnology
companies, and medical device companies to invest in research and
development with respect to antibiotic drugs, antivirals, diagnostic
tests, and vaccines that may be used to identify, treat, or prevent an
infectious disease, 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 ``Infectious Diseases Research and
Development Act of 2005''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Infections caused by resistant bacteria can strike
anyone, including the young and the old, the healthy and the
chronically ill. Antibiotic resistance is a particularly
serious problem for patients whose immune systems are
compromised, such as people with HIV/AIDS and patients in
critical care units.
(2) About 2 million people acquire bacterial infections in
United States hospitals each year, and 90,000 die as a result.
About 70 percent of those infections are resistant to at least
one drug. The trends toward increasing numbers of infection and
increasing drug resistance show no sign of abating.
(3) Resistant pathogens lead to higher health care costs
because they often require more expensive drugs and extended
hospital stays. The total cost to United States society is
nearly $5,000,000,000 annually.
(4) The Institute of Medicine, the Infectious Diseases
Society of America, and Federal officials have identified
antibiotic resistance and the dearth of antibiotic research and
development as increasing threats to United States public
health.
(5) Without innovative public policy and additional
financial support, fewer and fewer antibiotics will be
available to treat the increasing number of drug-resistant and
dangerous microbes that threaten Americans and the global
community.
(6) The pipeline of new antibiotics is drying up. Major
pharmaceutical companies are losing interest in the antibiotics
market because these drugs simply are not as profitable as
drugs that treat chronic (long-term) conditions and lifestyle
issues.
(7) Drug research and development is expensive, risky, and
time-consuming. An aggressive research and development program
initiated today would likely require 10 or more years and an
investment of $800,000,000 to $1,700,000,000 to bring a new
drug to market.
(8) Resistant bacterial infections are not only a public
health problem; they have national and global security
implications as well.
(9) The Institute of Medicine in its 2004 report entitled
``The Threat of Pandemic Influenza'' stated that the United
States is not adequately prepared to deal with the next
pandemic of influenza.
(10) The Centers for Disease Control and Prevention
estimates that, without adequate preparation, 100,000 to
250,000 deaths could occur in the United States from a mild
pandemic of influenza.
(11) The limited influenza vaccine market and few dedicated
manufacturers pose a substantial challenge to the Nation's
preparedness efforts. Currently, there are two manufacturers of
influenza vaccine for the United States market. In 2004, the
Food and Drug Administration suspended a manufacturer's license
due to bacterial contamination. This action led to a shortage
of injectable influenza vaccine in the United States.
(12) New rapid diagnostics would greatly reduce the cost
and time needed to conduct clinical trials for new anti-
infectives. For many infectious diseases, there currently are
no rapid diagnostic tests available to assist in identifying
eligible patients for clinical trials. Cutting costs and time
will serve as incentives for greater investment in this area.
In addition, new rapid diagnostics will permit physicians to
diagnose specific bacterial infections in their patients. This
will enable physicians to prescribe the most appropriate
therapies, including antibiotics, which will slow the evolution
of new antimicrobial resistance.
SEC. 3. DEFINITIONS.
In this Act:
(1) The term ``antibiotic drug'' has the meaning given to
that term in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321).
(2) The term ``antiviral'' means a drug or biological
product intended for human use that impedes the reproduction of
a virus.
(3) The term ``biological product'' has the meaning given
to that term in section 351 of the Public Health Service Act
(42 U.S.C. 262).
(4) The term ``device'' has the meaning given to that term
in section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321).
(5) The term ``diagnostic test'' means a device or product
used to detect the presence, concentration, or characteristics
of an infectious human disease.
(6) The term ``drug'' has the meaning given to that term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321).
(7) The term ``qualified infectious disease product'' means
any antibiotic drug, antiviral, diagnostic test, or vaccine
that is developed for the purpose of treating, detecting,
preventing, or identifying--
(A) a qualifying pathogen (for the period beginning
on the date of the enactment of this Act and ending on
commencement of the period described in subparagraph
(B)); or
(B) an infectious pathogen identified by the
Commission under section 319E-1(b) of the Public Health
Service Act, as added by section 10 of this Act (for
the period beginning on the date on which the
Commission on Infectious Diseases Product Development
first identifies infectious pathogens under such
section).
(8) The term ``qualifying pathogen'' means--
(A) community-acquired methicillin-resistant
staphylococcus areus (CA-MRSA);
(B) life-threatening gram negative bacteria, such
as Escherichia coli (E. coli), Acinetobacter,
Klebsiella species, and Pseudomonas aeruginosa;
(C) influenza; or
(D) any other infectious pathogen identified for
purposes of this Act by the Secretary of Health and
Human Services, in concurrence with infectious disease
clinicians and appropriate professional associations,
as a significant threat to public health because of
drug resistance or other factors (or likely to become
such a threat).
(9) The term ``vaccine'' means a vaccine intended for human
use.
SEC. 4. LIABILITY PROTECTION.
(a) Applicability.--This section applies when--
(1) an individual is injured or dies as the result of a use
or misuse of a qualified infectious disease product (other than
a vaccine);
(2) a person is entitled, by reason of such injury or
death, to recover damages from a manufacturer of the product;
and
(3) such manufacturer was, as of the date of such injury or
death, in substantial compliance with all applicable Federal
requirements with respect to the product.
(b) Federal Action Required.--The district courts of the United
States shall have jurisdiction over a civil action covered by
subsection (a). Such a civil action may not be brought in any Federal,
State, or local court other than a district court of the United States.
(c) Limitation on Punitive Damages.--In a civil action covered by
subsection (a), the person may recover punitive damages from the
manufacturer to the extent otherwise available by law, except that--
(1) it must be proven, in addition to any other matter that
must be proven, that the manufacturer--
(A) acted with malicious intent to injure the
individual; or
(B) deliberately failed to avoid unnecessary injury
that the manufacturer knew the individual was
substantially certain to suffer; and
(2) the person may not recover punitive damages from the
manufacturer if the person does not recover compensatory
damages from the manufacturer.
(d) Limitation on Non-Economic Damages.--In a civil action covered
by subsection (a), the person may recover non-economic damages from the
manufacturer to the extent otherwise available by law, except that the
amount of such damages may not exceed $250,000.
SEC. 5. PATENT PROTECTION.
(a) Purpose.--The purpose of this section is to provide an
incentive for research and development relating to qualified infectious
disease products.
(b) Restoration of Patent Terms.--
(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 QUALIFIED
INFECTIOUS DISEASE PRODUCTS.
``(a) Definitions.--In this section--
``(1) the term `diagnostic test' has the meaning given to
that term in section 3 of the Infectious Diseases Research and
Development Act of 2005;
``(2) the term `qualified infectious disease product' has
the meaning given to that term in section 3 of the Infectious
Diseases Research and Development Act of 2005;
``(3) the term `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
issued;
``(ii) the date that an exemption under
section 505(i) of the Federal Food, Drug, and
Cosmetic Act became effective for the product;
or
``(iii) the date on which an
investigational device exemption is approved
pursuant to section 520(g) of the Federal Food,
Drug and Cosmetic Act; and
``(B) ends on the date that is--
``(i) in the case of a drug, the date on
which an application submitted for such drug
under section 505(b) of the Federal Food, Drug,
and Cosmetic Act is approved;
``(ii) in the case of a biologic, the date
on which an application submitted under section
351 of the Public Health Service Act is
approved; or
``(iii) in the case of a medical device,
the date on which an application for premarket
approval submitted for such device under the
Federal Food, Drug, and Cosmetic Act is
approved; and
``(4) the term `eligible patent' means a patent that--
``(A) claims a qualified infectious disease
product, or claims an active ingredient of such
product, or a process of making or using the product or
an active ingredient of such product; and
``(B) is owned by or licensed to an entity that
sponsored the application described in paragraph (3)(B)
for the product.
``(b) Patent Term Extension.--The term of an eligible patent shall
be extended from the expiration date of the patent that would otherwise
apply, which shall include any patent term adjustment granted under
section 154(b), by a period equal to the number of days in the
regulatory review period if each of the following is met:
``(1) An application in conformance with the requirements
of subsection (c) is submitted to the Director by either the
owner of record of the patent or its agent by the later of 60
days after the end of the regulatory review period or 45 days
after issuance of the patent.
``(2) The patent that is the basis of the application has
not been previously extended under this section, or under
section 156.
``(3) The term of the patent that is the basis of the
application has not expired before the date that the
application is submitted under subsection (c).
``(4) The regulatory review period for the qualified
infectious disease product has not been relied upon to support
an application to extend the term of another patent under this
section or under section 156.
``(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
its agent shall submit an application to the Director.
``(2) Content.--The application shall contain--
``(A) a description of the qualified infectious
disease product and the Federal statute under which
regulatory review occurred;
``(B) the identity of the patent for which an
extension is sought under this section; and
``(C) such other information as the Director may
require including to establish that the applicant meets
the requirements of this section.
``(3) 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.''.
(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 qualified infectious
disease products.''.
(c) Extension of Patent Terms.--
(1) Certification of successful development.--
(A) Application.--An entity may submit to the
Secretary of Health and Human Services (in this section
referred to as the ``Secretary'') an application for
certification that the entity--
(i) has successfully developed a qualified
infectious disease prevention product, as that
term is defined in section 158 of title 35,
United States Code; and
(ii) the entity may receive a patent term
extension under the provisions of such section.
(B) Certification.--With respect to an application
submitted by an entity under this paragraph, the
Secretary shall--
(i) approve the application if the
Secretary determines that the entity has
successfully developed the qualified infectious
disease prevention product;
(ii) deny the application if the Secretary
determines that the entity has not successfully
developed the product; and
(iii) notify the entity of the approval or
denial, and the reasons therefore.
(C) Successful development.--In carrying out
subparagraph (B), the Secretary shall determine that an
entity has successfully developed a product if--
(i) the product is a qualified infectious
disease prevention product; and
(ii) the product has been approved under
section 505 or 515 of the Federal Food, Drug,
and Cosmetic Act or section 351 of the Public
Health Service Act.
(D) Effect of certification.--If the Secretary
approves an application submitted by an entity under
this paragraph, the entity may use the patent extension
provisions of section 158 of title 35, United States
Code.
(E) Application.--This paragraph and the amendment
made by paragraph (2) apply only with respect to a
product that is approved under section 505 or 515 of
the Federal Food, Drug, and Cosmetic Act or section 351
of the Public Health Service Act after the date of the
enactment of this Act.
(2) 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 qualified infectious
disease prevention products.
``(a) Definitions.--In this section:
``(1) The term `qualified infectious disease prevention
product' means a qualified infectious disease prevention
product, as that term is defined in section 3 of the Infectious
Diseases Research and Development Act of 2005.
``(2) The term `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) The term `diagnostic test' has the meaning given to
that term in section 3 of the Infectious Diseases Research and
Development Act of 2005.
``(4) The term `eligible entity' means a natural or legal
person that has successfully developed a qualified infectious
disease prevention product.
``(5) The term `eligible patent' means a patent that at the
time the eligible entity entered into the contract to develop
the qualified infectious disease prevention product involved,
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.
``(b) Patent Term Extension.--The term of an eligible patent shall
be extended for a period of 2 years, 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 patent has not expired before the date that the
application is submitted;
``(4) 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
``(5) 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 qualified
infectious disease prevention 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 5(c)(1) of the Infectious Diseases
Research and Development Act of 2005 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 qualified infectious
disease prevention 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 5(c)(1) of
the Infectious Diseases Research and Development Act of 2005
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.''.
(3) 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.''.
SEC. 6. ACCELERATED APPROVAL OF QUALIFIED INFECTIOUS DISEASE PRODUCTS.
(a) Designation as Fast-Track Product.--
(1) In general.--The Secretary of Health and Human Services
shall designate qualified infectious disease products as fast-
track products, pursuant to section 506 or section 515(d)(5),
as applicable, of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356, 360e(5)). Such designation may be made prior to the
submission of--
(A) a request for designation by the sponsor or
applicant; or
(B) an application for the investigation of the
qualified infectious disease product under section 505
or 520(g) 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).
(2) Rule of construction.--Nothing in this section shall be
construed to prohibit a sponsor or applicant from declining a
designation under paragraph (1).
(b) Grants for Clinical Tests.--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. CLINICAL TRIALS ON QUALIFIED INFECTIOUS DISEASE PRODUCTS.
``(a) Grants.--In carrying out section 446, the Director of the
Institute shall expand and intensify efforts to assist small
manufacturers to conduct end-stage clinical trials on qualified
infectious disease products, including by awarding grants for such
clinical trials.
``(b) Definition.--In this section, the term `qualified infectious
disease product' has the meaning given to that term in section 3 of the
Infectious Diseases Research and Development Act of 2005.''.
SEC. 7. TAX CREDIT FOR MEDICAL RESEARCH RELATED TO DEVELOPING QUALIFIED
INFECTIOUS DISEASE PRODUCTS.
(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 QUALIFIED
INFECTIOUS DISEASE PRODUCTS.
``(a) General Rule.--For purposes of section 38, the infectious
disease research credit determined under this section for the taxable
year is an amount equal to 35 percent of the qualified infectious
disease research expenses for the taxable year.
``(b) Qualified Infectious Disease Research Expenses.--For purposes
of this section--
``(1) Qualified infectious disease research expenses.--
Except as otherwise provided in this subsection, the term
`qualified infectious disease research expenses' means the
amounts which are paid or incurred by the taxpayer during the
taxable year with respect to any research and development of
qualified infectious disease products which would be described
in subsection (b) of section 41 if such subsection were applied
with the modifications set forth in paragraph (2).
``(2) Modifications; increased incentive for contract
research payments.--For purposes of paragraph (1), subsection
(b) of section 41 shall be applied--
``(A) by substituting `qualified infectious disease
research' for `qualified research' each place it
appears in paragraphs (2) and (3) of such subsection,
and
``(B) by substituting `100 percent' for `65
percent' in paragraph (3)(A) of such subsection.
``(3) Exclusion for amounts funded by grants, etc.--The
term `qualified infectious disease 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).
``(4) Qualified infectious disease research.--The term
`qualified infectious disease research' means qualified
research (as defined in section 41(d)) which relates to the
development of a qualified infectious disease product, except
that qualified infectious disease research shall include
expenses related to re-formulating existing qualified
infectious disease products.
``(5) Qualified infectious disease products.--The term
`qualified infectious disease products' has the meaning given
such term in section 3 of the Infectious Diseases Research and
Development Act of 2005.
``(c) Coordination With Credit for Increasing Research
Expenditures.--
``(1) In general.--Except as provided in paragraph (2), any
qualified infectious disease 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 qualified infectious disease 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) Special Rules.--
``(1) 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.
``(2) Coordination with credit for clinical testing
expenses for certain drugs for rare diseases.--Any qualified
infectious disease 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 45C for such taxable year.
``(3) Election.--This section shall apply to any taxpayer
for any taxable year only if such taxpayer elects (at such time
and in such manner as the Secretary may by regulations
prescribe) to have this section apply for such taxable year.''.
(b) Inclusion in General Business Credit.--Section 38(b) of the
Internal Revenue Code of 1986 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 infectious disease research credit determined
under section 45J.''.
(c) Denial of Double Benefit.--Section 280C of the Internal Revenue
Code of 1986 (relating to certain expenses for which credits are
allowable) is amended by adding at the end the following new
subsection:
``(e) Credit for Qualified Infectious Disease Research Expenses.--
``(1) In general.--No deduction shall be allowed for that
portion of the qualified infectious disease 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 the
Internal Revenue Code of 1986 (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 infectious disease 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 the Internal Revenue Code of
1986 is amended by adding at the end the following new item:
``Sec. 45J. Credit for medical research related to developing qualified
infectious disease products.''.
(f) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2004.
SEC. 8. INCENTIVES FOR THE CONSTRUCTION OF QUALIFIED INFECTIOUS DISEASE
PRODUCTS MANUFACTURING FACILITIES.
(a) Qualified Infectious Disease Products 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 qualified infectious disease products
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. QUALIFIED INFECTIOUS DISEASE PRODUCTS MANUFACTURING
FACILITIES CREDIT.
``(a) In General.--For purposes of section 46, the qualified
infectious disease products 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
qualified infectious disease products manufacturing facilities
property placed in service by the taxpayer during such taxable
year.
``(2) Qualified infectious disease products manufacturing
facilities property.--For purposes of this section, the term
`qualified infectious disease products 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 qualified
infectious disease products, 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.
``(3) Qualified infectious disease products.--For purposes
of this subsection, the term `qualified infectious disease
products' has the meaning given such term in section 3 of the
Infectious Diseases Research and Development Act of 2005.
``(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 qualified
infectious disease products 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. Qualified infectious disease products 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).
SEC. 9. COMBATING ANTIMICROBIAL RESISTANCE.
Subsection (g) of section 319E of the Public Health Service Act (42
U.S.C. 247d-5) is amended to read as follows:
``(g) Authorization of Appropriations.--
``(1) Authorization.--There are authorized to be
appropriated to carry out this section $40,000,000 for fiscal
year 2001 and such sums as may be necessary for each of fiscal
years 2002 through 2006.
``(2) Allocation.--
``(A) In general.--Of the amount appropriated to
carry out this section for a fiscal year, the Secretary
shall make available not less than $25,000,000 for
activities of the Centers for Disease Control and
Prevention under subsections (b), (c), (d), and (e).
``(B) Ratable reduction.--If amounts appropriated
to carry out this section for a fiscal year are less
than $25,000,000, the Secretary shall ratably reduce
the amount to be made available under subparagraph
(A).''.
SEC. 10. COMMISSION ON INFECTIOUS DISEASES PRODUCT DEVELOPMENT.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 319E the following:
``SEC. 319E-1. COMMISSION ON INFECTIOUS DISEASES PRODUCT DEVELOPMENT.
``(a) Establishment.--There is established a permanent commission
to be known as the `Commission on Infectious Diseases Product
Development'.
``(b) Duties.--
``(1) Identification of pathogens.--The Commission shall--
``(A) not later than the end of calendar year 2006,
identify the infectious pathogens that are (or are
likely to become) a significant threat to public health
because of drug resistance or other factors;
``(B) taking into consideration the risks and
benefits to public health, make recommendations to the
Secretary on how best to address such pathogens,
including through the development of qualified
infectious disease products to prevent, detect, and
treat such pathogens; and
``(C) periodically review and update the list of
pathogens identified under subparagraph (A).
``(2) Recommendations.--Not later than 90 days after the
date of the enactment of this section, the Commission shall
submit a report to the Secretary containing recommendations on
the actions the Secretary should take to ensure that a
sufficient quantity of vaccines and anti-virals are available
to treat the American population in the event of a pandemic
influenza outbreak.
``(c) Antimicrobial Resistance Task Force.--In carrying out this
section, the Commission shall consult with the Antimicrobial Resistance
Task Force established under section 319-E.
``(d) Membership.--
``(1) In general.--The Commission shall be composed of--
``(A) not more than 19 voting members appointed by
the President under paragraph (2); and
``(B) the nonvoting ex officio members listed in
paragraph (3).
``(2) Voting members.--The President shall appoint not more
than 19 voting members of the Commission as follows:
``(A) 12 of the voting members shall be appointed
from among the leading representatives (including
individuals in industry) of the infectious disease
medical, research, pharmaceutical, and biological
communities.
``(B) 7 of the voting members--
``(i) shall be appointed from among the
general public; and
``(ii) shall include leaders in the fields
of public policy, law, health policy,
economics, and management.
``(3) Nonvoting ex officio members.--The Commission shall
include the following nonvoting ex officio members:
``(A) The Secretary of Homeland Security (or the
Secretary's designee).
``(B) The Secretary of Health and Human Services
(or the Secretary's designee).
``(C) The Director of the National Institutes of
Health (or the Director's designee).
``(D) The Commissioner of Food and Drugs (or the
Commissioner's designee).
``(E) The Director of the Centers for Disease
Control and Prevention (or the Director's designee).
``(F) The Assistant Secretary of Defense for Health
Affairs (or the Assistant Secretary's designee).
``(G) The Under Secretary for Health of the
Department of Veterans Affairs (or the Under
Secretary's designee).
``(H) The Secretary of Agriculture (or the
Secretary's designee).
``(I) Such additional ex officio members as the
Secretary determines necessary for the Commission to
carry out its functions.
``(4) Terms.--Each member appointed under paragraph (2)
shall be appointed for a term of 6 years.
``(5) Vacancies.--Any member appointed to fill a vacancy
occurring before the expiration of the term for which the
member's predecessor was appointed shall be appointed only for
the remainder of that term. A member may serve after the
expiration of that member's term until a successor has taken
office. A vacancy in the Commission shall be filled in the
manner in which the original appointment was made.
``(6) Basic pay.--
``(A) Rates of pay.--Members of the Commission who
are officers or employees of the United States shall
not receive any compensation for service on the
Commission. The other members of the Commission shall
receive, for each day (including traveltime) they are
engaged in the performance of the functions of the
Commission, compensation at rates not to exceed the
daily equivalent of the annual rate in effect for grade
GS-15 of the General Schedule.
``(B) Travel expenses.--Each member of the
Commission shall receive travel expenses, including per
diem in lieu of subsistence, in accordance with
applicable provisions under subchapter I of chapter 57
of title 5, United States Code.
``(7) Chairperson.--The Chairperson of the Commission shall
be a representative of the infectious disease medical or
research community selected by the President from among the
members appointed under subsection (d)(2). The term of office
of the Chairperson shall be 2 years.
``(8) Meetings.--The Commission shall meet at the call of
the Chairperson of the Commission or the Secretary, but not
less than 4 times each year.
``(e) Director and Staff of Commission; Experts and Consultants.--
``(1) Director.--The Commission shall have a Director who
shall be appointed by the Commission.
``(2) Staff.--The Director of the Commission may appoint
such additional personnel as the Director considers
appropriate.
``(3) Applicability of certain civil services laws.--The
Director and staff of the Commission shall be appointed without
regard to the provisions of title 5, United States Code,
governing appointments in the competitive service, and shall be
paid without regard to the provisions of chapter 51 and
subchapter III of chapter 53 of that title relating to
classification of positions and General Schedule pay rates,
except that the rate of pay for the Director and staff of the
Commission may not exceed the daily equivalent of the annual
rate in effect for grade GS-15 of the General Schedule.
``(4) Experts and consultants.--The Commission may procure
temporary and intermittent services under section 3109(b) of
title 5, United States Code.
``(5) Staff of federal agencies.--Upon the request of the
Commission, the head of any Federal agency may detail, without
reimbursement, any of the personnel of such agency to the
Commission to assist in carrying out the duties of the
Commission. Any such detail shall not interrupt or otherwise
affect the civil service status or privileges of the Federal
employee.
``(f) Powers of Commission.--
``(1) Hearings and sessions.--The Commission may, for the
purpose of carrying out this Act, hold hearings, sit and act at
times and places, take testimony, and receive evidence as the
Commission considers appropriate.
``(2) Powers of members and agents.--Any member or agent of
the Commission may, if authorized by the Commission, take any
action which the Commission is authorized to take by this
section.
``(3) Mails.--The Commission may use the United States
mails in the same manner and under the same conditions as other
departments and agencies of the United States.
``(4) Administrative support services.--Upon the request of
the Commission, the Administrator of General Services shall
provide to the Commission, on a reimbursable basis, the
administrative support services necessary for the Commission to
carry out its responsibilities under this section.
``(g) Annual Reports.--Not later than the end of calendar year 2006
and annually thereafter, the Commission shall prepare and submit to the
President, the appropriate committees of the Congress, and the
Secretary of Health and Human Services a report that contains a
detailed statement of the recommendations, findings, and conclusions of
the Commission. Each such report shall include an updated list of the
infectious pathogens identified by the Commission pursuant to
subsection (b)(1)(A).
``(h) Definitions.--In this section:
``(1) The term `Commission' means the Commission on
Infectious Diseases Product Development established under this
section.
``(2) The term `qualified infectious disease product' has
the meaning given to that term in section 3 of the Infectious
Diseases Research and Development Act of 2005.
``(i) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $3,000,000 for fiscal year 2006
and such sums as may be necessary for each subsequent fiscal year.''.
SEC. 11. CLINICAL TRIAL GUIDELINES FOR ANTIBIOTIC DRUGS.
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 ANTIBIOTIC DRUGS.
``(a) In General.--Not later than 1 year after the date of
enactment of the Infectious Diseases Research and Development 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 antibiotic drugs, including antimicrobials 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 Infectious Diseases Research and Development 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.''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Ways and Means, 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 Committees on the Judiciary, and Ways and Means, 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 Committees on the Judiciary, and Ways and Means, 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 Committees on the Judiciary, and Ways and Means, 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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