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-resist-
ant staphylococcus areus (CA–MRSA); 
(B) life-threatening gram negative bac-
teria, such as Escherichia coli (E. coli), 
Acinetobacter, 
Klebsiella 
species, 
and 
Pseudomonas aeruginosa; 
(C) influenza; or 
(D) any other infectious pathogen identi-
fied for purposes of this Act by the Secretary 
of Health and Human Services, in concurrence 
with infectious disease clinicians and appro-
priate professional associations, as a significant 
threat to public health because of drug resist-
ance or other factors (or likely to become such 
a threat). 
(9) The term ‘‘vaccine’’ means a vaccine in-
tended 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 in-
jury or death, to recover damages from a manufac-
turer 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 manufac-
turer—
(A) acted with malicious intent to injure 
the individual; or 
(B) deliberately failed to avoid unnecessary 
injury that the manufacturer knew the indi-
vidual was substantially certain to suffer; and 
(2) the person may not recover punitive dam-
ages from the manufacturer if the person does not 
recover compensatory damages from the manufac-
turer. 
(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 pro-
vide 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 Dis-
eases Research and Development Act of 2005; 
‘‘(2) the term ‘qualified infectious disease prod-
uct’ has the meaning given to that term in section 
3 of the Infectious Diseases Research and Develop-
ment 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 investiga-
tional device exemption is approved pursu-
ant 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 pre-
market approval submitted for such device 
under the Federal Food, Drug, and Cos-
metic 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 el-
igible patent shall be extended from the expiration date 
of the patent that would otherwise apply, which shall in-
clude 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 re-
quirements of subsection (c) is submitted to the Di-
rector 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 applica-
tion has not been previously extended under this sec-
tion, 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 quali-
fied 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 con-
tain—
‘‘(A) a description of the qualified infec-
tious 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 Direc-
tor may require including to establish that the 
applicant meets the requirements of this sec-
tion. 
‘‘(3) IRREVOCABLE
ELECTION.—The submis-
sion of an application under this section is an irrev-
ocable election of the application of this section to 
the patent that is the basis of the application. A pat-
ent that has been the basis of an application made 
under this section may not be the subject of an ap-
plication made under section 156 or 158.’’.
(2) TECHNICAL
AND
CONFORMING
AMEND-
MENT.—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 prod-
ucts.’’.
(c) EXTENSION OF PATENT TERMS.—
(1) CERTIFICATION OF SUCCESSFUL DEVELOP-
MENT.—
(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 quali-
fied 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 Sec-
retary determines that the entity has suc-
cessfully developed the qualified infectious 
disease prevention product; 
(ii) deny the application if the Sec-
retary 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 car-
rying out subparagraph (B), the Secretary shall 
determine that an entity has successfully devel-
oped 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: 
‘‘§ 158. Extension of patent terms relating to qualified 
infectious disease prevention products. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) The term ‘qualified infectious disease pre-
vention product’ means a qualified infectious disease 
prevention product, as that term is defined in sec-
tion 3 of the Infectious Diseases Research and De-
velopment 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 Dis-
eases 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 li-
censed to that eligible entity, and claims a des-
ignated 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 el-
igible 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 sub-
mitted to the Director by either the owner of record 
of the patent or its agent on or before the date spec-
ified in subsection (c)(3); 
‘‘(2) the patent has not been previously ex-
tended 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 ex-
tended based on the certification being relied upon 
by the eligible entity to request extension of the pat-
ent; and 
‘‘(5) no other patent that claims the designated 
product, an active ingredient of the designated prod-
uct, a method of making or using a designated prod-
uct or a method of making or using an active ingre-
dient 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 quali-
fied infectious disease prevention product and 
the Federal statute under which regulatory re-
view 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 enti-
ty); 
‘‘(D) the identity of the designated product 
to which the eligible patent relates; 
‘‘(E) information concerning the certifi-
cation specified in section 5(c)(1) of the Infec-
tious 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 quali-
fied infectious disease prevention product; and 
‘‘(G) such other information as the Direc-
tor may require including to establish that the 
applicant meets the requirements of this sec-
tion. 
‘‘(3) SUBMISSION OF APPLICATION.—An appli-
cation under this section shall be submitted to the 
Director within 60 days after the date of the certifi-
cation 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
AMEND-
MENT.—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 INFEC-
TIOUS 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 spon-
sor 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 para-
graph (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 Di-
rector 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 ‘quali-
fied 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 DIS-
EASE PRODUCTS. 
(a) IN GENERAL.—Subpart D of part IV of sub-
chapter 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 DIS-
EASE 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 ex-
penses for the taxable year. 
‘‘(b) QUALIFIED INFECTIOUS DISEASE RESEARCH 
EXPENSES.—For purposes of this section—
‘‘(1) QUALIFIED
INFECTIOUS
DISEASE
RE-
SEARCH EXPENSES.—Except as otherwise provided 
in this subsection, the term ‘qualified infectious dis-
ease research expenses’ means the amounts which 
are paid or incurred by the taxpayer during the tax-
able year with respect to any research and develop-
ment 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 pur-
poses 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 sub-
section. 
‘‘(3) EXCLUSION
FOR
AMOUNTS
FUNDED
BY 
GRANTS, ETC.—The term ‘qualified infectious dis-
ease 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
RE-
SEARCH.—The term ‘qualified infectious disease re-
search’ means qualified research (as defined in sec-
tion 41(d)) which relates to the development of a 
qualified infectious disease product, except that 
qualified infectious disease research shall include ex-
penses related to re-formulating existing qualified in-
fectious disease products. 
‘‘(5) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCTS.—The term ‘qualified infectious disease prod-
ucts’ has the meaning given such term in section 3 
of the Infectious Diseases Research and Develop-
ment Act of 2005. 
‘‘(c) COORDINATION WITH CREDIT FOR INCREASING 
RESEARCH EXPENDITURES.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), any qualified infectious disease research 
expenses for a taxable year to which an election 
under this section applies shall not be taken into ac-
count for purposes of determining the credit allow-
able 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 ac-
count 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 sec-
tion. 
‘‘(2) COORDINATION WITH CREDIT FOR CLIN-
ICAL 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 tax-
payer 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 de-
termined 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 al-
lowed for that portion of the qualified infectious dis-
ease 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 de-
termined 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 sub-
section (c) shall apply for purposes of this sub-
section.’’. 
(d) DEDUCTION FOR UNUSED PORTION OF CRED-
IT.—Section 196(c) of the Internal Revenue Code of 1986 
(defining qualified business credits) is amended by strik-
ing ‘‘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 de-
termined 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 add-
ing 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 QUALI-
FIED INFECTIOUS DISEASE PRODUCTS MANU-
FACTURING FACILITIES. 
(a) QUALIFIED INFECTIOUS DISEASE PRODUCTS 
MANUFACTURING FACILITIES INVESTMENT TAX CRED-
IT.—
(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 para-
graph: 
‘‘(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 (relat-
ing 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 facili-
ties 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 prod-
ucts manufacturing facilities property placed in serv-
ice by the taxpayer during such taxable year. 
‘‘(2) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCTS MANUFACTURING FACILITIES PROPERTY.—For 
purposes of this section, the term ‘qualified infec-
tious disease products manufacturing facilities prop-
erty’ means real and tangible personal property—
‘‘(A)(i) the original use of which com-
mences 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 promul-
gated by the Food and Drug Administration, 
the Occupational Safety and Health Adminis-
tration, or the Environmental Protection Agen-
cy and which are applicable to such property. 
‘‘(3) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCTS.—For purposes of this subsection, the term 
‘qualified infectious disease products’ has the mean-
ing 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 infec-
tious disease products manufacturing fa-
cilities property.’’. 
(2) Subparagraph (E) of section 50(a)(2) of 
such Code is amended by inserting ‘‘or 48A(c)’’ be-
fore 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 sec-
tion 48 the following:
‘‘Sec. 48A. Qualified infectious disease products manufacturing facilities cred-
it.’’.
(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 appro-
priated 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 sub-
sections (b), (c), (d), and (e). 
‘‘(B) RATABLE
REDUCTION.—If amounts 
appropriated to carry out this section for a fis-
cal year are less than $25,000,000, the Sec-
retary 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 sec-
tion 319E the following: 
‘‘SEC. 319E–1. COMMISSION ON INFECTIOUS DISEASES 
PRODUCT DEVELOPMENT. 
‘‘(a) ESTABLISHMENT.—There is established a per-
manent 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 resist-
ance or other factors; 
‘‘(B) taking into consideration the risks 
and benefits to public health, make rec-
ommendations to the Secretary on how best to 
address such pathogens, including through the 
development of qualified infectious disease prod-
ucts to prevent, detect, and treat such patho-
gens; 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 Sec-
retary 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 pan-
demic 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 ap-
pointed by the President under paragraph (2); 
and 
‘‘(B) the nonvoting ex officio members list-
ed 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 ap-
pointed from among the leading representatives 
(including individuals in industry) of the infec-
tious 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, econom-
ics, 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 Insti-
tutes 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 Dis-
ease 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 ap-
pointed 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 com-
pensation for service on the Commission. The 
other members of the Commission shall receive, 
for each day (including traveltime) they are en-
gaged 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 ac-
cordance with applicable provisions under sub-
chapter I of chapter 57 of title 5, United States 
Code. 
‘‘(7) CHAIRPERSON.—The Chairperson of the 
Commission shall be a representative of the infec-
tious disease medical or research community selected 
by the President from among the members ap-
pointed 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; EX-
PERTS 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 Direc-
tor considers appropriate. 
‘‘(3) APPLICABILITY OF CERTAIN CIVIL SERV-
ICES LAWS.—The Director and staff of the Commis-
sion shall be appointed without regard to the provi-
sions of title 5, United States Code, governing ap-
pointments 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 relat-
ing to classification of positions and General Sched-
ule pay rates, except that the rate of pay for the Di-
rector 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 Com-
mission 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 af-
fect the civil service status or privileges of the Fed-
eral employee. 
‘‘(f) POWERS OF COMMISSION.—
‘‘(1) HEARINGS AND SESSIONS.—The Commis-
sion 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 author-
ized 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 agen-
cies of the United States.
‘‘(4) ADMINISTRATIVE
SUPPORT
SERVICES.—
Upon the request of the Commission, the Adminis-
trator of General Services shall provide to the Com-
mission, 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 Commis-
sion shall prepare and submit to the President, the appro-
priate committees of the Congress, and the Secretary of 
Health and Human Services a report that contains a de-
tailed statement of the recommendations, findings, and 
conclusions of the Commission. Each such report shall in-
clude 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 Com-
mission on Infectious Diseases Product Development 
established under this section. 
‘‘(2) The term ‘qualified infectious disease 
product’ has the meaning given to that term in sec-
tion 3 of the Infectious Diseases Research and De-
velopment Act of 2005. 
‘‘(i) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $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 guide-
lines for the conduct of clinical trials with respect to anti-
biotic 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 ap-
propriate 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 De-
velopment 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 de-
velopments in scientific and medical information and tech-
nology.’’.
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