I 

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Infectious Diseases 

3 Research and Development Act of 2005’’. 

4 SEC. 2. FINDINGS. 

5 The Congress finds as follows: 

6 (1) Infections caused by resistant bacteria can 

7 strike anyone, including the young and the old, the 

8 healthy and the chronically ill. Antibiotic resistance 

9 is a particularly serious problem for patients whose 

10 immune systems are compromised, such as people 

11 with HIV/AIDS and patients in critical care units. 

12 (2) About 2 million people acquire bacterial in13 fections in United States hospitals each year, and 

14 90,000 die as a result. About 70 percent of those in15 fections are resistant to at least one drug. The 

16 trends toward increasing numbers of infection and 

17 increasing drug resistance show no sign of abating. 

18 (3) Resistant pathogens lead to higher health 

19 care costs because they often require more expensive 

20 drugs and extended hospital stays. The total cost to 

21 United States society is nearly $5,000,000,000 an22 nually. 

23 (4) The Institute of Medicine, the Infectious 

24 Diseases Society of America, and Federal officials 

25 have identified antibiotic resistance and the dearth 
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1 of antibiotic research and development as increasing 

2 threats to United States public health. 

3 (5) Without innovative public policy and addi4 tional financial support, fewer and fewer antibiotics 

5 will be available to treat the increasing number of 

6 drug-resistant and dangerous microbes that threaten 

7 Americans and the global community. 

8 (6) The pipeline of new antibiotics is drying up. 

9 Major pharmaceutical companies are losing interest 

10 in the antibiotics market because these drugs simply 

11 are not as profitable as drugs that treat chronic 

12 (long-term) conditions and lifestyle issues. 

13 (7) Drug research and development is expen14 sive, risky, and time-consuming. An aggressive re15 search and development program initiated today 

16 would likely require 10 or more years and an invest17 ment of $800,000,000 to $1,700,000,000 to bring a 

18 new drug to market. 

19 (8) Resistant bacterial infections are not only a 

20 public health problem; they have national and global 

21 security implications as well. 

22 (9) The Institute of Medicine in its 2004 report 

23 entitled ‘‘The Threat of Pandemic Influenza’’ stated 

24 that the United States is not adequately prepared to 

25 deal with the next pandemic of influenza. 
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1 (10) The Centers for Disease Control and Pre2 vention estimates that, without adequate prepara3 tion, 100,000 to 250,000 deaths could occur in the 

4 United States from a mild pandemic of influenza. 

5 (11) The limited influenza vaccine market and 

6 few dedicated manufacturers pose a substantial chal7 lenge to the Nation’s preparedness efforts. Cur8 rently, there are two manufacturers of influenza vac9 cine for the United States market. In 2004, the 

10 Food and Drug Administration suspended a manu11 facturer’s license due to bacterial contamination. 

12 This action led to a shortage of injectable influenza 

13 vaccine in the United States. 

14 (12) New rapid diagnostics would greatly re15 duce the cost and time needed to conduct clinical 

16 trials for new anti-infectives. For many infectious 

17 diseases, there currently are no rapid diagnostic 

18 tests available to assist in identifying eligible pa19 tients for clinical trials. Cutting costs and time will 

20 serve as incentives for greater investment in this 

21 area. In addition, new rapid diagnostics will permit 

22 physicians to diagnose specific bacterial infections in 

23 their patients. This will enable physicians to pre24 scribe the most appropriate therapies, including 
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1 antibiotics, which will slow the evolution of new anti2 microbial resistance. 

3 SEC. 3. DEFINITIONS. 

4 In this Act: 

5 (1) The term ‘‘antibiotic drug’’ has the meaning 

6 given to that term in section 201 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

8 (2) The term ‘‘antiviral’’ means a drug or bio9 logical product intended for human use that impedes 

10 the reproduction of a virus. 

11 (3) The term ‘‘biological product’’ has the 

12 meaning given to that term in section 351 of the 

13 Public Health Service Act (42 U.S.C. 262). 

14 (4) The term ‘‘device’’ has the meaning given to 

15 that term in section 201 of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 321). 

17 (5) The term ‘‘diagnostic test’’ means a device 

18 or product used to detect the presence, concentra19 tion, or characteristics of an infectious human dis20 ease. 

21 (6) The term ‘‘drug’’ has the meaning given to 

22 that term in section 201 of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 321). 

24 (7) The term ‘‘qualified infectious disease prod25 uct’’ means any antibiotic drug, antiviral, diagnostic 
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1 test, or vaccine that is developed for the purpose of 

2 treating, detecting, preventing, or identifying—

3 (A) a qualifying pathogen (for the period 

4 beginning on the date of the enactment of this 

5 Act and ending on commencement of the period 

6 described in subparagraph (B)); or 

7 (B) an infectious pathogen identified by 

8 the Commission under section 319E–1(b) of the 

9 Public Health Service Act, as added by section 

10 10 of this Act (for the period beginning on the 

11 date on which the Commission on Infectious 

12 Diseases Product Development first identifies 

13 infectious pathogens under such section). 

14 (8) The term ‘‘qualifying pathogen’’ means—

15 (A) community-acquired methicillin-resist16 ant staphylococcus areus (CA–MRSA); 

17 (B) life-threatening gram negative bac18 teria, such as Escherichia coli (E. coli), 

19 Acinetobacter, Klebsiella species, and 

20 Pseudomonas aeruginosa; 

21 (C) influenza; or 

22 (D) any other infectious pathogen identi23 fied for purposes of this Act by the Secretary 

24 of Health and Human Services, in concurrence 

25 with infectious disease clinicians and appro-
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1 priate professional associations, as a significant 

2 threat to public health because of drug resist3 ance or other factors (or likely to become such 

4 a threat). 

5 (9) The term ‘‘vaccine’’ means a vaccine in6 tended for human use. 

7 SEC. 4. LIABILITY PROTECTION. 

8 (a) APPLICABILITY.—This section applies when—

9 (1) an individual is injured or dies as the result 

10 of a use or misuse of a qualified infectious disease 

11 product (other than a vaccine); 

12 (2) a person is entitled, by reason of such in13 jury or death, to recover damages from a manufac14 turer of the product; and 

15 (3) such manufacturer was, as of the date of 

16 such injury or death, in substantial compliance with 

17 all applicable Federal requirements with respect to 

18 the product. 

19 (b) FEDERAL ACTION REQUIRED.—The district 

20 courts of the United States shall have jurisdiction over a 

21 civil action covered by subsection (a). Such a civil action 

22 may not be brought in any Federal, State, or local court 

23 other than a district court of the United States. 

24 (c) LIMITATION ON PUNITIVE DAMAGES.—In a civil 

25 action covered by subsection (a), the person may recover 
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1 punitive damages from the manufacturer to the extent 

2 otherwise available by law, except that—

3 (1) it must be proven, in addition to any other 

4 matter that must be proven, that the manufac5 turer—

6 (A) acted with malicious intent to injure 

7 the individual; or 

8 (B) deliberately failed to avoid unnecessary 

9 injury that the manufacturer knew the indi10 vidual was substantially certain to suffer; and 

11 (2) the person may not recover punitive dam12 ages from the manufacturer if the person does not 

13 recover compensatory damages from the manufac14 turer. 

15 (d) LIMITATION ON NON-ECONOMIC DAMAGES.—In 

16 a civil action covered by subsection (a), the person may 

17 recover non-economic damages from the manufacturer to 

18 the extent otherwise available by law, except that the 

19 amount of such damages may not exceed $250,000. 

20 SEC. 5. PATENT PROTECTION. 

21 (a) PURPOSE.—The purpose of this section is to pro22 vide an incentive for research and development relating 

23 to qualified infectious disease products. 

24 (b) RESTORATION OF PATENT TERMS.—
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1 (1) IN GENERAL.—Chapter 14 of title 35, 

2 United States Code, is amended by inserting after 

3 section 156 the following: 

4 ‘‘SEC. 156a. RESTORATION OF PATENT TERMS RELATING TO 

5 QUALIFIED INFECTIOUS DISEASE PRODUCTS. 

6 ‘‘(a) DEFINITIONS.—In this section—

7 ‘‘(1) the term ‘diagnostic test’ has the meaning 

8 given to that term in section 3 of the Infectious Dis9 eases Research and Development Act of 2005; 

10 ‘‘(2) the term ‘qualified infectious disease prod11 uct’ has the meaning given to that term in section 

12 3 of the Infectious Diseases Research and Develop13 ment Act of 2005; 

14 ‘‘(3) the term ‘regulatory review period’ means 

15 the period of time that—

16 ‘‘(A) starts on the date that is the later 

17 of—

18 ‘‘(i) the date that an eligible patent 

19 sought to be extended under this section is 

20 issued; 

21 ‘‘(ii) the date that an exemption under 

22 section 505(i) of the Federal Food, Drug, 

23 and Cosmetic Act became effective for the 

24 product; or 
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1 ‘‘(iii) the date on which an investiga2 tional device exemption is approved pursu3 ant to section 520(g) of the Federal Food, 

4 Drug and Cosmetic Act; and 

5 ‘‘(B) ends on the date that is—

6 ‘‘(i) in the case of a drug, the date on 

7 which an application submitted for such 

8 drug under section 505(b) of the Federal 

9 Food, Drug, and Cosmetic Act is approved; 

10 ‘‘(ii) in the case of a biologic, the date 

11 on which an application submitted under 

12 section 351 of the Public Health Service 

13 Act is approved; or 

14 ‘‘(iii) in the case of a medical device, 

15 the date on which an application for pre16 market approval submitted for such device 

17 under the Federal Food, Drug, and Cos18 metic Act is approved; and 

19 ‘‘(4) the term ‘eligible patent’ means a patent 

20 that—

21 ‘‘(A) claims a qualified infectious disease 

22 product, or claims an active ingredient of such 

23 product, or a process of making or using the 

24 product or an active ingredient of such product; 

25 and 
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1 ‘‘(B) is owned by or licensed to an entity 

2 that sponsored the application described in 

3 paragraph (3)(B) for the product. 

4 ‘‘(b) PATENT TERM EXTENSION.—The term of an el5 igible patent shall be extended from the expiration date 

6 of the patent that would otherwise apply, which shall in7 clude any patent term adjustment granted under section 

8 154(b), by a period equal to the number of days in the 

9 regulatory review period if each of the following is met: 

10 ‘‘(1) An application in conformance with the re11 quirements of subsection (c) is submitted to the Di12 rector by either the owner of record of the patent or 

13 its agent by the later of 60 days after the end of the 

14 regulatory review period or 45 days after issuance of 

15 the patent. 

16 ‘‘(2) The patent that is the basis of the applica17 tion has not been previously extended under this sec18 tion, or under section 156. 

19 ‘‘(3) The term of the patent that is the basis 

20 of the application has not expired before the date 

21 that the application is submitted under subsection 

22 (c). 

23 ‘‘(4) The regulatory review period for the quali24 fied infectious disease product has not been relied 

25 upon to support an application to extend the term 
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1 of another patent under this section or under section 

2 156. 

3 ‘‘(c) ADMINISTRATIVE PROVISIONS.—

4 ‘‘(1) IN GENERAL.—To obtain an extension of 

5 the term of a patent under this section, the owner 

6 of record of the patent or its agent shall submit an 

7 application to the Director. 

8 ‘‘(2) CONTENT.—The application shall con9 tain—

10 ‘‘(A) a description of the qualified infec11 tious disease product and the Federal statute 

12 under which regulatory review occurred; 

13 ‘‘(B) the identity of the patent for which 

14 an extension is sought under this section; and 

15 ‘‘(C) such other information as the Direc16 tor may require including to establish that the 

17 applicant meets the requirements of this sec18 tion. 

19 ‘‘(3) IRREVOCABLE ELECTION.—The submis20 sion of an application under this section is an irrev21 ocable election of the application of this section to 

22 the patent that is the basis of the application. A pat23 ent that has been the basis of an application made 

24 under this section may not be the subject of an ap25 plication made under section 156 or 158.’’. 
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1 (2) TECHNICAL AND CONFORMING AMEND2 MENT.—The table of sections for chapter 14 of title 

3 35, United States Code, is amended by inserting 

4 after the item relating to section 156 the following:

‘‘156a. Restoration of patent terms relating to qualified infectious disease products.’’.

5 (c) EXTENSION OF PATENT TERMS.—

6 (1) CERTIFICATION OF SUCCESSFUL DEVELOP7 MENT.—

8 (A) APPLICATION.—An entity may submit 

9 to the Secretary of Health and Human Services 

10 (in this section referred to as the ‘‘Secretary’’) 

11 an application for certification that the entity—

12 (i) has successfully developed a quali13 fied infectious disease prevention product, 

14 as that term is defined in section 158 of 

15 title 35, United States Code; and 

16 (ii) the entity may receive a patent 

17 term extension under the provisions of 

18 such section. 

19 (B) CERTIFICATION.—With respect to an 

20 application submitted by an entity under this 

21 paragraph, the Secretary shall—

22 (i) approve the application if the Sec23 retary determines that the entity has suc-
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1 cessfully developed the qualified infectious 

2 disease prevention product; 

3 (ii) deny the application if the Sec4 retary determines that the entity has not 

5 successfully developed the product; and 

6 (iii) notify the entity of the approval 

7 or denial, and the reasons therefore. 

8 (C) SUCCESSFUL DEVELOPMENT.—In car9 rying out subparagraph (B), the Secretary shall 

10 determine that an entity has successfully devel11 oped a product if—

12 (i) the product is a qualified infectious 

13 disease prevention product; and 

14 (ii) the product has been approved 

15 under section 505 or 515 of the Federal 

16 Food, Drug, and Cosmetic Act or section 

17 351 of the Public Health Service Act. 

18 (D) EFFECT OF CERTIFICATION.—If the 

19 Secretary approves an application submitted by 

20 an entity under this paragraph, the entity may 

21 use the patent extension provisions of section 

22 158 of title 35, United States Code. 

23 (E) APPLICATION.—This paragraph and 

24 the amendment made by paragraph (2) apply 

25 only with respect to a product that is approved 
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1 under section 505 or 515 of the Federal Food, 

2 Drug, and Cosmetic Act or section 351 of the 

3 Public Health Service Act after the date of the 

4 enactment of this Act. 

5 (2) IN GENERAL.—Chapter 14 of title 35, 

6 United States Code, is amended by adding at the 

7 end the following: 

8 ‘‘§ 158. Extension of patent terms relating to qualified 

9 infectious disease prevention products. 

10 ‘‘(a) DEFINITIONS.—In this section: 

11 ‘‘(1) The term ‘qualified infectious disease pre12 vention product’ means a qualified infectious disease 

13 prevention product, as that term is defined in sec14 tion 3 of the Infectious Diseases Research and De15 velopment Act of 2005. 

16 ‘‘(2) The term ‘designated product’ means a 

17 drug, antibiotic drug, or device, as those terms are 

18 defined in section 201 of the Federal Food, Drug 

19 and Cosmetic Act (21 U.S.C. 321), or a biological 

20 product, as that term is defined in section 351 of 

21 the Public Health Service Act. 

22 ‘‘(3) The term ‘diagnostic test’ has the meaning 

23 given to that term in section 3 of the Infectious Dis24 eases Research and Development Act of 2005. 
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1 ‘‘(4) The term ‘eligible entity’ means a natural 

2 or legal person that has successfully developed a 

3 qualified infectious disease prevention product. 

4 ‘‘(5) The term ‘eligible patent’ means a patent 

5 that at the time the eligible entity entered into the 

6 contract to develop the qualified infectious disease 

7 prevention product involved, was owned by or li8 censed to that eligible entity, and claims a des9 ignated product, an active ingredient of a designated 

10 product, a method of making or using a designated 

11 product or a method of making or using an active 

12 ingredient of a designated product. 

13 ‘‘(b) PATENT TERM EXTENSION.—The term of an el14 igible patent shall be extended for a period of 2 years, 

15 in addition to the term which would otherwise apply except 

16 for this section, if—

17 ‘‘(1) an application under subsection (c) is sub18 mitted to the Director by either the owner of record 

19 of the patent or its agent on or before the date spec20 ified in subsection (c)(3); 

21 ‘‘(2) the patent has not been previously ex22 tended under this section, or under section 156 or 

23 156a; 

24 ‘‘(3) the patent has not expired before the date 

25 that the application is submitted; 
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1 ‘‘(4) the term of no other patent has been ex2 tended based on the certification being relied upon 

3 by the eligible entity to request extension of the pat4 ent; and 

5 ‘‘(5) no other patent that claims the designated 

6 product, an active ingredient of the designated prod7 uct, a method of making or using a designated prod8 uct or a method of making or using an active ingre9 dient of a designated product has been extended 

10 under this section or under section 156a. 

11 ‘‘(c) ADMINISTRATIVE PROVISIONS.—

12 ‘‘(1) IN GENERAL.—To obtain an extension of 

13 the term of a patent under this section, the owner 

14 of record of the patent or the agent of the owner 

15 shall submit an application to the Director. 

16 ‘‘(2) CONTENT.—An application filed under this 

17 section shall contain—

18 ‘‘(A) a description of the approved quali19 fied infectious disease prevention product and 

20 the Federal statute under which regulatory re21 view occurred; 

22 ‘‘(B) the identity of the eligible patent for 

23 which an extension is sought under this section; 
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1 ‘‘(C) the identity of the eligible entity and 

2 the applicant (if different from the eligible enti3 ty); 

4 ‘‘(D) the identity of the designated product 

5 to which the eligible patent relates; 

6 ‘‘(E) information concerning the certifi7 cation specified in section 5(c)(1) of the Infec8 tious Diseases Research and Development Act 

9 of 2005 being relied upon as the basis of the 

10 extension being requested; 

11 ‘‘(F) information indicating that the entity 

12 owned or licensed the eligible patent at the time 

13 it entered into the contract to develop the quali14 fied infectious disease prevention product; and 

15 ‘‘(G) such other information as the Direc16 tor may require including to establish that the 

17 applicant meets the requirements of this sec18 tion. 

19 ‘‘(3) SUBMISSION OF APPLICATION.—An appli20 cation under this section shall be submitted to the 

21 Director within 60 days after the date of the certifi22 cation specified in section 5(c)(1) of the Infectious 

23 Diseases Research and Development Act of 2005 

24 that is being relied upon to request extension of the 

25 patent that is the subject of the application. 
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1 ‘‘(d) IRREVOCABLE ELECTION.—The submission of 

2 an application under this section is an irrevocable election 

3 of the application of this section to the patent that is the 

4 basis of the application. A patent that has been the basis 

5 of an application made under this section may not be the 

6 subject of an application made under sections 156 or 

7 156a.’’. 

8 (3) TECHNICAL AND CONFORMING AMEND9 MENT.—The table of sections for chapter 14 of title 

10 35, United States Code, is amended by adding at 

11 the end the following:

‘‘158. Extension of patent terms relating to countermeasure products.’’.

12 SEC. 6. ACCELERATED APPROVAL OF QUALIFIED INFEC13 TIOUS DISEASE PRODUCTS. 

14 (a) DESIGNATION AS FAST-TRACK PRODUCT.—

15 (1) IN GENERAL.—The Secretary of Health and 

16 Human Services shall designate qualified infectious 

17 disease products as fast-track products, pursuant to 

18 section 506 or section 515(d)(5), as applicable, of 

19 the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 356, 360e(5)). Such designation may be 

21 made prior to the submission of—

22 (A) a request for designation by the spon23 sor or applicant; or 

24 (B) an application for the investigation of 

25 the qualified infectious disease product under 
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1 section 505 or 520(g) of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 355) or 

3 section 351 of the Public Health Service Act 

4 (42 U.S.C. 262). 

5 (2) RULE OF CONSTRUCTION.—Nothing in this 

6 section shall be construed to prohibit a sponsor or 

7 applicant from declining a designation under para8 graph (1). 

9 (b) GRANTS FOR CLINICAL TESTS.—Subpart 6 of 

10 part C of title IV of the Public Health Service Act (42 

11 U.S.C. 285f et seq.) is amended by adding at the end the 

12 following: 

13 ‘‘SEC. 447C. CLINICAL TRIALS ON QUALIFIED INFECTIOUS 

14 DISEASE PRODUCTS. 

15 ‘‘(a) GRANTS.—In carrying out section 446, the Di16 rector of the Institute shall expand and intensify efforts 

17 to assist small manufacturers to conduct end-stage clinical 

18 trials on qualified infectious disease products, including by 

19 awarding grants for such clinical trials. 

20 ‘‘(b) DEFINITION.—In this section, the term ‘quali21 fied infectious disease product’ has the meaning given to 

22 that term in section 3 of the Infectious Diseases Research 

23 and Development Act of 2005.’’. 
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1 SEC. 7. TAX CREDIT FOR MEDICAL RESEARCH RELATED TO 

2 DEVELOPING QUALIFIED INFECTIOUS DIS3 EASE PRODUCTS. 

4 (a) IN GENERAL.—Subpart D of part IV of sub5 chapter A of chapter 1 of the Internal Revenue Code of 

6 1986 (relating to business-related credits) is amended by 

7 adding at the end the following new section: 

8 ‘‘SEC. 45J. CREDIT FOR MEDICAL RESEARCH RELATED TO 

9 DEVELOPING QUALIFIED INFECTIOUS DIS10 EASE PRODUCTS. 

11 ‘‘(a) GENERAL RULE.—For purposes of section 38, 

12 the infectious disease research credit determined under 

13 this section for the taxable year is an amount equal to 

14 35 percent of the qualified infectious disease research ex15 penses for the taxable year. 

16 ‘‘(b) QUALIFIED INFECTIOUS DISEASE RESEARCH

17 EXPENSES.—For purposes of this section—

18 ‘‘(1) QUALIFIED INFECTIOUS DISEASE RE19 SEARCH EXPENSES.—Except as otherwise provided 

20 in this subsection, the term ‘qualified infectious dis21 ease research expenses’ means the amounts which 

22 are paid or incurred by the taxpayer during the tax23 able year with respect to any research and develop24 ment of qualified infectious disease products which 

25 would be described in subsection (b) of section 41 if 
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1 such subsection were applied with the modifications 

2 set forth in paragraph (2). 

3 ‘‘(2) MODIFICATIONS; INCREASED INCENTIVE

4 FOR CONTRACT RESEARCH PAYMENTS.—For pur5 poses of paragraph (1), subsection (b) of section 41 

6 shall be applied—

7 ‘‘(A) by substituting ‘qualified infectious 

8 disease research’ for ‘qualified research’ each 

9 place it appears in paragraphs (2) and (3) of 

10 such subsection, and 

11 ‘‘(B) by substituting ‘100 percent’ for ‘65 

12 percent’ in paragraph (3)(A) of such sub13 section. 

14 ‘‘(3) EXCLUSION FOR AMOUNTS FUNDED BY

15 GRANTS, ETC.—The term ‘qualified infectious dis16 ease research expenses’ shall not include any amount 

17 to the extent such amount is funded by any grant, 

18 contract, or otherwise by another person (or any 

19 governmental entity). 

20 ‘‘(4) QUALIFIED INFECTIOUS DISEASE RE21 SEARCH.—The term ‘qualified infectious disease re22 search’ means qualified research (as defined in sec23 tion 41(d)) which relates to the development of a 

24 qualified infectious disease product, except that 

25 qualified infectious disease research shall include ex-
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1 penses related to re-formulating existing qualified in2 fectious disease products. 

3 ‘‘(5) QUALIFIED INFECTIOUS DISEASE PROD4 UCTS.—The term ‘qualified infectious disease prod5 ucts’ has the meaning given such term in section 3 

6 of the Infectious Diseases Research and Develop7 ment Act of 2005. 

8 ‘‘(c) COORDINATION WITH CREDIT FOR INCREASING

9 RESEARCH EXPENDITURES.—

10 ‘‘(1) IN GENERAL.—Except as provided in para11 graph (2), any qualified infectious disease research 

12 expenses for a taxable year to which an election 

13 under this section applies shall not be taken into ac14 count for purposes of determining the credit allow15 able under section 41 for such taxable year. 

16 ‘‘(2) EXPENSES INCLUDED IN DETERMINING

17 BASE PERIOD RESEARCH EXPENSES.—Any qualified 

18 infectious disease research expenses for any taxable 

19 year which are qualified research expenses (within 

20 the meaning of section 41(b)) shall be taken into ac21 count in determining base period research expenses 

22 for purposes of applying section 41 to subsequent 

23 taxable years. 

24 ‘‘(d) SPECIAL RULES.—
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1 ‘‘(1) CERTAIN RULES MADE APPLICABLE.—

2 Rules similar to the rules of paragraphs (1) and (2) 

3 of section 41(f) shall apply for purposes of this sec4 tion. 

5 ‘‘(2) COORDINATION WITH CREDIT FOR CLIN6 ICAL TESTING EXPENSES FOR CERTAIN DRUGS FOR

7 RARE DISEASES.—Any qualified infectious disease 

8 research expenses for a taxable year to which an 

9 election under this section applies shall not be taken 

10 into account for purposes of determining the credit 

11 allowable under section 45C for such taxable year. 

12 ‘‘(3) ELECTION.—This section shall apply to 

13 any taxpayer for any taxable year only if such tax14 payer elects (at such time and in such manner as 

15 the Secretary may by regulations prescribe) to have 

16 this section apply for such taxable year.’’. 

17 (b) INCLUSION IN GENERAL BUSINESS CREDIT.—

18 Section 38(b) of the Internal Revenue Code of 1986 is 

19 amended by striking ‘‘plus’’ at the end of paragraph (18), 

20 by striking the period at the end of paragraph (19) and 

21 inserting ‘‘, plus’’, and by adding at the end the following 

22 new paragraph: 

23 ‘‘(20) the infectious disease research credit de24 termined under section 45J.’’. 
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1 (c) DENIAL OF DOUBLE BENEFIT.—Section 280C of 

2 the Internal Revenue Code of 1986 (relating to certain 

3 expenses for which credits are allowable) is amended by 

4 adding at the end the following new subsection: 

5 ‘‘(e) CREDIT FOR QUALIFIED INFECTIOUS DISEASE

6 RESEARCH EXPENSES.—

7 ‘‘(1) IN GENERAL.—No deduction shall be al8 lowed for that portion of the qualified infectious dis9 ease research expenses (as defined in section 45J(b)) 

10 otherwise allowable as a deduction for the taxable 

11 year which is equal to the amount of the credit de12 termined for such taxable year under section 45J(a). 

13 ‘‘(2) CERTAIN RULES TO APPLY.—Rules similar 

14 to the rules of paragraphs (2), (3), and (4) of sub15 section (c) shall apply for purposes of this sub16 section.’’. 

17 (d) DEDUCTION FOR UNUSED PORTION OF CRED18 IT.—Section 196(c) of the Internal Revenue Code of 1986 

19 (defining qualified business credits) is amended by strik20 ing ‘‘and’’ at the end of paragraph (11), by striking the 

21 period at the end of paragraph (12) and inserting ‘‘, and’’, 

22 and by adding at the end the following new paragraph: 

23 ‘‘(13) the infectious disease research credit de24 termined under section 45J(a) (other than such 
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1 credit determined under the rules of section 

2 280C(e)(2)).’’. 

3 (e) TECHNICAL AMENDMENT.—The table of sections 

4 for subpart D of part IV of subchapter A of chapter 1 

5 of the Internal Revenue Code of 1986 is amended by add6 ing at the end the following new item:

‘‘Sec. 45J. Credit for medical research related to developing qualified infectious 

disease products.’’.

7 (f) EFFECTIVE DATE.—The amendments made by 

8 this section shall apply to taxable years beginning after 

9 December 31, 2004. 

10 SEC. 8. INCENTIVES FOR THE CONSTRUCTION OF QUALI11 FIED INFECTIOUS DISEASE PRODUCTS MANU12 FACTURING FACILITIES. 

13 (a) QUALIFIED INFECTIOUS DISEASE PRODUCTS

14 MANUFACTURING FACILITIES INVESTMENT TAX CRED15 IT.—

16 (1) ALLOWANCE OF CREDIT.—Section 46 of the 

17 Internal Revenue Code of 1986 (relating to amount 

18 of investment credit) is amended by striking ‘‘and’’ 

19 at the end of paragraph (1), by striking the period 

20 at the end of paragraph (2) and inserting ‘‘, and’’, 

21 and by adding at the end the following new para22 graph: 

23 ‘‘(3) the qualified infectious disease products 

24 manufacturing facilities investment credit.’’. 
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1 (2) AMOUNT OF CREDIT.—Subpart E of part 

2 IV of subchapter A of chapter 1 of such Code (relat3 ing to rules for computing investment credit) is 

4 amended by inserting after section 48 the following 

5 new section: 

6 ‘‘SEC. 48A. QUALIFIED INFECTIOUS DISEASE PRODUCTS 

7 MANUFACTURING FACILITIES CREDIT. 

8 ‘‘(a) IN GENERAL.—For purposes of section 46, the 

9 qualified infectious disease products manufacturing facili10 ties investment credit for any taxable year is an amount 

11 equal to 20 percent of the qualified investment for such 

12 taxable year. 

13 ‘‘(b) QUALIFIED INVESTMENT.—

14 ‘‘(1) IN GENERAL.—For purposes of subsection 

15 (a), the qualified investment for any taxable year is 

16 the basis of each qualified infectious disease prod17 ucts manufacturing facilities property placed in serv18 ice by the taxpayer during such taxable year. 

19 ‘‘(2) QUALIFIED INFECTIOUS DISEASE PROD20 UCTS MANUFACTURING FACILITIES PROPERTY.—For 

21 purposes of this section, the term ‘qualified infec22 tious disease products manufacturing facilities prop23 erty’ means real and tangible personal property—

24 ‘‘(A)(i) the original use of which com25 mences with the taxpayer, or 
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1 ‘‘(ii) which is acquired through purchase 

2 (as defined by section 179(d)(2)), 

3 ‘‘(B) which is depreciable under section 

4 167, 

5 ‘‘(C) which is used for the manufacture, 

6 distribution, or research and development of 

7 qualified infectious disease products, and 

8 ‘‘(D) which is in compliance with any 

9 standards and regulations which are promul10 gated by the Food and Drug Administration, 

11 the Occupational Safety and Health Adminis12 tration, or the Environmental Protection Agen13 cy and which are applicable to such property. 

14 ‘‘(3) QUALIFIED INFECTIOUS DISEASE PROD15 UCTS.—For purposes of this subsection, the term 

16 ‘qualified infectious disease products’ has the mean17 ing given such term in section 3 of the Infectious 

18 Diseases Research and Development Act of 2005. 

19 ‘‘(c) CERTAIN PROGRESS EXPENDITURE RULES

20 MADE APPLICABLE.—Rules similar to rules of subsections 

21 (c)(4) and (d) of section 46 (as in effect on the day before 

22 the date of the enactment of the Revenue Reconciliation 

23 Act of 1990) shall apply for purposes of this subsection. 
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1 ‘‘(d) TERMINATION.—This subsection shall not apply 

2 to any property placed in service after December 31, 

3 2009.’’. 

4 (b) TECHNICAL AMENDMENTS.—

5 (1) Clause (iii) of section 49(a)(1)(C) of such 

6 Code is amended to read as follows: 

7 ‘‘(iii) the basis of any qualified infec8 tious disease products manufacturing fa9 cilities property.’’. 

10 (2) Subparagraph (E) of section 50(a)(2) of 

11 such Code is amended by inserting ‘‘or 48A(c)’’ be12 fore the period. 

13 (3) The table of sections for subpart E of part 

14 IV of subchapter A of chapter 1 of such Code is 

15 amended by inserting after the item relating to sec16 tion 48 the following:

‘‘Sec. 48A. Qualified infectious disease products manufacturing facilities credit.’’.

17 (c) EFFECTIVE DATE.—The amendments made by 

18 this section shall apply to property placed in service after 

19 December 31, 2004, under rules similar to the rules of 

20 section 48(m) of the Internal Revenue Code of 1986 (as 

21 in effect on the day before the date of enactment of the 

22 Revenue Reconciliation Act of 1990). 
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1 SEC. 9. COMBATING ANTIMICROBIAL RESISTANCE. 

2 Subsection (g) of section 319E of the Public Health 

3 Service Act (42 U.S.C. 247d–5) is amended to read as 

4 follows: 

5 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—

6 ‘‘(1) AUTHORIZATION.—There are authorized to 

7 be appropriated to carry out this section 

8 $40,000,000 for fiscal year 2001 and such sums as 

9 may be necessary for each of fiscal years 2002 

10 through 2006. 

11 ‘‘(2) ALLOCATION.—

12 ‘‘(A) IN GENERAL.—Of the amount appro13 priated to carry out this section for a fiscal 

14 year, the Secretary shall make available not less 

15 than $25,000,000 for activities of the Centers 

16 for Disease Control and Prevention under sub17 sections (b), (c), (d), and (e). 

18 ‘‘(B) RATABLE REDUCTION.—If amounts 

19 appropriated to carry out this section for a fis20 cal year are less than $25,000,000, the Sec21 retary shall ratably reduce the amount to be 

22 made available under subparagraph (A).’’. 
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1 SEC. 10. COMMISSION ON INFECTIOUS DISEASES PRODUCT 

2 DEVELOPMENT. 

3 Part B of title III of the Public Health Service Act 

4 (42 U.S.C. 243 et seq.) is amended by inserting after sec5 tion 319E the following: 

6 ‘‘SEC. 319E–1. COMMISSION ON INFECTIOUS DISEASES 

7 PRODUCT DEVELOPMENT. 

8 ‘‘(a) ESTABLISHMENT.—There is established a per9 manent commission to be known as the ‘Commission on 

10 Infectious Diseases Product Development’. 

11 ‘‘(b) DUTIES.—

12 ‘‘(1) IDENTIFICATION OF PATHOGENS.—The 

13 Commission shall—

14 ‘‘(A) not later than the end of calendar 

15 year 2006, identify the infectious pathogens 

16 that are (or are likely to become) a significant 

17 threat to public health because of drug resist18 ance or other factors; 

19 ‘‘(B) taking into consideration the risks 

20 and benefits to public health, make rec21 ommendations to the Secretary on how best to 

22 address such pathogens, including through the 

23 development of qualified infectious disease prod24 ucts to prevent, detect, and treat such patho25 gens; and 
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1 ‘‘(C) periodically review and update the list 

2 of pathogens identified under subparagraph 

3 (A). 

4 ‘‘(2) RECOMMENDATIONS.—Not later than 90 

5 days after the date of the enactment of this section, 

6 the Commission shall submit a report to the Sec7 retary containing recommendations on the actions 

8 the Secretary should take to ensure that a sufficient 

9 quantity of vaccines and anti-virals are available to 

10 treat the American population in the event of a pan11 demic influenza outbreak. 

12 ‘‘(c) ANTIMICROBIAL RESISTANCE TASK FORCE.—In 

13 carrying out this section, the Commission shall consult 

14 with the Antimicrobial Resistance Task Force established 

15 under section 319–E. 

16 ‘‘(d) MEMBERSHIP.—

17 ‘‘(1) IN GENERAL.—The Commission shall be 

18 composed of—

19 ‘‘(A) not more than 19 voting members ap20 pointed by the President under paragraph (2); 

21 and 

22 ‘‘(B) the nonvoting ex officio members list23 ed in paragraph (3). 
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1 ‘‘(2) VOTING MEMBERS.—The President shall 

2 appoint not more than 19 voting members of the 

3 Commission as follows: 

4 ‘‘(A) 12 of the voting members shall be ap5 pointed from among the leading representatives 

6 (including individuals in industry) of the infec7 tious disease medical, research, pharmaceutical, 

8 and biological communities. 

9 ‘‘(B) 7 of the voting members—

10 ‘‘(i) shall be appointed from among 

11 the general public; and 

12 ‘‘(ii) shall include leaders in the fields 

13 of public policy, law, health policy, econom14 ics, and management. 

15 ‘‘(3) NONVOTING EX OFFICIO MEMBERS.—The 

16 Commission shall include the following nonvoting ex 

17 officio members: 

18 ‘‘(A) The Secretary of Homeland Security 

19 (or the Secretary’s designee). 

20 ‘‘(B) The Secretary of Health and Human 

21 Services (or the Secretary’s designee). 

22 ‘‘(C) The Director of the National Insti23 tutes of Health (or the Director’s designee). 

24 ‘‘(D) The Commissioner of Food and 

25 Drugs (or the Commissioner’s designee). 
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1 ‘‘(E) The Director of the Centers for Dis2 ease Control and Prevention (or the Director’s 

3 designee). 

4 ‘‘(F) The Assistant Secretary of Defense 

5 for Health Affairs (or the Assistant Secretary’s 

6 designee). 

7 ‘‘(G) The Under Secretary for Health of 

8 the Department of Veterans Affairs (or the 

9 Under Secretary’s designee). 

10 ‘‘(H) The Secretary of Agriculture (or the 

11 Secretary’s designee). 

12 ‘‘(I) Such additional ex officio members as 

13 the Secretary determines necessary for the 

14 Commission to carry out its functions. 

15 ‘‘(4) TERMS.—Each member appointed under 

16 paragraph (2) shall be appointed for a term of 6 

17 years. 

18 ‘‘(5) VACANCIES.—Any member appointed to 

19 fill a vacancy occurring before the expiration of the 

20 term for which the member’s predecessor was ap21 pointed shall be appointed only for the remainder of 

22 that term. A member may serve after the expiration 

23 of that member’s term until a successor has taken 

24 office. A vacancy in the Commission shall be filled 
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1 in the manner in which the original appointment was 

2 made. 

3 ‘‘(6) BASIC PAY.—

4 ‘‘(A) RATES OF PAY.—Members of the 

5 Commission who are officers or employees of 

6 the United States shall not receive any com7 pensation for service on the Commission. The 

8 other members of the Commission shall receive, 

9 for each day (including traveltime) they are en10 gaged in the performance of the functions of 

11 the Commission, compensation at rates not to 

12 exceed the daily equivalent of the annual rate in 

13 effect for grade GS–15 of the General Schedule. 

14 ‘‘(B) TRAVEL EXPENSES.—Each member 

15 of the Commission shall receive travel expenses, 

16 including per diem in lieu of subsistence, in ac17 cordance with applicable provisions under sub18 chapter I of chapter 57 of title 5, United States 

19 Code. 

20 ‘‘(7) CHAIRPERSON.—The Chairperson of the 

21 Commission shall be a representative of the infec22 tious disease medical or research community selected 

23 by the President from among the members ap24 pointed under subsection (d)(2). The term of office 

25 of the Chairperson shall be 2 years. 
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1 ‘‘(8) MEETINGS.—The Commission shall meet 

2 at the call of the Chairperson of the Commission or 

3 the Secretary, but not less than 4 times each year. 

4 ‘‘(e) DIRECTOR AND STAFF OF COMMISSION; EX5 PERTS AND CONSULTANTS.—

6 ‘‘(1) DIRECTOR.—The Commission shall have a 

7 Director who shall be appointed by the Commission. 

8 ‘‘(2) STAFF.—The Director of the Commission 

9 may appoint such additional personnel as the Direc10 tor considers appropriate. 

11 ‘‘(3) APPLICABILITY OF CERTAIN CIVIL SERV12 ICES LAWS.—The Director and staff of the Commis13 sion shall be appointed without regard to the provi14 sions of title 5, United States Code, governing ap15 pointments in the competitive service, and shall be 

16 paid without regard to the provisions of chapter 51 

17 and subchapter III of chapter 53 of that title relat18 ing to classification of positions and General Sched19 ule pay rates, except that the rate of pay for the Di20 rector and staff of the Commission may not exceed 

21 the daily equivalent of the annual rate in effect for 

22 grade GS–15 of the General Schedule. 

23 ‘‘(4) EXPERTS AND CONSULTANTS.—The Com24 mission may procure temporary and intermittent 
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1 services under section 3109(b) of title 5, United 

2 States Code. 

3 ‘‘(5) STAFF OF FEDERAL AGENCIES.—Upon the 

4 request of the Commission, the head of any Federal 

5 agency may detail, without reimbursement, any of 

6 the personnel of such agency to the Commission to 

7 assist in carrying out the duties of the Commission. 

8 Any such detail shall not interrupt or otherwise af9 fect the civil service status or privileges of the Fed10 eral employee. 

11 ‘‘(f) POWERS OF COMMISSION.—

12 ‘‘(1) HEARINGS AND SESSIONS.—The Commis13 sion may, for the purpose of carrying out this Act, 

14 hold hearings, sit and act at times and places, take 

15 testimony, and receive evidence as the Commission 

16 considers appropriate. 

17 ‘‘(2) POWERS OF MEMBERS AND AGENTS.—Any 

18 member or agent of the Commission may, if author19 ized by the Commission, take any action which the 

20 Commission is authorized to take by this section. 

21 ‘‘(3) MAILS.—The Commission may use the 

22 United States mails in the same manner and under 

23 the same conditions as other departments and agen24 cies of the United States. 
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1 ‘‘(4) ADMINISTRATIVE SUPPORT SERVICES.—

2 Upon the request of the Commission, the Adminis3 trator of General Services shall provide to the Com4 mission, on a reimbursable basis, the administrative 

5 support services necessary for the Commission to 

6 carry out its responsibilities under this section. 

7 ‘‘(g) ANNUAL REPORTS.—Not later than the end of 

8 calendar year 2006 and annually thereafter, the Commis9 sion shall prepare and submit to the President, the appro10 priate committees of the Congress, and the Secretary of 

11 Health and Human Services a report that contains a de12 tailed statement of the recommendations, findings, and 

13 conclusions of the Commission. Each such report shall in14 clude an updated list of the infectious pathogens identified 

15 by the Commission pursuant to subsection (b)(1)(A). 

16 ‘‘(h) DEFINITIONS.—In this section: 

17 ‘‘(1) The term ‘Commission’ means the Com18 mission on Infectious Diseases Product Development 

19 established under this section. 

20 ‘‘(2) The term ‘qualified infectious disease 

21 product’ has the meaning given to that term in sec22 tion 3 of the Infectious Diseases Research and De23 velopment Act of 2005. 

24 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—To 

25 carry out this section, there are authorized to be appro-
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1 priated $3,000,000 for fiscal year 2006 and such sums 

2 as may be necessary for each subsequent fiscal year.’’. 

3 SEC. 11. CLINICAL TRIAL GUIDELINES FOR ANTIBIOTIC 

4 DRUGS. 

5 Chapter V of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

7 section 510 the following: 

8 ‘‘SEC. 511. CLINICAL TRIAL GUIDELINES FOR ANTIBIOTIC 

9 DRUGS. 

10 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

11 date of enactment of the Infectious Diseases Research and 

12 Development Act of 2005, the Secretary, acting through 

13 the Commissioner of Food and Drugs, shall issue guide14 lines for the conduct of clinical trials with respect to anti15 biotic drugs, including antimicrobials to treat resistant 

16 pathogens, bacterial meningitis, acute bacterial sinusitis, 

17 acute bacterial otitis media, and acute exacerbation of 

18 chronic bronchitis. Such guidelines shall indicate the ap19 propriate animal models of infection, in vitro techniques, 

20 and valid microbiologic surrogate markers. 

21 ‘‘(b) REVIEW.—Not later than 5 years after the date 

22 of enactment of the Infectious Diseases Research and De23 velopment Act of 2005, the Secretary, acting through the 

24 Commissioner of Food and Drugs, shall review and update 

25 the guidelines described under subsection (a) to reflect de-
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1 velopments in scientific and medical information and tech2 nology.’’.

Æ