I 

110TH CONGRESS 

1ST SESSION H. R. 1496 

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 serious and life-threatening 

infectious diseases. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 13, 2007 

Mr. BAIRD (for himself, Mrs. CUBIN, and Mr. MATHESON) 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 serious 

and life-threatening infectious diseases. 

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 ‘‘Beating Infections 

3 through Research and Development Act of 2007’’. 

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 (13) Extensively drug-resistant tuberculosis 

4 (XDR–TB) is highly drug-resistant not only to first 

5 line anti-tuberculosis drugs, but also to second line 

6 oral and even injectable drugs. In 2004, there were 

7 about 424,000 new cases of multi-drug resistant tu8 berculosis. Four percent of all multi-drug resistant 

9 tuberculosis cases in the United States fit the defini10 tion of XDR–TB. The Advisory Council for the 

11 Elimination of Tuberculosis (ACET) has warned 

12 that XDR–TB poses ‘‘an imminent airborne biologi13 cal threat’’ to the United States and requires imme14 diate action. 

15 SEC. 3. DEFINITIONS. 

16 In this Act: 

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

18 given to that term in section 201 of the Federal 

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

20 (2) The term ‘‘antiviral’’ means a drug or bio21 logical product intended for human use that impedes 

22 the reproduction of a virus. 

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

24 meaning given to that term in section 351 of the 

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


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

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

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

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

5 or product used to detect the presence, concentra6 tion, or characteristics of an infectious human dis7 ease. 

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

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

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

11 (7) The term ‘‘qualified infectious disease prod12 uct’’ means any antibiotic drug, antiviral, diagnostic 

13 test, or vaccine that is developed for the purpose of 

14 treating, detecting, preventing, or identifying— 

15 (A) a qualifying pathogen (for the period 

16 beginning on the date of the enactment of this 

17 Act and ending on commencement of the period 

18 described in subparagraph (B)); or 

19 (B) an infectious pathogen identified by 

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

21 Public Health Service Act, as added by section 

22 10 of this Act (for the period beginning on the 

23 date on which the Commission on Infectious 

24 Diseases Product Development first identifies 

25 infectious pathogens under such section). 


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

2 (A) community-acquired methicillin-resist3 ant staphylococcus areus (CA–MRSA); 

4 (B) life-threatening gram negative bac5 teria, such as Escherichia coli (E. coli), 

6 Acinetobacter, Klebsiella species, and 

7 Pseudomonas aeruginosa; 

8 (C) influenza; 

9 (D) extensively drug resistant tuberculosis 

10 (XDR–TB); or 

11 (E) any other infectious pathogen identi12 fied for purposes of this Act by the Secretary 

13 of Health and Human Services, in concurrence 

14 with infectious disease clinicians and appro15 priate professional associations, as a significant 

16 threat to public health because of drug resist17 ance or other factors (or likely to become such 

18 a threat). 

19 (9) The term ‘‘vaccine’’ means a vaccine in20 tended for human use. 

21 SEC. 4. PATENT PROTECTION. 

22 (a) PURPOSE.—The purpose of this section is to pro23 vide an incentive for research and development relating 

24 to qualified infectious disease products. 

25 (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 Beating Infec9 tions through Research and Development Act of 

10 2007; 

11 ‘‘(2) the term ‘qualified infectious disease prod12 uct’ has the meaning given to that term in section 

13 3 of the Beating Infections through Research and 

14 Development Act of 2007; 

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

16 the period of time that— 

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

18 of— 

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

20 sought to be extended under this section is 

21 issued; 

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

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

24 and Cosmetic Act became effective for the 

25 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 product, as that 

14 term is defined in section 158 of title 35, 

15 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 sucVerDate Aug 31 2005 02:43 Mar 15, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H1496.IH H1496

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1 cessfully developed the qualified infectious 

2 disease 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 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 products 

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

11 ‘‘(1) The term ‘qualified infectious disease 

12 product’ means a qualified infectious disease prod13 uct, as that term is defined in section 3 of the Beat14 ing Infections through Research and Development 

15 Act of 2007. 

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 Beating Infec24 tions through Research and Development Act of 

25 2007. 


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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 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 product involved, was owned by or licensed to that 

8 eligible entity, and claims a designated product, an 

9 active ingredient of a designated product, a method 

10 of making or using a designated product or a meth11 od of making or using an active ingredient of a des12 ignated 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 product and the Federal 

20 statute under which regulatory review occurred; 

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

22 which an extension is sought under this section; 

23 ‘‘(C) the identity of the eligible entity and 

24 the applicant (if different from the eligible enti25 ty); 


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

2 to which the eligible patent relates; 

3 ‘‘(E) information concerning the certifi4 cation specified in section 4(c)(1) of the Beat5 ing Infections through Research and Develop6 ment Act of 2007 being relied upon as the basis 

7 of the extension being requested; 

8 ‘‘(F) information indicating that the entity 

9 owned or licensed the eligible patent at the time 

10 it entered into the contract to develop the quali11 fied infectious disease product; and 

12 ‘‘(G) such other information as the Direc13 tor may require including to establish that the 

14 applicant meets the requirements of this sec15 tion. 

16 ‘‘(3) SUBMISSION OF APPLICATION.—An appli17 cation under this section shall be submitted to the 

18 Director within 60 days after the date of the certifi19 cation specified in section 4(c)(1) of the Beating In20 fections through Research and Development Act of 

21 2007 that is being relied upon to request extension 

22 of the patent that is the subject of the application. 

23 ‘‘(d) IRREVOCABLE ELECTION.—The submission of 

24 an application under this section is an irrevocable election 

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


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

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

3 subject of an application made under sections 156 or 

4 156a.’’. 

5 (3) TECHNICAL AND CONFORMING AMEND6 MENT.—The table of sections for chapter 14 of title 

7 35, United States Code, is amended by adding at 

8 the end the following: 

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

9 SEC. 5. ACCELERATED APPROVAL OF QUALIFIED INFEC10 TIOUS DISEASE PRODUCTS. 

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

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

13 Human Services shall designate qualified infectious 

14 disease products as fast-track products, pursuant to 

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

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

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

18 made prior to the submission of— 

19 (A) a request for designation by the spon20 sor or applicant; or 

21 (B) an application for the investigation of 

22 the qualified infectious disease product under 

23 section 505 or 520(g) of the Federal Food, 

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


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1 section 351 of the Public Health Service Act 

2 (42 U.S.C. 262). 

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

4 section shall be construed to prohibit a sponsor or 

5 applicant from declining a designation under para6 graph (1). 

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

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

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

10 following: 

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

12 DISEASE PRODUCTS. 

13 ‘‘(a) GRANTS.—In carrying out section 446, the Di14 rector of the Institute shall expand and intensify efforts 

15 to assist small manufacturers to conduct end-stage clinical 

16 trials on qualified infectious disease products, including by 

17 awarding grants for such clinical trials. 

18 ‘‘(b) DEFINITION.—In this section, the term ‘quali19 fied infectious disease product’ has the meaning given to 

20 that term in section 3 of the Beating Infections through 

21 Research and Development Act of 2007.’’. 


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1 SEC. 6. 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. 45O. 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 50 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 

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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 Beating Infections through Research and De7 velopment Act of 2007. 

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 (30), 

20 by striking the period at the end of paragraph (31) and 

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

22 new paragraph: 

23 ‘‘(32) the infectious disease research credit de24 termined under section 45O.’’. 


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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 

10 45O(b)) otherwise allowable as a deduction for the 

11 taxable year which is equal to the amount of the 

12 credit determined for such taxable year under sec13 tion 45O(a). 

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

15 to the rules of paragraphs (2), (3), and (4) of sub16 section (c) shall apply for purposes of this sub17 section.’’. 

18 (d) DEDUCTION FOR UNUSED PORTION OF CRED19 IT.—Section 196(c) of the Internal Revenue Code of 1986 

20 (defining qualified business credits) is amended by strik21 ing ‘‘and’’ at the end of paragraph (12), by striking the 

22 period at the end of paragraph (13) and inserting ‘‘, and’’, 

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

24 ‘‘(14) the infectious disease research credit de25 termined under section 45O(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. 45O. 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, 2006. 

10 SEC. 7. 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 (3), by striking the period 

20 at the end of paragraph (4) and inserting ‘‘, and’’, 

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

23 ‘‘(5) 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 48B the following 

5 new section: 

6 ‘‘SEC. 48C. 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 Beating In18 fections through Research and Development Act of 

19 2007. 

20 ‘‘(c) CERTAIN PROGRESS EXPENDITURE RULES

21 MADE APPLICABLE.—Rules similar to rules of subsections 

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

23 the date of the enactment of the Revenue Reconciliation 

24 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 2011.’’. 

4 (b) TECHNICAL AMENDMENTS.— 

5 (1) Subparagraph (C) of section 49(a)(1) of 

6 such Code is amended by striking ‘‘and’’ at the end 

7 of clause (iii), by striking the period at the end of 

8 clause (iv) and inserting ‘‘, and’’, and by adding at 

9 the end the following new clause: 

10 ‘‘(v) the basis of any qualified infec11 tious disease products manufacturing fa12 cilities property under section 48C.’’. 

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

14 such Code is amended by inserting ‘‘or 48C(c)’’ be15 fore the period. 

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

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

18 amended by inserting after the item relating to sec19 tion 48B the following: 

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

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

21 this section shall apply to property placed in service after 

22 December 31, 2006, under rules similar to the rules of 

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


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

2 Revenue Reconciliation Act of 1990). 

3 SEC. 8. DEVELOPMENT AND DISSEMINATION OF MODEL 

4 STATE LAWS AND INCENTIVES. 

5 The Secretary of Health and Human Services, acting 

6 jointly with the Secretary of Commerce, shall— 

7 (1) not less than 24 months after the enact8 ment of this Act, conduct a survey of current State 

9 laws and incentives that support research and devel10 opment of qualified infectious disease products; 

11 (2) based on the results of the survey and an 

12 analysis of the effectiveness of such laws and incen13 tives, develop recommendations for model State laws 

14 and incentives to support research and development 

15 of qualified infectious disease products; and 

16 (3) disseminate the model State laws and incen17 tives to State legislatures and State economic devel18 opment offices. 

19 SEC. 9. COMMISSION ON INFECTIOUS DISEASES PRODUCT 

20 DEVELOPMENT. 

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

22 (42 U.S.C. 243 et seq.) is amended by inserting after sec23 tion 319E the following: 


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

2 PRODUCT DEVELOPMENT. 

3 ‘‘(a) ESTABLISHMENT.—There is established a per4 manent commission to be known as the ‘Commission on 

5 Infectious Diseases Product Development’. 

6 ‘‘(b) DUTIES.—The Commission shall— 

7 ‘‘(1) not later than the end of calendar year 

8 2008, identify the infectious pathogens that are (or 

9 are likely to become) a significant threat to public 

10 health because of drug resistance or other factors; 

11 ‘‘(2) taking into consideration the risks and 

12 benefits to public health, make recommendations to 

13 the Secretary on how best to address such patho14 gens, including through the development of qualified 

15 infectious disease products to prevent, detect, and 

16 treat such pathogens; and 

17 ‘‘(3) periodically review and update the list of 

18 pathogens identified under paragraph (1). 

19 ‘‘(c) CONSULTATION.—In carrying out this section, 

20 the Commission shall consult with— 

21 ‘‘(1) the Antimicrobial Resistance Task Force 

22 established under section 319–E; and 

23 ‘‘(2) the National Biodefense Science Board es24 tablished under section 319M. 

25 ‘‘(d) MEMBERSHIP.— 


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

2 composed of— 

3 ‘‘(A) not more than 19 voting members ap4 pointed by the President under paragraph (2); 

5 and 

6 ‘‘(B) the nonvoting ex officio members list7 ed in paragraph (3). 

8 ‘‘(2) VOTING MEMBERS.—The President shall 

9 appoint not more than 19 voting members of the 

10 Commission as follows: 

11 ‘‘(A) 12 of the voting members shall be ap12 pointed from among the leading representatives 

13 (including individuals in industry) of the infec14 tious disease medical, research, pharmaceutical, 

15 and biological communities. 

16 ‘‘(B) 7 of the voting members— 

17 ‘‘(i) shall be appointed from among 

18 the general public; and 

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

20 of public policy, law, health policy, econom21 ics, and management. 

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

23 Commission shall include the following nonvoting ex 

24 officio members: 


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1 ‘‘(A) The Secretary of Homeland Security 

2 (or the Secretary’s designee). 

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

4 Services (or the Secretary’s designee). 

5 ‘‘(C) The Director of the National Insti6 tutes of Health (or the Director’s designee). 

7 ‘‘(D) The Commissioner of Food and 

8 Drugs (or the Commissioner’s designee). 

9 ‘‘(E) The Director of the Centers for Dis10 ease Control and Prevention (or the Director’s 

11 designee). 

12 ‘‘(F) The Assistant Secretary of Defense 

13 for Health Affairs (or the Assistant Secretary’s 

14 designee). 

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

16 the Department of Veterans Affairs (or the 

17 Under Secretary’s designee). 

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

19 Secretary’s designee). 

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

21 the Secretary determines necessary for the 

22 Commission to carry out its functions. 

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

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

25 years. 


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

2 fill a vacancy occurring before the expiration of the 

3 term for which the member’s predecessor was ap4 pointed shall be appointed only for the remainder of 

5 that term. A member may serve after the expiration 

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

7 office. A vacancy in the Commission shall be filled 

8 in the manner in which the original appointment was 

9 made. 

10 ‘‘(6) BASIC PAY.— 

11 ‘‘(A) RATES OF PAY.—Members of the 

12 Commission who are officers or employees of 

13 the United States shall not receive any com14 pensation for service on the Commission. The 

15 other members of the Commission shall receive, 

16 for each day (including travel time) they are en17 gaged in the performance of the functions of 

18 the Commission, compensation at rates not to 

19 exceed the daily equivalent of the annual rate in 

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

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

22 of the Commission shall receive travel expenses, 

23 including per diem in lieu of subsistence, in ac24 cordance with applicable provisions under subVerDate Aug 31 2005 02:43 Mar 15, 2007 Jkt 059200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\H1496.IH H1496

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1 chapter I of chapter 57 of title 5, United States 

2 Code. 

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

4 Commission shall be a representative of the infec5 tious disease medical or research community selected 

6 by the President from among the members ap7 pointed under paragraph (2). The term of office of 

8 the Chairperson shall be 2 years. 

9 ‘‘(8) MEETINGS.—The Commission shall meet 

10 at the call of the Chairperson of the Commission or 

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

12 ‘‘(e) DIRECTOR AND STAFF OF COMMISSION; EX13 PERTS AND CONSULTANTS.— 

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

15 Director who shall be appointed by the Commission. 

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

17 may appoint such additional personnel as the Direc18 tor considers appropriate. 

19 ‘‘(3) APPLICABILITY OF CERTAIN CIVIL SERV20 ICES LAWS.—The Director and staff of the Commis21 sion shall be appointed without regard to the provi22 sions of title 5, United States Code, governing ap23 pointments in the competitive service, and shall be 

24 paid without regard to the provisions of chapter 51 

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1 ing to classification of positions and General Sched2 ule pay rates, except that the rate of pay for the Di3 rector and staff of the Commission may not exceed 

4 the daily equivalent of the annual rate in effect for 

5 grade GS–15 of the General Schedule. 

6 ‘‘(4) EXPERTS AND CONSULTANTS.—The Com7 mission may procure temporary and intermittent 

8 services under section 3109(b) of title 5, United 

9 States Code. 

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

11 request of the Commission, the head of any Federal 

12 agency may detail, without reimbursement, any of 

13 the personnel of such agency to the Commission to 

14 assist in carrying out the duties of the Commission. 

15 Any such detail shall not interrupt or otherwise af16 fect the civil service status or privileges of the Fed17 eral employee. 

18 ‘‘(f) POWERS OF COMMISSION.— 

19 ‘‘(1) HEARINGS AND SESSIONS.—The Commis20 sion may, for the purpose of carrying out this Act, 

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

22 testimony, and receive evidence as the Commission 

23 considers appropriate. 

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

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1 ized by the Commission, take any action which the 

2 Commission is authorized to take by this section. 

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

4 United States mails in the same manner and under 

5 the same conditions as other departments and agen6 cies of the United States. 

7 ‘‘(4) ADMINISTRATIVE SUPPORT SERVICES.— 

8 Upon the request of the Commission, the Adminis9 trator of General Services shall provide to the Com10 mission, on a reimbursable basis, the administrative 

11 support services necessary for the Commission to 

12 carry out its responsibilities under this section. 

13 ‘‘(g) ANNUAL REPORTS.— 

14 ‘‘(1) IN GENERAL.—Not later than the end of 

15 calendar year 2007 and annually thereafter, the 

16 Commission shall prepare and submit to the Presi17 dent, the appropriate committees of the Congress, 

18 and the Secretary of Health and Human Services a 

19 report that contains a detailed statement of the rec20 ommendations, findings, and conclusions of the 

21 Commission, including— 

22 ‘‘(A) an updated list of the infectious 

23 pathogens identified by the Commission pursu24 ant to subsection (b)(1)(A); and 


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1 ‘‘(B) an updated assessment of challenges 

2 faced by small biotechnology companies in se3 curing financing for infectious disease research 

4 and development. 

5 ‘‘(2) FIRST REPORT.—In addition to the con6 tents required by paragraph (1), the first report 

7 under this subsection shall include an examination 

8 of— 

9 ‘‘(A) the impact of medical liability insur10 ance payment obligations on the financing of 

11 infectious disease research and development; 

12 and 

13 ‘‘(B) the potential benefits of medical li14 ability relief to infectious disease research and 

15 development. 

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 Beating Infections through Research 

23 and Development Act of 2007. 

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

25 carry out this section, there are authorized to be approVerDate Aug 31 2005 02:43 Mar 15, 2007 Jkt 059200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H1496.IH H1496

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1 priated $3,000,000 for fiscal year 2008 and such sums 

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

3 SEC. 10. 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 Beating Infections through Re12 search and Development Act of 2007, the Secretary, act13 ing through the Commissioner of Food and Drugs, shall 

14 issue guidelines for the conduct of clinical trials with re15 spect to antibiotic drugs, including antimicrobials to treat 

16 resistant pathogens, bacterial meningitis, acute bacterial 

17 sinusitis, acute bacterial otitis media, and acute exacer18 bation of chronic bronchitis. Such guidelines shall indicate 

19 the appropriate animal models of infection, in vitro tech20 niques, and valid microbiologic surrogate markers. 

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

22 of enactment of the Beating Infections through Research 

23 and Development Act of 2007, the Secretary, acting 

24 through the Commissioner of Food and Drugs, shall re25 view and update the guidelines described under subsection 


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1 (a) to reflect developments in scientific and medical infor2 mation and technology.’’. 

Æ 


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