I 

109TH CONGRESS 

2D SESSION H. R. 5533 

To prepare and strengthen the biodefenses of the United States against 

deliberate, accidental, and natural outbreaks of illness, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 6, 2006 

Mr. ROGERS of Michigan (for himself, Ms. ESHOO, Mr. HOEKSTRA, and Mr. 

MCHUGH) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To prepare and strengthen the biodefenses of the United 

States against deliberate, accidental, and natural outbreaks of illness, 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Biodefense and Pan5 demic Vaccine and Drug Development Act of 2006’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. Biomedical Advanced Research and Development Authority; National 

Biodefense Science Board. 


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Sec. 4. Clarification of countermeasures covered by Project BioShield. 

Sec. 5. Technical assistance. 

Sec. 6. Procurement.

Sec. 7. Rule of construction. 

1 SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOP2 MENT AUTHORITY; NATIONAL BIODEFENSE 

3 SCIENCE BOARD. 

4 Title III of the Public Health Service Act (42 U.S.C. 

5 241 et seq.) is amended by inserting after section 319K 

6 the following: 

7 ‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DE8 VELOPMENT AUTHORITY. 

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

10 ‘‘(1) BARDA.—The term ‘BARDA’ means the 

11 Biomedical Advanced Research and Development 

12 Authority. 

13 ‘‘(2) FUND.—The term ‘Fund’ means the Bio14 defense Medical Countermeasure Development Fund 

15 established under subsection (d). 

16 ‘‘(3) OTHER TRANSACTIONS.—The term ‘other 

17 transactions’ means transactions, other than pro18 curement contracts, grants, and cooperative agree19 ments, such as the Secretary of Defense may enter 

20 into under section 2371 of title 10, United States 

21 Code. 


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1 ‘‘(4) QUALIFIED COUNTERMEASURE.—The term 

2 ‘qualified countermeasure’ has the meaning given 

3 such term in section 319F–1. 

4 ‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PROD5 UCT.—The term ‘qualified pandemic or epidemic 

6 product’ has the meaning given the term in section 

7 319F–3. 

8 ‘‘(6) ADVANCED RESEARCH AND DEVELOP9 MENT.— 

10 ‘‘(A) IN GENERAL.—The term ‘advanced 

11 research and development’ means, with respect 

12 to a product that is or may become a qualified 

13 countermeasure or a qualified pandemic or epi14 demic product, activities that predominantly— 

15 ‘‘(i) are conducted after basic research 

16 and preclinical development of the product; 

17 and 

18 ‘‘(ii) are related to manufacturing the 

19 product on a commercial scale and in a 

20 form that satisfies the regulatory require21 ments under the Federal Food, Drug, and 

22 Cosmetic Act or under section 351 of this 

23 Act. 

24 ‘‘(B) ACTIVITIES INCLUDED.—The term 

25 under subparagraph (A) includes— 


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1 ‘‘(i) testing of the product to deter2 mine whether the product may be ap3 proved, cleared, or licensed under the Fed4 eral Food, Drug, and Cosmetic Act or 

5 under section 351 of this Act for a use 

6 that is or may be the basis for such prod7 uct becoming a qualified countermeasure 

8 or qualified pandemic or epidemic product, 

9 or to help obtain such approval, clearance, 

10 or license; 

11 ‘‘(ii) design and development of tests 

12 or models, including animal models, for 

13 such testing; 

14 ‘‘(iii) activities to facilitate manufac15 ture of the product on a commercial scale 

16 with consistently high quality, as well as to 

17 improve and make available new tech18 nologies to increase manufacturing surge 

19 capacity; 

20 ‘‘(iv) activities to improve the shelf-life 

21 of the product or technologies for admin22 istering the product; and 

23 ‘‘(v) such other activities as are part 

24 of the advanced stages of testing, refine25 ment, improvement, or preparation of the 


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1 product for such use and as are specified 

2 by the Secretary. 

3 ‘‘(7) RESEARCH TOOL.—The term ‘research 

4 tool’ means a device, technology, biological material 

5 (including a cell line or an antibody), reagent, ani6 mal model, computer system, computer software, or 

7 analytical technique that is developed to assist in the 

8 discovery, development, or manufacture of qualified 

9 countermeasures or qualified pandemic or epidemic 

10 products. 

11 ‘‘(8) PROGRAM MANAGER.—The term ‘program 

12 manager’ means an individual appointed to carry out 

13 functions under this section and authorized to pro14 vide project oversight and management of strategic 

15 initiatives. 

16 ‘‘(9) PERSON.—The term ‘person’ includes an 

17 individual, partnership, corporation, association, en18 tity, or public or private corporation, and a Federal, 

19 State, or local government agency or department. 

20 ‘‘(b) STRATEGIC PLAN FOR COUNTERMEASURE RE21 SEARCH, DEVELOPMENT, AND PROCUREMENT.— 

22 ‘‘(1) IN GENERAL.—Not later than 6 months 

23 after the date of enactment of the Biodefense and 

24 Pandemic Vaccine and Drug Development Act of 

25 2006, the Secretary shall develop, make public, and 


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1 present to the appropriate Congressional committees 

2 a strategic plan to integrate biodefense and emerg3 ing infectious disease requirements with the ad4 vanced research and development, strategic initia5 tives for innovation, and the procurement of quali6 fied countermeasures and qualified pandemic or epi7 demic products. The Secretary shall periodically re8 view and, as appropriate, revise the plan. 

9 ‘‘(2) CONTENT.—The strategic plan under 

10 paragraph (1) shall— 

11 ‘‘(A) guide research and development, con12 ducted or supported by the Department of 

13 Health and Human Services, of qualified coun14 termeasures and qualified pandemic or epidemic 

15 products against possible biological, chemical, 

16 radiological, and nuclear agents and to emerg17 ing infectious diseases; 

18 ‘‘(B) guide innovation in technologies that 

19 may assist advanced research and development 

20 of qualified countermeasures and qualified pan21 demic or epidemic products (such research and 

22 development referred to in this section as ‘coun23 termeasure and product advanced research and 

24 development’); 


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1 ‘‘(C) guide procurement of such qualified 

2 countermeasures and qualified pandemic or epi3 demic products by such Department; 

4 ‘‘(D) include immediate, short-term, and 

5 long-term goals; 

6 ‘‘(E) include immediate, short-term, and 

7 long-term procurement priorities; and 

8 ‘‘(F) identify processes used to designate a 

9 range of funds available for various types of 

10 countermeasure procurements. 

11 ‘‘(c) BIOMEDICAL ADVANCED RESEARCH AND DE12 VELOPMENT AUTHORITY.— 

13 ‘‘(1) ESTABLISHMENT.—There is established 

14 within the Department of Health and Human Serv15 ices the Biomedical Advanced Research and Develop16 ment Authority. 

17 ‘‘(2) IN GENERAL.—Based upon the strategic 

18 plan described in subsection (b), the Secretary shall 

19 coordinate and oversee the acceleration of counter20 measure and product advanced research and devel21 opment by— 

22 ‘‘(A) facilitating collaboration among the 

23 Department of Health and Human Services, 

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1 demia, and other persons, with respect to such 

2 advanced research and development; 

3 ‘‘(B) promoting countermeasure and prod4 uct advanced research and development; 

5 ‘‘(C) facilitating contacts between inter6 ested persons and the offices or employees au7 thorized by the Secretary to advise such persons 

8 regarding requirements under the Federal 

9 Food, Drug, and Cosmetic Act and under sec10 tion 351 of this Act; and 

11 ‘‘(D) promoting innovation to reduce the 

12 time and cost of countermeasure and product 

13 advanced research and development. 

14 ‘‘(3) DIRECTOR.—The BARDA shall be headed 

15 by a Director (referred to in this section as the ‘Di16 rector’) who shall be appointed by the Secretary and 

17 to whom the Secretary shall delegate such functions 

18 and authorities as necessary to implement this sec19 tion. 

20 ‘‘(4) DUTIES.— 

21 ‘‘(A) COLLABORATION.—To carry out the 

22 purpose described in paragraph (2)(A), the Sec23 retary shall— 

24 ‘‘(i) facilitate and increase the expedi25 tious and direct communication between 


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1 the Department of Health and Human 

2 Services and relevant persons with respect 

3 to countermeasure and product advanced 

4 research and development, including by— 

5 ‘‘(I) facilitating such communica6 tion regarding the processes for pro7 curing such advanced research and 

8 development with respect to qualified 

9 countermeasures and qualified pan10 demic or epidemic products of inter11 est; and 

12 ‘‘(II) soliciting information about 

13 and data from research on potential 

14 qualified countermeasures and quali15 fied pandemic or epidemic products 

16 and related technologies; 

17 ‘‘(ii) at least annually— 

18 ‘‘(I) convene meetings with rep19 resentatives from relevant industries, 

20 academia, other Federal agencies, 

21 international agencies as appropriate, 

22 and other interested persons; 

23 ‘‘(II) sponsor opportunities to 

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1 tiveness of relevant biodefense coun2 termeasure technologies; and 

3 ‘‘(III) convene such working 

4 groups on countermeasure and prod5 uct advanced research and develop6 ment as the Secretary may determine 

7 are necessary to carry out this sec8 tion; and 

9 ‘‘(iii) carry out the activities described 

10 in section 7 of the Biodefense and Pan11 demic Vaccine and Drug Development Act 

12 of 2006. 

13 ‘‘(B) SUPPORT ADVANCED RESEARCH AND

14 DEVELOPMENT.—To carry out the purpose de15 scribed in paragraph (2)(B), the Secretary 

16 shall— 

17 ‘‘(i) conduct ongoing searches for, and 

18 support calls for, potential qualified coun19 termeasures and qualified pandemic or epi20 demic products; 

21 ‘‘(ii) direct and coordinate the coun22 termeasure and product advanced research 

23 and development activities of the Depart24 ment of Health and Human Services; 


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1 ‘‘(iii) establish strategic initiatives to 

2 accelerate countermeasure and product ad3 vanced research and development and in4 novation in such areas as the Secretary 

5 may identify as priority unmet need areas; 

6 and 

7 ‘‘(iv) award contracts, grants, cooper8 ative agreements, and enter into other 

9 transactions, for countermeasure and prod10 uct advanced research and development. 

11 ‘‘(C) FACILITATING ADVICE.—To carry out 

12 the purpose described in paragraph (2)(C) the 

13 Secretary shall— 

14 ‘‘(i) connect interested persons with 

15 the offices or employees authorized by the 

16 Secretary to advise such persons regarding 

17 the regulatory requirements under the 

18 Federal Food, Drug, and Cosmetic Act 

19 and under section 351 of this Act related 

20 to the approval, clearance, or licensure of 

21 qualified countermeasures or qualified pan22 demic or epidemic products; and 

23 ‘‘(ii) ensure that, with respect to per24 sons performing countermeasure and prod25 uct advanced research and development 


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1 funded under this section, such offices or 

2 employees provide such advice in a manner 

3 that is ongoing and that is otherwise des4 ignated to facilitate expeditious develop5 ment of qualified countermeasures and 

6 qualified pandemic or epidemic products 

7 that may achieve such approval, clearance, 

8 or licensure. 

9 ‘‘(D) SUPPORTING INNOVATION.—To carry 

10 out the purpose described in paragraph (2)(D), 

11 the Secretary may award contracts, grants, and 

12 cooperative agreements, or enter into other 

13 transactions, such as prize payments, to pro14 mote— 

15 ‘‘(i) innovation in technologies that 

16 may assist countermeasure and product 

17 advanced research and development; 

18 ‘‘(ii) research on and development of 

19 research tools and other devices and tech20 nologies; and 

21 ‘‘(iii) research to promote strategic 

22 initiatives, such as rapid diagnostics, broad 

23 spectrum antimicrobials, and vaccine man24 ufacturing technologies. 

25 ‘‘(5) TRANSACTION AUTHORITIES.— 


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1 ‘‘(A) OTHER TRANSACTIONS.—In carrying 

2 out the functions under subparagraph (B) or 

3 (D) of paragraph (4), the Secretary shall have 

4 authority to enter into other transactions for 

5 countermeasure and product advanced research 

6 and development. 

7 ‘‘(B) EXPEDITED AUTHORITIES.— 

8 ‘‘(i) IN GENERAL.—In awarding con9 tracts, grants, and cooperative agreements, 

10 and in entering into other transactions 

11 under subparagraph (B) or (D) of para12 graph (4), the Secretary shall have the ex13 pedited procurement authorities, the au14 thority to expedite peer review, and the au15 thority for personal services contracts, sup16 plied by subsections (b), (c), and (d) of 

17 section 319F–1. 

18 ‘‘(ii) APPLICATION OF PROVISIONS.— 

19 Provisions in such section 319F–1 that 

20 apply to such authorities and that require 

21 institution of internal controls, limit re22 view, provide for Federal Tort Claims Act 

23 coverage of personal services contractors, 

24 and commit decisions to the discretion of 


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1 the Secretary shall apply to the authorities 

2 as exercised pursuant to this paragraph. 

3 ‘‘(iii) AUTHORITY TO LIMIT COMPETI4 TION.—For purposes of applying section 

5 319F–1(b)(1)(D) to this paragraph, the 

6 phrase ‘BioShield Program under the 

7 Project BioShield Act of 2004’ shall be 

8 deemed to mean the countermeasure and 

9 product advanced research and develop10 ment program under this section. 

11 ‘‘(iv) AVAILABILITY OF DATA.—The 

12 Secretary shall require that, as a condition 

13 of being awarded a contract, grant, cooper14 ative agreement, or other transaction 

15 under subparagraph (B) or (D) of para16 graph (4), a person make available to the 

17 Secretary on an ongoing basis, and submit 

18 upon request to the Secretary, all data re19 lated to or resulting from countermeasure 

20 and product advanced research and devel21 opment carried out pursuant to this sec22 tion. 

23 ‘‘(C) ADVANCE PAYMENTS; ADVER24 TISING.—The authority of the Secretary to 

25 enter into contracts under this section shall not 


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1 be limited by section 3324(a) of title 31, United 

2 States Code, or by section 3709 of the Revised 

3 Statutes of the United States (41 U.S.C. 5). 

4 ‘‘(D) MILESTONE-BASED PAYMENTS AL5 LOWED.—In awarding contracts, grants, and 

6 cooperative agreements, and in entering into 

7 other transactions, under this section, the Sec8 retary may use milestone-based awards and 

9 payments. 

10 ‘‘(E) FOREIGN NATIONALS ELIGIBLE.— 

11 The Secretary may under this section award 

12 contracts, grants, and cooperative agreements 

13 to, and may enter into other transactions with, 

14 highly qualified foreign national persons outside 

15 the United States, alone or in collaboration with 

16 American participants, when such transactions 

17 may inure to the benefit of the American peo18 ple. 

19 ‘‘(F) ESTABLISHMENT OF RESEARCH CEN20 TERS.—The Secretary may establish one or 

21 more federally-funded research and development 

22 centers, or university-affiliated research centers 

23 in accordance with section 303(c)(3) of the 

24 Federal Property and Administrative Services 

25 Act of 1949 (41 U.S.C. 253(c)(3)), provided 


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1 that such centers are consistent and com2 plementary with the duties described in para3 graph (4), and are consistent and complemen4 tary with, and deemed necessary after consid5 ering the availability of, existing federally-sup6 ported basic research programs. 

7 ‘‘(6) VULNERABLE POPULATIONS.—In carrying 

8 out the functions under this section, the Secretary 

9 may give priority to the advanced research and de10 velopment of qualified countermeasures and qualified 

11 pandemic or epidemic products that are likely to be 

12 safe and effective with respect to children, pregnant 

13 women, and other vulnerable populations. 

14 ‘‘(7) PERSONNEL AUTHORITIES.— 

15 ‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC

16 AND PROFESSIONAL PERSONNEL.—In addition 

17 to any other personnel authorities, the Sec18 retary may— 

19 ‘‘(i) without regard to those provisions 

20 of title 5, United States Code, governing 

21 appointments in the competitive service, 

22 appoint highly qualified individuals to sci23 entific or professional positions in 

24 BARDA, such as program managers, to 

25 carry out this section; and 


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1 ‘‘(ii) compensate them in the same 

2 manner in which individuals appointed 

3 under section 9903 of such title are com4 pensated, without regard to the provisions 

5 of chapter 51 and subchapter III of chap6 ter 53 of such title relating to classification 

7 and General Schedule pay rates. 

8 ‘‘(B) SPECIAL CONSULTANTS.—In carrying 

9 out this section, the Secretary may— 

10 ‘‘(i) appoint special consultants pursu11 ant to section 207(f); and 

12 ‘‘(ii) accept voluntary and uncompen13 sated services. 

14 ‘‘(d) FUND.— 

15 ‘‘(1) ESTABLISHMENT.—There is established 

16 the Biodefense Medical Countermeasure Develop17 ment Fund, which shall be available to carry out this 

18 section in addition to such amounts as are otherwise 

19 available for this purpose. 

20 ‘‘(2) FUNDING.—To carry out the purposes of 

21 this section, there are authorized to be appropriated 

22 to the Fund— 

23 ‘‘(A) $1,070,000,000 for fiscal years 2006 

24 through 2008, the amounts to remain available 

25 until expended; and 


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1 ‘‘(B) such sums as may be necessary for 

2 subsequent fiscal years, the amounts to remain 

3 available until expended. 

4 ‘‘(e) INAPPLICABILITY OF CERTAIN PROVISIONS.— 

5 ‘‘(1) DISCLOSURE.— 

6 ‘‘(A) IN GENERAL.—The Secretary shall 

7 withhold from disclosure under section 552 of 

8 title 5, United States Code, specific technical 

9 data or scientific information that is created or 

10 obtained during the countermeasure and prod11 uct advanced research and development funded 

12 by the Secretary that reveal vulnerabilities of 

13 existing medical or public health defenses 

14 against biological, chemical, nuclear, or radio15 logical threats. Such information shall be 

16 deemed to be information described in section 

17 552(b)(3) of title 5, United States Code. 

18 ‘‘(B) OVERSIGHT.—Information subject to 

19 nondisclosure under subparagraph (A) shall be 

20 reviewed by the Secretary every 5 years to de21 termine the relevance or necessity of continued 

22 nondisclosure. 

23 ‘‘(2) FEDERAL ADVISORY COMMITTEE ACT.— 

24 Section 14 of the Federal Advisory Committee Act 

25 (5 U.S.C. App.) shall not apply to a working group 


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1 of BARDA or to the National Biodefense Science 

2 Board under section 319M. 

3 ‘‘SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND 

4 WORKING GROUPS. 

5 ‘‘(a) IN GENERAL.— 

6 ‘‘(1) ESTABLISHMENT AND FUNCTION.—The 

7 Secretary shall establish the National Biodefense 

8 Science Board (referred to in this section as the 

9 ‘Board’) to provide expert advice and guidance to 

10 the Secretary on scientific, technical and other mat11 ters of special interest to the Department of Health 

12 and Human Services regarding current and future 

13 chemical, biological, nuclear, and radiological agents, 

14 whether naturally occurring, accidental, or delib15 erate. 

16 ‘‘(2) MEMBERSHIP.—The membership of the 

17 Board shall be comprised of individuals who rep18 resent the Nation’s preeminent scientific, public 

19 health, and medical experts, as follows— 

20 ‘‘(A) such Federal officials as the Sec21 retary may determine are necessary to support 

22 the functions of the Board; 

23 ‘‘(B) four individuals representing the 

24 pharmaceutical, biotechnology, and device in25 dustries; 


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1 ‘‘(C) four individuals representing aca2 demia; and 

3 ‘‘(D) five other members as determined ap4 propriate by the Secretary. 

5 ‘‘(3) TERM OF APPOINTMENT.—A member of 

6 the Board described in subparagraph (B), (C), or 

7 (D) of paragraph (2) shall serve for a term of 3 

8 years, except that the Secretary may adjust the 

9 terms of the initial Board appointees in order to 

10 provide for a staggered term of appointment for all 

11 members. 

12 ‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM

13 TERMS.—A member may be appointed to serve not 

14 more than 3 terms on the Board and may serve not 

15 more than 2 consecutive terms. 

16 ‘‘(5) DUTIES.—The Board shall— 

17 ‘‘(A) advise the Secretary on current and 

18 future trends, challenges, and opportunities pre19 sented by advances in biological and life 

20 sciences, biotechnology, and genetic engineering 

21 with respect to threats posed by naturally oc22 curring infectious diseases and chemical, bio23 logical, radiological, and nuclear agents; 

24 ‘‘(B) at the request of the Secretary, re25 view and consider any information and findings 


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1 received from the working groups established 

2 under subsection (b); and 

3 ‘‘(C) at the request of the Secretary, pro4 vide recommendations and findings for ex5 panded, intensified, and coordinated biodefense 

6 research and development activities. 

7 ‘‘(6) MEETINGS.— 

8 ‘‘(A) INITIAL MEETING.—Not later than 

9 one year after the date of enactment of the Bio10 defense and Pandemic Vaccine and Drug Devel11 opment Act of 2006, the Secretary shall hold 

12 the first meeting of the Board. 

13 ‘‘(B) SUBSEQUENT MEETINGS.—The 

14 Board shall meet at the call of the Secretary, 

15 but in no case less than twice annually. 

16 ‘‘(7) VACANCIES.—Any vacancy in the Board 

17 shall not affect its powers, but shall be filled in the 

18 same manner as the original appointment. 

19 ‘‘(8) CHAIRPERSON.—The Secretary shall ap20 point a chairperson from among the members of the 

21 Board. 

22 ‘‘(9) POWERS.— 

23 ‘‘(A) HEARINGS.—The Board may hold 

24 such hearings, sit and act at such times and 

25 places, take such testimony, and receive such 


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1 evidence as the Board considers advisable to 

2 carry out this subsection. 

3 ‘‘(B) POSTAL SERVICES.—The Board may 

4 use the United States mails in the same man5 ner and under the same conditions as other de6 partments and agencies of the Federal Govern7 ment. 

8 ‘‘(10) PERSONNEL.— 

9 ‘‘(A) EMPLOYEES OF THE FEDERAL GOV10 ERNMENT.—A member of the Board that is an 

11 employee of the Federal Government may not 

12 receive additional pay, allowances, or benefits 

13 by reason of the member’s service on the 

14 Board. 

15 ‘‘(B) OTHER MEMBERS.—A member of the 

16 Board that is not an employee of the Federal 

17 Government may be compensated at a rate not 

18 to exceed the daily equivalent of the annual rate 

19 of basic pay prescribed for level IV of the Exec20 utive Schedule under section 5315 of title 5, 

21 United States Code, for each day (including 

22 travel time) during which the member is en23 gaged in the actual performance of duties as a 

24 member of the Board. 


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1 ‘‘(C) TRAVEL EXPENSES.—Each member 

2 of the Board shall receive travel expenses, in3 cluding per diem in lieu of subsistence, in ac4 cordance with applicable provisions under sub5 chapter I of chapter 57 of title 5, United States 

6 Code. 

7 ‘‘(D) DETAIL OF GOVERNMENT EMPLOY8 EES.—Any Federal Government employee may 

9 be detailed to the Board with the approval for 

10 the contributing agency without reimbursement, 

11 and such detail shall be without interruption or 

12 loss of civil service status or privilege. 

13 ‘‘(b) OTHER WORKING GROUPS.—The Secretary may 

14 establish a working group of experts, or may use an exist15 ing working group or advisory committee, to— 

16 ‘‘(1) identify innovative research with the po17 tential to be developed as a qualified countermeasure 

18 or a qualified pandemic or epidemic product; 

19 ‘‘(2) identify accepted animal models for par20 ticular diseases and conditions associated with any 

21 biological, chemical, radiological, or nuclear agent, 

22 any toxin, or any potential pandemic infectious dis23 ease, and identify strategies to accelerate animal 

24 model and research tool development and validation; 

25 and 


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1 ‘‘(3) obtain advice regarding supporting and fa2 cilitating advanced research and development related 

3 to qualified countermeasures and qualified pandemic 

4 or epidemic products that are likely to be safe and 

5 effective with respect to children, pregnant women, 

6 and other vulnerable populations, and other issues 

7 regarding activities under this section that affect 

8 such populations. 

9 ‘‘(c) DEFINITIONS.—Any term that is defined in sec10 tion 319L and that is used in this section shall have the 

11 same meaning in this section as such term is given in sec12 tion 319L. 

13 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

14 are authorized to be appropriated $1,000,000 to carry out 

15 this section for fiscal year 2007 and each fiscal year there16 after.’’. 

17 SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 

18 BY PROJECT BIOSHIELD. 

19 (a) QUALIFIED COUNTERMEASURE.—Section 319F– 

20 1(a) of the Public Health Service Act (42 U.S.C. 247d– 

21 6a(a)) is amended by striking paragraph (2) and inserting 

22 the following: 

23 ‘‘(2) DEFINITIONS.—In this section: 

24 ‘‘(A) QUALIFIED COUNTERMEASURE.—The 

25 term ‘qualified countermeasure’ means a drug 


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1 (as that term is defined by section 201(g)(1) of 

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

3 U.S.C. 321(g)(1))), biological product (as that 

4 term is defined by section 351(i) of this Act (42 

5 U.S.C. 262(i))), or device (as that term is de6 fined by section 201(h) of the Federal Food, 

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

8 that the Secretary determines to be a priority 

9 (consistent with sections 302(2) and 304(a) of 

10 the Homeland Security Act of 2002) to— 

11 ‘‘(i) diagnose, mitigate, prevent, or 

12 treat harm from any biological agent (in13 cluding organisms that cause an infectious 

14 disease) or toxin, chemical, radiological, or 

15 nuclear agent that may cause a public 

16 health emergency affecting national secu17 rity; or 

18 ‘‘(ii) diagnose, mitigate, prevent, or 

19 treat harm from a condition that may re20 sult in adverse health consequences or 

21 death and may be caused by administering 

22 a drug, biological product, or device that is 

23 used as described in this subparagraph. 

24 ‘‘(B) INFECTIOUS DISEASE.—The term ‘in25 fectious disease’ means a disease potentially 


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1 caused by a pathogenic organism (including a 

2 bacteria, virus, fungus, or parasite) that is ac3 quired by a person and that reproduces in that 

4 person.’’. 

5 (b) SECURITY COUNTERMEASURE.—Section 319F– 

6 2(c)(1)(B)(i)(I) is amended by striking ‘‘to treat’’ the first 

7 place such term appears and all that follows through 

8 ‘‘from a condition’’ and inserting the following: ‘‘to diag9 nose, mitigate, prevent, or treat harm from any biological 

10 agent (including organisms that cause an infectious dis11 ease) or toxin, chemical, radiological, or nuclear agent 

12 identified as a material threat under paragraph (2)(A)(ii), 

13 or to diagnose, mitigate, prevent, or treat harm from a 

14 condition’’. 

15 SEC. 5. TECHNICAL ASSISTANCE. 

16 Subchapter E of chapter V of the Federal Food, 

17 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

18 amended by adding at the end the following: 

19 ‘‘SEC. 565. TECHNICAL ASSISTANCE. 

20 ‘‘The Secretary, in consultation with the Commis21 sioner of Food and Drugs, shall establish within the Food 

22 and Drug Administration a team of experts on manufac23 turing and regulatory activities (including compliance with 

24 current Good Manufacturing Practice) to provide both off25 site and on-site technical assistance to the manufacturers 


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1 of qualified countermeasures (as defined in section 319F– 

2 1 of the Public Health Service Act), security counter3 measures (as defined in section 319F–2 of such Act), or 

4 vaccines, at the request of such a manufacturer and at 

5 the discretion of the Secretary, if the Secretary determines 

6 that a shortage or potential shortage may occur in the 

7 United States in the supply of such vaccines or counter8 measures and that the provision of such assistance would 

9 be beneficial in helping alleviate or avert such shortage.’’. 

10 SEC. 6. PROCUREMENT. 

11 (a) SECURITY COUNTERMEASURES.—Section 319F– 

12 2 of the Public Health Service Act (42 U.S.C. 247d–6b) 

13 is amended— 

14 (1) in the section heading, by inserting ‘‘AND

15 SECURITY COUNTERMEASURE PROCURE16 MENTS’’ before the period; and 

17 (2) in subsection (c)— 

18 (A) in the subsection heading, by striking 

19 ‘‘BIOMEDICAL’’; 

20 (B) in paragraph (5)(B)(i), by striking ‘‘to 

21 meet the needs of the stockpile’’ and inserting 

22 ‘‘to meet the stockpile needs’’; 

23 (C) in paragraph (7)(B)— 

24 (i) by striking the subparagraph head25 ing and all that follows through ‘‘HomeVerDate Aug 31 2005 05:31 Jun 09, 2006 Jkt 049196 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.IH H5533

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1 land Security Secretary’’ and inserting the 

2 following: ‘‘INTERAGENCY AGREEMENT; 

3 COST.—The Homeland Security Sec4 retary’’; and 

5 (ii) by striking clause (ii); 

6 (D) in paragraph (7)(C)(ii)— 

7 (i) by amending clause (I) to read as 

8 follows: 

9 ‘‘(I) PAYMENT CONDITIONED ON

10 DELIVERY.—The contract shall pro11 vide that no payment may be made 

12 until delivery of a portion, acceptable 

13 to the Secretary, of the total number 

14 of units contracted for, except that, 

15 notwithstanding any other provision of 

16 law, the contract may provide that, if 

17 the Secretary determines (in the Sec18 retary’s discretion) that an advance 

19 payment, partial payment for signifi20 cant milestones, or payment to in21 crease manufacturing capacity is nec22 essary to ensure success of a project, 

23 the Secretary shall pay an amount, 

24 not to exceed 10 percent of the con25 tract amount, in advance of delivery. 


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1 The Secretary shall, to the extent 

2 practicable, make the determination of 

3 advance payment at the same time as 

4 the issuance of a solicitation. The con5 tract shall provide that such advance 

6 payment is required to be repaid if 

7 there is a failure to perform by the 

8 vendor under the contract. The con9 tract may also provide for additional 

10 advance payments of 5 percent each 

11 for meeting the milestones specified in 

12 such contract. Provided that the spec13 ified milestones are reached, these ad14 vanced payments of 5 percent shall 

15 not be required to be repaid. Nothing 

16 in this subclause shall be construed as 

17 affecting the rights of vendors under 

18 provisions of law or regulation (in19 cluding the Federal Acquisition Regu20 lation) relating to the termination of 

21 contracts for the convenience of the 

22 Government.’’; and 

23 (ii) by adding at the end the fol24 lowing: 


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1 ‘‘(VII) PROCUREMENT OF MUL2 TIPLE PRODUCTS AND TECH3 NOLOGIES.—Notwithstanding any 

4 other provision of law or regulation, 

5 the Secretary shall, where possible, 

6 enter into multiple transactions for 

7 the procurement of multiple tech8 nologies and products from multiple 

9 manufacturers of security counter10 measures in order to mitigate against 

11 the risks associated with dependence 

12 on a single supplier or technology. 

13 ‘‘(VIII) SALES EXCLUSIVITY.— 

14 The contract may provide that the 

15 vendor is the exclusive supplier of the 

16 product to the Federal Government 

17 for a specified period of time, not to 

18 exceed the term of the contract, on 

19 the condition that the vendor is able 

20 to satisfy the needs of the Govern21 ment. During the agreed period of 

22 sales exclusivity, the vendor shall not 

23 assign its rights of sales exclusivity to 

24 another entity or entities without ap25 proval by the Secretary. Such a sales 


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1 exclusivity provision in such a con2 tract shall constitute a valid basis for 

3 a sole source procurement under sec4 tion 303(c)(1) of the Federal Property 

5 and Administrative Services Act of 

6 1949 (41 U.S.C. 253(c)(1)). 

7 ‘‘(IX) SURGE CAPACITY.—The 

8 contract may provide that the vendor 

9 establish domestic manufacturing ca10 pacity of the product to ensure that 

11 additional production of the product is 

12 available in the event that the Sec13 retary determines that there is a need 

14 to quickly purchase additional quan15 tities of the product. Such contract 

16 may provide a fee to the vendor for 

17 establishing and maintaining such ca18 pacity in excess of the initial require19 ment for the purchase of the product. 

20 Additionally, the cost of maintaining 

21 the domestic manufacturing capacity 

22 shall be an allowable and allocable di23 rect cost of the contract. 

24 ‘‘(X) ADDITIONAL CONTRACT

25 TERMS.—The Secretary, in any conVerDate Aug 31 2005 05:31 Jun 09, 2006 Jkt 049196 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.IH H5533

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1 tract for procurement under this sec2 tion, may specify— 

3 ‘‘(aa) the dosing and admin4 istration requirements for coun5 termeasures to be developed and 

6 procured; 

7 ‘‘(bb) the amount of funding 

8 that will be dedicated by the Sec9 retary for development and ac10 quisition of the countermeasure; 

11 and 

12 ‘‘(cc) the specifications the 

13 countermeasure must meet to 

14 qualify for procurement under a 

15 contract under this section.’’; and 

16 (E) in paragraph (8)(A), by adding at the 

17 end the following: ‘‘Such agreements may allow 

18 other executive agencies to order qualified and 

19 security countermeasures under procurement 

20 contracts or other agreements established by 

21 the Secretary. Such ordering process (including 

22 transfers of appropriated funds between an 

23 agency and the Department of Health and 

24 Human Services as reimbursements for such or25 ders for countermeasures) may be conducted 


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1 under the authority of section 1535 of title 31, 

2 United States Code, except that all such orders 

3 shall be processed under the terms established 

4 under this section for the procurement of coun5 termeasures.’’. 

6 (b) QUALIFIED COUNTERMEASURES.—Section 

7 319F–1(b) of the Public Health Service Act (42 U.S.C. 

8 247d–6a(b)) is amended by adding at the end the fol9 lowing: 

10 ‘‘(5) PROCUREMENT OF MULTIPLE PRODUCTS

11 AND TECHNOLOGIES.—Notwithstanding any other 

12 provision of law or regulation, the Secretary shall, 

13 where possible, enter into multiple transactions for 

14 the procurement of multiple technologies and prod15 ucts from multiple manufacturers of qualified coun16 termeasures in order to mitigate against the risks 

17 associated with dependence on a single supplier or 

18 technology.’’. 

19 SEC. 7. RULE OF CONSTRUCTION. 

20 Nothing in this Act, or any amendment made by this 

21 Act, shall be construed to affect any law that applies to 

22 the National Vaccine Injury Compensation Program under 

23 title XXI of the Public Health Service Act (42 U.S.C. 

24 300aa–1 et seq.), including such laws regarding— 


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1 (1) whether claims may be filed or compensa2 tion may be paid for a vaccine-related injury or 

3 death under such Program; 

4 (2) claims pending under such Program; and 

5 (3) any petitions, cases, or other proceedings 

6 before the United States Court of Federal Claims 

7 pursuant to such title. 

Æ 


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