IIB 

109TH CONGRESS 

2D SESSION H. R. 5533 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 27, 2006 

Received 

NOVEMBER 13, 2006 

Read twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

AN ACT 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Biodefense and Pan3 demic Vaccine and Drug Development Act of 2006’’. 

4 SEC. 2. TABLE OF CONTENTS. 

5 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. 

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

Sec. 5. Technical assistance. 

Sec. 6. Procurement. 

6 SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOP7 MENT AUTHORITY; NATIONAL BIODEFENSE 

8 SCIENCE BOARD. 

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

10 241 et seq.) is amended by inserting after section 319K 

11 the following: 

12 ‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DE13 VELOPMENT AUTHORITY. 

14 ‘‘(a) BIOMEDICAL ADVANCED RESEARCH AND DE15 VELOPMENT AUTHORITY.— 

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

17 within the Department of Health and Human Serv18 ices the Biomedical Advanced Research and Develop19 ment Authority. 

20 ‘‘(2) IN GENERAL.—The Secretary shall coordi21 nate and oversee the acceleration of countermeasure 


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1 and product advanced research and development 

2 by— 

3 ‘‘(A) facilitating collaboration among the 

4 Department of Health and Human Services, 

5 other Federal agencies, relevant industries, aca6 demia, and other persons, with respect to such 

7 advanced research and development; 

8 ‘‘(B) promoting countermeasure and prod9 uct advanced research and development; 

10 ‘‘(C) facilitating contacts between inter11 ested persons and the offices or employees au12 thorized by the Secretary to advise such persons 

13 regarding requirements under the Federal 

14 Food, Drug, and Cosmetic Act and under sec15 tion 351 of this Act; and 

16 ‘‘(D) promoting innovation to reduce the 

17 time and cost of countermeasure and product 

18 advanced research and development. 

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

20 by a Director (referred to in this section as the ‘Di21 rector’) who shall be appointed by the Secretary and 

22 to whom the Secretary shall delegate such functions 

23 and authorities as necessary to implement this sec24 tion. 

25 ‘‘(4) DUTIES.— 


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

2 purpose described in paragraph (2)(A), the Sec3 retary shall— 

4 ‘‘(i) facilitate and increase the expedi5 tious and direct communication between 

6 the Department of Health and Human 

7 Services and relevant persons with respect 

8 to countermeasure and product advanced 

9 research and development, including by— 

10 ‘‘(I) facilitating such communica11 tion regarding the processes for pro12 curing such advanced research and 

13 development with respect to qualified 

14 countermeasures and qualified pan15 demic or epidemic products of inter16 est; and 

17 ‘‘(II) soliciting information about 

18 and data from research on potential 

19 qualified countermeasures and quali20 fied pandemic or epidemic products 

21 and related technologies; 

22 ‘‘(ii) at least annually— 

23 ‘‘(I) convene meetings with rep24 resentatives from relevant industries, 

25 academia, other Federal agencies, 


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1 international agencies as appropriate, 

2 and other interested persons; 

3 ‘‘(II) sponsor opportunities to 

4 demonstrate the operation and effec5 tiveness of relevant biodefense coun6 termeasure technologies; and 

7 ‘‘(III) convene such working 

8 groups on countermeasure and prod9 uct advanced research and develop10 ment as the Secretary may determine 

11 are necessary to carry out this sec12 tion; and 

13 ‘‘(iii) carry out the activities described 

14 in section 6 of the Biodefense and Pan15 demic Vaccine and Drug Development Act 

16 of 2006. 

17 ‘‘(B) SUPPORT ADVANCED RESEARCH AND

18 DEVELOPMENT.—To carry out the purpose de19 scribed in paragraph (2)(B), the Secretary 

20 shall— 

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

22 support calls for, potential qualified coun23 termeasures and qualified pandemic or epi24 demic products; 


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1 ‘‘(ii) direct and coordinate the coun2 termeasure and product advanced research 

3 and development activities of the Depart4 ment of Health and Human Services; 

5 ‘‘(iii) establish strategic initiatives to 

6 accelerate countermeasure and product ad7 vanced research and development and in8 novation in such areas as the Secretary 

9 may identify as priority unmet need areas; 

10 and 

11 ‘‘(iv) award contracts, grants, cooper12 ative agreements, and enter into other 

13 transactions, for countermeasure and prod14 uct advanced research and development. 

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

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

17 Secretary shall— 

18 ‘‘(i) connect interested persons with 

19 the offices or employees authorized by the 

20 Secretary to advise such persons regarding 

21 the regulatory requirements under the 

22 Federal Food, Drug, and Cosmetic Act 

23 and under section 351 of this Act related 

24 to the approval, clearance, or licensure of 


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1 qualified countermeasures or qualified pan2 demic or epidemic products; and 

3 ‘‘(ii) ensure that, with respect to per4 sons performing countermeasure and prod5 uct advanced research and development 

6 funded under this section, such offices or 

7 employees provide such advice in a manner 

8 that is ongoing and that is otherwise des9 ignated to facilitate expeditious develop10 ment of qualified countermeasures and 

11 qualified pandemic or epidemic products 

12 that may achieve such approval, clearance, 

13 or licensure. 

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

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

16 the Secretary may award contracts, grants, and 

17 cooperative agreements, or enter into other 

18 transactions, such as prize payments, to pro19 mote— 

20 ‘‘(i) innovation in technologies that 

21 may assist countermeasure and product 

22 advanced research and development; 

23 ‘‘(ii) research on and development of 

24 research tools and other devices and tech25 nologies; and 


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1 ‘‘(iii) research to promote strategic 

2 initiatives, such as rapid diagnostics, broad 

3 spectrum antimicrobials, and vaccine man4 ufacturing technologies. 

5 ‘‘(5) TRANSACTION AUTHORITIES.— 

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

7 out the functions under subparagraph (B) or 

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

9 authority to enter into other transactions for 

10 countermeasure and product advanced research 

11 and development. 

12 ‘‘(B) EXPEDITED AUTHORITIES.— 

13 ‘‘(i) IN GENERAL.—In awarding con14 tracts, grants, and cooperative agreements, 

15 and in entering into other transactions 

16 under subparagraph (B) or (D) of para17 graph (4), the Secretary shall have the ex18 pedited procurement authorities, the au19 thority to expedite peer review, and the au20 thority for personal services contracts, sup21 plied by subsections (b), (c), and (d) of 

22 section 319F–1. 

23 ‘‘(ii) APPLICATION OF PROVISIONS.— 

24 Provisions in such section 319F–1 that 

25 apply to such authorities and that require 


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1 institution of internal controls, limit re2 view, provide for Federal Tort Claims Act 

3 coverage of personal services contractors, 

4 and commit decisions to the discretion of 

5 the Secretary shall apply to the authorities 

6 as exercised pursuant to this paragraph. 

7 ‘‘(iii) AUTHORITY TO LIMIT COMPETI8 TION.—For purposes of applying section 

9 319F–1(b)(1)(D) to this paragraph, the 

10 phrase ‘BioShield Program under the 

11 Project BioShield Act of 2004’ shall be 

12 deemed to mean the countermeasure and 

13 product advanced research and develop14 ment program under this section. 

15 ‘‘(iv) AVAILABILITY OF DATA.—The 

16 Secretary may require that, as a condition 

17 of being awarded a contract, grant, cooper18 ative agreement, or other transaction 

19 under subparagraph (B) or (D) of para20 graph (4), a person make available to the 

21 Secretary on an ongoing basis, and submit 

22 upon request to the Secretary, relevant 

23 data related to or resulting from counter24 measure and product advanced research 


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1 and development carried out pursuant to 

2 this section. 

3 ‘‘(C) ADVANCE PAYMENTS; ADVER4 TISING.—The authority of the Secretary to 

5 enter into contracts under this section shall not 

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

7 States Code, or by section 3709 of the Revised 

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

9 ‘‘(D) MILESTONE-BASED PAYMENTS AL10 LOWED.—In awarding contracts, grants, and 

11 cooperative agreements, and in entering into 

12 other transactions, under this section, the Sec13 retary may use milestone-based awards and 

14 payments. 

15 ‘‘(E) FOREIGN NATIONALS ELIGIBLE.— 

16 The Secretary may under this section award 

17 contracts, grants, and cooperative agreements 

18 to, and may enter into other transactions with, 

19 highly qualified foreign national persons outside 

20 the United States, alone or in collaboration with 

21 American participants, when such transactions 

22 may inure to the benefit of the American people 

23 and are consistent with National security. 

24 ‘‘(F) ESTABLISHMENT OF ADVANCED RE25 SEARCH CENTERS.—The Secretary may estabVerDate Aug 31 2005 22:06 Nov 14, 2006 Jkt 059196 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.RFS H5533

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1 lish one or more federally-funded research and 

2 development centers, or university-affiliated re3 search centers in accordance with section 

4 303(c)(3) of the Federal Property and Adminis5 trative Services Act of 1949 (41 U.S.C. 

6 253(c)(3)), provided that such centers are con7 sistent and complementary with the duties de8 scribed in paragraph (4), and are consistent 

9 and complementary with, and deemed necessary 

10 after considering the availability of, existing 

11 federally-supported basic research programs. 

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

13 out the functions under this section, the Secretary 

14 may give priority to the advanced research and de15 velopment of qualified countermeasures and qualified 

16 pandemic or epidemic products that are likely to be 

17 safe and effective with respect to the emergency 

18 health security needs of children and other vulner19 able populations. 

20 ‘‘(7) PERSONNEL AUTHORITIES.— 

21 ‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC

22 AND PROFESSIONAL PERSONNEL.—In addition 

23 to any other personnel authorities, the Sec24 retary may— 


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1 ‘‘(i) without regard to those provisions 

2 of title 5, United States Code, governing 

3 appointments in the competitive service, 

4 appoint highly qualified individuals to sci5 entific or professional positions in 

6 BARDA, such as program managers, to 

7 carry out this section; and 

8 ‘‘(ii) compensate them in the same 

9 manner in which individuals appointed 

10 under section 9903 of such title are com11 pensated, without regard to the provisions 

12 of chapter 51 and subchapter III of chap13 ter 53 of such title relating to classification 

14 and General Schedule pay rates. 

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

16 out this section, the Secretary may— 

17 ‘‘(i) appoint special consultants pursu18 ant to section 207(f); and 

19 ‘‘(ii) accept voluntary and uncompen20 sated services. 

21 ‘‘(c) INAPPLICABILITY OF CERTAIN PROVISIONS.— 

22 ‘‘(1) DISCLOSURE.— 

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

24 withhold from disclosure under section 552 of 

25 title 5, United States Code, specific technical 


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1 data or scientific information that is created or 

2 obtained during the countermeasure and prod3 uct advanced research and development funded 

4 by the Secretary that reveal vulnerabilities of 

5 existing medical or public health defenses 

6 against biological, chemical, nuclear, or radio7 logical threats. Such information shall be 

8 deemed to be information described in section 

9 552(b)(3) of title 5, United States Code. 

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

11 nondisclosure under subparagraph (A) shall be 

12 reviewed by the Secretary every 5 years to de13 termine the relevance or necessity of continued 

14 nondisclosure. 

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

16 Section 14 of the Federal Advisory Committee Act 

17 (5 U.S.C. App.) shall not apply to a working group 

18 of BARDA or to the National Biodefense Science 

19 Board under section 319M. 

20 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 

21 purpose of carrying out advanced research and develop22 ment under this section, there are authorized to be appro23 priated $160,000,000 for each of the fiscal years 2007 

24 and 2008. Such authorizations are in addition to other 

25 authorizations of appropriations that are available for 


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1 such purpose. Amounts appropriated under the preceding 

2 sentence are available until expended. 

3 ‘‘(e) DEFINITIONS.—For purposes of this section: 

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

5 Biomedical Advanced Research and Development 

6 Authority. 

7 ‘‘(2) OTHER TRANSACTIONS.—The term ‘other 

8 transactions’ means transactions, other than pro9 curement contracts, grants, and cooperative agree10 ments, such as the Secretary of Defense may enter 

11 into under section 2371 of title 10, United States 

12 Code. 

13 ‘‘(3) QUALIFIED COUNTERMEASURE.—The term 

14 ‘qualified countermeasure’ has the meaning given 

15 such term in section 319F–1. 

16 ‘‘(4) QUALIFIED PANDEMIC OR EPIDEMIC PROD17 UCT.—The term ‘qualified pandemic or epidemic 

18 product’ has the meaning given the term in section 

19 319F–3. 

20 ‘‘(5) ADVANCED RESEARCH AND DEVELOP21 MENT.— 

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

23 research and development’ means, with respect 

24 to a product that is or may become a qualified 


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1 countermeasure or a qualified pandemic or epi2 demic product, activities that predominantly— 

3 ‘‘(i) are conducted after basic research 

4 and preclinical development of the product; 

5 and 

6 ‘‘(ii) are related to manufacturing the 

7 product on a commercial scale and in a 

8 form that satisfies the regulatory require9 ments under the Federal Food, Drug, and 

10 Cosmetic Act or under section 351 of this 

11 Act. 

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

13 under subparagraph (A) includes— 

14 ‘‘(i) testing of the product to deter15 mine whether the product may be ap16 proved, cleared, or licensed under the Fed17 eral Food, Drug, and Cosmetic Act or 

18 under section 351 of this Act for a use 

19 that is or may be the basis for such prod20 uct becoming a qualified countermeasure 

21 or qualified pandemic or epidemic product, 

22 or to help obtain such approval, clearance, 

23 or license; 


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1 ‘‘(ii) design and development of tests 

2 or models, including animal models, for 

3 such testing; 

4 ‘‘(iii) activities to facilitate manufac5 ture of the product on a commercial scale 

6 with consistently high quality, as well as to 

7 improve and make available new tech8 nologies to increase manufacturing surge 

9 capacity; 

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

11 of the product or technologies for admin12 istering the product; and 

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

14 of the advanced stages of testing, refine15 ment, improvement, or preparation of the 

16 product for such use and as are specified 

17 by the Secretary. 

18 ‘‘(6) RESEARCH TOOL.—The term ‘research 

19 tool’ means a device, technology, biological material, 

20 reagent, animal model, computer system, computer 

21 software, or analytical technique that is developed to 

22 assist in the discovery, development, or manufacture 

23 of qualified countermeasures or qualified pandemic 

24 or epidemic products. 


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1 ‘‘(7) PROGRAM MANAGER.—The term ‘program 

2 manager’ means an individual appointed to carry out 

3 functions under this section and authorized to pro4 vide project oversight and management of strategic 

5 initiatives. 

6 ‘‘(8) PERSON.—The term ‘person’ includes an 

7 individual, partnership, corporation, association, en8 tity, or public or private corporation, and a Federal, 

9 State, or local government agency or department. 

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

11 WORKING GROUPS. 

12 ‘‘(a) IN GENERAL.— 

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

14 Secretary shall establish the National Biodefense 

15 Science Board (referred to in this section as the 

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

17 the Secretary on scientific, technical and other mat18 ters of special interest to the Department of Health 

19 and Human Services regarding current and future 

20 chemical, biological, nuclear, and radiological agents, 

21 whether naturally occurring, accidental, or delib22 erate. 

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

24 Board shall be comprised of individuals who repVerDate Aug 31 2005 22:06 Nov 14, 2006 Jkt 059196 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.RFS H5533

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1 resent the Nation’s preeminent scientific, public 

2 health, and medical experts, as follows— 

3 ‘‘(A) such Federal officials as the Sec4 retary may determine are necessary to support 

5 the functions of the Board; 

6 ‘‘(B) four individuals representing the 

7 pharmaceutical, biotechnology, and device in8 dustries; 

9 ‘‘(C) four individuals representing aca10 demia; and 

11 ‘‘(D) five other members as determined ap12 propriate by the Secretary. 

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

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

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

16 years, except that the Secretary may adjust the 

17 terms of the initial Board appointees in order to 

18 provide for a staggered term of appointment for all 

19 members. 

20 ‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM

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

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

23 more than 2 consecutive terms. 

24 ‘‘(5) DUTIES.—The Board shall— 


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

2 future trends, challenges, and opportunities pre3 sented by advances in biological and life 

4 sciences, biotechnology, and genetic engineering 

5 with respect to threats to biodefense or public 

6 health security posed by naturally occurring in7 fectious diseases and chemical, biological, radio8 logical, and nuclear agents; 

9 ‘‘(B) at the request of the Secretary, re10 view and consider any information and findings 

11 received from the working groups established 

12 under subsection (b); and 

13 ‘‘(C) at the request of the Secretary, pro14 vide recommendations and findings for ex15 panded, intensified, and coordinated biodefense 

16 research and development activities. 

17 ‘‘(6) MEETINGS.— 

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

19 one year after the date of enactment of the Bio20 defense and Pandemic Vaccine and Drug Devel21 opment Act of 2006, the Secretary shall hold 

22 the first meeting of the Board. 

23 ‘‘(B) SUBSEQUENT MEETINGS.—The 

24 Board shall meet at the call of the Secretary, 

25 but in no case less than twice annually. 


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

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

3 same manner as the original appointment. 

4 ‘‘(8) CHAIRPERSON.—The Secretary shall ap5 point a chairperson from among the members of the 

6 Board. 

7 ‘‘(9) POWERS.— 

8 ‘‘(A) HEARINGS.—The Board may hold 

9 such hearings, sit and act at such times and 

10 places, take such testimony, and receive such 

11 evidence as the Board considers advisable to 

12 carry out this subsection. 

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

14 use the United States mails in the same man15 ner and under the same conditions as other de16 partments and agencies of the Federal Govern17 ment. 

18 ‘‘(10) PERSONNEL.— 

19 ‘‘(A) EMPLOYEES OF THE FEDERAL GOV20 ERNMENT.—A member of the Board that is an 

21 employee of the Federal Government may not 

22 receive additional pay, allowances, or benefits 

23 by reason of the member’s service on the 

24 Board. 


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

2 Board that is not an employee of the Federal 

3 Government may be compensated at a rate not 

4 to exceed the daily equivalent of the annual rate 

5 of basic pay prescribed for level IV of the Exec6 utive Schedule under section 5315 of title 5, 

7 United States Code, for each day (including 

8 travel time) during which the member is en9 gaged in the actual performance of duties as a 

10 member of the Board. 

11 ‘‘(C) TRAVEL EXPENSES.—Each member 

12 of the Board shall receive travel expenses, in13 cluding per diem in lieu of subsistence, in ac14 cordance with applicable provisions under sub15 chapter I of chapter 57 of title 5, United States 

16 Code. 

17 ‘‘(D) DETAIL OF GOVERNMENT EMPLOY18 EES.—Any Federal Government employee may 

19 be detailed to the Board with the approval for 

20 the contributing agency without reimbursement, 

21 and such detail shall be without interruption or 

22 loss of civil service status or privilege. 

23 ‘‘(b) DEFINITIONS.—Any term that is defined in sec24 tion 319L and that is used in this section shall have the 


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1 same meaning in this section as such term is given in sec2 tion 319L. 

3 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

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

5 this section for each of the fiscal years 2007 and 2008.’’. 

6 SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 

7 BY PROJECT BIOSHIELD. 

8 (a) QUALIFIED COUNTERMEASURES.—Section 

9 319F–1(a)(2) of the Public Health Service Act (42 U.S.C. 

10 247d–6a(a)(2)) is amended— 

11 (1) by amending subparagraph (A) to read as 

12 follows: 

13 ‘‘(A) diagnose, mitigate, prevent, or treat 

14 harm from any biological agent (including orga15 nisms that cause an infectious disease) or toxin, 

16 or from any chemical, radiological, or nuclear 

17 agent, that may cause a public health emer18 gency affecting national security; or’’; 

19 (2) in subparagraph (B), by striking ‘‘treat, 

20 identify, or prevent harm’’ and inserting ‘‘diagnose, 

21 mitigate, prevent, or treat harm’’; and 

22 (3) by adding after and below subparagraph 

23 (B) the following: 

24 ‘‘If through publication in the Federal Register the 

25 Secretary makes a determination that there is credVerDate Aug 31 2005 22:06 Nov 14, 2006 Jkt 059196 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.RFS H5533

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1 ible evidence that a biological agent has the potential 

2 to cause an epidemic or pandemic that may con3 stitute a public health emergency, a countermeasure 

4 to such agent shall, without further administrative 

5 action, be considered a qualified countermeasure 

6 within the meaning of this paragraph.’’. 

7 (b) SECURITY COUNTERMEASURES.—Section 319F– 

8 2(c)(1)(B)(i)(I) of the Public Health Service Act (42 

9 U.S.C. 247d–6b(c)(1)(B)(i)(I)) is amended by striking ‘‘to 

10 treat’’ the first place such term appears and all that fol11 lows through ‘‘from a condition’’ and inserting the fol12 lowing: ‘‘to diagnose, mitigate, prevent, or treat harm 

13 from any biological agent (including organisms that cause 

14 an infectious disease) or toxin or from any chemical, radio15 logical, or nuclear agent identified as a material threat 

16 under paragraph (2)(A)(ii), or to diagnose, mitigate, pre17 vent, or treat harm from a condition’’. 

18 SEC. 5. TECHNICAL ASSISTANCE. 

19 Subchapter E of chapter V of the Federal Food, 

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

21 amended by adding at the end the following: 

22 ‘‘SEC. 565. TECHNICAL ASSISTANCE. 

23 ‘‘The Secretary, in consultation with the Commis24 sioner of Food and Drugs, shall establish within the Food 

25 and Drug Administration a team of experts on manufacVerDate Aug 31 2005 22:06 Nov 14, 2006 Jkt 059196 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.RFS H5533

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1 turing and regulatory activities (including compliance with 

2 current Good Manufacturing Practice) to provide both off3 site and on-site technical assistance to the manufacturers 

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

5 1 of the Public Health Service Act), security counter6 measures (as defined in section 319F–2 of such Act), or 

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

8 the discretion of the Secretary, if the Secretary determines 

9 that a shortage or potential shortage may occur in the 

10 United States in the supply of such vaccines or counter11 measures and that the provision of such assistance would 

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

13 SEC. 6. PROCUREMENT. 

14 Section 319F–2 of the Public Health Service Act (42 

15 U.S.C. 247d–6b) is amended— 

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

17 SECURITY COUNTERMEASURE PROCURE18 MENTS’’ before the period; and 

19 (2) in subsection (c)— 

20 (A) in the subsection heading, by striking 

21 ‘‘BIOMEDICAL’’; 

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

23 meet the needs of the stockpile’’ and inserting 

24 ‘‘to meet the stockpile needs’’; 

25 (C) in paragraph (7)(B)— 


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1 (i) by striking the subparagraph head2 ing and all that follows through ‘‘Home3 land Security Secretary’’ and inserting the 

4 following: ‘‘INTERAGENCY AGREEMENT; 

5 COST.—The Homeland Security Sec6 retary’’; and 

7 (ii) by striking clause (ii); 

8 (D) in paragraph (7)(C)(ii)— 

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

10 follows: 

11 ‘‘(I) PAYMENT CONDITIONED ON

12 DELIVERY.—The contract shall pro13 vide that no payment may be made 

14 until delivery of a portion, acceptable 

15 to the Secretary, of the total number 

16 of units contracted for, except that, 

17 notwithstanding any other provision of 

18 law, the contract may provide that, if 

19 the Secretary determines (in the Sec20 retary’s discretion) that an advance 

21 payment, partial payment for signifi22 cant milestones, or payment to in23 crease manufacturing capacity is nec24 essary to ensure success of a project, 

25 the Secretary shall pay an amount, 


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1 not to exceed 10 percent of the con2 tract amount, in advance of delivery. 

3 The Secretary shall, to the extent 

4 practicable, make the determination of 

5 advance payment at the same time as 

6 the issuance of a solicitation. The con7 tract shall provide that such advance 

8 payment is required to be repaid if 

9 there is a failure to perform by the 

10 vendor under the contract. The con11 tract may also provide for additional 

12 advance payments of 5 percent each 

13 for meeting the milestones specified in 

14 such contract. Provided that the spec15 ified milestones are reached, these ad16 vance payments of 5 percent shall not 

17 be required to be repaid. Nothing in 

18 this subclause shall be construed as 

19 affecting the rights of vendors under 

20 provisions of law or regulation (in21 cluding the Federal Acquisition Regu22 lation) relating to the termination of 

23 contracts for the convenience of the 

24 Government.’’; and 


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1 (ii) by adding at the end the fol2 lowing: 

3 ‘‘(VII) PROCUREMENT OF MUL4 TIPLE PRODUCTS AND TECH5 NOLOGIES.—The Secretary may enter 

6 into multiple transactions for the pro7 curement of multiple technologies and 

8 products from multiple manufacturers 

9 of security countermeasures in order 

10 to mitigate against the risks associ11 ated with dependence on a single sup12 plier 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 22:06 Nov 14, 2006 Jkt 059196 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.RFS 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: ‘‘In the case of such agree18 ments by the Secretary, the Secretary may 

19 allow other executive agencies to order qualified 

20 and security countermeasures under procure21 ment contracts or other agreements established 

22 by the Secretary, and such ordering process (in23 cluding transfers of appropriated funds between 

24 an agency and the Department of Health and 

25 Human Services as reimbursements for such orVerDate Aug 31 2005 22:06 Nov 14, 2006 Jkt 059196 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H5533.RFS H5533

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1 ders for countermeasures) may be conducted 

2 under the authority of section 1535 of title 31, 

3 United States Code, except that all such orders 

4 shall be processed under the terms established 

5 under this section for the procurement of coun6 termeasures.’’ 

Passed the House of Representatives September 26, 

2006. 

Attest: KAREN L. HAAS, 

Clerk. 


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