II 

109TH CONGRESS 

2D SESSION S. 2564 

To prepare and strengthen the biodefenses of the United States against 

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

IN THE SENATE OF THE UNITED STATES 

APRIL 6, 2006 

Mr. BURR (for himself, Mr. FRIST, Mr. ENZI, Mr. GREGG, Mr. ALEXANDER, 

and Mrs. DOLE) introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

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. 


HMoore on PROD1PC68 with HMBILLS
2 

•S 2564 IS

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

Sec. 5. Orphan drug market exclusivity for countermeasure products. 

Sec. 6. Technical assistance. 

Sec. 7. Collaboration and coordination. 

Sec. 8. Procurement. 

Sec. 9. Rule of construction. 

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

3 SCIENCE BOARD. 

4 (a) IN GENERAL.—Title III of the Public Health 

5 Service Act (42 U.S.C. 241 et seq.) is amended by insert6 ing after section 319K 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. 


HMoore on PROD1PC68 with HMBILLS
3 

•S 2564 IS

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— 


HMoore on PROD1PC68 with HMBILLS
4 

•S 2564 IS

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 


HMoore on PROD1PC68 with HMBILLS
5 

•S 2564 IS

1 product for such use and as are specified 

2 by the Secretary. 

3 ‘‘(7) SECURITY COUNTERMEASURE.—The term 

4 ‘security countermeasure’ has the meaning given 

5 such term in section 319F–2. 

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

7 tool’ means a device, technology, biological material 

8 (including a cell line or an antibody), reagent, ani9 mal model, computer system, computer software, or 

10 analytical technique that is developed to assist in the 

11 discovery, development, or manufacture of qualified 

12 countermeasures or qualified pandemic or epidemic 

13 products. 

14 ‘‘(9) PROGRAM MANAGER.—The term ‘program 

15 manager’ means an individual appointed to carry out 

16 functions under this section and authorized to pro17 vide project oversight and management of strategic 

18 initiatives. 

19 ‘‘(10) PERSON.—The term ‘person’ includes an 

20 individual, partnership, corporation, association, en21 tity, or public or private corporation, and a Federal, 

22 State, or local government agency or department. 

23 ‘‘(b) STRATEGIC PLAN FOR COUNTERMEASURE RE24 SEARCH, DEVELOPMENT, AND PROCUREMENT.— 


HMoore on PROD1PC68 with HMBILLS
6 

•S 2564 IS

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

2 after the date of enactment of the Biodefense and 

3 Pandemic Vaccine and Drug Development Act of 

4 2006, the Secretary shall develop and make public a 

5 strategic plan to integrate biodefense and emerging 

6 infectious disease requirements with the advanced 

7 research and development, strategic initiatives for 

8 innovation, and the procurement of qualified coun9 termeasures and qualified pandemic or epidemic 

10 products. 

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

12 paragraph (1) shall guide— 

13 ‘‘(A) research and development, conducted 

14 or supported by the Department of Health and 

15 Human Services, of qualified countermeasures 

16 and qualified pandemic or epidemic products 

17 against possible biological, chemical, radio18 logical, and nuclear agents and to emerging in19 fectious diseases; 

20 ‘‘(B) innovation in technologies that may 

21 assist advanced research and development of 

22 qualified countermeasures and qualified pan23 demic or epidemic products (such research and 

24 development referred to in this section as ‘counVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
7 

•S 2564 IS

1 termeasure and product advanced research and 

2 development’); and 

3 ‘‘(C) procurement of such qualified coun4 termeasures and qualified pandemic or epidemic 

5 products by such Department. 

6 ‘‘(c) BIOMEDICAL ADVANCED RESEARCH AND DE7 VELOPMENT AUTHORITY.— 

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

9 within the Department of Health and Human Serv10 ices the Biomedical Advanced Research and Develop11 ment Authority. 

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

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

14 coordinate and oversee the acceleration of counter15 measure and product advanced research and devel16 opment by— 

17 ‘‘(A) facilitating collaboration among the 

18 Department of Health and Human Services, 

19 other Federal agencies, relevant industries, aca20 demia, and other persons, with respect to such 

21 advanced research and development; 

22 ‘‘(B) promoting countermeasure and prod23 uct advanced research and development; 

24 ‘‘(C) facilitating contacts between inter25 ested persons and the offices or employees auVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
8 

•S 2564 IS

1 thorized by the Secretary to advise such persons 

2 regarding requirements under the Federal 

3 Food, Drug, and Cosmetic Act and under sec4 tion 351 of this Act; and 

5 ‘‘(D) promoting innovation to reduce the 

6 time and cost of countermeasure and product 

7 advanced research and development. 

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

9 by a Director (referred to in this section as the ‘Di10 rector’) who shall be appointed by the Secretary and 

11 to whom the Secretary shall delegate such functions 

12 and authorities as necessary to implement this sec13 tion. 

14 ‘‘(4) DUTIES.— 

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

16 purpose described in paragraph (2)(A), the Sec17 retary shall— 

18 ‘‘(i) facilitate and increase the expedi19 tious and direct communication between 

20 the Department of Health and Human 

21 Services and relevant persons with respect 

22 to countermeasure and product advanced 

23 research and development, including by— 

24 ‘‘(I) facilitating such communica25 tion regarding the processes for proVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
9 

•S 2564 IS

1 curing such advanced research and 

2 development with respect to qualified 

3 countermeasures and qualified pan4 demic or epidemic products of inter5 est; and 

6 ‘‘(II) soliciting information about 

7 and data from research on potential 

8 qualified countermeasures and quali9 fied pandemic or epidemic products 

10 and related technologies; 

11 ‘‘(ii) at least annually— 

12 ‘‘(I) convene meetings with rep13 resentatives from relevant industries, 

14 academia, other Federal agencies, 

15 international agencies as appropriate, 

16 and other interested persons; 

17 ‘‘(II) sponsor opportunities to 

18 demonstrate the operation and effec19 tiveness of relevant biodefense coun20 termeasure technologies; and 

21 ‘‘(III) convene such working 

22 groups on countermeasure and prod23 uct advanced research and develop24 ment as the Secretary may determine 


HMoore on PROD1PC68 with HMBILLS
10 

•S 2564 IS

1 are necessary to carry out this sec2 tion; and 

3 ‘‘(iii) carry out the activities described 

4 in section 7 of the Biodefense and Pan5 demic Vaccine and Drug Development Act 

6 of 2006. 

7 ‘‘(B) SUPPORT ADVANCED RESEARCH AND

8 DEVELOPMENT.—To carry out the purpose de9 scribed in paragraph (2)(B), the Secretary 

10 shall— 

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

12 support calls for, potential qualified coun13 termeasures and qualified pandemic or epi14 demic products; 

15 ‘‘(ii) direct and coordinate the coun16 termeasure and product advanced research 

17 and development activities of the Depart18 ment of Health and Human Services; 

19 ‘‘(iii) establish strategic initiatives to 

20 accelerate countermeasure and product ad21 vanced research and development and in22 novation in such areas as the Secretary 

23 may identify as priority unmet need areas; 

24 and 


HMoore on PROD1PC68 with HMBILLS
11 

•S 2564 IS

1 ‘‘(iv) award contracts, grants, cooper2 ative agreements, and enter into other 

3 transactions, for countermeasure and prod4 uct advanced research and development. 

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

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

7 Secretary shall— 

8 ‘‘(i) connect interested persons with 

9 the offices or employees authorized by the 

10 Secretary to advise such persons regarding 

11 the regulatory requirements under the 

12 Federal Food, Drug, and Cosmetic Act 

13 and under section 351 of this Act related 

14 to the approval, clearance, or licensure of 

15 qualified countermeasures or qualified pan16 demic or epidemic products; and 

17 ‘‘(ii) ensure that, with respect to per18 sons performing countermeasure and prod19 uct advanced research and development 

20 funded under this section, such offices or 

21 employees provide such advice in a manner 

22 that is ongoing and that is otherwise des23 ignated to facilitate expeditious develop24 ment of qualified countermeasures and 

25 qualified pandemic or epidemic products 


HMoore on PROD1PC68 with HMBILLS
12 

•S 2564 IS

1 that may achieve such approval, clearance, 

2 or licensure. 

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

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

5 the Secretary may award contracts, grants, and 

6 cooperative agreements, or enter into other 

7 transactions, such as prize payments, to pro8 mote— 

9 ‘‘(i) innovation in technologies that 

10 may assist countermeasure and product 

11 advanced research and development; 

12 ‘‘(ii) research on and development of 

13 research tools and other devices and tech14 nologies; and 

15 ‘‘(iii) research to promote strategic 

16 initiatives, such as rapid diagnostics, broad 

17 spectrum antimicrobials, and vaccine man18 ufacturing technologies. 

19 ‘‘(5) TRANSACTION AUTHORITIES.— 

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

21 out the functions under subparagraph (B) or 

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

23 authority to enter into other transactions for 

24 countermeasure and product advanced research 

25 and development. 


HMoore on PROD1PC68 with HMBILLS
13 

•S 2564 IS

1 ‘‘(B) EXPEDITED AUTHORITIES.— 

2 ‘‘(i) IN GENERAL.—In awarding con3 tracts, grants, and cooperative agreements, 

4 and in entering into other transactions 

5 under subparagraph (B) or (D) of para6 graph (4), the Secretary shall have the ex7 pedited procurement authorities, the au8 thority to expedite peer review, and the au9 thority for personal services contracts, sup10 plied by subsections (b), (c), and (d) of 

11 section 319F–1. 

12 ‘‘(ii) APPLICATION OF PROVISIONS.— 

13 Provisions in such section 319F–1 that 

14 apply to such authorities and that require 

15 institution of internal controls, limit re16 view, provide for Federal Tort Claims Act 

17 coverage of personal services contractors, 

18 and commit decisions to the discretion of 

19 the Secretary shall apply to the authorities 

20 as exercised pursuant to this paragraph. 

21 ‘‘(iii) AUTHORITY TO LIMIT COMPETI22 TION.—For purposes of applying section 

23 319F–1(b)(1)(D) to this paragraph, the 

24 phrase ‘BioShield Program under the 

25 Project BioShield Act of 2004’ shall be 


HMoore on PROD1PC68 with HMBILLS
14 

•S 2564 IS

1 deemed to mean the countermeasure and 

2 product advanced research and develop3 ment program under this section. 

4 ‘‘(iv) AVAILABILITY OF DATA.—The 

5 Secretary shall require that, as a condition 

6 of being awarded a contract, grant, cooper7 ative agreement, or other transaction 

8 under subparagraph (B) or (D) of para9 graph (4), a person make available to the 

10 Secretary on an ongoing basis, and submit 

11 upon request to the Secretary, all data re12 lated to or resulting from countermeasure 

13 and product advanced research and devel14 opment carried out pursuant to this sec15 tion. 

16 ‘‘(C) ADVANCE PAYMENTS; ADVER17 TISING.—The authority of the Secretary to 

18 enter into contracts under this section shall not 

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

20 States Code, or by section 3709 of the Revised 

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

22 ‘‘(D) MILESTONE-BASED PAYMENTS AL23 LOWED.—In awarding contracts, grants, and 

24 cooperative agreements, and in entering into 

25 other transactions, under this section, the SecVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
15 

•S 2564 IS

1 retary may use milestone-based awards and 

2 payments. 

3 ‘‘(E) FOREIGN NATIONALS ELIGIBLE.— 

4 The Secretary may under this section award 

5 contracts, grants, and cooperative agreements 

6 to, and may enter into other transactions with, 

7 highly qualified foreign national persons outside 

8 the United States, alone or in collaboration with 

9 American participants, when such transactions 

10 may inure to the benefit of the American peo11 ple. 

12 ‘‘(F) ESTABLISHMENT OF RESEARCH CEN13 TERS.—The Secretary may establish one or 

14 more federally-funded research and development 

15 centers, or university-affiliated research centers 

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

17 Federal Property and Administrative Services 

18 Act of 1949 (41 U.S.C. 253(c)(3)). 

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

20 out the functions under this section, the Secretary 

21 may give priority to the advanced research and de22 velopment of qualified countermeasures and qualified 

23 pandemic or epidemic products that are likely to be 

24 safe and effective with respect to children, pregnant 

25 women, and other vulnerable populations. 


HMoore on PROD1PC68 with HMBILLS
16 

•S 2564 IS

1 ‘‘(7) PERSONNEL AUTHORITIES.— 

2 ‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC

3 AND PROFESSIONAL PERSONNEL.—In addition 

4 to any other personnel authorities, the Sec5 retary may— 

6 ‘‘(i) without regard to those provisions 

7 of title 5, United States Code, governing 

8 appointments in the competitive service, 

9 appoint highly qualified individuals to sci10 entific or professional positions in 

11 BARDA, such as program managers, to 

12 carry out this section; and 

13 ‘‘(ii) compensate them in the same 

14 manner in which individuals appointed 

15 under section 9903 of such title are com16 pensated, without regard to the provisions 

17 of chapter 51 and subchapter III of chap18 ter 53 of such title relating to classification 

19 and General Schedule pay rates. 

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

21 out this section, the Secretary may— 

22 ‘‘(i) appoint special consultants pursu23 ant to section 207(f); and 

24 ‘‘(ii) accept voluntary and uncompen25 sated services. 


HMoore on PROD1PC68 with HMBILLS
17 

•S 2564 IS

1 ‘‘(d) FUND.— 

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

3 the Biodefense Medical Countermeasure Develop4 ment Fund, which shall be available to carry out this 

5 section. 

6 ‘‘(2) FUNDS.— 

7 ‘‘(A) FIRST FISCAL YEAR.— 

8 ‘‘(i) AUTHORIZATION AND APPROPRIA9 TION.—There are authorized to be appro10 priated and there are appropriated to the 

11 Fund $340,000,000 to carry out this sec12 tion for fiscal year 2007. Such funds shall 

13 remain available until expended. 

14 ‘‘(ii) AUTHORIZATION OF APPROPRIA15 TIONS.—There are authorized to be appro16 priated, in addition to the amounts appro17 priated under clause (i), $160,000,000 to 

18 carry out this section for fiscal year 2007. 

19 Such funds shall remain available until ex20 pended. 

21 ‘‘(B) SUBSEQUENT FISCAL YEARS.— 

22 ‘‘(i) IN GENERAL.—There are author23 ized to be appropriated to carry out this 

24 section— 


HMoore on PROD1PC68 with HMBILLS
18 

•S 2564 IS

1 ‘‘(I) $500,000,000 for fiscal year 

2 2008; and 

3 ‘‘(II) such sums as may be nec4 essary for fiscal years 2009 through 

5 2012. 

6 ‘‘(ii) AVAILABILITY OF FUNDS.—Such 

7 sums authorized under clause (i) shall re8 main available until expended. 

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

10 ‘‘(1) DISCLOSURE.— 

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

12 withhold from disclosure under section 552 of 

13 title 5, United States Code, specific technical 

14 data or scientific information that is created or 

15 obtained during the countermeasure and prod16 uct advanced research and development funded 

17 by the Secretary that reveal vulnerabilities of 

18 existing medical or public health defenses 

19 against biological, chemical, nuclear, or radio20 logical threats. Such information shall be 

21 deemed to be information described in section 

22 552(b)(3) of title 5, United States Code. 

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

24 nondisclosure under subparagraph (A) shall be 

25 reviewed by the Secretary every 5 years to deVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
19 

•S 2564 IS

1 termine the relevance or necessity of continued 

2 nondisclosure. 

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

4 Section 14 of the Federal Advisory Committee Act 

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

6 of BARDA or to the National Biodefense Science 

7 Board under section 319M. 

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

9 WORKING GROUPS. 

10 ‘‘(a) IN GENERAL.— 

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

12 Secretary shall establish the National Biodefense 

13 Science Board (referred to in this section as the 

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

15 the Secretary on scientific, technical and other mat16 ters of special interest to the Department of Health 

17 and Human Services regarding current and future 

18 chemical, biological, nuclear, and radiological agents, 

19 whether naturally occurring, accidental, or delib20 erate. 

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

22 Board shall be comprised of individuals who rep23 resent the Nation’s preeminent scientific, public 

24 health, and medical experts, as follows— 


HMoore on PROD1PC68 with HMBILLS
20 

•S 2564 IS

1 ‘‘(A) such Federal officials as the Sec2 retary may determine are necessary to support 

3 the functions of the Board; 

4 ‘‘(B) four individuals representing the 

5 pharmaceutical, biotechnology, and device in6 dustries; 

7 ‘‘(C) four individuals representing aca8 demia; and 

9 ‘‘(D) five other members as determined ap10 propriate by the Secretary. 

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

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

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

14 years, except that the Secretary may adjust the 

15 terms of the initial Board appointees in order to 

16 provide for a staggered term of appointment for all 

17 members. 

18 ‘‘(4) CONSECUTIVE APPOINTMENTS; MAXIMUM

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

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

21 more than 2 consecutive terms. 

22 ‘‘(5) DUTIES.—The Board shall— 

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

24 future trends, challenges, and opportunities pre25 sented by advances in biological and life 


HMoore on PROD1PC68 with HMBILLS
21 

•S 2564 IS

1 sciences, biotechnology, and genetic engineering 

2 with respect to threats posed by naturally oc3 curring infectious diseases and chemical, bio4 logical, radiological, and nuclear agents; 

5 ‘‘(B) at the request of the Secretary, re6 view and consider any information and findings 

7 received from the working groups established 

8 under subsection (b); and 

9 ‘‘(C) at the request of the Secretary, pro10 vide recommendations and findings for ex11 panded, intensified, and coordinated biodefense 

12 research and development activities. 

13 ‘‘(6) MEETINGS.— 

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

15 one year after the date of enactment of the Bio16 defense and Pandemic Vaccine and Drug Devel17 opment Act of 2006, the Secretary shall hold 

18 the first meeting of the Board. 

19 ‘‘(B) SUBSEQUENT MEETINGS.—The 

20 Board shall meet at the call of the Secretary, 

21 but in no case less than twice annually. 

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

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

24 same manner as the original appointment. 


HMoore on PROD1PC68 with HMBILLS
22 

•S 2564 IS

1 ‘‘(8) CHAIRPERSON.—The Secretary shall ap2 point a chairperson from among the members of the 

3 Board. 

4 ‘‘(9) POWERS.— 

5 ‘‘(A) HEARINGS.—The Board may hold 

6 such hearings, sit and act at such times and 

7 places, take such testimony, and receive such 

8 evidence as the Board considers advisable to 

9 carry out this subsection. 

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

11 use the United States mails in the same man12 ner and under the same conditions as other de13 partments and agencies of the Federal Govern14 ment. 

15 ‘‘(10) PERSONNEL.— 

16 ‘‘(A) EMPLOYEES OF THE FEDERAL GOV17 ERNMENT.—A member of the Board that is an 

18 employee of the Federal Government may not 

19 receive additional pay, allowances, or benefits 

20 by reason of the member’s service on the 

21 Board. 

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

23 Board that is not an employee of the Federal 

24 Government may be compensated at a rate not 

25 to exceed the daily equivalent of the annual rate 


HMoore on PROD1PC68 with HMBILLS
23 

•S 2564 IS

1 of basic pay prescribed for level IV of the Exec2 utive Schedule under section 5315 of title 5, 

3 United States Code, for each day (including 

4 travel time) during which the member is en5 gaged in the actual performance of duties as a 

6 member of the Board. 

7 ‘‘(C) TRAVEL EXPENSES.—Each member 

8 of the Board shall receive travel expenses, in9 cluding per diem in lieu of subsistence, in ac10 cordance with applicable provisions under sub11 chapter I of chapter 57 of title 5, United States 

12 Code. 

13 ‘‘(D) DETAIL OF GOVERNMENT EMPLOY14 EES.—Any Federal Government employee may 

15 be detailed to the Board with the approval for 

16 the contributing agency without reimbursement, 

17 and such detail shall be without interruption or 

18 loss of civil service status or privilege. 

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

20 establish a working group of experts, or may use an exist21 ing working group or advisory committee, to— 

22 ‘‘(1) identify innovative research with the po23 tential to be developed as a qualified countermeasure 

24 or a qualified pandemic or epidemic product; 


HMoore on PROD1PC68 with HMBILLS
24 

•S 2564 IS

1 ‘‘(2) identify accepted animal models for par2 ticular diseases and conditions associated with any 

3 biological, chemical, radiological, or nuclear agent, 

4 any toxin, or any potential pandemic infectious dis5 ease, and identify strategies to accelerate animal 

6 model and research tool development and validation; 

7 and 

8 ‘‘(3) obtain advice regarding supporting and fa9 cilitating advanced research and development related 

10 to qualified countermeasures and qualified pandemic 

11 or epidemic products that are likely to be safe and 

12 effective with respect to children, pregnant women, 

13 and other vulnerable populations, and other issues 

14 regarding activities under this section that affect 

15 such populations. 

16 ‘‘(c) DEFINITIONS.—Any term that is defined in sec17 tion 319L and that is used in this section shall have the 

18 same meaning in this section as such term is given in sec19 tion 319L. 

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

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

22 this section for fiscal year 2007 and each fiscal year there23 after.’’. 

24 (b) OFFSET OF FUNDING.—The amount appro25 priated under the subheading ‘‘Biodefense CounterVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
25 

•S 2564 IS

1 measures’’ under the heading ‘‘Emergency Preparedness 

2 and Response’’ in title III of the Department of Homeland 

3 Security Appropriations Act, 2004 (Public Law 108–90) 

4 shall be decreased by $340,000,000. 

5 SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 

6 BY PROJECT BIOSHIELD. 

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

8 1(a) of the Public Health Service Act (42 U.S.C. 247d– 

9 6a(a)) is amended by striking paragraph (2) and inserting 

10 the following: 

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

12 ‘‘(A) QUALIFIED COUNTERMEASURE.—The 

13 term ‘qualified countermeasure’ means a drug 

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

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

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

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

18 U.S.C. 262(i))), or device (as that term is de19 fined by section 201(h) of the Federal Food, 

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

21 that the Secretary determines to be a priority 

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

23 the Homeland Security Act of 2002) to— 

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

25 treat harm from any biological agent (inVerDate Aug 31 2005 01:53 Apr 12, 2006 Jkt 049200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
26 

•S 2564 IS

1 cluding organisms that cause an infectious 

2 disease) or toxin, chemical, radiological, or 

3 nuclear agent that may cause a public 

4 health emergency affecting national secu5 rity; or 

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

7 treat harm from a condition that may re8 sult in adverse health consequences or 

9 death and may be caused by administering 

10 a drug, biological product, or device that is 

11 used as described in this subparagraph. 

12 ‘‘(B) INFECTIOUS DISEASE.—The term ‘in13 fectious disease’ means a disease potentially 

14 caused by a pathogenic organism (including a 

15 bacteria, virus, fungus, or parasite) that is ac16 quired by a person and that reproduces in that 

17 person.’’. 

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

19 2(c)(1)(B) is amended by striking ‘‘treat, identify, or pre20 vent’’ each place it appears and inserting ‘‘diagnose, miti21 gate, prevent, or treat’’. 

22 (c) LIMITATION ON USE OF FUNDS.—Section 510(a) 

23 of the Homeland Security Act of 2002 (6 U.S.C. 320(a)) 

24 is amended by adding at the end the following: ‘‘None of 

25 the funds made available under this subsection shall be 


HMoore on PROD1PC68 with HMBILLS
27 

•S 2564 IS

1 used to procure countermeasures to diagnose, mitigate, 

2 prevent, or treat harm resulting from any naturally occur3 ring infectious disease.’’. 

4 SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUN5 TERMEASURE PRODUCTS. 

6 (a) IN GENERAL.—Section 527 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended 

8 by adding at the end the following: 

9 ‘‘(c) MARKET EXCLUSIVITIES FOR COUNTER10 MEASURES, ANTIBIOTICS, AND ANTIINFECTIVES.— 

11 ‘‘(1) IN GENERAL.—Except as provided in para12 graph (2), with respect to a drug that is designated 

13 under section 526 for a rare disease or condition, 

14 the period referred to in this section is deemed to be 

15 10 years in lieu of 7 years if— 

16 ‘‘(A) such rare disease or condition is di17 rectly caused by a— 

18 ‘‘(i)(I) biological agent (including an 

19 organism that causes infectious disease); 

20 ‘‘(II) toxin; or 

21 ‘‘(III) chemical, radiological, or nu22 clear agent; and 

23 ‘‘(ii) such biological agent (including 

24 an organism that causes an infectious dis25 ease), toxin, or chemical, radiological or 


HMoore on PROD1PC68 with HMBILLS
28 

•S 2564 IS

1 nuclear agent, is identified as a material 

2 threat under subsection (c)(2)(A)(ii) of 

3 section 319F–2 of the Public Health Serv4 ice Act; 

5 ‘‘(B) such drug is determined by the Sec6 retary to be a security countermeasure under 

7 subsection (c)(1)(B) of such section 319F–2 

8 with respect to such agent or toxin; 

9 ‘‘(C) no active ingredient (including a salt 

10 or ester of the active ingredient) of the drug 

11 has been approved under an application under 

12 section 505(b) prior to the submission of the re13 quest for designation of the new drug under 

14 section 526; and 

15 ‘‘(D) notice respecting the designation of a 

16 drug under section 526 has been made available 

17 to the public. 

18 ‘‘(2) APPLICATION OF PROVISION.—Paragraph 

19 (1) shall apply with respect to an antibiotic drug or 

20 antiinfective drug designated under section 526 only 

21 if— 

22 ‘‘(A) no active ingredient (including a salt 

23 or ester of the active ingredient) of such drug 

24 has been approved as a feed or water additive 

25 for an animal in the absence of any clinical sign 


HMoore on PROD1PC68 with HMBILLS
29 

•S 2564 IS

1 of disease in the animal for growth promotion, 

2 feed efficiency, weight gain, routine disease pre3 vention, or other routine purpose; 

4 ‘‘(B) no active ingredient (including a salt 

5 or ester of the active ingredient) of such drug 

6 has been approved for use in humans under 

7 section 505 or approved for human use under 

8 section 507 (as in effect prior to November 21, 

9 1997) prior to the submission of the request for 

10 designation of the new drug under section 526; 

11 ‘‘(C) the Secretary has made a determina12 tion that— 

13 ‘‘(i) such drug is not a member of a 

14 class of antibiotics that is particularly 

15 prone to creating antibiotic resistance; 

16 ‘‘(ii) sufficient antibiotics do not al17 ready exist in the same class; 

18 ‘‘(iii) such drug represents a signifi19 cant clinical improvement over other anti20 biotic drugs; 

21 ‘‘(iv) such drug is for a serious or life22 threatening disease or conditions; and 

23 ‘‘(v) such drug is for a counter24 measure use; and 


HMoore on PROD1PC68 with HMBILLS
30 

•S 2564 IS

1 ‘‘(D) notice respecting the designation of a 

2 drug under section 526 has been made available 

3 to the public. 

4 ‘‘(3) RULE OF CONSTRUCTION.—With respect 

5 to a drug to which this subsection applies, and which 

6 is also approved for additional uses to which this 

7 subsection does not apply, nothing in section 

8 505(b)(2) or 505(j) shall prohibit the Secretary from 

9 approving a drug under section 505(b)(2) or 505(j) 

10 with different or additional labeling for the drug as 

11 the Secretary deems necessary to ensure that the 

12 drug is safe and effective for the uses to which this 

13 subsection does not apply. 

14 ‘‘(4) STUDY AND REPORT.—Not later than Jan15 uary 1, 2011, the Comptroller General of the United 

16 States shall conduct a study and submit to Congress 

17 a report concerning the effect of and activities under 

18 this subsection. Such study and report shall examine 

19 all relevant issues including— 

20 ‘‘(A) the effectiveness of this subsection in 

21 improving the availability of novel counter22 measures for procurement under section 319F– 

23 2 of the Public Health Service Act; 

24 ‘‘(B) the effectiveness of this subsection in 

25 improving the availability of drugs that treat 


HMoore on PROD1PC68 with HMBILLS
31 

•S 2564 IS

1 serious or life threatening diseases or conditions 

2 and offer significant clinical improvements; 

3 ‘‘(C) the continued need for additional in4 centives to create more antibiotics and 

5 antiinfectives; 

6 ‘‘(D) the economic impact of the section on 

7 taxpayers and consumers, including— 

8 ‘‘(i) the economic value of additional 

9 drugs provided for under this subsection, 

10 including the impact of improved health 

11 care and hospitalization times associated 

12 with treatment of nosocomial infections; 

13 and 

14 ‘‘(ii) the economic cost of any delay in 

15 the availability of lower cost generic drugs 

16 on patients, the insured, and Federal and 

17 private health plans; 

18 ‘‘(E) the adequacy of limits under subpara19 graphs (A) and (B) of paragraph (2) to maxi20 mize the useful period during which antibiotic 

21 drugs or antiinfective drugs remain therapeuti22 cally useful treatments; and 

23 ‘‘(F) any recommendations for modifica24 tions to this subsection that the Comptroller de25 termines to be appropriate. 


HMoore on PROD1PC68 with HMBILLS
32 

•S 2564 IS

1 ‘‘(5) EFFECTIVE DATE.—This subsection shall 

2 apply only to products for which an applicant has 

3 applied for designation under section 526 after the 

4 date of enactment of the Biodefense and Pandemic 

5 Vaccine and Drug Development Act of 2006. 

6 ‘‘(6) SUNSET.—This subsection shall not apply 

7 with respect to any designation of a drug under sec8 tion 526 made by the Secretary on or after October 

9 1, 2011.’’. 

10 SEC. 6. TECHNICAL ASSISTANCE. 

11 Subchapter E of chapter V of the Federal Food, 

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

13 amended by adding at the end the following: 

14 ‘‘SEC. 565. TECHNICAL ASSISTANCE. 

15 ‘‘The Secretary, in consultation with the Commis16 sioner of Food and Drugs, shall establish within the Food 

17 and Drug Administration a team of experts on manufac18 turing and regulatory activities (including compliance with 

19 current Good Manufacturing Practice) to provide both off20 site and on-site technical assistance to the manufacturers 

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

22 1 of the Public Health Service Act), security counter23 measures (as defined in section 319F–2 of such Act), or 

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

25 the discretion of the Secretary, if the Secretary determines 


HMoore on PROD1PC68 with HMBILLS
33 

•S 2564 IS

1 that a shortage or potential shortage may occur in the 

2 United States in the supply of such vaccines or counter3 measures and that the provision of such assistance would 

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

5 SEC. 7. COLLABORATION AND COORDINATION. 

6 (a) LIMITED ANTITRUST EXEMPTION.— 

7 (1) MEETINGS AND CONSULTATIONS TO DIS8 CUSS SECURITY COUNTERMEASURES, QUALIFIED

9 COUNTERMEASURES, OR QUALIFIED PANDEMIC OR

10 EPIDEMIC PRODUCT DEVELOPMENT.— 

11 (A) AUTHORITY TO CONDUCT MEETINGS

12 AND CONSULTATIONS.—The Secretary of 

13 Health and Human Services (referred to in this 

14 subsection as the ‘‘Secretary’’), in coordination 

15 with the Attorney General and the Secretary of 

16 Homeland Security, may conduct meetings and 

17 consultations with persons engaged in the devel18 opment of a security countermeasure (as de19 fined in section 319F–2 of the Public Health 

20 Service Act (42 U.S.C. 247d–6b)) (as amended 

21 by this Act), a qualified countermeasure (as de22 fined in section 319F–1 of the Public Health 

23 Service Act (42 U.S.C. 247d–6a)) (as amended 

24 by this Act), or a qualified pandemic or epi25 demic product (as defined in section 319F–3 of 


HMoore on PROD1PC68 with HMBILLS
34 

•S 2564 IS

1 the Public Health Service Act (42 U.S.C. 

2 247d–6d)) for the purpose of the development, 

3 manufacture, distribution, purchase, or storage 

4 of a countermeasure or product. The Secretary 

5 may convene such meeting or consultation at 

6 the request of the Secretary of Homeland Secu7 rity, the Attorney General, the Chairman of the 

8 Federal Trade Commission (referred to in this 

9 section as the ‘‘Chairman’’), or any interested 

10 person, or upon initiation by the Secretary. The 

11 Secretary shall give prior notice of any such 

12 meeting or consultation, and the topics to be 

13 discussed, to the Attorney General, the Chair14 man, and the Secretary of Homeland Security. 

15 (B) MEETING AND CONSULTATION CONDI16 TIONS.—A meeting or consultation conducted 

17 under subparagraph (A) shall— 

18 (i) be chaired or, in the case of a con19 sultation, facilitated by the Secretary; 

20 (ii) be open to persons involved in the 

21 development, manufacture, distribution, 

22 purchase, or storage of a countermeasure 

23 or product, as determined by the Sec24 retary; 


HMoore on PROD1PC68 with HMBILLS
35 

•S 2564 IS

1 (iii) be open to the Attorney General, 

2 the Secretary of Homeland Security, and 

3 the Chairman; 

4 (iv) be limited to discussions involving 

5 covered activities; and 

6 (v) be conducted in such manner as to 

7 ensure that no national security, confiden8 tial commercial, or proprietary information 

9 is disclosed outside the meeting or con10 sultation. 

11 (C) LIMITATION.—The Secretary may not 

12 require participants to disclose confidential 

13 commercial or proprietary information. 

14 (D) TRANSCRIPT.—The Secretary shall 

15 maintain a complete verbatim transcript of each 

16 meeting or consultation conducted under this 

17 subsection, which shall not be disclosed under 

18 section 552 of title 5, United States Code, un19 less such Secretary, in consultation with the At20 torney General and the Secretary of Homeland 

21 Security, determines that disclosure would pose 

22 no threat to national security. The determina23 tion regarding possible threats to national secu24 rity shall not be subject to judicial review. 

25 (E) EXEMPTION.— 


HMoore on PROD1PC68 with HMBILLS
36 

•S 2564 IS

1 (i) IN GENERAL.—Subject to clause 

2 (ii), it shall not be a violation of the anti3 trust laws for any person to participate in 

4 a meeting or consultation conducted in ac5 cordance with this paragraph. 

6 (ii) LIMITATION.—Clause (i) shall not 

7 apply to any agreement or conduct that re8 sults from a meeting or consultation and 

9 that is not covered by an exemption grant10 ed under paragraph (4). 

11 (2) SUBMISSION OF WRITTEN AGREEMENTS.— 

12 The Secretary shall submit each written agreement 

13 regarding covered activities that is made pursuant to 

14 meetings or consultations conducted under para15 graph (1) to the Attorney General and the Chairman 

16 for consideration. In addition to the proposed agree17 ment itself, any submission shall include— 

18 (A) an explanation of the intended purpose 

19 of the agreement; 

20 (B) a specific statement of the substance 

21 of the agreement; 

22 (C) a description of the methods that will 

23 be utilized to achieve the objectives of the 

24 agreement; 


HMoore on PROD1PC68 with HMBILLS
37 

•S 2564 IS

1 (D) an explanation of the necessity for a 

2 cooperative effort among the particular partici3 pating persons to achieve the objectives of the 

4 agreement; and 

5 (E) any other relevant information deter6 mined necessary by the Attorney General, in 

7 consultation with the Chairman and the Sec8 retary. 

9 (3) EXEMPTION FOR CONDUCT UNDER AP10 PROVED AGREEMENT.—It shall not be a violation of 

11 the antitrust laws for a person to engage in conduct 

12 in accordance with a written agreement to the extent 

13 that such agreement has been granted an exemption 

14 under paragraph (4), during the period for which 

15 the exemption is in effect. 

16 (4) ACTION ON WRITTEN AGREEMENTS.— 

17 (A) IN GENERAL.—The Attorney General, 

18 in consultation with the Chairman, shall grant, 

19 deny, grant in part and deny in part, or pro20 pose modifications to an exemption request re21 garding a written agreement submitted under 

22 paragraph (2), in a written statement to the 

23 Secretary, within 15 business days of the re24 ceipt of such request. An exemption granted 


HMoore on PROD1PC68 with HMBILLS
38 

•S 2564 IS

1 under this paragraph shall take effect imme2 diately. 

3 (B) EXTENSION.—The Attorney General 

4 may extend the 15-day period referred to in 

5 subparagraph (A) for an additional period of 

6 not to exceed 10 business days. 

7 (C) DETERMINATION.—An exemption shall 

8 be granted regarding a written agreement sub9 mitted in accordance with paragraph (2) only to 

10 the extent that the Attorney General, in con11 sultation with the Chairman and the Secretary, 

12 finds that the conduct that will be exempted 

13 will not have any substantial anticompetitive ef14 fect that is not reasonably necessary for ensur15 ing the availability of the countermeasure or 

16 product involved. 

17 (5) LIMITATION ON AND RENEWAL OF EXEMP18 TIONS.—An exemption granted under paragraph (4) 

19 shall be limited to covered activities, and such ex20 emption shall be renewed (with modifications, as ap21 propriate, consistent with the finding described in 

22 paragraph (4)(C)), on the date that is 3 years after 

23 the date on which the exemption is granted unless 

24 the Attorney General in consultation with the Chair25 man determines that the exemption should not be 


HMoore on PROD1PC68 with HMBILLS
39 

•S 2564 IS

1 renewed (with modifications, as appropriate) consid2 ering the factors described in paragraph (4). 

3 (6) AUTHORITY TO OBTAIN INFORMATION.— 

4 Consideration by the Attorney General for granting 

5 or renewing an exemption submitted under this sec6 tion shall be considered an antitrust investigation for 

7 purposes of the Antitrust Civil Process Act (15 

8 U.S.C. 1311 et seq.). 

9 (7) LIMITATION ON PARTIES.—The use of any 

10 information acquired under an agreement for which 

11 an exemption has been granted under paragraph (4), 

12 for any purpose other than specified in the exemp13 tion, shall be subject to the antitrust laws and any 

14 other applicable laws. 

15 (8) REPORT.—Not later than one year after the 

16 date of enactment of this Act and biannually there17 after, the Attorney General and the Chairman shall 

18 report to Congress on the use of the exemption from 

19 the antitrust laws provided by this subsection. 

20 (b) SUNSET.—The applicability of this section shall 

21 expire at the end of the 6-year period that begins on the 

22 date of enactment of this Act. 

23 (c) DEFINITIONS.—In this section: 

24 (1) ANTITRUST LAWS.—The term ‘‘antitrust 

25 laws’’— 


HMoore on PROD1PC68 with HMBILLS
40 

•S 2564 IS

1 (A) has the meaning given such term in 

2 subsection (a) of the first section of the Clayton 

3 Act (15 U.S.C. 12(a)), except that such term 

4 includes section 5 of the Federal Trade Com5 mission Act (15 U.S.C. 45) to the extent such 

6 section 5 applies to unfair methods of competi7 tion; and 

8 (B) includes any State law similar to the 

9 laws referred to in subparagraph (A). 

10 (2) COUNTERMEASURE OR PRODUCT.—The 

11 term ‘‘countermeasure or product’’ refers to a secu12 rity countermeasure, qualified countermeasure, or 

13 qualified pandemic or epidemic product (as those 

14 terms are defined in subsection (a)(1)). 

15 (3) COVERED ACTIVITIES.— 

16 (A) IN GENERAL.—Except as provided in 

17 subparagraph (B), the term ‘‘covered activities’’ 

18 includes any activity relating to the develop19 ment, manufacture, distribution, purchase, or 

20 storage of a countermeasure or product. 

21 (B) EXCEPTION.—The term ‘‘covered ac22 tivities’’ shall not include, with respect to a 

23 meeting or consultation conducted under sub24 section (a)(1) or an agreement for which an ex25 emption has been granted under subsection 


HMoore on PROD1PC68 with HMBILLS
41 

•S 2564 IS

1 (a)(4), the following activities involving 2 or 

2 more persons: 

3 (i) Exchanging information among 

4 competitors relating to costs, profitability, 

5 or distribution of any product, process, or 

6 service if such information is not reason7 ably necessary to carry out covered activi8 ties— 

9 (I) with respect to a counter10 measure or product regarding which 

11 such meeting or consultation is being 

12 conducted; or 

13 (II) that are described in the 

14 agreement as exempted. 

15 (ii) Entering into any agreement or 

16 engaging in any other conduct— 

17 (I) to restrict or require the sale, 

18 licensing, or sharing of inventions, de19 velopments, products, processes, or 

20 services not developed through, pro21 duced by, or distributed or sold 

22 through such covered activities; or 

23 (II) to restrict or require partici24 pation, by any person participating in 

25 such covered activities, in other reVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
42 

•S 2564 IS

1 search and development activities, ex2 cept as reasonably necessary to pre3 vent the misappropriation of propri4 etary information contributed by any 

5 person participating in such covered 

6 activities or of the results of such cov7 ered activities. 

8 (iii) Entering into any agreement or 

9 engaging in any other conduct allocating a 

10 market with a competitor that is not ex11 pressly exempted from the antitrust laws 

12 under subsection (a)(4). 

13 (iv) Exchanging information among 

14 competitors relating to production (other 

15 than production by such covered activities) 

16 of a product, process, or service if such in17 formation is not reasonably necessary to 

18 carry out such covered activities. 

19 (v) Entering into any agreement or 

20 engaging in any other conduct restricting, 

21 requiring, or otherwise involving the pro22 duction of a product, process, or service 

23 that is not expressly exempted from the 

24 antitrust laws under subsection (a)(4). 


HMoore on PROD1PC68 with HMBILLS
43 

•S 2564 IS

1 (vi) Except as otherwise provided in 

2 this subsection, entering into any agree3 ment or engaging in any other conduct to 

4 restrict or require participation by any per5 son participating in such covered activities, 

6 in any unilateral or joint activity that is 

7 not reasonably necessary to carry out such 

8 covered activities. 

9 (vii) Entering into any agreement or 

10 engaging in any other conduct restricting 

11 or setting the price at which a counter12 measure or product is offered for sale, 

13 whether by bid or otherwise. 

14 SEC. 8. PROCUREMENT. 

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

16 U.S.C. 247d–6b) is amended— 

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

18 SECURITY COUNTERMEASURE PROCURE19 MENTS’’ before the period; and 

20 (2) in subsection (c)— 

21 (A) in the subsection heading, by striking 

22 ‘‘BIOMEDICAL’’; 

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

24 meet the needs of the stockpile’’ and inserting 

25 ‘‘to meet the stockpile needs’’; 


HMoore on PROD1PC68 with HMBILLS
44 

•S 2564 IS

1 (C) in paragraph (7)(B)— 

2 (i) by striking the subparagraph head3 ing and all that follows through ‘‘Home4 land Security Secretary’’ and inserting the 

5 following: ‘‘INTERAGENCY AGREEMENT; 

6 COST.—The Homeland Security Sec7 retary’’; and 

8 (ii) by striking clause (ii); 

9 (D) in paragraph (7)(C)(ii)— 

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

11 follows: 

12 ‘‘(I) PAYMENT CONDITIONED ON

13 DELIVERY.—The contract shall pro14 vide that no payment may be made 

15 until delivery of a portion, acceptable 

16 to the Secretary, of the total number 

17 of units contracted for, except that, 

18 notwithstanding any other provision of 

19 law, the contract may provide that, if 

20 the Secretary determines (in the Sec21 retary’s discretion) that an advance 

22 payment, partial payment for signifi23 cant milestones, or payment to in24 crease manufacturing capacity is nec25 essary to ensure success of a project, 


HMoore on PROD1PC68 with HMBILLS
45 

•S 2564 IS

1 the Secretary shall pay an amount, 

2 not to exceed 10 percent of the con3 tract amount, in advance of delivery. 

4 The Secretary shall, to the extent 

5 practicable, make the determination of 

6 advance payment at the same time as 

7 the issuance of a solicitation. The con8 tract shall provide that such advance 

9 payment is required to be repaid if 

10 there is a failure to perform by the 

11 vendor under the contract. The con12 tract may also provide for additional 

13 advance payments of 5 percent each 

14 for meeting the milestones specified in 

15 such contract. Provided that the spec16 ified milestones are reached, these ad17 vanced payments of 5 percent shall 

18 not be required to be repaid. Nothing 

19 in this subclause shall be construed as 

20 affecting the rights of vendors under 

21 provisions of law or regulation (in22 cluding the Federal Acquisition Regu23 lation) relating to the termination of 

24 contracts for the convenience of the 

25 Government.’’; and 


HMoore on PROD1PC68 with HMBILLS
46 

•S 2564 IS

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

3 ‘‘(VII) SALES EXCLUSIVITY.— 

4 The contract may provide that the 

5 vendor is the exclusive supplier of the 

6 product to the Federal Government 

7 for a specified period of time, not to 

8 exceed the term of the contract, on 

9 the condition that the vendor is able 

10 to satisfy the needs of the Govern11 ment. During the agreed period of 

12 sales exclusivity, the vendor shall not 

13 assign its rights of sales exclusivity to 

14 another entity or entities without ap15 proval by the Secretary. Such a sales 

16 exclusivity provision in such a con17 tract shall constitute a valid basis for 

18 a sole source procurement under sec19 tion 303(c)(1) of the Federal Property 

20 and Administrative Services Act of 

21 1949 (41 U.S.C. 253(c)(1)). 

22 ‘‘(VIII) SURGE CAPACITY.—The 

23 contract may provide that the vendor 

24 establish domestic manufacturing ca25 pacity of the product to ensure that 


HMoore on PROD1PC68 with HMBILLS
47 

•S 2564 IS

1 additional production of the product is 

2 available in the event that the Sec3 retary determines that there is a need 

4 to quickly purchase additional quan5 tities of the product. Such contract 

6 may provide a fee to the vendor for 

7 establishing and maintaining such ca8 pacity in excess of the initial require9 ment for the purchase of the product. 

10 Additionally, the cost of maintaining 

11 the domestic manufacturing capacity 

12 shall be an allowable and allocable di13 rect cost of the contract. 

14 ‘‘(IX) CONTRACT TERMS.—The 

15 Secretary, in any contract for procure16 ment under this section, may speci17 fy— 

18 ‘‘(aa) the dosing and admin19 istration requirements for coun20 termeasures to be developed and 

21 procured; 

22 ‘‘(bb) the amount of funding 

23 that will be dedicated by the Sec24 retary for development and acVerDate Aug 31 2005 05:25 Apr 08, 2006 Jkt 049200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\S2564.IS S2564

HMoore on PROD1PC68 with HMBILLS
48 

•S 2564 IS

1 quisition of the countermeasure; 

2 and 

3 ‘‘(cc) the specifications the 

4 countermeasure must meet to 

5 qualify for procurement under a 

6 contract under this section.’’; and 

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

8 end the following: ‘‘Such agreements may allow 

9 other executive agencies to order qualified and 

10 security countermeasures under procurement 

11 contracts or other agreements established by 

12 the Secretary. Such ordering process (including 

13 transfers of appropriated funds between an 

14 agency and the Department of Health and 

15 Human Services as reimbursements for such or16 ders for countermeasures) may be conducted 

17 under the authority of section 1535 of title 31, 

18 United States Code, except that all such orders 

19 shall be processed under the terms established 

20 under this section for the procurement of coun21 termeasures.’’. 

22 SEC. 9. RULE OF CONSTRUCTION. 

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

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

25 the National Vaccine Injury Compensation Program under 


HMoore on PROD1PC68 with HMBILLS
49 

•S 2564 IS

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

2 300aa–1 et seq.), including such laws regarding— 

3 (1) whether claims may be filed or compensa4 tion may be paid for a vaccine-related injury or 

5 death under such Program; 

6 (2) claims pending under such Program; and 

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

8 before the United States Court of Federal Claims 

9 pursuant to such title. 

Æ 


HMoore on PROD1PC68 with HMBILLS