II 

109TH CONGRESS 

1ST SESSION S. 1873 

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 

OCTOBER 17, 2005 

Mr. BURR (for himself, Mr. ENZI, Mr. GREGG, Mr. FRIST, and Mr. ALEXANDER) 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 2005’’. 

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 Agency. 

Sec. 4. Clarification of countermeasures covered by Project BioShield. 
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Sec. 5. Orphan drug market exclusivity for countermeasure products. 

Sec. 6. Liability protections for pandemics, epidemics, and countermeasures. 

Sec. 7. Compensation. 

Sec. 8. Rebates and grants for research development, and manufacturing of 

vaccines, qualified countermeasures and pandemic or epidemic 

products. 

Sec. 9. Technical assistance. 

Sec. 10. Animal models for certain diseases. 

Sec. 11. Animal Model/Research Tool Scientific Advisory Committee. 

Sec. 12. Collaboration and coordination. 

Sec. 13. Procurement. 

Sec. 14. National Pathology Center. 

1 SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOP2 MENT AGENCY. 

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

4 241 et seq.) is amended by inserting after section 319K 

5 the following: 

6 ‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DE7 VELOPMENT AGENCY. 

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

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

10 Biomedical Advanced Research and Development 

11 Agency. 

12 ‘‘(2) FUND.—The term ‘Fund’ means the Bio13 defense Medical Countermeasure Development Fund 

14 established under subsection (d). 

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

16 transactions’ means transactions, other than pro17 curement contracts, grants, and cooperative agree18 ments, including transactions for prototypes, as pro19 vided to the Secretary of Defense under section 

20 2371 of title 10, United States 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 COUNTERMEASURE AND

5 QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT AD6 VANCED RESEARCH AND DEVELOPMENT.— 

7 ‘‘(A) IN GENERAL.—The term ‘qualified 

8 countermeasure and qualified pandemic or epi9 demic product advanced research and develop10 ment’ means any applied research, testing, or 

11 evaluation (including those conducted on hu12 mans or animals), related to the safety or effec13 tiveness, that is required for approval, clear14 ance, or licensing by the Secretary under this 

15 Act or the Federal Food, Drug, and Cosmetic 

16 Act, of such countermeasure or pandemic or 

17 epidemic product to diagnose, mitigate, prevent, 

18 or treat harm from a deliberate, accidental, or 

19 natural exposure to a chemical, biological, radi20 ological, or nuclear agent, particularly such ex21 posure resulting from an act of terrorism or po22 tential pandemic infectious disease. 

23 ‘‘(B) INCLUSION.—The term under sub24 paragraph (A) includes any investigation to im25 prove the manufacturing, formulation, finish, 
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1 fill, delivery, or shelf-life of such qualified coun2 termeasures or qualified pandemic or epidemic 

3 products. 

4 ‘‘(6) 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(c)(5). 

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

9 ‘security countermeasure’ has the meaning given 

10 such term in section 319F–2. 

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

12 individual, partnership, corporation, association, en13 tity, or public or private corporation, including a 

14 Federal, State, or local agency or department. 

15 ‘‘(b) BIOMEDICAL ADVANCED RESEARCH AND DE16 VELOPMENT AGENCY.— 

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

18 within the Department of Health and Human Serv19 ices, the Biomedical Advanced Research and Devel20 opment Agency. 

21 ‘‘(2) PURPOSE.—It shall be the purpose of the 

22 BARDA to coordinate and oversee activities that 

23 support and accelerate qualified countermeasure or 

24 qualified pandemic or epidemic product (referred to 
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1 in this section as ‘countermeasure or product’) ad2 vanced research and development by— 

3 ‘‘(A) directing and coordinating collabora4 tion among the Department of Health and 

5 Human Services, other Federal agencies, rel6 evant industries, academia, and other persons, 

7 with respect to such advanced research and de8 velopment; 

9 ‘‘(B) supporting countermeasure and prod10 uct advanced research and development; 

11 ‘‘(C) recommending approaches to mod12 ernize and streamline the countermeasure or 

13 product development process and reduce regu14 latory burdens with respect to procurement of 

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

17 ‘‘(D) supporting innovation to reduce the 

18 time and cost of countermeasure and product 

19 advanced research and development. 

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

21 by a Director (referred to in this section as the ‘Di22 rector’) who shall— 

23 ‘‘(A) be appointed by the President, with 

24 the advice and consent of the Senate; 

25 ‘‘(B) report to the Secretary; and 
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1 ‘‘(C) serve as the principal advisor to the 

2 Secretary on countermeasure and product ad3 vanced research and development. 

4 ‘‘(4) DUTIES OF DIRECTOR.— 

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

6 purpose described in paragraph (2)(A), the Sec7 retary, acting through the Director, shall— 

8 ‘‘(i) increase appropriate communica9 tion between the Federal Government and 

10 relevant industries, academia, and other 

11 interested persons with respect to counter12 measure and product advanced research 

13 and development by establishing trans14 parent, expeditious, and direct processes 

15 to— 

16 ‘‘(I) facilitate regular, ongoing 

17 communication regarding the proc18 esses established under subparagraph 

19 (C)(ii) and new countermeasures or 

20 products of interest; 

21 ‘‘(II) solicit research and associ22 ated data on potential counter23 measures and products and related 

24 technologies; and 
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1 ‘‘(III) provide technical assist2 ance with respect to such processes 

3 and the Food and Drug Administra4 tion approval process; 

5 ‘‘(ii) at least annually— 

6 ‘‘(I) convene meetings with rep7 resentatives from relevant industries, 

8 academia, other Federal agencies, 

9 international agencies, and other in10 terested persons; and 

11 ‘‘(II) sponsor relevant biodefense 

12 countermeasure technology dem13 onstrations; 

14 ‘‘(iii) carry out the activities described 

15 in subsection (g) of section 2 of the Clay16 ton Act; and 

17 ‘‘(iv) encourage and coordinate coun18 termeasure or product advanced research 

19 and development, including by convening 

20 working groups as identified in paragraph 

21 (5). 

22 ‘‘(B) SUPPORT ADVANCED RESEARCH AND

23 DEVELOPMENT.—To carry out the purpose de24 scribed in paragraph (2)(B), the Secretary, act25 ing through the Director, shall— 
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1 ‘‘(i) conduct continuous searches and 

2 support calls for potential countermeasures 

3 or products for drugs, biological products, 

4 devices, or research tools to diagnose, miti5 gate, prevent, or treat harm from existing, 

6 emerging, or possible chemical, biological, 

7 radiological, and nuclear agents or poten8 tial pandemic infectious diseases that 

9 threaten public health and national secu10 rity, as identified by the Assistant Sec11 retary for Public Health Emergency Pre12 paredness; 

13 ‘‘(ii) direct the countermeasure and 

14 product advanced research and develop15 ment activities of the Department of 

16 Health and Human Services, in consulta17 tion with the Assistant Secretary for Pub18 lic Health Emergency Preparedness, the 

19 Director of the National Institutes of 

20 Health, the Director of the Centers for the 

21 Disease Control and Prevention, and the 

22 Commissioner of Food and Drugs; and 

23 ‘‘(iii) award contracts, grants, cooper24 ative agreements, and enter into other 

25 transactions, to include use of simplified 
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1 acquisition authorities provided under sec2 tions 319F–1 and 319F–2(c)(7)(C)(iii), to 

3 public and private persons, including for4 profit and nonprofit persons, federally 

5 funded research and development centers, 

6 and universities, to— 

7 ‘‘(I) support the cost of counter8 measure and product advanced re9 search and development; and 

10 ‘‘(II) ensure accelerated develop11 ment of countermeasures and prod12 ucts. 

13 ‘‘(C) STREAMLINE PROCESSES.—To carry 

14 out the purpose described in paragraph (2)(C), 

15 the Secretary, acting through the Director, 

16 shall— 

17 ‘‘(i) receive from the Assistant Sec18 retary for Public Health Emergency Pre19 paredness, requirements for national civil20 ian biodefense needs, particularly counter21 measures or products and other tech22 nologies, to diagnose, mitigate, prevent, or 

23 treat harm from existing, emerging, or po24 tential chemical, biological, radiological, or 
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1 nuclear agents or potential pandemic infec2 tious diseases; 

3 ‘‘(ii) establish transparent, expedi4 tious, and direct processes for selecting 

5 promising countermeasures and products, 

6 supporting them through advanced re7 search and development and recommending 

8 them for procurement; 

9 ‘‘(iii) establish an office within the 

10 BARDA, in consultation with the Commis11 sioner of Food and Drugs, to— 

12 ‘‘(I) facilitate regular and ongo13 ing communication between the 

14 BARDA and the Food and Drug Ad15 ministration regarding the status of 

16 BARDA advanced research and devel17 opment activities; 

18 ‘‘(II) ensure that such activities 

19 are coordinated with the approval re20 quirements of the Food and Drug Ad21 ministration, with the goal of expe22 diting the development and approval 

23 of countermeasures and products; and 

24 ‘‘(III) connect interested persons 

25 with additional technical assistance 
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1 made available under section 565 of 

2 the Federal Food, Drug, and Cos3 metic Act; 

4 ‘‘(iv) coordinate with the Food and 

5 Drug Administration to facilitate regu6 latory review and approval of promising 

7 classes of countermeasures or products 

8 through the development of research tools; 

9 and 

10 ‘‘(v) recommend to the Secretary, 

11 through the Assistant Secretary for Public 

12 Health Emergency Preparedness, procure13 ment of the most promising eligible secu14 rity countermeasures or qualified pandemic 

15 or epidemic products identified in clause 

16 (i). 

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

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

19 the Secretary, acting through the Director, 

20 shall award contracts, grants, cooperative 

21 agreements, or enter into other transactions, to 

22 include use of simplified acquisition authorities 

23 provided under sections 319F–1 and 319F– 

24 2(c)(7)(C)(iii), to the entities described in sub25 paragraph (B)(iii), to promote innovation in 
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1 technologies supporting the advanced research 

2 and development and production of qualified or 

3 security countermeasures or qualified pandemic 

4 or epidemic products, such as research tools, 

5 manufacturing, countermeasure administration, 

6 storage, and bioinformatics and other devices. 

7 ‘‘(E) OTHER DUTIES.— 

8 ‘‘(i) IN GENERAL.—The Director 

9 may— 

10 ‘‘(I) prepare and submit to the 

11 President and Congress, an annual 

12 budget estimate for qualified counter13 measure and pandemic or epidemic 

14 product advanced research and devel15 opment and other BARDA activities, 

16 after opportunity for comment by the 

17 Secretary; and 

18 ‘‘(II) receive from the President 

19 and the Office of Management and 

20 Budget directly all funds appropriated 

21 by Congress for obligation and ex22 penditure by the BARDA. 

23 ‘‘(ii) SECRETARY DUTIES.—The Sec24 retary, acting through the Director, may— 
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1 ‘‘(I) enter into such contracts, 

2 leases, cooperative agreements, or 

3 other transactions, as may be nec4 essary to carry out the functions of 

5 BARDA, without regard to section 

6 3648 and 3709 of the Revised Stat7 utes of the United States (31 U.S.C. 

8 3324(a) and (b)), (41 U.S.C. 5), with 

9 any public agency, any firm, associa10 tion, corporation, or educational insti11 tution, or any other person; 

12 ‘‘(II) support advanced research 

13 and development and innovation of 

14 potential countermeasures or products 

15 by highly qualified foreign nationals 

16 outside the United States that may 

17 inure to the benefit of the American 

18 people and collaborative research in19 volving American and foreign partici20 pants; 

21 ‘‘(III) administer grants using 

22 milestone-based awards and pay23 ments; and 

24 ‘‘(IV) establish 1 or more feder25 ally funded research and development 
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1 centers or university affiliated re2 search centers in accordance with sec3 tion 253(c)(3) of title 41, United 

4 States Code. 

5 ‘‘(5) VULNERABLE POPULATIONS.—In carrying 

6 out the activities under this section, the Director, in 

7 consultation with the Vulnerable Populations Work8 ing Group, may give priority to supporting and fa9 cilitating advanced research and development of 

10 countermeasures or products, and formulations of 

11 countermeasures or products, that are likely to be 

12 safe and effective for pediatric populations, pregnant 

13 women, and other vulnerable populations. 

14 ‘‘(6) WORKING GROUPS.— 

15 ‘‘(A) IDENTIFICATION OF TECH16 NOLOGIES.— 

17 ‘‘(i) IN GENERAL.—The Director may 

18 establish and convene, or enter into a con19 tract with a public or private research in20 stitution to convene, one or more working 

21 groups that consists of experts on counter22 measure technology to identify innovative 

23 technologies that have the potential to be 

24 developed as countermeasures or products. 
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1 ‘‘(ii) MEETINGS.—A working group 

2 established under clause (i) shall partici3 pate in regular meetings with sponsors of 

4 countermeasures, products, or related tech5 nologies to— 

6 ‘‘(I) review the scientific evidence 

7 or concept of such countermeasures, 

8 products, or related technologies; 

9 ‘‘(II) provide guidance on re10 search protocols or studies; and 

11 ‘‘(III) provide guidance on the 

12 regulatory approval process for coun13 termeasures, products, and related 

14 technologies. 

15 ‘‘(iii) RECOMMENDATIONS.—Not later 

16 than 30 days after each meeting with a 

17 sponsor of a countermeasure, product, or 

18 related technology, the working group shall 

19 make recommendations to the Director 

20 concerning such countermeasure, product, 

21 or related technology. 

22 ‘‘(iv) CONFIDENTIALITY.—Any com23 mercial confidential or proprietary infor24 mation that is disclosed to the working 

25 group in a meeting under this section shall 
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1 remain confidential and shall not be dis2 closed other than to the Secretary or the 

3 Director, or their designees. 

4 ‘‘(v) CONSTRUCTION.—Nothing in 

5 this subparagraph shall be construed to 

6 prohibit a sponsor from meeting with the 

7 Director to discuss potential counter8 measures, products, or related tech9 nologies. 

10 ‘‘(B) PUBLIC WORKING GROUP.—The Di11 rector may establish and convene one or more 

12 working groups composed of private citizens 

13 and officials of Federal, State, and local govern14 ments to advise such Director with respect to 

15 the functions of the BARDA and the Director. 

16 ‘‘(C) VULNERABLE POPULATIONS WORK17 ING GROUP.—The Director shall establish and 

18 convene a Vulnerable Populations Working 

19 Group composed of experts on pediatric popu20 lations, pregnant women, and other vulnerable 

21 populations to advise such Director with respect 

22 to— 

23 ‘‘(i) supporting and facilitating ad24 vanced research and development of coun25 termeasures, and formulations of counter-
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1 measures, that are safe and effective for 

2 such populations; and 

3 ‘‘(ii) other activities of the BARDA 

4 that effect such populations. 

5 ‘‘(7) PERSONNEL AUTHORITIES.— 

6 ‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC

7 AND PROFESSIONAL PERSONNEL.—In hiring 

8 personnel for the BARDA, the Director shall 

9 have the hiring and management authorities de10 scribed in section 1101 of the Strom Thurmond 

11 National Defense Authorization Act for Fiscal 

12 Year 1999 (5 U.S.C. 3104 note; Public Law 

13 105–261). With respect to the personnel of the 

14 BARDA, the term of appointments for employ15 ees referred to under subsection (c)(1) of that 

16 section may not exceed 5 years before the 

17 granting of any extension under subsection 

18 (c)(2) of that section. 

19 ‘‘(B) SPECIAL CONSULTANTS.—The Direc20 tor may accept special consultants as personnel 

21 for the BARDA under section 207(f). 

22 ‘‘(C) INTERGOVERNMENTAL PERSONNEL

23 ACT.—The Director may accept as personnel 

24 for the BARDA, employees under subchapter 
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1 VI of chapter 33 of subpart B of part III of 

2 title 5, United States Code. 

3 ‘‘(D) OTHER SERVICES.—The Director 

4 may accept voluntary and uncompensated serv5 ices. 

6 ‘‘(c) NATIONAL BIODEFENSE ADVISORY BOARD.— 

7 ‘‘(1) IN GENERAL.— 

8 ‘‘(A) PURPOSE.—The National Biodefense 

9 Advisory Board shall provide expert advice and 

10 guidance to the Secretary on the threats, chal11 lenges, and opportunities presented by advances 

12 in biological and life sciences and the threat 

13 from natural infectious diseases and chemical, 

14 biological, radiological, and nuclear threats. 

15 ‘‘(B) MEMBERSHIP.—There is established 

16 the National Biodefense Advisory Board (here17 inafter in this section referred to as the 

18 ‘Board’) to be composed of 23 members who 

19 represent the Nation’s preeminent scientific, 

20 public health, and medical experts on the sub21 ject of biological, chemical, nuclear, and radio22 logical threats, whether naturally occurring, ac23 cidental, or deliberate, as follows: 
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1 ‘‘(i) EX OFFICIO.—The following 

2 members shall serve on the Board ex offi3 cio: 

4 ‘‘(I) The Assistant to the Presi5 dent for Homeland Security and 

6 Counterterrorism. 

7 ‘‘(II) The Director of the Office 

8 of Science and Technology Policy. 

9 ‘‘(III) The Assistant Secretary 

10 for Public Health Emergency Pre11 paredness. 

12 ‘‘(IV) The Director of the Na13 tional Institutes of Health. 

14 ‘‘(V) The Director of the Centers 

15 for Disease Control and Prevention. 

16 ‘‘(VI) The Commissioner of Food 

17 and Drugs. 

18 ‘‘(VII) The Director of BARDA. 

19 ‘‘(VIII) The Assistant Secretary 

20 of Defense for Health Affairs. 

21 ‘‘(IX) The Assistant Secretary of 

22 Homeland Security for Science and 

23 Technology. 

24 ‘‘(X) The Secretary of Agri25 culture (or a designee). 
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1 ‘‘(ii) APPOINTED MEMBERS.—The fol2 lowing individuals, as appointed by the 

3 Secretary: 

4 ‘‘(I) Four representatives of the 

5 pharmaceutical and biotechnology in6 dustries. 

7 ‘‘(II) Four representatives of aca8 demia. 

9 ‘‘(III) Five other members as de10 termined appropriate by the Sec11 retary. 

12 ‘‘(C) TERM OF APPOINTMENT.—A member 

13 of the Board described in subparagraph (B)(ii) 

14 shall serve for a term of 3 years, except that 

15 the Secretary may adjust the terms of the ini16 tial Board appointees in order to provide for a 

17 staggered term of appointment for all members. 

18 ‘‘(D) CONSECUTIVE APPOINTMENTS; MAX19 IMUM TERMS.—A member may be appointed to 

20 serve not more than 3 terms on the Board and 

21 may serve not more than 2 consecutive terms. 

22 ‘‘(2) DUTIES.—The Board shall— 

23 ‘‘(A) advise the Secretary on major bio24 defense initiatives and review ongoing and pro-
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1 posed biodefense programs, which may include 

2 potential activities of the BARDA; and 

3 ‘‘(B) in consultation with the Director of 

4 BARDA, and in coordination with the Director 

5 of National Institute of Allergy and Infectious 

6 Diseases, provide to the Secretary, rec7 ommendations and findings for an expanded, 

8 intensified, and coordinated biodefense research 

9 program encompassing the programs of the 

10 BARDA and other Federal agencies and related 

11 programs of the other research institutes. 

12 ‘‘(3) MEETINGS.—The Board shall meet at the 

13 call of the Secretary, but in no case less than twice 

14 annually to provide to the Secretary updated assess15 ments, findings, and recommendations of the current 

16 trends, challenges, and opportunities posed in bio17 technology and genetic engineering. 

18 ‘‘(4) VACANCIES.—Any vacancy in the Board 

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

20 same manner as the original appointment. 

21 ‘‘(5) CHAIRPERSON.—The Secretary shall ap22 point a chairperson from among the members of the 

23 Board. 

24 ‘‘(6) POWERS.— 
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1 ‘‘(A) HEARINGS.—The Board may hold 

2 such hearings, sit and act at such times and 

3 places, take such testimony, and receive such 

4 evidence as the Board considers advisable to 

5 carry out this subsection. 

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

7 use the United States mails in the same man8 ner and under the same conditions as other de9 partments and agencies of the Federal Govern10 ment. 

11 ‘‘(7) PERSONNEL.— 

12 ‘‘(A) OFFICERS OF THE FEDERAL GOV13 ERNMENT.—A member of the Board that is an 

14 employee of the Federal Government may not 

15 receive additional pay, allowances, or benefits 

16 by reason of the member’s service on the 

17 Board. 

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

19 Board that is not an employee of the Federal 

20 Government shall be compensated at a rate 

21 equivalent to the daily equivalent of the annual 

22 rate of basic pay prescribed for level IV of the 

23 Executive Schedule under section 5315 of title 

24 5, United States Code, for each day (including 

25 travel time) during which the member is en-
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1 gaged in the actual performance of duties as a 

2 member of the Board. 

3 ‘‘(C) TRAVEL EXPENSES.—Each member 

4 of the Board shall receive travel expenses, in5 cluding per diem in lieu of subsistence, in ac6 cordance with applicable provisions under sub7 chapter I of chapter 57 of title 5, United States 

8 Code. 

9 ‘‘(D) DETAIL OF GOVERNMENT EMPLOY10 EES.—Any Federal Government employee may 

11 be detailed to the Board without reimburse12 ment, and such detail shall be without interrup13 tion or loss of civil service status or privilege. 

14 ‘‘(d) FUND.— 

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

16 the Biodefense Medical Countermeasure Develop17 ment Fund, which shall be administered by the Di18 rector of the BARDA. 

19 ‘‘(2) FUNDS.— 

20 ‘‘(A) FIRST FISCAL YEAR.—Of the 

21 amounts appropriated to carry out the Project 

22 BioShield Act of 2004 (Public Law 108–276) 

23 and not obligated, $1,000,000,000 shall be 

24 available to the Fund to carry out this section 
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1 for fiscal year 2006. Such amounts shall remain 

2 available until expended. 

3 ‘‘(B) SUBSEQUENT FISCAL YEARS.—There 

4 are authorized to be appropriated such sums as 

5 may be necessary to carry out this section for 

6 fiscal year 2007 and each subsequent fiscal 

7 year. Such sums shall remain available until ex8 pended. 

9 ‘‘(e) EFFECT OF SECTION.—Nothing in this section 

10 shall be construed to limit any authority of the Depart11 ment of Health and Human Services, including those au12 thorities provided under the Project BioShield Act of 2004 

13 (Public Law 108–276). 

14 ‘‘(f) INAPPLICABILITY OF CERTAIN ACTS.— 

15 ‘‘(1) FACA.—The Federal Advisory Committee 

16 Act (5 U.S.C. App.) shall not apply to the duties, 

17 activities, working groups, and advisory boards of 

18 the BARDA. 

19 ‘‘(2) FOIA.—Information that relates to the ac20 tivities, working groups, and advisory boards of the 

21 BARDA shall not be subject to disclosure under sec22 tion 552 of title 5, United States Code, unless the 

23 Secretary or Director determines that such disclo24 sure would pose no threat to national security. Such 
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1 a determination shall not be subject to judicial re2 view. 

3 ‘‘(3) CERTAIN COST PRINCIPLES AND COST AC4 COUNTING STANDARDS.—Notwithstanding any other 

5 provision of law, the cost principles set forth under 

6 part 31 of title 48, Code of Federal Regulations, the 

7 cost accounting standards set forth under chapter 

8 99 of title 48, Code of Federal Regulations, and the 

9 requirement for the submission of certified cost and 

10 pricing information under section 304A of the Fed11 eral Property and Administrative Services Act of 

12 1949 (41 U.S.C. 254b), shall not apply to any con13 tract, grant, cooperative agreement, or other trans14 action entered into under the Project BioShield Act 

15 of 2004 (Public Law 108–276).’’. 

16 SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 

17 BY PROJECT BIOSHIELD. 

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

19 1(a) of the Public Health Service Act (42 U.S.C. 247d– 

20 6a(a)) is amended by striking paragraph (2) and inserting 

21 the following: 

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

23 ‘‘(A) QUALIFIED COUNTERMEASURE.—The 

24 term ‘qualified countermeasure’ means a drug 

25 (as that term is defined by section 201(g)(1) of 
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1 the Federal Food, Drug, and Cosmetic Act (21 

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

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

4 U.S.C. 262(i))), device (as that term is defined 

5 by section 201(h) of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 321(h))), or re7 search tool (as that term is defined in section 

8 201(rr) of the Federal Food, Drug, and Cos9 metic Act) that the Secretary determines to be 

10 a priority (consistent with sections 302(2) and 

11 304(a) of the Homeland Security Act of 2002) 

12 to— 

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

14 treat harm from any biological agent (in15 cluding organisms that cause an infectious 

16 disease) or toxins, chemical, radiological, 

17 or nuclear agent that may cause a public 

18 health emergency affecting national secu19 rity; 

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

21 treat harm from a condition that may re22 sult in adverse health consequences or 

23 death and may be caused by administering 

24 a drug, biological product, or device that is 

25 used as described in this subparagraph; or 
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1 ‘‘(iii) in the case of a research tool, 

2 enable the rapid and effective identifica3 tion, assessment, or development of a drug, 

4 biological product, or device to diagnose, 

5 mitigate, prevent, or treat harm, as de6 scribed in clause (i) or (ii). 

7 ‘‘(B) INFECTIOUS DISEASE.—The term ‘in8 fectious disease’ means a disease potentially 

9 caused by a pathogenic organism (including a 

10 bacteria, virus, fungus, or parasite) that is ac11 quired by a person and that reproduces in that 

12 person.’’. 

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

14 2(c)(1)(B) is amended by— 

15 (A) striking ‘‘treat, identify, or prevent’’ 

16 each place it appears and inserting ‘‘diagnose, 

17 mitigate, prevent, or treat’’; and 

18 (B) inserting ‘‘agent (including organisms 

19 that cause an infectious disease) or toxin’’ after 

20 ‘‘any biological’’. 

21 (c) RESEARCH TOOL.—Section 201 of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amend23 ed by adding at the end the following: 

24 ‘‘(rr) RESEARCH TOOL.—The term ‘research tool’ in25 cludes the full range of tools and systems that assist in 
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1 the discovery, development, or manufacture of drugs, bio2 logical products (as defined in section 351 of the Public 

3 Health Service Act), or devices.’’. 

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

6 (a) MARKET EXCLUSIVITY.—Subchapter A of chap7 ter V of the Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 351 et seq.) is amended by inserting after section 

9 505B the following: 

10 ‘‘SEC. 505C. ORPHAN DRUG MARKET EXCLUSIVITY FOR 

11 COUNTERMEASURE PRODUCTS. 

12 ‘‘(a) IN GENERAL.—With respect to countermeasure 

13 products (as such term is defined in this section), if a 

14 countermeasure product is designated under section 526 

15 for a rare disease or condition, the period referred to in 

16 section 527(a) shall be 10 years instead of 7 years. 

17 ‘‘(b) DEFINITION.—For the purpose of this section, 

18 the term ‘countermeasure’ means a drug or biological 

19 product (as such term is defined by section 351(i) of the 

20 Public Health Service Act) that the Secretary determines 

21 to be a priority (consistent with sections 302(2) and 

22 304(a) of the Homeland Security Act of 2002) to diag23 nose, mitigate, prevent, or treat harm from any biological, 

24 chemical, radiological, or nuclear agent (including orga25 nisms that cause an infectious disease) or toxin identified 
29 

•S 1873 IS 

1 as a material threat under subsection (c)(2)(A)(ii) of sec2 tion 319F–2 of the Public Health Service Act.’’. 

3 (b) ORPHAN DRUGS.—For purposes of section 526 

4 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

5 360bb) a biological, chemical, radiological, or nuclear 

6 agent (including organisms that cause an infectious dis7 ease) or toxin identified as a material threat under sub8 section (c)(2)(A)(ii) of section 319F–2 of the Public 

9 Health Service Act shall be considered to be a ‘‘rare dis10 ease or condition’’ within the meaning of such term in 

11 such section 526. The Secretary may designate antibiotics 

12 and anti-infective products that treat infectious diseases 

13 as designated drugs or biological products under such sec14 tion 526. 

15 (c) EFFECT OF SECTION.—This section, and the 

16 amendments made by this section, shall apply to new drug 

17 applications and biological product licenses approved 

18 under the Federal Food, Drug, and Cosmetic Act or the 

19 Public Health Service Act after the date of enactment of 

20 this Act. 

21 SEC. 6. LIABILITY PROTECTIONS FOR PANDEMICS, 

22 EPIDEMICS, AND COUNTERMEASURES. 

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

24 is amended by inserting after section 319F–2 (42 U.S.C. 

25 247d–6b) the following: 
30 

•S 1873 IS 

1 ‘‘SEC. 319F–3. LIABILITY PROTECTIONS FOR PANDEMIC AND 

2 EPIDEMIC PRODUCTS AND SECURITY COUN3 TERMEASURES. 

4 ‘‘(a) AUTHORITY.—As provided in subsection (b), 

5 and subject to subsection (b)(1)(C), a manufacturer, 

6 distibutor, or administrator of a security countermeasure, 

7 or a qualified pandemic and epidemic product, described 

8 in subsection (b)(1)(A) or a health care provider shall be 

9 immune from suit or liability caused by or arising out of 

10 the design, development, clinical testing and investigation, 

11 manufacture, labeling, distribution, sale, purchase, dona12 tion, dispensing, prescribing, administration, or use of a 

13 security countermeasure, or a qualified pandemic and epi14 demic product, described in subsection (b)(1)(A). 

15 ‘‘(b) LITIGATION MANAGEMENT.— 

16 ‘‘(1) LIMITATION ON CAUSE OF ACTION.— 

17 ‘‘(A) IN GENERAL.— 

18 ‘‘(i) IN GENERAL.—No cause of action 

19 shall exist against a person described in 

20 subsection (a) for claims for loss of prop21 erty, personal injury, or death arising out 

22 of, reasonably relating to, or resulting from 

23 the design, development, clinical testing 

24 and investigation, manufacture, labeling, 

25 distribution, sale, purchase, donation, dis26 pensing, prescribing, administration, or use 
31 

•S 1873 IS 

1 of a security countermeasure or qualified 

2 pandemic or epidemic product distributed, 

3 sold, purchased, donated, dispensed, pre4 scribed, administered, or used in anticipa5 tion of and preparation for, in defense 

6 against, or in response to, or recovery from 

7 an actual or potential public health emer8 gency that is a designated security coun9 termeasure or a qualified pandemic or epi10 demic product by the Secretary in a dec11 laration described in paragraph (2). 

12 ‘‘(ii) RULE OF CONSTRUCTION.—For 

13 purposes of this section, the phrase ‘aris14 ing out of, reasonably relating to, or re15 sulting from’ shall not be construed to 

16 apply to loss of property, personal injury, 

17 or death that has no alleged or potential 

18 causal relationship with the design, devel19 opment, clinical testing and investigation, 

20 manufacture, labeling, distribution, sale, 

21 purchase, donation, dispensing, pre22 scribing, administration, or use of a prod23 uct described in clause (i). 

24 ‘‘(B) RULE.— 
32 

•S 1873 IS 

1 ‘‘(i) SUBSEQUENT INJURY.—The pro2 tections set forth in subsection (a) and 

3 subparagraph (A) shall apply to all claims 

4 identified in subparagraph (A) that involve 

5 products distributed, sold, purchased, do6 nated, dispensed, prescribed, administered, 

7 or used during the effective period set 

8 forth in the designation provided for in 

9 paragraph (2), regardless of the date of al10 leged injury. 

11 ‘‘(ii) PRIVATE DONATION OR SALE.— 

12 The protections set forth in subsection (a) 

13 and subparagraph (A) shall apply to all 

14 claims identified in subparagraph (A) that 

15 involve security countermeasures or quali16 fied pandemic or epidemic products distrib17 uted, sold, purchased, donated, dispensed, 

18 prescribed, administered, or used during 

19 the effective period set forth in the des20 ignation provided for in paragraph (2) by 

21 a manufacturer through the commercial 

22 market, provided that the security counter23 measures or the qualified pandemic or epi24 demic product are the security counter25 measure or qualified pandemic or epidemic 
33 

•S 1873 IS 

1 product described in a declaration de2 scribed in paragraph (2) and the Secretary 

3 does not specifically prohibit such private 

4 donation or sale in such declaration. 

5 ‘‘(C) POTENTIAL LIABILITY UPON DETER6 MINATION.— 

7 ‘‘(i) IN GENERAL.—A manufacturer, 

8 distributor, administrator, or health care 

9 provider shall not be immune under sub10 section (a) or exempted from a cause of ac11 tion under subparagraph (A) if the Sec12 retary makes a determination as provided 

13 for in subparagraph (D). 

14 ‘‘(ii) INVESTIGATION BY SEC15 RETARY.—A party seeking a determination 

16 under subparagraph (D) may petition the 

17 Secretary to investigate allegations against 

18 a manufacturer, distributor, administrator, 

19 or health care provider arising out of, re20 lating to, or resulting from the design, de21 velopment, clinical testing and investiga22 tion, manufacture, labeling, distribution, 

23 sale, purchase, donation, dispensing, pre24 scribing, administration, or use of products 

25 as provided for in subparagraph (A)(i). 
34 

•S 1873 IS 

1 The decision to undertake such investiga2 tion shall be within the Secretary’s discre3 tion and shall not be subject to judicial re4 view. 

5 ‘‘(iii) RULE OF CONSTRUCTION.— 

6 Nothing in this section shall be construed 

7 to abrogate or limit the application of sub8 title II of chapter 5 and chapter 7 of title 

9 5, United States Code (commonly known 

10 as the Administrative Procedure Act). 

11 ‘‘(D) DETERMINATION BY SECRETARY.— 

12 ‘‘(i) IN GENERAL.—In making a de13 termination under this subparagraph, the 

14 Secretary, acting through an administra15 tive law judge, must find clear and con16 vincing evidence that— 

17 ‘‘(I) the manufacturer, dis18 tributor, administrator, or health care 

19 provider violated a provision of the 

20 Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 301 et seq.) or this 

22 Act; and 

23 ‘‘(II) in violating such Act, such 

24 manufacturer, distributor, adminis-
35 

•S 1873 IS 

1 trator, or health care provider acted 

2 with willful misconduct. 

3 ‘‘(ii) EFFECT OF DETERMINATION.— 

4 If the Secretary finds such clear and con5 vincing evidence under clause (i), the Sec6 retary shall examine whether such willful 

7 misconduct to violate an Act under such 

8 clause— 

9 ‘‘(I) caused the product to 

10 present a significant or unreasonable 

11 risk to human health; and 

12 ‘‘(II) proximately caused the in13 jury alleged by the party. 

14 ‘‘(iii) NOTICE AND HEARING.—Prior 

15 to the Secretary’s making a determination 

16 under clause (i), the manufacturer, dis17 tributor, administrator, or health care pro18 vider shall have notice and a right to a for19 mal hearing in accordance with section 556 

20 of title 5, United States Code. 

21 ‘‘(iv) EFFECT OF DETERMINATION.— 

22 Subject to subsection (c), the sole excep23 tion to the immunity from suit and liability 

24 of manufacturers, distributors, administra25 tors, or healthcare providers set forth in 
36 

•S 1873 IS 

1 subsection (a) and subparagraph (A) shall 

2 be for actions against a manufacturer, dis3 tributor, administrator, or healthcare pro4 vider as provided in subparagraph (A). 

5 ‘‘(v) JUDICIAL REVIEW.—At any time 

6 prior to the 90th day following a deter7 mination by the Secretary under clause (i), 

8 any manufacturer, distributor, adminis9 trator, or health care provider named in 

10 such determination may file a petition with 

11 the United States Court District Court for 

12 the District of Columbia, for a judicial re13 view of such determination. A copy of the 

14 petition shall be forthwith transmitted by 

15 the clerk of the court to the Secretary or 

16 other officer designated by the Secretary 

17 for that purpose. The Secretary thereupon 

18 shall file in the court the record of the 

19 findings on which the Secretary based his 

20 or her determination. The filing of a peti21 tion under this clause shall automatically 

22 stay the Secretary’s determination for the 

23 duration of the judicial proceeding. The 

24 sole parties to the judicial proceeding shall 

25 be the Secretary and the petitioner. Inter-
37 

•S 1873 IS 

1 vention by third parties in the judicial pro2 ceeding shall not be permitted. No sub3 poenas shall be issued nor shall other com4 pulsory process apply. The court’s review 

5 of a determination by the Secretary under 

6 this clause shall conform to the procedures 

7 for judicial review of administrative orders 

8 set forth in paragraphs (2) through (6) of 

9 section 701(f) of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 371(f)) to 

11 the extent consistent with this section. 

12 ‘‘(vi) TOLLING OF STATUTE OF LIMI13 TATIONS.—The computation of the statute 

14 of limitations for any action against a 

15 manufacturer, distributor, administrator, 

16 or health care provider described under 

17 this subparagraph shall not include any 

18 time occurring before the determination by 

19 the Secretary under this subparagraph. 

20 ‘‘(vii) REGULATORY AUTHORITY.— 

21 The Secretary, in consultation with the At22 torney General, shall promulgate regula23 tions defining what actions by a manufac24 turer, distributor, administrator, or 

25 healthcare provider of a security counter-
38 

•S 1873 IS 

1 measure or a qualified pandemic and epi2 demic product shall be deemed to con3 stitute ‘willful misconduct’ for purposes of 

4 clause (i). In promulgating such regula5 tions, the Secretary shall consider the na6 ture of the actual or potential public health 

7 emergency, the timing and extent of any 

8 vaccination or countermeasure program, 

9 and any other circumstances they deem 

10 significant, so that any civil actions per11 mitted under this subsection will not ad12 versely affect the public health. The Sec13 retary may specify the period of time for 

14 which such regulations apply. 

15 ‘‘(viii) EVIDENCE REQUIRED.—The 

16 Secretary, in consultation with the Attor17 ney General, shall promulgate regulations 

18 that require, in order to be a party under 

19 this section, that an individual present evi20 dence that reasonably demonstrates that— 

21 ‘‘(I) such individual has suffered 

22 a loss as a direct result of the design, 

23 development, clinical testing and in24 vestigation, manufacture, labeling, 

25 distribution, sale, purchase, donation, 
39 

•S 1873 IS 

1 dispensing, prescribing, or administra2 tion of a security countermeasure or 

3 qualified epidemic or pandemic prod4 uct; and 

5 ‘‘(II) the loss as described in sub6 clause (I) was a direct result of the 

7 willful misconduct of the manufac8 turer, distributor, administrator, or 

9 health care provider in violating the 

10 Federal Food, Drug, and Cosmetic 

11 Act or this Act. 

12 ‘‘(E) SCOPE.—Subparagraph (C) shall 

13 apply regardless of whether the suit or liability 

14 described in subsection (a) or the claim de15 scribed in subparagraph (A) arises from the de16 sign, development, clinical testing and investiga17 tion, manufacture, labeling, distribution, sale, 

18 purchase, donation, dispensing, prescribing, ad19 ministration, or use by the Federal Government 

20 or by any person. 

21 ‘‘(2) DECLARATION BY SECRETARY.— 

22 ‘‘(A) IN GENERAL.—The Secretary may 

23 issue a declaration, pursuant to this paragraph, 

24 that an actual or potential public health emer25 gency makes advisable the distribution, admin-
40 

•S 1873 IS 

1 istration, or use of a security countermeasure 

2 or qualified pandemic or epidemic product. 

3 ‘‘(B) SECURITY COUNTERMEASURE OR

4 QUALIFIED PANDEMIC OR EPIDEMIC PROD5 UCT.—The Secretary shall specify in such dec6 laration the security countermeasures or quali7 fied pandemic or epidemic products to be sold 

8 by, purchased from, or donated by a manufac9 turer or drawn from the Strategic National 

10 Stockpile. 

11 ‘‘(C) EFFECTIVE PERIOD.—The Secretary 

12 shall specify in such declaration the beginning 

13 and the ending dates of the effective period of 

14 the declaration, which shall be not longer than 

15 6 months. The Secretary may subsequently 

16 amend such declaration to shorten or extend 

17 such effective period, provided that the new 

18 ending data is after the date on which the dec19 laration is amended. 

20 ‘‘(D) PUBLICATION.—The Secretary shall 

21 promptly publish each such declaration and 

22 amendment in the Federal Register. 

23 ‘‘(c) ACTIONS BY THE UNITED STATES.—Nothing in 

24 this section shall be construed to abrogate or limit any 

25 right, remedy, or authority that the United States or any 
41 

•S 1873 IS 

1 agency thereof may possess under any other provision of 

2 law. 

3 ‘‘(d) DEFINITIONS.—In this section: 

4 ‘‘(1) ADMINISTRATOR.—The term ‘adminis5 trator’ means a person employed by the State or 

6 local government, or their designee, who supervised 

7 or administered a program with respect to the ad8 ministration, dispensing, distribution, or provision of 

9 a security countermeasure or a qualified pandemic 

10 or epidemic product, including a person who has es11 tablished requirements, provided policy guidance, 

12 supplied technical or scientific advice or assistance. 

13 ‘‘(2) HEALTH CARE PROVIDER.—The term 

14 ‘health care provider’ means a person, including a 

15 volunteer, who distributes, prescribes, administers, 

16 dispenses, provides a facility to administer, or super17 vises or oversees the administration of a security 

18 countermeasure or a qualified pandemic or epidemic 

19 product, including persons who distribute, prescribe, 

20 administer, dispense, or provide a facility to admin21 ister in accordance with a designation under sub22 section (b)(2). 

23 ‘‘(3) LOSS.—The term ‘loss’ means death, phys24 ical injury, or loss of or damage to property, includ25 ing business interruption loss. 
42 

•S 1873 IS 

1 ‘‘(4) MANUFACTURER.—The term ‘manufac2 turer’ includes— 

3 ‘‘(A) a contractor or subcontractor of a 

4 manufacturer; 

5 ‘‘(B) a supplier of any product or service, 

6 research tool, or component to the manufac7 turer; and 

8 ‘‘(C) any or all of the parents, subsidiaries, 

9 affiliates, successors, and assigns of a manufac10 turer. 

11 ‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PROD12 UCT.—The term ‘qualified pandemic or epidemic 

13 product’ means a drug (as such term is defined in 

14 section 201(g)(1) of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 321(g)(1))), biological 

16 product (as such term is defined by section 351(i) 

17 of this Act) or device (as such term is defined by 

18 section 201(h) of the Federal Food, Drug and Cos19 metic Act (21 U.S.C. 321(h))) designed, developed, 

20 modified, or procured to diagnose, mitigate, prevent, 

21 treat, or cure a pandemic or epidemic or limit the 

22 harm such pandemic or epidemic might otherwise 

23 cause or a serious or life-threatening disease or con24 dition caused by such a product, that— 
43 

•S 1873 IS 

1 ‘‘(A) is approved or cleared under chapter 

2 V of the Federal Food, Drug, and Cosmetic Act 

3 or licensed under section 351 of this Act; 

4 ‘‘(B) is a product for which the Secretary 

5 determines that sufficient and satisfactory clin6 ical experience or research data (including data, 

7 if available, from pre-clinical and clinical trials) 

8 support a reasonable conclusion that the prod9 uct will qualify for approval or licensing within 

10 8 years after the date the Secretary makes a 

11 declaration under paragraph (2); or 

12 ‘‘(C) is authorized for emergency use sec13 tion 564 of the Federal Food, Drug, and Cos14 metic Act, except that subsection (b) of such 

15 section shall not apply. 

16 ‘‘(6) PARTY.— The term ‘party’ means an indi17 vidual who can reasonably demonstrate to the Sec18 retary that such individual has suffered a loss (as 

19 defined in paragraph (3)) as a direct result of the 

20 willful misconduct of a manufacturer, distributor, 

21 administrator, or health care provider. 

22 ‘‘(7) PERSON.—The term ‘person’ includes an 

23 individual, partnership, corporation, association, en24 tity, or public or private corporation, including a 

25 Federal, State, or local agency or department. 
44 

•S 1873 IS 

1 ‘‘(8) SECURITY COUNTERMEASURE.—The term 

2 ‘security countermeasure’ has the meaning given 

3 such term in section 319F–2(c)(1)(B).’’. 

4 SEC. 7. COMPENSATION. 

5 Title II of the Public Health Service Act (42 U.S.C. 

6 202 et seq.) is amended by adding at the end the fol7 lowing: 

8 ‘‘PART D—OTHER COMPENSATION PROGRAMS 

9 ‘‘SEC. 271. COVERED COUNTERMEASURES PROGRAM. 

10 ‘‘(a) IN GENERAL.—If the Secretary issues a Procla11 mation stating that there is a critical public health need 

12 for a covered individual to receive a covered counter13 measure during the effective period of the Proclamation, 

14 the Secretary shall establish a process to provide com15 pensation to such covered individuals for a covered injury, 

16 consistent with the Smallpox Emergency Personnel Pro17 tection program under part C. 

18 ‘‘(b) DEFINITION.—For purposes of this section: 

19 ‘‘(1) COVERED COUNTERMEASURE.—The term 

20 ‘covered countermeasure’ means a qualified pan21 demic or epidemic (as defined in section 319F– 

22 3(c)(5)) or a security countermeasure (as defined in 

23 section 319F–2(c)(1)(B)) specified in the Proclama24 tion. 
45 

•S 1873 IS 

1 ‘‘(2) COVERED INDIVIDUAL.—The term ‘cov2 ered individual’ means an individual— 

3 ‘‘(A) who is a health care worker, law en4 forcement officer, firefighter, security per5 sonnel, emergency medical personnel, other 

6 public health or safety personnel, or support 

7 personnel for such occupational specialties; 

8 ‘‘(B) who is or will be functioning in a role 

9 identified in a State, local, or Department of 

10 Health and Human Services emergency re11 sponse plan approved by the Secretary; 

12 ‘‘(C) who has volunteered and been se13 lected to be a member of an emergency re14 sponse plan; and 

15 ‘‘(D) to whom a covered countermeasure is 

16 administered pursuant to such approved plan 

17 during the effective period of the Proclamation 

18 and prior to the time at which the Secretary de19 clares a public health emergency pursuant to 

20 section 319 related to a covered countermeasure 

21 specified in the Proclamation. 

22 ‘‘(3) COVERED INJURY.—The term ‘covered in23 jury’ means an injury, disability, illness, condition, 

24 or death (other than a minor injury such as minor 

25 scarring or minor local reaction) determined by the 
46 

•S 1873 IS 

1 Secretary to have been sustained by a covered indi2 vidual as the direct result of administration to the 

3 individual of a covered countermeasure. 

4 ‘‘(4) EFFECTIVE PERIOD OF THE PROCLAMA5 TION.—The term ‘effective period of the Proclama6 tion’ means the effective period specified in the 

7 Proclamation, unless extended by the Secretary. 

8 ‘‘(5) EMERGENCY RESPONSE PLAN.—The term 

9 ‘emergency response plan’ or ‘plan’ means a re10 sponse plan detailing actions to be taken in prepara11 tion for a pandemic, epidemic, or biological, chem12 ical, nuclear agent or toxin that presents, or may 

13 present, a public health emergency. 

14 ‘‘(6) PROCLAMATION.—The term ‘Proclama15 tion’ means a Proclamation regarding the critical 

16 public health need for the administration of a cov17 ered countermeasure issued by the Secretary and 

18 published in the Federal Register. Such Proclama19 tion shall specify the specific covered counter20 measure recommended for administration. 

21 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec22 tion shall be construed to require the creation of a com23 pensation program if the covered injuries are only minor 

24 injuries consistent with section (b)(3).’’. 
47 

•S 1873 IS 

1 SEC. 8. REBATES AND GRANTS FOR RESEARCH DEVELOP2 MENT, AND MANUFACTURING OF VACCINES, 

3 QUALIFIED COUNTERMEASURES AND PAN4 DEMIC OR EPIDEMIC PRODUCTS. 

5 (a) IN GENERAL.—The Secretary of Health and 

6 Human Services (referred to in this section as the ‘‘Sec7 retary’’) may award to a person with respect to an invest8 ment described in this section (or an amendment made 

9 by this section)— 

10 (1) a rebate pursuant to subsection (b); or 

11 (2) a grant pursuant to section 319M of the 

12 Public Health Service Act (as added by subsection 

13 (c)). 

14 (b) SURGE CAPACITY AND RESEARCH REBATES.— 

15 (1) IN GENERAL.—The Secretary may award 

16 rebates out of any money in the Treasury not other17 wise appropriated to persons for the expansion of 

18 surge capacity for manufacturing vaccines, qualified 

19 countermeasures (as defined in 319F–1 of the Pub20 lic Health Service Act, as amended by this Act) or 

21 qualified pandemic or epidemic products (as defined 

22 in 319F–3(c)(5) of such Act, as added by this Act) 

23 (referred to in this section as ‘‘vaccines, counter24 measures or products’’) and for vaccines, counter25 measures, or products research. 
48 

•S 1873 IS 

1 (2) VACCINES, COUNTERMEASURES OR PROD2 UCTS MANUFACTURING FACILITIES INVESTMENT RE3 BATE.— 

4 (A) IN GENERAL.—For purposes of this 

5 section, vaccines, countermeasures or products 

6 manufacturing facilities investment rebate for 

7 any taxable year for a person (as defined with 

8 respect to such person for purposes of the In9 ternal Revenue Code of 1986) shall be an 

10 amount equal to 20 percent of the qualified in11 vestment for such taxable year. 

12 (B) VACCINES, COUNTERMEASURES OR

13 PRODUCTS MANUFACTURING FACILITIES IN14 VESTMENT.—For purposes of subparagraph 

15 (A), the qualified investment for any taxable 

16 year for a person is the basis of each vaccines, 

17 countermeasures or products manufacturing fa18 cilities property placed in service by the person 

19 during the taxable year involved. 

20 (C) VACCINES, COUNTERMEASURES AND

21 PRODUCTS MANUFACTURING FACILITIES PROP22 ERTY.—For purposes of this subsection, the 

23 term ‘‘vaccines, countermeasures and products 

24 manufacturing facilities property’’ means real 

25 and tangible personal property— 
49 

•S 1873 IS 

1 (i)(I) the original use of which com2 mences with the person applying for the 

3 rebate; or 

4 (II) which is acquired through pur5 chase (as defined by section 179(d)(2) of 

6 the Internal Revenue Code of 1986); 

7 (ii) which is depreciable under section 

8 167 of the Internal Revenue Code of 1986; 

9 (iii) which is physically located in a 

10 State; 

11 (iv) which is used for the manufac12 ture, distribution, or research and develop13 ment of vaccines, countermeasures, or 

14 products; and 

15 (v) which is in compliance with appli16 cable good manufacturing practice and 

17 with any other applicable requirements 

18 which are promulgated by the Secretary, 

19 the Occupational Safety and Health Ad20 ministration, or the Environmental Protec21 tion Agency, and which are applicable to 

22 such property. 

23 (D) DENIAL OF DOUBLE BENEFIT FOR

24 MANUFACTURING FACILITIES EXPENSES.—If 

25 any portion of the vaccines, countermeasures, 
50 

•S 1873 IS 

1 and products manufacturing facilities property 

2 investment expenses is otherwise allowable as a 

3 deduction for the taxable year involved, the Sec4 retary shall only provide a rebate under this 

5 section for the portion of such expenses not cov6 ered by the rebate determined by such deduc7 tion. 

8 (E) ELIGIBILITY.—To be eligible to receive 

9 a rebate under this subsection, a manufacturer 

10 shall submit to the Secretary an application at 

11 such time, in such manner, and containing such 

12 information as the Secretary may require, in13 cluding— 

14 (i) a detailed description and intended 

15 use of the facilities that is the basis of ap16 plication; 

17 (ii) a detailed description of the vac18 cine, countermeasure, or product being 

19 produced or that may be produced at the 

20 facility; 

21 (iii) a detailed accounting of qualified 

22 manufacturing facilities investment of the 

23 person; 
51 

•S 1873 IS 

1 (iv) a certification as to the compli2 ance of the person with clauses (i) through 

3 (iv) of subparagraph (C); and 

4 (v) copies of tax returns for the tax5 able year involved. 

6 (F) EFFECTIVE DATE.—This paragraph 

7 shall apply to property placed in service after 

8 December 31, 2005. 

9 (G) TERMINATION.—This paragraph shall 

10 not apply to any property placed in service after 

11 December 31, 2010. 

12 (3) MEDICAL RESEARCH RELATED TO DEVEL13 OPING VACCINES, COUNTERMEASURES OR QUALIFIED

14 PANDEMIC OR EPIDEMIC PRODUCTS REBATE.— 

15 (A) IN GENERAL.—For purposes of this 

16 subsection, the research rebate determined 

17 under this section for the taxable year involved 

18 (as determined as provided for in paragraph 

19 (2)(A)) is an amount equal to 35 percent of the 

20 vaccines, qualified countermeasures, or qualified 

21 pandemic or epidemic products (referred to in 

22 this section as ‘‘vaccine, countermeasure, or 

23 product’’) research expenses for the taxable 

24 year. 
52 

•S 1873 IS 

1 (B) VACCINES, COUNTERMEASURES, OR

2 PRODUCTS RESEARCH EXPENSES.—Except as 

3 otherwise provided in this paragraph, the term 

4 ‘‘vaccines, countermeasures, or products re5 search expenses’’ means the amounts which are 

6 paid or incurred by the researcher or manufac7 turer during the taxable year with respect to 

8 any research and development of vaccines, 

9 countermeasures, or products. Qualified re10 search and development expenses include ex11 penses related to reformulating existing vac12 cines, countermeasures, or products. 

13 (C) DETERMINING RESEARCH EX14 PENSES.—Any vaccines, countermeasures, or 

15 products research expenses for any taxable year 

16 which are qualified research expenses (within 

17 the meaning of this subsection) shall be taken 

18 into account in determining base period re19 search expenses for purposes of applying this 

20 paragraph to subsequent taxable years. 

21 (D) DENIAL OF DOUBLE BENEFIT FOR

22 VACCINES, COUNTERMEASURES, OR PRODUCTS

23 RESEARCH EXPENSES.—If any portion of the 

24 vaccines, countermeasures, or products research 

25 expenses is otherwise allowable as a deduction 
53 

•S 1873 IS 

1 for the taxable year involved, the Secretary 

2 shall only provide a rebate under this section 

3 for the portion of such expenses not covered by 

4 any rebate determined by such deduction. 

5 (E) ELIGIBILITY.—To be eligible to receive 

6 a rebate under this paragraph, a manufacturer 

7 or researcher shall submit to the Secretary an 

8 application at such time, in such manner, and 

9 containing such information as the Secretary 

10 may require, including— 

11 (i) a detailed description of the vac12 cine, countermeasure, or product being re13 searched or developed; 

14 (ii) a detailed description of the re15 search that is the subject of the rebate; 

16 (iii) a detailed accounting of the quali17 fied research expenses involved; 

18 (iv) an assurance that the researcher 

19 or manufacturer is following good labora20 tory practice, as required by the Secretary 

21 pursuant to the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 301 et seq.) and 

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

24 201 et seq.); and 
54 

•S 1873 IS 

1 (v) copies of tax returns for the tax2 able year involved. 

3 (F) EFFECTIVE DATE.—This paragraph 

4 shall apply to expenses for taxable years begin5 ning after December 31, 2005. 

6 (4) EXCLUSION FOR AMOUNTS FUNDED BY

7 GRANTS, ETC.—The terms ‘‘vaccines, counter8 measures, or products manufacturing investment’’ 

9 and ‘‘qualified research expenses’’ shall not include 

10 any amount to the extent such amount is funded by 

11 any grant, contract, or otherwise funded by another 

12 person (or any governmental entity). 

13 (c) GRANTS TO EXPAND AND IMPROVE RESEARCH

14 AND DEVELOPMENT AND MANUFACTURING OF VACCINES, 

15 COUNTERMEASURES OR PRODUCTS.—Part B of title III 

16 of the Public Health Service Act is amended by inserting 

17 after section 319L, as added by this Act, the following: 

18 ‘‘SEC. 319M. GRANTS TO EXPAND AND IMPROVE RESEARCH 

19 AND DEVELOPMENT AND MANUFACTURING 

20 OF VACCINES, QUALIFIED COUNTER21 MEASURES OR QUALIFIED PANDEMIC OR EPI22 DEMIC PRODUCTS. 

23 ‘‘(a) IN GENERAL.—The Secretary may award grants 

24 to a manufacturer to purchase or improve real property 

25 and tangible personal property used in the research and 
55 

•S 1873 IS 

1 development, manufacture, or distribution of a vaccine, 

2 qualified countermeasure (as defined in section 319F–1) 

3 or qualified pandemic or epidemic product (as defined in 

4 section 319F–3(c)(5)). 

5 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

6 under subsection (a), a manufacturer shall submit to the 

7 Secretary an application at such time, in such manner, 

8 and containing such information as the Secretary may re9 quire, including— 

10 ‘‘(1) a detailed description of the planned ex11 pansion; 

12 ‘‘(2) a detailed description of the equipment, fa13 cility, or property involved; 

14 ‘‘(3) a certification that such facility or prop15 erty is physically located in a State; 

16 ‘‘(4) a detailed description of the vaccine, quali17 fied countermeasure or qualified pandemic or epi18 demic product involved; 

19 ‘‘(5) a detailed description of the research and 

20 development, manufacturer, or distribution involved; 

21 ‘‘(6) a description of how such equipment, facil22 ity, or property is to be used; 

23 ‘‘(7) a description of whether such equipment, 

24 facility, or property can be used for the research and 

25 development, manufacture, or distribution of a drug, 
56 

•S 1873 IS 

1 biological product, device or other countermeasure 

2 not described in paragraph (4); and 

3 ‘‘(8) a certification that the equipment, facility, 

4 or property involved complies with all applicable 

5 Federal, State, and local laws. 

6 ‘‘(c) RECAPTURE.— 

7 ‘‘(1) IN GENERAL.—If, at any time prior to the 

8 expiration of the 20-year period beginning on the 

9 date on which a grant is awarded under this section, 

10 the facility or property involved ceases to be used for 

11 the purpose for which the grant was awarded, the 

12 United States shall be entitled to recover from the 

13 manufacturer an amount bearing the same ratio to 

14 the value of the facility or property at such time as 

15 the amount of the grant bore to the total cost of the 

16 purchase or improvement involved. The value of the 

17 facility or property at such time may be determined 

18 by agreement of the manufacturer and the Sec19 retary, or by order of the United States District 

20 Court for the district in which such facility or prop21 erty is situated. 

22 ‘‘(2) LIMITATION.—The Secretary may not re23 capture the facility or property under this subsection 

24 if the Secretary determines, in accordance with regu-
57 

•S 1873 IS 

1 lations promulgated by the Secretary, that there is 

2 good cause for the failure of proper use. 

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

4 is authorized to be appropriated such sums as may be nec5 essary to carry out this section.’’. 

6 SEC. 9. TECHNICAL ASSISTANCE. 

7 Subchapter E of chapter V of the Federal Food, 

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

9 amended by adding at the end the following: 

10 ‘‘SEC. 565. TECHNICAL ASSISTANCE. 

11 ‘‘The Secretary, in consultation with the Commis12 sioner of Food and Drugs, shall establish within the Food 

13 and Drug Administration a team of experts on manufac14 turing and regulatory activities (including compliance with 

15 current Good Manufacturing Practices) to provide both 

16 off-site and on-site technical assistance to the manufactur17 ers of qualified countermeasures (as defined in section 

18 319F–1 of the Public Health Service Act), security coun19 termeasures (as defined in section 319F–2 of such Act), 

20 or vaccines, at the request of such a manufacturer and 

21 at the discretion of the Secretary, if the Secretary deter22 mines that a shortage or potential shortage may occur in 

23 the United States in the supply of such vaccines or prod24 ucts and that the provision of such assistance would be 

25 beneficial in helping alleviate or avert such shortage.’’. 
58 

•S 1873 IS 

1 SEC. 10. ANIMAL MODELS FOR CERTAIN DISEASES. 

2 Part B of title IV of the Public Health Service Act 

3 (42 U.S.C. 284 et seq.) is amended by adding at the end 

4 the following: 

5 ‘‘SEC. 409J. ANIMAL MODELS FOR CERTAIN DISEASES. 

6 ‘‘(a) IN GENERAL.—The Secretary, acting through 

7 the Director of NIH, in coordination with the Director of 

8 the Biomedical Advanced Research and Development 

9 Agency, the Director of the Centers for Disease Control 

10 and Prevention, and the Commissioner of Food and 

11 Drugs, shall establish and award grants under this section 

12 to eligible entities, including other Federal agencies, to 

13 study the physiological responses of certain animal species 

14 and, where appropriate, juvenile models, to chemical, bio15 logical, radiological, or nuclear agents or toxins or poten16 tial pandemic infectious disease, and to develop and vali17 date such animal models. 

18 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

19 under this section, an entity shall— 

20 ‘‘(1) provide assurances to the Secretary that 

21 the entity— 

22 ‘‘(A) has access to an appropriate biosafety 

23 laboratory or facility, as determined by the Sec24 retary; and 

25 ‘‘(B) will follow good laboratory practices; 
59 

•S 1873 IS 

1 ‘‘(2) submit to the Secretary an application at 

2 such time, in such manner, and containing such in3 formation as the Secretary may require, including— 

4 ‘‘(A) a detailed description of the animal 

5 model involved; 

6 ‘‘(B) a detailed description of the chemical, 

7 biological, radiological, nuclear, or other infec8 tious agents involved; 

9 ‘‘(C) a detailed description of how the ani10 mal model will be used for the development of 

11 a drug, biological product, or device for use as 

12 a countermeasure; 

13 ‘‘(D) a detailed description of validation 

14 methods; and 

15 ‘‘(E) an assurance that the entity will fol16 low good laboratory practices; and 

17 ‘‘(3) agree to submit the results of the research 

18 funded under the grant to the Director of the Bio19 medical Advanced Research and Development Agen20 cy and the Director of NIH. 

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

22 are authorized to be appropriated such sums as may be 

23 necessary to carry out this section.’’. 
60 

•S 1873 IS 

1 SEC. 11. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC AD2 VISORY COMMITTEE. 

3 Subchapter E of chapter V of the Federal Food, 

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

5 amended by this Act, is amended by adding at the end 

6 the following: 

7 ‘‘SEC. 566. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC 

8 ADVISORY COMMITTEE. 

9 ‘‘(a) ESTABLISHMENT.—Not later than 6 months 

10 after the date of enactment of this section, the Secretary 

11 shall establish an 11-member advisory committee to be 

12 known as the ‘Animal Model/Research Tool Scientific Ad13 visory Committee’ (referred to in this section as the ‘Advi14 sory Committee’). 

15 ‘‘(b) MEMBERSHIP.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall appoint 

17 as members of the Advisory Committee individuals 

18 who are technically qualified by training and experi19 ence, including in medicine, veterinarian medicine, 

20 biology, technology involving the manufacture, eval21 uation, or use of research tools, who are of appro22 priately diversified professional backgrounds to 

23 evaluate the priority animal models and research 

24 tools. 

25 ‘‘(2) EX OFFICIO MEMBERS.—The Secretary 

26 may appoint Federal officials, including at least 1 
61 

•S 1873 IS 

1 representative of the Biomedical Advanced Research 

2 and Development Agency, to serve as ex officio 

3 members of the Advisory Committee. 

4 ‘‘(3) CHAIRPERSON.—The Secretary shall des5 ignate 1 of the members of the Advisory Committee 

6 to serve as the chairperson. 

7 ‘‘(c) DUTIES.—The Advisory Committee shall provide 

8 advice, information, and recommendations to the Sec9 retary on— 

10 ‘‘(1) accepted animal models for diseases and 

11 conditions associated with any biological (including 

12 organisms that cause infectious diseases), chemical, 

13 radiological, or nuclear agent or toxin or potential 

14 pandemic infectious disease; 

15 ‘‘(2) strategies to accelerate animal model and 

16 research tool development and validation; and 

17 ‘‘(3) scientific issues raised in applications as 

18 requested by the Secretary. 

19 ‘‘(d) PRIORITIES.—Priorities for animal models and 

20 research tools shall be established by the Secretary. 

21 ‘‘(e) COMPENSATION; SUPPORT; FACA.— 

22 ‘‘(1) COMPENSATION AND TRAVEL.—Members 

23 of the Advisory Committee who are not officers or 

24 employees of the United States, while attending con25 ferences or meetings of the committee or otherwise 
62 

•S 1873 IS 

1 engaged in its business, shall be entitled to receive 

2 compensation at rates to be fixed by the Secretary, 

3 which may not exceed daily equivalent of the rate in 

4 effect for level 4 of the Senior Executive Schedule 

5 under section 5382 of title 5, United States Code, 

6 for each day (including travel time) they are so en7 gaged, and while so serving away from their homes 

8 or regular places of business each member may be 

9 allowed travel expenses, including per diem in lieu of 

10 subsistence, as authorized by section 5703 of title 5, 

11 United States Code, for persons in the Federal Gov12 ernment service employed intermittently. 

13 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec14 retary shall furnish the Advisory Committee clerical 

15 and other assistance. 

16 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

17 the Federal Advisory Committee Act (5 U.S.C. 

18 App.) shall not apply to the Advisory Committee. 

19 ‘‘(f) PROCEEDINGS.—The Advisory Committee shall 

20 make and maintain a transcript of any proceeding of the 

21 Committee. The Committee shall delete from any tran22 script made under this subsection information, which is 

23 exempt from disclosure under section 552(b) of title 5, 

24 United States Code.’’. 
63 

•S 1873 IS 

1 SEC. 12. COLLABORATION AND COORDINATION. 

2 Section 2 of the Clayton Act (15 U.S.C. 13) is 

3 amended by adding at the end the following: 

4 ‘‘(g) LIMITED ANTITRUST EXEMPTION.— 

5 ‘‘(1) SECURITY COUNTERMEASURES, QUALIFIED

6 COUNTERMEASURES AND QUALIFIED PANDEMIC OR

7 EPIDEMIC PRODUCT DEVELOPMENT MEETINGS.— 

8 ‘‘(A) COUNTERMEASURES AND PRODUCTS

9 DEVELOPMENT MEETINGS AND CONSULTA10 TIONS.—The Secretary of Health and Human 

11 Services (referred to in this subsection as the 

12 ‘Secretary’) or the Director of the Biomedical 

13 Advanced Research and Development Agency 

14 (referred to in this subsection as the ‘Director’), 

15 in coordination with the Attorney General and 

16 the Secretary of Homeland Security, may con17 duct meetings and consultations with parties in18 volved in the development of security counter19 measures (as defined in section 319F–2 of the 

20 Public Health Service Act) qualified counter21 measures (as defined in section 319F–1 of the 

22 Public Health Service Act) or qualified pan23 demic or epidemic products (as defined in sec24 tion 319F–3(c)(5) of the Public Health Service 

25 Act) (referred to in this section as ‘‘counter26 measures or products’’) for the purpose of the 
64 

•S 1873 IS 

1 development, manufacture, distribution, pur2 chase, sale, or storage of countermeasures or 

3 products consistent with the purposes of this 

4 title. The Secretary or Director may convene 

5 such meeting or consultation at the request of 

6 any person, the Secretary of Homeland Secu7 rity, the Attorney General, the Chairperson of 

8 the Federal Trade Commission, an industry 

9 representative or member, or upon initiation by 

10 such Secretary. The Secretary or Director shall 

11 give notice of such meetings and consultations 

12 to the Chairperson of the Federal Trade Com13 mission (referred to in this subsection as the 

14 ‘Chairperson’) and the Attorney General. 

15 ‘‘(B) MEETING AND CONSULTATION CON16 DITIONS.—A meeting or consultation conducted 

17 under subparagraph (A) shall— 

18 ‘‘(i) be chaired or, in the case of a 

19 consultation, facilitated by the Secretary or 

20 Director; 

21 ‘‘(ii) be open to parties involved in the 

22 development, manufacture, distribution, 

23 purchase, or sale of countermeasures or 

24 products, as determined by the Secretary 

25 or Director; 
65 

•S 1873 IS 

1 ‘‘(iii) be open to the Attorney General, 

2 the Secretary of Homeland Security, and 

3 the Chairperson; 

4 ‘‘(iv) be limited to discussions involv5 ing the development, manufacture, dis6 tribution, or sale of countermeasures or 

7 products, consistent with the purposes of 

8 this title; and 

9 ‘‘(v) be conducted in such manner as 

10 to ensure that national security, confiden11 tial, and proprietary information is not dis12 closed outside the meeting or consultation. 

13 ‘‘(C) LIMITATION.—The Secretary or Di14 rector may not require the disclosure of con15 fidential commercial or proprietary information. 

16 ‘‘(D) MINUTES.—The Secretary or Direc17 tor shall maintain minutes of meetings and con18 sultations under this subsection, which shall not 

19 be disclosed under section 552 of title 5, United 

20 States Code, unless such Secretary or Director, 

21 in consultation with the Attorney General, de22 termines that disclosure would pose no threat to 

23 national security. Such determination shall not 

24 be subject to judicial review. 

25 ‘‘(E) EXEMPTION.— 
66 

•S 1873 IS 

1 ‘‘(i) IN GENERAL.—The antitrust laws 

2 shall not apply to meetings and consulta3 tions under this paragraph. 

4 ‘‘(ii) LIMITATION.—Clause (i) shall 

5 not apply to any agreement or conduct 

6 that results from a meeting or consultation 

7 and that does not receive an exemption 

8 pursuant to this subsection. 

9 ‘‘(2) WRITTEN AGREEMENTS.—The Secretary 

10 or the Director shall file a written agreement regard11 ing covered activities, made pursuant to meetings or 

12 consultations conducted under paragraph (1) and 

13 that is consistent with this paragraph, with the At14 torney General and the Chairperson for a determina15 tion of the compliance of such agreement with anti16 trust laws. In addition to the proposed agreement 

17 itself, any such filing shall include— 

18 ‘‘(A) an explanation of the intended pur19 pose 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; 
67 

•S 1873 IS 

1 ‘‘(D) an explanation of the necessity of a 

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

4 agreement; and 

5 ‘‘(E) any other relevant information deter6 mined necessary by the Secretary or Director in 

7 consultation with the Attorney General and the 

8 Chairperson. 

9 ‘‘(3) DETERMINATION.—The Attorney General, 

10 in consultation with the Chairperson, shall determine 

11 whether an agreement regarding covered activities 

12 referred to in paragraph (2) would likely— 

13 ‘‘(A) be in compliance with the antitrust 

14 laws, and so inform the Secretary or Director 

15 and the participating parties; or 

16 ‘‘(B) violate the antitrust laws, in which 

17 case, the filing shall be deemed to be a request 

18 for an exemption from the antitrust laws, lim19 ited to the performance of the agreement con20 sistent with the purposes of this title. 

21 ‘‘(4) ACTION ON REQUEST FOR EXEMPTION.— 

22 ‘‘(A) IN GENERAL.—The Attorney General, 

23 in consultation with the Chairperson, shall 

24 grant, deny, grant in part and deny in part, or 

25 propose modifications to a request for exemp-
68 

•S 1873 IS 

1 tion from the antitrust laws under paragraph 

2 (3) within 15 business days of the receipt of 

3 such request. 

4 ‘‘(B) EXTENSION.—The Attorney General 

5 may extend the 15-day period referred to in 

6 subparagraph (A) for an additional period of 

7 not to exceed 10 days. Such additional period 

8 may be further extended only by the United 

9 States district court, upon an application by the 

10 Attorney General after notice to the Secretary 

11 or Director and the parties involved. 

12 ‘‘(C) DETERMINATION.—In granting an 

13 exemption under this paragraph, the Attorney 

14 General, in consultation with the Chairperson 

15 and the Secretary or Director— 

16 ‘‘(i) shall find— 

17 ‘‘(I) that the agreement involved 

18 is necessary to ensure the availability 

19 of countermeasures or products; 

20 ‘‘(II) that the exemption from 

21 the antitrust laws would promote the 

22 public interest; and 

23 ‘‘(III) that there is no substantial 

24 competitive impact to areas not di-
69 

•S 1873 IS 

1 rectly related to the purposes of the 

2 agreement; and 

3 ‘‘(ii) may consider any other factors 

4 determined relevant by the Attorney Gen5 eral and the Chairperson. 

6 ‘‘(5) LIMITATION ON AND RENEWAL OF EXEMP7 TIONS.—An exemption granted under paragraph (4) 

8 shall be limited to covered activities, and shall be re9 newed (with modifications, as appropriate) on the 

10 date that is 3 years after the date on which the ex11 emption becomes effective (and at 3-year intervals 

12 thereafter, if renewed) unless the Attorney General 

13 in consultation with the Chairperson determines that 

14 the exemption should not be renewed (with modifica15 tions, as appropriate) considering the factors de16 scribed in paragraph (4). 

17 ‘‘(6) LIMITATION ON PARTIES.—The use of any 

18 information acquired under an exempted agreement 

19 by the parties to such an agreement for any pur20 poses other than those specified in the antitrust ex21 emption granted by the Attorney General shall be 

22 subject to the antitrust laws and any other applica23 ble laws. 
70 

•S 1873 IS 

1 ‘‘(7) GUIDELINES.—The Attorney General and 

2 the Chairperson may develop and issue guidelines to 

3 implement this subsection. 

4 ‘‘(8) REPORT.—Not later than 1 year after the 

5 date of enactment of the Biodefense and Pandemic 

6 Vaccine and Drug Development Act of 2005, and 

7 annually thereafter, the Attorney General and the 

8 Chairperson shall report to Congress on the use and 

9 continuing need for the exemption from the antitrust 

10 laws provided by this subsection. 

11 ‘‘(9) STATUS OF MEMORANDUMS.—Minutes 

12 maintained by the Secretary or Director pursuant to 

13 paragraph (1)(D) shall not be disclosed under sec14 tion 552 of title 5, United States Code, if the ex15 emption is not renewed under paragraph (5), or if 

16 meetings are no longer conducted, unless the Sec17 retary or Director, in consultation with the Attorney 

18 General, determines that the disclosure would pose 

19 no threat to national security. Such determination 

20 shall not be subject to judicial review. 

21 ‘‘(h) SUNSET.—The authority of the Attorney Gen22 eral to grant or renew a limited antitrust exemption under 

23 this section shall expire at the end of the 6-year period 

24 that begins on the date of enactment of the Biodefense 
71 

•S 1873 IS 

1 and Pandemic Vaccine and Drug Development Act of 

2 2005. 

3 ‘‘(i) DEFINITIONS.—In this section: 

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

5 laws’— 

6 ‘‘(A) has the meaning given such term in 

7 subsection (a) of the first section of this Act, 

8 except that such term includes the Act of June 

9 19, 1936 (15 U.S.C. 13 et seq.) (commonly 

10 known as the Robinson-Patman Act), and sec11 tion 5 of the Federal Trade Commission Act 

12 (15 U.S.C. 45) to the extent such section 5 ap13 plies to unfair methods of competition; and 

14 ‘‘(B) includes any State law similar to the 

15 laws referred to in subparagraph (A). 

16 ‘‘(2) COVERED ACTIVITIES.— 

17 ‘‘(A) IN GENERAL.—Except as provided in 

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

19 means any group of activities or conduct, in20 cluding attempting to make, making, or per21 forming a contract or agreement or engaging in 

22 other conduct, for the purpose of— 

23 ‘‘(i) theoretical analysis, experimen24 tation, or the systematic study of phe25 nomena or observable facts necessary to 
72 

•S 1873 IS 

1 the development of countermeasures or 

2 products; 

3 ‘‘(ii) the development or testing of 

4 basic engineering techniques necessary to 

5 the development of countermeasures or 

6 products; 

7 ‘‘(iii) the extension of investigative 

8 findings or theory of a scientific or tech9 nical nature into practical application for 

10 experimental and demonstration purposes, 

11 including the experimental production and 

12 testing of models, prototypes, equipment, 

13 materials, and processes necessary to the 

14 development of countermeasures or prod15 ucts; 

16 ‘‘(iv) the production, distribution, or 

17 marketing of a product, process, or service 

18 that is a countermeasures or products; 

19 ‘‘(v) the testing in connection with the 

20 production of a product, process, or serv21 ices necessary to the development of coun22 termeasures or products; 

23 ‘‘(vi) the collection, exchange, and 

24 analysis of research or production informa-
73 

•S 1873 IS 

1 tion necessary to the development of coun2 termeasures or products; or 

3 ‘‘(vii) any combination of the purposes 

4 described in clauses (i) through (vi); 

5 and such term may include the establishment 

6 and operation of facilities for the conduct of 

7 covered activities described in clauses (i) 

8 through (vi), the conduct of such covered activi9 ties on a protracted and proprietary basis, and 

10 the processing of applications for patents and 

11 the granting of licenses for the results of such 

12 covered activities. 

13 ‘‘(B) EXCEPTION.—The term ‘covered ac14 tivities’ shall not include the following activities 

15 involving 2 or more persons: 

16 ‘‘(i) Exchanging information among 

17 competitors relating to costs, profitability, 

18 marketing, or distribution of any product, 

19 process, or service if such information is 

20 not reasonably necessary to carry out the 

21 purposes of covered activities. 

22 ‘‘(ii) Entering into any agreement or 

23 engaging in any other conduct— 

24 ‘‘(I) to restrict or require the 

25 sale, licensing, or sharing of inven-
74 

•S 1873 IS 

1 tions, developments, products, proc2 esses, or services not developed 

3 through, produced by, or distributed 

4 or sold through such covered activi5 ties; or 

6 ‘‘(II) to restrict or require par7 ticipation by any person who is a 

8 party to such covered activities in 

9 other research and development activi10 ties, that is not reasonably necessary 

11 to prevent the misappropriation of 

12 proprietary information contributed 

13 by any person who is a party to such 

14 covered activities or of the results of 

15 such covered activities. 

16 ‘‘(iii) Entering into any agreement or 

17 engaging in any other conduct allocating a 

18 market with a competitor that is not ex19 pressly exempted from the antitrust laws 

20 by a determination under subsection 

21 (g)(4). 

22 ‘‘(iv) Exchanging information among 

23 competitors relating to production (other 

24 than production by such covered activities) 

25 of a product, process, or service if such in-
75 

•S 1873 IS 

1 formation is not reasonably necessary to 

2 carry out the purpose of such covered ac3 tivities. 

4 ‘‘(v) Entering into any agreement or 

5 engaging in any other conduct restricting, 

6 requiring, or otherwise involving the pro7 duction of a product, process, or service 

8 that is not so expressly exempted from the 

9 antitrust laws by a determination under 

10 subsection (g)(4). 

11 ‘‘(vi) Except as otherwise provided in 

12 this subsection, entering into any agree13 ment or engaging in any other conduct to 

14 restrict or require participation by any per15 son who is a party to such activities, in 

16 any unilateral or joint activity that is not 

17 reasonably necessary to carry out the pur18 pose of such covered activities. 

19 ‘‘(vii) Entering into any agreement or 

20 engaging in any other conduct restricting 

21 or setting the price at which a product is 

22 offered for sale, whether by bid or other23 wise. 

24 ‘‘(3) DEVELOPMENT.—The term ‘development’ 

25 includes the identification of suitable compounds or 
76 

•S 1873 IS 

1 biological materials, the conduct of preclinical and 

2 clinical studies, the preparation of an application for 

3 marketing approval, and any other actions related to 

4 preparation of a countermeasure or product.’’. 

5 SEC. 13. PROCUREMENT. 

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

7 U.S.C. 247d–6b) is amended— 

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

9 SECURITY COUNTERMEASURE PROCURE10 MENTS’’ before the period; and 

11 (2) in subsection (c)— 

12 (A) in the subsection heading, by striking 

13 ‘‘BIOMEDICAL’’; 

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

15 meet the needs of the stockpile’’ and inserting 

16 ‘‘to meet the stockpile needs’’; 

17 (C) in paragraph (7)(C)(ii)— 

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

19 follows: 

20 ‘‘(I) PAYMENT CONDITIONED ON

21 DELIVERY.—The contract shall pro22 vide that no payment may be made 

23 until delivery of a portion, acceptable 

24 to the Secretary, of the total number 

25 of units contracted for, except that, 
77 

•S 1873 IS 

1 notwithstanding any other provision of 

2 law, the contract may provide that, if 

3 the Secretary determines (as the Sec4 retary’s discretion) that an advance 

5 payment, partial payment for signifi6 cant milestones, or payment to in7 crease manufacturing capacity is nec8 essary to ensure success of a project, 

9 the Secretary shall pay an amount, 

10 not to exceed 10 percent of the con11 tract amount, in advance of delivery. 

12 The contract shall provide that such 

13 advance payment is required to be re14 paid if there is a failure to perform by 

15 the vendor under the contract. The 

16 contract may also provide for up to 3 

17 additional advance payments of 5 per18 cent each for meeting the milestones 

19 specified in such contract. Provided 

20 that the specified milestones are 

21 reached, these advanced payments of 

22 5 percent shall not be required to be 

23 repaid. Nothing in this subclause shall 

24 be construed as affecting the rights of 

25 vendors under provisions of law or 
78 

•S 1873 IS 

1 regulation (including the Federal Ac2 quisition Regulation) relating to the 

3 termination of contracts for the con4 venience of the Government.’’; and 

5 (ii) by adding at the end the fol6 lowing: 

7 ‘‘(VII) SALES EXCLUSIVITY.— 

8 The contract may provide that the 

9 vendor is the sole and exclusive sup10 plier of the product to the Federal 

11 Government for a specified period of 

12 time, not to exceed 15 years, on the 

13 condition that the vendor is able to 

14 satisfy the needs of the Government. 

15 During the agreed period of sales ex16 clusivity, the vendor shall not assign 

17 its rights of sales exclusivity to an18 other entity or entities without ap19 proval by the Secretary. 

20 ‘‘(VIII) SURGE CAPACITY.—The 

21 contract may provide that the vendor 

22 establish domestic manufacturing ca23 pacity of the product to ensure that 

24 additional production of the product is 

25 available in the event that the Sec-
79 

•S 1873 IS 

1 retary determines that there is a need 

2 to quickly purchase additional quan3 tities of the product. Such contract 

4 may provide a fee to the vendor for 

5 establishing and maintaining such ca6 pacity in excess of the initial require7 ment for the purchase of the product. 

8 Additionally, the cost of maintaining 

9 the domestic manufacturing capacity 

10 shall be an allowable and allocable di11 rect cost of the contract. 

12 ‘‘(IX) CONTRACT TERMS.—The 

13 Secretary, in any contract for procure14 ment under this section, may speci15 fy— 

16 ‘‘(aa) the dosing and admin17 istration requirements for coun18 termeasures to be developed and 

19 procured; 

20 ‘‘(bb) the amount of funding 

21 that will be dedicated by the Sec22 retary for research and develop23 ment of the countermeasure; and 

24 ‘‘(cc) the specifications the 

25 countermeasure must meet to 
80 

•S 1873 IS 

1 qualify for procurement under a 

2 contract under this section.’’; and 

3 (D) in paragraph (8)(A), by adding at the 

4 end the following: ‘‘Such agreements may allow 

5 other executive agencies to order qualified and 

6 security countermeasures under procurement 

7 contracts or other agreements established by 

8 the Secretary. Such ordering process (including 

9 transfers of appropriated funds between an 

10 agency and the Department of Health and 

11 Human Services as reimbursements for such or12 ders for countermeasures) may be conducted 

13 under the authority of section 1535 of title 31, 

14 United States Code, except that all such orders 

15 shall be processed under the terms established 

16 under the Biodefense and Pandemic Vaccine 

17 and Drug Development Act of 2005 and the 

18 Project BioShield Act of 2004, for the procure19 ment of countermeasures under section 319F– 

20 1 or 319F–2.’’ 

21 SEC. 14. NATIONAL PATHOLOGY CENTER. 

22 (a) IN GENERAL.—Title IV of the Public Health 

23 Service Act (42 U.S.C. 281 et seq.) is amended— 

24 (1) in section 401(b)(2), by adding at the end 

25 the following: 
81 

•S 1873 IS 

1 ‘‘(H) The National Pathology Center.’’; and 

2 (2) by adding at the end of part E (42 U.S.C. 

3 287 et seq.) the following: 

4 ‘‘Subpart 7—National Pathology Center 

5 ‘‘SEC. 485A. ESTABLISHMENT OF NATIONAL PATHOLOGY 

6 CENTER. 

7 ‘‘In order to provide pathology consultation for civil8 ian and military health professionals (including Depart9 ment of Veterans Affairs health professionals) there is es10 tablished the National Pathology Center (in this subpart 

11 referred to as the ‘Center’). The Center shall be headed 

12 by a director, who shall be appointed by the Secretary. 

13 The Director of the Center shall report directly to the Di14 rector of NIH. 

15 ‘‘SEC. 485B. PURPOSES AND FUNCTIONS OF THE CENTER. 

16 ‘‘(a) PURPOSES OF THE CENTER.—The general pur17 poses of the Center are to— 

18 ‘‘(1) conduct and support research, education, 

19 training, and other programs with respect to the 

20 science and clinical practice of pathology; 

21 ‘‘(2) maintain and improve a pathology tissue 

22 repository; and 

23 ‘‘(3) provide pathology consultation services. 
82 

•S 1873 IS 

1 ‘‘(b) ACTIVITIES OF THE DIRECTOR.—In order to 

2 carry out the purposes of the Center described in sub3 section (a), the Director of the Center— 

4 ‘‘(1) shall— 

5 ‘‘(A) maintain and improve a comprehen6 sive repository of pathological specimens; 

7 ‘‘(B) provide consultations on request re8 garding clinical cases; 

9 ‘‘(C) conduct educational programs and 

10 publish educational materials on the science 

11 and clinical practice of pathology; 

12 ‘‘(D) maintain and improve registries on 

13 such clinical conditions as the Director of the 

14 Center determines appropriate; and 

15 ‘‘(E) conduct and support research on pa16 thology; and 

17 ‘‘(2) may— 

18 ‘‘(A) collect reasonable and appropriate 

19 fees for the activities described in paragraph 

20 (1)(B); and 

21 ‘‘(B) conduct such other activities as the 

22 Director of the Center determines appropriate 

23 to carry out the purposes described in sub24 section (a). 
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1 ‘‘(c) AUTHORITY FOR EXPERT OPINIONS.—The Di2 rector of the Center may enter into memoranda of under3 standing with officials at the Department of Veterans Af4 fairs and the Department of Defense to provide expert sec5 ond opinion pathology consultations and pathology edu6 cation or training if the Secretary of either such Depart7 ment determines that such provision would be in the best 

8 interest of either of their respective departments. 

9 ‘‘SEC. 485C. BOARD OF REGENTS. 

10 ‘‘(a) MEMBERSHIP.— 

11 ‘‘(1) IN GENERAL.—There is established a 

12 Board of Regents of the Center (in this subpart re13 ferred to as the ‘Board’) consisting of— 

14 ‘‘(A) the Surgeons General of— 

15 ‘‘(i) the Public Health Service; 

16 ‘‘(ii) the Army; 

17 ‘‘(iii) the Navy; and 

18 ‘‘(iv) the Air Force; 

19 ‘‘(B) the Chief Medical Director of the De20 partment of Medicine and Surgery of the De21 partment of Veterans Affairs; 

22 ‘‘(C) the Deputy Director of the National 

23 Library of Medicine; 

24 ‘‘(D) the Assistant Secretary of Health of 

25 the Department of Defense; 
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1 ‘‘(E) the Dean of the Uniformed Services 

2 University of the Health Sciences; and 

3 ‘‘(F) 11 members to be appointed by the 

4 Secretary from among leaders in pathology re5 search, education and clinical practice. 

6 ‘‘(2) EX OFFICIO MEMBERS.—The members of 

7 the Board described in subparagraphs (A) through 

8 (E) of paragraph (1) shall serve as ex officio mem9 bers of the Board. 

10 ‘‘(3) CHAIRPERSON.—The members of the 

11 Board appointed under paragraph (1)(F) shall an12 nually elect one of such members to serve as the 

13 Chairperson of the Board until the next election. 

14 ‘‘(b) DUTIES OF THE BOARD.—It shall be the duty 

15 of the Board to advise, consult with, and make rec16 ommendations to the Director of NIH on important mat17 ters of policy in regard to the Center, including such mat18 ters as the scope, content and organization of the research, 

19 education and consultative services provided by the Cen20 ter. The Board shall make recommendations to the Direc21 tor of NIH regarding the rules under which specimens 

22 from the tissue repository will be used and under which 

23 it’s publications, facilities and services will be made avail24 able to various kinds of users. 
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1 ‘‘(c) TERMS OF OFFICE.—Each appointed member of 

2 the Board shall hold office for a term of 4 years, except 

3 that any member appointed to fill a vacancy occurring 

4 prior to the expiration of the term for which the prede5 cessor of such member was appointed shall be appointed 

6 for the remainder of such term. None of the appointed 

7 members shall be eligible for reappointment within 1 year 

8 after the end of the preceding term of such member. 

9 ‘‘(d) COMPENSATION.—Appointed members of the 

10 Board who are not otherwise in the employ of the United 

11 States, while attending conferences of the Board or other12 wise serving at the request of the Secretary in connection 

13 with the administration of the Board, shall be entitled to 

14 receive compensation, per diem in lieu of subsistence, and 

15 travel expenses in the same manner and under the same 

16 conditions as that prescribed under section 208(c). 

17 ‘‘SEC. 485D. GIFTS TO THE CENTER. 

18 ‘‘Section 231 shall be applicable to the acceptance 

19 and administration of gifts made for the benefit of the 

20 Center or for carrying out any of its functions. 

21 ‘‘SEC. 485E. CENTER FACILITIES. 

22 ‘‘There are authorized to be appropriated amounts 

23 sufficient for the erection and equipment of suitable and 

24 adequate buildings and facilities for use of the Center. The 

25 Administrator of General Services may acquire, by pur-
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1 chase, condemnation, donation, or otherwise, a suitable 

2 site or sites, selected by the Secretary in accordance with 

3 the direction of the Board, for such buildings and facilities 

4 and to erect thereon, furnish, and equip such buildings 

5 and facilities. The amounts authorized to be appropriated 

6 by this section include the cost of preparation of drawings 

7 and specifications, supervision of construction, and other 

8 administrative expenses incident to the work. The Admin9 istrator of General Services shall prepare the plans and 

10 specifications, make all necessary contracts, and supervise 

11 construction.’’. 

12 (b) REPORT.—Not later than 12 months after the 

13 date of enactment of this Act, the Secretary of Health and 

14 Human Services shall submit a report to the appropriate 

15 committees of Congress that contains— 

16 (1) a review of all functions and duties of the 

17 National Pathology Center under subpart 7 of part 

18 E of title IV of the Public Health Service Act,as es19 tablished by subsection (a); 

20 (2) areas where such functions and duties over21 lap with the functions and duties of the National In22 stitutes of Health; and 

23 (3) recommendations concerning necessary 

24 modifications to the National Pathology Center. 
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1 (c) TRANSFER OF THE ARMED FORCES INSTITUTE

2 OF PATHOLOGY.— 

3 (1) IN GENERAL.— 

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

5 subparagraph (B), there are transferred to the 

6 National Pathology Center established under 

7 subpart 7 of part E of title IV of the Public 

8 Health Service Act all functions, duties, per9 sonnel, assets, liabilities, contracts, property, 

10 records, and unexpended balances of appropria11 tions of the Armed Forces Institute of Pathol12 ogy. The preceding sentence shall not affect any 

13 proceedings, pending applications, suits, or 

14 other actions pending on the date of enactment 

15 of this Act. 

16 (B) EXCEPTIONS.—The following compo17 nents of the Armed Forces Institute of Pathol18 ogy shall not be transferred from the Depart19 ment of Defense pursuant to subparagraph (A): 

20 (i) The Armed Forces Medical Exam21 iner. 

22 (ii) The Department of Defense DNA 

23 registry. 

24 (iii) Accident Investigation Program. 
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1 (iv) The histopathology training pro2 gram. 

3 (v) The patient safety center. 

4 (vi) Department of Legal Medicine. 

5 (vii) Center for Clinical Laboratory 

6 Medicine. 

7 (viii) Drug Testing and Quality As8 surance Program. 

9 (ix) Subject to the discretion of the 

10 Secretary of Defense, medical research 

11 programs on the following: 

12 (I) Body armor. 

13 (II) Environmental sarcoidosis. 

14 (III) Depleted uranium. 

15 (IV) Military working dogs. 

16 (V) Such other areas of research 

17 related to pathology as the Secretary 

18 of Defense shall choose to conduct. 

19 (2) REFERENCES.—Any reference in any Fed20 eral law, Executive order, rule, regulation, or delega21 tion of authority, or any document of or relating to 

22 the Armed Forces Institute of Pathology shall be 

23 deemed to be a reference to the National Pathology 
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1 Center established under subpart 7 of part E of title 

2 IV of the Public Health Service Act. 

Æ