II 

Calendar No. 257 

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, Mr. ALEXANDER, 

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

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

OCTOBER 24, 2005 

Reported by Mr. ENZI, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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’’. 
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1 SEC. 2. TABLE OF CONTENTS. 

2 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. 

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. 

3 SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOP4 MENT AGENCY. 

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

6 241 et seq.) is amended by inserting after section 319K 

7 the following: 

8 ‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DE9 VELOPMENT AGENCY. 

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

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

12 Biomedical Advanced Research and Development 

13 Agency. 

14 ‘‘(2) FUND.—The term ‘Fund’ means the Bio15 defense Medical Countermeasure Development Fund 

16 established under subsection (d). 

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

18 transactions’ means transactions, other than pro-
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1 curement contracts, grants, and cooperative agree2 ments, including transactions for prototypes, as pro3 vided to the Secretary of Defense under section 

4 2371 of title 10, United States Code. 

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

6 ‘qualified countermeasure’ has the meaning given 

7 such term in section 319F–1. 

8 ‘‘(5) QUALIFIED COUNTERMEASURE AND

9 QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT AD10 VANCED RESEARCH AND DEVELOPMENT.— 

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

12 countermeasure and qualified pandemic or epi13 demic product advanced research and develop14 ment’ means any applied research, testing, or 

15 evaluation (including those conducted on hu16 mans or animals), related to the safety or effec17 tiveness, that is required for approval, clear18 ance, or licensing by the Secretary under this 

19 Act or the Federal Food, Drug, and Cosmetic 

20 Act, of such countermeasure or pandemic or 

21 epidemic product to diagnose, mitigate, prevent, 

22 or treat harm from a deliberate, accidental, or 

23 natural exposure to a chemical, biological, radi24 ological, or nuclear agent, particularly such ex-
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1 posure resulting from an act of terrorism or po2 tential pandemic infectious disease. 

3 ‘‘(B) INCLUSION.—The term under sub4 paragraph (A) includes any investigation to im5 prove the manufacturing, formulation, finish, 

6 fill, delivery, or shelf-life of such qualified coun7 termeasures or qualified pandemic or epidemic 

8 products. 

9 ‘‘(6) QUALIFIED PANDEMIC OR EPIDEMIC PROD10 UCT.—The term ‘qualified pandemic or epidemic 

11 product’ has the meaning given the term in section 

12 319F–3(c)(5). 

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

14 ‘security countermeasure’ has the meaning given 

15 such term in section 319F–2. 

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

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

19 Federal, State, or local agency or department. 

20 ‘‘(b) BIOMEDICAL ADVANCED RESEARCH AND DE21 VELOPMENT AGENCY.— 

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

23 within the Department of Health and Human Serv24 ices, the Biomedical Advanced Research and Devel25 opment Agency. 
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1 ‘‘(2) PURPOSE.—It shall be the purpose of the 

2 BARDA to coordinate and oversee activities that 

3 support and accelerate qualified countermeasure or 

4 qualified pandemic or epidemic product (referred to 

5 in this section as ‘countermeasure or product’) ad6 vanced research and development by— 

7 ‘‘(A) directing and coordinating collabora8 tion among the Department of Health and 

9 Human Services, other Federal agencies, rel10 evant industries, academia, and other persons, 

11 with respect to such advanced research and de12 velopment; 

13 ‘‘(B) supporting countermeasure and prod14 uct advanced research and development; 

15 ‘‘(C) recommending approaches to mod16 ernize and streamline the countermeasure or 

17 product development process and reduce regu18 latory burdens with respect to procurement of 

19 security countermeasures and qualified pan20 demic or epidemic products; and 

21 ‘‘(D) supporting innovation to reduce the 

22 time and cost of countermeasure and product 

23 advanced research and development. 
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1 ‘‘(3) DIRECTOR.—The BARDA shall be headed 

2 by a Director (referred to in this section as the ‘Di3 rector’) who shall— 

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

5 the advice and consent of the Senate; 

6 ‘‘(B) report to the Secretary; and 

7 ‘‘(C) serve as the principal advisor to the 

8 Secretary on countermeasure and product ad9 vanced research and development. 

10 ‘‘(4) DUTIES OF DIRECTOR.— 

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

12 purpose described in paragraph (2)(A), the Sec13 retary, acting through the Director, shall— 

14 ‘‘(i) increase appropriate communica15 tion between the Federal Government and 

16 relevant industries, academia, and other 

17 interested persons with respect to counter18 measure and product advanced research 

19 and development by establishing trans20 parent, expeditious, and direct processes 

21 to— 

22 ‘‘(I) facilitate regular, ongoing 

23 communication regarding the proc24 esses established under subparagraph 
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1 (C)(ii) and new countermeasures or 

2 products of interest; 

3 ‘‘(II) solicit research and associ4 ated data on potential counter5 measures and products and related 

6 technologies; and 

7 ‘‘(III) provide technical assist8 ance with respect to such processes 

9 and the Food and Drug Administra10 tion approval process; 

11 ‘‘(ii) at least annually— 

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

14 academia, other Federal agencies, 

15 international agencies, and other in16 terested persons; and 

17 ‘‘(II) sponsor relevant biodefense 

18 countermeasure technology dem19 onstrations; 

20 ‘‘(iii) carry out the activities described 

21 in subsection (g) of section 2 of the Clay22 ton Act; and 

23 ‘‘(iv) encourage and coordinate coun24 termeasure or product advanced research 

25 and development, including by convening 
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1 working groups as identified in paragraph 

2 (5). 

3 ‘‘(B) SUPPORT ADVANCED RESEARCH AND

4 DEVELOPMENT.—To carry out the purpose de5 scribed in paragraph (2)(B), the Secretary, act6 ing through the Director, shall— 

7 ‘‘(i) conduct continuous searches and 

8 support calls for potential countermeasures 

9 or products for drugs, biological products, 

10 devices, or research tools to diagnose, miti11 gate, prevent, or treat harm from existing, 

12 emerging, or possible chemical, biological, 

13 radiological, and nuclear agents or poten14 tial pandemic infectious diseases that 

15 threaten public health and national secu16 rity, as identified by the Assistant Sec17 retary for Public Health Emergency Pre18 paredness; 

19 ‘‘(ii) direct the countermeasure and 

20 product advanced research and develop21 ment activities of the Department of 

22 Health and Human Services, in consulta23 tion with the Assistant Secretary for Pub24 lic Health Emergency Preparedness, the 

25 Director of the National Institutes of 
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1 Health, the Director of the Centers for the 

2 Disease Control and Prevention, and the 

3 Commissioner of Food and Drugs; and 

4 ‘‘(iii) award contracts, grants, cooper5 ative agreements, and enter into other 

6 transactions, to include use of simplified 

7 acquisition authorities provided under sec8 tions 319F–1 and 319F–2(c)(7)(C)(iii), to 

9 public and private persons, including for10 profit and nonprofit persons, federally 

11 funded research and development centers, 

12 and universities, to— 

13 ‘‘(I) support the cost of counter14 measure and product advanced re15 search and development; and 

16 ‘‘(II) ensure accelerated develop17 ment of countermeasures and prod18 ucts. 

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

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

21 the Secretary, acting through the Director, 

22 shall— 

23 ‘‘(i) receive from the Assistant Sec24 retary for Public Health Emergency Pre25 paredness, requirements for national civil-
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1 ian biodefense needs, particularly counter2 measures or products and other tech3 nologies, to diagnose, mitigate, prevent, or 

4 treat harm from existing, emerging, or po5 tential chemical, biological, radiological, or 

6 nuclear agents or potential pandemic infec7 tious diseases; 

8 ‘‘(ii) establish transparent, expedi9 tious, and direct processes for selecting 

10 promising countermeasures and products, 

11 supporting them through advanced re12 search and development and recommending 

13 them for procurement; 

14 ‘‘(iii) establish an office within the 

15 BARDA, in consultation with the Commis16 sioner of Food and Drugs, to— 

17 ‘‘(I) facilitate regular and ongo18 ing communication between the 

19 BARDA and the Food and Drug Ad20 ministration regarding the status of 

21 BARDA advanced research and devel22 opment activities; 

23 ‘‘(II) ensure that such activities 

24 are coordinated with the approval re25 quirements of the Food and Drug Ad-
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1 ministration, with the goal of expe2 diting the development and approval 

3 of countermeasures and products; and 

4 ‘‘(III) connect interested persons 

5 with additional technical assistance 

6 made available under section 565 of 

7 the Federal Food, Drug, and Cos8 metic Act; 

9 ‘‘(iv) coordinate with the Food and 

10 Drug Administration to facilitate regu11 latory review and approval of promising 

12 classes of countermeasures or products 

13 through the development of research tools; 

14 and 

15 ‘‘(v) recommend to the Secretary, 

16 through the Assistant Secretary for Public 

17 Health Emergency Preparedness, procure18 ment of the most promising eligible secu19 rity countermeasures or qualified pandemic 

20 or epidemic products identified in clause 

21 (i). 

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

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

24 the Secretary, acting through the Director, 

25 shall award contracts, grants, cooperative 
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1 agreements, or enter into other transactions, to 

2 include use of simplified acquisition authorities 

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

4 2(c)(7)(C)(iii), to the entities described in sub5 paragraph (B)(iii), to promote innovation in 

6 technologies supporting the advanced research 

7 and development and production of qualified or 

8 security countermeasures or qualified pandemic 

9 or epidemic products, such as research tools, 

10 manufacturing, countermeasure administration, 

11 storage, and bioinformatics and other devices. 

12 ‘‘(E) OTHER DUTIES.— 

13 ‘‘(i) IN GENERAL.—The Director 

14 may— 

15 ‘‘(I) prepare and submit to the 

16 President and Congress, an annual 

17 budget estimate for qualified counter18 measure and pandemic or epidemic 

19 product advanced research and devel20 opment and other BARDA activities, 

21 after opportunity for comment by the 

22 Secretary; and 

23 ‘‘(II) receive from the President 

24 and the Office of Management and 

25 Budget directly all funds appropriated 
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1 by Congress for obligation and ex2 penditure by the BARDA. 

3 ‘‘(ii) SECRETARY DUTIES.—The Sec4 retary, acting through the Director, may— 

5 ‘‘(I) enter into such contracts, 

6 leases, cooperative agreements, or 

7 other transactions, as may be nec8 essary to carry out the functions of 

9 BARDA, without regard to section 

10 3648 and 3709 of the Revised Stat11 utes of the United States (31 U.S.C. 

12 3324(a) and (b)), (41 U.S.C. 5), with 

13 any public agency, any firm, associa14 tion, corporation, or educational insti15 tution, or any other person; 

16 ‘‘(II) support advanced research 

17 and development and innovation of 

18 potential countermeasures or products 

19 by highly qualified foreign nationals 

20 outside the United States that may 

21 inure to the benefit of the American 

22 people and collaborative research in23 volving American and foreign partici24 pants; 
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1 ‘‘(III) administer grants using 

2 milestone-based awards and pay3 ments; and 

4 ‘‘(IV) establish 1 or more feder5 ally funded research and development 

6 centers or university affiliated re7 search centers in accordance with sec8 tion 253(c)(3) of title 41, United 

9 States Code. 

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

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

12 consultation with the Vulnerable Populations Work13 ing Group, may give priority to supporting and fa14 cilitating advanced research and development of 

15 countermeasures or products, and formulations of 

16 countermeasures or products, that are likely to be 

17 safe and effective for pediatric populations, pregnant 

18 women, and other vulnerable populations. 

19 ‘‘(6) WORKING GROUPS.— 

20 ‘‘(A) IDENTIFICATION OF TECH21 NOLOGIES.— 

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

23 establish and convene, or enter into a con24 tract with a public or private research in25 stitution to convene, one or more working 
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1 groups that consists of experts on counter2 measure technology to identify innovative 

3 technologies that have the potential to be 

4 developed as countermeasures or products. 

5 ‘‘(ii) MEETINGS.—A working group 

6 established under clause (i) shall partici7 pate in regular meetings with sponsors of 

8 countermeasures, products, or related tech9 nologies to— 

10 ‘‘(I) review the scientific evidence 

11 or concept of such countermeasures, 

12 products, or related technologies; 

13 ‘‘(II) provide guidance on re14 search protocols or studies; and 

15 ‘‘(III) provide guidance on the 

16 regulatory approval process for coun17 termeasures, products, and related 

18 technologies. 

19 ‘‘(iii) RECOMMENDATIONS.—Not later 

20 than 30 days after each meeting with a 

21 sponsor of a countermeasure, product, or 

22 related technology, the working group shall 

23 make recommendations to the Director 

24 concerning such countermeasure, product, 

25 or related technology. 
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1 ‘‘(iv) CONFIDENTIALITY.—Any com2 mercial confidential or proprietary infor3 mation that is disclosed to the working 

4 group in a meeting under this section shall 

5 remain confidential and shall not be dis6 closed other than to the Secretary or the 

7 Director, or their designees. 

8 ‘‘(v) CONSTRUCTION.—Nothing in 

9 this subparagraph shall be construed to 

10 prohibit a sponsor from meeting with the 

11 Director to discuss potential counter12 measures, products, or related tech13 nologies. 

14 ‘‘(B) PUBLIC WORKING GROUP.—The Di15 rector may establish and convene one or more 

16 working groups composed of private citizens 

17 and officials of Federal, State, and local govern18 ments to advise such Director with respect to 

19 the functions of the BARDA and the Director. 

20 ‘‘(C) VULNERABLE POPULATIONS WORK21 ING GROUP.—The Director shall establish and 

22 convene a Vulnerable Populations Working 

23 Group composed of experts on pediatric popu24 lations, pregnant women, and other vulnerable 
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1 populations to advise such Director with respect 

2 to— 

3 ‘‘(i) supporting and facilitating ad4 vanced research and development of coun5 termeasures, and formulations of counter6 measures, that are safe and effective for 

7 such populations; and 

8 ‘‘(ii) other activities of the BARDA 

9 that effect such populations. 

10 ‘‘(7) PERSONNEL AUTHORITIES.— 

11 ‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC

12 AND PROFESSIONAL PERSONNEL.—In hiring 

13 personnel for the BARDA, the Director shall 

14 have the hiring and management authorities de15 scribed in section 1101 of the Strom Thurmond 

16 National Defense Authorization Act for Fiscal 

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

18 105–261). With respect to the personnel of the 

19 BARDA, the term of appointments for employ20 ees referred to under subsection (c)(1) of that 

21 section may not exceed 5 years before the 

22 granting of any extension under subsection 

23 (c)(2) of that section. 
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1 ‘‘(B) SPECIAL CONSULTANTS.—The Direc2 tor may accept special consultants as personnel 

3 for the BARDA under section 207(f). 

4 ‘‘(C) INTERGOVERNMENTAL PERSONNEL

5 ACT.—The Director may accept as personnel 

6 for the BARDA, employees under subchapter 

7 VI of chapter 33 of subpart B of part III of 

8 title 5, United States Code. 

9 ‘‘(D) OTHER SERVICES.—The Director 

10 may accept voluntary and uncompensated serv11 ices. 

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

13 ‘‘(1) IN GENERAL.— 

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

15 Advisory Board shall provide expert advice and 

16 guidance to the Secretary on the threats, chal17 lenges, and opportunities presented by advances 

18 in biological and life sciences and the threat 

19 from natural infectious diseases and chemical, 

20 biological, radiological, and nuclear threats. 

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

22 the National Biodefense Advisory Board (here23 inafter in this section referred to as the 

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

25 represent the Nation’s preeminent scientific, 
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1 public health, and medical experts on the sub2 ject of biological, chemical, nuclear, and radio3 logical threats, whether naturally occurring, ac4 cidental, or deliberate, as follows: 

5 ‘‘(i) EX OFFICIO.—The following 

6 members shall serve on the Board ex offi7 cio: 

8 ‘‘(I) The Assistant to the Presi9 dent for Homeland Security and 

10 Counterterrorism. 

11 ‘‘(II) The Director of the Office 

12 of Science and Technology Policy. 

13 ‘‘(III) The Assistant Secretary 

14 for Public Health Emergency Pre15 paredness. 

16 ‘‘(IV) The Director of the Na17 tional Institutes of Health. 

18 ‘‘(V) The Director of the Centers 

19 for Disease Control and Prevention. 

20 ‘‘(VI) The Commissioner of Food 

21 and Drugs. 

22 ‘‘(VII) The Director of BARDA. 

23 ‘‘(VIII) The Assistant Secretary 

24 of Defense for Health Affairs. 
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1 ‘‘(IX) The Assistant Secretary of 

2 Homeland Security for Science and 

3 Technology. 

4 ‘‘(X) The Secretary of Agri5 culture (or a designee). 

6 ‘‘(ii) APPOINTED MEMBERS.—The fol7 lowing individuals, as appointed by the 

8 Secretary: 

9 ‘‘(I) Four representatives of the 

10 pharmaceutical and biotechnology in11 dustries. 

12 ‘‘(II) Four representatives of aca13 demia. 

14 ‘‘(III) Five other members as de15 termined appropriate by the Sec16 retary. 

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

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

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

20 the Secretary may adjust the terms of the ini21 tial Board appointees in order to provide for a 

22 staggered term of appointment for all members. 

23 ‘‘(D) CONSECUTIVE APPOINTMENTS; MAX24 IMUM TERMS.—A member may be appointed to 
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1 serve not more than 3 terms on the Board and 

2 may serve not more than 2 consecutive terms. 

3 ‘‘(2) DUTIES.—The Board shall— 

4 ‘‘(A) advise the Secretary on major bio5 defense initiatives and review ongoing and pro6 posed biodefense programs, which may include 

7 potential activities of the BARDA; and 

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

9 BARDA, and in coordination with the Director 

10 of National Institute of Allergy and Infectious 

11 Diseases, provide to the Secretary, rec12 ommendations and findings for an expanded, 

13 intensified, and coordinated biodefense research 

14 program encompassing the programs of the 

15 BARDA and other Federal agencies and related 

16 programs of the other research institutes. 

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

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

19 annually to provide to the Secretary updated assess20 ments, findings, and recommendations of the current 

21 trends, challenges, and opportunities posed in bio22 technology and genetic engineering. 

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

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

25 same manner as the original appointment. 
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1 ‘‘(5) CHAIRPERSON.—The Secretary shall ap2 point a chairperson from among the members of the 

3 Board. 

4 ‘‘(6) POWERS.— 

5 ‘‘(A) HEARINGS.—The Board may hold 

6 such hearings, sit and act at such times and 

7 places, take such testimony, and receive such 

8 evidence as the Board considers advisable to 

9 carry out this subsection. 

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

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

15 ‘‘(7) PERSONNEL.— 

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

18 employee of the Federal Government may not 

19 receive additional pay, allowances, or benefits 

20 by reason of the member’s service on the 

21 Board. 

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

23 Board that is not an employee of the Federal 

24 Government shall be compensated at a rate 

25 equivalent to the daily equivalent of the annual 
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1 rate of basic pay prescribed for level IV of the 

2 Executive Schedule under section 5315 of title 

3 5, United States Code, for each day (including 

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

6 member of the Board. 

7 ‘‘(C) TRAVEL EXPENSES.—Each member 

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

12 Code. 

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

15 be detailed to the Board without reimburse16 ment, and such detail shall be without interrup17 tion or loss of civil service status or privilege. 

18 ‘‘(d) FUND.— 

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

20 the Biodefense Medical Countermeasure Develop21 ment Fund, which shall be administered by the Di22 rector of the BARDA. 

23 ‘‘(2) FUNDS.— 

24 ‘‘(A) FIRST FISCAL YEAR.—Of the 

25 amounts appropriated to carry out the Project 
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1 BioShield Act of 2004 (Public Law 108–276) 

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

3 available to the Fund to carry out this section 

4 for fiscal year 2006. Such amounts shall remain 

5 available until expended. 

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

7 are authorized to be appropriated such sums as 

8 may be necessary to carry out this section for 

9 fiscal year 2007 and each subsequent fiscal 

10 year. Such sums shall remain available until ex11 pended. 

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

13 shall be construed to limit any authority of the Depart14 ment of Health and Human Services, including those au15 thorities provided under the Project BioShield Act of 2004 

16 (Public Law 108–276). 

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

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

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

20 activities, working groups, and advisory boards of 

21 the BARDA. 

22 ‘‘(2) FOIA.—Information that relates to the ac23 tivities, working groups, and advisory boards of the 

24 BARDA shall not be subject to disclosure under sec25 tion 552 of title 5, United States Code, unless the 
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1 Secretary or Director determines that such disclo2 sure would pose no threat to national security. Such 

3 a determination shall not be subject to judicial re4 view. 

5 ‘‘(3) CERTAIN COST PRINCIPLES AND COST AC6 COUNTING STANDARDS.—Notwithstanding any other 

7 provision of law, the cost principles set forth under 

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

9 cost accounting standards set forth under chapter 

10 99 of title 48, Code of Federal Regulations, and the 

11 requirement for the submission of certified cost and 

12 pricing information under section 304A of the Fed13 eral Property and Administrative Services Act of 

14 1949 (41 U.S.C. 254b), shall not apply to any con15 tract, grant, cooperative agreement, or other trans16 action entered into under the Project BioShield Act 

17 of 2004 (Public Law 108–276).’’. 

18 SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 

19 BY PROJECT BIOSHIELD. 

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

21 1(a) of the Public Health Service Act (42 U.S.C. 247d– 

22 6a(a)) is amended by striking paragraph (2) and inserting 

23 the following: 

24 ‘‘(2) DEFINITIONS.—In this section: 
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1 ‘‘(A) QUALIFIED COUNTERMEASURE.—The 

2 term ‘qualified countermeasure’ means a drug 

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

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

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

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

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

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

9 and Cosmetic Act (21 U.S.C. 321(h))), or re10 search tool (as that term is defined in section 

11 201(rr) of the Federal Food, Drug, and Cos12 metic Act) that the Secretary determines to be 

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

14 304(a) of the Homeland Security Act of 2002) 

15 to— 

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

17 treat harm from any biological agent (in18 cluding organisms that cause an infectious 

19 disease) or toxins, chemical, radiological, 

20 or nuclear agent that may cause a public 

21 health emergency affecting national secu22 rity; 

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

24 treat harm from a condition that may re25 sult in adverse health consequences or 
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1 death and may be caused by administering 

2 a drug, biological product, or device that is 

3 used as described in this subparagraph; or 

4 ‘‘(iii) in the case of a research tool, 

5 enable the rapid and effective identifica6 tion, assessment, or development of a drug, 

7 biological product, or device to diagnose, 

8 mitigate, prevent, or treat harm, as de9 scribed in clause (i) or (ii). 

10 ‘‘(B) INFECTIOUS DISEASE.—The term ‘in11 fectious disease’ means a disease potentially 

12 caused by a pathogenic organism (including a 

13 bacteria, virus, fungus, or parasite) that is ac14 quired by a person and that reproduces in that 

15 person.’’. 

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

17 2(c)(1)(B) is amended by— 

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

19 each place it appears and inserting ‘‘diagnose, 

20 mitigate, prevent, or treat’’; and 

21 (B) inserting ‘‘agent (including organisms 

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

23 ‘‘any biological’’. 
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1 (c) RESEARCH TOOL.—Section 201 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amend3 ed by adding at the end the following: 

4 ‘‘(rr) RESEARCH TOOL.—The term ‘research tool’ in5 cludes the full range of tools and systems that assist in 

6 the discovery, development, or manufacture of drugs, bio7 logical products (as defined in section 351 of the Public 

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

9 SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUN10 TERMEASURE PRODUCTS. 

11 (a) MARKET EXCLUSIVITY.—Subchapter A of chap12 ter V of the Federal Food, Drug, and Cosmetic Act (21 

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

14 505B the following: 

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

16 COUNTERMEASURE PRODUCTS. 

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

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

19 countermeasure product is designated under section 526 

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

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

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

23 the term ‘countermeasure’ means a drug or biological 

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

25 Public Health Service Act) that the Secretary determines 
29 

•S 1873 RS 

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

2 304(a) of the Homeland Security Act of 2002) to diag3 nose, mitigate, prevent, or treat harm from any biological, 

4 chemical, radiological, or nuclear agent (including orga5 nisms that cause an infectious disease) or toxin identified 

6 as a material threat under subsection (c)(2)(A)(ii) of sec7 tion 319F–2 of the Public Health Service Act.’’. 

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

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

10 360bb) a biological, chemical, radiological, or nuclear 

11 agent (including organisms that cause an infectious dis12 ease) or toxin identified as a material threat under sub13 section (c)(2)(A)(ii) of section 319F–2 of the Public 

14 Health Service Act shall be considered to be a ‘‘rare dis15 ease or condition’’ within the meaning of such term in 

16 such section 526. The Secretary may designate antibiotics 

17 and anti-infective products that treat infectious diseases 

18 as designated drugs or biological products under such sec19 tion 526. 

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

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

22 applications and biological product licenses approved 

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

24 Public Health Service Act after the date of enactment of 

25 this Act. 
30 

•S 1873 RS 

1 SEC. 6. LIABILITY PROTECTIONS FOR PANDEMICS, 

2 EPIDEMICS, AND COUNTERMEASURES. 

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

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

5 247d–6b) the following: 

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

7 EPIDEMIC PRODUCTS AND SECURITY COUN8 TERMEASURES. 

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

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

11 distibutor, or administrator of a security countermeasure, 

12 or a qualified pandemic and epidemic product, described 

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

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

15 the design, development, clinical testing and investigation, 

16 manufacture, labeling, distribution, sale, purchase, dona17 tion, dispensing, prescribing, administration, or use of a 

18 security countermeasure, or a qualified pandemic and epi19 demic product, described in subsection (b)(1)(A). 

20 ‘‘(b) LITIGATION MANAGEMENT.— 

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

22 ‘‘(A) IN GENERAL.— 

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

24 shall exist against a person described in 

25 subsection (a) for claims for loss of prop26 erty, personal injury, or death arising out 
31 

•S 1873 RS 

1 of, reasonably relating to, or resulting from 

2 the design, development, clinical testing 

3 and investigation, manufacture, labeling, 

4 distribution, sale, purchase, donation, dis5 pensing, prescribing, administration, or use 

6 of a security countermeasure or qualified 

7 pandemic or epidemic product distributed, 

8 sold, purchased, donated, dispensed, pre9 scribed, administered, or used in anticipa10 tion of and preparation for, in defense 

11 against, or in response to, or recovery from 

12 an actual or potential public health emer13 gency that is a designated security coun14 termeasure or a qualified pandemic or epi15 demic product by the Secretary in a dec16 laration described in paragraph (2). 

17 ‘‘(ii) RULE OF CONSTRUCTION.—For 

18 purposes of this section, the phrase ‘aris19 ing out of, reasonably relating to, or re20 sulting from’ shall not be construed to 

21 apply to loss of property, personal injury, 

22 or death that has no alleged or potential 

23 causal relationship with the design, devel24 opment, clinical testing and investigation, 

25 manufacture, labeling, distribution, sale, 
32 

•S 1873 RS 

1 purchase, donation, dispensing, pre2 scribing, administration, or use of a prod3 uct described in clause (i). 

4 ‘‘(B) RULE.— 

5 ‘‘(i) SUBSEQUENT INJURY.—The pro6 tections set forth in subsection (a) and 

7 subparagraph (A) shall apply to all claims 

8 identified in subparagraph (A) that involve 

9 products distributed, sold, purchased, do10 nated, dispensed, prescribed, administered, 

11 or used during the effective period set 

12 forth in the designation provided for in 

13 paragraph (2), regardless of the date of al14 leged injury. 

15 ‘‘(ii) PRIVATE DONATION OR SALE.— 

16 The protections set forth in subsection (a) 

17 and subparagraph (A) shall apply to all 

18 claims identified in subparagraph (A) that 

19 involve security countermeasures or quali20 fied pandemic or epidemic products distrib21 uted, sold, purchased, donated, dispensed, 

22 prescribed, administered, or used during 

23 the effective period set forth in the des24 ignation provided for in paragraph (2) by 

25 a manufacturer through the commercial 
33 

•S 1873 RS 

1 market, provided that the security counter2 measures or the qualified pandemic or epi3 demic product are the security counter4 measure or qualified pandemic or epidemic 

5 product described in a declaration de6 scribed in paragraph (2) and the Secretary 

7 does not specifically prohibit such private 

8 donation or sale in such declaration. 

9 ‘‘(C) POTENTIAL LIABILITY UPON DETER10 MINATION.— 

11 ‘‘(i) IN GENERAL.—A manufacturer, 

12 distributor, administrator, or health care 

13 provider shall not be immune under sub14 section (a) or exempted from a cause of ac15 tion under subparagraph (A) if the Sec16 retary makes a determination as provided 

17 for in subparagraph (D). 

18 ‘‘(ii) INVESTIGATION BY SEC19 RETARY.—A party seeking a determination 

20 under subparagraph (D) may petition the 

21 Secretary to investigate allegations against 

22 a manufacturer, distributor, administrator, 

23 or health care provider arising out of, re24 lating to, or resulting from the design, de25 velopment, clinical testing and investiga-
34 

•S 1873 RS 

1 tion, manufacture, labeling, distribution, 

2 sale, purchase, donation, dispensing, pre3 scribing, administration, or use of products 

4 as provided for in subparagraph (A)(i). 

5 The decision to undertake such investiga6 tion shall be within the Secretary’s discre7 tion and shall not be subject to judicial re8 view. 

9 ‘‘(iii) RULE OF CONSTRUCTION.— 

10 Nothing in this section shall be construed 

11 to abrogate or limit the application of sub12 title II of chapter 5 and chapter 7 of title 

13 5, United States Code (commonly known 

14 as the Administrative Procedure Act). 

15 ‘‘(D) DETERMINATION BY SECRETARY.— 

16 ‘‘(i) IN GENERAL.—In making a de17 termination under this subparagraph, the 

18 Secretary, acting through an administra19 tive law judge, must find clear and con20 vincing evidence that— 

21 ‘‘(I) the manufacturer, dis22 tributor, administrator, or health care 

23 provider violated a provision of the 

24 Federal Food, Drug, and Cosmetic 
35 

•S 1873 RS 

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

2 Act; and 

3 ‘‘(II) in violating such Act, such 

4 manufacturer, distributor, adminis5 trator, or health care provider acted 

6 with willful misconduct. 

7 ‘‘(ii) EFFECT OF DETERMINATION.— 

8 If the Secretary finds such clear and con9 vincing evidence under clause (i), the Sec10 retary shall examine whether such willful 

11 misconduct to violate an Act under such 

12 clause— 

13 ‘‘(I) caused the product to 

14 present a significant or unreasonable 

15 risk to human health; and 

16 ‘‘(II) proximately caused the in17 jury alleged by the party. 

18 ‘‘(iii) NOTICE AND HEARING.—Prior 

19 to the Secretary’s making a determination 

20 under clause (i), the manufacturer, dis21 tributor, administrator, or health care pro22 vider shall have notice and a right to a for23 mal hearing in accordance with section 556 

24 of title 5, United States Code. 
36 

•S 1873 RS 

1 ‘‘(iv) EFFECT OF DETERMINATION.— 

2 Subject to subsection (c), the sole excep3 tion to the immunity from suit and liability 

4 of manufacturers, distributors, administra5 tors, or healthcare providers set forth in 

6 subsection (a) and subparagraph (A) shall 

7 be for actions against a manufacturer, dis8 tributor, administrator, or healthcare pro9 vider as provided in subparagraph (A). 

10 ‘‘(v) JUDICIAL REVIEW.—At any time 

11 prior to the 90th day following a deter12 mination by the Secretary under clause (i), 

13 any manufacturer, distributor, adminis14 trator, or health care provider named in 

15 such determination may file a petition with 

16 the United States Court District Court for 

17 the District of Columbia, for a judicial re18 view of such determination. A copy of the 

19 petition shall be forthwith transmitted by 

20 the clerk of the court to the Secretary or 

21 other officer designated by the Secretary 

22 for that purpose. The Secretary thereupon 

23 shall file in the court the record of the 

24 findings on which the Secretary based his 

25 or her determination. The filing of a peti-
37 

•S 1873 RS 

1 tion under this clause shall automatically 

2 stay the Secretary’s determination for the 

3 duration of the judicial proceeding. The 

4 sole parties to the judicial proceeding shall 

5 be the Secretary and the petitioner. Inter6 vention by third parties in the judicial pro7 ceeding shall not be permitted. No sub8 poenas shall be issued nor shall other com9 pulsory process apply. The court’s review 

10 of a determination by the Secretary under 

11 this clause shall conform to the procedures 

12 for judicial review of administrative orders 

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

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

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

16 the extent consistent with this section. 

17 ‘‘(vi) TOLLING OF STATUTE OF LIMI18 TATIONS.—The computation of the statute 

19 of limitations for any action against a 

20 manufacturer, distributor, administrator, 

21 or health care provider described under 

22 this subparagraph shall not include any 

23 time occurring before the determination by 

24 the Secretary under this subparagraph. 
38 

•S 1873 RS 

1 ‘‘(vii) REGULATORY AUTHORITY.— 

2 The Secretary, in consultation with the At3 torney General, shall promulgate regula4 tions defining what actions by a manufac5 turer, distributor, administrator, or 

6 healthcare provider of a security counter7 measure or a qualified pandemic and epi8 demic product shall be deemed to con9 stitute ‘willful misconduct’ for purposes of 

10 clause (i). In promulgating such regula11 tions, the Secretary shall consider the na12 ture of the actual or potential public health 

13 emergency, the timing and extent of any 

14 vaccination or countermeasure program, 

15 and any other circumstances they deem 

16 significant, so that any civil actions per17 mitted under this subsection will not ad18 versely affect the public health. The Sec19 retary may specify the period of time for 

20 which such regulations apply. 

21 ‘‘(viii) EVIDENCE REQUIRED.—The 

22 Secretary, in consultation with the Attor23 ney General, shall promulgate regulations 

24 that require, in order to be a party under 
39 

•S 1873 RS 

1 this section, that an individual present evi2 dence that reasonably demonstrates that— 

3 ‘‘(I) such individual has suffered 

4 a loss as a direct result of the design, 

5 development, clinical testing and in6 vestigation, manufacture, labeling, 

7 distribution, sale, purchase, donation, 

8 dispensing, prescribing, or administra9 tion of a security countermeasure or 

10 qualified epidemic or pandemic prod11 uct; and 

12 ‘‘(II) the loss as described in sub13 clause (I) was a direct result of the 

14 willful misconduct of the manufac15 turer, distributor, administrator, or 

16 health care provider in violating the 

17 Federal Food, Drug, and Cosmetic 

18 Act or this Act. 

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

20 apply regardless of whether the suit or liability 

21 described in subsection (a) or the claim de22 scribed in subparagraph (A) arises from the de23 sign, development, clinical testing and investiga24 tion, manufacture, labeling, distribution, sale, 

25 purchase, donation, dispensing, prescribing, ad-
40 

•S 1873 RS 

1 ministration, or use by the Federal Government 

2 or by any person. 

3 ‘‘(2) DECLARATION BY SECRETARY.— 

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

5 issue a declaration, pursuant to this paragraph, 

6 that an actual or potential public health emer7 gency makes advisable the distribution, admin8 istration, or use of a security countermeasure 

9 or qualified pandemic or epidemic product. 

10 ‘‘(B) SECURITY COUNTERMEASURE OR

11 QUALIFIED PANDEMIC OR EPIDEMIC PROD12 UCT.—The Secretary shall specify in such dec13 laration the security countermeasures or quali14 fied pandemic or epidemic products to be sold 

15 by, purchased from, or donated by a manufac16 turer or drawn from the Strategic National 

17 Stockpile. 

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

19 shall specify in such declaration the beginning 

20 and the ending dates of the effective period of 

21 the declaration, which shall be not longer than 

22 6 months. The Secretary may subsequently 

23 amend such declaration to shorten or extend 

24 such effective period, provided that the new 
41 

•S 1873 RS 

1 ending data is after the date on which the dec2 laration is amended. 

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

4 promptly publish each such declaration and 

5 amendment in the Federal Register. 

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

7 this section shall be construed to abrogate or limit any 

8 right, remedy, or authority that the United States or any 

9 agency thereof may possess under any other provision of 

10 law. 

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

12 ‘‘(1) ADMINISTRATOR.—The term ‘adminis13 trator’ means a person employed by the State or 

14 local government, or their designee, who supervised 

15 or administered a program with respect to the ad16 ministration, dispensing, distribution, or provision of 

17 a security countermeasure or a qualified pandemic 

18 or epidemic product, including a person who has es19 tablished requirements, provided policy guidance, 

20 supplied technical or scientific advice or assistance. 

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

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

23 volunteer, who distributes, prescribes, administers, 

24 dispenses, provides a facility to administer, or super25 vises or oversees the administration of a security 
42 

•S 1873 RS 

1 countermeasure or a qualified pandemic or epidemic 

2 product, including persons who distribute, prescribe, 

3 administer, dispense, or provide a facility to admin4 ister in accordance with a designation under sub5 section (b)(2). 

6 ‘‘(3) LOSS.—The term ‘loss’ means death, phys7 ical injury, or loss of or damage to property, includ8 ing business interruption loss. 

9 ‘‘(4) MANUFACTURER.—The term ‘manufac10 turer’ includes— 

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

12 manufacturer; 

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

14 research tool, or component to the manufac15 turer; and 

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

17 affiliates, successors, and assigns of a manufac18 turer. 

19 ‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PROD20 UCT.—The term ‘qualified pandemic or epidemic 

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

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

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

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

25 of this Act) or device (as such term is defined by 
43 

•S 1873 RS 

1 section 201(h) of the Federal Food, Drug and Cos2 metic Act (21 U.S.C. 321(h))) designed, developed, 

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

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

5 harm such pandemic or epidemic might otherwise 

6 cause or a serious or life-threatening disease or con7 dition caused by such a product, that— 

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

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

10 or licensed under section 351 of this Act; 

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

12 determines that sufficient and satisfactory clin13 ical experience or research data (including data, 

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

15 support a reasonable conclusion that the prod16 uct will qualify for approval or licensing within 

17 8 years after the date the Secretary makes a 

18 declaration under paragraph (2); or 

19 ‘‘(C) is authorized for emergency use sec20 tion 564 of the Federal Food, Drug, and Cos21 metic Act, except that subsection (b) of such 

22 section shall not apply. 

23 ‘‘(6) PARTY.— The term ‘party’ means an indi24 vidual who can reasonably demonstrate to the Sec25 retary that such individual has suffered a loss (as 
44 

•S 1873 RS 

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

2 willful misconduct of a manufacturer, distributor, 

3 administrator, or health care provider. 

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

5 individual, partnership, corporation, association, en6 tity, or public or private corporation, including a 

7 Federal, State, or local agency or department. 

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

9 ‘security countermeasure’ has the meaning given 

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

11 SEC. 7. COMPENSATION. 

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

13 202 et seq.) is amended by adding at the end the fol14 lowing: 

15 ‘‘PART D—OTHER COMPENSATION PROGRAMS 

16 ‘‘SEC. 271. COVERED COUNTERMEASURES PROGRAM. 

17 ‘‘(a) IN GENERAL.—If the Secretary issues a Procla18 mation stating that there is a critical public health need 

19 for a covered individual to receive a covered counter20 measure during the effective period of the Proclamation, 

21 the Secretary shall establish a process to provide com22 pensation to such covered individuals for a covered injury, 

23 consistent with the Smallpox Emergency Personnel Pro24 tection program under part C. 

25 ‘‘(b) DEFINITION.—For purposes of this section: 
45 

•S 1873 RS 

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

2 ‘covered countermeasure’ means a qualified pan3 demic or epidemic (as defined in section 319F– 

4 3(c)(5)) or a security countermeasure (as defined in 

5 section 319F–2(c)(1)(B)) specified in the Proclama6 tion. 

7 ‘‘(2) COVERED INDIVIDUAL.—The term ‘cov8 ered individual’ means an individual— 

9 ‘‘(A) who is a health care worker, law en10 forcement officer, firefighter, security per11 sonnel, emergency medical personnel, other 

12 public health or safety personnel, or support 

13 personnel for such occupational specialties; 

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

15 identified in a State, local, or Department of 

16 Health and Human Services emergency re17 sponse plan approved by the Secretary; 

18 ‘‘(C) who has volunteered and been se19 lected to be a member of an emergency re20 sponse plan; and 

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

22 administered pursuant to such approved plan 

23 during the effective period of the Proclamation 

24 and prior to the time at which the Secretary de25 clares a public health emergency pursuant to 
46 

•S 1873 RS 

1 section 319 related to a covered countermeasure 

2 specified in the Proclamation. 

3 ‘‘(3) COVERED INJURY.—The term ‘covered in4 jury’ means an injury, disability, illness, condition, 

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

6 scarring or minor local reaction) determined by the 

7 Secretary to have been sustained by a covered indi8 vidual as the direct result of administration to the 

9 individual of a covered countermeasure. 

10 ‘‘(4) EFFECTIVE PERIOD OF THE PROCLAMA11 TION.—The term ‘effective period of the Proclama12 tion’ means the effective period specified in the 

13 Proclamation, unless extended by the Secretary. 

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

15 ‘emergency response plan’ or ‘plan’ means a re16 sponse plan detailing actions to be taken in prepara17 tion for a pandemic, epidemic, or biological, chem18 ical, nuclear agent or toxin that presents, or may 

19 present, a public health emergency. 

20 ‘‘(6) PROCLAMATION.—The term ‘Proclama21 tion’ means a Proclamation regarding the critical 

22 public health need for the administration of a cov23 ered countermeasure issued by the Secretary and 

24 published in the Federal Register. Such Proclama-
47 

•S 1873 RS 

1 tion shall specify the specific covered counter2 measure recommended for administration. 

3 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to require the creation of a com5 pensation program if the covered injuries are only minor 

6 injuries consistent with section (b)(3).’’. 

7 SEC. 8. REBATES AND GRANTS FOR RESEARCH DEVELOP8 MENT, AND MANUFACTURING OF VACCINES, 

9 QUALIFIED COUNTERMEASURES AND PAN10 DEMIC OR EPIDEMIC PRODUCTS. 

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

12 Human Services (referred to in this section as the ‘‘Sec13 retary’’) may award to a person with respect to an invest14 ment described in this section (or an amendment made 

15 by this section)— 

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

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

18 Public Health Service Act (as added by subsection 

19 (c)). 

20 (b) SURGE CAPACITY AND RESEARCH REBATES.— 

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

22 rebates out of any money in the Treasury not other23 wise appropriated to persons for the expansion of 

24 surge capacity for manufacturing vaccines, qualified 

25 countermeasures (as defined in 319F–1 of the Pub-
48 

•S 1873 RS 

1 lic Health Service Act, as amended by this Act) or 

2 qualified pandemic or epidemic products (as defined 

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

4 (referred to in this section as ‘‘vaccines, counter5 measures or products’’) and for vaccines, counter6 measures, or products research. 

7 (2) VACCINES, COUNTERMEASURES OR PROD8 UCTS MANUFACTURING FACILITIES INVESTMENT RE9 BATE.— 

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

11 section, vaccines, countermeasures or products 

12 manufacturing facilities investment rebate for 

13 any taxable year for a person (as defined with 

14 respect to such person for purposes of the In15 ternal Revenue Code of 1986) shall be an 

16 amount equal to 20 percent of the qualified in17 vestment for such taxable year. 

18 (B) VACCINES, COUNTERMEASURES OR

19 PRODUCTS MANUFACTURING FACILITIES IN20 VESTMENT.—For purposes of subparagraph 

21 (A), the qualified investment for any taxable 

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

23 countermeasures or products manufacturing fa24 cilities property placed in service by the person 

25 during the taxable year involved. 
49 

•S 1873 RS 

1 (C) VACCINES, COUNTERMEASURES AND

2 PRODUCTS MANUFACTURING FACILITIES PROP3 ERTY.—For purposes of this subsection, the 

4 term ‘‘vaccines, countermeasures and products 

5 manufacturing facilities property’’ means real 

6 and tangible personal property— 

7 (i)(I) the original use of which com8 mences with the person applying for the 

9 rebate; or 

10 (II) which is acquired through pur11 chase (as defined by section 179(d)(2) of 

12 the Internal Revenue Code of 1986); 

13 (ii) which is depreciable under section 

14 167 of the Internal Revenue Code of 1986; 

15 (iii) which is physically located in a 

16 State; 

17 (iv) which is used for the manufac18 ture, distribution, or research and develop19 ment of vaccines, countermeasures, or 

20 products; and 

21 (v) which is in compliance with appli22 cable good manufacturing practice and 

23 with any other applicable requirements 

24 which are promulgated by the Secretary, 

25 the Occupational Safety and Health Ad-
50 

•S 1873 RS 

1 ministration, or the Environmental Protec2 tion Agency, and which are applicable to 

3 such property. 

4 (D) DENIAL OF DOUBLE BENEFIT FOR

5 MANUFACTURING FACILITIES EXPENSES.—If 

6 any portion of the vaccines, countermeasures, 

7 and products manufacturing facilities property 

8 investment expenses is otherwise allowable as a 

9 deduction for the taxable year involved, the Sec10 retary shall only provide a rebate under this 

11 section for the portion of such expenses not cov12 ered by the rebate determined by such deduc13 tion. 

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

15 a rebate under this subsection, a manufacturer 

16 shall submit to the Secretary an application at 

17 such time, in such manner, and containing such 

18 information as the Secretary may require, in19 cluding— 

20 (i) a detailed description and intended 

21 use of the facilities that is the basis of ap22 plication; 

23 (ii) a detailed description of the vac24 cine, countermeasure, or product being 
51 

•S 1873 RS 

1 produced or that may be produced at the 

2 facility; 

3 (iii) a detailed accounting of qualified 

4 manufacturing facilities investment of the 

5 person; 

6 (iv) a certification as to the compli7 ance of the person with clauses (i) through 

8 (iv) of subparagraph (C); and 

9 (v) copies of tax returns for the tax10 able year involved. 

11 (F) EFFECTIVE DATE.—This paragraph 

12 shall apply to property placed in service after 

13 December 31, 2005. 

14 (G) TERMINATION.—This paragraph shall 

15 not apply to any property placed in service after 

16 December 31, 2010. 

17 (3) MEDICAL RESEARCH RELATED TO DEVEL18 OPING VACCINES, COUNTERMEASURES OR QUALIFIED

19 PANDEMIC OR EPIDEMIC PRODUCTS REBATE.— 

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

21 subsection, the research rebate determined 

22 under this section for the taxable year involved 

23 (as determined as provided for in paragraph 

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

25 vaccines, qualified countermeasures, or qualified 
52 

•S 1873 RS 

1 pandemic or epidemic products (referred to in 

2 this section as ‘‘vaccine, countermeasure, or 

3 product’’) research expenses for the taxable 

4 year. 

5 (B) VACCINES, COUNTERMEASURES, OR

6 PRODUCTS RESEARCH EXPENSES.—Except as 

7 otherwise provided in this paragraph, the term 

8 ‘‘vaccines, countermeasures, or products re9 search expenses’’ means the amounts which are 

10 paid or incurred by the researcher or manufac11 turer during the taxable year with respect to 

12 any research and development of vaccines, 

13 countermeasures, or products. Qualified re14 search and development expenses include ex15 penses related to reformulating existing vac16 cines, countermeasures, or products. 

17 (C) DETERMINING RESEARCH EX18 PENSES.—Any vaccines, countermeasures, or 

19 products research expenses for any taxable year 

20 which are qualified research expenses (within 

21 the meaning of this subsection) shall be taken 

22 into account in determining base period re23 search expenses for purposes of applying this 

24 paragraph to subsequent taxable years. 
53 

•S 1873 RS 

1 (D) DENIAL OF DOUBLE BENEFIT FOR

2 VACCINES, COUNTERMEASURES, OR PRODUCTS

3 RESEARCH EXPENSES.—If any portion of the 

4 vaccines, countermeasures, or products research 

5 expenses is otherwise allowable as a deduction 

6 for the taxable year involved, the Secretary 

7 shall only provide a rebate under this section 

8 for the portion of such expenses not covered by 

9 any rebate determined by such deduction. 

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

11 a rebate under this paragraph, a manufacturer 

12 or researcher shall submit to the Secretary an 

13 application at such time, in such manner, and 

14 containing such information as the Secretary 

15 may require, including— 

16 (i) a detailed description of the vac17 cine, countermeasure, or product being re18 searched or developed; 

19 (ii) a detailed description of the re20 search that is the subject of the rebate; 

21 (iii) a detailed accounting of the quali22 fied research expenses involved; 

23 (iv) an assurance that the researcher 

24 or manufacturer is following good labora25 tory practice, as required by the Secretary 
54 

•S 1873 RS 

1 pursuant to the Federal Food, Drug, and 

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

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

4 201 et seq.); and 

5 (v) copies of tax returns for the tax6 able year involved. 

7 (F) EFFECTIVE DATE.—This paragraph 

8 shall apply to expenses for taxable years begin9 ning after December 31, 2005. 

10 (4) EXCLUSION FOR AMOUNTS FUNDED BY

11 GRANTS, ETC.—The terms ‘‘vaccines, counter12 measures, or products manufacturing investment’’ 

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

14 any amount to the extent such amount is funded by 

15 any grant, contract, or otherwise funded by another 

16 person (or any governmental entity). 

17 (c) GRANTS TO EXPAND AND IMPROVE RESEARCH

18 AND DEVELOPMENT AND MANUFACTURING OF VACCINES, 

19 COUNTERMEASURES OR PRODUCTS.—Part B of title III 

20 of the Public Health Service Act is amended by inserting 

21 after section 319L, as added by this Act, the following: 
55 

•S 1873 RS 

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

2 AND DEVELOPMENT AND MANUFACTURING 

3 OF VACCINES, QUALIFIED COUNTER4 MEASURES OR QUALIFIED PANDEMIC OR EPI5 DEMIC PRODUCTS. 

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

7 to a manufacturer to purchase or improve real property 

8 and tangible personal property used in the research and 

9 development, manufacture, or distribution of a vaccine, 

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

11 or qualified pandemic or epidemic product (as defined in 

12 section 319F–3(c)(5)). 

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

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

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

16 and containing such information as the Secretary may re17 quire, including— 

18 ‘‘(1) a detailed description of the planned ex19 pansion; 

20 ‘‘(2) a detailed description of the equipment, fa21 cility, or property involved; 

22 ‘‘(3) a certification that such facility or prop23 erty is physically located in a State; 

24 ‘‘(4) a detailed description of the vaccine, quali25 fied countermeasure or qualified pandemic or epi26 demic product involved; 
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1 ‘‘(5) a detailed description of the research and 

2 development, manufacturer, or distribution involved; 

3 ‘‘(6) a description of how such equipment, facil4 ity, or property is to be used; 

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

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

7 development, manufacture, or distribution of a drug, 

8 biological product, device or other countermeasure 

9 not described in paragraph (4); and 

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

11 or property involved complies with all applicable 

12 Federal, State, and local laws. 

13 ‘‘(c) RECAPTURE.— 

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

15 expiration of the 20-year period beginning on the 

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

17 the facility or property involved ceases to be used for 

18 the purpose for which the grant was awarded, the 

19 United States shall be entitled to recover from the 

20 manufacturer an amount bearing the same ratio to 

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

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

23 purchase or improvement involved. The value of the 

24 facility or property at such time may be determined 

25 by agreement of the manufacturer and the Sec-
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1 retary, or by order of the United States District 

2 Court for the district in which such facility or prop3 erty is situated. 

4 ‘‘(2) LIMITATION.—The Secretary may not re5 capture the facility or property under this subsection 

6 if the Secretary determines, in accordance with regu7 lations promulgated by the Secretary, that there is 

8 good cause for the failure of proper use. 

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

10 is authorized to be appropriated such sums as may be nec11 essary to carry out this section.’’. 

12 SEC. 9. TECHNICAL ASSISTANCE. 

13 Subchapter E of chapter V of the Federal Food, 

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

15 amended by adding at the end the following: 

16 ‘‘SEC. 565. TECHNICAL ASSISTANCE. 

17 ‘‘The Secretary, in consultation with the Commis18 sioner of Food and Drugs, shall establish within the Food 

19 and Drug Administration a team of experts on manufac20 turing and regulatory activities (including compliance with 

21 current Good Manufacturing Practices) to provide both 

22 off-site and on-site technical assistance to the manufactur23 ers of qualified countermeasures (as defined in section 

24 319F–1 of the Public Health Service Act), security coun25 termeasures (as defined in section 319F–2 of such Act), 
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1 or vaccines, at the request of such a manufacturer and 

2 at the discretion of the Secretary, if the Secretary deter3 mines that a shortage or potential shortage may occur in 

4 the United States in the supply of such vaccines or prod5 ucts and that the provision of such assistance would be 

6 beneficial in helping alleviate or avert such shortage.’’. 

7 SEC. 10. ANIMAL MODELS FOR CERTAIN DISEASES. 

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

9 (42 U.S.C. 284 et seq.) is amended by adding at the end 

10 the following: 

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

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

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

14 the Biomedical Advanced Research and Development 

15 Agency, the Director of the Centers for Disease Control 

16 and Prevention, and the Commissioner of Food and 

17 Drugs, shall establish and award grants under this section 

18 to eligible entities, including other Federal agencies, to 

19 study the physiological responses of certain animal species 

20 and, where appropriate, juvenile models, to chemical, bio21 logical, radiological, or nuclear agents or toxins or poten22 tial pandemic infectious disease, and to develop and vali23 date such animal models. 

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

25 under this section, an entity shall— 
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1 ‘‘(1) provide assurances to the Secretary that 

2 the entity— 

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

4 laboratory or facility, as determined by the Sec5 retary; and 

6 ‘‘(B) will follow good laboratory practices; 

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

8 such time, in such manner, and containing such in9 formation as the Secretary may require, including— 

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

11 model involved; 

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

13 biological, radiological, nuclear, or other infec14 tious agents involved; 

15 ‘‘(C) a detailed description of how the ani16 mal model will be used for the development of 

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

18 a countermeasure; 

19 ‘‘(D) a detailed description of validation 

20 methods; and 

21 ‘‘(E) an assurance that the entity will fol22 low good laboratory practices; and 

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

24 funded under the grant to the Director of the Bio-
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1 medical Advanced Research and Development Agen2 cy and the Director of NIH. 

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

4 are authorized to be appropriated such sums as may be 

5 necessary to carry out this section.’’. 

6 SEC. 11. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC AD7 VISORY COMMITTEE. 

8 Subchapter E of chapter V of the Federal Food, 

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

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

11 the following: 

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

13 ADVISORY COMMITTEE. 

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

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

16 shall establish an 11-member advisory committee to be 

17 known as the ‘Animal Model/Research Tool Scientific Ad18 visory Committee’ (referred to in this section as the ‘Advi19 sory Committee’). 

20 ‘‘(b) MEMBERSHIP.— 

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

22 as members of the Advisory Committee individuals 

23 who are technically qualified by training and experi24 ence, including in medicine, veterinarian medicine, 

25 biology, technology involving the manufacture, eval-
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1 uation, or use of research tools, who are of appro2 priately diversified professional backgrounds to 

3 evaluate the priority animal models and research 

4 tools. 

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

6 may appoint Federal officials, including at least 1 

7 representative of the Biomedical Advanced Research 

8 and Development Agency, to serve as ex officio 

9 members of the Advisory Committee. 

10 ‘‘(3) CHAIRPERSON.—The Secretary shall des11 ignate 1 of the members of the Advisory Committee 

12 to serve as the chairperson. 

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

14 advice, information, and recommendations to the Sec15 retary on— 

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

17 conditions associated with any biological (including 

18 organisms that cause infectious diseases), chemical, 

19 radiological, or nuclear agent or toxin or potential 

20 pandemic infectious disease; 

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

22 research tool development and validation; and 

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

24 requested by the Secretary. 
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1 ‘‘(d) PRIORITIES.—Priorities for animal models and 

2 research tools shall be established by the Secretary. 

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

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

5 of the Advisory Committee who are not officers or 

6 employees of the United States, while attending con7 ferences or meetings of the committee or otherwise 

8 engaged in its business, shall be entitled to receive 

9 compensation at rates to be fixed by the Secretary, 

10 which may not exceed daily equivalent of the rate in 

11 effect for level 4 of the Senior Executive Schedule 

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

13 for each day (including travel time) they are so en14 gaged, and while so serving away from their homes 

15 or regular places of business each member may be 

16 allowed travel expenses, including per diem in lieu of 

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

18 United States Code, for persons in the Federal Gov19 ernment service employed intermittently. 

20 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec21 retary shall furnish the Advisory Committee clerical 

22 and other assistance. 

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

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

25 App.) shall not apply to the Advisory Committee. 
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1 ‘‘(f) PROCEEDINGS.—The Advisory Committee shall 

2 make and maintain a transcript of any proceeding of the 

3 Committee. The Committee shall delete from any tran4 script made under this subsection information, which is 

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

6 United States Code.’’. 

7 SEC. 12. COLLABORATION AND COORDINATION. 

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

9 amended by adding at the end the following: 

10 ‘‘(g) LIMITED ANTITRUST EXEMPTION.— 

11 ‘‘(1) SECURITY COUNTERMEASURES, QUALIFIED

12 COUNTERMEASURES AND QUALIFIED PANDEMIC OR

13 EPIDEMIC PRODUCT DEVELOPMENT MEETINGS.— 

14 ‘‘(A) COUNTERMEASURES AND PRODUCTS

15 DEVELOPMENT MEETINGS AND CONSULTA16 TIONS.—The Secretary of Health and Human 

17 Services (referred to in this subsection as the 

18 ‘Secretary’) or the Director of the Biomedical 

19 Advanced Research and Development Agency 

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

21 in coordination with the Attorney General and 

22 the Secretary of Homeland Security, may con23 duct meetings and consultations with parties in24 volved in the development of security counter25 measures (as defined in section 319F–2 of the 
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1 Public Health Service Act) qualified counter2 measures (as defined in section 319F–1 of the 

3 Public Health Service Act) or qualified pan4 demic or epidemic products (as defined in sec5 tion 319F–3(c)(5) of the Public Health Service 

6 Act) (referred to in this section as ‘‘counter7 measures or products’’) for the purpose of the 

8 development, manufacture, distribution, pur9 chase, sale, or storage of countermeasures or 

10 products consistent with the purposes of this 

11 title. The Secretary or Director may convene 

12 such meeting or consultation at the request of 

13 any person, the Secretary of Homeland Secu14 rity, the Attorney General, the Chairperson of 

15 the Federal Trade Commission, an industry 

16 representative or member, or upon initiation by 

17 such Secretary. The Secretary or Director shall 

18 give notice of such meetings and consultations 

19 to the Chairperson of the Federal Trade Com20 mission (referred to in this subsection as the 

21 ‘Chairperson’) and the Attorney General. 

22 ‘‘(B) MEETING AND CONSULTATION CON23 DITIONS.—A meeting or consultation conducted 

24 under subparagraph (A) shall— 
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1 ‘‘(i) be chaired or, in the case of a 

2 consultation, facilitated by the Secretary or 

3 Director; 

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

5 development, manufacture, distribution, 

6 purchase, or sale of countermeasures or 

7 products, as determined by the Secretary 

8 or Director; 

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

10 the Secretary of Homeland Security, and 

11 the Chairperson; 

12 ‘‘(iv) be limited to discussions involv13 ing the development, manufacture, dis14 tribution, or sale of countermeasures or 

15 products, consistent with the purposes of 

16 this title; and 

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

18 to ensure that national security, confiden19 tial, and proprietary information is not dis20 closed outside the meeting or consultation. 

21 ‘‘(C) LIMITATION.—The Secretary or Di22 rector may not require the disclosure of con23 fidential commercial or proprietary information. 

24 ‘‘(D) MINUTES.—The Secretary or Direc25 tor shall maintain minutes of meetings and con-
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1 sultations under this subsection, which shall not 

2 be disclosed under section 552 of title 5, United 

3 States Code, unless such Secretary or Director, 

4 in consultation with the Attorney General, de5 termines that disclosure would pose no threat to 

6 national security. Such determination shall not 

7 be subject to judicial review. 

8 ‘‘(E) EXEMPTION.— 

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

10 shall not apply to meetings and consulta11 tions under this paragraph. 

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

13 not apply to any agreement or conduct 

14 that results from a meeting or consultation 

15 and that does not receive an exemption 

16 pursuant to this subsection. 

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

18 or the Director shall file a written agreement regard19 ing covered activities, made pursuant to meetings or 

20 consultations conducted under paragraph (1) and 

21 that is consistent with this paragraph, with the At22 torney General and the Chairperson for a determina23 tion of the compliance of such agreement with anti24 trust laws. In addition to the proposed agreement 

25 itself, any such filing shall include— 
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1 ‘‘(A) an explanation of the intended pur2 pose of the agreement; 

3 ‘‘(B) a specific statement of the substance 

4 of the agreement; 

5 ‘‘(C) a description of the methods that will 

6 be utilized to achieve the objectives of the 

7 agreement; 

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

9 cooperative effort among the particular partici10 pating parties to achieve the objectives of the 

11 agreement; and 

12 ‘‘(E) any other relevant information deter13 mined necessary by the Secretary or Director in 

14 consultation with the Attorney General and the 

15 Chairperson. 

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

17 in consultation with the Chairperson, shall determine 

18 whether an agreement regarding covered activities 

19 referred to in paragraph (2) would likely— 

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

21 laws, and so inform the Secretary or Director 

22 and the participating parties; or 

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

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

25 for an exemption from the antitrust laws, lim-
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1 ited to the performance of the agreement con2 sistent with the purposes of this title. 

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

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

5 in consultation with the Chairperson, shall 

6 grant, deny, grant in part and deny in part, or 

7 propose modifications to a request for exemp8 tion from the antitrust laws under paragraph 

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

10 such request. 

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

12 may extend the 15-day period referred to in 

13 subparagraph (A) for an additional period of 

14 not to exceed 10 days. Such additional period 

15 may be further extended only by the United 

16 States district court, upon an application by the 

17 Attorney General after notice to the Secretary 

18 or Director and the parties involved. 

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

20 exemption under this paragraph, the Attorney 

21 General, in consultation with the Chairperson 

22 and the Secretary or Director— 

23 ‘‘(i) shall find— 
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1 ‘‘(I) that the agreement involved 

2 is necessary to ensure the availability 

3 of countermeasures or products; 

4 ‘‘(II) that the exemption from 

5 the antitrust laws would promote the 

6 public interest; and 

7 ‘‘(III) that there is no substantial 

8 competitive impact to areas not di9 rectly related to the purposes of the 

10 agreement; and 

11 ‘‘(ii) may consider any other factors 

12 determined relevant by the Attorney Gen13 eral and the Chairperson. 

14 ‘‘(5) LIMITATION ON AND RENEWAL OF EXEMP15 TIONS.—An exemption granted under paragraph (4) 

16 shall be limited to covered activities, and shall be re17 newed (with modifications, as appropriate) on the 

18 date that is 3 years after the date on which the ex19 emption becomes effective (and at 3-year intervals 

20 thereafter, if renewed) unless the Attorney General 

21 in consultation with the Chairperson determines that 

22 the exemption should not be renewed (with modifica23 tions, as appropriate) considering the factors de24 scribed in paragraph (4). 
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1 ‘‘(6) LIMITATION ON PARTIES.—The use of any 

2 information acquired under an exempted agreement 

3 by the parties to such an agreement for any pur4 poses other than those specified in the antitrust ex5 emption granted by the Attorney General shall be 

6 subject to the antitrust laws and any other applica7 ble laws. 

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

9 the Chairperson may develop and issue guidelines to 

10 implement this subsection. 

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

12 date of enactment of the Biodefense and Pandemic 

13 Vaccine and Drug Development Act of 2005, and 

14 annually thereafter, the Attorney General and the 

15 Chairperson shall report to Congress on the use and 

16 continuing need for the exemption from the antitrust 

17 laws provided by this subsection. 

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

19 maintained by the Secretary or Director pursuant to 

20 paragraph (1)(D) shall not be disclosed under sec21 tion 552 of title 5, United States Code, if the ex22 emption is not renewed under paragraph (5), or if 

23 meetings are no longer conducted, unless the Sec24 retary or Director, in consultation with the Attorney 

25 General, determines that the disclosure would pose 
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1 no threat to national security. Such determination 

2 shall not be subject to judicial review. 

3 ‘‘(h) SUNSET.—The authority of the Attorney Gen4 eral to grant or renew a limited antitrust exemption under 

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

6 that begins on the date of enactment of the Biodefense 

7 and Pandemic Vaccine and Drug Development Act of 

8 2005. 

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

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

11 laws’— 

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

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

14 except that such term includes the Act of June 

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

16 known as the Robinson-Patman Act), and sec17 tion 5 of the Federal Trade Commission Act 

18 (15 U.S.C. 45) to the extent such section 5 ap19 plies to unfair methods of competition; and 

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

21 laws referred to in subparagraph (A). 

22 ‘‘(2) COVERED ACTIVITIES.— 

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

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

25 means any group of activities or conduct, in-
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1 cluding attempting to make, making, or per2 forming a contract or agreement or engaging in 

3 other conduct, for the purpose of— 

4 ‘‘(i) theoretical analysis, experimen5 tation, or the systematic study of phe6 nomena or observable facts necessary to 

7 the development of countermeasures or 

8 products; 

9 ‘‘(ii) the development or testing of 

10 basic engineering techniques necessary to 

11 the development of countermeasures or 

12 products; 

13 ‘‘(iii) the extension of investigative 

14 findings or theory of a scientific or tech15 nical nature into practical application for 

16 experimental and demonstration purposes, 

17 including the experimental production and 

18 testing of models, prototypes, equipment, 

19 materials, and processes necessary to the 

20 development of countermeasures or prod21 ucts; 

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

23 marketing of a product, process, or service 

24 that is a countermeasures or products; 
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1 ‘‘(v) the testing in connection with the 

2 production of a product, process, or serv3 ices necessary to the development of coun4 termeasures or products; 

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

6 analysis of research or production informa7 tion necessary to the development of coun8 termeasures or products; or 

9 ‘‘(vii) any combination of the purposes 

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

11 and such term may include the establishment 

12 and operation of facilities for the conduct of 

13 covered activities described in clauses (i) 

14 through (vi), the conduct of such covered activi15 ties on a protracted and proprietary basis, and 

16 the processing of applications for patents and 

17 the granting of licenses for the results of such 

18 covered activities. 

19 ‘‘(B) EXCEPTION.—The term ‘covered ac20 tivities’ shall not include the following activities 

21 involving 2 or more persons: 

22 ‘‘(i) Exchanging information among 

23 competitors relating to costs, profitability, 

24 marketing, or distribution of any product, 

25 process, or service if such information is 
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1 not reasonably necessary to carry out the 

2 purposes of covered activities. 

3 ‘‘(ii) Entering into any agreement or 

4 engaging in any other conduct— 

5 ‘‘(I) to restrict or require the 

6 sale, licensing, or sharing of inven7 tions, developments, products, proc8 esses, or services not developed 

9 through, produced by, or distributed 

10 or sold through such covered activi11 ties; or 

12 ‘‘(II) to restrict or require par13 ticipation by any person who is a 

14 party to such covered activities in 

15 other research and development activi16 ties, that is not reasonably necessary 

17 to prevent the misappropriation of 

18 proprietary information contributed 

19 by any person who is a party to such 

20 covered activities or of the results of 

21 such covered activities. 

22 ‘‘(iii) Entering into any agreement or 

23 engaging in any other conduct allocating a 

24 market with a competitor that is not ex25 pressly exempted from the antitrust laws 
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1 by a determination under subsection 

2 (g)(4). 

3 ‘‘(iv) Exchanging information among 

4 competitors relating to production (other 

5 than production by such covered activities) 

6 of a product, process, or service if such in7 formation is not reasonably necessary to 

8 carry out the purpose of such covered ac9 tivities. 

10 ‘‘(v) Entering into any agreement or 

11 engaging in any other conduct restricting, 

12 requiring, or otherwise involving the pro13 duction of a product, process, or service 

14 that is not so expressly exempted from the 

15 antitrust laws by a determination under 

16 subsection (g)(4). 

17 ‘‘(vi) Except as otherwise provided in 

18 this subsection, entering into any agree19 ment or engaging in any other conduct to 

20 restrict or require participation by any per21 son who is a party to such activities, in 

22 any unilateral or joint activity that is not 

23 reasonably necessary to carry out the pur24 pose of such covered activities. 
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1 ‘‘(vii) Entering into any agreement or 

2 engaging in any other conduct restricting 

3 or setting the price at which a product is 

4 offered for sale, whether by bid or other5 wise. 

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

7 includes the identification of suitable compounds or 

8 biological materials, the conduct of preclinical and 

9 clinical studies, the preparation of an application for 

10 marketing approval, and any other actions related to 

11 preparation of a countermeasure or product.’’. 

12 SEC. 13. PROCUREMENT. 

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

14 U.S.C. 247d–6b) is amended— 

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

16 SECURITY COUNTERMEASURE PROCURE17 MENTS’’ before the period; and 

18 (2) in subsection (c)— 

19 (A) in the subsection heading, by striking 

20 ‘‘BIOMEDICAL’’; 

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

22 meet the needs of the stockpile’’ and inserting 

23 ‘‘to meet the stockpile needs’’; 

24 (C) in paragraph (7)(C)(ii)— 
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1 (i) by amending clause (I) to read as 

2 follows: 

3 ‘‘(I) PAYMENT CONDITIONED ON

4 DELIVERY.—The contract shall pro5 vide that no payment may be made 

6 until delivery of a portion, acceptable 

7 to the Secretary, of the total number 

8 of units contracted for, except that, 

9 notwithstanding any other provision of 

10 law, the contract may provide that, if 

11 the Secretary determines (as the Sec12 retary’s discretion) that an advance 

13 payment, partial payment for signifi14 cant milestones, or payment to in15 crease manufacturing capacity is nec16 essary to ensure success of a project, 

17 the Secretary shall pay an amount, 

18 not to exceed 10 percent of the con19 tract amount, in advance of delivery. 

20 The contract shall provide that such 

21 advance payment is required to be re22 paid if there is a failure to perform by 

23 the vendor under the contract. The 

24 contract may also provide for up to 3 

25 additional advance payments of 5 per-
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1 cent each for meeting the milestones 

2 specified in such contract. Provided 

3 that the specified milestones are 

4 reached, these advanced payments of 

5 5 percent shall not be required to be 

6 repaid. Nothing in this subclause shall 

7 be construed as affecting the rights of 

8 vendors under provisions of law or 

9 regulation (including the Federal Ac10 quisition Regulation) relating to the 

11 termination of contracts for the con12 venience of the Government.’’; and 

13 (ii) by adding at the end the fol14 lowing: 

15 ‘‘(VII) SALES EXCLUSIVITY.— 

16 The contract may provide that the 

17 vendor is the sole and exclusive sup18 plier of the product to the Federal 

19 Government for a specified period of 

20 time, not to exceed 15 years, on the 

21 condition that the vendor is able to 

22 satisfy the needs of the Government. 

23 During the agreed period of sales ex24 clusivity, the vendor shall not assign 

25 its rights of sales exclusivity to an-
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1 other entity or entities without ap2 proval by the Secretary. 

3 ‘‘(VIII) SURGE CAPACITY.—The 

4 contract may provide that the vendor 

5 establish domestic manufacturing ca6 pacity of the product to ensure that 

7 additional production of the product is 

8 available in the event that the Sec9 retary determines that there is a need 

10 to quickly purchase additional quan11 tities of the product. Such contract 

12 may provide a fee to the vendor for 

13 establishing and maintaining such ca14 pacity in excess of the initial require15 ment for the purchase of the product. 

16 Additionally, the cost of maintaining 

17 the domestic manufacturing capacity 

18 shall be an allowable and allocable di19 rect cost of the contract. 

20 ‘‘(IX) CONTRACT TERMS.—The 

21 Secretary, in any contract for procure22 ment under this section, may speci23 fy— 

24 ‘‘(aa) the dosing and admin25 istration requirements for coun-
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1 termeasures to be developed and 

2 procured; 

3 ‘‘(bb) the amount of funding 

4 that will be dedicated by the Sec5 retary for research and develop6 ment of the countermeasure; and 

7 ‘‘(cc) the specifications the 

8 countermeasure must meet to 

9 qualify for procurement under a 

10 contract under this section.’’; and 

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

12 end the following: ‘‘Such agreements may allow 

13 other executive agencies to order qualified and 

14 security countermeasures under procurement 

15 contracts or other agreements established by 

16 the Secretary. Such ordering process (including 

17 transfers of appropriated funds between an 

18 agency and the Department of Health and 

19 Human Services as reimbursements for such or20 ders for countermeasures) may be conducted 

21 under the authority of section 1535 of title 31, 

22 United States Code, except that all such orders 

23 shall be processed under the terms established 

24 under the Biodefense and Pandemic Vaccine 

25 and Drug Development Act of 2005 and the 
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1 Project BioShield Act of 2004, for the procure2 ment of countermeasures under section 319F– 

3 1 or 319F–2.’’ 

4 SEC. 14. NATIONAL PATHOLOGY CENTER. 

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

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

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

8 the following: 

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

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

11 287 et seq.) the following: 

12 ‘‘Subpart 7—National Pathology Center 

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

14 CENTER. 

15 ‘‘In order to provide pathology consultation for civil16 ian and military health professionals (including Depart17 ment of Veterans Affairs health professionals) there is es18 tablished the National Pathology Center (in this subpart 

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

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

21 The Director of the Center shall report directly to the Di22 rector of NIH. 

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

24 ‘‘(a) PURPOSES OF THE CENTER.—The general pur25 poses of the Center are to— 
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1 ‘‘(1) conduct and support research, education, 

2 training, and other programs with respect to the 

3 science and clinical practice of pathology; 

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

5 repository; and 

6 ‘‘(3) provide pathology consultation services. 

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

8 carry out the purposes of the Center described in sub9 section (a), the Director of the Center— 

10 ‘‘(1) shall— 

11 ‘‘(A) maintain and improve a comprehen12 sive repository of pathological specimens; 

13 ‘‘(B) provide consultations on request re14 garding clinical cases; 

15 ‘‘(C) conduct educational programs and 

16 publish educational materials on the science 

17 and clinical practice of pathology; 

18 ‘‘(D) maintain and improve registries on 

19 such clinical conditions as the Director of the 

20 Center determines appropriate; and 

21 ‘‘(E) conduct and support research on pa22 thology; and 

23 ‘‘(2) may— 
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1 ‘‘(A) collect reasonable and appropriate 

2 fees for the activities described in paragraph 

3 (1)(B); and 

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

5 Director of the Center determines appropriate 

6 to carry out the purposes described in sub7 section (a). 

8 ‘‘(c) AUTHORITY FOR EXPERT OPINIONS.—The Di9 rector of the Center may enter into memoranda of under10 standing with officials at the Department of Veterans Af11 fairs and the Department of Defense to provide expert sec12 ond opinion pathology consultations and pathology edu13 cation or training if the Secretary of either such Depart14 ment determines that such provision would be in the best 

15 interest of either of their respective departments. 

16 ‘‘SEC. 485C. BOARD OF REGENTS. 

17 ‘‘(a) MEMBERSHIP.— 

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

19 Board of Regents of the Center (in this subpart re20 ferred to as the ‘Board’) consisting of— 

21 ‘‘(A) the Surgeons General of— 

22 ‘‘(i) the Public Health Service; 

23 ‘‘(ii) the Army; 

24 ‘‘(iii) the Navy; and 

25 ‘‘(iv) the Air Force; 
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1 ‘‘(B) the Chief Medical Director of the De2 partment of Medicine and Surgery of the De3 partment of Veterans Affairs; 

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

5 Library of Medicine; 

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

7 the Department of Defense; 

8 ‘‘(E) the Dean of the Uniformed Services 

9 University of the Health Sciences; and 

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

11 Secretary from among leaders in pathology re12 search, education and clinical practice. 

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

14 the Board described in subparagraphs (A) through 

15 (E) of paragraph (1) shall serve as ex officio mem16 bers of the Board. 

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

18 Board appointed under paragraph (1)(F) shall an19 nually elect one of such members to serve as the 

20 Chairperson of the Board until the next election. 

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

22 of the Board to advise, consult with, and make rec23 ommendations to the Director of NIH on important mat24 ters of policy in regard to the Center, including such mat25 ters as the scope, content and organization of the research, 
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1 education and consultative services provided by the Cen2 ter. The Board shall make recommendations to the Direc3 tor of NIH regarding the rules under which specimens 

4 from the tissue repository will be used and under which 

5 it’s publications, facilities and services will be made avail6 able to various kinds of users. 

7 ‘‘(c) TERMS OF OFFICE.—Each appointed member of 

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

9 that any member appointed to fill a vacancy occurring 

10 prior to the expiration of the term for which the prede11 cessor of such member was appointed shall be appointed 

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

13 members shall be eligible for reappointment within 1 year 

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

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

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

17 States, while attending conferences of the Board or other18 wise serving at the request of the Secretary in connection 

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

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

21 travel expenses in the same manner and under the same 

22 conditions as that prescribed under section 208(c). 
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1 ‘‘SEC. 485D. GIFTS TO THE CENTER. 

2 ‘‘Section 231 shall be applicable to the acceptance 

3 and administration of gifts made for the benefit of the 

4 Center or for carrying out any of its functions. 

5 ‘‘SEC. 485E. CENTER FACILITIES. 

6 ‘‘There are authorized to be appropriated amounts 

7 sufficient for the erection and equipment of suitable and 

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

9 Administrator of General Services may acquire, by pur10 chase, condemnation, donation, or otherwise, a suitable 

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

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

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

14 and facilities. The amounts authorized to be appropriated 

15 by this section include the cost of preparation of drawings 

16 and specifications, supervision of construction, and other 

17 administrative expenses incident to the work. The Admin18 istrator of General Services shall prepare the plans and 

19 specifications, make all necessary contracts, and supervise 

20 construction.’’. 

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

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

23 Human Services shall submit a report to the appropriate 

24 committees of Congress that contains— 

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

26 National Pathology Center under subpart 7 of part 
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1 E of title IV of the Public Health Service Act,as es2 tablished by subsection (a); 

3 (2) areas where such functions and duties over4 lap with the functions and duties of the National In5 stitutes of Health; and 

6 (3) recommendations concerning necessary 

7 modifications to the National Pathology Center. 

8 (c) TRANSFER OF THE ARMED FORCES INSTITUTE

9 OF PATHOLOGY.— 

10 (1) IN GENERAL.— 

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

12 subparagraph (B), there are transferred to the 

13 National Pathology Center established under 

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

15 Health Service Act all functions, duties, per16 sonnel, assets, liabilities, contracts, property, 

17 records, and unexpended balances of appropria18 tions of the Armed Forces Institute of Pathol19 ogy. The preceding sentence shall not affect any 

20 proceedings, pending applications, suits, or 

21 other actions pending on the date of enactment 

22 of this Act. 

23 (B) EXCEPTIONS.—The following compo24 nents of the Armed Forces Institute of Pathol-
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1 ogy shall not be transferred from the Depart2 ment of Defense pursuant to subparagraph (A): 

3 (i) The Armed Forces Medical Exam4 iner. 

5 (ii) The Department of Defense DNA 

6 registry. 

7 (iii) Accident Investigation Program. 

8 (iv) The histopathology training pro9 gram. 

10 (v) The patient safety center. 

11 (vi) Department of Legal Medicine. 

12 (vii) Center for Clinical Laboratory 

13 Medicine. 

14 (viii) Drug Testing and Quality As15 surance Program. 

16 (ix) Subject to the discretion of the 

17 Secretary of Defense, medical research 

18 programs on the following: 

19 (I) Body armor. 

20 (II) Environmental sarcoidosis. 

21 (III) Depleted uranium. 

22 (IV) Military working dogs. 

23 (V) Such other areas of research 

24 related to pathology as the Secretary 

25 of Defense shall choose to conduct. 
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1 (2) REFERENCES.—Any reference in any Fed2 eral law, Executive order, rule, regulation, or delega3 tion of authority, or any document of or relating to 

4 the Armed Forces Institute of Pathology shall be 

5 deemed to be a reference to the National Pathology 

6 Center established under subpart 7 of part E of title 

7 IV of the Public Health Service Act. 

8 SECTION 1. SHORT TITLE. 

9 This Act may be cited as the ‘‘Biodefense and Pan10 demic Vaccine and Drug Development Act of 2005’’. 

11 SEC. 2. TABLE OF CONTENTS. 

12 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. 

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. 

Sec. 15. Rule of construction. 

13 SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOP14 MENT AGENCY. 

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

16 241 et seq.) is amended by inserting after section 319K the 

17 following: 
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1 ‘‘SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DE2 VELOPMENT AGENCY. 

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

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

5 Biomedical Advanced Research and Development 

6 Agency. 

7 ‘‘(2) FUND.—The term ‘Fund’ means the Bio8 defense Medical Countermeasure Development Fund 

9 established under subsection (d). 

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

11 transactions’ means transactions, other than procure12 ment contracts, grants, and cooperative agreements, 

13 including transactions for prototypes, as provided to 

14 the Secretary of Defense under section 2371 of title 

15 10, United States Code. 

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

17 ‘qualified countermeasure’ has the meaning given 

18 such term in section 319F–1. 

19 ‘‘(5) QUALIFIED COUNTERMEASURE AND QUALI20 FIED PANDEMIC OR EPIDEMIC PRODUCT ADVANCED

21 RESEARCH AND DEVELOPMENT.— 

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

23 countermeasure and qualified pandemic or epi24 demic product advanced research and develop25 ment’ means any applied research, testing, or 

26 evaluation (including those conducted on hu-
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1 mans or animals), related to the safety or effec2 tiveness, that is required for approval, clearance, 

3 or licensing by the Secretary under this Act or 

4 the Federal Food, Drug, and Cosmetic Act, of 

5 such countermeasure or pandemic or epidemic 

6 product to diagnose, mitigate, prevent, or treat 

7 harm from a deliberate, accidental, or natural 

8 exposure to a chemical, biological, radiological, 

9 or nuclear agent, particularly such exposure re10 sulting from an act of terrorism or potential 

11 pandemic infectious disease. 

12 ‘‘(B) INCLUSION.—The term under subpara13 graph (A) includes any investigation to improve 

14 the manufacturing, formulation, finish, fill, de15 livery, or shelf-life of such qualified counter16 measures or qualified pandemic or epidemic 

17 products. 

18 ‘‘(6) QUALIFIED PANDEMIC OR EPIDEMIC PROD19 UCT.—The term ‘qualified pandemic or epidemic 

20 product’ has the meaning given the term in section 

21 319F–3(c)(5). 

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

23 ‘security countermeasure’ has the meaning given such 

24 term in section 319F–2. 
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1 ‘‘(8) PERSON.—The term ‘person’ includes an in2 dividual, partnership, corporation, association, enti3 ty, or public or private corporation, including a Fed4 eral, State, or local government agency or depart5 ment. 

6 ‘‘(b) BIOMEDICAL ADVANCED RESEARCH AND DEVEL7 OPMENT AGENCY.— 

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

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

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

13 BARDA to coordinate and oversee activities that sup14 port and accelerate qualified countermeasure or quali15 fied pandemic or epidemic product (referred to in this 

16 section as ‘countermeasure or product’) advanced re17 search and development by— 

18 ‘‘(A) facilitating collaboration among the 

19 Department of Health and Human Services, 

20 other Federal agencies, relevant industries, aca21 demia, and other persons, with respect to such 

22 advanced research and development; 

23 ‘‘(B) supporting countermeasure and prod24 uct advanced research and development; 
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1 ‘‘(C) recommending approaches to mod2 ernize and streamline the countermeasure or 

3 product development process and reduce regu4 latory burdens with respect to procurement of se5 curity countermeasures and qualified pandemic 

6 or epidemic products; and 

7 ‘‘(D) supporting innovation to reduce the 

8 time and cost of countermeasure and product ad9 vanced research and development. 

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

11 by a Director (referred to in this section as the ‘Direc12 tor’) who shall— 

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

14 the advice and consent of the Senate; 

15 ‘‘(B) report to the Secretary; and 

16 ‘‘(C) serve as the principal advisor to the 

17 Secretary on countermeasure and product ad18 vanced research and development. 

19 ‘‘(4) DUTIES OF DIRECTOR.— 

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

21 purpose described in paragraph (2)(A), the Sec22 retary, acting through the Director, shall— 

23 ‘‘(i) increase appropriate communica24 tion between the Federal Government and 

25 relevant industries, academia, and other in-
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1 terested persons with respect to counter2 measure and product advanced research and 

3 development by establishing transparent, ex4 peditious, and direct processes to— 

5 ‘‘(I) facilitate regular, ongoing 

6 communication regarding the processes 

7 established under subparagraph (C)(ii) 

8 and new countermeasures or products 

9 of interest; 

10 ‘‘(II) solicit research and associ11 ated data on potential countermeasures 

12 and products and related technologies; 

13 and 

14 ‘‘(III) provide technical assistance 

15 with respect to such processes and the 

16 Food and Drug Administration ap17 proval process; 

18 ‘‘(ii) at least annually— 

19 ‘‘(I) convene meetings with rep20 resentatives from relevant industries, 

21 academia, other Federal agencies, 

22 international agencies, and other inter23 ested persons; and 
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1 ‘‘(II) sponsor relevant biodefense 

2 countermeasure technology demonstra3 tions; 

4 ‘‘(iii) carry out the activities described 

5 in subsection (g) of section 2 of the Clayton 

6 Act; and 

7 ‘‘(iv) encourage and coordinate coun8 termeasure or product advanced research 

9 and development, including by convening 

10 working groups as identified in paragraph 

11 (5). 

12 ‘‘(B) SUPPORT ADVANCED RESEARCH AND

13 DEVELOPMENT.—To carry out the purpose de14 scribed in paragraph (2)(B), the Secretary, act15 ing through the Director, shall— 

16 ‘‘(i) conduct continuous searches and 

17 support calls for potential countermeasures 

18 or products for drugs, biological products, 

19 devices, or research tools to diagnose, miti20 gate, prevent, or treat harm from existing, 

21 emerging, or possible chemical, biological, 

22 radiological, and nuclear agents or poten23 tial pandemic infectious diseases that 

24 threaten public health and national secu25 rity, as identified by the Assistant Sec-
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1 retary for Public Health Emergency Pre2 paredness; 

3 ‘‘(ii) direct the countermeasure and 

4 product advanced research and development 

5 activities of the Department of Health and 

6 Human Services, in consultation with the 

7 Assistant Secretary for Public Health 

8 Emergency Preparedness, the Director of the 

9 National Institutes of Health, the Director 

10 of the Centers for the Disease Control and 

11 Prevention, and the Commissioner of Food 

12 and Drugs; and 

13 ‘‘(iii) award contracts, grants, coopera14 tive agreements, and enter into other trans15 actions, to include use of simplified acquisi16 tion authorities provided under sections 

17 319F–1 and 319F–2(c)(7)(C)(iii), to public 

18 and private persons, including for-profit 

19 and nonprofit persons, federally funded re20 search and development centers, and univer21 sities, to— 

22 ‘‘(I) support the cost of counter23 measure and product advanced re24 search and development; and 
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1 ‘‘(II) ensure accelerated develop2 ment of countermeasures and products. 

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

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

5 the Secretary, acting through the Director, 

6 shall— 

7 ‘‘(i) receive from the Assistant Sec8 retary for Public Health Emergency Pre9 paredness, requirements for national civil10 ian biodefense needs, particularly counter11 measures or products and other technologies, 

12 to diagnose, mitigate, prevent, or treat 

13 harm from existing, emerging, or potential 

14 chemical, biological, radiological, or nuclear 

15 agents (consistent with sections 302(2) and 

16 304(a) of the Homeland Security Act of 

17 2002) or potential pandemic infectious dis18 eases; 

19 ‘‘(ii) establish transparent, expeditious, 

20 and direct processes for selecting promising 

21 countermeasures and products, supporting 

22 them through advanced research and devel23 opment and recommending them for pro24 curement; 
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1 ‘‘(iii) establish an office within the 

2 BARDA, in consultation with the Commis3 sioner of Food and Drugs, to— 

4 ‘‘(I) facilitate regular and ongo5 ing communication between the 

6 BARDA and the Food and Drug Ad7 ministration regarding the status of 

8 BARDA advanced research and devel9 opment activities; 

10 ‘‘(II) ensure that such activities 

11 are coordinated with the approval re12 quirements of the Food and Drug Ad13 ministration, with the goal of expe14 diting the development and approval of 

15 countermeasures and products; and 

16 ‘‘(III) connect interested persons 

17 with additional technical assistance 

18 made available under section 565 of 

19 the Federal Food, Drug, and Cosmetic 

20 Act; 

21 ‘‘(iv) coordinate with the Food and 

22 Drug Administration to facilitate regu23 latory review and approval of promising 

24 classes of countermeasures or products 
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1 through the development of research tools; 

2 and 

3 ‘‘(v) recommend to the Secretary, 

4 through the Assistant Secretary for Public 

5 Health Emergency Preparedness, procure6 ment of the most promising eligible security 

7 countermeasures or qualified pandemic or 

8 epidemic products identified in clause (i). 

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

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

11 the Secretary, acting through the Director, may 

12 award contracts, grants, cooperative agreements, 

13 or enter into other transactions, such as prize 

14 payments, to include use of simplified acquisi15 tion authorities provided under sections 319F–1 

16 and 319F–2(c)(7)(C)(iii), to the entities de17 scribed in subparagraph (B)(iii), to promote in18 novation in technologies supporting the advanced 

19 research and development and production of 

20 qualified or security countermeasures or quali21 fied pandemic or epidemic products, such as re22 search tools, manufacturing, countermeasure ad23 ministration, storage, and bioinformatics and 

24 other devices. 

25 ‘‘(E) OTHER DUTIES.— 
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1 ‘‘(i) IN GENERAL.—The Director 

2 may— 

3 ‘‘(I) prepare and submit to the 

4 President and Congress, an annual 

5 budget estimate for qualified counter6 measure and pandemic or epidemic 

7 product advanced research and devel8 opment and other BARDA activities, 

9 after opportunity for comment by the 

10 Secretary; and 

11 ‘‘(II) receive from the President 

12 and the Office of Management and 

13 Budget directly all funds appropriated 

14 by Congress for obligation and expend15 iture by the BARDA. 

16 ‘‘(ii) SECRETARY DUTIES.—The Sec17 retary, acting through the Director, may— 

18 ‘‘(I) enter into such contracts, 

19 leases, cooperative agreements, or other 

20 transactions, as may be necessary to 

21 carry out the functions of BARDA, 

22 without regard to section 3648 and 

23 3709 of the Revised Statutes of the 

24 United States (31 U.S.C. 3324(a) and 

25 (b), (41 U.S.C. 5), with any public 
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1 agency, any firm, association, corpora2 tion, or educational institution, or any 

3 other person; 

4 ‘‘(II) support advanced research 

5 and development and innovation of po6 tential countermeasures or products by 

7 highly qualified foreign national per8 sons outside the United States that 

9 may inure to the benefit of the Amer10 ican people and collaborative research 

11 involving American and foreign par12 ticipants; 

13 ‘‘(III) administer grants using 

14 milestone–based awards and payments; 

15 and 

16 ‘‘(IV) establish 1 or more federally 

17 funded research and development cen18 ters or university affiliated research 

19 centers in accordance with section 

20 253(c)(3) of title 41, United States 

21 Code. 

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

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

24 consultation with the Vulnerable Populations Working 

25 Group, may give priority to supporting and facili-
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1 tating advanced research and development of counter2 measures or products, and formulations of counter3 measures or products, that are likely to be safe and 

4 effective for pediatric populations, pregnant women, 

5 and other vulnerable populations. 

6 ‘‘(6) WORKING GROUPS.— 

7 ‘‘(A) IDENTIFICATION OF TECHNOLOGIES.— 

8 ‘‘(i) IN GENERAL.—The Director may 

9 establish and convene, or enter into a con10 tract with a public or private research in11 stitution to convene, one or more working 

12 groups that consists of experts on counter13 measure technology to identify innovative 

14 technologies that have the potential to be de15 veloped as countermeasures or products. 

16 ‘‘(ii) MEETINGS.—A working group es17 tablished under clause (i) shall participate 

18 in regular meetings with sponsors of coun19 termeasures, products, or related tech20 nologies to— 

21 ‘‘(I) review the scientific evidence 

22 or concept of such countermeasures, 

23 products, or related technologies; 

24 ‘‘(II) provide guidance on re25 search protocols or studies; and 
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1 ‘‘(III) provide guidance on the 

2 regulatory approval process for coun3 termeasures, products, and related 

4 technologies. 

5 ‘‘(iii) RECOMMENDATIONS.—Not later 

6 than 30 days after concluding a meeting 

7 with a sponsor of a countermeasure, prod8 uct, or related technology, the working 

9 group shall make recommendations to the 

10 Director concerning such countermeasure, 

11 product, or related technology. 

12 ‘‘(iv) CONFIDENTIALITY.—Any com13 mercial confidential or proprietary infor14 mation that is disclosed to the working 

15 group in a meeting under this section shall 

16 remain confidential and shall not be dis17 closed other than to the Secretary or the Di18 rector, or their designees. 

19 ‘‘(v) CONSTRUCTION.—Nothing in this 

20 subparagraph shall be construed to prohibit 

21 a sponsor from meeting with the Director to 

22 discuss potential countermeasures, products, 

23 or related technologies. 

24 ‘‘(B) PUBLIC WORKING GROUP.—The Direc25 tor may establish and convene one or more work-
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1 ing groups composed of private citizens and offi2 cials of Federal, State, and local governments to 

3 advise such Director with respect to the functions 

4 of the BARDA and the Director. 

5 ‘‘(C) VULNERABLE POPULATIONS WORKING

6 GROUP.—The Director shall establish and con7 vene a Vulnerable Populations Working Group 

8 composed of experts on pediatric populations, 

9 pregnant women, and other vulnerable popu10 lations to advise such Director with respect to— 

11 ‘‘(i) supporting and facilitating ad12 vanced research and development of counter13 measures, and formulations of counter14 measures, that are safe and effective for 

15 such populations; and 

16 ‘‘(ii) other activities of the BARDA 

17 that effect such populations. 

18 ‘‘(7) PERSONNEL AUTHORITIES.— 

19 ‘‘(A) SPECIALLY QUALIFIED SCIENTIFIC AND

20 PROFESSIONAL PERSONNEL.—In hiring per21 sonnel for the BARDA, the Director shall have 

22 the hiring and management authorities described 

23 in section 9903 of title 5, United States Code (as 

24 added by section 1101 of the National Defense 

25 Authorization Act for Fiscal Year 2004 (Public 
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1 Law 108–136)). With respect to the personnel of 

2 the BARDA, the term of appointments for em3 ployees referred to under subsection (c)(1) of that 

4 section may not exceed 5 years before the grant5 ing of any extension under subsection (c)(2) of 

6 that section. 

7 ‘‘(B) SPECIAL CONSULTANTS.—The Director 

8 may accept special consultants as personnel for 

9 the BARDA under section 207(f). 

10 ‘‘(C) INTERGOVERNMENTAL PERSONNEL

11 ACT.—The Director may accept as personnel for 

12 the BARDA, employees under subchapter VI of 

13 chapter 33 of subpart B of part III of title 5, 

14 United States Code. 

15 ‘‘(D) OTHER SERVICES.—The Director may 

16 accept voluntary and uncompensated services. 

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

18 ‘‘(1) IN GENERAL.— 

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

20 Advisory Board shall provide expert advice and 

21 guidance to the Secretary on the threats, chal22 lenges, and opportunities presented by advances 

23 in biological and life sciences and the threat 

24 from natural infectious diseases and chemical, 

25 biological, radiological, and nuclear threats. 
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1 ‘‘(B) MEMBERSHIP.—There is established 

2 the National Biodefense Advisory Board (herein3 after in this section referred to as the ‘Board’) to 

4 be composed of 23 members who represent the 

5 Nation’s preeminent scientific, public health, and 

6 medical experts on the subject of biological, 

7 chemical, nuclear, and radiological threats, 

8 whether naturally occurring, accidental, or delib9 erate, as follows: 

10 ‘‘(i) EX OFFICIO.—The following mem11 bers shall serve on the Board ex officio: 

12 ‘‘(I) The Assistant to the Presi13 dent for Homeland Security and 

14 Counterterrorism. 

15 ‘‘(II) The Director of the Office of 

16 Science and Technology Policy. 

17 ‘‘(III) The Assistant Secretary for 

18 Public Health Emergency Prepared19 ness. 

20 ‘‘(IV) The Director of the National 

21 Institutes of Health. 

22 ‘‘(V) The Director of the Centers 

23 for Disease Control and Prevention. 

24 ‘‘(VI) The Commissioner of Food 

25 and Drugs. 
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1 ‘‘(VII) The Director of BARDA. 

2 ‘‘(VIII) The Assistant Secretary of 

3 Defense for Health Affairs. 

4 ‘‘(IX) The Under Secretary of 

5 Homeland Security for Science and 

6 Technology. 

7 ‘‘(X) The Secretary of Agriculture 

8 (or a designee). 

9 ‘‘(ii) APPOINTED MEMBERS.—The fol10 lowing individuals, as appointed by the 

11 Secretary: 

12 ‘‘(I) Four representatives of the 

13 pharmaceutical, biotechnology, and de14 vice industries. 

15 ‘‘(II) Four representatives of aca16 demia. 

17 ‘‘(III) Five other members as de18 termined appropriate by the Secretary. 

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

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

21 shall serve for a term of 3 years, except that the 

22 Secretary may adjust the terms of the initial 

23 Board appointees in order to provide for a stag24 gered term of appointment for all members. 
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1 ‘‘(D) CONSECUTIVE APPOINTMENTS; MAX2 IMUM TERMS.—A member may be appointed to 

3 serve not more than 3 terms on the Board and 

4 may serve not more than 2 consecutive terms. 

5 ‘‘(2) DUTIES.—The Board shall— 

6 ‘‘(A) advise the Secretary on major bio7 defense initiatives and review ongoing and pro8 posed biodefense programs, which may include 

9 potential activities of the BARDA; and 

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

11 BARDA, and in coordination with the Director 

12 of National Institute of Allergy and Infectious 

13 Diseases, provide to the Secretary, recommenda14 tions and findings for an expanded, intensified, 

15 and coordinated biodefense research program en16 compassing the programs of the BARDA and 

17 other Federal agencies and related programs of 

18 the other research institutes. 

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

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

21 annually to provide to the Secretary updated assess22 ments, findings, and recommendations of the current 

23 trends, challenges, and opportunities posed in life 

24 sciences biotechnology and genetic engineering. 
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1 ‘‘(4) VACANCIES.—Any vacancy in the Board 

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

3 same manner as the original appointment. 

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

6 Board. 

7 ‘‘(6) POWERS.— 

8 ‘‘(A) HEARINGS.—The Board may hold 

9 such hearings, sit and act at such times and 

10 places, take such testimony, and receive such evi11 dence as the Board considers advisable to carry 

12 out this subsection. 

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

14 use the United States mails in the same manner 

15 and under the same conditions as other depart16 ments and agencies of the Federal Government. 

17 ‘‘(7) PERSONNEL.— 

18 ‘‘(A) OFFICERS OF THE FEDERAL GOVERN19 MENT.—A member of the Board that is an em20 ployee of the Federal Government may not re21 ceive additional pay, allowances, or benefits by 

22 reason of the member’s service on the Board. 

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

24 Board that is not an employee of the Federal 

25 Government shall be compensated at a rate 
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1 equivalent to the daily equivalent of the annual 

2 rate of basic pay prescribed for level IV of the 

3 Executive Schedule under section 5315 of title 5, 

4 United States Code, for each day (including 

5 travel time) during which the member is engaged 

6 in the actual performance of duties as a member 

7 of the Board. 

8 ‘‘(C) TRAVEL EXPENSES.—Each member of 

9 the Board shall receive travel expenses, including 

10 per diem in lieu of subsistence, in accordance 

11 with applicable provisions under subchapter I of 

12 chapter 57 of title 5, United States Code. 

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

15 be detailed to the Board with the approval for 

16 the contributing agency without reimbursement, 

17 and such detail shall be without interruption or 

18 loss of civil service status or privilege. 

19 ‘‘(d) FUND.— 

20 ‘‘(1) ESTABLISHMENT.—There is established the 

21 Biodefense Medical Countermeasure Development 

22 Fund, which shall be administered by the Director of 

23 the BARDA. 

24 ‘‘(2) FUNDS.— 
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1 ‘‘(A) FIRST FISCAL YEAR.—Of the amounts 

2 appropriated to carry out the Project BioShield 

3 Act of 2004 (Public Law 108–276) and not obli4 gated, $1,000,000,000 shall be available to the 

5 Fund to carry out this section for fiscal year 

6 2006. Such amounts shall remain available until 

7 expended. 

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

9 are authorized to be appropriated such sums as 

10 may be necessary to carry out this section for fis11 cal year 2007 and each subsequent fiscal year. 

12 Such sums shall remain available until ex13 pended. 

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

15 shall be construed to limit any authority of the Department 

16 of Health and Human Services, including those authorities 

17 provided under the Project BioShield Act of 2004 (Public 

18 Law 108–276). 

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

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

21 Act (5 U.S.C. App.) shall not apply to the duties, ac22 tivities, working groups, and advisory boards of the 

23 BARDA. 

24 ‘‘(2) FOIA.—Information that relates to the ac25 tivities, working groups, and advisory boards of the 
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1 BARDA shall not be subject to disclosure under sec2 tion 552 of title 5, United States Code, unless the Sec3 retary or Director determines that such disclosure 

4 would pose no threat to national security. Such a de5 termination shall not be subject to judicial review. 

6 ‘‘(3) CERTAIN COST PRINCIPLES AND COST AC7 COUNTING STANDARDS.—Notwithstanding any other 

8 provision of law, the cost principles set forth under 

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

10 cost accounting standards set forth under chapter 99 

11 of title 48, Code of Federal Regulations, and the re12 quirement for the submission of certified cost and 

13 pricing information under section 304A of the Fed14 eral Property and Administrative Services Act of 

15 1949 (41 U.S.C. 254b), shall not apply to any con16 tract, grant, cooperative agreement, or other trans17 action entered into under the Project BioShield Act of 

18 2004 (Public Law 108–276).’’. 

19 SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED 

20 BY PROJECT BIOSHIELD. 

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

22 1(a) of the Public Health Service Act (42 U.S.C. 247d– 

23 6a(a)) is amended by striking paragraph (2) and inserting 

24 the following: 

25 ‘‘(2) DEFINITIONS.—In this section: 
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1 ‘‘(A) QUALIFIED COUNTERMEASURE.—The 

2 term ‘qualified countermeasure’ means a drug 

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

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

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

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

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

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

9 Cosmetic Act (21 U.S.C. 321(h))), or research 

10 tool (as that term is defined in section 201(rr) 

11 of the Federal Food, Drug, and Cosmetic Act) 

12 that the Secretary determines to be a priority 

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

14 the Homeland Security Act of 2002) to— 

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

16 treat harm from any biological agent (in17 cluding organisms that cause an infectious 

18 disease) or toxins, chemical, radiological, or 

19 nuclear agent that may cause a public 

20 health emergency affecting national secu21 rity; 

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

23 treat harm from a condition that may re24 sult in adverse health consequences or death 

25 and may be caused by administering a 
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1 drug, biological product, or device that is 

2 used as described in this subparagraph; or 

3 ‘‘(iii) in the case of a research tool, en4 able the rapid and effective identification, 

5 assessment, or development of a drug, bio6 logical product, or device to diagnose, miti7 gate, prevent, or treat harm, as described in 

8 clause (i) or (ii). 

9 ‘‘(B) INFECTIOUS DISEASE.—The term ‘in10 fectious disease’ means a disease potentially 

11 caused by a pathogenic organism (including a 

12 bacteria, virus, fungus, or parasite) that is ac13 quired by a person and that reproduces in that 

14 person.’’. 

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

16 2(c)(1)(B) is amended by— 

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

18 each place it appears and inserting ‘‘diagnose, 

19 mitigate, prevent, or treat’’; and 

20 (B) inserting ‘‘agent (including organisms 

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

22 ‘‘any biological’’. 

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

24 Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended 

25 by adding at the end the following: 
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1 ‘‘(rr) RESEARCH TOOL.—The term ‘research tool’ in2 cludes the full range of tools and systems that assist in the 

3 discovery, development, or manufacture of drugs, biological 

4 products (as defined in section 351 of the Public Health 

5 Service Act), or devices.’’. 

6 SEC. 5. ORPHAN DRUG MARKET EXCLUSIVITY FOR COUN7 TERMEASURE PRODUCTS. 

8 (a) MARKET EXCLUSIVITY.—Subchapter A of chapter 

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

10 351 et seq.) is amended by inserting after section 505B the 

11 following: 

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

13 COUNTERMEASURE PRODUCTS. 

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

15 products (as such term is defined in this section), if a coun16 termeasure product is designated under section 526 for a 

17 rare disease or condition, the period referred to in section 

18 527(a) shall be 10 years instead of 7 years. 

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

20 term ‘countermeasure’ means a drug or biological product 

21 (as such term is defined by section 351(i) of the Public 

22 Health Service Act) that the Secretary determines to be a 

23 priority (consistent with sections 302(2) and 304(a) of the 

24 Homeland Security Act of 2002) to diagnose, mitigate, pre25 vent, or treat harm from any biological, chemical, radio-
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1 logical, or nuclear agent (including organisms that cause 

2 an infectious disease) or toxin identified as a material 

3 threat under subsection (c)(2)(A)(ii) of section 319F–2 of 

4 the Public Health Service Act.’’. 

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

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

7 360bb) a biological, chemical, radiological, or nuclear agent 

8 (including organisms that cause an infectious disease) or 

9 toxin identified as a material threat under subsection 

10 (c)(2)(A)(ii) of section 319F–2 of the Public Health Service 

11 Act shall be considered to be a ‘‘rare disease or condition’’ 

12 within the meaning of such term in such section 526. The 

13 Secretary may designate antibiotics and anti-infective 

14 products that treat infectious diseases as designated drugs 

15 or biological products under such section 526. 

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

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

18 applications and biological product licenses approved under 

19 the Federal Food, Drug, and Cosmetic Act or the Public 

20 Health Service Act after the date of enactment of 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: 
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1 ‘‘SEC. 319F–3. LIABILITY PROTECTIONS FOR PANDEMIC AND 

2 EPIDEMIC PRODUCTS AND SECURITY COUN3 TERMEASURES. 

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

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

6 or administrator of a security countermeasure, or a quali7 fied pandemic and epidemic product, described in sub8 section (b)(1)(A) or a health care provider shall be immune 

9 from suit or liability caused by or arising out of the design, 

10 development, clinical testing and investigation, manufac11 ture, labeling, distribution, sale, purchase, donation, dis12 pensing, prescribing, administration, or use of a security 

13 countermeasure, or a qualified pandemic and epidemic 

14 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 and 

24 investigation, manufacture, labeling, dis25 tribution, sale, purchase, donation, dis26 pensing, prescribing, administration, or use 
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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 counter9 measure 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 ‘arising 

14 out of, reasonably relating to, or resulting 

15 from’ shall not be construed to apply to loss 

16 of property, personal injury, or death that 

17 has no alleged or potential causal relation18 ship with the design, development, clinical 

19 testing and investigation, manufacture, la20 beling, distribution, sale, purchase, dona21 tion, dispensing, prescribing, administra22 tion, or use of a product described in clause 

23 (i). 

24 ‘‘(B) RULE.— 
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1 ‘‘(i) SUBSEQUENT INJURY.—The pro2 tections set forth in subsection (a) and sub3 paragraph (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 forth 

8 in the designation provided for in para9 graph (2), regardless of the date of alleged 

10 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 the 

19 effective period set forth in the designation 

20 provided for in paragraph (2) by a manu21 facturer through the commercial market, 

22 provided that the security countermeasures 

23 or the qualified pandemic or epidemic prod24 uct are the security countermeasure or 

25 qualified pandemic or epidemic product de-
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1 scribed in a declaration described in para2 graph (2) and the Secretary does not spe3 cifically prohibit such private donation or 

4 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 SECRETARY.— 

15 A party seeking a determination under sub16 paragraph (D) may petition the Secretary 

17 to investigate allegations against a manu18 facturer, distributor, administrator, or 

19 health care provider arising out of, relating 

20 to, or resulting from the design, develop21 ment, clinical testing and investigation, 

22 manufacture, labeling, distribution, sale, 

23 purchase, donation, dispensing, prescribing, 

24 administration, or use of products as pro25 vided for in subparagraph (A)(i). The deci-
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1 sion to undertake such investigation shall be 

2 within the Secretary’s discretion and shall 

3 not be subject to judicial review. 

4 ‘‘(iii) RULE OF CONSTRUCTION.—Noth5 ing in this section shall be construed to ab6 rogate or limit the application of subtitle II 

7 of chapter 5 and chapter 7 of title 5, United 

8 States Code (commonly known as the Ad9 ministrative Procedure Act). 

10 ‘‘(D) DETERMINATION BY SECRETARY.— 

11 ‘‘(i) IN GENERAL.—In making a deter12 mination under this subparagraph, the Sec13 retary, acting through an administrative 

14 law judge, must find clear and convincing 

15 evidence that— 

16 ‘‘(I) the manufacturer, dis17 tributor, administrator, or health care 

18 provider violated a provision of the 

19 Federal Food, Drug, and Cosmetic Act 

20 (21 U.S.C. 301 et seq.) or this Act; and 

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

22 manufacturer, distributor, adminis23 trator, or health care provider acted 

24 with willful misconduct. 
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1 ‘‘(ii) EFFECT OF DETERMINATION.—If 

2 the Secretary finds such clear and con3 vincing evidence under clause (i), the Sec4 retary shall examine whether such willful 

5 misconduct to violate an Act under such 

6 clause— 

7 ‘‘(I) caused the product to present 

8 a significant or unreasonable risk to 

9 human health; and 

10 ‘‘(II) proximately caused the in11 jury alleged by the party. 

12 ‘‘(ii) NOTICE AND HEARING.—Prior to 

13 the Secretary’s making a determination 

14 under clause (i), the manufacturer, dis15 tributor, administrator, or health care pro16 vider shall have notice and a right to a for17 mal hearing in accordance with section 556 

18 of title 5, United States Code. 

19 ‘‘(iii) EFFECT OF DETERMINATION.— 

20 Subject to subsection (c), the sole exception 

21 to the immunity from suit and liability of 

22 manufacturers, distributors, administrators, 

23 or health care providers set forth in sub24 section (a) and subparagraph (A) shall be 

25 for actions against a manufacturer, dis-
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1 tributor, administrator, or health care pro2 vider as provided in subparagraph (A). 

3 ‘‘(iv) JUDICIAL REVIEW.—At any time 

4 prior to the 90th day following a deter5 mination by the Secretary under clause (i), 

6 any manufacturer, distributor, adminis7 trator, or health care provider named in 

8 such determination may file a petition with 

9 the United States Court District Court for 

10 the District of Columbia, for a judicial re11 view of such determination. A copy of the 

12 petition shall be forthwith transmitted by 

13 the clerk of the court to the Secretary or 

14 other officer designated by the Secretary for 

15 that purpose. The Secretary thereupon shall 

16 file in the court the record of the findings 

17 on which the Secretary based his or her de18 termination. The filing of a petition under 

19 this clause shall automatically stay the Sec20 retary’s determination for the duration of 

21 the judicial proceeding. The sole parties to 

22 the judicial proceeding shall be the Sec23 retary and the petitioner. Intervention by 

24 third parties in the judicial proceeding 

25 shall not be permitted. No subpoenas shall 
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1 be issued nor shall other compulsory process 

2 apply. The court’s review of a determina3 tion by the Secretary under this clause shall 

4 conform to the procedures for judicial re5 view of administrative orders set forth in 

6 paragraphs (2) through (6) of section 701(f) 

7 of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 371(f)) to the extent con9 sistent with this section. 

10 ‘‘(v) TOLLING OF STATUTE OF LIMITA11 TIONS.—The computation of the statute of 

12 limitations for any action against a manu13 facturer, distributor, administrator, or 

14 health care provider described under this 

15 subparagraph shall not include any time 

16 occurring before the determination by the 

17 Secretary under this subparagraph. 

18 ‘‘(vi) REGULATORY AUTHORITY.—The 

19 Secretary, in consultation with the Attorney 

20 General, shall promulgate regulations defin21 ing what actions by a manufacturer, dis22 tributor, administrator, or health care pro23 vider of a security countermeasure or a 

24 qualified pandemic and epidemic product 

25 shall be deemed to constitute ‘willful mis-
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1 conduct’ for purposes of clause (i). In pro2 mulgating such regulations, the Secretary 

3 shall consider the nature of the actual or 

4 potential public health emergency, the tim5 ing and extent of any vaccination or coun6 termeasure program, and any other cir7 cumstances they deem significant, so that 

8 any civil actions permitted under this sub9 section will not adversely affect the public 

10 health. The Secretary may specify the pe11 riod of time for which such regulations 

12 apply. 

13 ‘‘(vii) EVIDENCE REQUIRED.—The Sec14 retary, in consultation with the Attorney 

15 General, shall promulgate regulations that 

16 require, in order to be a party under this 

17 section, that an individual present evidence 

18 that reasonably demonstrates that— 

19 ‘‘(I) such individual has suffered 

20 a loss as a direct result of the design, 

21 development, clinical testing and inves22 tigation, manufacture, labeling, dis23 tribution, sale, purchase, donation, dis24 pensing, prescribing, or administration 

25 of a security countermeasure or quali-
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1 fied epidemic or pandemic product; 

2 and 

3 ‘‘(II) the loss as described in sub4 clause (I) was a direct result of the 

5 willful misconduct of the manufac6 turer, distributor, administrator, or 

7 health care provider in violating the 

8 Federal Food, Drug, and Cosmetic Act 

9 or this Act. 

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

11 apply regardless of whether the suit or liability 

12 described in subsection (a) or the claim described 

13 in subparagraph (A) arises from the design, de14 velopment, clinical testing and investigation, 

15 manufacture, labeling, distribution, sale, pur16 chase, donation, dispensing, prescribing, admin17 istration, or use by the Federal Government or 

18 by any person. 

19 ‘‘(2) DECLARATION BY SECRETARY.— 

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

21 issue a declaration, pursuant to this paragraph, 

22 that an actual or potential public health emer23 gency makes advisable the distribution, adminis24 tration, or use of a security countermeasure or 

25 qualified pandemic or epidemic product. 
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1 ‘‘(B) SECURITY COUNTERMEASURE OR

2 QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.— 

3 The Secretary shall specify in such declaration 

4 the security countermeasures or qualified pan5 demic or epidemic products to be sold by, pur6 chased from, or donated by a manufacturer or 

7 drawn from the Strategic National Stockpile. 

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

9 shall specify in such declaration the beginning 

10 and the ending dates of the effective period of the 

11 declaration, which shall be not longer than 6 

12 months. The Secretary may subsequently amend 

13 such declaration to shorten or extend such effec14 tive period, provided that the new ending data 

15 is after the date on which the declaration is 

16 amended. 

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

18 promptly publish each such declaration and 

19 amendment in the Federal Register. 

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

21 this section shall be construed to abrogate or limit any 

22 right, remedy, or authority that the United States or any 

23 agency thereof may possess under any other provision of 

24 law. 

25 ‘‘(d) DEFINITIONS.—In this section: 
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1 ‘‘(1) ADMINISTRATOR.—The term ‘administrator’ 

2 means a person employed by the State or local gov3 ernment, or their designee, who supervised or admin4 istered a program with respect to the administration, 

5 dispensing, distribution, or provision of a security 

6 countermeasure or a qualified pandemic or epidemic 

7 product, including a person who has established re8 quirements, provided policy guidance, supplied tech9 nical or scientific advice or assistance. 

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

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

12 volunteer, who distributes, prescribes, administers, 

13 dispenses, provides a facility to administer, or super14 vises or oversees the administration of a security 

15 countermeasure or a qualified pandemic or epidemic 

16 product, including persons who distribute, prescribe, 

17 administer, dispense, or provide a facility to admin18 ister in accordance with a designation under sub19 section (b)(2). 

20 ‘‘(3) LOSS.—The term ‘loss’ means death, phys21 ical injury, or loss of or damage to property, includ22 ing business interruption loss. 

23 ‘‘(4) MANUFACTURER.—The term ‘manufacturer’ 

24 includes— 
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1 ‘‘(A) a contractor or subcontractor of a 

2 manufacturer; 

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

4 research tool, or component to the manufacturer; 

5 and 

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

7 affiliates, successors, and assigns of a manufac8 turer. 

9 ‘‘(5) QUALIFIED PANDEMIC OR EPIDEMIC PROD10 UCT.—The term ‘qualified pandemic or epidemic 

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

12 section 201(g)(1) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 321(g)(1))), biological product 

14 (as such term is defined by section 351(i) of this Act) 

15 or device (as such term is defined by section 201(h) 

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

17 U.S.C. 321(h))) designed, developed, modified, or pro18 cured to diagnose, mitigate, prevent, treat, or cure a 

19 pandemic or epidemic or limit the harm such pan20 demic or epidemic might otherwise cause or a serious 

21 or life-threatening disease or condition caused by such 

22 a product, that— 

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

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

25 or licensed under section 351 of this Act; 
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1 ‘‘(B) is a product for which the Secretary 

2 determines that sufficient and satisfactory clin3 ical experience or research data (including data, 

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

5 support a reasonable conclusion that the product 

6 will qualify for approval or licensing within 8 

7 years after the date the Secretary makes a dec8 laration under paragraph (2); or 

9 ‘‘(C) is authorized for emergency use in ac10 cordance with section 564 of the Federal Food, 

11 Drug, and Cosmetic Act, except that subsection 

12 (b) of such section shall not apply. 

13 ‘‘(6) PARTY.— The term ‘party’ means an indi14 vidual who can reasonably demonstrate to the Sec15 retary that such individual has suffered a loss (as de16 fined in paragraph (3)) as a direct result of the will17 ful misconduct of a manufacturer, distributor, admin18 istrator, or health care provider. 

19 ‘‘(7) PERSON.—The term ‘person’ includes an in20 dividual, partnership, corporation, association, enti21 ty, or public or private corporation, including a Fed22 eral, State, or local government agency or depart23 ment. 
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1 ‘‘(8) SECURITY COUNTERMEASURE.—The term 

2 ‘security countermeasure’ has the meaning given such 

3 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 following: 

7 ‘‘PART D—OTHER COMPENSATION PROGRAMS 

8 ‘‘SEC. 271. COVERED COUNTERMEASURES PROGRAM. 

9 ‘‘(a) IN GENERAL.—If the Secretary issues a Procla10 mation stating that there is a critical public health need 

11 for a covered individual to receive a covered countermeasure 

12 during the effective period of the Proclamation, the Sec13 retary shall establish a process to provide compensation to 

14 such covered individuals for a covered injury, consistent 

15 with the Smallpox Emergency Personnel Protection pro16 gram under part C. 

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

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

19 ‘covered countermeasure’ means a qualified pandemic 

20 or epidemic product (as defined in section 319F– 

21 3(c)(5)) or a security countermeasure (as defined in 

22 section 319F–2(c)(1)(B)) specified in the Proclama23 tion. 

24 ‘‘(2) COVERED INDIVIDUAL.—The term ‘covered 

25 individual’ means an individual— 
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1 ‘‘(A) who is a health care worker, law en2 forcement officer, firefighter, security personnel, 

3 emergency medical personnel, other public health 

4 or safety personnel, or support personnel for such 

5 occupational specialties; 

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

7 identified in a State, local, or Department of 

8 Health and Human Services emergency response 

9 plan approved by the Secretary; 

10 ‘‘(C) who has volunteered and been selected 

11 to be a member of an emergency response plan; 

12 and 

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

14 administered or used pursuant to such approved 

15 plan during the effective period of the Proclama16 tion and prior to the time at which the Secretary 

17 declares a public health emergency pursuant to 

18 section 319 related to a covered countermeasure 

19 specified in the Proclamation. 

20 ‘‘(3) COVERED INJURY.—The term ‘covered in21 jury’ means an injury, disability, illness, condition, 

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

23 scarring or minor local reaction) determined by the 

24 Secretary to have been sustained by a covered indi-
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1 vidual as the direct result of administration or use to 

2 the individual of a covered countermeasure. 

3 ‘‘(4) EFFECTIVE PERIOD OF THE PROCLAMA4 TION.—The term ‘effective period of the Proclamation’ 

5 means the effective period specified in the Proclama6 tion, unless extended by the Secretary. 

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

8 ‘emergency response plan’ or ‘plan’ means a response 

9 plan detailing actions to be taken in preparation for 

10 a pandemic, epidemic, or biological, chemical, radio11 logical, nuclear agent or toxin that presents, or may 

12 present, a public health emergency. 

13 ‘‘(6) PROCLAMATION.—The term ‘Proclamation’ 

14 means a Proclamation regarding the critical public 

15 health need for the administration or use of a covered 

16 countermeasure issued by the Secretary and published 

17 in the Federal Register. Such Proclamation shall 

18 specify the specific covered countermeasure rec19 ommended for administration. 

20 ‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec21 tion shall be construed to require the creation of a com22 pensation program if the covered injuries are only minor 

23 injuries consistent with section (b)(3).’’. 
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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 by 

9 this section)— 

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

11 (2) a grant pursuant to section 319M of the Pub12 lic Health Service Act (as added by subsection (c)). 

13 (b) SURGE CAPACITY AND RESEARCH REBATES.— 

14 (1) IN GENERAL.—The Secretary may award re15 bates out of any money in the Treasury not otherwise 

16 appropriated to persons for the expansion of surge ca17 pacity for manufacturing vaccines, qualified counter18 measures (as defined in 319F–1 of the Public Health 

19 Service Act, as amended by this Act) or qualified 

20 pandemic or epidemic products (as defined in 319F– 

21 3(c)(5) of such Act, as added by this Act) (referred to 

22 in this section as ‘‘vaccines, countermeasures or prod23 ucts’’) and for vaccines, countermeasures, or products 

24 research. 

25 (2) VACCINES, COUNTERMEASURES OR PRODUCTS

26 MANUFACTURING FACILITIES INVESTMENT REBATE.— 
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1 (A) IN GENERAL.—For purposes of this sec2 tion, vaccines, countermeasures or products man3 ufacturing facilities investment rebate for any 

4 taxable year for a person (as defined with respect 

5 to such person for purposes of the Internal Rev6 enue Code of 1986) shall be an amount equal to 

7 20 percent of the qualified investment for such 

8 taxable year. 

9 (B) VACCINES, COUNTERMEASURES OR

10 PRODUCTS MANUFACTURING FACILITIES INVEST11 MENT.—For purposes of subparagraph (A), the 

12 qualified investment for any taxable year for a 

13 person is the basis of each vaccines, counter14 measures or products manufacturing facilities 

15 property placed in service by the person during 

16 the taxable year involved. 

17 (C) VACCINES, COUNTERMEASURES AND

18 PRODUCTS MANUFACTURING FACILITIES PROP19 ERTY.—For purposes of this subsection, the term 

20 ‘‘vaccines, countermeasures and products manu21 facturing facilities property’’ means real and 

22 tangible personal property— 

23 (i)(I) the original use of which com24 mences with the person applying for the re25 bate; or 
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1 (II) which is acquired through pur2 chase (as defined by section 179(d)(2) of the 

3 Internal Revenue Code of 1986); 

4 (ii) which is depreciable under section 

5 167 of the Internal Revenue Code of 1986; 

6 (iii) which is physically located in a 

7 State; 

8 (iv) which is used for the manufacture, 

9 distribution, or research and development of 

10 vaccines, countermeasures, or products; and 

11 (v) which is in compliance with appli12 cable good manufacturing practice and with 

13 any other applicable requirements which 

14 are promulgated by the Secretary, the Occu15 pational Safety and Health Administration, 

16 or the Environmental Protection Agency, 

17 and which are applicable to such property. 

18 (D) DENIAL OF DOUBLE BENEFIT FOR MAN19 UFACTURING FACILITIES EXPENSES.—If any 

20 portion of the vaccines, countermeasures, and 

21 products manufacturing facilities property in22 vestment expenses is otherwise allowable as a de23 duction for the taxable year involved, the Sec24 retary shall only provide a rebate under this sec-
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1 tion for the portion of such expenses not covered 

2 by the rebate determined by such deduction. 

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

4 a rebate under this subsection, a manufacturer 

5 shall submit to the Secretary an application at 

6 such time, in such manner, and containing such 

7 information as the Secretary may require, in8 cluding— 

9 (i) a detailed description and intended 

10 use of the facilities that is the basis of ap11 plication; 

12 (ii) a detailed description of the vac13 cine, countermeasure, or product being pro14 duced or that may be produced at the facil15 ity; 

16 (iii) a detailed accounting of qualified 

17 manufacturing facilities investment of the 

18 person; 

19 (iv) a certification as to the compli20 ance of the person with clauses (i) through 

21 (iv) of subparagraph (C); and 

22 (v) copies of tax returns for the taxable 

23 year involved. 
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1 (F) EFFECTIVE DATE.—This paragraph 

2 shall apply to property placed in service after 

3 December 31, 2005. 

4 (G) TERMINATION.—This paragraph shall 

5 not apply to any property placed in service after 

6 December 31, 2010. 

7 (3) MEDICAL RESEARCH RELATED TO DEVEL8 OPING VACCINES, COUNTERMEASURES OR QUALIFIED

9 PANDEMIC OR EPIDEMIC PRODUCTS REBATE.— 

10 (A) IN GENERAL.—For purposes of this sub11 section, the research rebate determined under this 

12 section for the taxable year involved (as deter13 mined as provided for in paragraph (2)(A)) is 

14 an amount equal to 35 percent of the vaccines, 

15 qualified countermeasures, or qualified pandemic 

16 or epidemic products (referred to in this section 

17 as ‘‘vaccine, countermeasure, or product’’) re18 search expenses for the taxable year. 

19 (B) VACCINES, COUNTERMEASURES, OR

20 PRODUCTS RESEARCH EXPENSES.—Except as 

21 otherwise provided in this paragraph, the term 

22 ‘‘vaccines, countermeasures, or products research 

23 expenses’’ means the amounts which are paid or 

24 incurred by the researcher or manufacturer dur25 ing the taxable year with respect to any research 
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1 and development of vaccines, countermeasures, or 

2 products. Qualified research and development ex3 penses include expenses related to reformulating 

4 existing vaccines, countermeasures, or products. 

5 (C) DETERMINING RESEARCH EXPENSES.— 

6 Any vaccines, countermeasures, or products re7 search expenses for any taxable year which are 

8 qualified research expenses (within the meaning 

9 of this subsection) shall be taken into account in 

10 determining base period research expenses for 

11 purposes of applying this paragraph to subse12 quent taxable years. 

13 (D) DENIAL OF DOUBLE BENEFIT FOR VAC14 CINES, COUNTERMEASURES, OR PRODUCTS RE15 SEARCH EXPENSES.—If any portion of the vac16 cines, countermeasures, or products research ex17 penses is otherwise allowable as a deduction for 

18 the taxable year involved, the Secretary shall 

19 only provide a rebate under this section for the 

20 portion of such expenses not covered by any re21 bate determined by such deduction. 

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

23 a rebate under this paragraph, a manufacturer 

24 or researcher shall submit to the Secretary an 

25 application at such time, in such manner, and 
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1 containing such information as the Secretary 

2 may require, including— 

3 (i) a detailed description of the vac4 cine, countermeasure, or product being re5 searched or developed; 

6 (ii) a detailed description of the re7 search that is the subject of the rebate; 

8 (iii) a detailed accounting of the quali9 fied research expenses involved; 

10 (iv) an assurance that the researcher or 

11 manufacturer is following good laboratory 

12 practice, as required by the Secretary pur13 suant to the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 301 et seq.) and the 

15 Public Health Service Act (42 U.S.C. 201 et 

16 seq.); and 

17 (v) copies of tax returns for the taxable 

18 year involved. 

19 (F) EFFECTIVE DATE.—This paragraph 

20 shall apply to expenses for taxable years begin21 ning after December 31, 2005. 

22 (4) EXCLUSION FOR AMOUNTS FUNDED BY

23 GRANTS, ETC.—The terms ‘‘vaccines, countermeasures, 

24 or products manufacturing investment’’ and ‘‘quali25 fied research expenses’’ shall not include any amount 
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1 to the extent such amount is funded by any grant, 

2 contract, or otherwise funded by another person (or 

3 any governmental entity). 

4 (c) GRANTS TO EXPAND AND IMPROVE RESEARCH AND

5 DEVELOPMENT AND MANUFACTURING OF VACCINES, COUN6 TERMEASURES OR PRODUCTS.—Part B of title III of the 

7 Public Health Service Act is amended by inserting after 

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

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

10 AND DEVELOPMENT AND MANUFACTURING 

11 OF VACCINES, QUALIFIED COUNTER12 MEASURES OR QUALIFIED PANDEMIC OR EPI13 DEMIC PRODUCTS. 

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

15 to a manufacturer to purchase or improve real property 

16 and tangible personal property used in the research and 

17 development, manufacture, or distribution of a vaccine, 

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

19 qualified pandemic or epidemic product (as defined in sec20 tion 319F–3(c)(5)). 

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

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

23 Secretary an application at such time, in such manner, and 

24 containing such information as the Secretary may require, 

25 including— 
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1 ‘‘(1) a detailed description of the planned expan2 sion; 

3 ‘‘(2) a detailed description of the equipment, fa4 cility, or property involved; 

5 ‘‘(3) a certification that such facility or property 

6 is physically located in a State; 

7 ‘‘(4) a detailed description of the vaccine, quali8 fied countermeasure or qualified pandemic or epi9 demic product involved; 

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

11 development, manufacturer, or distribution involved; 

12 ‘‘(6) a description of how such equipment, facil13 ity, or property is to be used; 

14 ‘‘(7) a description of whether such equipment, fa15 cility, or property can be used for the research and 

16 development, manufacture, or distribution of a drug, 

17 biological product, device or other countermeasure not 

18 described in paragraph (4); and 

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

20 or property involved complies with all applicable 

21 Federal, State, and local laws. 

22 ‘‘(c) RECAPTURE.— 

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

24 expiration of the 20-year period beginning on the date 

25 on which a grant is awarded under this section, the 
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1 facility or property involved ceases to be used for the 

2 purpose for which the grant was awarded, the United 

3 States shall be entitled to recover from the manufac4 turer an amount bearing the same ratio to the value 

5 of the facility or property at such time as the amount 

6 of the grant bore to the total cost of the purchase or 

7 improvement involved. The value of the facility or 

8 property at such time may be determined by agree9 ment of the manufacturer and the Secretary, or by 

10 order of the United States District Court for the dis11 trict in which such facility or property is situated. 

12 ‘‘(2) LIMITATION.—The Secretary may not re13 capture the facility or property under this subsection 

14 if the Secretary determines, in accordance with regu15 lations promulgated by the Secretary, that there is 

16 good cause for the failure of proper use. 

17 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There is 

18 authorized to be appropriated such sums as may be nec19 essary to carry out this section.’’. 

20 SEC. 9. TECHNICAL ASSISTANCE. 

21 Subchapter E of chapter V of the Federal Food, Drug, 

22 and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 

23 by adding at the end the following: 
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1 ‘‘SEC. 565. TECHNICAL ASSISTANCE. 

2 ‘‘The Secretary, in consultation with the Commis3 sioner of Food and Drugs, shall establish within the Food 

4 and Drug Administration a team of experts on manufac5 turing and regulatory activities (including compliance with 

6 current Good Manufacturing Practices) to provide both off7 site and on-site technical assistance to the manufacturers 

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

9 1 of the Public Health Service Act), security counter10 measures (as defined in section 319F–2 of such Act), or vac11 cines, at the request of such a manufacturer and at the dis12 cretion of the Secretary, if the Secretary determines that 

13 a shortage or potential shortage may occur in the United 

14 States in the supply of such vaccines or products and that 

15 the provision of such assistance would be beneficial in help16 ing alleviate or avert such shortage.’’. 

17 SEC. 10. ANIMAL MODELS FOR CERTAIN DISEASES. 

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

19 (42 U.S.C. 284 et seq.) is amended by adding at the end 

20 the following: 

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

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

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

24 Biomedical Advanced Research and Development Agency, 

25 the Director of the Centers for Disease Control and Preven26 tion, and the Commissioner of Food and Drugs, shall estab-
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1 lish and award grants under this section to eligible entities, 

2 including other Federal agencies, to study the physiological 

3 responses of certain animal species and, where appropriate, 

4 juvenile models, to chemical, biological, radiological, or nu5 clear agents or toxins or potential pandemic infectious dis6 ease, and to develop and validate such animal models. 

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

8 under this section, an entity shall— 

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

10 entity— 

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

12 laboratory or facility, as determined by the Sec13 retary; and 

14 ‘‘(B) will follow good laboratory practices; 

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

16 such time, in such manner, and containing such in17 formation as the Secretary may require, including— 

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

19 model involved; 

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

21 biological, radiological, nuclear, or other infec22 tious agents involved; 

23 ‘‘(C) a detailed description of how the ani24 mal model will be used for the development of a 
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1 drug, biological product, or device for use as a 

2 countermeasure; 

3 ‘‘(D) a detailed description of validation 

4 methods; and 

5 ‘‘(E) an assurance that the entity will fol6 low good laboratory practices; and 

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

8 funded under the grant to the Director of the Bio9 medical Advanced Research and Development Agency 

10 and the Director of NIH. 

11 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There are 

12 authorized to be appropriated such sums as may be nec13 essary to carry out this section.’’. 

14 SEC. 11. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC ADVI15 SORY COMMITTEE. 

16 Subchapter E of chapter V of the Federal Food, Drug, 

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

18 by this Act, is amended by adding at the end the following: 

19 ‘‘SEC. 566. ANIMAL MODEL/RESEARCH TOOL SCIENTIFIC AD20 VISORY COMMITTEE. 

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

22 the date of enactment of this section, the Secretary shall 

23 establish an 11-member advisory committee to be known as 

24 the ‘Animal Model/Research Tool Scientific Advisory Com-
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1 mittee’ (referred to in this section as the ‘Advisory Com2 mittee’). 

3 ‘‘(b) MEMBERSHIP.— 

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

5 as members of the Advisory Committee individuals 

6 who are technically qualified by training and experi7 ence, including in medicine, veterinarian medicine, 

8 biology, technology involving the manufacture, eval9 uation, or use of research tools, who are of appro10 priately diversified professional backgrounds to evalu11 ate the priority animal models and research tools. 

12 ‘‘(2) EX OFFICIO MEMBERS.—The Secretary may 

13 appoint Federal officials, including at least 1 rep14 resentative of the Biomedical Advanced Research and 

15 Development Agency, to serve as ex officio members of 

16 the Advisory Committee. 

17 ‘‘(3) CHAIRPERSON.—The Secretary shall des18 ignate 1 of the members of the Advisory Committee to 

19 serve as the chairperson. 

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

21 advice, information, and recommendations to the Secretary 

22 on— 

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

24 conditions associated with any biological (including 

25 organisms that cause infectious diseases), chemical, 
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1 radiological, or nuclear agent or toxin or potential 

2 pandemic infectious disease; 

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

4 research tool development and validation; and 

5 ‘‘(3) scientific issues raised in applications as re6 quested by the Secretary. 

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

8 research tools shall be established by the Secretary. 

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

10 ‘‘(1) COMPENSATION AND TRAVEL.—Members of 

11 the Advisory Committee who are not officers or em12 ployees of the United States, while attending con13 ferences or meetings of the committee or otherwise en14 gaged in its business, shall be entitled to receive com15 pensation at rates to be fixed by the Secretary, which 

16 may not exceed daily equivalent of the rate in effect 

17 for level 4 of the Senior Executive Schedule under sec18 tion 5382 of title 5, United States Code, for each day 

19 (including travel time) they are so engaged, and while 

20 so serving away from their homes or regular places of 

21 business each member may be allowed travel expenses, 

22 including per diem in lieu of subsistence, as author23 ized by section 5703 of title 5, United States Code, for 

24 persons in the Federal Government service employed 

25 intermittently. 
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1 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary 

2 shall furnish the Advisory Committee clerical and 

3 other assistance. 

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

5 the Federal Advisory Committee Act (5 U.S.C. App.) 

6 shall not apply to the Advisory Committee. 

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

8 make and maintain a transcript of any proceeding of the 

9 Committee. The Committee shall delete from any transcript 

10 made under this subsection information, which is exempt 

11 from disclosure under section 552(b) of title 5, United 

12 States Code.’’. 

13 SEC. 12. COLLABORATION AND COORDINATION. 

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

15 by adding at the end the following: 

16 ‘‘(g) LIMITED ANTITRUST EXEMPTION.— 

17 ‘‘(1) SECURITY COUNTERMEASURES, QUALIFIED

18 COUNTERMEASURES AND QUALIFIED PANDEMIC OR

19 EPIDEMIC PRODUCT DEVELOPMENT MEETINGS.— 

20 ‘‘(A) COUNTERMEASURES AND PRODUCTS

21 DEVELOPMENT MEETINGS AND CONSULTA22 TIONS.—The Secretary of Health and Human 

23 Services (referred to in this subsection as the 

24 ‘Secretary’) or the Director of the Biomedical 

25 Advanced Research and Development Agency (re-
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1 ferred to in this subsection as the ‘Director’), in 

2 coordination with the Attorney General and the 

3 Secretary of Homeland Security, may conduct 

4 meetings and consultations with parties involved 

5 in the development of security countermeasures 

6 (as defined in section 319F–2 of the Public 

7 Health Service Act) qualified countermeasures 

8 (as defined in section 319F–1 of the Public 

9 Health Service Act) or qualified pandemic or 

10 epidemic products (as defined in section 319F– 

11 3(c)(5) of the Public Health Service Act) (re12 ferred to in this section as ‘‘countermeasures or 

13 products’’) for the purpose of the development, 

14 manufacture, distribution, purchase, sale, or 

15 storage of countermeasures or products consistent 

16 with the purposes of this title. The Secretary or 

17 Director may convene such meeting or consulta18 tion at the request of any person, the Secretary 

19 of Homeland Security, the Attorney General, the 

20 Chairperson of the Federal Trade Commission, 

21 an industry representative or member, or upon 

22 initiation by such Secretary. The Secretary or 

23 Director shall give notice of such meetings and 

24 consultations to the Chairperson of the Federal 
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1 Trade Commission (referred to in this subsection 

2 as the ‘Chairperson’) and the Attorney General. 

3 ‘‘(B) MEETING AND CONSULTATION CONDI4 TIONS.—A meeting or consultation conducted 

5 under subparagraph (A) shall— 

6 ‘‘(i) be chaired or, in the case of a con7 sultation, facilitated by the Secretary or Di8 rector; 

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

10 development, manufacture, distribution, 

11 purchase, or sale of countermeasures or 

12 products, as determined by the Secretary or 

13 Director; 

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

15 the Secretary of Homeland Security, and 

16 the Chairperson; 

17 ‘‘(iv) be limited to discussions involv18 ing the development, manufacture, distribu19 tion, or sale of countermeasures or products, 

20 consistent with the purposes of this title; 

21 and 

22 ‘‘(v) be conducted in such manner as to 

23 ensure that national security, confidential, 

24 and proprietary information is not dis25 closed outside the meeting or consultation. 
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1 ‘‘(C) LIMITATION.—The Secretary or Direc2 tor may not require the disclosure of confidential 

3 commercial or proprietary information. 

4 ‘‘(D) MINUTES.—The Secretary or Director 

5 shall maintain minutes of meetings and con6 sultations under this subsection, which shall not 

7 be disclosed under section 552 of title 5, United 

8 States Code, unless such Secretary or Director, 

9 in consultation with the Attorney General, deter10 mines that disclosure would pose no threat to na11 tional security. Such determination shall not be 

12 subject to judicial review. 

13 ‘‘(E) EXEMPTION.— 

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

15 shall not apply to meetings and consulta16 tions under this paragraph. 

17 ‘‘(ii) LIMITATION.—Clause (i) shall not 

18 apply to any agreement or conduct that re19 sults from a meeting or consultation and 

20 that does not receive an exemption pursuant 

21 to this subsection. 

22 ‘‘(2) WRITTEN AGREEMENTS.—The Secretary or 

23 the Director shall file a written agreement regarding 

24 covered activities, made pursuant to meetings or con25 sultations conducted under paragraph (1) and that is 
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1 consistent with this paragraph, with the Attorney 

2 General and the Chairperson for a determination of 

3 the compliance of such agreement with antitrust laws. 

4 In addition to the proposed agreement itself, any such 

5 filing shall include— 

6 ‘‘(A) an explanation of the intended purpose 

7 of the agreement; 

8 ‘‘(B) a specific statement of the substance of 

9 the agreement; 

10 ‘‘(C) a description of the methods that will 

11 be utilized to achieve the objectives of the agree12 ment; 

13 ‘‘(D) an explanation of the necessity of a co14 operative effort among the particular partici15 pating parties to achieve the objectives of the 

16 agreement; and 

17 ‘‘(E) any other relevant information deter18 mined necessary by the Secretary or Director in 

19 consultation with the Attorney General and the 

20 Chairperson. 

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

22 in consultation with the Chairperson, shall determine 

23 whether an agreement regarding covered activities re24 ferred to in paragraph (2) would likely— 
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1 ‘‘(A) be in compliance with the antitrust 

2 laws, and so inform the Secretary or Director 

3 and the participating parties; or 

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

5 case, the filing shall be deemed to be a request for 

6 an exemption from the antitrust laws, limited to 

7 the performance of the agreement consistent with 

8 the purposes of this title. 

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

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

11 in consultation with the Chairperson, shall 

12 grant, deny, grant in part and deny in part, or 

13 propose modifications to a request for exemption 

14 from the antitrust laws under paragraph (3) 

15 within 15 business days of the receipt of such re16 quest. 

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

18 may extend the 15-day period referred to in sub19 paragraph (A) for an additional period of not to 

20 exceed 10 business days. Such additional period 

21 may be further extended only by the United 

22 States district court, upon an application by the 

23 Attorney General after notice to the Secretary or 

24 Director and the parties involved. 
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1 ‘‘(C) DETERMINATION.—In granting an ex2 emption under this paragraph, the Attorney 

3 General, in consultation with the Chairperson 

4 and the Secretary or Director— 

5 ‘‘(i) shall find— 

6 ‘‘(I) that the agreement involved 

7 is necessary to ensure the availability 

8 of countermeasures or products; 

9 ‘‘(II) that the exemption from the 

10 antitrust laws would promote the pub11 lic interest; and 

12 ‘‘(III) that there is no substantial 

13 competitive impact to areas not di14 rectly related to the purposes of the 

15 agreement; and 

16 ‘‘(ii) may consider any other factors 

17 determined relevant by the Attorney General 

18 and the Chairperson. 

19 ‘‘(5) LIMITATION ON AND RENEWAL OF EXEMP20 TIONS.—An exemption granted under paragraph (4) 

21 shall be limited to covered activities, and shall be re22 newed (with modifications, as appropriate) on the 

23 date that is 3 years after the date on which the ex24 emption becomes effective (and at 3-year intervals 

25 thereafter, if renewed) unless the Attorney General in 
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1 consultation with the Chairperson determines that the 

2 exemption should not be renewed (with modifications, 

3 as appropriate) considering the factors described in 

4 paragraph (4). 

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

6 information acquired under an exempted agreement 

7 by the parties to such an agreement for any purposes 

8 other than those specified in the antitrust exemption 

9 granted by the Attorney General shall be subject to the 

10 antitrust laws and any other applicable laws. 

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

12 the Chairperson may develop and issue guidelines to 

13 implement this subsection. 

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

15 date of enactment of the Biodefense and Pandemic 

16 Vaccine and Drug Development Act of 2005, and an17 nually thereafter, the Attorney General and the 

18 Chairperson shall report to Congress on the use and 

19 continuing need for the exemption from the antitrust 

20 laws provided by this subsection. 

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

22 maintained by the Secretary or Director pursuant to 

23 paragraph (1)(D) shall not be disclosed under section 

24 552 of title 5, United States Code, if the exemption 

25 is not renewed under paragraph (5), or if meetings 
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1 are no longer conducted, unless the Secretary or Di2 rector, in consultation with the Attorney General, de3 termines that the disclosure would pose no threat to 

4 national security. Such determination shall not be 

5 subject to judicial review. 

6 ‘‘(h) SUNSET.—The authority of the Attorney General 

7 to grant or renew a limited antitrust exemption under this 

8 section shall expire at the end of the 6-year period that be9 gins on the date of enactment of the Biodefense and Pan10 demic Vaccine and Drug Development Act of 2005. 

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

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

13 laws’— 

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

15 subsection (a) of the first section of this Act, ex16 cept that such term includes the Act of June 19, 

17 1936 (15 U.S.C. 13 et seq.) (commonly known as 

18 the Robinson-Patman Act), and section 5 of the 

19 Federal Trade Commission Act (15 U.S.C. 45) to 

20 the extent such section 5 applies to unfair meth21 ods of competition; and 

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

23 laws referred to in subparagraph (A). 

24 ‘‘(2) COVERED ACTIVITIES.— 
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1 ‘‘(A) IN GENERAL.—Except as provided in 

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

3 means any group of activities or conduct, includ4 ing attempting to make, making, or performing 

5 a contract or agreement or engaging in other 

6 conduct, for the purpose of— 

7 ‘‘(i) theoretical analysis, experimen8 tation, or the systematic study of phe9 nomena or observable facts necessary to the 

10 development of countermeasures or products; 

11 ‘‘(ii) the development or testing of 

12 basic engineering techniques necessary to 

13 the development of countermeasures or prod14 ucts; 

15 ‘‘(iii) the extension of investigative 

16 findings or theory of a scientific or tech17 nical nature into practical application for 

18 experimental and demonstration purposes, 

19 including the experimental production and 

20 testing of models, prototypes, equipment, 

21 materials, and processes necessary to the de22 velopment of countermeasures or products; 

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

24 marketing of a product, process, or service 

25 that is a countermeasures or products; 
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1 ‘‘(v) the testing in connection with the 

2 production of a product, process, or services 

3 necessary to the development of counter4 measures or products; 

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

6 analysis of research or production informa7 tion necessary to the development of coun8 termeasures or products; or 

9 ‘‘(vii) any combination of the purposes 

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

11 and such term may include the establishment 

12 and operation of facilities for the conduct of cov13 ered activities described in clauses (i) through 

14 (vi), the conduct of such covered activities on a 

15 protracted and proprietary basis, and the proc16 essing of applications for patents and the grant17 ing of licenses for the results of such covered ac18 tivities. 

19 ‘‘(B) EXCEPTION.—The term ‘covered ac20 tivities’ shall not include the following activities 

21 involving 2 or more persons: 

22 ‘‘(i) Exchanging information among 

23 competitors relating to costs, profitability, 

24 marketing, or distribution of any product, 

25 process, or service if such information is not 
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1 reasonably necessary to carry out the pur2 poses of covered activities. 

3 ‘‘(ii) Entering into any agreement or 

4 engaging in any other conduct— 

5 ‘‘(I) to restrict or require the sale, 

6 licensing, or sharing of inventions, de7 velopments, products, processes, or 

8 services not developed through, pro9 duced by, or distributed or sold 

10 through such covered activities; or 

11 ‘‘(II) to restrict or require partici12 pation by any person who is a party 

13 to such covered activities in other re14 search and development activities, that 

15 is not reasonably necessary to prevent 

16 the misappropriation of proprietary 

17 information contributed by any person 

18 who is a party to such covered activi19 ties or of the results of such covered ac20 tivities. 

21 ‘‘(iii) Entering into any agreement or 

22 engaging in any other conduct allocating a 

23 market with a competitor that is not ex24 pressly exempted from the antitrust laws by 

25 a determination under subsection (g)(4). 
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1 ‘‘(iv) Exchanging information among 

2 competitors relating to production (other 

3 than production by such covered activities) 

4 of a product, process, or service if such in5 formation is not reasonably necessary to 

6 carry out the purpose of such covered activi7 ties. 

8 ‘‘(v) Entering into any agreement or 

9 engaging in any other conduct restricting, 

10 requiring, or otherwise involving the pro11 duction of a product, process, or service that 

12 is not so expressly exempted from the anti13 trust laws by a determination under sub14 section (g)(4). 

15 ‘‘(vi) Except as otherwise provided in 

16 this subsection, entering into any agreement 

17 or engaging in any other conduct to restrict 

18 or require participation by any person who 

19 is a party to such activities, in any unilat20 eral or joint activity that is not reasonably 

21 necessary to carry out the purpose of such 

22 covered activities. 

23 ‘‘(vii) Entering into any agreement or 

24 engaging in any other conduct restricting or 
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1 setting the price at which a product is of2 fered for sale, whether by bid or otherwise. 

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

4 includes the identification of suitable compounds or 

5 biological materials, the conduct of preclinical and 

6 clinical studies, the preparation of an application for 

7 marketing approval, and any other actions related to 

8 preparation of a countermeasure or product.’’. 

9 SEC. 13. PROCUREMENT. 

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

11 U.S.C. 247d–6b) is amended— 

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

13 SECURITY COUNTERMEASURE PROCURE14 MENTS’’ before the period; and 

15 (2) in subsection (c)— 

16 (A) in the subsection heading, by striking 

17 ‘‘BIOMEDICAL’’; 

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

19 meet the needs of the stockpile’’ and inserting ‘‘to 

20 meet the stockpile needs’’; 

21 (C) in paragraph (7)(C)(ii)— 

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

23 follows: 

24 ‘‘(I) PAYMENT CONDITIONED ON

25 DELIVERY.—The contract shall provide 
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1 that no payment may be made until 

2 delivery of a portion, acceptable to the 

3 Secretary, of the total number of units 

4 contracted for, except that, notwith5 standing any other provision of law, 

6 the contract may provide that, if the 

7 Secretary determines (as the Sec8 retary’s discretion) that an advance 

9 payment, partial payment for signifi10 cant milestones, or payment to increase 

11 manufacturing capacity is necessary to 

12 ensure success of a project, the Sec13 retary shall pay an amount, not to ex14 ceed 10 percent of the contract amount, 

15 in advance of delivery. The contract 

16 shall provide that such advance pay17 ment is required to be repaid if there 

18 is a failure to perform by the vendor 

19 under the contract. The contract may 

20 also provide for up to 3 additional ad21 vance payments of 5 percent each for 

22 meeting the milestones specified in 

23 such contract. Provided that the speci24 fied milestones are reached, these ad25 vanced payments of 5 percent shall not 
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1 be required to be repaid. Nothing in 

2 this subclause shall be construed as af3 fecting the rights of vendors under pro4 visions of law or regulation (including 

5 the Federal Acquisition Regulation) re6 lating to the termination of contracts 

7 for the convenience of the Govern8 ment.’’; and 

9 (ii) by adding at the end the following: 

10 ‘‘(VII) SALES EXCLUSIVITY.—The 

11 contract may provide that the vendor 

12 is the sole and exclusive supplier of the 

13 product to the Federal Government for 

14 a specified period of time, not to exceed 

15 15 years, on the condition that the ven16 dor is able to satisfy the needs of the 

17 Government. During the agreed period 

18 of sales exclusivity, the vendor shall not 

19 assign its rights of sales exclusivity to 

20 another entity or entities without ap21 proval by the Secretary. 

22 ‘‘(VIII) SURGE CAPACITY.—The 

23 contract may provide that the vendor 

24 establish domestic manufacturing ca25 pacity of the product to ensure that ad-
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1 ditional production of the product is 

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

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

6 may provide a fee to the vendor for es7 tablishing and maintaining such ca8 pacity in excess of the initial require9 ment for the purchase of the product. 

10 Additionally, the cost of maintaining 

11 the domestic manufacturing capacity 

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

14 ‘‘(IX) CONTRACT TERMS.—The 

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

17 ‘‘(aa) the dosing and admin18 istration requirements for coun19 termeasures to be developed and 

20 procured; 

21 ‘‘(bb) the amount of funding 

22 that will be dedicated by the Sec23 retary for research and develop24 ment of the countermeasure; and 
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1 ‘‘(cc) the specifications the 

2 countermeasure must meet to 

3 qualify for procurement under a 

4 contract under this section.’’; and 

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

6 end the following: ‘‘Such agreements may allow 

7 other executive agencies to order qualified and 

8 security countermeasures under procurement 

9 contracts or other agreements established by the 

10 Secretary. Such ordering process (including 

11 transfers of appropriated funds between an agen12 cy and the Department of Health and Human 

13 Services as reimbursements for such orders for 

14 countermeasures) may be conducted under the 

15 authority of section 1535 of title 31, United 

16 States Code, except that all such orders shall be 

17 processed under the terms established under the 

18 Biodefense and Pandemic Vaccine and Drug De19 velopment Act of 2005 and the Project BioShield 

20 Act of 2004, for the procurement of counter21 measures under section 319F–1 or 319F–2.’’ 

22 SEC. 14. NATIONAL PATHOLOGY CENTER. 

23 (a) IN GENERAL.—Title IV of the Public Health Serv24 ice Act (42 U.S.C. 281 et seq.) is amended— 
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1 (1) in section 401(b)(2), by adding at the end the 

2 following: 

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

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

5 287 et seq.) the following: 

6 ‘‘Subpart 7—National Pathology Center 

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

8 CENTER. 

9 ‘‘In order to provide pathology consultation for civil10 ian and military health professionals (including Depart11 ment of Veterans Affairs health professionals) there is estab12 lished the National Pathology Center (in this subpart re13 ferred to as the ‘Center’). The Center shall be headed by 

14 a director, who shall be appointed by the Secretary. The 

15 Director of the Center shall report directly to the Director 

16 of NIH. 

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

18 ‘‘(a) PURPOSES OF THE CENTER.—The general pur19 poses of the Center are to— 

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

21 training, and other programs with respect to the 

22 science and clinical practice of pathology; 

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

24 repository; and 

25 ‘‘(3) provide pathology consultation services. 
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1 ‘‘(b) ACTIVITIES OF THE DIRECTOR.—In order to 

2 carry out the purposes of the Center described in subsection 

3 (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 and 

11 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 fees 

19 for the activities described in paragraph (1)(B); 

20 and 

21 ‘‘(B) conduct such other activities as the Di22 rector of the Center determines appropriate to 

23 carry out the purposes described in subsection 

24 (a). 
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1 ‘‘(c) AUTHORITY FOR EXPERT OPINIONS.—The Direc2 tor 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 Board 

12 of Regents of the Center (in this subpart referred to 

13 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 the 

7 Board described in subparagraphs (A) through (E) of 

8 paragraph (1) shall serve as ex officio members of the 

9 Board. 

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

11 appointed under paragraph (1)(F) shall annually 

12 elect one of such members to serve as the Chairperson 

13 of the Board until the next election. 

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

15 the Board to advise, consult with, and make recommenda16 tions to the Director of NIH on important matters of policy 

17 in regard to the Center, including such matters as the scope, 

18 content and organization of the research, education and 

19 consultative services provided by the Center. The Board 

20 shall make recommendations to the Director of NIH regard21 ing the rules under which specimens from the tissue reposi22 tory will be used and under which publications, facilities 

23 and services of the Center will be made available to various 

24 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 predecessor 

5 of such member was appointed shall be appointed for the 

6 remainder of such term. None of the appointed members 

7 shall be eligible for reappointment within 1 year after the 

8 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 and 

19 administration of gifts made for the benefit of the Center 

20 or for carrying out any of its functions. 

21 ‘‘SEC. 485E. CENTER FACILITIES. 

22 ‘‘There are authorized to be appropriated amounts suf23 ficient for the erection and equipment of suitable and ade24 quate buildings and facilities for use of the Center. The Ad25 ministrator of General Services may acquire, by purchase, 
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1 condemnation, donation, or otherwise, a suitable site or 

2 sites, selected by the Secretary in accordance with the direc3 tion of the Board, for such buildings and facilities and to 

4 erect thereon, furnish, and equip such buildings and facili5 ties. The amounts authorized to be appropriated by this sec6 tion include the cost of preparation of drawings and speci7 fications, supervision of construction, and other adminis8 trative expenses incident to the work. The Administrator 

9 of General Services shall prepare the plans and specifica10 tions, make all necessary contracts, and supervise construc11 tion.’’. 

12 (b) REPORT.—Not later than 1 year after the date of 

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

14 Services shall submit a report to the appropriate commit15 tees of Congress that contains— 

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

17 National Pathology Center under subpart 7 of part E 

18 of title IV of the Public Health Service Act,as estab19 lished 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 modi24 fications to the National Pathology Center. 
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1 (c) TRANSFER OF THE ARMED FORCES INSTITUTE OF

2 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 sub7 part 7 of part E of title IV of the Public Health 

8 Service Act all functions, duties, personnel, as9 sets, liabilities, contracts, property, records, and 

10 unexpended balances of appropriations of the 

11 Armed Forces Institute of Pathology. The pre12 ceding sentence shall not affect any proceedings, 

13 pending applications, suits, or other actions 

14 pending on the date of enactment of this Act. 

15 (B) EXCEPTIONS.—The following compo16 nents of the Armed Forces Institute of Pathology 

17 shall not be transferred from the Department of 

18 Defense pursuant to subparagraph (A): 

19 (i) The Armed Forces Medical Exam20 iner. 

21 (ii) The Department of Defense DNA 

22 registry. 

23 (iii) Accident Investigation Program. 

24 (iv) The histopathology training pro25 gram. 
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1 (v) The patient safety center. 

2 (vi) Department of Legal Medicine. 

3 (vii) Center for Clinical Laboratory 

4 Medicine. 

5 (viii) Drug Testing and Quality Assur6 ance Program. 

7 (ix) Subject to the discretion of the 

8 Secretary of Defense, medical research pro9 grams on the following: 

10 (I) Body armor. 

11 (II) Environmental sarcoidosis. 

12 (III) Depleted uranium. 

13 (IV) Military working dogs. 

14 (V) Such other areas of research 

15 related to pathology as the Secretary of 

16 Defense shall choose to conduct. 

17 (2) REFERENCES.—Any reference in any Federal 

18 law, Executive order, rule, regulation, or delegation of 

19 authority, or any document of or relating to the 

20 Armed Forces Institute of Pathology shall be deemed 

21 to be a reference to the National Pathology Center es22 tablished under subpart 7 of part E of title IV of the 

23 Public Health Service Act. 
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1 SEC. 15. RULE OF CONSTRUCTION. 

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

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

4 the National Vaccine Injury Compensation Program under 

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

6 300aa–1 et seq.), including such laws regarding— 

7 (1) whether claims may be filed or compensation 

8 may be paid for a vaccine-related injury or death 

9 under such Program; 

10 (2) claims pending under such Program; and 

11 (3) any petitions, cases, or other proceedings be12 fore the United States Court of Federal Claims pursu13 ant to such title. 
Calendar No. 257 

109TH CONGRESS 

1ST SESSION S. 1873 

A BILL 

To prepare and strengthen the biodefenses of the 

poses. natural outbreaks of illness, and for other purUnited States against deliberate, accidental, and 

OCTOBER 24, 2005 

Reported with an amendment