II 

109TH CONGRESS 

1ST SESSION S. 1880 

To amend the Public Health Service Act to enhance biodefense and pandemic 

preparedness activities, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 17, 2005 

Mr. KENNEDY (for himself, Mr. DODD, Mr. HARKIN, Ms. MIKULSKI, Mr. 

BINGAMAN, Mrs. CLINTON, Mr. SCHUMER, and Mr. OBAMA) introduced 

the following bill; which was read twice and referred to the Committee 

on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to enhance biodefense and pandemic preparedness activities, 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘National Biodefense and Pandemic Preparedness Act of 

6 2005’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 
2 

•S 1880 IS 

TITLE I—RESTRUCTURING THE NATIONAL BIODEFENSE 

INITIATIVE 

Sec. 101. National Biodefense Trust. 

Sec. 102. Strategic Biodefense Initiative. 

Sec. 103. Collaboration and coordination. 

TITLE II—ENSURING NATIONAL VACCINE MANUFACTURING 

CAPACITY 

Sec. 201. Warm-based manufacturing for biological countermeasures. 

Sec. 202. Emergency manufacturing. 

Sec. 203. Construction of facilities. 

TITLE III—IMPROVING PROJECT BIOSHIELD 

Sec. 301. Improving project BioShield. 

TITLE IV—INCENTIVES FOR COUNTERMEASURE DEVELOPMENT 

Sec. 401. Prize payments for countermeasures development. 

Sec. 402. Providing for long-term sole-sourcing of countermeasures. 

TITLE V—CROSSING THE VALLEY OF DEATH 

Sec. 501. Early support for countermeasure development. 

Sec. 502. Incentive payments. 

TITLE VI—ACCELERATING THE APPROVAL OF 

COUNTERMEASURES 

Sec. 601. Accelerating the approval of countermeasures. 

Sec. 602. Postmarketing studies for countermeasures. 

TITLE VII—BIODEFENSE INJURY COMPENSATION PROGRAM 

Sec. 701. National Biodefense Injury Compensation Program. 

TITLE VIII—INDEMNIFICATION FOR PRODUCERS OF 

COUNTERMEASURES 

Sec. 801. Indemnification for manufacturers and health care professionals who 

administer medical products needed for biodefense. 

TITLE IX—STRENGTHENING PUBLIC HEALTH READINESS FOR 

PANDEMICS 

Subtitle A—Improved Planning for Pandemic Influenza 

Sec. 901. Federal Pandemic Influenza Preparedness Plan. 

Sec. 902. Requirement to develop State pandemic influenza plans. 

Sec. 903. Use of CDC and HRSA funds for public health preparedness. 

Subtitle B—Vaccine Supply 

Sec. 911. Buy-back program for flu vaccine. 

Subtitle C—Enhancing the National Strategic Stockpile 

Sec. 921. Stockpiling of antivirals and other medications. 
3 

•S 1880 IS 

Sec. 922. Strategic plan for stockpile. 

Subtitle D—Prohibiting Price Gouging on Needed Flu Medicines 

Sec. 931. Unfair or deceptive acts or practices in commerce related to treatments for pandemic influenza. 

Subtitle E—National Institute of Pathology 

Sec. 941. National Institute of Pathology. 

Sec. 942. Transfer of the Armed Forces Institute of Pathology. 

Subtitle F—Increased Influenza Vaccine and Outbreak Surveillance Activities 

Sec. 951. Tracking network and demonstration grants. 

Sec. 952. Educational efforts and grants. 

Subtitle G—Miscellaneous Provisions 

Sec. 961. HRSA curriculum development and training programs. 

Sec. 962. Using health information technology to enahnce epidemic detection. 

Sec. 963. Naturally occurring or deliberately introduced agents. 

Sec. 964. Use of Federal facilities in emergencies. 

Sec. 965. Advisory Committee on Vulnerable Populations. 

Sec. 966. Emergency system for advance registration of health professions volunteers. 

TITLE X—ENHANCING ANTIBIOTICS 

Sec. 1001. Preserving the effectiveness of medically important antibiotics. 

TITLE XI—IMPROVING RESEARCH ON BIODEFENSE 

COUNTERMEASURES 

Sec. 1101. Improving the ability of biodefense researchers to work with select 

agents. 

1 TITLE I—RESTRUCTURING THE 

2 NATIONAL BIODEFENSE INI3 TIATIVE 

4 SEC. 101. NATIONAL BIODEFENSE TRUST. 

5 (a) NATIONAL BIOVENTURE TRUST.— 

6 (1) PURPOSE.—It is the purpose of this sub7 section to establish a Federal Government corpora8 tion for the purpose of— 

9 (A) administering the Federal BioShield 

10 program; and 
4 

•S 1880 IS 

1 (B) identifying and supporting the develop2 ment of promising technologies that could lead 

3 to the development of qualified counter4 measures. 

5 (2) ESTABLISHMENT OF TRUST.—There is es6 tablished a body corporate to be known as the ‘‘Na7 tional BioVenture Trust’’ (referred to in this section 

8 as the ‘‘Trust’’) which shall be in the Department of 

9 Health and Human Services. The Trust shall have 

10 succession until dissolved by Act of Congress. It 

11 shall maintain its principal office in the District of 

12 Columbia and shall be deemed, for purposes of 

13 venue in civil actions, to be a resident thereof. Agen14 cies or offices may be established by the Trust in 

15 such other place or places as it may deem necessary 

16 or appropriate in the conduct of its business. 

17 (3) CAPITALIZATION.—The Trust shall have 

18 common stock, without par value, which shall be 

19 vested with all voting rights, each share being enti20 tled to one vote with rights of cumulative voting at 

21 all elections of directors. The Trust may eliminate 

22 such rights of cumulative voting by a resolution 

23 adopted by its board of directors and approved by 

24 the holders of a majority of the shares of common 

25 stock voting in person or by proxy at the annual 
5 

•S 1880 IS 

1 meeting, or other special meeting, at which such res2 olution is considered. The corporation may have pre3 ferred stock on such terms and conditions as the 

4 board of directors shall prescribe. The free transfer5 ability of the stock at all times to any person, firm, 

6 corporation, or other entity shall not be restricted 

7 except that, as to the Trust, it shall be transferable 

8 only on the books of the Trust. The Trust may issue 

9 shares of common stock in return for appropriate 

10 payments into capital or capital and surplus. Any 

11 proceeds derived by the Trust under this paragraph 

12 shall be reinvested for the develop of new technology. 

13 Notwithstanding any other provision of law, the Sec14 retary of Health and Human Service shall ensure 

15 that not less than 51 percent of the stock provided 

16 for under this paragraph s held by the Department 

17 of Health and Human Services. 

18 (4) GENERAL MANAGEMENT.—There is hereby 

19 established in the Department of Health and 

20 Human Services the position of Chief Executive Of21 ficer, National BioVenture Trust, who shall be ap22 pointed by the President in consultation with the 

23 Secretary, subject to the advice and consent of the 

24 Senate. All the powers and duties of the Trust shall 

25 be vested in the Chief Executive Officer. The Sec-
6 

•S 1880 IS 

1 retary shall select and effect the appointment of 

2 qualified persons to fill the offices of vice president, 

3 and such other offices as may be provided for in the 

4 bylaws of the Trust. Persons appointed under the 

5 preceding sentence shall perform such executive 

6 functions, powers, and duties as may be prescribed 

7 by the bylaws or by the Secretary, and such persons 

8 shall be executive officers of the Trust and shall dis9 charge all such executive functions, powers, and du10 ties. The Chief Executive Officer may participate in 

11 meeting provided for under section 2(g) of the Clay12 ton Act (15 U.S.C. 13) (as added by section 103 of 

13 this Act). In carrying out the activities under this 

14 subsection, the Chief Executive Officer, in consulta15 tion with the National Advisory Committee on Vul16 nerable Populations and Terrorism, and the Vulner17 able Populations Working Group, and based on the 

18 recommendations of the Secretary, shall give priority 

19 to supporting and facilitating research and develop20 ment of countermeasures, and formulations of coun21 termeasures, that are likely to be safe and effective 

22 for pediatric populations, pregnant women, and 

23 other vulnerable populations. 

24 (5) BOARD OF DIRECTORS.— 
7 

•S 1880 IS 

1 (A) IN GENERAL.—The Trust shall have a 

2 board of directors, which shall consist of 18 in3 dividuals, 9 of whom shall be appointed annu4 ally by the Secretary, and the remainder of 

5 whom shall be elected annually by the common 

6 stockholders. The board shall at all times have 

7 as members appointed by the Secretary at least 

8 3 individuals from the biotechnology or pharma9 cology industry, at least 3 individuals with ex10 perience in chemical, nuclear, or biological 

11 threats to the United States (including natu12 rally occurring biological threats), and at least 

13 3 individuals who are representatives of 

14 healthcare consumers or workers. 

15 (B) TERMS AND VACANCIES.—Each mem16 ber of the board of directors shall be appointed 

17 or elected for a term ending on the date of the 

18 next annual meeting of the stockholders, except 

19 that any such appointed member may be re20 moved from office by the Secretary for good 

21 cause. Any elective seat on the board which be22 comes vacant after the annual election of the 

23 directors shall be filled by the board, but only 

24 for the unexpired portion of the term. Any ap25 pointive seat which becomes vacant shall be 
8 

•S 1880 IS 

1 filled by appointment of the Secretary, but only 

2 for the unexpired portion of the term. 

3 (C) POWERS.—Within the limitations of 

4 law and regulation, the board shall determine 

5 the general policies which shall govern the oper6 ations of the Trust, and shall have power to 

7 adopt, amend, and repeal bylaws governing the 

8 performance of the powers and duties granted 

9 to or imposed upon it by law. The board of di10 rectors shall select and effect the appointment 

11 of qualified persons to fill the offices of presi12 dent and vice president, and such other offices 

13 as may be provided for in the bylaws. The 

14 board shall make recommendations to the Chief 

15 Executive Officer concerning the policies for ad16 ministering the Trust. 

17 (D) COMPENSATION.—Any member of the 

18 board who is a full-time officer or employee of 

19 the Federal Government shall not, as such 

20 member, receive compensation for his or her 

21 services. 

22 (6) GRANTS.— 

23 (A) IN GENERAL.—The Trust shall award 

24 grants to entities that have developed tech25 nologies that may (as determined by the Trust) 
9 

•S 1880 IS 

1 lead to the development of qualified counter2 measures. The Trust shall ensure that grant 

3 funds are not provided under this section for 

4 activities that will substantially occur outside of 

5 the United States. 

6 (B) POLICIES.—The Trust shall develop 

7 policies and procedures for the awarding of 

8 grants under subparagraph (A). 

9 (C) REASONABLE PRICING.—To be eligible 

10 to receive a grant under subparagraph (A), an 

11 entity shall enter into an agreement with the 

12 Trust under which— 

13 (i) products developed using grant 

14 funds will be made available at reasonable 

15 prices to the Trust, the Federal Govern16 ment, and other consumers, except that in 

17 lieu of such an agreement, a grantee may 

18 provide the Trust with equity in return for 

19 the receipt of grant funds; 

20 (ii) product developed using grant 

21 funds will be made available as provided 

22 for under clause (i) at not more than the 

23 market share price that exists on the com24 mercial market; and 
10 

•S 1880 IS 

1 (iii) the Trust is provided with the au2 thority to sell equity in products developed 

3 using grant funds and obtained by the 

4 Trust and to apply the proceeds from such 

5 sales for the awarding f grants under sub6 paragraph (A). 

7 (7) MISCELLANEOUS PROVISIONS.— 

8 (A) IN GENERAL.—The Trust shall have 

9 power to— 

10 (i) adopt, alter, and use a corporate 

11 seal, which shall be judicially noticed; 

12 (ii) to enter into and perform con13 tracts, leases, cooperative agreements, or 

14 other transactions, on such terms as it 

15 may deem appropriate, with any agency or 

16 instrumentality of the United States, or 

17 with any State, Territory, or possession, or 

18 the Commonwealth of Puerto Rico, or with 

19 any political subdivision thereof, or with 

20 any person, firm, association, or corpora21 tion; to execute, in accordance with its by22 laws, all instruments necessary or appro23 priate in the exercise of any of its powers; 

24 (iii) in its corporate name, to sue and 

25 to be sued, and to complain and to defend, 
11 

•S 1880 IS 

1 in any court of competent jurisdiction, 

2 State or Federal, but no attachment, in3 junction, or other similar process, final, 

4 shall be issued against the property of the 

5 Trust or against the Trust with respect to 

6 its property; 

7 (iv) to conduct its business without re8 gard to any qualification or similar statute 

9 in any State of the United States, includ10 ing the District of Columbia, the Common11 wealth of Puerto Rico, and the Territories 

12 and possessions of the United States; 

13 (v) to lease, purchase, or acquire any 

14 property, real, personal, or mixed, or any 

15 interest therein, to hold, rent, maintain, 

16 modernize, use, and operate such property, 

17 and to sell, for cash or credit, lease, or oth18 erwise dispose of the same, at such time 

19 and in such manner as and to the extent 

20 that it may deem necessary or appropriate; 

21 (vi) to prescribe, repeal, and amend or 

22 modify, rules, regulations, or requirements 

23 governing the manner in which its general 

24 business may be conducted; and 
12 

•S 1880 IS 

1 (vii) to do all things as are necessary 

2 or incidental to the proper management of 

3 its affairs and the proper conduct of its 

4 business. 

5 (B) DETERMINATION WITH RESPECT TO

6 OBLIGATIONS AND EXPENDITURES.—Except as 

7 may be otherwise provided in this section, with 

8 respect to chapter 91 of title 31, or in other 

9 laws specifically applicable to Government cor10 porations, the Trust shall determine the neces11 sity for and the character and amount of its ob12 ligations and expenditures and the manner in 

13 which they shall be incurred, allowed, paid, and 

14 accounted for. 

15 (C) EXEMPTION FROM TAXATION.—The 

16 Trust, including its franchise, capital, reserves, 

17 surplus, security holdings, and income shall be 

18 exempt from all taxation now or hereafter im19 posed by the United States, by any territory, 

20 dependency, or possession thereof, or by any 

21 State, county, municipality, or local taxing au22 thority, except that any real property of the 

23 Trust shall be subject to State, territorial, 

24 county, municipal, or local taxation to the same 
13 

•S 1880 IS 

1 extent according to its value as other real prop2 erty is taxed. 

3 (D) APPOINTMENT AND COMPENSATION

4 OF PERSONNEL; USE OF SERVICES OF OTHER

5 AGENCIES.— 

6 (i) APPOINTMENT AND COMPENSA7 TION.—The Secretary shall have to power 

8 to select and appoint or employ such offi9 cers, attorneys, employees, and agents of 

10 the Trust, to vest them with such powers 

11 and duties, and to fix and to cause the 

12 Trust to pay such compensation to them 

13 for their services, as he may determine, 

14 subject to the civil service and classifica15 tion laws. 

16 (ii) USE OF AGENCIES.—With the 

17 consent of any Government corporation, or 

18 of any board, commission, independent es19 tablishment, or executive department of 

20 the Government, the Trust may avail itself 

21 on a reimbursable basis of the use of infor22 mation, services, facilities, officers, and 

23 employees thereof, including any field serv24 ice thereof, in carrying out the provisions 

25 of the section. 
14 

•S 1880 IS 

1 (iii) COMPENSATION.—The board of 

2 directors of the Trust shall have the power 

3 to select and appoint or employ such offi4 cers, attorneys, employees, and agents, to 

5 vest them with such powers and duties, 

6 and to fix and to cause the Trust to pay 

7 such compensation to them for their serv8 ices, as the board of directors determines 

9 reasonable and comparable with compensa10 tion for employment in other similar busi11 nesses involving similar duties and respon12 sibilities, except that a significant portion 

13 of potential compensation of all executive 

14 officers of the Trust shall be based on the 

15 performance of the Trust, and any such 

16 action shall be without regard to the Fed17 eral civil service and classification laws. 

18 Appointments, promotions, and separations 

19 so made shall be based on merit and effi20 ciency, and no political tests or qualifica21 tions shall be permitted or given consider22 ation. 

23 (E) PROHIBITION AGAINST USE OF NAMES; 

24 INJUNCTION; DAMAGES.—No individual, asso25 ciation, partnership, or corporation, except the 
15 

•S 1880 IS 

1 Trust shall use the words ‘‘National BioVenture 

2 Trust’’ as the name under which the individual, 

3 association, partnership, or corporation shall do 

4 business. Violations of the foregoing sentence 

5 may be enjoined by any court of general juris6 diction at the suit of the proper body corporate. 

7 In any such suit, the plaintiff may recover any 

8 actual damages flowing from such violation, 

9 and, in addition, shall be entitled to punitive 

10 damages (regardless of the existence or non11 existence of actual damages) of not exceeding 

12 $100 for each day during which such violation 

13 is committed or repeated. 

14 (F) VULNERABLE POPULATIONS WORKING

15 GROUP.—The Trust shall establish and convene 

16 a Vulnerable Populations Working Group com17 posed of experts on pediatric populations, preg18 nant women, and other vulnerable populations 

19 to advise the Trust with respect to— 

20 (i) supporting and facilitating re21 search and development of counter22 measures, and formulations of counter23 measures, that are safe and effective for 

24 such populations; and 
16 

•S 1880 IS 

1 (ii) other activities of the Trust that 

2 effect such populations. 

3 (b) STUDY.—Not later than 120 days after the date 

4 of enactment of this Act, the Government Accountability 

5 Office shall conduct a study, and submit to the appro6 priate committees of Congress, a report on the efficient 

7 organization of the administrative structure of the Federal 

8 Government for responding to public health emergencies. 

9 Such report shall contain the specific recommendations of 

10 the Government Accountability Office on— 

11 (1) whether the Assistant Secretary for Health 

12 of the Department of Health and Human Services 

13 and the Surgeon General positions should be held by 

14 same individual; and 

15 (2) the manner in which to improve coordina16 tion between the Assistant Secretary for Health, the 

17 Surgeon General, the National Institutes of Health, 

18 and the Centers for Disease Control and Prevention 

19 with respect to biodefense preparedness. 

20 (c) AUTHORIZATION OF APPROPRIATIONS.—There is 

21 authorized to be appropriate to carry out this section, 

22 $1,000,000,000 for fiscal year 2006, and such sums as 

23 may be necessary for each subsequent fiscal year. 
17 

•S 1880 IS 

1 (d) CONFORMING AMENDMENTS.—Section 319F– 

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

3 6b(c)) is amended— 

4 (1) in paragraph (3), by striking ‘‘Secretary, in 

5 consultation with the Homeland Security Secretary,’’ 

6 and inserting ‘‘National BioVenture Trust (referred 

7 to in this section as the ‘Trust’)’’; 

8 (2) in paragraph (4)— 

9 (A) in subparagraph (A)— 

10 (i) by striking ‘‘Homeland Security 

11 Secretary and the Secretary make’’ and in12 serting ‘‘Trust makes’’; and 

13 (ii) by striking ‘‘such Secretaries may 

14 jointly submit to the President a proposal 

15 to’’ and inserting ‘‘the Trust may’’; 

16 (B) in subparagraph (B), by striking 

17 ‘‘Homeland Security Secretary and the Sec18 retary’’ and inserting ‘‘Trust’’; and 

19 (C) by striking subparagraph (C); 

20 (3) in paragraph (5)— 

21 (A) in subparagraph (A)— 

22 (i) by striking ‘‘The Secretary’’ and 

23 inserting ‘‘The Trust’’; and 

24 (ii) by striking ‘‘Secretary determines, 

25 in consultation with the Homeland Secu-
18 

•S 1880 IS 

1 rity Secretary,’’ and inserting ‘‘Trust de2 termines’’; and 

3 (B) in subparagraph (B), by striking ‘‘Sec4 retary’’ and inserting ‘‘Trust’’; 

5 (4) in paragraph (6)— 

6 (A) by striking subparagraphs (A) and 

7 (B); 

8 (B) in subparagraph (C), by striking ‘‘Sec9 retary and the Homeland Security Secretary’’ 

10 and inserting ‘‘Trust’’; and 

11 (C) by redesignating subparagraphs (C) 

12 through (E), as subparagraphs (A) through 

13 (C), respectively; 

14 (5) in paragraph (7)— 

15 (A) in subparagraph (B), by striking ‘‘the 

16 Secretary’’ each place that such appears and in17 serting ‘‘the Trust’’; and 

18 (B) in subparagraph (C)— 

19 (i) by striking ‘‘the Secretary’’ each 

20 place that such appears and inserting ‘‘the 

21 Trust’’; 

22 (ii) in clause (i), by striking ‘‘The 

23 Secretary’’ and inserting ‘‘The Trust’’; 

24 (iii) in clause (ii)— 
19 

•S 1880 IS 

1 (I) in subclause (I), by striking 

2 ‘‘The Secretary’s’’ and inserting ‘‘The 

3 Trust’s’’; and 

4 (II) by adding at the end the fol5 lowing: 

6 ‘‘(VII) DELIVERY TO SEC7 RETARY.—The contract shall provide 

8 that the products that are the subject 

9 of the contract shall be delivered to 

10 the Secretary (subject to the provi11 sions of subclause (IV)) for inclusion 

12 in the National Strategic Stockpile.’’; 

13 (iv) in clause (iii), by striking ‘‘the 

14 Secretary’’ each place that such appears 

15 and inserting ‘‘the Trust’’; 

16 (v) in clause (iv), by striking ‘‘the 

17 Secretary’’ each place that such appears 

18 and inserting ‘‘the Trust’’; 

19 (vi) in clause (v)— 

20 (I) by striking ‘‘the Secretary’’ 

21 each place that such appears and in22 serting ‘‘the Trust’’; and 

23 (II) in subclause (II), by striking 

24 ‘‘The Secretary’s’’ and inserting ‘‘The 

25 Trust’s’’; 
20 

•S 1880 IS 

1 (vii) in clause (vi), by striking ‘‘The 

2 Secretary’’ and inserting ‘‘The Trust’’; and 

3 (viii) in clause (vii), by striking ‘‘The 

4 Secretary’’ and inserting ‘‘The Trust’’; 

5 (6) by striking paragraph (8); and 

6 (7) by redesignating paragraphs (9) and (10) 

7 as paragraphs (8) and (9), respectively. 

8 SEC. 102. STRATEGIC BIODEFENSE INITIATIVE. 

9 (a) CALL FOR THE DEVELOPMENT OF COUNTER10 MEASURES.—Section 319F–2(c)(4) of the Public Health 

11 Service Act (as added by Public Law 108–276) is amend12 ed by adding at the end the following: 

13 ‘‘(D) STATEMENT OF INTENT.— 

14 ‘‘(i) IN GENERAL.—On any date that 

15 is subsequent to the date on which the 

16 Trust issues under subparagraph (B) a 

17 call for the development of a counter18 measure, a person planning to develop the 

19 countermeasure that is the subject of such 

20 call may file with the Trust a statement of 

21 intent to develop such countermeasure. 

22 ‘‘(ii) CONTENTS.—A statement of in23 tent under clause (i) shall include a plan 

24 for the development of the countermeasure 
21 

•S 1880 IS 

1 that is the subject of the call approved 

2 under subparagraph (C). 

3 ‘‘(iii) ADVANCE PAYMENT.—The 

4 Trust may make an advance payment de5 scribed in paragraph (7)(C)(ii)(I) only to a 

6 person that has submitted a statement of 

7 intent under this subparagraph. 

8 ‘‘(E) EVALUATION OF STATEMENT OF IN9 TENT.— 

10 ‘‘(i) NO FILING OF QUALIFIED STATE11 MENT.—If, by the date that is 120 days 

12 after the date on which the Trust issues a 

13 call for the development of a security coun14 termeasure under subparagraph (B) (and 

15 subject to an extension of such period 

16 under clause (iii)), the Trust finds that no 

17 person has filed a statement of intent 

18 under subparagraph (D) that includes a 

19 plan for the development of such counter20 measure that, in the determination of the 

21 Trust, is likely to lead to the development 

22 of such countermeasure in a manner 

23 that— 
22 

•S 1880 IS 

1 ‘‘(I) meets the specifications de2 scribed under subparagraph (B) with 

3 respect to the countermeasure; and 

4 ‘‘(II) satisfies the requirement of 

5 paragraph (5)(B)(ii); 

6 then the Trust shall make the declaration 

7 of non-response described in subsection 

8 (d). 

9 ‘‘(ii) EXTENSION OF TIME PERIOD— 

10 .—The 120-day period described in clause 

11 (i) shall be extended in the case of a grant 

12 awarded under subparagraph (F) for the 

13 duration of the grant period.’’. 

14 (b) ESTABLISHMENT OF INITIATIVE.—Section 

15 319F–2 of the Public Health Service Act (as added by 

16 Public Law 108–276) is amended— 

17 (1) by redesignating subsections (d) through 

18 (f), as subsections (e) through (g), respectively; and 

19 (2) by inserting after subsection (c), the fol20 lowing: 

21 ‘‘(d) STRATEGIC BIODEFENSE INITIATIVE.— 

22 ‘‘(1) DECLARATION OF NON-RESPONSE.—If the 

23 Trust makes the finding described in subsection 

24 (c)(4)(E)(i), the Trust shall declare and commu25 nicate promptly to the Secretary that no person has 
23 

•S 1880 IS 

1 responded adequately to the call for the development 

2 of a security countermeasure under subsection 

3 (c)(4). Such declaration shall specify the security 

4 countermeasure with respect to which the declara5 tion applies. 

6 ‘‘(2) REQUIREMENT FOR FEASIBILITY DETER7 MINATION.— 

8 ‘‘(A) DETERMINATION OF FEASIBILITY.— 

9 If the Trust makes a declaration described in 

10 paragraph (1) with respect to a security coun11 termeasure, the Secretary shall determine 

12 whether it is feasible to produce the counter13 measure at reasonable cost and within a reason14 able time through the procedures described in 

15 paragraph (3). 

16 ‘‘(B) FURTHER REVIEW REQUIRED.—If 

17 the Secretary makes a negative determination 

18 under subparagraph (A), the Secretary shall de19 termine whether it is feasible to produce such 

20 countermeasure at reasonable cost and within a 

21 reasonable period of time through the proce22 dures described in paragraph (4). 

23 ‘‘(3) PRODUCTION OF COUNTERMEASURES

24 THROUGH CONTRACT.— 
24 

•S 1880 IS 

1 ‘‘(A) IN GENERAL.—This paragraph shall 

2 apply only if the Secretary has made a positive 

3 determination under paragraph (2)(A). 

4 ‘‘(B) DEVELOPMENT OF PLAN.—Not later 

5 than 120 days after making a positive deter6 mination under paragraph (2)(A), the Secretary 

7 shall develop a plan for the production of the 

8 countermeasure involved through the proce9 dures described in subparagraph (C). 

10 ‘‘(C) OFFERS OF CONTRACT.—Following 

11 the development of the plan under subpara12 graph (B), the Secretary shall issue an offer to 

13 enter into contracts with any person for re14 search, development, testing, production, or any 

15 other activity that, in the determination of the 

16 Secretary, is likely to expedite the implementa17 tion of the plan under such subparagraph. 

18 ‘‘(D) TERMS OF OFFER.—The offer de19 scribed in subparagraph (C) shall describe the 

20 service or other activity for which the Secretary 

21 desires to enter into the contract and shall in22 clude a description of the terms of the contract 

23 as specified in subparagraph (E). 
25 

•S 1880 IS 

1 ‘‘(E) TERMS OF CONTRACT.—A contract 

2 entered into pursuant to an offer under sub3 paragraph (C) shall provide that— 

4 ‘‘(i) the Secretary will retain the intel5 lectual property rights to any product de6 veloped under the contract; 

7 ‘‘(ii) the Secretary will own the prod8 uct developed under the contract; 

9 ‘‘(iii) the product developed under the 

10 contract will become a part of the national 

11 stockpile under subsection (a); and 

12 ‘‘(iv) the terms described in sub13 section (c)(7)(C)(ii) shall apply. 

14 ‘‘(F) SATISFACTORY BIDS NOT RE15 CEIVED.—If, within 120 days of the issuance of 

16 an offer described in subparagraph (C), the 

17 Secretary has not received a bid or bids from 

18 any person or persons to enter into a contract 

19 or contracts for the services or other activities 

20 described in such offer that, in the determina21 tion of the Secretary, will result in the produc22 tion of the specified countermeasure at reason23 able cost and within a reasonable time, the Sec24 retary shall issue a statement indicating that 

25 satisfactory bids have not been received and 
26 

•S 1880 IS 

1 shall conduct the feasibility determination de2 scribed in paragraph (2)(B). 

3 ‘‘(4) PRODUCTION OF COUNTERMEASURES BY

4 THE SECRETARY.— 

5 ‘‘(A) IN GENERAL.—This paragraph shall 

6 apply only if the Secretary has made a positive 

7 determination under paragraph (2)(B) or if the 

8 Secretary has issued a statement under para9 graph (3)(F). 

10 ‘‘(B) PLAN REQUIRED.—Not later than 

11 120 days after making a positive determination 

12 under paragraph (2)(B) or issuing a statement 

13 under paragraph (3)(F), the Secretary shall de14 velop a plan for producing the countermeasure 

15 involved. 

16 ‘‘(C) PRODUCTION OF COUNTER17 MEASURES.—Following the development of the 

18 plan under subparagraph (B), the Secretary 

19 shall conduct activities, subject to the avail20 ability of funds under paragraph (8), necessary 

21 to implement the plan under subparagraph (B). 

22 Such activities may include the production of 

23 countermeasures at facilities owned or operated 

24 by the Secretary or the expansion, enhancement 

25 or improvement of such facilities. 
27 

•S 1880 IS 

1 ‘‘(5) APPLICATION OF PROVISIONS.—The provi2 sions of clauses (iii) through (vii) of subsection 

3 (c)(7)(C) shall apply to the procurement of counter4 measures under contracts under this subsection. The 

5 provisions of section 3l9F–1(f) shall apply to actions 

6 of the Secretary under paragraphs (1) through (4). 

7 ‘‘(6) GUIDELINES.—The Secretary, pursuant to 

8 existing authority with respect to contracts with pri9 vate sector entities, shall establish guidelines con10 cerning the process of entering into contracts under 

11 this subsection, including the submission and review 

12 of bids by entities. 

13 ‘‘(7) FUNDING.— 

14 ‘‘(A) IN GENERAL.—To carry out this sub15 section, the Secretary may use not to exceed 10 

16 percent of the amounts in the special reserve 

17 fund under subsection (c)(10) in each fiscal 

18 year. 

19 ‘‘(B) AUTHORIZATION.—In addition to the 

20 amounts described in subparagraph (A), there 

21 are authorized to be appropriated such addi22 tional funds as may be necessary for each of 

23 fiscal years 2005 through 2009 to carry out 

24 this subsection.’’. 
28 

•S 1880 IS 

1 SEC. 103. COLLABORATION AND COORDINATION. 

2 (a) IN GENERAL.—Section 2 of the Clayton Act (15 

3 U.S.C. 13) is amended by adding at the end the following: 

4 ‘‘(g) LIMITED ANTITRUST EXEMPTION.— 

5 ‘‘(1) QUALIFIED COUNTERMEASURES AND

6 QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT DE7 VELOPMENT MEETINGS.— 

8 ‘‘(A) COUNTERMEASURES AND PRODUCTS

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

11 Services (referred to in this subsection as the 

12 ‘Secretary’) or the Chief Executive Officer of 

13 the National BioVenture Trust (referred to in 

14 this subsection as the ‘CEO’), in coordination 

15 with the Attorney General and the Secretary of 

16 Homeland Security, may conduct meetings and 

17 consultations with parties involved in the devel18 opment of qualified countermeasures (as de19 fined in section 319F–2 of the Public Health 

20 Service Act) or qualified pandemic or epidemic 

21 products (as defined in section 319F–3(c)(5) of 

22 the Public Health Service Act) (referred to in 

23 this section as ‘‘countermeasures or products’’) 

24 for the purpose of the development, manufac25 ture, distribution, purchase, sale, or storage of 

26 countermeasures or products consistent with 
29 

•S 1880 IS 

1 the purposes of this title. The Secretary or 

2 CEO may convene such meeting or consultation 

3 at the request of any person, the Secretary of 

4 Homeland Security, the Attorney General, the 

5 Chairperson of the Federal Trade Commission, 

6 an industry representative or member, or upon 

7 initiation by such Secretary. The Secretary or 

8 CEO shall give notice of such meetings and 

9 consultations to the Chairperson of the Federal 

10 Trade Commission (referred to in this sub11 section as the ‘Chairperson’). 

12 ‘‘(B) MEETING AND CONSULTATION CON13 DITIONS.—A meeting or consultation conducted 

14 under subparagraph (A) shall— 

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

16 consultation, facilitated by the Secretary or 

17 CEO; 

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

19 development, manufacture, distribution, 

20 purchase, or sale of countermeasures or 

21 products, as determined by the Secretary 

22 or CEO; 

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

24 the Secretary of Homeland Security, and 

25 the Chairperson; 
30 

•S 1880 IS 

1 ‘‘(iv) be limited to discussions involv2 ing the development, manufacture, dis3 tribution, or sale of countermeasures or 

4 products, consistent with the purposes of 

5 this title; and 

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

7 to ensure that national security, confiden8 tial, and proprietary information is not dis9 closed outside the meeting or consultation. 

10 ‘‘(C) LIMITATION.—The Secretary or CEO 

11 may not require the disclosure of confidential 

12 commercial or proprietary information. 

13 ‘‘(D) MINUTES.—The Secretary or CEO 

14 shall maintain minutes of meetings and con15 sultations under this subsection, which shall not 

16 be disclosed under section 552 of title 5, United 

17 States Code, unless such Secretary or CEO, in 

18 consultation with the Attorney General, deter19 mines that disclosure would pose no threat to 

20 national security. Such determination shall not 

21 be subject to judicial review. 

22 ‘‘(E) EXEMPTION.— 

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

24 shall not apply to meetings and consulta25 tions under this paragraph. 
31 

•S 1880 IS 

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

2 not apply to any agreement or conduct 

3 that results from a meeting or consultation 

4 and that does not receive an exemption 

5 pursuant to this subsection. 

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

7 or the CEO shall file a written agreement regarding 

8 covered activities, made pursuant to meetings or 

9 consultations conducted under paragraph (1) and 

10 that is consistent with this paragraph, with the At11 torney General and the Chairperson for a determina12 tion of the compliance of such agreement with anti13 trust laws. In addition to the proposed agreement 

14 itself, any such filing shall include— 

15 ‘‘(A) an explanation of the intended pur16 pose of the agreement; 

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

18 of the agreement; 

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

20 be utilized to achieve the objectives of the 

21 agreement; 

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

23 cooperative effort among the particular partici24 pating parties to achieve the objectives of the 

25 agreement; and 
32 

•S 1880 IS 

1 ‘‘(E) any other relevant information deter2 mined necessary by the Secretary or CEO in 

3 consultation with the Attorney General and the 

4 Chairperson. 

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

6 in consultation with the Chairperson, shall determine 

7 whether an agreement regarding covered activities 

8 referred to in paragraph (2) would likely— 

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

10 laws, and so inform the Secretary or CEO and 

11 the participating parties; or 

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

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

14 for an exemption from the antitrust laws, lim15 ited to the performance of the agreement con16 sistent with the purposes of this title. 

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

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

19 in consultation with the Chairperson, shall 

20 grant, deny, grant in part and deny in part, or 

21 propose modifications to a request for exemp22 tion from the antitrust laws under paragraph 

23 (3) within 15 days of the receipt of such re24 quest. 
33 

•S 1880 IS 

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

2 may extend the 15-day period referred to in 

3 subparagraph (A) for an additional period of 

4 not to exceed 10 days. Such additional period 

5 may be further extended only by the United 

6 States district court, upon an application by the 

7 Attorney General after notice to the Secretary 

8 or CEO and the parties involved. 

9 ‘‘(C) DETERMINATION.—The Attorney 

10 General, in consultation with the Chairperson 

11 and the Secretary or CEO— 

12 ‘‘(i) may not grant an exemption 

13 under this paragraph unless the Attorney 

14 General finds— 

15 ‘‘(I) that the agreement involved 

16 is necessary to ensure the availability 

17 of countermeasures or products; 

18 ‘‘(II) that the exemption from 

19 the antitrust laws would promote the 

20 public interest; and 

21 ‘‘(III) that there is no substantial 

22 competitive impact to areas not di23 rectly related to the purposes of the 

24 agreement; and 
34 

•S 1880 IS 

1 ‘‘(ii) may consider any other factors 

2 determined relevant by the Attorney Gen3 eral or the Chairperson. 

4 ‘‘(5) LIMITATION ON AND RENEWAL OF EXEMP5 TIONS.—An exemption granted under paragraph (4) 

6 shall be limited to covered activities, and shall be re7 newed (with modifications, as appropriate) on the 

8 date that is 3 years after the date on which the ex9 emption becomes effective (and at 3-year intervals 

10 thereafter, if renewed) unless the Attorney General 

11 in consultation with the Chairperson determines that 

12 the exemption should not be renewed (with modifica13 tions, as appropriate) considering the factors de14 scribed in paragraph (4). 

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

16 information acquired under an exempted agreement 

17 by the parties to such an agreement for any pur18 poses other than those specified in the antitrust ex19 emption granted by the Attorney General shall be 

20 subject to the antitrust laws and any other applica21 ble laws. 

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

23 the Chairperson may develop and issue guidelines to 

24 implement this subsection. 
35 

•S 1880 IS 

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

2 date of enactment of this subsection, and annually 

3 thereafter, the Attorney General and the Chair4 person shall report to Congress on the use and con5 tinuing need for the exemption from the antitrust 

6 laws provided by this subsection. 

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

8 maintained by the Secretary or CEO pursuant to 

9 paragraph (1)(D) shall not be disclosed under sec10 tion 552 of title 5, United States Code, if the ex11 emption is not renewed under paragraph (5), or if 

12 meetings are no longer conducted, unless the Sec13 retary or CEO, in consultation with the Attorney 

14 General, determines that the disclosure would pose 

15 no threat to national security. Such determination 

16 shall not be subject to judicial review. 

17 ‘‘(h) DEFINITIONS.—In this section: 

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

19 laws’— 

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

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

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

23 includes the Act of June 19, 1936 (15 U.S.C. 

24 13 et seq.) commonly known as the Robinson25 Patman Act), and section 5 of the Federal 
36 

•S 1880 IS 

1 Trade Commission Act (15 U.S.C. 45) to the 

2 extent such section 5 applies to unfair methods 

3 of competition; and 

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

5 laws referred to in subparagraph (A). 

6 ‘‘(2) COVERED ACTIVITIES.— 

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

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

9 means any group of activities or conduct, in10 cluding attempting to make, making, or per11 forming a contract or agreement or engaging in 

12 other conduct, for the purpose of— 

13 ‘‘(i) theoretical analysis, experimen14 tation, or the systematic study of phe15 nomena or observable facts necessary to 

16 the development of countermeasures or 

17 products; 

18 ‘‘(ii) the development or testing of 

19 basic engineering techniques necessary to 

20 the development of countermeasures or 

21 products; 

22 ‘‘(iii) the extension of investigative 

23 findings or theory of a scientific or tech24 nical nature into practical application for 

25 experimental and demonstration purposes, 
37 

•S 1880 IS 

1 including the experimental production and 

2 testing of models, prototypes, equipment, 

3 materials, and processes necessary to the 

4 development of countermeasures or prod5 ucts; 

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

7 marketing of a product, process, or service 

8 that is a countermeasures or products; 

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

10 production of a product, process, or serv11 ices necessary to the development of coun12 termeasures or products; 

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

14 analysis of research or production informa15 tion necessary to the development of coun16 termeasures or products; or 

17 ‘‘(vii) any combination of the purposes 

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

19 and such term may include the establishment 

20 and operation of facilities for the conduct of 

21 covered activities described in clauses (i) 

22 through (vi), the conduct of such covered activi23 ties on a protracted and proprietary basis, and 

24 the processing of applications for patents and 
38 

•S 1880 IS 

1 the granting of licenses for the results of such 

2 covered activities. 

3 ‘‘(B) EXCEPTION.—The term ‘covered ac4 tivities’ shall not include the following activities 

5 involving 2 or more persons: 

6 ‘‘(i) Exchanging information among 

7 competitors relating to costs, sales, profit8 ability, prices, marketing, or distribution of 

9 any product, process, or service if such in10 formation is not reasonably necessary to 

11 carry out the purposes of covered activi12 ties. 

13 ‘‘(ii) Entering into any agreement or 

14 engaging in any other conduct— 

15 ‘‘(I) to restrict or require the 

16 sale, licensing, or sharing of inven17 tions, developments, products, proc18 esses, or services not developed 

19 through, produced by, or distributed 

20 or sold through such covered activi21 ties; or 

22 ‘‘(II) to restrict or require par23 ticipation by any person who is a 

24 party to such covered activities in 

25 other research and development activi-
39 

•S 1880 IS 

1 ties, that is not reasonably necessary 

2 to prevent the misappropriation of 

3 proprietary information contributed 

4 by any person who is a party to such 

5 covered activities or of the results of 

6 such covered activities. 

7 ‘‘(iii) Entering into any agreement or 

8 engaging in any other conduct allocating a 

9 market with a competitor that is not ex10 pressly exempted from the antitrust laws 

11 by a determination under subsection 

12 (g)(4). 

13 ‘‘(iv) Exchanging information among 

14 competitors relating to production (other 

15 than production by such covered activities) 

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

18 carry out the purpose of such covered ac19 tivities. 

20 ‘‘(v) Entering into any agreement or 

21 engaging in any other conduct restricting, 

22 requiring, or otherwise involving the pro23 duction of a product, process, or service 

24 that is not so expressly exempted from the 
40 

•S 1880 IS 

1 antitrust laws by a determination under 

2 subsection (g)(4). 

3 ‘‘(vi) Except as otherwise provided in 

4 this subsection, entering into any agree5 ment or engaging in any other conduct to 

6 restrict or require participation by any per7 son who is a party to such activities, in 

8 any unilateral or joint activity that is not 

9 reasonably necessary to carry out the pur10 pose of such covered activities. 

11 ‘‘(4) DEVELOPMENT.—The term ‘development’ 

12 includes the identification of suitable compounds or 

13 biological materials, the conduct of preclinical and 

14 clinical studies, the preparation of an application for 

15 marketing approval, and any other actions related to 

16 preparation of a countermeasure or products.’’. 

17 (b) TERMINATION OF AUTHORITY.—The authority 

18 provided for in the amendment made by subsection (a) 

19 shall terminate on the date that is 5 years after the date 

20 of enactment of this Act. 

21 (c) REPORT.—Not later than 4 years after the date 

22 of enactment of this Act, the Government Accountability 

23 Office shall submit to the appropriate committees of Con24 gress a report on the activities conducted under the au-
41 

•S 1880 IS 

1 thority provided under the amendment made by subsection 

2 (a). 

3 TITLE II—ENSURING NATIONAL 

4 VACCINE MANUFACTURING 

5 CAPACITY 

6 SEC. 201. WARM-BASED MANUFACTURING FOR BIOLOGICAL 

7 COUNTERMEASURES. 

8 Section 319F–2(c)(7)(C)(ii) of the Public Health 

9 Service Act (42 U.S.C. 247d–6b(c)(7)(C)(ii)), as amended 

10 by section 101(d), is further amended by adding at the 

11 end the following: 

12 ‘‘(VIII) WARM-BASED MANUFAC13 TURING.—The contract shall, if the 

14 product is a biological product, pro15 vide for annual payments after the 

16 initial delivery of the product to meet 

17 the needs of the stockpile to pay the 

18 cost of maintaining domestic manu19 facturing capacity for, and providing 

20 additional units of, the product to the 

21 stockpile sufficient to allow the Sec22 retary in an emergency or other time 

23 of need to promptly acquire additional 

24 units of the product for the stock25 pile.’’. 
42 

•S 1880 IS 

1 SEC. 202. EMERGENCY MANUFACTURING. 

2 Section 319F–2(c)(7)(C)(ii) of the Public Health 

3 Service Act (42 U.S.C. 247d–6b(c)(7)(C)(ii)), as amended 

4 by section 201, is further amended by adding at the end 

5 the following: 

6 ‘‘(IX) EMERGENCY MANUFAC7 TURING.—The contract shall, if the 

8 product is not a biological product, 

9 provide for domestic manufacturing 

10 capacity, including through alternate 

11 domestic manufacturing arrangements 

12 such as through licensing to another 

13 manufacturer and preapproval of such 

14 manufacturer’s product by the Food 

15 and Drug Administration, sufficient 

16 to allow the Trust in an emergency or 

17 other time of need to promptly ac18 quire additional units of the product 

19 for the stockpile. Such contract shall 

20 ensure that the intellectual property 

21 resulting from such contract become 

22 the property of the Federal Govern23 ment.’’. 
43 

•S 1880 IS 

1 SEC. 203. CONSTRUCTION OF FACILITIES. 

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

3 U.S.C. 247d–6) is amended by adding at the end the fol4 lowing: 

5 ‘‘(k) LOANS FOR CONSTRUCTION.— 

6 ‘‘(1) IN GENERAL.—The Secretary shall estab7 lish a program under which the Secretary may make 

8 loans to eligible entities to enable such entities to 

9 provide for the construction of countermeasure man10 ufacturing facilities. 

11 ‘‘(2) ELIGIBILITY.—To be eligible to receive a 

12 loan under paragraph (1), an entity shall submit an 

13 application to the Secretary at such time, in such 

14 manner, and containing such information as the Sec15 retary may require. 

16 ‘‘(3) FORGIVENESS OF LOAN AMOUNTS.—The 

17 Secretary may forgive up to 25 percent of the 

18 amount of a loan if the entity involved enters into 

19 an agreement with the Secretary to permit the facili20 ties constructed using loan amounts to be made 

21 available to produce any countermeasure product 

22 specified by the Secretary upon the declaration of a 

23 public health emergency under section 319. 

24 ‘‘(4) LABOR STANDARDS.—All laborers and me25 chanics employed by contractors or subcontractors 

26 on projects assisted by the Secretary of Health and 
44 

•S 1880 IS 

1 Human Services under this Act (or an amendment 

2 made by this Act) shall be paid wages at rates not 

3 less than those prevailing on similar construction in 

4 the locality involved, as determined by the Secretary 

5 of Labor, in accordance with sections 3141 through 

6 3144, 3146, and 3147 of title 40, United States 

7 Code. The Secretary of Health and Human Services 

8 shall not award any contract, grant, cooperative 

9 agreement, or other transaction under this Act (or 

10 amendments) for such a project without first obtain11 ing adequate assurance that the labor standards pro12 vided for in this subsection will be maintained upon 

13 the construction project. The Secretary of Labor 

14 shall have, with respect to the labor standards speci15 fied in this subsection, the authority and functions 

16 set forth in Reorganization Plan Numbered 14 of 

17 1950 (15 F.R. 3176; 64 Stat. 1267), and section 

18 3145 of title 40, United States Code. 

19 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 

20 There is authorized to be appropriated, such sums 

21 as may be necessary to carry out this section.’’. 
45 

•S 1880 IS 

1 TITLE III—IMPROVING PROJECT 

2 BIOSHIELD 

3 SEC. 301. IMPROVING PROJECT BIOSHIELD. 

4 (a) STATEMENT OF CONGRESSIONAL INTENT.—Sec5 tion 319F–2(c) of the Public Health Service Act (42 

6 U.S.C. 247d–6b(c)) is amended— 

7 (1) by redesignating paragraphs (1) through 

8 (9) as paragraphs (2) through (10), respectively; 

9 and 

10 (2) by inserting before paragraph (2), as so re11 designated, the following: 

12 ‘‘(1) STATEMENT OF CONGRESSIONAL IN13 TENT.— 

14 ‘‘(A) IN GENERAL.—The intent of Con15 gress in establishing Project BioShield (under 

16 the Project BioShield Act of 2004 (Public law 

17 108–276)) is— 

18 ‘‘(i) that the Project provide a guar19 anteed market for products for which the 

20 incentives of the commercial market are in21 adequate to induce their development and 

22 which meet important national needs in 

23 preparing for material threats to the 

24 health of the American public; 
46 

•S 1880 IS 

1 ‘‘(ii) that the Project is not intended 

2 simply to procure products that are in ad3 vanced stages of development; and 

4 ‘‘(iii) that the Project should identify 

5 national needs in preparing for material 

6 threats to the health of the American pub7 lic and accelerate the development of coun8 termeasures to meet those needs. 

9 ‘‘(B) REQUIREMENT TO FOLLOW IN10 TENT.—Activities conducted under this sub11 section shall be consistent with the statement of 

12 intent described in subparagraph (A).’’. 

13 (b) AMENDMENTS.—Section 319F–2(c) of the Public 

14 Health Service Act (42 U.S.C. 247d–6b(c)), as amended 

15 by subsection (a), is further amended— 

16 (1) in paragraph (2)(B)— 

17 (A) in clause (i)— 

18 (i) in subclause (I), by striking ‘‘(con19 sistent with sections 302(2) and 304(a) of 

20 the Homeland Security Act of 2002)’’; 

21 (ii) in subclause (III)(bb), by striking 

22 ‘‘within eight years’’ and inserting ‘‘within 

23 8 years or such additional time as the 

24 Trust determines to be reasonable’’; and 
47 

•S 1880 IS 

1 (iii) by striking ‘‘or’’ at the end there2 of; 

3 (B) in clause (ii), by striking the period 

4 and inserting ‘‘; or’’; and 

5 (C) by adding at the end the following: 

6 ‘‘(iii) is a vaccine or microbicide used 

7 to treat or prevent AIDS, tuberculosis, 

8 Malaria, or a strain of influenza that may 

9 (in the determination of the Secretary) 

10 contribute to a pandemic.’’; 

11 (2) in paragraph (3)— 

12 (A) by redesignating subparagraphs (C) 

13 and (D) as subparagraphs (D) and (E), respec14 tively; 

15 (B) by inserting after subparagraph (B), 

16 the following: 

17 ‘‘(C) REQUESTS FOR DETERMINATIONS.— 

18 The Secretary may request the Homeland Secu19 rity Secretary to make a determination with re20 spect to a specific chemical, biological, radio21 logical, or nuclear agent. The Homeland Secu22 rity Secretary shall respond to such request 

23 within 90 days of such request.’’; and 
48 

•S 1880 IS 

1 (C) in subparagraph (D) (as so redesig2 nated), by striking ‘‘or (B)’’ and inserting ‘‘, 

3 (B), or (C)’’; and 

4 (3) in paragraph (6)(B)— 

5 (A) in clause (ii), by striking ‘‘within eight 

6 years’’ and inserting ‘‘within 8 years or such 

7 additional time as the Trust determines to be 

8 reasonable’’; and 

9 (B) by striking clause (iii) and inserting 

10 the following: 

11 ‘‘(iii) Whether the commercial market 

12 for the product is sufficient to ensure the 

13 continued development of the product. If 

14 the determination under this clause is that 

15 the commercial market for the product is 

16 sufficient, funds available under this sub17 section may not be provided for such prod18 uct.’’. 
49 

•S 1880 IS 

1 TITLE IV—INCENTIVES FOR 

2 COUNTERMEASURE DEVEL3 OPMENT 

4 SEC. 401. PRIZE PAYMENTS FOR COUNTERMEASURES DE5 VELOPMENT. 

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

7 (42 U.S.C. 247d–6b(f)) is amended by adding at the end 

8 the following: 

9 ‘‘(3) PRIZE PAYMENT FOR COUNTERMEASURE

10 DEVELOPMENT AND PRODUCTION.— 

11 ‘‘(A) IN GENERAL.—If the Secretary deter12 mines that it is necessary to engage a bio13 technology or pharmaceutical company to en14 sure the development and production of a coun15 termeasure, and that procurement under sub16 section (c)(7) will not engage such a company, 

17 the Secretary may recommend that the Presi18 dent request that Congress appropriate a prize 

19 payment, in a sum that shall not exceed 

20 $1,000,000,000, to be made to such company 

21 upon the delivery of the total number of units 

22 of the countermeasure contracted for. 

23 ‘‘(B) REQUIREMENTS.—If the Secretary 

24 makes a recommendation under subparagraph 

25 (A), the President shall promptly— 
50 

•S 1880 IS 

1 ‘‘(i) request that Congress appropriate 

2 such a sum for a prize payment for such 

3 countermeasure; or 

4 ‘‘(ii) report to Congress concerning 

5 why such recommendation is inappropriate. 

6 ‘‘(C) REASONABLE PRICING.—To be eligi7 ble to receive a payment under this paragraph, 

8 a manufacturer shall provide assurances that 

9 the countermeasure with respect to which the 

10 payment is to be made will be made available— 

11 ‘‘(i) to the Federal Government at the 

12 lowest of — 

13 ‘‘(I) the price paid for that prod14 uct by the Department of Veterans 

15 Affairs; 

16 ‘‘(II) the Federal ceiling price; or 

17 ‘‘(III) the Federal supply sched18 ule price; and 

19 ‘‘(ii) to the general public at a reason20 able price determined by the Secretary 

21 through negotiations with the recipient, 

22 but in no case shall such price be higher 

23 than the average price paid for the coun24 termeasure in the G–8 nations. 
51 

•S 1880 IS 

1 ‘‘(D) LICENSE.—To be eligible to receive a 

2 payment under this paragraph, a manufacturer 

3 shall provide assurances that a license for the 

4 countermeasure with respect to which the pay5 ment is to be made will be made shall be grant6 ed to produce the product at low cost in the de7 veloping world (as determined by the Sec8 retary). 

9 ‘‘(E) PREFERENCE.—In making payments 

10 under this paragraph, the Secretary shall give 

11 preference to any vaccine or microbicide for 

12 AIDS, Tuberculosis, malaria, or a strain of in13 fluenza that (in the determination of the Sec14 retary) contribute to a pandemic that is likely 

15 to significantly reduce global mortality from 

16 these diseases. 

17 ‘‘(F) FUNDING.— 

18 ‘‘(i) AUTHORIZATION OF APPROPRIA19 TIONS.—For purposes of this paragraph, 

20 there are authorized to be appropriated 

21 $3,000,000,000 for fiscal year 2006, and 

22 such sums as may be necessary in each fis23 cal year thereafter, to be used as a prize 

24 payment to be made to the vendor involved 

25 in the fiscal year in which the vendor deliv-
52 

•S 1880 IS 

1 ers the total number of units contracted 

2 for. Amounts appropriated under this sub3 paragraph shall remain available until ex4 pended. 

5 ‘‘(ii) ACCEPTANCE OF DONATIONS.— 

6 Notwithstanding any other provision of 

7 law, the Secretary may accept donations 

8 from foreign governments and other enti9 ties for the purpose of awarding prizes 

10 under this paragraph. The Secretary may 

11 use amounts received under this clause to 

12 increase the amount of prizes under this 

13 paragraph.’’. 

14 SEC. 402. PROVIDING FOR LONG-TERM SOLE-SOURCING OF 

15 COUNTERMEASURES. 

16 Section 319F–2(c)(8)(C)(ii) of the Public Health 

17 Service Act (42 U.S.C. 247d–6b(c)(7)(C)(ii)), as amended 

18 by section 202, is further amended by adding at the end 

19 the following: 

20 ‘‘(X) SOLE SOURCING.— 

21 ‘‘(aa) IN GENERAL.—The 

22 contract shall provide that the 

23 vendor shall be the sole source 

24 for the countermeasure for the 

25 stockpile under subsection (a) for 
53 

•S 1880 IS 

1 a period of 20 years from the 

2 first date of delivery of the prod3 uct to the Secretary under the 

4 contract, except that the contract 

5 shall provide that the Secretary 

6 may purchase the counter7 measure from another source to 

8 the extent to which the vendor is 

9 unable or unwilling to deliver the 

10 product in the quantity or time11 frame required by the Secretary 

12 or if the vendor permits purchase 

13 from another source. 

14 ‘‘(bb) RULE OF CONSTRUC15 TION.—Nothing in item (aa) 

16 shall be construed to prevent the 

17 Secretary from purchasing a 

18 countermeasure from a source 

19 other than the source described 

20 in such item.’’. 
54 

•S 1880 IS 

1 TITLE V—CROSSING THE 

2 VALLEY OF DEATH 

3 SEC. 501. EARLY SUPPORT FOR COUNTERMEASURE DEVEL4 OPMENT. 

5 Section 319F–2(c)(4) of the Public Health Service 

6 Act (42 U.S.C. 247d–6b(c)(4)), as amended by section 

7 102, is further amended by adding at the end the fol8 lowing: 

9 ‘‘(F) SUPPORT FOR CALL FOR COUNTER10 MEASURE.—The Secretary may provide grants 

11 to one or more of the persons to whom a call 

12 for a countermeasure is made known under 

13 subparagraph (C) to support the cost of screen14 ing, research, development, testing, and initial 

15 manufacture of potential candidates for such 

16 countermeasure.’’. 

17 SEC. 502. INCENTIVE PAYMENTS. 

18 Section 319F–2(c)(7)(C)(ii)(I) of the Public Health 

19 Service Act (42 U.S.C. 247d–6b(c)(7)(C)(ii)(I)) is amend20 ed by adding at the end the following: ‘‘In addition to the 

21 advance payments described in the preceding sentences, 

22 the contract may provide for not more than 3 incentive 

23 payments to be made, each in an amount that does not 

24 exceed 5 percent of the contract amount, for the achieve25 ment by the manufacturer of specific milestones. Any such 
55 

•S 1880 IS 

1 incentive payments shall not be required to be repaid for 

2 failure to perform.’’. 

3 TITLE VI—ACCELERATING THE 

4 APPROVAL OF COUNTER5 MEASURES 

6 SEC. 601. ACCELERATING THE APPROVAL OF COUNTER7 MEASURES. 

8 The Secretary of Health and Human Services, acting 

9 through the Commissioner of Food and Drugs, shall facili10 tate the prompt development, review, and approval of se11 curity countermeasures that, pursuant to section 319F– 

12 2(c)(6) of the Public Health Service Act, the Secretary 

13 has identified for inclusion in the stockpile under section 

14 319F–2(a) of such Act, including, as appropriate, by— 

15 (1) working with such Directors or Administra16 tors as may be appropriate, to facilitate the identi17 fication and development of animal models necessary 

18 to assess the effectiveness of such countermeasures, 

19 if applicable; 

20 (2) meeting and otherwise interacting with the 

21 sponsor of an application under the Federal Food, 

22 Drug, and Cosmetic Act or under section 351 of the 

23 Public Health Service Act for approval of such coun24 termeasure to facilitate the development and clinical 
56 

•S 1880 IS 

1 testing of the product necessary for preparation and 

2 review of such application; 

3 (3) considering such an application to be a pri4 ority, subject to the performance goals established 

5 by the Commissioner of Food and Drugs for priority 

6 drugs or devices; or 

7 (3) reviewing such an application in reviewable 

8 unites, as provided by the Commissioner of Food 

9 and Drugs in a pilot for fast-track products under 

10 the performance goals established by the Commis11 sioner of Food and Drugs, or providing a modular 

12 review, under section 515(c)(3) of the Federal Food, 

13 Drug, and Cosmetic Act. 

14 SEC. 602. POSTMARKETING STUDIES FOR COUNTER15 MEASURES. 

16 (a) NEW DRUGS.—Section 505(k) of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 355(k)) is 

18 amended by adding at the end the following: 

19 ‘‘(3) POSTMARKETING STUDIES FOR DRUGS AP20 PROVED USING ANIMAL DATA.— 

21 ‘‘(A) IN GENERAL.—The sponsor of a drug 

22 approved or licensed pursuant to the regula23 tions under subpart I of part 314 or under sub24 part H of part 601 of title 21, Code of Federal 

25 Regulations (as in effect on the date of enact-
57 

•S 1880 IS 

1 ment of the National Biodefense Act of 2005), 

2 shall— 

3 ‘‘(i) when feasible and ethical, conduct 

4 postmarketing studies, according to the 

5 plan approved by the Secretary under sub6 paragraph (D), to— 

7 ‘‘(I) verify and describe the clin8 ical benefit of the drug when used as 

9 indicated; and 

10 ‘‘(II) assess the safety of the 

11 drug when used as indicated; and 

12 ‘‘(ii) immediately submit reports of all 

13 data from such studies to the Secretary 

14 (excluding names and any other informa15 tion that identifies a patient or provider). 

16 ‘‘(B) FEASIBILITY.—Postmarketing stud17 ies under subparagraph (A) shall not be consid18 ered feasible until an exigency requiring use of 

19 the drug arises. 

20 ‘‘(C) DUE DILIGENCE.—When post21 marketing studies are feasible, the sponsor shall 

22 conduct such studies with due diligence. 

23 ‘‘(D) PLAN SUBMISSION AND APPROVAL.— 

24 A sponsor shall include, as part of an applica25 tion under subsection (b) or section 351 of the 
58 

•S 1880 IS 

1 Public Health Service Act for which approval is 

2 sought under the regulations described in sub3 paragraph (A), a plan for postmarketing study 

4 commitments in the event such studies become 

5 ethical and feasible. The Secretary shall ap6 prove such a plan with modifications deemed 

7 necessary by the Secretary. 

8 ‘‘(E) PLAN REQUIREMENTS.—Studies re9 quired under a plan approved under subpara10 graph (D) shall include— 

11 ‘‘(i) short-term field studies, to be 

12 completed after the first, second, and 

13 fourth weeks of initial administration of 

14 the drug; 

15 ‘‘(ii) long-term tracking studies; 

16 ‘‘(iii) civilian and military populations; 

17 and 

18 ‘‘(iv) major population subgroups such 

19 as men, women (including pregnant and 

20 lactating women), children, the elderly, 

21 persons with multiple chronic conditions, 

22 and different racial and ethnic subgroups. 

23 ‘‘(F) REPORTS ON STUDIES.—The Sec24 retary shall make available— 
59 

•S 1880 IS 

1 ‘‘(i) to the public, not later than 1 

2 week after submission of data from a study 

3 required under subparagraph (A), a sum4 mary of the data from such study, includ5 ing data for the major population sub6 groups identified in clauses (iii) and (iv) of 

7 subparagraph (E); and 

8 ‘‘(ii) to any physician or expert in 

9 public health, as soon as practicable but in 

10 no case later than 30 days after submis11 sion, the raw data from such a study.’’. 

12 (b) AUTHORIZATION FOR MEDICAL PRODUCTS FOR

13 USE IN EMERGENCIES.—Section 564(e) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(e)) 

15 is amended— 

16 (1) in paragraph (1)(A), by— 

17 (A) redesignating clauses (iii) and (iv) as 

18 clauses (iv) and (v), respectively; and 

19 (B) inserting after clause (ii), the fol20 lowing: 

21 ‘‘(iii)(I) Appropriate postmarketing 

22 studies, conducted with due diligence, in23 cluding short-term field studies (to be com24 pleted after the first, second, and fourth 

25 weeks of initial administration of the prod-
60 

•S 1880 IS 

1 uct) and long-term tracking studies, civil2 ian and military populations (as appro3 priate to the declaration under subsection 

4 (b)), and major populations subgroups 

5 such as men, women (including pregnant 

6 and lactating women), children, the elderly, 

7 persons with multiple chronic conditions, 

8 and different racial and ethnic subgroups, 

9 to— 

10 ‘‘(aa) verify and describe the clin11 ical benefit of the product when used 

12 as indicated; and 

13 ‘‘(bb) assess the safety of the 

14 product when used as indicated. 

15 ‘‘(II) Immediate submission of reports 

16 of all data from such studies to the Sec17 retary (excluding names and any other in18 formation that identifies a patient or pro19 vider).’’; 

20 (2) in paragraph (2)(A), by striking ‘‘clauses (i) 

21 and (ii) of paragraph (1)(A), and may establish con22 ditions described in clauses (iii) and (iv)’’ and insert23 ing ‘‘clauses (i), (ii), and (iii) of paragraph (1)(A), 

24 and may establish conditions described in clauses 

25 (iv) and (v)’’; and 
61 

•S 1880 IS 

1 (3) by adding at the end the following: 

2 ‘‘(5) REPORTS ON STUDIES.—The Secretary 

3 shall make available— 

4 ‘‘(A) to the public, not later than 1 week 

5 after submission of data from a study required 

6 under paragraph (1)(A)(iii) or (2)(A), a sum7 mary of the data from such study, including 

8 data for the major population subgroups identi9 fied in paragraph (1)(A)(iii); and 

10 ‘‘(B) to any physician or expert in public 

11 health, as soon as practicable but in no case 

12 later than 30 days after submission, the raw 

13 data from such a study.’’. 

14 (c) STUDIES REQUIRED.—The Secretary of Health 

15 and Human Services shall conduct the postmarketing 

16 studies required by the amendments made by subsection 

17 (a) and (b) for any countermeasure that— 

18 (1) is the subject of a declaration under section 

19 224(p)(2) of the Public Health Service Act; and 

20 (2) is not subject to the amendments made by 

21 subsection (a) or subsection (b). 

22 (d) COORDINATED SURVEILLANCE.—The Secretary 

23 of Health and Human Services, the Secretary of Defense, 

24 and the Secretary of Veterans Affairs shall coordinate ef25 forts to collect information on adverse events associated 
62 

•S 1880 IS 

1 with the use of vaccines and other countermeasures 

2 through both active and passive surveillance, including 

3 through the Clinical Immunization Safety Assessment net4 work, the Vaccine Healthcare Centers, and State and local 

5 health departments. 

6 TITLE VII—BIODEFENSE INJURY 

7 COMPENSATION PROGRAM 

8 SEC. 701. NATIONAL BIODEFENSE INJURY COMPENSATION 

9 PROGRAM. 

10 (a) ESTABLISHMENT.—Section 224 of the Public 

11 Health Service Act (42 U.S.C. 233) is amended by adding 

12 at the end the following: 

13 ‘‘(q) BIODEFENSE INJURY COMPENSATION PRO14 GRAM.— 

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

16 the Biodefense Injury Compensation Program (re17 ferred to in this subsection as the ‘Compensation 

18 Program’) under which compensation may be paid 

19 for death or any injury, illness, disability, or condi20 tion that is likely (based on best available evidence) 

21 to have been caused by the administration of a cov22 ered countermeasure to an individual pursuant to a 

23 declaration under subsection (p)(2). 

24 ‘‘(2) ADMINISTRATION AND INTERPRETA25 TION.—The statutory provisions governing the Com-
63 

•S 1880 IS 

1 pensation Program shall be administered and inter2 preted in consideration of the program goals de3 scribed in paragraph (4)(B)(iii). 

4 ‘‘(3) PROCEDURES AND STANDARDS.—The Sec5 retary shall by regulation establish procedures and 

6 standards applicable to the Compensation Program 

7 that follow the procedures and standards applicable 

8 under the National Vaccine Injury Compensation 

9 Program established under section 2110, except that 

10 the regulations promulgated under this paragraph 

11 shall permit a person claiming injury or death re12 lated to the administration of any covered counter13 measure to file either— 

14 ‘‘(A) a civil action for relief under sub15 section (p); or 

16 ‘‘(B) a petition for compensation under 

17 this subsection. 

18 ‘‘(4) INJURY TABLE.— 

19 ‘‘(A) INCLUSION.—For purposes of receiv20 ing compensation under the Compensation Pro21 gram with respect to a countermeasure that is 

22 the subject of a declaration under subsection 

23 (p)(2), the Vaccine Injury Table under section 

24 2114 shall be deemed to include death and the 

25 injuries, disabilities, illnesses, and conditions 
64 

•S 1880 IS 

1 specified by the Secretary under subparagraph 

2 (B)(ii). 

3 ‘‘(B) INJURIES, DISABILITIES, ILLNESSES, 

4 AND CONDITIONS.— 

5 ‘‘(i) INSTITUTE OF MEDICINE.—Not 

6 later than 30 days after making a declara7 tion described in subsection (p)(2), the 

8 Secretary shall enter into a contract with 

9 the Institute of Medicine, under which the 

10 Institute shall, within 180 days of the date 

11 on which the contract is entered into, and 

12 periodically thereafter as new information, 

13 including information derived from the 

14 monitoring of those who were administered 

15 the countermeasure, becomes available, 

16 provide its expert recommendations on the 

17 injuries, disabilities, illnesses, and condi18 tions whose occurrence in one or more in19 dividuals are likely (based on best available 

20 evidence) to have been caused by the ad21 ministration of a countermeasure that is 

22 the subject of the declaration. 

23 ‘‘(ii) SPECIFICATION BY SEC24 RETARY.—Not later than 30 days after the 

25 receipt of the expert recommendations de-
65 

•S 1880 IS 

1 scribed in clause (i), the Secretary shall, 

2 based on such recommendations, specify 

3 those injuries, disabilities, illnesses, and 

4 conditions deemed to be included in the 

5 Vaccine Injury Table under section 2114 

6 for the purposes described in subparagraph 

7 (A). 

8 ‘‘(iii) PROGRAM GOALS.—The Insti9 tute of Medicine, under the contract under 

10 clause (i), shall make such recommenda11 tions, the Secretary shall specify, under 

12 clause (ii), such injuries, disabilities, ill13 nesses, and conditions, and claims under 

14 the Compensation Program under this sub15 section shall be processed and decided tak16 ing into account the following goals of such 

17 program: 

18 ‘‘(I) To encourage persons to de19 velop, manufacture, and distribute 

20 countermeasures, and to administer 

21 covered countermeasures to individ22 uals, by limiting such persons’ liability 

23 for damages related to death and such 

24 injuries, disabilities, illnesses, and 

25 conditions. 
66 

•S 1880 IS 

1 ‘‘(II) To encourage individuals to 

2 consent to the administration of a 

3 covered countermeasure by providing 

4 adequate and just compensation for 

5 damages related to death and such in6 juries, disabilities, illnesses, or condi7 tions. 

8 ‘‘(III) To provide individuals 

9 seeking compensation for damages re10 lated to the administration of a coun11 termeasure with a non-adversarial ad12 ministrative process for obtaining ade13 quate and just compensation. 

14 ‘‘(iv) USE OF BEST AVAILABLE EVI15 DENCE.—The Institute of Medicine, under 

16 the contract under clause (i), shall make 

17 such recommendations, the Secretary shall 

18 specify, under clause (ii), such injuries, 

19 disabilities, illnesses, and conditions, and 

20 claims under the Compensation Program 

21 under this subsection shall be processed 

22 and decided using the best available evi23 dence, including information from adverse 

24 event reporting or other monitoring of 

25 those individuals who were administered 
67 

•S 1880 IS 

1 the countermeasure, whether evidence from 

2 clinical trials or other scientific studies in 

3 humans is available. 

4 ‘‘(v) APPLICATION OF SECTION

5 2116.—Section 2116(b) shall apply to in6 juries, disabilities, illnesses, and conditions 

7 initially specified or revised by the Sec8 retary under clause (ii), except that the ex9 ceptions contained in paragraphs (1) and 

10 (2) of such section shall not apply. 

11 ‘‘(C) RULE OF CONSTRUCTION.—Section 

12 13632 (a)(3) of Public Law 103–66 (107 Stat. 

13 646) (making revisions by Secretary to the Vac14 cine Injury Table effective on the effective date 

15 of a corresponding tax) shall not be construed 

16 to apply to any revision to the Vaccine Injury 

17 Table made under regulations under this para18 graph. 

19 ‘‘(5) APPLICATION.—The Compensation Pro20 gram applies to any death or injury, illness, dis21 ability, or condition that is likely (based on best 

22 available evidence) to have been caused by the ad23 ministration of a covered countermeasure to an indi24 vidual pursuant to a declaration under subsection 

25 (p)(2). 
68 

•S 1880 IS 

1 ‘‘(6) SPECIAL MASTERS.— 

2 ‘‘(A) HIRING.—In accordance with section 

3 2112, the judges of the United States Claims 

4 Court shall appoint a sufficient number of spe5 cial masters to address claims for compensation 

6 under this subsection. 

7 ‘‘(B) BUDGET AUTHORITY.—There are ap8 propriated to carry out this paragraph such 

9 sums as may be necessary for fiscal year 2005 

10 and each fiscal year thereafter. This subpara11 graph constitutes budget authority in advance 

12 of appropriations and represents the obligation 

13 of the Federal Government. 

14 ‘‘(7) COVERED COUNTERMEASURE.—For pur15 poses of this subsection, the term ‘covered counter16 measure’ has the meaning given to such term in sub17 section (p)(7)(A). 

18 ‘‘(8) FUNDING.—Compensation made under the 

19 Compensation Program shall be made from the same 

20 source of funds as payments made under subsection 

21 (p).’’. 

22 (b) EFFECTIVE DATE.—This section shall take effect 

23 as of November 25, 2002 (the date of enactment of the 

24 Homeland Security Act of 2002 (Public Law 107–296; 

25 116 Stat. 2135)). 
69 

•S 1880 IS 

1 TITLE VIII—INDEMNIFICATION 

2 FOR PRODUCERS OF COUN3 TERMEASURES 

4 SEC. 801. INDEMNIFICATION FOR MANUFACTURERS AND 

5 HEALTH CARE PROFESSIONALS WHO ADMIN6 ISTER MEDICAL PRODUCTS NEEDED FOR 

7 BIODEFENSE. 

8 Section 224(p) of the Public Health Service Act (42 

9 U.S.C. 233(p)) is amended— 

10 (1) in the subsection heading by striking 

11 ‘‘SMALLPOX’’; 

12 (2) in paragraph (1), by striking ‘‘against 

13 smallpox’’; 

14 (3) in paragraph (2)— 

15 (A) in the paragraph heading, by striking 

16 ‘‘AGAINST SMALLPOX’’; and 

17 (B) in subparagraph (B), by striking 

18 clause (ii); 

19 (4) by striking paragraph (3) and inserting the 

20 following: 

21 ‘‘(3) EXCLUSIVITY; OFFSET.— 

22 ‘‘(A) EXCLUSIVITY.—With respect to an 

23 individual to which this subsection applies, such 

24 individual may bring a claim for relief under— 

25 ‘‘(i) this subsection; 
70 

•S 1880 IS 

1 ‘‘(ii) subsection (q); or 

2 ‘‘(iii) part C. 

3 ‘‘(B) ELECTION OF ALTERNATIVES.—An 

4 individual may only pursue one remedy under 

5 subparagraph (A) at any one time based on the 

6 same incident or series of incidents. Nothing in 

7 the preceding sentence shall be construed to 

8 prevent an individual from pursuing a remedy 

9 under subparagraph (A) after such individual 

10 has elected to decline to pursue another remedy. 

11 ‘‘(C) STATUTE OF LIMITATIONS.—For pur12 poses of determining how much time has lapsed 

13 when applying statute of limitations require14 ments relating to remedies under subparagraph 

15 (A), any limitation of time for commencing an 

16 action, or filing an application, petition, or 

17 claim for such remedies, shall be deemed to 

18 have been suspended for the periods during 

19 which an individual pursues a remedy under 

20 such subparagraph. 

21 ‘‘(D) OFFSET.—The value of all compensa22 tion and benefits provided under part C of this 

23 title for an incident or series of incidents shall 

24 be offset against the amount of an award, com25 promise, or settlement of money damages in a 
71 

•S 1880 IS 

1 claim or suit under this subsection based on the 

2 same incident or series of incidents.’’; 

3 (5) in paragraph (6)— 

4 (A) in subparagraph (A), by inserting ‘‘or 

5 under subsection (q)’’ after ‘‘under this sub6 section’’; and 

7 (B) by redesignating subparagraph (B) as 

8 subparagraph (C); 

9 (C) by inserting after subparagraph (A), 

10 the following: 

11 ‘‘(B) GROSSLY NEGLIGENT, RECKLESS, OR

12 ILLEGAL CONDUCT AND WILLFUL MIS13 CONDUCT.—For purposes of subparagraph (A), 

14 grossly negligent, reckless, or illegal conduct or 

15 willful misconduct shall include the administra16 tion by a qualified person of a covered counter17 measure to an individual who was not within a 

18 category of individuals covered by a declaration 

19 under subsection (p)(2) with respect to such 

20 countermeasure where the qualified person fails 

21 to have had reasonable grounds to believe such 

22 individual was within such a category.’’; and 

23 (D) by adding at the end the following: 

24 ‘‘(D) LIABILITY OF THE UNITED

25 STATES.—The United States shall be liable 
72 

•S 1880 IS 

1 under this subsection with respect to a claim 

2 arising out of the manufacture, distribution, or 

3 administration of a covered countermeasure re4 gardless of whether— 

5 ‘‘(i) the cause of action seeking com6 pensation is alleged as negligence, strict li7 ability, breach of warranty, failure to warn, 

8 or other action; or 

9 ‘‘(ii) the covered countermeasure is 

10 designated as a qualified anti-terrorism 

11 technology under the SAFETY Act (6 

12 U.S.C. 441 et seq.). 

13 ‘‘(E) GOVERNING LAW.—Notwithstanding 

14 the provisions of section 1346(b)(1) and chap15 ter 171 of title 28, United States Code, as they 

16 relate to governing law, the liability of the 

17 United States as provided in this subsection 

18 shall be in accordance with the law of the place 

19 of injury. 

20 ‘‘(F) MILITARY PERSONNEL AND UNITED

21 STATES CITIZENS OVERSEAS.— 

22 ‘‘(i) MILITARY PERSONNEL.—The li23 ability of the United States as provided in 

24 this subsection shall extend to claims 
73 

•S 1880 IS 

1 brought by United States military per2 sonnel. 

3 ‘‘(ii) CLAIMS ARISING IN A FOREIGN

4 COUNTRY.—Notwithstanding the provisions 

5 of section 2680(k) of title 28, United 

6 States Code, the liability of the United 

7 States as provided for in the subsection 

8 shall extend to claims based on injuries 

9 arising in a foreign country where the in10 jured party is a member of the United 

11 States military, is the spouse or child of a 

12 member of the United States military, or is 

13 a United States citizen. 

14 ‘‘(iii) GOVERNING LAW.—With regard 

15 to all claims brought under clause (ii), and 

16 notwithstanding the provisions of section 

17 1346(b)(1) and chapter 171 of title 28, 

18 United States Code, and of subparagraph 

19 (C), as they relate to governing law, the li20 ability of the United States as provided in 

21 this subsection shall be in accordance with 

22 the law of the claimant’s domicile in the 

23 United States or most recent domicile with 

24 the United States.’’; and 

25 (6) in paragraph (7)— 
74 

•S 1880 IS 

1 (A) by striking subparagraph (A) and in2 serting the following: 

3 ‘‘(A) COVERED COUNTERMEASURE.—The 

4 term ‘covered countermeasure’, means— 

5 ‘‘(i) a substance that is— 

6 ‘‘(I)(aa) used to prevent or treat 

7 smallpox (including the vaccinia or 

8 another vaccine); or 

9 ‘‘(bb) vaccinia immune globulin 

10 used to control or treat the adverse 

11 effects of vaccinia inoculation; and 

12 ‘‘(II) specified in a declaration 

13 under paragraph (2); or 

14 ‘‘(ii) a drug (as such term is defined 

15 in section 201(g)(1) of the Federal Food, 

16 Drug, and Cosmetic Act), biological prod17 uct (as such term is defined in section 

18 351(i) of this Act), or device (as such term 

19 is defined in section 201(h) of the Federal 

20 Food, Drug, and Cosmetic Act) that— 

21 ‘‘(I) the Secretary determines to 

22 be a priority (consistent with sections 

23 302(2) and 304(a) of the Homeland 

24 Security Act of 2002) to treat, iden25 tify, or prevent harm from any bio-
75 

•S 1880 IS 

1 logical, chemical, radiological, or nu2 clear agent identified as a material 

3 threat under section 319F– 

4 2(c)(2)(A)(ii), or to treat, identify, or 

5 prevent harm from a condition that 

6 may result in adverse health con7 sequences or death and may be caused 

8 by administering a drug, biological 

9 product, or device against such an 

10 agent; 

11 ‘‘(II) is— 

12 ‘‘(aa) authorized for emer13 gency use under section 564 of 

14 the Federal Food, Drug, and 

15 Cosmetic Act, so long as the 

16 manufacturer of such drug, bio17 logical product, or device has— 

18 ‘‘(AA) made all reason19 able efforts to obtain applicable 

20 approval, clearance, or licensure; 

21 and 

22 ‘‘(BB) cooperated fully 

23 with the requirements of the Sec24 retary under such section 564; or 
76 

•S 1880 IS 

1 ‘‘(bb) approved or licensed 

2 solely pursuant to the regulations 

3 under subpart I of part 314 or 

4 under subpart H of part 601 of 

5 title 21, Code of Federal Regula6 tions (as in effect on the date of 

7 enactment of the National Bio8 defense Act of 2005); and 

9 ‘‘(III) is specified in a declaration 

10 under paragraph (2).’’; and 

11 (B) in subparagraph (B)— 

12 (i) by striking clause (ii), and insert13 ing the following: 

14 ‘‘(ii) a health care entity, a State, or 

15 a political subdivision of a State under 

16 whose auspices such countermeasure was 

17 administered;’’ and 

18 (vi) in clause (viii), by inserting before 

19 the period ‘‘if such individual performs a 

20 function for which a person described in 

21 clause (i), (ii), or (iv) is a covered person’’. 
77 

•S 1880 IS 

1 TITLE IX—STRENGTHENING 

2 PUBLIC HEALTH READINESS 

3 FOR PANDEMICS 

4 Subtitle A—Improved Planning for 

5 Pandemic Influenza 

6 SEC. 901. FEDERAL PANDEMIC INFLUENZA PREPAREDNESS 

7 PLAN. 

8 Not later than 10 days after the date of enactment 

9 of this Act, the Secretary of Health and Human Services 

10 shall issue in final form a Pandemic Influenza Prepared11 ness Plan to provide for a coordinated Federal, State, and 

12 local preparation and response to an influenza pandemic. 

13 SEC. 902. REQUIREMENT TO DEVELOP STATE PANDEMIC 

14 INFLUENZA PLANS. 

15 (a) IN GENERAL.—In fiscal years after the fiscal year 

16 in which the Secretary issues the Plan described in section 

17 901, the Secretary shall withhold from a State that has 

18 not submitted to the Secretary an acceptable State pan19 demic influenza plan (as determined by the Secretary) the 

20 amounts described in subsection (b) for each fiscal year 

21 for which such a plan is not submitted. The Secretary 

22 shall develop criteria for what constitutes an acceptable 

23 State plan based on the Plan described in section 901. 

24 (b) AMOUNTS DESCRIBED.—The amounts described 

25 in this subsection with respect to a State described in sub-
78 

•S 1880 IS 

1 section (a) are the following amounts that are payable to 

2 a State for a fiscal year under section 319C, 319C–1, or 

3 319C–2 of the Public Health Service Act or from the Pub4 lic Health and Social Services Emergency Fund (or any 

5 successor to such Fund): 

6 (1) For the first fiscal year after the initial year 

7 in which the Secretary of Health and Human Serv8 ices issues the Plan described in section 901, an 

9 amount equal to 10 percent of the amount the State 

10 was eligible to receive for such fiscal year. 

11 (2) For the second such fiscal year, an amount 

12 equal to 15 percent of the amount the State was eli13 gible to receive for such fiscal year. 

14 (3) For the third such fiscal year, an amount 

15 equal to 20 percent of the amount the State was eli16 gible to receive for such fiscal year. 

17 (4) For the fourth and each subsequent fiscal 

18 years, an amount equal to 25 percent of the amount 

19 the State was eligible to receive for such fiscal year. 

20 (c) DISTRIBUTION.—The Secretary shall redistribute 

21 amounts withheld under this section to compliant States 

22 in proportion to the populations of such States. 

23 (d) PLANNING GRANTS.—The Secretary shall award 

24 planning grants to States to assist such States in pre25 paring or enhancing the plans described in subsection (a). 
79 

•S 1880 IS 

1 (e) AUTHORIZATION OF APPROPRIATIONS.—There is 

2 authorized to be appropriated to carry out this section, 

3 such sums as may be necessary for each of fiscal years 

4 2006 through 2010. 

5 SEC. 903. USE OF CDC AND HRSA FUNDS FOR PUBLIC 

6 HEALTH PREPAREDNESS. 

7 (a) APPLICABILITY OF PRIORITY STATEMENT TO

8 CDC PREPAREDNESS PROGRAMS.— 

9 (1) IN GENERAL.—The statement of priorities 

10 described in section 319C–1(e) of the Public Health 

11 Service Act shall apply to awards made by the Cen12 ters for Disease Control and Prevention— 

13 (A) from amounts under the Public Health 

14 and Social Services Emergency Fund (or any 

15 successor to such Fund); and 

16 (B) under the Public Health Preparedness 

17 and Response for Bioterrorism program or any 

18 successor to such program. 

19 (2) LIMITATION.—No State that receives as 

20 award under a program described in paragraph (1) 

21 may deny funding or impose any other sanction 

22 against an entity that uses funds received under 

23 such program to enhance preparedness for naturally 

24 occurring outbreaks of infectious disease. 
80 

•S 1880 IS 

1 (2) APPLICABILITY OF PRIORITY STATEMENT

2 TO HRSA PREPAREDNESS PROGRAMS.— 

3 (1) IN GENERAL.—The statement of priorities 

4 described in section 319C–2(g) of the Public Health 

5 Service Act shall apply to awards made by the 

6 Health Resources and Service Administration— 

7 (A) from amounts under the Public Health 

8 and Social Services Emergency Fund (or any 

9 successor to such Fund); and 

10 (B) under the National Bioterrorism Hos11 pital Preparedness Program or any successor to 

12 such program. 

13 (2) LIMITATION.—No State that receives as 

14 award under a program described in paragraph (1) 

15 may deny funding or impose any other sanction 

16 against an entity that uses funds received under 

17 such program to enhance preparedness for naturally 

18 occurring outbreaks of infectious disease. 

19 Subtitle B—Vaccine Supply 

20 SEC. 911. BUY-BACK PROGRAM FOR FLU VACCINE. 

21 (a) REQUESTS FOR MORE DOSES.— 

22 (1) IN GENERAL.—Not later than March 15 of 

23 each year, the Secretary of Health and Human Serv24 ices shall enter into contracts with manufacturers to 
81 

•S 1880 IS 

1 produce such additional doses of the influenza vac2 cine as determined necessary by the Secretary. 

3 (2) CONTENT OF CONTRACT.—A contract for 

4 additional doses shall provide that the manufacturer 

5 will be compensated by the Secretary at an equitable 

6 rate negotiated by the Secretary and the manufac7 turer for any doses that— 

8 (A) were not sold by the manufacturer 

9 through routine market mechanisms at the end 

10 of the influenza season for that year; and 

11 (B) were requested by the Secretary to be 

12 produced by such manufacturer. 

13 (3) WHEN SUCH VACCINE PURCHASES SHOULD

14 TAKE PLACE.—The Secretary of Health and Human 

15 Services may purchase from the manufacturer the 

16 doses for which it has contracted at any time after 

17 which it is determined by the Secretary, in consulta18 tion with the manufacturer, that the doses will likely 

19 not be absorbed by the private market. 

20 (b) AUTHORIZATION OF APPROPRIATIONS.—There 

21 are authorized to be appropriated to carry out this section 

22 such sums as may be necessary. 
82 

•S 1880 IS 

1 Subtitle C—Enhancing the 

2 National Strategic Stockpile 

3 SEC. 921. STOCKPILING OF ANTIVIRALS AND OTHER MEDI4 CATIONS. 

5 (a) IN GENERAL.—Section 319F–2(b) of the Public 

6 Health Service Act (42 U.S.C. 247d–6b(b)) is amended— 

7 (1) by striking the subsection heading and in8 serting the following: ‘‘STOCKPILING NATIONAL PRI9 ORITY COUNTERMEASURES’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(3) MEDICATION FOR PANDEMIC INFLU12 ENZA.— 

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

14 ensure that the stockpile described in subsection 

15 (a) includes an amount of antiviral medication 

16 sufficient to provide for the emergency health 

17 security of the United States (including the 

18 emergency health security of children and other 

19 vulnerable populations) with respect to strains 

20 of influenza that may (in the determination of 

21 the Secretary) contribute to a pandemic. 

22 ‘‘(B) AMOUNT AND TYPE.—In determining 

23 the types and amounts of the antivirals and 

24 other medications to be placed in the stockpile 

25 under subparagraph (A), the Secretary shall 
83 

•S 1880 IS 

1 take into account the recommendations of the 

2 World Health Organization and of professional 

3 societies with expertise in infectious diseases. 

4 ‘‘(C) AUTHORIZATION OF APPROPRIA5 TIONS.— 

6 ‘‘(i) IN GENERAL.—There is author7 ized to be appropriated to carry out sub8 paragraph (A), $3,080,000,000 for fiscal 

9 year 2006. Amounts appropriated under 

10 this paragraph shall remain available until 

11 expended. 

12 ‘‘(ii) REALLOCATION OF UNEXPENDED

13 AMOUNTS.—The Secretary shall reallocate 

14 amounts appropriated under clause (i) that 

15 are not utilized by the Secretary for the 

16 purchase of antivirals under such clause, 

17 for activities under sections 319C–1 and 

18 319C–2 of the Public Health Service Act 

19 (42 U.S.C. 247d–3a and 247d–3b). Such 

20 amounts shall be reallocated equally be21 tween such sections.’’. 

22 (b) TECHNICAL AMENDMENT.—Section 319F– 

23 2(a)(1) of the Public Health Service Act (42 U.S.C. 247d– 

24 6b(a)(1)) is amended by inserting ‘‘(including drugs, bio25 logics, and devices to address acute exacerbation of chron-
84 

•S 1880 IS 

1 ic illness and mental health disorders)’’ after ‘‘other sup2 plies’’. 

3 SEC. 922. STRATEGIC PLAN FOR STOCKPILE. 

4 (a) IN GENERAL.—Not later than 1 year after the 

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

6 Human Services shall develop a comprehensive plan for 

7 the use of each medical intervention contained in the na8 tional stockpile under section 121 of the Public Health 

9 Security and Bioterrorism Preparedness and Response 

10 Act of 2002 (42 U.S.C. 300hh–12). 

11 (b) REQUIREMENTS OF PLAN.—The plan developed 

12 under subsection (a) shall— 

13 (1) cover all relevant Federal, State, and local 

14 agencies as well as necessary members of the private 

15 sector; 

16 (2) with respect to all products in the stockpile, 

17 provide for the coordination of activation, distribu18 tion, and dissemination of such products to the pop19 ulation at large and to specific high-risk groups such 

20 as health care professionals; 

21 (3) with respect to new medicines or vaccines 

22 that are added to the stockpile, provide, within a 

23 reasonable period of time, for the coordination of ac24 tivation, distribution, and dissemination of the prod-
85 

•S 1880 IS 

1 uct to the population at large and specific high-risk 

2 groups such as health care professionals; and 

3 (4) include procedures for triage or other meth4 ods to prioritize the distribution of materials from 

5 the stockpile in the event of multiple transit attacks 

6 or other public health emergencies occurring simul7 taneously in different areas of the nation. 

8 (c) PERIODIC UPDATING.—The plan developed under 

9 subsection (a) shall be periodically reviewed and updated 

10 to ensure the consideration of the needs of the changing 

11 nature of threats, the State of medical practice, and the 

12 capacities of the agencies and organizations involved. 

13 Subtitle D—Prohibiting Price 

14 Gouging on Needed Flu Medicines 

15 SEC. 931. UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN 

16 COMMERCE RELATED TO TREATMENTS FOR 

17 PANDEMIC INFLUENZA. 

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

19 U.S.C. 247d–6b) is amended by adding at the end the fol20 lowing: 

21 ‘‘(g) UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN

22 COMMERCE RELATED TO TREATMENTS FOR PANDEMIC

23 INFLUENZA.— 

24 ‘‘(1) SALES TO CONSUMERS AT UNCONSCION25 ABLE PRICE.— 
86 

•S 1880 IS 

1 ‘‘(A) IN GENERAL.—During any public 

2 health emergency declared by the Secretary 

3 under section 319 related to pandemic influ4 enza, it shall be unlawful for any person to sell 

5 any drug (including an anti-viral drug), device, 

6 or biologic for the prevention or treatment of 

7 influenza in, or for use in, the area to which 

8 that declaration applies at a price that— 

9 ‘‘(i) is unconscionably excessive (as 

10 determined by the Secretary); or 

11 ‘‘(ii) indicates the seller is taking un12 fair advantage of the circumstances to in13 crease prices unreasonably. 

14 ‘‘(B) FACTORS TO BE CONSIDERED.—In 

15 determining whether a violation of paragraph 

16 (1) has occurred, a court shall take into ac17 count, among other factors, whether— 

18 ‘‘(i) the amount charged represents a 

19 gross disparity between the price of a 

20 drug, device, or biologic for the prevention 

21 or treatment of influenza and the price at 

22 which the drug, device, or biologic was of23 fered for sale in the usual course of the 

24 seller’s business immediately prior to the 

25 public health emergency; or 
87 

•S 1880 IS 

1 ‘‘(ii) the amount charged grossly ex2 ceeds the price at which the same or simi3 lar drug, device, or biologic for the preven4 tion or treatment of influenza was readily 

5 obtainable by other purchasers in the area 

6 in which the declaration applies. 

7 ‘‘(C) MITIGATING FACTORS.—In deter8 mining whether a violation of subparagraph (A) 

9 has occurred, the court shall also take into ac10 count, among other factors, the price that 

11 would reasonably equate supply and demand in 

12 a competitive and freely functioning market and 

13 whether the price at which the drug, device, or 

14 biologic for the prevention or treatment of influ15 enza was sold reasonably reflects additional 

16 costs, not within the control of the seller, that 

17 were paid or incurred by the seller. 

18 ‘‘(2) FALSE PRICING INFORMATION.—It shall 

19 be unlawful for any person to report information re20 lated to the wholesale price of any drug, device, or 

21 biologic for the prevention or treatment of influenza 

22 to the Secretary if— 

23 ‘‘(A) that person knew, or reasonably 

24 should have known, the information to be false 

25 or misleading; 
88 

•S 1880 IS 

1 ‘‘(B) the information was required by law 

2 to be reported; and 

3 ‘‘(C) the person intended the false or mis4 leading data to affect data compiled by the de5 partment or agency involved for statistical or 

6 analytical purposes with respect to the market 

7 for drugs, devices, or biologics for the preven8 tion or treatment of influenza. 

9 ‘‘(3) MARKET MANIPULATION.—It shall be un10 lawful for any person, directly or indirectly, to use 

11 or employ, in connection with the purchase or sale 

12 of drugs, devices, or biologics for the prevention or 

13 treatment of influenza at wholesale, any manipula14 tive or deceptive device or contrivance, in contraven15 tion of such rules and regulations as the Secretary 

16 may prescribe as necessary or appropriate in the 

17 public interest or for the protection of United States 

18 citizens.’’. 

19 Subtitle E—National Institute of 

20 Pathology 

21 SEC. 941. NATIONAL INSTITUTE OF PATHOLOGY. 

22 Title IV of the Public Health Service Act (42 U.S.C. 

23 281 et seq.) is amended— 

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

25 the following: 
89 

•S 1880 IS 

1 ‘‘(H) The National Institute of Pathology.’’; 

2 and 

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

4 287 et seq.) the following: 

5 ‘‘Subpart 7—National Institute of Pathology 

6 ‘‘SEC. 485A. ESTABLISHMENT OF NATIONAL INSTITUTE OF 

7 PATHOLOGY. 

8 ‘‘In order to provide pathology consultation for civil9 ian and military health professionals (including Depart10 ment of Veterans Affairs health professionals) there is es11 tablished the National Institute of Pathology (in this sub12 part referred to as the ‘Institute’). The Institute shall be 

13 headed by a director, who shall be appointed by the Sec14 retary. The Director of the Institute shall report directly 

15 to the Director of NIH. 

16 ‘‘SEC. 485B. PURPOSES AND FUNCTIONS OF THE INSTITUTE. 

17 ‘‘(a) PURPOSES OF THE INSTITUTE.—The general 

18 purposes of the Institute are to— 

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

20 training, and other programs with respect to the 

21 science and clinical practice of pathology; 

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

23 repository; and 

24 ‘‘(3) provide pathology consultation services. 
90 

•S 1880 IS 

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

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

4 ‘‘(1) shall— 

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

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

9 ‘‘(C) conduct educational programs and 

10 publish educational materials on the science 

11 and clinical practice of pathology; 

12 ‘‘(D) maintain and improve registries on 

13 such clinical conditions as the Director of the 

14 Institute determines appropriate; and 

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

17 ‘‘(2) may— 

18 ‘‘(A) collect reasonable and appropriate 

19 fees for the activities described in paragraph 

20 (1)(B); and 

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

22 Director of the Institute determines appropriate 

23 to carry out the purposes described in sub24 section (a). 
91 

•S 1880 IS 

1 ‘‘(c) AUTHORITY FOR EXPERT OPINIONS.—The Di2 rector of the Institute may enter into memoranda of un3 derstanding with officials at the Department of Veterans 

4 Affairs and the Department of Defense to provide expert 

5 second opinion pathology consultations and pathology edu6 cation or training if the Secretary of either such Depart7 ment determines that such provision would be in the best 

8 interest of either of their respective departments. 

9 ‘‘SEC. 485C. BOARD OF REGENTS. 

10 ‘‘(a) MEMBERSHIP.— 

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

12 Board of Regents of the Institute (in this subpart 

13 referred to as the ‘Board’) consisting of— 

14 ‘‘(A) the Surgeons General of— 

15 ‘‘(i) the Public Health Service; 

16 ‘‘(ii) the Army; 

17 ‘‘(iii) the Navy; and 

18 ‘‘(iv) the Air Force; 

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

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

23 Library of Medicine; 

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

25 the Department of Defense; 
92 

•S 1880 IS 

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

2 University of the Health Sciences; and 

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

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

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

7 the Board described in subparagraphs (A) through 

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

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

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

13 Chairperson of the Board until the next election. 

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

15 of the Board to advise, consult with, and make rec16 ommendations to the Director of NIH on important mat17 ters of policy in regard to the Institute, including such 

18 matters as the scope, content and organization of the re19 search, education and consultative services provided by the 

20 Institute. The Board shall make recommendations to the 

21 Director of NIH regarding the rules under which speci22 mens from the tissue repository will be used and under 

23 which it’s publications, facilities and services will be made 

24 available to various kinds users 
93 

•S 1880 IS 

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

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

3 that any member appointed to fill a vacancy occurring 

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

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

7 members shall be eligible for reappointment within 1 year 

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

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

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

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

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

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

15 travel expenses in the same manner and under the same 

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

17 ‘‘SEC. 485D. GIFTS TO THE INSTITUTE. 

18 ‘‘Section 231 shall be applicable to the acceptance 

19 and administration of gifts made for the benefit of the 

20 Institute or for carrying out any of its functions. 

21 ‘‘SEC. 485E. INSTITUTE FACILITIES. 

22 ‘‘There are authorized to be appropriated amounts 

23 sufficient for the erection and equipment of suitable and 

24 adequate buildings and facilities for use of the Institute. 

25 The Administrator of General Services may acquire, by 
94 

•S 1880 IS 

1 purchase, condemnation, donation, or otherwise, a suitable 

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

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

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

5 and facilities. The amounts authorized to be appropriated 

6 by this section include the cost of preparation of drawings 

7 and specifications, supervision of construction, and other 

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

10 specifications, make all necessary contracts, and supervise 

11 construction.’’. 

12 SEC. 942. TRANSFER OF THE ARMED FORCES INSTITUTE OF 

13 PATHOLOGY. 

14 (a) IN GENERAL.— 

15 (1) IN GENERAL.—Except as provided in para16 graph (2), there are transferred to the National In17 stitute of Pathology established under subpart 7 of 

18 part E of title IV of the Public Health Service Act 

19 all functions, duties, personnel, assets, liabilities, 

20 contracts, property, records, and unexpended bal21 ances of appropriations of the Armed Forces Insti22 tute of Pathology. The preceding sentence shall not 

23 affect any proceedings, pending applications, suits, 

24 or other actions pending on the date of enactment 

25 of this Act. 
95 

•S 1880 IS 

1 (2) EXCEPTIONS.—The following components of 

2 the Armed Forces Institute of Pathology shall not be 

3 transferred from the Department of Defense pursu4 ant to paragraph (1): 

5 (A) The Armed Forces Medical Examiner. 

6 (B) The Department of Defense DNA reg7 istry. 

8 (C) Accident Investigation Program. 

9 (D) The histopathology training program. 

10 (E) The patient safety center. 

11 (F) Department of Legal Medicine. 

12 (G) Center for Clinical Laboratory Medi13 cine. 

14 (H) Drug Testing and Quality Assurance 

15 Program. 

16 (I) Subject to the discretion of the Sec17 retary of Defense, medical research programs 

18 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 re24 lated to pathology as the Secretary of De25 fense shall choose to conduct. 
96 

•S 1880 IS 

1 (b) REFERENCES.—Any reference in any Federal 

2 law, Executive order, rule, regulation, or delegation of au3 thority, or any document of or relating to the Armed 

4 Forces Institute of Pathology shall be deemed to be a ref5 erence to the National Institute of Pathology established 

6 under subpart 7 of part E of title IV of the Public Health 

7 Service Act. 

8 Subtitle F—Increased Influenza 

9 Vaccine and Outbreak Surveil10 lance Activities 

11 SEC. 951. TRACKING NETWORK AND DEMONSTRATION 

12 GRANTS. 

13 Title III of the Public Health Service Act is amended 

14 by inserting after section 319B (42 U.S.C. 247d–2) the 

15 following: 

16 ‘‘SEC. 319B-1. TRACKING NETWORK AND DEMONSTRATION 

17 GRANTS. 

18 ‘‘(a) TRACKING SYSTEM.— 

19 ‘‘(1) ESTABLISHMENT.—Not later than 2 years 

20 after the date of enactment of this section, the Di21 rector of the Centers for Disease Control and Pre22 vention, in conjunction with State and local public 

23 health officials, shall establish an electronic tracking 

24 system through which the Director and such officials 

25 can determine the amount of influenza vaccine that 
97 

•S 1880 IS 

1 is available for distribution to patients, as well as 

2 the need for such vaccine on a county-by-county 

3 basis, and the progress of vaccine delivery and dis4 tribution efforts at the State and local level. 

5 ‘‘(2) ESTIMATES.—The tracking system estab6 lished under paragraph (1) shall collect estimates of 

7 the size of high priority populations (as defined by 

8 the Advisory Committee on Immunization Practices 

9 and the Centers for Disease Control and Prevention) 

10 (referred to in this section as ‘high priority popu11 lations’) in each county in the United States, so as 

12 to better determine where influenza vaccine re13 sources may need to be directed in the case of an 

14 emergency. 

15 ‘‘(3) PROVISION OF INFORMATION.—To be eli16 gible to participate in the program under section 

17 911 the vaccine manufacturer shall provide informa18 tion to the tracking system as the Director of the 

19 Centers for Disease Control and Prevention deter20 mines appropriate in accordance with subtitle 3 of 

21 title XXI. 

22 ‘‘(4) DATABASE.—In consultation with manu23 facturers, distributors, wholesalers, and State and 

24 local health departments, the Secretary shall develop 

25 guidelines for the development and use of a database 
98 

•S 1880 IS 

1 in order to maintain confidentiality and ensure that 

2 none of the information provided under paragraph 

3 (3) and contained in the database can be used to 

4 provide a proprietary advantage within the vaccine 

5 market while allowing State and local health officials 

6 such information to maximize the delivery and avail7 ability of vaccines to high priority populations. 

8 ‘‘(b) EXPANSION OF CURRENT SYSTEMS AND ACTIVI9 TIES.— 

10 ‘‘(1) SURVEILLANCE SYSTEM.—Not later than 

11 4 years after the date of enactment of this section, 

12 the Director of the Centers for Disease Control and 

13 Prevention shall upgrade the influenza surveillance 

14 system of the Centers for Disease Control and Pre15 vention to report influenza data from State and local 

16 health departments into the tracking system estab17 lished under subsection (a)(1). 

18 ‘‘(2) EDUCATIONAL MATERIALS.—The tracking 

19 system shall contain information to assist users in 

20 accessing influenza education, outreach, and commu21 nications tools. 

22 ‘‘(3) EMERGENCY PROVIDER DATABASE.—The 

23 Director of the Centers for Disease Control and Pre24 vention shall coordinate access to, in conjunction 

25 with State and local health departments and State 
99 

•S 1880 IS 

1 licensing boards for health professionals, a database 

2 registry of medical personnel who can provide serv3 ices in the event of a health emergency, including 

4 pandemic influenza or an influenza vaccine shortage. 

5 Such information shall be made available through 

6 the tracking network. 

7 ‘‘(c) DEMONSTRATION GRANTS.— 

8 ‘‘(1) IN GENERAL.—The Director of the Cen9 ters for Disease Control and Prevention shall award 

10 demonstration grants to State and local health de11 partments to enable such departments to enter into 

12 contract with hospitals, community health centers, 

13 long-term care facilities, physicians’ offices, and 

14 health care facilities operated or funded by such de15 partments to assist such entities in upgrading their 

16 information technology, and workforce in a manner 

17 that will allow such entities to improve their ability 

18 to report and track influenza vaccine dissemination. 

19 ‘‘(2) PRIORITY.—In awarding grants under 

20 paragraph (1), priority shall be given to entities that 

21 serve high priority populations in medically under22 served areas. 

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

24 are authorized to be appropriated— 
100 

•S 1880 IS 

1 ‘‘(1) to carry out subsection (a), $100,000,000 

2 for each of fiscal years 2007 through 2011, of which 

3 $500,000 for each fiscal year shall be made available 

4 to implement subsection (b)(3); and 

5 ‘‘(2) to carry out subsection (c), $100,000,000 

6 for each of fiscal years 2007 through 2011.’’. 

7 SEC. 952. EDUCATIONAL EFFORTS AND GRANTS. 

8 Title III of the Public Health Service Act is amended 

9 by inserting after section 319B–1 (as added by section 

10 951) the following: 

11 ‘‘SEC. 319B–2. IMMUNIZATION EDUCATIONAL EFFORTS AND 

12 GRANTS. 

13 ‘‘(a) IN GENERAL.—The Director of the Centers for 

14 Disease Control and Prevention, in conjunction with State 

15 and local health departments, shall revise and expand the 

16 influenza-related educational materials to the Centers for 

17 Disease Control and Prevention, and facilitate the use of 

18 such materials by health care providers and patients. The 

19 Director is authorized to coordinate such educational ef20 forts with nonprofit provider and patient advocacy groups. 

21 ‘‘(b) INFLUENZA VACCINE EDUCATION AND OUT22 REACH.— 

23 ‘‘(1) IN GENERAL.—In order to achieve an opti24 mal balance in the influenza vaccine market, and to 

25 ensure that the recommendations of the Advisory 
101 

•S 1880 IS 

1 Committee on Immunization Practices to the Cen2 ters for Disease Control and Prevention for vaccine 

3 administration are carried out to the maximum ex4 tent possible, the Director of the Centers for Disease 

5 Control and Prevention, in conjunction with State 

6 and local health departments, shall carry out influ7 enza immunization education and outreach activities 

8 that target physicians and other health care pro9 viders, health insurance providers, health care insti10 tutions and patients, particularly those in high pri11 ority populations (as defined by the Advisory Com12 mittee on Immunization Practices and the Centers 

13 for Disease Control and Prevention) (referred to in 

14 this section as ‘high priority populations’). 

15 ‘‘(2) TYPES OF ACTIVITIES.—The education 

16 and outreach activities under paragraph (1) shall in17 clude— 

18 ‘‘(A) activities to encourage voluntary par19 ticipation in influenza vaccination programs, 

20 with the goal of increasing overall influenza 

21 vaccination rates in the United States, achiev22 ing full influenza vaccination of all high priority 

23 populations, and full use of each season’s influ24 enza vaccine supply; 
102 

•S 1880 IS 

1 ‘‘(B) the provision of information on influ2 enza prevention; 

3 ‘‘(C) activities to increase the number of 

4 healthcare providers who receive influenza vac5 cines each year; and 

6 ‘‘(D) other influenza educational efforts 

7 determined appropriate by the Director. 

8 ‘‘(c) GRANTS.—The Director of the Centers for Dis9 ease Control and Prevention may award grants to State 

10 and local health departments to carry out activities to en11 courage individuals, particularly those from high priority 

12 populations, to seek out influenza vaccinations. 

13 ‘‘(d) COLLABORATION.—State and local health de14 partments that receive grants under subsection (b) are en15 couraged to collaborate on projects with physicians and 

16 other health care providers, health insurance providers, 

17 health care institutions, and groups representing high pri18 ority populations. 

19 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—In ad20 dition to any amounts otherwise available through the Sec21 retary for influenza outreach and education, there is au22 thorized to be appropriated to carry out this section, 

23 $10,000,000 for each of fiscal years 2007 through 2011.’’. 
103 

•S 1880 IS 

1 Subtitle G—Miscellaneous 

2 Provisions 

3 SEC. 961. HRSA CURRICULUM DEVELOPMENT AND TRAIN4 ING PROGRAMS. 

5 In carrying out activities under section 319F(g) of 

6 the Public Health Service Act and any related activities 

7 on the development of training program for health profes8 sionals in the recognition of the signs and symptoms of 

9 exposure to a potential bioweapon and other agents that 

10 may create a public health emergency (including the Bio11 terrorism Training and Curriculum Development program 

12 of the Health Resources and Services Administration), the 

13 Secretary of Health and Human Services shall, to the 

14 maximum extent practicable, provide awards to a single 

15 entity or a small number of entities that have the capacity 

16 to provide consistent training nationwide. In carrying out 

17 the requirement of the preceding sentence, the Secretary 

18 may not, except if there is no practicable alternative, pro19 vide awards to any single entity that is less than 20 per20 cent of the total awards made for any fiscal year. 

21 SEC. 962. USING HEALTH INFORMATION TECHNOLOGY TO 

22 ENAHNCE EPIDEMIC DETECTION. 

23 Section 319F of the Public Health Service Act (42 

24 U.S.C. 247d–6) is amended by adding at the end the fol25 lowing: 
104 

•S 1880 IS 

1 ‘‘(k) USING HEALTH INFORMATION TECHNOLOGY

2 TO ENHANCE EPIDEMIC DETECTION.— 

3 ‘‘(1) IN GENERAL.—The Secretary may award 

4 demonstration grants to eligible entities to enable 

5 such entities to establish or enhance information 

6 technology systems for the rapid detection of infec7 tious disease outbreaks. 

8 ‘‘(2) ELIGIBILITY.—To be eligible to receive a 

9 grant under paragraph (1), an entity shall— 

10 ‘‘(A) be a State or local government or 

11 nonprofit entity; and 

12 ‘‘(B) submit to the Secretary an applica13 tion at such time, in such manner, and con14 taining such information as the Secretary may 

15 require, including and assurance that the entity 

16 will submit to the Secretary a report on the ef17 fective of the systems funded under the grant. 

18 ‘‘(3) EVALUATION OF SYSTEMS.—Not later 

19 than 1 year after the date of enactment of this sub20 section, and annually thereafter, the Director of the 

21 Centers for Disease Control and Prevention shall 

22 conduct an evaluation of the systems implemented 

23 under grants under this subsection to determined 

24 which systems are most effective. The Director shall 
105 

•S 1880 IS 

1 issue recommendations on best practices for such 

2 systems. 

3 ‘‘(4) INDEPENDENT EVALUATION.—Not later 

4 than 4 years after the date of enactment of this sub5 section, the Government Accountability Office shall 

6 conduct an independent evaluation, and submit to 

7 the Secretary and the appropriate committees of 

8 Congress a report, concerning the activities con9 ducted under this subsection. 

10 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 

11 There are authorized to be appropriated to carry out 

12 this subsection, $50,000,000 for each of fiscal years 

13 2006 through 2010.’’. 

14 SEC. 963. NATURALLY OCCURRING OR DELIBERATELY IN15 TRODUCED AGENTS. 

16 Section 319C–1(d)(7)(A) of the Public Health Serv17 ice Act (42 U.S.C. 247d–3a(d)(7)(A)) is amended by in18 serting ‘‘(where such biological agent may be naturally oc19 curring or deliberately introduced)’’ after ‘‘agent’’. 

20 SEC. 964. USE OF FEDERAL FACILITIES IN EMERGENCIES. 

21 (a) IDENTIFICATION.—Not later than 90 days after 

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

23 and Human Services shall identify Federal facilities that 

24 are capable of being used to provide health care as surge 
106 

•S 1880 IS 

1 capacity hospitals during a public health emergency under 

2 section 319 of the Public Health Service Act. 

3 (b) MEMORANDUM OF UNDERSTANDING.—The Sec4 retary of Health and Human Services may enter into a 

5 memorandum of understanding with the heads of appro6 priate Federal agencies and other workforce groups to uti7 lize the facilities identified under subsection (a) during a 

8 public health emergency under section 319 of the Public 

9 Health Service Act. 

10 SEC. 965. ADVISORY COMMITTEE ON VULNERABLE POPU11 LATIONS. 

12 (a) IN GENERAL.—Section 319F(b)(2) of the Public 

13 Health Service Act (42 U.S.C. 247d–6(b)(2)) is amended 

14 to read as follows: 

15 ‘‘(2) NATIONAL ADVISORY COMMITTEE ON VUL16 NERABLE POPULATIONS AND TERRORISM.— 

17 ‘‘(A) IN GENERAL.—For purposes of para18 graph (1), the Secretary shall establish an advi19 sory committee to be known as the National 

20 Advisory Committee on Vulnerable Populations 

21 and Terrorism (referred to in this paragraph as 

22 the ‘Advisory Committee’). 

23 ‘‘(B) DUTIES.—The Advisory Committee 

24 shall— 
107 

•S 1880 IS 

1 ‘‘(i) provide recommendations regard2 ing— 

3 ‘‘(I) the preparedness of the 

4 health care (including mental health 

5 care) system to respond to bioter6 rorism as it relates to children, preg7 nant women, and other vulnerable 

8 populations; 

9 ‘‘(II) needed changes to the 

10 health care and emergency medical 

11 service systems and emergency med12 ical services protocols to meet the spe13 cial needs of children, pregnant 

14 women, and other vulnerable popu15 lations; and 

16 ‘‘(III) changes, if necessary, to 

17 the national stockpile under section 

18 121 of the Public Health Security and 

19 Bioterrorism Preparedness and Re20 sponse Act of 2002 to meet the emer21 gency health security of children, 

22 pregnant women, and other vulnerable 

23 populations; and 

24 ‘‘(ii) advise the National BioVenture 

25 Trust with respect to granting priority to 
108 

•S 1880 IS 

1 supporting and facilitating research and 

2 development of countermeasures, and for3 mulations of countermeasures, that are 

4 likely to be safe and effective for children, 

5 pregnant women, and other vulnerable 

6 populations. 

7 ‘‘(C) COMPOSITION.—The Advisory Com8 mittee shall be composed of such Federal offi9 cials as may be appropriate to address the spe10 cial needs of the diverse population groups of 

11 children, pregnant women, and other popu12 lations and health experts on infectious disease, 

13 environmental health, toxicology, and other rel14 evant professional disciplines.’’. 

15 (b) ANNUAL REVIEW OF STRATEGIC NATIONAL

16 STOCKPILE.— 

17 (1) IN GENERAL.—The Secretary, in consulta18 tion with the National Advisory Committee on Vul19 nerable Populations and Terrorism and other ex20 perts as determined appropriate by the Secretary, 

21 shall annually conduct a review of— 

22 (A) the capacity of the Strategic National 

23 Stockpile under section 319F–2 of the Public 

24 Health Service Act (42 U.S.C. 247d–6b) to ad25 dress the emergency health needs of pediatric 
109 

•S 1880 IS 

1 populations, pregnant women, and other vulner2 able populations; and 

3 (B) any formulary additions or modifica4 tions with respect to the contents of such 

5 Stockpile to ensure that the needs of such pop6 ulations are met. 

7 (2) RECOMMENDATIONS.—Based on the review 

8 under paragraph (1), the Secretary shall— 

9 (A) determine and prioritize recommenda10 tions of formulary additions to the Strategic 

11 National Stockpile with respect to pediatric 

12 populations, pregnant women, and other vulner13 able populations; and 

14 (B) submit such recommendations to Con15 gress. 

16 SEC. 966. EMERGENCY SYSTEM FOR ADVANCE REGISTRA17 TION OF HEALTH PROFESSIONS VOLUN18 TEERS. 

19 Section 319I(a) of the Public Health Service Act (42 

20 U.S.C. 247d–7b(a)) is amended by striking ‘‘maintain a 

21 system’’ and inserting ‘‘maintain a single system’’. 
110 

•S 1880 IS 

1 TITLE X—ENHANCING 

2 ANTIBIOTICS 

3 SEC. 1001. PRESERVING THE EFFECTIVENESS OF MEDI4 CALLY IMPORTANT ANTIBIOTICS. 

5 (a) PROOF OF SAFETY OF CRITICAL ANTIMICROBIAL

6 ANIMAL DRUGS.— 

7 (1) DEFINITIONS.—Section 201 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 321) is 

9 amended by adding at the end the following: 

10 ‘‘(nn) CRITICAL ANTIMICROBIAL ANIMAL DRUG.— 

11 The term ‘critical antimicrobial animal drug’ means a 

12 drug that— 

13 ‘‘(1) is intended for use in food-producing ani14 mals; and 

15 ‘‘(2) is composed wholly or partly of— 

16 ‘‘(A) any kind of penicillin, tetracycline, 

17 bacitracin, macrolide, lincomycin, 

18 streptogramin, aminoglycoside, sulfonamide; or 

19 ‘‘(B) any other drug or derivative of a 

20 drug that is used in humans or intended for use 

21 in humans to treat or prevent disease or infec22 tion caused by microorganisms. 

23 ‘‘(oo) NONTHERAPEUTIC USE.—The term ‘nonthera24 peutic use’, with respect to a critical antimicrobial animal 

25 drug, means any use of the drug as a feed or water addi-
111 

•S 1880 IS 

1 tive for an animal in the absence of any clinical sign of 

2 disease in the animal for growth promotion, feed effi3 ciency, weight gain, routine disease prevention, or other 

4 routine purpose.’’. 

5 (2) NONTHERAPEUTIC USE.—Section 512(d)(1) 

6 of the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 360b(d)(1)) is amended— 

8 (A) in the first sentence— 

9 (i) in subparagraph (H), by striking 

10 ‘‘or’’ at the end; 

11 (ii) by redesignating subparagraph (I) 

12 as subparagraph (J); and 

13 (iii) by inserting after subparagraph 

14 (H) the following: 

15 ‘‘(I) with respect to a critical antimicrobial 

16 animal drug or a drug of the same chemical 

17 class as a critical antimicrobial animal drug, 

18 the applicant has failed to demonstrate that 

19 there is a reasonable certainty of no harm to 

20 human health due to the development of anti21 microbial resistance that is attributable, in 

22 whole or in part, to the nontherapeutic use of 

23 the drug; or’’; and 
112 

•S 1880 IS 

1 (B) in the second sentence, by striking 

2 ‘‘(A) through (I)’’ and inserting ‘‘(A) through 

3 (J)’’. 

4 (3) PHASED ELIMINATION OF NONTHERA5 PEUTIC USE IN ANIMALS OF CRITICAL ANTI6 MICROBIAL ANIMAL DRUGS IMPORTANT FOR HUMAN

7 HEALTH.—Section 512 of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 360b) is amended by 

9 adding at the end the following: 

10 ‘‘(q) PHASED ELIMINATION OF NONTHERAPEUTIC

11 USE IN ANIMALS OF CRITICAL ANTIMICROBIAL ANIMAL

12 DRUGS IMPORTANT FOR HUMAN HEALTH.— 

13 ‘‘(1) APPLICABILITY.—This subsection applies 

14 to the nontherapeutic use in a food-producing ani15 mal of— 

16 ‘‘(A)(i) a drug that is a critical anti17 microbial animal drug; or 

18 ‘‘(ii) a drug that is of the same chemical 

19 class as a critical antimicrobial animal drug; 

20 and 

21 ‘‘(B) a drug— 

22 ‘‘(i) for which, as of the day before 

23 the date of enactment of this subsection, 

24 there was in effect an approval of an appli-
113 

•S 1880 IS 

1 cation filed under subsection (b) or (j) of 

2 section 505; or 

3 ‘‘(ii) that was otherwise marketed for 

4 use. 

5 ‘‘(2) WITHDRAWAL.—The Secretary shall with6 draw the approval of a nontherapeutic use in food7 producing animals described in paragraph (1) on the 

8 date that is 2 years after the date of enactment of 

9 this subsection unless— 

10 ‘‘(A) before the date that is 2 years after 

11 that date of enactment, the Secretary makes a 

12 written determination that the holder of the ap13 proved application has demonstrated that there 

14 is a reasonable certainty of no harm to human 

15 health due to the development of antimicrobial 

16 resistance that is attributable in whole or in 

17 part to the nontherapeutic use of the drug; or 

18 ‘‘(B) before the date specified in subpara19 graph (A), the Secretary makes a final written 

20 determination under this subsection, with re21 spect to a risk analysis of the drug conducted 

22 by the Secretary and other relevant informa23 tion, that there is a reasonable certainty of no 

24 harm to human health due to the development 

25 of antimicrobial resistance that is attributable 
114 

•S 1880 IS 

1 in whole or in part to the nontherapeutic use of 

2 the drug. 

3 ‘‘(3) EXEMPTIONS.—Except as provided in 

4 paragraph (5), if the Secretary grants an exemption 

5 under section 505(i) for a drug that is a critical 

6 antimicrobial animal drug, the Secretary shall re7 scind each approval of a nontherapeutic use in a 

8 food-producing animal of the critical antimicrobial 

9 animal drug, or of a drug in the same chemical class 

10 as the critical antimicrobial animal drug, as of the 

11 date that is 2 years after the date on which the Sec12 retary grants the exemption. 

13 ‘‘(4) APPROVALS.—If an application for a drug 

14 that is critical antimicrobial animal drug is sub15 mitted to the Secretary under section 505(b), the 

16 Secretary shall rescind each approval of a nonthera17 peutic use in a food-producing animal of the critical 

18 antimicrobial animal drug, or of a drug in the same 

19 chemical class as the critical antimicrobial animal 

20 drug, as of the date that is 2 years after the date 

21 on which the application is submitted to the Sec22 retary. 

23 ‘‘(5) EXCEPTION.—Paragraph (3) or (4), as the 

24 case may be, shall not apply if, before the date on 

25 which approval would be rescinded under that sub-
115 

•S 1880 IS 

1 paragraph, the Secretary determines that the holder 

2 of the approved application has demonstrated that 

3 there is a reasonable certainty of no harm to human 

4 health due to the development of antimicrobial re5 sistance that is attributable, in whole or in part, to 

6 the nontherapeutic use in the food-producing animal 

7 of the critical antimicrobial animal drug.’’. 

8 (b) ASSISTANCE TO DEFRAY EXPENSES OF LIVE9 STOCK OR POULTRY PRODUCERS IN PHASING OUT NON10 THERAPEUTIC USE OF CRITICAL ANTIMICROBIAL ANIMAL

11 DRUGS.— 

12 (1) DEFINITIONS.—In this subsection, the 

13 terms ‘‘critical antimicrobial animal drug’’ and 

14 ‘‘nontherapeutic use’’ have the meanings given the 

15 terms in section 201 of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 321). 

17 (2) PAYMENTS.—The Secretary of Agriculture 

18 may make payments to producers of livestock or 

19 poultry that the Secretary determines are substan20 tially reducing, or have substantially reduced, the 

21 nontherapeutic use of critical antimicrobial animal 

22 drugs in livestock or poultry in order to defray the 

23 costs of such reduction. 

24 (3) PRIORITY FOR FAMILY FARMERS AND

25 SMALL FARMS.—In awarding payments under para-
116 

•S 1880 IS 

1 graph (2), the Secretary of Agriculture shall give 

2 priority to family-owned and family-operated farms 

3 or ranches and to small farms or ranches, as deter4 mined by the Secretary. 

5 (4) AUTHORIZATION OF APPROPRIATIONS.— 

6 There are authorized to be appropriated such sums 

7 as are necessary to carry out this subsection for fis8 cal year 2005 and for each subsequent fiscal year. 

9 (c) RESEARCH AND DEMONSTRATION PROGRAMS.— 

10 Subtitle D of title VII of the Farm Security and Rural 

11 Investment Act of 2002 (116 Stat. 455) is amended by 

12 adding at the end the following: 

13 ‘‘SEC. 7413. PHASING OUT OF NONTHERAPEUTIC USE OF 

14 CRITICAL ANTIMICROBIAL ANIMAL DRUGS. 

15 ‘‘(a) DEFINITIONS.—In this section, the terms ‘crit16 ical antimicrobial animal drug’ and ‘nontherapeutic use’ 

17 have the meanings given the terms in section 201 of the 

18 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

19 ‘‘(b) GRANTS.—The Secretary, in consultation with 

20 the Secretary of Health and Human Services, shall award 

21 grants to colleges and universities to establish research 

22 and demonstration programs for— 

23 ‘‘(1) phasing out the nontherapeutic use of crit24 ical antimicrobial animal drugs in livestock or poul25 try; and 
117 

•S 1880 IS 

1 ‘‘(2) informing livestock and poultry producers 

2 of methods for accomplishing the objective described 

3 in paragraph (1). 

4 ‘‘(c) EDUCATION.—The Secretary shall use the re5 sults of the research and demonstration programs and the 

6 experience of agricultural producers that have reduced or 

7 eliminated the nontherapeutic use of critical antimicrobial 

8 animal drugs to educate other agricultural producers, 

9 through the Cooperative Research, Education, and Exten10 sion Service, concerning how to successfully phase out 

11 such use in livestock or poultry. 

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

13 are authorized to be appropriated such sums as are nec14 essary to carry out this section for fiscal years 2004 

15 through 2007.’’. 

16 (d) COLLECTION OF DATA ON CRITICAL ANTI17 MICROBIAL ANIMAL DRUGS.— 

18 (1) IN GENERAL.—Chapter V of the Federal 

19 Food, Drug, and Cosmetic Act is amended by insert20 ing after section 512 (21 U.S.C. 360b) the following: 

21 ‘‘SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTI22 MICROBIAL ANIMAL DRUGS. 

23 ‘‘(a) IN GENERAL.—Not later than July 1 of each 

24 year, a manufacturer of a critical antimicrobial animal 

25 drug or an animal feed for food-producing animals bearing 
118 

•S 1880 IS 

1 or containing a critical antimicrobial animal drug shall 

2 submit to the Secretary a report, in such form as the Sec3 retary shall require, containing information on the sales 

4 during the previous calendar year of the critical anti5 microbial animal drug or animal feed. 

6 ‘‘(b) INFORMATION TO BE INCLUDED.—A report 

7 under subsection (a) shall— 

8 ‘‘(1) state separately the quantity of the critical 

9 antimicrobial animal drug, including in animal feed 

10 bearing or containing the critical antimicrobial ani11 mal drug, sold for each kind of food-producing ani12 mal; 

13 ‘‘(2) describe the claimed purpose of use for 

14 each kind of food-producing animal as being for 

15 growth promotion, weight gain, feed efficiency, dis16 ease prevention, disease control, disease treatment, 

17 or another purpose; and 

18 ‘‘(3) describe the dosage form of the drug. 

19 ‘‘(c) PUBLICATION.— 

20 ‘‘(1) IN GENERAL.—The Secretary shall— 

21 ‘‘(A) make the information submitted 

22 under subsection (a) available to the public; and 

23 ‘‘(B) publish the information at least an24 nually. 
119 

•S 1880 IS 

1 ‘‘(2) PROTECTION OF CONFIDENTIALITY.—The 

2 Secretary shall aggregate information, if necessary, 

3 to avoid disclosure under paragraph (1) of confiden4 tial business information.’’. 

5 (2) PROHIBITED ACTS.—Section 301(e) of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 331(e)) is amended by striking ‘‘515(f)’’ and insert8 ing ‘‘512A, 515(f),’’. 

9 (3) EFFECTIVE DATE.—The amendments made 

10 by this subsection take effect on January 1, 2005. 

11 (e) LIMITATION ON ANTIBIOTIC USES.—If a counter12 measure that is developed using assistance provided under 

13 the Project BioShield Program (under the Project Bio14 Shield Act of 2004, and the amendments made by such 

15 Act) is an antibiotic (as defined for purposes of the Fed16 eral Food, Drug, and Cosmetic Act)— 

17 (1) such countermeasure may not be used for 

18 nontherapeutic uses (as defined in section 201(oo) of 

19 the Federal Food, Drug, and Cosmetic Act (as 

20 added by subsection (a)) in animals; and 

21 (2) the Secretary of Health and Human Serv22 ices shall transfer from the BioShield fund an 

23 amount equal to 10 percent of the funds provided to 

24 the programs authorized under section 319E of the 
120 

•S 1880 IS 

1 Public Health Service Act (42 U.S.C. 247d–5) for 

2 purposes of funding the countermeasure. 

3 TITLE XI—IMPROVING RE4 SEARCH ON BIODEFENSE 

5 COUNTERMEASURES 

6 SEC. 1101. IMPROVING THE ABILITY OF BIODEFENSE RE7 SEARCHERS TO WORK WITH SELECT AGENTS. 

8 Section 351A of the Public Health Service Act (42 

9 U.S.C. 262a) is amended— 

10 (1) in subsection (a)— 

11 (A) in paragraph (1)(B)(ii), by inserting ‘‘, 

12 and with the Advisory Committee established 

13 under subsection (m) in the manner described 

14 in paragraph (3) of such subsection’’ before the 

15 period; and 

16 (B) by striking paragraph (2), and insert17 ing the following: 

18 ‘‘(2) BIENNIAL REVIEW.— 

19 ‘‘(A) IN GENERAL.—The Secretary shall, 

20 on a biennial or more frequent basis as deter21 mined appropriate, review and republish the list 

22 established under paragraph (1), and by regula23 tion revise such list as necessary in accordance 

24 with such paragraph. 
121 

•S 1880 IS 

1 ‘‘(B) CONSULTATION.—In carrying out the 

2 activities described in subparagraph (A), the 

3 Secretary shall consult with the Advisory Com4 mittee established under subsection (m) in the 

5 manner described in paragraph (3) of such sub6 section.’’; 

7 (2) in subsection (e)(3), by adding at the end 

8 the following: 

9 ‘‘(D) PRESUMPTION OF ALLOWED AC10 CESS.— 

11 ‘‘(i) IN GENERAL.—If an individual 

12 described in subclause (I) or (II) of clause 

13 (iii) transfers employment or professional 

14 affiliation from one registered person (re15 ferred to in this subparagraph as the 

16 ‘sender’) to another registered person (re17 ferred to in this subparagraph as the ‘re18 cipient’), and the recipient determines that 

19 such individual is an individual described 

20 in paragraph (2)(A), the recipient shall 

21 take the actions described in paragraph (2) 

22 with respect to such individual. 

23 ‘‘(ii) TREATMENT DURING ATTORNEY

24 GENERAL REVIEW.—During the period in 

25 which the Attorney General is conducting a 
122 

•S 1880 IS 

1 review pursuant to this paragraph with re2 spect to an individual described in clause 

3 (i), such individual shall be presumed not 

4 to be an individual described in clauses (i) 

5 or (ii) of subparagraph (B). 

6 ‘‘(iii) INDIVIDUAL DESCRIBED.—An 

7 individual described in this clause is— 

8 ‘‘(I) an individual the name of 

9 whom the sender has submitted to the 

10 Secretary and the Attorney General 

11 under paragraph (2)(B) and whom 

12 the Attorney General has determined 

13 is not described in clause (i) or (ii) of 

14 subparagraph (B); or 

15 ‘‘(II) an individual who is a reg16 istered person under paragraph 

17 (6)(A). 

18 ‘‘(iv) Not later than 180 days after 

19 the date of enactment of this subpara20 graph, the Secretary shall promulgate reg21 ulations to implement this subparagraph.’’; 

22 (3) by redesignating subsection (m) as sub23 section (p); and 

24 (4) by inserting after subsection (l), the fol25 lowing: 
123 

•S 1880 IS 

1 ‘‘(m) SELECT AGENT SCIENTIFIC ADVISORY COM2 MITTEE.— 

3 ‘‘(1) ESTABLISHMENT.—The Secretary shall es4 tablish a Select Agent Advisory Committee (referred 

5 to in this section as the ‘Advisory Committee’) to 

6 consult with, and provide expert advice to, the Sec7 retary and the Secretary of Agriculture in the man8 ner described in paragraph (3). 

9 ‘‘(2) MEMBERSHIP.— 

10 ‘‘(A) IN GENERAL.—The Advisory Com11 mittee shall be composed of individuals, to be 

12 appointed by the Secretary, having expertise in 

13 scientific research with select agents or other 

14 microbial or viral pathogens. 

15 ‘‘(B) TERMS.—An individual appointed 

16 under subparagraph (A) shall serve for a 2-year 

17 term. The terms of the initial members ap18 pointed under such subparagraph shall be stag19 gered as determined by the Secretary, 

20 ‘‘(3) CONSULTATION AND RESPONSE.— 

21 ‘‘(A) IN GENERAL.—Except during a pub22 lic health emergency, the Secretary shall, not 

23 later than 90 days prior to promulgating a reg24 ulation under this section, transmit a draft of 

25 such regulation to the Advisory Committee. 
124 

•S 1880 IS 

1 ‘‘(B) COMMENTS AND RECOMMENDA2 TIONS.—The Advisory Committee may submit 

3 to the Secretary comments and recommenda4 tions regarding a draft regulation submitted by 

5 the Secretary under subparagraph (A). 

6 ‘‘(C) With respect to any recommendations 

7 submitted by the Advisory Committee under 

8 subparagraph (B) relating to a draft regulation 

9 during the 60-day period beginning on the date 

10 on which such draft regulation was transmitted 

11 to the Advisory Committee, the Secretary shall, 

12 prior to promulgating such regulation— 

13 ‘‘(i) modify the draft regulation to in14 corporate the recommendations of the Ad15 visory Committee; or 

16 ‘‘(ii) publish an explanation of why 

17 the recommendation has not been adopted. 

18 ‘‘(n) REPORT BY COMPTROLLER GENERAL.—Not 

19 later than 1 year after the date of enactment of this sub20 section, the Comptroller shall submit to the appropriate 

21 committees of Congress a report that— 

22 ‘‘(1) describes the length of time required to 

23 complete the security checks and other procedures 

24 required for an institution to become a registered 

25 person; 
125 

•S 1880 IS 

1 ‘‘(2) makes recommendations on ways to reduce 

2 the length of time described in paragraph (1) with3 out compromising security; 

4 ‘‘(3) describes the ongoing costs for a registered 

5 person to comply with the requirements of regula6 tions promulgated under this section; 

7 ‘‘(4) makes recommendations on ways to reduce 

8 the costs described in paragraph (3) without com9 promising security; and 

10 ‘‘(5) describes the degree to which registered 

11 persons that are nonprofit institutions are able to 

12 recoup the costs described in paragraph (3) from 

13 Federal agencies that provide financial support for 

14 research conducted at such institutions; and 

15 ‘‘(6) describes the source or sources of funding 

16 used by registered persons that are nonprofit institu17 tions to comply with the requirements of regulations 

18 promulgated under this section. 

19 ‘‘(o) CLARIFICATION OF CERTAIN TERMS.— 

20 ‘‘(1) FINDINGS.—Congress finds that— 

21 ‘‘(A) certainty and predictability are essen22 tial for registered persons to be able to comply 

23 properly with the requirements of the regula24 tions promulgated under this section; 
126 

•S 1880 IS 

1 ‘‘(B) the terms ‘access’ and ‘incident’ are 

2 of central importance in the requirements of 

3 such regulations; and 

4 ‘‘(C) it is essential for there to be a clear 

5 definition in such regulations of such terms. 

6 ‘‘(2) REQUIREMENT TO PUBLISH.— 

7 ‘‘(A) IN GENERAL.—Not later than 180 

8 days after the date of enactment of this sub9 section, the Secretary shall by regulation pro10 mulgate a definition of the terms ‘access’ and 

11 ‘incident’ as such terms are used in regulations 

12 promulgated pursuant to this section. 

13 ‘‘(B) CONSULTATION.—In carrying out 

14 subparagraph (A), the Secretary shall consult 

15 with the Advisory Committee established under 

16 subsection (m) in the manner paragraph (3) of 

17 such subsection.’’. 

Æ