II 

Calendar No. 214

108TH CONGRESS 

1ST SESSION H. R. 2122

IN THE SENATE OF THE UNITED STATES 

JULY 17, 2003

Received; read twice and placed on the calendar 

AN ACT

To enhance research, development, procurement, and use 

of biomedical countermeasures to respond to public 

health threats affecting national security, and for other 

purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Project BioShield Act 

3 of 2003’’. 

4 SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND 

5 DEVELOPMENT AUTHORITIES. 

6 (a) IN GENERAL.—Part B of title III of the Public 

7 Health Service Act (42 U.S.C. 243 et seq.) is amended 

8 by inserting after section 319F the following section: 

9 ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE10 DURES REGARDING QUALIFIED COUNTER11 MEASURE RESEARCH AND DEVELOPMENT 

12 ACTIVITIES. 

13 ‘‘(a) IN GENERAL.—

14 ‘‘(1) AUTHORITY.—In conducting and sup15 porting research and development activities regard16 ing biomedical countermeasures under section 

17 319F(h), the Secretary may conduct and support 

18 such activities in accordance with this section if the 

19 activities concern qualified countermeasures. 

20 ‘‘(2) QUALIFIED COUNTERMEASURE.—For pur21 poses of this section, the term ‘qualified counter22 measure’ means a priority countermeasure (as de23 fined in section 319F(h) and as determined by the 

24 Secretary in accordance with such section and con25 sistent with sections 302(2) and 304(a) of the 

26 Homeland Security Act of 2002) against a chemical, 
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1 biological, radiological, or nuclear agent that may 

2 cause a public health emergency affecting national 

3 security. 

4 ‘‘(3) INTERAGENCY COOPERATION.—

5 ‘‘(A) IN GENERAL.—In carrying out activi6 ties under this section, the Secretary is author7 ized, subject to subparagraph (B), to enter into 

8 interagency agreements and other collaborative 

9 undertakings with other agencies of the United 

10 States Government. 

11 ‘‘(B) LIMITATION.—An agreement or un12 dertaking under this paragraph shall not au13 thorize another agency to exercise the authori14 ties provided by this section. 

15 ‘‘(4) AVAILABILITY OF FACILITIES TO THE SEC16 RETARY.—In any grant, contract, or cooperative 

17 agreement entered into under the authority provided 

18 in this section with respect to a biocontainment lab19 oratory or other related or ancillary specialized re20 search facility that the Secretary determines nec21 essary for the purpose of performing, administering, 

22 or supporting qualified countermeasure research and 

23 development, the Secretary may provide that the fa24 cility that is the object of such grant, contract, or 

25 cooperative agreement shall be available as needed to 
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1 the Secretary to respond to public health emer2 gencies affecting national security. 

3 ‘‘(5) TRANSFERS OF QUALIFIED COUNTER4 MEASURES.—Each agreement for an award of a 

5 grant, contract, or cooperative agreement under sec6 tion 319F(h) for the development of a qualified 

7 countermeasure shall provide that the recipient of 

8 the award will comply with all applicable export-re9 lated controls with respect to such countermeasure. 

10 ‘‘(b) EXPEDITED PROCUREMENT AUTHORITY.—

11 ‘‘(1) INCREASED SIMPLIFIED ACQUISITION

12 THRESHOLD FOR QUALIFIED COUNTERMEASURE

13 PROCUREMENTS.—

14 ‘‘(A) IN GENERAL.—For any procurement 

15 by the Secretary of property or services for use 

16 (as determined by the Secretary) in performing, 

17 administering, or supporting qualified counter18 measure research or development activities 

19 under this section that the Secretary deter20 mines necessary to respond to pressing research 

21 and development needs under this section, the 

22 amount specified in section 4(11) of the Office 

23 of Federal Procurement Policy Act (41 U.S.C. 

24 403(11)), as applicable pursuant to section 

25 302A(a) of the Federal Property and Adminis-
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1 trative Services Act of 1949 (41 U.S.C. 

2 252a(a)), shall be deemed to be $25,000,000 in 

3 the administration, with respect to such pro4 curement, of—

5 ‘‘(i) section 303(g)(1)(A) of the Fed6 eral Property and Administrative Services 

7 Act of 1949 (41 U.S.C. 253(g)(1)(A)) and 

8 its implementing regulations; and 

9 ‘‘(ii) section 302A(b) of such Act (41 

10 U.S.C. 252a(b)) and its implementing reg11 ulations. 

12 ‘‘(B) APPLICATION OF CERTAIN PROVI13 SIONS.—Notwithstanding subparagraph (A) 

14 and the provision of law and regulations re15 ferred to in such subparagraph, each of the fol16 lowing provisions shall apply to procurements 

17 described in this paragraph to the same extent 

18 that such provisions would apply to such pro19 curements in the absence of subparagraph (A): 

20 ‘‘(i) Chapter 37 of title 40, United 

21 States Code (relating to contract work 

22 hours and safety standards). 

23 ‘‘(ii) Subsections (a) and (b) of sec24 tion 7 of the Anti-Kickback Act of 1986 

25 (41 U.S.C. 57(a) and (b)). 
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1 ‘‘(iii) Section 304C of the Federal 

2 Property and Administrative Services Act 

3 of 1949 (41 U.S.C. 254d) (relating to the 

4 examination of contractor records). 

5 ‘‘(C) INTERNAL CONTROLS TO BE INSTI6 TUTED.—The Secretary shall institute appro7 priate internal controls for procurements that 

8 are under this paragraph, including require9 ments with regard to documenting the justifica10 tion for use of the authority in this paragraph. 

11 ‘‘(2) PROCEDURES OTHER THAN FULL AND

12 OPEN COMPETITION.—

13 ‘‘(A) IN GENERAL.—In using the authority 

14 provided in section 303(c)(1) of title III of the 

15 Federal Property and Administrative Services 

16 Act of 1949 (41 U.S.C. 253(c)(1)) to use proce17 dures other than competitive procedures in the 

18 case of a procurement described in paragraph 

19 (1) of this subsection, the phrase ‘available 

20 from only one responsible source’ in such sec21 tion 303(c)(1) shall be deemed to mean ‘avail22 able from only one responsible source or only 

23 from a limited number of responsible sources’. 

24 ‘‘(B) RELATION TO OTHER AUTHORI25 TIES.—The authority under subparagraph (A) 
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1 is in addition to any other authority to use pro2 cedures other than competitive procedures. 

3 ‘‘(C) APPLICABLE GOVERNMENT-WIDE

4 REGULATIONS.—The Secretary shall implement 

5 this paragraph in accordance with applicable 

6 government-wide regulations, including require7 ments that offers be solicited from as many po8 tential sources as is practicable under the cir9 cumstances, that required notices be published, 

10 and that submitted offers be considered. 

11 ‘‘(3) INCREASED MICROPURCHASE THRESH12 OLD.—

13 ‘‘(A) IN GENERAL.—For a procurement 

14 described by paragraph (1), the amount speci15 fied in subsections (c), (d), and (f) of section 32 

16 of the Office of Federal Procurement Policy Act 

17 (41 U.S.C. 428) shall be deemed to be $15,000 

18 in the administration of that section with re19 spect to such procurement. 

20 ‘‘(B) INTERNAL CONTROLS TO BE INSTI21 TUTED.—The Secretary shall institute appro22 priate internal controls for purchases that are 

23 under this paragraph and that are greater than 

24 $2,500. 
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1 ‘‘(C) EXCEPTION TO PREFERENCE FOR

2 PURCHASE CARD MECHANISM.—No provision of 

3 law establishing a preference for using a Gov4 ernment purchase card method for purchases 

5 shall apply to purchases that are under this 

6 paragraph and that are greater than $2,500. 

7 ‘‘(4) REVIEW.—

8 ‘‘(A) REVIEW ALLOWED.—Notwithstanding 

9 any other provision of law, including subsection 

10 (f), review of a contracting agency decision re11 lating to a procurement described in paragraph 

12 (1) may be had only by filing a protest—

13 ‘‘(i) with a contracting agency; or 

14 ‘‘(ii) with the Comptroller General 

15 under subchapter V of chapter 35 of title 

16 31, United States Code. 

17 ‘‘(B) OVERRIDE OF STAY OF CONTRACT

18 AWARD OR PERFORMANCE COMMITTED TO

19 AGENCY DISCRETION.—Notwithstanding any 

20 other provision of law, the following authoriza21 tions by the head of a procuring activity are 

22 committed to agency discretion: 

23 ‘‘(i) An authorization under section 

24 3553(c)(2) of title 31, United States Code, 
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1 to award a contract for a procurement de2 scribed in paragraph (1) of this subsection. 

3 ‘‘(ii) An authorization under section 

4 3553(d)(3)(C) of such title to perform a 

5 contract for a procurement described in 

6 paragraph (1) of this subsection. 

7 ‘‘(c) AUTHORITY TO EXPEDITE PEER REVIEW.—

8 ‘‘(1) IN GENERAL.—The Secretary may, as the 

9 Secretary determines necessary to respond to press10 ing qualified countermeasure research and develop11 ment needs under this section, employ such expe12 dited peer review procedures (including consultation 

13 with appropriate scientific experts) as the Secretary, 

14 in consultation with the Director of NIH, deems ap15 propriate to obtain assessment of scientific and tech16 nical merit and likely contribution to the field of 

17 qualified countermeasure research, in place of the 

18 peer review and advisory council review procedures 

19 that would be required under sections 301(a)(3), 

20 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 

21 494, as applicable to a grant, contract, or coopera22 tive agreement—

23 ‘‘(A) that is for performing, administering, 

24 or supporting qualified countermeasure research 

25 and development activities; and 
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1 ‘‘(B) the amount of which is not greater 

2 than $1,500,000. 

3 ‘‘(2) SUBSEQUENT PHASES OF RESEARCH.—

4 The Secretary’s determination of whether to employ 

5 expedited peer review with respect to subsequent 

6 phases of a research grant, contract, or cooperative 

7 agreement under this section shall be determined 

8 without regard to the peer review procedures used 

9 for any prior peer review of that same grant, con10 tract, or cooperative agreement. 

11 ‘‘(d) AUTHORITY FOR PERSONAL SERVICES CON12 TRACTS.—

13 ‘‘(1) IN GENERAL.—For the purpose of per14 forming, administering, or supporting qualified 

15 countermeasure research and development activities, 

16 the Secretary may, as the Secretary determines nec17 essary to respond to pressing qualified counter18 measure research and development needs under this 

19 section, obtain by contract (in accordance with sec20 tion 3109 of title 5, United States Code, but without 

21 regard to the limitations in such section on the pe22 riod of service and on pay) the personal services of 

23 experts or consultants who have scientific or other 

24 professional qualifications, except that in no case 

25 shall the compensation provided to any such expert 
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1 or consultant exceed the daily equivalent of the an2 nual rate of compensation for the President. 

3 ‘‘(2) FEDERAL TORT CLAIMS ACT COVERAGE.—

4 ‘‘(A) IN GENERAL.—A person carrying out 

5 a contract under paragraph (1), and an officer, 

6 employee, or governing board member of such 

7 person, shall be deemed to be an employee of 

8 the Department of Health and Human Services 

9 for purposes of claims under sections 1346(b) 

10 and 2672 of title 28, United States Code, for 

11 money damages for personal injury, including 

12 death, resulting from performance of functions 

13 under such contract. 

14 ‘‘(B) EXCLUSIVITY OF REMEDY.—The 

15 remedy provided by subparagraph (A) shall be 

16 exclusive of any other civil action or proceeding 

17 by reason of the same subject matter against 

18 the person, officer, employee, or governing 

19 board member. 

20 ‘‘(3) INTERNAL CONTROLS TO BE INSTI21 TUTED.—

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

23 institute appropriate internal controls for con24 tracts under this subsection, including proce25 dures for the Secretary to make a determina-
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1 tion of whether a person, or an officer, em2 ployee, or governing board member of a person, 

3 is deemed to be an employee of the Department 

4 of Health and Human Services pursuant to 

5 paragraph (2). 

6 ‘‘(B) DETERMINATION OF EMPLOYEE STA7 TUS TO BE FINAL.—A determination by the 

8 Secretary under subparagraph (A) that a per9 son, or an officer, employee, or governing board 

10 member of a person, is or is not deemed to be 

11 an employee of the Department of Health and 

12 Human Services shall be final and binding on 

13 the Secretary and the Attorney General and 

14 other parties to any civil action or proceeding. 

15 ‘‘(4) NUMBER OF PERSONAL SERVICES CON16 TRACTS LIMITED.—The number of experts and con17 sultants whose personal services are obtained under 

18 paragraph (1) shall not exceed 30 at any time. 

19 ‘‘(e) STREAMLINED PERSONNEL AUTHORITY.—

20 ‘‘(1) IN GENERAL.—In addition to any other 

21 personnel authorities, the Secretary may, as the Sec22 retary determines necessary to respond to pressing 

23 qualified countermeasure research and development 

24 needs under this section, without regard to such pro25 visions of title 5, United States Code, governing ap-
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1 pointments in the competitive service, and without 

2 regard to the provisions of chapter 51 and sub3 chapter III of chapter 53 of such title relating to 

4 classification and General Schedule pay rates, ap5 point professional and technical employees, not to 

6 exceed 30 such employees at any time, to positions 

7 in the National Institutes of Health to perform, ad8 minister, or support qualified countermeasure re9 search and development activities in carrying out 

10 this section. 

11 ‘‘(2) INTERNAL CONTROLS TO BE INSTI12 TUTED.—The Secretary shall institute appropriate 

13 internal controls for appointments under this sub14 section. 

15 ‘‘(f) ACTIONS COMMITTED TO AGENCY DISCRE16 TION.—Actions by the Secretary under the authority of 

17 this section are committed to agency discretion.’’. 

18 (b) TECHNICAL AMENDMENT.—Section 481A of the 

19 Public Health Service Act (42 U.S.C. 287a-2) is amend20 ed—

21 (1) in subsection (a)(1)—

22 (A) by inserting ‘‘or the Director of the 

23 National Institute of Allergy and Infectious 

24 Diseases’’ after ‘‘Director of the Center’’; and 
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1 (B) by inserting ‘‘, or in the case of the In2 stitute, to any qualified public or private enti3 ty,’’ after ‘‘private entities’’; 

4 (2) in subsection (c)—

5 (A) in paragraph (1), by inserting ‘‘or the 

6 Director of the National Institute of Allergy 

7 and Infectious Diseases’’ after ‘‘Director of the 

8 Center’’; and 

9 (B) in paragraph (2), in the matter pre10 ceding subparagraph (A), by striking ‘‘sub11 section (i)’’ and inserting ‘‘subsection (i)(1)’’; 

12 (3) in subsection (d), by inserting ‘‘or the Di13 rector of the National Institute of Allergy and Infec14 tious Diseases’’ after ‘‘Director of the Center’’; 

15 (4) in subsection (e)—

16 (A) in paragraph (1)—

17 (i) in the matter preceding subpara18 graph (A), by inserting ‘‘or the Director of 

19 the National Institute of Allergy and Infec20 tious Diseases’’ after ‘‘Director of the Cen21 ter’’; 

22 (ii) in subparagraph (A), by inserting 

23 ‘‘(or, in the case of the Institute, 75 per24 cent)’’ after ‘‘50 percent’’; and 
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1 (iii) in subparagraph (B), by inserting 

2 ‘‘(or, in the case of the Institute, 75 per3 cent)’’ after ‘‘40 percent’’; 

4 (B) in paragraph (2), by inserting ‘‘or the 

5 Director of the National Institute of Allergy 

6 and Infectious Diseases’’ after ‘‘Director of the 

7 Center’’; and 

8 (C) in paragraph (4), by inserting ‘‘of the 

9 Center or the Director of the National Institute 

10 of Allergy and Infectious Diseases’’ after ‘‘Di11 rector’’; 

12 (5) in subsection (f)—

13 (A) in paragraph (1), by inserting ‘‘in the 

14 case of an award by the Director of the Cen15 ter,’’ before ‘‘the applicant’’; and 

16 (B) in paragraph (2), by inserting ‘‘of the 

17 Center or the Director of the National Institute 

18 of Allergy and Infectious Diseases’’ after ‘‘Di19 rector’’; and 

20 (6) in subsection (i)—

21 (A) by striking ‘‘APPROPRIATIONS.—For 

22 the purpose of carrying out this section,’’ and 

23 inserting the following: ‘‘APPROPRIATIONS.—

24 ‘‘(1) CENTER.—For the purpose of carrying out 

25 this section with respect to the Center,’’; and 
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1 (B) by adding at the end the following: 

2 ‘‘(2) NATIONAL INSTITUTE OF ALLERGY AND

3 INFECTIOUS DISEASES.—For the purpose of car4 rying out this section with respect to the National 

5 Institute of Allergy and Infectious Diseases, there 

6 are authorized to be appropriated such sums as may 

7 be necessary for each of the fiscal years 2003 and 

8 2004.’’. 

9 (c) ADDITIONAL AUTHORITY.—Section 319F of the 

10 Public Health Service Act (42 U.S.C. 247d–6) is amend11 ed—

12 (1) by redesignating subsections (i) and (j) as 

13 subsections (j) and (k), respectively; and 

14 (2) by inserting after subsection (h) the fol15 lowing subsection: 

16 ‘‘(i) PRIORITY COUNTERMEASURES FOR STRATEGIC

17 NATIONAL STOCKPILE.—

18 ‘‘(1) IN GENERAL.—The Secretary, taking into 

19 consideration any recommendations of the working 

20 group under subsection (a), may initiate and sustain 

21 a program that results in the delivery of priority 

22 countermeasures for placement in the stockpile 

23 under section 319F–2. 

24 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—

25 For the purpose of carrying out paragraph (1), there 
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1 are authorized to be appropriated such sums as may 

2 be necessary for each of the fiscal years 2004 

3 through 2013.’’. 

4 (d) ADDITIONAL AUTHORIZATIONS OF APPROPRIA5 TIONS.—Section 2106 of the Public Health Service Act 

6 (42 U.S.C. 300aa–6) is amended—

7 (1) in subsection (a), by striking ‘‘authorized to 

8 be appropriated’’ and all that follows and inserting 

9 the following: ‘‘authorized to be appropriated such 

10 sums as may be necessary for each of the fiscal 

11 years 2004 through 2013.’’; and 

12 (2) in subsection (b), by striking ‘‘authorized to 

13 be appropriated’’ and all that follows and inserting 

14 the following: ‘‘authorized to be appropriated such 

15 sums as may be necessary for each of the fiscal 

16 years 2004 through 2013.’’. 

17 (e) TECHNICAL AMENDMENTS.—Section 319F of the 

18 Public Health Service Act (42 U.S.C. 247d–6) is amend19 ed—

20 (1) in subsection (a), by inserting ‘‘the Sec21 retary of Homeland Security,’’ after ‘‘Management 

22 Agency,’’; and 

23 (2) in subsection (h)(4)(B), by striking ‘‘to di24 agnose conditions’’ and inserting ‘‘to treat, identify, 

25 or prevent conditions’’. 
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1 (f) RULE OF CONSTRUCTION.—Nothing in this sec2 tion has any legal effect on sections 302(2), 302(4), 

3 304(a), or 304(b) of the Homeland Security Act of 2002. 

4 SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT. 

5 (a) ADDITIONAL AUTHORITY REGARDING STRATEGIC

6 NATIONAL STOCKPILE.—

7 (1) TRANSFER OF PROGRAM.—Section 121 of 

8 the Public Health Security and Bioterrorism Pre9 paredness and Response Act of 2002 (116 Stat. 

10 611; 42 U.S.C. 300hh–12) is transferred from such 

11 Act to the Public Health Service Act, is redesignated 

12 as section 319F–2, and is inserted after section 

13 319F–1 of the Public Health Service Act (as added 

14 by section 2 of this Act). 

15 (2) ADDITIONAL AUTHORITY.—Section 319F–2 

16 of the Public Health Service Act, as added by para17 graph (1), is amended to read as follows: 

18 ‘‘SEC. 319F–2. STRATEGIC NATIONAL STOCKPILE. 

19 ‘‘(a) STRATEGIC NATIONAL STOCKPILE.—

20 ‘‘(1) IN GENERAL.—The Secretary of Homeland 

21 Security (referred to in this section as the ‘Home22 land Security Secretary’), in coordination with the 

23 Secretary and the Secretary of Veterans Affairs, 

24 shall maintain a stockpile or stockpiles of drugs, vac25 cines and other biological products, medical devices, 
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1 and other supplies in such numbers, types, and 

2 amounts as are determined by the Secretary to be 

3 appropriate and practicable, taking into account 

4 other available sources, to provide for the emergency 

5 health security of the United States, including the 

6 emergency health security of children and other vul7 nerable populations, in the event of a bioterrorist at8 tack or other public health emergency. 

9 ‘‘(2) PROCEDURES.—The Secretary, in man10 aging the stockpile under paragraph (1), shall—

11 ‘‘(A) consult with the working group under 

12 section 319F(a); 

13 ‘‘(B) ensure that adequate procedures are 

14 followed with respect to such stockpile for in15 ventory management and accounting, and for 

16 the physical security of the stockpile; 

17 ‘‘(C) in consultation with Federal, State, 

18 and local officials, take into consideration the 

19 timing and location of special events; 

20 ‘‘(D) review and revise, as appropriate, the 

21 contents of the stockpile on a regular basis to 

22 ensure that emerging threats, advanced tech23 nologies, and new countermeasures are ade24 quately considered; 
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1 ‘‘(E) devise plans for the effective and 

2 timely supply-chain management of the stock3 pile, in consultation with appropriate Federal, 

4 State and local agencies, and the public and 

5 private health care infrastructure; and 

6 ‘‘(F) ensure the adequate physical security 

7 of the stockpile. 

8 ‘‘(b) SMALLPOX VACCINE DEVELOPMENT.—

9 ‘‘(1) IN GENERAL.—The Secretary shall award 

10 contracts, enter into cooperative agreements, or 

11 carry out such other activities as may reasonably be 

12 required in order to ensure that the stockpile under 

13 subsection (a) includes an amount of vaccine against 

14 smallpox as determined by such Secretary to be suf15 ficient to meet the health security needs of the 

16 United States. 

17 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

18 this section shall be construed to limit the private 

19 distribution, purchase, or sale of vaccines from 

20 sources other than the stockpile described in sub21 section (a). 

22 ‘‘(c) ADDITIONAL AUTHORITY REGARDING PRO23 CUREMENT OF CERTAIN BIOMEDICAL COUNTER24 MEASURES; AVAILABILITY OF SPECIAL RESERVE

25 FUND.—
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1 ‘‘(1) IN GENERAL.—

2 ‘‘(A) USE OF FUND.—A security counter3 measure may, in accordance with this sub4 section, be procured with amounts in the special 

5 reserve fund under paragraph (10). 

6 ‘‘(B) SECURITY COUNTERMEASURE.—For 

7 purposes of this subsection, the term ‘security 

8 countermeasure’ means a priority counter9 measure (as defined in section 319F(h) and as 

10 determined by the Secretary in accordance with 

11 such section and consistent with sections 

12 302(2) and 304(a) of the Homeland Security 

13 Act of 2002) that—

14 ‘‘(i)(I) is against a chemical, biologi15 cal, radiological, or nuclear agent identified 

16 as a material threat under paragraph 

17 (2)(A)(ii); 

18 ‘‘(II) is determined under paragraph 

19 (2)(B)(ii) to be a necessary counter20 measure; and 

21 ‘‘(III)(aa) is approved or cleared 

22 under chapter V of the Federal Food, 

23 Drug, and Cosmetic Act, or licensed under 

24 section 351 of this Act, for use as a coun25 termeasure to a chemical, biological, radio-
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1 logical, or nuclear agent identified as a 

2 material threat under paragraph (2)(A)(ii); 

3 or 

4 ‘‘(bb) is a priority countermeasure for 

5 which the Secretary determines that suffi6 cient and satisfactory clinical experience or 

7 research data (including data, if available, 

8 from pre-clinical and clinical trials) sup9 port a reasonable conclusion that the coun10 termeasure will qualify for approval or li11 censing after the date of a determination 

12 under paragraph (5); or 

13 ‘‘(ii) is authorized under section 564 

14 of the Federal Food, Drug, and Cosmetic 

15 Act for emergency use. 

16 ‘‘(2) DETERMINATION OF MATERIAL

17 THREATS.—

18 ‘‘(A) MATERIAL THREAT.—The Homeland 

19 Security Secretary, in consultation with the 

20 heads of other agencies as appropriate, shall on 

21 an ongoing basis—

22 ‘‘(i) assess current and emerging 

23 threats of chemical, biological, radiological, 

24 and nuclear agents; and 
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1 ‘‘(ii) determine which of such agents 

2 present a material threat against the 

3 United States population. 

4 ‘‘(B) PUBLIC HEALTH IMPACT; NECESSARY

5 COUNTERMEASURES.—The Secretary shall on 

6 an ongoing basis—

7 ‘‘(i) assess the potential public health 

8 consequences of use against the United 

9 States population of agents identified 

10 under subparagraph (A)(ii); and 

11 ‘‘(ii) determine, on the basis of such 

12 assessment, the agents for which priority 

13 countermeasures are necessary to protect 

14 the public health from a material threat. 

15 ‘‘(C) NOTICE TO CONGRESS.—The Sec16 retary and the Homeland Security Secretary 

17 shall promptly notify the designated congres18 sional committees (as defined in paragraph (10) 

19 that a determination has been made pursuant 

20 to subparagraph (A) or (B). Such notice shall 

21 be in unclassified or, if necessary, classified 

22 form. 

23 ‘‘(D) ASSURING ACCESS TO THREAT IN24 FORMATION.—In making the assessment and 

25 determination required under subparagraph 
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1 (A), the Homeland Security Secretary shall use 

2 all information to which such Secretary is enti3 tled under section 202 of the Homeland Secu4 rity Act of 2002, including but not limited to 

5 information, regardless of its level of classifica6 tion, relating to current and emerging threats 

7 of chemical, biological, radiological, and nuclear 

8 agents. 

9 ‘‘(3) ASSESSMENT OF AVAILABILITY AND AP10 PROPRIATENESS OF COUNTERMEASURES.—The Sec11 retary, in consultation with the Homeland Security 

12 Secretary, shall assess on an ongoing basis the avail13 ability and appropriateness of specific counter14 measures to address specific threats identified under 

15 paragraph (2). 

16 ‘‘(4) CALL FOR DEVELOPMENT OF COUNTER17 MEASURES; COMMITMENT FOR RECOMMENDATION

18 FOR PROCUREMENT.—

19 ‘‘(A) PROPOSAL TO THE PRESIDENT.—If, 

20 pursuant to an assessment under paragraph 

21 (3), the Homeland Security Secretary and the 

22 Secretary make a determination that a counter23 measure would be appropriate but is either cur24 rently unavailable for procurement as a security 

25 countermeasure or is approved, licensed, or 
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1 cleared only for alternative uses, such Secre2 taries may jointly submit to the President a 

3 proposal to—

4 ‘‘(i) issue a call for the development of 

5 such countermeasure; and 

6 ‘‘(ii) make a commitment that, upon 

7 the first development of such counter8 measure that meets the conditions for pro9 curement under paragraph (5), the Secre10 taries will, based in part on information 

11 obtained pursuant to such call, make a rec12 ommendation under paragraph (6) that the 

13 special reserve fund under paragraph (10) 

14 be made available for the procurement of 

15 such countermeasure. 

16 ‘‘(B) COUNTERMEASURE SPECIFICA17 TIONS.—The Homeland Security Secretary and 

18 the Secretary shall, to the extent practicable, 

19 include in the proposal under subparagraph 

20 (A)—

21 ‘‘(i) estimated quantity of purchase 

22 (in the form of number of doses or number 

23 of effective courses of treatments regard24 less of dosage form); 
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1 ‘‘(ii) necessary measures of minimum 

2 safety and effectiveness; 

3 ‘‘(iii) estimated price for each dose or 

4 effective course of treatment regardless of 

5 dosage form; and 

6 ‘‘(iv) other information that may be 

7 necessary to encourage and facilitate re8 search, development, and manufacture of 

9 the countermeasure or to provide specifica10 tions for the countermeasure. 

11 ‘‘(C) PRESIDENTIAL APPROVAL.—If the 

12 President approves a proposal under subpara13 graph (A), the Homeland Security Secretary 

14 and the Secretary shall make known to persons 

15 who may respond to a call for the counter16 measure involved—

17 ‘‘(i) the call for the countermeasure; 

18 ‘‘(ii) specifications for the counter19 measure under subparagraph (B); and 

20 ‘‘(iii) the commitment described in 

21 subparagraph (A)(ii). 

22 ‘‘(5) SECRETARY’S DETERMINATION OF COUN23 TERMEASURES APPROPRIATE FOR FUNDING FROM

24 SPECIAL RESERVE FUND.—
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1 ‘‘(A) IN GENERAL.—The Secretary, in ac2 cordance with the provisions of this paragraph, 

3 shall identify specific security countermeasures 

4 that the Secretary determines, in consultation 

5 with the Homeland Security Secretary, to be 

6 appropriate for inclusion in the stockpile under 

7 subsection (a) pursuant to procurements made 

8 with amounts in the special reserve fund under 

9 paragraph (10) (referred to in this subsection 

10 individually as a ‘procurement under this sub11 section’). 

12 ‘‘(B) REQUIREMENTS.—In making a deter13 mination under subparagraph (A) with respect 

14 to a security countermeasure, the Secretary 

15 shall determine and consider the following: 

16 ‘‘(i) The quantities of the product 

17 that will be needed to meet the needs of 

18 the stockpile. 

19 ‘‘(ii) The feasibility of production and 

20 delivery within five years of sufficient 

21 quantities of the product. 

22 ‘‘(iii) Whether there is a lack of a sig23 nificant commercial market for the product 

24 at the time of procurement, other than as 

25 a security countermeasure. 
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1 ‘‘(6) RECOMMENDATION FOR PRESIDENT’S AP2 PROVAL.—

3 ‘‘(A) RECOMMENDATION FOR PROCURE4 MENT.—In the case of a security counter5 measure that the Secretary has, in accordance 

6 with paragraphs (3) and (5), determined to be 

7 appropriate for procurement under this sub8 section, the Homeland Security Secretary and 

9 the Secretary shall jointly submit to the Presi10 dent, in coordination with the Director of the 

11 Office of Management and Budget, a rec12 ommendation that the special reserve fund 

13 under paragraph (10) be made available for the 

14 procurement of such countermeasure. 

15 ‘‘(B) PRESIDENTIAL APPROVAL.—The spe16 cial reserve fund under paragraph (10) is avail17 able for a procurement of a security counter18 measure only if the President has approved a 

19 recommendation under subparagraph (A) re20 garding the countermeasure. 

21 ‘‘(C) NOTICE TO DESIGNATED CONGRES22 SIONAL COMMITTEES.—The Secretary and the 

23 Homeland Security Secretary shall notify the 

24 designated congressional committees of each de25 cision of the President to approve a rec-
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1 ommendation under subparagraph (A). Such 

2 notice shall include an explanation of the deci3 sion to make available the special reserve fund 

4 under paragraph (10) for procurement of such 

5 a countermeasure, including, where available, 

6 the identification of the potential supplier or 

7 suppliers of such countermeasure, and whether 

8 other potential suppliers of the same or similar 

9 countermeasures were considered and rejected 

10 for procurement under this section and the rea11 sons therefor. 

12 ‘‘(D) SUBSEQUENT SPECIFIC COUNTER13 MEASURES.—Procurement under this sub14 section of a security countermeasure for a par15 ticular purpose does not preclude the subse16 quent procurement under this subsection of any 

17 other security countermeasure for such purpose 

18 if the Secretary has determined under para19 graph (5)(A) that such countermeasure is ap20 propriate for inclusion in the stockpile and if, 

21 as determined by the Secretary, such counter22 measure provides improved safety or effective23 ness, or for other reasons enhances prepared24 ness to respond to threats of use of a biological, 

25 chemical, radiological, or nuclear agent. Such a 
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1 determination by the Secretary is committed to 

2 agency discretion. 

3 ‘‘(E) RULE OF CONSTRUCTION.—Rec4 ommendations and approvals under this para5 graph apply solely to determinations that the 

6 special reserve fund under paragraph (10) will 

7 be made available for a procurement of a secu8 rity countermeasure, and not to the substance 

9 of contracts for such procurement or other mat10 ters relating to awards of such contracts. 

11 ‘‘(7) PROCUREMENT.—

12 ‘‘(A) IN GENERAL.—For purposes of a 

13 procurement under this subsection that is ap14 proved by the President under paragraph (6), 

15 the Homeland Security Secretary and the Sec16 retary shall have responsibilities in accordance 

17 with subparagraphs (B) and (C). 

18 ‘‘(B) INTERAGENCY AGREEMENTS.—

19 ‘‘(i) FOR PROCUREMENT.—The 

20 Homeland Security Secretary shall enter 

21 into an agreement with the Secretary for 

22 procurement of a security countermeasure 

23 in accordance with the provisions of this 

24 paragraph. The special reserve fund under 

25 paragraph (10) shall be available for the 
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1 Secretary’s costs of such procurement, 

2 other than as provided in clause (ii). 

3 ‘‘(ii) FOR ADMINISTRATIVE COSTS.—

4 The agreement entered into between the 

5 Homeland Security Secretary and the Sec6 retary for managing the stockpile under 

7 subsection (a) shall provide for reimburse8 ment of the Secretary’s administrative 

9 costs relating to procurements under this 

10 subsection. 

11 ‘‘(C) PROCUREMENT.—

12 ‘‘(i) IN GENERAL.—The Secretary 

13 shall be responsible for—

14 ‘‘(I) arranging for procurement 

15 of a security countermeasure, includ16 ing negotiating terms (including quan17 tity, production schedule, and price) 

18 of, and entering into, contracts and 

19 cooperative agreements, and for car20 rying out such other activities as may 

21 reasonably be required, in accordance 

22 with the provisions of this subpara23 graph; and 

24 ‘‘(II) promulgating such regula25 tions as the Secretary determines nec-
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1 essary to implement the provisions of 

2 this subsection. 

3 ‘‘(ii) CONTRACT TERMS.—A contract 

4 for procurements under this subsection 

5 shall (or, as specified below, may) include 

6 the following terms: 

7 ‘‘(I) PAYMENT CONDITIONED ON

8 SUBSTANTIAL DELIVERY.—The con9 tract shall provide that no payment 

10 may be made until delivery has been 

11 made of a substantial portion (as de12 termined by the Secretary) of the 

13 total number of units contracted for, 

14 except that, notwithstanding any 

15 other provision of law, the contract 

16 may provide that, if the Secretary de17 termines (in the Secretary’s discre18 tion) that an advance payment is nec19 essary to ensure success of a project, 

20 the Secretary may pay an amount, not 

21 to exceed 10 percent of the contract 

22 amount, in advance of delivery. The 

23 contract shall provide that such ad24 vance payment is required to be re25 paid if there is a failure to perform 
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1 under the contract, except in special 

2 circumstances as determined by the 

3 Secretary on a contract by contract 

4 basis. Nothing in this subclause may 

5 be construed as affecting rights of 

6 vendors under provisions of law or 

7 regulation (including the Federal Ac8 quisition Regulation) relating to ter9 mination of contracts for the conven10 ience of the Government. 

11 ‘‘(II) CONTRACT DURATION.—

12 The contract shall be for a period not 

13 to exceed five years, except that, in 

14 first awarding the contract, the Sec15 retary may provide for a longer dura16 tion, not exceeding eight years, if the 

17 Secretary determines that complexities 

18 or other difficulties in performance 

19 under the contract justify such a pe20 riod. The contract shall be renewable 

21 for additional periods, none of which 

22 shall exceed five years. 

23 ‘‘(III) STORAGE BY VENDOR.—

24 The contract may provide that the 

25 vendor will provide storage for stocks 
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1 of a product delivered to the owner2 ship of the Federal Government under 

3 the contract, for such period and 

4 under such terms and conditions as 

5 the Secretary may specify, and in 

6 such case amounts from the special 

7 reserve fund under paragraph (10) 

8 shall be available for costs of ship9 ping, handling, storage, and related 

10 costs for such product. 

11 ‘‘(IV) NON-STOCKPILE TRANS12 FERS OF SECURITY COUNTER13 MEASURES.—The contract shall pro14 vide that the vendor will comply with 

15 all applicable export-related controls 

16 with respect to such countermeasure. 

17 ‘‘(iii) AVAILABILITY OF SIMPLIFIED

18 ACQUISITION PROCEDURES.—

19 ‘‘(I) IN GENERAL.—If the Sec20 retary determines that there is a 

21 pressing need for a procurement of a 

22 specific countermeasure, the amount 

23 of the procurement under this sub24 section shall be deemed to be below 

25 the threshold amount specified in sec-
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1 tion 4(11) of the Office of Federal 

2 Procurement Policy Act (41 U.S.C. 

3 403(11)), for purposes of application 

4 to such procurement, pursuant to sec5 tion 302A(a) of the Federal Property 

6 and Administrative Services Act of 

7 1949 (41 U.S.C. 252a(a)), of—

8 ‘‘(aa) section 303(g)(1)(A) 

9 of the Federal Property and Ad10 ministrative Services Act of 1949 

11 (41 U.S.C. 253(g)(1)(A)) and its 

12 implementing regulations; and 

13 ‘‘(bb) section 302A(b) of 

14 such Act (41 U.S.C. 252a(b)) 

15 and its implementing regulations. 

16 ‘‘(II) APPLICATION OF CERTAIN

17 PROVISIONS.—Notwithstanding sub18 clause (I) and the provision of law 

19 and regulations referred to in such 

20 clause, each of the following provi21 sions shall apply to procurements de22 scribed in this clause to the same ex23 tent that such provisions would apply 

24 to such procurements in the absence 

25 of subclause (I): 
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1 ‘‘(aa) Chapter 37 of title 40, 

2 United States Code (relating to 

3 contract work hours and safety 

4 standards). 

5 ‘‘(bb) Subsections (a) and 

6 (b) of section 7 of the Anti-Kick7 back Act of 1986 (41 U.S.C. 

8 57(a) and (b)). 

9 ‘‘(cc) Section 304C of the 

10 Federal Property and Adminis11 trative Services Act of 1949 (41 

12 U.S.C. 254d) (relating to the ex13 amination of contractor records). 

14 ‘‘(iv) PROCEDURES OTHER THAN

15 FULL AND OPEN COMPETITION.—

16 ‘‘(I) IN GENERAL.—In using the 

17 authority provided in section 

18 303(c)(1) of title III of the Federal 

19 Property and Administrative Services 

20 Act of 1949 (41 U.S.C. 253(c)(1)) to 

21 use procedures other than competitive 

22 procedures in the case of a procure23 ment under this subsection, the 

24 phrase ‘available from only one re25 sponsible source’ in such section 
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1 303(c)(1) shall be deemed to mean 

2 ‘available from only one responsible 

3 source or only from a limited number 

4 of responsible sources’. 

5 ‘‘(II) RELATION TO OTHER AU6 THORITIES.—The authority under 

7 subclause (I) is in addition to any 

8 other authority to use procedures 

9 other than competitive procedures. 

10 ‘‘(III) APPLICABLE GOVERN11 MENT-WIDE REGULATIONS.—The Sec12 retary shall implement this clause in 

13 accordance with applicable govern14 ment-wide regulations, including re15 quirements that offers be solicited 

16 from as many potential sources as is 

17 practicable under the circumstances, 

18 that required notices be published, 

19 and that submitted offers be consid20 ered. 

21 ‘‘(v) PREMIUM PROVISION IN MUL22 TIPLE AWARD CONTRACTS.—

23 ‘‘(I) IN GENERAL.—If, under this 

24 subsection, the Secretary enters into 

25 contracts with more than one vendor 
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1 to procure a security countermeasure, 

2 such Secretary may, notwithstanding 

3 any other provision of law, include in 

4 each of such contracts a provision 

5 that—

6 ‘‘(aa) identifies an increment 

7 of the total quantity of security 

8 countermeasure required, wheth9 er by percentage or by numbers 

10 of units; and 

11 ‘‘(bb) promises to pay one or 

12 more specified premiums based 

13 on the priority of such vendors’ 

14 production and delivery of the in15 crement identified under item 

16 (aa), in accordance with the 

17 terms and conditions of the con18 tract. 

19 ‘‘(II) DETERMINATION OF GOV20 ERNMENT’S REQUIREMENT NOT RE21 VIEWABLE.—If the Secretary includes 

22 in each of a set of contracts a provi23 sion as described in subclause (I), 

24 such Secretary’s determination of the 

25 total quantity of security counter-
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1 measure required, and any amend2 ment of such determination, is com3 mitted to agency discretion. 

4 ‘‘(vi) EXTENSION OF CLOSING DATE

5 FOR RECEIPT OF PROPOSALS NOT REVIEW6 ABLE.—A decision by the Secretary to ex7 tend the closing date for receipt of pro8 posals for a procurement under this sub9 section is committed to agency discretion. 

10 ‘‘(vii) LIMITING COMPETITION TO

11 SOURCES RESPONDING TO REQUEST FOR

12 INFORMATION.—In conducting a procure13 ment under this subsection, the Secretary 

14 may exclude a source that has not re15 sponded to a request for information under 

16 section 303A(a)(1)(B) of the Federal 

17 Property and Administrative Services Act 

18 of 1949 (41 U.S.C. 253a(a)(1)(B)) if such 

19 request has given notice that the Secretary 

20 may so exclude such a source. 

21 ‘‘(8) INTERAGENCY COOPERATION.—

22 ‘‘(A) IN GENERAL.—In carrying out activi23 ties under this section, the Homeland Security 

24 Secretary and the Secretary are authorized, 

25 subject to subparagraph (B), to enter into 
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1 interagency agreements and other collaborative 

2 undertakings with other agencies of the United 

3 States Government. 

4 ‘‘(B) LIMITATION.—An agreement or un5 dertaking under this paragraph shall not au6 thorize another agency to exercise the authori7 ties provided by this section to the Homeland 

8 Security Secretary or to the Secretary. 

9 ‘‘(9) RESTRICTIONS ON USE OF FUNDS.—

10 Amounts in the special reserve fund under para11 graph (10) shall not be used to pay—

12 ‘‘(A) costs for the purchase of vaccines 

13 under procurement contracts entered into be14 fore the date of the enactment of the Project 

15 BioShield Act of 2003; or 

16 ‘‘(B) administrative costs. 

17 ‘‘(10) DEFINITIONS.—

18 ‘‘(A) SPECIAL RESERVE FUND.—For pur19 poses of this subsection, the term ‘special re20 serve fund’ has the meaning given such term in 

21 section 510 of the Homeland Security Act of 

22 2002. 

23 ‘‘(B) DESIGNATED CONGRESSIONAL COM24 MITTEES.—For purposes of this section, the 

25 term ‘designated congressional committees’ 
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1 means the following committees of the Con2 gress: 

3 ‘‘(i) In the House of Representatives: 

4 the Committee on Energy and Commerce, 

5 the Committee on Appropriations, the 

6 Committee on Government Reform, and 

7 the Select Committee on Homeland Secu8 rity (or any successor to the Select Com9 mittee). 

10 ‘‘(ii) In the Senate: the Committee on 

11 Health, Education, Labor, and Pensions, 

12 the Committee on Appropriations, and the 

13 Committee on Government Affairs. 

14 ‘‘(d) DISCLOSURES.—No Federal agency shall dis15 close under section 552 of title 5, United States Code, any 

16 information identifying the location at which materials in 

17 the stockpile under subsection (a) are stored. 

18 ‘‘(e) DEFINITION.—For purposes of subsection (a), 

19 the term ‘stockpile’ includes—

20 ‘‘(1) a physical accumulation (at one or more 

21 locations) of the supplies described in subsection (a); 

22 or 

23 ‘‘(2) a contractual agreement between the Sec24 retary and a vendor or vendors under which such 
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1 vendor or vendors agree to provide to such Secretary 

2 supplies described in subsection (a). 

3 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

4 ‘‘(1) STRATEGIC NATIONAL STOCKPILE.—For 

5 the purpose of carrying out subsection (a), there are 

6 authorized to be appropriated $640,000,000 for fis7 cal year 2002, and such sums as may be necessary 

8 for each of fiscal years 2003 through 2006. Such 

9 authorization is in addition to amounts in the special 

10 reserve fund under subsection (c)(10). 

11 ‘‘(2) SMALLPOX VACCINE DEVELOPMENT.—For 

12 the purpose of carrying out subsection (b), there are 

13 authorized to be appropriated $509,000,000 for fis14 cal year 2002, and such sums as may be necessary 

15 for each of fiscal years 2003 through 2006.’’. 

16 (b) AMENDMENT TO HOMELAND SECURITY ACT OF

17 2002.—Title V of the Homeland Security Act of 2002 

18 (116 Stat. 2212; 6 U.S.C. 311 et seq.) is amended by add19 ing at the end the following: 

20 ‘‘SEC. 510. PROCUREMENT OF SECURITY COUNTER21 MEASURES FOR STRATEGIC NATIONAL 

22 STOCKPILE. 

23 ‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—For the 

24 procurement of security countermeasures under section 

25 319F–2(c) of the Public Health Service Act (referred to 
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1 in this section as the ‘security countermeasures program’), 

2 there is authorized to be appropriated up to 

3 $5,593,000,000 for the fiscal years 2004 through 2013. 

4 Of the amounts appropriated under the preceding sen5 tence, not to exceed $3,418,000,000 may be obligated dur6 ing the fiscal years 2004 through 2008, of which not to 

7 exceed $890,000,000 may be obligated during fiscal year 

8 2004. 

9 ‘‘(b) SPECIAL RESERVE FUND.—For purposes of the 

10 security countermeasures program, the term ‘special re11 serve fund’ means the appropriations account established 

12 as a result of any appropriations made under subsection 

13 (a). 

14 ‘‘(c) AVAILABILITY.—

15 ‘‘(1) INTEGRITY OF SPECIAL RESERVE FUND; 

16 LIMITATION OF OBLIGATIONAL AUTHORITY TO FUND

17 PURPOSES; INTENT OF CONGRESS AGAINST RE18 PROGRAMMING.—Subject to paragraph (2), all 

19 amounts appropriated under subsection (a) are 

20 available for obligation through the end of fiscal year 

21 2013 and only for the specific purposes set forth in 

22 the security countermeasures program. It is the in23 tent of the Congress that no portion of such amount 

24 that remains unobligated for such purposes shall be 
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1 applied, through reprogramming or otherwise, to any 

2 other purpose. 

3 ‘‘(2) INITIAL AVAILABILITY FOR PARTICULAR

4 PROCUREMENTS.—Amounts appropriated under sub5 section (a) become available for a procurement 

6 under the security countermeasures program only 

7 upon the approval by the President of such avail8 ability for the procurement in accordance with para9 graph (6)(B) of such program. 

10 ‘‘(d) RELATED AUTHORIZATIONS OF APPROPRIA11 TIONS.—

12 ‘‘(1) THREAT ASSESSMENT CAPABILITIES.—For 

13 the purpose of carrying out the responsibilities of 

14 the Secretary for terror threat assessment under the 

15 security countermeasures program, there are author16 ized to be appropriated $5,000,000 for fiscal year 

17 2003, and such sums as may be necessary for each 

18 of the fiscal years 2004 through 2006, for the hiring 

19 of professional personnel within the Directorate for 

20 Information Analysis and Infrastructure Protection, 

21 who shall be analysts responsible for chemical, bio22 logical, radiological, and nuclear threat assessment 

23 (including but not limited to analysis of chemical, bi24 ological, radiological, and nuclear agents, the means 

25 by which such agents could be weaponized or used 
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1 in a terrorist attack, and the capabilities, plans, and 

2 intentions of terrorists and other non-state actors 

3 who may have or acquire such agents). All such ana4 lysts shall meet the applicable standards and quali5 fications for the performance of intelligence activities 

6 promulgated by the Director of Central Intelligence 

7 pursuant to section 104 of the National Security Act 

8 of 1947. 

9 ‘‘(2) INTELLIGENCE SHARING INFRASTRUC10 TURE.—For the purpose of carrying out the acquisi11 tion and deployment of secure facilities (including 

12 information technology and physical infrastructure, 

13 whether mobile and temporary, or permanent) suffi14 cient to permit the Secretary to receive, not later 

15 than December 31, 2003, all classified information 

16 and products to which the Under Secretary for In17 formation Analysis and Infrastructure Protection is 

18 entitled under subtitle A of title II, there are author19 ized to be appropriated such sums as may be nec20 essary for each of the fiscal years 2003 through 

21 2006.’’. 
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1 SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

2 USE IN EMERGENCIES. 

3 Subchapter E of chapter V of the Federal Food, 

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

5 amended by adding at the end the following section: 

6 ‘‘SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

7 USE IN EMERGENCIES. 

8 ‘‘(a) IN GENERAL.—

9 ‘‘(1) EMERGENCY USES.—Notwithstanding sec10 tions 505, 510(k), and 515 of this Act and section 

11 351 of the Public Health Service Act, and subject to 

12 the provisions of this section, the Secretary may au13 thorize the introduction into interstate commerce, 

14 during the effective period of a declaration under 

15 subsection (b), of a drug, device, or biological prod16 uct intended for use in an actual or potential emer17 gency (referred to in this section as an ‘emergency 

18 use’). 

19 ‘‘(2) APPROVAL STATUS OF PRODUCT.—An au20 thorization under paragraph (1) may authorize an 

21 emergency use of a product that—

22 ‘‘(A) is not approved, licensed, or cleared 

23 for commercial distribution under a provision of 

24 law referred to in such paragraph (referred to 

25 in this section as an ‘unapproved product’); or 
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1 ‘‘(B) is approved, licensed, or cleared 

2 under such a provision, but which use is not 

3 under such provision an approved, licensed, or 

4 cleared use of the product (referred to in this 

5 section as an ‘unapproved use of an approved 

6 product’). 

7 ‘‘(3) RELATION TO OTHER USES.—An emer8 gency use authorized under paragraph (1) for a 

9 product is in addition to any other use that is au10 thorized for the product under a provision of law re11 ferred to in such paragraph. 

12 ‘‘(4) DEFINITIONS.—For purposes of this sec13 tion: 

14 ‘‘(A) The term ‘biological product’ has the 

15 meaning given such term in section 351 of the 

16 Public Health Service Act. 

17 ‘‘(B) The term ‘emergency use’ has the 

18 meaning indicated for such term in paragraph 

19 (1). 

20 ‘‘(C) The term ‘product’ means a drug, de21 vice, or biological product. 

22 ‘‘(D) The term ‘unapproved product’ has 

23 the meaning indicated for such term in para24 graph (2)(A). 
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1 ‘‘(E) The term ‘unapproved use of an ap2 proved product’ has the meaning indicated for 

3 such term in paragraph (2)(B). 

4 ‘‘(b) DECLARATION OF EMERGENCY.—

5 ‘‘(1) IN GENERAL.—The Secretary may declare 

6 an emergency justifying the authorization under this 

7 subsection for a product on the basis of—

8 ‘‘(A) a determination by the Secretary of 

9 Homeland Security that there is a national 

10 emergency, or a significant potential for a na11 tional emergency, involving a heightened risk of 

12 attack with a specified biological, chemical, ra13 diological, or nuclear agent or agents; 

14 ‘‘(B) a determination by the Secretary of 

15 Defense that there is a military emergency, or 

16 a significant potential for a military emergency, 

17 involving a heightened risk to United States 

18 military forces of attack with a biological, 

19 chemical, radiological, or nuclear agent or 

20 agents; or 

21 ‘‘(C) a determination by the Secretary of a 

22 public health emergency under section 319 of 

23 the Public Health Service Act, affecting na24 tional security and involving a specified biologi25 cal, chemical, radiological, or nuclear agent or 
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1 agents, or a specified disease or condition that 

2 may be attributable to such agent or agents. 

3 ‘‘(2) TERMINATION OF DECLARATION.—

4 ‘‘(A) IN GENERAL.—A declaration under 

5 this subsection shall terminate upon the earlier 

6 of—

7 ‘‘(i) a determination by the Secretary, 

8 in consultation as appropriate with the 

9 Secretary of Homeland Security or the 

10 Secretary of Defense, that the cir11 cumstances described in paragraph (1) 

12 have ceased to exist; or 

13 ‘‘(ii) the expiration of the one-year pe14 riod beginning on the date on which the 

15 declaration is made. 

16 ‘‘(B) RENEWAL.—Notwithstanding sub17 paragraph (A), the Secretary may renew a dec18 laration under this subsection, and this para19 graph shall apply to any such renewal. 

20 ‘‘(3) ADVANCE NOTICE OF TERMINATION.—In 

21 terminating a declaration under this section, the 

22 Secretary shall provide advance notice that the dec23 laration will be terminated. The period of advance 

24 notice shall be a period reasonably determined to 

25 provide—
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1 ‘‘(A) in the case of an unapproved product, 

2 a sufficient period for disposition of shipments 

3 of the product, including the return of such 

4 shipments to the manufacturer (in the case of 

5 a manufacturer that chooses to have the ship6 ments returned); and 

7 ‘‘(B) in the case of unapproved uses of ap8 proved products, a sufficient period for the dis9 position of any labeling that was provided with 

10 respect to the emergency use involved. 

11 ‘‘(4) PUBLICATION.—The Secretary shall 

12 promptly publish in the Federal Register each dec13 laration, determination, and renewal under this sub14 section. 

15 ‘‘(c) CRITERIA FOR ISSUANCE OF AUTHORIZATION.—

16 The Secretary may issue an authorization under this sec17 tion with respect to the emergency use of a product only 

18 if, after consultation with the Director of the National In19 stitutes of Health and the Director of the Centers for Dis20 ease Control and Prevention, to the extent feasible and 

21 appropriate given the circumstances of the emergency in22 volved, the Secretary concludes—

23 ‘‘(1) that an agent specified in a declaration 

24 under subsection (b) can cause a serious or life25 threatening disease or condition; 
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1 ‘‘(2) that, based on the totality of scientific evi2 dence available to the Secretary, including data from 

3 adequate and well-controlled clinical trials, if avail4 able, it is reasonable to believe that—

5 ‘‘(A) the product may be effective in de6 tecting, diagnosing, treating, or preventing—

7 ‘‘(i) such disease or condition; or 

8 ‘‘(ii) a serious or life-threatening dis9 ease or condition caused by a product au10 thorized under this section or approved 

11 under this Act or the Public Health Serv12 ice Act, for detecting, diagnosing, treating, 

13 or preventing such a disease or condition 

14 caused by such an agent; and 

15 ‘‘(B) the known and potential benefits of 

16 the product, when used to detect, diagnose, pre17 vent, or treat such disease or condition, out18 weigh the known and potential risks of the 

19 product; 

20 ‘‘(3) that there is no adequate, approved, and 

21 available alternative to the product for detecting, di22 agnosing, preventing, or treating such disease or 

23 condition; and 

24 ‘‘(4) that such other criteria as the Secretary 

25 may by regulation prescribe are satisfied. 
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1 ‘‘(d) SCOPE OF AUTHORIZATION.—

2 ‘‘(1) IN GENERAL.—An authorization of a prod3 uct under this section shall state—

4 ‘‘(A) each disease or condition that the 

5 product may be used to detect, diagnose, pre6 vent, or treat within the scope of the authoriza7 tion; 

8 ‘‘(B) the Secretary’s conclusions, made 

9 under subsection (c)(2)(B), that the known and 

10 potential benefits of the product, when used to 

11 detect, diagnose, prevent, or treat such disease 

12 or condition, outweigh the known and potential 

13 risks of the product; and 

14 ‘‘(C) the Secretary’s conclusions, made 

15 under subsection (c), concerning the safety and 

16 potential effectiveness of the product in detect17 ing, diagnosing, preventing, or treating such 

18 diseases or conditions, including an assessment 

19 of the available scientific evidence. 

20 ‘‘(2) CONFIDENTIAL INFORMATION.—Nothing 

21 in this section alters or amends section 1905 of title 

22 18, United States Code, or section 552(b)(4) of title 

23 5 of such Code. 

24 ‘‘(e) CONDITIONS OF AUTHORIZATION.—

25 ‘‘(1) UNAPPROVED PRODUCT.—
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1 ‘‘(A) REQUIRED CONDITIONS.—With re2 spect to the emergency use of an unapproved 

3 product, the Secretary, to the extent feasible 

4 given the circumstances of the emergency, shall, 

5 for persons who choose to carry out one or 

6 more activities for which the authorization is 

7 issued, establish such conditions on an author8 ization under this section as the Secretary finds 

9 necessary or appropriate to protect the public 

10 health, including the following: 

11 ‘‘(i) Appropriate conditions designed 

12 to ensure that, to the extent feasible given 

13 the circumstances of the emergency, health 

14 care professionals administering the prod15 uct are informed—

16 ‘‘(I) that the Secretary has au17 thorized the emergency use of the 

18 product; 

19 ‘‘(II) of the significant known 

20 and potential benefits and risks of the 

21 emergency use of the product, and of 

22 the extent to which such benefits and 

23 risks are unknown; and 
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1 ‘‘(III) of the alternatives to the 

2 product that are available, and of 

3 their benefits and risks. 

4 ‘‘(ii) Appropriate conditions designed 

5 to ensure that, to the extent feasible given 

6 the circumstances of the emergency, indi7 viduals to whom the product is adminis8 tered are informed—

9 ‘‘(I) that the Secretary has au10 thorized the emergency use of the 

11 product; 

12 ‘‘(II) of the significant known 

13 and potential benefits and risks of 

14 such use, and of the extent to which 

15 such benefits and risks are unknown; 

16 and 

17 ‘‘(III) of the option to accept or 

18 refuse administration of the product, 

19 of the consequences, if any, of refus20 ing administration of the product, and 

21 of the alternatives to the product that 

22 are available and of their benefits and 

23 risks. 

24 ‘‘(iii) Appropriate conditions for the 

25 monitoring and reporting of adverse events 
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1 associated with the emergency use of the 

2 product. 

3 ‘‘(iv) For manufacturers of the prod4 uct, appropriate conditions concerning rec5 ordkeeping and reporting, including 

6 records access by the Secretary, with re7 spect to the emergency use of the product. 

8 ‘‘(B) AUTHORITY FOR ADDITIONAL CONDI9 TIONS.—With respect to the emergency use of 

10 an unapproved product, the Secretary, to the 

11 extent feasible given the circumstances of the 

12 emergency, may, for persons who choose to 

13 carry out one or more activities for which the 

14 authorization is issued, establish such condi15 tions on an authorization under this section as 

16 the Secretary finds necessary or appropriate to 

17 protect the public health, including the fol18 lowing: 

19 ‘‘(i) Appropriate conditions on which 

20 entities may distribute the product with re21 spect to the emergency use of the product 

22 (including limitation to distribution by gov23 ernment entities), and on how distribution 

24 is to be performed. 
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1 ‘‘(ii) Appropriate conditions on who 

2 may administer the product with respect to 

3 the emergency use of the product, and on 

4 the categories of individuals to whom, and 

5 the circumstances under which, the prod6 uct may be administered with respect to 

7 such use. 

8 ‘‘(iii) For persons other than manu9 facturers of the product, appropriate con10 ditions concerning recordkeeping and re11 porting, including records access by the 

12 Secretary, with respect to the emergency 

13 use of the product. 

14 ‘‘(iv) With respect to the emergency 

15 use of the product, waive or limit, to the 

16 extent appropriate given the circumstances 

17 of the emergency, conditions regarding 

18 current good manufacturing practice other19 wise applicable to the manufacture, proc20 essing, packing, or holding of products 

21 subject to regulation under this Act, in22 cluding such requirements established in 

23 section 501. 
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1 ‘‘(2) UNAPPROVED USE.—With respect to the 

2 emergency use of a product that is an unapproved 

3 use of an approved product: 

4 ‘‘(A) The Secretary may, for manufactur5 ers of the product who choose to carry out one 

6 or more activities for which the authorization is 

7 issued, establish any of the conditions described 

8 in clauses (i) through (iv) of paragraph (1)(A). 

9 ‘‘(B)(i) If the authorization under this sec10 tion regarding the emergency use authorizes a 

11 change in the labeling of the product, but the 

12 manufacturer of the product chooses not to 

13 make such change, such authorization may not 

14 authorize distributors of the product or any 

15 other person to alter or obscure the labeling 

16 provided by the manufacturer. 

17 ‘‘(ii) In the circumstances described in 

18 clause (i), an authorization under this section 

19 regarding the emergency use may, for persons 

20 who do not manufacture the product and who 

21 choose to act under this clause, authorize such 

22 persons to provide information on the product 

23 in addition to the labeling provided by the man24 ufacturer, subject to compliance with clause (i). 
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1 Such additional information shall not be consid2 ered labeling for purposes of section 502. 

3 ‘‘(f) DURATION OF AUTHORIZATION.—

4 ‘‘(1) IN GENERAL.—Except as provided in para5 graph (2), an authorization under this section shall 

6 be effective until the earlier of the termination of the 

7 declaration under subsection (b) or a revocation 

8 under subsection (g). 

9 ‘‘(2) CONTINUED USE AFTER END OF EFFEC10 TIVE PERIOD.—Notwithstanding the termination of 

11 the declaration under subsection (b) or a revocation 

12 under subsection (g), an authorization shall continue 

13 to be effective for continued use with respect to pa14 tients to whom it was administered during the pe15 riod described by paragraph (1), to the extent found 

16 necessary by such patients’ attending physicians. 

17 ‘‘(g) REVOCATION OF AUTHORIZATION.—

18 ‘‘(1) REVIEW.—The Secretary shall periodically 

19 review the circumstances and the appropriateness of 

20 an authorization under this section. 

21 ‘‘(2) REVOCATION.—The Secretary may revoke 

22 an authorization under this section if, in the Sec23 retary’s unreviewable discretion, the criteria under 

24 subsection (c) for issuance of such authorization are 

25 no longer met. 
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1 ‘‘(h) PUBLICATION.—The Secretary shall promptly 

2 publish in the Federal Register a notice of each authoriza3 tion, and each termination or revocation of an authoriza4 tion, and an explanation of the reasons therefor, under 

5 this section. 

6 ‘‘(i) ACTIONS COMMITTED TO AGENCY DISCRE7 TION.—Actions under the authority of this section by the 

8 Secretary, by the Secretary of Defense, or by the Sec9 retary of Homeland Security are committed to agency dis10 cretion. 

11 ‘‘(j) RULES OF CONSTRUCTION.—Nothing in this sec12 tion shall be construed to impair or otherwise affect—

13 ‘‘(1) the authority of the President as Com14 mander in Chief of the Armed Forces of the United 

15 States under article II, section 2 of the United 

16 States Constitution; 

17 ‘‘(2) the authority of the Secretary of Defense 

18 with respect to the Department of Defense, includ19 ing the armed forces, under other provisions of Fed20 eral law; or 

21 ‘‘(3) the authority of the Secretary under sec22 tion 319F–2 to manage the stockpile under such 

23 section. 

24 ‘‘(k) APPLICATION TO MEMBERS OF ARMED

25 FORCES.—
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1 ‘‘(1) WAIVER OF REQUIREMENT RELATING TO

2 OPTION TO REFUSE.—In the case of administration 

3 of a countermeasure to members of the armed 

4 forces, a requirement, under subsection 

5 (e)(1)(A)(ii)(III), designed to ensure that individuals 

6 are informed of an option to accept or refuse admin7 istration of a product, may be waived by the Presi8 dent if the President determines, in writing, that 

9 complying with such requirement is not feasible, is 

10 contrary to the best interests of the members af11 fected, or is not in the interests of national security. 

12 ‘‘(2) PROVISION OF INFORMATION TO MEMBER

13 OF THE ARMED FORCES.—If the Secretary makes a 

14 determination that it is not feasible for the informa15 tion required by subsection (e)(1)(A)(ii) to be pro16 vided to a member of the armed forces prior to the 

17 administration of the product, such information shall 

18 be provided to such member of the armed forces (or 

19 next-of-kin in the case of the death of a member) to 

20 whom the product was administered as soon as pos21 sible, but not later than 30 days, after such adminis22 tration. Information concerning the administration 

23 of the product shall be recorded in the medical 

24 record of the member. 
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1 ‘‘(3) EFFECT ON STATUTE PERTAINING TO IN2 VESTIGATIONAL NEW DRUGS.—In the case of an au3 thorization based on a determination by the Sec4 retary of Defense under subsection (b)(1)(B), sec5 tion 1107 of title 10, United States Code, shall not 

6 apply to use of a product that is the subject of such 

7 authorization, within the scope of such authorization 

8 and while such authorization is effective. 

9 ‘‘(l) RELATION TO OTHER PROVISIONS.—If a prod10 uct is the subject of an authorization under this section, 

11 the use of such product within the scope of the authoriza12 tion —

13 ‘‘(1) shall not be subject to any requirements 

14 pursuant to section 505(i) or 520(g); and 

15 ‘‘(2) shall not be subject to any requirements 

16 otherwise applicable to clinical investigations pursu17 ant to other provisions of this Act. 

18 ‘‘(m) DISCRETION REGARDING USE OF AUTHORIZA19 TION.—Nothing in this section provides the Secretary any 

20 authority to require any person to carry out any activity 

21 that becomes lawful pursuant to an authorization under 

22 this section, and no person is required to inform the Sec23 retary that the person will not be carrying out such activ24 ity, except that a manufacturer of a sole-source unap25 proved product authorized for emergency use shall notify 
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1 the Secretary within a reasonable period of time after the 

2 issuance by the Secretary of such authorization if such 

3 manufacturer does not intend to carry out an activity or 

4 activities under the authorization. This section does not 

5 have any legal effect on a person who does not carry out 

6 any activity for which an authorization under this section 

7 is issued, or who carries out such an activity pursuant to 

8 other provisions of this Act or section 351 of the Public 

9 Health Service Act. 

10 ‘‘(n) ENFORCEMENT.—A person who carries out an 

11 activity pursuant to an authorization under this section, 

12 but who fails to comply with applicable conditions under 

13 subsection (e), is with respect to that act of noncompliance 

14 subject to the provisions of law specified in subsection (a) 

15 and to the enforcement of such provisions under section 

16 301.’’. 

17 SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS 

18 ACT. 

19 (a) SECRETARY OF HEALTH AND HUMAN SERV20 ICES.—

21 (1) ANNUAL REPORTS ON PARTICULAR EXER22 CISES OF AUTHORITY.—

23 (A) RELEVANT AUTHORITIES.—The Sec24 retary of Health and Human Services (referred 

25 to in this subsection as the ‘‘Secretary’’) shall 
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1 submit reports in accordance with subpara2 graph (B) regarding the exercise of authority 

3 under the following provisions of law: 

4 (i) With respect to section 319F–1 of 

5 the Public Health Service Act (as added by 

6 section 2 of this Act): 

7 (I) Subsection (b)(1) (relating to 

8 increased simplified acquisition 

9 threshold). 

10 (II) Subsection (b)(2) (relating to 

11 procedures other than full and open 

12 competition). 

13 (III) Subsection (c) (relating to 

14 expedited peer review procedures). 

15 (ii) With respect to section 319F–2 of 

16 the Public Health Service Act (as added by 

17 section 3 of this Act): 

18 (I) Subsection (c)(7)(C)(iii) (re19 lating to simplified acquisition proce20 dures). 

21 (II) Subsection (c)(7)(C)(iv) (re22 lating to procedures other than full 

23 and open competition). 
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1 (III) Subsection (c)(7)(C)(v) (re2 lating to premium provision in mul3 tiple-award contracts). 

4 (iii) With respect to section 564 of the 

5 Federal Food, Drug, and Cosmetic Act (as 

6 added by section 4 of this Act): 

7 (I) Subsection (a)(1) (relating to 

8 emergency uses of certain drugs and 

9 devices). 

10 (II) Subsection (b)(1) (relating to 

11 a declaration of an emergency). 

12 (III) Subsection (e) (relating to 

13 conditions on authorization). 

14 (B) CONTENTS OF REPORTS.—The Sec15 retary shall annually submit to the designated 

16 congressional committees a report that summa17 rizes—

18 (i) the particular actions that were 

19 taken under the authorities specified in 

20 subparagraph (A), including, as applicable, 

21 the identification of the threat agent, 

22 emergency, or the biomedical counter23 measure with respect to which the author24 ity was used; 
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1 (ii) the reasons underlying the deci2 sion to use such authorities, including, as 

3 applicable, the options that were consid4 ered and rejected with respect to the use of 

5 such authorities; 

6 (iii) the identification of each person 

7 or entity that received, or was considered 

8 and rejected for, grants, cooperative agree9 ments, or contracts pursuant to the use of 

10 such authorities; and 

11 (iv) whether, with respect to each pro12 curement that is approved by the President 

13 under section 319F–2(c)(6) of the Public 

14 Health Service Act (as added by section 3 

15 of this Act), a contract was entered into 

16 within one year after such approval by the 

17 President. 

18 (2) ANNUAL SUMMARIES REGARDING CERTAIN

19 ACTIVITY.—The Secretary shall annually submit to 

20 the designated congressional committees a report 

21 that summarizes the activity undertaken pursuant to 

22 the following authorities under section 319F–1 of 

23 the Public Health Service Act (as added by section 

24 2 of this Act): 
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1 (A) Subsection (b)(3) (relating to in2 creased micropurchase threshold). 

3 (B) Subsection (d) (relating to authority 

4 for personal services contracts). 

5 (C) Subsection (e) (relating to streamlined 

6 personnel authority). 

7 With respect to subparagraph (B), the report shall 

8 include a provision specifying, for the one-year pe9 riod for which the report is submitted, the number 

10 of persons who were paid amounts greater than 

11 $100,000 and the number of persons who were paid 

12 amounts between $50,000 and $100,000. 

13 (b) NATIONAL ACADEMY OF SCIENCES REVIEW.—

14 (1) IN GENERAL.—Not later than four years 

15 after the date of the enactment of this Act, the Sec16 retary of Health and Human Services shall request 

17 the National Academy of Sciences to enter into an 

18 agreement for a review of the biomedical counter19 measure research and development authorities estab20 lished in this Act to determine whether and to what 

21 extent activities undertaken pursuant to such au22 thorities have enhanced the development of bio23 medical countermeasures affecting national security, 

24 and to recommend any legislative or administrative 

25 changes necessary to improve the ability of the Sec-
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1 retary to carry out these activities in the future. The 

2 Secretary shall ensure that the results of the study 

3 are submitted to the designated congressional com4 mittees not later than five years after such date of 

5 enactment. 

6 (2) CERTAIN CONTENTS.—The report under 

7 paragraph (1) shall include—

8 (A) a summary of the most recent analysis 

9 by the Department of Homeland Security and 

10 the intelligence community of the domestic 

11 threat from chemical, biological, radiological, 

12 and nuclear agents; 

13 (B) the Academy’s assessment of the cur14 rent availability of countermeasures to address 

15 such threats; 

16 (C) the Academy’s assessment of the ex17 tent to which programs and activities under this 

18 Act will reduce any gap between the threat and 

19 the availability of countermeasures to an ac20 ceptable level of risk; and 

21 (D)(i) the Academy’s assessment of threats 

22 to national security that are posed by tech23 nology that will enable, during the 10-year pe24 riod beginning on the date of the enactment of 

25 this Act, the development of antibiotic resistant, 
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1 mutated, or bioengineered strains of biological 

2 agents; and 

3 (ii) recommendations on short-term and 

4 long-term governmental strategies for address5 ing such threats, including recommendations for 

6 Federal policies regarding research priorities, 

7 the development of countermeasures, and in8 vestments in technology. 

9 (c) GENERAL ACCOUNTING OFFICE REVIEW.—Four 

10 years after the date of the enactment of this Act, the 

11 Comptroller General of the United States shall initiate a 

12 study—

13 (1)(A) to review the Secretary of Health and 

14 Human Services’ utilization of the authorities grant15 ed under this Act with respect to simplified acquisi16 tion procedures, procedures other than full and open 

17 competition, increased micropurchase thresholds, 

18 personal services contracts, streamlined personnel 

19 authority, and the purchase of security counter20 measures under the special reserve fund; and 

21 (B) to recommend any legislative or administra22 tive changes necessary to improve the utilization or 

23 effectiveness of such authorities in the future; 
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1 (2)(A) to review the internal controls instituted 

2 by such Secretary with respect to such authorities, 

3 where required by this Act; and 

4 (B) to recommend any legislative or administra5 tive changes necessary to improve the effectiveness 

6 of such controls; and 

7 (3)(A) to review such Secretary’s utilization of 

8 the authority granted under this Act to authorize an 

9 emergency use of a biomedical countermeasure, in10 cluding the means by which the Secretary deter11 mines whether and under what conditions any such 

12 authorizations should be granted and the benefits 

13 and adverse impacts, if any, resulting from the use 

14 of such authority; and 

15 (B) to recommend any legislative or administra16 tive changes necessary to improve the utilization or 

17 effectiveness of such authority and to enhance pro18 tection of the public health. 

19 The results of the study shall be submitted to the des20 ignated congressional committees not later than five years 

21 after the date of the enactment of this Act. 

22 (d) REPORT REGARDING BARRIERS TO PROCURE23 MENT OF SECURITY COUNTERMEASURES.—

24 (1) BIOCONTAINMENT FACILITIES.—Not later 

25 than 120 days after the date of the enactment of 
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1 this Act, the Secretary of Homeland Security and 

2 the Secretary of Health and Human Services shall 

3 jointly report to the designated congressional com4 mittees whether there is a lack of adequate large5 scale biocontainment facilities necessary for the test6 ing of security countermeasures in accordance with 

7 Food and Drug Administration requirements. 

8 (2) ADDITIONAL BARRIERS.—Not later than 

9 one year after the date of enactment of this Act, 

10 such Secretaries shall jointly report to the des11 ignated congressional committees any other potential 

12 barriers to the procurement of security counter13 measures that have not been addressed by this Act. 

14 (e) STATUS OF PROGRAM FOR CHEMICAL TER15 RORISM PREPAREDNESS.—Not later than 270 days after 

16 the date of the enactment of this Act, the Secretary of 

17 Homeland Security shall submit to the designated con18 gressional committees a report describing the status of the 

19 program carried out by the Secretary to enhance the pre20 paredness of the United States to respond to terrorist at21 tacks involving chemical agents. 

22 (f) DESIGNATED CONGRESSIONAL COMMITTEES.—

23 For purposes of this section, the term ‘‘designated con24 gressional committees’’ means the following committees of 

25 the Congress: 
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1 (1) In the House of Representatives: the Com2 mittee on Energy and Commerce, the Committee on 

3 Appropriations, the Committee on Government Re4 form, and the Select Committee on Homeland Secu5 rity (or any successor to the Select Committee). 

6 (2) In the Senate: the Committee on Health, 

7 Education, Labor, and Pensions, the Committee on 

8 Appropriations, and the Committee on Government 

9 Affairs. 

10 SEC. 6. OUTREACH. 

11 The Secretary of Health and Human Services shall 

12 develop outreach measures to ensure to the extent prac13 ticable that diverse institutions, including Historically 

14 Black Colleges and Universities and those serving large 

15 proportions of Hispanics, Native Americans, Asian-Pacific 

16 Americans, or other underrepresented populations, are 

17 meaningfully aware of available research and development 

18 grants, contracts, cooperative agreements, and procure19 ments conducted under sections 2 and 3 of this Act. 

20 SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON 

21 CERTAIN BIOMEDICAL COUNTERMEASURES. 

22 Upon the award of any grant, contract, or cooperative 

23 agreement under section 2 or 3 of this Act for the re24 search, development, or procurement of a qualified coun25 termeasure or a security countermeasure (as those terms 
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1 are defined in this Act), the Secretary of Health and 

2 Human Services shall, in consultation with the heads of 

3 other appropriate Federal agencies, determine whether the 

4 countermeasure involved in such grant, contract, or coop5 erative agreement is subject to existing export-related con6 trols and, if not, may make a recommendation to the ap7 propriate Federal agency or agencies that such counter8 measure should be included on the list of controlled items 

9 subject to such controls. 

10 SEC. 8. ENSURING COORDINATION, COOPERATION AND 

11 THE ELIMINATION OF UNNECESSARY DUPLI12 CATION IN PROGRAMS DESIGNED TO PRO13 TECT THE HOMELAND FROM BIOLOGICAL, 

14 CHEMICAL, RADIOLOGICAL, AND NUCLEAR 

15 AGENTS. 

16 (a) ENSURING COORDINATION OF PROGRAMS.—The 

17 Secretary of Health and Human Services, the Secretary 

18 of Homeland Security, and the Secretary of Defense shall 

19 ensure that the activities of their respective Departments 

20 coordinate, complement, and do not unnecessarily dupli21 cate programs to identify potential domestic threats from 

22 biological, chemical, radiological or nuclear agents, detect 

23 domestic incidents involving such agents, analyze such in24 cidents, and develop necessary countermeasures. The 

25 aforementioned Secretaries shall further ensure that infor-
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1 mation and technology possessed by the Departments rel2 evant to these activities are shared with the other Depart3 ments. 

4 (b) DESIGNATION OF AGENCY COORDINATION OFFI5 CER.—The Secretary of Health and Human Services, the 

6 Secretary of Homeland Security, and the Secretary of De7 fense shall each designate an officer or employee of their 

8 respective Departments who shall coordinate, through reg9 ular meetings and communications, with the other afore10 mentioned Departments such programs and activities car11 ried out by their Departments.

Passed the House of Representatives July 16, 2003. 

Attest: JEFF TRANDAHL, 

Clerk. 
Calendar No. 214

108TH CONGRESS 

1ST SESSION H. R. 2122

AN ACT

To enhance research, development, procurement, 

and use of biomedical countermeasures to respond to public health threats affecting national security, and for other purposes. 

JULY 17, 2003

Received; read twice and placed on the calendar