IB 

Union Calendar No. 98

108TH CONGRESS 

1ST SESSION H. R. 2122

[Report No. 108–147, Parts I, II, and III] 

To enhance research, development, procurement, and use of biomedical countermeasures to respond to public health threats affecting national security, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 15, 2003

Mr. TAUZIN (for himself, Mr. DINGELL, Mr. COX, Mr. TOM DAVIS of Virginia, 

Mr. MARKEY, Mr. BILIRAKIS, Mr. DAVIS of Florida, Mr. UPTON, Mr. 

STEARNS, Mr. GREENWOOD, Mr. SHADEGG, Mr. ISSA, Mr. LINCOLN

DIAZ-BALART of Florida, and Ms. ESHOO) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committees on Government Reform, and Select Homeland 

Security, for a period to be subsequently determined by the Speaker, in 

each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

JUNE 10, 2003

Reported from the Committee on Energy and Commerce 

JUNE 10, 2003

Referral to the Committee on Government Reform and the Select Committee 

on Homeland Security extended for a period ending not later than June 

13, 2003

JUNE 10, 2003

Referred to the Committee on Armed Services for a period ending not later 

than June 11, 2003 pursuant to clause 1(c), rule X 

JUNE 11, 2003

The Committee on Armed Services discharged 

JUNE 12, 2003

Reported from the Committee on Government Reform with an amendment 
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[Strike out all after the enacting clause and insert the part printed in italic] 

JUNE 13, 2003

Referral to the Select Committee on Homeland Security extended for a period 

ending not later than June 27, 2003

JUNE 27, 2003

Referral to the Select Committee on Homeland Security extended for a period 

ending not later than July 8, 2003

JULY 8, 2003

Additional sponsors: Mr. BURR and Mr. HALL

JULY 8, 2003

Reported from the Select Committee on Homeland Security with an amendment, committed to the Committee of the Whole House on the State of 

the Union and ordered to be printed 

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

[For text of introduced bill, see copy of bill as introduced on May 15, 2003] 

A BILL

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,

3 SECTION 1. SHORT TITLE. 

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

5 of 2003’’. 
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1 SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND 

2 DEVELOPMENT –––AUTHORITIES. 

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

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

5 by inserting after section 319F the following section: 

6 ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE7 DURES REGARDING BIOMEDICAL COUNTER8 MEASURE RESEARCH AND DEVELOPMENT 

9 ACTIVITIES. 

10 ‘‘(a) IN GENERAL.—

11 ‘‘(1) AUTHORITY.—In conducting and sup12 porting research and development activities regard13 ing biomedical countermeasures under section 

14 319F(h), the Secretary may conduct and support 

15 such activities in accordance with this section if the 

16 activities concern qualified countermeasures. 

17 ‘‘(2) QUALIFIED COUNTERMEASURE.—For pur18 poses of this section, the term ‘qualified counter19 measure’ means a priority countermeasure (as de20 fined in section 319F(h)) that affects national secu21 rity. 

22 ‘‘(3) INTERAGENCY COOPERATION.—

23 ‘‘(A) IN GENERAL.—In carrying out activi24 ties under this section, the Secretary is author25 ized, subject to subparagraph (B), to enter into 

26 interagency agreements and other collaborative 
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1 undertakings with other agencies of the United 

2 States Government. 

3 ‘‘(B) LIMITATION.—An agreement or un4 dertaking under this paragraph shall not au5 thorize another agency to exercise the authori6 ties provided by this section. 

7 ‘‘(4) AVAILABILITY OF FACILITIES TO THE SEC8 RETARY.—In any grant or cooperative agreement 

9 entered into under the authority provided in this 

10 section with respect to a biocontainment laboratory 

11 or other related or ancillary specialized research fa12 cility that the Secretary determines necessary for the 

13 purpose of performing, administering, and sup14 porting qualified countermeasure research and devel15 opment, the Secretary may provide that the facility 

16 that is the object of such grant or cooperative agree17 ment shall be available as needed to the Secretary 

18 to respond to public health emergencies affecting na19 tional security. 

20 ‘‘(b) EXPEDITED PROCUREMENT AUTHORITY.—

21 ‘‘(1) INCREASED SIMPLIFIED ACQUISITION

22 THRESHOLD FOR BIOMEDICAL COUNTERMEASURE

23 PROCUREMENTS.—

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

25 by the Secretary of property or services for use 
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1 (as determined by the Secretary) in performing, 

2 administering, or supporting qualified counter3 measure research or development activities 

4 under this section that the Secretary deter5 mines necessary to respond to pressing research 

6 and development needs under this section, the 

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

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

9 403(11)), as applicable pursuant to section 

10 302A(a) of the Federal Property and Adminis11 trative Services Act of 1949 (41 U.S.C. 

12 252a(a)), shall be deemed to be $25,000,000 in 

13 the administration, with respect to such pro14 curement, of—

15 ‘‘(i) section 303(g)(1)(A) of the Fed16 eral Property and Administrative Services 

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

18 its implementing regulations; and

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

20 U.S.C. 252a(b)) and its implementing reg21 ulations. 

22 ‘‘(B) APPLICATION OF CERTAIN PROVI23 SIONS.—Notwithstanding subparagraph (A) 

24 and the provision of law and regulations re25 ferred to in such subparagraph, each of the fol-
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1 lowing provisions shall apply to procurements 

2 described in this paragraph to the same extent 

3 that such provisions would apply to such pro4 curements in the absence of subparagraph (A): 

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

6 States Code (relating to contract work 

7 hours and safety standards). 

8 ‘‘(ii) Subsections (a) and (b) of Sec9 tion 7 of the Anti-Kickback Act of 1986 

10 (41 U.S.C. 57(a) and (b)). 

11 ‘‘(iii) Section 304C of the Federal 

12 Property and Administrative Services Act 

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

14 ––– examination of contractor records). 

15 ‘‘(C) INTERNAL CONTROLS TO BE INSTI16 TUTED.—The Secretary shall institute appro17 priate internal controls for procurements that 

18 are under this paragraph, including require19 ments with regard to documenting the justifica20 tion for use of the authority in this paragraph. 

21 ‘‘(2) USE OF NONCOMPETITIVE PROCEDURES.—

22 In addition to any other authority to use procedures 

23 other than competitive procedures, the Secretary 

24 may use such other procedures when—
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1 ‘‘(A) the procurement is as described by 

2 paragraph (1); and 

3 ‘‘(B) the property or services needed by 

4 the Secretary are available from only one re5 sponsible source or only from a limited number 

6 of responsible sources, and no other type of 

7 property or services will satisfy the Secretary’s 

8 needs. 

9 ‘‘(3) INCREASED MICROPURCHASE THRESH10 OLD.—

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

12 described by paragraph (1), the amount speci13 fied in subsections (c), (d), and (f) of section 32 

14 of the Office of Federal Procurement Policy Act 

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

16 in the administration of that section with re17 spect to such procurement. 

18 ‘‘(B) INTERNAL CONTROLS TO BE INSTI19 TUTED.—The Secretary shall institute appro20 priate internal controls for purchases that are 

21 under this paragraph and that are greater than 

22 $2,500. 

23 ‘‘(C) EXCEPTION TO PREFERENCE FOR

24 PURCHASE CARD MECHANISM.—No provision of 

25 law establishing a preference for using a Gov-
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1 ernment purchase card method for purchases 

2 shall apply to purchases that are under this 

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

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

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

6 Secretary determines necessary to respond to press7 ing qualified countermeasure research and develop8 ment needs under this section, employ such expe9 dited peer review procedures (including consultation 

10 with appropriate scientific experts) as the Secretary, 

11 in consultation with the Director of NIH, deems ap12 propriate to obtain assessment of scientific and tech13 nical merit and likely contribution to the field of 

14 qualified countermeasure research, in place of the 

15 peer review and advisory council review procedures 

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

17 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 

18 494, as applicable to a grant, contract, or coopera19 tive agreement—

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

21 or supporting qualified countermeasure research 

22 and development activities; and 

23 ‘‘(B) the amount of which is not greater 

24 than $1,500,000. 
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1 ‘‘(2) SUBSEQUENT PHASES OF RESEARCH.—

2 The Secretary’s determination of whether to employ 

3 expedited peer review with respect to subsequent 

4 phases of a research grant or cooperative agreement 

5 under this section shall be determined without re6 gard to the peer review procedures used for any 

7 prior peer review of that same grant or cooperative 

8 agreement. 

9 ‘‘(d) AUTHORITY FOR PERSONAL SERVICES CON10 TRACTS.—

11 ‘‘(1) IN GENERAL.—For the purpose of per12 forming, administering, and supporting qualified 

13 countermeasure research and development activities, 

14 the Secretary may, as the Secretary determines nec15 essary to respond to pressing qualified counter16 measure research and development needs under this 

17 section, obtain by contract (in accordance with sec18 tion 3109 of title 5, United States Code, but without 

19 regard to the limitations in such section on the pe20 riod of service and on pay) the personal services of 

21 experts or consultants who have scientific or other 

22 professional qualifications, except that in no case 

23 shall the compensation provided to any such expert 

24 or consultant exceed the daily equivalent of the an25 nual rate of compensation for the President. 
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1 ‘‘(2) FEDERAL TORT CLAIMS ACT COVERAGE.—

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

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

4 employee, or governing board member of such 

5 person, shall be deemed to be an employee of 

6 the Department of Health and Human Services 

7 for purposes of claims under sections 1346(b) 

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

9 money damages for personal injury, including 

10 death, resulting from performance of functions 

11 under such contract. 

12 ‘‘(B) EXCLUSIVITY OF REMEDY.—The 

13 remedy provided by subparagraph (A) shall be 

14 exclusive of any other civil action or proceeding 

15 by reason of the same subject matter against 

16 the person, officer, employee, or governing 

17 board member. 

18 ‘‘(3) INTERNAL CONTROLS TO BE INSTI19 TUTED.—

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

21 institute appropriate internal controls for con22 tracts under this subsection, including proce23 dures for the Secretary to make a determina24 tion of whether a person, or an officer, em25 ployee, or governing board member of a person, 
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1 is deemed to be an employee of the Department 

2 of Health and Human Services pursuant to 

3 paragraph (2). 

4 ‘‘(B) DETERMINATION OF EMPLOYEE STA5 TUS TO BE FINAL.—A determination by the 

6 Secretary under subparagraph (A) that a per7 son, or an officer, employee, or governing board 

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

9 an employee of the Department of Health and 

10 Human Services shall be final and binding on 

11 the Secretary and the Attorney General and 

12 other parties to any civil action or proceeding. 

13 ‘‘(4) NUMBER OF PERSONAL SERVICES CON14 TRACTS LIMITED.—The number of experts and con15 sultants whose personal services are obtained under 

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

17 ‘‘(e) STREAMLINED PERSONNEL AUTHORITY.—

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

19 personnel authorities, the Secretary may, as the Sec20 retary determines necessary to respond to pressing 

21 qualified countermeasure research and development 

22 needs under this section, without regard to such pro23 visions of title 5, United States Code, governing ap24 pointments in the competitive service, and without 

25 regard to the provisions of chapter 51 and sub-
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1 chapter III of chapter 53 of such title relating to 

2 classification and General Schedule pay rates, ap3 point professional and technical employees, not to 

4 exceed 30 such employees at any time, to positions 

5 in the National Institutes of Health to perform, ad6 minister, or support qualified countermeasure re7 search and development activities in carrying out 

8 this section. 

9 ‘‘(2) INTERNAL CONTROLS TO BE INSTI10 TUTED.—The Secretary shall institute appropriate 

11 internal controls for appointments under this sub12 section. 

13 ‘‘(f) ACTIONS COMMITTED TO AGENCY DISCRE14 TION.—Actions by the Secretary under the authority of 

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

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

17 Public Health Service Act (42 U.S.C. 287a–2) is amend18 ed—

19 (1) in subsection (a)(1), by inserting ‘‘or the 

20 Director of the National Institute of Allergy and In21 fectious Diseases’’ after ‘‘Director of the Center’’; 

22 (2) in subsection (c)—

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

24 Director of the National Institute of Allergy 
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1 and Infectious Diseases’’ after ‘‘Director of the 

2 Center’’; and 

3 (B) in paragraph (2), in the matter pre4 ceding subparagraph (A), by striking ‘‘sub5 section (i)’’ and inserting ‘‘subsection (i)(1)’’; 

6 (3) in subsection (d), by inserting ‘‘or the Di7 rector of the National Institute of Allergy and Infec8 tious Diseases’’ after ‘‘Director of the Center’’; 

9 (4) in subsection (e)—

10 (A) in paragraph (1)—

11 (i) in the matter preceding subpara12 graph (A), by inserting ‘‘or the Director of 

13 the National Institute of Allergy and Infec14 tious Diseases’’ after ‘‘Director of the Cen15 ter’’; 

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

17 ‘‘(or, in the case of the Institute, 75 per18 cent)’’ after ‘‘50 percent’’; and 

19 (iii) in subparagraph (B), by inserting 

20 ‘‘(or, in the case of the Institute, 75 per21 cent)’’ after ‘‘40 percent’’; 

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

23 Director of the National Institute of Allergy 

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

25 Center’’; and 
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1 (C) in paragraph (4), by inserting ‘‘of the 

2 Center or the Director of the National Institute 

3 of Allergy and Infectious Diseases’’ after ‘‘Di4 rector’’; 

5 (5) in subsection (f)—

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

7 case of an award by the Director of the Cen8 ter,’’ before ‘‘the applicant’’; and 

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

10 Center or the Director of the National Institute 

11 of Allergy and Infectious Diseases’’ after ‘‘Di12 rector’’; and 

13 (6) in subsection (i)—

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

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

16 inserting the following: ‘‘APPROPRIATIONS.—

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

18 this section with respect to the Center,’’; and 

19 (B) by adding at the end the following: 

20 ‘‘(2) NATIONAL INSTITUTE OF ALLERGY AND

21 INFECTIOUS DISEASES.—For the purpose of car22 rying out this section with respect to the National 

23 Institute of Allergy and Infectious Diseases, there 

24 are authorized to be appropriated such sums as may 

25 be necessary for fiscal year 2003.’’. 
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1 SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT. 

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

3 Health Service Act, as amended by section 2 of this Act, 

4 is amended by inserting after section 319F–1 the fol5 lowing section: 

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

7 ‘‘(a) STRATEGIC NATIONAL STOCKPILE.—

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

9 Security (referred to in this section as the ‘Home10 land Security Secretary’), in coordination with the 

11 Secretary and the Secretary of Veterans Affairs, 

12 shall maintain a stockpile or stockpiles of drugs, vac13 cines and other biological products, medical devices, 

14 and other supplies in such numbers, types, and 

15 amounts as are determined by the Secretary to be 

16 appropriate and practicable, taking into account 

17 other available sources, to provide for the emergency 

18 health security of the United States, including the

19 emergency health security of children and other vul20 nerable populations, in the event of a bioterrorist at21 tack or other public health emergency. 

22 ‘‘(2) PROCEDURES.—The Secretary, in man23 aging the stockpile under paragraph (1), shall—

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

25 section 319F(a); 
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1 ‘‘(B) ensure that adequate procedures are 

2 followed with respect to such stockpile for in3 ventory management and accounting, and for 

4 the physical security of the stockpile; 

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

6 and local officials, take into consideration the 

7 timing and location of special events; 

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

9 contents of the stockpile on a regular basis to 

10 ensure that emerging threats, advanced tech11 nologies, and new countermeasures are ade12 quately considered; 

13 ‘‘(E) devise plans for the effective and 

14 timely supply-chain management of the stock15 pile, in consultation with appropriate Federal, 

16 State and local agencies, and the public and 

17 private health care infrastructure; and 

18 ‘‘(F) ensure the adequate physical security 

19 of the stockpile. 

20 ‘‘(b) SMALLPOX VACCINE DEVELOPMENT.—

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

22 contracts, enter into cooperative agreements, or 

23 carry out such other activities as may reasonably be 

24 required in order to ensure that the stockpile under 

25 subsection (a) includes an amount of vaccine against 
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1 smallpox as determined by such Secretary to be suf2 ficient to meet the health security needs of the 

3 United States. 

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

5 this section shall be construed to limit the private 

6 distribution, purchase, or sale of vaccines from 

7 sources other than the stockpile described in sub8 section (a). 

9 ‘‘(c) ADDITIONAL AUTHORITY REGARDING PRO10 CUREMENT OF CERTAIN BIOMEDICAL COUNTER11 MEASURES; AVAILABILITY OF SPECIAL RESERVE

12 FUND.—

13 ‘‘(1) IN GENERAL.—

14 ‘‘(A) USE OF FUND.—A security counter15 measure may, in accordance with this sub16 section, be procured with amounts in the special 

17 reserve fund under paragraph (10). 

18 ‘‘(B) SECURITY COUNTERMEASURE.—For 

19 purposes of this subsection, the term ‘security 

20 countermeasure’ means a priority counter21 measure (as defined in section 319F(h))—

22 ‘‘(i) that affects national security; 

23 ‘‘(ii) that is determined under para24 graph (2)(B)(ii) to be a necessary counter25 measure; and 
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1 ‘‘(iii)(I) that is approved or cleared 

2 under chapter V of the Federal Food, 

3 Drug, and Cosmetic Act, or licensed under 

4 section 351 of this Act, for use as a coun5 termeasure to a chemical, biological, radio6 logical, or nuclear agent identified as a 

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

8 or 

9 ‘‘(II) for which the Secretary deter10 mines that sufficient and satisfactory clin11 ical experience or research data (including 

12 data, if available, from pre-clinical and 

13 clinical trials) support a reasonable conclu14 sion that the countermeasure will qualify 

15 for approval or licensing after the date of 

16 a determination under paragraph (5).

17 ‘‘(2) DETERMINATION OF MATERIAL

18 THREATS.—

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

20 Security Secretary, in consultation with the 

21 heads of other agencies as appropriate, shall on 

22 an ongoing basis—

23 ‘‘(i) assess current and emerging 

24 threats of chemical, biological, radiological, 

25 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 ‘‘(3) ASSESSMENT OF AVAILABILITY AND AP16 PROPRIATENESS OF COUNTERMEASURES.—The Sec17 retary, in consultation with the Homeland Security 

18 Secretary, shall assess on an ongoing basis the avail19 ability and appropriateness of specific counter20 measures to address specific threats identified under 

21 paragraph (2). 

22 ‘‘(4) CALL FOR SECURITY COUNTERMEASURES; 

23 COMMITMENT FOR RECOMMENDATION FOR PRO24 CUREMENT.—
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1 ‘‘(A) PROPOSAL TO THE PRESIDENT.—If, 

2 pursuant to an assessment under paragraph 

3 (3), the Homeland Security Secretary and the 

4 Secretary make a determination that a security 

5 countermeasure would be appropriate, such Sec6 retaries may jointly submit to the President a 

7 proposal to—

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

9 such security countermeasure; and 

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

11 the first development of such security 

12 countermeasure that meets the conditions 

13 for procurement under paragraph (5), the 

14 Secretaries will, based in part on informa15 tion obtained pursuant to such call, make 

16 a recommendation under paragraph (6) 

17 that the special reserve fund under para18 graph (10) be made available for the pro19 curement of such security countermeasure. 

20 ‘‘(B) COUNTERMEASURE SPECIFICA21 TIONS.—The Homeland Security Secretary and 

22 the Secretary shall, to the extent practicable, 

23 include in the proposal under subparagraph 

24 (A)—
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1 ‘‘(i) estimated quantity of purchase 

2 (in the form of number of doses or number 

3 of effective courses of treatments regard4 less of dosage form); 

5 ‘‘(ii) necessary measures of minimum 

6 safety and effectiveness; 

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

8 effective course of treatment regardless of 

9 dosage form; and 

10 ‘‘(iv) other information that may be 

11 necessary to encourage and facilitate re12 search, development, and manufacture of 

13 the countermeasure or to provide specifica14 tions for the countermeasure. 

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

16 President approves a proposal under subpara17 graph (A), the Homeland Security Secretary 

18 and the Secretary shall make known to persons 

19 who may respond to a call for the security 

20 countermeasure involved—

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

22 ‘‘(ii) specifications for the counter23 measure under subparagraph (B); and 

24 ‘‘(iii) a commitment described in sub25 paragraph (A)(ii). 
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1 ‘‘(5) SECRETARY’S DETERMINATION OF COUN2 TERMEASURES APPROPRIATE FOR FUNDING FROM

3 SPECIAL RESERVE FUND.—

4 ‘‘(A) IN GENERAL.—The Secretary, in ac5 cordance with the provisions of this paragraph, 

6 shall identify specific security countermeasures 

7 that the Secretary determines, in consultation 

8 with the Homeland Security Secretary, to be 

9 appropriate for inclusion in the stockpile under 

10 subsection (a) pursuant to procurements made 

11 with amounts in the special reserve fund under 

12 paragraph (10) (referred to in this subsection 

13 individually as a ‘procurement under this sub14 section’). 

15 ‘‘(B) REQUIREMENTS.—In making a deter16 mination under subparagraph (A) with respect 

17 to a security countermeasure, the Secretary 

18 shall determine and consider the following: 

19 ‘‘(i) The quantities of the product 

20 that will be needed to meet the needs of 

21 the stockpile. 

22 ‘‘(ii) The feasibility of production and 

23 delivery within five years of sufficient 

24 quantities of the product. 
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1 ‘‘(iii) Whether there is a lack of a sig2 nificant commercial market for the product 

3 at the time of procurement, other than as 

4 a security countermeasure. 

5 ‘‘(6) RECOMMENDATION FOR PRESIDENT’S AP6 PROVAL.—

7 ‘‘(A) RECOMMENDATION FOR PROCURE8 MENT.—In the case of a security counter9 measure that the Secretary has, in accordance 

10 with paragraphs (2), (3), and (5), determined 

11 to be appropriate for procurement under this 

12 subsection, the Homeland Security Secretary 

13 and the Secretary shall jointly submit to the 

14 President, in coordination with the Director of 

15 the Office of Management and Budget, a rec16 ommendation that the special reserve fund 

17 under paragraph (10) be made available for the 

18 procurement of such countermeasure.

19 ‘‘(B) PRESIDENTIAL APPROVAL.—The spe20 cial reserve fund under paragraph (10) is avail21 able for a procurement of a security counter22 measure only if the President has approved a 

23 recommendation under subparagraph (A) re24 garding the countermeasure. 
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1 ‘‘(C) NOTICE TO CONGRESS.—The Sec2 retary and the Homeland Security Secretary 

3 shall notify the Congress of each decision of the 

4 President to approve a recommendation under 

5 subparagraph (A). Such notice shall include an 

6 explanation of the decision to make available 

7 the special reserve fund under paragraph (10) 

8 for procurement of such a countermeasure, in9 cluding, where available, the identification of 

10 the potential supplier or suppliers of such coun11 termeasure, and whether other potential sup12 pliers of the same or similar countermeasures 

13 were considered and rejected for procurement 

14 under this section and the reasons therefor. 

15 ‘‘(D) SUBSEQUENT SPECIFIC COUNTER16 MEASURES.—Procurement under this sub17 section of a security countermeasure for a par18 ticular purpose does not preclude the subse19 quent procurement under this subsection of any 

20 other security countermeasure for such purpose 

21 if the Secretary has determined under para22 graph (5)(A) that such countermeasure is ap23 propriate for inclusion in the stockpile and if, 

24 as determined by the Secretary, such counter25 measure provides improved safety or effective-
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1 ness, or for other reasons enhances prepared2 ness to respond to threats of use of a biological, 

3 chemical, radiological, or nuclear agent. Such a 

4 determination by the Secretary is committed to 

5 agency discretion. 

6 ‘‘(E) RULE OF CONSTRUCTION.—Rec7 ommendations and approvals under this para8 graph apply solely to determinations that the 

9 special reserve fund under paragraph (10) will 

10 be made available for a procurement of a secu11 rity countermeasure, and not to the substance 

12 of contracts for such procurement or other mat13 ters relating to awards of such contracts. 

14 ‘‘(7) PROCUREMENT.—

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

16 procurement under this subsection that is ap17 proved by the President under paragraph (6), 

18 the Homeland Security Secretary and the Sec19 retary shall have responsibilities in accordance 

20 with subparagraphs (B) and (C). 

21 ‘‘(B) INTERAGENCY AGREEMENTS.—

22 ‘‘(i) FOR PROCUREMENT.—The 

23 Homeland Security Secretary shall enter 

24 into an agreement with the Secretary for 

25 procurement of a security countermeasure 
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1 in accordance with the provisions of this 

2 paragraph. The special reserve fund under 

3 paragraph (10) shall be available for the 

4 Secretary’s costs of such procurement, 

5 other than as provided in clause (ii). 

6 ‘‘(ii) FOR ADMINISTRATIVE COSTS.—

7 The agreement entered into between the 

8 Homeland Security Secretary and the Sec9 retary for managing the stockpile under 

10 subsection (a) shall provide for reimburse11 ment of the Secretary’s administrative 

12 costs relating to procurements under this 

13 subsection. 

14 ‘‘(C) PROCUREMENT.—

15 ‘‘(i) IN GENERAL.—The Secretary 

16 shall be responsible for—

17 ‘‘(I) arranging for procurement 

18 of a security countermeasure, includ19 ing negotiating terms (including quan20 tity, production schedule, and price) 

21 of, and entering into, contracts and 

22 cooperative agreements, and for car23 rying out such other activities as may 

24 reasonably be required, in accordance 
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1 with the provisions of this subpara2 graph; and 

3 ‘‘(II) promulgating regulations to 

4 implement clauses (v), (vi), and (vii), 

5 and any other provisions of this sub6 section. 

7 ‘‘(ii) CONTRACT TERMS.—A contract 

8 for procurements under this subsection 

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

10 the following terms: 

11 ‘‘(I) PAYMENT CONDITIONED ON

12 SUBSTANTIAL DELIVERY.—The con13 tract shall provide that no payment 

14 may be made until delivery has been 

15 made of a substantial portion (as de16 termined by the Secretary) of the 

17 total number of units contracted for, 

18 except that, notwithstanding any 

19 other provision of law, the contract 

20 may provide that, if the Secretary de21 termines (in the Secretary’s discre22 tion) that an advance payment is nec23 essary to ensure success of a project, 

24 the Secretary may pay an amount, not 

25 to exceed 10 percent of the contract 
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1 amount, in advance of delivery. The 

2 contract shall provide that such ad3 vance payment is required to be re4 paid if there is a failure to perform 

5 under the contract, except in special 

6 circumstances as determined by the 

7 Secretary on a contract by contract 

8 basis. 

9 ‘‘(II) CONTRACT DURATION.—

10 The contract shall be for a period not 

11 to exceed five years, except that, in 

12 first awarding the contract, the Sec13 retary may provide for a longer dura14 tion, not exceeding eight years, if the 

15 Secretary determines that complexities 

16 or other difficulties in performance 

17 under the contract justify such a pe18 riod. The contract shall be renewable

19 for additional periods, none of which 

20 shall exceed five years. 

21 ‘‘(III) STORAGE BY VENDOR.—

22 The contract may provide that the 

23 vendor will provide storage for stocks 

24 of a product delivered to the owner25 ship of the Federal Government under 
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1 the contract, for such period and 

2 under such terms and conditions as 

3 the Secretary may specify, and in 

4 such case amounts from the special 

5 reserve fund under paragraph (10) 

6 shall be available for costs of ship7 ping, handling, storage, and related 

8 costs for such product. 

9 ‘‘(iii) AVAILABILITY OF SIMPLIFIED

10 ACQUISITION PROCEDURES.—

11 ‘‘(I) IN GENERAL.—The amount 

12 of any procurement under this sub13 section shall be deemed to be below 

14 the threshold amount specified in sec15 tion 4(11) of the Office of Federal 

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

17 403(11)), for purposes of application 

18 to such procurement, pursuant to sec19 tion 302A(a) of the Federal Property 

20 and Administrative Services Act of 

21 1949 (41 U.S.C. 252a(a)), of—

22 ‘‘(aa) section 303(g)(1)(A) 

23 of the Federal Property and Ad24 ministrative Services Act of 1949 
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1 (41 U.S.C. 253(g)(1)(A)) and its 

2 implementing regulations; and 

3 ‘‘(bb) section 302A(b) of 

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

5 and its implementing regulations. 

6 ‘‘(II) APPLICATION OF CERTAIN

7 PROVISIONS.—Notwithstanding sub8 clause (I) and the provision of law 

9 and regulations referred to in such 

10 clause, each of the following provi11 sions shall apply to procurements de12 scribed in this clause to the same ex13 tent that such provisions would apply 

14 to such procurements in the absence 

15 of subclause (I): 

16 ‘‘(aa) Chapter 37 of title 40, 

17 United States Code (relating to 

18 contract work hours and safety 

19 standards). 

20 ‘‘(bb) Subsections (a) and 

21 (b) of Section 7 of the Anti-Kick22 back Act of 1986 (41 U.S.C. 

23 57(a) and (b)). 

24 ‘‘(cc) Section 304C of the 

25 Federal Property and Adminis-
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1 trative Services Act of 1949 (41 

2 U.S.C. 254d) (relating to the ––

3 – examination of contractor 

4 records). 

5 ‘‘(iv) USE OF NONCOMPETITIVE PRO6 CEDURES.—In addition to any other au7 thority to use procedures other than com8 petitive procedures, the Secretary may use 

9 such other procedures for a procurement 

10 under this subsection if the product is 

11 available from only one responsible source 

12 or only from a limited number of respon13 sible sources, and no other type of product 

14 will satisfy the Secretary’s needs. 

15 ‘‘(v) PREMIUM PROVISION IN MUL16 TIPLE AWARD CONTRACTS.—

17 ‘‘(I) IN GENERAL.—If, under this 

18 subsection, the Secretary enters into 

19 contracts with more than one vendor 

20 to procure a security countermeasure, 

21 such Secretary may, notwithstanding 

22 any other provision of law, include in 

23 each of such contracts a provision 

24 that—
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1 ‘‘(aa) identifies an increment 

2 of the total quantity of security 

3 countermeasure required, wheth4 er by percentage or by numbers 

5 of units; and 

6 ‘‘(bb) promises to pay one or 

7 more specified premiums based 

8 on the priority of such vendors’ 

9 production and delivery of the in10 crement identified under item 

11 (aa), in accordance with the 

12 terms and conditions of the con13 tract. 

14 ‘‘(II) DETERMINATION OF GOV15 ERNMENT’S REQUIREMENT NOT RE16 VIEWABLE.—If the Secretary includes 

17 in each of a set of contracts a provi18 sion as described in subclause (I), 

19 such Secretary’s determination of the 

20 total quantity of security counter21 measure required, and any amend22 ment of such determination, is com23 mitted to agency discretion. 

24 ‘‘(vi) EXTENSION OF CLOSING DATE

25 FOR RECEIPT OF PROPOSALS NOT REVIEW-
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1 ABLE.—A decision by the Secretary to ex2 tend the closing date for receipt of pro3 posals for a procurement under this sub4 section is committed to agency discretion. 

5 ‘‘(vii) LIMITING COMPETITION TO

6 SOURCES RESPONDING TO REQUEST FOR

7 INFORMATION.—In conducting a procure8 ment under this subsection, the Secretary 

9 may exclude a source that has not re10 sponded to a request for information under 

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

12 Property and Administrative Services Act 

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

14 request has given notice that the Secretary 

15 may so exclude such a source. 

16 ‘‘(8) INTERAGENCY COOPERATION.—

17 ‘‘(A) IN GENERAL.—In carrying out activi18 ties under this section, the Homeland Security 

19 Secretary and the Secretary are authorized, 

20 subject to subparagraph (B), to enter into 

21 interagency agreements and other collaborative

22 undertakings with other agencies of the United 

23 States Government. 

24 ‘‘(B) LIMITATION.—An agreement or un25 dertaking under this paragraph shall not au-
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1 thorize another agency to exercise the authori2 ties provided by this section to the Homeland 

3 Security Secretary or to the Secretary. 

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

5 Amounts in the special reserve fund under para6 graph (10) shall not be used to pay—

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

8 under procurement contracts entered into be9 fore the date of the enactment of the Project 

10 BioShield Act of 2003; or 

11 ‘‘(B) administrative costs. 

12 ‘‘(10) SPECIAL RESERVE FUND.—For purposes 

13 of this subsection, the term ‘special reserve fund’ 

14 has the meaning given such term in section 510 of 

15 the Homeland Security Act of 2002. 

16 ‘‘(d) DISCLOSURES.—No Federal agency shall dis17 close under section 552, United States Code, any informa18 tion identifying the location at which materials in the 

19 stockpile under subsection (a) are stored. 

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

21 the term ‘stockpile’ includes—

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

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

24 or 
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1 ‘‘(2) a contractual agreement between the 

2 Homeland Security Secretary and a vendor or ven3 dors under which such vendor or vendors agree to 

4 provide to such Secretary supplies described in sub5 section (a). 

6 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

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

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

9 authorized to be appropriated $640,000,000 for fis10 cal year 2002, and such sums as may be necessary 

11 for each of fiscal years 2003 through 2006. Such 

12 authorization is in addition to amounts in the special 

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

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

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

16 authorized to be appropriated $509,000,000 for fis17 cal year 2002, and such sums as may be necessary 

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

19 (b) AMENDMENT TO HOMELAND SECURITY ACT OF

20 2002.—Title V of the Homeland Security Act of 2002 

21 (116 Stat. 2212; 6 U.S.C. 311 et seq.) is amended by add22 ing at the end the following: 
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1 ‘‘SEC. 510. PROCUREMENT OF SECURITY COUNTER2 MEASURES FOR STRATEGIC NATIONAL 

3 STOCKPILE. 

4 ‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—For 

5 procurement of security countermeasures under section 

6 319F–2(c) of the Public Health Service Act (referred to 

7 in this section as the ‘security countermeasures program’), 

8 there is authorized to be appropriated up to 

9 $5,593,000,000 for the fiscal years 2004 through 2013. 

10 Of the amounts appropriated under the preceding sen11 tence, not to exceed $3,418,000,000 may be obligated dur12 ing the fiscal years 2004 through 2008, of which not to 

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

14 2004. 

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

16 security countermeasures program, the term ‘special re17 serve fund’ means the appropriations account established 

18 as a result of any appropriations made under subsection 

19 (a). 

20 ‘‘(c) AVAILABILITY.—

21 ‘‘(1) DURATION OF AVAILABILITY FOR OBLIGA22 TION.—Subject to paragraph (2), all amounts appro23 priated under subsection (a) are available for obliga24 tion through the end of fiscal year 2013, provided 

25 that any portion of such amount that remains unob26 ligated for such purposes on the expiration of such 
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1 term shall be returned to the United States Treas2 ury and shall not be available for subsequent obliga3 tion for any purpose. 

4 ‘‘(2) INITIAL AVAILABILITY FOR PARTICULAR

5 PROCUREMENTS.—Amounts appropriated under sub6 section (a) become available for a procurement 

7 under the security countermeasures program only 

8 upon the approval by the President of such avail9 ability for the procurement in accordance with para10 graph (6)(B) of such program.’’. 

11 (c) CONFORMING AMENDMENT.—Section 121 of the 

12 Public Health Security and Bioterrorism Preparedness 

13 and Response Act of 2002 (116 Stat. 611; 42 U.S.C. 

14 300hh–12) is repealed. With respect to the program estab15 lished under former section 121 of such Act, the repeal 

16 of such section under the preceding sentence applies as 

17 a modification of the program in accordance with the 

18 amendment made by subsection (a) of this section, and 

19 not as the termination of the program and the establish20 ment of a different program. 

21 SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

22 USE IN EMERGENCIES. 

23 Subchapter E of chapter V of the Federal Food, 

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

25 amended by adding at the end the following section: 
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1 ‘‘SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

2 USE IN EMERGENCIES. 

3 ‘‘(a) IN GENERAL.—

4 ‘‘(1) EMERGENCY USES.—Notwithstanding sec5 tions 505, 510(k), and 515 of this Act and section 

6 351 of the Public Health Service Act, and subject to 

7 the provisions of this section, the Secretary may au8 thorize the introduction into interstate commerce, 

9 during the effective period of a declaration under 

10 subsection (b), of a drug or device intended for use 

11 in an actual or potential emergency (referred to in 

12 this section as an ‘emergency use’). 

13 ‘‘(2) APPROVAL STATUS OF PRODUCT.—An au14 thorization under paragraph (1) may authorize an 

15 emergency use of a product that—

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

17 for commercial distribution under a provision of 

18 law referred to in such paragraph (referred to 

19 in this section as an ‘unapproved product’); or 

20 ‘‘(B) is approved, licensed, or cleared 

21 under such a provision, but which use is not 

22 under such provision an approved, licensed, or 

23 cleared use of the product (referred to in this 

24 section as an ‘unapproved use of an approved 

25 product’).
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1 ‘‘(3) RELATION TO OTHER USES.—An emer2 gency use authorized under paragraph (1) for a 

3 product is in addition to any other use that is au4 thorized for the product under a provision of law re5 ferred to in such paragraph. 

6 ‘‘(4) DEFINITIONS.—For purposes of this sec7 tion: 

8 ‘‘(A) The term ‘emergency use’ has the 

9 meaning indicated for such term in paragraph 

10 (1). 

11 ‘‘(B) The term ‘product’ means a drug or 

12 device. 

13 ‘‘(C) The term ‘unapproved product’ has 

14 the meaning indicated for such term in para15 graph (2)(A). 

16 ‘‘(D) The term ‘unapproved use of an ap17 proved product’ has the meaning indicated for 

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

19 ‘‘(b) DECLARATION OF EMERGENCY.—

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

21 an emergency justifying the authorization under this 

22 subsection for a product on the basis of—

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

24 Homeland Security that there is a national 

25 emergency, or a significant potential for a na-
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1 tional emergency, involving a heightened risk of 

2 attack with a specified biological, chemical, ra3 diological, or nuclear agent or agents; 

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

5 Defense that there is a military emergency, or 

6 a significant potential for a military emergency, 

7 involving a heightened risk to United States 

8 military forces of attack with a biological, 

9 chemical, radiological, or nuclear agent or 

10 agents; or 

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

12 public health emergency under section 319 of 

13 the Public Health Service Act, affecting na14 tional security and involving a specified biologi15 cal, chemical, radiological, or nuclear agent or 

16 agents, or a specified disease or condition that 

17 may be attributable to such agent or agents. 

18 ‘‘(2) TERMINATION OF DECLARATION.—

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

20 this subsection shall terminate upon the earlier 

21 of—

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

23 in consultation as appropriate with the 

24 Secretary of Homeland Security or the 

25 Secretary of Defense, that the cir-
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1 cumstances described in paragraph (1) 

2 have ceased to exist; or 

3 ‘‘(ii) the expiration of the one-year pe4 riod beginning on the date on which the 

5 declaration is made. 

6 ‘‘(B) RENEWAL.—Notwithstanding sub7 paragraph (A), the Secretary may renew a dec8 laration under this subsection, and this para9 graph shall apply to any such renewal. 

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

11 terminating a declaration under this section, the 

12 Secretary shall provide advance notice that the dec13 laration will be terminated. The period of advance 

14 notice shall be a period reasonably determined to 

15 provide—

16 ‘‘(A) in the case of an unapproved product, 

17 a sufficient period for disposition of shipments 

18 of the product, including the return of such 

19 shipments to the manufacturer (in the case of 

20 a manufacturer that chooses to have the ship21 ments returned); and 

22 ‘‘(B) in the case of unapproved uses of ap23 proved products, a sufficient period for the dis24 position of any labeling that was provided with 

25 respect to the emergency use involved. 
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1 ‘‘(4) PUBLICATION.—The Secretary shall 

2 promptly publish in the Federal Register each dec3 laration, determination, and renewal under this sub4 section. 

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

6 The Secretary may issue an authorization under this sec7 tion with respect to the emergency use of a product only 

8 if, after consultation with the Director of the National In9 stitutes of Health and the Director of the Centers for Dis10 ease Control and Prevention, to the extent feasible and 

11 appropriate given the circumstances of the emergency in12 volved, the Secretary concludes—

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

14 under subsection (b) can cause a serious or life15 threatening disease or condition; 

16 ‘‘(2) that, based on the totality of scientific evi17 dence available to the Secretary, including data from 

18 adequate and well-controlled clinical trials, if avail19 able, it is reasonable to believe that—

20 ‘‘(A) the product may be effective in de21 tecting, diagnosing, treating, or preventing—

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

23 ‘‘(ii) a serious or life-threatening dis24 ease or condition caused by a product au25 thorized under this section or approved 
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1 under this Act or the Public Health Serv2 ice Act, for detecting, diagnosing, treating, 

3 or preventing such a disease or condition 

4 caused by such an agent; and 

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

6 the product, when used to detect, diagnose, pre7 vent, or treat such disease or condition, out8 weigh the known and potential risks of the 

9 product; 

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

11 available alternative to the product for detecting, di12 agnosing, preventing, or treating such disease or 

13 condition; and 

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

15 may by regulation prescribe are satisfied. 

16 ‘‘(d) SCOPE OF AUTHORIZATION.—

17 ‘‘(1) IN GENERAL.—An authorization of a prod18 uct under this section shall state—

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

20 product may be used to detect, diagnose, pre21 vent, or treat within the scope of the authoriza22 tion; 

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

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

25 potential benefits of the product, when used to
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1 detect, diagnose, prevent, or treat such disease 

2 or condition, outweigh the known and potential 

3 risks of the product; and 

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

5 under subsection (c), concerning the safety and 

6 potential effectiveness of the product in detect7 ing, diagnosing, preventing, or treating such 

8 diseases or conditions, including an assessment 

9 of the available scientific evidence. 

10 ‘‘(2) CONFIDENTIAL INFORMATION.—Nothing 

11 in this section alters or amends section 1905 of title 

12 18, United States Code, or section 552(b)(4) of title 

13 5 of such Code. 

14 ‘‘(e) CONDITIONS OF AUTHORIZATION.—

15 ‘‘(1) UNAPPROVED PRODUCT.—

16 ‘‘(A) REQUIRED CONDITIONS.—With re17 spect to the emergency use of an unapproved 

18 product, the Secretary, to the extent feasible 

19 given the circumstances of the emergency, shall, 

20 for persons who choose to carry out one or 

21 more activities for which the authorization is 

22 issued, establish such conditions on an author23 ization under this section as the Secretary finds 

24 necessary or appropriate to protect the public 

25 health, including the following: 
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1 ‘‘(i) Appropriate conditions designed 

2 to ensure that, to the extent feasible given 

3 the circumstances of the emergency, health 

4 care professionals administering the prod5 uct are informed—

6 ‘‘(I) that the Secretary has au7 thorized the emergency use of the 

8 product; 

9 ‘‘(II) of the significant known 

10 and potential benefits and risks of the 

11 emergency use of the product, and of 

12 the extent to which such benefits and 

13 risks are unknown; and 

14 ‘‘(III) of the alternatives to the 

15 product that are available, and of 

16 their benefits and risks. 

17 ‘‘(ii) Appropriate conditions designed 

18 to ensure that, to the extent feasible given 

19 the circumstances of the emergency, indi20 viduals to whom the product is adminis21 tered are informed—

22 ‘‘(I) that the Secretary has au23 thorized the emergency use of the 

24 product; 
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1 ‘‘(II) of the significant known 

2 and potential benefits and risks of 

3 such use, and of the extent to which 

4 such benefits and risks are unknown; 

5 and 

6 ‘‘(III) of the option to accept or 

7 refuse administration of the product, 

8 of the consequences, if any, of refus9 ing administration of the product, and 

10 of the alternatives to the product that 

11 are available and of their benefits and 

12 risks. 

13 ‘‘(iii) Appropriate conditions for the 

14 monitoring and reporting of adverse events 

15 associated with the emergency use of the 

16 product. 

17 ‘‘(iv) For manufacturers of the prod18 uct, appropriate conditions concerning rec19 ordkeeping and reporting, including 

20 records access by the Secretary, with re21 spect to the emergency use of the product. 

22 ‘‘(B) AUTHORITY FOR ADDITIONAL CONDI23 TIONS.—With respect to the emergency use of 

24 an unapproved product, the Secretary, to the 

25 extent feasible given the circumstances of the 
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1 emergency, may, for persons who choose to 

2 carry out one or more activities for which the 

3 authorization is issued, establish such condi4 tions on an authorization under this section as 

5 the Secretary finds necessary or appropriate to 

6 protect the public health, including the fol7 lowing: 

8 ‘‘(i) Appropriate conditions on which 

9 entities may distribute the product with re10 spect to the emergency use of the product 

11 (including limitation to distribution by gov12 ernment entities), and on how distribution 

13 is to be performed. 

14 ‘‘(ii) Appropriate conditions on who 

15 may administer the product with respect to 

16 the emergency use of the product, and on 

17 the categories of individuals to whom, and 

18 the circumstances under which, the prod19 uct may be administered with respect to 

20 such use. 

21 ‘‘(iii) For persons other than manu22 facturers of the product, appropriate con23 ditions concerning recordkeeping and re24 porting, including records access by the 
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1 Secretary, with respect to the emergency 

2 use of the product. 

3 ‘‘(iv) With respect to the emergency 

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

5 extent appropriate given the circumstances 

6 of the emergency, conditions regarding 

7 current good manufacturing practice other8 wise applicable to the manufacture, proc9 essing, packing, or holding of products 

10 subject to regulation under this Act, in11 cluding such requirements established in 

12 section 501. 

13 ‘‘(2) UNAPPROVED USE.—With respect to the 

14 emergency use of a product that is an unapproved 

15 use of an approved product: 

16 ‘‘(A) The Secretary may, for manufactur17 ers of the product who choose to carry out one 

18 or more activities for which the authorization is 

19 issued, establish any of the conditions described 

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

21 ‘‘(B)(i) If the authorization under this sec22 tion regarding the emergency use authorizes a 

23 change in the labeling of the product, but the 

24 manufacturer of the product chooses not to 

25 make such change, such authorization may not
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1 authorize distributors of the product or any 

2 other person to alter or obscure the labeling 

3 provided by the manufacturer. 

4 ‘‘(ii) In the circumstances described in 

5 clause (i), an authorization under this section 

6 regarding the emergency use may, for persons 

7 who do not manufacture the product and who 

8 choose to act under this clause, authorize such 

9 persons to provide information on the product 

10 in addition to the labeling provided by the man11 ufacturer, subject to compliance with clause (i). 

12 Such additional information shall not be consid13 ered labeling for purposes of section 502. 

14 ‘‘(f) DURATION OF AUTHORIZATION.—

15 ‘‘(1) IN GENERAL.—Except as provided in para16 graph (2), an authorization under this section shall 

17 be effective until the earlier of the termination of the 

18 declaration under subsection (b) or a revocation 

19 under subsection (g). 

20 ‘‘(2) CONTINUED USE AFTER END OF EFFEC21 TIVE PERIOD.—An authorization shall continue to be 

22 effective for continued use with respect to patients 

23 to whom it was administered during the period de24 scribed by paragraph (1), to the extent found nec25 essary by such patients’ attending physicians. 
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1 ‘‘(g) REVOCATION OF AUTHORIZATION.—

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

3 review the circumstances and the appropriateness of 

4 an authorization under this section. 

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

6 an authorization under this section if, in the Sec7 retary’s unreviewable discretion, the criteria under 

8 subsection (c) for issuance of such authorization are 

9 no longer met. 

10 ‘‘(h) PUBLICATION.—The Secretary shall promptly 

11 publish in the Federal Register a notice of each authoriza12 tion, and each termination or revocation of an authoriza13 tion, and an explanation of the reasons therefor, under 

14 this section. 

15 ‘‘(i) ACTIONS COMMITTED TO AGENCY DISCRE16 TION.—Actions under the authority of this section by the 

17 Secretary, by the Secretary of Defense, or by the Sec18 retary of Homeland Security are committed to agency dis19 cretion. 

20 ‘‘(j) RULES OF CONSTRUCTION.—Nothing in this sec21 tion shall be construed to impair or otherwise affect—

22 ‘‘(1) the authority of the President as Com23 mander in Chief of the Armed Forces of the United 

24 States under article II, section 2 of the United 

25 States Constitution; 
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1 ‘‘(2) the authority of the Secretary of Defense 

2 with respect to the Department of Defense, includ3 ing the armed forces, under other provisions of Fed4 eral law; or 

5 ‘‘(3) the authority of the Secretary under sec6 tion 319F–2 to manage the stockpile under such 

7 section. 

8 ‘‘(k) APPLICATION TO MEMBERS OF ARMED

9 FORCES.—

10 ‘‘(1) WAIVER OF REQUIREMENT RELATING TO

11 OPTION TO REFUSE.—In the case of administration 

12 of a countermeasure to members of the armed 

13 forces, a requirement, under subsection 

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

15 are informed of an option to accept or refuse admin16 istration of a product, may be waived by the Presi17 dent if the President determines, in writing, that 

18 complying with such requirement is not feasible, is 

19 contrary to the best interests of the members af20 fected, or is not in the interests of national security. 

21 ‘‘(2) PROVISION OF INFORMATION TO MEMBER

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

23 determination that it is not feasible for the informa24 tion required by subsection (e)(1)(A)(ii) to be pro25 vided to a member of the armed forces prior to the 
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1 administration of the product, such information shall 

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

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

4 whom the product was administered as soon as pos5 sible, but not later than 30 days, after such adminis6 tration. Information concerning the administration 

7 of the product shall be recorded in the medical 

8 record of the member. 

9 ‘‘(3) EFFECT ON STATUTE PERTAINING TO IN10 VESTIGATIONAL NEW DRUGS.—In the case of an au11 thorization based on a determination by the Sec12 retary of Defense under subsection (b)(1)(B), sec13 tion 1107 of title 10, United States Code, shall not 

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

15 authorization, within the scope of such authorization 

16 and while such authorization is effective. 

17 ‘‘(l) RELATION TO OTHER PROVISIONS.—If a prod18 uct is the subject of an authorization under this section, 

19 the use of such product within the scope of the authoriza20 tion —

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

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

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

24 otherwise applicable to clinical investigations pursu25 ant to other provisions of this Act. 
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1 ‘‘(m) DISCRETION REGARDING USE OF AUTHORIZA2 TION.—Nothing in this section provides the Secretary any 

3 authority to require any person to carry out any activity 

4 that becomes lawful pursuant to an authorization under 

5 this section, and no person is required to inform the Sec6 retary that the person will not be carrying out such activ7 ity, except that a manufacturer of a sole-source unap8 proved product authorized for emergency use shall notify 

9 the Secretary within a reasonable period of time after the 

10 issuance by the Secretary of such authorization if such 

11 manufacturer does not intend to carry out an activity or 

12 activities under the authorization. This section does not 

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

14 any activity for which an authorization under this section 

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

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

17 Health Service Act. 

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

19 activity pursuant to an authorization under this section, 

20 but who fails to comply with applicable conditions under 

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

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

23 and to the enforcement of such provisions under section 

24 301.’’.
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1 SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS 

2 ACT. 

3 (a) SECRETARY OF HEALTH AND HUMAN SERV4 ICES.—

5 (1) ANNUAL REPORTS ON PARTICULAR EXER6 CISES OF AUTHORITY.—

7 (A) RELEVANT AUTHORITIES.—The Sec8 retary of Health and Human Services (referred 

9 to in this subsection as the ‘‘Secretary’’) shall 

10 submit reports in accordance with subpara11 graph (B) regarding the exercise of authority 

12 under the following provisions of law: 

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

14 the Public Health Service Act (as added by 

15 section 2 of this Act): 

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

17 increased simplified acquisition 

18 threshold). 

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

20 use of noncompetitive procedures). 

21 (III) Subsection (c) (relating to 

22 expedited peer review procedures). 

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

24 the Public Health Service Act (as added by 

25 section 3 of this Act): 
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1 (I) Subsection (c)(7)(C)(iii) (re2 lating to simplified acquisition proce3 dures). 

4 (II) Subsection (c)(7)(C)(iv) (re5 lating to use of noncompetitive proce6 dures). 

7 (III) Subsection (c)(7)(C)(v) (re8 lating to premium provision in mul9 tiple-award contracts). 

10 (iii) With respect to section 564 of the 

11 Federal Food, Drug, and Cosmetic Act (as 

12 added by section 4 of this Act): 

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

14 emergency uses of certain drugs and 

15 devices). 

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

17 a declaration of an emergency). 

18 (III) Subsection (e) (relating to 

19 conditions on authorization). 

20 (B) CONTENTS OF REPORTS.—The Sec21 retary shall annually submit to the Congress a 

22 report that summarizes—

23 (i) the particular actions that were 

24 taken under the authorities specified in 

25 subparagraph (A), including, as applicable, 
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1 the identification of the threat agent, 

2 emergency, or the biomedical counter3 measure with respect to which the author4 ity was used; 

5 (ii) the reasons underlying the deci6 sion to use such authorities, including, as 

7 applicable, the options that were consid8 ered and rejected with respect to the use of 

9 such authorities; and 

10 (iii) the identification of each person 

11 or entity that received, or was considered 

12 and rejected for, grants, cooperative agree13 ments, or contracts pursuant to the use of 

14 such authorities. 

15 (2) ANNUAL SUMMARIES REGARDING CERTAIN

16 ACTIVITY.—The Secretary shall annually submit to 

17 the Congress a report that summarizes the activity 

18 undertaken pursuant to the following authorities 

19 under section 319F–1 of the Public Health Service 

20 Act (as added by section 2 of this Act): 

21 (A) Subsection (b)(3) (relating to in22 creased micropurchase threshold). 

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

24 for personal services contracts). 
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1 (C) Subsection (e) (relating to streamlined 

2 personnel authority). 

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

4 include a provision specifying, for the one-year pe5 riod for which the report is submitted, the number 

6 of persons who were paid amounts greater than 

7 $100,000 and the number of persons who were paid 

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

9 (b) NATIONAL ACADEMY OF SCIENCES REVIEW.—

10 Not later than three years after the date of the enactment 

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

12 shall request the National Academy of Sciences to enter 

13 into an agreement for a review of the biomedical counter14 measure research and development authorities established 

15 in this Act to determine whether and to what extent activi16 ties undertaken pursuant to such authorities have en17 hanced the development of biomedical countermeasures af18 fecting national security, and to recommend any legislative 

19 or administrative changes necessary to improve the ability 

20 of the Secretary to carry out these activities in the future. 

21 The Secretary shall ensure that the results of the study 

22 are submitted to the Congress not later than five years 

23 after such date of enactment. 

24 (c) GENERAL ACCOUNTING OFFICE REVIEW.—Four 

25 years after the date of the enactment of this Act, the 
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1 Comptroller General of the United States shall initiate a 

2 study—

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

4 Human Services’ utilization of the authorities grant5 ed under this Act with respect to simplified acquisi6 tion procedures, use of noncompetitive procedures, 

7 increased micropurchase thresholds, personal serv8 ices contracts, streamlined personnel authority, and 

9 the purchase of security countermeasures under the 

10 special reserve fund; and 

11 (B) to recommend any legislative or administra12 tive changes necessary to improve the utilization or 

13 effectiveness of such authorities in the future; 

14 (2)(A) to review the internal controls instituted 

15 by such Secretary with respect to such authorities, 

16 where required by this Act; and 

17 (B) to recommend any legislative or administra18 tive changes necessary to improve the effectiveness 

19 of such controls; and 

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

21 the authority granted under this Act to authorize an 

22 emergency use of a biomedical countermeasure, in23 cluding the means by which the Secretary deter24 mines whether and under what conditions any such 

25 authorizations should be granted and the benefits 
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1 and adverse impacts, if any, resulting from the use 

2 of such authority; and 

3 (B) to recommend any legislative or administra4 tive changes necessary to improve the utilization or 

5 effectiveness of such authority and to enhance pro6 tection of the public health. 

7 The results of the study shall be submitted to the Con8 gress not later than five years after the date of the enact9 ment of this Act.

10 SECTION 1. SHORT TITLE. 

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

12 of 2003’’. 

13 SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND 

14 DEVELOPMENT AUTHORITIES. 

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

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

17 inserting after section 319F the following section: 

18 ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE19 DURES REGARDING BIOMEDICAL COUNTER20 MEASURE RESEARCH AND DEVELOPMENT AC21 TIVITIES. 

22 ‘‘(a) IN GENERAL.—

23 ‘‘(1) AUTHORITY.—In conducting and sup24 porting research and development activities regarding 

25 biomedical countermeasures under section 319F(h), 
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1 the Secretary may conduct and support such activi2 ties in accordance with this section if the activities 

3 concern qualified countermeasures. 

4 ‘‘(2) QUALIFIED COUNTERMEASURE.—For pur5 poses of this section, the term ‘qualified counter6 measure’ means a priority countermeasure (as defined 

7 in section 319F(h)) that affects national security. 

8 ‘‘(3) INTERAGENCY COOPERATION.—

9 ‘‘(A) IN GENERAL.—In carrying out activi10 ties under this section, the Secretary is author11 ized, subject to subparagraph (B), to enter into 

12 interagency agreements and other collaborative 

13 undertakings with other agencies of the United 

14 States Government. 

15 ‘‘(B) LIMITATION.—An agreement or under16 taking under this paragraph shall not authorize 

17 another agency to exercise the authorities pro18 vided by this section. 

19 ‘‘(4) AVAILABILITY OF FACILITIES TO THE SEC20 RETARY.—In any grant or cooperative agreement en21 tered into under the authority provided in this section 

22 with respect to a biocontainment laboratory or other 

23 related or ancillary specialized research facility that 

24 the Secretary determines necessary for the purpose of 

25 performing, administering, and supporting qualified 
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1 countermeasure research and development, the Sec2 retary may provide that the facility that is the object 

3 of such grant or cooperative agreement shall be avail4 able as needed to the Secretary to respond to public 

5 health emergencies affecting national security. 

6 ‘‘(b) EXPEDITED PROCUREMENT AUTHORITY.—

7 ‘‘(1) INCREASED SIMPLIFIED ACQUISITION

8 THRESHOLD FOR BIOMEDICAL COUNTERMEASURE

9 PROCUREMENTS.—

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

11 by the Secretary of property or services for use 

12 (as determined by the Secretary) in performing, 

13 administering, or supporting qualified counter14 measure research or development activities under 

15 this section that the Secretary determines nec16 essary to respond to pressing research and devel17 opment needs under this section, the amount 

18 specified in section 4(11) of the Office of Federal 

19 Procurement Policy Act (41 U.S.C. 403(11)), as 

20 applicable pursuant to section 302A(a) of the 

21 Federal Property and Administrative Services 

22 Act of 1949 (41 U.S.C. 252a(a)), shall be deemed 

23 to be $25,000,000 in the administration, with re24 spect to such procurement, of—
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1 ‘‘(i) section 303(g)(1)(A) of the Federal 

2 Property and Administrative Services Act 

3 of 1949 (41 U.S.C. 253(g)(1)(A)) and its 

4 implementing regulations; and

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

6 U.S.C. 252a(b)) and its implementing regu7 lations. 

8 ‘‘(B) APPLICATION OF CERTAIN PROVI9 SIONS.—Notwithstanding subparagraph (A) and 

10 the provision of law and regulations referred to 

11 in such subparagraph, each of the following pro12 visions shall apply to procurements described in 

13 this paragraph to the same extent that such pro14 visions would apply to such procurements in the 

15 absence of subparagraph (A): 

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

17 States Code (relating to contract work hours 

18 and safety standards). 

19 ‘‘(ii) Subsections (a) and (b) of section 

20 7 of the Anti-Kickback Act of 1986 (41 

21 U.S.C. 57(a) and (b)). 

22 ‘‘(iii) Section 304C of the Federal 

23 Property and Administrative Services Act 

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

25 examination of contractor records). 
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1 ‘‘(C) INTERNAL CONTROLS TO BE INSTI2 TUTED.—The Secretary shall institute appro3 priate internal controls for procurements that 

4 are under this paragraph, including require5 ments with regard to documenting the justifica6 tion for use of the authority in this paragraph.

7 ‘‘(2) OTHER THAN FULL AND OPEN COMPETI8 TION.—(A) In using the authority provided in section 

9 303(c)(1) of title III of the Federal Property and Ad10 ministrative Services Act of 1949 (41 U.S.C. 

11 253(c)(1)) to use procedures other than competitive 

12 procedures in the case of a procurement described in 

13 paragraph (1) of this subsection, the phrase ‘available 

14 from only one responsible source’ in such section 

15 303(c)(1) shall be deemed to mean ‘available from 

16 only one responsible source or only from a limited 

17 number of responsible sources’. 

18 ‘‘(B) The authority under subparagraph (A) is 

19 in addition to any other authority to use procedures 

20 other than competitive procedures. 

21 ‘‘(C) The Secretary shall implement this para22 graph in accordance with applicable government-wide 

23 regulations, including requirements that offers be so24 licited from as many potential sources as is prac-
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1 ticable under the circumstances, that required notices 

2 be published, and that submitted offers be considered. 

3 ‘‘(3) INCREASED MICROPURCHASE THRESH4 OLD.—

5 ‘‘(A) IN GENERAL.—For a procurement de6 scribed by paragraph (1), the amount specified 

7 in subsections (c), (d), and (f) of section 32 of the 

8 Office of Federal Procurement Policy Act (41 

9 U.S.C. 428) shall be deemed to be $15,000 in the 

10 administration of that section with respect to 

11 such procurement.

12 ‘‘(B) INTERNAL CONTROLS TO BE INSTI13 TUTED.—The Secretary shall institute appro14 priate internal controls for purchases that are 

15 under this paragraph and that are greater than 

16 $2,500. 

17 ‘‘(C) EXCEPTION TO PREFERENCE FOR PUR18 CHASE CARD MECHANISM.—No provision of law 

19 establishing a preference for using a Government 

20 purchase card method for purchases shall apply 

21 to purchases that are under this paragraph and 

22 that are greater than $2,500. 

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

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

25 Secretary determines necessary to respond to pressing 
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1 qualified countermeasure research and development 

2 needs under this section, employ such expedited peer 

3 review procedures (including consultation with ap4 propriate scientific experts) as the Secretary, in con5 sultation with the Director of NIH, deems appro6 priate to obtain assessment of scientific and technical 

7 merit and likely contribution to the field of qualified 

8 countermeasure research, in place of the peer review 

9 and advisory council review procedures that would be 

10 required under sections 301(a)(3), 405(b)(1)(B), 

11 405(b)(2), 406(a)(3)(A), 492, and 494, as applicable 

12 to a grant, contract, or cooperative agreement—

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

14 or supporting qualified countermeasure research 

15 and development activities; and 

16 ‘‘(B) the amount of which is not greater 

17 than $1,500,000. 

18 ‘‘(2) SUBSEQUENT PHASES OF RESEARCH.—The 

19 Secretary’s determination of whether to employ expe20 dited peer review with respect to subsequent phases of 

21 a research grant or cooperative agreement under this 

22 section shall be determined without regard to the peer 

23 review procedures used for any prior peer review of 

24 that same grant or cooperative agreement. 
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1 ‘‘(d) AUTHORITY FOR PERSONAL SERVICES CON2 TRACTS.—

3 ‘‘(1) IN GENERAL.—For the purpose of per4 forming, administering, and supporting qualified 

5 countermeasure research and development activities, 

6 the Secretary may, as the Secretary determines nec7 essary to respond to pressing qualified counter8 measure research and development needs under this 

9 section, obtain by contract (in accordance with sec10 tion 3109 of title 5, United States Code, but without 

11 regard to the limitations in such section on the period 

12 of service and on pay) the personal services of experts 

13 or consultants who have scientific or other profes14 sional qualifications, except that in no case shall the 

15 compensation provided to any such expert or consult16 ant exceed the daily equivalent of the annual rate of 

17 compensation for the President. 

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

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

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

21 employee, or governing board member of such 

22 person, shall be deemed to be an employee of the 

23 Department of Health and Human Services for 

24 purposes of claims under sections 1346(b) and 

25 2672 of title 28, United States Code, for money 
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1 damages for personal injury, including death, re2 sulting from performance of functions under such 

3 contract. 

4 ‘‘(B) EXCLUSIVITY OF REMEDY.—The rem5 edy provided by subparagraph (A) shall be exclu6 sive of any other civil action or proceeding by 

7 reason of the same subject matter against the 

8 person, officer, employee, or governing board 

9 member. 

10 ‘‘(3) INTERNAL CONTROLS TO BE INSTITUTED.—

11 ‘‘(A) IN GENERAL.—The Secretary shall in12 stitute appropriate internal controls for con13 tracts under this subsection, including proce14 dures for the Secretary to make a determination 

15 of whether a person, or an officer, employee, or 

16 governing board member of a person, is deemed 

17 to be an employee of the Department of Health 

18 and Human Services pursuant to paragraph (2). 

19 ‘‘(B) DETERMINATION OF EMPLOYEE STA20 TUS TO BE FINAL.—A determination by the Sec21 retary under subparagraph (A) that a person, or 

22 an officer, employee, or governing board member 

23 of a person, is or is not deemed to be an em24 ployee of the Department of Health and Human 

25 Services shall be final and binding on the Sec-
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1 retary and the Attorney General and other par2 ties to any civil action or proceeding. 

3 ‘‘(4) NUMBER OF PERSONAL SERVICES CON4 TRACTS LIMITED.—The number of experts and con5 sultants whose personal services are obtained under 

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

7 ‘‘(e) STREAMLINED PERSONNEL AUTHORITY.—

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

9 personnel authorities, the Secretary may, as the Sec10 retary determines necessary to respond to pressing 

11 qualified countermeasure research and development 

12 needs under this section, without regard to such pro13 visions of title 5, United States Code, governing ap14 pointments in the competitive service, and without re15 gard to the provisions of chapter 51 and subchapter 

16 III of chapter 53 of such title relating to classification 

17 and General Schedule pay rates, appoint professional 

18 and technical employees, not to exceed 30 such em19 ployees at any time, to positions in the National In20 stitutes of Health to perform, administer, or support 

21 qualified countermeasure research and development 

22 activities in carrying out this section. 

23 ‘‘(2) INTERNAL CONTROLS TO BE INSTITUTED.—

24 The Secretary shall institute appropriate internal 

25 controls for appointments under this subsection. 
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1 ‘‘(f) ACTIONS COMMITTED TO AGENCY DISCRETION.—

2 Actions by the Secretary under the authority of this section 

3 are committed to agency discretion. 

4 ‘‘(g) EFFECT ON RIGHT TO FILE PROTEST.—Nothing 

5 in this section shall affect the right of an interested party 

6 to file a protest with the contracting agency, to file a protest 

7 with the Comptroller General under subchapter V of chapter 

8 35 of title 31, United States Code, or to file an action in 

9 the United States Court of Federal Claims under section 

10 1491(b) of title 28, United States Code.’’.

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

12 Public Health Service Act (42 U.S.C. 287a–2) is amend13 ed—

14 (1) in subsection (a)(1), by inserting ‘‘or the Di15 rector of the National Institute of Allergy and Infec16 tious Diseases’’ after ‘‘Director of the Center’’; 

17 (2) in subsection (c)—

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

19 Director of the National Institute of Allergy and 

20 Infectious Diseases’’ after ‘‘Director of the Cen21 ter’’; and 

22 (B) in paragraph (2), in the matter pre23 ceding subparagraph (A), by striking ‘‘subsection 

24 (i)’’ and inserting ‘‘subsection (i)(1)’’; 
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1 (3) in subsection (d), by inserting ‘‘or the Direc2 tor of the National Institute of Allergy and Infectious 

3 Diseases’’ after ‘‘Director of the Center’’; 

4 (4) in subsection (e)—

5 (A) in paragraph (1)—

6 (i) in the matter preceding subpara7 graph (A), by inserting ‘‘or the Director of 

8 the National Institute of Allergy and Infec9 tious Diseases’’ after ‘‘Director of the Cen10 ter’’; 

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

12 ‘‘(or, in the case of the Institute, 75 per13 cent)’’ after ‘‘50 percent’’; and 

14 (iii) in subparagraph (B), by inserting 

15 ‘‘(or, in the case of the Institute, 75 per16 cent)’’ after ‘‘40 percent’’; 

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

18 Director of the National Institute of Allergy and 

19 Infectious Diseases’’ after ‘‘Director of the Cen20 ter’’; and 

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

22 Center or the Director of the National Institute 

23 of Allergy and Infectious Diseases’’ after ‘‘Direc24 tor’’; 

25 (5) in subsection (f)—
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1 (A) in paragraph (1), by inserting ‘‘in the 

2 case of an award by the Director of the Center,’’ 

3 before ‘‘the applicant’’; and 

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

5 Center or the Director of the National Institute 

6 of Allergy and Infectious Diseases’’ after ‘‘Direc7 tor’’; and 

8 (6) in subsection (i)—

9 (A) by striking ‘‘APPROPRIATIONS.—For the 

10 purpose of carrying out this section,’’ and insert11 ing the following: ‘‘APPROPRIATIONS.—

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

13 this section with respect to the Center,’’; and 

14 (B) by adding at the end the following: 

15 ‘‘(2) NATIONAL INSTITUTE OF ALLERGY AND IN16 FECTIOUS DISEASES.—For the purpose of carrying 

17 out this section with respect to the National Institute 

18 of Allergy and Infectious Diseases, there are author19 ized to be appropriated such sums as may be nec20 essary for fiscal year 2003.’’. 

21 SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT. 

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

23 Health Service Act, as amended by section 2 of this Act, 

24 is amended by inserting after section 319F–1 the following 

25 section: 
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1 ‘‘SEC. 319F–2. STRATEGIC NATIONAL STOCKPILE. 

2 ‘‘(a) STRATEGIC NATIONAL STOCKPILE.—

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

4 Security (referred to in this section as the ‘Homeland 

5 Security Secretary’), in coordination with the Sec6 retary and the Secretary of Veterans Affairs, shall 

7 maintain a stockpile or stockpiles of drugs, vaccines 

8 and other biological products, medical devices, and 

9 other supplies in such numbers, types, and amounts 

10 as are determined by the Secretary to be appropriate 

11 and practicable, taking into account other available 

12 sources, to provide for the emergency health security 

13 of the United States, including the emergency health 

14 security of children and other vulnerable populations, 

15 in the event of a bioterrorist attack or other public 

16 health emergency. 

17 ‘‘(2) PROCEDURES.—The Secretary, in man18 aging the stockpile under paragraph (1), shall—

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

20 section 319F(a); 

21 ‘‘(B) ensure that adequate procedures are 

22 followed with respect to such stockpile for inven23 tory management and accounting, and for the 

24 physical security of the stockpile; 
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1 ‘‘(C) in consultation with Federal, State, 

2 and local officials, take into consideration the 

3 timing and location of special events; 

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

5 contents of the stockpile on a regular basis to en6 sure that emerging threats, advanced tech7 nologies, and new countermeasures are ade8 quately considered; 

9 ‘‘(E) devise plans for the effective and time10 ly supply-chain management of the stockpile, in 

11 consultation with appropriate Federal, State 

12 and local agencies, and the public and private 

13 health care infrastructure; and 

14 ‘‘(F) ensure the adequate physical security 

15 of the stockpile. 

16 ‘‘(b) SMALLPOX VACCINE DEVELOPMENT.—

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

18 contracts, enter into cooperative agreements, or carry 

19 out such other activities as may reasonably be re20 quired in order to ensure that the stockpile under sub21 section (a) includes an amount of vaccine against 

22 smallpox as determined by such Secretary to be suffi23 cient to meet the health security needs of the United 

24 States. 
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1 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in this 

2 section shall be construed to limit the private dis3 tribution, purchase, or sale of vaccines from sources 

4 other than the stockpile described in subsection (a). 

5 ‘‘(c) ADDITIONAL AUTHORITY REGARDING PROCURE6 MENT OF CERTAIN BIOMEDICAL COUNTERMEASURES; 

7 AVAILABILITY OF SPECIAL RESERVE FUND.—

8 ‘‘(1) IN GENERAL.—

9 ‘‘(A) USE OF FUND.—A security counter10 measure may, in accordance with this subsection, 

11 be procured with amounts in the special reserve 

12 fund under paragraph (10). 

13 ‘‘(B) SECURITY COUNTERMEASURE.—For 

14 purposes of this subsection, the term ‘security 

15 countermeasure’ means a priority counter16 measure (as defined in section 319F(h))—

17 ‘‘(i) that affects national security; 

18 ‘‘(ii) that is determined under para19 graph (2)(B)(ii) to be a necessary counter20 measure; and 

21 ‘‘(iii)(I) that is approved or cleared 

22 under chapter V of the Federal Food, Drug, 

23 and Cosmetic Act, or licensed under section 

24 351 of this Act, for use as a countermeasure 

25 to a chemical, biological, radiological, or 
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1 nuclear agent identified as a material 

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

3 ‘‘(II) for which the Secretary deter4 mines that sufficient and satisfactory clin5 ical experience or research data (including 

6 data, if available, from pre-clinical and 

7 clinical trials) support a reasonable conclu8 sion that the countermeasure will qualify 

9 for approval or licensing after the date of a 

10 determination under paragraph (5).

11 ‘‘(2) DETERMINATION OF MATERIAL THREATS.—

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

13 Security Secretary, in consultation with the 

14 heads of other agencies as appropriate, shall on 

15 an ongoing basis—

16 ‘‘(i) assess current and emerging 

17 threats of chemical, biological, radiological, 

18 and nuclear agents; and 

19 ‘‘(ii) determine which of such agents 

20 present a material threat against the 

21 United States population. 

22 ‘‘(B) PUBLIC HEALTH IMPACT; NECESSARY

23 COUNTERMEASURES.—The Secretary shall on an 

24 ongoing basis—
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1 ‘‘(i) assess the potential public health 

2 consequences of use against the United 

3 States population of agents identified under 

4 subparagraph (A)(ii); and 

5 ‘‘(ii) determine, on the basis of such as6 sessment, the agents for which priority 

7 countermeasures are necessary to protect the 

8 public health from a material threat. 

9 ‘‘(3) ASSESSMENT OF AVAILABILITY AND APPRO10 PRIATENESS OF COUNTERMEASURES.—The Secretary, 

11 in consultation with the Homeland Security Sec12 retary, 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 SECURITY COUNTERMEASURES; 

17 COMMITMENT FOR RECOMMENDATION FOR PROCURE18 MENT.—

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

20 pursuant to an assessment under paragraph (3), 

21 the Homeland Security Secretary and the Sec22 retary make a determination that a security 

23 countermeasure would be appropriate, such Sec24 retaries may jointly submit to the President a 

25 proposal to—
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1 ‘‘(i) issue a call for the development of 

2 such security countermeasure; and 

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

4 the first development of such security coun5 termeasure that meets the conditions for 

6 procurement under paragraph (5), the Sec7 retaries will, based in part on information 

8 obtained pursuant to such call, make a rec9 ommendation under paragraph (6) that the 

10 special reserve fund under paragraph (10) 

11 be made available for the procurement of 

12 such security countermeasure. 

13 ‘‘(B) COUNTERMEASURE SPECIFICATIONS.—

14 The Homeland Security Secretary and the Sec15 retary shall, to the extent practicable, include in 

16 the proposal under subparagraph (A)—

17 ‘‘(i) estimated quantity of purchase (in 

18 the form of number of doses or number of ef19 fective courses of treatments regardless of 

20 dosage form); 

21 ‘‘(ii) necessary measures of minimum 

22 safety and effectiveness; 

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

24 effective course of treatment regardless of 

25 dosage form; and 
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1 ‘‘(iv) other information that may be 

2 necessary to encourage and facilitate re3 search, development, and manufacture of the 

4 countermeasure or to provide specifications 

5 for the countermeasure. 

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

7 President approves a proposal under subpara8 graph (A), the Homeland Security Secretary and 

9 the Secretary shall make known to persons who 

10 may respond to a call for the security counter11 measure involved—

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

13 ‘‘(ii) specifications for the counter14 measure under subparagraph (B); and 

15 ‘‘(iii) a commitment described in sub16 paragraph (A)(ii). 

17 ‘‘(5) SECRETARY’S DETERMINATION OF COUN18 TERMEASURES APPROPRIATE FOR FUNDING FROM

19 SPECIAL RESERVE FUND.—

20 ‘‘(A) IN GENERAL.—The Secretary, in ac21 cordance with the provisions of this paragraph, 

22 shall identify specific security countermeasures 

23 that the Secretary determines, in consultation 

24 with the Homeland Security Secretary, to be ap25 propriate for inclusion in the stockpile under 
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1 subsection (a) pursuant to procurements made 

2 with amounts in the special reserve fund under 

3 paragraph (10) (referred to in this subsection in4 dividually as a ‘procurement under this sub5 section’). 

6 ‘‘(B) REQUIREMENTS.—In making a deter7 mination under subparagraph (A) with respect

8 to a security countermeasure, the Secretary shall 

9 determine and consider the following: 

10 ‘‘(i) The quantities of the product that 

11 will be needed to meet the needs of the stock12 pile. 

13 ‘‘(ii) The feasibility of production and 

14 delivery within five years of sufficient 

15 quantities of the product. 

16 ‘‘(iii) Whether there is a lack of a sig17 nificant commercial market for the product 

18 at the time of procurement, other than as a 

19 security countermeasure. 

20 ‘‘(6) RECOMMENDATION FOR PRESIDENT’S AP21 PROVAL.—

22 ‘‘(A) RECOMMENDATION FOR PROCURE23 MENT.—In the case of a security countermeasure 

24 that the Secretary has, in accordance with para25 graphs (2), (3), and (5), determined to be appro-
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1 priate for procurement under this subsection, the 

2 Homeland Security Secretary and the Secretary 

3 shall jointly submit to the President, in coordi4 nation with the Director of the Office of Manage5 ment and Budget, a recommendation that the 

6 special reserve fund under paragraph (10) be 

7 made available for the procurement of such coun8 termeasure.

9 ‘‘(B) PRESIDENTIAL APPROVAL.—The spe10 cial reserve fund under paragraph (10) is avail11 able for a procurement of a security counter12 measure only if the President has approved a 

13 recommendation under subparagraph (A) re14 garding the countermeasure. 

15 ‘‘(C) NOTICE TO CONGRESS.—The Secretary 

16 and the Homeland Security Secretary shall no17 tify the Congress of each decision of the President 

18 to approve a recommendation under subpara19 graph (A). Such notice shall include an expla20 nation of the decision to make available the spe21 cial reserve fund under paragraph (10) for pro22 curement of such a countermeasure, including, 

23 where available, the identification of the poten24 tial supplier or suppliers of such counter25 measure, and whether other potential suppliers 
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1 of the same or similar countermeasures were con2 sidered and rejected for procurement under this 

3 section and the reasons therefor. 

4 ‘‘(D) SUBSEQUENT SPECIFIC COUNTER5 MEASURES.—Procurement under this subsection 

6 of a security countermeasure for a particular 

7 purpose does not preclude the subsequent pro8 curement under this subsection of any other secu9 rity countermeasure for such purpose if the Sec10 retary has determined under paragraph (5)(A) 

11 that such countermeasure is appropriate for in12 clusion in the stockpile and if, as determined by 

13 the Secretary, such countermeasure provides im14 proved safety or effectiveness, or for other reasons 

15 enhances preparedness to respond to threats of 

16 use of a biological, chemical, radiological, or nu17 clear agent. Such a determination by the Sec18 retary is committed to agency discretion. 

19 ‘‘(E) RULE OF CONSTRUCTION.—Rec20 ommendations and approvals under this para21 graph apply solely to determinations that the 

22 special reserve fund under paragraph (10) will 

23 be made available for a procurement of a secu24 rity countermeasure, and not to the substance of 
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1 contracts for such procurement or other matters 

2 relating to awards of such contracts. 

3 ‘‘(7) PROCUREMENT.—

4 ‘‘(A) IN GENERAL.—For purposes of a pro5 curement under this subsection that is approved 

6 by the President under paragraph (6), the 

7 Homeland Security Secretary and the Secretary 

8 shall have responsibilities in accordance with 

9 subparagraphs (B) and (C). 

10 ‘‘(B) INTERAGENCY AGREEMENTS.—

11 ‘‘(i) FOR PROCUREMENT.—The Home12 land Security Secretary shall enter into an 

13 agreement with the Secretary for procure14 ment of a security countermeasure in ac15 cordance with the provisions of this para16 graph. The special reserve fund under para17 graph (10) shall be available for the Sec18 retary’s costs of such procurement, other 

19 than as provided in clause (ii). 

20 ‘‘(ii) FOR ADMINISTRATIVE COSTS.—

21 The agreement entered into between the 

22 Homeland Security Secretary and the Sec23 retary for managing the stockpile under 

24 subsection (a) shall provide for reimburse25 ment of the Secretary’s administrative costs 
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1 relating to procurements under this sub2 section. 

3 ‘‘(C) PROCUREMENT.—

4 ‘‘(i) IN GENERAL.—The Secretary shall 

5 be responsible for—

6 ‘‘(I) arranging for procurement of 

7 a security countermeasure, including 

8 negotiating terms (including quantity, 

9 production schedule, and price) of, and 

10 entering into, contracts and coopera11 tive agreements, and for carrying out 

12 such other activities as may reasonably 

13 be required, in accordance with the 

14 provisions of this subparagraph; and 

15 ‘‘(II) promulgating regulations to 

16 implement clauses (v), (vi), and (vii), 

17 and any other provisions of this sub18 section. 

19 ‘‘(ii) CONTRACT TERMS.—A contract 

20 for procurements under this subsection shall 

21 (or, as specified below, may) include the fol22 lowing terms: 

23 ‘‘(I) PAYMENT CONDITIONED ON

24 SUBSTANTIAL DELIVERY.—The contract 

25 shall provide that no payment may be 
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1 made until delivery has been made of 

2 a substantial portion (as determined 

3 by the Secretary) of the total number 

4 of units contracted for, except that, 

5 notwithstanding any other provision of 

6 law, the contract may provide that, if 

7 the Secretary determines (in the Sec8 retary’s discretion) that an advance 

9 payment is necessary to ensure success 

10 of a project, the Secretary may pay an 

11 amount, not to exceed 10 percent of the 

12 contract amount, in advance of deliv13 ery. The contract shall provide that 

14 such advance payment is required to be 

15 repaid if there is a failure to perform 

16 under the contract, except in special 

17 circumstances as determined by the 

18 Secretary on a contract by contract 

19 basis. 

20 ‘‘(II) CONTRACT DURATION.—The 

21 contract shall be for a period not to ex22 ceed five years, except that, in first 

23 awarding the contract, the Secretary 

24 may provide for a longer duration, not 

25 exceeding eight years, if the Secretary 
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1 determines that complexities or other 

2 difficulties in performance under the 

3 contract justify such a period. The con4 tract shall be renewable for additional 

5 periods, none of which shall exceed five 

6 years.

7 ‘‘(III) STORAGE BY VENDOR.—

8 The contract may provide that the ven9 dor will provide storage for stocks of a 

10 product delivered to the ownership of 

11 the Federal Government under the con12 tract, for such period and under such 

13 terms and conditions as the Secretary 

14 may specify, and in such case amounts 

15 from the special reserve fund under 

16 paragraph (10) shall be available for 

17 costs of shipping, handling, storage, 

18 and related costs for such product. 

19 ‘‘(iii) AVAILABILITY OF SIMPLIFIED AC20 QUISITION PROCEDURES.—

21 ‘‘(I) IN GENERAL.—If the Sec22 retary determines that there is a press23 ing need for a procurement of a spe24 cific countermeasure, the amount of the 

25 procurement under this subsection 
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1 shall be deemed to be below the thresh2 old amount specified in section 4(11) 

3 of the Office of Federal Procurement 

4 Policy Act (41 U.S.C. 403(11)), for 

5 purposes of application to such pro6 curement, pursuant to section 302A(a) 

7 of the Federal Property and Adminis8 trative Services Act of 1949 (41 U.S.C. 

9 252a(a)), of—

10 ‘‘(aa) section 303(g)(1)(A) of 

11 the Federal Property and Admin12 istrative Services Act of 1949 (41 

13 U.S.C. 253(g)(1)(A)) and its im14 plementing regulations; and 

15 ‘‘(bb) section 302A(b) of such 

16 Act (41 U.S.C. 252a(b)) and its 

17 implementing regulations. 

18 ‘‘(II) APPLICATION OF CERTAIN

19 PROVISIONS.—Notwithstanding sub20 clause (I) and the provision of law and 

21 regulations referred to in such clause, 

22 each of the following provisions shall 

23 apply to procurements described in 

24 this clause to the same extent that such 

25 provisions would apply to such pro-
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1 curements in the absence of subclause 

2 (I): 

3 ‘‘(aa) Chapter 37 of title 40, 

4 United States Code (relating to 

5 contract work hours and safety 

6 standards). 

7 ‘‘(bb) Subsections (a) and (b) 

8 of section 7 of the Anti-Kickback 

9 Act of 1986 (41 U.S.C. 57(a) and 

10 (b)). 

11 ‘‘(cc) Section 304C of the 

12 Federal Property and Adminis13 trative Services Act of 1949 (41 

14 U.S.C. 254d) (relating to the ex15 amination of contractor records).

16 ‘‘(iv) OTHER THAN FULL AND OPEN

17 COMPETITION.—(I) In using the authority 

18 provided in section 303(c)(1) of title III of 

19 the Federal Property and Administrative 

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

21 to use procedures other than competitive 

22 procedures in the case of a procurement 

23 under this subsection, the phrase ‘available 

24 from only one responsible source’ in such 

25 section 303(c)(1) shall be deemed to mean 
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1 ‘available from only one responsible source 

2 or only from a limited number of respon3 sible sources’. 

4 ‘‘(II) The authority under subclause (I) 

5 is in addition to any other authority to use 

6 procedures other than competitive proce7 dures. 

8 ‘‘(III) The Secretary shall implement 

9 this clause in accordance with applicable 

10 government-wide regulations, including re11 quirements that offers be solicited from as 

12 many potential sources as is practicable 

13 under the circumstances, that required no14 tices be published, and that submitted offers 

15 be considered. 

16 ‘‘(v) PREMIUM PROVISION IN MULTIPLE

17 AWARD CONTRACTS.—

18 ‘‘(I) IN GENERAL.—If, under this 

19 subsection, the Secretary enters into 

20 contracts with more than one vendor to 

21 procure a security countermeasure, 

22 such Secretary may, notwithstanding 

23 any other provision of law, include in 

24 each of such contracts a provision 

25 that—
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1 ‘‘(aa) identifies an increment 

2 of the total quantity of security 

3 countermeasure required, whether 

4 by percentage or by numbers of 

5 units; and

6 ‘‘(bb) promises to pay one or 

7 more specified premiums based on 

8 the priority of such vendors’ pro9 duction and delivery of the incre10 ment identified under item (aa), 

11 in accordance with the terms and 

12 conditions of the contract. 

13 ‘‘(II) DETERMINATION OF GOV14 ERNMENT’S REQUIREMENT NOT RE15 VIEWABLE.—If the Secretary includes 

16 in each of a set of contracts a provision 

17 as described in subclause (I), such Sec18 retary’s determination of the total 

19 quantity of security countermeasure re20 quired, and any amendment of such 

21 determination, is committed to agency 

22 discretion. 

23 ‘‘(vi) EXTENSION OF CLOSING DATE

24 FOR RECEIPT OF PROPOSALS NOT REVIEW25 ABLE.—A decision by the Secretary to ex-
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1 tend the closing date for receipt of proposals 

2 for a procurement under this subsection is 

3 committed to agency discretion. 

4 ‘‘(vii) LIMITING COMPETITION TO

5 SOURCES RESPONDING TO REQUEST FOR IN6 FORMATION.—In conducting a procurement 

7 under this subsection, the Secretary may ex8 clude a source that has not responded to a 

9 request for information under section 

10 303A(a)(1)(B) of the Federal Property and 

11 Administrative Services Act of 1949 (41 

12 U.S.C. 253a(a)(1)(B)) if such request has 

13 given notice that the Secretary may so ex14 clude such a source. 

15 ‘‘(8) INTERAGENCY COOPERATION.—

16 ‘‘(A) IN GENERAL.—In carrying out activi17 ties under this section, the Homeland Security 

18 Secretary and the Secretary are authorized, sub19 ject to subparagraph (B), to enter into inter20 agency agreements and other collaborative under21 takings with other agencies of the United States 

22 Government. 

23 ‘‘(B) LIMITATION.—An agreement or under24 taking under this paragraph shall not authorize 

25 another agency to exercise the authorities pro-
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1 vided by this section to the Homeland Security 

2 Secretary or to the Secretary. 

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

4 Amounts in the special reserve fund under paragraph 

5 (10) shall not be used to pay—

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

7 under procurement contracts entered into before 

8 the date of the enactment of the Project Bio9 Shield Act of 2003; or 

10 ‘‘(B) administrative costs. 

11 ‘‘(10) SPECIAL RESERVE FUND.—For purposes of 

12 this subsection, the term ‘special reserve fund’ has the 

13 meaning given such term in section 510 of the Home14 land Security Act of 2002. 

15 ‘‘(d) DISCLOSURES.—No Federal agency shall disclose 

16 under section 552, United States Code, any information 

17 identifying the location at which materials in the stockpile 

18 under subsection (a) are stored. 

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

20 term ‘stockpile’ includes—

21 ‘‘(1) a physical accumulation (at one or more lo22 cations) of the supplies described in subsection (a); or 

23 ‘‘(2) a contractual agreement between the Home24 land Security Secretary and a vendor or vendors 
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1 under which such vendor or vendors agree to provide 

2 to such Secretary supplies described in subsection (a). 

3 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

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

5 purpose of carrying out subsection (a), there are au6 thorized to be appropriated $640,000,000 for fiscal 

7 year 2002, and such sums as may be necessary for 

8 each of fiscal years 2003 through 2006. Such author9 ization is in addition to amounts in the special re10 serve 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 fiscal 

14 year 2002, and such sums as may be necessary for 

15 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 (116 

18 Stat. 2212; 6 U.S.C. 311 et seq.) is amended by adding at 

19 the end the following: 

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

22 STOCKPILE. 

23 ‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—For pro24 curement of security countermeasures under section 319F–

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

2 authorized to be appropriated up to $5,593,000,000 for the 

3 fiscal years 2004 through 2013. Of the amounts appro4 priated under the preceding sentence, not to exceed 

5 $3,418,000,000 may be obligated during the fiscal years 

6 2004 through 2008, of which not to exceed $890,000,000 

7 may be obligated during fiscal year 2004. 

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

9 security countermeasures program, the term ‘special reserve 

10 fund’ means the appropriations account established as a re11 sult of any appropriations made under subsection (a). 

12 ‘‘(c) AVAILABILITY.—

13 ‘‘(1) DURATION OF AVAILABILITY FOR OBLIGA14 TION.—Subject to paragraph (2), all amounts appro15 priated under subsection (a) are available for obliga16 tion through the end of fiscal year 2013, provided 

17 that any portion of such amount that remains unobli18 gated for such purposes on the expiration of such term 

19 shall be returned to the United States Treasury and 

20 shall not be available for subsequent obligation for 

21 any purpose. 

22 ‘‘(2) INITIAL AVAILABILITY FOR PARTICULAR

23 PROCUREMENTS.—Amounts appropriated under sub24 section (a) become available for a procurement under 

25 the security countermeasures program only upon the 
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1 approval by the President of such availability for the 

2 procurement in accordance with paragraph (6)(B) of 

3 such program.’’. 

4 (c) CONFORMING AMENDMENTS.—(1) Section 121 of 

5 the Public Health Security and Bioterrorism Preparedness

6 and Response Act of 2002 (116 Stat. 611; 42 U.S.C. 300hh–

7 12) is repealed. 

8 (2) The item relating to section 121 in the table of 

9 contents (contained in section 1(b)) of such Act is repealed. 

10 (3) With respect to the program established under 

11 former section 121 of such Act, the repeal of such section 

12 under paragraph (1) applies as a modification of the pro13 gram in accordance with the amendment made by sub14 section (a) of this section, and not as the termination of 

15 the program and the establishment of a different program. 

16 SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE 

17 IN EMERGENCIES. 

18 Subchapter E of chapter V of the Federal Food, Drug, 

19 and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 

20 by adding at the end the following section: 

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

22 USE IN EMERGENCIES. 

23 ‘‘(a) IN GENERAL.—

24 ‘‘(1) EMERGENCY USES.—Notwithstanding sec25 tions 505, 510(k), and 515 of this Act and section 351 
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1 of the Public Health Service Act, and subject to the 

2 provisions of this section, the Secretary may authorize 

3 the introduction into interstate commerce, during the 

4 effective period of a declaration under subsection (b), 

5 of a drug or device intended for use in an actual or 

6 potential emergency (referred to in this section as an 

7 ‘emergency use’). 

8 ‘‘(2) APPROVAL STATUS OF PRODUCT.—An au9 thorization under paragraph (1) may authorize an 

10 emergency use of a product that—

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

12 for commercial distribution under a provision of 

13 law referred to in such paragraph (referred to in 

14 this section as an ‘unapproved product’); or 

15 ‘‘(B) is approved, licensed, or cleared under 

16 such a provision, but which use is not under 

17 such provision an approved, licensed, or cleared 

18 use of the product (referred to in this section as 

19 an ‘unapproved use of an approved product’).

20 ‘‘(3) RELATION TO OTHER USES.—An emergency 

21 use authorized under paragraph (1) for a product is 

22 in addition to any other use that is authorized for the 

23 product under a provision of law referred to in such 

24 paragraph. 

25 ‘‘(4) DEFINITIONS.—For purposes of this section: 
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1 ‘‘(A) The term ‘emergency use’ has the 

2 meaning indicated for such term in paragraph 

3 (1). 

4 ‘‘(B) The term ‘product’ means a drug or 

5 device. 

6 ‘‘(C) The term ‘unapproved product’ has the 

7 meaning indicated for such term in paragraph 

8 (2)(A). 

9 ‘‘(D) The term ‘unapproved use of an ap10 proved product’ has the meaning indicated for 

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

12 ‘‘(b) DECLARATION OF EMERGENCY.—

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

14 an emergency justifying the authorization under this 

15 subsection for a product on the basis of—

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

17 Homeland Security that there is a national 

18 emergency, or a significant potential for a na19 tional emergency, involving a heightened risk of 

20 attack with a specified biological, chemical, radi21 ological, or nuclear agent or agents; 

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

23 Defense that there is a military emergency, or a 

24 significant potential for a military emergency, 

25 involving a heightened risk to United States 
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1 military forces of attack with a biological, chem2 ical, radiological, or nuclear agent or agents; or 

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

4 public health emergency under section 319 of the 

5 Public Health Service Act, affecting national se6 curity and involving a specified biological, chem7 ical, radiological, or nuclear agent or agents, or 

8 a specified disease or condition that may be at9 tributable to such agent or agents. 

10 ‘‘(2) TERMINATION OF DECLARATION.—

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

12 this subsection shall terminate upon the earlier 

13 of—

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

15 in consultation as appropriate with the Sec16 retary of Homeland Security or the Sec17 retary of Defense, that the circumstances de18 scribed in paragraph (1) have ceased to 

19 exist; or 

20 ‘‘(ii) the expiration of the one-year pe21 riod beginning on the date on which the 

22 declaration is made. 

23 ‘‘(B) RENEWAL.—Notwithstanding subpara24 graph (A), the Secretary may renew a declara-
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1 tion under this subsection, and this paragraph 

2 shall apply to any such renewal. 

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

4 terminating a declaration under this section, the Sec5 retary shall provide advance notice that the declara6 tion will be terminated. The period of advance notice 

7 shall be a period reasonably determined to provide—

8 ‘‘(A) in the case of an unapproved product, 

9 a sufficient period for disposition of shipments of 

10 the product, including the return of such ship11 ments to the manufacturer (in the case of a man12 ufacturer that chooses to have the shipments re13 turned); and 

14 ‘‘(B) in the case of unapproved uses of ap15 proved products, a sufficient period for the dis16 position of any labeling that was provided with 

17 respect to the emergency use involved. 

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

19 promptly publish in the Federal Register each dec20 laration, determination, and renewal under this sub21 section. 

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

23 The Secretary may issue an authorization under this sec24 tion with respect to the emergency use of a product only 

25 if, after consultation with the Director of the National Insti-
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1 tutes of Health and the Director of the Centers for Disease 

2 Control and Prevention, to the extent feasible and appro3 priate given the circumstances of the emergency involved, 

4 the Secretary concludes—

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

6 under subsection (b) can cause a serious or life-threat7 ening disease or condition; 

8 ‘‘(2) that, based on the totality of scientific evi9 dence available to the Secretary, including data from 

10 adequate and well-controlled clinical trials, if avail11 able, it is reasonable to believe that—

12 ‘‘(A) the product may be effective in detect13 ing, diagnosing, treating, or preventing—

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

15 ‘‘(ii) a serious or life-threatening dis16 ease or condition caused by a product au17 thorized under this section or approved 

18 under this Act or the Public Health Service 

19 Act, for detecting, diagnosing, treating, or 

20 preventing such a disease or condition 

21 caused by such an agent; and 

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

23 product, when used to detect, diagnose, prevent, 

24 or treat such disease or condition, outweigh the 

25 known and potential risks of the product; 
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1 ‘‘(3) that there is no adequate, approved, and 

2 available alternative to the product for detecting, di3 agnosing, preventing, or treating such disease or con4 dition; and 

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

6 may by regulation prescribe are satisfied. 

7 ‘‘(d) SCOPE OF AUTHORIZATION.—

8 ‘‘(1) IN GENERAL.—An authorization of a prod9 uct under this section shall state—

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

11 product may be used to detect, diagnose, prevent, 

12 or treat within the scope of the authorization; 

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

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

15 potential benefits of the product, when used to 

16 detect, diagnose, prevent, or treat such disease or 

17 condition, outweigh the known and potential 

18 risks of the product; and 

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

20 under subsection (c), concerning the safety and 

21 potential effectiveness of the product in detecting, 

22 diagnosing, preventing, or treating such diseases 

23 or conditions, including an assessment of the 

24 available scientific evidence. 
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1 ‘‘(2) CONFIDENTIAL INFORMATION.—Nothing in 

2 this section alters or amends section 1905 of title 18, 

3 United States Code, or section 552(b)(4) of title 5 of 

4 such Code. 

5 ‘‘(e) CONDITIONS OF AUTHORIZATION.—

6 ‘‘(1) UNAPPROVED PRODUCT.—

7 ‘‘(A) REQUIRED CONDITIONS.—With respect 

8 to the emergency use of an unapproved product, 

9 the Secretary, to the extent feasible given the cir10 cumstances of the emergency, shall, for persons 

11 who choose to carry out one or more activities for 

12 which the authorization is issued, establish such 

13 conditions on an authorization under this sec14 tion as the Secretary finds necessary or appro15 priate to protect the public health, including the 

16 following: 

17 ‘‘(i) Appropriate conditions designed to 

18 ensure that, to the extent feasible given the 

19 circumstances of the emergency, health care 

20 professionals administering the product are 

21 informed—

22 ‘‘(I) that the Secretary has au23 thorized the emergency use of the prod24 uct; 
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1 ‘‘(II) of the significant known and 

2 potential benefits and risks of the 

3 emergency use of the product, and of 

4 the extent to which such benefits and 

5 risks are unknown; and 

6 ‘‘(III) of the alternatives to the 

7 product that are available, and of their 

8 benefits and risks. 

9 ‘‘(ii) Appropriate conditions designed 

10 to ensure that, to the extent feasible given 

11 the circumstances of the emergency, individ12 uals to whom the product is administered 

13 are informed—

14 ‘‘(I) that the Secretary has au15 thorized the emergency use of the prod16 uct; 

17 ‘‘(II) of the significant known and 

18 potential benefits and risks of such use, 

19 and of the extent to which such benefits 

20 and risks are unknown; and 

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

22 refuse administration of the product, of 

23 the consequences, if any, of refusing 

24 administration of the product, and of 

25 the alternatives to the product that are 
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1 available and of their benefits and 

2 risks. 

3 ‘‘(iii) Appropriate conditions for the 

4 monitoring and reporting of adverse events 

5 associated with the emergency use of the 

6 product. 

7 ‘‘(iv) For manufacturers of the prod8 uct, appropriate conditions concerning rec9 ordkeeping and reporting, including records 

10 access by the Secretary, with respect to the 

11 emergency use of the product. 

12 ‘‘(B) AUTHORITY FOR ADDITIONAL CONDI13 TIONS.—With respect to the emergency use of an 

14 unapproved product, the Secretary, to the extent 

15 feasible given the circumstances of the emergency, 

16 may, for persons who choose to carry out one or 

17 more activities for which the authorization is 

18 issued, establish such conditions on an author19 ization under this section as the Secretary finds 

20 necessary or appropriate to protect the public 

21 health, including the following: 

22 ‘‘(i) Appropriate conditions on which 

23 entities may distribute the product with re24 spect to the emergency use of the product 

25 (including limitation to distribution by 
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1 government entities), and on how distribu2 tion is to be performed. 

3 ‘‘(ii) Appropriate conditions on who 

4 may administer the product with respect to

5 the emergency use of the product, and on 

6 the categories of individuals to whom, and 

7 the circumstances under which, the product 

8 may be administered with respect to such 

9 use. 

10 ‘‘(iii) For persons other than manufac11 turers of the product, appropriate condi12 tions concerning recordkeeping and report13 ing, including records access by the Sec14 retary, with respect to the emergency use of 

15 the product. 

16 ‘‘(iv) With respect to the emergency use 

17 of the product, waive or limit, to the extent 

18 appropriate given the circumstances of the 

19 emergency, conditions regarding current 

20 good manufacturing practice otherwise ap21 plicable to the manufacture, processing, 

22 packing, or holding of products subject to 

23 regulation under this Act, including such 

24 requirements established in section 501. 
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1 ‘‘(2) UNAPPROVED USE.—With respect to the 

2 emergency use of a product that is an unapproved use 

3 of an approved product: 

4 ‘‘(A) The Secretary may, for manufacturers 

5 of the product who choose to carry out one or 

6 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 make 

13 such change, such authorization may not author14 ize distributors of the product or any other per15 son to alter or obscure the labeling provided by 

16 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 in 

23 addition to the labeling provided by the manu24 facturer, 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 EFFECTIVE

10 PERIOD.—An authorization shall continue to be effec11 tive for continued use with respect to patients to 

12 whom it was administered during the period de13 scribed by paragraph (1), to the extent found nec14 essary by such patients’ attending physicians. 

15 ‘‘(g) REVOCATION OF AUTHORIZATION.—

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

17 review the circumstances and the appropriateness of 

18 an authorization under this section. 

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

20 an authorization under this section if, in the Sec21 retary’s unreviewable discretion, the criteria under 

22 subsection (c) for issuance of such authorization are 

23 no longer met. 

24 ‘‘(h) PUBLICATION.—The Secretary shall promptly 

25 publish in the Federal Register a notice of each authoriza-
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1 tion, and each termination or revocation of an authoriza2 tion, and an explanation of the reasons therefor, under this 

3 section. 

4 ‘‘(i) ACTIONS COMMITTED TO AGENCY DISCRETION.—

5 Actions under the authority of this section by the Secretary, 

6 by the Secretary of Defense, or by the Secretary of Home7 land Security are committed to agency discretion. 

8 ‘‘(j) RULES OF CONSTRUCTION.—Nothing in this sec9 tion shall be construed to impair or otherwise affect—

10 ‘‘(1) the authority of the President as Com11 mander in Chief of the Armed Forces of the United 

12 States under article II, section 2 of the United States 

13 Constitution; 

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

15 with respect to the Department of Defense, including 

16 the armed forces, under other provisions of Federal 

17 law; or 

18 ‘‘(3) the authority of the Secretary under section 

19 319F–2 to manage the stockpile under such section. 

20 ‘‘(k) APPLICATION TO MEMBERS OF ARMED

21 FORCES.—

22 ‘‘(1) WAIVER OF REQUIREMENT RELATING TO

23 OPTION TO REFUSE.—In the case of administration of 

24 a countermeasure to members of the armed forces, a 

25 requirement, under subsection (e)(1)(A)(ii)(III), de-
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1 signed to ensure that individuals are informed of an 

2 option to accept or refuse administration of a prod3 uct, may be waived by the President if the President 

4 determines, in writing, that complying with such re5 quirement is not feasible, is contrary to the best inter6 ests of the members affected, or is not in the interests 

7 of national security. 

8 ‘‘(2) PROVISION OF INFORMATION TO MEMBER OF

9 THE ARMED FORCES.—If the Secretary makes a deter10 mination that it is not feasible for the information re11 quired by subsection (e)(1)(A)(ii) to be provided to a 

12 member of the armed forces prior to the administra13 tion of the product, such information shall be pro14 vided to such member of the armed forces (or next-of15 kin in the case of the death of a member) to whom 

16 the product was administered as soon as possible, but 

17 not later than 30 days, after such administration. In18 formation concerning the administration of the prod19 uct shall be recorded in the medical record of the 

20 member. 

21 ‘‘(3) EFFECT ON STATUTE PERTAINING TO INVES22 TIGATIONAL NEW DRUGS.—In the case of an author23 ization based on a determination by the Secretary of 

24 Defense under subsection (b)(1)(B), section 1107 of 

25 title 10, United States Code, shall not apply to use 
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1 of a product that is the subject of such authorization, 

2 within the scope of such authorization and while such 

3 authorization is effective. 

4 ‘‘(l) RELATION TO OTHER PROVISIONS.—If a product 

5 is the subject of an authorization under this section, the

6 use of such product within the scope of the authorization—

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

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

9 ‘‘(2) shall not be subject to any requirements oth10 erwise applicable to clinical investigations pursuant 

11 to other provisions of this Act. 

12 ‘‘(m) DISCRETION REGARDING USE OF AUTHORIZA13 TION.—Nothing in this section provides the Secretary any 

14 authority to require any person to carry out any activity 

15 that becomes lawful pursuant to an authorization under 

16 this section, and no person is required to inform the Sec17 retary that the person will not be carrying out such activ18 ity, except that a manufacturer of a sole-source unapproved 

19 product authorized for emergency use shall notify the Sec20 retary within a reasonable period of time after the issuance 

21 by the Secretary of such authorization if such manufacturer 

22 does not intend to carry out an activity or activities under 

23 the authorization. This section does not have any legal effect 

24 on a person who does not carry out any activity for which 

25 an authorization under this section is issued, or who carries 
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1 out such an activity pursuant to other provisions of this 

2 Act or section 351 of the Public Health Service Act. 

3 ‘‘(n) ENFORCEMENT.—A person who carries out an ac4 tivity pursuant to an authorization under this section, but 

5 who fails to comply with applicable conditions under sub6 section (e), is with respect to that act of noncompliance sub7 ject to the provisions of law specified in subsection (a) and 

8 to the enforcement of such provisions under section 301.’’.

9 SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS 

10 ACT. 

11 (a) SECRETARY OF HEALTH AND HUMAN SERVICES.—

12 (1) ANNUAL REPORTS ON PARTICULAR EXER13 CISES OF AUTHORITY.—

14 (A) RELEVANT AUTHORITIES.—The Sec15 retary of Health and Human Services (referred 

16 to in this subsection as the ‘‘Secretary’’) shall 

17 submit reports in accordance with subparagraph 

18 (B) regarding the exercise of authority under the 

19 following provisions of law: 

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

21 the Public Health Service Act (as added by 

22 section 2 of this Act): 

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

24 increased simplified acquisition thresh25 old). 
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1 (II) Subsection (b)(2) (relating to 

2 use of noncompetitive procedures). 

3 (III) Subsection (c) (relating to 

4 expedited peer review procedures). 

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

6 the Public Health Service Act (as added by 

7 section 3 of this Act): 

8 (I) Subsection (c)(7)(C)(iii) (re9 lating to simplified acquisition proce10 dures). 

11 (II) Subsection (c)(7)(C)(iv) (re12 lating to use of noncompetitive proce13 dures). 

14 (III) Subsection (c)(7)(C)(v) (re15 lating to premium provision in mul16 tiple-award contracts). 

17 (iii) With respect to section 564 of the 

18 Federal Food, Drug, and Cosmetic Act (as 

19 added by section 4 of this Act): 

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

21 emergency uses of certain drugs and 

22 devices). 

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

24 a declaration of an emergency). 
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1 (III) Subsection (e) (relating to 

2 conditions on authorization). 

3 (B) CONTENTS OF REPORTS.—The Sec4 retary shall annually submit to the Congress a 

5 report that summarizes—

6 (i) the particular actions that were 

7 taken under the authorities specified in sub8 paragraph (A), including, as applicable, the 

9 identification of the threat agent, emer10 gency, or the biomedical countermeasure 

11 with respect to which the authority was 

12 used; 

13 (ii) the reasons underlying the decision 

14 to use such authorities, including, as appli15 cable, the options that were considered and 

16 rejected with respect to the use of such au17 thorities; and 

18 (iii) the identification of each person 

19 or entity that received, or was considered 

20 and rejected for, grants, cooperative agree21 ments, or contracts pursuant to the use of 

22 such authorities. 

23 (2) ANNUAL SUMMARIES REGARDING CERTAIN

24 ACTIVITY.—The Secretary shall annually submit to 

25 the Congress a report that summarizes the activity 
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1 undertaken pursuant to the following authorities 

2 under section 319F–1 of the Public Health Service 

3 Act (as added by section 2 of this Act): 

4 (A) Subsection (b)(3) (relating to increased 

5 micropurchase threshold). 

6 (B) Subsection (d) (relating to authority for 

7 personal services contracts). 

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

9 personnel authority). 

10 With respect to subparagraph (B), the report shall in11 clude a provision specifying, for the one-year period 

12 for which the report is submitted, the number of per13 sons who were paid amounts greater than $100,000 

14 and the number of persons who were paid amounts 

15 between $50,000 and $100,000. 

16 (b) NATIONAL ACADEMY OF SCIENCES REVIEW.—Not 

17 later than three years after the date of the enactment of 

18 this Act, the Secretary of Health and Human Services shall 

19 request the National Academy of Sciences to enter into an 

20 agreement for a review of the biomedical countermeasure 

21 research and development authorities established in this Act 

22 to determine whether and to what extent activities under23 taken pursuant to such authorities have enhanced the devel24 opment of biomedical countermeasures affecting national se25 curity, and to recommend any legislative or administrative 
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1 changes necessary to improve the ability of the Secretary 

2 to carry out these activities in the future. The Secretary 

3 shall ensure that the results of the study are submitted to 

4 the Congress not later than five years after such date of 

5 enactment.

6 (c) GENERAL ACCOUNTING OFFICE REVIEW.—Four 

7 years after the date of the enactment of this Act, the Comp8 troller General of the United States shall initiate a study—

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

10 Human Services’ utilization of the authorities grant11 ed under this Act with respect to simplified acquisi12 tion procedures, use of noncompetitive procedures, in13 creased micropurchase thresholds, personal services 

14 contracts, streamlined personnel authority, and the 

15 purchase of security countermeasures under the spe16 cial reserve fund; and 

17 (B) to recommend any legislative or administra18 tive changes necessary to improve the utilization or 

19 effectiveness of such authorities in the future; 

20 (2)(A) to review the internal controls instituted 

21 by such Secretary with respect to such authorities, 

22 where required by this Act; and 

23 (B) to recommend any legislative or administra24 tive changes necessary to improve the effectiveness of 

25 such controls; and 
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1 (3)(A) to review such Secretary’s utilization of 

2 the authority granted under this Act to authorize an 

3 emergency use of a biomedical countermeasure, in4 cluding the means by which the Secretary determines 

5 whether and under what conditions any such author6 izations should be granted and the benefits and ad7 verse impacts, if any, resulting from the use of such 

8 authority; and 

9 (B) to recommend any legislative or administra10 tive changes necessary to improve the utilization or 

11 effectiveness of such authority and to enhance protec12 tion of the public health. 

13 The results of the study shall be submitted to the Congress 

14 not later than five years after the date of the enactment 

15 of this Act.

16 SECTION 1. SHORT TITLE. 

17 This Act may be cited as the ‘‘Project Bio18 Shield Act of 2003’’. 

19 SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND 

20 DEVELOPMENT –––AUTHORITIES. 

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

22 Public Health Service Act (42 U.S.C. 243 et 

23 seq.) is amended by inserting after section 

24 319F the following section: 
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1 ‘‘SEC. 319F–1. AUTHORITY FOR USE OF CERTAIN PROCE2 DURES REGARDING BIOMEDICAL COUNTER3 MEASURE RESEARCH AND DEVELOPMENT 

4 ACTIVITIES. 

5 ‘‘(a) IN GENERAL.—

6 ‘‘(1) AUTHORITY.—In conducting and 

7 supporting research and development ac8 tivities regarding biomedical counter9 measures under section 319F(h), the Sec10 retary may conduct and support such ac11 tivities in accordance with this section if 

12 the activities concern qualified counter13 measures. 

14 ‘‘(2) QUALIFIED COUNTERMEASURE.—For 

15 purposes of this section, the term ‘quali16 fied countermeasure’ means a priority 

17 countermeasure (as defined in section 

18 319F(h)) that affects national security. 

19 ‘‘(3) INTERAGENCY COOPERATION.—

20 ‘‘(A) IN GENERAL.—In carrying out 

21 activities under this section, the Sec22 retary is authorized, subject to sub23 paragraph (B), to enter into inter24 agency agreements and other collabo25 rative undertakings with other agen26 cies of the United States Government. 
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1 ‘‘(B) LIMITATION.—An agreement 

2 or undertaking under this paragraph 

3 shall not authorize another agency to 

4 exercise the authorities provided by 

5 this section. 

6 ‘‘(4) AVAILABILITY OF FACILITIES TO THE

7 SECRETARY.—In any grant or cooperative 

8 agreement entered into under the author9 ity provided in this section with respect 

10 to a biocontainment laboratory or other 

11 related or ancillary specialized research 

12 facility that the Secretary determines 

13 necessary for the purpose of performing, 

14 administering, and supporting qualified 

15 countermeasure research and develop16 ment, the Secretary may provide that the 

17 facility that is the object of such grant or 

18 cooperative agreement shall be available 

19 as needed to the Secretary to respond to 

20 public health emergencies affecting na21 tional security. 

22 ‘‘(b) EXPEDITED PROCUREMENT AUTHOR23 ITY.—
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1 ‘‘(1) INCREASED SIMPLIFIED ACQUISITION

2 THRESHOLD FOR BIOMEDICAL COUNTER3 MEASURE PROCUREMENTS.—

4 ‘‘(A) IN GENERAL.—For any pro5 curement by the Secretary of prop6 erty or services for use (as deter7 mined by the Secretary) in per8 forming, administering, or supporting 

9 qualified countermeasure research or 

10 development activities under this sec11 tion that the Secretary determines 

12 necessary to respond to pressing re13 search and development needs under 

14 this section, the amount specified in 

15 section 4(11) of the Office of Federal 

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

17 403(11)), as applicable pursuant to 

18 section 302A(a) of the Federal Prop19 erty and Administrative Services Act 

20 of 1949 (41 U.S.C. 252a(a)), shall be 

21 deemed to be $25,000,000 in the ad22 ministration, with respect to such 

23 procurement, of—

24 ‘‘(i) section 303(g)(1)(A) of the 

25 Federal Property and Administra-
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1 tive Services Act of 1949 (41 

2 U.S.C. 253(g)(1)(A)) and its imple3 menting regulations; and

4 ‘‘(ii) section 302A(b) of such 

5 Act (41 U.S.C. 252a(b)) and its im6 plementing regulations. 

7 ‘‘(B) APPLICATION OF CERTAIN PRO8 VISIONS.—Notwithstanding subpara9 graph (A) and the provision of law 

10 and regulations referred to in such 

11 subparagraph, each of the following 

12 provisions shall apply to procure13 ments described in this paragraph to 

14 the same extent that such provisions 

15 would apply to such procurements in 

16 the absence of subparagraph (A): 

17 ‘‘(i) Chapter 37 of title 40, 

18 United States Code (relating to 

19 contract work hours and safety 

20 standards). 

21 ‘‘(ii) Subsections (a) and (b) of 

22 Section 7 of the Anti-Kickback Act 

23 of 1986 (41 U.S.C. 57(a) and (b)). 

24 ‘‘(iii) Section 304C of the Fed25 eral Property and Administrative 
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1 Services Act of 1949 (41 U.S.C. 

2 254d) (relating to the examination 

3 of contractor records). 

4 ‘‘(C) INTERNAL CONTROLS TO BE IN5 STITUTED.—The Secretary shall insti6 tute appropriate internal controls for 

7 procurements that are under this 

8 paragraph, including requirements 

9 with regard to documenting the jus10 tification for use of the authority in 

11 this paragraph. 

12 ‘‘(2) USE OF NONCOMPETITIVE PROCE13 DURES.—In addition to any other author14 ity to use procedures other than competi15 tive procedures, the Secretary may use 

16 such other procedures when—

17 ‘‘(A) the procurement is as de18 scribed by paragraph (1); and 

19 ‘‘(B) the property or services 

20 needed by the Secretary are available 

21 from only one responsible source or 

22 only from a limited number of re23 sponsible sources, and no other type 

24 of property or services will satisfy the 

25 Secretary’s needs. 
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1 ‘‘(3) INCREASED MICROPURCHASE

2 THRESHOLD.—

3 ‘‘(A) IN GENERAL.—For a procure4 ment described by paragraph (1), the 

5 amount specified in subsections (c), 

6 (d), and (f) of section 32 of the Office 

7 of Federal Procurement Policy Act 

8 (41 U.S.C. 428) shall be deemed to be 

9 $15,000 in the administration of that 

10 section with respect to such procure11 ment. 

12 ‘‘(B) INTERNAL CONTROLS TO BE IN13 STITUTED.—The Secretary shall insti14 tute appropriate internal controls for 

15 purchases that are under this para16 graph and that are greater than 

17 $2,500. 

18 ‘‘(C) EXCEPTION TO PREFERENCE

19 FOR PURCHASE CARD MECHANISM.—No 

20 provision of law establishing a pref21 erence for using a Government pur22 chase card method for purchases 

23 shall apply to purchases that are 

24 under this paragraph and that are 

25 greater than $2,500. 
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1 ‘‘(c) AUTHORITY TO EXPEDITE PEER RE2 VIEW.—

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

4 as the Secretary determines necessary to 

5 respond to pressing qualified counter6 measure research and development needs 

7 under this section, employ such expe8 dited peer review procedures (including 

9 consultation with appropriate scientific 

10 experts) as the Secretary, in consultation 

11 with the Director of NIH, deems appro12 priate to obtain assessment of scientific 

13 and technical merit and likely contribu14 tion to the field of qualified counter15 measure research, in place of the peer re16 view and advisory council review proce17 dures that would be required under sec18 tions 301(a)(3), 405(b)(1)(B), 405(b)(2), 

19 406(a)(3)(A), 492, and 494, as applicable to 

20 a grant, contract, or cooperative agree21 ment—

22 ‘‘(A) that is for performing, ad23 ministering, or supporting qualified 

24 countermeasure research and devel25 opment activities; and 
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1 ‘‘(B) the amount of which is not 

2 greater than $1,500,000. 

3 ‘‘(2) SUBSEQUENT PHASES OF RE4 SEARCH.—The Secretary’s determination 

5 of whether to employ expedited peer re6 view with respect to subsequent phases 

7 of a research grant or cooperative agree8 ment under this section shall be deter9 mined without regard to the peer review 

10 procedures used for any prior peer re11 view of that same grant or cooperative 

12 agreement. 

13 ‘‘(d) AUTHORITY FOR PERSONAL SERVICES

14 CONTRACTS.—

15 ‘‘(1) IN GENERAL.—For the purpose of 

16 performing, administering, and sup17 porting qualified countermeasure re18 search and development activities, the 

19 Secretary may, as the Secretary deter20 mines necessary to respond to pressing 

21 qualified countermeasure research and 

22 development needs under this section, 

23 obtain by contract (in accordance with 

24 section 3109 of title 5, United States Code, 

25 but without regard to the limitations in 
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1 such section on the period of service and 

2 on pay) the personal services of experts

3 or consultants who have scientific or 

4 other professional qualifications, except 

5 that in no case shall the compensation 

6 provided to any such expert or consult7 ant exceed the daily equivalent of the an8 nual rate of compensation for the Presi9 dent. 

10 ‘‘(2) FEDERAL TORT CLAIMS ACT COV11 ERAGE.—

12 ‘‘(A) IN GENERAL.—A person car13 rying out a contract under paragraph 

14 (1), and an officer, employee, or gov15 erning board member of such person, 

16 shall be deemed to be an employee of 

17 the Department of Health and Human 

18 Services for purposes of claims under 

19 sections 1346(b) and 2672 of title 28, 

20 United States Code, for money dam21 ages for personal injury, including 

22 death, resulting from performance of 

23 functions under such contract. 

24 ‘‘(B) EXCLUSIVITY OF REMEDY.—The 

25 remedy provided by subparagraph 
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1 (A) shall be exclusive of any other 

2 civil action or proceeding by reason 

3 of the same subject matter against 

4 the person, officer, employee, or gov5 erning board member. 

6 ‘‘(3) INTERNAL CONTROLS TO BE INSTI7 TUTED.—

8 ‘‘(A) IN GENERAL.—The Secretary 

9 shall institute appropriate internal 

10 controls for contracts under this sub11 section, including procedures for the 

12 Secretary to make a determination of 

13 whether a person, or an officer, em14 ployee, or governing board member 

15 of a person, is deemed to be an em16 ployee of the Department of Health 

17 and Human Services pursuant to 

18 paragraph (2). 

19 ‘‘(B) DETERMINATION OF EMPLOYEE

20 STATUS TO BE FINAL.—A determination 

21 by the Secretary under subparagraph 

22 (A) that a person, or an officer, em23 ployee, or governing board member 

24 of a person, is or is not deemed to be 

25 an employee of the Department of 
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1 Health and Human Services shall be 

2 final and binding on the Secretary 

3 and the Attorney General and other 

4 parties to any civil action or pro5 ceeding. 

6 ‘‘(4) NUMBER OF PERSONAL SERVICES

7 CONTRACTS LIMITED.—The number of ex8 perts and consultants whose personal 

9 services are obtained under paragraph 

10 (1) shall not exceed 30 at any time. 

11 ‘‘(e) STREAMLINED PERSONNEL AUTHORITY.—

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

13 other personnel authorities, the Sec14 retary may, as the Secretary determines 

15 necessary to respond to pressing quali16 fied countermeasure research and devel17 opment needs under this section, without 

18 regard to such provisions of title 5, 

19 United States Code, governing appoint20 ments in the competitive service, and 

21 without regard to the provisions of chap22 ter 51 and subchapter III of chapter 53 of 

23 such title relating to classification and 

24 General Schedule pay rates, appoint pro25 fessional and technical employees, not to 
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1 exceed 30 such employees at any time, to 

2 positions in the National Institutes of 

3 Health to perform, administer, or support 

4 qualified countermeasure research and 

5 development activities in carrying out 

6 this section. 

7 ‘‘(2) INTERNAL CONTROLS TO BE INSTI8 TUTED.—The Secretary shall institute ap9 propriate internal controls for appoint10 ments under this subsection. 

11 ‘‘(f) ACTIONS COMMITTED TO AGENCY DIS12 CRETION.—Actions by the Secretary under the 

13 authority of this section are committed to 

14 agency discretion.’’. 

15 (b) TECHNICAL AMENDMENT.—Section 481A 

16 of the Public Health Service Act (42 U.S.C. 

17 287a–2) is amended—

18 (1) in subsection (a)(1), by inserting 

19 ‘‘or the Director of the National Institute 

20 of Allergy and Infectious Diseases’’ after 

21 ‘‘Director of the Center’’; 

22 (2) in subsection (c)—

23 (A) in paragraph (1), by inserting 

24 ‘‘or the Director of the National Insti25 tute of Allergy and Infectious Dis-
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1 eases’’ after ‘‘Director of the Center’’; 

2 and 

3 (B) in paragraph (2), in the matter 

4 preceding subparagraph (A), by strik5 ing ‘‘subsection (i)’’ and inserting 

6 ‘‘subsection (i)(1)’’; 

7 (3) in subsection (d), by inserting ‘‘or 

8 the Director of the National Institute of 

9 Allergy and Infectious Diseases’’ after 

10 ‘‘Director of the Center’’; 

11 (4) in subsection (e)—

12 (A) in paragraph (1)—

13 (i) in the matter preceding 

14 subparagraph (A), by inserting 

15 ‘‘or the Director of the National 

16 Institute of Allergy and Infectious 

17 Diseases’’ after ‘‘Director of the 

18 Center’’; 

19 (ii) in subparagraph (A), by 

20 inserting ‘‘(or, in the case of the 

21 Institute, 75 percent)’’ after ‘‘50 

22 percent’’; and 

23 (iii) in subparagraph (B), by 

24 inserting ‘‘(or, in the case of the 
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1 Institute, 75 percent)’’ after ‘‘40 

2 percent’’;

3 (B) in paragraph (2), by inserting 

4 ‘‘or the Director of the National Insti5 tute of Allergy and Infectious Dis6 eases’’ after ‘‘Director of the Center’’; 

7 and 

8 (C) in paragraph (4), by inserting 

9 ‘‘of the Center or the Director of the 

10 National Institute of Allergy and In11 fectious Diseases’’ after ‘‘Director’’; 

12 (5) in subsection (f)—

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

14 ‘‘in the case of an award by the Direc15 tor of the Center,’’ before ‘‘the appli16 cant’’; and 

17 (B) in paragraph (2), by inserting 

18 ‘‘of the Center or the Director of the 

19 National Institute of Allergy and In20 fectious Diseases’’ after ‘‘Director’’; 

21 and 

22 (6) in subsection (i)—

23 (A) by striking ‘‘APPROPRIA24 TIONS.—For the purpose of carrying 
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1 out this section,’’ and inserting the 

2 following: ‘‘APPROPRIATIONS.—

3 ‘‘(1) CENTER.—For the purpose of car4 rying out this section with respect to the 

5 Center,’’; and 

6 (B) by adding at the end the fol7 lowing: 

8 ‘‘(2) NATIONAL INSTITUTE OF ALLERGY

9 AND INFECTIOUS DISEASES.—For the pur10 pose of carrying out this section with re11 spect to the National Institute of Allergy 

12 and Infectious Diseases, there are author13 ized to be appropriated such sums as may 

14 be necessary for fiscal year 2003.’’. 

15 SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT. 

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

17 Public Health Service Act, as amended by sec18 tion 2 of this Act, is amended by inserting 

19 after section 319F–1 the following section: 

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

21 ‘‘(a) STRATEGIC NATIONAL STOCKPILE.—

22 ‘‘(1) IN GENERAL.—The Secretary of 

23 Homeland Security (referred to in this 

24 section as the ‘Homeland Security Sec25 retary’), in coordination with the Sec-
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1 retary and the Secretary of Veterans Af2 fairs, shall maintain a stockpile or stock3 piles of drugs, vaccines and other biologi4 cal products, medical devices, and other 

5 supplies in such numbers, types, and 

6 amounts as are determined by the Sec7 retary to be appropriate and practicable, 

8 taking into account other available 

9 sources, to provide for the emergency 

10 health security of the United States, in11 cluding the emergency health security of 

12 children and other vulnerable popu13 lations, in the event of a bioterrorist at14 tack or other public health emergency. 

15 ‘‘(2) PROCEDURES.—The Secretary, in 

16 managing the stockpile under paragraph 

17 (1), shall—

18 ‘‘(A) consult with the working 

19 group under section 319F(a); 

20 ‘‘(B) ensure that adequate proce21 dures are followed with respect to 

22 such stockpile for inventory manage23 ment and accounting, and for the 

24 physical security of the stockpile; 
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1 ‘‘(C) in consultation with Federal, 

2 State, and local officials, take into 

3 consideration the timing and location 

4 of special events; 

5 ‘‘(D) review and revise, as appro6 priate, the contents of the stockpile 

7 on a regular basis to ensure that 

8 emerging threats, advanced tech9 nologies, and new countermeasures 

10 are adequately considered; 

11 ‘‘(E) devise plans for the effective 

12 and timely supply-chain management 

13 of the stockpile, in consultation with 

14 appropriate Federal, State and local 

15 agencies, and the public and private 

16 health care infrastructure; and 

17 ‘‘(F) ensure the adequate physical 

18 security of the stockpile. 

19 ‘‘(b) SMALLPOX VACCINE DEVELOPMENT.—

20 ‘‘(1) IN GENERAL.—The Secretary shall 

21 award contracts, enter into cooperative 

22 agreements, or carry out such other ac23 tivities as may reasonably be required in 

24 order to ensure that the stockpile under 

25 subsection (a) includes an amount of vac-
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1 cine against smallpox as determined by 

2 such Secretary to be sufficient to meet 

3 the health security needs of the United 

4 States. 

5 ‘‘(2) RULE OF CONSTRUCTION.—Nothing 

6 in this section shall be construed to limit 

7 the private distribution, purchase, or sale 

8 of vaccines from sources other than the 

9 stockpile described in subsection (a). 

10 ‘‘(c) ADDITIONAL AUTHORITY REGARDING

11 PROCUREMENT OF CERTAIN BIOMEDICAL COUN12 TERMEASURES; AVAILABILITY OF SPECIAL RE13 SERVE FUND.—

14 ‘‘(1) IN GENERAL.—

15 ‘‘(A) USE OF FUND.—A security 

16 countermeasure may, in accordance 

17 with this subsection, be procured 

18 with amounts in the special reserve 

19 fund under paragraph (10). 

20 ‘‘(B) SECURITY COUNTERMEASURE.—

21 For purposes of this subsection, the 

22 term ‘security countermeasure’

23 means a priority countermeasure (as 

24 defined in section 319F(h))—
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1 ‘‘(i) against a chemical, bio2 logical, radiological, or nuclear

3 agent identified as a material 

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

5 ‘‘(ii) that is determined under 

6 paragraph (2)(B)(ii) to be a nec7 essary countermeasure; 

8 ‘‘(iii) that is designed, devel9 oped, modified, or procured for 

10 the specific purpose of pre11 venting, detecting, identifying, 

12 deterring, or mitigating actual or 

13 potential acts of chemical, biologi14 cal, radiological, or nuclear catas15 trophe; 

16 ‘‘(iv)(I) that is approved or 

17 cleared under chapter V of the 

18 Federal Food, Drug, and Cosmetic 

19 Act, or licensed under section 351 

20 of this Act, for use as a counter21 measure to a chemical, biological, 

22 radiological, or nuclear agent 

23 identified as a material threat 

24 under paragraph (2)(A)(ii); or 
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1 ‘‘(II) for which the Secretary 

2 determines that sufficient and 

3 satisfactory clinical experience or 

4 research data (including data, if 

5 available, from pre-clinical and 

6 clinical trials) support a reason7 able conclusion that the counter8 measure will qualify for approval 

9 or licensing after the date of a de10 termination under paragraph (5); 

11 and 

12 ‘‘(v) that relates to an actual 

13 or potential act of terrorism or 

14 catastrophic event or to actual or 

15 potential warfare. 

16 ‘‘(2) DETERMINATION OF MATERIAL

17 THREATS.—

18 ‘‘(A) MATERIAL THREAT.—The 

19 Homeland Security Secretary, in con20 sultation with the heads of other 

21 agencies as appropriate, shall on an 

22 ongoing basis—

23 ‘‘(i) assess current and emerg24 ing threats of chemical, biologi-
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1 cal, radiological, and nuclear 

2 agents; and 

3 ‘‘(ii) determine which of such 

4 agents present a material threat 

5 against the United States popu6 lation. 

7 ‘‘(B) PUBLIC HEALTH IMPACT; NEC8 ESSARY COUNTERMEASURES.—The Sec9 retary shall on an ongoing basis—

10 ‘‘(i) assess the potential public 

11 health consequences of use 

12 against the United States popu13 lation of agents identified under 

14 subparagraph (A)(ii); and 

15 ‘‘(ii) determine, on the basis of 

16 such assessment, the agents for 

17 which priority countermeasures 

18 are necessary to protect the pub19 lic health from a material threat. 

20 ‘‘(C) NOTICE TO CONGRESS.—The 

21 Secretary and the Homeland Security 

22 Secretary shall promptly notify the 

23 designated congressional committees 

24 (as defined in paragraph (10)) of any 

25 determination made pursuant to sub-
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1 paragraph (A) or (B). Such notice 

2 shall be in unclassified and, if nec3 essary, classified form. 

4 ‘‘(D) ASSURING ACCESS TO THREAT

5 INFORMATION.—In making the assess6 ment and determination required 

7 under subparagraph (A), the Home8 land Security Secretary shall use all 

9 information to which such Secretary 

10 is entitled under section 202 of the 

11 Homeland Security Act of 2002, in12 cluding but not limited to informa13 tion, regardless of its level of classi14 fication, relating to current and 

15 emerging threats of chemical, biologi16 cal, radiological, and nuclear agents. 

17 ‘‘(3) ASSESSMENT OF AVAILABILITY AND

18 APPROPRIATENESS OF COUNTERMEASURES.—

19 The Secretary, in consultation with the 

20 Homeland Security Secretary, shall as21 sess on an ongoing basis the availability 

22 and appropriateness of specific counter23 measures to address specific threats iden24 tified under paragraph (2). 
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1 ‘‘(4) CALL FOR DEVELOPMENT OF COUN2 TERMEASURES; COMMITMENT FOR REC3 OMMENDATION FOR PROCUREMENT.—

4 ‘‘(A) PROPOSAL TO THE PRESI5 DENT.—If, pursuant to an assessment 

6 under paragraph (3), the Homeland 

7 Security Secretary and the Secretary 

8 make a determination that a counter9 measure would be appropriate but is 

10 either currently unavailable for pro11 curement or available under unsuit12 able conditions, such Secretaries may 

13 jointly submit to the President a pro14 posal to—

15 ‘‘(i) issue a call for the devel16 opment of such countermeasure; 

17 and 

18 ‘‘(ii) make a commitment that, 

19 upon the first development of 

20 such countermeasure that meets 

21 the conditions for procurement 

22 under paragraph (5), the Secre23 taries will, based in part on infor24 mation obtained pursuant to such 

25 call, make a recommendation 
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1 under paragraph (6) that the spe2 cial reserve fund under para3 graph (10) be made available for

4 the procurement of such counter5 measure. 

6 ‘‘(B) COUNTERMEASURE SPECIFICA7 TIONS.—The Homeland Security Sec8 retary and the Secretary shall, to the 

9 extent practicable, include in the pro10 posal under subparagraph (A)—

11 ‘‘(i) estimated quantity of pur12 chase (in the form of number of 

13 doses or number of effective 

14 courses of treatments regardless 

15 of dosage form); 

16 ‘‘(ii) necessary measures of 

17 minimum safety and effective18 ness; 

19 ‘‘(iii) estimated price for each 

20 dose or effective course of treat21 ment regardless of dosage form; 

22 and 

23 ‘‘(iv) other information that 

24 may be necessary to encourage 

25 and facilitate research, develop-
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1 ment, and manufacture of the 

2 countermeasure or to provide 

3 specifications for the counter4 measure. 

5 ‘‘(C) PRESIDENTIAL APPROVAL.—If 

6 the President approves a proposal 

7 under subparagraph (A), the Home8 land Security Secretary and the Sec9 retary shall make known to persons 

10 who may respond to a call for the 

11 countermeasure involved—

12 ‘‘(i) the call for the counter13 measure; 

14 ‘‘(ii) specifications for the 

15 countermeasure under subpara16 graph (B); and 

17 ‘‘(iii) a commitment described 

18 in subparagraph (A)(ii). 

19 ‘‘(5) SECRETARY’S DETERMINATION OF

20 COUNTERMEASURES APPROPRIATE FOR FUND21 ING FROM SPECIAL RESERVE FUND.—

22 ‘‘(A) IN GENERAL.—The Secretary, 

23 in accordance with the provisions of 

24 this paragraph, shall identify specific 

25 security countermeasures that the 
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1 Secretary determines, in consultation 

2 with the Homeland Security Sec3 retary, to be appropriate for inclu4 sion in the stockpile under subsection 

5 (a) pursuant to procurements made 

6 with amounts in the special reserve 

7 fund under paragraph (10) (referred 

8 to in this subsection individually as a 

9 ‘procurement under this subsection’). 

10 ‘‘(B) REQUIREMENTS.—In making a 

11 determination under subparagraph 

12 (A) with respect to a security counter13 measure, the Secretary shall deter14 mine and consider the following: 

15 ‘‘(i) The quantities of the 

16 product that will be needed to 

17 meet the needs of the stockpile. 

18 ‘‘(ii) The feasibility of produc19 tion and delivery within five 

20 years of sufficient quantities of 

21 the product. 

22 ‘‘(iii) Whether there is a lack 

23 of a significant commercial mar24 ket for the product at the time of 
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1 procurement, other than as a se2 curity countermeasure. 

3 ‘‘(6) RECOMMENDATION FOR PRESIDENT’S

4 APPROVAL.—

5 ‘‘(A) RECOMMENDATION FOR PRO6 CUREMENT.—In the case of a security 

7 countermeasure that the Secretary 

8 has, in accordance with paragraphs 

9 (2), (3), and (5), determined to be ap10 propriate for procurement under this 

11 subsection, the Homeland Security 

12 Secretary and the Secretary shall 

13 jointly submit to the President, in co14 ordination with the Director of the 

15 Office of Management and Budget, a 

16 recommendation that the special re17 serve fund under paragraph (10) be 

18 made available for the procurement 

19 of such countermeasure. 

20 ‘‘(B) PRESIDENTIAL APPROVAL.—The 

21 special reserve fund under paragraph 

22 (10) is available for a procurement of 

23 a security countermeasure only if the 

24 President has approved a rec-
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1 ommendation under subparagraph 

2 (A) regarding the countermeasure. 

3 ‘‘(C) NOTICE TO CONGRESS.—The 

4 Secretary and the Homeland Security 

5 Secretary shall notify the designated 

6 congressional committees of each de7 cision of the President to approve a 

8 recommendation under subparagraph 

9 (A). Such notice shall include an ex10 planation of the decision to make 

11 available the special reserve fund 

12 under paragraph (10) for procure13 ment of such a countermeasure, in14 cluding, where available, the identi15 fication of the potential supplier or 

16 suppliers of such countermeasure, 

17 and whether other potential sup18 pliers of the same or similar counter19 measures were considered and re20 jected for procurement under this 

21 section and the reasons therefor. 

22 ‘‘(D) SUBSEQUENT SPECIFIC COUN23 TERMEASURES.—Procurement under 

24 this subsection of a security counter25 measure for a particular purpose 
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1 does not preclude the subsequent 

2 procurement under this subsection of

3 any other security countermeasure 

4 for such purpose if the Secretary has 

5 determined under paragraph (5)(A) 

6 that such countermeasure is appro7 priate for inclusion in the stockpile 

8 and if, as determined by the Sec9 retary, such countermeasure provides 

10 improved safety or effectiveness, or 

11 for other reasons enhances prepared12 ness to respond to threats of use of a 

13 biological, chemical, radiological, or 

14 nuclear agent. Such a determination 

15 by the Secretary is committed to 

16 agency discretion. 

17 ‘‘(E) RULE OF CONSTRUCTION.—Rec18 ommendations and approvals under 

19 this paragraph apply solely to deter20 minations that the special reserve 

21 fund under paragraph (10) will be 

22 made available for a procurement of 

23 a security countermeasure, and not to 

24 the substance of contracts for such 
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1 procurement or other matters relat2 ing to awards of such contracts. 

3 ‘‘(7) PROCUREMENT.—

4 ‘‘(A) IN GENERAL.—For purposes of 

5 a procurement under this subsection 

6 that is approved by the President 

7 under paragraph (6), the Homeland 

8 Security Secretary and the Secretary 

9 shall have responsibilities in accord10 ance with subparagraphs (B) and (C). 

11 ‘‘(B) INTERAGENCY AGREEMENTS.—

12 ‘‘(i) FOR PROCUREMENT.—The 

13 Homeland Security Secretary 

14 shall enter into an agreement 

15 with the Secretary for procure16 ment of a security counter17 measure in accordance with the 

18 provisions of this paragraph. The 

19 special reserve fund under para20 graph (10) shall be available for 

21 the Secretary’s costs of such pro22 curement, other than as provided 

23 in clause (ii). 

24 ‘‘(ii) FOR ADMINISTRATIVE

25 COSTS.—The agreement entered 
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1 into between the Homeland Secu2 rity Secretary and the Secretary 

3 for managing the stockpile under 

4 subsection (a) shall provide for 

5 reimbursement of the Secretary’s 

6 administrative costs relating to 

7 procurements under this sub8 section. 

9 ‘‘(C) PROCUREMENT.—

10 ‘‘(i) IN GENERAL.—The Sec11 retary shall be responsible for—

12 ‘‘(I) arranging for procure13 ment of a security counter14 measure, including negoti15 ating terms (including quan16 tity, production schedule, and 

17 price) of, and entering into, 

18 contracts and cooperative 

19 agreements, and for carrying 

20 out such other activities as 

21 may reasonably be required, 

22 in accordance with the provi23 sions of this subparagraph; 

24 and 
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1 ‘‘(II) promulgating regula2 tions to implement clauses (v), 

3 (vi), and (vii), and any other 

4 provisions of this subsection. 

5 ‘‘(ii) CONTRACT TERMS.—A con6 tract for procurements under this 

7 subsection shall (or, as specified 

8 below, may) include the following 

9 terms: 

10 ‘‘(I) PAYMENT CONDITIONED

11 ON SUBSTANTIAL DELIVERY.—

12 The contract shall provide 

13 that no payment may be made 

14 until delivery has been made 

15 of a substantial portion (as 

16 determined by the Secretary) 

17 of the total number of units 

18 contracted for, except that, 

19 notwithstanding any other 

20 provision of law, the contract 

21 may provide that, if the Sec22 retary determines (in the Sec23 retary’s discretion) that an 

24 advance payment is necessary 

25 to ensure success of a project, 
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1 the Secretary may pay an 

2 amount, not to exceed 10 per3 cent of the contract amount, 

4 in advance of delivery. The

5 contract shall provide that 

6 such advance payment is re7 quired to be repaid if there is 

8 a failure to perform under the 

9 contract, except in special cir10 cumstances as determined by 

11 the Secretary on a contract by 

12 contract basis. 

13 ‘‘(II) CONTRACT DURA14 TION.—The contract shall be 

15 for a period not to exceed five 

16 years, except that, in first 

17 awarding the contract, the 

18 Secretary may provide for a 

19 longer duration, not exceed20 ing eight years, if the Sec21 retary determines that com22 plexities or other difficulties 

23 in performance under the 

24 contract justify such a period. 

25 The contract shall be renew-
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1 able for additional periods, 

2 none of which shall exceed 

3 five years. 

4 ‘‘(III) STORAGE BY VEN5 DOR.—The contract may pro6 vide that the vendor will pro7 vide storage for stocks of a 

8 product delivered to the own9 ership of the Federal Govern10 ment under the contract, for 

11 such period and under such 

12 terms and conditions as the 

13 Secretary may specify, and in 

14 such case amounts from the 

15 special reserve fund under 

16 paragraph (10) shall be avail17 able for costs of shipping, 

18 handling, storage, and related 

19 costs for such product. 

20 ‘‘(IV) NON-STOCKPILE SALES

21 OF SECURITY COUNTER22 MEASURES.—The contract may 

23 provide that the vendor will 

24 not at any time (including 

25 after performance under the 
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1 contract is otherwise com2 pleted) sell or otherwise pro3 vide such countermeasure to 

4 any domestic or foreign per5 son, or transfer to any such 

6 person any quantity of such 

7 security countermeasure, or 

8 any intellectual property re9 lating thereto that would en10 able the development or pro11 duction of the counter12 measure, without certification 

13 by the Secretary, in consulta14 tion with the Homeland Secu15 rity Secretary, the Secretary 

16 of Defense, and the Secretary 

17 of State, that such sale or 

18 transfer, or category of sales 

19 or transfers, would not ad20 versely affect the national se21 curity; and that, for each vio22 lation of this provision of the 

23 contract, the United States is 

24 entitled to recover from the 

25 person as liquidated damages 
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1 an amount equal to three 

2 times the sum of the pay3 ments made to the vendor 

4 under the contract. 

5 ‘‘(iii) AVAILABILITY OF SIM6 PLIFIED ACQUISITION PROCE7 DURES.—

8 ‘‘(I) IN GENERAL.—The 

9 amount of any procurement 

10 under this subsection shall be 

11 deemed to be below the 

12 threshold amount specified in 

13 section 4(11) of the Office of 

14 Federal Procurement Policy 

15 Act (41 U.S.C. 403(11)), for 

16 purposes of application to 

17 such procurement, pursuant 

18 to section 302A(a) of the Fed19 eral Property and Administra20 tive Services Act of 1949 (41 

21 U.S.C. 252a(a)), of—

22 ‘‘(aa) section 

23 303(g)(1)(A) of the Federal 

24 Property and Administra25 tive Services Act of 1949 
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1 (41 U.S.C. 253(g)(1)(A)) and 

2 its implementing regula3 tions; and 

4 ‘‘(bb) section 302A(b) 

5 of such Act (41 U.S.C. 

6 252a(b)) and its imple7 menting regulations. 

8 ‘‘(II) APPLICATION OF CER9 TAIN PROVISIONS.—Notwith10 standing subclause (I) and the 

11 provision of law and regula12 tions referred to in such 

13 clause, each of the following 

14 provisions shall apply to pro15 curements described in this 

16 clause to the same extent that 

17 such provisions would apply 

18 to such procurements in the 

19 absence of subclause (I): 

20 ‘‘(aa) Chapter 37 of 

21 title 40, United States 

22 Code (relating to contract 

23 work hours and safety 

24 standards). 
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1 ‘‘(bb) Subsections (a) 

2 and (b) of Section 7 of the

3 Anti-Kickback Act of 1986 

4 (41 U.S.C. 57(a) and (b)). 

5 ‘‘(cc) Section 304C of 

6 the Federal Property and 

7 Administrative Services 

8 Act of 1949 (41 U.S.C. 

9 254d) (relating to the ex10 amination of contractor 

11 records). 

12 ‘‘(iv) USE OF NONCOMPETITIVE

13 PROCEDURES.—In addition to any 

14 other authority to use procedures 

15 other than competitive proce16 dures, the Secretary may use such 

17 other procedures for a procure18 ment under this subsection if the 

19 product is available from only one 

20 responsible source or only from a 

21 limited number of responsible 

22 sources, and no other type of 

23 product will satisfy the Sec24 retary’s needs. 
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1 ‘‘(v) PREMIUM PROVISION IN

2 MULTIPLE AWARD CONTRACTS.—

3 ‘‘(I) IN GENERAL.—If, under 

4 this subsection, the Secretary 

5 enters into contracts with 

6 more than one vendor to pro7 cure a security counter8 measure, such Secretary may, 

9 notwithstanding any other 

10 provision of law, include in 

11 each of such contracts a pro12 vision that—

13 ‘‘(aa) identifies an in14 crement of the total quan15 tity of security counter16 measure required, wheth17 er by percentage or by 

18 numbers of units; and 

19 ‘‘(bb) promises to pays 

20 one or more specified pre21 miums based on the pri22 ority of such vendors’ pro23 duction and delivery of 

24 the increment identified 

25 under item (aa), in accord-
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1 ance with the terms and 

2 conditions of the contract. 

3 ‘‘(II) DETERMINATION OF

4 GOVERNMENT’S REQUIREMENT

5 NOT REVIEWABLE.—If the Sec6 retary includes in each of a 

7 set of contracts a provision as 

8 described in subclause (I), 

9 such Secretary’s determina10 tion of the total quantity of 

11 security countermeasure re12 quired, and any amendment 

13 of such determination, is com14 mitted to agency discretion. 

15 ‘‘(vi) EXTENSION OF CLOSING

16 DATE FOR RECEIPT OF PROPOSALS

17 NOT REVIEWABLE.—A decision by 

18 the Secretary to extend the clos19 ing date for receipt of proposals 

20 for a procurement under this sub21 section is committed to agency 

22 discretion. 

23 ‘‘(vii) LIMITING COMPETITION TO

24 SOURCES RESPONDING TO REQUEST

25 FOR INFORMATION.—In conducting 
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1 a procurement under this sub2 section, the Secretary may ex3 clude a source that has not re4 sponded to a request for informa5 tion under section 303A(a)(1)(B) 

6 of the Federal Property and Ad7 ministrative Services Act of 1949 

8 (41 U.S.C. 253a(a)(1)(B)) if such re9 quest has given notice that the 

10 Secretary may so exclude such a 

11 source. 

12 ‘‘(8) INTERAGENCY COOPERATION.—

13 ‘‘(A) IN GENERAL.—In carrying out 

14 activities under this section, the 

15 Homeland Security Secretary and the 

16 Secretary are authorized, subject to 

17 subparagraph (B), to enter into inter18 agency agreements and other collabo19 rative undertakings with other agen20 cies of the United States Government. 

21 ‘‘(B) LIMITATION.—An agreement 

22 or undertaking under this paragraph 

23 shall not authorize another agency to 

24 exercise the authorities provided by 
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1 this section to the Homeland Security 

2 Secretary or to the Secretary. 

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

4 Amounts in the special reserve fund 

5 under paragraph (10) shall not be used to 

6 pay—

7 ‘‘(A) costs for the purchase of vac8 cines under procurement contracts 

9 entered into before the date of the en10 actment of the Project BioShield Act 

11 of 2003; or 

12 ‘‘(B) administrative costs. 

13 ‘‘(10) DEFINITIONS.—

14 ‘‘(A) SPECIAL RESERVE FUND.—For 

15 purposes of this subsection, the term 

16 ‘special reserve fund’ has the mean17 ing given such term in section 510 of 

18 the Homeland Security Act of 2002. 

19 ‘‘(B) DESIGNATED CONGRESSIONAL

20 COMMITTEES.—For purposes of this 

21 section, the term ‘designated congres22 sional committees’ means the fol23 lowing committees of the Congress: 

24 ‘‘(i) In the House of Represent25 atives: the Committee on Energy 
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1 and Commerce, the Committee on 

2 Appropriations, the Committee on

3 Government Reform, and the Se4 lect Committee on Homeland Se5 curity (or any successor to the Se6 lect Committee). 

7 ‘‘(ii) In the Senate: the Com8 mittee on Health, Education, 

9 Labor, and Pensions, the Com10 mittee on Appropriations, and the 

11 Committee on Government Af12 fairs. 

13 ‘‘(d) DISCLOSURES.—No Federal agency 

14 shall disclose under section 552 of title 5, 

15 United States Code, any information identi16 fying the location at which materials in the 

17 stockpile under subsection (a) are stored. 

18 ‘‘(e) DEFINITION.—For purposes of sub19 section (a), the term ‘stockpile’ includes—

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

21 or more locations) of the supplies de22 scribed in subsection (a); or 

23 ‘‘(2) a contractual agreement between 

24 the Homeland Security Secretary and a 

25 vendor or vendors under which such ven-
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1 dor or vendors agree to provide to such 

2 Secretary supplies described in sub3 section (a). 

4 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

5 ‘‘(1) STRATEGIC NATIONAL STOCKPILE.—

6 For the purpose of carrying out sub7 section (a), there are authorized to be ap8 propriated $640,000,000 for fiscal year 

9 2002, and such sums as may be necessary 

10 for each of fiscal years 2003 through 2006. 

11 Such authorization is in addition to 

12 amounts in the special reserve fund 

13 under subsection (c)(10). 

14 ‘‘(2) SMALLPOX VACCINE DEVELOP15 MENT.—For the purpose of carrying out 

16 subsection (b), there are authorized to be 

17 appropriated $509,000,000 for fiscal year 

18 2002, and such sums as may be necessary 

19 for each of fiscal years 2003 through 

20 2006.’’. 

21 (b) AMENDMENT TO HOMELAND SECURITY

22 ACT OF 2002.—Title V of the Homeland Secu23 rity Act of 2002 (116 Stat. 2212; 6 U.S.C. 311 et 

24 seq.) is amended by adding at the end the fol25 lowing: 
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1 ‘‘SEC. 510. PROCUREMENT OF SECURITY COUNTER2 MEASURES FOR STRATEGIC NATIONAL 

3 STOCKPILE. 

4 ‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—

5 For the procurement of security counter6 measures under section 319F–2(c) of the Pub7 lic Health Service Act (referred to in this sec8 tion as the ‘security countermeasures pro9 gram’), there is authorized to be appropriated 

10 up to $5,593,000,000 for the fiscal years 2004 

11 through 2013. Of the amounts appropriated 

12 under the preceding sentence, not to exceed 

13 $3,418,000,000 may be obligated during the fis14 cal years 2004 through 2008, of which not to 

15 exceed $890,000,000 may be obligated during 

16 fiscal year 2004. 

17 ‘‘(b) SPECIAL RESERVE FUND.—For pur18 poses of the security countermeasures pro19 gram, the term ‘special reserve fund’ means 

20 the appropriations account established as a 

21 result of any appropriations made under sub22 section (a). 

23 ‘‘(c) AVAILABILITY.—

24 ‘‘(1) INTEGRITY OF SPECIAL RESERVE

25 FUND; LIMITATION OF OBLIGATIONAL AU26 THORITY TO FUND PURPOSES; INTENT OF
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1 CONGRESS AGAINST REPROGRAMMING.—Sub2 ject to paragraph (2), all amounts appro3 priated under subsection (a) are available 

4 for obligation through the end of fiscal 

5 year 2013 and only for the specific pur6 poses set forth in the security counter7 measures program. It is the intent of the 

8 Congress that no portion of such amount 

9 that remains unobligated for such pur10 poses shall be applied, through re11 programming or otherwise, to any other 

12 purpose. 

13 ‘‘(2) INITIAL AVAILABILITY FOR PAR14 TICULAR PROCUREMENTS.—Amounts appro15 priated under subsection (a) become 

16 available for a procurement under the se17 curity countermeasures program only 

18 upon the approval by the President of 

19 such availability for the procurement in 

20 accordance with paragraph (6)(B) of such 

21 program. 

22 ‘‘(d) RELATED AUTHORIZATIONS OF APPRO23 PRIATIONS.—

24 ‘‘(1) THREAT ASSESSMENT CAPABILI25 TIES.—For the purpose of carrying out the 
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1 responsibilities of the Secretary for ter2 ror threat assessment under the security 

3 countermeasures program, there are au4 thorized to be appropriated $5,000,000 for 

5 fiscal year 2004, and such sums as may be 

6 necessary for each of the fiscal years 2005 

7 and 2006, for the hiring of professional 

8 personnel within the Directorate for In9 formation Analysis and Infrastructure 

10 Protection, who shall be analysts respon11 sible for chemical, biological, radio12 logical, and nuclear threat assessment 

13 (including but not limited to analysis of 

14 chemical, biological, radiological, and nu15 clear agents, the means by which such 

16 agents could be weaponized or used in a 

17 terrorist attack, and the capabilities, 

18 plans, and intentions of terrorists and 

19 other non-state actors who may have or 

20 acquire such agents). All such analysts 

21 shall meet the applicable standards and 

22 qualifications for the performance of in23 telligence activities promulgated by the 

24 Director of Central Intelligence pursuant
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1 to section 104 of the National Security 

2 Act of 1947. 

3 ‘‘(2) INTELLIGENCE SHARING INFRA4 STRUCTURE.—For the purpose of carrying 

5 out the acquisition and deployment of se6 cure facilities (including information 

7 technology and physical infrastructure, 

8 whether mobile and temporary, or per9 manent) sufficient to permit the Sec10 retary to receive, not later than Decem11 ber 31, 2003, all classified information 

12 and products to which the Under Sec13 retary for Information Analysis and In14 frastructure Protection is entitled under 

15 subtitle A of title II, there are authorized 

16 to be appropriated such sums as may be 

17 necessary for each of the fiscal years 2003 

18 through 2006. 

19 ‘‘(e) EMERGENCY DEVELOPMENT OF SECURITY

20 COUNTERMEASURES.—If the Secretary of Home21 land Security and the Secretary of Health and 

22 Human Services jointly determine that pro23 curement of a security countermeasure that 

24 has been approved for procurement using the 

25 special reserve fund under subsection (a)—
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1 ‘‘(1) is not proceeding at a sufficiently 

2 rapid pace under 319F–2 of the Public 

3 Health Service Act to protect the national 

4 security; or 

5 ‘‘(2) could be produced significantly 

6 less expensively by the government di7 rectly than through procurements under 

8 such section; 

9 then amounts in the special reserve fund may 

10 be used by the Secretary of Health and 

11 Human Services to produce security counter12 measures for placement in the stockpile 

13 under subsection (a) of section 319F–2 of such 

14 Act if the joint determination is submitted to 

15 the President and the President approves 

16 such use of the special reserve fund. Amounts 

17 made available for such use in accordance 

18 with the preceding sentence are available for 

19 obligation as of the date on which the presi20 dential approval is made, subject to applica21 ble law regarding the apportionment of ap22 propriations. This subsection applies notwith23 standing other provisions of this section, and 

24 notwithstanding section 319F–2 of the Public 

25 Health Service Act. This subsection may not 
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1 be construed as affecting the amounts speci2 fied in subsection (a) as authorizations of ap3 propriations or the obligation limits con4 tained therein.’’. 

5 (c) CONFORMING AMENDMENT.—Section 121 

6 of the Public Health Security and Bioter7 rorism Preparedness and Response Act of 

8 2002 (116 Stat. 611; 42 U.S.C. 300hh–12) is re9 pealed. With respect to the program estab10 lished under former section 121 of such Act, 

11 the repeal of such section under the pre12 ceding sentence applies as a modification of 

13 the program in accordance with the amend14 ment made by subsection (a) of this section, 

15 and not as the termination of the program 

16 and the establishment of a different program. 

17 SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

18 USE IN EMERGENCIES. 

19 Subchapter E of chapter V of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 

21 360bbb et seq.) is amended by adding at the 

22 end the following section: 

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

24 USE IN EMERGENCIES. 

25 ‘‘(a) IN GENERAL.—
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1 ‘‘(1) EMERGENCY USES.—Notwith2 standing sections 505, 510(k), and 515 of 

3 this Act and section 351 of the Public 

4 Health Service Act, and subject to the 

5 provisions of this section, the Secretary 

6 may authorize the introduction into 

7 interstate commerce, during the effective 

8 period of a declaration under subsection 

9 (b), of a drug or device intended for use 

10 in an actual or potential emergency (re11 ferred to in this section as an ‘emergency 

12 use’). 

13 ‘‘(2) APPROVAL STATUS OF PRODUCT.—

14 An authorization under paragraph (1) 

15 may authorize an emergency use of a 

16 product that—

17 ‘‘(A) is not approved, licensed, or 

18 cleared for commercial distribution 

19 under a provision of law referred to 

20 in such paragraph (referred to in this 

21 section as an ‘unapproved product’); 

22 or 

23 ‘‘(B) is approved, licensed, or 

24 cleared under such a provision, but 

25 which use is not under such provi-
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1 sion an approved, licensed, or cleared 

2 use of the product (referred to in this 

3 section as an ‘unapproved use of an 

4 approved product’). 

5 ‘‘(3) RELATION TO OTHER USES.—An 

6 emergency use authorized under para7 graph (1) for a product is in addition to 

8 any other use that is authorized for the 

9 product under a provision of law referred 

10 to in such paragraph. 

11 ‘‘(4) DEFINITIONS.—For purposes of 

12 this section: 

13 ‘‘(A) The term ‘emergency use’ has 

14 the meaning indicated for such term 

15 in paragraph (1). 

16 ‘‘(B) The term ‘product’ means a 

17 drug or device. 

18 ‘‘(C) The term ‘unapproved prod19 uct’ has the meaning indicated for 

20 such term in paragraph (2)(A). 

21 ‘‘(D) The term ‘unapproved use of 

22 an approved product’ has the mean23 ing indicated for such term in para24 graph (2)(B). 

25 ‘‘(b) DECLARATION OF EMERGENCY.—
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1 ‘‘(1) IN GENERAL.—The Secretary may 

2 declare an emergency justifying the au3 thorization under this subsection for a 

4 product on the basis of—

5 ‘‘(A) a determination by the Sec6 retary of Homeland Security that 

7 there is a national emergency, or a 

8 significant potential for a national 

9 emergency, involving a heightened 

10 risk of attack with a specified biologi11 cal, chemical, radiological, or nuclear 

12 agent or agents; 

13 ‘‘(B) a determination by the Sec14 retary of Defense that there is a mili15 tary emergency, or a significant po16 tential for a military emergency, in17 volving a heightened risk to United 

18 States military forces of attack with a 

19 biological, chemical, radiological, or 

20 nuclear agent or agents; or 

21 ‘‘(C) a determination by the Sec22 retary of a public health emergency 

23 under section 319 of the Public 

24 Health Service Act, affecting national 

25 security and involving a specified bio-
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1 logical, chemical, radiological, or nu2 clear agent or agents, or a specified 

3 disease or condition that may be at4 tributable to such agent or agents. 

5 ‘‘(2) TERMINATION OF DECLARATION.—

6 ‘‘(A) IN GENERAL.—A declaration 

7 under this subsection shall terminate 

8 upon the earlier of—

9 ‘‘(i) a determination by the 

10 Secretary, in consultation as ap11 propriate with the Secretary of 

12 Homeland Security or the Sec13 retary of Defense, that the cir14 cumstances described in para15 graph (1) have ceased to exist; or 

16 ‘‘(ii) the expiration of the one17 year period beginning on the date 

18 on which the declaration is made. 

19 ‘‘(B) RENEWAL.—Notwithstanding 

20 subparagraph (A), the Secretary may 

21 renew a declaration under this sub22 section, and this paragraph shall 

23 apply to any such renewal. 

24 ‘‘(3) ADVANCE NOTICE OF TERMI25 NATION.—In terminating a declaration 
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1 under this section, the Secretary shall 

2 provide advance notice that the declara3 tion will be terminated. The period of ad4 vance notice shall be a period reasonably 

5 determined to provide—

6 ‘‘(A) in the case of an unapproved 

7 product, a sufficient period for dis8 position of shipments of the product, 

9 including the return of such ship10 ments to the manufacturer (in the 

11 case of a manufacturer that chooses 

12 to have the shipments returned); and 

13 ‘‘(B) in the case of unapproved 

14 uses of approved products, a suffi15 cient period for the disposition of any 

16 labeling that was provided with re17 spect to the emergency use involved. 

18 ‘‘(4) PUBLICATION.—The Secretary 

19 shall promptly publish in the Federal 

20 Register each declaration, determination, 

21 and renewal under this subsection. 

22 ‘‘(c) CRITERIA FOR ISSUANCE OF AUTHORIZA23 TION.—The Secretary may issue an authoriza24 tion under this section with respect to the 

25 emergency use of a product only if, after con-
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1 sultation with the Director of the National In2 stitutes of Health and the Director of the Cen3 ters for Disease Control and Prevention, to 

4 the extent feasible and appropriate given the 

5 circumstances of the emergency involved, the 

6 Secretary concludes—

7 ‘‘(1) that an agent specified in a dec8 laration under subsection (b) can cause a 

9 serious or life-threatening disease or con10 dition; 

11 ‘‘(2) that, based on the totality of sci12 entific evidence available to the Sec13 retary, including data from adequate and 

14 well-controlled clinical trials, if available, 

15 it is reasonable to believe that—

16 ‘‘(A) the product may be effective 

17 in detecting, diagnosing, treating, or 

18 preventing—

19 ‘‘(i) such disease or condition; 

20 or 

21 ‘‘(ii) a serious or life-threat22 ening disease or condition caused 

23 by a product authorized under 

24 this section or approved under 

25 this Act or the Public Health 
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1 Service Act, for detecting, diag2 nosing, treating, or preventing 

3 such a disease or condition 

4 caused by such an agent; and 

5 ‘‘(B) the known and potential ben6 efits of the product, when used to de7 tect, diagnose, prevent, or treat such 

8 disease or condition, outweigh the 

9 known and potential risks of the 

10 product; 

11 ‘‘(3) that there is no adequate, ap12 proved, and available alternative to the 

13 product for detecting, diagnosing, pre14 venting, or treating such disease or con15 dition; and 

16 ‘‘(4) that such other criteria as the 

17 Secretary may by regulation prescribe 

18 are satisfied. 

19 ‘‘(d) SCOPE OF AUTHORIZATION.—

20 ‘‘(1) IN GENERAL.—An authorization of 

21 a product under this section shall state—

22 ‘‘(A) each disease or condition 

23 that the product may be used to de24 tect, diagnose, prevent, or treat with25 in the scope of the authorization;
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1 ‘‘(B) the Secretary’s conclusions, 

2 made under subsection (c)(2)(B), that 

3 the known and potential benefits of 

4 the product, when used to detect, di5 agnose, prevent, or treat such disease 

6 or condition, outweigh the known 

7 and potential risks of the product; 

8 and 

9 ‘‘(C) the Secretary’s conclusions, 

10 made under subsection (c), con11 cerning the safety and potential effec12 tiveness of the product in detecting, 

13 diagnosing, preventing, or treating 

14 such diseases or conditions, including 

15 an assessment of the available sci16 entific evidence. 

17 ‘‘(2) CONFIDENTIAL INFORMATION.—

18 Nothing in this section alters or amends 

19 section 1905 of title 18, United States 

20 Code, or section 552(b)(4) of title 5 of 

21 such Code. 

22 ‘‘(e) CONDITIONS OF AUTHORIZATION.—

23 ‘‘(1) UNAPPROVED PRODUCT.—

24 ‘‘(A) REQUIRED CONDITIONS.—With 

25 respect to the emergency use of an 
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1 unapproved product, the Secretary, 

2 to the extent feasible given the cir3 cumstances of the emergency, shall, 

4 for persons who choose to carry out 

5 one or more activities for which the 

6 authorization is issued, establish such 

7 conditions on an authorization under 

8 this section as the Secretary finds 

9 necessary or appropriate to protect 

10 the public health, including the fol11 lowing: 

12 ‘‘(i) Appropriate conditions 

13 designed to ensure that, to the ex14 tent feasible given the cir15 cumstances of the emergency, 

16 health care professionals admin17 istering the product are in18 formed—

19 ‘‘(I) that the Secretary has 

20 authorized the emergency use 

21 of the product; 

22 ‘‘(II) of the significant 

23 known and potential benefits 

24 and risks of the emergency 

25 use of the product, and of the 
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1 extent to which such benefits 

2 and risks are unknown; and 

3 ‘‘(III) of the alternatives to 

4 the product that are avail5 able, and of their benefits and 

6 risks. 

7 ‘‘(ii) Appropriate conditions 

8 designed to ensure that, to the ex9 tent feasible given the cir10 cumstances of the emergency, in11 dividuals to whom the product is 

12 administered are informed—

13 ‘‘(I) that the Secretary has 

14 authorized the emergency use 

15 of the product; 

16 ‘‘(II) of the significant 

17 known and potential benefits 

18 and risks of such use, and of 

19 the extent to which such ben20 efits and risks are unknown; 

21 and 

22 ‘‘(III) of the option to ac23 cept or refuse administration 

24 of the product, of the con25 sequences, if any, of refusing 
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1 administration of the product, 

2 and of the alternatives to the 

3 product that are available 

4 and of their benefits and 

5 risks. 

6 ‘‘(iii) Appropriate conditions 

7 for the monitoring and reporting 

8 of adverse events associated with 

9 the emergency use of the product. 

10 ‘‘(iv) For manufacturers of the 

11 product, appropriate conditions 

12 concerning recordkeeping and re13 porting, including records access 

14 by the Secretary, with respect to 

15 the emergency use of the product. 

16 ‘‘(B) AUTHORITY FOR ADDITIONAL

17 CONDITIONS.—With respect to the 

18 emergency use of an unapproved 

19 product, the Secretary, to the extent 

20 feasible given the circumstances of 

21 the emergency, may, for persons who 

22 choose to carry out one or more ac23 tivities for which the authorization is 

24 issued, establish such conditions on 

25 an authorization under this section
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1 as the Secretary finds necessary or 

2 appropriate to protect the public 

3 health, including the following: 

4 ‘‘(i) Appropriate conditions on 

5 which entities may distribute the 

6 product with respect to the emer7 gency use of the product (includ8 ing limitation to distribution by 

9 government entities), and on how 

10 distribution is to be performed. 

11 ‘‘(ii) Appropriate conditions 

12 on who may administer the prod13 uct with respect to the emergency 

14 use of the product, and on the 

15 categories of individuals to 

16 whom, and the circumstances 

17 under which, the product may be 

18 administered with respect to such 

19 use. 

20 ‘‘(iii) For persons other than 

21 manufacturers of the product, ap22 propriate conditions concerning 

23 recordkeeping and reporting, in24 cluding records access by the Sec-
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1 retary, with respect to the emer2 gency use of the product. 

3 ‘‘(iv) With respect to the emer4 gency use of the product, waive 

5 or limit, to the extent appropriate 

6 given the circumstances of the 

7 emergency, conditions regarding 

8 current good manufacturing prac9 tice otherwise applicable to the 

10 manufacture, processing, packing, 

11 or holding of products subject to 

12 regulation under this Act, includ13 ing such requirements estab14 lished in section 501. 

15 ‘‘(2) UNAPPROVED USE.—With respect 

16 to the emergency use of a product that is 

17 an unapproved use of an approved prod18 uct: 

19 ‘‘(A) The Secretary may, for manu20 facturers of the product who choose 

21 to carry out one or more activities for 

22 which the authorization is issued, es23 tablish any of the conditions de24 scribed in clauses (i) through (iv) of 

25 paragraph (1)(A). 
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1 ‘‘(B)(i) If the authorization under 

2 this section regarding the emergency 

3 use authorizes a change in the label4 ing of the product, but the manufac5 turer of the product chooses not to 

6 make such change, such authoriza7 tion may not authorize distributors of 

8 the product or any other person to 

9 alter or obscure the labeling provided 

10 by the manufacturer. 

11 ‘‘(ii) In the circumstances de12 scribed in clause (i), an authorization 

13 under this section regarding the 

14 emergency use may, for persons who 

15 do not manufacture the product and 

16 who choose to act under this clause, 

17 authorize such persons to provide in18 formation on the product in addition 

19 to the labeling provided by the manu20 facturer, subject to compliance with 

21 clause (i). Such additional informa22 tion shall not be considered labeling 

23 for purposes of section 502. 

24 ‘‘(f) DURATION OF AUTHORIZATION.—
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1 ‘‘(1) IN GENERAL.—Except as provided 

2 in paragraph (2), an authorization under 

3 this section shall be effective until the 

4 earlier of the termination of the declara5 tion under subsection (b) or a revocation 

6 under subsection (g). 

7 ‘‘(2) CONTINUED USE AFTER END OF EF8 FECTIVE PERIOD.—An authorization shall 

9 continue to be effective for continued use 

10 with respect to patients to whom it was 

11 administered during the period described 

12 by paragraph (1), to the extent found nec13 essary by such patients’ attending physi14 cians. 

15 ‘‘(g) REVOCATION OF AUTHORIZATION.—

16 ‘‘(1) REVIEW.—The Secretary shall pe17 riodically review the circumstances and 

18 the appropriateness of an authorization 

19 under this section. 

20 ‘‘(2) REVOCATION.—The Secretary may 

21 revoke an authorization under this sec22 tion if, in the Secretary’s unreviewable 

23 discretion, the criteria under subsection 

24 (c) for issuance of such authorization are 

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

2 promptly publish in the Federal Register a 

3 notice of each authorization, and each termi4 nation or revocation of an authorization, and 

5 an explanation of the reasons therefor, under 

6 this section. 

7 ‘‘(i) ACTIONS COMMITTED TO AGENCY DIS8 CRETION.—Actions under the authority of this 

9 section by the Secretary, by the Secretary of 

10 Defense, or by the Secretary of Homeland Se11 curity are committed to agency discretion. 

12 ‘‘(j) RULES OF CONSTRUCTION.—Nothing in 

13 this section shall be construed to impair or 

14 otherwise affect—

15 ‘‘(1) the authority of the President as 

16 Commander in Chief of the Armed Forces 

17 of the United States under article II, sec18 tion 2 of the United States Constitution; 

19 ‘‘(2) the authority of the Secretary of 

20 Defense with respect to the Department 

21 of Defense, including the armed forces, 

22 under other provisions of Federal law; or 

23 ‘‘(3) the authority of the Secretary 

24 under section 319F–2 to manage the 

25 stockpile under such section.
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1 ‘‘(k) APPLICATION TO MEMBERS OF ARMED

2 FORCES.—

3 ‘‘(1) WAIVER OF REQUIREMENT RELATING

4 TO OPTION TO REFUSE.—In the case of ad5 ministration of a countermeasure to 

6 members of the armed forces, a require7 ment, under subsection (e)(1)(A)(ii)(III), 

8 designed to ensure that individuals are 

9 informed of an option to accept or refuse 

10 administration of a product, may be 

11 waived by the President if the President 

12 determines, in writing, that complying 

13 with such requirement is not feasible, is 

14 contrary to the best interests of the mem15 bers affected, or is not in the interests of 

16 national security. 

17 ‘‘(2) PROVISION OF INFORMATION TO

18 MEMBER OF THE ARMED FORCES.—If the 

19 Secretary makes a determination that it 

20 is not feasible for the information re21 quired by subsection (e)(1)(A)(ii) to be 

22 provided to a member of the armed 

23 forces prior to the administration of the 

24 product, such information shall be pro25 vided to such member of the armed 
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1 forces (or next-of-kin in the case of the 

2 death of a member) to whom the product 

3 was administered as soon as possible, but 

4 not later than 30 days, after such admin5 istration. Information concerning the ad6 ministration of the product shall be re7 corded in the medical record of the mem8 ber. 

9 ‘‘(3) EFFECT ON STATUTE PERTAINING TO

10 INVESTIGATIONAL NEW DRUGS.—In the case 

11 of an authorization based on a deter12 mination by the Secretary of Defense 

13 under subsection (b)(1)(B), section 1107 of 

14 title 10, United States Code, shall not 

15 apply to use of a product that is the sub16 ject of such authorization, within the 

17 scope of such authorization and while 

18 such authorization is effective. 

19 ‘‘(l) RELATION TO OTHER PROVISIONS.—If a 

20 product is the subject of an authorization 

21 under this section, the use of such product 

22 within the scope of the authorization—

23 ‘‘(1) shall not be subject to any re24 quirements pursuant to section 505(i) or 

25 520(g); and 
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1 ‘‘(2) shall not be subject to any re2 quirements otherwise applicable to clin3 ical investigations pursuant to other pro4 visions of this Act. 

5 ‘‘(m) DISCRETION REGARDING USE OF AU6 THORIZATION.—Nothing in this section pro7 vides the Secretary any authority to require 

8 any person to carry out any activity that be9 comes lawful pursuant to an authorization 

10 under this section, and no person is required 

11 to inform the Secretary that the person will 

12 not be carrying out such activity, except that 

13 a manufacturer of a sole-source unapproved 

14 product authorized for emergency use shall 

15 notify the Secretary within a reasonable pe16 riod of time after the issuance by the Sec17 retary of such authorization if such manufac18 turer does not intend to carry out an activity 

19 or activities under the authorization. This 

20 section does not have any legal effect on a 

21 person who does not carry out any activity for 

22 which an authorization under this section is 

23 issued, or who carries out such an activity 

24 pursuant to other provisions of this Act or 

25 section 351 of the Public Health Service Act. 
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1 ‘‘(n) ENFORCEMENT.—A person who carries 

2 out an activity pursuant to an authorization 

3 under this section, but who fails to comply 

4 with applicable conditions under subsection 

5 (e), is with respect to that act of noncompli6 ance subject to the provisions of law specified 

7 in subsection (a) and to the enforcement of 

8 such provisions under section 301.’’. 

9 SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS 

10 ACT. 

11 (a) SECRETARY OF HEALTH AND HUMAN

12 SERVICES.—

13 (1) ANNUAL REPORTS ON PARTICULAR

14 EXERCISES OF AUTHORITY.—

15 (A) RELEVANT AUTHORITIES.—The 

16 Secretary of Health and Human Serv17 ices (referred to in this subsection as 

18 the ‘‘Secretary’’) shall submit reports 

19 in accordance with subparagraph (B) 

20 regarding the exercise of authority 

21 under the following provisions of law: 

22 (i) With respect to section 

23 319F–1 of the Public Health Serv24 ice Act (as added by section 2 of 

25 this Act): 
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1 (I) Subsection (b)(1) (relat2 ing to increased simplified ac3 quisition threshold). 

4 (II) Subsection (b)(2) (re5 lating to use of noncompeti6 tive procedures). 

7 (III) Subsection (c) (relat8 ing to expedited peer review 

9 procedures). 

10 (ii) With respect to section 

11 319F–2 of the Public Health Serv12 ice Act (as added by section 3 of 

13 this Act): 

14 (I) Subsection (c)(7)(C)(iii) 

15 (relating to simplified acquisi16 tion procedures). 

17 (II) Subsection 

18 (c)(7)(C)(iv) (relating to use of 

19 noncompetitive procedures). 

20 (III) Subsection 

21 (c)(7)(C)(v) (relating to pre22 mium provision in multiple23 award contracts). 

24 (iii) With respect to section 

25 564 of the Federal Food, Drug,
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1 and Cosmetic Act (as added by 

2 section 4 of this Act): 

3 (I) Subsection (a)(1) (relat4 ing to emergency uses of cer5 tain drugs and devices). 

6 (II) Subsection (b)(1) (re7 lating to a declaration of an 

8 emergency). 

9 (III) Subsection (e) (relat10 ing to conditions on author11 ization). 

12 (B) CONTENTS OF REPORTS.—The 

13 Secretary shall annually submit to 

14 the designated congressional commit15 tees (as defined in subsection (e)) a 

16 report that summarizes—

17 (i) the particular actions that 

18 were taken under the authorities 

19 specified in subparagraph (A), in20 cluding, as applicable, the identi21 fication of the threat agent, emer22 gency, or the biomedical counter23 measure with respect to which 

24 the authority was used; 
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1 (ii) the reasons underlying the 

2 decision to use such authorities, 

3 including, as applicable, the op4 tions that were considered and 

5 rejected with respect to the use of 

6 such authorities; 

7 (iii) the identification of each 

8 person or entity that received, or 

9 was considered and rejected for, 

10 grants, cooperative agreements, 

11 or contracts pursuant to the use 

12 of such authorities; and 

13 (iv) whether, with respect to 

14 each procurement that is ap15 proved by the President under 

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

17 Health Service Act (as added by 

18 section 3 of this Act), a contract 

19 was not entered into within one 

20 year after such approval by the 

21 President. 

22 (2) ANNUAL SUMMARIES REGARDING CER23 TAIN ACTIVITY.—The Secretary shall annu24 ally submit to the designated congres25 sional committees a report that summa-
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1 rizes the activity undertaken pursuant to 

2 the following authorities under section 

3 319F–1 of the Public Health Service Act 

4 (as added by section 2 of this Act): 

5 (A) Subsection (b)(3) (relating to 

6 increased micropurchase threshold). 

7 (B) Subsection (d) (relating to au8 thority for personal services con9 tracts). 

10 (C) Subsection (e) (relating to 

11 streamlined personnel authority). 

12 With respect to subparagraph (B), the re13 port shall include a provision specifying, 

14 for the one-year period for which the re15 port is submitted, the number of persons 

16 who were paid amounts greater than 

17 $100,000 and the number of persons who 

18 were paid amounts between $50,000 and 

19 $100,000. 

20 (b) NATIONAL ACADEMY OF SCIENCES RE21 VIEW.—

22 (1) IN GENERAL.—Not later than four 

23 years after the date of the enactment of 

24 this Act, the Secretary of Health and 

25 Human Services shall request the Na-
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1 tional Academy of Sciences to enter into 

2 an agreement for a review of the bio3 medical countermeasure research and de4 velopment authorities established in this 

5 Act to determine whether and to what ex6 tent activities undertaken pursuant to 

7 such authorities have enhanced the de8 velopment of biomedical counter9 measures affecting national security, and 

10 to recommend any legislative or adminis11 trative changes necessary to improve the 

12 ability of the Secretary to carry out these 

13 activities in the future. The Secretary 

14 shall ensure that the results of the study 

15 are submitted to the designated congres16 sional committees not later than five 

17 years after such date of enactment. 

18 (2) CERTAIN CONTENTS.—The report 

19 under paragraph (1) shall include—

20 (A) a summary of the most recent 

21 analysis by the Department of Home22 land Security and the intelligence 

23 community of the domestic threat 

24 from chemical, biological, radio25 logical, and nuclear agents; 
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1 (B) the Academy’s assessment of 

2 the current availability of counter3 measures to address such threats; 

4 (C) the Academy’s assessment of 

5 the extent to which programs and ac6 tivities under this Act will reduce any 

7 gap between the threat and the avail8 ability of countermeasures to an ac9 ceptable level of risk; and 

10 (D)(i) the Academy’s assessment 

11 of threats to national security that 

12 are posed by technology that will en13 able, during the 10-year period begin14 ning on the date of the enactment of 

15 this Act, the development of anti16 biotic resistant, mutated, and bioengi17 neered strains of biological agents; 

18 and 

19 (ii) recommendations on short20 term and long-term governmental 

21 strategies for addressing such 

22 threats, including recommendations 

23 for Federal policies regarding re24 search priorities, the development of
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1 countermeasures, and investments in 

2 technology. 

3 (c) GENERAL ACCOUNTING OFFICE REVIEW.—

4 Four years after the date of the enactment of 

5 this Act, the Comptroller General of the 

6 United States shall initiate a study—

7 (1)(A) to review the Secretary of 

8 Health and Human Services’ utilization of 

9 the authorities granted under this Act 

10 with respect to simplified acquisition 

11 procedures, use of noncompetitive proce12 dures, increased micropurchase thresh13 olds, personal services contracts, stream14 lined personnel authority, and the pur15 chase of security countermeasures under 

16 the special reserve fund; and 

17 (B) to recommend any legislative or 

18 administrative changes necessary to im19 prove the utilization or effectiveness of 

20 such authorities in the future; 

21 (2)(A) to review the internal controls 

22 instituted by such Secretary with respect 

23 to such authorities, where required by 

24 this Act; and 
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1 (B) to recommend any legislative or 

2 administrative changes necessary to im3 prove the effectiveness of such controls; 

4 and 

5 (3)(A) to review such Secretary’s utili6 zation of the authority granted under 

7 this Act to authorize an emergency use of 

8 a biomedical countermeasure, including 

9 the means by which the Secretary deter10 mines whether and under what condi11 tions any such authorizations should be 

12 granted and the benefits and adverse im13 pacts, if any, resulting from the use of 

14 such authority; and 

15 (B) to recommend any legislative or 

16 administrative changes necessary to im17 prove the utilization or effectiveness of 

18 such authority and to enhance protection 

19 of the public health. 

20 The results of the study shall be submitted to 

21 the designated congressional committees not 

22 later than five years after the date of the en23 actment of this Act. 

24 (d) REPORT REGARDING ADDITIONAL BAR25 RIERS TO PROCUREMENT OF SECURITY COUNTER-
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1 MEASURES.—Not later than 180 days after the 

2 date of the enactment of this Act, the Sec3 retary of Homeland Security and the Sec4 retary of Health and Human Services shall re5 port to the designated congressional commit6 tees any barriers to the procurement of secu7 rity countermeasures that have not been ad8 dressed by this Act. 

9 (e) STATUS OF PROGRAM FOR CHEMICAL TER10 RORISM PREPAREDNESS.—Not later than 180 

11 days after the date of the enactment of this 

12 Act, the Secretary of Homeland Security shall 

13 submit to the designated congressional com14 mittees a report describing the status of the 

15 program carried out by the Secretary to en16 hance the preparedness of the United States 

17 to respond to terrorist attacks involving 

18 chemical agents. 

19 (f) DESIGNATED CONGRESSIONAL COMMIT20 TEES.—For purposes of this section, the term 

21 ‘‘designated congressional committees’’ means 

22 the following committees of the Congress: 

23 (1) In the House of Representatives: 

24 the Committee on Energy and Commerce, 

25 the Committee on Appropriations, the 
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1 Committee on Government Reform, and 

2 the Select Committee on Homeland Secu3 rity (or any successor to the Select Com4 mittee). 

5 (2) In the Senate: the Committee on 

6 Health, Education, Labor, and Pensions, 

7 the Committee on Appropriations, and 

8 the Committee on Government Affairs. 

9 SEC. 6. OUTREACH. 

10 The Secretary of Health and Human Serv11 ices shall develop outreach measures to en12 sure to the extent practicable that diverse in13 stitutions, including Historically Black Col14 leges and Universities and those serving large 

15 proportions of Hispanics, Native Americans, 

16 Asian-Pacific Americans, or other underrep17 resented populations, are meaningfully aware 

18 of available research and development grants 

19 and procurements conducted under sections 2 

20 and 3 of this Act. 
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1 SEC. 7. ENSURING COORDINATION, COOPERATION AND 

2 THE ELIMINATION OF UNNECESSARY DUPLI3 CATION IN PROGRAMS DESIGNED TO PRO4 TECT THE HOMELAND FROM BIOLOGICAL, 

5 CHEMICAL, RADIOLOGICAL, AND NUCLEAR 

6 AGENTS. 

7 (a) ENSURING COORDINATION OF PRO8 GRAMS.—The Secretary of Health and Human 

9 Services, the Secretary of Homeland Security, 

10 and the Secretary of Defense shall ensure the 

11 activities of their respective Departments co12 ordinate, complement, and do not unneces13 sarily duplicate programs to identify poten14 tial domestic threats from biological, chem15 ical, radiological or nuclear agents, detect 

16 such domestic incidents, analyze such inci17 dents, and develop necessary counter18 measures. The aforementioned Secretaries 

19 shall further ensure that information and 

20 technology possessed by the Departments rel21 evant to these activities are shared with the 

22 other Departments. 

23 (b) DESIGNATION OF AGENCY COORDINATION

24 OFFICER.—The Secretary of Health and 

25 Human Services, the Secretary of Homeland 

26 Security, and the Secretary of Defense shall 
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1 each designate an officer or employee of their 

2 respective Departments who shall coordinate, 

3 through regular meetings and communica4 tions, with the other aforementioned Depart5 ments such programs and activities carried 

6 out by their Departments.
Union Calendar No. 98

108TH CONGRESS 

1ST SESSION H. R. 2122

[Report No. 108–147, Parts I, II, and III] 

A BILL

To enhance research, development, procurement, 

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

JULY 8, 2003

Reported from the Select Committee on Homeland Security with an amendment; committed to the Committee 

of the Whole House on the State of the Union and ordered to be printed