I 

108TH CONGRESS 

1ST SESSION H. R. 2122

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 

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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•HR 2122 IH 

1 trative Services Act of 1949 (41 

2 U.S.C. 254d) (relating to the ex3 amination of contractor records). 

4 ‘‘(iv) USE OF NONCOMPETITIVE PRO5 CEDURES.—In addition to any other au6 thority to use procedures other than com7 petitive procedures, the Secretary may use 

8 such other procedures for a procurement 

9 under this subsection if the product is 

10 available from only one responsible source 

11 or only from a limited number of respon12 sible sources, and no other type of product 

13 will satisfy the Secretary’s needs. 

14 ‘‘(v) PREMIUM PROVISION IN MUL15 TIPLE AWARD CONTRACTS.—

16 ‘‘(I) IN GENERAL.—If, under this 

17 subsection, the Secretary enters into 

18 contracts with more than one vendor 

19 to procure a security countermeasure, 

20 such Secretary may, notwithstanding 

21 any other provision of law, include in 

22 each of such contracts a provision 

23 that—

24 ‘‘(aa) identifies an increment 

25 of the total quantity of security 
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•HR 2122 IH 

1 countermeasure required, wheth2 er by percentage or by numbers 

3 of units; and 

4 ‘‘(bb) promises to pay one or 

5 more specified premiums based 

6 on the priority of such vendors’ 

7 production and delivery of the in8 crement identified under item 

9 (aa), in accordance with the 

10 terms and conditions of the con11 tract. 

12 ‘‘(II) DETERMINATION OF GOV13 ERNMENT’S REQUIREMENT NOT RE14 VIEWABLE.—If the Secretary includes 

15 in each of a set of contracts a provi16 sion as described in subclause (I), 

17 such Secretary’s determination of the 

18 total quantity of security counter19 measure required, and any amend20 ment of such determination, is com21 mitted to agency discretion. 

22 ‘‘(vi) EXTENSION OF CLOSING DATE

23 FOR RECEIPT OF PROPOSALS NOT REVIEW24 ABLE.—A decision by the Secretary to ex25 tend the closing date for receipt of pro-
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•HR 2122 IH 

1 posals for a procurement under this sub2 section is committed to agency discretion. 

3 ‘‘(vii) LIMITING COMPETITION TO

4 SOURCES RESPONDING TO REQUEST FOR

5 INFORMATION.—In conducting a procure6 ment under this subsection, the Secretary 

7 may exclude a source that has not re8 sponded to a request for information under 

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

10 Property and Administrative Services Act 

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

12 request has given notice that the Secretary 

13 may so exclude such a source. 

14 ‘‘(8) INTERAGENCY COOPERATION.—

15 ‘‘(A) IN GENERAL.—In carrying out activi16 ties under this section, the Homeland Security 

17 Secretary and the Secretary are authorized, 

18 subject to subparagraph (B), to enter into 

19 interagency agreements and other collaborative

20 undertakings with other agencies of the United 

21 States Government. 

22 ‘‘(B) LIMITATION.—An agreement or un23 dertaking under this paragraph shall not au24 thorize another agency to exercise the authori-
33

•HR 2122 IH 

1 ties provided by this section to the Homeland 

2 Security Secretary or to the Secretary. 

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

4 Amounts in the special reserve fund under para5 graph (10) shall not be used to pay—

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

7 under procurement contracts entered into be8 fore the date of the enactment of the Project 

9 BioShield Act of 2003; or 

10 ‘‘(B) administrative costs. 

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

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

13 has the meaning given such term in section 510 of 

14 the Homeland Security Act of 2002. 

15 ‘‘(d) DISCLOSURES.—No Federal agency shall dis16 close under section 552, United States Code, any informa17 tion identifying the location at which materials in the 

18 stockpile under subsection (a) are stored. 

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

20 the term ‘stockpile’ includes—

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

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

23 or 

24 ‘‘(2) a contractual agreement between the 

25 Homeland Security Secretary and a vendor or ven-
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•HR 2122 IH 

1 dors under which such vendor or vendors agree to 

2 provide to such Secretary supplies described in sub3 section (a). 

4 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

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

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

7 authorized to be appropriated $640,000,000 for fis8 cal year 2002, and such sums as may be necessary 

9 for each of fiscal years 2003 through 2006. Such 

10 authorization is in addition to amounts in the special 

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

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

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

14 authorized to be appropriated $509,000,000 for fis15 cal year 2002, and such sums as may be necessary 

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

17 (b) AMENDMENT TO HOMELAND SECURITY ACT OF

18 2002.—Title V of the Homeland Security Act of 2002 

19 (116 Stat. 2212; 6 U.S.C. 311 et seq.) is amended by add20 ing at the end the following: 

21 ‘‘SEC. 510. PROCUREMENT OF SECURITY COUNTER22 MEASURES FOR STRATEGIC NATIONAL 

23 STOCKPILE. 

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

25 procurement of security countermeasures under section 
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•HR 2122 IH 

1 319F–2(c) of the Public Health Service Act (referred to 

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

3 there is authorized to be appropriated up to 

4 $5,593,000,000 for the fiscal years 2004 through 2013. 

5 Of the amounts appropriated under the preceding sen6 tence, not to exceed $3,418,000,000 may be obligated dur7 ing the fiscal years 2004 through 2008, of which not to 

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

9 2004. 

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

11 security countermeasures program, the term ‘special re12 serve fund’ means the appropriations account established 

13 as a result of any appropriations made under subsection 

14 (a). 

15 ‘‘(c) AVAILABILITY.—

16 ‘‘(1) DURATION OF AVAILABILITY FOR OBLIGA17 TION.—Subject to paragraph (2), all amounts appro18 priated under subsection (a) are available for obliga19 tion through the end of fiscal year 2013, provided 

20 that any portion of such amount that remains unob21 ligated for such purposes on the expiration of such 

22 term shall be returned to the United States Treas23 ury and shall not be available for subsequent obliga24 tion for any purpose. 
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1 ‘‘(2) INITIAL AVAILABILITY FOR PARTICULAR

2 PROCUREMENTS.—Amounts appropriated under sub3 section (a) become available for a procurement 

4 under the security countermeasures program only 

5 upon the approval by the President of such avail6 ability for the procurement in accordance with para7 graph (6)(B) of such program.’’. 

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

9 Public Health Security and Bioterrorism Preparedness 

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

11 300hh–12) is repealed. With respect to the program estab12 lished under former section 121 of such Act, the repeal 

13 of such section under the preceding sentence applies as 

14 a modification of the program in accordance with the 

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

16 not as the termination of the program and the establish17 ment of a different program. 

18 SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

19 USE IN EMERGENCIES. 

20 Subchapter E of chapter V of the Federal Food, 

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

22 amended by adding at the end the following section: 

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

24 USE IN EMERGENCIES. 

25 ‘‘(a) IN GENERAL.—
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•HR 2122 IH 

1 ‘‘(1) EMERGENCY USES.—Notwithstanding sec2 tions 505, 510(k), and 515 of this Act and section 

3 351 of the Public Health Service Act, and subject to 

4 the provisions of this section, the Secretary may au5 thorize the introduction into interstate commerce, 

6 during the effective period of a declaration under 

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

8 in an actual or potential emergency (referred to in 

9 this section as an ‘emergency use’). 

10 ‘‘(2) APPROVAL STATUS OF PRODUCT.—An au11 thorization under paragraph (1) may authorize an 

12 emergency use of a product that—

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

14 for commercial distribution under a provision of 

15 law referred to in such paragraph (referred to 

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

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

18 under such a provision, but which use is not 

19 under such provision an approved, licensed, or 

20 cleared use of the product (referred to in this 

21 section as an ‘unapproved use of an approved 

22 product’).

23 ‘‘(3) RELATION TO OTHER USES.—An emer24 gency use authorized under paragraph (1) for a 

25 product is in addition to any other use that is au-
38

•HR 2122 IH 

1 thorized for the product under a provision of law re2 ferred to in such paragraph. 

3 ‘‘(4) DEFINITIONS.—For purposes of this sec4 tion: 

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

6 meaning indicated for such term in paragraph 

7 (1). 

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

9 device. 

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

11 the meaning indicated for such term in para12 graph (2)(A). 

13 ‘‘(D) The term ‘unapproved use of an ap14 proved product’ has the meaning indicated for 

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

16 ‘‘(b) DECLARATION OF EMERGENCY.—

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

18 an emergency justifying the authorization under this 

19 subsection for a product on the basis of—

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

21 Homeland Security that there is a national 

22 emergency, or a significant potential for a na23 tional emergency, involving a heightened risk of 

24 attack with a specified biological, chemical, ra25 diological, or nuclear agent or agents; 
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•HR 2122 IH 

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

2 Defense that there is a military emergency, or 

3 a significant potential for a military emergency, 

4 involving a heightened risk to United States 

5 military forces of attack with a biological, 

6 chemical, radiological, or nuclear agent or 

7 agents; or 

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

9 public health emergency under section 319 of 

10 the Public Health Service Act, affecting na11 tional security and involving a specified biologi12 cal, chemical, radiological, or nuclear agent or 

13 agents, or a specified disease or condition that 

14 may be attributable to such agent or agents. 

15 ‘‘(2) TERMINATION OF DECLARATION.—

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

17 this subsection shall terminate upon the earlier 

18 of—

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

20 in consultation as appropriate with the 

21 Secretary of Homeland Security or the 

22 Secretary of Defense, that the cir23 cumstances described in paragraph (1) 

24 have ceased to exist; or 
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•HR 2122 IH 

1 ‘‘(ii) the expiration of the one-year pe2 riod beginning on the date on which the 

3 declaration is made. 

4 ‘‘(B) RENEWAL.—Notwithstanding sub5 paragraph (A), the Secretary may renew a dec6 laration under this subsection, and this para7 graph shall apply to any such renewal. 

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

9 terminating a declaration under this section, the 

10 Secretary shall provide advance notice that the dec11 laration will be terminated. The period of advance 

12 notice shall be a period reasonably determined to 

13 provide—

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

15 a sufficient period for disposition of shipments 

16 of the product, including the return of such 

17 shipments to the manufacturer (in the case of 

18 a manufacturer that chooses to have the ship19 ments returned); and 

20 ‘‘(B) in the case of unapproved uses of ap21 proved products, a sufficient period for the dis22 position of any labeling that was provided with 

23 respect to the emergency use involved. 

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

25 promptly publish in the Federal Register each dec-
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•HR 2122 IH 

1 laration, determination, and renewal under this sub2 section. 

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

4 The Secretary may issue an authorization under this sec5 tion with respect to the emergency use of a product only 

6 if, after consultation with the Director of the National In7 stitutes of Health and the Director of the Centers for Dis8 ease Control and Prevention, to the extent feasible and 

9 appropriate given the circumstances of the emergency in10 volved, the Secretary concludes—

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

12 under subsection (b) can cause a serious or life13 threatening disease or condition; 

14 ‘‘(2) that, based on the totality of scientific evi15 dence available to the Secretary, including data from 

16 adequate and well-controlled clinical trials, if avail17 able, it is reasonable to believe that—

18 ‘‘(A) the product may be effective in de19 tecting, diagnosing, treating, or preventing—

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

21 ‘‘(ii) a serious or life-threatening dis22 ease or condition caused by a product au23 thorized under this section or approved 

24 under this Act or the Public Health Serv25 ice Act, for detecting, diagnosing, treating, 
42

•HR 2122 IH 

1 or preventing such a disease or condition 

2 caused by such an agent; and 

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

4 the product, when used to detect, diagnose, pre5 vent, or treat such disease or condition, out6 weigh the known and potential risks of the 

7 product; 

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

9 available alternative to the product for detecting, di10 agnosing, preventing, or treating such disease or 

11 condition; and 

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

13 may by regulation prescribe are satisfied. 

14 ‘‘(d) SCOPE OF AUTHORIZATION.—

15 ‘‘(1) IN GENERAL.—An authorization of a prod16 uct under this section shall state—

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

18 product may be used to detect, diagnose, pre19 vent, or treat within the scope of the authoriza20 tion; 

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

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

23 potential benefits of the product, when used to

24 detect, diagnose, prevent, or treat such disease 
43

•HR 2122 IH 

1 or condition, outweigh the known and potential 

2 risks of the product; and 

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

4 under subsection (c), concerning the safety and 

5 potential effectiveness of the product in detect6 ing, diagnosing, preventing, or treating such 

7 diseases or conditions, including an assessment 

8 of the available scientific evidence. 

9 ‘‘(2) CONFIDENTIAL INFORMATION.—Nothing 

10 in this section alters or amends section 1905 of title 

11 18, United States Code, or section 552(b)(4) of title 

12 5 of such Code. 

13 ‘‘(e) CONDITIONS OF AUTHORIZATION.—

14 ‘‘(1) UNAPPROVED PRODUCT.—

15 ‘‘(A) REQUIRED CONDITIONS.—With re16 spect to the emergency use of an unapproved 

17 product, the Secretary, to the extent feasible 

18 given the circumstances of the emergency, shall, 

19 for persons who choose to carry out one or 

20 more activities for which the authorization is 

21 issued, establish such conditions on an author22 ization under this section as the Secretary finds 

23 necessary or appropriate to protect the public 

24 health, including the following: 
44

•HR 2122 IH 

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; 
45

•HR 2122 IH 

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 
46

•HR 2122 IH 

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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•HR 2122 IH 

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 
51

•HR 2122 IH 

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.

Æ