[Congressional Record (Bound Edition), Volume 149 (2003), Part 13]
[House]
[Pages 18160-18167]
[From the U.S. Government Publishing Office, www.gpo.gov]




    MAKING IN ORDER AT ANY TIME CONSIDERATION OF H.R. 2122, PROJECT 
                         BIOSHIELD ACT OF 2003

  Mr. HASTINGS of Washington (during the DeLauro Motion to Instruct 
conferees on H.R. 1308). Mr. Speaker, I ask unanimous consent that it 
be in order at any time without intervention of any point of order to 
consider in the House H.R. 2122; that the bill be considered as read 
for amendment; that in lieu of the amendments recommended by the 
Committee on Government Reform and the Select Committee on Homeland 
Security now printed in the bill, the amendment in the nature of a 
substitute I have placed at the desk be considered as adopted; that all 
points of order against the bill, as amended, be waived; that the bill, 
as amended, be debatable for 90 minutes, with 60 minutes equally 
divided and controlled by the chairman and ranking minority member of 
the Committee on Energy and Commerce, 15 minutes equally divided and 
controlled by the chairman and ranking minority member of the Committee 
on Government Reform, and 15 minutes equally divided and controlled by 
the chairman and ranking minority member of the Select Committee on 
Homeland Security; and that the previous question be considered as 
ordered on the bill, as amended, to final passage, without intervening 
motion, except one motion to recommit with or without instructions.
  The SPEAKER pro tempore. The Clerk will report the amendment.
  The Clerk read as follows:
       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Project BioShield Act of 
     2003''.

     SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT 
                   AUTHORITIES.

       (a) In General.--Part B of title III of the Public Health 
     Service Act (42 U.S.C. 243 et seq.) is amended by inserting 
     after section 319F the following section:

     ``SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES 
                   REGARDING QUALIFIED COUNTERMEASURE RESEARCH AND 
                   DEVELOPMENT ACTIVITIES.

       ``(a) In General.--
       ``(1) Authority.--In conducting and supporting research and 
     development activities regarding biomedical countermeasures 
     under section 319F(h), the Secretary may conduct and support 
     such activities in accordance with this section if the 
     activities concern qualified countermeasures.
       ``(2) Qualified countermeasure.--For purposes of this 
     section, the term `qualified countermeasure' means a priority 
     countermeasure (as defined in section 319F(h) and as 
     determined by the Secretary in accordance with such section 
     and consistent with sections 302(2) and 304(a) of the 
     Homeland Security Act of 2002) against a chemical, 
     biological, radiological, or nuclear agent that may cause a 
     public health emergency affecting national security.
       ``(3) Interagency cooperation.--
       ``(A) In general.--In carrying out activities under this 
     section, the Secretary is authorized, subject to subparagraph 
     (B), to enter into interagency agreements and other 
     collaborative undertakings with other agencies of the United 
     States Government.
       ``(B) Limitation.--An agreement or undertaking under this 
     paragraph shall not authorize another agency to exercise the 
     authorities provided by this section.
       ``(4) Availability of facilities to the secretary.--In any 
     grant, contract, or cooperative agreement entered into under 
     the authority provided in this section with respect to a 
     biocontainment laboratory or other related or ancillary 
     specialized research facility that the Secretary determines 
     necessary for the purpose of performing, administering, or 
     supporting qualified countermeasure research and development, 
     the Secretary may provide that the facility that is the 
     object of such grant, contract, or cooperative agreement 
     shall be available as needed to the Secretary to respond to 
     public health emergencies affecting national security.
       ``(5) Tranfers of qualifed countermeasures.--Each agreement 
     for an award of a grant, contract, or cooperative agreement 
     under section 319F(h) for the development of a qualified 
     countermeasure shall provide that the recipient of the award 
     will comply with all applicable export-related controls with 
     respect to such countermeasure.
       ``(b) Expedited Procurement Authority.--
       ``(1) Increased simplified acquisition threshold for 
     qualified countermeasure procurements.--
       ``(A) In general.--For any procurement by the Secretary of 
     property or services for use (as determined by the Secretary) 
     in performing, administering, or supporting qualified 
     countermeasure research or development activities under this 
     section that the Secretary determines necessary to respond to 
     pressing research and development needs under this section, 
     the amount specified in section 4(11) of the Office of 
     Federal Procurement Policy Act (41 U.S.C. 403(11)), as 
     applicable pursuant to section 302A(a) of the Federal 
     Property and Administrative Services Act of 1949 (41 U.S.C. 
     252a(a)), shall be deemed to be $25,000,000 in the 
     administration, with respect to such procurement, of--
       ``(i) section 303(g)(1)(A) of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) 
     and its implementing regulations; and
       ``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and 
     its implementing regulations.
       ``(B) Application of certain provisions.--Notwithstanding 
     subparagraph (A) and the provision of law and regulations 
     referred to in such subparagraph, each of the following 
     provisions shall apply to procurements described in this 
     paragraph to the same extent that such provisions would apply 
     to such procurements in the absence of subparagraph (A):
       ``(i) Chapter 37 of title 40, United States Code (relating 
     to contract work hours and safety standards).
       ``(ii) Subsections (a) and (b) of section 7 of the Anti-
     Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
       ``(iii) Section 304C of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 254d) 
     (relating to the examination of contractor records).
       ``(C) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     procurements that are under this paragraph, including 
     requirements with regard to documenting the justification for 
     use of the authority in this paragraph.
       ``(2) Procedures other than full and open competition.--
       ``(A) In general.--In using the authority provided in 
     section 303(c)(1) of title III of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to 
     use procedures other than competitive procedures in the case 
     of a procurement described in paragraph (1) of this 
     subsection, the phrase `available from only one responsible

[[Page 18161]]

     source' in such section 303(c)(1) shall be deemed to mean 
     `available from only one responsible source or only from a 
     limited number of responsible sources'.
       ``(B) Relation to other authorities.--The authority under 
     subparagraph (A) is in addition to any other authority to use 
     procedures other than competitive procedures.
       ``(C) Applicable government-wide regulations.--The 
     Secretary shall implement this paragraph in accordance with 
     applicable government-wide regulations, including 
     requirements that offers be solicited from as many potential 
     sources as is practicable under the circumstances, that 
     required notices be published, and that submitted offers be 
     considered.
       ``(3) Increased micropurchase threshold.--
       ``(A) In general.--For a procurement described by paragraph 
     (1), the amount specified in subsections (c), (d), and (f) of 
     section 32 of the Office of Federal Procurement Policy Act 
     (41 U.S.C. 428) shall be deemed to be $15,000 in the 
     administration of that section with respect to such 
     procurement.
       ``(B) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for purchases 
     that are under this paragraph and that are greater than 
     $2,500.
       ``(C) Exception to preference for purchase card 
     mechanism.--No provision of law establishing a preference for 
     using a Government purchase card method for purchases shall 
     apply to purchases that are under this paragraph and that are 
     greater than $2,500.
       ``(4) Review.--
       ``(A) Review allowed.--Notwithstanding any other provision 
     of law, including subsection (f), review of a contracting 
     agency decision relating to a procurement described in 
     paragraph (1) may be had only by filing a protest--
       ``(i) with a contracting agency; or
       ``(ii) with the Comptroller General under subchapter V of 
     chapter 35 of title 31, United States Code.
       ``(B) Override of stay of contract award or performance 
     committed to agency discretion.--Notwithstanding any other 
     provision of law, the following authorizations by the head of 
     a procuring activity are committed to agency discretion:
       ``(i) An authorization under section 3553(c)(2) of title 
     31, United States Code, to award a contract for a procurement 
     described in paragraph (1) of this subsection.
       ``(ii) An authorization under section 3553(d)(3)(C) of such 
     title to perform a contract for a procurement described in 
     paragraph (1) of this subsection.
       ``(c) Authority to Expedite Peer Review.--
       ``(1) In general.--The Secretary may, as the Secretary 
     determines necessary to respond to pressing qualified 
     countermeasure research and development needs under this 
     section, employ such expedited peer review procedures 
     (including consultation with appropriate scientific experts) 
     as the Secretary, in consultation with the Director of NIH, 
     deems appropriate to obtain assessment of scientific and 
     technical merit and likely contribution to the field of 
     qualified countermeasure research, in place of the peer 
     review and advisory council review procedures that would be 
     required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 
     406(a)(3)(A), 492, and 494, as applicable to a grant, 
     contract, or cooperative agreement--
       ``(A) that is for performing, administering, or supporting 
     qualified countermeasure research and development activities; 
     and
       ``(B) the amount of which is not greater than $1,500,000.
       ``(2) Subsequent phases of research.--The Secretary's 
     determination of whether to employ expedited peer review with 
     respect to subsequent phases of a research grant, contract, 
     or cooperative agreement under this section shall be 
     determined without regard to the peer review procedures used 
     for any prior peer review of that same grant, contract, or 
     cooperative agreement.
       ``(d) Authority for Personal Services Contracts.--
       ``(1) In general.--For the purpose of performing, 
     administering, or supporting qualified countermeasure 
     research and development activities, the Secretary may, as 
     the Secretary determines necessary to respond to pressing 
     qualified countermeasure research and development needs under 
     this section, obtain by contract (in accordance with section 
     3109 of title 5, United States Code, but without regard to 
     the limitations in such section on the period of service and 
     on pay) the personal services of experts or consultants who 
     have scientific or other professional qualifications, except 
     that in no case shall the compensation provided to any such 
     expert or consultant exceed the daily equivalent of the 
     annual rate of compensation for the President.
       ``(2) Federal tort claims act coverage.--
       ``(A) In general.--A person carrying out a contract under 
     paragraph (1), and an officer, employee, or governing board 
     member of such person, shall be deemed to be an employee of 
     the Department of Health and Human Services for purposes of 
     claims under sections 1346(b) and 2672 of title 28, United 
     States Code, for money damages for personal injury, including 
     death, resulting from performance of functions under such 
     contract.
       ``(B) Exclusivity of remedy.--The remedy provided by 
     subparagraph (A) shall be exclusive of any other civil action 
     or proceeding by reason of the same subject matter against 
     the person, officer, employee, or governing board member.
       ``(3) Internal controls to be instituted.--
       ``(A) In general.--The Secretary shall institute 
     appropriate internal controls for contracts under this 
     subsection, including procedures for the Secretary to make a 
     determination of whether a person, or an officer, employee, 
     or governing board member of a person, is deemed to be an 
     employee of the Department of Health and Human Services 
     pursuant to paragraph (2).
       ``(B) Determination of employee status to be final.--A 
     determination by the Secretary under subparagraph (A) that a 
     person, or an officer, employee, or governing board member of 
     a person, is or is not deemed to be an employee of the 
     Department of Health and Human Services shall be final and 
     binding on the Secretary and the Attorney General and other 
     parties to any civil action or proceeding.
       ``(4) Number of personal services contracts limited.--The 
     number of experts and consultants whose personal services are 
     obtained under paragraph (1) shall not exceed 30 at any time.
       ``(e) Streamlined Personnel Authority.--
       ``(1) In general.--In addition to any other personnel 
     authorities, the Secretary may, as the Secretary determines 
     necessary to respond to pressing qualified countermeasure 
     research and development needs under this section, without 
     regard to such provisions of title 5, United States Code, 
     governing appointments in the competitive service, and 
     without regard to the provisions of chapter 51 and subchapter 
     III of chapter 53 of such title relating to classification 
     and General Schedule pay rates, appoint professional and 
     technical employees, not to exceed 30 such employees at any 
     time, to positions in the National Institutes of Health to 
     perform, administer, or support qualified countermeasure 
     research and development activities in carrying out this 
     section.
       ``(2) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     appointments under this subsection.
       ``(f) Actions Committed to Agency Discretion.--Actions by 
     the Secretary under the authority of this section are 
     committed to agency discretion.''.
       (b) Technical Amendment.--Section 481A of the Public Health 
     Service Act (42 U.S.C. 287a-2) is amended--
       (1) in subsection (a)(1)--
       (A) by inserting ``or the Director of the National 
     Institute of Allergy and Infectious Diseases'' after 
     "Director of the Center''; and
       (B) by inserting ``, or in the case of the Institute, to 
     any qualified public or private entity,'' after ``private 
     entities'';
       (2) in subsection (c)--
       (A) in paragraph (1), by inserting ``or the Director of the 
     National Institute of Allergy and Infectious Diseases'' after 
     ``Director of the Center''; and
       (B) in paragraph (2), in the matter preceding subparagraph 
     (A), by striking ``subsection (i)'' and inserting 
     ``subsection (i)(1)'';
       (3) in subsection (d), by inserting ``or the Director of 
     the National Institute of Allergy and Infectious Diseases'' 
     after ``Director of the Center'';
       (4) in subsection (e)--
       (A) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by inserting 
     ``or the Director of the National Institute of Allergy and 
     Infectious Diseases'' after ``Director of the Center'';
       (ii) in subparagraph (A), by inserting ``(or, in the case 
     of the Institute, 75 percent)'' after ``50 percent''; and
       (iii) in subparagraph (B), by inserting ``(or, in the case 
     of the Institute, 75 percent)'' after ``40 percent'';
       (B) in paragraph (2), by inserting ``or the Director of the 
     National Institute of Allergy and Infectious Diseases'' after 
     ``Director of the Center''; and
       (C) in paragraph (4), by inserting ``of the Center or the 
     Director of the National Institute of Allergy and Infectious 
     Diseases'' after ``Director'';
       (5) in subsection (f)--
       (A) in paragraph (1), by inserting ``in the case of an 
     award by the Director of the Center,'' before ``the 
     applicant''; and
       (B) in paragraph (2), by inserting ``of the Center or the 
     Director of the National Institute of Allergy and Infectious 
     Diseases'' after ``Director''; and
       (6) in subsection (i)--
       (A) by striking ``Appropriations.--For the purpose of 
     carrying out this section,'' and inserting the following: 
     ``Appropriations.--
       ``(1) Center.--For the purpose of carrying out this section 
     with respect to the Center,''; and
       (B) by adding at the end the following:
       ``(2) National institute of allergy and infectious 
     diseases.--For the purpose of carrying out this section with 
     respect to the National Institute of Allergy and Infectious 
     Diseases, there are authorized to be appropriated such sums 
     as may be necessary for each of the fiscal years 2003 and 
     2004.''.
       (c) Additional Authority.--Section 319F of the Public 
     Health Service Act (42 U.S.C. 247d-6) is amended--

[[Page 18162]]

       (1) by redesignating subsections (i) and (j) as subsections 
     (j) and (k), respectively; and
       (2) by inserting after subsection (h) the following 
     subsection:
       ``(i) Priority Countermeasures for Strategic National 
     Stockpile.--
       ``(1) In general.--The Secretary, taking into consideration 
     any recommendations of the working group under subsection 
     (a), may initiate and sustain a program that results in the 
     delivery of priority countermeasures for placement in the 
     stockpile under section 319F-2.
       ``(2) Authorization of appropriations.--For the purpose of 
     carrying out paragraph (1), there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2004 through 2013.''.
       (d) Additional Authorizations of Appropriations.--Section 
     2106 of the Public Health Service Act (42 U.S.C. 300aa-6) is 
     amended--
       (1) in subsection (a), by striking ``authorized to be 
     appropriated'' and all that follows and inserting the 
     following: ``authorized to be appropriated such sums as may 
     be necessary for each of the fiscal years 2004 through 
     2013.''; and
       (2) in subsection (b), by striking ``authorized to be 
     appropriated'' and all that follows and inserting the 
     following: ``authorized to be appropriated such sums as may 
     be necessary for each of the fiscal years 2004 through 
     2013.''.
       (e) Technical Amendments.--Section 319F of the Public 
     Health Service Act (42 U.S.C. 247d-6) is amended--
       (1) in subsection (a), by inserting ``the Secretary of 
     Homeland Security,'' after ``Management Agency,''; and
       (2) in subsection (h)(4)(B), by striking ``to diagnose 
     conditions'' and inserting ``to treat, identify, or prevent 
     conditions''.
       (f) Rule of Construction.--Nothing in this section has any 
     legal effect on sections 302(2), 302(4), 304(a), or 304(b) of 
     the Homeland Security Act of 2002.

     SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

       (a) Additional Authority Regarding Strategic National 
     Stockpile.--
       (1) Transfer of program.--Section 121 of the Public Health 
     Security and Bioterrorism Preparedness and Response Act of 
     2002 (116 Stat. 611; 42 U.S.C. 300hh-12) is transferred from 
     such Act to the Public Health Service Act, is redesignated as 
     section 319F-2, and is inserted after section 319F-1 of the 
     Public Health Service Act (as added by section 2 of this 
     Act).
       (2) Additional authority.--Section 319F-2 of the Public 
     Health Service Act, as added by paragraph (1), is amended to 
     read as follows:

     ``SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.

       ``(a) Strategic National Stockpile.--
       ``(1) In general.--The Secretary of Homeland Security 
     (referred to in this section as the `Homeland Security 
     Secretary'), in coordination with the Secretary and the 
     Secretary of Veterans Affairs, shall maintain a stockpile or 
     stockpiles of drugs, vaccines and other biological products, 
     medical devices, and other supplies in such numbers, types, 
     and amounts as are determined by the Secretary to be 
     appropriate and practicable, taking into account other 
     available sources, to provide for the emergency health 
     security of the United States, including the emergency health 
     security of children and other vulnerable populations, in the 
     event of a bioterrorist attack or other public health 
     emergency.
       ``(2) Procedures.--The Secretary, in managing the stockpile 
     under paragraph (1), shall--
       ``(A) consult with the working group under section 319F(a);
       ``(B) ensure that adequate procedures are followed with 
     respect to such stockpile for inventory management and 
     accounting, and for the physical security of the stockpile;
       ``(C) in consultation with Federal, State, and local 
     officials, take into consideration the timing and location of 
     special events;
       ``(D) review and revise, as appropriate, the contents of 
     the stockpile on a regular basis to ensure that emerging 
     threats, advanced technologies, and new countermeasures are 
     adequately considered;
       ``(E) devise plans for the effective and timely supply-
     chain management of the stockpile, in consultation with 
     appropriate Federal, State and local agencies, and the public 
     and private health care infrastructure; and
       ``(F) ensure the adequate physical security of the 
     stockpile.
       ``(b) Smallpox Vaccine Development.--
       ``(1) In general.--The Secretary shall award contracts, 
     enter into cooperative agreements, or carry out such other 
     activities as may reasonably be required in order to ensure 
     that the stockpile under subsection (a) includes an amount of 
     vaccine against smallpox as determined by such Secretary to 
     be sufficient to meet the health security needs of the United 
     States.
       ``(2) Rule of construction.--Nothing in this section shall 
     be construed to limit the private distribution, purchase, or 
     sale of vaccines from sources other than the stockpile 
     described in subsection (a).
       ``(c) Additional Authority Regarding Procurement of Certain 
     Biomedical Countermeasures; Availability of Special Reserve 
     Fund.--
       ``(1) In general.--
       ``(A) Use of fund.--A security countermeasure may, in 
     accordance with this subsection, be procured with amounts in 
     the special reserve fund under paragraph (10).
       ``(B) Security countermeasure.--For purposes of this 
     subsection, the term `security countermeasure' means a 
     priority countermeasure (as defined in section 319F(h) and as 
     determined by the Secretary in accordance with such section 
     and consistent with sections 302(2) and 304(a) of the 
     Homeland Security Act of 2002) that--
       ``(i)(I) is against a chemical, biological, radiological, 
     or nuclear agent identified as a material threat under 
     paragraph (2)(A)(ii);
       ``(II) is determined under paragraph (2)(B)(ii) to be a 
     necessary countermeasure; and
       ``(III)(aa) is approved or cleared under chapter V of the 
     Federal Food, Drug, and Cosmetic Act, or licensed under 
     section 351 of this Act, for use as a countermeasure to a 
     chemical, biological, radiological, or nuclear agent 
     identified as a material threat under paragraph (2)(A)(ii); 
     or
       ``(bb) is a priority countermeasure for which the Secretary 
     determines that sufficient and satisfactory clinical 
     experience or research data (including data, if available, 
     from pre-clinical and clinical trials) support a reasonable 
     conclusion that the countermeasure will qualify for approval 
     or licensing after the date of a determination under 
     paragraph (5); or
       ``(ii) is authorized under section 564 of the Federal Food, 
     Drug, and Cosmetic Act for emergency use.
       ``(2) Determination of material threats.--
       ``(A) Material threat.--The Homeland Security Secretary, in 
     consultation with the heads of other agencies as appropriate, 
     shall on an ongoing basis--
       ``(i) assess current and emerging threats of chemical, 
     biological, radiological, and nuclear agents; and
       ``(ii) determine which of such agents present a material 
     threat against the United States population.
       ``(B) Public health impact; necessary countermeasures.--The 
     Secretary shall on an ongoing basis--
       ``(i) assess the potential public health consequences of 
     use against the United States population of agents identified 
     under subparagraph (A)(ii); and
       ``(ii) determine, on the basis of such assessment, the 
     agents for which priority countermeasures are necessary to 
     protect the public health from a material threat.
       ``(C) Notice to congress.--The Secretary and the Homeland 
     Security Secretary shall promptly notify the designated 
     congressional committees (as defined in paragraph (10) that a 
     determination has been made pursuant to subparagraph (A) or 
     (B). Such notice shall be in unclassified or, if necessary, 
     classified form.
       ``(D) Assuring access to threat information.--In making the 
     assessment and determination required under subparagraph (A), 
     the Homeland Security Secretary shall use all information to 
     which such Secretary is entitled under section 202 of the 
     Homeland Security Act of 2002, including but not limited to 
     information, regardless of its level of classification, 
     relating to current and emerging threats of chemical, 
     biological, radiological, and nuclear agents.
       ``(3) Assessment of availability and appropriateness of 
     countermeasures.--The Secretary, in consultation with the 
     Homeland Security Secretary, shall assess on an ongoing basis 
     the availability and appropriateness of specific 
     countermeasures to address specific threats identified under 
     paragraph (2).
       ``(4) Call for development of countermeasures; commitment 
     for recommendation for procurement.--
       ``(A) Proposal to the president.--If, pursuant to an 
     assessment under paragraph (3), the Homeland Security 
     Secretary and the Secretary make a determination that a 
     countermeasure would be appropriate but is either currently 
     unavailable for procurement as a security countermeasure or 
     is approved, licensed, or cleared only for alternative uses, 
     such Secretaries may jointly submit to the President a 
     proposal to--
       ``(i) issue a call for the development of such 
     countermeasure; and
       ``(ii) make a commitment that, upon the first development 
     of such countermeasure that meets the conditions for 
     procurement under paragraph (5), the Secretaries will, based 
     in part on information obtained pursuant to such call, make a 
     recommendation under paragraph (6) that the special reserve 
     fund under paragraph (10) be made available for the 
     procurement of such countermeasure.
       ``(B) Countermeasure specifications.--The Homeland Security 
     Secretary and the Secretary shall, to the extent practicable, 
     include in the proposal under subparagraph (A)--
       ``(i) estimated quantity of purchase (in the form of number 
     of doses or number of effective courses of treatments 
     regardless of dosage form);
       ``(ii) necessary measures of minimum safety and 
     effectiveness;
       ``(iii) estimated price for each dose or effective course 
     of treatment regardless of dosage form; and
       ``(iv) other information that may be necessary to encourage 
     and facilitate research,

[[Page 18163]]

     development, and manufacture of the countermeasure or to 
     provide specifications for the countermeasure.
       ``(C) Presidential approval.--If the President approves a 
     proposal under subparagraph (A), the Homeland Security 
     Secretary and the Secretary shall make known to persons who 
     may respond to a call for the countermeasure involved--
       ``(i) the call for the countermeasure;
       ``(ii) specifications for the countermeasure under 
     subparagraph (B); and
       ``(iii) the commitment described in subparagraph (A)(ii).
       ``(5) Secretary's determination of countermeasures 
     appropriate for funding from special reserve fund.--
       ``(A) In general.--The Secretary, in accordance with the 
     provisions of this paragraph, shall identify specific 
     security countermeasures that the Secretary determines, in 
     consultation with the Homeland Security Secretary, to be 
     appropriate for inclusion in the stockpile under subsection 
     (a) pursuant to procurements made with amounts in the special 
     reserve fund under paragraph (10) (referred to in this 
     subsection individually as a `procurement under this 
     subsection').
       ``(B) Requirements.--In making a determination under 
     subparagraph (A) with respect to a security countermeasure, 
     the Secretary shall determine and consider the following:
       ``(i) The quantities of the product that will be needed to 
     meet the needs of the stockpile.
       ``(ii) The feasibility of production and delivery within 
     five years of sufficient quantities of the product.
       ``(iii) Whether there is a lack of a significant commercial 
     market for the product at the time of procurement, other than 
     as a security countermeasure.
       ``(6) Recommendation for president's approval.--
       ``(A) Recommendation for procurement.--In the case of a 
     security countermeasure that the Secretary has, in accordance 
     with paragraphs (3) and (5), determined to be appropriate for 
     procurement under this subsection, the Homeland Security 
     Secretary and the Secretary shall jointly submit to the 
     President, in coordination with the Director of the Office of 
     Management and Budget, a recommendation that the special 
     reserve fund under paragraph (10) be made available for the 
     procurement of such countermeasure.
       ``(B) Presidential approval.--The special reserve fund 
     under paragraph (10) is available for a procurement of a 
     security countermeasure only if the President has approved a 
     recommendation under subparagraph (A) regarding the 
     countermeasure.
       ``(C) Notice to designated congressional committees.--The 
     Secretary and the Homeland Security Secretary shall notify 
     the designated congressional committees of each decision of 
     the President to approve a recommendation under subparagraph 
     (A). Such notice shall include an explanation of the decision 
     to make available the special reserve fund under paragraph 
     (10) for procurement of such a countermeasure, including, 
     where available, the identification of the potential supplier 
     or suppliers of such countermeasure, and whether other 
     potential suppliers of the same or similar countermeasures 
     were considered and rejected for procurement under this 
     section and the reasons therefor.
       ``(D) Subsequent specific countermeasures.--Procurement 
     under this subsection of a security countermeasure for a 
     particular purpose does not preclude the subsequent 
     procurement under this subsection of any other security 
     countermeasure for such purpose if the Secretary has 
     determined under paragraph (5)(A) that such countermeasure is 
     appropriate for inclusion in the stockpile and if, as 
     determined by the Secretary, such countermeasure provides 
     improved safety or effectiveness, or for other reasons 
     enhances preparedness to respond to threats of use of a 
     biological, chemical, radiological, or nuclear agent. Such a 
     determination by the Secretary is committed to agency 
     discretion.
       ``(E) Rule of construction.--Recommendations and approvals 
     under this paragraph apply solely to determinations that the 
     special reserve fund under paragraph (10) will be made 
     available for a procurement of a security countermeasure, and 
     not to the substance of contracts for such procurement or 
     other matters relating to awards of such contracts.
       ``(7) Procurement.--
       ``(A) In general.--For purposes of a procurement under this 
     subsection that is approved by the President under paragraph 
     (6), the Homeland Security Secretary and the Secretary shall 
     have responsibilities in accordance with subparagraphs (B) 
     and (C).
       ``(B) Interagency agreements.--
       ``(i) For procurement.--The Homeland Security Secretary 
     shall enter into an agreement with the Secretary for 
     procurement of a security countermeasure in accordance with 
     the provisions of this paragraph. The special reserve fund 
     under paragraph (10) shall be available for the Secretary's 
     costs of such procurement, other than as provided in clause 
     (ii).
       ``(ii) For administrative costs.--The agreement entered 
     into between the Homeland Security Secretary and the 
     Secretary for managing the stockpile under subsection (a) 
     shall provide for reimbursement of the Secretary's 
     administrative costs relating to procurements under this 
     subsection.
       ``(C) Procurement.--
       ``(i) In general.--The Secretary shall be responsible for--

       ``(I) arranging for procurement of a security 
     countermeasure, including negotiating terms (including 
     quantity, production schedule, and price) of, and entering 
     into, contracts and cooperative agreements, and for carrying 
     out such other activities as may reasonably be required, in 
     accordance with the provisions of this subparagraph; and
       ``(II) promulgating such regulations as the Secretary 
     determines necessary to implement the provisions of this 
     subsection.

       ``(ii) Contract terms.--A contract for procurements under 
     this subsection shall (or, as specified below, may) include 
     the following terms:

       ``(I) Payment conditioned on substantial delivery.--The 
     contract shall provide that no payment may be made until 
     delivery has been made of a substantial portion (as 
     determined by the Secretary) of the total number of units 
     contracted for, except that, notwithstanding any other 
     provision of law, the contract may provide that, if the 
     Secretary determines (in the Secretary's discretion) that an 
     advance payment is necessary to ensure success of a project, 
     the Secretary may pay an amount, not to exceed 10 percent of 
     the contract amount, in advance of delivery. The contract 
     shall provide that such advance payment is required to be 
     repaid if there is a failure to perform under the contract, 
     except in special circumstances as determined by the 
     Secretary on a contract by contract basis. Nothing in this 
     subclause may be construed as affecting rights of vendors 
     under provisions of law or regulation (including the Federal 
     Acquisition Regulation) relating to termination of contracts 
     for the convenience of the Government.
       ``(II) Contract duration.--The contract shall be for a 
     period not to exceed five years, except that, in first 
     awarding the contract, the Secretary may provide for a longer 
     duration, not exceeding eight years, if the Secretary 
     determines that complexities or other difficulties in 
     performance under the contract justify such a period. The 
     contract shall be renewable for additional periods, none of 
     which shall exceed five years.
       ``(III) Storage by vendor.--The contract may provide that 
     the vendor will provide storage for stocks of a product 
     delivered to the ownership of the Federal Government under 
     the contract, for such period and under such terms and 
     conditions as the Secretary may specify, and in such case 
     amounts from the special reserve fund under paragraph (10) 
     shall be available for costs of shipping, handling, storage, 
     and related costs for such product.
       ``(IV) Non-stockpile transfers of security 
     countermeasures.--The contract shall provide that the vendor 
     will comply with all applicable export-related controls with 
     respect to such countermeasure.

       ``(iii) Availability of simplified acquisition 
     procedures.--

       ``(I) In general.--If the Secretary determines that there 
     is a pressing need for a procurement of a specific 
     countermeasure, the amount of the procurement under this 
     subsection shall be deemed to be below the threshold amount 
     specified in section 4(11) of the Office of Federal 
     Procurement Policy Act (41 U.S.C. 403(11)), for purposes of 
     application to such procurement, pursuant to section 302A(a) 
     of the Federal Property and Administrative Services Act of 
     1949 (41 U.S.C. 252a(a)), of--

       ``(aa) section 303(g)(1)(A) of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) 
     and its implementing regulations; and
       ``(bb) section 302A(b) of such Act (41 U.S.C. 252a(b)) and 
     its implementing regulations.

       ``(II) Application of certain provisions.--Notwithstanding 
     subclause (I) and the provision of law and regulations 
     referred to in such clause, each of the following provisions 
     shall apply to procurements described in this clause to the 
     same extent that such provisions would apply to such 
     procurements in the absence of subclause (I):

       ``(aa) Chapter 37 of title 40, United States Code (relating 
     to contract work hours and safety standards).
       ``(bb) Subsections (a) and (b) of section 7 of the Anti-
     Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
       ``(cc) Section 304C of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 254d) 
     (relating to the examination of contractor records).
       ``(iv) Procedures other than full and open competition.--

       ``(I) In general.--In using the authority provided in 
     section 303(c)(1) of title III of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to 
     use procedures other than competitive procedures in the case 
     of a procurement under this subsection, the phrase `available 
     from only one responsible source' in such section 303(c)(1) 
     shall be deemed to mean `available from only one responsible 
     source or only from a limited number of responsible sources'.
       ``(II) Relation to other authorities.--The authority under 
     subclause (I) is in addition to any other authority to use 
     procedures other than competitive procedures.

[[Page 18164]]

       ``(III) Applicable government-wide regulations.--The 
     Secretary shall implement this clause in accordance with 
     applicable government-wide regulations, including 
     requirements that offers be solicited from as many potential 
     sources as is practicable under the circumstances, that 
     required notices be published, and that submitted offers be 
     considered.

       ``(v) Premium provision in multiple award contracts.--

       ``(I) In general.--If, under this subsection, the Secretary 
     enters into contracts with more than one vendor to procure a 
     security countermeasure, such Secretary may, notwithstanding 
     any other provision of law, include in each of such contracts 
     a provision that--

       ``(aa) identifies an increment of the total quantity of 
     security countermeasure required, whether by percentage or by 
     numbers of units; and
       ``(bb) promises to pay one or more specified premiums based 
     on the priority of such vendors' production and delivery of 
     the increment identified under item (aa), in accordance with 
     the terms and conditions of the contract.

       ``(II) Determination of government's requirement not 
     reviewable.--If the Secretary includes in each of a set of 
     contracts a provision as described in subclause (I), such 
     Secretary's determination of the total quantity of security 
     countermeasure required, and any amendment of such 
     determination, is committed to agency discretion.

       ``(vi) Extension of closing date for receipt of proposals 
     not reviewable.--A decision by the Secretary to extend the 
     closing date for receipt of proposals for a procurement under 
     this subsection is committed to agency discretion.
       ``(vii) Limiting competition to sources responding to 
     request for information.--In conducting a procurement under 
     this subsection, the Secretary may exclude a source that has 
     not responded to a request for information under section 
     303A(a)(1)(B) of the Federal Property and Administrative 
     Services Act of 1949 (41 U.S.C. 253a(a)(1)(B)) if such 
     request has given notice that the Secretary may so exclude 
     such a source.
       ``(8) Interagency cooperation.--
       ``(A) In general.--In carrying out activities under this 
     section, the Homeland Security Secretary and the Secretary 
     are authorized, subject to subparagraph (B), to enter into 
     interagency agreements and other collaborative undertakings 
     with other agencies of the United States Government.
       ``(B) Limitation.--An agreement or undertaking under this 
     paragraph shall not authorize another agency to exercise the 
     authorities provided by this section to the Homeland Security 
     Secretary or to the Secretary.
       ``(9) Restrictions on use of funds.--Amounts in the special 
     reserve fund under paragraph (10) shall not be used to pay--
       ``(A) costs for the purchase of vaccines under procurement 
     contracts entered into before the date of the enactment of 
     the Project BioShield Act of 2003; or
       ``(B) administrative costs.
       ``(10) Definitions.--
       ``(A) Special reserve fund.--For purposes of this 
     subsection, the term `special reserve fund' has the meaning 
     given such term in section 510 of the Homeland Security Act 
     of 2002.
       ``(B) Designated congressional committees.--For purposes of 
     this section, the term `designated congressional committees' 
     means the following committees of the Congress:
       ``(i) In the House of Representatives: the Committee on 
     Energy and Commerce, the Committee on Appropriations, the 
     Committee on Government Reform, and the Select Committee on 
     Homeland Security (or any successor to the Select Committee).
       ``(ii) In the Senate: the Committee on Health, Education, 
     Labor, and Pensions, the Committee on Appropriations, and the 
     Committee on Government Affairs.
       ``(d) Disclosures.--No Federal agency shall disclose under 
     section 552 of title 5, United States Code, any information 
     identifying the location at which materials in the stockpile 
     under subsection (a) are stored.
       ``(e) Definition.--For purposes of subsection (a), the term 
     `stockpile' includes--
       ``(1) a physical accumulation (at one or more locations) of 
     the supplies described in subsection (a); or
       ``(2) a contractual agreement between the Secretary and a 
     vendor or vendors under which such vendor or vendors agree to 
     provide to such Secretary supplies described in subsection 
     (a).
       ``(f) Authorization of Appropriations.--
       ``(1) Strategic national stockpile.--For the purpose of 
     carrying out subsection (a), there are authorized to be 
     appropriated $640,000,000 for fiscal year 2002, and such sums 
     as may be necessary for each of fiscal years 2003 through 
     2006. Such authorization is in addition to amounts in the 
     special reserve fund under subsection (c)(10).
       ``(2) Smallpox vaccine development.--For the purpose of 
     carrying out subsection (b), there are authorized to be 
     appropriated $509,000,000 for fiscal year 2002, and such sums 
     as may be necessary for each of fiscal years 2003 through 
     2006.''.
       (b) Amendment to Homeland Security Act of 2002.--Title V of 
     the Homeland Security Act of 2002 (116 Stat. 2212; 6 U.S.C. 
     311 et seq.) is amended by adding at the end the following:

     ``SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR 
                   STRATEGIC NATIONAL STOCKPILE.

       ``(a) Authorization of Appropriations.--For the procurement 
     of security countermeasures under section 319F-2(c) of the 
     Public Health Service Act (referred to in this section as the 
     `security countermeasures program'), there is authorized to 
     be appropriated up to $5,593,000,000 for the fiscal years 
     2004 through 2013. Of the amounts appropriated under the 
     preceding sentence, not to exceed $3,418,000,000 may be 
     obligated during the fiscal years 2004 through 2008, of which 
     not to exceed $890,000,000 may be obligated during fiscal 
     year 2004.
       ``(b) Special Reserve Fund.--For purposes of the security 
     countermeasures program, the term `special reserve fund' 
     means the appropriations account established as a result of 
     any appropriations made under subsection (a).
       ``(c) Availability.--
       ``(1) Integrity of special reserve fund; limitation of 
     obligational authority to fund purposes; intent of congress 
     against reprogramming.--Subject to paragraph (2), all amounts 
     appropriated under subsection (a) are available for 
     obligation through the end of fiscal year 2013 and only for 
     the specific purposes set forth in the security 
     countermeasures program. It is the intent of the Congress 
     that no portion of such amount that remains unobligated for 
     such purposes shall be applied, through reprogramming or 
     otherwise, to any other purpose.
       ``(2) Initial availability for particular procurements.--
     Amounts appropriated under subsection (a) become available 
     for a procurement under the security countermeasures program 
     only upon the approval by the President of such availability 
     for the procurement in accordance with paragraph (6)(B) of 
     such program.
       ``(d) Related Authorizations of Appropriations.--
       ``(1) Threat assessment capabilities.--For the purpose of 
     carrying out the responsibilities of the Secretary for terror 
     threat assessment under the security countermeasures program, 
     there are authorized to be appropriated $5,000,000 for fiscal 
     year 2003, and such sums as may be necessary for each of the 
     fiscal years 2004 through 2006, for the hiring of 
     professional personnel within the Directorate for Information 
     Analysis and Infrastructure Protection, who shall be analysts 
     responsible for chemical, biological, radiological, and 
     nuclear threat assessment (including but not limited to 
     analysis of chemical, biological, radiological, and nuclear 
     agents, the means by which such agents could be weaponized or 
     used in a terrorist attack, and the capabilities, plans, and 
     intentions of terrorists and other non-state actors who may 
     have or acquire such agents). All such analysts shall meet 
     the applicable standards and qualifications for the 
     performance of intelligence activities promulgated by the 
     Director of Central Intelligence pursuant to section 104 of 
     the National Security Act of 1947.
       ``(2) Intelligence sharing infrastructure.--For the purpose 
     of carrying out the acquisition and deployment of secure 
     facilities (including information technology and physical 
     infrastructure, whether mobile and temporary, or permanent) 
     sufficient to permit the Secretary to receive, not later than 
     December 31, 2003, all classified information and products to 
     which the Under Secretary for Information Analysis and 
     Infrastructure Protection is entitled under subtitle A of 
     title II, there are authorized to be appropriated such sums 
     as may be necessary for each of the fiscal years 2003 through 
     2006.''.

     SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
                   EMERGENCIES.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding 
     at the end the following section:

     ``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
                   EMERGENCIES.

       ``(a) In General.--
       ``(1) Emergency uses.--Notwithstanding sections 505, 
     510(k), and 515 of this Act and section 351 of the Public 
     Health Service Act, and subject to the provisions of this 
     section, the Secretary may authorize the introduction into 
     interstate commerce, during the effective period of a 
     declaration under subsection (b), of a drug, device, or 
     biological product intended for use in an actual or potential 
     emergency (referred to in this section as an `emergency 
     use').
       ``(2) Approval status of product.--An authorization under 
     paragraph (1) may authorize an emergency use of a product 
     that--
       ``(A) is not approved, licensed, or cleared for commercial 
     distribution under a provision of law referred to in such 
     paragraph (referred to in this section as an `unapproved 
     product'); or
       ``(B) is approved, licensed, or cleared under such a 
     provision, but which use is not under such provision an 
     approved, licensed, or cleared use of the product (referred 
     to in this section as an `unapproved use of an approved 
     product').
       ``(3) Relation to other uses.--An emergency use authorized 
     under paragraph (1) for a product is in addition to any other 
     use that

[[Page 18165]]

     is authorized for the product under a provision of law 
     referred to in such paragraph.
       ``(4) Definitions.--For purposes of this section:
       ``(A) The term `biological product' has the meaning given 
     such term in section 351 of the Public Health Service Act.
       ``(B) The term `emergency use' has the meaning indicated 
     for such term in paragraph (1).
       ``(C) The term `product' means a drug, device, or 
     biological product.
       ``(D) The term `unapproved product' has the meaning 
     indicated for such term in paragraph (2)(A).
       ``(E) The term `unapproved use of an approved product' has 
     the meaning indicated for such term in paragraph (2)(B).
       ``(b) Declaration of Emergency.--
       ``(1) In general.--The Secretary may declare an emergency 
     justifying the authorization under this subsection for a 
     product on the basis of--
       ``(A) a determination by the Secretary of Homeland Security 
     that there is a national emergency, or a significant 
     potential for a national emergency, involving a heightened 
     risk of attack with a specified biological, chemical, 
     radiological, or nuclear agent or agents;
       ``(B) a determination by the Secretary of Defense that 
     there is a military emergency, or a significant potential for 
     a military emergency, involving a heightened risk to United 
     States military forces of attack with a biological, chemical, 
     radiological, or nuclear agent or agents; or
       ``(C) a determination by the Secretary of a public health 
     emergency under section 319 of the Public Health Service Act, 
     affecting national security and involving a specified 
     biological, chemical, radiological, or nuclear agent or 
     agents, or a specified disease or condition that may be 
     attributable to such agent or agents.
       ``(2) Termination of declaration.--
       ``(A) In general.--A declaration under this subsection 
     shall terminate upon the earlier of--
       ``(i) a determination by the Secretary, in consultation as 
     appropriate with the Secretary of Homeland Security or the 
     Secretary of Defense, that the circumstances described in 
     paragraph (1) have ceased to exist; or
       ``(ii) the expiration of the one-year period beginning on 
     the date on which the declaration is made.
       ``(B) Renewal.--Notwithstanding subparagraph (A), the 
     Secretary may renew a declaration under this subsection, and 
     this paragraph shall apply to any such renewal.
       ``(3) Advance notice of termination.--In terminating a 
     declaration under this section, the Secretary shall provide 
     advance notice that the declaration will be terminated. The 
     period of advance notice shall be a period reasonably 
     determined to provide--
       ``(A) in the case of an unapproved product, a sufficient 
     period for disposition of shipments of the product, including 
     the return of such shipments to the manufacturer (in the case 
     of a manufacturer that chooses to have the shipments 
     returned); and
       ``(B) in the case of unapproved uses of approved products, 
     a sufficient period for the disposition of any labeling that 
     was provided with respect to the emergency use involved.
       ``(4) Publication.--The Secretary shall promptly publish in 
     the Federal Register each declaration, determination, and 
     renewal under this subsection.
       ``(c) Criteria for Issuance of Authorization.--The 
     Secretary may issue an authorization under this section with 
     respect to the emergency use of a product only if, after 
     consultation with the Director of the National Institutes of 
     Health and the Director of the Centers for Disease Control 
     and Prevention, to the extent feasible and appropriate given 
     the circumstances of the emergency involved, the Secretary 
     concludes--
       ``(1) that an agent specified in a declaration under 
     subsection (b) can cause a serious or life-threatening 
     disease or condition;
       ``(2) that, based on the totality of scientific evidence 
     available to the Secretary, including data from adequate and 
     well-controlled clinical trials, if available, it is 
     reasonable to believe that--
       ``(A) the product may be effective in detecting, 
     diagnosing, treating, or preventing--
       ``(i) such disease or condition; or
       ``(ii) a serious or life-threatening disease or condition 
     caused by a product authorized under this section or approved 
     under this Act or the Public Health Service Act, for 
     detecting, diagnosing, treating, or preventing such a disease 
     or condition caused by such an agent; and
       ``(B) the known and potential benefits of the product, when 
     used to detect, diagnose, prevent, or treat such disease or 
     condition, outweigh the known and potential risks of the 
     product;
       ``(3) that there is no adequate, approved, and available 
     alternative to the product for detecting, diagnosing, 
     preventing, or treating such disease or condition; and
       ``(4) that such other criteria as the Secretary may by 
     regulation prescribe are satisfied.
       ``(d) Scope of Authorization.--
       ``(1) In general.--An authorization of a product under this 
     section shall state--
       ``(A) each disease or condition that the product may be 
     used to detect, diagnose, prevent, or treat within the scope 
     of the authorization;
       ``(B) the Secretary's conclusions, made under subsection 
     (c)(2)(B), that the known and potential benefits of the 
     product, when used to detect, diagnose, prevent, or treat 
     such disease or condition, outweigh the known and potential 
     risks of the product; and
       ``(C) the Secretary's conclusions, made under subsection 
     (c), concerning the safety and potential effectiveness of the 
     product in detecting, diagnosing, preventing, or treating 
     such diseases or conditions, including an assessment of the 
     available scientific evidence.
       ``(2) Confidential information.--Nothing in this section 
     alters or amends section 1905 of title 18, United States 
     Code, or section 552(b)(4) of title 5 of such Code.
       ``(e) Conditions of Authorization.--
       ``(1) Unapproved product.--
       ``(A) Required conditions.--With respect to the emergency 
     use of an unapproved product, the Secretary, to the extent 
     feasible given the circumstances of the emergency, shall, for 
     persons who choose to carry out one or more activities for 
     which the authorization is issued, establish such conditions 
     on an authorization under this section as the Secretary finds 
     necessary or appropriate to protect the public health, 
     including the following:
       ``(i) Appropriate conditions designed to ensure that, to 
     the extent feasible given the circumstances of the emergency, 
     health care professionals administering the product are 
     informed--

       ``(I) that the Secretary has authorized the emergency use 
     of the product;
       ``(II) of the significant known and potential benefits and 
     risks of the emergency use of the product, and of the extent 
     to which such benefits and risks are unknown; and
       ``(III) of the alternatives to the product that are 
     available, and of their benefits and risks.

       ``(ii) Appropriate conditions designed to ensure that, to 
     the extent feasible given the circumstances of the emergency, 
     individuals to whom the product is administered are 
     informed--

       ``(I) that the Secretary has authorized the emergency use 
     of the product;
       ``(II) of the significant known and potential benefits and 
     risks of such use, and of the extent to which such benefits 
     and risks are unknown; and
       ``(III) of the option to accept or refuse administration of 
     the product, of the consequences, if any, of refusing 
     administration of the product, and of the alternatives to the 
     product that are available and of their benefits and risks.

       ``(iii) Appropriate conditions for the monitoring and 
     reporting of adverse events associated with the emergency use 
     of the product.
       ``(iv) For manufacturers of the product, appropriate 
     conditions concerning recordkeeping and reporting, including 
     records access by the Secretary, with respect to the 
     emergency use of the product.
       ``(B) Authority for additional conditions.--With respect to 
     the emergency use of an unapproved product, the Secretary, to 
     the extent feasible given the circumstances of the emergency, 
     may, for persons who choose to carry out one or more 
     activities for which the authorization is issued, establish 
     such conditions on an authorization under this section as the 
     Secretary finds necessary or appropriate to protect the 
     public health, including the following:
       ``(i) Appropriate conditions on which entities may 
     distribute the product with respect to the emergency use of 
     the product (including limitation to distribution by 
     government entities), and on how distribution is to be 
     performed.
       ``(ii) Appropriate conditions on who may administer the 
     product with respect to the emergency use of the product, and 
     on the categories of individuals to whom, and the 
     circumstances under which, the product may be administered 
     with respect to such use.
       ``(iii) For persons other than manufacturers of the 
     product, appropriate conditions concerning recordkeeping and 
     reporting, including records access by the Secretary, with 
     respect to the emergency use of the product.
       ``(iv) With respect to the emergency use of the product, 
     waive or limit, to the extent appropriate given the 
     circumstances of the emergency, conditions regarding current 
     good manufacturing practice otherwise applicable to the 
     manufacture, processing, packing, or holding of products 
     subject to regulation under this Act, including such 
     requirements established in section 501.
       ``(2) Unapproved use.--With respect to the emergency use of 
     a product that is an unapproved use of an approved product:
       ``(A) The Secretary may, for manufacturers of the product 
     who choose to carry out one or more activities for which the 
     authorization is issued, establish any of the conditions 
     described in clauses (i) through (iv) of paragraph (1)(A).
       ``(B)(i) If the authorization under this section regarding 
     the emergency use authorizes a change in the labeling of the 
     product, but the manufacturer of the product chooses not to 
     make such change, such authorization may not authorize 
     distributors of the product or any other person to alter or 
     obscure the labeling provided by the manufacturer.

[[Page 18166]]

       ``(ii) In the circumstances described in clause (i), an 
     authorization under this section regarding the emergency use 
     may, for persons who do not manufacture the product and who 
     choose to act under this clause, authorize such persons to 
     provide information on the product in addition to the 
     labeling provided by the manufacturer, subject to compliance 
     with clause (i). Such additional information shall not be 
     considered labeling for purposes of section 502.
       ``(f) Duration of Authorization.--
       ``(1) In general.--Except as provided in paragraph (2), an 
     authorization under this section shall be effective until the 
     earlier of the termination of the declaration under 
     subsection (b) or a revocation under subsection (g).
       ``(2) Continued use after end of effective period.--
     Notwitstanding the termination of the declaration under 
     subsection (b) or a revocation under subsection (g), an 
     authorization shall continue to be effective for continued 
     use with respect to patients to whom it was administered 
     during the period described by paragraph (1), to the extent 
     found necessary by such patients' attending physicians.
       ``(g) Revocation of Authorization.--
       ``(1) Review.--The Secretary shall periodically review the 
     circumstances and the appropriateness of an authorization 
     under this section.
       ``(2) Revocation.--The Secretary may revoke an 
     authorization under this section if, in the Secretary's 
     unreviewable discretion, the criteria under subsection (c) 
     for issuance of such authorization are no longer met.
       ``(h) Publication.--The Secretary shall promptly publish in 
     the Federal Register a notice of each authorization, and each 
     termination or revocation of an authorization, and an 
     explanation of the reasons therefor, under this section.
       ``(i) Actions Committed to Agency Discretion.--Actions 
     under the authority of this section by the Secretary, by the 
     Secretary of Defense, or by the Secretary of Homeland 
     Security are committed to agency discretion.
       ``(j) Rules of Construction.--Nothing in this section shall 
     be construed to impair or otherwise affect--
       ``(1) the authority of the President as Commander in Chief 
     of the Armed Forces of the United States under article II, 
     section 2 of the United States Constitution;
       ``(2) the authority of the Secretary of Defense with 
     respect to the Department of Defense, including the armed 
     forces, under other provisions of Federal law; or
       ``(3) the authority of the Secretary under section 319F-2 
     to manage the stockpile under such section.
       ``(k) Application to Members of Armed Forces.--
       ``(1) Waiver of requirement relating to option to refuse.--
     In the case of administration of a countermeasure to members 
     of the armed forces, a requirement, under subsection 
     (e)(1)(A)(ii)(III), designed to ensure that individuals are 
     informed of an option to accept or refuse administration of a 
     product, may be waived by the President if the President 
     determines, in writing, that complying with such requirement 
     is not feasible, is contrary to the best interests of the 
     members affected, or is not in the interests of national 
     security.
       ``(2) Provision of information to member of the armed 
     forces.--If the Secretary makes a determination that it is 
     not feasible for the information required by subsection 
     (e)(1)(A)(ii) to be provided to a member of the armed forces 
     prior to the administration of the product, such information 
     shall be provided to such member of the armed forces (or 
     next-of-kin in the case of the death of a member) to whom the 
     product was administered as soon as possible, but not later 
     than 30 days, after such administration. Information 
     concerning the administration of the product shall be 
     recorded in the medical record of the member.
       ``(3) Effect on statute pertaining to investigational new 
     drugs.--In the case of an authorization based on a 
     determination by the Secretary of Defense under subsection 
     (b)(1)(B), section 1107 of title 10, United States Code, 
     shall not apply to use of a product that is the subject of 
     such authorization, within the scope of such authorization 
     and while such authorization is effective.
       ``(l) Relation to Other Provisions.--If a product is the 
     subject of an authorization under this section, the use of 
     such product within the scope of the authorization --
       ``(1) shall not be subject to any requirements pursuant to 
     section 505(i) or 520(g); and
       ``(2) shall not be subject to any requirements otherwise 
     applicable to clinical investigations pursuant to other 
     provisions of this Act.
       ``(m) Discretion Regarding Use of Authorization.--Nothing 
     in this section provides the Secretary any authority to 
     require any person to carry out any activity that becomes 
     lawful pursuant to an authorization under this section, and 
     no person is required to inform the Secretary that the person 
     will not be carrying out such activity, except that a 
     manufacturer of a sole-source unapproved product authorized 
     for emergency use shall notify the Secretary within a 
     reasonable period of time after the issuance by the Secretary 
     of such authorization if such manufacturer does not intend to 
     carry out an activity or activities under the authorization. 
     This section does not have any legal effect on a person who 
     does not carry out any activity for which an authorization 
     under this section is issued, or who carries out such an 
     activity pursuant to other provisions of this Act or section 
     351 of the Public Health Service Act.
       ``(n) Enforcement.--A person who carries out an activity 
     pursuant to an authorization under this section, but who 
     fails to comply with applicable conditions under subsection 
     (e), is with respect to that act of noncompliance subject to 
     the provisions of law specified in subsection (a) and to the 
     enforcement of such provisions under section 301.''.

     SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

       (a) Secretary of Health and Human Services.--
       (1) Annual reports on particular exercises of authority.--
       (A) Relevant authorities.--The Secretary of Health and 
     Human Services (referred to in this subsection as the 
     ``Secretary'') shall submit reports in accordance with 
     subparagraph (B) regarding the exercise of authority under 
     the following provisions of law:
       (i) With respect to section 319F-1 of the Public Health 
     Service Act (as added by section 2 of this Act):

       (I) Subsection (b)(1) (relating to increased simplified 
     acquisition threshold).
       (II) Subsection (b)(2) (relating to procedures other than 
     full and open competition).
       (III) Subsection (c) (relating to expedited peer review 
     procedures).

       (ii) With respect to section 319F-2 of the Public Health 
     Service Act (as added by section 3 of this Act):

       (I) Subsection (c)(7)(C)(iii) (relating to simplified 
     acquisition procedures).
       (II) Subsection (c)(7)(C)(iv) (relating to procedures other 
     than full and open competition).
       (III) Subsection (c)(7)(C)(v) (relating to premium 
     provision in multiple-award contracts).

       (iii) With respect to section 564 of the Federal Food, 
     Drug, and Cosmetic Act (as added by section 4 of this Act):

       (I) Subsection (a)(1) (relating to emergency uses of 
     certain drugs and devices).
       (II) Subsection (b)(1) (relating to a declaration of an 
     emergency).
       (III) Subsection (e) (relating to conditions on 
     authorization).

       (B) Contents of reports.--The Secretary shall annually 
     submit to the designated congressional committees a report 
     that summarizes--
       (i) the particular actions that were taken under the 
     authorities specified in subparagraph (A), including, as 
     applicable, the identification of the threat agent, 
     emergency, or the biomedical countermeasure with respect to 
     which the authority was used;
       (ii) the reasons underlying the decision to use such 
     authorities, including, as applicable, the options that were 
     considered and rejected with respect to the use of such 
     authorities;
       (iii) the identification of each person or entity that 
     received, or was considered and rejected for, grants, 
     cooperative agreements, or contracts pursuant to the use of 
     such authorities; and
       (iv) whether, with respect to each procurement that is 
     approved by the President under section 319F-2(c)(6) of the 
     Public Health Service Act (as added by section 3 of this 
     Act), a contract was entered into within one year after such 
     approval by the President.
       (2) Annual summaries regarding certain activity.--The 
     Secretary shall annually submit to the designated 
     congressional committees a report that summarizes the 
     activity undertaken pursuant to the following authorities 
     under section 319F-1 of the Public Health Service Act (as 
     added by section 2 of this Act):
       (A) Subsection (b)(3) (relating to increased micropurchase 
     threshold).
       (B) Subsection (d) (relating to authority for personal 
     services contracts).
       (C) Subsection (e) (relating to streamlined personnel 
     authority).

     With respect to subparagraph (B), the report shall include a 
     provision specifying, for the one-year period for which the 
     report is submitted, the number of persons who were paid 
     amounts greater than $100,000 and the number of persons who 
     were paid amounts between $50,000 and $100,000.
       (b) National Academy of Sciences Review.--
       (1) In general.--Not later than four years after the date 
     of the enactment of this Act, the Secretary of Health and 
     Human Services shall request the National Academy of Sciences 
     to enter into an agreement for a review of the biomedical 
     countermeasure research and development authorities 
     established in this Act to determine whether and to what 
     extent activities undertaken pursuant to such authorities 
     have enhanced the development of biomedical countermeasures 
     affecting national security, and to recommend any legislative 
     or administrative changes necessary to improve the ability of 
     the Secretary to carry out these activities in the future. 
     The Secretary shall ensure that the results of the study are 
     submitted to the

[[Page 18167]]

     designated congressional committees not later than five years 
     after such date of enactment.
       (2) Certain contents.--The report under paragraph (1) shall 
     include--
       (A) a summary of the most recent analysis by the Department 
     of Homeland Security and the intelligence community of the 
     domestic threat from chemical, biological, radiological, and 
     nuclear agents;
       (B) the Academy's assessment of the current availability of 
     countermeasures to address such threats;
       (C) the Academy's assessment of the extent to which 
     programs and activities under this Act will reduce any gap 
     between the threat and the availability of countermeasures to 
     an acceptable level of risk; and
       (D)(i) the Academy's assessment of threats to national 
     security that are posed by technology that will enable, 
     during the 10-year period beginning on the date of the 
     enactment of this Act, the development of antibiotic 
     resistant, mutated, or bioengineered strains of biological 
     agents; and
       (ii) recommendations on short-term and long-term 
     governmental strategies for addressing such threats, 
     including recommendations for Federal policies regarding 
     research priorities, the development of countermeasures, and 
     investments in technology.
       (c) General Accounting Office Review.--Four years after the 
     date of the enactment of this Act, the Comptroller General of 
     the United States shall initiate a study--
       (1)(A) to review the Secretary of Health and Human 
     Services' utilization of the authorities granted under this 
     Act with respect to simplified acquisition procedures, 
     procedures other than full and open competition, increased 
     micropurchase thresholds, personal services contracts, 
     streamlined personnel authority, and the purchase of security 
     countermeasures under the special reserve fund; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authorities in the future;
       (2)(A) to review the internal controls instituted by such 
     Secretary with respect to such authorities, where required by 
     this Act; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the effectiveness of such controls; and
       (3)(A) to review such Secretary's utilization of the 
     authority granted under this Act to authorize an emergency 
     use of a biomedical countermeasure, including the means by 
     which the Secretary determines whether and under what 
     conditions any such authorizations should be granted and the 
     benefits and adverse impacts, if any, resulting from the use 
     of such authority; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authority and to enhance protection of the public health.

     The results of the study shall be submitted to the designated 
     congressional committees not later than five years after the 
     date of the enactment of this Act.
       (d) Report Regarding Barriers to Procurement of Security 
     Countermeasures.--
       (1) Biocontainment facilities.--Not later than 120 days 
     after the date of the enactment of this Act, the Secretary of 
     Homeland Security and the Secretary of Health and Human 
     Services shall jointly report to the designated congressional 
     committees whether there is a lack of adequate large-scale 
     biocontainment facilities necessary for the testing of 
     security countermeasures in accordance with Food and Drug 
     Administration requirements.
       (2) Additional barriers.--Not later than one year after the 
     date of enactment of this Act, such Secretaries shall jointly 
     report to the designated congressional committees any other 
     potential barriers to the procurement of security 
     countermeasures that have not been addressed by this Act.
       (e) Status of Program for Chemical Terrorism 
     Preparedness.--Not later than 270 days after the date of the 
     enactment of this Act, the Secretary of Homeland Security 
     shall submit to the designated congressional committees a 
     report describing the status of the program carried out by 
     the Secretary to enhance the preparedness of the United 
     States to respond to terrorist attacks involving chemical 
     agents.
       (f) Designated Congressional Committees.--For purposes of 
     this section, the term ``designated congressional 
     committees'' means the following committees of the Congress:
       (1) In the House of Representatives: the Committee on 
     Energy and Commerce, the Committee on Appropriations, the 
     Committee on Government Reform, and the Select Committee on 
     Homeland Security (or any successor to the Select Committee).
       (2) In the Senate: the Committee on Health, Education, 
     Labor, and Pensions, the Committee on Appropriations, and the 
     Committee on Government Affairs.

     SEC. 6. OUTREACH.

       The Secretary of Health and Human Services shall develop 
     outreach measures to ensure to the extent practicable that 
     diverse institutions, including Historically Black Colleges 
     and Universities and those serving large proportions of 
     Hispanics, Native Americans, Asian-Pacific Americans, or 
     other underrepresented populations, are meaningfully aware of 
     available research and development grants, contracts, 
     cooperative agreements, and procurements conducted under 
     sections 2 and 3 of this Act.

     SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON CERTAIN 
                   BIOMEDICAL COUNTERMEASURES.

       Upon the award of any grant, contract, or cooperative 
     agreement under section 2 or 3 of this Act for the research, 
     development, or procurement of a qualified countermeasure or 
     a security countermeasure (as those terms are defined in this 
     Act), the Secretary of Health and Human Services shall, in 
     consultation with the heads of other appropriate Federal 
     agencies, determine whether the countermeasure involved in 
     such grant, contract, or cooperative agreement is subject to 
     existing export-related controls and, if not, may make a 
     recommendation to the appropriate Federal agency or agencies 
     that such countermeasure should be included on the list of 
     controlled items subject to such controls.

     SEC. 8. ENSURING COORDINATION, COOPERATION AND THE 
                   ELIMINATION OF UNNECESSARY DUPLICATION IN 
                   PROGRAMS DESIGNED TO PROTECT THE HOMELAND FROM 
                   BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND NUCLEAR 
                   AGENTS.

       (a) Ensuring Coordination of Programs.--The Secretary of 
     Health and Human Services, the Secretary of Homeland 
     Security, and the Secretary of Defense shall ensure that the 
     activities of their respective Departments coordinate, 
     complement, and do not unnecessarily duplicate programs to 
     identify potential domestic threats from biological, 
     chemical, radiological or nuclear agents, detect domestic 
     incidents involving such agents, analyze such incidents, and 
     develop necessary countermeasures. The aforementioned 
     Secretaries shall further ensure that information and 
     technology possessed by the Departments relevant to these 
     activities are shared with the other Departments.
       (b) Designation of Agency Coordination Officer.--The 
     Secretary of Health and Human Services, the Secretary of 
     Homeland Security, and the Secretary of Defense shall each 
     designate an officer or employee of their respective 
     Departments who shall coordinate, through regular meetings 
     and communications, with the other aforementioned Departments 
     such programs and activities carried out by their 
     Departments.
  Mr. HASTINGS of Washington (during the reading). Mr. Speaker, I ask 
unanimous consent that the amendment be considered as read and printed 
in the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Washington?
  There was no objection.
  The SPEAKER pro tempore. Is there objection to the original request 
of the gentleman from Washington?
  There was no objection.

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