[Congressional Record (Bound Edition), Volume 150 (2004), Part 11]
[House]
[Pages 15564-15585]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     PROJECT BIOSHIELD ACT OF 2004

  Mr. BARTON of Texas. Mr. Speaker, pursuant to the order of the House 
of Tuesday, July 13, 2004, I call up the Senate bill (S. 15) to amend 
the Public Health Service Act to provide protections and 
countermeasures against chemical, radiological, or nuclear agents that 
may be used in a terrorist attack against the United States by giving 
the National Institutes of Health contracting flexibility, 
infrastructure improvements, and expediting the scientific peer review 
process, and streamlining the Food and Drug Administration approval 
process of countermeasures, and ask for its immediate consideration.
  The Clerk read the title of the bill.
  The text of S. 15 is as follows:

                                 S. 15

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Project BioShield Act of 
     2004''.

     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 countermeasures under 
     section 319F(h), the Secretary may conduct and support such 
     activities in accordance with this section and, in 
     consultation with the Director of the National Institutes of 
     Health, as part of the program under section 446, if the 
     activities concern qualified countermeasures.
       ``(2) Qualified countermeasure.--For purposes of this 
     section, the term `qualified countermeasure' means a drug (as 
     that term is defined by section 201(g)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), 
     biological product (as that term is defined by section 351(i) 
     of this Act (42 U.S.C. 262(i))), or device (as that term is 
     defined by section 201(h) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(h))) that the Secretary 
     determines to be a priority (consistent with sections 302(2) 
     and 304(a) of the Homeland Security Act of 2002) to--
       ``(A) treat, identify, or prevent harm from any biological, 
     chemical, radiological, or nuclear agent that may cause a 
     public health emergency affecting national security; or
       ``(B) treat, identify, or prevent harm from a condition 
     that may result in adverse health consequences or death and 
     may be caused by administering a drug, biological product, or 
     device that is used as described in subparagraph (A).
       ``(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) Transfers of qualified 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).
       ``(iv) Section 3131 of title 40, United States Code 
     (relating to bonds of contractors of public buildings or 
     works).
       ``(v) Subsection (a) of section 304 of the Federal Property 
     and Administrative Services Act of 1949 (41 U.S.C. 254(a)) 
     (relating to contingent fees to middlemen).
       ``(vi) Section 6002 of the Solid Waste Disposal Act (42 
     U.S.C. 6962).
       ``(vii) Section 1354 of title 31, United States Code 
     (relating to the limitation on the use of appropriated funds 
     for contracts with entities not meeting veterans employment 
     reporting requirements).
       ``(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

[[Page 15565]]

     justification for use of the authority in this paragraph with 
     respect to the procurement involved.
       ``(D) Authority to limit competition.--In conducting a 
     procurement under this paragraph, the Secretary may not use 
     the authority provided for under subparagraph (A) to conduct 
     a procurement on a basis other than full and open competition 
     unless the Secretary determines that the mission of the 
     BioShield Program under the Project BioShield Act of 2004 
     would be seriously impaired without such a limitation.
       ``(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 
     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 
     government-wide regulations implementing such section 
     303(c)(1) (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), as such regulations apply to 
     procurements for which an agency has authority to use 
     procedures other than competitive procedures when the 
     property or services needed by the agency are available from 
     only one responsible source or only from a limited number of 
     responsible sources and no other type of property or services 
     will satisfy the needs of the agency.
       ``(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 subsection (f), 
     section 1491 of title 28, United States Code, and section 
     3556 of title 31 of such Code, 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 section 1491 
     of title 28, United States Code, and section 3553 of title 31 
     of such Code, 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 any 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. Nothing in the preceding sentence 
     may be construed to impose any requirement with respect to 
     peer review not otherwise required under any other law or 
     regulation.
       ``(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, subject to a determination by 
     the Secretary, 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 entity involved (person, officer, employee, or governing 
     board member) for any act or omission within the scope of the 
     Federal Tort Claims Act.
       ``(C) Recourse in case of gross misconduct or contract 
     violation.--
       ``(i) In general.--Should payment be made by the United 
     States to any claimant bringing a claim under this paragraph, 
     either by way of administrative determination, settlement, or 
     court judgment, the United States shall have, notwithstanding 
     any provision of State law, the right to recover against any 
     entity identified in subparagraph (B) for that portion of the 
     damages so awarded or paid, as well as interest and any costs 
     of litigation, resulting from the failure of any such entity 
     to carry out any obligation or responsibility assumed by such 
     entity under a contract with the United States or from any 
     grossly negligent or reckless conduct or intentional or 
     willful misconduct on the part of such entity.
       ``(ii) Venue.--The United States may maintain an action 
     under this subparagraph against such entity in the district 
     court of the United States in which such entity resides or 
     has its principal place of business.
       ``(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 those 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) Limitations.--The authority provided for under 
     paragraph (1) shall be exercised in a manner that--
       ``(A) recruits and appoints individuals based solely on 
     their abilities, knowledge, and skills;
       ``(B) does not discriminate for or against any applicant 
     for employment on any basis described in section 2302(b)(1) 
     of title 5, United States Code;

[[Page 15566]]

       ``(C) does not allow an official to appoint an individual 
     who is a relative (as defined in section 3110(a)(3) of such 
     title) of such official;
       ``(D) does not discriminate for or against an individual 
     because of the exercise of any activity described in 
     paragraph (9) or (10) of section 2302(b) of such title; and
       ``(E) accords a preference, among equally qualified 
     persons, to persons who are preference eligibles (as defined 
     in section 2108(3) of such title).
       ``(3) 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), by inserting ``or the Director of 
     the National Institute of Allergy and Infectious Diseases'' 
     after ``Director of the Center'';
       (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 2004 and 
     2005.''.
       (c) 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 and 2005.''; 
     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 and 2005.''.
       (d) 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''.
       (e) 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, in coordination with the 
     Secretary of Homeland Security (referred to in this section 
     as the `Homeland Security Secretary'), 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;
       ``(F) deploy the stockpile as required by the Secretary of 
     Homeland Security to respond to an actual or potential 
     emergency;
       ``(G) deploy the stockpile at the discretion of the 
     Secretary to respond to an actual or potential public health 
     emergency or other situation in which deployment is necessary 
     to protect the public health or safety; and
       ``(H) 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 drug 
     (as that term is defined by section 201(g)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), 
     biological product (as that term is defined by section 351(i) 
     of this Act (42 U.S.C. 262(i))), or device (as that term is 
     defined by section 201(h) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(h))) that--
       ``(i)(I) -the Secretary determines to be a priority 
     (consistent with sections 302(2) and 304(a) of the Homeland 
     Security Act of 2002) to treat, identify, or prevent harm 
     from any biological, chemical, radiological, or nuclear agent 
     identified as a material threat under paragraph (2)(A)(ii), 
     or to treat, identify, or prevent harm from a condition that 
     may result in adverse health consequences or death and may be 
     caused by administering a drug, biological product, or device 
     against such an agent;
       ``(II) the Secretary determines 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; or
       ``(bb) is a 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 within eight years after the date of a 
     determination under paragraph (5); or
       ``(ii) is authorized for emergency use under section 564 of 
     the Federal Food, Drug, and Cosmetic Act.
       ``(2) Determination of material threats.--
       ``(A) Material threat.--The Homeland Security Secretary, in 
     consultation with the Secretary and 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 sufficient to 
     affect national security.

[[Page 15567]]

       ``(B) Public health impact; necessary countermeasures.--The 
     Secretary shall on an ongoing basis--
       ``(i) assess the potential public health consequences for 
     the United States population of exposure to agents identified 
     under subparagraph (A)(ii); and
       ``(ii) determine, on the basis of such assessment, the 
     agents identified under subparagraph (A)(ii) for which 
     countermeasures are necessary to protect the public health.
       ``(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).
       ``(D) Assuring access to threat information.--In making the 
     assessment and determination required under subparagraph (A), 
     the Homeland Security Secretary shall use all relevant 
     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, 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 
     eight 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 number of, nature of, and other 
     information concerning potential 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 agreement; costs.--
       ``(i) Interagency agreement.--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 payments 
     made by the Secretary to a vendor for such procurement.
       ``(ii) Other costs.--The actual costs to the Secretary 
     under this section, other than the costs described in clause 
     (i), shall be paid from the appropriation provided for under 
     subsection (f)(1).
       ``(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 delivery.--The contract shall 
     provide that no payment may be made until delivery has been 
     made of a portion, acceptable to 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 by the vendor 
     under the contract. 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) Discounted payment.--The contract may provide for a 
     discounted price per unit of a product that is not licensed, 
     cleared, or approved as described in paragraph 
     (1)(B)(i)(III)(aa) at the time of delivery, and may provide 
     for payment of an additional

[[Page 15568]]

     amount per unit if the product becomes so licensed, cleared, 
     or approved before the expiration date of the contract 
     (including an additional amount per unit of product delivered 
     before the effective date of such licensing, clearance, or 
     approval).
       ``(III) 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.
       ``(IV) 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.
       ``(V) Product approval.--The contract shall provide that 
     the vendor seek approval, clearance, or licensing of the 
     product from the Secretary; for a timetable for the 
     development of data and other information to support such 
     approval, clearance, or licensing; and that the Secretary may 
     waive part or all of this contract term on request of the 
     vendor or on the initiative of the Secretary.
       ``(VI) 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).
       ``(dd) Section 3131 of title 40, United States Code 
     (relating to bonds of contractors of public buildings or 
     works).
       ``(ee) Subsection (a) of section 304 of the Federal 
     Property and Administrative Services Act of 1949 (41 U.S.C. 
     254(a)) (relating to contingent fees to middlemen).
       ``(ff) Section 6002 of the Solid Waste Disposal Act (42 
     U.S.C. 6962).
       ``(gg) Section 1354 of title 31, United States Code 
     (relating to the limitation on the use of appropriated funds 
     for contracts with entities not meeting veterans employment 
     reporting requirements).

       ``(III) Internal controls to be established.--The Secretary 
     shall establish appropriate internal controls for 
     procurements made under this clause, including requirements 
     with respect to documentation of the justification for the 
     use of the authority provided under this paragraph with 
     respect to the procurement involved.
       ``(IV) Authority to limit competition.--In conducting a 
     procurement under this subparagraph, the Secretary may not 
     use the authority provided for under subclause (I) to conduct 
     a procurement on a basis other than full and open competition 
     unless the Secretary determines that the mission of the 
     BioShield Program under the Project BioShield Act of 2004 
     would be seriously impaired without such a limitation.

       ``(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.
       ``(III) Applicable government-wide regulations.--The 
     Secretary shall implement this clause in accordance with 
     government-wide regulations implementing such section 
     303(c)(1) (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), as such regulations apply to 
     procurements for which an agency has authority to use 
     procedures other than competitive procedures when the 
     property or services needed by the agency are available from 
     only one responsible source or only from a limited number of 
     responsible sources and no other type of property or services 
     will satisfy the needs of the agency.

       ``(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 2004; or
       ``(B) costs other than payments made by the Secretary to a 
     vendor for a procurement of a security countermeasure under 
     paragraph (7).
       ``(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 appropriate committees.
       ``(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

[[Page 15569]]

     $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 referred to in subsection (c)(10)(A).
       ``(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) Amendments 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--
       (1) in section 502(3) (6 U.S.C. 312(3))--
       (A) in subparagraph (B), by striking ``the Strategic 
     National Stockpile,''; and
       (B) in subparagraph (D), by inserting ``, including 
     requiring deployment of the Strategic National Stockpile,'' 
     after ``resources''; and
       (2) 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 `Biodefense Countermeasures' appropriations account 
     or any other appropriation made under subsection (a).
       ``(c) Availability.--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 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 
     180 days after the date of enactment of the Project BioShield 
     Act of 2004, 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 2004 through 
     2006.''.
       (c) Stockpile Functions Transferred.--
       (1) In general.--Except as provided in paragraph (2), there 
     shall be transferred to the Secretary of Health and Human 
     Services the functions, personnel, assets, unexpended 
     balances, and liabilities of the Strategic National 
     Stockpile, including the functions of the Secretary of 
     Homeland Security relating thereto.
       (2) Exceptions.--
       (A) Functions.--The transfer of functions pursuant to 
     paragraph (1) shall not include such functions as are 
     explicitly assigned to the Secretary of Homeland Security by 
     this Act (including the amendments made by this Act).
       (B) Assets and unexpended balances.--The transfer of assets 
     and unexpended balances pursuant to paragraph (1) shall not 
     include the funds appropriated under the heading ``biodefense 
     countermeasures'' in the Department of Homeland Security 
     Appropriations Act, 2004 (Public law 108-90).
       (3) Conforming amendment.--Section 503 of the Homeland 
     Security Act of 2002 (6 U.S.C. 313) is amended by striking 
     paragraph (6).

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

       (a) In General.--Section 564 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb-3) is amended to read as 
     follows:

     ``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 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 domestic emergency, or a significant 
     potential for a domestic 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 specified 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 
     that affects, or has a significant potential to affect, 
     national security, and that involves 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.
       ``(C) Disposition of product.--If an authorization under 
     this section with respect to an unapproved product ceases to 
     be effective as a result of a termination under subparagraph 
     (A) of this paragraph, the Secretary shall consult with the 
     manufacturer of such product with respect to the appropriate 
     disposition of the product.
       ``(3) Advance notice of termination.--The Secretary shall 
     provide advance notice that a declaration under this 
     subsection 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 the product, including the return 
     of such product (except such quantities of product as are 
     necessary to provide for continued use consistent with 
     subsection (f)(2)) to the manufacturer (in the case of a 
     manufacturer that chooses to have such product returned); and
       ``(B) in the case of an unapproved use of an approved 
     product, a sufficient period for the disposition of any 
     labeling, or any information under subsection (e)(2)(B)(ii), 
     as the case may be, that was provided with respect to the 
     emergency use involved.
       ``(4) Publication.--The Secretary shall promptly publish in 
     the Federal Register

[[Page 15570]]

     each declaration, determination, advance notice of 
     termination, 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 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, approved 
     or cleared under this Act, or licensed under section 351 of 
     the Public Health Service Act, for 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 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 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.--An authorization of a 
     product under this section shall state--
       ``(1) each disease or condition that the product may be 
     used to diagnose, prevent, or treat within the scope of the 
     authorization;
       ``(2) the Secretary's conclusions, made under subsection 
     (c)(2)(B), that the known and potential benefits of the 
     product, when used to diagnose, prevent, or treat such 
     disease or condition, outweigh the known and potential risks 
     of the product; and
       ``(3) the Secretary's conclusions, made under subsection 
     (c), concerning the safety and potential effectiveness of the 
     product in diagnosing, preventing, or treating such diseases 
     or conditions, including an assessment of the available 
     scientific evidence.
       ``(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 
     practicable given the circumstances of the emergency, shall, 
     for a person who carries out any activity 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 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 
     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 
     may, for a person who carries out any activity 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) Appropriate conditions with respect to the 
     collection and analysis of information, during the period 
     when the authorization is in effect, concerning the safety 
     and effectiveness of the product with respect to the 
     emergency use of such product.
       ``(iv) 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.
       ``(2) Unapproved use.--With respect to the emergency use of 
     a product that is an unapproved use of an approved product:
       ``(A) For a manufacturer of the product who carries out any 
     activity for which the authorization is issued, the Secretary 
     shall, to the extent practicable given the circumstances of 
     the emergency, establish conditions described in clauses (i) 
     and (ii) of paragraph (1)(A), and may establish conditions 
     described in clauses (iii) and (iv) of such paragraph.
       ``(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.
       ``(ii) In the circumstances described in clause (i), for a 
     person who does not manufacture the product and who chooses 
     to act under this clause, an authorization under this section 
     regarding the emergency use shall, to the extent practicable 
     given the circumstances of the emergency, authorize such 
     person to provide appropriate information with respect to 
     such product in addition to the labeling provided by the 
     manufacturer, subject to compliance with clause (i). While 
     the authorization under this section is effective, such 
     additional information shall not be considered labeling for 
     purposes of section 502.
       ``(C) The Secretary may establish with respect to the 
     distribution and administration of the product for the 
     unapproved use conditions no more restrictive than those 
     established by the Secretary with respect to the distribution 
     and administration of the product for the approved use.
       ``(3) Good manufacturing practice.--With respect to the 
     emergency use of a product for which an authorization under 
     this section is issued (whether an unapproved product or an 
     unapproved use of an approved product), the Secretary may 
     waive or limit, to the extent appropriate given the 
     circumstances of the emergency, requirements 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 under section 501.
       ``(4) Advertising.--The Secretary may establish conditions 
     on advertisements and other promotional descriptive printed 
     matter that relate to the emergency use of a product for 
     which an authorization under this section is issued (whether 
     an unapproved product or an unapproved use of an approved 
     product), including, as appropriate--
       ``(A) with respect to drugs and biological products, 
     requirements applicable to prescription drugs pursuant to 
     section 502(n); or
       ``(B) with respect to devices, requirements applicable to 
     restricted devices pursuant to section 502(r).
       ``(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.--
     Notwithstanding the termination of the declaration under 
     subsection (b) or a revocation under subsection (g), an 
     authorization shall continue to be effective to provide for 
     continued use of an unapproved product with respect to a 
     patient to whom it was administered during the period 
     described by paragraph (1), to the extent found necessary by 
     such patient's attending physician.
       ``(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 the criteria under 
     subsection (c) for issuance of such authorization are no 
     longer met or other circumstances make such revocation 
     appropriate to protect the public health or safety.
       ``(h) Publication; Confidential Information.--
       ``(1) Publication.--The Secretary shall promptly publish in 
     the Federal Register a notice of each authorization, and each 
     termination or revocation of an authorization under this 
     section, and an explanation of the reasons therefor (which 
     may include a summary of data or information that has been 
     submitted to the Secretary in an application under section 
     505(i) or section 520(g), even if such summary may indirectly 
     reveal the existence of such application).

[[Page 15571]]

       ``(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.
       ``(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.--The following applies with 
     respect to this section:
       ``(1) Nothing in this section impairs 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) Nothing in this section impairs the authority of the 
     Secretary of Defense with respect to the Department of 
     Defense, including the armed forces, under other provisions 
     of Federal law.
       ``(3) Nothing in this section (including any exercise of 
     authority by a manufacturer under subsection (e)(2)) impairs 
     the authority of the United States to use or manage 
     quantities of a product that are owned or controlled by the 
     United States (including quantities in the stockpile 
     maintained under section 319F-2 of the Public Health Service 
     Act).
       ``(k) 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 shall not 
     be considered to constitute a clinical investigation for 
     purposes of section 505(i), section 520(g), or any other 
     provision of this Act or section 351 of the Public Health 
     Service Act.
       ``(l) Option to Carry Out Authorized Activities.--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 report to 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 any activity under the authorization. This section 
     only has legal effect on a person who carries out an activity 
     for which an authorization under this section is issued. This 
     section does not modify or affect activities carried out 
     pursuant to other provisions of this Act or section 351 of 
     the Public Health Service Act. Nothing in this subsection may 
     be construed as restricting the Secretary from imposing 
     conditions on persons who carry out any activity pursuant to 
     an authorization under this section.''.
       (b) Repeal of Termination Provision.--Subsection (d) of 
     section 1603 of the National Defense Authorization Act for 
     Fiscal Year 2004 (10 U.S.C. 1107a note) is repealed.

     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 number of, nature of, and other information 
     concerning the persons and entities that received a grant, 
     cooperative agreement, or contract pursuant to the use of 
     such authorities, and the persons and entities that were 
     considered and rejected for such a grant, cooperative 
     agreement, or contract, except that the report need not 
     disclose the identity of any such person or entity; 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.
       (3) Report on additional barriers to procurement of 
     security countermeasures.--Not later than one year after the 
     date of the enactment of this Act, the Secretary, in 
     consultation with the Secretary of Homeland Security, shall 
     report to the designated congressional committees any 
     potential barriers to the procurement of security 
     countermeasures that have not been addressed by this Act.
       (b) General Accounting Office Review.--
       (1) In general.--Four years after the date of the enactment 
     of this Act, the Comptroller General of the United States 
     shall initiate a study--
       (A)(i) 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
       (ii) to make recommendations to improve the utilization or 
     effectiveness of such authorities in the future;
       (B)(i) to review and assess the adequacy of the internal 
     controls instituted by such Secretary with respect to such 
     authorities, where required by this Act; and
       (ii) to make recommendations to improve the effectiveness 
     of such controls;
       (C)(i) 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
       (ii) to make recommendations to improve the utilization or 
     effectiveness of such authority and to enhance protection of 
     the public health;
       (D) to identify any purchases or procurements that would 
     not have been made or would have been significantly delayed 
     except for the authorities described in subparagraph (A)(i); 
     and
       (E)(i) to determine whether and to what extent activities 
     undertaken pursuant to the biomedical countermeasure research 
     and development authorities established in this Act have 
     enhanced the development of biomedical countermeasures 
     affecting national security; and
       (ii) to make recommendations to improve the ability of the 
     Secretary to carry out these activities in the future.
       (2) Additional provisions regarding determination on 
     development of biomedical countermeasures affecting national 
     security.--In the report under paragraph (1), the 
     determination under subparagraph (E) of such paragraph shall 
     include--
       (A) the Comptroller General's assessment of the current 
     availability of countermeasures to address threats identified 
     by the Secretary of Homeland Security;
       (B) the Comptroller General'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
       (C)(i) the Comptroller General'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

[[Page 15572]]

     research priorities, the development of countermeasures, and 
     investments in technology.
       (3) Report.--A report providing the results of the study 
     under paragraph (1) shall be submitted to the designated 
     congressional committees not later than five years after the 
     date of the enactment of this Act.
       (c) Report Regarding 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.
       (d) 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 appropriate committees.

     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 Black 
     or African Americans, American Indians, Appalachian 
     Americans, Alaska Natives, Asians, Native Hawaiians, other 
     Pacific Islanders, Hispanics or Latinos, 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.

     SEC. 9. AUTHORITY OF THE SECRETARY OF HEALTH AND HUMAN 
                   SERVICES DURING NATIONAL EMERGENCIES.

       Section 1135(b) of the Social Security Act (42 U.S.C. 
     1320b-5(b)) is amended--
       (1) by striking paragraph (3) and inserting the following:
       ``(3) actions under section 1867 (relating to examination 
     and treatment for emergency medical conditions and women in 
     labor) for--
       ``(A) a transfer of an individual who has not been 
     stabilized in violation of subsection (c) of such section if 
     the transfer is necessitated by the circumstances of the 
     declared emergency in the emergency area during the emergency 
     period; or
       ``(B) the direction or relocation of an individual to 
     receive medical screening in an alternate location pursuant 
     to an appropriate State emergency preparedness plan;'';
       (2) in paragraph (5), by striking ``and'' at the end;
       (3) in paragraph (6), by striking the period and inserting 
     ``; and'';
       (4) by inserting after paragraph (6), the following:
       ``(7) sanctions and penalties that arise from noncompliance 
     with the following requirements (as promulgated under the 
     authority of section 264(c) of the Health Insurance 
     Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
     note)--
       ``(A) section 164.510 of title 45, Code of Federal 
     Regulations, relating to--
       ``(i) requirements to obtain a patient's agreement to speak 
     with family members or friends; and
       ``(ii) the requirement to honor a request to opt out of the 
     facility directory;
       ``(B) section 164.520 of such title, relating to the 
     requirement to distribute a notice; or
       ``(C) section 164.522 of such title, relating to--
       ``(i) the patient's right to request privacy restrictions; 
     and
       ``(ii) the patient's right to request confidential 
     communications.''; and
       (5) by adding at the end the following: ``A waiver or 
     modification provided for under paragraph (3) or (7) shall 
     only be in effect if such actions are taken in a manner that 
     does not discriminate among individuals on the basis of their 
     source of payment or of their ability to pay, and shall be 
     limited to a 72-hour period beginning upon implementation of 
     a hospital disaster protocol. A waiver or modification under 
     such paragraph (7) shall be withdrawn after such period and 
     the provider shall comply with the requirements under such 
     paragraph for any patient still under the care of the 
     provider.''.

  The SPEAKER pro tempore. Pursuant to the order of the House of 
Tuesday, July 13, 2004, the gentleman from Texas (Mr. Barton) and the 
gentleman from Ohio (Mr. Brown) each will control 30 minutes. The 
gentleman from Virginia (Mr. Tom Davis), the gentleman from California 
(Mr. Waxman), the gentlewoman from Washington (Ms. Dunn), and the 
gentleman from Texas (Mr. Turner) each will control 7\1/2\ minutes.
  The Chair recognizes the gentleman from Texas (Mr. Barton).


                             General Leave

  Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days within which to revise and extend 
their remarks and include extraneous material on S. 15.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, the Senate recently joined the House in passing one of 
President Bush's top legislative initiatives for this Congress, Project 
Bioshield. The House passed a similar bill in July 2003 by a strong 
bipartisan vote of 421 to 2. I want to commend our colleagues in the 
Senate for working with us after the House passed its legislation to 
provide a bill that will be acceptable to both bodies.
  The bill largely reflects H.R. 2122, the bill that passed the House 
last year. Revisions in the Senate were made in close consultation with 
the House committees of jurisdiction. This is a bicameral and 
bipartisan product.
  On the House side, I want to thank the gentleman from Louisiana (Mr. 
Tauzin), my predecessor as chairman of the committee, who is on the 
floor this evening, for his strong leadership; and I would also like to 
thank the gentleman from California (Mr. Cox), the gentleman from 
Virginia (Mr. Tom Davis), the gentleman from Michigan (Mr. Dingell), 
the gentleman from Texas (Mr. Turner), and the gentleman from 
California (Mr. Waxman) for their cooperation and hard work on this 
bill.
  The bipartisan spirit reflected in this legislation is similar to the 
effort of the last Congress on the Public Health Security and 
Bioterrorism Preparedness and Response Act and also on the Homeland 
Security Act. We can be proud of this product, and America can be 
confident in our commitment to make the right investments and smart 
policy choices to meet the challenges and to protect our Nation's 
public health.
  Project Bioshield will spur the research and development of new 
vaccines, new drugs and other countermeasures to deal with those 
biological, chemical, nuclear, or radiological agents that pose a 
material threat to our national security. This list includes anthrax, 
the plague, ebola and other similar viruses, many of which lack any 
effective treatment or antidote today.
  The bill provides increased flexibility in a range of areas, from 
government

[[Page 15573]]

contracting rules and peer review to personnel matters, in order to 
speed up government-sponsored research and development into these 
deadly agents.
  It would also authorize a special reserve fund of money, authorized 
in advance, for the government's purchase of those countermeasures that 
ultimately are developed in response to the President's call. This 
latter feature is the most important because, without this clear 
commitment of funding in future years, private sector companies that 
are capable of such development will not undertake the heavy investment 
and risk associated with developing products that deal with agents that 
do not affect significant populations today and hopefully never will. 
Congress has already provided the advance appropriation of $5.6 billion 
over the next 10 years for this purpose, consistent with our 
authorization in the House budget resolution.
  The bill before us also provides new authority to the Secretary of 
Health and Human Services to authorize, in times of emergency, the use 
of unapproved products whose benefits in treating or preventing 
infection outweigh the risk of using those products. Under current law, 
the only way an individual can receive an unapproved product is 
pursuant to a clinical investigation. In a time of national emergency, 
however, it may be necessary to give such investigational drugs on a 
large-scale basis to millions of Americans. The bill before us today 
says that if there is such an emergency, if no adequate alternative 
therapy is available, then and only then the Secretary can authorize 
the use of such a drug, device, or vaccine in a flexible manner.
  I applaud the leadership of President Bush and the truly bipartisan 
work of both bodies across multiple committees of jurisdiction to 
protect our country and to promote public health security from the many 
new dangers that we face today.
  I would urge my colleagues to support the bill and look forward to 
President Bush signing into law another of his major homeland security 
initiatives.
  At this point in the Record, I will insert an exchange of letters 
between the gentleman from California (Mr. Thomas) and myself on this 
subject.
                                         House of Representatives,


                                   Committee on Ways and Means

                                    Washington, DC, July 13, 2004.
     The Hon. Joe Barton,
     Chairman, Committee on Energy and Commerce, 2125 Rayburn 
         House Office Building, Washington, DC.
       Dear Chairman Barton: I am writing concerning S. 15, the 
     ``Project Bioshield Act of 2004,'' which is scheduled for 
     floor consideration on Wednesday, July 14, 2004.
       As you know, the Committee on Ways and Means has 
     jurisdiction over matters concerning health issues. 
     Specifically, Section 9 of the bill provides a waiver for 
     application of Section 1867 of the Social Security Act, known 
     as the Examination and Treatment for Emergency Medical 
     Conditions and Women in Labor Act. Section 9 allows hospitals 
     and other providers to transfer unstable patients during a 
     declared emergency period or pursuant to a state emergency 
     preparedness plan by waiving hospital requirements under 
     Medicare, and thus falls within the jurisdiction of the 
     Committee on Ways and Means.
       However, in order to expedite this legislation for floor 
     consideration, the Committee will forego action on this bill. 
     This is being done with the understanding that it does not in 
     any way prejudice the Committee with respect to exercising 
     its jurisdictional prerogatives on this or similar 
     legislation.
       I would appreciate your response to this letter, confirming 
     this understanding with respect to S. 15 and would ask that a 
     copy of our exchange of letters on this matter be included in 
     the Congressional Record during floor consideration.
           Best regards,
                                                      Bill Thomas,
     Chairman.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                    Washington, DC, July 14, 2004.
     Hon. Bill Thomas,
     Chairman, Committee on Ways and Means, Longworth House Office 
         Building, Washington, DC.
       Dear Chairman Thomas: Thank you for your letter regarding 
     S. 15, the `` Project BioShield Act of 2004.'' As you noted, 
     the bill contains provisions that fall within the Rule X 
     jurisdiction of the Committee on Ways and Means.
       I appreciate your willingness not to seek a referral on S. 
     15. I agree that your decision to forego action on the bill 
     will not prejudice the Committee on Ways and Means with 
     respect to its jurisdictional prerogatives on this or similar 
     legislation.
       I will include a copy of your letter and this response in 
     the Congressional Record during consideration of S. 15 on the 
     House floor.
           Sincerely,
                                                       Joe Barton,
                                                         Chairman.

  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself as much time as I may 
consume.
  The United States, and the global community, can only benefit from 
the development of bioterrorism countermeasures.
  By rendering biological attacks less lethal and, therefore, less 
attractive to would-be terrorists, new countermeasures serve a dual 
purpose. They are both an antidote and a deterrent to future attacks.
  For the sake of national and international security, it makes sense 
to invest in both basic and advanced research aimed at producing new 
bioterrorism countermeasures. When an opportunity to produce one of 
these countermeasures presents itself, it makes sense to capitalize on 
that opportunity quickly.
  That is the logic behind this legislation. It establishes an 
expedited process for Federal support of countermeasure research and a 
procurement process to encourage private sector investment.
  But Project Bioshield is not a blank check. Congress has a 
responsibility to weigh competing priorities and set funding levels 
appropriately. In that context, Congress cannot rest easy once we have 
passed this bill.
  Bioterrorism funding is certainly important, the legislation before 
us today is certainly important, but our investment in bioterrorism 
must not come at the expense of research on cancer and research on 
Alzheimer's and muscular dystrophy and AIDS and other significant 
health threats.
  If investing in Bioshield means diverting from other promising 
medical research, TB, multiple sclerosis, all other kinds of medical 
research, we are not making progress. We are, in fact, making trade-
offs; trade-offs that set back the clock on cures for deadly and 
disabling diseases; trade-offs the public did not bargain for and 
should not abide.
  The last thing Congress or the President should do is assure the 
public that we are doing everything we can more than ever to find cures 
for major illnesses like cancer and Parkinson's when actually we are 
choking off funding for medical research.
  During his 2000 election campaign, President Bush said, ``As 
President, I will fund and lead a medical moonshot to reach far beyond 
what seems possible today.'' Apparently it was a short trip.
  According to a White House budget memo recently leaked to the press, 
if President Bush wins the election this fall, one of his first actions 
will be to propose a $587 million cut in funding for the National 
Institutes of Health.
  Medical researchers tell us that just to sustain the pace of medical 
progress that NIH has fostered, the agency's budget must increase 10 
percent annually, something I hope everyone here would agree with, even 
though the President does not. Compared to annual, double-digit 
increases in the NIH budget, a cut in funding is a major step backward 
that would undermine promising medical research.
  Finding ways to prevent, to treat, and to cure disease is an enduring 
national priority. Interest in that should not wax and wane. That is 
why we do not double NIH funding, which we did bipartisanly between 
1999 under President Clinton, into 2003 still supported by President 
Bush, but then reduced that increase and then proposed a cut in 
funding. Our investment must remain constant.
  We have a responsibility to prepare the country for a possible 
bioterrorist attack, but we also have a responsibility to maintain 
strong support for other medical research priorities.
  I urge my colleagues to support this legislation. In creating Project 
Bioshield, it gives America a promising weapon in the battle against 
terrorism.
  But bioterrorism, as I have said, is just one enemy in a much broader 
war

[[Page 15574]]

against disease and disability. If we fund Project Bioshield, as we 
should, at the expense of life-saving and life-improving NIH research, 
we risk winning the battle and losing the war.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I yield such time as he may consume 
to the gentleman from Louisiana (Mr. Tauzin), the distinguished former 
chairman of the Committee on Energy and Commerce, who in a very true 
sense is a principal author of this piece of legislation and who has 
toiled tirelessly for the last several years to have it passed.

                              {time}  1730

  Mr. TAUZIN. Mr. Speaker, I thank the gentleman for yielding me this 
time; and, on a very bipartisan note, let me first thank the Members of 
this House and of the Senate, and particularly my friend from 
Massachusetts, Mr. Kennedy, for the great success we had in passing the 
Public Health Security Act and the Bioterrorism Preparedness and 
Response Act.
  As my colleagues will recall, right after 9-11 it became clear to us 
as a Nation that we were under serious threat of attacks from agents 
like anthrax or perhaps even such horrible agents as botulism toxin or 
ebola or other similar viruses and that we were so unprepared in this 
country for that kind of attack that we got together, in a bipartisan 
fashion, and immediately passed an act to bolster the competence and 
the ability of the Center for Disease Control and of agents across the 
country to better respond to an attack of that nature.
  Since the passage of those two very important actions that have 
better armed our country for this danger that we face perhaps even more 
increasingly as years go by, it has come to our attention that there 
were some holes even in that great act. The most important hole which 
this act seeks to fill is the concern we have that when it comes to 
some of these agents, whether they be a botulism toxin agent, ebola, or 
whether it is a radioactive type of attack we have to deal with in this 
country, that we have not done enough research and development into the 
antidotes, the vaccines, the treatments that victims of these attacks 
might find are critically necessary to save lives and prevent injury.
  I do not have to tell my colleagues that this House and the Senate 
recently received another briefing on national security threats. The 
concern levels are up about an attack that might occur in this country 
from al Qaeda or other enemies of this country. As we fight them 
overseas, they are thinking about planning an attack on us here at home 
again. We know that. We know the attack may come in a place we do not 
know, in a place we are unprepared for, and it might involve 
radiological materials or it might involve some horrible virus or some 
agent the likes of which we are unprepared to deal with.
  This bill seeks to make sure that the private sector does the work 
along with government to find the antidotes, the treatment for these 
kinds of agents that might be used in such an attack which might not 
otherwise be developed in the private sector.
  What is the incentive today to develop a vaccine for ebola or for the 
plague when there is no real market for such a vaccine in this country? 
This bill and the appropriations we have already provided in the 
advance funds, some $5.6 billion, is designed to make sure that that 
research and development occurs and that those vaccines and those 
treatments are indeed available to our country in case the worst 
happens and we are subject to that kind of an attack by al Qaeda or 
other enemies of this country within our borders as we saw on 9-11.
  Secondly, the bill tries to do something else, and that is to say we 
are going to change our law a little bit when it comes to the 
government's approval of treatment and/or it might be a vaccine or some 
treatment that has not yet been approved by the Food and Drug 
Administration but yet has a greater ability to cure and help people 
than the risk involved with allowing it to be used. In other words, we 
are streamlining the law to make sure, if we do come under attack, if 
there is some vaccine, some treatment under study that has a lot of 
promise but has not yet been approved, that we are not forbidden to use 
it to help people who might be hurt or in need of that kind of 
treatment.
  In short, this Bioshield Act, an incredibly important new step in 
protecting our country at a time when we are increasingly learning of 
the hatred and evil that exists out there that wants to inflict more 
damage on our country, this new act, passed again in, I hope, a very 
strong bipartisan way, reaching the President's desk for his signature 
very soon, I hope, will add this new element of protection for our 
country that Senator Kennedy and I tried to provide in the first 
bioterrorism act for our Nation following 9-11.
  This is an important step in protecting our country at a time when we 
are under, as you know, this increasing warning that these evil 
individuals are thinking about planning and trying to figure out how 
they might hurt us again. It is a critical two-step process in making 
sure that we have the protective vaccines and treatments in place when 
the worst might happen to our people. So I urge its adoption.
  I want to congratulate all of those who have worked on completing the 
conference on this bill with the Senate. I want to thank the other body 
for its cooperation. The sooner this reaches the President's desk, the 
sooner all of us can feel a little better this country is becoming 
safer as fast as we can from the threat of these kind of agents, and I 
urge its final approval by this House.
  The SPEAKER pro tempore (Mr. Foley). The gentlewoman from New York 
(Mrs. Maloney) is recognized on behalf of the Committee on Government 
Reform.
  Mrs. MALONEY. Mr. Speaker, I do claim the time on behalf of the 
Committee on Government Reform, and I yield myself such time as I may 
consume.
  Mr. Speaker, we have before us today S. 15, the Project Bioshield 
Act. This bill is substantially the same as H.R. 2122, which passed 
this House on July 16 of last year by a vote of 421 to 2. This bill is, 
in essence, the conference report on the bill and includes some minor 
improvements made by the Senate. I urge Members to support this measure 
as well.
  Given the serious threat of bioterrorism, the development of 
effective countermeasures to biological agents is vital to our national 
security. The goal of Project Bioshield is to encourage the development 
of these projects. I fully support the intent of this legislation. I 
also agree with its premise, that when the market cannot foster the 
development of critical products by itself, the government must rise to 
the challenge.
  The bill before us today includes several significant improvements 
from earlier proposals. For example, it includes important protections 
against waste and abuse that are standard for government contracts, 
such as preserving the government's right to review contractors' books 
and records.
  The bill also permits the use of certain streamlined procurement 
procedures, but only if the Secretary of Health and Human Services 
determines that there is a pressing need to do so.
  The Senate bill appropriately strengthens some of these provisions 
and also allows for recovery by the government in the event of grossly 
negligent or reckless conduct on the part of a contractor.
  In emergency situations, we should not impede the development of 
necessary products. However, any exceptions from standard procurement 
procedures should be made only when necessary and should be subject to 
review. This proposal preserves that important standard.
  The provisions of Bioshield authorizing the emergency distribution of 
unapproved drugs and devices, whose risks and benefits are not fully 
tested, impose an unprecedented responsibility on the government. FDA 
must be vigilant in protecting the public against unnecessary risks 
from these products.

[[Page 15575]]

In part because of these concerns, the bill requires that health care 
providers and patients be informed that the products have not been 
approved and be informed of their risks.
  The bill also requires that manufacturers monitor and report adverse 
reactions to the products and keep other appropriate records about the 
use of the products. These conditions are essential for the safe use of 
unapproved products, and they should be imposed in all cases except in 
truly extraordinary circumstances.
  In addition, the HHS secretary is authorized to limit the 
distribution of the products, to limit who may administer the products, 
to waive good manufacturing practice requirements only when absolutely 
necessary, and to require recordkeeping by others in the chain of 
distribution. We expect the Secretary to consider the needs for these 
additional conditions in each case and to impose them to the full 
extent necessary to protect the public from the risk of these products.
  The bill before us today is an improvement over the original proposal 
and represents a bipartisan consensus of the House and the Senate and 
the White House. It deserves our support.
  Mr. Speaker, I ask unanimous consent to yield the balance of my time 
to the gentleman from Texas (Mr. Turner) as the ranking minority member 
of the Select Committee on Homeland Security and that he be allowed to 
control that time.
  The SPEAKER pro tempore. Without objection, the Chair will recognize 
the gentleman from Texas (Mr. Turner) for the time remaining to the 
representative from the Committee on Government Reform.
  There was no objection.
  Mr. BROWN of Ohio. Mr. Speaker, I also ask unanimous consent to yield 
the remainder of my time to the ranking member of the Select Committee 
on Homeland Security, the gentleman from Texas (Mr. Turner), and that 
he be allowed to control that time.
  The SPEAKER pro tempore. Without objection, the Chair will recognize 
the gentleman from Texas (Mr. Turner) for the balance of the time 
allocated to the minority on the Committee on Energy and Commerce.
  There was no objection.
  Mr. BARTON of Texas. Mr. Speaker, could I inquire as to how much time 
remains that I am controlling?
  The SPEAKER pro tempore. The gentleman from Texas (Mr. Barton) has 20 
minutes, and the gentleman from Texas (Mr. Turner), for the minority, 
has 37 minutes.
  Mr. BARTON of Texas. Mr. Speaker, I yield 2 minutes to the 
distinguished gentleman from Michigan (Mr. Rogers), a member of the 
committee.
  Mr. ROGERS of Michigan. Mr. Speaker, I thank the gentleman for 
yielding me this time; and I want to also thank Members on both sides 
of the aisle on this very, very important issue.
  This legislation will greatly strengthen our Nation's capability to 
protect our military, first responders, and U.S. citizens from the real 
threat of biological, chemical, radiological, and nuclear weapons of 
mass destruction.
  I am very pleased that this expands the definition of eligible 
countermeasures and would permit funding and procurement for certain 
FDA-licensed vaccines as well as experimental products for inclusion in 
the Strategic National Stockpile. I cannot say how important that is.
  We find heroes and patriots both abroad and at home risking their 
lives in defense of freedom in this war on terror, but there are 
patriots and unsung heroes in my community who, under withering 
criticism, toiled to make their product better and get it into the 
hands of those who needed it most. Thanks to the employees of Bioport 
in Lansing, Michigan, since 1998, more than 1.1 million military and 
civilian personnel have been safely vaccinated with more than 4 million 
doses of the vaccine, including both pre- and post-exposure 
vaccinations of many of our own congressional colleagues and staff 
members after the October, 2001, anthrax attacks.
  These existing products, like BioThrax vaccine, will provide our 
Nation with the insurance policy to strengthen its immediate 
bioterrorism preparedness capability in conjunction with working on new 
experimental vaccines.
  Mr. Speaker, I would even go further and urge the Departments of 
Homeland Security and Health and Human Services to consider the 
immediate procurement of millions of additional doses of the FDA-
licensed anthrax vaccines, as well as additional doses of antibiotics 
for the Strategic National Stockpile. These doses are essential to 
improving our capability and responding to another potential anthrax 
attack.
  I want to again thank the President of the United States for making 
this a priority and sending a very clear and strong message that our 
Nation is serious about protecting the citizens and first responders 
from deadly terrorist threats with proven countermeasures.
  The SPEAKER pro tempore. The Chair will clarify the time allotments.
  The gentleman from Texas (Mr. Barton) has 18 minutes remaining, and 
the gentleman from Texas (Mr. Turner) has 37 minutes. We also have a 
15-minute allocation to the majority, 7\1/2\ minutes to the gentlewoman 
from Washington (Ms. Dunn) on the Select Committee on Homeland 
Security, and 7\1/2\ minutes to the gentleman from Virginia (Mr. Tom 
Davis), chairman of the Committee on Government Reform.
  Mr. TURNER of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  I think we all understand that to win the war on terror we have to be 
much more aggressive about going after the terrorists wherever they 
are. Breaking up international terrorist cells is project number one 
for the national defense of this country.
  We also know that we have to strengthen our homeland defenses and 
protect our vulnerabilities and protect our population from threats 
posed by challenges as the one addressed in this bill today, 
bioterrorism.
  Finally, I hope we will soon learn that in order to win the war on 
terror we have to start addressing the policies that we need to pursue 
to prevent the rise of future terrorists so that someday we can stand 
on this floor and announce, as we did at the end of the Cold War, that 
we have won, that we have prevailed.

                              {time}  1745

  To win this war on terror, we must address the threat that is 
addressed by Project Bioshield, the threat of mass destruction through 
the use of bioweapons. Perhaps the most devastating weapon is a 
bioweapon of mass destruction. The anthrax attacks of 2001 woke this 
Nation up to the very real threat of bioterrorism. We know that al 
Qaeda intends to engage in bioterrorism, and we know that Osama bin 
Laden has called for the use of weapons of mass destruction against the 
American public. In fact, he has called it a religious duty.
  In spite of this dire and clear warning, our biodefenses are no 
better than they were in September of 2001. No new medical treatments, 
vaccines, or lifesaving drugs have been approved for use. There is no 
antitoxin for ricin poisoning, no vaccine to protect against the 
plague, and no treatments of any kind against the deadly ebola virus.
  Mr. Speaker, we must regain the sense of urgency that we all felt in 
this Chamber in the aftermath of September 11, and I hope that the 
passage of this bill will mark a renewed sense of urgency regarding the 
bioterror threat. Because this bill marks but the beginning, not the 
end, of a long road we must travel, I hope that the passage of this 
legislation will renew our urgency about the threat of bioterrorism. I 
support the Bioshield legislation because it is a good first step to 
addressing the challenge.
  From the beginning of this process, I and many of my colleagues on 
the Democratic side have been concerned that this legislation is not 
enough to address the threats that we face. Whether Bioshield will be a 
success is yet to be determined. Bioshield is, in fact, an experiment. 
We do not know if the incentives in this bill will drive our 
pharmaceutical industry to develop

[[Page 15576]]

medicines for biodefense when we all know they can make much more money 
developing and putting on the market other types of products. Many 
experts in the field believe that the best we can hope for is that in 
10 years we may have a few new countermeasures that will plug some of 
the holes in our biodefenses.
  The longer it takes for companies to step forward to fill these gaps, 
the longer we will remain vulnerable. Our terrorist enemies will not 
wait while we experiment and our national security is at stake. We must 
protect our population. That is our responsibility. If the private 
sector does not step up to address and accept the challenge presented 
in this bill, then our government needs to have the authority to do the 
job itself directly.
  One example of a capability that we clearly need and that Project 
Bioshield does not address is the ability to respond rapidly to a 
previously unknown or engineered pathogen. Terrorists may soon be able 
to genetically manipulate biological agents so they are resistant to 
our current stockpile of countermeasures and perhaps to those we 
develop in the future. That is why I, along with 35 of my Democratic 
colleagues, introduced H.R. 4258, the Rapid Cures Act. This legislation 
recognizes the fact that the growing power of biotechnology can render 
a pathogen like anthrax or smallpox immune to the vaccines and drugs we 
may develop through Project Bioshield. We need to develop the mechanism 
to go from bug to drug, that is from the identification of a pathogen 
to the development of a countermeasure to combat it in a matter of a 
few months or even weeks.
  Today the average development period for a vaccine is 8 years. That 
is too long to address the threat that our terrorist enemies of the 
future may present us. Personally, I cannot think of another research 
goal that would bring more benefits to the security and the health of 
this Nation than shortening the period of drug and vaccine development. 
It is that kind of capability that we need legislation to bring about 
today.
  Finally, it is incumbent on this Congress to exercise vigorous 
oversight in the implementation of this law and to ensure that the 
investment in resources which could be as much as $6 billion over 10 
years produces the results that we intend. We have had biodefense 
failures before. The national smallpox vaccine program which was 
announced by the President with much fanfare at the end of 2002 has 
fallen far short of its goal of vaccinating 500,000 health care workers 
with, in fact, less than 10 percent of that number actually vaccinated 
today.
  Forty percent of our States report that they are unable to vaccinate 
their populations within 10 days, that critical period, 10 days of an 
outbreak of smallpox. As soon as next month, we are likely to hear of 
the award of the first-ever Bioshield contract for 75 million doses of 
new anthrax vaccine. We need to be asking now before the ink dries on 
this multimillion-dollar contract, what is the plan? How does this 
vaccine fit into our biodefenses? Given the failure of our smallpox 
vaccine program, do we really expect our citizens to be any more 
receptive to the anthrax vaccine than they were to the smallpox 
vaccine? And if the old anthrax vaccine, as some have told us, is now 
safe and effective for our troops, why in fact do we need a new one?
  And if as is the case and we already have a vaccine but we lack good 
treatments for an anthrax infection, perhaps we need to be investing in 
the treatment for those who may contract anthrax and need a drug to 
cure that dread condition. And if anthrax is not a contagious disease 
and we know it is not and if this vaccine will only work after three 
injections over 3 weeks, as I understand the proposed new anthrax 
vaccine requires, how will that protect us in the event of an actual 
anthrax attack?
  So before the Secretary of Homeland Security and the Secretary of 
Health and Human Services decide to spend a billion dollars on a new 
vaccine, we in this Congress have a responsibility to get the answers 
to those questions.
  For this Nation, Project Bioshield is an important first step, but 
much more work remains to be done, and we must take even stronger steps 
as soon as possible to protect us and to secure us in the days ahead.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the gentleman 
from Arizona (Mr. Shadegg), the distinguished whip of the Committee on 
Energy and Commerce.
  Mr. SHADEGG. Mr. Speaker, I thank the gentleman for yielding me this 
time. I rise in strong support of the Project Bioshield Act. Is the act 
perfect? Does it solve all problems in this area? No. But I do not 
think we will hear anyone take to the floor and say that this is not a 
bicameral, bipartisan proposal to address a serious threat to this 
Nation.
  I want to thank the chairman of the Committee on Energy and Commerce 
and the previous chairman, the gentleman from Louisiana (Mr. Tauzin), 
both of whom have worked very hard on this legislation, as well as the 
chairman of the Select Committee on Homeland Security in bringing this 
initiative forward and moving it as rapidly as possible through the 
United States Congress. I also want to thank President Bush for putting 
this initiative on our agenda.
  Thirty years ago, perhaps 20 years ago, we had never even heard of 
biotechnology or genomics; but today, along with our country's 
unparalleled leadership in semiconductors and computing power, we are 
making breathtaking breakthroughs in the field of bioscience. And as my 
colleague from Texas just outlined, there is much more that can be 
done. This legislation goes at a serious vulnerability for our Nation.
  As has been referred to in this debate, we are aware by the briefings 
we get and by the press we read that we face a threat from al Qaeda and 
others who would seek to use these agents against us, chemical, 
biological, radiological, and even nuclear, weapons. They would like to 
use dangerous agents like anthrax, botulinum toxin, the plague, ebola 
and other similar viruses, as have just been noted, even some we are 
not even aware of. And of course as was well explained by my colleague, 
the former chairman of the Committee on Energy and Commerce, the 
gentleman from Louisiana, in the absence of this legislation, it is 
very clear that there is no incentive for anyone, not the government, 
not the private sector, not anyone, to develop and do the research to 
develop the countermeasures we need for these serious threats to the 
American people.
  This is critically important first-step legislation. It not only will 
encourage the research but it also encourages the development of those 
countermeasures and the stockpiling of them so that they are readily 
available. The American people expect that of us and both committees in 
both bodies have worked hard on this kind of legislation.
  I want to point out that I chair the Subcommittee on Emergency 
Preparedness and Response of the Select Committee on Homeland Security 
as well as serving on the Committee on Energy and Commerce; and I 
chaired hearings on the House parallel to this legislation, H.R. 2122. 
In those hearings we discovered a fact that has not been mentioned in 
this debate, and that is that the mere development of these 
countermeasures for such a biological attack will deter the attack. 
Think of that point. The reality is if al Qaeda knows that we are 
unprepared for a chemical, a biological or a radiological attack, then 
they are incentivized to make that kind of attack. On the other hand if 
they know that we have invested the money and done the research and we 
have developed countermeasures so that a biological attack or an 
anthrax attack, an attack of ebola or of the plague is something we are 
prepared for, then they are discouraged to even make that kind of 
attack.
  The American people expect us to do everything humanly possible to 
prepare for the event of an attack; but even more importantly they want 
us to deter any attacks. They want us to protect the American people 
from an

[[Page 15577]]

attack. This legislation, Project Bioshield, by not only encouraging 
the research of these antitoxins but also encouraging their development 
and their stockpiling will indeed deter such attacks.
  I strongly urge my colleagues to support this legislation.
  Mr. TURNER of Texas. Mr. Speaker, I yield 5 minutes to the 
distinguished gentleman from New Jersey (Mr. Andrews), who has spent a 
great deal of time and energy working on this important issue.
  Mr. ANDREWS. Mr. Speaker, I thank my friend from Texas for his 
leadership and hard work on this bill. I congratulate him, the 
gentleman from Ohio (Mr. Brown), the gentleman from Michigan (Mr. 
Dingell), the gentlewoman from New York (Mrs. Maloney), the gentleman 
from Texas (Mr. Barton), the gentleman from Louisiana (Mr. Tauzin), the 
gentleman from California (Mr. Cox), and all those responsible for the 
passage of this very important bill.
  One of the most frustrating failures of local government is when 
there is a traffic fatality at an intersection and the residents of the 
community say, for years we have been warning that there was going to 
be a fatality at this intersection. How come you did not put a traffic 
light or a stop sign up before? Why did it take a fatality to get 
government to pay attention?
  This is a massive and serious equivalent at the national level of 
whether we should prevent the traffic accident by putting up the signal 
ahead of time. Although this bill is not perfect, it recognizes an 
issue that is not much talked about today but is very much looming on 
the horizon as a potential catastrophe for the country. As the 
gentleman from Texas said very eloquently just a few minutes ago, 
perhaps the most ominous and destructive terrorist attack that could 
occur on this country would be a terrorist attack using a biological 
weapon. Unlike chemical weapons, unlike radiological weapons, even 
unlike nuclear weapons, the threat of a bioweapon is not localized 
because very often a bioweapon uses as its carrier a human being. So 
the spread of a bioweapon attack will not be limited to a discrete 
local area. It will likely be spread throughout the country and 
throughout the world. This makes it even more urgent that antidotes 
that could cure those exposed to the attack or prevent people from 
being sickened or killed by the attack, that these antidotes be 
developed as rapidly as possible.
  I am particularly pleased that the committees involved worked with us 
to include in this bill language that will protect the interests of 
companies that begin the process of developing an antidote and then 
have their contract terminated for convenience because a better idea 
comes along from another vendor. It is a very important provision that 
will permit these investors in research to recover the funds that they 
put into the contract.
  Let me express three concerns about the bill, and I hope that we 
return once this is made law to improve these areas. One is what the 
gentleman from Texas talks about, particularly with respect to mutant 
or new strains of bioweapons that would not be handled by the antidotes 
developed under this bill. We need a much more rapid and focused effort 
to deal with those mutant or new strains.
  Second, I am very concerned that the liability provisions in this 
bill are not sufficiently protective of the companies that would step 
forward to address the need to create these Bioshield defenses. I am 
not at all convinced that the immunity is broad enough or dependable 
enough. Time will tell.

                              {time}  1800

  If the immunity is not broad or dependable enough, we are going to 
have to revisit that issue.
  Finally, I am concerned, to the extent that funding under this bill 
is discretionary and not mandatory, the financial rewards that are 
necessary to induce a company to step forward and participate in this 
process may not be certain enough. An investor is not going to take a 
risk unless there is a guaranteed return. I think this bill takes a 
step in the right direction, but I am concerned it does not go far 
enough.
  I wholeheartedly support this bill. I am honored to have been a part 
of writing and pursuing the bill. I hope that the products produced as 
a result of this bill are never used. That would be the real measure of 
success. But, God forbid, if the day comes when they need to be used, 
let us be prepared. Let us not look upon ourselves and say, why did we 
not take action in the peaceful days before the attack when we had a 
chance to do so?
  This legislation is long overdue. I enthusiastically support it. I 
would ask colleagues on both the Republican and Democratic side to vote 
``yes.''
  Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the 
distinguished gentlewoman from Florida (Ms. Ginny Brown-Waite), a 
former president pro tempore with the Florida Senate who chaired the 
Homeland Security Select Committee in the Florida Senate.
  Ms. GINNY BROWN-WAITE of Florida. Mr. Speaker, I rise today in 
support of this legislation and certainly to congratulate both the 
former and current chairmen of the Committee on Energy and Commerce for 
their perseverance in bringing this bill to fruition today.
  Since the attacks of 9-11, America has been under siege. We are 
fighting a war against terror and must not waver in our commitment to 
combating this evil. This war knows no set battleground, and the 
terrorists' arsenal of weapons is limitless. From using a cell phone as 
a bomb detonator to contemplating a crop-duster, as we found in 
Florida, as a vessel of pestilence, these thugs have proven both their 
resourcefulness and also their boldness and audacity.
  For this reason, America must be prepared and must do everything in 
its power to protect its citizens. This legislation does exactly that. 
Among other things, the bill gives the Secretary of HHS the authority 
to conduct research and development for new vaccines that will offer 
protection from the possible chemical and biological agents that these 
arrogant fanatics conspire to exploit. Congress will provide the 
advance appropriation of $5.6 billion over the next 10 years to 
purchase these vital countermeasures.
  S. 15 adds to America's security and offers us the piece of mind in 
knowing that if terror strikes America will be ready and we will be a 
whole lot safer. The tragedies of 9-11 taught us that we must do much 
more to protect our Nation and that the unrest around the world can 
have a disastrous impact on us here at home. Terrorism knows no 
boundaries, and neither should our efforts to prevent it.
  This is a well-thought-out bill, and I encourage my colleagues on 
both sides of the aisle to support this proposal this evening.
  Mr. TURNER of Texas. Mr. Speaker, I yield 6 minutes to the 
distinguished gentlewoman from Texas (Ms. Jackson-Lee), who has worked 
very hard in the area of trying to improve our bioterror defenses.
  Ms. JACKSON-LEE of Texas. Mr. Speaker, I thank my friend and 
colleague from Texas for yielding me this time. I listened to him as he 
was outlining some of the positives and, of course, some of the 
challenges that we still have before us. We cannot thank him enough for 
the studious and deliberate approach that he has taken to protecting 
the homeland.
  It is important to note as well, since there are two Texans on the 
floor, now three, that this is a bipartisan bill; and we thank the 
distinguished chairman and the number of other Members who have worked 
so hard on this legislation. So my remarks should not be taken out of 
context to the extent that I disregard the hard work and the very 
valuable aspects of this legislation.
  Frankly, I think, in order to make it more understandable, it is 
simply the government doing what it should do. It is the big umbrella. 
It is the responsibility of this government to secure the homeland. And 
when the private sector has not yet reached the point when it can move 
with all due and deliberate speed and even faster, it is imperative 
that we, the government, move in to protect the American people.
  But there lies, I believe, the core of my criticism or my critique, 
because I

[[Page 15578]]

am concerned that the American people do not believe that they are more 
safe today than they were 4 years ago or more safe today in light of 
the horrific tragedy of 9-11. I think we should be very frank about 
questions being asked that if there was a tragedy, whether it would be 
by some form of nuclear reaction or activity or whether it would be 
bioterrorism or whether it be acts of terrorists, the question is who 
is in charge? All of these elements that we are now discussing, in this 
instance, bioterrorism, all need to relate to an orderly focus on 
securing the homeland; and I believe it is extremely important that we 
find ourselves organizing this whole effort of the war against 
terrorism in a methodical way.
  We are very delighted that a number of us Democrats are putting 
forward a number of initiatives that deal step by step with securing 
the homeland in an orderly fashion. I believe the bioterrorism in the 
Project Bioshield Act of 2004 is a positive first step. It is important 
to note that even as recently as April we were faced with challenges 
dealing with the question of bioterrorism.
  I am reminded of a couple of days after 9-11 when I gathered a number 
of our first responders from all over the county in a meeting held by 
my congressional district. In the midst of that meeting, just 3 days 
after 9-11, a number of my firefighters had to immediately leave in an 
emergency as some white powder was discovered at a major hospital in my 
community. We have not had a series of these lately, but they are 
occurring on a rapid basis or regularly, even though we do not see them 
in the news.
  As recently as April 22 of this year in Tacoma, Washington, we had a 
bioterrorism scare. A white powder was found in two envelopes, and 94 
people had been evacuated from a mail distribution facility. Initial 
tests of the powder tested positive for biotoxins that cause bubonic 
plague or botulism. Four people at the facility had to be 
decontaminated.
  The same day, a suspicious powder was found in a Federal Express 
cargo area at Southwest Florida International Airport in Fort Myers, 
Florida. Six people were taken to a hospital for possible 
decontamination, including one who suffered burning eyes and nose.
  We are presently faced with the threat of a worldwide SARS outbreak. 
The inability of many foreign countries to adequately deal with that 
outbreak raises questions about our own preparedness.
  What about other infectious diseases like tuberculosis? There are 
many ailments that our medical professionals are struggling to control, 
and we must do better in the area of biological weapons.
  Might I say also that we are confronting and fighting the devastation 
of HIV/AIDS. We have found in this country that sometimes the infected 
person has used it in a criminal manner. Who is to say that it could 
not also be engaged in some act of bioterrorism?
  So I do support the Project Bioshield Act of 2004. But, frankly, I 
believe that one of the things that we should get out of these 
legislative initiatives is to find an orderly way of putting all of 
these ways of protecting the homeland in a way that we know who is in 
charge, why they are in charge, and how they can intermesh with 
protecting the homeland. I will raise that question over and over 
again.
  Might I also acknowledge that, as we put forward Project Bioshield 
that will take now some $5.6 billion, we should not forget, as our 
friends and colleagues on the Committee on Energy and Commerce have 
noted, the other preventable diseases or other contagious diseases and 
the other work of NIH so that we are assured that we are protecting the 
homeland in many ways. We must seek to balance the fear of the American 
people with the health needs of the American people. Again, we must 
have an orderly process of protection.
  Let me make note of an amendment that I offered and added to this, 
because I am always concerned that protecting the homeland reaches the 
neighborhoods, reaches the families, the schools. In fact, I am a 
supporter of finding safe places in communities such as public 
buildings like schools and fire stations. But, Mr. Speaker, we added to 
this legislation that the Secretary of Health and Human Services reach 
out to Historically Black Colleges and Universities, those serving 
Black or African Americans, American Indians, Appalachian Americans, 
Alaska Natives, Asians, Native Hawaiians, other Pacific Islanders, 
Hispanics or Latinos, in order to reach out to provide resources for 
those institutions to be utilized in available research and development 
grants, contracts, cooperative agreements, and procurements under this 
particular legislation. If we secure the homeland, we must secure the 
rural homeland, the urban homeland, and all segments of our population. 
We must secure the neighborhoods.
  So I support this legislation, but I also believe that we still have 
work undone to complete our task of assuring the American people that 
the homeland is securely secure.
  Mr. Speaker, I rise today in support of S. 15, the ``Project 
Bioshield Act of 2004.'' I supported the predecessor of this bill, H.R. 
2122 as it passed previously. This is important legislation because it 
takes America one-step closer to being prepared to deal with a 
biochemical terrorist attack. As we consider this legislation, Mr. 
Speaker, America is still not safe. We remain vulnerable. Our ports are 
not secure. Our critical infrastructure is not secure. our communities 
are not protected from biochemical agents. S. 15, will help to make 
America safer.
  The purpose of the Project BioShield Act of 2004 is to ``enhance the 
research, development, procurement, and use of biomedical 
countermeasures to respond to public health threats affecting national 
security, and for other purposes.'' The stated purpose of H.R. 2122 and 
now of S. 15 are noble given the danger posed by biochemical weapons.
  The threat of bioterrorism is substantial, and protecting America 
from biochemical agents and terrorist attacks must be one of our chief 
concerns as we continue our work of protecting our homelands. 
Biological weapons pose a particularly dangerous threat. Biological 
weapons are highly portable and difficult to detect.
  Bioterrorism attacks not only pose a danger to human lives, they also 
have the ability to cripple the operation of our society and severely 
harm our economy. We all recall the primary and secondary impact of the 
anthrax attacks in 2001. The attacks involved a series of letters 
mailed in prestamped envelopes to media outlets in Florida and New York 
and to the offices of Senators Thomas Daschle and Patrick J. Leahy (D-
Vt.). The anthrax attacks killed 5 Americans and left 13 others 
severely ill. The five people who died from inhalation anthrax included 
two postal workers at the Brentwood postal facility in Washington, a 
Florida photojournalist, a New York hospital worker, and a 94-year-old 
woman in Connecticut. Thousands more were exposed to the lethal 
bacteria. The letters passed through various post offices and postal 
distribution centers along the east coast leaving a trail of 
contamination. Buildings from the Brentwood mail facility, to the 
congressional office buildings, to NBC headquarters had to cease 
operations.
  The threat of bioterrorism did not end in September 2001. As recently 
as April 22 of this year in Tacoma, WA, we had a bioterrorism scare. A 
white powder was found in two envelopes, and 94 people had to be 
evacuated from a mail distribution facility. Initial tests of the 
powder tested positive for biotoxins that cause bubonic plague or 
botulism. Four people at the facility had to be decontaminated. The 
same day, a suspicious powder was found in a Federal Express cargo area 
at Southwest Florida International Airport, in Fort Myers, FL. Six 
people were taken to a hospital for possible decontamination, including 
one who suffered burning eyes and nose.
  We are presently faced with the threat of a worldwide SARS outbreak. 
The inability of many foreign countries to adequately deal with that 
outbreak raises questions about our own preparedness. What about other 
infectious disease like tuberculosis? There are many ailments that our 
medical professionals are struggling to control. We must do better in 
the area of biological weapons.
  The ease with which biological weapons can be manufactured is also a 
danger. The equipment and ingredients needed to manufacture many 
biological agents can be purchased over the Internet. Additionally, as 
our failure to apprehend those responsible for the 2001 anthrax attacks 
illustrates, biological terrorists can operate with more secrecy than 
traditional terrorists.

[[Page 15579]]

  Positive strides have been made in the various biochemical fields. We 
have improved our ability to secure our borders and prevent deadly 
materials from entering our country. However, it is unrealistic to 
expect no biological weapons to enter the United States. Last year 
alone 30 million tons of cocaine was smuggled into the United States. 
If we can't stop 30 million tons of cocaine from crossing our borders, 
how can we expect to stop a vile filled with anthrax, botulism, or 
small pox? A vile that could kill hundreds or possibly thousands.
  To adequately protect our homeland from bioterrorist attacks we must 
address these and many other concerns in the Project Bioshield bill. 
The provisions of Project Bioshield provide a good start to protecting 
Americans from a bioterrorist attack but work remains. Presently 
Project Bioshield's provisions grant the National Institute of Health 
new powers, through grants and contract awards, to speed effective 
research and development efforts on bioterrorism countermeasures. 
Project Bioshield also creates a long-term funding mechanism for the 
development of medical counter measures, and empowers the government to 
purchase safe and effective vaccines. Finally, Project Bioshield 
authorizes the Food and Drug Administration to use promising, yet 
uncertified, biological treatments in the case of emergencies.
  The research, development, and procurement provisions of the Project 
Bioshield bill are instrumental to the development of countermeasures 
for protecting our communities. The development of effective vaccines 
will mean the difference between life and death. There needs to be 
research and development participation from diverse institutions 
nationwide, so that the expertise of as many biological and chemical 
industry leaders can be utilized. During markup of the House version of 
this legislation, H.R. 2212 in the Select Committee on Homeland 
Security, I negotiated the inclusion of language to ensure that 
Historically Black Colleges and Universities, and institutions serving 
large populations of Native Americans, Hispanic Americans, and Asian 
Pacific Americans are meaningfully aware of research and development 
grants. Provisions such as this not only include diverse scientists in 
the research and development process, they facilitate dispersal of 
information to all communities. I am very pleased to see the retention 
of this provision as ``Section 6, Outreach'' in the bill before us 
today, and I wholeheartedly support its passage.
  Protecting our communities is the most challenging and most important 
responsibility of the Federal Department of Homeland Security, the 
House and Senate Select Committees on Homeland Security, and all 
members of this Congress. An ongoing failure of all agencies 
responsible for homeland security is our inability to equip our local 
communities with the funds and supplies needed to counter a terrorist 
attack now. During recent on-site reviews in Colorado and California, I 
spoke with first responders and individuals responsible for securing 
our ports. I also organized a briefing with testimony on the issue of 
homeland security in Houston, TX, in April. During each of these 
events, America's first responders echoed the same sentiment: They lack 
the funding and equipment to deal with a terrorist attack.
  The Project Bioshield bill is an opportunity to correct this 
continuing failure. It is insufficient to simply research and develop 
bioterrorism countermeasures. We must also get those countermeasures 
into the hands of the health professionals and other first responders 
responsible for administering vaccines to the victims of bioterror 
attacks. We must not delay. First responders need these supplies 
immediately.
  Mr. Speaker, I believe the provisions of S. 15, the Project Bioshield 
bill, are good first steps in protecting Americans from biological 
attacks. However, I feel that our country is still not safe and that 
many protections need to be established to fully protect our 
communities from biochemical attacks.

     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 Black 
     or African Americans, American Indians, Appalachian 
     Americans, Alaska Natives, Asians, Native Hawaiians, other 
     Pacific Islanders, Hispanics or Latinos, or other 
     underrepresented populations, are meaningfully aware of 
     available research and development grants, contracts, 
     cooperative agreements, and procurements conducted under 
     section 2 and 3 of this Act.

  Mr. BARTON of Texas. Mr. Speaker, I yield such time as he may consume 
to the gentleman from California (Mr. Cox), the distinguished chairman 
of the Select Committee on Homeland Security.
  Mr. COX. Mr. Speaker, I thank the chairman for yielding me this time.
  This has been an extraordinary collaborative effort. I want to 
congratulate the gentleman from Texas (Mr. Turner), my ranking member, 
who is on the floor and who has been on his feet for much of this 
debate. I want to thank the gentleman from Texas (Mr. Barton), the 
chairman of the Committee on Energy and Commerce; and the gentleman 
from Michigan (Mr. Dingell), ranking Democrat on that committee.
  In the same way that this was a collaboration between the Committee 
on Energy and Commerce and the Select Committee on Homeland Security in 
the Congress and the Committee on Government Reform in the House of 
Representatives, chaired by the gentleman from Virginia (Mr. Tom 
Davis), who will speak shortly; likewise, it was a collaborative effort 
in the Senate, including their Government Affairs Committee. It is a 
collaborative effort within the administration that we are setting up. 
The Department of Homeland Security and the Department of Health and 
Human Services will partner in this first responder effort of 
unprecedented magnitude.
  And I should say, Mr. Speaker, that this is the largest first 
responder program ever enacted in American history. The purpose, of 
course, is to protect Americans, to protect Americans in the event of 
an attack. That puts this squarely in the orbit of what we consider to 
be first response. But we need to make sure that our first responders 
have the tools that they need to arrest the spread of a biological 
attack and to protect Americans before it is too late. Every second, 
every moment really does count in the event of a terror attack, as the 
Senate Majority Leader Dr. Frist has so ably pointed out in his book on 
this topic.
  It was 18 months ago that President Bush called on Congress to enact 
a bill to speed the development of antidotes, vaccines, against 
biological warfare and against chemical weapons. We need to have drugs, 
vaccines, and antidotes to combat these weapons if they are used 
against us, as we now expect they might be.
  We know, for example, that Mr. Zarqawi, when he was in Afghanistan, 
was working on biological and chemical weapons development. He is now 
attacking Americans and leading the terrorist attacks on Americans in 
Iraq. We know that Osama bin Laden at various times expressed interest 
in and may have acquired precursors of these same kinds of weapons.
  We cannot take these kinds of threats lightly, and we are not. The 
bill that we are passing today reflects a model for future legislation 
because it is so collaborative. Homeland security requires us to knit 
together different responsibilities, different authorities, the 
responsibilities of different agencies of government, of law 
enforcement, different levels of government, Federal, State, and local, 
as never before.

                              {time}  1815

  That is going to happen under this bill as well.
  In the first instance, it will be the responsibility of the 
Department of Homeland Security to assess the global threat, to tell us 
what are the most likely and most threatening agents that could be used 
against us. Then we will hand off to the Department of Health and Human 
Services, which will help, after the priorities are set for this 
research jointly with DHS, implement this program. The research 
priorities will be implemented based on the information that has been 
provided by the Department of Homeland Security.
  By properly understanding the threats that confront us based on our 
country's best intelligence, we can allocate our resources and focus 
our efforts where they are most needed, on the biological, chemical and 
radiological agents for which the risks and potential consequences of 
attacks are greatest.
  Another genius of this program is that it is not a government-run 
program. The government is putting significant resources at the ready 
to provide an incentive and a market to purchase any successful 
products that are

[[Page 15580]]

developed as a result of our call to action, but we are unleashing the 
creative genius of the private sector.
  Under the President's new national biodefense directive issued on 
April 28, 2004, all bioterrorism projects and programs will fall under 
a coordinated and focused strategic plan. This will help maximize these 
resources that we are putting to work here, and it will ensure a 
unified effort across all the Federal agencies.
  Bioshield is an integral part of this strategic plan. It will draw 
upon the expertise and resources of the private sector, as almost no 
other government program that is part of the strategic plan, in order 
to produce more quickly those countermeasures necessary to make our 
Nation safer.
  It is important to recognize the visionary leadership of the 
President in this regard. It is without exaggeration or embellishment 
that I can say that this President, President Bush, and his 
administration, and in particular Vice President Cheney, have devoted 
more attention and more resources to the fight against bioterror than 
any administration in history.
  Prior to 2001, our investments in research and development and other 
public health preparedness activities were minimal. They are now 
profound. The President and this Congress are allocating annually 
billions of dollars to this fight, and under Project Bioshield alone we 
will spend $5.6 billion over the next 10 years. The President is 
clearly leading the way.
  Project Bioshield was not dreamed up here in the halls of Congress, 
but with big obstacles to addressing that need we have acted. So it is 
with both bipartisan pride, I think, and also with collaboration in 
mind between the executive branch and the legislative branch that we 
can say that we have enacted into law, we very shortly will be able to 
do this, next week we will be able to say this, the most significant 
first responder program in our Nation's history.
  The Select Committee looks forward to working with President Bush, 
Secretary Ridge, Secretary Thompson, and the other committees in the 
House and Senate to make sure we leverage the resources provided by 
Project Bioshield to build a sustained countermeasure capacity to 
protect our Nation and our citizens from the ever-evolving threat of 
weapons of mass destruction.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TURNER of Texas. Mr. Speaker, I reserve the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I yield 3 minutes to the great 
volunteer, the gentleman from Tennessee (Mr. Wamp).
  Mr. WAMP. Mr. Speaker, I thank the chairman for yielding me time, and 
I thank all of those involved for bringing this legislation to the 
floor in the form of a conference report.
  I have to come to the floor, though, saying it is frustrating for me 
as a Member of the Subcommittee on Homeland Security of the Committee 
on Appropriations that it took a year to get the bill from the House 
floor back to the House floor in the form of a conference agreement, 
since time is very much of the essence.
  Also I want to tell a story. About a year ago, when I brought ``Buy 
America'' provisions to the floor trying to insert them in this 
legislation, received assurances from Secretary Thompson and the 
gentleman from Louisiana (Chairman Tauzin) that every effort would be 
made to buy America where possible in all of the implementation of not 
just Bioshield, but all of the different treatments and antidotes that 
fall under Bioshield or not. Then later in the fall I had an Assistant 
Secretary of Health and Human Services in my office, and I spoke about 
the treatment for a radiation event and how that was going to be 
procured. It is called Prussian Blue, and I was told that that was 
still in the process of being competed.
  Little did anyone know in the room under this interagency working 
group that a month earlier, an exclusive contract had already been 
committed to procure Prussian Blue and fill up our stockpiles to a 
German company.
  I have got to tell you, in Tennessee that does not go over very well, 
when there are U.S. manufacturers prepared to do this and time is of 
the essence. The FDA, HHS, DHS, we need to coordinate better. I am very 
concerned about ceding the responsibility to interagency working groups 
and not having an accountable person.
  This is billions of dollars. It is, frankly, late. We have been 
appropriating the money. It cannot go forward, and time is of the 
essence. We are going to the conventions, and the threats are real, and 
we do not have the stockpiles full.
  I commend the authorizers; but, darn, everybody involved needs to 
move quicker because we do not have the stockpiles full of these 
treatments, and many of them are available and on the shelf by U.S. 
manufacturers. I was in Tampa, Florida, a week ago Monday; and I saw 
those treatments, and they are not on the streets of New York or Boston 
or across the country, or in Athens, Greece; and U.S. manufacturers can 
export them.
  We have the best technology in the world. We do not have to lean on 
the French or the Germans to fill up our stockpiles for treatments in 
the event of more terrorism. It is not just Bioshield, it is Chemshield 
and Nuke-
shield. It is all of the major threats.
  So, yes, vote for this. It is long overdue. Move it quickly to the 
President's desk. And then get the administration to coordinate better 
together.
  I called Assistant Secretary Simonson today. I said, I need to talk 
to you. I am still waiting for the phone call. The legislation is on 
the floor. I am on the subcommittee. I am waiting for the phone to 
ring. We need action. The American people demand no less. This is the 
most target-rich environment in the next 4 months that we have ever 
faced in the history of this country. Let us get it on.
  Mr. BARTON of Texas. Mr. Speaker, I believe I have 4 minutes 
remaining. I yield that time to the gentleman from Virginia (Mr. Tom 
Davis), the chairman of the Committee on Government Reform, and ask 
that he control the balance of the Committee on Energy and Commerce 
time.
  The SPEAKER pro tempore (Mr. Foley). Is there objection to the 
request of the gentleman from Texas?
  There was no objection.
  The SPEAKER pro tempore. The gentleman from Virginia (Mr. Tom Davis) 
has 11\1/2\ minutes remaining, the gentlewoman from Washington (Ms. 
Dunn) has 7\1/2\ minutes remaining, and the gentleman from Texas (Mr. 
Turner) has 17 minutes remaining.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise in support of S. 15, the Project Bioshield Act of 
2004. The bill provides the government with the necessary tools to 
develop and purchase vaccines and other drugs to protect Americans in 
the event of a bioterrorist attack. The President first announced this 
proposal during his 2003 State of the Union address, and it serves as 
the cornerstone of the administration's strategy to prepare our Nation 
against the possibility of bioterrorism.
  A few minutes ago, we were privileged to hear from the chairman of 
the Select Committee on Homeland Security, the gentleman from 
California (Mr. Cox); and I will include for the Record an editorial 
written by the gentleman from California that appeared in the 
Washington Times and published July 12, 2004.

               [From the Washington Times, July 12, 2004]

                       Intercepting Bioterrorism

                          (By Christopher Cox)

       America is at a very dangerous crossroads. Not only al 
     Qaeda but also terrorist groups such as Jemaah Islamiah are 
     working on acquiring or developing new terrorism 
     capabilities, including bioweapons. Will we be prepared?
       Evidence in an Egyptian terrorism trial two years ago 
     indicated Osama bin Laden may already have access to 
     dangerous biological agents. Meanwhile, the risk of 
     proliferation to terrorists continues growing, with at least 
     eight nations running bioweapons programs, including genetic 
     engineering of pathogens and developmental programs for new 
     production and delivery methods.
       Winning the war on terrorism will require our nation not 
     only to defeat attacks with explosives and military-style 
     weapons, but also to be prepared to overcome potential 
     assaults with weaponized anthrax, ricin, smallpox, plague, 
     tularemia, botulism toxin and

[[Page 15581]]

     viral hemmorhagic fevers (such as the Ebola virus).
       Just how vulnerable are we to such attacks today? The 
     United States now can fully meet only a handful of the 57 
     ``top echelon'' bioterror threats. That's not an acceptable 
     level of preparedness for the greatest power on Earth. We can 
     launch a Tomahawk cruise missile and thread it down the 
     smokestack of a munitions factory from 1,000 miles away--once 
     thought to be a million-to-one shot at best--yet we aren't 
     prepared to deal with the frightening prospect of an anthrax 
     or sarin gas attack against our civilian population.
       It's vital that we put our best minds to work round-the-
     clock on new ways to prepare for a biological or chemical 
     attack here at home. But according to a study published in 
     the May 2004 issue of the journal Clinical Infectious 
     Diseases, only six of 506 drugs currently in development are 
     antibioltics--even though drug-resistant bacteria are a 
     growing threat.
       This is only because the proper incentives and funding 
     aren't there, not because the scientific challenge is too 
     great. Indeed, the germs that cause anthrax and plague are 
     not nearly as difficult to analyze as a virus such as HIV. 
     Vaccines and treatments for biological weapons such as these 
     can be developed.
       Certainly, America has made some progress in preparing for 
     possible germ warfare on our own soil, but we're not ready to 
     combat a major bioterror assault at this time and our enemies 
     know it. Worse, they're looking for ways to exploit our 
     weaknesses.
       We are now on the threshold of changing that. Project 
     Bioshield, expected to receive final legislative approval 
     tomorrow and then be sent to the president for his signature, 
     will shortly unleash the greatest force in world history: 
     American ingenuity.
       By guaranteeing a market for successful vaccines and 
     antidotes, Project BioShield will provide incentives for 
     private-sector scientists, physicians, and researchers to 
     develop lifesaving treatments. Congress has made available 
     $5.6 billion over 10 years to purchase and stockpile a 
     national supply of drugs and vaccines for use if a biological 
     weapon is set loose by terrorists on an unsuspecting American 
     public.
       BioShield will speed research and development on new drugs 
     and antidotes at the National Institutes of Health and in our 
     national laboratories. And it will allow, if germ warfare 
     breaks out, distribution of developmental lifesaving drugs on 
     a fast-track approval basis to save innocent lives, so long 
     as the benefits outweigh potential risks.
       President Bush asked Congress to move immediately on his 
     plans for Project BioShields in the 2003 State of the Union 
     address. The House quickly responded. Last July, the Homeland 
     Security Committee, which I chair, worked closely with other 
     House committees to turn the president's vision into 
     legislation. Unfortunately, after our bipartisan bill passed 
     the House by a wide margin, it languished in the Senate 
     nearly a year before being rescued by Majority Leader Bill 
     Frist, Tennessee Republican.
       But now that both chambers have worked out their 
     differences, America finally is ready to prepare in earnest 
     for a potential terrorist attack that won't yield to bullets 
     or bombs. Now, we'll be using the very best weapon in our 
     defensive arsenal--our brainpower.
       By approving Project BioShield, Congress is saying: ``Let 
     the race to find lifesaving countermeasures begin.'' 
     America's leaders have heeded the advice of experts who have 
     estimated that without BioShield it could take 10 years, and 
     cost up to $800 million or more, to bring a single new 
     vaccine from development through clinical trials to market.
       The war won't wait that long, of course: Terrorists could 
     strike us at any minute. And once a bioweapon is released, 
     every second will count.
       In many ways, the war on terrorism is like a chess game. We 
     must anticipate our enemy's moves, and mount an impenetrable 
     defense. In their pursuit of bioweapons, the terrorists have 
     revealed some of their game plan. Project BioShield will 
     ensure we stay one move ahead of them.
       Someday soon, when it comes to bioterrorism, Americans will 
     be able to say: Checkmate.

  Mr. Speaker, the bipartisan bill we are considering today is similar 
to H.R. 2122, which was passed by the House on July 16, 2003. S. 15 is 
a good bill that serves a compelling national interest.
  Over the past few decades, we have seen rapid progress in the 
development of treatments for many serious, naturally occurring 
diseases. Pharmaceutical and biotech companies are highly capable of 
producing diagnostics and therapeutics when consumer demand exists. 
However, there has been little progress in treatments for deadly 
diseases like smallpox, anthrax, ebola, and plague that affect today 
few Americans. There is little manufacturer interest in developing 
treatments for these diseases since there is no significant market, 
other than the government.
  Drug companies have little incentive for the substantial investment 
required to bring treatments to these deadly diseases to market. 
Moreover, the potential liability for an adverse reaction by a patient 
far outweighs any potential financial benefit in some of these cases.
  Should the United States be attacked with these deadly pathogens, 
however, the need for vaccines, tests and treatments would be great and 
immediate. S. 15 is designed to ensure that our country is prepared.
  The bill provides the Secretary of Health and Human Services with a 
number of flexible acquisition tools based on existing streamlined 
procedures to promote research and development and procure necessary 
drugs and vaccines. These tools are instrumental to the success of the 
Bioshield program.
  S. 15 gives the Secretary of Health and Human Services streamlined 
authorities to promote the research and development of drugs and other 
products needed to protect Americans in the event of a public health 
emergency affecting national security. The Secretary will be armed with 
flexible acquisition tools for research and development projects and 
would also have expedited authorities to award research grants and to 
hire technical experts and consultants. It would not be burdened with 
the existing procurement processes that could take months.
  The bill authorizes the procurement of biomedical countermeasures for 
the Nation's stockpile, using a special reserve fund. The Secretary of 
Health and Human Services and the Secretary of the Department of 
Homeland Security would be required to work together to recommend the 
countermeasures that are needed for the stockpile. Acquisition of 
countermeasures using the special reserve fund could only be made with 
the approval of the President of the United States.
  This bill would permit the use of simplified acquisition procedures 
only when the Secretary of Health and Human Services determines that 
the mission of the Bioshield program would be seriously impaired 
without the use of such special procedures.
  Finally, during national emergencies, the bill would permit the 
government to make available new and promising treatments prior to 
approval by the Food and Drug Administration.
  I especially want to thank my ranking member, the gentleman from 
California (Mr. Waxman), and his staff for working with us on this 
important legislation. I urge my colleagues to support it.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TURNER of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, first of all, let me thank all of the Members on both 
sides who have worked to bring us to this point in the passage of the 
legislation. I must say I have a great deal of agreement and sympathy 
for the remarks made by the gentleman from Tennessee (Mr. Wamp) a few 
moments ago, because the urgency of this matter certainly dictates that 
we move much more quickly than we have been able to move on this 
legislation.
  The President proposed this project in his State of the Union address 
in 2003. The House passed the bill in July of 2003, the Senate passed 
the bill 2 months ago, and we are just now bringing this conference 
report to the floor. So there is no question that in these times of 
terrorist threat the stakes are very high. The risks that we face are 
very great, and failure to close the security gaps in the area of 
bioterrorism or in a host of other areas where we have serious threats 
is not an option for this country.
  We also know that in Project Bioshield and its implementation, we 
face great risk; and it is my hope that the three committees who worked 
so well together in crafting this bill will also each in their own way 
vigorously exercise the oversight that is necessary to ensure that 
Project Bioshield is successful.
  When we know that we may be hearing of a decision in the near future 
by

[[Page 15582]]

Secretary Ridge and Secretary Thompson to begin to acquire a new 
anthrax vaccine, I think it is incumbent upon each of us in our 
committees, in our oversight responsibilities to ask the tough 
questions about whether or not we are moving in the right direction; 
for that first contract could be in the neighborhood of a $1 billion 
Federal contract.

                              {time}  1830

  Failure in making that decision in the appropriate and proper way to 
ensure that it is successful is an essential oversight responsibility 
that each of us have.
  So it is my hope that the good work and the good cooperation that 
occurred between the Committee on Commerce and the Committee on 
Homeland Security and the Committee on Government Reform will be 
carried forward as we provide the necessary oversight to ensure the 
success of this important piece of legislation.
  Again, Mr. Speaker, this is an important bill, and I urge every 
Member of the House to vote aye.
  Mr. Speaker, I yield back the balance of my time.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, I thank the gentleman from 
Texas and others who have been involved in getting this legislation 
before us.
  Let me just say I share the frustration that many Members of this 
body feel at the time it has taken to get this measure to this floor, 
in a conference report form, and then send it on to the President's 
desk for signature. We passed this legislation with bipartisan support 
a year ago, and it languished over in the other body until it was 
rescued by Senator Frist.
  The time is late, but the time is now. I urge my colleagues to adopt 
and support this legislation.


                Announcement by the Speaker Pro Tempore

  The SPEAKER pro tempore (Mr. Foley). The gentleman will refrain from 
improper references to the Senate.
  Ms. McCARTHY of Missouri. Mr. Speaker, I rise today in strong support 
of S. 15, legislation to protect our Nation from future biological and 
chemical terrorist attacks. The House passed H.R. 2122, similar 
legislation, last year by an overwhelming margin of 421 to 2. As a 
member of both the Homeland Security Committee and the Energy and 
Commerce Committee, I have been proud of the bipartisan work that has 
gone into this legislation which will add to our effort to protect the 
Nation from biochemical attack.
  Mr. Speaker, although five people were killed in the anthrax attacks 
of 2001, the death toll was kept relatively low because effective 
medical countermeasures were available. After the outbreak, strong 
antibiotics were immediately prescribed to deal with the crisis. In 
2002, Congress further enhanced our ability to respond by enacting the 
Public Health Security and Bioterrorism Preparedness Response Act (PL 
107-188), which authorized funds to increase the Nation's stockpile of 
medicines and vaccines--particularly for smallpox--and provided aid to 
state and local governments and health facilities to help them prepare 
for possible attacks.
  Unfortunately, effective vaccines or treatments do not exist for many 
biological threats deemed by the U.S. government to be most dangerous, 
including botulinum toxin, plague, and viral hemorrhagic fevers such as 
the Ebola virus.
  The development of effective countermeasures has been hindered by the 
lack of a significant commercial market. Currently, companies have 
little financial incentive to invest the funds needed to research, 
develop or produce vaccines or other countermeasures because there is 
little or no market.
  Despite these challenges, in my district, the Stowers Institute and 
the Kansas City Life Sciences Institute are both trailblazers in the 
field of research. The Stowers Institute's new research facility in 
Kansas City incorporates the best that present technology can offer. In 
my community, the best and the brightest are working to broaden the 
base of knowledge in hopes of discovering cures and vaccines for 
today's diseases and future threats.
  Today's legislation will encourage and support these efforts by 
providing additional funding for research and development of new 
countermeasures and vaccines. The bill will also provide for an 
expedited approval process to ensure that the fruits of our research 
can protect the public as soon as possible.
  Mr. Speaker, all over this Nation, our first responders serve on the 
front lines when disasters occur and continue to be the eyes and ears 
of our Nation. They are a significant part of the effort to protect our 
homeland and guard against the invisible threat of a chemical and 
biological attack. Today's legislation is an important step in that 
process and I support it.
  Mrs. CHRISTENSEN. Mr. Speaker, I want to begin by first thanking our 
Chairman, Mr. Cox from California and Ranking member, from Texas, Mr. 
Turner, for their leadership on the select committee and for this 
opportunity to offer my support for S. 15, Project Bioshield, and to 
draw attention to the critical issues of homeland security. And I also 
want to take the opportunity to again thank the minority leader, the 
gentlewoman from California, Ms. Pelosi, for the honor of serving on 
this important committee.
  In this post 9/11 world, it has been said that bioterrorism may 
represent our greatest threat. Project Bioshield is important because 
it will help to ensure that we can spur the development of vaccines and 
other countermeasures that will be needed to counteract or treat an 
infectious, radiological or chemical attack. But it can only go so far, 
because we have no idea what the agent might be or how a known one 
might be altered. Not only is it possible that hundreds of millions of 
dollars could be spent to develop a medicine or vaccine and it be 
totally useless, but the very best of medicines, vaccines or other 
agents will be worthless to you, me and the people we serve without an 
intact public health system.
  A recent bipartisan commission's report, ``First Responders 
Underfunded and Unprepared,'' documents the dire need of our public 
health and other responders in stark and frightening terms. I am still 
waiting for a formal hearing on their findings, and we should not be 
afraid to have the report aired. We should really be more afraid not to 
pay attention to its findings and its recommendations.
  Particular when we think about the health care disparities in 
minorities and in our rural areas that I have come to this floor to 
bring to the attention of our colleagues on many occasions did not just 
come about by chance. They exist because of the poor public health 
systems in these communities. The last 3 years of cuts to health 
budgets have been devastating. The lack of emphasis on minority and 
rural health and the even bigger cuts that the President is insisting 
on this year, so that those who already have the best of health care 
can get a tax cut and other perks, have sent States into a free fall of 
budget deficits, and local public health safety nets, like those in Los 
Angeles, and Detroit, to near collapse.
  Mr. Speaker, we cannot just throw money at the problem of terrorism, 
as this administration has a tendency to do, without adequate planning. 
In this case, we must first and foremost insist that our public health 
system is intact and that it can ensure that people are healthy and our 
bodies are in a better condition to fight off infections and the other 
biological assaults that may come from a bioterrorism attack.
  The anthrax scare taught us that lesson. The breakdowns were 
fundamental ones. Project Bioshield, the administration's centerpiece 
for public health preparedness and biological countermeasures, would 
not have saved the two postal workers just down the street from here 
who died because the public health system failed to respond. It 
happened here, but it could happen anywhere.
  Confronting the danger posed by these advanced biological weapons is 
a challenge we must begin today. Thus, we must ensure that 
biotechnology is fundamentally ``dual-use,'' that is it can be used 
both for peaceful and destructive purposes. Because of its potential 
for misuse, balanced biodefense policies must be developed and adopted 
to ensure our safety and security. These should include reasonable 
steps to prevent the spread of dangerous pathogens and the technology 
to enhance them. Preparedness of our health infrastructure must also be 
enhanced and maintained. Finally, protections, including drugs and 
vaccines, to counter potential weaponized pathogens need to be 
available during a crisis.
  It is in the area of protections for tomorrow's biological weapons 
threat that we are particularly weak. The primary proposal advanced to 
boost our protection capacities, Project Bioshield, will not address 
this threat because it is targeted to addressing classical agents. In 
addition, it relies on the current base of science and technology in 
drug and vaccine development, which takes an average of 14 years to 
develop and introduce a new medicine. As a consequence, our protective 
biodefenses are essentially static and unmoving in the face of a threat 
that is highly variable and unpredictable. The recent experience with 
SARS and the danger of a new flu pandemic demonstrate the dangers of a 
lack of effective countermeasures and a nimble ability to develop and 
field them.

[[Page 15583]]

  Recently, Ranking member Turner and I introduced H.R. 4258 The RAPID 
Cures Act. This bill seeks to commission the development of a strategy 
to achieve a dramatic reduction in the timeframe required today for the 
delivery of drugs and vaccines to counter pathogen threats for which we 
have no existing countermeasures. The achievement of reductions and the 
institution of a national rapid response ``Bug-to-Drug'' capability 
will be a significant boost to our biodefenses against the emerging and 
future threat of bioengineered biological weapons, as well as naturally 
occurring novel threats, such as SARS or pandemic flu.
  In addition to improving antimicrobial and vaccine development 
capabilities, an area currently neglected by the private sector, the 
technical spin-offs of such an endeavor are also likely to benefit the 
domestic pharmaceutical and biotechnology industries more generally. 
Broad public health benefits will also be forthcoming. Extensive 
literature exists to show that the long timeframes (14 years) and high 
failure rates typical of drug development processes today are a 
significant cause of high R&D costs, and thus high prescription drug 
costs.
  Mr. Speaker, today I know that we will pass this bill, but what I and 
other health providers, public health experts and officials and the 
people of this country want to know is that we will always move just as 
determinedly and expeditiously to fully fund the strengthening of our 
public health system, the training of our first responders and provide 
them with the tools and facilities they need to protect us in those 
first critical hours where lives can and must be saved.
  I again want to take this opportunity to thank and commend Chairman 
Cox and Ranking Member Turner for their leadership in moving this bill 
through Congress.
  Mr. SHAYS. Mr. Speaker, I rise today in strong support of this 
bipartisan legislation, the Project BioShield Act. The anthrax attacks 
in the fall of 2001 brought the once distant threat of biological 
weapons into these very buildings. It is not a question of if, but when 
terrorists will strike again. Project BioShield marks an important step 
toward preparedness to deter or defeat the next terrorist attack using 
deadly pathogens.
  I am particularly pleased that the legislation clarified some 
ambiguity that I had raised during the bill's initial consideration 
regarding safeguards for the application of medical products during 
emergencies for military personnel. Initially, the legislation appeared 
to allow the President or Secretary of HHS to remove safeguards for 
military personnel that were available to the general population. This 
legislation addressed those concerns.
  This legislation will provide $5.6 billion over 10 years to develop 
and procure effective countermeasures against biological, chemical and 
radiological weapons. To counter the grave and changing threat, the 
bill gives the Secretary of HHS new, flexible authorities to conduct 
and support research and development for new vaccines and drugs. Most 
importantly, Project BioShield removes barriers and provides important 
incentives to the private sector to spur the advance of 
biotechnologies. If used aggressively and wisely, the authorities in 
this legislation will result in significantly strengthened defenses 
against bioterrorism.
  Two words of caution: First, implementation of BioShield must be 
linked to the threat. Vaccines and antidotes against exotic agents may 
present easier, near-term opportunities for quick successes. But the 
Center for Disease Control and the intelligence community maintain a 
threat list of pathogens, and that list should focus and guide 
BioShield investments. Botulinum toxin ranks right behind anthrax as a 
known biological threat. But testimony before the Select Committee on 
Homeland Security concluded development of botulinum anti-toxin stocks 
could take up to 10 years. If Project BioShield is going to provide 
anything more than a symbolic barrier against biological attack, that 
estimate has to change.
  And, the success of BioShield also depends upon broader bio-
preparedness priorities. The Government Reform National Security 
Subcommittee, which I chair, has held several hearings on bioterrorism 
preparedness. We learned that massive caches of stockpiled vaccines, 
antibiotics and drugs will protect no one if they cannot be 
administered quickly and safely. Public health capacity is a critical 
enabler to BioShield success. Surveillance systems, diagnostic tools 
and trained medical personnel are prerequisites to any effective 
defense against natural and man-made biological outbreaks.
  Terrorism thrives on uncertainty. We cannot expect to vaccinate 
everyone against every possible pathogen. Instead, we need a well-
equipped, well-trained public health system that can rapidly respond to 
health emergencies.
  Mr. Speaker, Project Bioshield is a much needed initiative, and I 
would urge all of my colleagues to support for this legislation.
  Mr. DINGELL. Mr. Speaker, I rise in support of S. 15, the ``Project 
Bioshield Act of 2004.'' This legislation reflects bipartisan bicameral 
negotiations that have made minor modifications to the language of H.R. 
2122 which was passed by the House on July 16, 2003. I commend the hard 
work and dedication of all who participated in this endeavor.
  In this era of heightened threats to our national security and the 
increased risk of harm to Americans, Project Bioshield is an 
unfortunate but necessary measure. There are no effective therapies for 
many of the ``select agents'' that have been identified as potential 
instrumentalities of terrorism. The basic purpose of Project Bioshield 
is to support research that will lead to the development and 
availability in the Strategic National Stockpile of ``countermeasures'' 
to combat public health emergencies that threaten our national 
security.
  The bill has three basic features: enhanced countermeasure research; 
procurement of countermeasures; and emergency regulatory authority for 
approval and use of drugs, biologics, and devices that are qualified 
countermeasures. The Committees' work clarified, modified, and 
otherwise improved on the Administration's proposal in each of these 
areas. The bill before us reflects further refinements and does not 
contain major policy changes from last year's bill.
  Among the significant measures in this bill are provisions aimed at 
enhancing accountability for actions taken pursuant to Project 
Bioshield. Congress will receive comprehensive information, not less 
than annually, on the major activities authorized by this Act. In 
addition, the Government Accountability Office (GAO) will provide 
reports on key economic and scientific elements of this program after 
it has been in effect for several years.
  Finally, I am pleased to note that this bill maintains the approach 
of H.R. 2122 that funding be authorized, rather than a permanent, 
unlimited appropriation sought by the Administration. Bioshield should 
not automatically be given a higher priority over other national 
security or public health matters.
  This is a good bill, and is a worthy continuation of our important 
and bipartisan work on bioterrorism preparedness. I urge all of my 
colleagues to support it.
  Mr. WAXMAN. Mr. Speaker, we have before us today S. 15, the Project 
BioShield Act. This bill is substantially the same as H.R. 2122, which 
passed the House on July 16, of last year by a vote of 421 to 2. This 
bill is in essence the conference report on the bill, and includes some 
minor improvements made by the Senate. I urge members to support this 
measure as well.
  Given the serious threat of bioterrorism, the development of 
effective countermeasures to biological agents is vital to our national 
security. The goal of Project BioShield is to encourage the development 
of these products. I fully support the intent of this legislation. I 
also agree with its premise--that when the market cannot foster the 
development of critical products by itself, the government must rise to 
the challenge.
  The bill before us today includes several significant improvements 
from earlier proposals. For example, it includes important protections 
against waste and abuse that are standard for government contracts, 
such as preserving the government's rights to review contractor's books 
and records. The bill also permits the use of certain streamlined 
procurement procedures, but only if the Secretary of Health and Human 
Services determines that there is a pressing need to do so.
  The Senate bill appropriately strengthens some of these provisions 
and also allows for recovery by the government in the event of grossly 
negligent or reckless conduct on the part a contractor.
  In emergency situations we should not impede the development of 
necessary products. However, any exceptions from standard procurement 
procedures should be made only when necessary and should be subject to 
review. This proposal preserves that standard.
  The provisions of Bioshield authorizing the emergency distribution of 
unapproved drugs and devices, whose risks and benefits are not fully 
tested, impose an unprecedented responsibility on the government. FDA 
must be vigilant in protecting the public against unnecessary risks 
from these products.
  In part because of these concerns, the bill requires that health care 
providers and patients be informed that the products have not been 
approved and of their risks. The bill also requires that manufacturers 
monitor and report adverse reactions to the products and keep other 
appropriate records about the use of the products.
  These conditions are essential for the safe use of unapproved 
products, and they should

[[Page 15584]]

be imposed in all cases, except in truly extraordinary circumstances. 
In addition, the HHS Secretary is authorized to limit the distribution 
of the products, to limit who may administer the products, to waive 
good manufacturing practice requirements only when absolutely 
necessary, and to require record keeping by others in the chain of 
distribution.
  We expect the Secretary to consider the need for these additional 
conditions in each case and to impose them to the full extent necessary 
to protect the public from the risks of these products.
  The bill before us today is an improvement over the original 
proposal, and represents a bipartisan consensus of the House, the 
Senate, and the White House. It deserves our support.
  Mr. LANGEVIN. Mr. Speaker, I rise today in support of the Project 
Bioshield Act of 2004. Bioterrorism is a major threat to our national 
security, and I believe it is our job as members of Congress to instill 
confidence in the American people that a coordinated, concerted effort 
is being made to combat this threat. While Project Bioshield is not the 
only answer, it is certainly an important step towards that goal, and I 
hope Congress will continue to provide the funding and oversight the 
project needs to be effective.
  This bill, much like H.R. 2212 passed by the House a year ago, 
authorizes the Project Bioshield initiative and will set in motion 
crucial efforts to develop new countermeasures to treat diseases and 
conditions caused by bioterror attacks and chemical, radiological and 
nuclear agents. Under this program, the Federal government will be able 
to enhance the Strategic National Stockpile, promote research and 
development of countermeasures, and, in an emergency, move forward with 
public distribution of certain drugs and treatments that may not yet 
have FDA approval. It is never pleasant to imagine a scenario where 
this kind of preparation and flexibility will be necessary, but the 
threat is indeed there. Project Bioshield will help lay the groundwork 
to respond to that threat quickly and effectively.
  However, I must also mention my ongoing concern that until the 
Department of Homeland Security's Information Analysis and 
Infrastructure Protection Directorate is fully staffed and meeting 
expectations, the rest of DHS is at a tremendous disadvantage in 
determining how to allocate resources and focus energies. The proper 
implementation of Project Bioshield requires a reliable and 
comprehensive threat assessment from the Information Analysis team, a 
team that should include bioterror experts working closely with their 
peers at agencies like CDC and NIH to identify the most pressing 
dangers and develop a plan to combat them.
  So, Mr. Speaker, I urge my colleagues to support this legislation and 
hope that DHS will do its part to make Project Bioshield as effective 
as possible.
  Ms. ESHOO. Mr. Speaker, I'm pleased to support the Project Bioshield 
Act which encourages the development of new countermeasures to deal 
with diseases and conditions caused by bioterrorism attacks. It 
authorizes $5.6 billion over 10 years for purchasing countermeasures, 
such as vaccines and treatments, to bioterrorist attacks. The bill also 
allows the government, in the event of a national emergency involving a 
bioterrorism or similar attack, to distribute to the public certain 
drugs and treatments that have not yet been approved by the Federal 
Drug Administration (FDA).
  The Project Bioshield Act is an important part of our mission to 
secure and protect our homeland and hometowns. The threat of chemical, 
biological and radiological attacks is too great and this bill provides 
necessary regulatory flexibility to the Department of Homeland Security 
and the Department of Health and Human Services so they can speed and 
promote research and development of needed countermeasures.
  The September 11th tragedies and subsequent anthrax attacks made the 
Nation aware that the public health system is ill-prepared to mange a 
large scale emergency. Since then, our public health system has 
continued to respond to high profile threats like severe acute 
respiratory syndromes (SARS) and West Nile Virus which illustrate how 
quickly infections can spread among populations and across the globe.
  Over the last 3 years, our eyes have been opened to the threats we 
face on our own soil. We've discovered serious vulnerabilities and I'm 
proud of what we've done in this bill to address them. I urge the 
entire House to vote for this important legislation.
  Mr. SENSENBRENNER. Mr. Speaker, I rise in support of S. 15, the 
``Project BioShield Act of 2004.'' This important legislation will help 
us to be better prepared against bioterrorism and other forms of 
terrorism. I just want to briefly note the jurisdictional interest of 
the Committee on the Judiciary in the Federal Tort Claims Act provision 
contained in the new Sec. 319F-1(d)(2) which is contained in 2(a) of 
the bill. I support the inclusion of this provision. However, I want to 
note that by allowing this provision to be included in the bill, the 
Committee on the Judiciary does not waive its jurisdiction over the 
provision. With that, I urge my colleagues to support the bill.
  Mr. TOM DAVIS of Virginia Mr. Speaker, I yield back the balance of my 
time.
  The SPEAKER pro tempore. All time having been yielded back, pursuant 
to the order of the House of Tuesday, July 13, 2004, the Senate bill is 
considered read for amendment, and the previous question is ordered.
  The question is on third reading of the Senate bill.
  The Senate bill was ordered to be read a third time, and was read the 
third time.
  The SPEAKER pro tempore. The question is on the passage of the Senate 
bill.
  The question was taken; and the Speaker pro tempore announced that 
the ayes appeared to have it.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, on that I demand the yeas and 
nays.
  The yeas and nays were ordered.
  The vote was taken by electronic device, and there were--yeas 414, 
nays 2, not voting 17, as follows:

                             [Roll No. 376]

                               YEAS--414

     Abercrombie
     Ackerman
     Aderholt
     Akin
     Alexander
     Allen
     Andrews
     Baca
     Bachus
     Baird
     Baker
     Baldwin
     Ballenger
     Barrett (SC)
     Bartlett (MD)
     Barton (TX)
     Bass
     Beauprez
     Becerra
     Bell
     Bereuter
     Berkley
     Berman
     Berry
     Biggert
     Bilirakis
     Bishop (GA)
     Bishop (NY)
     Bishop (UT)
     Blackburn
     Blumenauer
     Blunt
     Boehlert
     Boehner
     Bonilla
     Bonner
     Bono
     Boozman
     Boswell
     Boucher
     Boyd
     Bradley (NH)
     Brady (PA)
     Brady (TX)
     Brown (OH)
     Brown (SC)
     Brown, Corrine
     Brown-Waite, Ginny
     Burgess
     Burns
     Burr
     Burton (IN)
     Buyer
     Calvert
     Camp
     Cannon
     Cantor
     Capito
     Capps
     Capuano
     Cardoza
     Carson (OK)
     Carter
     Case
     Castle
     Chabot
     Chandler
     Chocola
     Clay
     Clyburn
     Coble
     Cole
     Cooper
     Costello
     Cox
     Cramer
     Crane
     Crenshaw
     Crowley
     Cubin
     Culberson
     Cummings
     Cunningham
     Davis (AL)
     Davis (CA)
     Davis (FL)
     Davis (IL)
     Davis (TN)
     Davis, Jo Ann
     Davis, Tom
     Deal (GA)
     DeFazio
     DeGette
     Delahunt
     DeLauro
     DeLay
     DeMint
     Diaz-Balart, L.
     Diaz-Balart, M.
     Dicks
     Doggett
     Doolittle
     Doyle
     Dreier
     Duncan
     Dunn
     Edwards
     Ehlers
     Emanuel
     Emerson
     Engel
     English
     Eshoo
     Etheridge
     Evans
     Everett
     Farr
     Fattah
     Feeney
     Ferguson
     Filner
     Foley
     Forbes
     Fossella
     Franks (AZ)
     Frelinghuysen
     Frost
     Gallegly
     Garrett (NJ)
     Gerlach
     Gibbons
     Gilchrest
     Gillmor
     Gingrey
     Gonzalez
     Goode
     Goodlatte
     Gordon
     Goss
     Granger
     Graves
     Green (TX)
     Green (WI)
     Greenwood
     Grijalva
     Gutierrez
     Gutknecht
     Hall
     Harman
     Harris
     Hart
     Hastings (FL)
     Hastings (WA)
     Hayes
     Hayworth
     Hefley
     Hensarling
     Herger
     Herseth
     Hill
     Hinchey
     Hinojosa
     Hobson
     Hoekstra
     Holden
     Holt
     Honda
     Hooley (OR)
     Hostettler
     Hoyer
     Hulshof
     Hunter
     Hyde
     Inslee
     Israel
     Issa
     Istook
     Jackson (IL)
     Jackson-Lee (TX)
     Jefferson
     Jenkins
     John
     Johnson (CT)
     Johnson (IL)
     Johnson, E. B.
     Johnson, Sam
     Jones (NC)
     Jones (OH)
     Kanjorski
     Kaptur
     Keller
     Kelly
     Kennedy (MN)
     Kennedy (RI)
     Kildee
     Kilpatrick
     King (IA)
     King (NY)
     Kingston
     Kirk
     Kline
     Knollenberg
     Kolbe
     Kucinich
     LaHood
     Lampson
     Langevin
     Lantos
     Larsen (WA)
     Larson (CT)
     Latham
     LaTourette
     Leach
     Lee
     Levin
     Lewis (CA)
     Lewis (GA)
     Lewis (KY)
     Linder
     Lipinski
     LoBiondo
     Lofgren
     Lowey
     Lucas (KY)
     Lucas (OK)
     Lynch
     Maloney
     Manzullo
     Markey
     Marshall
     Matheson
     Matsui
     McCarthy (MO)
     McCarthy (NY)
     McCollum
     McCotter
     McCrery
     McDermott
     McGovern
     McHugh
     McInnis
     McIntyre
     McKeon
     McNulty
     Meehan
     Meek (FL)
     Meeks (NY)
     Menendez
     Mica
     Michaud
     Millender-McDonald
     Miller (FL)
     Miller (MI)
     Miller (NC)
     Miller, Gary
     Miller, George
     Mollohan
     Moore
     Moran (KS)
     Moran (VA)
     Murphy
     Murtha
     Musgrave
     Myrick
     Nadler
     Napolitano
     Neal (MA)
     Nethercutt
     Neugebauer
     Ney
     Northup
     Norwood
     Nunes
     Nussle
     Oberstar
     Obey

[[Page 15585]]


     Olver
     Ortiz
     Osborne
     Ose
     Otter
     Owens
     Oxley
     Pallone
     Pascrell
     Pastor
     Payne
     Pearce
     Pelosi
     Pence
     Peterson (MN)
     Peterson (PA)
     Petri
     Pickering
     Pitts
     Platts
     Pombo
     Pomeroy
     Porter
     Portman
     Price (NC)
     Pryce (OH)
     Putnam
     Quinn
     Radanovich
     Rahall
     Ramstad
     Regula
     Rehberg
     Renzi
     Reyes
     Reynolds
     Rodriguez
     Rogers (AL)
     Rogers (KY)
     Rogers (MI)
     Rohrabacher
     Ros-Lehtinen
     Ross
     Rothman
     Roybal-Allard
     Royce
     Ruppersberger
     Rush
     Ryan (OH)
     Ryan (WI)
     Ryun (KS)
     Sabo
     Sanchez, Linda T.
     Sanchez, Loretta
     Sanders
     Sandlin
     Saxton
     Schakowsky
     Schiff
     Schrock
     Scott (GA)
     Scott (VA)
     Sensenbrenner
     Serrano
     Sessions
     Shadegg
     Shaw
     Shays
     Sherman
     Sherwood
     Shimkus
     Shuster
     Simmons
     Simpson
     Skelton
     Slaughter
     Smith (MI)
     Smith (NJ)
     Smith (TX)
     Smith (WA)
     Snyder
     Solis
     Souder
     Spratt
     Stark
     Stearns
     Stenholm
     Strickland
     Stupak
     Sullivan
     Sweeney
     Tancredo
     Tanner
     Tauscher
     Tauzin
     Taylor (MS)
     Taylor (NC)
     Terry
     Thomas
     Thompson (CA)
     Thompson (MS)
     Thornberry
     Tiahrt
     Tiberi
     Tierney
     Toomey
     Towns
     Turner (OH)
     Turner (TX)
     Udall (CO)
     Udall (NM)
     Upton
     Van Hollen
     Velazquez
     Visclosky
     Vitter
     Walden (OR)
     Walsh
     Wamp
     Waters
     Watson
     Watt
     Waxman
     Weiner
     Weldon (FL)
     Weldon (PA)
     Weller
     Wexler
     Whitfield
     Wicker
     Wilson (NM)
     Wilson (SC)
     Wolf
     Woolsey
     Wu
     Wynn
     Young (AK)
     Young (FL)

                                NAYS--2

     Flake
     Paul
       

                             NOT VOTING--17

     Cardin
     Carson (IN)
     Collins
     Conyers
     Deutsch
     Dingell
     Dooley (CA)
     Ford
     Frank (MA)
     Gephardt
     Hoeffel
     Houghton
     Isakson
     Kind
     Kleczka
     Majette
     Rangel


                Announcement by the Speaker Pro Tempore

  The SPEAKER pro tempore (Mr. Foley) (during the vote). Members are 
advised 2 minutes remain in this vote.

                              {time}  1900

  Mr. FLAKE changed his vote from ``yea'' to ``nay.''
  Mr. WAXMAN changed his vote from ``nay'' to ``yea.''
  So the Senate bill was passed.
  The result of the vote was announced as above recorded.
  A motion to reconsider was laid on the table.

                          ____________________