[Congressional Record (Bound Edition), Volume 149 (2003), Part 13]
[House]
[Pages 18330-18364]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              {time}  1400
                     PROJECT BIOSHIELD ACT OF 2003

  Mr. TAUZIN. Mr. Speaker, pursuant to the order of the House of 
Tuesday, July 15, 2003, I call up the bill (H.R. 2122) to enhance 
research, development, procurement, and use of biomedical 
countermeasures to respond to public health threats affecting national 
security, and for other purposes, and ask for its immediate 
consideration.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore (Mr. Jenkins). Pursuant to the order of the 
House of Tuesday, July 15, 2003, the bill is considered read for 
amendment.
  Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
  The text of H.R. 2122 is as follows:

                               H.R. 2122

     SECTION 1. SHORT TITLE.

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

     SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT 
                   AUTHORITIES.

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

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

       ``(a) In General.--
       ``(1) Authority.--In conducting and supporting research and 
     development activities regarding biomedical countermeasures 
     under section 319F(h), the Secretary may conduct and support 
     such activities in accordance with this section if the 
     activities concern qualified countermeasures.
       ``(2) Qualified countermeasure.--For purposes of this 
     section, the term `qualified countermeasure' means a priority 
     countermeasure (as defined in section 319F(h)) that affects 
     national security.
       ``(3) Interagency cooperation.--
       ``(A) In general.--In carrying out activities under this 
     section, the Secretary is authorized, subject to subparagraph 
     (B), to enter into interagency agreements and other 
     collaborative undertakings with other agencies of the United 
     States Government.
       ``(B) Limitation.--An agreement or undertaking under this 
     paragraph shall not authorize another agency to exercise the 
     authorities provided by this section.
       ``(4) Availability of facilities to the secretary.--In any 
     grant 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, and 
     supporting qualified countermeasure research and development, 
     the Secretary may provide that the facility that is the 
     object of such grant or cooperative agreement shall be 
     available as needed to the Secretary to respond to public 
     health emergencies affecting national security.
       ``(b) Expedited Procurement Authority.--
       ``(1) Increased simplified acquisition threshold for 
     biomedical 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

[[Page 18331]]

     U.S.C. 254d) (relating to the examination of contractor 
     records).
       ``(C) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     procurements that are under this paragraph, including 
     requirements with regard to documenting the justification for 
     use of the authority in this paragraph.
       ``(2) Other than full and open competition.--(A) 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) The authority under subparagraph (A) is in addition 
     to any other authority to use procedures other than 
     competitive procedures.
       ``(C) The Secretary shall implement this paragraph in 
     accordance with applicable government-wide regulations, 
     including requirements that offers be solicited from as many 
     potential sources as is practicable under the circumstances, 
     that required notices be published, and that submitted offers 
     be considered.
       ``(3) Increased micropurchase threshold.--
       ``(A) In general.--For a procurement described by paragraph 
     (1), the amount specified in subsections (c), (d), and (f) of 
     section 32 of the Office of Federal Procurement Policy Act 
     (41 U.S.C. 428) shall be deemed to be $15,000 in the 
     administration of that section with respect to such 
     procurement.
       ``(B) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for purchases 
     that are under this paragraph and that are greater than 
     $2,500.
       ``(C) Exception to preference for purchase card 
     mechanism.--No provision of law establishing a preference for 
     using a Government purchase card method for purchases shall 
     apply to purchases that are under this paragraph and that are 
     greater than $2,500.
       ``(c) Authority To Expedite Peer Review.--
       ``(1) In general.--The Secretary may, as the Secretary 
     determines necessary to respond to pressing qualified 
     countermeasure research and development needs under this 
     section, employ such expedited peer review procedures 
     (including consultation with appropriate scientific experts) 
     as the Secretary, in consultation with the Director of NIH, 
     deems appropriate to obtain assessment of scientific and 
     technical merit and likely contribution to the field of 
     qualified countermeasure research, in place of the peer 
     review and advisory council review procedures that would be 
     required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 
     406(a)(3)(A), 492, and 494, as applicable to a grant, 
     contract, or cooperative agreement--
       ``(A) that is for performing, administering, or supporting 
     qualified countermeasure research and development activities; 
     and
       ``(B) the amount of which is not greater than $1,500,000.
       ``(2) Subsequent phases of research.--The Secretary's 
     determination of whether to employ expedited peer review with 
     respect to subsequent phases of a research grant 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 or cooperative 
     agreement.
       ``(d) Authority for Personal Services Contracts.--
       ``(1) In general.--For the purpose of performing, 
     administering, and supporting qualified countermeasure 
     research and development activities, the Secretary may, as 
     the Secretary determines necessary to respond to pressing 
     qualified countermeasure research and development needs under 
     this section, obtain by contract (in accordance with section 
     3109 of title 5, United States Code, but without regard to 
     the limitations in such section on the period of service and 
     on pay) the personal services of experts or consultants who 
     have scientific or other professional qualifications, except 
     that in no case shall the compensation provided to any such 
     expert or consultant exceed the daily equivalent of the 
     annual rate of compensation for the President.
       ``(2) Federal tort claims act coverage.--
       ``(A) In general.--A person carrying out a contract under 
     paragraph (1), and an officer, employee, or governing board 
     member of such person, shall be deemed to be an employee of 
     the Department of Health and Human Services for purposes of 
     claims under sections 1346(b) and 2672 of title 28, United 
     States Code, for money damages for personal injury, including 
     death, resulting from performance of functions under such 
     contract.
       ``(B) Exclusivity of remedy.--The remedy provided by 
     subparagraph (A) shall be exclusive of any other civil action 
     or proceeding by reason of the same subject matter against 
     the person, officer, employee, or governing board member.
       ``(3) Internal controls to be instituted.--
       ``(A) In general.--The Secretary shall institute 
     appropriate internal controls for contracts under this 
     subsection, including procedures for the Secretary to make a 
     determination of whether a person, or an officer, employee, 
     or governing board member of a person, is deemed to be an 
     employee of the Department of Health and Human Services 
     pursuant to paragraph (2).
       ``(B) Determination of employee status to be final.--A 
     determination by the Secretary under subparagraph (A) that a 
     person, or an officer, employee, or governing board member of 
     a person, is or is not deemed to be an employee of the 
     Department of Health and Human Services shall be final and 
     binding on the Secretary and the Attorney General and other 
     parties to any civil action or proceeding.
       ``(4) Number of personal services contracts limited.--The 
     number of experts and consultants whose personal services are 
     obtained under paragraph (1) shall not exceed 30 at any time.
       ``(e) Streamlined Personnel Authority.--
       ``(1) In general.--In addition to any other personnel 
     authorities, the Secretary may, as the Secretary determines 
     necessary to respond to pressing qualified countermeasure 
     research and development needs under this section, without 
     regard to such provisions of title 5, United States Code, 
     governing appointments in the competitive service, and 
     without regard to the provisions of chapter 51 and subchapter 
     III of chapter 53 of such title relating to classification 
     and General Schedule pay rates, appoint professional and 
     technical employees, not to exceed 30 such employees at any 
     time, to positions in the National Institutes of Health to 
     perform, administer, or support qualified countermeasure 
     research and development activities in carrying out this 
     section.
       ``(2) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     appointments under this subsection.
       ``(f) Actions Committed to Agency Discretion.--Actions by 
     the Secretary under the authority of this section are 
     committed to agency discretion.
       ``(g) Effect on Right To File Protest.--Nothing in this 
     section shall affect the right of an interested party to file 
     a protest with the contracting agency, to file a protest with 
     the Comptroller General under subchapter V of chapter 35 of 
     title 31, United States Code, or to file an action in the 
     United States Court of Federal Claims under section 1491(b) 
     of title 28, United States Code.''.
       (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 fiscal year 2003.''.

     SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

       (a) In General.--Part B of title III of the Public Health 
     Service Act, as amended by section 2 of this Act, is amended 
     by inserting after section 319F-1 the following section:

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

       ``(a) Strategic National Stockpile.--
       ``(1) In general.--The Secretary of Homeland Security 
     (referred to in this section as the `Homeland Security 
     Secretary'), in coordination with the Secretary and the 
     Secretary of Veterans Affairs, shall maintain a stockpile or 
     stockpiles of drugs, vaccines and other biological products, 
     medical devices, and other supplies in such numbers, types, 
     and amounts as are determined by the Secretary to be 
     appropriate and practicable, taking into account other 
     available

[[Page 18332]]

     sources, to provide for the emergency health security of the 
     United States, including the emergency health security of 
     children and other vulnerable populations, in the event of a 
     bioterrorist attack or other public health emergency.
       ``(2) Procedures.--The Secretary, in managing the stockpile 
     under paragraph (1), shall--
       ``(A) consult with the working group under section 319F(a);
       ``(B) ensure that adequate procedures are followed with 
     respect to such stockpile for inventory management and 
     accounting, and for the physical security of the stockpile;
       ``(C) in consultation with Federal, State, and local 
     officials, take into consideration the timing and location of 
     special events;
       ``(D) review and revise, as appropriate, the contents of 
     the stockpile on a regular basis to ensure that emerging 
     threats, advanced technologies, and new countermeasures are 
     adequately considered;
       ``(E) devise plans for the effective and timely supply-
     chain management of the stockpile, in consultation with 
     appropriate Federal, State and local agencies, and the public 
     and private health care infrastructure; and
       ``(F) ensure the adequate physical security of the 
     stockpile.
       ``(b) Smallpox Vaccine Development.--
       ``(1) In general.--The Secretary shall award contracts, 
     enter into cooperative agreements, or carry out such other 
     activities as may reasonably be required in order to ensure 
     that the stockpile under subsection (a) includes an amount of 
     vaccine against smallpox as determined by such Secretary to 
     be sufficient to meet the health security needs of the United 
     States.
       ``(2) Rule of construction.--Nothing in this section shall 
     be construed to limit the private distribution, purchase, or 
     sale of vaccines from sources other than the stockpile 
     described in subsection (a).
       ``(c) Additional Authority Regarding Procurement of Certain 
     Biomedical Countermeasures; Availability of Special Reserve 
     Fund.--
       ``(1) In general.--
       ``(A) Use of fund.--A security countermeasure may, in 
     accordance with this subsection, be procured with amounts in 
     the special reserve fund under paragraph (10).
       ``(B) Security countermeasure.--For purposes of this 
     subsection, the term `security countermeasure' means a 
     priority countermeasure (as defined in section 319F(h))--
       ``(i) that affects national security;
       ``(ii) that is determined under paragraph (2)(B)(ii) to be 
     a necessary countermeasure; and
       ``(iii)(I) that is approved or cleared under chapter V of 
     the Federal Food, Drug, and Cosmetic Act, or licensed under 
     section 351 of this Act, for use as a countermeasure to a 
     chemical, biological, radiological, or nuclear agent 
     identified as a material threat under paragraph (2)(A)(ii); 
     or
       ``(II) for which the Secretary determines that sufficient 
     and satisfactory clinical experience or research data 
     (including data, if available, from pre-clinical and clinical 
     trials) support a reasonable conclusion that the 
     countermeasure will qualify for approval or licensing after 
     the date of a determination under paragraph (5).
       ``(2) Determination of material threats.--
       ``(A) Material threat.--The Homeland Security Secretary, in 
     consultation with the heads of other agencies as appropriate, 
     shall on an ongoing basis--
       ``(i) assess current and emerging threats of chemical, 
     biological, radiological, and nuclear agents; and
       ``(ii) determine which of such agents present a material 
     threat against the United States population.
       ``(B) Public health impact; necessary countermeasures.--The 
     Secretary shall on an ongoing basis--
       ``(i) assess the potential public health consequences of 
     use against the United States population of agents identified 
     under subparagraph (A)(ii); and
       ``(ii) determine, on the basis of such assessment, the 
     agents for which priority countermeasures are necessary to 
     protect the public health from a material threat.
       ``(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 security 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 
     security countermeasure would be appropriate, such 
     Secretaries may jointly submit to the President a proposal 
     to--
       ``(i) issue a call for the development of such security 
     countermeasure; and
       ``(ii) make a commitment that, upon the first development 
     of such security 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 security 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 security countermeasure 
     involved--
       ``(i) the call for the countermeasure;
       ``(ii) specifications for the countermeasure under 
     subparagraph (B); and
       ``(iii) a commitment described in subparagraph (A)(ii).
       ``(5) Secretary's determination of countermeasures 
     appropriate for funding from special reserve fund.--
       ``(A) In general.--The Secretary, in accordance with the 
     provisions of this paragraph, shall identify specific 
     security countermeasures that the Secretary determines, in 
     consultation with the Homeland Security Secretary, to be 
     appropriate for inclusion in the stockpile under subsection 
     (a) pursuant to procurements made with amounts in the special 
     reserve fund under paragraph (10) (referred to in this 
     subsection individually as a `procurement under this 
     subsection').
       ``(B) Requirements.--In making a determination under 
     subparagraph (A) with respect to a security countermeasure, 
     the Secretary shall determine and consider the following:
       ``(i) The quantities of the product that will be needed to 
     meet the needs of the stockpile.
       ``(ii) The feasibility of production and delivery within 
     five years of sufficient quantities of the product.
       ``(iii) Whether there is a lack of a significant commercial 
     market for the product at the time of procurement, other than 
     as a security countermeasure.
       ``(6) Recommendation for president's approval.--
       ``(A) Recommendation for procurement.--In the case of a 
     security countermeasure that the Secretary has, in accordance 
     with paragraphs (2), (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 congress.--The Secretary and the Homeland 
     Security Secretary shall notify the Congress of each decision 
     of the President to approve a recommendation under 
     subparagraph (A). Such notice shall include an explanation of 
     the decision to make available the special reserve fund under 
     paragraph (10) for procurement of such a countermeasure, 
     including, where available, the identification of the 
     potential supplier or suppliers of such countermeasure, and 
     whether other potential suppliers of the same or similar 
     countermeasures were considered and rejected for procurement 
     under this section and the reasons therefor.
       ``(D) Subsequent specific countermeasures.--Procurement 
     under this subsection of a security countermeasure for a 
     particular purpose does not preclude the subsequent 
     procurement under this subsection of any other security 
     countermeasure for such purpose if the Secretary has 
     determined under paragraph (5)(A) that such countermeasure is 
     appropriate for inclusion in the stockpile and if, as 
     determined by the Secretary, such countermeasure provides 
     improved safety or effectiveness, or for other reasons 
     enhances preparedness to respond to threats of use of a 
     biological, chemical, radiological, or nuclear agent. Such a 
     determination by the Secretary is committed to agency 
     discretion.
       ``(E) Rule of construction.--Recommendations and approvals 
     under this paragraph apply solely to determinations that the 
     special reserve fund under paragraph (10) will be made 
     available for a procurement of a security countermeasure, and 
     not to the substance of contracts for such procurement or 
     other matters relating to awards of such contracts.
       ``(7) Procurement.--
       ``(A) In general.--For purposes of a procurement under this 
     subsection that is approved by the President under paragraph 
     (6), the Homeland Security Secretary and the Secretary shall 
     have responsibilities in accordance with subparagraphs (B) 
     and (C).
       ``(B) Interagency agreements.--
       ``(i) For procurement.--The Homeland Security Secretary 
     shall enter into an agreement with the Secretary for 
     procurement of a security countermeasure in accordance with 
     the provisions of this paragraph. The special reserve fund 
     under paragraph (10) shall be available for the Secretary's 
     costs of such procurement, other than as provided in clause 
     (ii).
       ``(ii) For administrative costs.--The agreement entered 
     into between the Homeland Security Secretary and the 
     Secretary for managing

[[Page 18333]]

     the stockpile under subsection (a) shall provide for 
     reimbursement of the Secretary's administrative costs 
     relating to procurements under this subsection.
       ``(C) Procurement.--
       ``(i) In general.--The Secretary shall be responsible for--

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

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

       ``(I) Payment conditioned on substantial delivery.--The 
     contract shall provide that no payment may be made until 
     delivery has been made of a substantial portion (as 
     determined by the Secretary) of the total number of units 
     contracted for, except that, notwithstanding any other 
     provision of law, the contract may provide that, if the 
     Secretary determines (in the Secretary's discretion) that an 
     advance payment is necessary to ensure success of a project, 
     the Secretary may pay an amount, not to exceed 10 percent of 
     the contract amount, in advance of delivery. The contract 
     shall provide that such advance payment is required to be 
     repaid if there is a failure to perform under the contract, 
     except in special circumstances as determined by the 
     Secretary on a contract by contract basis.
       ``(II) Contract duration.--The contract shall be for a 
     period not to exceed five years, except that, in first 
     awarding the contract, the Secretary may provide for a longer 
     duration, not exceeding eight years, if the Secretary 
     determines that complexities or other difficulties in 
     performance under the contract justify such a period. The 
     contract shall be renewable for additional periods, none of 
     which shall exceed five years.

       ``(III) Storage by vendor.--The contract may provide that 
     the vendor will provide storage for stocks of a product 
     delivered to the ownership of the Federal Government under 
     the contract, for such period and under such terms and 
     conditions as the Secretary may specify, and in such case 
     amounts from the special reserve fund under paragraph (10) 
     shall be available for costs of shipping, handling, storage, 
     and related costs for such product.

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

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

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

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

       ``(aa) Chapter 37 of title 40, United States Code (relating 
     to contract work hours and safety standards).
       ``(bb) Subsections (a) and (b) of section 7 of the Anti-
     Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
       ``(cc) Section 304C of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 254d) 
     (relating to the examination of contractor records).
       ``(iv) Other than full and open competition.--(I) 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) The authority under subclause (I) is in addition to 
     any other authority to use procedures other than competitive 
     procedures.
       ``(III) The Secretary shall implement this clause in 
     accordance with applicable government-wide regulations, 
     including requirements that offers be solicited from as many 
     potential sources as is practicable under the circumstances, 
     that required notices be published, and that submitted offers 
     be considered.
       ``(v) Premium provision in multiple award contracts.--

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

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

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

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

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

       ``(a) Authorization of Appropriations.--For procurement of 
     security countermeasures under section 319F-2(c) of the 
     Public Health Service Act (referred to in this section as the 
     `security countermeasures program'), there is authorized to 
     be appropriated up to $5,593,000,000 for the fiscal years 
     2004 through 2013. Of the amounts appropriated under the 
     preceding sentence, not to exceed $3,418,000,000 may be 
     obligated during the fiscal years 2004 through 2008, of which 
     not to exceed $890,000,000 may be obligated during fiscal 
     year 2004.
       ``(b) Special Reserve Fund.--For purposes of the security 
     countermeasures program, the term `special reserve fund' 
     means the appropriations account established as a result of 
     any appropriations made under subsection (a).
       ``(c) Availability.--
       ``(1) Duration of availability for obligation.--Subject to 
     paragraph (2), all amounts appropriated under subsection (a) 
     are available for obligation through the end of fiscal year 
     2013, provided that any portion of such amount that remains 
     unobligated for such purposes on the expiration of such term 
     shall be returned to the United States Treasury and shall not 
     be available for subsequent obligation for any purpose.
       ``(2) Initial availability for particular procurements.--
     Amounts appropriated under subsection (a) become available 
     for a procurement under the security countermeasures program 
     only upon the approval by the President

[[Page 18334]]

     of such availability for the procurement in accordance with 
     paragraph (6)(B) of such program.''.
       (c) Conforming Amendments.--(1) 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 repealed.
       (2) The item relating to section 121 in the table of 
     contents (contained in section 1(b)) of such Act is repealed.
       (3) With respect to the program established under former 
     section 121 of such Act, the repeal of such section under 
     paragraph (1) applies as a modification of the program in 
     accordance with the amendment made by subsection (a) of this 
     section, and not as the termination of the program and the 
     establishment of a different program.

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

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

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

       ``(a) In General.--
       ``(1) Emergency uses.--Notwithstanding sections 505, 
     510(k), and 515 of this Act and section 351 of the Public 
     Health Service Act, and subject to the provisions of this 
     section, the Secretary may authorize the introduction into 
     interstate commerce, during the effective period of a 
     declaration under subsection (b), of a drug or device 
     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 `emergency use' has the meaning indicated 
     for such term in paragraph (1).
       ``(B) The term `product' means a drug or device.
       ``(C) The term `unapproved product' has the meaning 
     indicated for such term in paragraph (2)(A).
       ``(D) The term `unapproved use of an approved product' has 
     the meaning indicated for such term in paragraph (2)(B).
       ``(b) Declaration of Emergency.--
       ``(1) In general.--The Secretary may declare an emergency 
     justifying the authorization under this subsection for a 
     product on the basis of--
       ``(A) a determination by the Secretary of Homeland Security 
     that there is a national emergency, or a significant 
     potential for a national emergency, involving a heightened 
     risk of attack with a specified biological, chemical, 
     radiological, or nuclear agent or agents;
       ``(B) a determination by the Secretary of Defense that 
     there is a military emergency, or a significant potential for 
     a military emergency, involving a heightened risk to United 
     States military forces of attack with a biological, chemical, 
     radiological, or nuclear agent or agents; or
       ``(C) a determination by the Secretary of a public health 
     emergency under section 319 of the Public Health Service Act, 
     affecting national security and involving a specified 
     biological, chemical, radiological, or nuclear agent or 
     agents, or a specified disease or condition that may be 
     attributable to such agent or agents.
       ``(2) Termination of declaration.--
       ``(A) In general.--A declaration under this subsection 
     shall terminate upon the earlier of--
       ``(i) a determination by the Secretary, in consultation as 
     appropriate with the Secretary of Homeland Security or the 
     Secretary of Defense, that the circumstances described in 
     paragraph (1) have ceased to exist; or
       ``(ii) the expiration of the one-year period beginning on 
     the date on which the declaration is made.
       ``(B) Renewal.--Notwithstanding subparagraph (A), the 
     Secretary may renew a declaration under this subsection, and 
     this paragraph shall apply to any such renewal.
       ``(3) Advance notice of termination.--In terminating a 
     declaration under this section, the Secretary shall provide 
     advance notice that the declaration will be terminated. The 
     period of advance notice shall be a period reasonably 
     determined to provide--
       ``(A) in the case of an unapproved product, a sufficient 
     period for disposition of shipments of the product, including 
     the return of such shipments to the manufacturer (in the case 
     of a manufacturer that chooses to have the shipments 
     returned); and
       ``(B) in the case of unapproved uses of approved products, 
     a sufficient period for the disposition of any labeling that 
     was provided with respect to the emergency use involved.
       ``(4) Publication.--The Secretary shall promptly publish in 
     the Federal Register each declaration, determination, and 
     renewal under this subsection.
       ``(c) Criteria for Issuance of Authorization.--The 
     Secretary may issue an authorization under this section with 
     respect to the emergency use of a product only if, after 
     consultation with the Director of the National Institutes of 
     Health and the Director of the Centers for Disease Control 
     and Prevention, to the extent feasible and appropriate given 
     the circumstances of the emergency involved, the Secretary 
     concludes--
       ``(1) that an agent specified in a declaration under 
     subsection (b) can cause a serious or life-threatening 
     disease or condition;
       ``(2) that, based on the totality of scientific evidence 
     available to the Secretary, including data from adequate and 
     well-controlled clinical trials, if available, it is 
     reasonable to believe that--
       ``(A) the product may be effective in detecting, 
     diagnosing, treating, or preventing--
       ``(i) such disease or condition; or
       ``(ii) a serious or life-threatening disease or condition 
     caused by a product authorized under this section or approved 
     under this Act or the Public Health Service Act, for 
     detecting, diagnosing, treating, or preventing such a disease 
     or condition caused by such an agent; and
       ``(B) the known and potential benefits of the product, when 
     used to detect, diagnose, prevent, or treat such disease or 
     condition, outweigh the known and potential risks of the 
     product;
       ``(3) that there is no adequate, approved, and available 
     alternative to the product for detecting, diagnosing, 
     preventing, or treating such disease or condition; and
       ``(4) that such other criteria as the Secretary may by 
     regulation prescribe are satisfied.
       ``(d) Scope of Authorization.--
       ``(1) In general.--An authorization of a product under this 
     section shall state--
       ``(A) each disease or condition that the product may be 
     used to detect, diagnose, prevent, or treat within the scope 
     of the authorization;
       ``(B) the Secretary's conclusions, made under subsection 
     (c)(2)(B), that the known and potential benefits of the 
     product, when used to detect, diagnose, prevent, or treat 
     such disease or condition, outweigh the known and potential 
     risks of the product; and
       ``(C) the Secretary's conclusions, made under subsection 
     (c), concerning the safety and potential effectiveness of the 
     product in detecting, diagnosing, preventing, or treating 
     such diseases or conditions, including an assessment of the 
     available scientific evidence.
       ``(2) Confidential information.--Nothing in this section 
     alters or amends section 1905 of title 18, United States 
     Code, or section 552(b)(4) of title 5 of such Code.
       ``(e) Conditions of Authorization.--
       ``(1) Unapproved product.--
       ``(A) Required conditions.--With respect to the emergency 
     use of an unapproved product, the Secretary, to the extent 
     feasible given the circumstances of the emergency, shall, for 
     persons who choose to carry out one or more activities for 
     which the authorization is issued, establish such conditions 
     on an authorization under this section as the Secretary finds 
     necessary or appropriate to protect the public health, 
     including the following:
       ``(i) Appropriate conditions designed to ensure that, to 
     the extent feasible given the circumstances of the emergency, 
     health care professionals administering the product are 
     informed--

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

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

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

       ``(iii) Appropriate conditions for the monitoring and 
     reporting of adverse events associated with the emergency use 
     of the product.
       ``(iv) For manufacturers of the product, appropriate 
     conditions concerning recordkeeping and reporting, including 
     records access by the Secretary, with respect to the 
     emergency use of the product.
       ``(B) Authority for additional conditions.--With respect to 
     the emergency use of an unapproved product, the Secretary, to 
     the extent feasible given the circumstances of the emergency, 
     may, for persons who choose to carry out one or more 
     activities for which the authorization is issued, establish 
     such conditions on an authorization under this section as the 
     Secretary finds necessary or appropriate to protect the 
     public health, including the following:
       ``(i) Appropriate conditions on which entities may 
     distribute the product with respect to the emergency use of 
     the product (including limitation to distribution by 
     government entities), and on how distribution is to be 
     performed.
       ``(ii) Appropriate conditions on who may administer the 
     product with respect to the emergency use of the product, and 
     on the categories of individuals to whom, and the 
     circumstances under which, the product may be administered 
     with respect to such use.

[[Page 18335]]

       ``(iii) For persons other than manufacturers of the 
     product, appropriate conditions concerning recordkeeping and 
     reporting, including records access by the Secretary, with 
     respect to the emergency use of the product.
       ``(iv) With respect to the emergency use of the product, 
     waive or limit, to the extent appropriate given the 
     circumstances of the emergency, conditions regarding current 
     good manufacturing practice otherwise applicable to the 
     manufacture, processing, packing, or holding of products 
     subject to regulation under this Act, including such 
     requirements established in section 501.
       ``(2) Unapproved use.--With respect to the emergency use of 
     a product that is an unapproved use of an approved product:
       ``(A) The Secretary may, for manufacturers of the product 
     who choose to carry out one or more activities for which the 
     authorization is issued, establish any of the conditions 
     described in clauses (i) through (iv) of paragraph (1)(A).
       ``(B)(i) If the authorization under this section regarding 
     the emergency use authorizes a change in the labeling of the 
     product, but the manufacturer of the product chooses not to 
     make such change, such authorization may not authorize 
     distributors of the product or any other person to alter or 
     obscure the labeling provided by the manufacturer.
       ``(ii) In the circumstances described in clause (i), an 
     authorization under this section regarding the emergency use 
     may, for persons who do not manufacture the product and who 
     choose to act under this clause, authorize such persons to 
     provide information on the product in addition to the 
     labeling provided by the manufacturer, subject to compliance 
     with clause (i). Such additional information shall not be 
     considered labeling for purposes of section 502.
       ``(f) Duration of Authorization.--
       ``(1) In general.--Except as provided in paragraph (2), an 
     authorization under this section shall be effective until the 
     earlier of the termination of the declaration under 
     subsection (b) or a revocation under subsection (g).
       ``(2) Continued use after end of effective period.--An 
     authorization shall continue to be effective for continued 
     use with respect to patients to whom it was administered 
     during the period described by paragraph (1), to the extent 
     found necessary by such patients' attending physicians.
       ``(g) Revocation of Authorization.--
       ``(1) Review.--The Secretary shall periodically review the 
     circumstances and the appropriateness of an authorization 
     under this section.
       ``(2) Revocation.--The Secretary may revoke an 
     authorization under this section if, in the Secretary's 
     unreviewable discretion, the criteria under subsection (c) 
     for issuance of such authorization are no longer met.
       ``(h) Publication.--The Secretary shall promptly publish in 
     the Federal Register a notice of each authorization, and each 
     termination or revocation of an authorization, and an 
     explanation of the reasons therefor, under this section.
       ``(i) Actions Committed to Agency Discretion.--Actions 
     under the authority of this section by the Secretary, by the 
     Secretary of Defense, or by the Secretary of Homeland 
     Security are committed to agency discretion.
       ``(j) Rules of Construction.--Nothing in this section shall 
     be construed to impair or otherwise affect--
       ``(1) the authority of the President as Commander in Chief 
     of the Armed Forces of the United States under article II, 
     section 2 of the United States Constitution;
       ``(2) the authority of the Secretary of Defense with 
     respect to the Department of Defense, including the armed 
     forces, under other provisions of Federal law; or
       ``(3) the authority of the Secretary under section 319F-2 
     to manage the stockpile under such section.
       ``(k) Application to Members of Armed Forces.--
       ``(1) Waiver of requirement relating to option to refuse.--
     In the case of administration of a countermeasure to members 
     of the armed forces, a requirement, under subsection 
     (e)(1)(A)(ii)(III), designed to ensure that individuals are 
     informed of an option to accept or refuse administration of a 
     product, may be waived by the President if the President 
     determines, in writing, that complying with such requirement 
     is not feasible, is contrary to the best interests of the 
     members affected, or is not in the interests of national 
     security.
       ``(2) Provision of information to member of the armed 
     forces.--If the Secretary makes a determination that it is 
     not feasible for the information required by subsection 
     (e)(1)(A)(ii) to be provided to a member of the armed forces 
     prior to the administration of the product, such information 
     shall be provided to such member of the armed forces (or 
     next-of-kin in the case of the death of a member) to whom the 
     product was administered as soon as possible, but not later 
     than 30 days, after such administration. Information 
     concerning the administration of the product shall be 
     recorded in the medical record of the member.
       ``(3) Effect on statute pertaining to investigational new 
     drugs.--In the case of an authorization based on a 
     determination by the Secretary of Defense under subsection 
     (b)(1)(B), section 1107 of title 10, United States Code, 
     shall not apply to use of a product that is the subject of 
     such authorization, within the scope of such authorization 
     and while such authorization is effective.
       ``(l) Relation to Other Provisions.--If a product is the 
     subject of an authorization under this section, the use of 
     such product within the scope of the authorization--
       ``(1) shall not be subject to any requirements pursuant to 
     section 505(i) or 520(g); and
       ``(2) shall not be subject to any requirements otherwise 
     applicable to clinical investigations pursuant to other 
     provisions of this Act.
       ``(m) Discretion Regarding Use of Authorization.--Nothing 
     in this section provides the Secretary any authority to 
     require any person to carry out any activity that becomes 
     lawful pursuant to an authorization under this section, and 
     no person is required to inform the Secretary that the person 
     will not be carrying out such activity, except that a 
     manufacturer of a sole-source unapproved product authorized 
     for emergency use shall notify the Secretary within a 
     reasonable period of time after the issuance by the Secretary 
     of such authorization if such manufacturer does not intend to 
     carry out an activity or activities under the authorization. 
     This section does not have any legal effect on a person who 
     does not carry out any activity for which an authorization 
     under this section is issued, or who carries out such an 
     activity pursuant to other provisions of this Act or section 
     351 of the Public Health Service Act.
       ``(n) Enforcement.--A person who carries out an activity 
     pursuant to an authorization under this section, but who 
     fails to comply with applicable conditions under subsection 
     (e), is with respect to that act of noncompliance subject to 
     the provisions of law specified in subsection (a) and to the 
     enforcement of such provisions under section 301.''.

     SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

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

       (I) Subsection (b)(1) (relating to increased simplified 
     acquisition threshold).
       (II) Subsection (b)(2) (relating to use of noncompetitive 
     procedures).
       (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 use of 
     noncompetitive procedures).
       (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 Congress 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; and
       (iii) the identification of each person or entity that 
     received, or was considered and rejected for, grants, 
     cooperative agreements, or contracts pursuant to the use of 
     such authorities.
       (2) Annual summaries regarding certain activity.--The 
     Secretary shall annually submit to the Congress a report that 
     summarizes the activity undertaken pursuant to the following 
     authorities under section 319F-1 of the Public Health Service 
     Act (as added by section 2 of this Act):
       (A) Subsection (b)(3) (relating to increased micropurchase 
     threshold).
       (B) Subsection (d) (relating to authority for personal 
     services contracts).
       (C) Subsection (e) (relating to streamlined personnel 
     authority).
     With respect to subparagraph (B), the report shall include a 
     provision specifying, for the one-year period for which the 
     report is submitted, the number of persons who were paid 
     amounts greater than $100,000 and the number of persons who 
     were paid amounts between $50,000 and $100,000.
       (b) National Academy of Sciences Review.--Not later than 
     three years after the date of the enactment of this Act, the 
     Secretary of Health and Human Services shall request the 
     National Academy of Sciences to enter into an agreement for a 
     review of the biomedical countermeasure research and 
     development authorities established in this Act to determine 
     whether and to what extent activities undertaken pursuant to 
     such authorities have enhanced the development of biomedical 
     countermeasures affecting national security, and to recommend 
     any legislative or administrative changes necessary to 
     improve the ability of the Secretary to carry out these 
     activities in the future. The Secretary shall ensure that the 
     results of the study are

[[Page 18336]]

     submitted to the Congress not later than five years after 
     such date of enactment.
       (c) General Accounting Office Review.--Four years after the 
     date of the enactment of this Act, the Comptroller General of 
     the United States shall initiate a study--
       (1)(A) to review the Secretary of Health and Human 
     Services' utilization of the authorities granted under this 
     Act with respect to simplified acquisition procedures, use of 
     noncompetitive procedures, increased micropurchase 
     thresholds, personal services contracts, streamlined 
     personnel authority, and the purchase of security 
     countermeasures under the special reserve fund; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authorities in the future;
       (2)(A) to review the internal controls instituted by such 
     Secretary with respect to such authorities, where required by 
     this Act; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the effectiveness of such controls; and
       (3)(A) to review such Secretary's utilization of the 
     authority granted under this Act to authorize an emergency 
     use of a biomedical countermeasure, including the means by 
     which the Secretary determines whether and under what 
     conditions any such authorizations should be granted and the 
     benefits and adverse impacts, if any, resulting from the use 
     of such authority; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authority and to enhance protection of the public health.
     The results of the study shall be submitted to the Congress 
     not later than five years after the date of the enactment of 
     this Act.

     SECTION 1. SHORT TITLE.

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

     SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT--
                   AUTHORITIES.

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

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

       ``(a) In General.--
       ``(1) Authority--In conducting and supporting research and 
     development activities regarding biomedical countermeasures 
     under section 319F(h), the Secretary may conduct and support 
     such activities in accordance with this section if the 
     activities concern qualified countermeasures.
       ``(2) Qualified countermeasure--For purposes of this 
     section, the term `qualified countermeasure' means a priority 
     countermeasure (as defined in section 319F(h)) that affects 
     national security.
       ``(3) Interagency cooperation--
       ``(A) In general--In carrying out activities under this 
     section, the Secretary is authorized, subject to subparagraph 
     (B), to enter into interagency agreements and other 
     collaborative undertakings with other agencies of the United 
     States Government.
       ``(B) Limitation--An agreement or undertaking under this 
     paragraph shall not authorize another agency to exercise the 
     authorities provided by this section.
       ``(4) Availability of facilities to the secretary--In any 
     grant 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, and 
     supporting qualified countermeasure research and development, 
     the Secretary may provide that the facility that is the 
     object of such grant or cooperative agreement shall be 
     available as needed to the Secretary to respond to public 
     health emergencies affecting national security.
       ``(b) Expedited Procurement Authority--
       ``(1) Increased simplified acquisition threshold for 
     biomedical countermeasure procurements--
       ``(A) In general--For any procurement by the Secretary of 
     property or services for use (as determined by the Secretary) 
     in performing, administering, or supporting qualified 
     countermeasure research or development activities under this 
     section that the Secretary determines necessary to respond to 
     pressing research and development needs under this section, 
     the amount specified in section 4(11) of the Office of 
     Federal Procurement Policy Act (41 U.S.C. 403(11)), as 
     applicable pursuant to section 302A(a) of the Federal 
     Property and Administrative Services Act of 1949 (41 U.S.C. 
     252a(a)), shall be deemed to be $25,000,000 in the 
     administration, with respect to such procurement, of--
       ``(i) section 303(g)(1)(A) of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) 
     and its implementing regulations; and
       ``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and 
     its implementing regulations.
       ``(B) Application of certain provisions--Notwithstanding 
     subparagraph (A) and the provision of law and regulations 
     referred to in such subparagraph, each of the following 
     provisions shall apply to procurements described in this 
     paragraph to the same extent that such provisions would apply 
     to such procurements in the absence of subparagraph (A):
       ``(i) Chapter 37 of title 40, United States Code (relating 
     to contract work hours and safety standards).
       ``(ii) Subsections (a) and (b) of Section 7 of the Anti-
     Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
       ``(iii) Section 304C of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 254d) 
     (relating to the examination of contractor records).
       ``(C) Internal controls to be instituted--The Secretary 
     shall institute appropriate internal controls for 
     procurements that are under this paragraph, including 
     requirements with regard to documenting the justification for 
     use of the authority in this paragraph.
       ``(2) Use of noncompetitive procedures--In addition to any 
     other authority to use procedures other than competitive 
     procedures, the Secretary may use such other procedures 
     when--
       ``(A) the procurement is as described by paragraph (1); and
       ``(B) the property or services needed by the Secretary 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 Secretary's needs.
       ``(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.
       ``(c) Authority To Expedite Peer Review--
       ``(1) In general--The Secretary may, as the Secretary 
     determines necessary to respond to pressing qualified 
     countermeasure research and development needs under this 
     section, employ such expedited peer review procedures 
     (including consultation with appropriate scientific experts) 
     as the Secretary, in consultation with the Director of NIH, 
     deems appropriate to obtain assessment of scientific and 
     technical merit and likely contribution to the field of 
     qualified countermeasure research, in place of the peer 
     review and advisory council review procedures that would be 
     required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 
     406(a)(3)(A), 492, and 494, as applicable to a grant, 
     contract, or cooperative agreement--
       ``(A) that is for performing, administering, or supporting 
     qualified countermeasure research and development activities; 
     and
       ``(B) the amount of which is not greater than $1,500,000.
       ``(2) Subsequent phases of research--The Secretary's 
     determination of whether to employ expedited peer review with 
     respect to subsequent phases of a research grant 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 or cooperative 
     agreement.
       ``(d) Authority for Personal Services Contracts--
       ``(1) In general--For the purpose of performing, 
     administering, and supporting qualified countermeasure 
     research and development activities, the Secretary may, as 
     the Secretary determines necessary to respond to pressing 
     qualified countermeasure research and development needs under 
     this section, obtain by contract (in accordance with section 
     3109 of title 5, United States Code, but without regard to 
     the limitations in such section on the period of service and 
     on pay) the personal services of experts or consultants who 
     have scientific or other professional qualifications, 
     except that in no case shall the compensation provided to 
     any such expert or consultant exceed the daily equivalent 
     of the annual rate of compensation for the President.
       ``(2) Federal tort claims act coverage--
       ``(A) In general--A person carrying out a contract under 
     paragraph (1), and an officer, employee, or governing board 
     member of such person, shall be deemed to be an employee of 
     the Department of Health and Human Services for purposes of 
     claims under sections 1346(b) and 2672 of title 28, United 
     States Code, for money damages for personal injury, including 
     death, resulting from performance of functions under such 
     contract.
       ``(B) Exclusivity of remedy--The remedy provided by 
     subparagraph (A) shall be exclusive of any other civil action 
     or proceeding by reason of the same subject matter against 
     the person, officer, employee, or governing board member.
       ``(3) Internal controls to be instituted--

[[Page 18337]]

       ``(A) In general--The Secretary shall institute appropriate 
     internal controls for contracts under this subsection, 
     including procedures for the Secretary to make a 
     determination of whether a person, or an officer, employee, 
     or governing board member of a person, is deemed to be an 
     employee of the Department of Health and Human Services 
     pursuant to paragraph (2).
       ``(B) Determination of employee status to be final--A 
     determination by the Secretary under subparagraph (A) that a 
     person, or an officer, employee, or governing board member of 
     a person, is or is not deemed to be an employee of the 
     Department of Health and Human Services shall be final and 
     binding on the Secretary and the Attorney General and other 
     parties to any civil action or proceeding.
       ``(4) Number of personal services contracts limited--The 
     number of experts and consultants whose personal services are 
     obtained under paragraph (1) shall not exceed 30 at any time.
       ``(e) Streamlined Personnel Authority--
       ``(1) In general--In addition to any other personnel 
     authorities, the Secretary may, as the Secretary determines 
     necessary to respond to pressing qualified countermeasure 
     research and development needs under this section, without 
     regard to such provisions of title 5, United States Code, 
     governing appointments in the competitive service, and 
     without regard to the provisions of chapter 51 and subchapter 
     III of chapter 53 of such title relating to classification 
     and General Schedule pay rates, appoint professional and 
     technical employees, not to exceed 30 such employees at any 
     time, to positions in the National Institutes of Health to 
     perform, administer, or support qualified countermeasure 
     research and development activities in carrying out this 
     section.
       ``(2) Internal controls to be instituted--The Secretary 
     shall institute appropriate internal controls for 
     appointments under this subsection.
       ``(f) Actions Committed to Agency Discretion--Actions by 
     the Secretary under the authority of this section are 
     committed to agency discretion.''.
       (b) Technical Amendment--Section 481A of the Public Health 
     Service Act (42 U.S.C. 287a-2) is amended--
       (1) in subsection (a)(1), 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 fiscal year 2003.''.

     SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

       (a) In General--Part B of title III of the Public Health 
     Service Act, as amended by section 2 of this Act, is amended 
     by inserting after section 319F-1 the following section:

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

       ``(a) Strategic National Stockpile--
       ``(1) In general--The Secretary of Homeland Security 
     (referred to in this section as the `Homeland Security 
     Secretary'), in coordination with the Secretary and the 
     Secretary of Veterans Affairs, shall maintain a stockpile or 
     stockpiles of drugs, vaccines and other biological products, 
     medical devices, and other supplies in such numbers, types, 
     and amounts as are determined by the Secretary to be 
     appropriate and practicable, taking into account other 
     available sources, to provide for the emergency health 
     security of the United States, including the emergency health 
     security of children and other vulnerable populations, in the 
     event of a bioterrorist attack or other public health 
     emergency.
       ``(2) Procedures--The Secretary, in managing the stockpile 
     under paragraph (1), shall--
       ``(A) consult with the working group under section 319F(a);
       ``(B) ensure that adequate procedures are followed with 
     respect to such stockpile for inventory management and 
     accounting, and for the physical security of the stockpile;
       ``(C) in consultation with Federal, State, and local 
     officials, take into consideration the timing and location of 
     special events;
       ``(D) review and revise, as appropriate, the contents of 
     the stockpile on a regular basis to ensure that emerging 
     threats, advanced technologies, and new countermeasures are 
     adequately considered;
       ``(E) devise plans for the effective and timely supply-
     chain management of the stockpile, in consultation with 
     appropriate Federal, State and local agencies, and the public 
     and private health care infrastructure; and
       ``(F) ensure the adequate physical security of the 
     stockpile.
       ``(b) Smallpox Vaccine Development--
       ``(1) In general--The Secretary shall award contracts, 
     enter into cooperative agreements, or carry out such other 
     activities as may reasonably be required in order to ensure 
     that the stockpile under subsection (a) includes an amount of 
     vaccine against smallpox as determined by such Secretary to 
     be sufficient to meet the health security needs of the United 
     States.
       ``(2) Rule of construction--Nothing in this section shall 
     be construed to limit the private distribution, purchase, or 
     sale of vaccines from sources other than the stockpile 
     described in subsection (a).
       ``(c) Additional Authority Regarding Procurement of Certain 
     Biomedical Countermeasures; Availability of Special Reserve 
     Fund--
       ``(1) In general--
       ``(A) Use of fund--A security countermeasure may, in 
     accordance with this subsection, be procured with amounts in 
     the special reserve fund under paragraph (10).
       ``(B) Security countermeasure--For purposes of this 
     subsection, the term `security countermeasure' means a 
     priority countermeasure (as defined in section 319F(h))--
       ``(i) against a chemical, biological, radiological, or 
     nuclear agent identified as a material threat under paragraph 
     (2)(A)(ii);
       ``(ii) that is determined under paragraph (2)(B)(ii) to be 
     a necessary countermeasure;
       ``(iii) that is designed, developed, modified, or procured 
     for the specific purpose of preventing, detecting, 
     identifying, deterring, or mitigating actual or potential 
     acts of chemical, biological, radiological, or nuclear 
     catastrophe;
       ``(iv)(I) that is approved or cleared under chapter V of 
     the Federal Food, Drug, and Cosmetic Act, or licensed under 
     section 351 of this Act, for use as a countermeasure to a 
     chemical, biological, radiological, or nuclear agent 
     identified as a material threat under paragraph (2)(A)(ii); 
     or
       ``(II) for which the Secretary determines that sufficient 
     and satisfactory clinical experience or research data 
     (including data, if available, from pre-clinical and clinical 
     trials) support a reasonable conclusion that the 
     countermeasure will qualify for approval or licensing after 
     the date of a determination under paragraph (5); and
       ``(v) that relates to an actual or potential act of 
     terrorism or catastrophic event or to actual or potential 
     warfare.
       ``(2) Determination of material threats--
       ``(A) Material threat--The Homeland Security Secretary, in 
     consultation with the heads of other agencies as appropriate, 
     shall on an ongoing basis--
       ``(i) assess current and emerging threats of chemical, 
     biological, radiological, and nuclear agents; and
       ``(ii) determine which of such agents present a material 
     threat against the United States population.
       ``(B) Public health impact; necessary countermeasures--The 
     Secretary shall on an ongoing basis--
       ``(i) assess the potential public health consequences of 
     use against the United States population of agents identified 
     under subparagraph (A)(ii); and
       ``(ii) determine, on the basis of such assessment, the 
     agents for which priority countermeasures are necessary to 
     protect the public health from a material threat.
       ``(C) Notice to congress--The Secretary and the Homeland 
     Security Secretary shall promptly notify the designated 
     congressional committees (as defined in paragraph (10)) of 
     any determination made pursuant to subparagraph (A) or (B). 
     Such notice shall be in unclassified and, if necessary, 
     classified form.
       ``(D) Assuring access to threat information--In making the 
     assessment and determination required under subparagraph (A), 
     the Homeland Security Secretary shall use

[[Page 18338]]

     all information to which such Secretary is entitled under 
     section 202 of the Homeland Security Act of 2002, including 
     but not limited to information, regardless of its level of 
     classification, relating to current and emerging threats of 
     chemical, biological, radiological, and nuclear agents.
       ``(3) Assessment of availability and appropriateness of 
     countermeasures--The Secretary, in consultation with the 
     Homeland Security Secretary, shall assess on an ongoing basis 
     the availability and appropriateness of specific 
     countermeasures to address specific threats identified under 
     paragraph (2).
       ``(4) Call for development of countermeasures; commitment 
     for recommendation for procurement--
       ``(A) Proposal to the president--If, pursuant to an 
     assessment under paragraph (3), the Homeland Security 
     Secretary and the Secretary make a determination that a 
     countermeasure would be appropriate but is either currently 
     unavailable for procurement or available under unsuitable 
     conditions, 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) a commitment described in subparagraph (A)(ii).
       ``(5) Secretary's determination of countermeasures 
     appropriate for funding from special reserve fund--
       ``(A) In general--The Secretary, in accordance with the 
     provisions of this paragraph, shall identify specific 
     security countermeasures that the Secretary determines, in 
     consultation with the Homeland Security Secretary, to be 
     appropriate for inclusion in the stockpile under subsection 
     (a) pursuant to procurements made with amounts in the special 
     reserve fund under paragraph (10) (referred to in this 
     subsection individually as a `procurement under this 
     subsection').
       ``(B) Requirements--In making a determination under 
     subparagraph (A) with respect to a security countermeasure, 
     the Secretary shall determine and consider the following:
       ``(i) The quantities of the product that will be needed to 
     meet the needs of the stockpile.
       ``(ii) The feasibility of production and delivery within 
     five years of sufficient quantities of the product.
       ``(iii) Whether there is a lack of a significant commercial 
     market for the product at the time of procurement, other than 
     as a security countermeasure.
       ``(6) Recommendation for president's approval--
       ``(A) Recommendation for procurement--In the case of a 
     security countermeasure that the Secretary has, in accordance 
     with paragraphs (2), (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 congress--The Secretary and the Homeland 
     Security Secretary shall notify the designated congressional 
     committees of each decision of the President to approve a 
     recommendation under subparagraph (A). Such notice shall 
     include an explanation of the decision to make available the 
     special reserve fund under paragraph (10) for procurement of 
     such a countermeasure, including, where available, the 
     identification of the potential supplier or suppliers of such 
     countermeasure, and whether other potential suppliers of the 
     same or similar countermeasures were considered and rejected 
     for procurement under this section and the reasons therefor.
       ``(D) Subsequent specific countermeasures--Procurement 
     under this subsection of a security countermeasure for a 
     particular purpose does not preclude the subsequent 
     procurement under this subsection of any other security 
     countermeasure for such purpose if the Secretary has 
     determined under paragraph (5)(A) that such countermeasure is 
     appropriate for inclusion in the stockpile and if, as 
     determined by the Secretary, such countermeasure provides 
     improved safety or effectiveness, or for other reasons 
     enhances preparedness to respond to threats of use of a 
     biological, chemical, radiological, or nuclear agent. Such a 
     determination by the Secretary is committed to agency 
     discretion.
       ``(E) Rule of construction--Recommendations and approvals 
     under this paragraph apply solely to determinations that the 
     special reserve fund under paragraph (10) will be made 
     available for a procurement of a security countermeasure, and 
     not to the substance of contracts for such procurement or 
     other matters relating to awards of such contracts.
       ``(7) Procurement--
       ``(A) In general--For purposes of a procurement under this 
     subsection that is approved by the President under paragraph 
     (6), the Homeland Security Secretary and the Secretary shall 
     have responsibilities in accordance with subparagraphs (B) 
     and (C).
       ``(B) Interagency agreements--
       ``(i) For procurement--The Homeland Security Secretary 
     shall enter into an agreement with the Secretary for 
     procurement of a security countermeasure in accordance with 
     the provisions of this paragraph. The special reserve fund 
     under paragraph (10) shall be available for the Secretary's 
     costs of such procurement, other than as provided in clause 
     (ii).
       ``(ii) For administrative costs--The agreement entered into 
     between the Homeland Security Secretary and the Secretary for 
     managing the stockpile under subsection (a) shall provide for 
     reimbursement of the Secretary's administrative costs 
     relating to procurements under this subsection.
       ``(C) Procurement--
       ``(i) In general--The Secretary shall be responsible for--

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

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

       ``(I) Payment conditioned on substantial delivery--The 
     contract shall provide that no payment may be made until 
     delivery has been made of a substantial portion (as 
     determined by the Secretary) of the total number of units 
     contracted for, except that, notwithstanding any other 
     provision of law, the contract may provide that, if the 
     Secretary determines (in the Secretary's discretion) that an 
     advance payment is necessary to ensure success of a project, 
     the Secretary may pay an amount, not to exceed 10 percent of 
     the contract amount, in advance of delivery. The contract 
     shall provide that such advance payment is required to be 
     repaid if there is a failure to perform under the contract, 
     except in special circumstances as determined by the 
     Secretary on a contract by contract basis.
       ``(II) Contract duration--The contract shall be for a 
     period not to exceed five years, except that, in first 
     awarding the contract, the Secretary may provide for a longer 
     duration, not exceeding eight years, if the Secretary 
     determines that complexities or other difficulties in 
     performance under the contract justify such a period. The 
     contract shall be renewable for additional periods, none of 
     which shall exceed five years.
       ``(III) Storage by vendor--The contract may provide that 
     the vendor will provide storage for stocks of a product 
     delivered to the ownership of the Federal Government under 
     the contract, for such period and under such terms and 
     conditions as the Secretary may specify, and in such case 
     amounts from the special reserve fund under paragraph (10) 
     shall be available for costs of shipping, handling, storage, 
     and related costs for such product.
       ``(IV) Non-stockpile sales of security countermeasures--The 
     contract may provide that the vendor will not at any time 
     (including after performance under the contract is otherwise 
     completed) sell or otherwise provide such countermeasure to 
     any domestic or foreign person, or transfer to any such 
     person any quantity of such security countermeasure, or any 
     intellectual property relating thereto that would enable the 
     development or production of the countermeasure, without 
     certification by the Secretary, in consultation with the 
     Homeland Security

[[Page 18339]]

     Secretary, the Secretary of Defense, and the Secretary of 
     State, that such sale or transfer, or category of sales or 
     transfers, would not adversely affect the national security; 
     and that, for each violation of this provision of the 
     contract, the United States is entitled to recover from the 
     person as liquidated damages an amount equal to three times 
     the sum of the payments made to the vendor under the 
     contract.

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

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

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

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

       ``(aa) Chapter 37 of title 40, United States Code (relating 
     to contract work hours and safety standards).
       ``(bb) Subsections (a) and (b) of Section 7 of the Anti-
     Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
       ``(cc) Section 304C of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 254d) 
     (relating to the examination of contractor records).
       ``(iv) Use of noncompetitive procedures--In addition to any 
     other authority to use procedures other than competitive 
     procedures, the Secretary may use such other procedures for a 
     procurement under this subsection if the product is available 
     from only one responsible source or only from a limited 
     number of responsible sources, and no other type of product 
     will satisfy the Secretary's needs.
       ``(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 pays one or more specified premiums 
     based on the priority of such vendors' production and 
     delivery of the increment identified under item (aa), in 
     accordance with the terms and conditions of the contract.

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

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

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

       ``(a) Authorization of Appropriations--For the procurement 
     of security countermeasures under section 319F-2(c) of the 
     Public Health Service Act (referred to in this section as the 
     `security countermeasures program'), there is authorized to 
     be appropriated up to $5,593,000,000 for the fiscal years 
     2004 through 2013. Of the amounts appropriated under the 
     preceding sentence, not to exceed $3,418,000,000 may be 
     obligated during the fiscal years 2004 through 2008, of which 
     not to exceed $890,000,000 may be obligated during fiscal 
     year 2004.
       ``(b) Special Reserve Fund--For purposes of the security 
     countermeasures program, the term `special reserve fund' 
     means the appropriations account established as a result of 
     any appropriations made under subsection (a).
       ``(c) Availability--
       ``(1) Integrity of special reserve fund; limitation of 
     obligational authority to fund purposes; intent of congress 
     against reprogramming--Subject to paragraph (2), all amounts 
     appropriated under subsection (a) are available for 
     obligation through the end of fiscal year 2013 and only for 
     the specific purposes set forth in the security 
     countermeasures program. It is the intent of the Congress 
     that no portion of such amount that remains unobligated for 
     such purposes shall be applied, through reprogramming or 
     otherwise, to any other purpose.
       ``(2) Initial availability for particular procurements--
     Amounts appropriated under subsection (a) become available 
     for a procurement under the security countermeasures program 
     only upon the approval by the President of such availability 
     for the procurement in accordance with paragraph (6)(B) of 
     such program.
       ``(d) Related Authorizations of Appropriations--
       ``(1) Threat assessment capabilities--For the purpose of 
     carrying out the responsibilities of the Secretary for terror 
     threat assessment under the security countermeasures program, 
     there are authorized to be appropriated $5,000,000 for fiscal 
     year 2004, and such sums as may be necessary for each of the 
     fiscal years 2005 and 2006, for the hiring of professional 
     personnel within the Directorate for Information Analysis and 
     Infrastructure Protection, who shall be analysts responsible 
     for chemical, biological, radiological, and nuclear threat 
     assessment (including but not limited to analysis of 
     chemical, biological, radiological, and nuclear agents, the 
     means by which such agents could be weaponized or used in a 
     terrorist attack, and the capabilities, plans, and intentions 
     of terrorists and other non-state actors who may have or 
     acquire such agents). All such analysts shall meet the 
     applicable standards and qualifications for the performance 
     of intelligence activities promulgated by the Director of 
     Central Intelligence pursuant to section 104 of the National 
     Security Act of 1947.
       ``(2) Intelligence sharing infrastructure--For the purpose 
     of carrying out the acquisition and deployment of secure 
     facilities (including information technology and physical 
     infrastructure, whether mobile and temporary, or permanent) 
     sufficient to permit the Secretary to receive, not later than 
     December 31, 2003, all classified information

[[Page 18340]]

     and products to which the Under Secretary for Information 
     Analysis and Infrastructure Protection is entitled under 
     subtitle A of title II, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2003 through 2006.
       ``(e) Emergency Development of Security Countermeasures--If 
     the Secretary of Homeland Security and the Secretary of 
     Health and Human Services jointly determine that procurement 
     of a security countermeasure that has been approved for 
     procurement using the special reserve fund under subsection 
     (a)--
       ``(1) is not proceeding at a sufficiently rapid pace under 
     319F-2 of the Public Health Service Act to protect the 
     national security; or
       ``(2) could be produced significantly less expensively by 
     the government directly than through procurements under such 
     section;
     then amounts in the special reserve fund may be used by the 
     Secretary of Health and Human Services to produce security 
     countermeasures for placement in the stockpile under 
     subsection (a) of section 319F-2 of such Act if the joint 
     determination is submitted to the President and the President 
     approves such use of the special reserve fund. Amounts made 
     available for such use in accordance with the preceding 
     sentence are available for obligation as of the date on which 
     the presidential approval is made, subject to applicable law 
     regarding the apportionment of appropriations. This 
     subsection applies notwithstanding other provisions of this 
     section, and notwithstanding section 319F-2 of the Public 
     Health Service Act. This subsection may not be construed as 
     affecting the amounts specified in subsection (a) as 
     authorizations of appropriations or the obligation limits 
     contained therein.''.
       (c) Conforming Amendment--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 repealed. With 
     respect to the program established under former section 121 
     of such Act, the repeal of such section under the preceding 
     sentence applies as a modification of the program in 
     accordance with the amendment made by subsection (a) of this 
     section, and not as the termination of the program and the 
     establishment of a different program.

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

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

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

       ``(a) In General--
       ``(1) Emergency uses--Notwithstanding sections 505, 510(k), 
     and 515 of this Act and section 351 of the Public Health 
     Service Act, and subject to the provisions of this section, 
     the Secretary may authorize the introduction into interstate 
     commerce, during the effective period of a declaration under 
     subsection (b), of a drug or device 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 `emergency use' has the meaning indicated 
     for such term in paragraph (1).
       ``(B) The term `product' means a drug or device.
       ``(C) The term `unapproved product' has the meaning 
     indicated for such term in paragraph (2)(A).
       ``(D) The term `unapproved use of an approved product' has 
     the meaning indicated for such term in paragraph (2)(B).
       ``(b) Declaration of Emergency--
       ``(1) In general--The Secretary may declare an emergency 
     justifying the authorization under this subsection for a 
     product on the basis of--
       ``(A) a determination by the Secretary of Homeland Security 
     that there is a national emergency, or a significant 
     potential for a national emergency, involving a heightened 
     risk of attack with a specified biological, chemical, 
     radiological, or nuclear agent or agents;
       ``(B) a determination by the Secretary of Defense that 
     there is a military emergency, or a significant potential for 
     a military emergency, involving a heightened risk to United 
     States military forces of attack with a biological, chemical, 
     radiological, or nuclear agent or agents; or
       ``(C) a determination by the Secretary of a public health 
     emergency under section 319 of the Public Health Service Act, 
     affecting national security and involving a specified 
     biological, chemical, radiological, or nuclear agent or 
     agents, or a specified disease or condition that may be 
     attributable to such agent or agents.
       ``(2) Termination of declaration--
       ``(A) In general--A declaration under this subsection shall 
     terminate upon the earlier of--
       ``(i) a determination by the Secretary, in consultation as 
     appropriate with the Secretary of Homeland Security or the 
     Secretary of Defense, that the circumstances described in 
     paragraph (1) have ceased to exist; or
       ``(ii) the expiration of the one-year period beginning on 
     the date on which the declaration is made.
       ``(B) Renewal--Notwithstanding subparagraph (A), the 
     Secretary may renew a declaration under this subsection, and 
     this paragraph shall apply to any such renewal.
       ``(3) Advance notice of termination--In terminating a 
     declaration under this section, the Secretary shall provide 
     advance notice that the declaration will be terminated. The 
     period of advance notice shall be a period reasonably 
     determined to provide--
       ``(A) in the case of an unapproved product, a sufficient 
     period for disposition of shipments of the product, including 
     the return of such shipments to the manufacturer (in the case 
     of a manufacturer that chooses to have the shipments 
     returned); and
       ``(B) in the case of unapproved uses of approved products, 
     a sufficient period for the disposition of any labeling that 
     was provided with respect to the emergency use involved.
       ``(4) Publication--The Secretary shall promptly publish in 
     the Federal Register each declaration, determination, and 
     renewal under this subsection.
       ``(c) Criteria for Issuance of Authorization--The Secretary 
     may issue an authorization under this section with respect to 
     the emergency use of a product only if, after consultation 
     with the Director of the National Institutes of Health and 
     the Director of the Centers for Disease Control and 
     Prevention, to the extent feasible and appropriate given the 
     circumstances of the emergency involved, the Secretary 
     concludes--
       ``(1) that an agent specified in a declaration under 
     subsection (b) can cause a serious or life-threatening 
     disease or condition;
       ``(2) that, based on the totality of scientific evidence 
     available to the Secretary, including data from adequate and 
     well-controlled clinical trials, if available, it is 
     reasonable to believe that--
       ``(A) the product may be effective in detecting, 
     diagnosing, treating, or preventing--
       ``(i) such disease or condition; or
       ``(ii) a serious or life-threatening disease or condition 
     caused by a product authorized under this section or approved 
     under this Act or the Public Health Service Act, for 
     detecting, diagnosing, treating, or preventing such a disease 
     or condition caused by such an agent; and
       ``(B) the known and potential benefits of the product, when 
     used to detect, diagnose, prevent, or treat such disease or 
     condition, outweigh the known and potential risks of the 
     product;
       ``(3) that there is no adequate, approved, and available 
     alternative to the product for detecting, diagnosing, 
     preventing, or treating such disease or condition; and
       ``(4) that such other criteria as the Secretary may by 
     regulation prescribe are satisfied.
       ``(d) Scope of Authorization--
       ``(1) In general--An authorization of a product under this 
     section shall state--
       ``(A) each disease or condition that the product may be 
     used to detect, diagnose, prevent, or treat within the scope 
     of the authorization;
       ``(B) the Secretary's conclusions, made under subsection 
     (c)(2)(B), that the known and potential benefits of the 
     product, when used to detect, diagnose, prevent, or treat 
     such disease or condition, outweigh the known and potential 
     risks of the product; and
       ``(C) the Secretary's conclusions, made under subsection 
     (c), concerning the safety and potential effectiveness of the 
     product in detecting, diagnosing, preventing, or treating 
     such diseases or conditions, including an assessment of the 
     available scientific evidence.
       ``(2) Confidential information--Nothing in this section 
     alters or amends section 1905 of title 18, United States 
     Code, or section 552(b)(4) of title 5 of such Code.
       ``(e) Conditions of Authorization--
       ``(1) Unapproved product--
       ``(A) Required conditions--With respect to the emergency 
     use of an unapproved product, the Secretary, to the extent 
     feasible given the circumstances of the emergency, shall, for 
     persons who choose to carry out one or more activities for 
     which the authorization is issued, establish such conditions 
     on an authorization under this section as the Secretary finds 
     necessary or appropriate to protect the public health, 
     including the following:
       ``(i) Appropriate conditions designed to ensure that, to 
     the extent feasible given the circumstances of the emergency, 
     health care professionals administering the product are 
     informed--

       ``(I) that the Secretary has authorized the emergency use 
     of the product;
       ``(II) of the significant known and potential benefits and 
     risks of the emergency use of

[[Page 18341]]

     the product, and of the extent to which such benefits and 
     risks are unknown; and
       ``(III) of the alternatives to the product that are 
     available, and of their benefits and risks.

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

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

       ``(iii) Appropriate conditions for the monitoring and 
     reporting of adverse events associated with the emergency use 
     of the product.
       ``(iv) For manufacturers of the product, appropriate 
     conditions concerning recordkeeping and reporting, including 
     records access by the Secretary, with respect to the 
     emergency use of the product.
       ``(B) Authority for additional conditions--With respect to 
     the emergency use of an unapproved product, the Secretary, to 
     the extent feasible given the circumstances of the emergency, 
     may, for persons who choose to carry out one or more 
     activities for which the authorization is issued, establish 
     such conditions on an authorization under this section as the 
     Secretary finds necessary or appropriate to protect the 
     public health, including the following:
       ``(i) Appropriate conditions on which entities may 
     distribute the product with respect to the emergency use of 
     the product (including limitation to distribution by 
     government entities), and on how distribution is to be 
     performed.
       ``(ii) Appropriate conditions on who may administer the 
     product with respect to the emergency use of the product, and 
     on the categories of individuals to whom, and the 
     circumstances under which, the product may be administered 
     with respect to such use.
       ``(iii) For persons other than manufacturers of the 
     product, appropriate conditions concerning recordkeeping and 
     reporting, including records access by the Secretary, with 
     respect to the emergency use of the product.
       ``(iv) With respect to the emergency use of the product, 
     waive or limit, to the extent appropriate given the 
     circumstances of the emergency, conditions regarding current 
     good manufacturing practice otherwise applicable to the 
     manufacture, processing, packing, or holding of products 
     subject to regulation under this Act, including such 
     requirements established in section 501.
       ``(2) Unapproved use--With respect to the emergency use of 
     a product that is an unapproved use of an approved product:
       ``(A) The Secretary may, for manufacturers of the product 
     who choose to carry out one or more activities for which the 
     authorization is issued, establish any of the conditions 
     described in clauses (i) through (iv) of paragraph (1)(A).
       ``(B)(i) If the authorization under this section regarding 
     the emergency use authorizes a change in the labeling of the 
     product, but the manufacturer of the product chooses not to 
     make such change, such authorization may not authorize 
     distributors of the product or any other person to alter or 
     obscure the labeling provided by the manufacturer.
       ``(ii) In the circumstances described in clause (i), an 
     authorization under this section regarding the emergency use 
     may, for persons who do not manufacture the product and who 
     choose to act under this clause, authorize such persons to 
     provide information on the product in addition to the 
     labeling provided by the manufacturer, subject to compliance 
     with clause (i). Such additional information shall not be 
     considered labeling for purposes of section 502.
       ``(f) Duration of Authorization--
       ``(1) In general--Except as provided in paragraph (2), an 
     authorization under this section shall be effective until the 
     earlier of the termination of the declaration under 
     subsection (b) or a revocation under subsection (g).
       ``(2) Continued use after end of effective period--An 
     authorization shall continue to be effective for continued 
     use with respect to patients to whom it was administered 
     during the period described by paragraph (1), to the extent 
     found necessary by such patients' attending physicians.
       ``(g) Revocation of Authorization--
       ``(1) Review--The Secretary shall periodically review the 
     circumstances and the appropriateness of an authorization 
     under this section.
       ``(2) Revocation--The Secretary may revoke an authorization 
     under this section if, in the Secretary's unreviewable 
     discretion, the criteria under subsection (c) for issuance of 
     such authorization are no longer met.
       ``(h) Publication--The Secretary shall promptly publish in 
     the Federal Register a notice of each authorization, and each 
     termination or revocation of an authorization, and an 
     explanation of the reasons therefor, under this section.
       ``(i) Actions Committed to Agency Discretion--Actions under 
     the authority of this section by the Secretary, by the 
     Secretary of Defense, or by the Secretary of Homeland 
     Security are committed to agency discretion.
       ``(j) Rules of Construction--Nothing in this section shall 
     be construed to impair or otherwise affect--
       ``(1) the authority of the President as Commander in Chief 
     of the Armed Forces of the United States under article II, 
     section 2 of the United States Constitution;
       ``(2) the authority of the Secretary of Defense with 
     respect to the Department of Defense, including the armed 
     forces, under other provisions of Federal law; or
       ``(3) the authority of the Secretary under section 319F-2 
     to manage the stockpile under such section.
       ``(k) Application to Members of Armed Forces--
       ``(1) Waiver of requirement relating to option to refuse--
     In the case of administration of a countermeasure to members 
     of the armed forces, a requirement, under subsection 
     (e)(1)(A)(ii)(III), designed to ensure that individuals are 
     informed of an option to accept or refuse administration of a 
     product, may be waived by the President if the President 
     determines, in writing, that complying with such requirement 
     is not feasible, is contrary to the best interests of the 
     members affected, or is not in the interests of national 
     security.
       ``(2) Provision of information to member of the armed 
     forces--If the Secretary makes a determination that it is not 
     feasible for the information required by subsection 
     (e)(1)(A)(ii) to be provided to a member of the armed forces 
     prior to the administration of the product, such information 
     shall be provided to such member of the armed forces (or 
     next-of-kin in the case of the death of a member) to whom the 
     product was administered as soon as possible, but not later 
     than 30 days, after such administration. Information 
     concerning the administration of the product shall be 
     recorded in the medical record of the member.
       ``(3) Effect on statute pertaining to investigational new 
     drugs--In the case of an authorization based on a 
     determination by the Secretary of Defense under subsection 
     (b)(1)(B), section 1107 of title 10, United States Code, 
     shall not apply to use of a product that is the subject of 
     such authorization, within the scope of such authorization 
     and while such authorization is effective.
       ``(l) Relation to Other Provisions--If a product is the 
     subject of an authorization under this section, the use of 
     such product within the scope of the authorization--
       ``(1) shall not be subject to any requirements pursuant to 
     section 505(i) or 520(g); and
       ``(2) shall not be subject to any requirements otherwise 
     applicable to clinical investigations pursuant to other 
     provisions of this Act.
       ``(m) Discretion Regarding Use of Authorization--Nothing in 
     this section provides the Secretary any authority to require 
     any person to carry out any activity that becomes lawful 
     pursuant to an authorization under this section, and no 
     person is required to inform the Secretary that the person 
     will not be carrying out such activity, except that a 
     manufacturer of a sole-source unapproved product authorized 
     for emergency use shall notify the Secretary within a 
     reasonable period of time after the issuance by the Secretary 
     of such authorization if such manufacturer does not intend to 
     carry out an activity or activities under the authorization. 
     This section does not have any legal effect on a person who 
     does not carry out any activity for which an authorization 
     under this section is issued, or who carries out such an 
     activity pursuant to other provisions of this Act or section 
     351 of the Public Health Service Act.
       ``(n) Enforcement--A person who carries out an activity 
     pursuant to an authorization under this section, but who 
     fails to comply with applicable conditions under subsection 
     (e), is with respect to that act of noncompliance subject to 
     the provisions of law specified in subsection (a) and to the 
     enforcement of such provisions under section 301.''.

     SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

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

       (I) Subsection (b)(1) (relating to increased simplified 
     acquisition threshold).
       (II) Subsection (b)(2) (relating to use of noncompetitive 
     procedures).
       (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 use of 
     noncompetitive procedures).
       (III) Subsection (c)(7)(C)(v) (relating to premium 
     provision in multiple-award contracts).

[[Page 18342]]

       (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 (as defined 
     in subsection (e)) a report that summarizes--
       (i) the particular actions that were taken under the 
     authorities specified in subparagraph (A), including, as 
     applicable, the identification of the threat agent, 
     emergency, or the biomedical countermeasure with respect to 
     which the authority was used;
       (ii) the reasons underlying the decision to use such 
     authorities, including, as applicable, the options that were 
     considered and rejected with respect to the use of such 
     authorities;
       (iii) the identification of each person or entity that 
     received, or was considered and rejected for, grants, 
     cooperative agreements, or contracts pursuant to the use of 
     such authorities; and
       (iv) whether, with respect to each procurement that is 
     approved by the President under section 319F-2(c)(6) of the 
     Public Health Service Act (as added by section 3 of this 
     Act), a contract was not entered into within one year after 
     such approval by the President.
       (2) Annual summaries regarding certain activity--The 
     Secretary shall annually submit to the designated 
     congressional committees a report that summarizes the 
     activity undertaken pursuant to the following authorities 
     under section 319F-1 of the Public Health Service Act (as 
     added by section 2 of this Act):
       (A) Subsection (b)(3) (relating to increased micropurchase 
     threshold).
       (B) Subsection (d) (relating to authority for personal 
     services contracts).
       (C) Subsection (e) (relating to streamlined personnel 
     authority).
     With respect to subparagraph (B), the report shall include a 
     provision specifying, for the one-year period for which the 
     report is submitted, the number of persons who were paid 
     amounts greater than $100,000 and the number of persons who 
     were paid amounts between $50,000 and $100,000.
       (b) National Academy of Sciences Review--
       (1) In general--Not later than four years after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services shall request the National Academy of Sciences to 
     enter into an agreement for a review of the biomedical 
     countermeasure research and development authorities 
     established in this Act to determine whether and to what 
     extent activities undertaken pursuant to such authorities 
     have enhanced the development of biomedical countermeasures 
     affecting national security, and to recommend any legislative 
     or administrative changes necessary to improve the ability of 
     the Secretary to carry out these activities in the future. 
     The Secretary shall ensure that the results of the study are 
     submitted to the designated congressional committees not 
     later than five years after such date of enactment.
       (2) Certain contents--The report under paragraph (1) shall 
     include--
       (A) a summary of the most recent analysis by the Department 
     of Homeland Security and the intelligence community of the 
     domestic threat from chemical, biological, radiological, and 
     nuclear agents;
       (B) the Academy's assessment of the current availability of 
     countermeasures to address such threats;
       (C) the Academy's assessment of the extent to which 
     programs and activities under this Act will reduce any gap 
     between the threat and the availability of countermeasures to 
     an acceptable level of risk; and
       (D)(i) the Academy's assessment of threats to national 
     security that are posed by technology that will enable, 
     during the 10-year period beginning on the date of the 
     enactment of this Act, the development of antibiotic 
     resistant, mutated, and bioengineered strains of biological 
     agents; and
       (ii) recommendations on short-term and long-term 
     governmental strategies for addressing such threats, 
     including recommendations for Federal policies regarding 
     research priorities, the development of countermeasures, and 
     investments in technology.
       (c) General Accounting Office Review--Four years after the 
     date of the enactment of this Act, the Comptroller General of 
     the United States shall initiate a study--
       (1)(A) to review the Secretary of Health and Human 
     Services' utilization of the authorities granted under this 
     Act with respect to simplified acquisition procedures, use of 
     noncompetitive procedures, increased micropurchase 
     thresholds, personal services contracts, streamlined 
     personnel authority, and the purchase of security 
     countermeasures under the special reserve fund; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authorities in the future;
       (2)(A) to review the internal controls instituted by such 
     Secretary with respect to such authorities, where required by 
     this Act; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the effectiveness of such controls; and
       (3)(A) to review such Secretary's utilization of the 
     authority granted under this Act to authorize an emergency 
     use of a biomedical countermeasure, including the means by 
     which the Secretary determines whether and under what 
     conditions any such authorizations should be granted and the 
     benefits and adverse impacts, if any, resulting from the use 
     of such authority; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authority and to enhance protection of the public health.
     The results of the study shall be submitted to the designated 
     congressional committees not later than five years after the 
     date of the enactment of this Act.
       (d) Report Regarding Additional Barriers to Procurement of 
     Security Countermeasures--Not later than 180 days after the 
     date of the enactment of this Act, the Secretary of Homeland 
     Security and the Secretary of Health and Human Services shall 
     report to the designated congressional committees any 
     barriers to the procurement of security countermeasures that 
     have not been addressed by this Act.
       (e) Status of Program for Chemical Terrorism Preparedness--
     Not later than 180 days after the date of the enactment of 
     this Act, the Secretary of Homeland Security shall submit to 
     the designated congressional committees a report describing 
     the status of the program carried out by the Secretary to 
     enhance the preparedness of the United States to respond to 
     terrorist attacks involving chemical agents.
       (f) Designated Congressional Committees--For purposes of 
     this section, the term ``designated congressional 
     committees'' means the following committees of the Congress:
       (1) In the House of Representatives: the Committee on 
     Energy and Commerce, the Committee on Appropriations, the 
     Committee on Government Reform, and the Select Committee on 
     Homeland Security (or any successor to the Select Committee).
       (2) In the Senate: the Committee on Health, Education, 
     Labor, and Pensions, the Committee on Appropriations, and the 
     Committee on Government Affairs.

     SEC. 6. OUTREACH.

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

     SEC. 7. 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 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 such 
     domestic incidents, 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.

  The SPEAKER pro tempore. In lieu of the amendments recommended by the 
Committee on Government Reform and the Select Committee on Homeland 
Security printed in the bill, the amendment in the nature of a 
substitute designate in the previous order of the House is adopted.
  The text of the amendment in the nature of a substitute is as 
follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

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

     SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT 
                   AUTHORITIES.

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

[[Page 18343]]



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

       ``(a) In General.--
       ``(1) Authority.--In conducting and supporting research and 
     development activities regarding biomedical countermeasures 
     under section 319F(h), the Secretary may conduct and support 
     such activities in accordance with this section if the 
     activities concern qualified countermeasures.
       ``(2) Qualified countermeasure.--For purposes of this 
     section, the term `qualified countermeasure' means a priority 
     countermeasure (as defined in section 319F(h) and as 
     determined by the Secretary in accordance with such section 
     and consistent with sections 302(2) and 304(a) of the 
     Homeland Security Act of 2002) against a chemical, 
     biological, radiological, or nuclear agent that may cause a 
     public health emergency affecting national security.
       ``(3) Interagency cooperation.--
       ``(A) In general.--In carrying out activities under this 
     section, the Secretary is authorized, subject to subparagraph 
     (B), to enter into interagency agreements and other 
     collaborative undertakings with other agencies of the United 
     States Government.
       ``(B) Limitation.--An agreement or undertaking under this 
     paragraph shall not authorize another agency to exercise the 
     authorities provided by this section.
       ``(4) Availability of facilities to the secretary.--In any 
     grant, contract, or cooperative agreement entered into under 
     the authority provided in this section with respect to a 
     biocontainment laboratory or other related or ancillary 
     specialized research facility that the Secretary determines 
     necessary for the purpose of performing, administering, or 
     supporting qualified countermeasure research and development, 
     the Secretary may provide that the facility that is the 
     object of such grant, contract, or cooperative agreement 
     shall be available as needed to the Secretary to respond to 
     public health emergencies affecting national security.
       ``(5) Tranfers of qualifed countermeasures.--Each agreement 
     for an award of a grant, contract, or cooperative agreement 
     under section 319F(h) for the development of a qualified 
     countermeasure shall provide that the recipient of the award 
     will comply with all applicable export-related controls with 
     respect to such countermeasure.
       ``(b) Expedited Procurement Authority.--
       ``(1) Increased simplified acquisition threshold for 
     qualified countermeasure procurements.--
       ``(A) In general.--For any procurement by the Secretary of 
     property or services for use (as determined by the Secretary) 
     in performing, administering, or supporting qualified 
     countermeasure research or development activities under this 
     section that the Secretary determines necessary to respond to 
     pressing research and development needs under this section, 
     the amount specified in section 4(11) of the Office of 
     Federal Procurement Policy Act (41 U.S.C. 403(11)), as 
     applicable pursuant to section 302A(a) of the Federal 
     Property and Administrative Services Act of 1949 (41 U.S.C. 
     252a(a)), shall be deemed to be $25,000,000 in the 
     administration, with respect to such procurement, of--
       ``(i) section 303(g)(1)(A) of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) 
     and its implementing regulations; and
       ``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and 
     its implementing regulations.
       ``(B) Application of certain provisions.--Notwithstanding 
     subparagraph (A) and the provision of law and regulations 
     referred to in such subparagraph, each of the following 
     provisions shall apply to procurements described in this 
     paragraph to the same extent that such provisions would apply 
     to such procurements in the absence of subparagraph (A):
       ``(i) Chapter 37 of title 40, United States Code (relating 
     to contract work hours and safety standards).
       ``(ii) Subsections (a) and (b) of section 7 of the Anti-
     Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
       ``(iii) Section 304C of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 254d) 
     (relating to the examination of contractor records).
       ``(C) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     procurements that are under this paragraph, including 
     requirements with regard to documenting the justification for 
     use of the authority in this paragraph.
       ``(2) Procedures other than full and open competition.--
       ``(A) In general.--In using the authority provided in 
     section 303(c)(1) of title III of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to 
     use procedures other than competitive procedures in the case 
     of a procurement described in paragraph (1) of this 
     subsection, the phrase `available from only one responsible 
     source' in such section 303(c)(1) shall be deemed to mean 
     `available from only one responsible source or only from a 
     limited number of responsible sources'.
       ``(B) Relation to other authorities.--The authority under 
     subparagraph (A) is in addition to any other authority to use 
     procedures other than competitive procedures.
       ``(C) Applicable government-wide regulations.--The 
     Secretary shall implement this paragraph in accordance with 
     applicable government-wide regulations, including 
     requirements that offers be solicited from as many potential 
     sources as is practicable under the circumstances, that 
     required notices be published, and that submitted offers be 
     considered.
       ``(3) Increased micropurchase threshold.--
       ``(A) In general.--For a procurement described by paragraph 
     (1), the amount specified in subsections (c), (d), and (f) of 
     section 32 of the Office of Federal Procurement Policy Act 
     (41 U.S.C. 428) shall be deemed to be $15,000 in the 
     administration of that section with respect to such 
     procurement.
       ``(B) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for purchases 
     that are under this paragraph and that are greater than 
     $2,500.
       ``(C) Exception to preference for purchase card 
     mechanism.--No provision of law establishing a preference for 
     using a Government purchase card method for purchases shall 
     apply to purchases that are under this paragraph and that are 
     greater than $2,500.
       ``(4) Review.--
       ``(A) Review allowed.--Notwithstanding any other provision 
     of law, including subsection (f), review of a contracting 
     agency decision relating to a procurement described in 
     paragraph (1) may be had only by filing a protest--
       ``(i) with a contracting agency; or
       ``(ii) with the Comptroller General under subchapter V of 
     chapter 35 of title 31, United States Code.
       ``(B) Override of stay of contract award or performance 
     committed to agency discretion.--Notwithstanding any other 
     provision of law, the following authorizations by the head of 
     a procuring activity are committed to agency discretion:
       ``(i) An authorization under section 3553(c)(2) of title 
     31, United States Code, to award a contract for a procurement 
     described in paragraph (1) of this subsection.
       ``(ii) An authorization under section 3553(d)(3)(C) of such 
     title to perform a contract for a procurement described in 
     paragraph (1) of this subsection.
       ``(c) Authority to Expedite Peer Review.--
       ``(1) In general.--The Secretary may, as the Secretary 
     determines necessary to respond to pressing qualified 
     countermeasure research and development needs under this 
     section, employ such expedited peer review procedures 
     (including consultation with appropriate scientific experts) 
     as the Secretary, in consultation with the Director of NIH, 
     deems appropriate to obtain assessment of scientific and 
     technical merit and likely contribution to the field of 
     qualified countermeasure research, in place of the peer 
     review and advisory council review procedures that would be 
     required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 
     406(a)(3)(A), 492, and 494, as applicable to a grant, 
     contract, or cooperative agreement--
       ``(A) that is for performing, administering, or supporting 
     qualified countermeasure research and development activities; 
     and
       ``(B) the amount of which is not greater than $1,500,000.
       ``(2) Subsequent phases of research.--The Secretary's 
     determination of whether to employ expedited peer review with 
     respect to subsequent phases of a research grant, contract, 
     or cooperative agreement under this section shall be 
     determined without regard to the peer review procedures used 
     for any prior peer review of that same grant, contract, or 
     cooperative agreement.
       ``(d) Authority for Personal Services Contracts.--
       ``(1) In general.--For the purpose of performing, 
     administering, or supporting qualified countermeasure 
     research and development activities, the Secretary may, as 
     the Secretary determines necessary to respond to pressing 
     qualified countermeasure research and development needs under 
     this section, obtain by contract (in accordance with section 
     3109 of title 5, United States Code, but without regard to 
     the limitations in such section on the period of service and 
     on pay) the personal services of experts or consultants who 
     have scientific or other professional qualifications, except 
     that in no case shall the compensation provided to any such 
     expert or consultant exceed the daily equivalent of the 
     annual rate of compensation for the President.
       ``(2) Federal tort claims act coverage.--
       ``(A) In general.--A person carrying out a contract under 
     paragraph (1), and an officer, employee, or governing board 
     member of such person, shall be deemed to be an employee of 
     the Department of Health and Human Services for purposes of 
     claims under sections 1346(b) and 2672 of title 28, United 
     States Code, for money damages for personal injury, including 
     death, resulting from performance of functions under such 
     contract.
       ``(B) Exclusivity of remedy.--The remedy provided by 
     subparagraph (A) shall be exclusive of any other civil action 
     or proceeding by reason of the same subject matter against 
     the person, officer, employee, or governing board member.

[[Page 18344]]

       ``(3) Internal controls to be instituted.--
       ``(A) In general.--The Secretary shall institute 
     appropriate internal controls for contracts under this 
     subsection, including procedures for the Secretary to make a 
     determination of whether a person, or an officer, employee, 
     or governing board member of a person, is deemed to be an 
     employee of the Department of Health and Human Services 
     pursuant to paragraph (2).
       ``(B) Determination of employee status to be final.--A 
     determination by the Secretary under subparagraph (A) that a 
     person, or an officer, employee, or governing board member of 
     a person, is or is not deemed to be an employee of the 
     Department of Health and Human Services shall be final and 
     binding on the Secretary and the Attorney General and other 
     parties to any civil action or proceeding.
       ``(4) Number of personal services contracts limited.--The 
     number of experts and consultants whose personal services are 
     obtained under paragraph (1) shall not exceed 30 at any time.
       ``(e) Streamlined Personnel Authority.--
       ``(1) In general.--In addition to any other personnel 
     authorities, the Secretary may, as the Secretary determines 
     necessary to respond to pressing qualified countermeasure 
     research and development needs under this section, without 
     regard to such provisions of title 5, United States Code, 
     governing appointments in the competitive service, and 
     without regard to the provisions of chapter 51 and subchapter 
     III of chapter 53 of such title relating to classification 
     and General Schedule pay rates, appoint professional and 
     technical employees, not to exceed 30 such employees at any 
     time, to positions in the National Institutes of Health to 
     perform, administer, or support qualified countermeasure 
     research and development activities in carrying out this 
     section.
       ``(2) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     appointments under this subsection.
       ``(f) Actions Committed to Agency Discretion.--Actions by 
     the Secretary under the authority of this section are 
     committed to agency discretion.''.
       (b) Technical Amendment.--Section 481A of the Public Health 
     Service Act (42 U.S.C. 287a-2) is amended--
       (1) in subsection (a)(1)--
       (A) by inserting ``or the Director of the National 
     Institute of Allergy and Infectious Diseases'' after 
     "Director of the Center''; and
       (B) by inserting ``, or in the case of the Institute, to 
     any qualified public or private entity,'' after ``private 
     entities'';
       (2) in subsection (c)--
       (A) in paragraph (1), by inserting ``or the Director of the 
     National Institute of Allergy and Infectious Diseases'' after 
     ``Director of the Center''; and
       (B) in paragraph (2), in the matter preceding subparagraph 
     (A), by striking ``subsection (i)'' and inserting 
     ``subsection (i)(1)'';
       (3) in subsection (d), by inserting ``or the Director of 
     the National Institute of Allergy and Infectious Diseases'' 
     after ``Director of the Center'';
       (4) in subsection (e)--
       (A) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by inserting 
     ``or the Director of the National Institute of Allergy and 
     Infectious Diseases'' after ``Director of the Center'';
       (ii) in subparagraph (A), by inserting ``(or, in the case 
     of the Institute, 75 percent)'' after ``50 percent''; and
       (iii) in subparagraph (B), by inserting ``(or, in the case 
     of the Institute, 75 percent)'' after ``40 percent'';
       (B) in paragraph (2), by inserting ``or the Director of the 
     National Institute of Allergy and Infectious Diseases'' after 
     ``Director of the Center''; and
       (C) in paragraph (4), by inserting ``of the Center or the 
     Director of the National Institute of Allergy and Infectious 
     Diseases'' after ``Director'';
       (5) in subsection (f)--
       (A) in paragraph (1), by inserting ``in the case of an 
     award by the Director of the Center,'' before ``the 
     applicant''; and
       (B) in paragraph (2), by inserting ``of the Center or the 
     Director of the National Institute of Allergy and Infectious 
     Diseases'' after ``Director''; and
       (6) in subsection (i)--
       (A) by striking ``Appropriations.--For the purpose of 
     carrying out this section,'' and inserting the following: 
     ``Appropriations.--
       ``(1) Center.--For the purpose of carrying out this section 
     with respect to the Center,''; and
       (B) by adding at the end the following:
       ``(2) National institute of allergy and infectious 
     diseases.--For the purpose of carrying out this section with 
     respect to the National Institute of Allergy and Infectious 
     Diseases, there are authorized to be appropriated such sums 
     as may be necessary for each of the fiscal years 2003 and 
     2004.''.
       (c) Additional Authority.--Section 319F of the Public 
     Health Service Act (42 U.S.C. 247d-6) is amended--
       (1) by redesignating subsections (i) and (j) as subsections 
     (j) and (k), respectively; and
       (2) by inserting after subsection (h) the following 
     subsection:
       ``(i) Priority Countermeasures for Strategic National 
     Stockpile.--
       ``(1) In general.--The Secretary, taking into consideration 
     any recommendations of the working group under subsection 
     (a), may initiate and sustain a program that results in the 
     delivery of priority countermeasures for placement in the 
     stockpile under section 319F-2.
       ``(2) Authorization of appropriations.--For the purpose of 
     carrying out paragraph (1), there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 2004 through 2013.''.
       (d) Additional Authorizations of Appropriations.--Section 
     2106 of the Public Health Service Act (42 U.S.C. 300aa-6) is 
     amended--
       (1) in subsection (a), by striking ``authorized to be 
     appropriated'' and all that follows and inserting the 
     following: ``authorized to be appropriated such sums as may 
     be necessary for each of the fiscal years 2004 through 
     2013.''; and
       (2) in subsection (b), by striking ``authorized to be 
     appropriated'' and all that follows and inserting the 
     following: ``authorized to be appropriated such sums as may 
     be necessary for each of the fiscal years 2004 through 
     2013.''.
       (e) Technical Amendments.--Section 319F of the Public 
     Health Service Act (42 U.S.C. 247d-6) is amended--
       (1) in subsection (a), by inserting ``the Secretary of 
     Homeland Security,'' after ``Management Agency,''; and
       (2) in subsection (h)(4)(B), by striking ``to diagnose 
     conditions'' and inserting ``to treat, identify, or prevent 
     conditions''.
       (f) Rule of Construction.--Nothing in this section has any 
     legal effect on sections 302(2), 302(4), 304(a), or 304(b) of 
     the Homeland Security Act of 2002.

     SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

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

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

       ``(a) Strategic National Stockpile.--
       ``(1) In general.--The Secretary of Homeland Security 
     (referred to in this section as the `Homeland Security 
     Secretary'), in coordination with the Secretary and the 
     Secretary of Veterans Affairs, shall maintain a stockpile or 
     stockpiles of drugs, vaccines and other biological products, 
     medical devices, and other supplies in such numbers, types, 
     and amounts as are determined by the Secretary to be 
     appropriate and practicable, taking into account other 
     available sources, to provide for the emergency health 
     security of the United States, including the emergency health 
     security of children and other vulnerable populations, in the 
     event of a bioterrorist attack or other public health 
     emergency.
       ``(2) Procedures.--The Secretary, in managing the stockpile 
     under paragraph (1), shall--
       ``(A) consult with the working group under section 319F(a);
       ``(B) ensure that adequate procedures are followed with 
     respect to such stockpile for inventory management and 
     accounting, and for the physical security of the stockpile;
       ``(C) in consultation with Federal, State, and local 
     officials, take into consideration the timing and location of 
     special events;
       ``(D) review and revise, as appropriate, the contents of 
     the stockpile on a regular basis to ensure that emerging 
     threats, advanced technologies, and new countermeasures are 
     adequately considered;
       ``(E) devise plans for the effective and timely supply-
     chain management of the stockpile, in consultation with 
     appropriate Federal, State and local agencies, and the public 
     and private health care infrastructure; and
       ``(F) ensure the adequate physical security of the 
     stockpile.
       ``(b) Smallpox Vaccine Development.--
       ``(1) In general.--The Secretary shall award contracts, 
     enter into cooperative agreements, or carry out such other 
     activities as may reasonably be required in order to ensure 
     that the stockpile under subsection (a) includes an amount of 
     vaccine against smallpox as determined by such Secretary to 
     be sufficient to meet the health security needs of the United 
     States.
       ``(2) Rule of construction.--Nothing in this section shall 
     be construed to limit the private distribution, purchase, or 
     sale of vaccines from sources other than the stockpile 
     described in subsection (a).
       ``(c) Additional Authority Regarding Procurement of Certain 
     Biomedical Countermeasures; Availability of Special Reserve 
     Fund.--
       ``(1) In general.--
       ``(A) Use of fund.--A security countermeasure may, in 
     accordance with this subsection, be procured with amounts in 
     the special reserve fund under paragraph (10).

[[Page 18345]]

       ``(B) Security countermeasure.--For purposes of this 
     subsection, the term `security countermeasure' means a 
     priority countermeasure (as defined in section 319F(h) and as 
     determined by the Secretary in accordance with such section 
     and consistent with sections 302(2) and 304(a) of the 
     Homeland Security Act of 2002) that--
       ``(i)(I) is against a chemical, biological, radiological, 
     or nuclear agent identified as a material threat under 
     paragraph (2)(A)(ii);
       ``(II) is determined under paragraph (2)(B)(ii) to be a 
     necessary countermeasure; and
       ``(III)(aa) is approved or cleared under chapter V of the 
     Federal Food, Drug, and Cosmetic Act, or licensed under 
     section 351 of this Act, for use as a countermeasure to a 
     chemical, biological, radiological, or nuclear agent 
     identified as a material threat under paragraph (2)(A)(ii); 
     or
       ``(bb) is a priority countermeasure for which the Secretary 
     determines that sufficient and satisfactory clinical 
     experience or research data (including data, if available, 
     from pre-clinical and clinical trials) support a reasonable 
     conclusion that the countermeasure will qualify for approval 
     or licensing after the date of a determination under 
     paragraph (5); or
       ``(ii) is authorized under section 564 of the Federal Food, 
     Drug, and Cosmetic Act for emergency use.
       ``(2) Determination of material threats.--
       ``(A) Material threat.--The Homeland Security Secretary, in 
     consultation with the heads of other agencies as appropriate, 
     shall on an ongoing basis--
       ``(i) assess current and emerging threats of chemical, 
     biological, radiological, and nuclear agents; and
       ``(ii) determine which of such agents present a material 
     threat against the United States population.
       ``(B) Public health impact; necessary countermeasures.--The 
     Secretary shall on an ongoing basis--
       ``(i) assess the potential public health consequences of 
     use against the United States population of agents identified 
     under subparagraph (A)(ii); and
       ``(ii) determine, on the basis of such assessment, the 
     agents for which priority countermeasures are necessary to 
     protect the public health from a material threat.
       ``(C) Notice to congress.--The Secretary and the Homeland 
     Security Secretary shall promptly notify the designated 
     congressional committees (as defined in paragraph (10) that a 
     determination has been made pursuant to subparagraph (A) or 
     (B). Such notice shall be in unclassified or, if necessary, 
     classified form.
       ``(D) Assuring access to threat information.--In making the 
     assessment and determination required under subparagraph (A), 
     the Homeland Security Secretary shall use all information to 
     which such Secretary is entitled under section 202 of the 
     Homeland Security Act of 2002, including but not limited to 
     information, regardless of its level of classification, 
     relating to current and emerging threats of chemical, 
     biological, radiological, and nuclear agents.
       ``(3) Assessment of availability and appropriateness of 
     countermeasures.--The Secretary, in consultation with the 
     Homeland Security Secretary, shall assess on an ongoing basis 
     the availability and appropriateness of specific 
     countermeasures to address specific threats identified under 
     paragraph (2).
       ``(4) Call for development of countermeasures; commitment 
     for recommendation for procurement.--
       ``(A) Proposal to the president.--If, pursuant to an 
     assessment under paragraph (3), the Homeland Security 
     Secretary and the Secretary make a determination that a 
     countermeasure would be appropriate but is either currently 
     unavailable for procurement as a security countermeasure or 
     is approved, licensed, or cleared only for alternative uses, 
     such Secretaries may jointly submit to the President a 
     proposal to--
       ``(i) issue a call for the development of such 
     countermeasure; and
       ``(ii) make a commitment that, upon the first development 
     of such countermeasure that meets the conditions for 
     procurement under paragraph (5), the Secretaries will, based 
     in part on information obtained pursuant to such call, make a 
     recommendation under paragraph (6) that the special reserve 
     fund under paragraph (10) be made available for the 
     procurement of such countermeasure.
       ``(B) Countermeasure specifications.--The Homeland Security 
     Secretary and the Secretary shall, to the extent practicable, 
     include in the proposal under subparagraph (A)--
       ``(i) estimated quantity of purchase (in the form of number 
     of doses or number of effective courses of treatments 
     regardless of dosage form);
       ``(ii) necessary measures of minimum safety and 
     effectiveness;
       ``(iii) estimated price for each dose or effective course 
     of treatment regardless of dosage form; and
       ``(iv) other information that may be necessary to encourage 
     and facilitate research, development, and manufacture of the 
     countermeasure or to provide specifications for the 
     countermeasure.
       ``(C) Presidential approval.--If the President approves a 
     proposal under subparagraph (A), the Homeland Security 
     Secretary and the Secretary shall make known to persons who 
     may respond to a call for the countermeasure involved--
       ``(i) the call for the countermeasure;
       ``(ii) specifications for the countermeasure under 
     subparagraph (B); and
       ``(iii) the commitment described in subparagraph (A)(ii).
       ``(5) Secretary's determination of countermeasures 
     appropriate for funding from special reserve fund.--
       ``(A) In general.--The Secretary, in accordance with the 
     provisions of this paragraph, shall identify specific 
     security countermeasures that the Secretary determines, in 
     consultation with the Homeland Security Secretary, to be 
     appropriate for inclusion in the stockpile under subsection 
     (a) pursuant to procurements made with amounts in the special 
     reserve fund under paragraph (10) (referred to in this 
     subsection individually as a `procurement under this 
     subsection').
       ``(B) Requirements.--In making a determination under 
     subparagraph (A) with respect to a security countermeasure, 
     the Secretary shall determine and consider the following:
       ``(i) The quantities of the product that will be needed to 
     meet the needs of the stockpile.
       ``(ii) The feasibility of production and delivery within 
     five years of sufficient quantities of the product.
       ``(iii) Whether there is a lack of a significant commercial 
     market for the product at the time of procurement, other than 
     as a security countermeasure.
       ``(6) Recommendation for president's approval.--
       ``(A) Recommendation for procurement.--In the case of a 
     security countermeasure that the Secretary has, in accordance 
     with paragraphs (3) and (5), determined to be appropriate for 
     procurement under this subsection, the Homeland Security 
     Secretary and the Secretary shall jointly submit to the 
     President, in coordination with the Director of the Office of 
     Management and Budget, a recommendation that the special 
     reserve fund under paragraph (10) be made available for the 
     procurement of such countermeasure.
       ``(B) Presidential approval.--The special reserve fund 
     under paragraph (10) is available for a procurement of a 
     security countermeasure only if the President has approved a 
     recommendation under subparagraph (A) regarding the 
     countermeasure.
       ``(C) Notice to designated congressional committees.--The 
     Secretary and the Homeland Security Secretary shall notify 
     the designated congressional committees of each decision of 
     the President to approve a recommendation under subparagraph 
     (A). Such notice shall include an explanation of the decision 
     to make available the special reserve fund under paragraph 
     (10) for procurement of such a countermeasure, including, 
     where available, the identification of the potential supplier 
     or suppliers of such countermeasure, and whether other 
     potential suppliers of the same or similar countermeasures 
     were considered and rejected for procurement under this 
     section and the reasons therefor.
       ``(D) Subsequent specific countermeasures.--Procurement 
     under this subsection of a security countermeasure for a 
     particular purpose does not preclude the subsequent 
     procurement under this subsection of any other security 
     countermeasure for such purpose if the Secretary has 
     determined under paragraph (5)(A) that such countermeasure is 
     appropriate for inclusion in the stockpile and if, as 
     determined by the Secretary, such countermeasure provides 
     improved safety or effectiveness, or for other reasons 
     enhances preparedness to respond to threats of use of a 
     biological, chemical, radiological, or nuclear agent. Such a 
     determination by the Secretary is committed to agency 
     discretion.
       ``(E) Rule of construction.--Recommendations and approvals 
     under this paragraph apply solely to determinations that the 
     special reserve fund under paragraph (10) will be made 
     available for a procurement of a security countermeasure, and 
     not to the substance of contracts for such procurement or 
     other matters relating to awards of such contracts.
       ``(7) Procurement.--
       ``(A) In general.--For purposes of a procurement under this 
     subsection that is approved by the President under paragraph 
     (6), the Homeland Security Secretary and the Secretary shall 
     have responsibilities in accordance with subparagraphs (B) 
     and (C).
       ``(B) Interagency agreements.--
       ``(i) For procurement.--The Homeland Security Secretary 
     shall enter into an agreement with the Secretary for 
     procurement of a security countermeasure in accordance with 
     the provisions of this paragraph. The special reserve fund 
     under paragraph (10) shall be available for the Secretary's 
     costs of such procurement, other than as provided in clause 
     (ii).
       ``(ii) For administrative costs.--The agreement entered 
     into between the Homeland Security Secretary and the 
     Secretary for managing the stockpile under subsection (a) 
     shall provide for reimbursement of the Secretary's 
     administrative costs relating to procurements under this 
     subsection.

[[Page 18346]]

       ``(C) Procurement.--
       ``(i) In general.--The Secretary shall be responsible for--

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

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

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

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

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

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

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

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

       ``(I) In general.--In using the authority provided in 
     section 303(c)(1) of title III of the Federal Property and 
     Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to 
     use procedures other than competitive procedures in the case 
     of a procurement under this subsection, the phrase `available 
     from only one responsible source' in such section 303(c)(1) 
     shall be deemed to mean `available from only one responsible 
     source or only from a limited number of responsible sources'.
       ``(II) Relation to other authorities.--The authority under 
     subclause (I) is in addition to any other authority to use 
     procedures other than competitive procedures.
       ``(III) Applicable government-wide regulations.--The 
     Secretary shall implement this clause in accordance with 
     applicable government-wide regulations, including 
     requirements that offers be solicited from as many potential 
     sources as is practicable under the circumstances, that 
     required notices be published, and that submitted offers be 
     considered.

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

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

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

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

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

[[Page 18347]]

     seq.) is amended by adding at the end the following:

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

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

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

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

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

       ``(a) In General.--
       ``(1) Emergency uses.--Notwithstanding sections 505, 
     510(k), and 515 of this Act and section 351 of the Public 
     Health Service Act, and subject to the provisions of this 
     section, the Secretary may authorize the introduction into 
     interstate commerce, during the effective period of a 
     declaration under subsection (b), of a drug, device, or 
     biological product intended for use in an actual or potential 
     emergency (referred to in this section as an `emergency 
     use').
       ``(2) Approval status of product.--An authorization under 
     paragraph (1) may authorize an emergency use of a product 
     that--
       ``(A) is not approved, licensed, or cleared for commercial 
     distribution under a provision of law referred to in such 
     paragraph (referred to in this section as an `unapproved 
     product'); or
       ``(B) is approved, licensed, or cleared under such a 
     provision, but which use is not under such provision an 
     approved, licensed, or cleared use of the product (referred 
     to in this section as an `unapproved use of an approved 
     product').
       ``(3) Relation to other uses.--An emergency use authorized 
     under paragraph (1) for a product is in addition to any other 
     use that is authorized for the product under a provision of 
     law referred to in such paragraph.
       ``(4) Definitions.--For purposes of this section:
       ``(A) The term `biological product' has the meaning given 
     such term in section 351 of the Public Health Service Act.
       ``(B) The term `emergency use' has the meaning indicated 
     for such term in paragraph (1).
       ``(C) The term `product' means a drug, device, or 
     biological product.
       ``(D) The term `unapproved product' has the meaning 
     indicated for such term in paragraph (2)(A).
       ``(E) The term `unapproved use of an approved product' has 
     the meaning indicated for such term in paragraph (2)(B).
       ``(b) Declaration of Emergency.--
       ``(1) In general.--The Secretary may declare an emergency 
     justifying the authorization under this subsection for a 
     product on the basis of--
       ``(A) a determination by the Secretary of Homeland Security 
     that there is a national emergency, or a significant 
     potential for a national emergency, involving a heightened 
     risk of attack with a specified biological, chemical, 
     radiological, or nuclear agent or agents;
       ``(B) a determination by the Secretary of Defense that 
     there is a military emergency, or a significant potential for 
     a military emergency, involving a heightened risk to United 
     States military forces of attack with a biological, chemical, 
     radiological, or nuclear agent or agents; or
       ``(C) a determination by the Secretary of a public health 
     emergency under section 319 of the Public Health Service Act, 
     affecting national security and involving a specified 
     biological, chemical, radiological, or nuclear agent or 
     agents, or a specified disease or condition that may be 
     attributable to such agent or agents.
       ``(2) Termination of declaration.--
       ``(A) In general.--A declaration under this subsection 
     shall terminate upon the earlier of--
       ``(i) a determination by the Secretary, in consultation as 
     appropriate with the Secretary of Homeland Security or the 
     Secretary of Defense, that the circumstances described in 
     paragraph (1) have ceased to exist; or
       ``(ii) the expiration of the one-year period beginning on 
     the date on which the declaration is made.
       ``(B) Renewal.--Notwithstanding subparagraph (A), the 
     Secretary may renew a declaration under this subsection, and 
     this paragraph shall apply to any such renewal.
       ``(3) Advance notice of termination.--In terminating a 
     declaration under this section, the Secretary shall provide 
     advance notice that the declaration will be terminated. The 
     period of advance notice shall be a period reasonably 
     determined to provide--
       ``(A) in the case of an unapproved product, a sufficient 
     period for disposition of shipments of the product, including 
     the return of such shipments to the manufacturer (in the case 
     of a manufacturer that chooses to have the shipments 
     returned); and
       ``(B) in the case of unapproved uses of approved products, 
     a sufficient period for the disposition of any labeling that 
     was provided with respect to the emergency use involved.
       ``(4) Publication.--The Secretary shall promptly publish in 
     the Federal Register each declaration, determination, and 
     renewal under this subsection.
       ``(c) Criteria for Issuance of Authorization.--The 
     Secretary may issue an authorization under this section with 
     respect to the emergency use of a product only if, after 
     consultation with the Director of the National Institutes of 
     Health and the Director of the Centers for Disease Control 
     and Prevention, to the extent feasible and appropriate given 
     the circumstances of the emergency involved, the Secretary 
     concludes--
       ``(1) that an agent specified in a declaration under 
     subsection (b) can cause a serious or life-threatening 
     disease or condition;
       ``(2) that, based on the totality of scientific evidence 
     available to the Secretary, including data from adequate and 
     well-controlled clinical trials, if available, it is 
     reasonable to believe that--
       ``(A) the product may be effective in detecting, 
     diagnosing, treating, or preventing--
       ``(i) such disease or condition; or
       ``(ii) a serious or life-threatening disease or condition 
     caused by a product authorized under this section or approved 
     under this Act or the Public Health Service Act, for 
     detecting, diagnosing, treating, or preventing such a disease 
     or condition caused by such an agent; and
       ``(B) the known and potential benefits of the product, when 
     used to detect, diagnose, prevent, or treat such disease or 
     condition, outweigh the known and potential risks of the 
     product;
       ``(3) that there is no adequate, approved, and available 
     alternative to the product for detecting, diagnosing, 
     preventing, or treating such disease or condition; and
       ``(4) that such other criteria as the Secretary may by 
     regulation prescribe are satisfied.
       ``(d) Scope of Authorization.--
       ``(1) In general.--An authorization of a product under this 
     section shall state--

[[Page 18348]]

       ``(A) each disease or condition that the product may be 
     used to detect, diagnose, prevent, or treat within the scope 
     of the authorization;
       ``(B) the Secretary's conclusions, made under subsection 
     (c)(2)(B), that the known and potential benefits of the 
     product, when used to detect, diagnose, prevent, or treat 
     such disease or condition, outweigh the known and potential 
     risks of the product; and
       ``(C) the Secretary's conclusions, made under subsection 
     (c), concerning the safety and potential effectiveness of the 
     product in detecting, diagnosing, preventing, or treating 
     such diseases or conditions, including an assessment of the 
     available scientific evidence.
       ``(2) Confidential information.--Nothing in this section 
     alters or amends section 1905 of title 18, United States 
     Code, or section 552(b)(4) of title 5 of such Code.
       ``(e) Conditions of Authorization.--
       ``(1) Unapproved product.--
       ``(A) Required conditions.--With respect to the emergency 
     use of an unapproved product, the Secretary, to the extent 
     feasible given the circumstances of the emergency, shall, for 
     persons who choose to carry out one or more activities for 
     which the authorization is issued, establish such conditions 
     on an authorization under this section as the Secretary finds 
     necessary or appropriate to protect the public health, 
     including the following:
       ``(i) Appropriate conditions designed to ensure that, to 
     the extent feasible given the circumstances of the emergency, 
     health care professionals administering the product are 
     informed--

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

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

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

       ``(iii) Appropriate conditions for the monitoring and 
     reporting of adverse events associated with the emergency use 
     of the product.
       ``(iv) For manufacturers of the product, appropriate 
     conditions concerning recordkeeping and reporting, including 
     records access by the Secretary, with respect to the 
     emergency use of the product.
       ``(B) Authority for additional conditions.--With respect to 
     the emergency use of an unapproved product, the Secretary, to 
     the extent feasible given the circumstances of the emergency, 
     may, for persons who choose to carry out one or more 
     activities for which the authorization is issued, establish 
     such conditions on an authorization under this section as the 
     Secretary finds necessary or appropriate to protect the 
     public health, including the following:
       ``(i) Appropriate conditions on which entities may 
     distribute the product with respect to the emergency use of 
     the product (including limitation to distribution by 
     government entities), and on how distribution is to be 
     performed.
       ``(ii) Appropriate conditions on who may administer the 
     product with respect to the emergency use of the product, and 
     on the categories of individuals to whom, and the 
     circumstances under which, the product may be administered 
     with respect to such use.
       ``(iii) For persons other than manufacturers of the 
     product, appropriate conditions concerning recordkeeping and 
     reporting, including records access by the Secretary, with 
     respect to the emergency use of the product.
       ``(iv) With respect to the emergency use of the product, 
     waive or limit, to the extent appropriate given the 
     circumstances of the emergency, conditions regarding current 
     good manufacturing practice otherwise applicable to the 
     manufacture, processing, packing, or holding of products 
     subject to regulation under this Act, including such 
     requirements established in section 501.
       ``(2) Unapproved use.--With respect to the emergency use of 
     a product that is an unapproved use of an approved product:
       ``(A) The Secretary may, for manufacturers of the product 
     who choose to carry out one or more activities for which the 
     authorization is issued, establish any of the conditions 
     described in clauses (i) through (iv) of paragraph (1)(A).
       ``(B)(i) If the authorization under this section regarding 
     the emergency use authorizes a change in the labeling of the 
     product, but the manufacturer of the product chooses not to 
     make such change, such authorization may not authorize 
     distributors of the product or any other person to alter or 
     obscure the labeling provided by the manufacturer.
       ``(ii) In the circumstances described in clause (i), an 
     authorization under this section regarding the emergency use 
     may, for persons who do not manufacture the product and who 
     choose to act under this clause, authorize such persons to 
     provide information on the product in addition to the 
     labeling provided by the manufacturer, subject to compliance 
     with clause (i). Such additional information shall not be 
     considered labeling for purposes of section 502.
       ``(f) Duration of Authorization.--
       ``(1) In general.--Except as provided in paragraph (2), an 
     authorization under this section shall be effective until the 
     earlier of the termination of the declaration under 
     subsection (b) or a revocation under subsection (g).
       ``(2) Continued use after end of effective period.--
     Notwithstanding the termination of the declaration under 
     subsection (b) or a revocation under subsection (g), an 
     authorization shall continue to be effective for continued 
     use with respect to patients to whom it was administered 
     during the period described by paragraph (1), to the extent 
     found necessary by such patients' attending physicians.
       ``(g) Revocation of Authorization.--
       ``(1) Review.--The Secretary shall periodically review the 
     circumstances and the appropriateness of an authorization 
     under this section.
       ``(2) Revocation.--The Secretary may revoke an 
     authorization under this section if, in the Secretary's 
     unreviewable discretion, the criteria under subsection (c) 
     for issuance of such authorization are no longer met.
       ``(h) Publication.--The Secretary shall promptly publish in 
     the Federal Register a notice of each authorization, and each 
     termination or revocation of an authorization, and an 
     explanation of the reasons therefor, under this section.
       ``(i) Actions Committed to Agency Discretion.--Actions 
     under the authority of this section by the Secretary, by the 
     Secretary of Defense, or by the Secretary of Homeland 
     Security are committed to agency discretion.
       ``(j) Rules of Construction.--Nothing in this section shall 
     be construed to impair or otherwise affect--
       ``(1) the authority of the President as Commander in Chief 
     of the Armed Forces of the United States under article II, 
     section 2 of the United States Constitution;
       ``(2) the authority of the Secretary of Defense with 
     respect to the Department of Defense, including the armed 
     forces, under other provisions of Federal law; or
       ``(3) the authority of the Secretary under section 319F-2 
     to manage the stockpile under such section.
       ``(k) Application to Members of Armed Forces.--
       ``(1) Waiver of requirement relating to option to refuse.--
     In the case of administration of a countermeasure to members 
     of the armed forces, a requirement, under subsection 
     (e)(1)(A)(ii)(III), designed to ensure that individuals are 
     informed of an option to accept or refuse administration of a 
     product, may be waived by the President if the President 
     determines, in writing, that complying with such requirement 
     is not feasible, is contrary to the best interests of the 
     members affected, or is not in the interests of national 
     security.
       ``(2) Provision of information to member of the armed 
     forces.--If the Secretary makes a determination that it is 
     not feasible for the information required by subsection 
     (e)(1)(A)(ii) to be provided to a member of the armed forces 
     prior to the administration of the product, such information 
     shall be provided to such member of the armed forces (or 
     next-of-kin in the case of the death of a member) to whom the 
     product was administered as soon as possible, but not later 
     than 30 days, after such administration. Information 
     concerning the administration of the product shall be 
     recorded in the medical record of the member.
       ``(3) Effect on statute pertaining to investigational new 
     drugs.--In the case of an authorization based on a 
     determination by the Secretary of Defense under subsection 
     (b)(1)(B), section 1107 of title 10, United States Code, 
     shall not apply to use of a product that is the subject of 
     such authorization, within the scope of such authorization 
     and while such authorization is effective.
       ``(l) Relation to Other Provisions.--If a product is the 
     subject of an authorization under this section, the use of 
     such product within the scope of the authorization --
       ``(1) shall not be subject to any requirements pursuant to 
     section 505(i) or 520(g); and
       ``(2) shall not be subject to any requirements otherwise 
     applicable to clinical investigations pursuant to other 
     provisions of this Act.
       ``(m) Discretion Regarding Use of Authorization.--Nothing 
     in this section provides the Secretary any authority to 
     require any person to carry out any activity that becomes 
     lawful pursuant to an authorization under this section, and 
     no person is required to inform the Secretary that the person 
     will not be carrying out such activity, except that a 
     manufacturer of a sole-source unapproved product authorized 
     for emergency use

[[Page 18349]]

     shall notify the Secretary within a reasonable period of time 
     after the issuance by the Secretary of such authorization if 
     such manufacturer does not intend to carry out an activity or 
     activities under the authorization. This section does not 
     have any legal effect on a person who does not carry out any 
     activity for which an authorization under this section is 
     issued, or who carries out such an activity pursuant to other 
     provisions of this Act or section 351 of the Public Health 
     Service Act.
       ``(n) Enforcement.--A person who carries out an activity 
     pursuant to an authorization under this section, but who 
     fails to comply with applicable conditions under subsection 
     (e), is with respect to that act of noncompliance subject to 
     the provisions of law specified in subsection (a) and to the 
     enforcement of such provisions under section 301.''.

     SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

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

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

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

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

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

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

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

     With respect to subparagraph (B), the report shall include a 
     provision specifying, for the one-year period for which the 
     report is submitted, the number of persons who were paid 
     amounts greater than $100,000 and the number of persons who 
     were paid amounts between $50,000 and $100,000.
       (b) National Academy of Sciences Review.--
       (1) In general.--Not later than four years after the date 
     of the enactment of this Act, the Secretary of Health and 
     Human Services shall request the National Academy of Sciences 
     to enter into an agreement for a review of the biomedical 
     countermeasure research and development authorities 
     established in this Act to determine whether and to what 
     extent activities undertaken pursuant to such authorities 
     have enhanced the development of biomedical countermeasures 
     affecting national security, and to recommend any legislative 
     or administrative changes necessary to improve the ability of 
     the Secretary to carry out these activities in the future. 
     The Secretary shall ensure that the results of the study are 
     submitted to the designated congressional committees not 
     later than five years after such date of enactment.
       (2) Certain contents.--The report under paragraph (1) shall 
     include--
       (A) a summary of the most recent analysis by the Department 
     of Homeland Security and the intelligence community of the 
     domestic threat from chemical, biological, radiological, and 
     nuclear agents;
       (B) the Academy's assessment of the current availability of 
     countermeasures to address such threats;
       (C) the Academy's assessment of the extent to which 
     programs and activities under this Act will reduce any gap 
     between the threat and the availability of countermeasures to 
     an acceptable level of risk; and
       (D)(i) the Academy's assessment of threats to national 
     security that are posed by technology that will enable, 
     during the 10-year period beginning on the date of the 
     enactment of this Act, the development of antibiotic 
     resistant, mutated, or bioengineered strains of biological 
     agents; and
       (ii) recommendations on short-term and long-term 
     governmental strategies for addressing such threats, 
     including recommendations for Federal policies regarding 
     research priorities, the development of countermeasures, and 
     investments in technology.
       (c) General Accounting Office Review.--Four years after the 
     date of the enactment of this Act, the Comptroller General of 
     the United States shall initiate a study--
       (1)(A) to review the Secretary of Health and Human 
     Services' utilization of the authorities granted under this 
     Act with respect to simplified acquisition procedures, 
     procedures other than full and open competition, increased 
     micropurchase thresholds, personal services contracts, 
     streamlined personnel authority, and the purchase of security 
     countermeasures under the special reserve fund; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authorities in the future;
       (2)(A) to review the internal controls instituted by such 
     Secretary with respect to such authorities, where required by 
     this Act; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the effectiveness of such controls; and
       (3)(A) to review such Secretary's utilization of the 
     authority granted under this Act to authorize an emergency 
     use of a biomedical countermeasure, including the means by 
     which the Secretary determines whether and under what 
     conditions any such authorizations should be granted and the 
     benefits and adverse impacts, if any, resulting from the use 
     of such authority; and
       (B) to recommend any legislative or administrative changes 
     necessary to improve the utilization or effectiveness of such 
     authority and to enhance protection of the public health.

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

     SEC. 6. OUTREACH.

       The Secretary of Health and Human Services shall develop 
     outreach measures to ensure to the extent practicable that 
     diverse institutions, including Historically Black Colleges 
     and Universities and those serving

[[Page 18350]]

      large proportions of Hispanics, Native Americans, Asian-
     Pacific Americans, or other underrepresented populations, are 
     meaningfully aware of available research and development 
     grants, contracts, cooperative agreements, and procurements 
     conducted under sections 2 and 3 of this Act.

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

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

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

       (a) Ensuring Coordination of Programs.--The Secretary of 
     Health and Human Services, the Secretary of Homeland 
     Security, and the Secretary of Defense shall ensure that the 
     activities of their respective Departments coordinate, 
     complement, and do not unnecessarily duplicate programs to 
     identify potential domestic threats from biological, 
     chemical, radiological or nuclear agents, detect domestic 
     incidents involving such agents, analyze such incidents, and 
     develop necessary countermeasures. The aforementioned 
     Secretaries shall further ensure that information and 
     technology possessed by the Departments relevant to these 
     activities are shared with the other Departments.
       (b) Designation of Agency Coordination Officer.--The 
     Secretary of Health and Human Services, the Secretary of 
     Homeland Security, and the Secretary of Defense shall each 
     designate an officer or employee of their respective 
     Departments who shall coordinate, through regular meetings 
     and communications, with the other aforementioned Departments 
     such programs and activities carried out by their 
     Departments.

  The SPEAKER pro tempore. The gentleman from Louisiana (Mr. Tauzin) 
and the gentleman from Ohio (Mr. Brown) each will control 30 minutes. 
The gentleman from Virginia (Mr. Tom Davis) and the gentleman from 
California (Mr. Waxman) each will control 7\1/2\ minutes. The gentleman 
from California (Mr. Cox) and the gentleman from Texas (Mr. Turner) 
each will control 7\1/2\ minutes.
  The Chair recognizes the gentleman from Louisiana (Mr. Tauzin).


                             General Leave

  Mr. TAUZIN. 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 H.R. 2122.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Louisiana?
  There was no objection.
  Mr. TAUZIN. Mr. Speaker, I yield myself 4 minutes.
  Today, Mr. Speaker, the House will address one of President Bush's 
top initiatives in the war against terror, Project Bioshield.
  Mr. Speaker, it is absolutely critical that America's public health 
emergency system be prepared to respond to new and emerging threats, 
and we are here today to take care of that job. This bipartisan 
legislation is about the safety and security of American families and 
of our country. America is stepping up to the profound threat of 
terrorism and other public health emergencies, and I am proud to report 
that H.R. 2122 combines smart policy and provides additional resources 
to prepare the Nation for bioterrorism threats and for other public 
health emergencies.
  The chairman and ranking member of both the committees of 
jurisdiction and the Select Committee of Homeland Security have arrived 
at this consensus product that is before us today. I would like to 
thank the gentleman from Michigan (Mr. Dingell), the gentleman from 
Virginia (Mr. Tom Davis), the gentleman from California (Mr. Waxman), 
the gentleman from California (Mr. Cox), the gentleman from Texas (Mr. 
Turner) for their cooperation and hard work on this bill. This 
bipartisan spirit is similar to last year's effort on the Public Health 
Security and Bioterrorism Preparedness and Response Act that Senator 
Kennedy and I had the privilege to move through the Congress last year.
  Project Bioshield will spur the research and development of new 
vaccines, drugs, and other countermeasures to deal with these 
biological, chemical, nuclear or radiological agents that pose a 
material threat to our Nation's security. The list includes, among 
other dangerous agents, such things as anthrax, botulinum toxin, the 
plague, ebola, and other similar viruses, many of which lack any 
effective treatment or antidote today.
  The bill before us accomplishes this goal by doing two important 
things. First, it provides the needed flexibility in a range of areas 
from government contracting rules to peer review to personnel matters 
in order to speed up government-sponsored research and development into 
these deadly agents. Second, it creates a special reserve fund of money 
for the government to purchase these countermeasures that may 
ultimately be developed in response to the President's call. Without 
this clear commitment of funding in future years, private sector 
companies that are capable of such development simply will not 
undertake the heavy investment and risk associated with developing 
products to deal with agents that do not affect significant populations 
today and hopefully never will.
  At our urging, the House has already provided an advanced 
appropriations of $5.6 billion over the next 10 years for this purpose, 
and this is all consistent with our authorization in the House budget 
resolution.
  The bill 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. Under current law, the only way an individual can receive an 
unapproved product is pursuant to a clinical investigation. But in time 
of national emergency, when this Nation is under attack, it may be 
necessary to give such investigational drugs on a large scale basis to 
millions of Americans. H.R. 2122 provides that if there is such an 
emergency, and if no adequate alternative therapy is available, the 
Secretary can authorize the use of a drug, device, or vaccine in such a 
flexible manner.
  While we have made improvements to the administration's initial 
proposal in certain areas, our bill stays close to that original 
proposal, granting all the additional flexibilities and authorities 
requested by the President and even expanding them in some cases to 
further encourage companies to heed our call for innovation.
  Once again, I want to applaud the leadership of President Bush and 
the truly bipartisan work of this body across multiple committees of 
jurisdiction to protect our country and to promote public health 
security from the many new dangers that we face today.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3\1/2\ minutes.
  Mr. Speaker, this legislation is the product of a good-faith 
bipartisan process. I want to thank the gentleman from Louisiana (Mr. 
Tauzin), the gentleman from Florida (Mr. Bilirakis), as well as the 
ranking member, the gentleman from Michigan (Mr. Dingell), for their 
work on this bill.
  The United States and the global community of which we are part can 
only benefit from the development of bioterrorism countermeasures. 
Because the very existence of countermeasures renders bioterrorism less 
lethal and, therefore, less attractive to would-be terrorists, new 
countermeasures, therefore, 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

[[Page 18351]]

sense to capitalize quickly on that opportunity. That is the logic 
behind this legislation.
  The bill establishes an expedited process for Federal support of 
countermeasure research and a procurement process to encourage private 
sector investment in this research. At the same time, Mr. Speaker, the 
legislation is not a blank check. Congress has a responsibility to 
weigh competing funding priorities and set funding levels 
appropriately.
  In that context, it is appropriate to reiterate a concern that I 
raised last week while we debated the Labor, Health and Human Services 
appropriations bill. Bioterrorism funding is essential and important. 
The legislation before us is essential and important, but our 
investment in bioterrorism should not and must not come at the expense 
of research focusing on cancer and other health threats.
  Let me repeat that. Our investment in bioterrorism should not and 
must not come at the expense of research focusing on cancer and other 
health threats. The appropriations bill we passed last week here funds 
the National Institutes of Health at a level barely sufficient to 
support existing research projects, much less new research. That is a 
direct outgrowth from the tax cut that this Congress passed recently 
and the tax cuts for the wealthiest, most privileged citizens this 
Congress passed 2 years ago. It means we have not had enough money to 
appropriate for basic research, for medical research for the National 
Institutes of Health. It means it may be difficult for us in the future 
to deal with bioterrorism funding as fully as we should.
  This Congress has made choices by giving tax cuts to the wealthiest, 
most privileged citizens, and as a result has made far too many cuts in 
health care; and health care is clearly inadequately funded, as our 
committee has discussed over and over again.
  Mr. Speaker, finding ways to prevent and to treat and to cure disease 
is an enduring national priority. Interest in it does not wax, does not 
wane. Our investment in it should not either. We need to make these 
decisions in a way that serves the public and serves the interest of 
more medical research. We have a responsibility to balance priorities 
to provide adequate resources to prepare the country for a possible 
bioterrorist attack while maintaining strong support for other medical 
research priorities.
  Mr. Speaker, I hope we can work on a bipartisan basis to restore the 
momentum that we once had behind groundbreaking medical research while 
continuing to move forward in the area of bioterrorism preparedness. 
This legislation before us today promotes the latter goal, and I urge 
my colleagues to support it. I thank the gentleman from Louisiana (Mr. 
Tauzin), the gentleman from Florida (Mr. Bilirakis), the gentleman from 
Michigan (Mr. Dingell), the gentleman from Massachusetts (Mr. Markey), 
and others who worked on this legislation.
  Mr. Speaker, I yield 5 minutes to the gentleman from Massachusetts 
(Mr. Markey), my good friend.
  Mr. MARKEY. Mr. Speaker, I thank the gentleman from Ohio (Mr. Brown) 
for yielding me time.
  I rise for the purpose of entering into a colloquy with the gentleman 
from Louisiana (Mr. Tauzin).
  I want to commend the chairman and his staff along with the gentleman 
from California (Mr. Cox); the ranking member, the gentleman from 
Michigan (Mr. Dingell); and the gentleman from Ohio (Mr. Brown); and 
the ranking member, the gentleman from Texas (Mr. Turner) for all of 
their hard work and for working with me and my staff in a bipartisan 
fashion that ultimately led to a resolution of all of the concerns 
which I raised with the legislation.
  I do have, however, two outstanding issues that I wish to clarify at 
this time. Mr. Speaker, I have concerns that relate to the emergency 
use section of Project Bioshield. Specifically, I want to be sure that 
once a declaration of an emergency is terminated or revoked, that 
current law applies and it will then be impermissible for anyone to 
move such drugs, devices or biologics in interstate commerce without 
going through the proper approval process. Is this the case under the 
legislation?
  Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
  Mr. MARKEY. I yield to the gentleman from Louisiana.
  Mr. TAUZIN. The gentleman is correct. Like you, I too want to ensure 
that unapproved products are available in times of emergency. And while 
we allow the FDA to make products available during such time of 
emergency, absent such emergency, current law applies. We do allow for 
the shipments of such therapies in limited circumstances, namely, where 
a physician authorizes the continued treatment of an individual who 
initially received the drug during an emergency. However, this is the 
only exception. Absent that, present law applies to these unapproved 
products.
  Mr. MARKEY. I thank the gentleman.
  Secondly, I very much appreciate the gentleman's work on crafting 
language to ensure that the countermeasures developed under this 
legislation are, where necessary, subject to the same export control 
laws and regulations as other chemical and biological agents and their 
associated countermeasures. One of the new responsibilities the 
Secretary of HHS is directed to assume is to review new countermeasures 
both in the R&D phase as well as in the procurement phase of the 
Bioshield Program. The Secretary is encouraged to consult with other 
Federal agencies who play a role in setting export control policy and 
to recommend whether the new countermeasure or countermeasure R&D 
should be added to the various lists of controlled technologies that 
cannot be transferred to other countries without prior permission.
  Is it your understanding that the Secretary should do this as 
expeditiously as possible, and that each beneficiary of Bioshield funds 
be directed as part of the contract or grant to abide by all applicable 
U.S. export laws governing the transfer of technology and R&D?
  Mr. TAUZIN. The gentleman is absolutely correct. The Secretary should 
perform these reviews as expeditiously as possible once the R&D or 
procurement has started so as to prevent any exports of countermeasures 
or countermeasure R&D that could harm our U.S. national security.
  Mr. MARKEY. I just want to thank the chairman. He has worked very 
hard and long on this legislation. I want to thank the gentleman's 
staff and Kendra Bodner from my staff for working out this language.
  Mr. TAUZIN. Let me thank the gentleman from Massachusetts (Mr. 
Markey). He raised a great number of concerns as we went true this 
process. I want to thank the gentleman for the way in which he worked 
with Members on both sides of the aisle so we cannot only take care of 
those concerns but produce a great product for the security of our 
country, and he has added immeasurably to that effort.
  Mr. MARKEY. Good job, Mr. Chairman, and good job to everyone who has 
worked on this bill on both sides of the aisle.
  Mr. TAUZIN. Mr. Speaker, I yield 3 minutes to the gentleman from Ohio 
(Mr. LaTourette).
  Mr. LaTOURETTE. Mr. Speaker, I thank the chairman for yielding to me 
for the purpose of a colloquy in order to clarify the intent of two 
provisions.
  This legislation authorizes the director of the National Institute of 
Allergies and Infectious Diseases to issue grants to non-Federal 
entities for the construction and operation of specialized research 
facilities. A second provision of the bill authorizes the Secretary of 
HHS to take control of these facilities in the event or threat of 
bioterror emergency.
  As you know, the Public Buildings Act of 1959, which is under the 
exclusive jurisdiction of the Committee on Transportation and 
Infrastructure, governs the construction, acquisitions, repair and 
alteration of public buildings, including many laboratories and 
research facilities.
  Mr. Chairman, am I correct that nothing in this legislation exempts 
the

[[Page 18352]]

Secretary of HHS or the director of the institute from the requirements 
of the Public Buildings Act?
  Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
  Mr. LaTOURETTE. I yield to the gentleman from Louisiana.
  Mr. TAUZIN. The gentleman is absolutely correct. These provisions do 
not preempt the Public Buildings Act to the extent that it would 
otherwise apply to such activities.

                              {time}  1415

  Mr. LaTOURETTE. Mr. Speaker, it is also my understanding that the 
facilities authority granted to the Secretary of HHS and the Director 
of the Institute of Diseases is intended only for special use 
facilities, which do not meet the definition of a public building under 
the Public Buildings Act. Is that also correct?
  Mr. TAUZIN. Mr. Speaker, if the gentleman will continue to yield, 
that is also correct. The Project Bioshield Act authorizes the 
construction of highly specialized laboratories, all of which I would 
expect to be biosafety level 3 or 4 laboratories unsuitable for general 
purpose use. Project Bioshield does not authorize the construction of 
``public buildings'' as defined by the Public Buildings Act of 1959.
  Mr. LaTOURETTE. Mr. Speaker, lastly, it is my understanding that the 
march in authority granted the Secretary of HHS is intended to give the 
Secretary control of these facilities for a limited period of time 
only. Is that also correct?
  Mr. TAUZIN. If the gentleman would continue to yield, that is also 
correct. The authority allows the Secretary to take control of these 
facilities only during, and as necessary to respond to, public health 
emergencies affecting national security. Under the Bioterrorism 
Response Act passed last year, a public health emergency can be 
declared by the Secretary for up to 90 days at a time; and although the 
Secretary may extend the designation for multiple 90-day periods, it is 
not the intention of this legislation to allow the Secretary to control 
a facility for the useful life of that facility.
  Mr. LaTOURETTE. Mr. Speaker, I thank the chairman for the 
clarification.
  Mr. BROWN of Ohio. Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. TAUZIN. Mr. Speaker, I think we have a couple of other Members 
who need to do colloquies.
  While we are waiting, I wanted to take this time, Mr. Speaker, to 
refer to a letter received today from the Secretary of Health and Human 
Services, Secretary Tommy Thompson, dated July 16, 2003; and I want to 
place the letter in the Record at this point.

                                           The Secretary of Health


                                           and Human Services,

                                    Washington, DC, July 16, 2003.
     Hon. Billy Tauzin,
     Chairman, Committee on Energy and Commerce, House of 
         Representatives, Washington, DC.
       Dear Chairman Tauzin: Thank you for your leadership on H.R. 
     2122, the Project BioShield Act of 2003. This legislation is 
     a critical step toward strengthening our ability to protect 
     Americans against chemical, biological, radiological and 
     nuclear threats.
       H.R. 2122 would: (1) speed the Government's ability to turn 
     promising scientific discoveries into necessary 
     countermeasures by one-third or more; (2) authorize funding 
     to purchase critical new countermeasures targeted against the 
     most worrisome threats; and (3) allow the Food and Drug 
     Administration to make promising treatments quickly available 
     to Americans in emergency situations.
       I would like to address two issues that have arisen as the 
     House takes up this vital priority. First, I share 
     Representative Wamp's interest in building domestic capacity 
     to produce countermeasures. In implementing Project 
     BioShield, I will do everything in my power to purchase from 
     domestic sources. To have a secure supply, we must build 
     capacity within the United States and my department is 
     committed to achieving that objective. The essential purpose 
     of Project BioShield is to ensure we have necessary and 
     timely countermeasures. We cannot achieve this goal by 
     relying on foreign sources. Building a robust domestic 
     capacity to produce countermeasures is, therefore, at the 
     very heart of Project BioShield.
       Second, I agree with Representative Jackson-Lee that the 
     Strategic National Stockpile must serve all areas of the 
     Nation, including rural areas. The Centers for Disease 
     Control and Prevention has positioned stockpile assets to 
     deliver needed medical supplies anywhere in the country 
     within 12 hours. I have a personal understanding of the 
     challenges that rural areas face and share Representative 
     Jackson-Lee's interest in rural America. My department is 
     pro-actively working with state and local health departments 
     to ensure the effective and timely delivery of stockpile 
     assets to both rural and urban parts our Nation.
       If I can provide you or the members of the Committee with 
     any further information or if I can otherwise be of 
     assistance, please do not hesitate to contact me.
           Sincerely,
                                                Tommy G. Thompson.

  Mr. Speaker, I wanted to refer to it because the Secretary refers to 
several concerns raised by other Members of the House, of which I also 
share with him, and I think we will have a colloquy on one of those.
  The first is a concern by the gentleman from Tennessee (Mr. Wamp) 
whose interest is in building domestic capacity to produce 
countermeasures; and, indeed, the Secretary indicates in his letter 
that it is indeed his desire to make sure those countermeasures are 
developed within this country. We cannot achieve the goal of securing 
our country if indeed we rely upon foreign sources for these measures; 
and, therefore, the building of robust domestic capacity to produce 
these countermeasures is at the very heart of the Bioshield Project.
  I wanted to assure my friend, the gentleman from Tennessee (Mr. 
Wamp), that I share the Secretary's comments and his intentions in that 
regard.
  Secondly, the gentlewoman from Texas (Ms. Jackson-Lee) was concerned 
that strategic national stockpile must be developed in such a way as to 
serve rural areas of the country, not simply the urban areas of our 
country, because rural areas can be affected by these bioterrorism 
threats just as easily, obviously, as urban areas. The Secretary 
indicates that the Centers for Disease Control and Prevention has 
positioned stockpile assets anywhere in the country, delivery within 12 
hours, in effect making sure that rural areas are not left out of the 
protection of this bill and the other bioterrorism bills that have 
passed the House and are part of the Centers for Disease Control 
stockpiles and distribution system.
  So that those two concerns by our colleagues are addressed in this 
letter, and I wanted to share with those colleagues my agreement with 
the Secretary on both of those points.
  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.
  Mr. Speaker, I share the comments both of the chairman of the 
committee and Secretary Thompson in his letter that the chairman just 
mentioned.
  I applaud the gentleman from Tennessee's (Mr. Wamp) interest in 
building domestic capacity; and in terms of purchasing from domestic 
sources, I think that is an important thing that this Congress too 
often forgets. When we look at our trade policy, often that tends to 
favor investors and tends often to hurt workers, both in this country 
and internationally, whether it is the Singapore-Chile agreement coming 
up or whether it is the fast track authority that this Congress I think 
wrongly gave the President fairly recently.
  I also support the efforts of the gentlewoman from Texas (Ms. 
Jackson-Lee) from Houston in terms of serving all the Nation, including 
rural areas. I think that our ability to deliver all kinds of health 
care, all kinds of public health care, especially in rural areas and 
urban areas alike, is especially important.
  And I want to reiterate from my opening comments, Mr. Speaker, that 
while Bioshield is so very, very, very important and it gives us great 
opportunity to further develop our public health system, it is 
important that we keep in mind our long-standing, day-to-day public 
health system.
  Bioshield can serve some synergism with the public health system as 
long as we keep focussed on the Centers for Disease Control, as long as 
we keep focused on local public health departments, because that has 
served the public very well, this public health system. It is too often 
starved, too often

[[Page 18353]]

woefully, inadequately funded. I would hope that the synergism we can 
create with Bioshield and with public health will serve this country 
well, both in terms of deterring as an antidote and as a deterrence for 
bioterrorism attacks and in terms of the day-to-day issue of public 
health, whether it is lead-based paints, whether it is eliminating the 
discrepancy between rich and poor and the health care they get, whether 
it is providing safe drinking water and clean air and all the things 
that public health provide to us.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I yield myself such time again as I may 
consume.
  Mr. Speaker, I insert at this point into the Record of these 
proceedings a statement of administration policy in strong support of 
this bill.

         Executive Office of the President, Office of Management 
           and Budget,
                                    Washington, DC, July 16, 2003.

                   Statement of Administration Policy

       The Administration supports House passage of H.R. 2122, 
     Project BioShield Act of 2003. This bill would implement a 
     Presidential initiative to help spur the development and 
     availability of next generation countermeasures against 
     biological, chemical, nuclear, and radiological weapons. 
     Specifically, H.R. 2122 would: (1) speed the Government's 
     ability to turn promising scientific discoveries into 
     necessary countermeasures by one-third or more; (2) authorize 
     funding to purchase critical new countermeasures targeted 
     against the most worrisome threats; and (3) allow the Food 
     and Drug Administration to make promising treatments quickly 
     available to Americans in emergency situations. Project 
     BioShield is critical for strengthening our ability to 
     protect Americans against biological, chemical, radiological, 
     and nuclear terrorist threats.
       The Administration notes that provisions on submission of 
     legislative proposals, and of reports on options considered 
     and rejected, should reflect Constitutional principles 
     regarding Executive-originated legislative proposals and 
     protecting Executive deliberations.

  Mr. Speaker, I again center Congress's attention on the concerns that 
our colleague from Tennessee (Mr. Wamp) raises regarding the lack of 
domestic capacity to develop and produce new vaccines and 
countermeasures, indeed the concern he has that we might end up relying 
upon foreign sources for these critical supplies.
  Let me first say that I share that concern about our lack of a robust 
domestic vaccine industry. I know that the Secretary of Health and 
Human Services shares that concern.
  I also know that one of the primary purposes behind Project Bioshield 
is to help the Nation address this important problem by giving 
incentives to all companies, but especially our domestic pharmaceutical 
companies, to invest in this capacity, in this vaccine antidote 
producing capacity so that we have domestic supplies and domestic 
countermeasures available without relying upon foreign sources to 
protect this country in case of a domestic attack.
  I just read from the Secretary's letter his commitment to do exactly 
that, to use this Act to make sure that we incentivize the capacity of 
our country to produce those vaccines and those countermeasures, those 
antidotes, whatever may be required, in case of the unbelievable attack 
upon our country with some of these awful agents, and I am confident 
the Secretary will implement the Act with that goal in mind.
  We obviously on the Committee on Energy and Commerce will 
aggressively oversight the implementation of this Act so that we are 
satisfied that we are, in fact, encouraging domestic corporations to 
compete for these contracts.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I have no other speakers, and I am 
willing to yield back if the gentleman from Louisiana (Mr. Tauzin) is.
  Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentleman from Georgia (Mr. Norwood), a distinguished member of our 
committee.
  Mr. NORWOOD. Mr. Speaker, I rise out of breath simply to urge my 
colleagues to vote for this. This is an enormous undertaking. The 
Secretary has done a great job for us. I think all Americans I know are 
as concerned about bioterrorism as any part of terrorism out there.
  I thank the chairman for bringing this bill, and hopefully everybody 
here will help him and help the Secretary move this thing forward.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 3 minutes to the gentleman 
from California (Mr. Waxman).
  Mr. WAXMAN. Mr. Speaker, I thank the gentleman for yielding time to 
me.
  I have had the opportunity to review this legislation from the 
prospect of two committees, as a member of the Committee on Energy and 
Commerce, which looks at the health impact of the threat of 
bioterrorism, as well as the Committee on Government Reform; and given 
the serious threat of bioterrorism, the development of effective 
countermeasures is vital to our national security.
  Project Bioshield represents the administration's proposal to 
encourage the development of these products, and 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.
  This bill is the product of collaboration between the majority and 
minority of three separate committees. Although the final bill may not 
be perfect, I believe the end product is one that all Members should 
support.
  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 contractors' books 
and records.
  The bill also permits the use of certain streamlined procurement 
procedures but only if the Secretary determines that there is a 
pressing need to do so. In emergency situations, we should not impede 
the development of necessary products. However, any exception from the 
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. The 
FDA must be vigilant in protecting the public against unnecessary risks 
from these products.
  In part because of these concerns, the bill has been modified to 
require that health care providers and patients be informed that the 
products have not been approved and of their risks. The bill also has 
been modified to require 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 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 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 it deserves our support.
  Mr. TAUZIN. Mr. Speaker, I am pleased to yield 2 minutes to the 
gentleman from Florida (Mr. Bilirakis), the distinguished chairman of 
the Subcommittee on Health of the Committee on Energy and Commerce, who 
celebrates his birthday today.
  Mr. BILIRAKIS. Mr. Speaker, I appreciate the gentleman, my good 
friend, the chairman for recognizing me, and I speak in support of the 
Project Bioshield Act of 2003.

[[Page 18354]]

  Mr. Speaker, in 2001, we really learned about the real threat of 
terrorism and the importance of being adequately prepared for an 
attack. The possibility that our enemies might attack us with 
biological, chemical or radiological weapons still remains, 
unfortunately, a significant threat.
  During the last Congress, the Committee on Energy and Commerce worked 
together in a bipartisan fashion to produce the Public Health Security 
and Bioterrorism Response Act which became law in June of 2002. I was 
proud to have been a small part of this important effort. However, 
while our legislation has helped get critical resources out to the 
States and moved us closer to the reality of a more comprehensive 
strategic national stockpile, more still needs to be done.
  I am pleased to have worked with my colleagues and the Bush 
administration to develop legislation that would help make the vision 
of Project Bioshield a reality. As we have heard, this initiative is 
designed to speed the development and availability of medical 
countermeasures that will help us respond to any future terrorist 
attacks. The bill will also provide the Federal Government with tools 
to help encourage our research-driven pharmaceutical, biotechnology and 
medical technology to develop new countermeasures where none exists 
today.
  It remains our responsibility to do what we can to ensure that the 
United States is ready for whatever biological, chemical or 
radiological threat we might face.

                              {time}  1430

  It is for that reason that I join the others in urging my colleagues 
to join us in supporting the Project BioShield Act of 2003.
  Mr. WAXMAN. Mr. Speaker, I control the time on behalf of the 
Democrats on the Committee on Government Reform, and I ask unanimous 
consent to yield the time that we have to the gentleman from Ohio (Mr. 
Brown) to control that time.
  The SPEAKER pro tempore (Mr. Gilchrest). Is there objection to the 
request of the gentleman from California?
  There was no objection.
  The SPEAKER pro tempore. The gentleman from Ohio (Mr. Brown) will be 
recognized for an additional 7\1/2\ minutes.
  Mr. BROWN of Ohio. Mr. Speaker, could you tell us how much time I 
have, the Committee on Energy and Commerce and the Committee on 
Government Reform, and how much time the gentleman from Louisiana (Mr. 
Tauzin) has?
  The SPEAKER pro tempore. The gentleman from Ohio (Mr. Brown) has 
24\1/2\ minutes remaining, and the gentleman from Louisiana (Mr. 
Tauzin) has 16\1/2\ minutes remaining.
  Mr. TAUZIN. Mr. Speaker, I yield 3 minutes to the gentleman from 
Connecticut (Mr. Shays).
  Mr. SHAYS. Mr. Speaker, I rise to engage the chairman of the 
Committee on Energy and Commerce, the gentleman from Louisiana (Mr. 
Tauzin), in a colloquy.
  Mr. Speaker, I am concerned that certain provisions of section 4 of 
the bill will unfairly treat the men and women of our armed services. 
Specifically, the bill would create a new section 564 of the Federal 
Food, Drug and Cosmetic Act that would allow the application of medical 
products to the general population in emergencies, but only with 
appropriate safeguards. New subsection (k) of the act, however, seems 
to allow the President to waive or the Secretary of HHS to modify the 
application of these safeguards for military personnel. Can the 
chairman enlighten me as to his intent in this provision?
  Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
  Mr. SHAYS. I yield to the gentleman from Louisiana.
  Mr. TAUZIN. Mr. Speaker, I will be happy to speak to that.
  New subsection (k) permits the President to waive, in writing, only 
the consent portion of the conditions of authorization set forth in 
section 564(e) with respect to armed services personnel, and only to 
the extent that complying with the requirement is not feasible, is 
contrary to the best interests of the personnel, or is not in the 
interest of national security.
  It is not my intent that the President may ever waive pursuant to 
subsection (k) the other conditions. They are that the individual to 
whom the product is to be administered is informed, one, that the 
Secretary has authorized the emergency use of a product, and, two, 
about the significant known and potential benefits and risks of the use 
of the product. The committee intends, absent extraordinary 
circumstances, that such information be provided to individuals prior 
to receiving the unapproved product.
  After the gentleman raised these issues with us, we took a closer 
look at the language, and I acknowledge that there is a crossreference 
in new section 564(k)(2) that could be confusing. I want to continue to 
work with the gentleman and the gentleman from New York (Mr. Towns), 
who I know cares deeply about this issue, along with you and many of 
us, to make sure that the final version of this bill from the 
conference that we will have with the Senate, I am sure, provides that 
our military are informed of the drugs that are given before these 
drugs are administered.
  Let me also assure the gentleman from Connecticut that we understand 
the importance of the protections for military personnel receiving 
unapproved countermeasures contained in current law, title X, section 
1107; and we intend the waiver authority in this bill to be used only 
in the very extraordinary circumstances that we describe in the bill.
  Mr. SHAYS. Mr. Speaker, reclaiming my time, I thank the gentleman for 
his explanation, and I look forward to working with him to make sure 
that we clear this matter up in conference with the Senate.
  Mr. TAUZIN. Mr. Speaker, if the gentleman will continue to yield, I 
thank my friend and give him that assurance.
  Mr. BROWN of Ohio. Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I yield 2 minutes to the gentleman from 
Nevada (Mr. Gibbons).
  Mr. GIBBONS. Mr. Speaker, I want to thank my friend, the chairman, 
for yielding me this time. I rise in support of Project BioShield. It 
is a very important step for the Department of Homeland Security.
  Project BioShield aims to rapidly transfer technology into products 
that can be used to protect individuals against biological and chemical 
agents used as weapons of terrorism or mass destruction. The emphasis 
is on rapid introduction of new countermeasures into actual use, as 
many technologies currently under development need to be transitioned 
through regulatory commercial or regulatory cycles.
  The Homeland Security Act gave the Department of Homeland Security 
responsibility for integrating intelligence information and assessing 
terrorist threats and vulnerabilities. This information makes full use 
of the Department's capabilities. Identifying the most urgent threats 
and setting research priorities will be vital to meeting the bioterror 
threat.
  Obtaining the best intelligence and performing accurate threat 
assessment is absolutely critical. By properly understanding the 
threats that confront us, we can allocate our resources and focus our 
efforts where they are most needed, on agents for which the risk and 
potential consequence of attack are greatest.
  BioShield tasks the Secretary of the Department of Homeland Security 
with using the best information available to identify the greatest 
threats to the national security. Incorporated into the bill are 
several provisions that will strengthen the Secretary's threat 
assessment capabilities.
  This legislation, Mr. Speaker, provides the Secretary of the 
Department of Homeland Security the authority and resources needed to 
quickly hire the necessary bioterror analysts and rapidly build a 
bioterror intelligence infrastructure.
  I urge all my colleagues to support H.R. 2122, the Project BioShield 
Act of 2003.
  Mr. BROWN of Ohio. Mr. Speaker, I rise again in support of this bill, 
and I

[[Page 18355]]

ask unanimous consent that I be allowed to yield my remaining 24\1/2\ 
minutes to the gentleman from New Jersey (Mr. Andrews) with permission 
that he be allowed to yield said time.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Ohio?
  There was no objection.
  The SPEAKER pro tempore. The gentleman from New Jersey (Mr. Andrews) 
is recognized for the remaining time.
  Mr. ANDREWS. Mr. Speaker, I yield myself such time as I may consume; 
and I thank my friend, the gentleman from Ohio (Mr. Brown), for 
yielding me this time. I assure my colleagues I will not personally 
take all 24 minutes; I will reserve the right to yield to other 
Members, and the gentleman from Texas (Mr. Turner) should be here 
forthrightly and he will be yielding.
  Mr. Speaker, I want to thank the gentleman from Louisiana (Mr. 
Tauzin) and the leadership of the gentleman from Michigan (Mr. Dingell) 
on our side of the aisle, the other committees of jurisdiction, the 
gentleman from California (Mr. Cox), and the gentleman from Texas (Mr. 
Turner) for bringing this very important legislation to the floor.
  Mr. Speaker, I think that history will reflect that this is our 
generation's version of the Manhattan Project. These are uncharted 
scientific waters. It is a world that we have not yet become accustomed 
to navigating. It is the world of massive biological attack against the 
United States of America. I have supreme confidence that we will be 
able to meet and deter such an attack, but only if we are able to 
engage the machinery of the best minds in our universities and our 
companies, in our government, and throughout society.
  I believe that is exactly what this legislation does. It brings to 
the forefront the abilities of our researchers, of our scientists, of 
our entrepreneurs, of our public officials to systematically identify 
the biological risks that our country faces, to methodically analyze 
the best opportunities for addressing those biological risks, and to 
use a process that will effectively meet those risks.
  I commend the authors for properly balancing the mechanisms of money, 
market, and exclusivity. It is very important there be adequate 
resources for the companies who we are asking to engage in this so that 
they will in fact engage in it. It is important that we create a 
market, because it is our fervent wish that there will never be a 
market for these products. We hope they are never needed. But in the 
absence of that market, it is important the law contain a specific 
guarantee to move forward.
  Finally, with respect to exclusivity and insulation from antitrust 
considerations, it is very important that those who are willing to risk 
their capital and their energy to come up with these agents are 
afforded the protection of the law.
  Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
  Mr. ANDREWS. I yield to the gentleman from Louisiana.
  Mr. TAUZIN. Mr. Speaker, I thank the gentleman and will be happy to 
enter into a discussion with him.
  Let me first thank him for the excellent statement he has made. I 
think the gentleman is correct. I think it is as important to our 
country as perhaps the Manhattan Project was. I remember when Speaker 
O'Neill used to remind this House that partisanship ended at the 
water's edge. He meant to tell us that when it came to protecting our 
country, we were not Democrats or Republicans, we were Americans. And 
where the water's edge used to be the boundary of the threats against 
our country, because of 9-11, we now understand the water's edge is no 
longer the boundary. Within our country we now face these potential 
threats.
  So I thank the gentleman. And, indeed, the bill is designed to do 
exactly that, to balance those important elements of the equation and 
to make sure we incentivize the private marketplace, but also provide 
the public monies, $5.6 billion over 10 years, to make sure we have the 
available money in a trust fund, through our budget resolution, 
appropriated through our process, to make sure we can acquire those 
countermeasures, stockpile them, distribute them around the country, as 
the Secretary is prepared to do, to make sure that those 
countermeasures are available.
  It also balances the need to build in our own country the capability 
of building those vaccines and countermeasures that otherwise would 
never be built. Because who would, in the private sector, want to build 
a vaccine for the plague today, without this particular legislation? So 
I thank the gentleman.
  Mr. ANDREWS. Mr. Speaker, reclaiming my time, I agree with the 
chairman. I think he is correct that bipartisanship cannot simply begin 
at the water's edge in a world where the battlefield is here. And there 
is a virtual battlefield that we are all, unfortunately, living in.
  I would like to make two other points before I stop. The first is 
that I very much appreciate the inclusion into this bill, with the help 
of the gentleman from California (Mr. Cox), language that I suggested 
with respect to making it clear that when there is a termination for 
reason of convenience by the government, that all of the normal cost 
recovery rights that would accrue to the vendor in fact accrue under 
this bill. I very much appreciate that inclusion.
  Mr. TAUZIN. Mr. Speaker, will the gentleman yield?
  Mr. ANDREWS. I yield to the gentleman from Louisiana.
  Mr. TAUZIN. Mr. Speaker, I want to thank the gentleman for that 
language. The neat thing about the way this bill has been processed is 
that all through the process Democrats and Republicans have assisted in 
building it into a much better bill. And the language the gentleman has 
added to the bill is an extraordinary addition to the bill, and I thank 
him for it.
  Mr. ANDREWS. Reclaiming my time once again, Mr. Speaker, I appreciate 
the chairman's cooperation in that regard.
  Second, I would like to say it is very important that the chairman 
has very skillfully, along with the ranking member, assured that there 
will be continuing oversight by the Congress of the activities under 
this bill. We had to strike the proper balance here between a 
guaranteed funding stream so that the companies involved in this would 
know that their investment would in fact be recovered, but at the same 
time not yielding the important oversight function that this Congress 
should exercise. And I commend the chairman and the ranking member and 
all the authors for making that the case.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TAUZIN. Mr. Speaker, I would ask how much time is available on 
both sides at this point.
  The SPEAKER pro tempore. The gentleman from Louisiana (Mr. Tauzin) 
has 11\1/2\ minutes remaining, and the gentleman from New Jersey (Mr. 
Andrews) has 19\1/2\ minutes remaining.
  Mr. TAUZIN. Mr. Speaker, I commended the gentleman from Virginia (Mr. 
Tom Davis) and the gentleman from California (Mr. Cox) previously, 
along with the ranking members for their extraordinary work we did 
together; and I now ask unanimous consent to yield the balance of my 
time to the gentleman from Virginia (Mr. Tom Davis) so that Chairman 
Davis can control the balance of that time.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Louisiana?
  There was no objection.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, as I understand it, I would 
have the time yielded to the Committee on Government Reform in addition 
to the time yielded to me by the Committee on Energy and Commerce?
  The SPEAKER pro tempore. The gentleman is correct.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield 3 minutes to the 
gentleman from New York (Mr. Boehlert).
  Mr. BOEHLERT. Mr. Speaker, we live in a different world than we did 2 
years ago, a world where the threat of

[[Page 18356]]

attack from biological and chemical agents remains high. Here on 
Capitol Hill we know this all too well. We were all victims of a 
vicious attack using anthrax and poisoning our own postal system. The 
attack shut down half of an entire branch of our government and lives 
were lost. A very real threat became a sad reality.
  Project BioShield will take the necessary steps to provide greater 
protection for Americans from those malicious attacks, to research, 
develop, manufacture and stockpile effective drugs and vaccines. In 
order to make this plan a reality, the Department of Health and Human 
Services and the National Institutes of Health must have a strong 
infrastructure of laboratories and facilities designed for research on 
the most dangerous of pathogens.
  The research stage of this process is the most important part of 
developing a broad and effective basis for this project. In my own 
district, there is an effort underway to build a national 
biocontainment laboratory to be administered by the National Institute 
of Allergy and Infectious Diseases. This state-of-the-art facility 
would take on the daunting task of testing these dangerous agents that 
could threaten our communities, and they have got the charge to come up 
with the vaccines and drugs necessary to effectively deal with them. I 
am fully supportive of this plan and hope this critical facility will 
soon call upstate New York home.
  Development of these vital medical countermeasures to biological and 
chemical agents can take years. With the building of new facilities to 
do the research and expedite the development of vaccines, more diseases 
may one day be eradicated or at least treatable to avoid mass casualty 
from any type of attack.
  I am pleased that Project BioShield may offer assistance to 
enterprising companies like Viral Therapeutics of Ithaca, New York, 
that are currently producing needed vaccines and is interested in 
answering the call to expand research and development as well as 
production.

                              {time}  1445

  Mr. Speaker, I am proud of my service on the Select Committee on 
Homeland Security and our determined effort to give the American people 
what they desire and deserve, a comprehensive and balanced effort to 
protect them from the evils of biological and chemical weapons. This 
legislation is designed to do exactly that. I commend all those 
involved with the formulation of this bipartisan product for the 
American good.
  Mr. ANDREWS. Mr. Speaker, I yield 4 minutes to the gentleman from 
Rhode Island (Mr. Langevin), who has had experience in State government 
with homeland security, who has had experience here on the Committee on 
Armed Services and now on the Select Committee on Homeland Security.
  Mr. LANGEVIN. Mr. Speaker, I thank the gentleman for yielding me this 
time on this incredibly important issue.
  Mr. Speaker, I rise today in strong support of the Project BioShield 
Act. Bioterrorism is a national threat to our national security, and I 
believe it is our job as the Members of the United States Congress to 
instill confidence in the American people that a coordinated, concerted 
effort is being made to combat this threat.
  We have some incredibly talented people in this country in the public 
and in the private sector, and this joint partnership will ensure that 
we are moving ahead to effectively protect the American people from the 
potential of a bioterrorism attack.
  While Project BioShield is not the only answer, it is certainly an 
important step toward that goal, and I hope Congress will continue to 
provide the funding and the oversight that the project needs to be 
effective.
  However, I must mention my ongoing concern with the operation of 
Department of Homeland Security's information analysis and 
infrastructure protection directorate. This is truly a life-and-death 
issue. If this unit is not running effectively, then the rest of DHS is 
at a tremendous disadvantage in determining how to allocate resources 
and where to 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, while working closely 
with their peers at CDC and NIH to identify the most pressing dangers.
  Mr. ANDREWS. Mr. Speaker, will the gentleman yield?
  Mr. LANGEVIN. I yield to the gentleman from New Jersey.
  Mr. ANDREWS. Mr. Speaker, I very much appreciate the point the 
gentleman is making. The BioShield Project is built on a foundation of 
accurate assessment of the threats that we face. For example, if there 
is an assessment that we face a significant threat from botulism, the 
full resources of this bill are applied to finding an antidote to 
botulism.
  The gentleman's point is very well taken. If the threat assessment is 
flawed, then we run the risk of either spending money on a threat that 
is not very viable, or failing to spend energy and money on a threat 
that is viable that we have failed to detect.
  So we can employ the very best resources of our scientists, our 
engineers, our researchers, our entrepreneurs, but have them working on 
the wrong problem if there is not an adequate intelligence-gathering 
capability and then an adequate response to that intelligence-gathering 
capability shared with the Department of Homeland Security. I think the 
gentleman's point is very well taken.
  Mr. LANGEVIN. Mr. Speaker, I thank the gentleman from New Jersey (Mr. 
Andrews) for interjecting that point, and I wholeheartedly concur.
  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.
  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.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise in support of H.R. 2122, the Project BioShield 
Act. This 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. It is the cornerstone of the administration's 
strategy to prepare our Nation against the possibility of a 
bioterrorist attack. The bill we are considering today was introduced 
by the gentleman from Louisiana (Mr. Tauzin), chairman of the Committee 
on Energy and Commerce, and was referred to the committee, as well as 
the Committee on Government Reform which I chair, and the Select 
Committee on Homeland Security. It is a good bill which serves a 
compelling national interest.
  As we tragically learned during the fall of 2001, our Nation is 
vulnerable to biological terrorism. Letters laced with anthrax caused 
the deaths of five individuals and thousands more had to be treated. 
The death toll could have been higher if there had not been an 
effective countermeasure to treat that form of anthrax. Unfortunately, 
there has been little progress in treatment for other deadly diseases, 
like smallpox, Ebola and plague, which effect few, if any, Americans.
  The reality is that there is little manufacturer interest in 
developing necessary treatments for these diseases because there is no 
significant commercial market existing outside of government. The 
absence of financial incentives has provided drug companies with little 
reason to make the substantial investment that would be required to 
develop treatments for these deadly diseases.
  Should the United States be attacked with any of these deadly 
pathogens, the needs for vaccines, tests and treatments would be great, 
and it would be

[[Page 18357]]

immediate. H.R. 2122 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 
procurement of necessary drugs and vaccines. These tools are 
instrumental to the success of the BioShield program.
  For example, the bill increases the simplified acquisition threshold 
for research and development projects from the current level of 
$100,000 to $25 million. This increase will help the Secretary promote 
sophisticated research and development projects by streamlining the 
acquisition process. The bill also authorizes the procurement of 
biomedical countermeasures, again using tailored, flexible acquisition 
tools for inclusion in the Nation's stockpile using a special reserve 
fund.
  The Secretary would also have expedited authorities to award research 
grants and hire technical experts and consultants. 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. The Committee on Government Reform, which I chair, held 
a hearing to examine the BioShield proposal on April 4, 2003. Witnesses 
from the government, academia, and pharmaceutical and biotech companies 
were supportive of the bill. They all recognize the need to create 
incentives for manufacturers to develop biomedical countermeasures.
  Our committee favorably reported the bill on May 22. Working in a 
bipartisan fashion with the gentleman from California (Mr. Waxman), we 
unanimously adopted some amendments to ensure greater accountability in 
the acquisition process and to clarify the circumstances when 
biocountermeasures can be processed.
  Specifically, the amendments we approved permit the use of simplified 
acquisition procedures only when the Secretary of Health and Human 
Services determines there is a pressing need for the procurement of 
specific countermeasures. The bill commits decisions about research and 
development projects to the discretion of the Secretary of Health and 
Human Services. However, we approved an amendment which preserves a 
limited right for companies to appeal to the General Accounting Office 
contracting decisions made by the Secretary, but appeals could not be 
used to stall the research and development procurement process.
  We also made some technical changes that seek to clarify the 
circumstances when the Secretary could use other than fully competitive 
procedures for research and development and production contracts.
  Mr. ANDREWS. Mr. Speaker, will the gentleman yield?
  Mr. TOM DAVIS of Virginia. I yield to the gentleman from New Jersey.
  Mr. ANDREWS. Mr. Speaker, I would like to thank the chairman for 
working with the gentleman from California (Mr. Cox) and the gentleman 
from Texas (Mr. Turner) on the issue of termination for convenience. We 
think it is a very important clarification that if there is a 
termination by the government for reasons of convenience, the companies 
involved in the project can recover their costs under the normal rules 
for that. I know that the gentleman's committee was involved in making 
that possible, and I wanted to thank him for his cooperation.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, the gentleman is correct, and 
it makes them more likely to be involved in this process.
  We think that all of these amendments, and I thank the gentleman from 
California (Mr. Waxman) for working with us as well, have been agreed 
to by the majority and the minority on the various committees; and they 
are part of the bill that we are considering today.
  Since our markup, we have continued to work on this bill in a 
bipartisan fashion. This issue is really too important to play party 
politics with. We have worked out language to ensure that the rights of 
contractors with respect to payment are protected in the event they are 
terminated for convenience. This is a good bill and deserves our 
support.
  Mr. Speaker, I reserve the balance of my time.
  Mr. ANDREWS. Mr. Speaker, I ask unanimous consent to yield the 
balance of my time to the gentleman from Texas (Mr. Turner) and that he 
may further allocate that time.
  The SPEAKER pro tempore (Mr. Gilchrest). Is there objection to the 
request of the gentleman from New Jersey?
  There was no objection.
  Mr. TURNER of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  To win the war on terror, we must do everything we can to protect the 
American people from the threat posed by terrorists using weapons of 
mass destruction. We know that our forces in Afghanistan uncovered 
plans by al Qaeda to engage in bioterrorism. We know from recent 
arrests in Europe that terrorist groups have the means and the will to 
carry out such attacks. It is without question that bioterrorism is a 
clear and present danger to the American people, perhaps one of our 
greatest threats.
  In response to this threat, the administration is proposing this 
legislation, commonly known as Project BioShield. This bill is a first 
step toward ensuring that we protect Americans from the horror of 
bioterrorism. The purpose of the BioShield legislation is to provide 
incentives to private companies to produce the medicines, the vaccines, 
the antidotes we need to counter a biological attack.
  Quite frankly, this concept is an experiment, a grand experiment, but 
no less an experiment. We do not know if the incentives will drive our 
pharmaceutical industry to invest the resources needed to truly prepare 
our country for the full range of possible biological attacks. If we 
do, we will have been successful and our country will be better off. If 
they do not, our country will remain dangerously vulnerable.
  I support Project BioShield because I believe this is an experiment 
worth conducting; but from the beginning of this process, I have been 
working to build mechanisms into the legislation that would monitor 
whether the legislation is truly making our Nation safer.
  For example, the Select Committee on Homeland Security added a 
requirement that the Secretary of Health and Human Services report 
annually if the President has identified biological agents that are 
threats to the United States, but no private company has contracted to 
produce a countermeasure. Thus, if there is a bioterrorist threat to 
the American people and private industry will not rise to the challenge 
of searching for a cure, we have the right to know about it.
  These concerns were shared by the gentleman from California (Mr. 
Cox), chairman of the Select Committee on Homeland Security. They were 
also shared by the gentleman from Louisiana (Chairman Tauzin) of the 
Committee on Energy and Commerce and the ranking member, the gentleman 
from Michigan (Mr. Dingell).
  If BioShield does not work as we hope it will, we will need plan B. 
Thus, I am very pleased that the legislation contains clear authority 
that allows the government to operate an emergency program to develop 
and produce vaccines. In my view, this is so very important because 
protecting our population is our first responsibility. If the private 
sector is not producing the medicines we need and we find ourselves 
under the threat of biological attack, then the government needs to 
have the authority to do the job directly.
  The language that has been inserted in the legislation gives the 
President, the Secretary of Health and Human Services, the Secretary of 
Homeland Security the necessary authority to take action in the event 
that this experiment with the private sector fails to produce the 
results we all hope it will produce.

                              {time}  1500

  My final concern, Mr. Speaker, is that Project BioShield, despite its 
creative name, is really a fairly modest

[[Page 18358]]

proposal. If we are lucky at the end of 10 years, we will have some 
vaccines to address a few of the possible pathogens that terrorists 
could use during a bioterror attack. But the potential problems are 
much more expansive. Terrorists may soon be able to genetically 
manipulate biological agents so they are resistant to our current 
stockpile of antibodies and perhaps to the vaccines we develop.
  This possibility presents a daunting threat to our Nation. That is 
why I would like to see a much more robust proposal than the one before 
us today, an approach that moves us faster and stronger toward creating 
a comprehensive defense to the full range of threats we face from 
bioterrorism. Based on the information that we all know about, we 
clearly need a Manhattan Project to prepare this country to deal with 
the vast array and the diverse types of biological threats that we may 
face in the years ahead.
  Time and time again when faced with such a great challenge, the 
government has played a central role in organizing a massive response. 
When war threatened to consume the world, we put an end to it through 
the success of the original Manhattan Project. When we raced the 
Russians to the stars, the Apollo Project put a man on the Moon. It 
will take these kinds of bold actions, this kind of bold leadership and 
deep resolve to prevail in the war on terror.
  Mr. Speaker, I wholeheartedly support this current legislation, but I 
also believe that our Nation must take even stronger steps much sooner 
in order to protect us and to secure us in the days ahead.
  Mr. Speaker, I reserve the balance of my time.
  Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield 4 minutes to the 
gentleman from Connecticut (Mr. Shays), the distinguished vice chairman 
of the Committee on Government Reform.
  Mr. SHAYS. Mr. Speaker, I appreciate my chairman yielding me this 
time.
  Throughout committee consideration of H.R. 2122, I expressed some 
skepticism about both the short- and long-term impact of the proposed 
approach on our ability to develop, procure, and use new medical 
countermeasures against chemical, biological, or radiological weapons. 
Thanks to the work of the Committee on Energy and Commerce, the 
Committee on Government Reform and the Select Committee on Homeland 
Security, the bill before us today represents a substantial improvement 
over the original proposal. This bill would create agile, proactive 
capabilities in meeting the threat of unconventional weapons, 
capabilities we do not have today.
  Part of the value of Project BioShield would be purely deterrent. 
Just having the ability to develop and stockpile vaccines and antidotes 
decreases the likelihood, or the lethality, of a biological attack.
  However, as I indicated in my earlier colloquy with Chairman Tauzin, 
any authority to actually use experimental drugs or medical devices in 
emergency situations has to be defined and wielded with nothing less 
than surgical precision. Prior informed consent in connection with the 
administration of experimental therapy is a basic human right, a right 
no one should be asked to surrender except under the most extraordinary 
of circumstances. For example, if a patient is unconscious and cannot 
give consent or be informed before onset of a life-threatening disease 
or event, medical ethics allow use of an experimental therapy.
  Mere military inconvenience can never justify waiving consent or 
failing to inform service members about medical countermeasures. No 
loosely defined concept of feasibility should allow the Secretary of 
HHS to waive or delay the requirement to provide essential information 
on medical risks and benefits prior to administration of a drug or 
vaccine, as could happen under the language in this bill Chairman 
Tauzin has agreed to revisit. If the medicine can get to the front, 
there should always be room in the transport for the leaflet describing 
its dosage, interactions and contraindications.
  In the 1991 Persian Gulf War, soldiers, sailors, aircrews and Marines 
were ordered to take experimental drugs and vaccines. Despite Pentagon 
promises to provide critical medical information and keep accurate 
medical records, very little information was provided and very few 
records survived the trip home. That cannot happen again. In the course 
of 14 hearings on the subsequent health problems of Gulf War veterans, 
the Government Reform subcommittee I chair reached this stark 
conclusion: ``Unless providing medical information to service members 
is mandatory, it's just too easy for the military, in the heat of 
battle, to decide it's just not feasible.''
  In the war against terrorism, we are all on the front lines. The 
citizen-soldiers of our all-voluntary Armed Forces fight and die to 
protect our rights and freedoms. They should not be asked to surrender 
those fundamental rights under different, less rigorous, circumstances 
than those they left behind.
  Again, I appreciate the very good work of Chairman Tauzin, Chairman 
Davis and Chairman Cox and their respective ranking members; and I look 
forward to a conference agreement that relies on the protections of 
current law and requires prior notification of service members whenever 
an unapproved drug or device has to be used.
  Mr. TURNER of Texas. Mr. Speaker, I yield 4 minutes to the 
distinguished gentlewoman from the Virgin Islands (Mrs. Christensen).
  Mrs. CHRISTENSEN. Mr. Speaker, I rise today as a member of the Select 
Committee on Homeland Security and also of the Subcommittee on 
Emergency Preparedness and Response in qualified support of the Project 
BioShield Act of 2003, the purpose of which is to increase the 
development of countermeasures to bioterrorism and facilitate their 
approval for use in mass production so that they would be readily 
available when needed.
  While research and development of such products is extremely 
important, I remain very concerned that a commensurate amount of time 
and effort has not been devoted to furthering our public health 
security, a broader, more basic and more immediate issue.
  Through the four or five hearings on Project BioShield, I joined 
several other of my colleagues in calling attention to the inadequacies 
and deficiencies that exist throughout the public health system in this 
country, especially in rural and minority communities.
  With the focus on cost containment rather than care, our lack of 
focus on prevention and our failure to insure everyone's equal access 
to quality health care, added to the system's continued deterioration 
because of repeated funding cuts and misguided departmental policies, 
our Nation's public health infrastructure today is in worse shape than 
ever.
  Project BioShield, though, is important because it will help to make 
sure that we have the vaccines and other countermeasures as quickly as 
possible in the case of a bioterrorism attack. But all of those fancy 
medicines and other agents will be worthless to you and me and to the 
people we serve without an intact public health system.
  The 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.
  Mr. Speaker, I am happy that the gentlewoman from Texas (Ms. Jackson-
Lee) and I were able to amend the bill in committee to ensure that the 
historically black colleges and universities and other minority-serving 
institutions of higher learning will be provided with special outreach 
to ensure their participation in this program to the fullest extent 
possible. This is an extremely important provision, and I thank our 
chair and ranking member and Chairman Tauzin for working with us to 
include it in the bill.
  Mr. Speaker, today I know that we will pass this bill, but what I and 
other health providers, public health experts

[[Page 18359]]

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 want to take this opportunity to thank and commend Chairman Cox and 
Ranking Member Turner for their guiding what is often not an easy 
committee to guide and for their shepherding of this bill through that 
committee.
  I ask the support of my colleagues for Project BioShield, but I also 
ask that when this is passed that we move on from here to soon pass 
``Project Public Health.''
  Mr. TOM DAVIS of Virginia. Mr. Speaker, I yield the balance of my 
time to the gentleman from California (Mr. Cox).
  Mr. COX. Mr. Speaker, I want to thank the chairman not only for 
yielding time but for the exceptional work that the Committee on 
Government Reform has done both on the majority and minority sides to 
bring us to this point; likewise, the Committee on Energy and Commerce, 
of which I am a member, and Chairman Tauzin and Chairman Dingell for 
their extraordinary leadership and commitment to bringing this bill to 
the floor; and my ranking member on the Select Committee on Homeland 
Security, which I chair, the gentleman from Texas (Mr. Turner), who is 
with me on the floor now.
  This has been a bipartisan effort for one simple reason. The 
terrorists do not discriminate between Democrats and Republicans. They 
certainly are not going to protect us because we are on one or another 
side of this debate. We are all in their sights. The committees of 
jurisdiction working closely together have managed to create a process 
in bringing this bill to the floor that has been focused on producing 
the best possible policy and thus the best possible security for our 
country. It is not focused on Capitol Hill turf battles. This type of 
cooperation serves as a model for our efforts to make America more 
secure against terrorist attack.
  In the fall of 2001, we caught a glimpse of the terrible potential of 
a bioterror attack when anthrax attacks were loosed on the Nation's 
capital. A broader attack on the American population, on our armed 
services involving one of the many biologic agents for which we have no 
antidote could be devastating. The potential toll in lives would far 
exceed what happened on September 11, 2001. We must, of course, do all 
we can to prevent such attacks, but ultimately we must be prepared. 
Because no scheme of prevention, no matter how expert and reliable our 
intelligence collection and analysis, is going to be perfect. We must 
be prepared.
  This legislation, the BioShield Project launched in this bill, will 
provide the resources and authorities we need to develop the next 
generation of biological countermeasures. It will help to ensure that 
we avoid the kind of catastrophe we are contemplating here on the floor 
today in the future.
  The ability of the Secretary of Homeland Security to identify from 
around the world the most serious potential biological threats to our 
population is key to making Project BioShield effective, and it is key 
to the vital task that we have of meeting this threat. To do that, 
Secretary Ridge will have to get the very best intelligence available. 
By learning everything we can about the biological weapon threats that 
confront us, we can allocate our resources and focus our efforts where 
they will be most effective. By identifying the bioterror agents for 
which the risks and potential consequences of attacks are greatest, we 
can use these substantial new first responder resources most wisely.
  That brings us, therefore, to the creation of Project BioShield in 
fulfillment of President Bush's charge to this Congress in his State of 
the Union message. Both President Bush and Vice President Cheney have 
made this a priority, and we are responding in this Congress.
  The BioShield Project is by far the most expansive, broadest, largest 
first responder program initiated in the history of our country. It is 
budgeted for $5.6 billion, but we have made it very plain that, through 
the appropriations process and through the budget process, we will put 
the resources behind this program that are needed to develop the 
antidotes and, if a presidential decision on a recommendation of both 
the Secretary of Health and Human Services and the Secretary of 
Homeland Security is made, if the President decides to stockpile enough 
antidotes, vaccines to immunize the entire American population in the 
event of a catastrophe.
  The Secretary of Homeland Security as part of this process is charged 
with identifying the most significant biological, chemical and nuclear 
agents that threaten the American population. Because our ability to 
collect, analyze and put to use timely and accurate intelligence 
information is at the very heart of doing this job, certainly in 
preventing a biological attack but also of being prepared to respond to 
it, in this legislation we have given the Secretary of Homeland 
Security the information analysis tools that he needs.

                              {time}  1515

  This bill is very important to the Select Committee on Homeland 
Security. We worked hard to get it right. We have held extensive 
hearings and nearly 3 months of work in three of our subcommittees and 
twice in the full committee. We conducted a series of oversight 
hearings which examined the new Department's ability to carry out its 
threat assessment function; and as a result, we have incorporated into 
the bill several provisions designed to strengthen the Secretary's 
threat assessment capabilities. We have given the Secretary the 
authority and the resources he needs to quickly hire the necessary 
bioterror analysts and to rapidly build a bioterror intelligence 
infrastructure. The Select Committee on Homeland Security added these 
provisions to this bill.
  This legislation greatly increases our ability to conduct bioterror 
research against the most urgent threats identified by the Department 
of Homeland Security. But most importantly, rather than trying to 
create a parallel government bioterror industry, or I should say 
bioterror response industry, BioShield will draw on the expertise and 
resources of the private sector.
  Our American industries lead the world in these categories. And our 
health care innovation, our free markets, our strong patent protections 
have led American industry to spend more on research and development on 
new products and treatments than all of Europe and Japan combined. To 
make the progress that is necessary in these noncommercial areas that 
are so essential to national security, it is essential we tap into this 
strength in the private sector. To accomplish this, the legislation 
establishes a reserve fund that will be available to stockpile security 
countermeasures that are produced against government requirements, even 
though these countermeasures do not presently exist.
  We want to stimulate the invention, the productivity, the research 
that is necessary to find these antidotes, these vaccines to bioweapons 
that exist but for which countermeasures do not presently exist. The 
gentleman from Louisiana (Chairman Tauzin) and I worked with the 
gentleman from Kentucky (Chairman Rogers) of the new Appropriations 
Homeland Security Subcommittee to provide this funding in a 10-year 
advance appropriation. This money will remain available for a full 
decade, creating, in essence, a homeland security market for the 
development of critical security countermeasures for which no 
commercial market exists. The knowledge that funding will be available 
for a full decade and not be subject to the annual appropriations 
process will encourage the biotech industry to devote resources to 
develop and produce the next generation of treatments for bioterror 
agents.
  So once again I want to thank the Members on both sides who have

[[Page 18360]]

worked so hard on this legislation for their spirit of cooperation, of 
bipartisan cooperation; and I strongly urge my colleagues to support 
this very important legislation.
  Mr. Speaker, I reserve the balance of my time.
  I inquire how much time I have remaining.
  The SPEAKER pro tempore (Mr. Gilchrest). The gentleman from 
California (Mr. Cox) has 6 minutes remaining.
  Mr. COX. Mr. Speaker, is that 6 minutes the time that was earlier 
yielded to me by the gentleman from Virginia (Mr. Tom Davis)?
  The SPEAKER pro tempore. The gentleman from Virginia (Mr. Tom Davis) 
yielded 7 minutes, with a total of 14\1/2\ minutes.
  Mr. COX. So the time that we are speaking of, Mr. Speaker, comprises 
also the time allotted for purposes of debate to the Select Committee 
on Homeland Security?
  The SPEAKER pro tempore. That is correct.
  Mr. TURNER of Texas. Mr. Speaker, I yield 6 minutes to the gentleman 
from New Jersey (Mr. Pascrell), one of the most vigorous advocates for 
equipping and training first responders to protect America.
  Mr. PASCRELL. Mr. Speaker, the tragic events of September 11, and the 
anthrax attacks shortly thereafter, reinforced the possibility of a 
widespread bioterrorist strike on America; and that is very real. There 
was a report submitted to us by Warren Rudman, who was the chairman of 
the Independent Task Force on Emergency Responders dealing with this 
subject very recently, and in that report it says the following: public 
health labs in most States still lack basic equipment and expertise to 
adequately respond to a chemical or a biological attack, and 75 percent 
of State laboratories report being overwhelmed by too many testing 
requests.
  In fact, Mr. Speaker, we were told of this threat well before 9-11. 
In January of 2001, a report submitted by the National Intelligence 
Council stated that the number of players, that is, state players and 
nonstate players, bioterrorism sponsored by state governments, 
bioterrorism sponsored by nonstate terrorist organizations throughout 
the world possessing or seeking to acquire a biological weapon, that 
group is growing despite the fact that biological weapons are banned by 
international treaty.
  We were warned of this in January, 2001. While Congress has made 
progress over the last 18 months on expanding our vaccine stockpile, an 
enormous amount of work still remains. The Project BioShield Act of 
2003 is so important because it encourages the development for new 
countermeasures against a bioterror attack in a comprehensive manner. 
This committee, the Select Committee on Homeland Security, was given a 
rude awakening upon hearing the testimony of Mr. Paul Redmond, the 
assistant secretary for information analysis at the Department of 
Homeland Security. We learned that Mr. Redmond's office had only one 
person working under him on the bioterror threat and that Mr. Redmond 
had limited access to the intelligence himself. Imagine, we are asking 
two people to protect 290 million Americans about a possible biological 
threat they do not know about.
  The Cox-Turner amendment, approved by our committee, correctly 
concentrates on increasing not only access to intelligence but an 
increase in the staff of those folks who collect intelligence. 
Specifically, it requires that the Secretary of the Department of 
Health and Human Services be provided all intelligence information from 
all other agencies relating to the threats regardless of classification 
and regardless of whether the Secretary has requested the information.
  This bill is not just about creating a significant stockpile of 
vaccines and medical devices. It is about making sure that our first 
responders do have the tools to effectively operate their attack. Mr. 
Speaker, they will be the first ones there, be it a firefighter, be it 
a cop, be it someone working in emergency services. They will be the 
first one there; and if they do not know what they are doing, if we do 
not train them, if we do not provide the training, we are doing a 
disservice to them and we are certainly putting them in harm's way. A 
nurse or a doctor will be able to immediately provide a vaccine and 
prevent the spread. A fireman will have a mask to breathe purified air 
while a building with biological agents burns.
  This bill will make those and other lifesaving tools available so we 
can begin to protect ourselves, protect our children and our 
grandchildren from the threats of today and the unfathomable biological 
threat of tomorrow. This is just the beginning, Mr. Speaker. There is a 
great deal that we still do not know. When one reads the report of the 
National Intelligence Council on biological warfare, one understands 
what scale we are talking about and what a delayed onset is and what a 
delayed response will lead to. Most biological agents cause symptoms 
that have a delayed onset ranging from a few hours to many days. This 
is serious business. The fact that an attack has taken place can be 
masked, and the identification of the perpetrators would be extremely 
difficult to find out. I am confident, Mr. Speaker, that H.R. 2122 will 
help, will help protect every American against the unimaginable.
  The importance of Project BioShield cannot be overstated, and I 
congratulate the leadership of both parties for bringing it to the 
floor today.
  Mr. COX. Mr. Speaker, I yield 3 minutes to the distinguished 
gentlewoman from the State of Washington (Ms. Dunn), the vice chairman 
of the full Select Committee on Homeland Security.
  Ms. DUNN. Mr. Speaker, I rise today in support of the Project 
BioShield Act of 2003. As the Members have heard today, Mr. Speaker, 
from the debate we have had on the floor, this is truly bipartisan 
legislation. It is also a major step towards giving Americans necessary 
protections to address the biological and the chemical threats that 
exist today. H.R. 2122 will provide for private companies the 
incentives they need to develop vaccines for biological agents. It also 
will increase our national pharmaceutical stockpile, and it will 
provide DHS, the Department of Homeland Security, better intelligence 
capabilities so that they can protect against biological and chemical 
attacks.
  Earlier this year, President Bush announced his intentions to develop 
a vaccination program that would protect against an attack involving 
biological and chemical weapons. For months, three committees, 
including my committee, the Select Committee on Homeland Security, have 
held numerous hearings to consider the best ways to protect our 
constituents. I believe it is time to pass this legislation. Mr. 
Speaker, this bill will provide $5.6 billion over a 10-year period to 
develop vaccines to protect against some of the most dangerous 
biological agents that this country and this world has ever known. 
These funds are necessary to create an incentive for private companies 
to do research and development on drugs that might not normally be in 
demand in the marketplace. I believe this investment is worthwhile, 
considering the possible effects of a large-scale biological attack.
  In addition to authorizing funds for this program, the BioShield 
program also addresses the sharing of intelligence. In order to develop 
an effective vaccination program, the Department of Homeland Security 
must have the intelligence capabilities to predict what the real 
threats are thought to be. By understanding the threats, DHS can focus 
its resources on those areas of highest vulnerability to the people who 
live in this country.
  This legislation will authorize specific funds to be used by DHS for 
terror threat assessment. In addition, it will require other 
intelligence agencies such as the CIA to share timely information and 
threat analyses with the Department of Homeland Security.
  One of the lessons we learned from the anthrax attacks during the 
fall of 2001 is the importance of responding to a biological attack 
quickly in order to minimize the damage it causes. While

[[Page 18361]]

it is indeed tragic that during those attacks five people died, we all 
have to appreciate that. It could have been far worse if the vaccine 
had not immediately been available. H.R. 2122 will help us be prepared 
to respond quickly to agents such as ebola, plague and smallpox. I ask 
that we answer the President's call to develop the BioShield Project 
and that people support and that we pass H.R. 2122.
  Mr. TURNER of Texas. Mr. Speaker, I yield 5 minutes to the 
gentlewoman from Texas (Ms. Jackson-Lee), one of the foremost leaders 
in trying to prepare her city and this country to protect us against 
the threat of bioterrorism.
  Ms. JACKSON-LEE of Texas. Mr. Speaker, I thank the distinguished 
gentleman from Texas for yielding me this time.
  This is an important statement, if you will, an actuality of the work 
that the Select Committee on Homeland Security has done along with 
collaborative efforts of our respective committees of jurisdiction.

                              {time}  1530

  Let me again thank the gentleman from Texas (Mr. Turner) for his work 
and the chairman for his work and realize that, as we begin this debate 
or as we engage in this debate, we need to do much more.
  I rise to support this legislation because it takes America one step 
closer to being prepared in dealing with a biochemical terrorist 
attack. But as we consider this legislation, Mr. Speaker, I think it is 
important to note that, while America is on the trail, on the pathway, 
on the journey toward being safe, we are still not safe. We remain 
vulnerable. Our ports are not secure, our critical infrastructures are 
not secure, our communities are not protected from biochemical agents, 
but H.R. 2122 will help to make America safer.
  The purpose of this Act is to enhance research, development, 
procurement, and use of biomedical countermeasures to respond to public 
health threats affecting national security and for other purposes. What 
it begins to do, Mr. Speaker, is to focus our attention narrowly on the 
question of what do we do if we are subjected to a bioterrorist attack. 
What kind of chemicals, if you will, will thwart the attack? What kind 
of research needs to be done in advance of the diabolical thoughts of 
anyone who would want to perpetrate a terrorist act with some chemical 
yet unknown?
  We already have had the experience of the fear and the intimidation 
of anthrax. We have already had the terrible situation of people who 
had nothing better to do or wanted to intimidate or scare or frighten, 
use anything from salt to sugar to powder to suggest that they were 
utilizing anthrax. We know what can be done through a bioterrorist 
attack or the suggestion that there would be an attack by some sort of 
chemical.
  Biological weapons pose a particularly dangerous threat. Biological 
weapons are highly portable and difficult to detect. So this concept of 
BioShield is more than overdue. Its time has come. 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.
  After 9/11, when we were allowed to fly home from Washington, I held 
one of the first town hall meetings with over 400 people on September 
14, 2001, on a Sunday, in fact, to be able to bring some sort of order 
to people's thoughts, the fear that was going on, the actual 
intimidation as far away as Houston. There were all kinds of 
suggestions that Houston was next in line, that Houston was about to be 
attacked.
  But, shortly thereafter, I also held a meeting with my first 
responders. As we were having a meeting, my hazardous materials team 
had to run out to a hospital about 50 miles down from where our meeting 
was being held because a woman drove to the hospital saying that she 
had anthrax; someone had put anthrax in her apartment or in her home. 
And without the understanding of what anthrax represents and the 
hospital officials not yet experienced, took whatever she had through 
the hospital, up the stairs, or wherever, up the elevator and, by its 
very exposure, caused the hazardous materials team to have to run out 
and shut down the hospital. A crippling effect, maybe just one 
hospital, but it shows the magnitude of what can happen if we are 
dealing with bioterrorism.
  We all recall the primary and secondary impact of the anthrax attacks 
in 2001. The attacks involved a series of letters mailed in pre-stamped 
envelopes to places like Florida and New York and to the offices of 
Senator Tom Daschle and Patrick Leahy. Those kinds of incidences prove 
that it is vital that we focus on the research aspect. I am gratified 
that my colleagues saw the importance of spreading the knowledge, the 
research, the input, the collaboration throughout our Nation.
  Therefore, we have included language to make sure that we include 
historically black, Hispanic-serving, Native American, and Pacific 
Islander institutions, that they are able to be exposed, if you will, 
to the various opportunities to engage in high-level research so that, 
as they are able to relate to different cultures and different 
communities, they, too, can be a part of securing the homeland.
  It is important as well, as I noted in an amendment that I was going 
to propose, that the stockpiles of chemicals that will thwart 
bioterrorist attacks that are in this country should be strategically 
placed, that they can reach any urban center and any rural area, any 
hamlet, any town, any village. I am glad to note by a letter that has 
been submitted into the Record dated July 16, 2003, that the Secretary 
of Health and Human Services recognizes that my letter had merit and 
that he will continue to monitor and be astutely aware of whether or 
not the stockpiles we have are sufficient, whether they are within the 
sufficient depth, and whether they will be able to protect all of 
America.
  Let me conclude, Mr. Speaker, by simply saying that I rise to support 
this legislation with the knowledge that we will be inclusive and that 
the idea is not only to secure the places we know and that are renowned 
but to secure the places where people live and to make sure that the 
home front and the home neighborhoods are secure in our country.
  I ask my colleagues to support this legislation.
  Mr. Speaker, I rise today in support of H.R. 2122, the ``Project 
Bioshield Act of 2003.'' I support this 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. H.R. 2122, will help to make 
America safer.
  The purpose of the Project BioShield Act of 2003 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 is 
a noble one 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 pre-stamped 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 five 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

[[Page 18362]]

mail facility, to the Congressional office buildings, to NBC 
headquarters had to cease operations.
  The threat of bioterrorism did not end in September of 2001. As 
recently as April 22nd 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 diseases like tuberculosis? There are many ailments that our 
medical professionals are struggling to control. We must do better in 
the ares 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.
  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 vial filled with anthrax, botulism, or 
smallpox? A vial 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 Institutes 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 countermeasures, and empowers the government to 
purchase safe and effective vaccines. Finally, Project Bioshield 
authorizes the Food and Drug Administration 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 this legislation 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.
  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. If 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 provision of H.R. 2122, 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.
  Mr. COX. Mr. Speaker, I yield 2 minutes to the gentleman from Arizona 
(Mr. Shadegg), the chairman of the Subcommittee on Emergency 
Preparedness and Response.
  Mr. SHADEGG. Mr. Speaker, I thank the gentleman for yielding me this 
time.
  As a member of both the Select Committee on Homeland Security and the 
Committee on Energy Commerce, I rise in strong support of H.R. 2122, 
the Project BioShield Act.
  Mr. Speaker, today, the House takes an important step toward 
preparing our Nation for the threat of bioterrorism. Clearly, we are 
living in a transformational era. Thirty years ago, none of us knew 
what biotechnology or genomics were, but, today, combined with our 
country's unparalleled leadership in semiconductors and computing 
power, we are on the verge of breathtaking breakthroughs in the field 
of bioscience.
  Congress has played an important role not only by doubling the 
funding for the National Institutes of Health, but also by committing 
$6 billion in fiscal year 2003 to develop strategies and 
countermeasures to protect the American public from bioterror attacks.
  Even though we are in a better position in terms of preparedness than 
we were just a few months ago prior to the anthrax attacks here on 
Capitol Hill, we have much more to do. Project BioShield is a 
critically important step in that process. In many ways, it will serve 
as our Nation's primary response to bioterror.
  Mr. Speaker, the Subcommittee on Emergency Preparedness and Response 
of the Select Committee on Homeland Security, which I chair, held 
several hearings on this issue; and, during that process, we learned 
that having measures to counter bioterror threats will actually serve 
as a deterrent to those threats, as would-be terrorists see that 
America can be protected against bioagents which al Qaeda or other 
terrorists would use against us.
  By providing a steady stream of funding for countermeasures, 
increased research capability at NIH, and expedited distribution during 
emergencies, project BioShield is a forward-thinking solution to 
bioterrorism.
  Mr. Speaker, our subcommittee worked hard on this legislation. I 
believe it takes an important step in the right direction. I commend 
the full committee chairman and the other committees for their work on 
it, and I urge my colleagues to support the Project BioShield Act and 
to support H.R. 2122.
  Mr. COX. Mr. Speaker, I yield 1 minute to the gentleman from Florida 
(Mr. Lincoln Diaz-Balart), the chairman of the Select Committee on 
Homeland Security Subcommittee on Rules.
  Mr. LINCOLN DIAZ-BALART of Florida. Mr. Speaker, I thank the 
gentleman for yielding me this time.
  For years the National Institutes of Health have served as our 
Pentagon in the war against disease. I think Americans, as well as 
people around the world, have benefited. Now, we must call upon, and we 
do so in this important piece of legislation, for the NIH to utilize 
its expertise and innovation, the expertise and innovation of all of 
its scientists to guard this Nation against the horrors that a serious 
biological attack would mean.
  We have already seen, Mr. Speaker, a biological attack on this 
country. We know the great damage that it can cause. So what this 
legislation is doing is taking another important step, taking another 
important step by this Congress to protect the Nation from the great 
damage that a biological attack would cause.
  I thank the gentleman from California (Chairman Cox) and the entire

[[Page 18363]]

committee for its hard work in bringing forth this important piece of 
legislation today.
  Mr. TURNER of Texas. Mr. Speaker, may I inquire of the time remaining 
on both sides?
  The SPEAKER pro tempore (Mr. Gilchrest). The gentleman from Texas 
(Mr. Turner) has 3 minutes remaining. The time of the gentleman from 
California (Mr. Cox) has expired.
  Mr. TURNER of Texas. Mr. Speaker, I yield myself 1\1/2\ minutes.
  Mr. Speaker, let me first commend the gentleman from California 
(Chairman Cox), along with the gentleman from Michigan (Mr. Dingell), 
the ranking member, and the gentleman from Louisiana (Chairman Tauzin), 
the gentleman from Virginia (Chairman Davis), and the gentleman from 
California (Mr. Waxman) for their excellent work on putting together 
this legislation in a bipartisan way. I know we all appreciate the work 
that Secretary Thompson and Secretary Ridge did on behalf of the 
President on this very important initiative.
  I hope that we are successful with this legislation, and I hope that 
the desired result can be accomplished. But I also want to end with a 
caution that the ability of our enemies in the years ahead to develop, 
alter, and modify biological pathogens will be at a level unknown to us 
today. I urge all of us to commit ourselves to the task of developing 
the agility and the responsiveness that we need to address those 
threats that we inevitably will face in the future.
  The Washington Post today spoke in an editorial entitled ``New Bugs'' 
that it is important for us to shorten the time frame from the 
identification of a dangerous pathogen to the development of a drug or 
antidote. The shortening of this time span will require a tremendous 
commitment on the part of the American people and our government, and I 
hope this step that we take today will be but a first step in ensuring 
that we can adequately meet the biological threat that this Nation will 
face in the future.
  Mr. Speaker, I yield the balance of my time to the distinguished 
gentleman from California (Mr. Cox), the chairman of the Select 
Committee on Homeland Security.
  Mr. COX. Mr. Speaker, I thank the gentleman from Texas for yielding 
me the remaining time.
  I want to take a moment to say not only how productive it was to work 
with the gentleman from Texas but what a pleasure it has been, because 
both sides of the aisle, the Republicans and the Democrats, have worked 
together, as we should, after September 11 to put our Nation's security 
first.
  I hope that our Nation never sees the kind of bioterror attack that 
we have been discussing on the floor here today. It is our job to be 
prepared against that eventuality. The legislative steps that we are 
taking today, the resources that we are providing, the intelligence 
infrastructure that we are building, the stockpile of vaccines and 
antidotes that we may requisition under Project BioShield are all 
intended to protect against mass casualties that would result in the 
event of a terrorist attack that we hope to prevent and we hope never 
to see in this country.
  After September 11, I daresay every Member of this body determined 
that we will win this war against these terrorists. They are not 
superhuman. They are individuals. They do not have infinite 
capabilities. They have finite resources. We can find them, we can 
defeat them, and we shall. And we will be prepared. That is the purpose 
of this legislation today. I strongly urge a vote in support.
  Mrs. LOWEY. Mr. Speaker, I support Project BioShield.
  Over the last few months. I have been having meetings with local 
officials, first responders, hospitals, and school superintendents, to 
talk about how we can better prepare for the unimaginable, improve 
emergency planning, implement 21st century communication systems, and 
foster better cooperation among local, state, and federal public health 
and safety officials.
  But all of these efforts won't amount to much if we do not have the 
right tools to counteract biological, chemical, radiological, or 
nuclear agents, and the diseases caused by such agents. And that's the 
crux of this legislation.
  With that said, I continue to have some concerns about whether this 
bill will be enough of an engine to spur research within the 
pharmaceutical industry and if our public health system is prepared and 
ready to assume the new products developed by BioShield.
  During the drafting process of this bill, a number of expert 
witnesses stated that Project BioShield might not be tempting enough 
bait to entice the pharmaceutical industry to bite. These fears are 
legitimate. And that is why I am pleased that the bill includes a 
provision allowing the federal government to assume this work in-hours 
if private industry does not or cannot produce countermeasures fast 
enough.
  On the other hand, if BioShield is successful, which I know we all 
hope it will be, and new countermeasures are developed, the success of 
these products depend on our public health systems' ability to 
distribute and deliver these serums to the general public in a timely, 
safe, and orderly fashion. In the case of smallpox, the cost of 
vaccinating--roughly $200 per vaccination because of screening, 
testing, post vaccination surveillance, and treatment of adverse 
reactions--has been a significant impediment to the program. Thus, the 
key to effective countermeasures depends on a lot of factors and costs 
other than buying countermeasures and putting them in the Strategic 
National Stockpile.
  As I have discussed with my colleagues and Administration officials 
during both Homeland Security Committee and Labor HHS Appropriations 
Subcommittee hearings, the bioterrorism grants provided through the 
Centers for Disease Control and Prevention and Health Resources 
Services Administration have not been adequate, particularly in the 
context of the current economy and failing state budgets. Basic health 
care programs are starved for cash for their core public health 
missions while also trying to take on greater responsibilities in the 
terrorism preparedness arena.
  So today, I want to go on record with my colleagues that we must be 
prepared to better invest in our public health network if we truly want 
a sound and secure homeland.
  Despite these criticisms, the BioShield proposal is a well-intended 
one, and a vitally important component in the fight against terrorism. 
The reality is: the more countermeasures we have, the less capable 
terrorists will be. And one way or another Project BioShield is going 
to make that happen.
  Mr. KENNEDY of Rhode Island. Mr. Speaker, I rise in support of the 
BioShield legislation, and commend the committees for their diligence 
in meeting the challenge of bioterrorism.
  While this bill is an important step in ensuring our nation's 
preparedness for bioterrorism, I am concerned that it does not fully 
meet our needs. This act does well in raising our defenses against the 
``bio,'' but does nothing to defend against the ``terror.''
  Mr. Speaker, the point of all terrorism, including bioterrorism, is 
not primarily to inflict physical damage, but to undermine our social, 
political, and economic vibrancy. Whether terrorists succeed depends 
not only on our ability to prevent or mitigate the physical impact of 
their acts, but whether we can prevent or mitigate the paralysis, 
panic, and demoralization they seek to create.
  Tom Kean, Rudolph Giuliani, the National Academy of Sciences, first 
responders, and others have talked about the need to build resilience 
in our communities. Our preparedness efforts must include plans to 
ensure that officials' communications calm instead of panic. We need to 
make sure that the public, first responders, teachers, and others have 
the proper information delivered in an appropriate way about threats, 
safety measures, and emergency plans. If we do not specifically address 
the social and behavioral impacts of terrorism and the threat of 
terrorism, the measure we debate today and our other preparations will 
not be as effective as they could be.
  I support this bill as component of our defense against biological 
terrorism, and hope that we can take the important next step as well.
  Mr. DINGELL. Mr. Speaker, I rise in support of the Project Bioshield 
Act of 2003. This legislation reflects bipartisan negotiations that 
have significantly improved the language submitted to us by the 
Administration. That is a credit to the Committee on Energy and 
Commerce and to other committees and colleagues. I commend the good 
work of all who participated in this endeavor.
  Project Bioshield is unfortunately a necessary measure in view of the 
increased risk of harm to Americans in this era of heightened threats 
to our national security. There are no effective therapies for many of 
the ``select agents'' that have been identified as potential

[[Page 18364]]

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 
counter-measures. The Committees' work clarified, modified, and 
otherwise improved on the Administration's proposal in each of these 
areas.
  Significantly, the bill before us contains an additional section that 
enhances 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 General Accounting Office and the National Academy of 
Sciences will provide reports on key economic and scientific elements 
of this program after it has been in effect for several years.
  Finally, I commend Chairman Tauzin of the Committee on Energy and 
Commerce and my other colleagues for deciding to proceed with an 
authorization for funding, rather than with the mandatory 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 vote for this bill.
  Mr. NUSSLE. Mr. Speaker, I rise today to speak on H.R. 2122, the 
Project BioShield Act of 2003. This Act would amend the Public Health 
Service Act to authorize appropriations to procure security 
countermeasures to treat, identify, and prevent the public health 
consequences of bio-terrorism.
  Project BioShield has been described by President Bush as ``a key 
part of our all-out effort to prepare for the threat of bio-terror.'' 
So I am pleased that the Project BioShield Act of 2003 will be voted on 
today in this House.
  The framework for this bill was initially established in the FY 04 
Budget Resolution that was adopted in April. The budget resolution set 
aside $5.593 billion over ten years to establish a program to 
accelerate the research, development and acquisition of biomedical 
threat countermeasures. Recognizing the importance of this legislation, 
it took the somewhat usual step of establishing firewalls around these 
funds to ensure they are not used for any other purpose.
  I am very pleased that the bill we are considering today is 
consistent with the budget resolution. It would authorize 
appropriations of $5.6 billion for fiscal years 2004 through 2013. As 
some of my colleagues may be aware, the House already passed 
appropriations for this bill as part of the Appropriations bill for 
Energy and Water. Accordingly, as provided by the budget resolution, I 
adjusted the 302(a) allocation to the Appropriations Committee to 
accommodate the appropriations for this important bill.
  I would also like to comment on the funding mechanism for BioShield. 
At the time the budget resolution was adopted, it was unclear whether 
this program would be funded through annual appropriations or with a 
permanent indefinite appropriation. Both the Budget and Appropriations 
Committees expressed a preference for subjecting the program to 
periodic review of the annual appropriation process. The Administration 
preferred a new entitlement that would be automatically funded without 
further legislative action.
  I believe the funding mechanism in this bill strikes the right 
balance. It would fund Project BioShield through what is effectively a 
multi-year appropriation that would give the Administration flexibility 
in the amount that is obligated in each year. It subjects the program 
to periodic Congressional review through the appropriations process but 
provides the pharmaceutical companies that develop the countermeasures 
the assurance of future funding.
  In conclusion, speaking for myself, and my colleagues, H.R. 2122 
reflects our strongest support for those necessary efforts to protect 
our people and our way of life.
  Mr. VAN HOLLEN. Mr. Speaker, I rise today as the Representative of 
the Congressional District that is the intended home of a key component 
of the Project Bioshield Act, a $186 million bio-defense laboratory 
that is planned to be built on the northeast corner of the National 
Institutes of Health campus in Bethesda, Maryland. While I support the 
Bioshield initiative, I have serious concerns about the proposed 
location of the bio-defense laboratory.
  Many of my constituents have expressed to me their concerns about the 
potential safety risks that the location of this laboratory poses to 
our community, and the possibility that it could become a target for 
terrorist attacks. Given that our government determined--even before 
this new laboratory was proposed--that a perimeter fence is required to 
safeguard the buildings and employees at the National Institutes of 
Health. I believe a number of questions must be answered before we 
proceed further with the plan to locate the laboratory on the NIH 
campus.
  I have written to the Director of the National Institutes of Health 
and asked him to address the following issues:
  (1) The property of locating this laboratory in an urban setting like 
Bethesda, as opposed to at Fort Detrick, where a bio-safety level 3 
laboratory is already under construction;
  (2) if located on the Bethesda campus, whether it can be located 
centrally on the campus, either in a new building or by renovating an 
existing building and relocating the offices and laboratories of that 
building to a building in the location chosen for Building 33; and
  (3) the precautions that will be taken to ensure that, in the event 
of a terrorist attack or human error, that any potential risk to our 
community presented by the presence of this laboratory on the Bethesda 
campus is minimized or eliminated.
  Mr. Speaker, I know that all of my colleagues in this House are 
united in our common effort to combat terrorism. But we owe it to our 
constituents to approach this endeavor carefully. I urge my colleagues 
and the Administration to consider all options so that we do right by 
all Americans.
  Mr. COX. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. Pursuant to the order of the House of 
Tuesday, July 15, 2003, the previous question is ordered on the bill, 
as amended.
  The question is on the engrossment and third reading of the bill.
  The bill was ordered to be engrossed and read a third time, was read 
the third time.
  The SPEAKER pro tempore. The question is on the passage of the bill.
  The question was taken; and the Speaker pro tempore announced that 
the ayes appeared to have it.
  Mr. COX. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this question will be postponed.

                          ____________________