[Congressional Record (Bound Edition), Volume 150 (2004), Part 8]
[Senate]
[Pages 10283-10307]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     PROJECT BIOSHIELD ACT OF 2003

  The PRESIDING OFFICER. Under the previous order, the Senate will 
proceed to the consideration of S. 15, which the clerk will report.
  The legislative clerk read as follows:

       A bill (S. 15) to amend the Public Health Service Act to 
     provide for the payment of compensation for certain 
     individuals with injuries resulting from the administration 
     of smallpox countermeasures, to provide protections and 
     countermeasures against chemical, radiological, or nuclear 
     agents that may be used in a terrorist attack against the 
     United States, and to improve immunization rates by 
     increasing the distribution of vaccines and improving and 
     clarifying the vaccine injury compensation program.

  Thereupon, the Senate proceeded to consider the bill, which had been 
reported from the Committee on Health, Education, Labor, and Pensions, 
with an amendment to strike all after the enacting clause and insert in 
lieu thereof the following:
  [Strike the part shown in black brackets and insert the part shown in 
italic.]

                                 S. 15

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

     [SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       [(a) Short Title.--This Act may be cited as the 
     ``Biodefense Improvement and Treatment for America Act''.
       [(b) Table of Contents.--The table of contents of this Act 
     is as follows:

[Sec. 1. Short title; table of contents.

         [TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL

[Sec. 101. Short title.
[Sec. 102. Amendment to the Public Health Service Act.

                      [TITLE II--PROJECT BIOSHIELD

[Sec. 201. Short title.
[Sec. 202. Biomedical countermeasure research and development 
              authorities.
[Sec. 203. Biomedical countermeasures procurement.
[Sec. 204. Authorization for medical products for use in emergencies.
[Sec. 205. Developing new countermeasures and protecting existing 
              countermeasures against bioterrorism.

      [TITLE III--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY

[Sec. 301. Short title.

                   [Subtitle A--State Vaccine Grants

[Sec. 311. Availability of influenza vaccine.
[Sec. 312. Program for increasing immunization rates for adults and 
              adolescents; collection of additional immunization data.
[Sec. 313. Immunization awareness.
[Sec. 314. Supply of vaccines.
[Sec. 315. Communication.
[Sec. 316. Fast track. 
[Sec. 317. Study.

            [Subtitle B--Vaccine Injury Compensation Program

[Sec. 321. Administrative revision of vaccine injury table.
[Sec. 322. Equitable relief.
[Sec. 323. Derivative petitions for compensation.
[Sec. 324. Jurisdiction to dismiss actions improperly brought.
[Sec. 325. Clarification of when injury is caused by factor unrelated 
              to administration of vaccine.
[Sec. 326. Increase in award in the case of a vaccine-related death and 
              for pain and suffering.
[Sec. 327. Basis for calculating projected lost earnings.
[Sec. 328. Allowing compensation for family counseling expenses and 
              expenses of establishing and maintaining guardianship.
[Sec. 329. Allowing payment of interim costs.
[Sec. 330. Procedure for paying attorneys' fees.
[Sec. 331. Extension of statute of limitations.
[Sec. 332. Advisory Commission on Childhood Vaccines.
[Sec. 333. Clarification of standards of responsibility.
[Sec. 334. Clarification of definition of manufacturer.
[Sec. 335. Clarification of definition of vaccine-related injury or 
              death.
[Sec. 336. Clarification of definition of vaccine and definition of 
              physical injury.
[Sec. 337. Amendments to Vaccine Injury Compensation Trust Fund.
[Sec. 338. Ongoing review of childhood vaccine data.
[Sec. 339. Pending actions.
[Sec. 340. Report.

         [TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL

     [SEC. 101. SHORT TITLE.

       [This title may be cited as the ``Smallpox Emergency 
     Personnel Protection Act of 2003''.

     [SEC. 102. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

       [Part A of title II of the Public Health Service Act (42 
     U.S.C. 202 et seq.) is amended by inserting after section 224 
     the following:

     [``SEC. 224A. PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL.

       [``(a) Definitions.--In this section:
       [``(1) Covered countermeasure.--The term `covered 
     countermeasure' means a covered countermeasure as specified 
     in article III of the Declaration.
       [``(2) Covered individual.--The term `covered individual' 
     means an individual--
       [``(A) who is--
       [``(i) a health care worker, a law enforcement officer, a 
     firefighter, a security-related worker, an emergency medical 
     worker, or a public safety worker who is identified in a 
     State, local, or Department of Health and Human Services plan 
     that is approved by the Secretary; or
       [``(ii) an individual with respect to whom the Secretary 
     determines and declares that it is advisable to administer 
     the vaccine (not including any individual to whom the 
     Secretary determines only that such vaccine should be made 
     available); and
       [``(B) to whom a vaccine is administered during the period 
     in which the Declaration is effective (including the portion 
     of such period before the date of enactment of this section) 
     and ending on the later of--
       [``(i) the expiration of the 120-day period that begins on 
     the effective date of the initial interim final regulations 
     to implement this section;
       [``(ii) the expiration of the 120-day period that begins on 
     the date on which an individual becomes an individual within 
     a category specified in subparagraph (A); or
       [``(iii) the date on which the Secretary publicly announces 
     that an active case of smallpox has been identified either 
     within or outside the United States.
       [``(3) Covered injury.--The term `covered injury' 
     includes--
       [``(A) an injury, disability, illness, condition, or death 
     determined, pursuant to the procedures established under 
     subsection (b), to have been sustained as the direct result 
     of administration to an individual of a covered 
     countermeasure during the effective period of the Declaration 
     (other than a minor injury such as minor scarring or minor 
     local reaction); and
       [``(B) an injury, disability, illness, condition, or death 
     determined, pursuant to the procedures established under 
     subsection (b), to have been sustained as the direct result 
     of accidental vaccinia inoculation through contact with an 
     individual who is (or who was accidentally inoculated by) an 
     individual in a category specified in Article IV of the 
     Declaration to whom vaccinia vaccine has been administered 
     during the effective period of the Declaration.
       [``(4) Declaration.--The term `Declaration' means the 
     Declaration Regarding Administration of Smallpox 
     Countermeasures issued by the Secretary of Health and Human 
     Services on January 24, 2003, and published in the Federal 
     Register on January 28, 2003, including any subsequent 
     amendment.
       [``(5) Eligible individual.--The term `eligible individual' 
     means an individual who is (as determined in accordance with 
     section 3)--
       [``(A) a covered individual who sustains a covered injury 
     as the direct result of administration of a covered 
     countermeasure; or
       [``(B) any individual who contracts vaccinia during the 
     effective period of the Declaration or within 30 days after 
     the end of such period--
       [``(i) to whom vaccinia vaccine was not administered;
       [``(ii) who has resided with, or has been in close contact 
     with, a covered individual; and
       [``(iii) who sustains a covered injury as the direct result 
     of contracting vaccinia.
       [``(6) Secretary.--Except as provided otherwise, the term 
     `Secretary' means the Secretary of Health and Human Services.
       [``(b) Determination of Eligibility.--
       [``(1) In general.--The Secretary, in consultation with the 
     Attorney General and the Secretary of Labor, shall establish 
     administrative procedures for determining, as applicable with 
     respect to an individual--
       [``(A) whether the individual is an eligible individual;
       [``(B) whether the individual has sustained a covered 
     injury or injuries for which medical benefits and employment 
     income-loss compensation may be available under subsections 
     (d) and (e), and the amount of such benefits or compensation; 
     and
       [``(C) whether the covered injury or injuries of the 
     individual constitute a compensable disability, or caused the 
     individual's death, for purposes of benefits under subsection 
     (f).

[[Page 10284]]

       [``(2) Covered individuals.--The Secretary may accept a 
     certification, by a Federal, State, or local government 
     entity or private health care entity participating in the 
     administration of covered countermeasures under the 
     Declaration, that an individual is an individual in a 
     category specified in article IV of the Declaration to whom 
     such a countermeasure has been administered by the applicable 
     deadline specified in subsection (a)(2)(B), as establishing 
     that the individual is a covered individual.
       [``(3) Determination of causation.--
       [``(A) Injuries specified in injury table.--In any case 
     where an injury or other adverse effect specified in the 
     injury table established under subsection (c) as a known 
     effect of a covered countermeasure manifests in an individual 
     within the time period specified in such table, such injury 
     or other effect shall be rebuttably presumed to have resulted 
     from administration of such covered countermeasure.
       [``(B) Other determinations.--In making determinations 
     other than those described in subparagraph (A) as to the 
     causation or severity of an injury, the Secretary shall take 
     into consideration all relevant medical and scientific 
     evidence presented for consideration, and may obtain and 
     consider the views of qualified medical experts.
       [``(4) Deadline for filing claim.--The Secretary shall not 
     consider any claim for a benefit under this subsection with 
     respect to an individual that is filed later than 1 year 
     after--
       [``(A) the date a covered countermeasure was administered 
     to the individual; or
       [``(B) in the case of a claim based on contact vaccination 
     (as described in subsection (a)(5)(B)), the date of the first 
     symptom or manifestation of onset of an adverse effect of 
     such vaccination.
       [``(5) Review of determination.--
       [``(A) Secretary's review authority.--The Secretary may 
     review a determination under this subsection at any time on 
     the Secretary's own motion or on application, and may affirm, 
     vacate, or modify such determination.
       [``(B) Secretary's action not judicially reviewable.--The 
     determinations of the Secretary under this subsection shall 
     not be subject to review by another official of the United 
     States or by a court by mandamus or otherwise.
       [``(c) Countermeasure Injury Table.--
       [``(1) Smallpox countermeasure injury table.--The Secretary 
     shall establish by interim final regulation a table 
     identifying--
       [``(A) adverse effects (including injuries, disabilities, 
     illnesses, conditions, and deaths) that shall be presumed to 
     result from the administration of (or exposure to) a covered 
     countermeasure; and
       [``(B) the time periods in which the first symptom, or 
     manifestation of onset of each such adverse effect, must 
     manifest in order for such presumption to apply.
       [``(2) Amendments.--The Secretary may amend by regulation 
     the table established under paragraph (1). Such amendments 
     shall apply retroactively to claims filed or pending at the 
     time of the promulgation of final amending regulations and to 
     claims filed after such promulgation.
       [``(d) Medical Benefits.--
       [``(1) In general.--Subject to paragraph (2), an eligible 
     individual shall be entitled to payment by the Secretary for 
     medical items and services as reasonable and necessary to 
     treat a covered injury. The Secretary may consider the 
     provisions of chapter 81 of title 5, United States Code, (and 
     the implementing regulations with respect to such chapter) in 
     determining the amount of such payment and the circumstances 
     under which such payments are reasonable and necessary.
       [``(2) Limitations.--
       [``(A) Benefits secondary to other coverage.--The 
     obligation of the Secretary to pay for any services or 
     benefits under paragraph (1) shall be secondary to the 
     obligation of the United States or any third party (including 
     any State or local governmental entity, private insurance 
     carrier, or employer) under any other provision of law or 
     contractual agreement, to pay for or provide such services or 
     benefits.
       [``(B) No benefits for medicare-eligible individual.--No 
     benefits shall be available to an individual under this 
     subsection with respect to any period in which the individual 
     is eligible for benefits under title XVIII of the Social 
     Security section (42 U.S.C. 1395 et seq.).
       [``(e) Compensation for Lost Employment Income.--
       [``(1) In general.--Subject to paragraphs (2) and (3), an 
     eligible individual shall be entitled to payment of 
     compensation by the Secretary for loss of employment income 
     incurred as a result of a covered injury, at the rate 
     specified in paragraph (2).
       [``(2) Amount of compensation.--
       [``(A) In general.--Compensation under this subsection 
     shall be at the rate of 66\2/3\ percent of monthly pay. The 
     Secretary may consider the provisions of sections 8114 and 
     8115 of title 5, United States Code (and any implementing 
     regulations) in determining the amount of such payment and 
     the circumstances under which such payments are reasonable 
     and necessary.
       [``(B) Treatment of self-employment income.--For purposes 
     of this subsection--
       [``(i) the term `employment income' includes income from 
     self-employment; and
       [``(ii) for purposes of computation of pay and 
     determination of wage-earning capacity under subparagraph 
     (A), self-employment income shall be treated as wages.
       [``(3) Limitations.--
       [``(A) Benefits secondary to other coverage.--The 
     obligation of the Secretary to pay compensation under 
     paragraph (1) shall be secondary to the obligation of the 
     United States or any third party (including any State or 
     local governmental entity, private insurance carrier, or 
     employer), under any other law or contractual agreement, to 
     pay compensation for loss of employment income.
       [``(B) No benefits for death or permanent and total 
     disability.--No payment shall be made under this subsection 
     in compensation for loss of employment income due to the 
     death or permanent and total disability of an eligible 
     individual.
       [``(C) Limit on total benefits.--Total benefits paid to an 
     individual under this subsection shall not exceed $50,000.
       [``(D) Waiting period.--An eligible individual is not 
     entitled to compensation under this subsection for the first 
     5 work days of disability.
       [``(f) Payment for Death and Permanent, Total Disability.--
       [``(1) Benefit for permanent and total disability.--Subject 
     to the succeeding provisions of this subsection, an eligible 
     individual who is determined, in accordance with the 
     procedures established under subsection (b), to have a 
     covered injury or injuries meeting the definition of 
     disability in section 216(i) of the Social Security Act (42 
     U.S.C. 416(i)) shall be entitled to have payment made by the 
     Secretary of an amount determined under paragraph (3), in the 
     same manner as disability benefits are paid pursuant to the 
     Public Safety Officers' Benefits Program under subpart 1 of 
     part L of title I of the Omnibus Crime Control and Safe 
     Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to 
     an eligible public safety officer.
       [``(2) Death benefit.--Subject to the succeeding provisions 
     of this subsection, in the case of an eligible individual 
     whose death is determined, in accordance with the procedures 
     established under subsection (b), to have directly resulted 
     from a covered injury or injuries a death benefit in the 
     amount determined under paragraph (3) shall be payable by the 
     Secretary to the survivor or survivors in the same manner as 
     death benefits are paid pursuant to the Public Safety 
     Officers' Benefits Program under subpart 1 of part L of title 
     I of the Omnibus Crime Control and Safe Streets Act of 1968 
     (42 U.S.C. 3796 et seq.) with respect to an eligible deceased 
     public safety officer.
       [``(3) Benefit amount.--The amount of the disability or 
     death benefit under paragraph (1) or (2) in a fiscal year 
     shall, subject to paragraph (5)(B), equal the amount of the 
     comparable benefit calculated under the Public Safety 
     Officers' Benefits Program under subpart 1 of part L of title 
     I of the Omnibus Crime Control and Safe Streets Act of 1968 
     (42 U.S.C. 3796 et seq.) in such fiscal year, without regard 
     to any reduction attributable to a limitation on 
     appropriations.
       [``(4) Benefit in addition to medical benefits.--A benefit 
     under this subsection shall be in addition to any amounts to 
     which an eligible individual may be entitled as medical 
     benefits under subsection (d).
       [``(5) Limitations.--
       [``(A) Disability benefits.--No benefit is payable under 
     paragraph (1) with respect to the disability of an eligible 
     individual if--
       [``(i) a disability benefit is paid or payable with respect 
     to such individual under Public Safety Officers' Benefits 
     Program under subpart 1 of part L of title I of the Omnibus 
     Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et 
     seq.); or
       [``(ii) a death benefit is paid or payable with respect to 
     such individual under paragraph (2) or the Public Safety 
     Officers' Benefits Program under subpart 1 of part L of title 
     I of the Omnibus Crime Control and Safe Streets Act of 1968 
     (42 U.S.C. 3796 et seq.).
       [``(B) Death benefits.--No benefit is payable under 
     paragraph (2) with respect to the death of an eligible 
     individual if--
       [``(i) a disability benefit is paid with respect to such 
     individual under paragraph (1) or the Public Safety Officers' 
     Benefits Program under subpart 1 of part L of title I of the 
     Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
     3796 et seq.); or
       [``(ii) a death benefit is paid or payable with respect to 
     such individual under the Public Safety Officers' Benefits 
     Program under subpart 1 of part L of title I of the Omnibus 
     Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et 
     seq.).
       [``(g) Administration.--
       [``(1) Administration by agreement with other agency or 
     agencies.--The Secretary may administer any or all of the 
     provisions of this section through Memorandum of Agreement 
     with the Attorney General or the Secretary of Labor.
       [``(2) Regulations.--The head of the agency administering 
     this section or any provisions thereof (including any agency 
     head administering such section or provisions through a 
     Memorandum of Agreement under

[[Page 10285]]

     paragraph (1)) may promulgate such implementing regulations 
     as may be determined necessary and appropriate. Initial 
     implementing regulations may be interim final regulations.
       [``(h) Authorization of Appropriations.--There are 
     authorized to be appropriated such sums as may be necessary 
     for fiscal year 2003 and each succeeding fiscal year to carry 
     out this section, to remain available until expended, 
     including administrative costs and costs of provision and 
     payment of benefits.
       [``(i) Relationship to Other Laws.--
       [``(1) No preemption of individual rights.--Except as 
     otherwise provided in this section, nothing in this section 
     shall be construed to override or limit any rights an 
     individual may have to seek compensation, benefits, or 
     redress under any other provision of Federal or State law.
       [``(2) Relationship to the federal tort claims act.--
       [``(A) Exhaustion requirement.--An individual may not seek 
     any remedy that may be available under section 224(p) 
     (providing a cause of action under the Federal Tort Claims 
     Act for injuries resulting from administration of smallpox 
     countermeasures under such section 224(p)) unless such 
     individual has first filed a claim for payment or 
     compensation under this section and has received a final 
     determination with respect to such claim.
       [``(B) Offset of compensation against federal tort claims 
     act recovery.--The value of any compensation or benefits paid 
     to an individual, or the survivor or survivors of such an 
     individual, or the estate of the individual pursuant to a 
     claim under this section shall be offset against any amount 
     to which such individual or the individual's survivor, 
     survivors, or estate are entitled under section 224(p).
       [``(3) Preemption of state laws providing exclusive remedy 
     for work-related injuries.--No provision of a State workers' 
     compensation law or other State law shall be construed to bar 
     claims or benefits under this section, to the extent that it 
     purports to make such State law the exclusive remedy for a 
     work-related injury or otherwise to make benefits under this 
     section unavailable to an otherwise eligible individual.''.

                      [TITLE II--PROJECT BIOSHIELD

     [SEC. 201. SHORT TITLE.

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

     [SEC. 202. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT 
                   AUTHORITIES.

       [Part B of title IV of the Public Health Service Act (42 
     U.S.C. 284 et seq.) is amended by adding at the end the 
     following:

     [``SEC. 409I. BIOMEDICAL COUNTERMEASURE RESEARCH AND 
                   DEVELOPMENT.

       [``(a) In General.--
       [``(1) Authority.--In carrying out research 
     responsibilities under this Act, the Secretary may conduct 
     and support research and development with respect to 
     biomedical countermeasures.
       [``(2) Implementation.--
       [``(A) In general.--Except as provided in subparagraph (C), 
     authorities assigned by this section to the Secretary shall 
     be carried out through the Director of NIH and the Director 
     of the National Institute of Allergy and Infectious Diseases.
       [``(B) Lead institute.--The National Institute of Allergy 
     and Infectious Diseases shall be the lead institute for 
     biomedical countermeasure research and development under this 
     section.
       [``(C) Chemical, radiological, and nuclear agents.--To the 
     extent that an authority described in subparagraph (A) is 
     exercised with respect to a chemical, radiological, or 
     nuclear agent, the Secretary may authorize the Director of 
     NIH to carry out the authority through any national research 
     institute.
       [``(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 Federal 
     Government and to use other agencies of the Department of 
     Health and Human Services.
       [``(B) Limitation.--An agreement or undertaking under this 
     paragraph may not authorize another agency to exercise the 
     authorities provided to the Secretary by this section.
       [``(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 
     biomedical countermeasure research or development, 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) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     procurements made under this paragraph, including 
     requirements with respect to documenting the justification 
     for use of the authority provided in this paragraph.
       [``(2) Use of noncompetitive procedures.--In addition to 
     any other authority to use procedures other than competitive 
     procedures for procurements, the Secretary may use such other 
     noncompetitive procedures when--
       [``(A) the procurement is as described by paragraph (1)(A); 
     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 meet the needs of the Secretary.
       [``(3) Increased micropurchase threshold.--
       [``(A) In general.--For a procurement described by 
     paragraph (1)(A), 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 
     procurements that are made 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 Federal Government purchase card method for purchases 
     shall apply to procurements made under this paragraph and 
     that are greater than $2,500.
       [``(c) Authority To Expedite Peer Review.--The Secretary 
     may, as the Secretary determines necessary to respond to 
     pressing 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, 
     determines to be appropriate to obtain an assessment of 
     scientific and technical merit and likely contribution to the 
     field of biomedical countermeasure research, in place of the 
     peer review and advisory council review procedures that would 
     otherwise 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--
       [``(1) that is for performing, administering, or supporting 
     biomedical countermeasure research and development; and
       [``(2) the amount of which is not greater than $1,500,000.
       [``(d) Facilities Authority.--
       [``(1) Agency facilities.--In addition to any similar 
     authority provided under any other provision of law, in 
     carrying out this section, the Secretary may--
       [``(A) acquire, lease, construct, improve, renovate, 
     remodel, repair, operate, and maintain laboratories, other 
     research facilities and equipment, and other real or personal 
     property as the Secretary determines necessary for the 
     purpose of performing, administering, and supporting 
     biomedical countermeasure research and development; and
       [``(B) acquire, without regard to section 8141 of title 40, 
     United States Code, by lease or otherwise, through the 
     Administrator of General Services, buildings or parts of 
     buildings in the District of Columbia.
       [``(2) Facilities of grantee or cooperative agreement 
     partner.--
       [``(A) In general.--The Secretary may exercise the 
     authorities described in section 481A with respect to 
     biocontainment laboratories and other related or ancillary 
     specialized research facilities as the Secretary determines 
     necessary for the purpose of performing, administering, and 
     supporting biomedical countermeasure research and 
     development.
       [``(B) Availability of facility to secretary.--A grant or 
     cooperative agreement under subparagraph (A) 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.
       [``(C) Twenty year use requirement.--A grant or cooperative 
     agreement under this paragraph shall include an agreement by 
     the grantee or cooperative agreement partner that, for not 
     less than 20 years after the completion of the acquisition, 
     construction, or other work described in subparagraph (A), 
     the facility will be used for the purposes of the research 
     and development for which it is to be acquired, constructed, 
     or otherwise improved.
       [``(D) Amount of grant; cost-sharing; payments.--The 
     provisions of section 481A(e) shall apply to a grant or 
     cooperative agreement under this paragraph, except that--
       [``(i) authorities exercised under that section by the 
     Director of the National Center for Research Resources shall, 
     for purposes of this paragraph, be exercised by the 
     Secretary; and
       [``(ii) for purposes of this paragraph, each of the 
     percentages in subparagraphs (A) and

[[Page 10286]]

     (B) of section 481A(e)(1) shall be deemed to be 75 percent.
       [``(E) Recapture of payments.--If, not later than 20 years 
     after the completion of construction for which a grant or 
     cooperative agreement has been awarded under this paragraph, 
     the facility shall cease to be used for the research and 
     development purposes for which it was constructed (unless the 
     Secretary determines, in accordance with regulations, that 
     there is good cause for releasing the applicant or other 
     owner from obligation to do so), the United States shall be 
     entitled to recover from the applicant or other owner of the 
     facility the amount bearing the same ratio to the current 
     value (as determined by an agreement between the parties or 
     by action brought in the United States District Court for the 
     district in which such facility is situated) of the facility 
     as the amount of the Federal participation bore to the cost 
     of the construction, acquisition, or other improvement of 
     such facility.
       [``(e) Authority for Personal Services Contracts.--
       [``(1) In general.--For the purpose of performing, 
     administering, and supporting biomedical countermeasure 
     research and development, the Secretary may, as the Secretary 
     determines necessary to respond to pressing 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.
       [``(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.
       [``(f) 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 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 
     biomedical countermeasure research and development in 
     carrying out this section.
       [``(2) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     appointments under this subsection.
       [``(g) Definition.--As used in this section, the term 
     `biomedical countermeasure' means a drug (as that term is 
     defined by section 201(g)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as 
     that term is defined by section 351(i) of this Act (42 U.S.C. 
     262(i))), or device (as that term is defined by section 
     201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321(h))) that is used--
       [``(1) to treat, identify, or prevent harm from any 
     biological, chemical, radiological, or nuclear agent that may 
     cause a public health emergency affecting national security; 
     or
       [``(2) to treat, identify, or prevent harm from a condition 
     that may result in adverse health consequences or death and 
     may be caused by administering a drug, biological product, or 
     device that is used as described in paragraph (1).
       [``(h) Actions Committed to Agency Discretion.--Actions by 
     the Secretary under the authority of this section are 
     committed to agency discretion.''.

     [SEC. 203. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

       [Section 121 of the Public Health Security and Bioterrorism 
     Preparedness and Response Act of 2002 (42 U.S.C. 300hh-12) is 
     amended--
       [(1) by redesignating subsections (c) through (e) as 
     subsections (d) through (f), respectively; and
       [(2) by inserting after subsection (b) the following:
       [``(c) Biomedical Countermeasures Procurement.--
       [``(1) Determination of material threats.--
       [``(A) Risk of use.--The Secretary, in consultation with 
     the heads of other agencies as appropriate, shall on an 
     ongoing basis--
       [``(i) assess current and emerging threats of use of 
     chemical, biological, radiological, and nuclear agents; and
       [``(ii) determine which of such agents present a material 
     risk of use against the United States population.
       [``(B) Public health impact.--The Secretary of Health and 
     Human Services, in consultation with 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 countermeasures are necessary to protect the 
     public health.
       [``(2) Assessment of availability and appropriateness of 
     countermeasures.--The Secretary of Health and Human Services, 
     in consultation with the Secretary, shall assess on an 
     ongoing basis the availability and appropriateness of 
     specific countermeasures to address specific threats 
     identified under paragraph (1).
       [``(3) Secretary's determination of countermeasures 
     appropriate for procurement under this subsection.--
       [``(A) In general.--The Secretary of Health and Human 
     Services, in accordance with this paragraph, shall identify 
     specific countermeasures to threats identified under 
     paragraph (1) that such Secretary determines, in consultation 
     with the Secretary of Homeland Security, to be appropriate 
     for procurement with appropriations under this subsection for 
     inclusion in the stockpile under subsection (a).
       [``(B) Requirements.--In order for the Secretary of Health 
     and Human Services to make the determination under 
     subparagraph (A) with respect to a countermeasure, the 
     following requirements must be met:
       [``(i) Determination of qualified countermeasure.--Such 
     Secretary must determine that the product is a qualified 
     countermeasure (as defined in paragraph (7)).
       [``(ii) Determination of quantities needed and feasibility 
     of production and distribution.--Such Secretary must 
     determine--

       [``(I) the quantities of the product that will be needed to 
     meet the needs of the stockpile; and
       [``(II) that production and delivery within 5 years of 
     sufficient quantities of the product, as so determined, is 
     reasonably expected to be feasible.

       [``(iii) Determination of no significant commercial 
     market.--Such Secretary shall--

       [``(I) determine that, at the time of the initial 
     determination under this paragraph, there is not a 
     significant commercial market for the product other than as a 
     homeland security threat countermeasure; and
       [``(II) annually redetermine and report to the President, 
     while a determination under subparagraph (A) remains in 
     effect with respect to the product, whether a significant 
     commercial market exists for the product other than as a 
     homeland security threat countermeasure.

       [``(4) Recommendation for president's approval.--
       [``(A) Recommendation for procurement.--In the case of a 
     countermeasure that the Secretary and the Secretary of Health 
     and Human Services have determined is appropriate for 
     procurement under this subsection for inclusion in the 
     stockpile, in accordance with the preceding provisions of 
     this subsection, the Secretary and the Secretary of Health 
     and Human Services shall jointly submit to the President, in 
     coordination with the Director of the Office of Management 
     and Budget, a recommendation for procurement under this 
     subsection.
       [``(B) Presidential approval.--A countermeasure may be 
     procured under this subsection only if the President has 
     approved a recommendation under subparagraph (A) with respect 
     to such countermeasure.
       [``(C) Notice to congress.--The Secretary shall notify 
     Congress of each decision of the President to approve a 
     recommendation under subparagraph (A).
       [``(5) Procurement.--The Secretary of Health and Human 
     Services and the Secretary shall be responsible for the 
     following, for purposes of procurement of qualified 
     countermeasures for the stockpile under subsection (a), as 
     approved by the President under paragraph (4):

[[Page 10287]]

       [``(A) Interagency agreements.--
       [``(i) For procurement.--The Secretary shall enter into an 
     agreement with the Secretary of Health and Human Services for 
     the procurement of the countermeasure in accordance with the 
     provisions of this paragraph. Amounts appropriated under 
     paragraph (8) shall be available for the Secretary of Health 
     and Human Service's costs of such procurement, other than as 
     provided in clause (ii).
       [``(ii) For administrative costs.--The agreement entered 
     into between the Secretary and the Secretary of Health and 
     Human Services for managing the stockpile under subsection 
     (a) shall provide for reimbursement of the Secretary of 
     Health and Human Service's administrative costs relating to 
     procurements under this subsection from appropriations to 
     carry out such subsection (a).
       [``(B) Procurement.--
       [``(i) In general.--The Secretary of Health and Human 
     Services shall be responsible for--

       [``(I) arranging for procurement of the 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 otherwise specified in this 
     clause, 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 Health and Human Services) of 
     the total number of units contracted for.
       [``(II) Discounted payment for unlicensed product.--The 
     contract may provide for a discounted price per unit of a 
     product that is not licensed or approved as described in 
     paragraph (7)(A) at the time of delivery, and may provide for 
     payment of an additional amount per unit if the product 
     becomes so licensed or approved before the expiration date of 
     the contract (including an additional amount per unit of 
     product delivered before the effective date of such licensing 
     or approval).
       [``(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 Government under the 
     contract, for such period and under such terms and conditions 
     as the Secretary of Health and Human Services may specify, 
     and in such case amounts appropriated under paragraph (8) 
     shall be available for costs of shipping, handling, storage, 
     and related costs for such product.
       [``(IV) Contract duration.--The contract shall be for a 
     period not to exceed 5 years, renewable for additional 
     periods none of which shall exceed 5 years.
       [``(V) Termination for nondelivery.--In addition to any 
     other rights of the Secretary of Health and Human Services to 
     terminate the contract, the contract may provide that such 
     Secretary may terminate the contract for failure to deliver a 
     reasonable number (as determined by such Secretary) of units 
     of the product by 3 years after the date the contract is 
     entered into, and may further provide that in such case the 
     vendor shall not be entitled to any payment under the 
     contract.

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

       [``(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.

       [``(iv) Use of noncompetitive procedures.--In addition to 
     any other authority to use procedures other than competitive 
     procedures, the Secretary of Health and Human Services 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 such Secretary's needs.
       [``(v) Premium provision in multiple award contracts.--

       [``(I) In general.--If, under this subsection, the 
     Secretary of Health and Human Services enters into contracts 
     with more than one person to procure a 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 
     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 persons' 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 of Health and Human Services 
     includes in each of a set of contracts a provision as 
     described in clause (I), such Secretary's determination of 
     the total quantity of 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 of Health and 
     Human Services 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 of Health and Human Services 
     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 such 
     Secretary may so exclude such a source.
       [``(6) Interagency cooperation.--
       [``(A) In general.--In carrying out activities under this 
     section, the Secretary and the Secretary of Health and Human 
     Services 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 Secretary or to 
     the Secretary of Health and Human Services.
       [``(7) Definitions.--In this subsection:
       [``(A) Qualified countermeasure.--The term `qualified 
     countermeasure' means a biomedical countermeasure--
       [``(i) that is approved under section 505(a) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensed 
     under section 351 of the Public Health Service Act (42 U.S.C. 
     262) for use as such a countermeasure to a chemical, 
     biological, radiological, or nuclear agent identified as a 
     material threat under paragraph (1); or
       [``(ii) for which the Secretary of Health and Human 
     Services determines that sufficient and satisfactory clinical 
     experience or research data (including data, if available, 
     from preclinical and clinical trials) support a reasonable 
     conclusion that the product will qualify for approval or 
     licensing as such a countermeasure within 5 years after the 
     date of a determination under paragraph (3).
       [``(B) Biomedical countermeasure.--The term `biomedical 
     countermeasure' means a drug (as that term is defined by 
     section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(g)(1))) or biological product (as that term is 
     defined by section 351(i) of the Public Health Service Act 
     (42 U.S.C. 262(i))) that is used--
       [``(i) to treat, identify, or prevent harm from any 
     biological, chemical, radiological, or nuclear agent that may 
     cause a public health emergency affecting national security; 
     or
       [``(ii) to treat, identify, or prevent harm from a 
     condition that may result in adverse health consequences or 
     death and may be caused by administering a drug or biological 
     product that is used as described in clause (i).
       [``(8) Appropriations.--
       [``(A) In general.-- There are appropriated, out of any 
     moneys in the Treasury not otherwise appropriated, for fiscal 
     year 2003 and for each fiscal year thereafter, such sums as 
     may be necessary for the costs incurred by the Secretary in 
     the procurement of countermeasures under this subsection as 
     approved by the President under paragraph (4) (other than 
     costs specified in subparagraph (B)).
       [``(B) Restrictions.--Amounts appropriated under this 
     paragraph shall not be available to pay--
       [``(i) costs for the purchase of vaccines under procurement 
     contracts entered into before January 1, 2003;
       [``(ii) costs under new contracts, or costs of new 
     obligations under contracts previously entered into, for 
     procurement of a countermeasure after the date of a 
     determination under paragraph (3)(B)(iii) that there is a 
     significant commercial market for the countermeasure other 
     than as a homeland security threat countermeasure; or
       [``(iii) administrative costs.''.

     [SEC. 204. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
                   EMERGENCIES.

       [(a) In General.--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:

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

       [``(a) In General.--Notwithstanding sections 505 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 solely for use in an actual 
     or potential emergency.

[[Page 10288]]

       [``(b) Declaration of Emergency.--
       [``(1) In general.--The Secretary may declare an emergency 
     justifying the authorization of a drug or device under this 
     subsection on the basis of a determination--
       [``(A) by the Secretary of Homeland Security, that there is 
     a national emergency (or a significant potential of a 
     national emergency) involving a heightened risk of attack 
     with a specified biological, chemical, radiological, or 
     nuclear agent or agents;
       [``(B) by the Secretary of Defense, that there is a 
     military emergency (or a significant potential of 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) by the Secretary of a public health emergency under 
     section 319 of the Public Health Service Act, involving a 
     specified disease or condition or a specified biological, 
     chemical, radiological, or nuclear 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 1-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) 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 a product if 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.--An authorization of a 
     product under this section shall state--
       [``(1) each disease or condition that the product may be 
     used to detect, diagnose, prevent, or treat within the scope 
     of the authorization; and
       [``(2) the Secretary's conclusions, 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.
       [``(e) Conditions of Authorization.--
       [``(1) In general.--The Secretary is authorized, by order 
     or regulation, to impose such conditions on an authorization 
     under this section as the Secretary determines are necessary 
     or appropriate to protect the public health, including the 
     following:
       [``(A) The Secretary shall impose requirements (including 
     requirements concerning product labeling and the provision of 
     information) designed to ensure that, to the maximum extent 
     feasible given the circumstances of the emergency, health 
     care professionals administering the product are informed--
       [``(i) that the Secretary has authorized the product solely 
     for emergency use;
       [``(ii) of the significant known and potential benefits and 
     risks of 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.
       [``(B) The Secretary shall impose requirements (including 
     requirements concerning product labeling and the provision of 
     information) designed to ensure that, to the maximum extent 
     feasible given the circumstances of the emergency, 
     individuals to whom the product is administered are 
     informed--
       [``(i) that the Secretary has authorized the product solely 
     for emergency use;
       [``(ii) of the significant known and potential benefits and 
     risks of use of the product, and of the extent to which such 
     benefits and risks are unknown; and
       [``(iii) of any option to accept or refuse administration 
     of the product, and of the alternatives to the product that 
     are available and of their benefits and risks.
       [``(C) The Secretary may impose limitations on which 
     entities may distribute the product (including limitation to 
     distribution by government entities), and on how distribution 
     is to be performed.
       [``(D) The Secretary may impose limitations on who may 
     administer the product, and on the categories of individuals 
     to whom, and the circumstances under which, the product may 
     be administered.
       [``(E) The Secretary may condition the authorization on the 
     performance of studies, clinical trials, or other research 
     needed to support marketing approval of the product.
       [``(F) The Secretary may impose requirements concerning 
     recordkeeping and reporting, including records access by the 
     Secretary and publication of data.
       [``(G) The Secretary may impose (or waive) requirements, 
     with respect to the product, of current good manufacturing 
     practice otherwise applicable to the manufacture, processing, 
     packing, or holding of products subject to regulation under 
     this Act.
       [``(H) The Secretary may impose requirements for the 
     monitoring and reporting of adverse events associated with 
     use of the product.
       [``(2) Waiver.--The Secretary may waive any condition 
     imposed under this subsection.
       [``(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--
       [``(A) the conditions for such an authorization are no 
     longer met; or
       [``(B) other circumstances make such revocation 
     appropriate.
       [``(h) Publication.--The Secretary shall promptly publish 
     in the Federal Register a notice of each authorization, and 
     each termination or revocation of an authorization, under 
     this section.
       [``(i) Recordkeeping.--
       [``(1) In general.--The Secretary may by order or 
     regulation require persons, including a person who holds an 
     authorization under this section, or who manufactures, 
     distributes, prescribes, or administers a product that is the 
     subject of such an authorization, to establish and maintain--
       [``(A) data that is obtained from such activity and that 
     pertains to the effectiveness or safety of such product;
       [``(B) such records as are necessary to determine, or 
     facilitate a determination, whether there may be any 
     violation of this section or of a regulation promulgated 
     under this section; and
       [``(C) such additional records as the Secretary may 
     determine necessary.
       [``(2) Access to records by secretary.--
       [``(A) Safety and effectiveness information.--The Secretary 
     may by order or regulation require a person who holds an 
     authorization under this section, or who manufactures, 
     distributes, prescribes, or administers a product that is the 
     subject of such an authorization to provide to the Secretary 
     all data that is obtained from such activity and that 
     pertains to the safety or effectiveness of such product.
       [``(B) Other information.--Every person required under this 
     section to establish or maintain records, and every person in 
     charge or custody of such records, shall, upon request by the 
     Secretary, permit the Secretary at all reasonable times to 
     have access to, to copy, and to verify such records.
       [``(j) Civil Monetary Penalties.--
       [``(1) In general.--A person who violates a requirement of 
     this section or of a regulation or order promulgated pursuant 
     to this section shall be subject to a civil money penalty of 
     not more than $100,000 in the case of an individual, and not 
     more than $250,000 in the case of any other person, for each 
     violation, not to exceed $1,000,000 for all such violations 
     adjudicated in a single proceeding.
       [``(2) Assessment of civil penalties.--Paragraphs (3), (4), 
     and (5) of section 303(g) shall apply to a civil penalty 
     under this subsection, and references in such paragraphs to 
     `paragraph (1) or (2)' shall, for purposes of this 
     subsection, be deemed to refer to paragraph (1) of this 
     subsection.
       [``(k) 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

[[Page 10289]]

     Homeland Security are committed to agency discretion.
       [``(l) Regulations.--The Secretary may promulgate 
     regulations to implement this section.
       [``(m) 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; or
       [``(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.
       [``(n) Application to Members of Armed Forces.--
       [``(1) Waiver of requirement relating to option to 
     refuse.--In the case of the administration of a 
     countermeasure to members of the armed forces, a requirement, 
     under subsection (e)(2)(C), 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) 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.
       [``(o) 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.''.
       [(b) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331) is amended--
       [(1) in subsection (e)--
       [(A) by striking ``504, 703'' and inserting ``504, 564, 
     703''; and
       [(B) by striking ``or 519'' and inserting ``519, or 564''; 
     and
       [(2) by adding at the end the following:
       [``(hh)(1) Promotion or use of a product that is the 
     subject of an authorization under section 564 other than as 
     stated in the authorization, or other than during the period 
     described by section 564(g), unless such promotion or use is 
     permitted under another provision of this Act.
       [``(2) Failure to comply with an information requirement 
     under section 564(e)(1).''.

     [SEC. 205. DEVELOPING NEW COUNTERMEASURES AND PROTECTING 
                   EXISTING COUNTERMEASURES AGAINST BIOTERRORISM.

       [Section 319F of the Public Health Service Act (42 U.S.C. 
     247d-6) is amended by adding at the end the following:
       [``(k) Limited Antitrust Exemption.--
       [``(1) Countermeasures development meetings.--
       [``(A) Countermeasures development meetings and 
     consultations.--The Secretary may conduct meetings and 
     consultations with parties involved in the development of 
     countermeasures for the purpose of the development, 
     manufacture, distribution, or sale of priority 
     countermeasures consistent with the purposes of this title. 
     The Secretary shall give notice of such meetings and 
     consultations to the Attorney General and the Chairperson of 
     the Federal Trade Commission (referred to in this subsection 
     as the `Chairperson').
       [``(B) Meeting and consultation conditions.--A meeting or 
     consultation conducted under subparagraph (A) shall--
       [``(i) be chaired or, in the case of a consultation, 
     facilitated by the Secretary or the designee of the 
     Secretary;
       [``(ii) be open to parties involved in the development, 
     manufacture, distribution, purchase, or sale of priority 
     countermeasures, as determined by the Secretary;
       [``(iii) be open to the Attorney General and the 
     Chairperson;
       [``(iv) be limited to discussions involving the 
     development, manufacture, distribution, or sale of priority 
     countermeasures, consistent with the purposes of this title; 
     and
       [``(v) be conducted in such manner as to ensure that 
     national security, confidential, and proprietary information 
     is not disclosed outside the meeting or consultation.
       [``(C) Minutes.--The Secretary shall maintain minutes of 
     meetings and consultations under this subsection, which shall 
     not be disclosed under section 552 of title 5, United States 
     Code.
       [``(D) Exemption.--The antitrust laws shall not apply to 
     meetings and consultations under this paragraph, except that 
     any agreement that results from a meeting or consultation and 
     that has been denied an exemption pursuant to this subsection 
     shall be subject to the antitrust laws.
       [``(2) Written agreements or conduct.--The Secretary or any 
     party to an agreement or other conduct regarding covered 
     activities entered into or undertaken pursuant to meetings or 
     consultations conducted under paragraph (1), and that is 
     consistent with this paragraph, shall file such written 
     agreement or a description of the conduct involved with the 
     Attorney General and the Chairperson for a determination of 
     whether such agreement or conduct should be exempt from the 
     antitrust laws. In addition to the proposed agreement or 
     description of conduct itself, any such filing shall 
     include--
       [``(A) an explanation of the intended purpose of the 
     agreement or conduct;
       [``(B) a specific statement of the substance of the 
     agreement or conduct;
       [``(C) a description of the methods that will be utilized 
     to achieve the objectives of the agreement or conduct;
       [``(D) an explanation of the necessity of a cooperative 
     effort among the particular participating parties to achieve 
     the objectives of the agreement or conduct; and
       [``(E) any other relevant information reasonably requested 
     by the Attorney General, in consultation with the Chairperson 
     and the Secretary.
       [``(3) Determination.--The Attorney General, in 
     consultation with the Chairperson, shall determine whether an 
     agreement or description of conduct submitted under paragraph 
     (2) should be exempt from the antitrust laws.
       [``(4) Limited antitrust exemption.--
       [``(A) In general.--The Attorney General, in consultation 
     with the Chairperson, may, within 30 days of the receipt of a 
     notification pursuant to paragraph (2), revoke in whole or in 
     part, the scope of any exemption granted by the Attorney 
     General under a determination under paragraph (3).
       [``(B) Extension.--The Attorney General may extend the 35-
     day period referred to in subparagraph (A) for an additional 
     period of not to exceed 20 days. Such additional period may 
     be further extended only by the United States district court, 
     upon an application by the Attorney General after notice to 
     the Secretary and the parties involved.
       [``(C) Application of laws.--
       [``(i) In general.--The antitrust laws shall not apply to 
     an agreement or conduct (described in a description of 
     conduct) that is submitted for review pursuant to paragraph 
     (2) until such time as the Attorney General determines, 
     pursuant to subparagraph (D), that such agreement or conduct 
     should not, in whole or in part, be exempt from the antitrust 
     laws.
       [``(ii) Limited liability.--No party to an agreement or 
     conduct referred to in clause (i) shall be liable under the 
     antitrust laws for any actions reasonably necessary to carry 
     out the agreement or for conduct taken after the agreement or 
     description has been submitted pursuant to paragraph (2) and 
     prior to any revocation of the exemption by the Attorney 
     General pursuant to subparagraph (D).
       [``(D) Determination.--In making a determination under this 
     subparagraph, the Attorney General, in consultation with the 
     Chairperson and the Secretary shall consider--
       [``(i) whether the agreement or conduct involved would 
     facilitate the availability of priority countermeasures;
       [``(ii) whether the exemption from the antitrust laws would 
     promote the public interest;
       [``(iii) the competitive impact to areas not directly 
     related to the purposes of the agreement or conduct; and
       [``(iv) any other factors determined relevant by the 
     Attorney General and the Chairperson.
       [``(5) Limitation on and renewal of exemptions.--An 
     exemption provided under paragraphs (3) or (4) shall be 
     limited to covered activities, and shall expire on the date 
     that is 3 years after the date on which the exemption becomes 
     effective (and at 3 year intervals thereafter, if renewed) 
     unless the Attorney General in consultation with the 
     Chairperson determines that the exemption should be renewed 
     (with modifications, as appropriate) considering the factors 
     described in paragraph (4).
       [``(6) Limitation on parties.--Any exemption from the 
     antitrust laws provided under this subsection shall not apply 
     to the use of any information acquired in conducting exempted 
     activities for any purposes other than those expressly 
     specified in the antitrust exemption provided for by this 
     subsection.
       [``(7) Guidelines.--The Attorney General and the 
     Chairperson may develop and issue guidelines to implement 
     this subsection.
       [``(8) Report.--Not later than 1 year after the date of 
     enactment of this subsection, and annually thereafter, the 
     Attorney General and the Chairperson shall report to the 
     Committee on Health, Education, Labor, and Pensions and the 
     Committee on the Judiciary of the Senate and the Committee on 
     Energy and Commerce and the Committee on the Judiciary of the 
     House of Representatives on the use and continuing need for 
     the exemption from the antitrust laws provided by this 
     subsection.
       [``(9) Sunset.--The authority of any party to apply for or 
     to obtain a limited antitrust exemption under this subsection 
     shall expire at the end of the 6-year period that begins on 
     the date of enactment of this subsection.
       [``(l) Definitions.--In this section:

[[Page 10290]]

       [``(1) Antitrust laws.--The term `antitrust laws'--
       [``(A) has the meaning given such term in subsection (a) of 
     the first section of the Clayton Act (15 U.S.C. 12(a)), 
     except that such term includes the Act of June 19, 1936 (15 
     U.S.C. 13 et seq.) commonly known as the Robinson-Patman 
     Act), and section 5 of the Federal Trade Commission Act (15 
     U.S.C. 45) to the extent such section 5 applies to unfair 
     methods of competition; and
       [``(B) includes any State law similar to the laws referred 
     to in subparagraph (A).
       [``(2) Covered activities.--
       [``(A) In general.--Except as provided in subparagraph (B), 
     the term `covered activities' means any group of activities 
     or conduct, including attempting to make, making, or 
     performing a contract or agreement or engaging in other 
     conduct, for the purpose of--
       [``(i) theoretical analysis, experimentation, or the 
     systematic study of phenomena or observable facts related to 
     the development of priority countermeasures;
       [``(ii) the development or testing of basic engineering 
     techniques related to the development of priority 
     countermeasures;
       [``(iii) the extension of investigative findings or theory 
     of a scientific or technical nature into practical 
     application for experimental and demonstration purposes, 
     including the experimental production and testing of models, 
     prototypes, equipment, materials, and processes related to 
     the development of priority countermeasures;
       [``(iv) the production, distribution, or marketing of a 
     product, process, or service related to the development of 
     priority countermeasures;
       [``(v) the testing in connection with the production of a 
     product, process, or service related to the development of 
     priority countermeasures;
       [``(vi) the collection, exchange, and analysis of research 
     or production information related to the development of 
     priority countermeasures; or
       [``(vii) any combination of the purposes described in 
     clauses (i) through (vi);

     and such term may include the establishment and operation of 
     facilities for the conduct of covered activities described in 
     clauses (i) through (vi), the conduct of such covered 
     activities on a protracted and proprietary basis, and the 
     processing of applications for patents and the granting of 
     licenses for the results of such covered activities.
       [``(B) Exception.--The term `covered activities' shall not 
     include the following activities involving 2 or more persons:
       [``(i) Exchanging information among competitors relating to 
     costs, sales, profitability, prices, marketing, or 
     distribution of any product, process, or service if such 
     information is not reasonably necessary to carry out the 
     purposes of covered activities.
       [``(ii) Entering into any agreement or engaging in any 
     other conduct--

       [``(I) to restrict or require the sale, licensing, or 
     sharing of inventions, developments, products, processes, or 
     services not developed through, produced by, or distributed 
     or sold through such covered activities; or
       [``(II) to restrict or require participation by any person 
     who is a party to such covered activities in other research 
     and development activities, that is not reasonably necessary 
     to prevent the misappropriation of proprietary information 
     contributed by any person who is a party to such covered 
     activities or of the results of such covered activities.

       [``(iii) Entering into any agreement or engaging in any 
     other conduct allocating a market with a competitor that is 
     not expressly exempted from the antitrust laws by a 
     determination under subsection (k)(4).
       [``(iv) Exchanging information among competitors relating 
     to production (other than production by such covered 
     activities) of a product, process, or service if such 
     information is not reasonably necessary to carry out the 
     purpose of such covered activities.
       [``(v) Except as otherwise provided in this subsection or 
     subsection (k), entering into any agreement or engaging in 
     any other conduct to restrict or require participation by any 
     person who is a party to such activities, in any unilateral 
     or joint activity that is not reasonably necessary to carry 
     out the purpose of such covered activities.
       [``(3) Development.--The term `development' includes the 
     identification of suitable compounds or biological materials, 
     the conduct of preclinical and clinical studies, the 
     preparation of an application for marketing approval, and any 
     other actions related to preparation of a countermeasure.
       [``(4) Person.--The term `person' has the meaning given 
     such term in subsection (a) of the first section of the 
     Clayton Act (15 U.S.C. 12(a)).
       [``(5) Priority countermeasure.--The term `priority 
     countermeasure' means a countermeasure, including a drug, 
     medical device, biological product, or diagnostic test to 
     treat, identify, or prevent infection by a biological agent 
     or toxin on the list developed under section 351A(a)(1) and 
     prioritized under subsection (a)(1).''.

      [TITLE III--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY

     [SEC. 301. SHORT TITLE.

       [This title may be cited as the ``Improved Vaccine 
     Affordability and Availability Act''.

                   [Subtitle A--State Vaccine Grants

     [SEC. 311. AVAILABILITY OF INFLUENZA VACCINE.

       [Section 317(j) of the Public Health Service Act (42 U.S.C. 
     247b(j)) is amended by adding at the end the following:
       [``(3)(A) For the purpose of carrying out activities 
     relating to influenza vaccine under the immunization program 
     under this subsection, there are authorized to be 
     appropriated such sums as may be necessary for each of fiscal 
     years 2003 and 2004. Such authorization shall be in addition 
     to amounts available under paragraphs (1) and (2) for such 
     purpose.
       [``(B) The authorization of appropriations established in 
     subparagraph (A) shall not be effective for a fiscal year 
     unless the total amount appropriated under paragraphs (1) and 
     (2) for the fiscal year is not less than such total for 
     fiscal year 2000.
       [``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available to the Secretary include 
     providing for improved State and local infrastructure for 
     influenza immunizations under this subsection in accordance 
     with the following:
       [``(i) Increasing influenza immunization rates in 
     populations considered by the Secretary to be at high risk 
     for influenza-related complications and in their contacts.
       [``(ii) Recommending that health care providers actively 
     target influenza vaccine that is available in September, 
     October, and November to individuals who are at increased 
     risk for influenza-related complications and to their 
     contacts.
       [``(iii) Providing for the continued availability of 
     influenza immunizations through December of such year, and 
     for additional periods to the extent that influenza vaccine 
     remains available.
       [``(iv) Encouraging States, as appropriate, to develop 
     contingency plans (including plans for public and 
     professional educational activities) for maximizing influenza 
     immunizations for high-risk populations in the event of a 
     delay or shortage of influenza vaccine.
       [``(D) The Secretary shall submit to the Committee on 
     Energy and Commerce of the House of Representatives, and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate, periodic reports describing the activities of the 
     Secretary under this subsection regarding influenza vaccine. 
     The first such report shall be submitted not later than June 
     6, 2003, the second report shall be submitted not later than 
     June 6, 2004, and subsequent reports shall be submitted 
     biennially thereafter.''.

     [SEC. 312. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR 
                   ADULTS AND ADOLESCENTS; COLLECTION OF 
                   ADDITIONAL IMMUNIZATION DATA.

       [(a) Activities of Centers for Disease Control and 
     Prevention.--Section 317(j) of the Public Health Service Act 
     (42 U.S.C. 247b(j)), as amended by section 311, is further 
     amended by adding at the end the following:
       [``(4)(A) For the purpose of carrying out activities to 
     increase immunization rates for adults and adolescents 
     through the immunization program under this subsection, and 
     for the purpose of carrying out subsection (k)(2), there are 
     authorized to be appropriated $50,000,000 for fiscal year 
     2003, and such sums as may be necessary for each of the 
     fiscal years 2004 through 2006. Such authorization is in 
     addition to amounts available under paragraphs (1), (2), and 
     (3) for such purposes.
       [``(B) In expending amounts appropriated under subparagraph 
     (A), the Secretary shall give priority to adults and 
     adolescents who are medically underserved and are at risk for 
     vaccine-preventable diseases, including as appropriate 
     populations identified through projects under subsection 
     (k)(2)(E).
       [``(C) The purposes for which amounts appropriated under 
     subparagraph (A) are available include (with respect to 
     immunizations for adults and adolescents) the payment of the 
     costs of storing vaccines, outreach activities to inform 
     individuals of the availability of the immunizations, and 
     other program expenses necessary for the establishment or 
     operation of immunization programs carried out or supported 
     by States or other public entities pursuant to this 
     subsection.
       [``(5) The Secretary shall annually submit to Congress a 
     report that--
       [``(A) evaluates the extent to which the immunization 
     system in the United States has been effective in providing 
     for adequate immunization rates for adults and adolescents, 
     taking into account the applicable year 2010 health 
     objectives established by the Secretary regarding the health 
     status of the people of the United States; and
       [``(B) describes any issues identified by the Secretary 
     that may affect such rates.
       [``(6) In carrying out this subsection and paragraphs (1) 
     and (2) of subsection (k), the Secretary shall consider 
     recommendations regarding immunizations that are made in 
     reports issued by the Institute of Medicine of the National 
     Academy of Sciences.''.
       [(b) Research, Demonstrations, and Education.--Section 
     317(k) of the Public Health Service Act (42 U.S.C. 247b(k)) 
     is amended--
       [(1) by redesignating paragraphs (2) through (4) as 
     paragraphs (3) through (5), respectively;
       [(2) by inserting after paragraph (1) the following:
       [``(2)(A) The Secretary, directly and through grants under 
     paragraph (1), shall

[[Page 10291]]

     provide for a program of research, demonstration projects, 
     and education in accordance with the following:
       [``(i) The Secretary shall coordinate with public and 
     private entities (including nonprofit private entities), and 
     develop and disseminate guidelines, toward the goal of 
     ensuring that immunizations are routinely offered to adults 
     and adolescents by public and private health care providers.
       [``(ii) The Secretary shall cooperate with public and 
     private entities to obtain information for the annual 
     evaluations required in subsection (j)(5)(A).
       [``(iii) The Secretary shall (relative to fiscal year 2003) 
     increase the extent to which the Secretary collects data on 
     the incidence, prevalence, and circumstances of diseases and 
     adverse events that are experienced by adults and adolescents 
     and may be associated with immunizations, including 
     collecting data in cooperation with commercial laboratories.
       [``(iv) The Secretary shall ensure that the entities with 
     which the Secretary cooperates for purposes of subparagraphs 
     (A) through (C) include managed care organizations, 
     community-based organizations that provide health services, 
     and other health care providers.
       [``(v) The Secretary shall provide for projects to identify 
     racial and ethnic minority groups and other health disparity 
     populations for which immunization rates for adults and 
     adolescents are below such rates for the general population, 
     and to determine the factors underlying such disparities.
       [``(B) Authorization of appropriations.--There are 
     authorized to be appropriated to carry out this subsection, 
     such sums as may be necessary for each of fiscal years 2003 
     through 2007.''.

     [SEC. 313. IMMUNIZATION AWARENESS.

       [(a) Development of Information Concerning Meningitis.--
       [(1) In general.--The Secretary of Health and Human 
     Services (in this title referred to as the ``Secretary''), in 
     consultation with the Director of the Centers for Disease 
     Control and Prevention, shall develop and make available to 
     entities described in paragraph (2) information concerning 
     bacterial meningitis and the availability and effectiveness 
     of vaccinations for populations targeted by the Advisory 
     Committee on Immunization Practices (an advisory committee 
     established by the Secretary, acting through the Director of 
     the Centers for Disease Control and Prevention).
       [(2) Entities.--An entity is described in this paragraph if 
     the entity--
       [(A) is--
       [(i) a college or university; or
       [(ii) any other facility with a setting similar to a 
     dormitory that houses age-appropriate populations for whom 
     the Advisory Committee on Immunization Practices recommends 
     such a vaccination; and
       [(B) is determined appropriate by the Secretary.
       [(b) Development of Information Concerning Hepatitis.--
       [(1) In general.--The Secretary, in consultation with the 
     Director of the Centers for Disease Control and Prevention, 
     shall develop and make available to entities described in 
     paragraph (2) information concerning hepatitis A and B and 
     the availability and effectiveness of vaccinations with 
     respect to such diseases.
       [(2) Entities.--An entity is described in this paragraph if 
     the entity--
       [(A) is--
       [(i) a health care clinic that serves individuals diagnosed 
     as being infected with HIV or as having other sexually 
     transmitted diseases;
       [(ii) an organization or business that counsels individuals 
     about international travel or who arranges for such travel;
       [(iii) a police, fire, or emergency medical services 
     organization that responds to natural or man-made disasters 
     or emergencies;
       [(iv) a prison or other detention facility;
       [(v) a college or university; or
       [(vi) a public health authority or children's health 
     service provider in areas of intermediate or high endemicity 
     for hepatitis A as defined by the Centers for Disease Control 
     and Prevention; and
       [(B) is determined appropriate by the Secretary.

     [SEC. 314. SUPPLY OF VACCINES.

       [(a) In General.--The Secretary of Health and Human 
     Services, acting through the Director of the Centers for 
     Disease Control and Prevention, shall prioritize, acquire, 
     and maintain a supply of such prioritized vaccines sufficient 
     to provide vaccinations throughout a 6-month period.
       [(b) Proceeds.--Any proceeds received by the Secretary of 
     Health and Human Services from the sale of vaccines contained 
     in the supply described in subsection (a), shall be available 
     to the Secretary for the purpose of purchasing additional 
     vaccines for the supply. Such proceeds shall remain available 
     until expended.
       [(c) Authorization of Appropriations.--There are authorized 
     to be appropriated for the purpose of carrying out subsection 
     (a) such sums as may be necessary for each of fiscal years 
     2003 through 2008.

     [SEC. 315. COMMUNICATION.

       [The Commissioner of Food and Drugs shall ensure that 
     vaccine manufacturers receive all forms of compliance 
     guidelines for vaccines and that such guidelines are kept up 
     to date.

     [SEC. 316. FAST TRACK.

       [The Commissioner of Food and Drugs shall issue regulations 
     to revise the policies of the Food and Drug Administration 
     regarding fast-tracking and priority review approval of 
     vaccine products currently under development, to allow for 
     the use of new forms of existing vaccines in cases where a 
     determination is made that applying such approvals is in the 
     public health interest to address the unmet need of 
     strengthening the overall vaccine supply.

     [SEC. 317. STUDY.

       [(a) In General.--The Secretary shall contract with the 
     Institute of Medicine of the National Academy of Sciences or 
     another independent and competent authority, to conduct a 
     study of the statutes, regulations, guidelines, and 
     compliance, inspection, and enforcement practices and 
     policies of the Department of Health and Human Services and 
     of the Food and Drug Administration that are applicable to 
     vaccines intended for human use that are in periodic short 
     supply in the United States.
       [(b) Requirements.--The study under subsection (a) shall 
     include a review of the regulatory requirements, guidelines, 
     practices, and policies--
       [(1) for the development and licensing of vaccines and the 
     licensing of vaccine manufacturing facilities;
       [(2) for inspections and other activities for maintaining 
     compliance and enforcement of the requirements applicable to 
     such vaccines and facilities; and
       [(3) that may have contributed to temporary or long-term 
     shortages of vaccines.
       [(c) Report.--Not later than 6 months after the date of 
     enactment of this Act, the Secretary shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report that contains--
       [(1) the results of the study under subsection (a); and
       [(2) recommendations for modifications to the regulatory 
     requirements, guidelines, practices, and policies described 
     in subsection (b).

            [Subtitle B--Vaccine Injury Compensation Program

     [SEC. 321. ADMINISTRATIVE REVISION OF VACCINE INJURY TABLE.

       [Section 2114 of the Public Health Service Act (42 U.S.C. 
     300aa-14) is amended--
       [(1) by striking subsection (c)(1) and inserting the 
     following:
       [``(1) The Secretary may promulgate regulations to modify 
     in accordance with paragraph (3) the Vaccine Injury Table. In 
     promulgating such regulations, the Secretary shall provide 
     for notice and for at least 60 days of public comment.''; and
       [(2) in subsection (d), by striking ``90 days'' and 
     inserting ``60 days''.

     [SEC. 322. EQUITABLE RELIEF.

       [Section 2111(a)(2)(A) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(2)(A)) is amended by striking ``No 
     person'' and all that follows through ``and--'' and inserting 
     the following: ``No person may bring or maintain a civil 
     action against a vaccine administrator or manufacturer in a 
     Federal or State court for damages arising from, or equitable 
     relief relating to, a vaccine-related injury or death 
     associated with the administration of a vaccine after October 
     1, 1988 and no such court may award damages or equitable 
     relief for any such vaccine-related injury or death, unless 
     the person proves past or present physical injury and a 
     timely petition has been filed in accordance with section 
     2116 for compensation under the Program for such injury or 
     death and--''.

     [SEC. 323. DERIVATIVE PETITIONS FOR COMPENSATION.

       [(a) Limitations on Derivative Petitions.--Section 
     2111(a)(2) of the Public Health Service Act (42 U.S.C. 300aa-
     11(a)(2)) is amended--
       [(1) in subparagraph (B), by inserting ``or (B)'' after 
     ``subparagraph (A)'';
       [(2) by redesignating subparagraph (B) as subparagraph (C); 
     and
       [(3) by inserting after subparagraph (A) the following:
       [``(B)(i) No parent or other third party may bring or 
     maintain a civil action against a vaccine administrator or 
     manufacturer in a Federal or State court for damages or 
     equitable relief relating to a vaccine-related injury or 
     death, including without limitation damages for loss of 
     consortium, society, companionship, or services, loss of 
     earnings, medical or other expenses, and emotional distress, 
     and no court may award damages or equitable relief in such an 
     action, unless--
       [``(I) the person who sustained the underlying vaccine-
     related injury or death upon which such parent's or other 
     third party's claim is premised has timely filed a petition 
     for compensation in accordance with section 2111;
       [``(II) such parent or other third party is the legal 
     representative or spouse of the person who sustained the 
     underlying vaccine-related injury or death, and such legal 
     representative or spouse has filed a timely derivative 
     petition, in accordance with section 2116; and
       [``(III)(aa) the United States Court of Federal Claims has 
     issued judgment under section 2112 on the derivative 
     petition, and such

[[Page 10292]]

     legal representative or spouse elects under section 2121(a) 
     to file a civil action; or
       [``(bb) such legal representative or spouse elects to 
     withdraw such derivative petition under section 2121(b) or 
     such petition is considered withdrawn under such section.
       [``(ii) Any civil action brought in accordance with this 
     subparagraph shall be subject to the standards and procedures 
     set forth in sections 2122 and 2123, regardless of whether 
     the action arises directly from a vaccine-related injury or 
     death associated with the administration of a vaccine. In a 
     case in which the person who sustained the underlying 
     vaccine-related injury or death upon which such legal 
     representative's or spouse's civil action is premised elects 
     under section 2121(a) to receive the compensation awarded, 
     such legal representative or spouse may not bring a civil 
     action for damages or equitable relief, and no court may 
     award damages or equitable relief, for any injury or loss of 
     the type set forth in section 2115(a) or that might in any 
     way overlap with or otherwise duplicate compensation of the 
     type available under section 2115(a).''.
       [(b) Eligible Persons.--Section 2111(a)(9) of the Public 
     Health Service Act (42 U.S.C. 300aa-11(a)(9)) is amended by 
     striking the period and inserting ``and to a parent or other 
     third party to the extent such parent or other third party 
     seeks damages or equitable relief relating to a vaccine-
     related injury or death sustained by a person who is 
     qualified to file a petition for compensation under the 
     Program.''.
       [(c) Petitioners.--Section 2111(b) of the Public Health 
     Service Act (42 U.S.C. 300aa-11(b)) is amended--
       [(1) in paragraph (1)--
       [(A) in subparagraph (A), by striking ``(B)'' and inserting 
     ``(C)'';
       [(B) by redesignating subparagraph (B) as subparagraph (C); 
     and
       [(C) by inserting after subparagraph (A) the following:
       [``(B) Except as provided in subparagraph (C), any legal 
     representative or spouse of a person--
       [``(i) who has sustained a vaccine-related injury or death; 
     and
       [``(ii) who has filed a petition for compensation under the 
     Program (or whose legal representative has filed such a 
     petition as authorized in subparagraph (A));

     may, if such legal representative or spouse meets the 
     requirements of subsection (d), file a derivative petition 
     under this section.''; and
       [(2) in paragraph (2)--
       [(A) by inserting ``by or on behalf of the person who 
     sustained the vaccine-related injury or death'' after 
     ``filed''; and
       [(B) by adding at the end the following: ``A legal 
     representative or spouse may file only 1 derivative petition 
     with respect to each underlying petition.''.
       [(d) Derivative Petition Contents.--Section 2111 of the 
     Public Health Service Act (42 U.S.C. 300aa-11) is amended--
       [(1) by redesignating subsections (d) and (e) as 
     subsections (e) and (f), respectively; and
       [(2) by inserting after subsection (c) the following:
       [``(d) Derivative Petitions.--
       [``(1) If the legal representative or spouse of the person 
     who sustained the vaccine-related injury or death seeks 
     compensation under the Program, such legal representative or 
     spouse shall file a timely derivative petition for 
     compensation under the Program in accordance with this 
     section.
       [``(2) Such a derivative petition shall contain--
       [``(A) except for records that are unavailable as described 
     in subsection (c)(3), an affidavit, and supporting 
     documentation, demonstrating that--
       [``(i) the child or spouse of such person has, in 
     accordance with section 2111, timely filed a petition for 
     compensation for the underlying vaccine-related injury or 
     death upon which such legal representative's or spouse's 
     derivative petition is premised;
       [``(ii) the derivative petition was timely filed;
       [``(iii) such legal representative or spouse suffered a 
     loss compensable under section 2115(b) as a result of the 
     vaccine-related injury or death sustained by such person; and
       [``(iv) such legal representative or spouse has not 
     previously collected an award or settlement of a civil action 
     for damages for such loss; and
       [``(B) records establishing such legal representative's or 
     spouse's relationship to the person who sustained the 
     vaccine-related injury or death.''.
       [(e) Determination of Eligibility for Compensation.--
     Section 2113(a)(1) of the Public Health Service Act (42 
     U.S.C. 300aa-13(a)(1)) is amended--
       [(1) in subparagraph (A), by striking ``and'' and inserting 
     ``or, as applicable, section 2111(d),'';
       [(2) in subparagraph (B), by striking the period and 
     inserting ``, and''; and
       [(3) by inserting before the flush matter at the end, the 
     following:
       [``(C) in the case of a derivative petition, that the 
     person who sustained the underlying vaccine-related injury or 
     death upon which the derivative petition is premised has 
     timely filed a petition for compensation in accordance with 
     section 2111 and that, with respect to such underlying 
     petition, the special master or court has made the findings 
     specified in subparagraphs (A) and (B) of this paragraph.''.
       [(f) Compensation.--Section 2115 of the Public Health 
     Service Act (42 U.S.C. 300aa-15) is amended--
       [(1) by redesignating subsections (b) through (j) as 
     subsections (c) through (k), respectively;
       [(2) by inserting after subsection (a) the following:
       [``(b) Derivative Petitions.--
       [``(1) In general.--Compensation awarded under the Program 
     to a legal representative or spouse who files a derivative 
     petition under section 2111 for a loss sustained as a result 
     of a vaccine-related injury or death sustained by such 
     petitioner's child or spouse shall only include compensation 
     for any loss of consortium, society, companionship, or 
     services, in an amount not to exceed the lesser of $250,000 
     or the total amount of compensation awarded to the person who 
     sustained the underlying vaccine-related injury or death.
       [``(2) Multiple individuals.--Where more than 1 person 
     files a derivative petition under section 2111 for losses 
     sustained as a result of the same underlying vaccine-related 
     injury or death, the aggregate compensation to such persons 
     shall not exceed the lesser of $250,000, or the total amount 
     of compensation awarded to the person who sustained the 
     underlying vaccine-related injury or death. The special 
     master or court shall apportion compensation among the 
     derivative petitioners in proportion to their respective 
     losses.'';
       [(3) in subsection (e)(2), as so redesignated by paragraph 
     (1)--
       [(A) by striking ``(2) and (3)'' and inserting ``(2), (3), 
     (4), (5), and (6)''; and
       [(B) by inserting ``and subsection (b),'' after ``(a),'';
       [(4) in subsection (g), as so redesignated by paragraph 
     (1), in paragraph (4)(B), by striking ``subsection (j)'' and 
     inserting ``subsection (k)'';
       [(5) in subsection (j), as so redesignated by paragraph 
     (1)--
       [(A) in paragraph (1), by striking ``subsection (j)'' and 
     inserting ``subsection (k)''; and
       [(B) in paragraph (2), by inserting ``, or to a legal 
     representative or spouse of a person who sustained a vaccine-
     related injury or death,'' after ``death''; and
       [(6) in subsection (k), as so redesignated by paragraph 
     (1), by striking ``subsection (f)(4)(B)'' and inserting 
     ``subsection (g)(4)(B)''.

     [SEC. 324. JURISDICTION TO DISMISS ACTIONS IMPROPERLY 
                   BROUGHT.

       [Section 2111(a)(3) of the Public Health Service Act (42 
     U.S.C. 300aa-11(a)(3)) is amended by adding at the end the 
     following: ``If any civil action which is barred under 
     subparagraph (A) or (B) of paragraph (2) is filed or 
     maintained in a State court, or any vaccine administrator or 
     manufacturer is made a party to any civil action brought in 
     State court (other than a civil action which may be brought 
     under paragraph (2)) for damages or equitable relief for a 
     vaccine-related injury or death associated with the 
     administration of a vaccine after October 1, 1988, the civil 
     action may be removed at any time before final judgment by 
     the defendant or defendants to the United States Court of 
     Federal Claims. Once removed, the United States Court of 
     Federal Claims shall have jurisdiction solely for the purpose 
     of adjudicating whether the civil action should be dismissed 
     pursuant to this section. If the United States Court of 
     Federal Claims determines that the civil action should not be 
     dismissed, the court shall remand the action to the State 
     Court. The notice required by section 1446 of title 28, 
     United States Code, shall be filed with the United States 
     Court of Federal Claims, and that court shall, except as 
     otherwise provided in this section, proceed in accordance 
     with sections 1446 through 1451 of title 28, United States 
     Code.''.

     [SEC. 325. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR 
                   UNRELATED TO ADMINISTRATION OF VACCINE.

       [Section 2113(a)(2)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-13(a)(2)(B)) is amended--
       [(1) by inserting ``structural lesions, genetic 
     disorders,'' after ``and related anoxia),'';
       [(2) by inserting ``(without regard to whether the cause of 
     the infection, toxin, trauma, structural lesion, genetic 
     disorder, or metabolic disturbance is known)'' after 
     ``metabolic disturbances''; and
       [(3) by striking ``but'' and inserting ``and''.

     [SEC. 326. INCREASE IN AWARD IN THE CASE OF A VACCINE-RELATED 
                   DEATH AND FOR PAIN AND SUFFERING.

       [(a) In General.--Section 2115(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-15(a)) is amended--
       [(1) in paragraph (2), by striking ``$250,000'' and 
     inserting ``$350,000''; and
       [(2) in paragraph (4), by striking ``$250,000'' and 
     inserting ``$350,000''.
       [(b) Death Awards.--Section 2115(a)(2) of the Public Health 
     Service Act (42 U.S.C. 300aa-15(a)(2)) is amended by 
     inserting ``(if the deceased incurred unreimbursable expenses 
     due to the vaccine-related injury prior to death in excess of 
     $50,000, the award shall also include reimbursement for those

[[Page 10293]]

     unreimbursable expenses that exceed $50,000)'' before the 
     period.

     [SEC. 327. BASIS FOR CALCULATING PROJECTED LOST EARNINGS.

       [Section 2115(a)(3)(B) of the Public Health Service Act (42 
     U.S.C. 300aa-15(a)(3)(B)) is amended by striking ``loss of 
     earnings'' and all that follows and inserting the following: 
     ``loss of earnings determined on the basis of the annual 
     estimate of the average (mean) gross weekly earnings of wage 
     and salary workers age 18 and over (excluding the 
     incorporated self-employed) in the private non-farm sector 
     (which includes all industries other than agricultural 
     production crops and livestock), as calculated annually by 
     the Bureau of Labor Statistics from the quarter sample data 
     of the Current Population Survey, or as calculated by such 
     similar method as the Secretary may prescribe by regulation, 
     less appropriate taxes and the average cost of a health 
     insurance policy, as determined by the Secretary.''.

     [SEC. 328. ALLOWING COMPENSATION FOR FAMILY COUNSELING 
                   EXPENSES AND EXPENSES OF ESTABLISHING AND 
                   MAINTAINING GUARDIANSHIP.

       [(a) Family Counseling Expenses in Post-1988 Cases.--
     Section 2115(a) of the Public Health Service Act (42 U.S.C. 
     300aa-15(a)) is amended by adding at the end the following:
       [``(5) Actual unreimbursable expenses that have been or 
     will be incurred for family counseling as is determined to be 
     reasonably necessary and that result from the vaccine-related 
     injury from which the petitioner seeks compensation.''.
       [(b) Expenses of Establishing and Maintaining Guardianships 
     in Post-1988 Cases.--Section 2115(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-15(a)), as amended by subsection 
     (a), is further amended by adding at the end the following:
       [``(6) Actual unreimbursable expenses that have been, or 
     will be reasonably incurred to establish and maintain a 
     guardianship or conservatorship for an individual who has 
     suffered a vaccine-related injury, including attorney fees 
     and other costs incurred in a proceeding to establish and 
     maintain such guardianship or conservatorship.''.
       [(c) Conforming Amendment for Cases From 1988 and 
     Earlier.--Section 2115 of the Public Health Service Act (42 
     U.S.C. 300aa-15) is amended in subsection (c), as so 
     redesignated by section 323(f)--
       [(1) in paragraph (2), by striking ``and'' at the end;
       [(2) in paragraph (3), by striking ``(e)'' and inserting 
     ``(f)'';
       [(3) by redesignating paragraph (3) as paragraph (5); and
       [(4) by inserting after paragraph (2), the following:
       [``(3) family counseling expenses (as provided for in 
     paragraph (5) of subsection (a));
       [``(4) expenses of establishing and maintaining 
     guardianships (as provided for in paragraph (6) of subsection 
     (a)); and''.

     [SEC. 329. ALLOWING PAYMENT OF INTERIM COSTS.

       [Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15) is amended in subsection (f), as so redesignated by 
     section 323(f), by adding at the end the following:
       [``(4) A special master or court may make an interim award 
     of costs subject to final adjustment if--
       [``(A) the case involves a vaccine administered on or after 
     October 1, 1988;
       [``(B) the special master or court has determined that the 
     petitioner is entitled to compensation under the Program;
       [``(C) the award is limited to other costs (within the 
     meaning of paragraph (1)(B)) incurred in the proceeding;
       [``(D) not more than 1 prior award has been made with 
     respect to such petition; and
       [``(E) the petitioner provides documentation verifying the 
     expenditure of the amount for which compensation is 
     sought.''.

     [SEC. 330. PROCEDURE FOR PAYING ATTORNEYS' FEES.

       [Section 2115 of the Public Health Service Act (42 U.S.C. 
     300aa-15), is amended in subsection (f), as so redesignated 
     by section 323(f) and amended by section 329, by adding at 
     the end the following:
       [``(5) When a special master or court awards attorney fees 
     or costs under paragraph (1) or (4), it may order that such 
     fees or costs be payable solely to the petitioner's attorney 
     if--
       [``(A) the petitioner expressly consents; or
       [``(B) the special master or court determines, after 
     affording to the Secretary and to all interested persons the 
     opportunity to submit relevant information, that--
       [``(i) the petitioner cannot be located or refuses to 
     respond to a request by the special master or court for 
     information, and there is no practical alternative means to 
     ensure that the attorney will be reimbursed for such fees or 
     costs expeditiously; or
       [``(ii) there are otherwise exceptional circumstances and 
     good cause for paying such fees or costs solely to the 
     petitioner's attorney.''.

     [SEC. 331. EXTENSION OF STATUTE OF LIMITATIONS.

       [(a) General Rule.--Section 2116(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-16(a)) is amended--
       [(1) in paragraph (2), by striking ``36 months'' and 
     inserting ``6 years''; and
       [(2) in paragraph (3), by striking ``48 months'' and 
     inserting ``6 years''.
       [(b) Claims Based on Revisions to Table.--Section 2116 of 
     the Public Health Service Act (42 U.S.C. 300aa-16) is amended 
     by striking subsection (b) and inserting the following:
       [``(b) Effect of Revised Table.--If at any time the Vaccine 
     Injury Table is revised and the effect of such revision is to 
     make an individual eligible for compensation under the 
     program, where, before such revision, such individual was not 
     eligible for compensation under the program, or to 
     significantly increase the likelihood that an individual will 
     be able to obtain compensation under the program, such person 
     may, and shall before filing a civil action for equitable 
     relief or monetary damages, notwithstanding section 
     2111(b)(2), file a petition for such compensation if--
       [``(1) the vaccine-related death or injury with respect to 
     which the petition is filed occurred not more than 10 years 
     before the effective date of the revision of the table; and
       [``(2) either--
       [``(A) the petition satisfies the conditions described in 
     subsection (a); or
       [``(B) the date of the occurrence of the first symptom or 
     manifestation of onset of the injury occurred more than 4 
     years before the petition is filed, and the petition is filed 
     not more than 2 years after the effective date of the 
     revision of the table.''.
       [(c) Derivative Petitions.--Section 2116 of the Public 
     Health Service Act (42 U.S.C. 300aa-16) is amended by adding 
     at the end the following:
       [``(d) Derivative Petitions.--No derivative petition may be 
     filed for compensation under the Program later than the 
     earlier of--
       [``(1) the last day on which the petition for compensation 
     for the underlying claim of the person who sustained the 
     vaccine-related injury or death upon which the derivative 
     petition is premised may be timely filed; or
       [``(2) 60 days after the date on which the special master 
     has issued a decision pursuant to section 2112(d)(3) on the 
     underlying claim of the person who sustained the vaccine-
     related injury or death upon which the derivative petition is 
     premised.''.
       [(d) Timely Resolutions of Claims.--
       [(1) Special master decision.--Section 2112(d)(3)(A) of the 
     Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(A)) is 
     amended by adding at the end the following: ``For purposes of 
     this subparagraph, the petition shall be deemed to be filed 
     on the date on which the special master issues a certificate 
     of completeness, indicating that all petition contents and 
     supporting documents required under section 2111(c) and, when 
     applicable, section 2111(d) and the Vaccine Rules of the 
     United States Court of Federal Claims, such as an affidavit 
     and supporting documentation, have been served on the 
     Secretary and filed with the clerk of the United States Court 
     of Federal Claims.''.
       [(2) Derivative petitions.--Section 2112(d)(3)(C) of the 
     Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(C)) is 
     amended by adding at the end the following: ``With respect to 
     any derivative petition filed under section 2111, the period 
     of time during which the petition for compensation for the 
     underlying vaccine-related injury or death upon which such 
     derivative petition is premised is pending shall be treated 
     as a suspension for purposes of this subparagraph.''.
       [(3) Court of federal claims decision.--Section 2121(b) of 
     the Public Health Service Act (42 U.S.C. 300aa-21(b)) is 
     amended by adding at the end the following: ``For purposes of 
     this subsection, the petition shall be deemed to be filed on 
     the date on which the special master issues a certificate of 
     completeness, indicating that all petition contents and 
     supporting documents required under section 2111(c) and, when 
     applicable, section 2111(d) and the Vaccine Rules of the 
     United States Court of Federal Claims, such as an affidavit 
     and supporting documentation, have been served on the 
     Secretary and filed with the clerk of the United States Court 
     of Federal Claims.''.

     [SEC. 332. ADVISORY COMMISSION ON CHILDHOOD VACCINES.

       [(a) Selection of Persons Injured by Vaccines as Public 
     Members.--Section 2119(a)(1)(B) of the Public Health Service 
     Act (42 U.S.C. 300aa-19(a)(1)(B)) is amended by striking ``of 
     whom'' and all that follows and inserting the following: ``of 
     whom 1 shall be the legal representative of a child who has 
     suffered a vaccine-related injury or death, and at least 1 
     other shall be either the legal representative of a child who 
     has suffered a vaccine-related injury or death or an 
     individual who has personally suffered a vaccine-related 
     injury.''.
       [(b) Mandatory Meeting Schedule Eliminated.--Section 
     2119(c) of the Public Health Service Act (42 U.S.C. 300aa-
     19(c)) is amended by striking ``not less often than four 
     times per year and''.

     [SEC. 333. CLARIFICATION OF STANDARDS OF RESPONSIBILITY.

       [(a) General Rule.--Section 2122(a) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(a)) is amended by striking 
     ``and (e) State law shall apply to a civil action brought for 
     damages'' and inserting ``(d), and (f) State law shall apply 
     to a civil action brought for damages or equitable relief''; 
     and
       [(b) Unavoidable Adverse Side Effects.--Section 2122(b)(1) 
     of the Public Health Service Act (42 U.S.C. 300aa-22(b)(1)) 
     is amended by inserting ``or equitable relief'' after ``for 
     damages''.

[[Page 10294]]

       [(c) Direct Warnings.--Section 2122(c) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(c)) is amended by inserting 
     ``or equitable relief'' after ``for damages''.
       [(d) Construction.--Section 2122(d) of the Public Health 
     Service Act (42 U.S.C. 300aa-22(d)) is amended--
       [(1) by inserting ``or equitable relief'' after ``for 
     damages''; and
       [(2) by inserting ``or relief'' after ``which damages''.
       [(e) Past or Present Physical Injury.--Section 2122 of the 
     Public Health Service Act (42 U.S.C. 300aa-22) is amended--
       [(1) by redesignating subsections (d) and (e) as 
     subsections (e) and (f), respectively; and
       [(2) by inserting after subsection (c) the following:
       [``(d) Past or Present Physical Injury.--No vaccine 
     manufacturer or vaccine administrator shall be liable in a 
     civil action brought after October 1, 1988, for equitable or 
     monetary relief absent proof of past or present physical 
     injury from the administration of a vaccine, nor shall any 
     vaccine manufacturer or vaccine administrator be liable in 
     any such civil action for claims of medical monitoring, or 
     increased risk of harm.''.

     [SEC. 334. CLARIFICATION OF DEFINITION OF MANUFACTURER.

       [Section 2133(3) of the Public Health Service Act (42 
     U.S.C. 300aa-33(3)) is amended--
       [(1) in the first sentence, by striking ``under its label 
     any vaccine set forth in the Vaccine Injury Table'' and 
     inserting ``any vaccine set forth in the Vaccine Injury 
     table, including any component or ingredient of any such 
     vaccine''; and
       [(2) in the second sentence, by inserting ``including any 
     component or ingredient of any such vaccine'' before the 
     period.

     [SEC. 335. CLARIFICATION OF DEFINITION OF VACCINE-RELATED 
                   INJURY OR DEATH.

       [Section 2133(5) of the Public Health Service Act (42 
     U.S.C. 300aa-33(5)) is amended by adding at the end the 
     following: ``For purposes of the preceding sentence, an 
     adulterant or contaminant shall not include any component or 
     ingredient listed in a vaccine's product license application 
     or product label.''.

     [SEC. 336. CLARIFICATION OF DEFINITION OF VACCINE AND 
                   DEFINITION OF PHYSICAL INJURY.

       [Section 2133 of the Public Health Service Act (42 U.S.C. 
     300aa-33) is amended by adding at the end the following:
       [``(7) The term `vaccine' means any preparation or 
     suspension, including a preparation or suspension containing 
     an attenuated or inactive microorganism or subunit thereof or 
     toxin, developed or administered to produce or enhance the 
     body's immune response to a disease or diseases and includes 
     all components and ingredients listed in the vaccine's 
     product license application and product label.
       [``(8) The term `physical injury' means a manifest physical 
     illness, condition, or death, including a neurological 
     disease or disorder.''.

     [SEC. 337. AMENDMENTS TO VACCINE INJURY COMPENSATION TRUST 
                   FUND.

       [(a) Expansion of Compensated Loss.--Section 9510(c)(1)(A) 
     of the Internal Revenue Code of 1986 is amended by inserting 
     ``, or related loss,'' after ``death''.
       [(b) Increase in Limit on Administrative Expenses.--
     Subparagraph (B) of section 9510(c)(1) of the Internal 
     Revenue Code of 1986 is amended--
       [(1) by striking ``(but not in excess of the base amount of 
     $9,500,000 for any fiscal year)''; and
       [(2) by striking the period and inserting ``, provided that 
     such administrative costs shall not exceed the greater of--
       [``(i) the base amount of $9,500,000 for any fiscal year,
       [``(ii) 125 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 150 percent of the average number of claims 
     pending in the preceding 5 years,
       [``(iii) 175 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 200 percent of the average number of claims 
     pending in the preceding 5 years,
       [``(iv) 225 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 250 percent of the average number of claims 
     pending in the preceding 5 years, or
       [``(v) 275 percent of the base amount for any fiscal year 
     in which the total number of claims pending under such 
     subtitle exceeds 300 percent of the average number of claims 
     pending in the preceding 5 years.''.
       [(c) Conforming Amendment.--Section 9510(c)(1)(A) of the 
     Internal Revenue Code of 1986 is amended by striking 
     ``October 18, 2000'' and inserting ``the date of enactment of 
     the Improved Vaccine Affordability and Availability Act''.

     [SEC. 338. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       [Part C of title XXI of the Public Health Service Act (42 
     U.S.C. 300a-25 et seq.) is amended by adding at the end the 
     following:

     [``SEC. 2129A. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

       [``(a) In General.--Not later than 6 months after the date 
     of enactment of this section, the Secretary shall enter into 
     a contract with the Institute of Medicine of the National 
     Academy of Science under which the Institute shall conduct an 
     ongoing, comprehensive review of new scientific data on 
     childhood vaccines (according to priorities agreed upon from 
     time to time by the Secretary and the Institute of Medicine).
       [``(b) Reports.--Not later than 3 years after the date on 
     which the contract is entered into under subsection (a), the 
     Institute of Medicine shall submit to the Secretary a report 
     on the findings of the studies conducted under such contract, 
     including findings as to any adverse events associated with 
     childhood vaccines, including conclusions concerning 
     causation of adverse events by such vaccines, and other 
     appropriate recommendations, based on such findings and 
     conclusions.
       [``(c) Failure to Enter Into Contract.--If the Secretary 
     and the Institute of Medicine are unable to enter into the 
     contract described in subsection (a), the Secretary shall 
     enter into a contract with another qualified nongovernmental 
     scientific organization for the purposes described in 
     subsections (a) and (b).
       [``(d) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated such sums as 
     may be necessary for each of fiscal years 2003, 2004, 2005 
     and 2006.''.

     [SEC. 339. PENDING ACTIONS.

       [The amendments made by this title shall apply to all 
     actions or proceedings pending on or after the date of 
     enactment of this Act, unless a court of competent 
     jurisdiction has entered judgment (regardless of whether the 
     time for appeal has expired) in such action or proceeding 
     disposing of the entire action or proceeding.

     [SEC. 340. REPORT.

       [Not later than 1 year after the date of enactment of this 
     Act, and annually thereafter, the Advisory Commission on 
     Childhood Vaccines shall report to the Secretary regarding 
     the status of the Vaccine Injury Compensation Trust Fund, and 
     shall make recommendations to the Secretary regarding the 
     allocation of funds from the Vaccine Injury Compensation 
     Trust Fund.]

     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 IV of the Public Health 
     Service Act (42 U.S.C. 284 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 409J. BIOMEDICAL COUNTERMEASURE RESEARCH AND 
                   DEVELOPMENT.

       ``(a) In General.--
       ``(1) Authority.--In carrying out research responsibilities 
     under this Act, the Secretary may conduct and support 
     research and development with respect to biomedical 
     countermeasures.
       ``(2) Implementation.--
       ``(A) In general.--Except as provided in subparagraph (C), 
     authorities assigned by this section to the Secretary shall 
     be carried out through the Director of NIH.
       ``(B) Lead institute.--The National Institute of Allergy 
     and Infectious Diseases shall be the lead institute for 
     performing, administering, or supporting biomedical 
     countermeasure research and development. The Director of NIH 
     may delegate to the Director of the Institute authorities as 
     are necessary to carry out this function.
       ``(C) Chemical, radiological, and nuclear agents.--To the 
     extent that an authority described in subparagraph (A) is 
     exercised with respect to a chemical, radiological, or 
     nuclear agent, the Secretary may authorize the Director of 
     NIH to carry out the authority through any national research 
     institute.
       ``(D) 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 preforming, administering, and 
     supporting biomedical countermeasures 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.
       ``(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 Federal 
     Government and to use other agencies of the Department of 
     Health and Human Services.
       ``(B) Limitation.--An agreement or undertaking under this 
     paragraph may not authorize another agency to exercise the 
     authorities provided to the Secretary by this section.
       ``(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 biomedical 
     countermeasure research or development, 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--

[[Page 10295]]

       ``(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) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     procurements made under this paragraph, including 
     requirements with respect to documenting the justification 
     for use of the authority provided in this paragraph.
       ``(2) Use of noncompetitive procedures.--In addition to any 
     other authority to use procedures other than competitive 
     procedures for procurements, the Secretary may use such other 
     noncompetitive procedures when--
       ``(A) the procurement is as described by paragraph (1)(A); 
     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 meet the needs of the Secretary.
       ``(3) Increased micropurchase threshold.--
       ``(A) In general.--For a procurement described by paragraph 
     (1)(A), 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 
     procurements that are made 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 Federal Government purchase card method for purchases 
     shall apply to procurements made under this paragraph and 
     that are greater than $2,500.
       ``(c) Authority To Expedite Peer Review.--The Secretary 
     may, as the Secretary determines necessary to respond to 
     pressing 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, 
     determines to be appropriate to obtain an assessment of 
     scientific and technical merit and likely contribution to the 
     field of biomedical countermeasure research, in place of the 
     peer review and advisory council review procedures that would 
     otherwise 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--
       ``(1) that is for performing, administering, or supporting 
     biomedical countermeasure research and development; and
       ``(2) the amount of which is not greater than $1,500,000.
       ``(d) Agency Facilities.--In addition to any similar 
     authority provided under any other provision of law, in 
     carrying out this section, the Secretary may--
       ``(1) acquire, lease, construct, improve, renovate, 
     remodel, repair, operate, and maintain laboratories, other 
     research facilities and equipment, and other real or personal 
     property as the Secretary determines necessary for the 
     purpose of performing, administering, and supporting 
     biomedical countermeasure research and development; and
       ``(2) acquire, without regard to section 8141 of title 40, 
     United States Code, by lease or otherwise, through the 
     Administrator of General Services, buildings or parts of 
     buildings in the District of Columbia.
       ``(e) Authority for Personal Services Contracts.--
       ``(1) In general.--For the purpose of performing, 
     administering, and supporting biomedical countermeasure 
     research and development, the Secretary may, as the Secretary 
     determines necessary to respond to pressing 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.
       ``(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 for 
     any act or omission within the scope of the Federal Tort 
     Claims Act.
       ``(C) Recourse in case of gross misconduct or contract 
     violation.--
       ``(i) In general.--Should payment be made by the United 
     States to any claimant bringing a claim under this paragraph, 
     either by way of administrative determination, settlement, or 
     court judgment, the United States shall have, notwithstanding 
     any provision of State law, the right to recover for that 
     portion of the damages so awarded or paid, as well as 
     interest and any costs of litigation, resulting from the 
     failure of any person, officer, employee, or governing board 
     member to carry out any obligation or responsibility assumed 
     by such person, officer, employee, or governing board member 
     under a contract with the United States or from any grossly 
     negligent, reckless, or illegal conduct or willful misconduct 
     on the part of such person, officer, employee, or governing 
     board member.
       ``(ii) Venue.--The United States may maintain an action 
     under this subparagraph against such person, officer, 
     employee, or governing board member in the district court of 
     the United States in which such person, officer, employee, or 
     governing board member resides or has its principal place of 
     business.
       ``(3) Internal controls to be instituted.--
       ``(A) In general.--The Secretary shall institute 
     appropriate internal controls for contracts under this 
     subsection, including procedures for the Secretary to make a 
     determination of whether a person, or an officer, employee, 
     or governing board member of a person, is deemed to be an 
     employee of the Department of Health and Human Services 
     pursuant to paragraph (2).
       ``(B) Determination of employee status to be final.--A 
     determination by the Secretary under subparagraph (A) that a 
     person, or an officer, employee, or governing board member of 
     a person, is or is not deemed to be an employee of the 
     Department of Health and Human Services shall be final and 
     binding on the Secretary and the Attorney General and other 
     parties to any civil action or proceeding.
       ``(4) Number of personal services contracts limited.--The 
     number of experts and consultants whose personal services are 
     obtained under paragraph (1) shall not exceed 30 at any time.
       ``(f) 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 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 
     biomedical countermeasure research and development in 
     carrying out this section.
       ``(2) Internal controls to be instituted.--The Secretary 
     shall institute appropriate internal controls for 
     appointments under this subsection.
       ``(g) Definition.--As used in this section, the term 
     `biomedical countermeasure' means a drug (as that term is 
     defined by section 201(g)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as 
     that term is defined by section 351(i) of this Act (42 U.S.C. 
     262(i))), or device (as that term is defined by section 
     201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321(h))) that is used--
       ``(1) to treat, identify, or prevent harm from any 
     biological, chemical, radiological, or nuclear agent that may 
     cause a public health emergency affecting national security; 
     or
       ``(2) to treat, identify, or prevent harm from a condition 
     that may result in adverse health consequences or death and 
     may be caused by administering a drug, biological product, or 
     device that is used as described in paragraph (1).
       ``(h) 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''; and
       (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''.

[[Page 10296]]



      SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

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

     ``SEC. 319A-1. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

       ``(a) Determination of Material Threats.--
       ``(1) Risk of use.--The Secretary of Homeland Security, in 
     consultation with the heads of other agencies as appropriate, 
     shall on an ongoing basis--
       ``(A) assess current and emerging threats of use of 
     chemical, biological, radiological, and nuclear agents; and
       ``(B) determine which of such agents present a material 
     risk of use against the United States population.
       ``(2) Public health impact.--The Secretary, in consultation 
     with the Secretary of Homeland Security, shall on an ongoing 
     basis--
       ``(A) assess the potential public health consequences of 
     use against the United States population of agents identified 
     under paragraph (1)(B); and
       ``(B) determine, on the basis of such assessment, the 
     agents for which countermeasures are necessary to protect the 
     public health.
       ``(b) Assessment of Availability and Appropriateness of 
     Countermeasures.--The Secretary, in consultation with the 
     Secretary of Homeland Security, shall assess on an ongoing 
     basis the availability and appropriateness of specific 
     countermeasures to address specific threats identified under 
     subsection (a).
       ``(c) Call for Necessary Countermeasures; Commitment for 
     Recommendation for Procurement.--
       ``(1) Proposal to the president.--Based on a determination 
     of necessary countermeasures under subsection (a), and the 
     assessment of availability and appropriateness of 
     countermeasures under subsection (b), the Secretary of 
     Homeland Security and the Secretary may jointly submit to the 
     President a proposal to--
       ``(A) call for a necessary countermeasure that is not 
     available; and
       ``(B) commit to make a recommendation for procurement under 
     subsection (e) of the first such specific countermeasure that 
     meets the conditions for procurement under subsection (d).
       ``(2) Countermeasure specifications.--The Secretary of 
     Homeland Security and the Secretary shall, to the extent 
     practicable, include in the recommendation under paragraph 
     (1)--
       ``(A) estimated quantity of purchase (in the form of number 
     of doses or number of effective courses of treatments 
     regardless of dosage form);
       ``(B) necessary measures of minimum safety and 
     effectiveness;
       ``(C) estimated price for each dose or effective course of 
     treatment regardless of dosage form; and
       ``(D) other information that may be necessary to encourage 
     and facilitate research, development, and manufacture of the 
     countermeasure or to provide specifications for the 
     countermeasure.
       ``(3) Presidential approval.--If the President has approved 
     a request under paragraph (1), the Secretary of Homeland 
     Security and the Secretary shall make known to persons who 
     may respond to a call for the countermeasure--
       ``(A) the call for the countermeasure;
       ``(B) specifications for the countermeasure under paragraph 
     (2); and
       ``(C) a commitment for a recommendation for procurement 
     under subsection (e) of the first such specific 
     countermeasure that meets the conditions for procurement 
     under subsection (d) and the specifications under paragraph 
     (2).
       ``(4) Subsequent specific countermeasures.--Procurement 
     under subsection (f) of the first such specific 
     countermeasure, or any other such countermeasure, that meets 
     the conditions for procurement under subsection (d) and the 
     specifications under paragraph (2) shall not preclude the 
     additional procurement under subsection (f) of a subsequent 
     such countermeasure that meets the conditions of procurement 
     under subsection (d) if such a 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.
       ``(d) Secretary's Determination of Countermeasures 
     Appropriate for Procurement under this Section.--
       ``(1) In general.--The Secretary, in accordance with this 
     section, shall identify specific countermeasures to threats 
     identified under subsection (a) that the Secretary 
     determines, in consultation with the Secretary of Homeland 
     Security, to be appropriate for procurement with 
     appropriations under this subsection for inclusion in the 
     stockpile under section 121(a) of the Public Health and 
     Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 
     300hh-12(a)).
       ``(2) Requirements.--In order for the Secretary to make the 
     determination under paragraph (1) with respect to a 
     countermeasure, the following requirements must be met:
       ``(A) Determination of qualified countermeasure.--The 
     Secretary must determine that the product is a qualified 
     countermeasure (as defined in subsection (h)).
       ``(B) Determination of quantities needed and feasibility of 
     production and distribution.--The Secretary must determine--
       ``(i) the quantities of the product that will be needed to 
     meet the needs of the stockpile; and
       ``(ii) that production and delivery within 5 years of 
     sufficient quantities of the product, as so determined, is 
     reasonably expected to be feasible.
       ``(C) Determination of no significant commercial market.--
     The Secretary shall--
       ``(i) determine that, at the time of the initial 
     determination under this subsection, there is not a 
     significant commercial market for the product other than as a 
     biomedical countermeasure; and
       ``(ii) annually redetermine and report to the President, 
     while a determination under paragraph (1) remains in effect 
     with respect to the product, whether a significant commercial 
     market exists for the product other than as a biomedical 
     countermeasure.
       ``(e) Recommendation for President's Approval.--
       ``(1) Recommendation for procurement.--In the case of a 
     countermeasure that the Secretary of Homeland Security and 
     the Secretary have determined is appropriate for procurement 
     under this section for inclusion in the stockpile, in 
     accordance with the preceding provisions of this section, the 
     Secretary of Homeland Security and the Secretary shall 
     jointly submit to the President, in coordination with the 
     Director of the Office of Management and Budget, a 
     recommendation for procurement under this section.
       ``(2) Presidential approval.--A countermeasure may be 
     procured under this section only if the President has 
     approved a recommendation under paragraph (1) with respect to 
     such countermeasure.
       ``(3) Notice to congress.--The Secretary of Homeland 
     Security shall notify Congress of each decision of the 
     President to approve a recommendation under paragraph (1).
       ``(f) Procurement.--The Secretary and the Secretary of 
     Homeland Security shall be responsible for the following, for 
     purposes of procurement of qualified countermeasures for the 
     stockpile under section 121(a) of the Public Health and 
     Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 
     300hh-12(a)), as approved by the President under subsection 
     (e):
       ``(1) In general.--The Secretary shall be responsible for--
       ``(A) arranging for procurement of the 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 paragraph; and
       ``(B) promulgating regulations to implement subparagraphs 
     (E), (F), and (G), and any other provisions of this section.
       ``(2) Contract terms.--A contract for procurement under 
     this section shall (or, as otherwise specified in this 
     paragraph, may) include the following terms:
       ``(A) 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.
       ``(B) Discounted payment for unlicensed product.--The 
     contract may provide for a discounted price per unit of a 
     product that is not licensed or approved as described in 
     subsection (h)(1) at the time of delivery, and may provide 
     for payment of an additional amount per unit if the product 
     becomes so licensed or approved before the expiration date of 
     the contract (including an additional amount per unit of 
     product delivered before the effective date of such licensing 
     or approval).
       ``(C) Storage by vendor.--The contract may provide that the 
     vendor will provide storage for stocks of a product delivered 
     to the ownership of the Government under the contract, for 
     such period and under such terms and conditions as the 
     Secretary may specify, and in such case amounts appropriated 
     under subsection (i) shall be available for costs of 
     shipping, handling, storage, and related costs for such 
     product.
       ``(D) Contract duration.--The contract shall be for a 
     period not to exceed 5 years, renewable for additional 
     periods none of which shall exceed 5 years.
       ``(E) Termination for nondelivery.--In addition to any 
     other rights of the Secretary to terminate the contract, the 
     contract may provide that such Secretary may terminate the 
     contract for failure to deliver a reasonable number (as 
     determined by the Secretary) of units of the product by 3 
     years after the date the contract is entered into, and may 
     further provide that in such case the vendor shall not be 
     entitled to any payment under the contract.
       ``(F) Product approval.--The contract shall provide that 
     the vendor seek approval, clearance, or licensing of the 
     product from the Secretary for a timetable for the 
     development of data and other information to support such 
     approval, clearance, or licensing, and that the Secretary may 
     waive part of all of this contract term on request of the 
     vendor or on the initiative of the Secretary.
       ``(3) Availability of simplified acquisition procedures.--
     The amount of any procurement under this section 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--
       ``(A) 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
       ``(B) section 302A(b) of such Act (41 U.S.C. 252a(b)) and 
     its implementing regulations.
       ``(4) Use of noncompetitive procedures.--In addition to any 
     other authority to use procedures other than competitive 
     procedures, the

[[Page 10297]]

     Secretary may use such other procedures for a procurement 
     under this section 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 such Secretary's needs.
       ``(5) Premium provision in multiple award contracts.--
       ``(A) In general.--If, under this section, the Secretary 
     enters into contracts with more than one person to procure a 
     countermeasure, such Secretary may, notwithstanding any other 
     provision of law, include in each of such contracts a 
     provision that--
       ``(i) identifies an increment of the total quantity of 
     countermeasure required, whether by percentage or by numbers 
     of units; and
       ``(ii) promises to pay one or more specified premiums based 
     on the priority of such persons' production and delivery of 
     the increment identified under clause (i), in accordance with 
     the terms and conditions of the contract.
       ``(B) Determination of government's requirement not 
     reviewable.--If the Secretary includes in each of a set of 
     contracts a provision as described in subparagraph (A), such 
     Secretary's determination of the total quantity of 
     countermeasure required, and any amendment of such 
     determination, is committed to agency discretion.
       ``(6) 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.
       ``(7) Limiting competition to sources responding to request 
     for information.--In conducting a procurement under this 
     section, 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 such Secretary may so exclude 
     such a source.
       ``(g) Interagency Cooperation.--
       ``(1) In general.--In carrying out activities under this 
     section, the Secretary of Homeland Security and the Secretary 
     are authorized, subject to paragraph (2), to enter into 
     interagency agreements and other collaborative undertakings 
     with other agencies of the United States Government.
       ``(2) Limitation.--An agreement or undertaking under this 
     subsection shall not authorize another agency to exercise the 
     authorities provided by this section to the Secretary of 
     Homeland Security or to the Secretary.
       ``(h) Definitions.--In this section:
       ``(1) Qualified countermeasure.--The term `qualified 
     countermeasure' means a biomedical countermeasure--
       ``(A) that is approved under section 505(a) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensed 
     under section 351 of this Act (42 U.S.C. 262) or that is 
     approved under section 515 or cleared under section 510(k) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e and 
     360) for use as such a countermeasure to a chemical, 
     biological, radiological, or nuclear agent identified as a 
     material threat under subsection (a); or
       ``(B) for which the Secretary determines that sufficient 
     and satisfactory clinical experience or research data 
     (including data, if available, from preclinical and clinical 
     trials) support a reasonable conclusion that the product will 
     qualify for approval or licensing as such a countermeasure 
     within 5 years after the date of a determination under 
     subsection (d).
       ``(2) Biomedical countermeasure.--The term `biomedical 
     countermeasure' means a drug (as that term is defined by 
     section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(g)(1))), device (as that term is defined by 
     section 201(h) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321(h))), or biological product (as that term is 
     defined by section 351(i) of this Act (42 U.S.C. 262(i))) 
     that is used--
       ``(A) to treat, identify, or prevent harm from any 
     biological, chemical, radiological, or nuclear agent that may 
     cause a public health emergency affecting national security; 
     or
       ``(B) to treat, identify, or prevent harm from a condition 
     that may result in adverse health consequences or death and 
     may be caused by administering a drug or biological product 
     that is used as described in subparagraph (A).
       ``(i) Appropriations.--
       ``(1) In general.-- There are appropriated, out of any 
     moneys in the Treasury not otherwise appropriated, for fiscal 
     year 2003 and for each fiscal year thereafter, such sums as 
     may be necessary for the costs incurred by the Secretary in 
     the procurement of countermeasures under this subsection as 
     approved by the President under subsection (e) (other than 
     costs specified in paragraph (2)).
       ``(2) Restrictions.--Amounts appropriated under this 
     subsection shall not be available to pay--
       ``(A) costs for the purchase of vaccines under procurement 
     contracts entered into before January 1, 2003;
       ``(B) costs under new contracts, or costs of new 
     obligations under contracts previously entered into, for 
     procurement of a countermeasure after the date of a 
     determination under subsection (d)(2)(C) that there is a 
     significant commercial market for the countermeasure other 
     than as a biomedical countermeasure; or
       ``(C) administrative costs.''.

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

       (a) In General.--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:

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

       ``(a) In General.--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, biological product, or device 
     intended solely for use in an actual or potential emergency.
       ``(b) Declaration of Emergency.--
       ``(1) In general.--The Secretary may declare an emergency 
     justifying the authorization of a drug, biological product, 
     or device under this subsection on the basis of a 
     determination--
       ``(A) by the Secretary of Homeland Security, that there is 
     a domestic emergency (or a significant potential of a 
     domestic emergency) involving a heightened risk of attack 
     with a specified biological, chemical, radiological, or 
     nuclear agent;
       ``(B) by the Secretary of Defense, that there is a military 
     emergency (or a significant potential of a military 
     emergency) involving a heightened risk to United States 
     military forces of attack with a biological, chemical, 
     radiological, or nuclear agent; or
       ``(C) 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 a specified 
     disease or condition that may be attributable to such agent.
       ``(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 1-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) Notification.--The Secretary shall promptly publish 
     in the Federal Register, and shall notify the appropriate 
     committees of Congress concerning, 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 a product if 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.--An authorization of a 
     product under this section shall state--
       ``(1) each disease or condition and the intended use of the 
     product within the scope of the authorization; and
       ``(2) the Secretary's conclusions, 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.
       ``(e) Conditions of Authorization.--The Secretary is 
     authorized to impose such conditions on an authorization 
     under this section as the Secretary determines are necessary 
     or appropriate to protect the public health, including the 
     following:
       ``(1) The Secretary shall impose requirements (including 
     requirements concerning product labeling and the provision of 
     information) designed to ensure that, to the maximum extent 
     feasible given the circumstances of the emergency, health 
     care professionals administering the product are informed--
       ``(A) that the Secretary has authorized the product solely 
     for emergency use;
       ``(B) of the significant known and potential benefits and 
     risks of use of the product, and of the extent to which such 
     benefits and risks are unknown; and
       ``(C) of the alternatives to the product that are 
     available, and of their benefits and risks.
       ``(2) The Secretary shall impose requirements (including 
     requirements concerning product labeling and the provision of 
     information) designed to ensure that, to the maximum extent 
     feasible given the circumstances of the emergency, 
     individuals to whom the product is administered are 
     informed--

[[Page 10298]]

       ``(A) that the Secretary has authorized the product solely 
     for emergency use;
       ``(B) of the significant known and potential benefits and 
     risks of use of the product, and of the extent to which such 
     benefits and risks are unknown; and
       ``(C) of any option to accept or refuse administration of 
     the product, and of the alternatives to the product that are 
     available and of their benefits and risks.
       ``(3) The Secretary may impose limitations on which 
     entities may distribute the product (including limitation to 
     distribution by government entities), and on how distribution 
     is to be performed.
       ``(4) The Secretary may impose limitations on who may 
     administer the product, and on the categories of individuals 
     to whom, and the circumstances under which, the product may 
     be administered.
       ``(5) The Secretary may condition the authorization on the 
     performance of studies, clinical trials, or other research 
     needed to support marketing approval of the product.
       ``(6) The Secretary shall impose, to the extent feasible 
     and appropriate given the circumstances of the emergency, 
     requirements concerning recordkeeping and reporting, 
     including records access by the Secretary and publication of 
     data.
       ``(7) The Secretary may waive, to the extent appropriate 
     given the circumstances of the emergency, requirements, with 
     respect to the product, of current good manufacturing 
     practice otherwise applicable to the manufacture, processing, 
     packing, or holding of products subject to regulation under 
     this Act.
       ``(8) The Secretary shall, to the extent feasible and 
     appropriate given the circumstances of the emergency, impose 
     requirements for the monitoring and reporting of adverse 
     events associated with use of the product.
       ``(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--
       ``(A) the conditions for such an authorization are no 
     longer met; or
       ``(B) other circumstances make such revocation appropriate.
       ``(h) Publication.--The Secretary shall promptly publish in 
     the Federal Register, and provide to the appropriate 
     committees of Congress, a notice of each authorization, and 
     each termination or revocation of an authorization, under 
     this section.
       ``(i) Recordkeeping.--
       ``(1) In general.--The Secretary may require persons, 
     including a person who holds an authorization under this 
     section, or who manufactures, distributes, prescribes, or 
     administers a product that is the subject of such an 
     authorization, to establish and maintain--
       ``(A) data that is obtained from such activity and that 
     pertains to the effectiveness or safety of such product;
       ``(B) such records as are necessary to determine, or 
     facilitate a determination, whether there may be any 
     violation of this section or of a regulation promulgated 
     under this section; and
       ``(C) such additional records as the Secretary may 
     determine necessary.
       ``(2) Access to records by secretary.--
       ``(A) Safety and effectiveness information.--The Secretary 
     may require a person who holds an authorization under this 
     section, or who manufactures, distributes, prescribes, or 
     administers a product that is the subject of such an 
     authorization to provide to the Secretary all data that is 
     obtained from such activity and that pertains to the safety 
     or effectiveness of such product.
       ``(B) Other information.--Every person required under this 
     section to establish or maintain records, and every person in 
     charge or custody of such records, shall, upon request by the 
     Secretary, permit the Secretary at all reasonable times to 
     have access to, to copy, and to verify such records.
       ``(j) Civil Monetary Penalties.--
       ``(1) In general.--A person who violates a requirement of 
     this section or of a regulation or order promulgated pursuant 
     to this section shall be subject to a civil money penalty of 
     not more than $100,000 in the case of an individual, and not 
     more than $250,000 in the case of any other person, for each 
     violation, not to exceed $1,000,000 for all such violations 
     adjudicated in a single proceeding.
       ``(2) Assessment of civil penalties.--Paragraphs (3), (4), 
     and (5) of section 303(g) shall apply to a civil penalty 
     under this subsection, and references in such paragraphs to 
     `paragraph (1) or (2)' shall, for purposes of this 
     subsection, be deemed to refer to paragraph (1) of this 
     subsection.
       ``(k) 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.
       ``(l) Regulations.--The Secretary may promulgate 
     regulations to implement this section.
       ``(m) 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; or
       ``(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.
       ``(n) Application to Members of Armed Forces.--
       ``(1) Waiver of requirement relating to option to refuse.--
     In the case of the administration of a countermeasure to 
     members of the armed forces, a requirement, under subsection 
     (e)(2), 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) 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.
       ``(o) 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.''.
       (b) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331) is amended--
       (1) in subsection (e)--
       (A) by striking ``504, 703'' and inserting ``504, 564, 
     703''; and
       (B) by striking ``or 519'' and inserting ``519, or 564''; 
     and
       (2) by adding at the end the following:
       ``(hh)(1) Promotion or use of a product that is the subject 
     of an authorization under section 564 other than as stated in 
     the authorization, or other than during the period described 
     by section 564(g), unless such promotion or use is permitted 
     under another provision of this Act.
       ``(2) Failure to comply with an information requirement 
     under section 564(e).''.

     SEC. 5. AMENDMENTS TO PROVISIONS OF THE HOMELAND SECURITY 
                   ACT.

       (a) Declaration Recommending Making Countermeasure 
     Available to Individuals.--Section 224(p)(2)(A)(i) of the 
     Public Health Service Act (42 U.S.C. 233(p)(2)(A)(i)) is 
     amended--
       (1) by striking ``advisable the administration'' and 
     inserting the following: ``advisable--

       ``(I) the administration'';

       (2) by striking the period and inserting ``; or''; and
       (3) by adding at the end the following:

       ``(II) making a covered countermeasure available to a 
     category or categories of individuals who may wish to receive 
     it.''.

       (b) Amendment to Accidental Vaccinia Inoculation 
     Provision.--Section 224(p)(2)(C)(ii)(II) of the Public Health 
     Service Act (42 U.S.C. 233(p)(2)(C)(ii)(II)) is amended by 
     striking ``resides or has resided with'' and inserting ``has 
     resided with, or has had close contact with,''.
       (c) Deeming Acts and Omissions to be Within Scope of 
     Employment.--Section 224(p)(2) of the Public Health Service 
     Act (42 U.S.C. 233(p)(2)) is amended by adding at the end the 
     following:
       ``(D) Acts and omissions deemed to be within scope of 
     employment.--
       ``(i) In general.--In the case of a claim arising out of 
     alleged transmission of vaccinia from an individual described 
     in clause (ii), acts or omissions by such individual shall be 
     deemed to have been taken within the scope of such 
     individual's office or employment for purposes of--

       ``(I) subsection (a); and
       ``(II) section 1346(b) and chapter 171 of title 28, United 
     States Code.

       ``(ii) Individuals to whom deeming applies.--An individual 
     is described by this clause if--

       ``(I) vaccinia vaccine was administered to such individual 
     as provided by paragraph (2)(B); and
       ``(II) such individual was within a category of individuals 
     covered by a declaration under paragraph (2)(A)(i)(I).''.

       (d) Requirement to Cooperate with United States.--Section 
     224(p)(5) of the Public Health Service Act (42 U.S.C. 
     233(p)(5)) is amended in paragraph heading by striking 
     ``Defendant'' and inserting ``Covered person''.
       (e) Amendment to Definition of Covered Countermeasure.--
     Subclause (II) of section 224(p)(7)(A)(i) of the Public 
     Health Service Act (42 U.S.C. 233(p)(7)(A)(i)(II)) is amended 
     to read as follows:

       ``(II) used to control or treat the adverse effects of 
     vaccinia inoculation or of administration of another covered 
     countermeasure; and''.

       (f) Amendment to Definition of Covered Person.--Section 
     224(p)(7)(B) of the Public

[[Page 10299]]

     Health Service Act (42 U.S.C. 233(p)(7)(B)) is amended--
       (1) in the matter preceding clause (i), by striking 
     ``includes any person'' and inserting ``means a person'';
       (2) in clause (ii)--
       (A) by striking ``auspices such'' and inserting the 
     following: ``auspices--

       ``(I) such''; and

       (B) by adding at the end the following:

       ``(II) a determination was made as to whether, or under 
     what circumstances, an individual should receive a covered 
     countermeasure;
       ``(III) the immediate site of administration of a covered 
     countermeasure was monitored, managed, or cared for; or
       ``(IV) an evaluation was made of whether the administration 
     of a covered countermeasure was effective;'';

       (3) in clause (iii) by striking ``or'';
       (4) by striking clause (iv) and inserting the following:
       ``(iv) a State, a political subdivision of a State, or an 
     agency or official of a State or of such a political 
     subdivision, if such State, subdivision, agency, or official 
     has established requirements, provided policy guidance, or 
     supplied technical or scientific advice or assistance with 
     respect to administration of such countermeasures;
       ``(v) in the case of a claim arising out of alleged 
     transmission of vaccinia from an individual--

       ``(I) the individual who allegedly transmitted the 
     vaccinia, if vaccinia vaccine was administered to such 
     individual as provided by paragraph (2)(B) and such 
     individual was within a category of individuals covered by a 
     declaration under paragraph (2)(A)(i)(I); or
       ``(II) an entity that employs an individual described by 
     clause (I) or where such individual has privileges to provide 
     health care;

       ``(vi) an official, agent, or employee of a person 
     described in clause (i), (ii), (iii), or (iv);
       ``(vii) a contractor of, or a volunteer working for, a 
     person described in clause (i), (ii), or (iv), if the 
     contractor or volunteer performs a function for which a 
     person described in clause (i), (ii), or (iv) is a covered 
     person; or
       ``(viii) an individual who has privileges to provide health 
     care under the auspices of an entity described in clause (ii) 
     or (v)(II).''.
       (g) Amendment to Definition of Qualified Person.--Section 
     224(p)(7)(C) of the Public Health Service Act (42 U.S.C. 
     233(p)(7)(C)) is amended--
       (1) by striking ``who is authorized to'' and inserting the 
     following: ``who--
       ``(i) is authorized to'';
       (2) by striking the period and inserting ``; or''; and
       (3) by adding at the end the following:
       ``(ii) is otherwise authorized by the Secretary to 
     administer such countermeasure.''.
       (h) Definition of ``Arising Out of Administration of a 
     Covered Countermeasure''.--Section 224(p)(7) of the Public 
     Health Service Act (42 U.S.C. 233(p)(7)) is amended by adding 
     at the end the following:
       ``(D) Arising out of administration of a covered 
     countermeasure.--
       ``(i) In general.--The term `arising out of administration 
     of a covered countermeasure', when used with respect to a 
     claim or liability, includes, except as provided in clause 
     (ii), a claim or liability arising out of--

       ``(I) determining whether, or under what conditions, an 
     individual should receive a covered countermeasure;
       ``(II) obtaining informed consent of an individual to the 
     administration of a covered countermeasure;
       ``(III) monitoring, management, or care of an immediate 
     site of administration of a covered countermeasure, or 
     evaluation of whether the administration of the 
     countermeasure has been effective; or
       ``(IV) transmission of vaccinia virus by an individual to 
     whom vaccinia vaccine was administered as provided by 
     paragraph (2)(B).

       ``(ii) Exception.--Such term shall not include a claim or 
     liability arising out of care for or treatment of 
     complications arising out of the administration of the 
     countermeasure.''.
       (i) Technical Correction.--Section 224(p)(2)(A)(ii) of the 
     Public Health Service Act (42 U.S.C. 233(p)(2)(A)(ii)) is 
     amended by striking ``paragraph (8)(A)'' and inserting 
     ``paragraph (7)(A)''.
       (j) Effective Date.--This amendments made by this section 
     shall take effect as if enacted on November 25, 2002.

     SEC. 6. GAO REPORT.

       Not later than 4 years after the date of enactment of this 
     Act, the Comptroller General of the United States shall 
     submit to the appropriate committees of Congress a report 
     that--
       (1) describes the activities conducted under the 
     authorities provided for in section 409J(b)(1) of the Public 
     Health Service Act (as added by section 2) and section 319A-
     1(f)(3) and (4) of such Act (as added by section 3);
       (2) identifies any procurements that would have been 
     prohibited except for the authorities provided in the 
     sections described in paragraph (1); and
       (3) assesses the adequacy of the internal controls 
     established by the Secretary of Health and Human Services 
     regarding procurements made under the authorities provided 
     for in the sections described in paragraph (1).

  The PRESIDING OFFICER. Under the previous order, there will now be 2 
hours of debate equally divided on the measure.
  The majority leader.
  Mr. FRIST. Mr. President, agents of bioterror are potentially the 
most powerful and devastating weapons of mass destruction that are 
known to man. Bioterror agents are more powerful than traditional 
weapons of mass destruction, are more powerful than chemical weapons, 
are more powerful than nuclear weapons.
  When I say that, people oftentimes say: How can you say that? And it 
really comes down to one simple concern: that many of the bioterror 
agents are and can be infectious. They are agents of virus, of 
bacteria, of another living organism that cannot be seen, that cannot 
be touched, that cannot be smelled or heard. Yet they are deadly. They 
know no borders. There are no geographic borders. They attack 
indiscriminately, and they can travel through a school, they can travel 
through a community, they can travel through a State, they can travel 
through a country, and they can travel, indeed, through a continent. 
They are powerful, powerful agents.
  The United States is less than adequately prepared today in terms of 
defense against these agents of bioterror. Over the next 2 hours, we 
will be talking about a bill--and ultimately will pass a bill--that is 
long overdue, legislation that bolsters, that strengthens our Nation's 
defenses against threats from bioterrorism.
  I applaud the leadership of Senator Judd Gregg, the distinguished 
chairman of the Health, Education, Labor, and Pensions Committee. He 
has done a tremendous service to this Nation by bringing this 
legislation through his committee and to the floor of the Senate today 
for passage.
  We absolutely must--we absolutely must--strengthen our defenses 
against the threats of biological weapons which I just referred to. But 
also covered in this bill are other weapons of mass destruction, 
including nuclear, including chemical, and including radiological 
weapons.
  I also commend the distinguished Senator from Massachusetts, Mr. 
Kennedy, for his efforts to achieve a bipartisan consensus on the 
bioshield legislation we are now considering on the Senate floor.
  This legislation has been a priority for President Bush. I 
congratulate him. He first outlined his bold initiative in his State of 
the Union Address in January 2003. Since then, we have worked closely 
with the administration and with our colleagues here in Congress to 
pass this critical legislation.
  What the legislation allows us to do is be proactive in developing a 
broad range of countermeasures to combat biological, chemical, 
radiological, and nuclear threats.
  It was just several months ago in my own office that there was a 
bioterror attack and ricin was sent. It is a deadly agent. It is an 
interesting agent to think about because it is deadly. It is ricin. It 
was here in our Nation's capital city, in an adjacent building. There 
is no antidote. We do not have a medicine that can counteract the 
effects of ricin today.
  It is now 3, almost 4 years ago that anthrax hit this same capital. 
It was deadly. With ricin, thank goodness, nobody was hurt and injured. 
With the anthrax, 3 years ago, the reality was being demonstrated that 
bioterror is here, it is on our own soil. It hit this Nation. It hit 
this Capitol. It hit the entire east coast. Indeed, it was deadly, that 
little anthrax bacteria that you cannot see.
  This legislation allows us to further our response to such agents, 
both here on our soil, which exist and are being used today, as well as 
internationally.
  It was just 2 days ago that a canister of sarin gas--it shifted just 
a little bit, with a mixing of two other chemicals, to become sarin 
gas--began to leak through that canister, again reminding us of the 
impact that chemical weapons can have today.
  So whether it is domestically or internationally, this piece of 
legislation will bolster and strengthen our defenses to fight, to use 
countermeasures that will prevent, hopefully, the use of and have an 
appropriate response to the use of these biological and chemical 
weapons.
  The bioshield legislation really does do just that. It improves our 
ability to

[[Page 10300]]

investigate, to develop, and to produce these new such countermeasures. 
For the first time, we have well defined this new paradigm of a public 
and private partnership working together to develop these 
countermeasures in our Nation's interests.
  While maintaining high standards of scientific excellence, the bill 
streamlines the ability of agencies and entities, such as the National 
Institutes of Health, to rapidly advance research into these much 
needed countermeasures, countermeasures to the realities of biological 
weapons today.
  The bill provides the private sector with new incentives to invest in 
research and development of biomedical countermeasures that otherwise 
simply would not have the business potential. We need to give those 
appropriate incentives to the private sector, to use its ingenuity, to 
use its innovation, to use its capitalism, to use its knowledge to 
respond to the realities, these real threats that are out there today.
  The legislation is critical to our efforts to protect our citizens. 
There is a whole series of biological threats that are categorized by 
categories 1, 2, and 3. For the category 1 list, we have vaccines for 
only two, one being anthrax and the other being smallpox. Both of those 
vaccines need continued research and refinement in order to minimize 
those side effects and to make sure we can improve the ease of delivery 
so that in the event we need to respond, we can respond quickly, 
efficiently, and safely, whether it be for our soldiers or for citizens 
throughout America.
  This bill also is a major component of our overall much larger 
strategy to improve our overall biodefense.
  There are other initiatives such as strengthening our public health 
system. Our public health system has been neglected over the last 25 or 
30 years. That public health system, that public health infrastructure, 
is the frontline in response to these agents.
  Another component I hope we will be able to address in the future, 
which is important as we develop this broad strategy against 
bioterrorism, is this whole element of vaccine liability. Clearly, our 
vaccine liability system needs reform.
  We have the latest public health challenges, things such as SARS, 
sudden acute respiratory syndrome--a year and a half ago that virus 
came, and nobody knew what it was, and the terror it created--West Nile 
virus, and vancomycin-resistant staphylococcus aureus. All of those 
have taught us the danger of sitting back and being too complacent and 
not being proactive. In this bill we are being proactive.
  I commend especially Chairman Gregg, the President of the United 
States for his bold leadership, Senator Kennedy, and all of our 
colleagues who have worked to craft this legislation to see that we 
respond to a clearly identifiable need. Passage of this legislation, 
indeed, is a major step forward in strengthening our national security.
  The PRESIDING OFFICER (Ms. Murkowski). The Senator from New 
Hampshire.
  Mr. GREGG. Madam President, I thank the majority leader for his kind 
statements. I certainly want to recognize the fact that without the 
majority leader's very strong and thoughtful leadership in this area, 
we would not have gotten this far. He is obviously an expert in the 
area of health care and especially sensitive to the need to do 
something in the area of fighting those agents which might be used 
against us as biological agents. His leadership and knowledge have made 
a significant difference in our ability to be successful with this 
bill. I thank him for that leadership.
  I join him in thanking the President. Obviously, this is an 
initiative high on the President's agenda and the people at NIH, Dr. 
Zerhouni and Dr. Fauci, who understand the threat and understand the 
need to address the threat.
  We have to put the threat in context, and, regrettably, the context 
is serious. Were this 1950, 1960, were this any time prior to the 
latter part of last century and the beginning of our century, and we 
had terrorists out there who wanted to do us harm, who were as 
fanatical as are the people who wish to do us harm, the Islamic 
fundamentalist movement, we would fight them and we would be concerned 
about them. But our concerns and our ability to handle their threat 
would be proportional. We would have been able to manage it at that 
time in an effective and rather contained way.
  The problem today is that when you have a fanatical group, a group 
willing to not only pursue its purposes without limitation and as part 
of that to be willing to kill innocent individuals, and when you have a 
group such as that that is also able to get or potentially take 
possession of weapons of mass destruction, you have created a whole new 
issue, a whole new threat, a threat of massive proportions. Because if 
individuals are willing to use weapons of mass destruction--biological, 
chemical, or nuclear--and they have no compunction about killing 
innocents--and in fact the purpose of Islamic fundamentalism is 
specifically to kill Western individuals, people who subscribe to the 
American philosophy, to our Nation--and their purpose is to undermine 
our country, to destroy our culture because they deem Western culture 
to be a threat to them, when you have people like that and they have 
the ability to possess weapons of mass destruction and the delivery 
systems to get those weapons into places where they could do massive 
harm, then you have a problem of immense proportion. The Nation must 
protect itself from that type of threat. That is what this bioshield 
initiative is an attempt to do.
  We recognize, as the majority leader stated, that probably the single 
most threatening weapon which these individuals can get their hands on 
easily and disperse easily--it is not the single most threatening 
weapon overall; I suspect a nuclear device, were they able to produce 
one, would be more threatening--the type of weaponry which they most 
likely can get their hands on which has the potential to do the most 
harm to the most innocent individuals is a biological weapon or 
potentially a chemical weapon, but more likely a biological weapon. 
Because if they were able, for example, as was seen in a small 
contained area in the Capitol, to spread anthrax or to spread smallpox 
or to spread botulism, Ebola, or any other agents which would be a 
disease which would be carried, as the majority leader mentioned, 
without sight, without sound, without smell, without noise, across a 
large dispersal area, they could literally harm tens of thousands, 
potentially even more, Americans.
  There is no question but if these fundamentalist terrorists, Islamic 
fundamentalists, get their hands on that type of weapon, get their 
hands on a biological weapon, come into possession of an anthrax 
capability or a smallpox capability, they will use it. There is no 
question about that. They will use it in a place where people gather 
who are gathering simply to go through their daily lives, whether it is 
in a subway system as occurred in Japan, or whether it is in a building 
as occurred here in the Capitol, or whether it is in some other area 
where people congregate.
  So we as a nation--and the President has made this very clear--have a 
responsibility to try to defend ourselves from that type of a threat. 
It is not an inexpensive responsibility. It is going to cost us a lot 
of money. Regrettably, it is a complex responsibility. There is no 
magic wand you can wave that will inoculate the American public against 
these threats. But we understand there is a procedure to go as far down 
the road as we can possibly go to accomplish that sort of an 
inoculation or have the capacity to defend our people from that type of 
a threat.
  One of the great advantages we have in fighting Islamic 
fundamentalism is that we are a sophisticated society which has 
technical capabilities which we can bring to bear in this war--and it 
is a war--and bring it to bear in a manner which allows us to take the 
position that gives us self-defense and also the capacity to carry the 
battle to them rather than have them carry the battle to us.
  This bioshield bill grew out of an initiative that the President 
suggested, which was that in the case of a series of agents which are 
biologically driven,

[[Page 10301]]

which we know can do the most harm, the top seven or eight agents which 
we know can do the most harm--six or seven agents--we are going to 
initiate an effort to try to develop the science necessary to develop 
ways to interdict, to stop, to cure, to make the attacks that use those 
types of agents less harmful to our people. But in order to accomplish 
that, we had to recognize as a government--and the administration 
certainly did--that there is no commercial applicability for this type 
of research. There is no commercial demand for this type of a 
commodity.
  A vaccine for anthrax is not in great commercial demand. People are 
not just going to go out and buy it or take it for the purposes of 
going through their daily lives. It is not like some other cure to some 
other sickness, and, therefore, we had to set up a structure where we 
make it viable for our private sector pharmaceutical industry and 
biotechnology industry to invest the extraordinary amount of money it 
takes to invest in the production of this type of response capability. 
That is essentially what bioshield does. It puts in place a regime 
which accomplishes three things.
  First, it creates a research and development initiative which is 
public and private, using the great strength of NIH, which is refocused 
under the leadership of Dr. Zerhouni and Dr. Fauci, which has refocused 
a large amount of their energy, time, and expertise on this issue. It 
combines that public effort, which is aggressive, with a private 
initiative.
  In order to get the private initiative going, it sets up a funding 
stream which makes it clear to the private sector that should they 
pursue development of vaccines or other ways to treat these agents 
which we see as the most threatening, whether it be anthrax, plague, 
smallpox, viral hemorrhagic fevers such as Ebola, or botulism, when 
they set up processes to address those diseases, whether it is a 
vaccine or whether it is something else, they will know there are going 
to be dollars in the pipeline to support that research and, more 
importantly, to purchase their product once they have produced it. And 
it will be purchased by the Government, obviously, because there is no 
market in the private sector for that.
  So along with the research component of having NIH focused on this 
and the private sector focused on this, this bill sets up a stockpiling 
and procurement procedure to make it clear that, first, once we develop 
these types of vaccines, we are going to have enough of them to be able 
to deal with a major attack. Second, the producers of these vaccines or 
other treatment processes developed--it might be a pharmaceutical--are 
going to be able to have adequate return on their investment so they 
can pay the cost of producing that and still make a reasonable return. 
Third, the bill sets up a process where, should the event occur, should 
we be attacked with some sort of an agent that we do not yet have the 
actual approved response to--don't have an approved vaccine--and it has 
not received all of the FDA clearing that vaccines must go through, 
which is a long, complicated process in order to approve a vaccine for 
human use, or approve a pharmaceutical, but should there be somewhere 
in the pipeline a vaccine which appears to have some success in 
remediating damage caused by one of these biological attacks, or a 
pharmaceutical which remediates that, and it is in the pipeline, we set 
up a procedure that allows, under certain very limited situations where 
there is a clear and obvious emergency, the administration to use that 
treatment that is in development for human consumption in order to 
confront an emergency situation where specifically we have been 
attacked.
  So that is the basic theme of the way this bill works. It creates the 
research component, the stockpiling and purchasing component, and 
creates an emergency outlet valve, if you will, for addressing a 
situation where we are attacked and we don't have a finalized product 
to address it.
  As the majority leader mentioned, of the six major areas of threat 
that we see in the biological area, today we only have vaccines to 
address two of them. One of the vaccine regimes is sort of difficult to 
deliver. That, of course, is in the anthrax area. We have, obviously, a 
very strong vaccine capability, and we are getting the production of 
new vaccines in the area of smallpox. Hopefully, people will get back 
to being vaccinated for smallpox because this is a legitimate threat. 
But in the area of plague, viral hemorrhagic fever, and botulism, there 
are no vaccines yet. That is why it is very important that we focus the 
resources, energy, and the genius of the American health community on 
making sure that we try to develop these types of responses.
  We are, regrettably, living in a world that has people who would do 
harm, who would pursue a course of inflicting massive harm for the 
purpose of making their political and quasi-religious point. It is an 
unfortunate fact. We need look no further than 9/11 to recognize that 
the killing of innocent people by the thousands is something that 
fundamentalist Islamic people, who ascribe to that belief, who are 
terrorists, basically are willing to pursue. We know that, regrettably, 
these biologic agents exist. Anthrax can be produced probably fairly 
easily if they have a chemistry background. We know it can be delivered 
and, regrettably, it was in the Capitol Building.
  We know that other types of agents can also be produced. Regrettably, 
there may even be a vial of smallpox somewhere out there that could be 
used. So it is critical, as the President has so appropriately stated, 
that we put into place the process for trying to, in this area, reduce 
the threat, and hopefully someday be able to totally mute the threat. 
Obviously, if we are capable as a culture of developing a vaccine or 
some other treatment that will neutralize the effect of these types of 
biological agents, then they will not be used against us because the 
harm they would cause would not be worth the risk of developing and 
spreading of the agent. So it is definitely in our interest to pursue 
this course.
  It is regrettable that it has taken us this long to get to this point 
from a legislative standpoint. But I congratulate the administration 
because they have not waited on us, the Congress. They have gone down 
the road as far as they think they can go toward letting contracts and 
putting into place the processes necessary to begin the development of 
these various vaccines and regimes necessary to address these risks. 
They have sort of come to a dead end, where they need this 
authorization in order to take the next steps necessary in the process 
of developing and expediting the process of getting these cures in 
place and the regimes in place.
  So this bill remains critical to our efforts in the fight on the war 
against terrorism. Therefore, it is good that we have finally been able 
to reach a consensus in the Senate, where we will be able to pass this 
bill later today. It is my understanding that the House of 
Representatives is likely to accept this bill as it passes the Senate. 
Hopefully, that will be the case, and we can move it down to the 
President, who I know has been waiting anxiously. He has talked to us 
many times about the need for this piece of legislation. This will be a 
good way, obviously, to complete this week.


                           Amendment No. 3178

  Mr. GREGG. Madam President, I send to the desk a substitute 
amendment.
  The PRESIDING OFFICER. The clerk will report the amendment.
  The legislative clerk read as follows:

       The Senator from New Hampshire [Mr. Gregg], for himself and 
     Mr. Kennedy, proposes an amendment numbered 3178.

  Mr. GREGG. Madam President, I ask unanimous consent that further 
reading of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The amendment is printed in today's Record under ``Text of 
Amendments.'')
  Mr. GREGG. Madam President, I thank the staff of the HELP Committee, 
Vincent Ventimiglia and Sharon Soderstrom, Steve Irizarry, and the 
other members of the staff who have done a great job in pulling this 
legislation together and following it through the process.

[[Page 10302]]

  It has been a complicated, tortured, difficult exercise. It would not 
have gotten to this point without strong and effective staff work. The 
country owes them a debt of gratitude.
  In the end, this bill is going to be one of the major components of 
our ability to protect ourselves as we move through this world that has 
such fundamentally evil individuals in it who might actually use this 
type of weapon against us or anyone else.
  There will also be some side benefits to this initiative. I honestly 
believe as we evolve various vaccines and initiate this research effort 
in trying to address issues such as anthrax and botulism and plague, we 
will actually have some spinoffs that will be positive in other health 
areas, and specifically in ways to deliver these types of vaccines in a 
less intrusive way. For example, anthrax has already gone from a six-
shot series down to a three-shot series. I understand there is 
significant progress being made toward having a single vaccination 
event, potentially, in the anthrax area. There is great progress being 
made that I think may pay dividends to the American people beyond just 
the fight on terrorism but in addressing other types of agents which 
need and require vaccines or pharmaceuticals.
  So this is a bill that not only is going to be a plus from the 
standpoint of fighting the war on terrorism but will be a plus from the 
standpoint of improving the health care delivery system in the United 
States, and specifically giving Americans better and more effective 
pharmaceuticals and vaccines.
  I reserve the remainder of our time.
  Madam President, I ask unanimous consent that at the conclusion or 
yielding back of time on S. 15, the bill be temporarily set aside, and 
the Senate then vote on passage at 2 p.m. today.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GREGG. Madam President, I ask that if we proceed to a quorum 
call, the time be charged equally to both sides.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GREGG. I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. BROWNBACK. Madam President, I ask unanimous consent that the 
order for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. BROWNBACK. Madam President, I ask unanimous consent to speak on 
the side of the proponent, Senator Gregg, for up to 7 minutes.
  The PRESIDING OFFICER (Mr. Hagel). Without objection, it is so 
ordered.
  Mr. BROWNBACK. Mr. President, I am here to address the Bioshield Act 
and particularly section 3 of that bill that directs the Secretary of 
Homeland Security on an ongoing basis to assess threats of use of 
chemical, biological, radiological, and nuclear agents and determine 
which threats pose a material risk of use against the U.S. population.
  I draw my colleagues' particular attention to what has recently been 
reported in the newspaper about one of the most recent uses of sarin 
gas that has occurred and its possibility of being used in the United 
States.
  I commend my colleagues for bringing this bill to the Senate, for a 
chance to talk about it. It is a very important issue. I see in this 
particular section our need to assess this. The discovery and 
confirmation of sarin gas in artillery shells in Iraq highlights 
evidence that Saddam Hussein had a weapons of mass destruction program 
that was not only fully operational but ready for use against U.S. 
troops.
  I raise this for two reasons. One, the argument that we have not been 
able to find WMD in Iraq is ongoing. I hope we will not dismiss the 
lack of any findings in the past and what we are finding now, the 
actual use of sarin gas against our troops. That should continue to be 
a focus that we hunt for, and we should be vigilant in looking for 
weapons of mass destruction, particularly chemicals such as sarin gas. 
But more importantly, Iraq had told the U.N. weapons inspection team 
they had produced tons of sarin gas and other chemical weapons. We 
should be concerned about where those are today and whether some of 
them may have found their way into Syria or other countries.
  I ask unanimous consent to have printed in the Record a news story 
that appeared today from Fox News.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                     [From Fox News, May 19, 2004]

              Tests Confirm Sarin in Iraqi Artillery Shell

                           (By Liza Porteus)

       New York.--Tests on an artillery shell that blew up in Iraq 
     on Saturday confirm that it did contain an estimated three or 
     four liters of the deadly nerve agent sarin (search), Defense 
     Department officials told Fox News Tuesday.
       The artillery shell was being used as an improvised 
     roadside bomb, the U.S. military said Monday. The 155-mm 
     shell exploded before it could be rendered inoperable, and 
     two U.S. soldiers were treated for minor exposure to the 
     nerve agent.
       Three liters is about three-quarters of a gallon; four 
     liters is a little more than a gallon.
       ``A little drop on your skin will kill you'' in the binary 
     form, said Ret. Air Force Col. Randall Larsen, founder of 
     Homeland Security Associates. ``So for those in immediate 
     proximity, three liters is a lot,'' but he added that from a 
     military standpoint, a barrage of shells with that much sarin 
     in them would more likely be used as a weapon than one single 
     shell.
       The soldiers displayed ``classic'' symptoms of sarin 
     exposure, most notably dilated pupils and nausea, officials 
     said. The symptoms ran their course fairly quickly, however, 
     and as of Tuesday the two had returned to duty.
       The munition found was a binary chemical shell, meaning it 
     featured two chambers, each containing separate chemical 
     compounds. Upon impact with the ground after the shell is 
     fired, the barrier between the chambers is broken, the 
     chemicals mix and sarin is created and dispersed.
       Intelligence officials stressed that the compounds did not 
     mix effectively on Saturday. Due to the detonation, burn-off 
     and resulting spillage, it was not clear exactly how much 
     harmful material was inside the shell.
       A 155-mm shell can hold two to five liters of sarin; three 
     to four liters is likely the right number, intelligence 
     officials said.
       Another shell filled with mustard gas (search), possibly 
     also part of an improvised explosive device (IED) was 
     discovered on May 2, Defense Dept. officials said.
       The second shell was found by passing soldiers in a median 
     on a thoroughfare west of Baghdad. It probably was simply 
     left there by someone, officials said, and it was unclear 
     whether it was meant to be used as a bomb.
       Testing done by the Iraqi Survey Group (search)--a U.S.-
     organized group of weapons inspectors who have been searching 
     for weapons of mass destruction (search) since the ouster of 
     Saddam Hussein--concluded that the mustard gas was ``stored 
     improperly'' and was thus ``ineffective.''
       ``It's not out of the ordinary or unusual that you would 
     find something [like these weapons] in a haphazard fashion'' 
     in Iraq, Edward Turzanski, a political and national security 
     analyst, told Fox News on Tuesday.
       But ``you have to be very careful not to be entirely 
     dismissive of it,'' he added. ``It remains to be seen whether 
     they have more shells like this.''


                     Iraq: A ``Bazaar of Weapons''

       New weapons caches are being found every day, experts said, 
     including ``hundreds of thousands'' of rocket-propelled 
     grenades and portable anti-aircraft weapons.
       ``Clearly, if we're gonna find one or two of these every so 
     often--used as an IED or some other way--the threat is not 
     all that high, but it does confirm suspicion that he [Saddam] 
     did have this stuff,'' said Ret. U.S. Army Col. Robert 
     Maginnis.
       ``It is a bazaar of weapons that are available on every 
     marketplace throughout that country,'' Maginnis added. 
     ``We're doing everything we can to aggressively disarm these 
     people, but there were so many things that were stored away 
     by Saddam Hussein in that country . . . it's a huge job that 
     we're tackling.''
       Some experts were concerned that enemy fighters with access 
     to potential weapons of mass destruction in a country full of 
     stockpiles could mean more risk to coalition forces and 
     Iraqis.
       ``What we don't know is if there are other shells, which 
     there certainly could be,'' said Dennis Ross, a former 
     ambassador and special Middle East coordinator and a Fox News 
     foreign affairs analyst. ``We also don't know whether or not 
     these kind of shells could be used as explosives, which could 
     have a more devastating effect on our troops.''
       Other experts said the individual shells themselves don't 
     pose a threat to the masses.
       ``I'm not as concerned they're going to use a lot of 
     chemical munitions,'' Maginnis said. ``They're not gonna use 
     these as improvised explosive devices because they don't have 
     a

[[Page 10303]]

     big blast associated with them, but they do combine those two 
     compounds into the noxious sarin gas. But they can't do it 
     all that well with a small explosive charge.''
       ``The reality is, they'd have to have a whole bunch of 
     these things,'' he added, ``have to find some way of blowing 
     them with a large charge to even create a cloud.''
       That doesn't mean insurgents couldn't find a better way to 
     make the devices to create a more ``terrorist-type of 
     attack'' against U.S. forces, Maginnis continued.
       The task of military analysts in Baghdad will be determine 
     how old the sarin shells is. A final determination will have 
     a significant effect on how weapons researchers and 
     inspectors proceed.
       Some experts suggested that the two shells, which were 
     unmarked, date back to the first Persian Gulf War. The 
     mustard gas shell may have been one of 550 projectiles that 
     Saddam failed to account for in his weapons declaration 
     shortly before Operation Iraqi Freedom began. Iraq also 
     failed to account for 450 aerial bombs containing mustard 
     gas.
       It's not clear if enemy fighters simply found an old 
     stockpile of weapons, or if they even knew what was inside.
       Defense Secretary Donald Rumsfeld reacted cautiously to the 
     news of the discoveries.
       ``What we have to then do is to try to track down and 
     figure out how it might be there, what caused that to be 
     there in this improvised explosive device, and what might it 
     mean in terms of the risks to our forces,'' Rumsfeld said 
     Monday.


                     Kurds: We Have Evidence of WMD

       An Iraqi Kurdish official had no doubt similar substances 
     will be found as the weapons hunt continues.
       ``We don't know where they are, but we suspect they are 
     hidden in many locations in Iraq,'' Howar Ziad, the Kurdish 
     representatives to the United Nations, told Fox News on 
     Tuesday. ``It's quite possible that even the neighboring 
     states who are against the reform of Iraq . . . are helping 
     the Saddamites in hiding.''
       ``As we know, the Baathist regime had a track record of 
     using'' these chemicals against people in Iraq, such as the 
     Kurds, Ziad continued. ``He's [Saddam] never kept any 
     commitment he's ever made to the international committee nor 
     to the people'' to not use such deadly materials.
       Saddam's regime used sarin in mass amounts during an air 
     attack on the Kurdish town of Halabja (search) in 1988, 
     toward the end of the Iran-Iraq War. More than 5,000 people 
     are believed to have died in Halabja and surrounding 
     villages, where more than 65,000 were injured.
       Both Iraq and Iran used chemical weapons during the 1980-88 
     war.
       Ziad said the United Nations, the World Health Organization 
     and others had not ``bothered'' to travel to the Iraqi 
     Kurdistan to see the firsthand effects sarin and other 
     chemical weapons had on people and to get proof that Saddam 
     did in fact possess such weapons.
       ``We have evidence--we have victims of the use of those 
     agents, and we're still waiting for WHO and the U.N. to come 
     investigate,'' Ziad said.

  Mr. BROWNBACK. I will read portions of this news story, dated today, 
Fox News:

       Tests on an artillery shell that blew up in Iraq on 
     Saturday confirmed that it did contain an estimated three or 
     four liters of the deadly nerve agent sarin.

  This has been confirmed by Defense Department officials. This is 
obviously a danger to our troops. It is obviously of great concern to 
us if this were to find its way into the United States.
  I will read from retired United States Army COL Robert Maginnis:

       Clearly, if we're gonna find one or two of these every so 
     often--used as an IED or some other way--the threat is not 
     all that high, but it does confirm suspicion that he [Saddam] 
     did have this stuff.

  He goes on to say this:

       It is a bazaar of weapons that are available on every 
     market place through that country. We're doing everything we 
     can to aggressively disarm these people but there are so many 
     things that were stored away by Saddam Hussein in that 
     country . . . it's a huge job that we're tackling.

  This next quote is from Dennis Ross, the former Ambassador, special 
envoy to the Middle East, a well-known figure on Middle East peace 
negotiations that took place:

       What we don't know is if there are other shells which there 
     certainly could be.

  He goes on to say:

       We also don't know whether or not these kinds of shells 
     could be used as explosives, which could have a more 
     devastating effect on our troops.

  A final quote for the Record from this story:

       Saddam's regime used sarin gas in mass amounts during an 
     air attack on the Kurdish town of Halabja in 1988, toward the 
     end of the Iran-Iraq War. More than 5,000 people are believed 
     to have died in Halabja and surrounding villages, with more 
     than 65,000 injured.

  This is deadly stuff. It exists. We are now finding it. We need to be 
aware of that as we move forward with this bioshield bill.
  Earlier this week the Wall Street Journal reported that U.S. 
inspectors found within the last few months ``warehouses full of 
commercial and agricultural chemicals'' which, if mixed and packaged 
properly, ``could quickly become chemical weapons.'' U.S. forces in 
Karbala have uncovered 55-gallon drums loaded with chemicals that were 
said to be ``pesticides,'' some of which were stored in what military 
sources described as a camouflaged bunker complex. Why would anyone 
camouflage insecticide?
  According to another article, the alleged agricultural site just 
happened to be located alongside a military ammunition dump. Why are we 
storing insecticide by a military ammunition dump?
  According to the Journal, the Iraq Survey Group, headed by Charles 
Duelfer, recently told Congress that some of Saddam's WMD facilities 
were newly built and contained stockpiled raw materials that would have 
allowed them to ``produce such weapons on a moment's notice.''
  If I recall, in early April, Jordanian authorities foiled an al-Qaida 
plot to kill 80,000 people in a chemical weapons attack in Amman.
  According to one of the conspirators whose confession was broadcast 
on Jordanian TV, al-Qaida WMD specialist Abu Musab al-Zarqawi, who was 
last seen in that chilling video beheading Nick Berg, trained and 
outfitted the WMD attackers in prewar Iraq. Like notorious terrorists 
Abu Nidal and Abu Abi Abbas, Zarqawi enjoyed sanctuary in Baghdad, 
courtesy of Saddam Hussein. Jordanian coverage of the plot included 
footage of 100-gallon jugs containing chemical weapons that had been 
intercepted 75 miles from the Syrian border where much of Saddam 
Hussein's prewar WMD stockpiles are believed to be hidden.
  The Zarqawi revelation comes on the heels of the April 26 explosion 
at a suspected chemical weapons factory in Baghdad just as a U.S. 
weapons team arrived to inspect its contents. This was disguised as ``a 
perfume factory,'' and the facility was boobytrapped to destroy 
evidence, investigators believe, of whatever was inside.
  We should not be surprised if, within the coming weeks, more sarin-
laden shells are uncovered in Iraq. In the meantime, we should focus on 
this and get coverage on what is taking place and what has been found 
of this deadly sarin gas.
  I note that Secretary Ridge, Homeland Security Department, has been 
warning of an increased risk of attack in coming months. In light of 
what we found in Iraq, it would not be farfetched to say if al-Qaida 
wants to strike on U.S. soil, it would likely be with a chemical or 
biological weapon, something other than a conventional explosive.
  In a recent interview with the Associated Press, retired LTG Patrick 
Hughes said that America has gotten better at predicting and 
safeguarding itself against attacks since September 11, but still 
Lieutenant General Hughes indicated that significant threats remain, 
especially now as high ``background noise'' from terrorists and 
heightened sensitivity during the election year has officials on guard 
for a possible attack whose nature they cannot quite pin down.
  Based on captured material, interviews, and other sources of 
information, Lieutenant General Hughes believes that al-Qaida will 
likely strike with something other than a conventional explosive 
device. He is particularly worried about chemical and biological 
attacks, including a dirty bomb, and particularly points to the 
possibility of another anthrax biological attack following the one that 
wreaked havoc on the postal system, closed a Senate office building for 
3 months, and killed five people in 2001.
  We first heard about sarin gas in an attack at a Japanese subway 
where twelve people died. It is a potent weapon in which a little drop 
on your skin will kill you. Sarin gas was confirmed

[[Page 10304]]

in the 155-mm shell and contained an estimated 3 or 4 liters. 
Fortunately, the two soldiers who may have been exposed are now safe 
and are returned to duty. They did show signs of being hit by chemical 
weapons, but it was a mild case and they are back on duty. This could 
have ended in tragedy had our soldiers not been more vigilant.
  I hope we will continue to be focused on finding these weapons of 
mass destruction, particularly before they find their way to our shores 
so we can make sure our troops are safe and that such weapons do not 
find their way here to the United States. I believe my colleagues' bill 
will go a long way toward securing that goal. I urge its immediate 
passage.
  I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. KENNEDY. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Mr. President, I strongly support the Project Bioshield 
Act. It is an essential part of our Nation's ability to respond 
effectively to the threat of terrorist attacks that use biological or 
chemical weapons.
  I commend Senators Gregg, Frist, Reed, and other members of our HELP 
Committee for their efficient and effective bipartisan work on this 
bill, and I thank Senator Levin for his expertise and thoughtful 
considerations.
  I also commend our colleagues on the Appropriations Committee, and 
especially the chairman, Senator Stevens, and the ranking member, 
Senator Byrd, for already providing the funding that Project Bioshield 
needs to be effective. Their leadership is essential in protecting the 
Nation.
  We have worked closely, too, with Secretary Tommy Thompson and CMS 
Administrator Mark McClellan on this important legislation. They 
deserve great credit for their leadership as well.
  The Project Bioshield Act is an important addition to the Public 
Health Security and Bioterrorism Preparedness and Response Act that we 
passed 2 years ago. Since that major legislation was enacted, we have 
seen new examples of the vicious impact of terrorism around the world. 
The brutal pictures from the appalling bomb attack in Madrid and the 
horrifying images of other terror attacks around the world are savage 
reminders that we must never let down our guard.
  The will to protect the Nation from terrorism is not enough. We must 
also provide the resources and the means. Bioshield is a major step 
toward giving the Nation's health care professionals the support they 
need to respond to attacks of biological, chemical, and nuclear 
weapons.
  A terrorist armed with a vial of a deadly pathogen could inflict pain 
and death on a vast scale. For too many of the weapons we face, our 
defenses are inadequate. The Nation needs better vaccines and drugs to 
fight ancient enemies such as smallpox or new plagues launched by 
genetically modified disease bacteria.
  The members of our HELP Committee have worked together to help 
America's skilled physicians and scientists develop the vaccines, the 
diagnostic tests, and treatments needed to meet these disease 
challenges. Clearly, new legislation is needed to improve America's 
defensive arsenal against these threats.
  The current bill will help guide the talents of America's medical 
researchers and biotechnology industry in building the stronger medical 
defenses we need to keep families safe from bioterrorism.
  I am proud that Boston is, once again, leading the way in developing 
pioneering new biodefense countermeasures. We have taken steps to 
expedite the discovery of new vaccines and cures needed to protect the 
Nation.
  This chart is a statement about this overall legislation:

       Bioshield will accelerate the development of new vaccines, 
     treatments and diagnostics to keep America safe from 
     biological, chemical and radiological weapons.

  The fact remains that there is little commercial interest in the 
development of countermeasures, because they will only be used in the 
event of some kind of assault or attack on the United States. 
Nonetheless, we need to develop these vaccines and the various 
treatments for treating these kinds of dangers because we may very well 
face them. If we are going to be serious about dealing with biodefense 
and bioterrorism, this is a very important part of the whole process.
  Harvard Medical School has worked with other academic centers to 
create a New England Regional Center for Excellence for Biodefense. The 
new center will be the incubator for innovative ideas for treatments of 
the future. The Boston University Medical Center is building a major 
new laboratory to enable these pioneering new treatments be tested in a 
safe and secure research facility.
  At the new laboratory, researchers from across America will be able 
to help turn promising new ideas into treatments to help patients. NIH 
has recognized the excellence of the center and the laboratory by 
making substantial investments in their development. The Project 
Bioshield will help complete this pipeline of discovery by harnessing 
the creativity and the skill of the flourishing biotechnology industry.
  The legislation will ensure companies know that investing in new 
responses for bioterrorist attacks is a risk worth taking. The bill 
before the Senate guarantees that any company which develops a 
successful new product for these threats will find a willing buyer in 
the Federal Government. With that guarantee, companies will make the 
investments needed to prepare for any attack. Without that guarantee, 
they will not. It is as simple as that.
  The act will accomplish several other important goals. It will 
streamline and accelerate the research at NIH on bioterrorism and other 
weapons of mass destruction. The most effective weapons in the war 
against biological and chemical attacks are often the skills of our 
health professionals and the ingenuity of our scientists. The new 
flexibility for NIH under this legislation will help use these 
extraordinary talents in the search for new responses.
  The act will also encourage the biotechnology, pharmaceutical, and 
medical device industries to use their creativity to develop 
countermeasures against the dangerous pathogens and chemical or 
radioactive agents. In addition, it authorizes the Food and Drug 
Administration to allow the emergency use of unapproved medicines when 
needed to deal with such attacks.
  The authorization for the emergency use of unapproved products also 
includes strong provisions on informed consent for patients and limits 
the scope of products that can qualify for emergency authorization. The 
FDA must carefully monitor adverse reactions to unapproved products and 
must require the recordkeeping and studies necessary to assure the 
safest possible use of these products.
  The enactment of the Project BioShield Act is a significant 
accomplishment, but there is much more work to be done.
  This is a brief outline of what this legislation is all about. It 
establishes the $5.6 billion fund as a guaranteed market for the new 
biodefense products, and it ensures that the Departments of Homeland 
Security and HHS set priorities in developing medicines for the threats 
that America faces. So you combine intelligence about the nature of the 
threat with expertise from HHS to set the priorities in developing 
medicines.
  It gives NIH, the gold standard in terms of research throughout the 
world, much needed flexibility to ensure promising research areas can 
advance quickly. Finally, it allows the FDA to authorize the emergency 
use of medicines under the tightly controlled conditions outlined in 
this legislation.
  The most sophisticated disease monitoring system will be of little 
use if public health agencies are so starved of funds that they cannot 
keep our communities safe.
  I want to take a few moments of the Senate's time to look at the 
progress for bioterror preparedness.

[[Page 10305]]

  This is taken from a GAO study from February 10 of this year. It 
says:

       No State reported meeting what they call the third 
     benchmark, a plan for the hospitals in the State to respond 
     to an epidemic involving at least 500 patients.

  This is extraordinary. On the one hand, dealing with bioterrorism we 
have to be able to detect and contain it, and then we have to be able 
to treat people. That is where BioShield can be enormously effective. 
But if we are going to be able to contain and treat a bioterror attack, 
we must be able to deal with it in our medical centers. What we are 
finding out now, as we review our preparedness, is that we are not 
making the progress that is absolutely essential to protect 
communities.
  Report after report shows that we are falling short in preparing our 
defenses against the threat of bioterrorism. The GAO conducted a 
detailed analysis of the readiness of hospitals for such attacks. How 
many communities do you think have plans--just plans to be able to 
treat a surge of 500 additional patients in a terrorism emergency? 
Would you say 75 percent? 50 percent? Only 25 percent? No, you would be 
wrong. The correct answer is none. Zero! Not a single community in the 
GAO survey had a plan to treat an additional 500 patients. That is 
basic--and none of the communities in the GAO survey could do it. That 
is a situation that has to be remedied.
  An expert panel assembled by the Trust for America's Health conducted 
an analysis of the readiness for bioterrorism of public health agencies 
in all 50 States. They examined 10 key indicators of readiness, such as 
adequate laboratory capacity to respond to bioterrorism emergencies. 
How many States do you think were fully prepared? The answer, again, 
shockingly, is none.
  This chart shows the different grades of States in bioterror 
preparedness. The highest we find is 7 out of 10. That would be the 
green. That includes California, Florida, Tennessee, and Maryland. But 
if you look at most of this chart you will see it is red or pink, which 
means they have only 2 or 3 of the 10 required actions necessary to be 
successful in dealing with bioterrorism. You need to have laboratories, 
hospital capacity and, as mentioned before in Bioshield, the basic 
medicines to treat the victims.
  The Institute of Medicine in 2003 found that America's health 
agencies have ``vulnerable and outdated health information systems and 
technologies, an insufficient and inadequately trained public health 
workforce, antiquated laboratory capacity, a lack of realtime 
surveillance in epidemiological systems, an ineffective and fragmented 
communications network, incomplete domestic preparedness and emergency 
response capabilities, and communities without access to essential 
public health services.''
  That is really the challenge. If we talk about homeland security, 
this is a key aspect in ensuring homeland security. It is a challenge 
we have to address. That puts the Project BioShield Act in an ominous 
perspective. It is a large step in the right direction, but without a 
commitment to adequately fund our hospitals and our health agencies, 
genuine preparedness and effective homeland security will still be far 
from what is needed.
  I urge my colleagues in approving this important bipartisan 
legislation to also do what it takes to see that our hospitals and 
health agencies have the resources they need to use the new tools that 
BioShield gives them. We don't know how much time we have, but we do 
know we have to get the job done and do it as quickly as we can.
  Mr. President, I want to take a moment to thank a number of our 
colleagues' staffs who have worked tirelessly in this endeavor over the 
period of these last 2 years. This has been an enormous effort on the 
part of many of them. They have done an extraordinary job working this 
through.
  The passage of the BioShield legislation owes much to the hard work 
and skill of dedicated staff members on both sides of the aisle in the 
Senate and the House of Representatives, and in the administration too.
  I would like to take a moment to thank the effective and skillful 
work of Senator Gregg's staff, particularly Vince Ventimiglia and Steve 
Irizarry. Their expertise was helpful in so many ways. I also want to 
thank Craig Burton of Senator Frist's staff for his effective work on 
the legislation.
  Our Republican colleagues on the House Commerce and Homeland Security 
committees were ably assisted by Tom DiLenge and Nandan Kenkeremath. 
John Ford worked tirelessly on behalf of the many Democratic Members 
with an interest in this legislation.
  I also commend many senior staff in the Department of Health and 
Human Services for their work in seeing this important legislation 
enacted. We owe particular thanks to Stewart Simonsen, the Assistant 
Secretary for Public Health Preparedness, as well as Raissa Downs, Ken 
Bernard and Scott Whitaker from the Office of the Secretary, and Amit 
Sachdev of the FDA.
  Staff members from many Democratic Senators made numerous helpful 
contributions to the success of this legislation. I would like to thank 
Peter Levine and Gary Leeling from Senator Levin's staff, as well as 
Lisa German from Senator Reed's staff. I would also like to thank my 
health staff, particularly David Nexon, David Bowen, David Dorsey and 
Paul Kim for their excellent work on this legislation.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. GREGG. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GREGG. Mr. President, I ask that my substitute amendment be 
accepted.
  The PRESIDING OFFICER. Under the previous order, the amendment is 
agreed to.
  The amendment (No. 3178) was agreed to.
  The PRESIDING OFFICER. Under the previous order, the committee 
substitute amendment, as amended, is agreed to.
  The committee amendment, in the nature of a substitute, as amended, 
was agreed to.


                           bioshield funding

  Mr. GREGG. Mr. President, I appreciate the hard work and cooperation 
of many of my colleagues to build a program to protect Americans from 
bioterrorism. I am grateful to Senator Cochran for his work last year 
to ensure that adequate funds were provided in advance to incentivize 
the immediate development of countermeasures. I also commend Senator 
Nickles for his efforts to safeguard these funds and ensure that they 
remain available solely for the intended purpose of protecting our 
citizens from biological attack.
  Mr. COCHRAN. I was pleased to work with the administration and my 
colleagues on the Appropriations Committee to secure funding for the 
program. It is my intention that any unobligated balances of funds 
appropriated for project BioShield remain available until expended, as 
the law requires, to ensure that the program has adequate resources in 
fiscal year 2005 to continue developing necessary countermeasures.
  Mr. NICKLES. I appreciate the leadership of my colleague from 
Mississippi in this effort, and agree that the funds should remain 
dedicated to the rapid development of effective countermeasures against 
emerging threats.
  Mr. BYRD. Mr. President, I commend Senators Gregg and Kennedy for 
their hard work in bringing this important legislation to the floor. I 
share in their commitment to protect Americans from bio-terrorism. Last 
year, I worked with Senator Cochran, the chairman of the Homeland 
Security Subcommittee of the Senate Appropriations Committee, to 
develop an extraordinary funding mechanism for the funding of Project 
Bioshield. The Congress approved $5.6 billion of advanced 
appropriations to create incentives for the development of vaccines, 
pharmaceuticals and other countermeasures for responding to a potential 
terrorist

[[Page 10306]]

attack. This funding demonstrated a strong commitment to implementing 
this important program.
  During debate on the budget resolution, the Senate approved an 
amendment offered by Senator Cochran and myself that struck from the 
resolution a provision that would have established different rules in 
the House and Senate for the treatment of Project Bioshield funding. I 
believe such a provision would have created confusion and potentially 
undermined future funding for homeland security programs.
  Is it the understanding of the Senator from New Hampshire that no 
such provision will be included in the final version of this 
legislation that will be presented to the President?
  Mr. GREGG. I thank the Senator from West Virginia for his cooperation 
and appreciate his efforts to help secure funding for this important 
program. While I am unable to guarantee an outcome in conference, I 
have no intention of including this provision and I will work to ensure 
that no such provision will be included in the bill presented to the 
President.
  Mr. BYRD. Is it also his understanding that no such provision, which 
is in neither the House nor Senate-passed budget resolutions, will be 
included in a conference report on the budget resolution?
  Mr. GREGG. I have discussed this with the chairman of the Budget 
Committee and the Senator's understanding is correct that no such 
provision will be included.
  Mr. BYRD. I thank the chairman for his assurances and cooperation in 
this matter and I commend both he and Senator Kennedy for their 
cooperation in bringing to the Senate this important legislation.


                          purchase of vaccines

  Mr. LEVIN. Mr. President, I would like to clarify the understanding 
of the managers of this bill with regard to the restriction in section 
319F-2(c)(9), as amended by the Gregg-Kennedy amendment, on the use of 
Bioshield funds from paying the costs for purchase of vaccines under 
procurement contracts entered into before the date of enactment. Is it 
the understanding of the bill's managers that this restriction would 
not apply to the purchase of additional doses of vaccines otherwise 
qualifying as security countermeasures if they are acquired under 
either new contracts or modifications to existing contracts to increase 
the numbers of doses to be procured for the Strategic National 
Stockpile?
  Mr. GREGG. I thank the Senator for his question. That is my 
understanding.
  Mr. KENNEDY. I agree with the Senator from Michigan and the Senator 
from New Hampshire that that is my understanding of the provision. 
However, it is also my understanding that the primary intent of the 
Bioshield program is to accelerate the development of new products 
rather than providing an additional funding source to pay for products 
developed prior to the enactment of the legislation.


                          special reserve fund

  Mr. KENNEDY. Mr. President, I commend the leadership of our 
distinguished chairman in bringing the Bioshield legislation to the 
Senate floor. I am optimistic that our colleagues will approve this 
urgently needed legislation. I would like to clarify with the chairman 
the intent behind one of the key provisions in the legislation.
  Would the chairman agree that as we have considered this legislation 
during our bipartisan and bicameral negotiations, it has been clear 
that the congressional intent is for the Bioshield special reserve fund 
to be one option for the Secretary with respect to procuring 
countermeasures against chemical, biological, radiological, or nuclear 
agents. A second option is ordinary appropriations for the stockpile 
outside of the special reserve fund. It is clear though that we expect 
that the Secretary will endeavor not to use the Bioshield special 
reserve fund as a substitute for the commercial market in procuring 
such countermeasures.
  Mr. GREGG. I thank my colleague from Massachusetts for his comments. 
I agree that his statements reflect the intent of Congress regarding 
the use of the Bioshield special reserve fund.
  Mr. LEVIN. Mr. President, I come to the floor today to express my 
support for the Project Bioshield legislation. This bill will make an 
important contribution to our Nation's preparedness by authorizing the 
expenditure of $5.6 billion from fiscal year 2004 to fiscal year 2013 
for the procurement of biomedical countermeasures for inclusion in a 
Strategic National Stockpile. Project Bioshield will bolster the 
Nation's ability to provide protections and countermeasures against 
biological, chemical, radiological, and nuclear agents that may be used 
in a terrorist attack. It includes provisions to facilitate research 
and development of biomedical countermeasures by the National 
Institutes of Health; to provide for procurement of needed 
countermeasures through a special reserve fund and to authorize, under 
limited circumstances, the emergency use of medical products that have 
not been approved by the Food and Drug Administration.
  I am pleased that the final version of the bill requires that any 
bioshield contract be awarded pursuant to full and open competition 
unless the Secretary determines that the mission of the bioshield 
program would be seriously impaired by this requirement. This provision 
ensures that the bioshield program, like other Federal programs, will 
be subject to governmentwide competition requirements.
  I am also pleased that the final version of the bill will not make it 
more likely that military personnel will be required to take unapproved 
products without their consent. This subject has been addressed in an 
appropriate manner in the National Defense Authorization Act for Fiscal 
Year 2005, which is being debated on the Senate floor right now.
  This legislation will help to better prepare our Nation and bolster 
our critical infrastructure to help us deal effectively with terrorist 
attacks. The mailing of anthrax and ricin tainted letters to Capitol 
Hill and other locations in 2001 and 2004, respectively, have 
highlighted our Nation's weaknesses in this area of biodefense. Now 
Project Bioshield will help give us the tools we need to develop 
appropriate countermeasures and combat bioterrorism more effectively.
  The PRESIDING OFFICER. The question is on the engrossment and third 
reading of the bill.
  The bill was ordered to be engrossed for a third reading and was read 
the third time.
  Mr. GREGG. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The bill having been read the third time, the question is, Shall the 
bill, as amended, pass?
  The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. REID. I announce that the Senator from Massachusetts (Mr. Kerry) 
is necessarily absent.
  The PRESIDING OFFICER (Mr. Sununu). Are there any other Senators in 
the Chamber desiring to vote?
  The result was announced--yeas 99, nays 0, as follows:

                      [Rollcall Vote No. 99 Leg.]

                                YEAS--99

     Akaka
     Alexander
     Allard
     Allen
     Baucus
     Bayh
     Bennett
     Biden
     Bingaman
     Bond
     Boxer
     Breaux
     Brownback
     Bunning
     Burns
     Byrd
     Campbell
     Cantwell
     Carper
     Chafee
     Chambliss
     Clinton
     Cochran
     Coleman
     Collins
     Conrad
     Cornyn
     Corzine
     Craig
     Crapo
     Daschle
     Dayton
     DeWine
     Dodd
     Dole
     Domenici
     Dorgan
     Durbin
     Edwards
     Ensign
     Enzi
     Feingold
     Feinstein
     Fitzgerald
     Frist
     Graham (FL)
     Graham (SC)
     Grassley
     Gregg
     Hagel
     Harkin
     Hatch
     Hollings
     Hutchison
     Inhofe
     Inouye
     Jeffords
     Johnson
     Kennedy
     Kohl
     Kyl
     Landrieu
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lincoln
     Lott
     Lugar
     McCain
     McConnell
     Mikulski
     Miller
     Murkowski
     Murray
     Nelson (FL)
     Nelson (NE)
     Nickles
     Pryor
     Reed
     Reid
     Roberts
     Rockefeller
     Santorum
     Sarbanes
     Schumer
     Sessions
     Shelby
     Smith
     Snowe
     Specter
     Stabenow
     Stevens
     Sununu
     Talent
     Thomas
     Voinovich
     Warner
     Wyden

[[Page 10307]]



                             NOT VOTING--1

       
     Kerry
       
  The bill (S. 15), as amended, was passed.
  Mr. WARNER. Mr. President, I move to reconsider the vote.
  Mr. REID. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The amendment (No. 3180) was agreed to, as follows:


                           amendment no. 3180

               (Purpose: To amend the title of the bill)

       Amend the title so as to read: To amend the Public Health 
     Service Act to provide protections and countermeasures 
     against chemical, radiological, or nuclear agents that may be 
     used in a terrorist attack against the United States by 
     giving the National Institutes of Health contracting 
     flexibility, infrastructure improvements, and expediting the 
     scientific peer review process, and streamlining the Food and 
     Drug Administration approval process of countermeasures.''.

                          ____________________