[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 15 Engrossed in Senate (ES)]

  
  
  
  
  
  
  
  
  
  
  
  
108th CONGRESS
  2d Session
                                 S. 15

_______________________________________________________________________

                                 AN ACT


 
   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.

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

SECTION 1. SHORT TITLE.

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

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

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

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

    ``(a) In General.--
            ``(1) Authority.--In conducting and supporting research and 
        development activities regarding countermeasures under section 
        319F(h), the Secretary may conduct and support such activities 
        in accordance with this section and, in consultation with the 
        Director of the National Institutes of Health, as part of the 
        program under section 446, if the activities concern qualified 
        countermeasures.
            ``(2) Qualified countermeasure.--For purposes of this 
        section, the term `qualified countermeasure' means a drug (as 
        that term is defined by section 201(g)(1) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological 
        product (as that term is defined by section 351(i) of this Act 
        (42 U.S.C. 262(i))), or device (as that term is defined by 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h))) that the Secretary determines to be a priority 
        (consistent with sections 302(2) and 304(a) of the Homeland 
        Security Act of 2002) to--
                    ``(A) treat, identify, or prevent harm from any 
                biological, chemical, radiological, or nuclear agent 
                that may cause a public health emergency affecting 
                national security; or
                    ``(B) treat, identify, or prevent harm from a 
                condition that may result in adverse health 
                consequences or death and may be caused by 
                administering a drug, biological product, or device 
                that is used as described in subparagraph (A).
            ``(3) Interagency cooperation.--
                    ``(A) In general.--In carrying out activities under 
                this section, the Secretary is authorized, subject to 
                subparagraph (B), to enter into interagency agreements 
                and other collaborative undertakings with other 
                agencies of the United States Government.
                    ``(B) Limitation.--An agreement or undertaking 
                under this paragraph shall not authorize another agency 
                to exercise the authorities provided by this section.
            ``(4) Availability of facilities to the secretary.--In any 
        grant, contract, or cooperative agreement entered into under 
        the authority provided in this section with respect to a 
        biocontainment laboratory or other related or ancillary 
        specialized research facility that the Secretary determines 
        necessary for the purpose of performing, administering, or 
        supporting qualified countermeasure research and development, 
        the Secretary may provide that the facility that is the object 
        of such grant, contract, or cooperative agreement shall be 
        available as needed to the Secretary to respond to public 
        health emergencies affecting national security.
            ``(5) Transfers of qualified countermeasures.--Each 
        agreement for an award of a grant, contract, or cooperative 
        agreement under section 319F(h) for the development of a 
        qualified countermeasure shall provide that the recipient of 
        the award will comply with all applicable export-related 
        controls with respect to such countermeasure.
    ``(b) Expedited Procurement Authority.--
            ``(1) Increased simplified acquisition threshold for 
        qualified countermeasure procurements.--
                    ``(A) In general.--For any procurement by the 
                Secretary of property or services for use (as 
                determined by the Secretary) in performing, 
                administering, or supporting qualified countermeasure 
                research or development activities under this section 
                that the Secretary determines necessary to respond to 
                pressing research and development needs under this 
                section, the amount specified in section 4(11) of the 
                Office of Federal Procurement Policy Act (41 U.S.C. 
                403(11)), as applicable pursuant to section 302A(a) of 
                the Federal Property and Administrative Services Act of 
                1949 (41 U.S.C. 252a(a)), shall be deemed to be 
                $25,000,000 in the administration, with respect to such 
                procurement, of--
                            ``(i) section 303(g)(1)(A) of the Federal 
                        Property and Administrative Services Act of 
                        1949 (41 U.S.C. 253(g)(1)(A)) and its 
                        implementing regulations; and
                            ``(ii) section 302A(b) of such Act (41 
                        U.S.C. 252a(b)) and its implementing 
                        regulations.
                    ``(B) Application of certain provisions.--
                Notwithstanding subparagraph (A) and the provision of 
                law and regulations referred to in such subparagraph, 
                each of the following provisions shall apply to 
                procurements described in this paragraph to the same 
                extent that such provisions would apply to such 
                procurements in the absence of subparagraph (A):
                            ``(i) Chapter 37 of title 40, United States 
                        Code (relating to contract work hours and 
                        safety standards).
                            ``(ii) Subsections (a) and (b) of section 7 
                        of the Anti-Kickback Act of 1986 (41 U.S.C. 
                        57(a) and (b)).
                            ``(iii) Section 304C of the Federal 
                        Property and Administrative Services Act of 
                        1949 (41 U.S.C. 254d) (relating to the 
                        examination of contractor records).
                            ``(iv) Section 3131 of title 40, United 
                        States Code (relating to bonds of contractors 
                        of public buildings or works).
                            ``(v) Subsection (a) of section 304 of the 
                        Federal Property and Administrative Services 
                        Act of 1949 (41 U.S.C. 254(a)) (relating to 
                        contingent fees to middlemen).
                            ``(vi) Section 6002 of the Solid Waste 
                        Disposal Act (42 U.S.C. 6962).
                            ``(vii) Section 1354 of title 31, United 
                        States Code (relating to the limitation on the 
                        use of appropriated funds for contracts with 
                        entities not meeting veterans employment 
                        reporting requirements).
                    ``(C) Internal controls to be instituted.--The 
                Secretary shall institute appropriate internal controls 
                for procurements that are under this paragraph, 
                including requirements with regard to documenting the 
                justification for use of the authority in this 
                paragraph with respect to the procurement involved.
                    ``(D) Authority to limit competition.--In 
                conducting a procurement under this paragraph, the 
                Secretary may not use the authority provided for under 
                subparagraph (A) to conduct a procurement on a basis 
                other than full and open competition unless the 
                Secretary determines that the mission of the BioShield 
                Program under the Project BioShield Act of 2004 would 
                be seriously impaired without such a limitation.
            ``(2) Procedures other than full and open competition.--
                    ``(A) In general.--In using the authority provided 
                in section 303(c)(1) of title III of the Federal 
                Property and Administrative Services Act of 1949 (41 
                U.S.C. 253(c)(1)) to use procedures other than 
                competitive procedures in the case of a procurement 
                described in paragraph (1) of this subsection, the 
                phrase `available from only one responsible source' in 
                such section 303(c)(1) shall be deemed to mean 
                `available from only one responsible source or only 
                from a limited number of responsible sources'.
                    ``(B) Relation to other authorities.--The authority 
                under subparagraph (A) is in addition to any other 
                authority to use procedures other than competitive 
                procedures.
                    ``(C) Applicable government-wide regulations.--The 
                Secretary shall implement this paragraph in accordance 
                with government-wide regulations implementing such 
                section 303(c)(1) (including requirements that offers 
                be solicited from as many potential sources as is 
                practicable under the circumstances, that required 
                notices be published, and that submitted offers be 
                considered), as such regulations apply to procurements 
                for which an agency has authority to use procedures 
                other than competitive procedures when the property or 
                services needed by the agency are available from only 
                one responsible source or only from a limited number of 
                responsible sources and no other type of property or 
                services will satisfy the needs of the agency.
            ``(3) Increased micropurchase threshold.--
                    ``(A) In general.--For a procurement described by 
                paragraph (1), the amount specified in subsections (c), 
                (d), and (f) of section 32 of the Office of Federal 
                Procurement Policy Act (41 U.S.C. 428) shall be deemed 
                to be $15,000 in the administration of that section 
                with respect to such procurement.
                    ``(B) Internal controls to be instituted.--The 
                Secretary shall institute appropriate internal controls 
                for purchases that are under this paragraph and that 
                are greater than $2,500.
                    ``(C) Exception to preference for purchase card 
                mechanism.--No provision of law establishing a 
                preference for using a Government purchase card method 
                for purchases shall apply to purchases that are under 
                this paragraph and that are greater than $2,500.
            ``(4) Review.--
                    ``(A) Review allowed.--Notwithstanding subsection 
                (f), section 1491 of title 28, United States Code, and 
                section 3556 of title 31 of such Code, review of a 
                contracting agency decision relating to a procurement 
                described in paragraph (1) may be had only by filing a 
                protest--
                            ``(i) with a contracting agency; or
                            ``(ii) with the Comptroller General under 
                        subchapter V of chapter 35 of title 31, United 
                        States Code.
                    ``(B) Override of stay of contract award or 
                performance committed to agency discretion.--
                Notwithstanding section 1491 of title 28, United States 
                Code, and section 3553 of title 31 of such Code, the 
                following authorizations by the head of a procuring 
                activity are committed to agency discretion:
                            ``(i) An authorization under section 
                        3553(c)(2) of title 31, United States Code, to 
                        award a contract for a procurement described in 
                        paragraph (1) of this subsection.
                            ``(ii) An authorization under section 
                        3553(d)(3)(C) of such title to perform a 
                        contract for a procurement described in 
                        paragraph (1) of this subsection.
    ``(c) Authority to Expedite Peer Review.--
            ``(1) In general.--The Secretary may, as the Secretary 
        determines necessary to respond to pressing qualified 
        countermeasure research and development needs under this 
        section, employ such expedited peer review procedures 
        (including consultation with appropriate scientific experts) as 
        the Secretary, in consultation with the Director of NIH, deems 
        appropriate to obtain assessment of scientific and technical 
        merit and likely contribution to the field of qualified 
        countermeasure research, in place of the peer review and 
        advisory council review procedures that would be required under 
        sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, 
        and 494, as applicable to a grant, contract, or cooperative 
        agreement--
                    ``(A) that is for performing, administering, or 
                supporting qualified countermeasure research and 
                development activities; and
                    ``(B) the amount of which is not greater than 
                $1,500,000.
            ``(2) Subsequent phases of research.--The Secretary's 
        determination of whether to employ expedited peer review with 
        respect to any subsequent phases of a research grant, contract, 
        or cooperative agreement under this section shall be determined 
        without regard to the peer review procedures used for any prior 
        peer review of that same grant, contract, or cooperative 
        agreement. Nothing in the preceding sentence may be construed 
        to impose any requirement with respect to peer review not 
        otherwise required under any other law or regulation.
    ``(d) Authority for Personal Services Contracts.--
            ``(1) In general.--For the purpose of performing, 
        administering, or supporting qualified countermeasure research 
        and development activities, the Secretary may, as the Secretary 
        determines necessary to respond to pressing qualified 
        countermeasure research and development needs under this 
        section, obtain by contract (in accordance with section 3109 of 
        title 5, United States Code, but without regard to the 
        limitations in such section on the period of service and on 
        pay) the personal services of experts or consultants who have 
        scientific or other professional qualifications, except that in 
        no case shall the compensation provided to any such expert or 
        consultant exceed the daily equivalent of the annual rate of 
        compensation for the President.
            ``(2) Federal tort claims act coverage.--
                    ``(A) In general.--A person carrying out a contract 
                under paragraph (1), and an officer, employee, or 
                governing board member of such person, shall, subject 
                to a determination by the Secretary, be deemed to be an 
                employee of the Department of Health and Human Services 
                for purposes of claims under sections 1346(b) and 2672 
                of title 28, United States Code, for money damages for 
                personal injury, including death, resulting from 
                performance of functions under such contract.
                    ``(B) Exclusivity of remedy.--The remedy provided 
                by subparagraph (A) shall be exclusive of any other 
                civil action or proceeding by reason of the same 
                subject matter against the entity involved (person, 
                officer, employee, or governing board member) for any 
                act or omission within the scope of the Federal Tort 
                Claims Act.
                    ``(C) Recourse in case of gross misconduct or 
                contract violation.--
                            ``(i) In general.--Should payment be made 
                        by the United States to any claimant bringing a 
                        claim under this paragraph, either by way of 
                        administrative determination, settlement, or 
                        court judgment, the United States shall have, 
                        notwithstanding any provision of State law, the 
                        right to recover against any entity identified 
                        in subparagraph (B) for that portion of the 
                        damages so awarded or paid, as well as interest 
                        and any costs of litigation, resulting from the 
                        failure of any such entity to carry out any 
                        obligation or responsibility assumed by such 
                        entity under a contract with the United States 
                        or from any grossly negligent or reckless 
                        conduct or intentional or willful misconduct on 
                        the part of such entity.
                            ``(ii) Venue.--The United States may 
                        maintain an action under this subparagraph 
                        against such entity in the district court of 
                        the United States in which such entity resides 
                        or has its principal place of business.
            ``(3) Internal controls to be instituted.--
                    ``(A) In general.--The Secretary shall institute 
                appropriate internal controls for contracts under this 
                subsection, including procedures for the Secretary to 
                make a determination of whether a person, or an 
                officer, employee, or governing board member of a 
                person, is deemed to be an employee of the Department 
                of Health and Human Services pursuant to paragraph (2).
                    ``(B) Determination of employee status to be 
                final.--A determination by the Secretary under 
                subparagraph (A) that a person, or an officer, 
                employee, or governing board member of a person, is or 
                is not deemed to be an employee of the Department of 
                Health and Human Services shall be final and binding on 
                the Secretary and the Attorney General and other 
                parties to any civil action or proceeding.
            ``(4) Number of personal services contracts limited.--The 
        number of experts and consultants whose personal services are 
        obtained under paragraph (1) shall not exceed 30 at any time.
    ``(e) Streamlined Personnel Authority.--
            ``(1) In general.--In addition to any other personnel 
        authorities, the Secretary may, as the Secretary determines 
        necessary to respond to pressing qualified countermeasure 
        research and development needs under this section, without 
        regard to those provisions of title 5, United States Code, 
        governing appointments in the competitive service, and without 
        regard to the provisions of chapter 51 and subchapter III of 
        chapter 53 of such title relating to classification and General 
        Schedule pay rates, appoint professional and technical 
        employees, not to exceed 30 such employees at any time, to 
        positions in the National Institutes of Health to perform, 
        administer, or support qualified countermeasure research and 
        development activities in carrying out this section.
            ``(2) Limitations.--The authority provided for under 
        paragraph (1) shall be exercised in a manner that--
                    ``(A) recruits and appoints individuals based 
                solely on their abilities, knowledge, and skills;
                    ``(B) does not discriminate for or against any 
                applicant for employment on any basis described in 
                section 2302(b)(1) of title 5, United States Code;
                    ``(C) does not allow an official to appoint an 
                individual who is a relative (as defined in section 
                3110(a)(3) of such title) of such official;
                    ``(D) does not discriminate for or against an 
                individual because of the exercise of any activity 
                described in paragraph (9) or (10) of section 2302(b) 
                of such title; and
                    ``(E) accords a preference, among equally qualified 
                persons, to persons who are preference eligibles (as 
                defined in section 2108(3) of such title).
            ``(3) Internal controls to be instituted.--The Secretary 
        shall institute appropriate internal controls for appointments 
        under this subsection.
    ``(f) Actions Committed to Agency Discretion.--Actions by the 
Secretary under the authority of this section are committed to agency 
discretion.''.
    (b) Technical Amendment.--Section 481A of the Public Health Service 
Act (42 U.S.C. 287a-2) is amended--
            (1) in subsection (a)(1), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
            (2) in subsection (c)--
                    (A) in paragraph (1), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by striking ``subsection (i)'' and 
                inserting ``subsection (i)(1)'';
            (3) in subsection (d), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
            (4) in subsection (e)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``or the Director of the 
                        National Institute of Allergy and Infectious 
                        Diseases'' after ``Director of the Center'';
                            (ii) in subparagraph (A), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``50 percent''; and
                            (iii) in subparagraph (B), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``40 percent'';
                    (B) in paragraph (2), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (C) in paragraph (4), by inserting ``of the Center 
                or the Director of the National Institute of Allergy 
                and Infectious Diseases'' after ``Director'';
            (5) in subsection (f)--
                    (A) in paragraph (1), by inserting ``in the case of 
                an award by the Director of the Center,'' before ``the 
                applicant''; and
                    (B) in paragraph (2), by inserting ``of the Center 
                or the Director of the National Institute of Allergy 
                and Infectious Diseases'' after ``Director''; and
            (6) in subsection (i)--
                    (A) by striking ``Appropriations.--For the purpose 
                of carrying out this section,'' and inserting the 
                following: ``Appropriations.--
            ``(1) Center.--For the purpose of carrying out this section 
        with respect to the Center,''; and
                    (B) by adding at the end the following:
            ``(2) National institute of allergy and infectious 
        diseases.--For the purpose of carrying out this section with 
        respect to the National Institute of Allergy and Infectious 
        Diseases, there are authorized to be appropriated such sums as 
        may be necessary for each of the fiscal years 2004 and 2005.''.
    (c) Additional Authorizations of Appropriations.--Section 2106 of 
the Public Health Service Act (42 U.S.C. 300aa-6) is amended--
            (1) in subsection (a), by striking ``authorized to be 
        appropriated'' and all that follows and inserting the 
        following: ``authorized to be appropriated such sums as may be 
        necessary for each of the fiscal years 2004 and 2005.''; and
            (2) in subsection (b), by striking ``authorized to be 
        appropriated'' and all that follows and inserting the 
        following: ``authorized to be appropriated such sums as may be 
        necessary for each of the fiscal years 2004 and 2005.''.
    (d) Technical Amendments.--Section 319F of the Public Health 
Service Act (42 U.S.C. 247d-6) is amended--
            (1) in subsection (a), by inserting ``the Secretary of 
        Homeland Security,'' after ``Management Agency,''; and
            (2) in subsection (h)(4)(B), by striking ``to diagnose 
        conditions'' and inserting ``to treat, identify, or prevent 
        conditions''.
    (e) Rule of Construction.--Nothing in this section has any legal 
effect on sections 302(2), 302(4), 304(a), or 304(b) of the Homeland 
Security Act of 2002.

SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

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

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

    ``(a) Strategic National Stockpile.--
            ``(1) In general.--The Secretary, in coordination with the 
        Secretary of Homeland Security (referred to in this section as 
        the `Homeland Security Secretary'), shall maintain a stockpile 
        or stockpiles of drugs, vaccines and other biological products, 
        medical devices, and other supplies in such numbers, types, and 
        amounts as are determined by the Secretary to be appropriate 
        and practicable, taking into account other available sources, 
        to provide for the emergency health security of the United 
        States, including the emergency health security of children and 
        other vulnerable populations, in the event of a bioterrorist 
        attack or other public health emergency.
            ``(2) Procedures.--The Secretary, in managing the stockpile 
        under paragraph (1), shall--
                    ``(A) consult with the working group under section 
                319F(a);
                    ``(B) ensure that adequate procedures are followed 
                with respect to such stockpile for inventory management 
                and accounting, and for the physical security of the 
                stockpile;
                    ``(C) in consultation with Federal, State, and 
                local officials, take into consideration the timing and 
                location of special events;
                    ``(D) review and revise, as appropriate, the 
                contents of the stockpile on a regular basis to ensure 
                that emerging threats, advanced technologies, and new 
                countermeasures are adequately considered;
                    ``(E) devise plans for the effective and timely 
                supply-chain management of the stockpile, in 
                consultation with appropriate Federal, State and local 
                agencies, and the public and private health care 
                infrastructure;
                    ``(F) deploy the stockpile as required by the 
                Secretary of Homeland Security to respond to an actual 
                or potential emergency;
                    ``(G) deploy the stockpile at the discretion of the 
                Secretary to respond to an actual or potential public 
                health emergency or other situation in which deployment 
                is necessary to protect the public health or safety; 
                and
                    ``(H) ensure the adequate physical security of the 
                stockpile.
    ``(b) Smallpox Vaccine Development.--
            ``(1) In general.--The Secretary shall award contracts, 
        enter into cooperative agreements, or carry out such other 
        activities as may reasonably be required in order to ensure 
        that the stockpile under subsection (a) includes an amount of 
        vaccine against smallpox as determined by such Secretary to be 
        sufficient to meet the health security needs of the United 
        States.
            ``(2) Rule of construction.--Nothing in this section shall 
        be construed to limit the private distribution, purchase, or 
        sale of vaccines from sources other than the stockpile 
        described in subsection (a).
    ``(c) Additional Authority Regarding Procurement of Certain 
Biomedical Countermeasures; Availability of Special Reserve Fund.--
            ``(1) In general.--
                    ``(A) Use of fund.--A security countermeasure may, 
                in accordance with this subsection, be procured with 
                amounts in the special reserve fund under paragraph 
                (10).
                    ``(B) Security countermeasure.--For purposes of 
                this subsection, the term `security countermeasure' 
                means a drug (as that term is defined by section 
                201(g)(1) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 321(g)(1))), biological product (as that 
                term is defined by section 351(i) of this Act (42 
                U.S.C. 262(i))), or device (as that term is defined by 
                section 201(h) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 321(h))) that--
                            ``(i)(I) -the Secretary determines to be a 
                        priority (consistent with sections 302(2) and 
                        304(a) of the Homeland Security Act of 2002) to 
                        treat, identify, or prevent harm from any 
                        biological, chemical, radiological, or nuclear 
                        agent identified as a material threat under 
                        paragraph (2)(A)(ii), or to treat, identify, or 
                        prevent harm from a condition that may result 
                        in adverse health consequences or death and may 
                        be caused by administering a drug, biological 
                        product, or device against such an agent;
                            ``(II) the Secretary determines under 
                        paragraph (2)(B)(ii) to be a necessary 
                        countermeasure; and
                            ``(III)(aa) is approved or cleared under 
                        chapter V of the Federal Food, Drug, and 
                        Cosmetic Act or licensed under section 351 of 
                        this Act; or
                            ``(bb) is a countermeasure for which the 
                        Secretary determines that sufficient and 
                        satisfactory clinical experience or research 
                        data (including data, if available, from pre-
                        clinical and clinical trials) support a 
                        reasonable conclusion that the countermeasure 
                        will qualify for approval or licensing within 
                        eight years after the date of a determination 
                        under paragraph (5); or
                            ``(ii) is authorized for emergency use 
                        under section 564 of the Federal Food, Drug, 
                        and Cosmetic Act.
            ``(2) Determination of material threats.--
                    ``(A) Material threat.--The Homeland Security 
                Secretary, in consultation with the Secretary and the 
                heads of other agencies as appropriate, shall on an 
                ongoing basis--
                            ``(i) assess current and emerging threats 
                        of chemical, biological, radiological, and 
                        nuclear agents; and
                            ``(ii) determine which of such agents 
                        present a material threat against the United 
                        States population sufficient to affect national 
                        security.
                    ``(B) Public health impact; necessary 
                countermeasures.--The Secretary shall on an ongoing 
                basis--
                            ``(i) assess the potential public health 
                        consequences for the United States population 
                        of exposure to agents identified under 
                        subparagraph (A)(ii); and
                            ``(ii) determine, on the basis of such 
                        assessment, the agents identified under 
                        subparagraph (A)(ii) for which countermeasures 
                        are necessary to protect the public health.
                    ``(C) Notice to congress.--The Secretary and the 
                Homeland Security Secretary shall promptly notify the 
                designated congressional committees (as defined in 
                paragraph (10)) that a determination has been made 
                pursuant to subparagraph (A) or (B).
                    ``(D) Assuring access to threat information.--In 
                making the assessment and determination required under 
                subparagraph (A), the Homeland Security Secretary shall 
                use all relevant information to which such Secretary is 
                entitled under section 202 of the Homeland Security Act 
                of 2002, including but not limited to information, 
                regardless of its level of classification, relating to 
                current and emerging threats of chemical, biological, 
                radiological, and nuclear agents.
            ``(3) Assessment of availability and appropriateness of 
        countermeasures.--The Secretary, in consultation with the 
        Homeland Security Secretary, shall assess on an ongoing basis 
        the availability and appropriateness of specific 
        countermeasures to address specific threats identified under 
        paragraph (2).
            ``(4) Call for development of countermeasures; commitment 
        for recommendation for procurement.--
                    ``(A) Proposal to the president.--If, pursuant to 
                an assessment under paragraph (3), the Homeland 
                Security Secretary and the Secretary make a 
                determination that a countermeasure would be 
                appropriate but is either currently unavailable for 
                procurement as a security countermeasure or is 
                approved, licensed, or cleared only for alternative 
                uses, such Secretaries may jointly submit to the 
                President a proposal to--
                            ``(i) issue a call for the development of 
                        such countermeasure; and
                            ``(ii) make a commitment that, upon the 
                        first development of such countermeasure that 
                        meets the conditions for procurement under 
                        paragraph (5), the Secretaries will, based in 
                        part on information obtained pursuant to such 
                        call, make a recommendation under paragraph (6) 
                        that the special reserve fund under paragraph 
                        (10) be made available for the procurement of 
                        such countermeasure.
                    ``(B) Countermeasure specifications.--The Homeland 
                Security Secretary and the Secretary shall, to the 
                extent practicable, include in the proposal under 
                subparagraph (A)--
                            ``(i) estimated quantity of purchase (in 
                        the form of number of doses or number of 
                        effective courses of treatments regardless of 
                        dosage form);
                            ``(ii) necessary measures of minimum safety 
                        and effectiveness;
                            ``(iii) estimated price for each dose or 
                        effective course of treatment regardless of 
                        dosage form; and
                            ``(iv) other information that may be 
                        necessary to encourage and facilitate research, 
                        development, and manufacture of the 
                        countermeasure or to provide specifications for 
                        the countermeasure.
                    ``(C) Presidential approval.--If the President 
                approves a proposal under subparagraph (A), the 
                Homeland Security Secretary and the Secretary shall 
                make known to persons who may respond to a call for the 
                countermeasure involved--
                            ``(i) the call for the countermeasure;
                            ``(ii) specifications for the 
                        countermeasure under subparagraph (B); and
                            ``(iii) the commitment described in 
                        subparagraph (A)(ii).
            ``(5) Secretary's determination of countermeasures 
        appropriate for funding from special reserve fund.--
                    ``(A) In general.--The Secretary, in accordance 
                with the provisions of this paragraph, shall identify 
                specific security countermeasures that the Secretary 
                determines, in consultation with the Homeland Security 
                Secretary, to be appropriate for inclusion in the 
                stockpile under subsection (a) pursuant to procurements 
                made with amounts in the special reserve fund under 
                paragraph (10) (referred to in this subsection 
                individually as a `procurement under this subsection').
                    ``(B) Requirements.--In making a determination 
                under subparagraph (A) with respect to a security 
                countermeasure, the Secretary shall determine and 
                consider the following:
                            ``(i) The quantities of the product that 
                        will be needed to meet the needs of the 
                        stockpile.
                            ``(ii) The feasibility of production and 
                        delivery within eight years of sufficient 
                        quantities of the product.
                            ``(iii) Whether there is a lack of a 
                        significant commercial market for the product 
                        at the time of procurement, other than as a 
                        security countermeasure.
            ``(6) Recommendation for president's approval.--
                    ``(A) Recommendation for procurement.--In the case 
                of a security countermeasure that the Secretary has, in 
                accordance with paragraphs (3) and (5), determined to 
                be appropriate for procurement under this subsection, 
                the Homeland Security Secretary and the Secretary shall 
                jointly submit to the President, in coordination with 
                the Director of the Office of Management and Budget, a 
                recommendation that the special reserve fund under 
                paragraph (10) be made available for the procurement of 
                such countermeasure.
                    ``(B) Presidential approval.--The special reserve 
                fund under paragraph (10) is available for a 
                procurement of a security countermeasure only if the 
                President has approved a recommendation under 
                subparagraph (A) regarding the countermeasure.
                    ``(C) Notice to designated congressional 
                committees.--The Secretary and the Homeland Security 
                Secretary shall notify the designated congressional 
                committees of each decision of the President to approve 
                a recommendation under subparagraph (A). Such notice 
                shall include an explanation of the decision to make 
                available the special reserve fund under paragraph (10) 
                for procurement of such a countermeasure, including, 
                where available, the number of, nature of, and other 
                information concerning potential suppliers of such 
                countermeasure, and whether other potential suppliers 
                of the same or similar countermeasures were considered 
                and rejected for procurement under this section and the 
                reasons therefor.
                    ``(D) Subsequent specific countermeasures.--
                Procurement under this subsection of a security 
                countermeasure for a particular purpose does not 
                preclude the subsequent procurement under this 
                subsection of any other security countermeasure for 
                such purpose if the Secretary has determined under 
                paragraph (5)(A) that such countermeasure is 
                appropriate for inclusion in the stockpile and if, as 
                determined by the Secretary, such countermeasure 
                provides improved safety or effectiveness, or for other 
                reasons enhances preparedness to respond to threats of 
                use of a biological, chemical, radiological, or nuclear 
                agent. Such a determination by the Secretary is 
                committed to agency discretion.
                    ``(E) Rule of construction.--Recommendations and 
                approvals under this paragraph apply solely to 
                determinations that the special reserve fund under 
                paragraph (10) will be made available for a procurement 
                of a security countermeasure, and not to the substance 
                of contracts for such procurement or other matters 
                relating to awards of such contracts.
            ``(7) Procurement.--
                    ``(A) In general.--For purposes of a procurement 
                under this subsection that is approved by the President 
                under paragraph (6), the Homeland Security Secretary 
                and the Secretary shall have responsibilities in 
                accordance with subparagraphs (B) and (C).
                    ``(B) Interagency agreement; costs.--
                            ``(i) Interagency agreement.--The Homeland 
                        Security Secretary shall enter into an 
                        agreement with the Secretary for procurement of 
                        a security countermeasure in accordance with 
                        the provisions of this paragraph. The special 
                        reserve fund under paragraph (10) shall be 
                        available for payments made by the Secretary to 
                        a vendor for such procurement.
                            ``(ii) Other costs.--The actual costs to 
                        the Secretary under this section, other than 
                        the costs described in clause (i), shall be 
                        paid from the appropriation provided for under 
                        subsection (f)(1).
                    ``(C) Procurement.--
                            ``(i) In general.--The Secretary shall be 
                        responsible for--
                                    ``(I) arranging for procurement of 
                                a security countermeasure, including 
                                negotiating terms (including quantity, 
                                production schedule, and price) of, and 
                                entering into, contracts and 
                                cooperative agreements, and for 
                                carrying out such other activities as 
                                may reasonably be required, in 
                                accordance with the provisions of this 
                                subparagraph; and
                                    ``(II) promulgating such 
                                regulations as the Secretary determines 
                                necessary to implement the provisions 
                                of this subsection.
                            ``(ii) Contract terms.--A contract for 
                        procurements under this subsection shall (or, 
                        as specified below, may) include the following 
                        terms:
                                    ``(I) Payment conditioned on 
                                delivery.--The contract shall provide 
                                that no payment may be made until 
                                delivery has been made of a portion, 
                                acceptable to the Secretary, of the 
                                total number of units contracted for, 
                                except that, notwithstanding any other 
                                provision of law, the contract may 
                                provide that, if the Secretary 
                                determines (in the Secretary's 
                                discretion) that an advance payment is 
                                necessary to ensure success of a 
                                project, the Secretary may pay an 
                                amount, not to exceed 10 percent of the 
                                contract amount, in advance of 
                                delivery. The contract shall provide 
                                that such advance payment is required 
                                to be repaid if there is a failure to 
                                perform by the vendor under the 
                                contract. Nothing in this subclause may 
                                be construed as affecting rights of 
                                vendors under provisions of law or 
                                regulation (including the Federal 
                                Acquisition Regulation) relating to 
                                termination of contracts for the 
                                convenience of the Government.
                                    ``(II) Discounted payment.--The 
                                contract may provide for a discounted 
                                price per unit of a product that is not 
                                licensed, cleared, or approved as 
                                described in paragraph 
                                (1)(B)(i)(III)(aa) at the time of 
                                delivery, and may provide for payment 
                                of an additional amount per unit if the 
                                product becomes so licensed, cleared, 
                                or approved before the expiration date 
                                of the contract (including an 
                                additional amount per unit of product 
                                delivered before the effective date of 
                                such licensing, clearance, or 
                                approval).
                                    ``(III) Contract duration.--The 
                                contract shall be for a period not to 
                                exceed five years, except that, in 
                                first awarding the contract, the 
                                Secretary may provide for a longer 
                                duration, not exceeding eight years, if 
                                the Secretary determines that 
                                complexities or other difficulties in 
                                performance under the contract justify 
                                such a period. The contract shall be 
                                renewable for additional periods, none 
                                of which shall exceed five years.
                                    ``(IV) Storage by vendor.--The 
                                contract may provide that the vendor 
                                will provide storage for stocks of a 
                                product delivered to the ownership of 
                                the Federal Government under the 
                                contract, for such period and under 
                                such terms and conditions as the 
                                Secretary may specify, and in such case 
                                amounts from the special reserve fund 
                                under paragraph (10) shall be available 
                                for costs of shipping, handling, 
                                storage, and related costs for such 
                                product.
                                    ``(V) Product approval.--The 
                                contract shall provide that the vendor 
                                seek approval, clearance, or licensing 
                                of the product from the Secretary; for 
                                a timetable for the development of data 
                                and other information to support such 
                                approval, clearance, or licensing; and 
                                that the Secretary may waive part or 
                                all of this contract term on request of 
                                the vendor or on the initiative of the 
                                Secretary.
                                    ``(VI) Non-stockpile transfers of 
                                security countermeasures.--The contract 
                                shall provide that the vendor will 
                                comply with all applicable export-
                                related controls with respect to such 
                                countermeasure.
                            ``(iii) Availability of simplified 
                        acquisition procedures.--
                                    ``(I) In general.--If the Secretary 
                                determines that there is a pressing 
                                need for a procurement of a specific 
                                countermeasure, the amount of the 
                                procurement under this subsection shall 
                                be deemed to be below the threshold 
                                amount specified in section 4(11) of 
                                the Office of Federal Procurement 
                                Policy Act (41 U.S.C. 403(11)), for 
                                purposes of application to such 
                                procurement, pursuant to section 
                                302A(a) of the Federal Property and 
                                Administrative Services Act of 1949 (41 
                                U.S.C. 252a(a)), of--
                                            ``(aa) section 303(g)(1)(A) 
                                        of the Federal Property and 
                                        Administrative Services Act of 
                                        1949 (41 U.S.C. 253(g)(1)(A)) 
                                        and its implementing 
                                        regulations; and
                                            ``(bb) section 302A(b) of 
                                        such Act (41 U.S.C. 252a(b)) 
                                        and its implementing 
                                        regulations.
                                    ``(II) Application of certain 
                                provisions.--Notwithstanding subclause 
                                (I) and the provision of law and 
                                regulations referred to in such clause, 
                                each of the following provisions shall 
                                apply to procurements described in this 
                                clause to the same extent that such 
                                provisions would apply to such 
                                procurements in the absence of 
                                subclause (I):
                                            ``(aa) Chapter 37 of title 
                                        40, United States Code 
                                        (relating to contract work 
                                        hours and safety standards).
                                            ``(bb) Subsections (a) and 
                                        (b) of section 7 of the Anti-
                                        Kickback Act of 1986 (41 U.S.C. 
                                        57(a) and (b)).
                                            ``(cc) Section 304C of the 
                                        Federal Property and 
                                        Administrative Services Act of 
                                        1949 (41 U.S.C. 254d) (relating 
                                        to the examination of 
                                        contractor records).
                                            ``(dd) Section 3131 of 
                                        title 40, United States Code 
                                        (relating to bonds of 
                                        contractors of public buildings 
                                        or works).
                                            ``(ee) Subsection (a) of 
                                        section 304 of the Federal 
                                        Property and Administrative 
                                        Services Act of 1949 (41 U.S.C. 
                                        254(a)) (relating to contingent 
                                        fees to middlemen).
                                            ``(ff) Section 6002 of the 
                                        Solid Waste Disposal Act (42 
                                        U.S.C. 6962).
                                            ``(gg) Section 1354 of 
                                        title 31, United States Code 
                                        (relating to the limitation on 
                                        the use of appropriated funds 
                                        for contracts with entities not 
                                        meeting veterans employment 
                                        reporting requirements).
                                    ``(III) Internal controls to be 
                                established.--The Secretary shall 
                                establish appropriate internal controls 
                                for procurements made under this 
                                clause, including requirements with 
                                respect to documentation of the 
                                justification for the use of the 
                                authority provided under this paragraph 
                                with respect to the procurement 
                                involved.
                                    ``(IV) Authority to limit 
                                competition.--In conducting a 
                                procurement under this subparagraph, 
                                the Secretary may not use the authority 
                                provided for under subclause (I) to 
                                conduct a procurement on a basis other 
                                than full and open competition unless 
                                the Secretary determines that the 
                                mission of the BioShield Program under 
                                the Project BioShield Act of 2004 would 
                                be seriously impaired without such a 
                                limitation.
                            ``(iv) Procedures other than full and open 
                        competition.--
                                    ``(I) In general.--In using the 
                                authority provided in section 303(c)(1) 
                                of title III of the Federal Property 
                                and Administrative Services Act of 1949 
                                (41 U.S.C. 253(c)(1)) to use procedures 
                                other than competitive procedures in 
                                the case of a procurement under this 
                                subsection, the phrase `available from 
                                only one responsible source' in such 
                                section 303(c)(1) shall be deemed to 
                                mean `available from only one 
                                responsible source or only from a 
                                limited number of responsible sources'.
                                    ``(II) Relation to other 
                                authorities.--The authority under 
                                subclause (I) is in addition to any 
                                other authority to use procedures other 
                                than competitive procedures.
                                    ``(III) Applicable government-wide 
                                regulations.--The Secretary shall 
                                implement this clause in accordance 
                                with government-wide regulations 
                                implementing such section 303(c)(1) 
                                (including requirements that offers be 
                                solicited from as many potential 
                                sources as is practicable under the 
                                circumstances, that required notices be 
                                published, and that submitted offers be 
                                considered), as such regulations apply 
                                to procurements for which an agency has 
                                authority to use procedures other than 
                                competitive procedures when the 
                                property or services needed by the 
                                agency are available from only one 
                                responsible source or only from a 
                                limited number of responsible sources 
                                and no other type of property or 
                                services will satisfy the needs of the 
                                agency.
                            ``(v) Premium provision in multiple award 
                        contracts.--
                                    ``(I) In general.--If, under this 
                                subsection, the Secretary enters into 
                                contracts with more than one vendor to 
                                procure a security countermeasure, such 
                                Secretary may, notwithstanding any 
                                other provision of law, include in each 
                                of such contracts a provision that--
                                            ``(aa) identifies an 
                                        increment of the total quantity 
                                        of security countermeasure 
                                        required, whether by percentage 
                                        or by numbers of units; and
                                            ``(bb) promises to pay one 
                                        or more specified premiums 
                                        based on the priority of such 
                                        vendors' production and 
                                        delivery of the increment 
                                        identified under item (aa), in 
                                        accordance with the terms and 
                                        conditions of the contract.
                                    ``(II) Determination of 
                                government's requirement not 
                                reviewable.--If the Secretary includes 
                                in each of a set of contracts a 
                                provision as described in subclause 
                                (I), such Secretary's determination of 
                                the total quantity of security 
                                countermeasure required, and any 
                                amendment of such determination, is 
                                committed to agency discretion.
                            ``(vi) Extension of closing date for 
                        receipt of proposals not reviewable.--A 
                        decision by the Secretary to extend the closing 
                        date for receipt of proposals for a procurement 
                        under this subsection is committed to agency 
                        discretion.
                            ``(vii) Limiting competition to sources 
                        responding to request for information.--In 
                        conducting a procurement under this subsection, 
                        the Secretary may exclude a source that has not 
                        responded to a request for information under 
                        section 303A(a)(1)(B) of the Federal Property 
                        and Administrative Services Act of 1949 (41 
                        U.S.C. 253a(a)(1)(B)) if such request has given 
                        notice that the Secretary may so exclude such a 
                        source.
            ``(8) Interagency cooperation.--
                    ``(A) In general.--In carrying out activities under 
                this section, the Homeland Security Secretary and the 
                Secretary are authorized, subject to subparagraph (B), 
                to enter into interagency agreements and other 
                collaborative undertakings with other agencies of the 
                United States Government.
                    ``(B) Limitation.--An agreement or undertaking 
                under this paragraph shall not authorize another agency 
                to exercise the authorities provided by this section to 
                the Homeland Security Secretary or to the Secretary.
            ``(9) Restrictions on use of funds.--Amounts in the special 
        reserve fund under paragraph (10) shall not be used to pay--
                    ``(A) costs for the purchase of vaccines under 
                procurement contracts entered into before the date of 
                the enactment of the Project BioShield Act of 2004; or
                    ``(B) costs other than payments made by the 
                Secretary to a vendor for a procurement of a security 
                countermeasure under paragraph (7).
            ``(10) Definitions.--
                    ``(A) Special reserve fund.--For purposes of this 
                subsection, the term `special reserve fund' has the 
                meaning given such term in section 510 of the Homeland 
                Security Act of 2002.
                    ``(B) Designated congressional committees.--For 
                purposes of this section, the term `designated 
                congressional committees' means the following 
                committees of the Congress:
                            ``(i) In the House of Representatives: the 
                        Committee on Energy and Commerce, the Committee 
                        on Appropriations, the Committee on Government 
                        Reform, and the Select Committee on Homeland 
                        Security (or any successor to the Select 
                        Committee).
                            ``(ii) In the Senate: the appropriate 
                        committees.
    ``(d) Disclosures.--No Federal agency shall disclose under section 
552 of title 5, United States Code, any information identifying the 
location at which materials in the stockpile under subsection (a) are 
stored.
    ``(e) Definition.--For purposes of subsection (a), the term 
`stockpile' includes--
            ``(1) a physical accumulation (at one or more locations) of 
        the supplies described in subsection (a); or
            ``(2) a contractual agreement between the Secretary and a 
        vendor or vendors under which such vendor or vendors agree to 
        provide to such Secretary supplies described in subsection (a).
    ``(f) Authorization of Appropriations.--
            ``(1) Strategic national stockpile.--For the purpose of 
        carrying out subsection (a), there are authorized to be 
        appropriated $640,000,000 for fiscal year 2002, and such sums 
        as may be necessary for each of fiscal years 2003 through 2006. 
        Such authorization is in addition to amounts in the special 
        reserve fund referred to in subsection (c)(10)(A).
            ``(2) Smallpox vaccine development.--For the purpose of 
        carrying out subsection (b), there are authorized to be 
        appropriated $509,000,000 for fiscal year 2002, and such sums 
        as may be necessary for each of fiscal years 2003 through 
        2006.''.
    (b) Amendments to Homeland Security Act of 2002.--Title V of the 
Homeland Security Act of 2002 (116 Stat. 2212; 6 U.S.C. 311 et seq.) is 
amended--
            (1) in section 502(3) (6 U.S.C. 312(3))--
                    (A) in subparagraph (B), by striking ``the 
                Strategic National Stockpile,''; and
                    (B) in subparagraph (D), by inserting ``, including 
                requiring deployment of the Strategic National 
                Stockpile,'' after ``resources''; and
            (2) by adding at the end the following:

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

    ``(a) Authorization of Appropriations.--For the procurement of 
security countermeasures under section 319F-2(c) of the Public Health 
Service Act (referred to in this section as the `security 
countermeasures program'), there is authorized to be appropriated up to 
$5,593,000,000 for the fiscal years 2004 through 2013. Of the amounts 
appropriated under the preceding sentence, not to exceed $3,418,000,000 
may be obligated during the fiscal years 2004 through 2008, of which 
not to exceed $890,000,000 may be obligated during fiscal year 2004.
    ``(b) Special Reserve Fund.--For purposes of the security 
countermeasures program, the term `special reserve fund' means the 
`Biodefense Countermeasures' appropriations account or any other 
appropriation made under subsection (a).
    ``(c) Availability.--Amounts appropriated under subsection (a) 
become available for a procurement under the security countermeasures 
program only upon the approval by the President of such availability 
for the procurement in accordance with paragraph (6)(B) of such 
program.
    ``(d) Related Authorizations of Appropriations.--
            ``(1) Threat assessment capabilities.--For the purpose of 
        carrying out the responsibilities of the Secretary for terror 
        threat assessment under the security countermeasures program, 
        there are authorized to be appropriated such sums as may be 
        necessary for each of the fiscal years 2004 through 2006, for 
        the hiring of professional personnel within the Directorate for 
        Information Analysis and Infrastructure Protection, who shall 
        be analysts responsible for chemical, biological, radiological, 
        and nuclear threat assessment (including but not limited to 
        analysis of chemical, biological, radiological, and nuclear 
        agents, the means by which such agents could be weaponized or 
        used in a terrorist attack, and the capabilities, plans, and 
        intentions of terrorists and other non-state actors who may 
        have or acquire such agents). All such analysts shall meet the 
        applicable standards and qualifications for the performance of 
        intelligence activities promulgated by the Director of Central 
        Intelligence pursuant to section 104 of the National Security 
        Act of 1947.
            ``(2) Intelligence sharing infrastructure.--For the purpose 
        of carrying out the acquisition and deployment of secure 
        facilities (including information technology and physical 
        infrastructure, whether mobile and temporary, or permanent) 
        sufficient to permit the Secretary to receive, not later than 
        180 days after the date of enactment of the Project BioShield 
        Act of 2004, all classified information and products to which 
        the Under Secretary for Information Analysis and Infrastructure 
        Protection is entitled under subtitle A of title II, there are 
        authorized to be appropriated such sums as may be necessary for 
        each of the fiscal years 2004 through 2006.''.
    (c) Stockpile Functions Transferred.--
            (1) In general.--Except as provided in paragraph (2), there 
        shall be transferred to the Secretary of Health and Human 
        Services the functions, personnel, assets, unexpended balances, 
        and liabilities of the Strategic National Stockpile, including 
        the functions of the Secretary of Homeland Security relating 
        thereto.
            (2) Exceptions.--
                    (A) Functions.--The transfer of functions pursuant 
                to paragraph (1) shall not include such functions as 
                are explicitly assigned to the Secretary of Homeland 
                Security by this Act (including the amendments made by 
                this Act).
                    (B) Assets and unexpended balances.--The transfer 
                of assets and unexpended balances pursuant to paragraph 
                (1) shall not include the funds appropriated under the 
                heading ``biodefense countermeasures'' in the 
                Department of Homeland Security Appropriations Act, 
                2004 (Public law 108-90).
            (3) Conforming amendment.--Section 503 of the Homeland 
        Security Act of 2002 (6 U.S.C. 313) is amended by striking 
        paragraph (6).

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

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

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

    ``(a) In General.--
            ``(1) Emergency uses.--Notwithstanding sections 505, 
        510(k), and 515 of this Act and section 351 of the Public 
        Health Service Act, and subject to the provisions of this 
        section, the Secretary may authorize the introduction into 
        interstate commerce, during the effective period of a 
        declaration under subsection (b), of a drug, device, or 
        biological product intended for use in an actual or potential 
        emergency (referred to in this section as an `emergency use').
            ``(2) Approval status of product.--An authorization under 
        paragraph (1) may authorize an emergency use of a product 
        that--
                    ``(A) is not approved, licensed, or cleared for 
                commercial distribution under a provision of law 
                referred to in such paragraph (referred to in this 
                section as an `unapproved product'); or
                    ``(B) is approved, licensed, or cleared under such 
                a provision, but which use is not under such provision 
                an approved, licensed, or cleared use of the product 
                (referred to in this section as an `unapproved use of 
                an approved product').
            ``(3) Relation to other uses.--An emergency use authorized 
        under paragraph (1) for a product is in addition to any other 
        use that is authorized for the product under a provision of law 
        referred to in such paragraph.
            ``(4) Definitions.--For purposes of this section:
                    ``(A) The term `biological product' has the meaning 
                given such term in section 351 of the Public Health 
                Service Act.
                    ``(B) The term `emergency use' has the meaning 
                indicated for such term in paragraph (1).
                    ``(C) The term `product' means a drug, device, or 
                biological product.
                    ``(D) The term `unapproved product' has the meaning 
                indicated for such term in paragraph (2)(A).
                    ``(E) The term `unapproved use of an approved 
                product' has the meaning indicated for such term in 
                paragraph (2)(B).
    ``(b) Declaration of Emergency.--
            ``(1) In general.--The Secretary may declare an emergency 
        justifying the authorization under this subsection for a 
        product on the basis of--
                    ``(A) a determination by the Secretary of Homeland 
                Security that there is a domestic emergency, or a 
                significant potential for a domestic emergency, 
                involving a heightened risk of attack with a specified 
                biological, chemical, radiological, or nuclear agent or 
                agents;
                    ``(B) a determination by the Secretary of Defense 
                that there is a military emergency, or a significant 
                potential for a military emergency, involving a 
                heightened risk to United States military forces of 
                attack with a specified biological, chemical, 
                radiological, or nuclear agent or agents; or
                    ``(C) a determination by the Secretary of a public 
                health emergency under section 319 of the Public Health 
                Service Act that affects, or has a significant 
                potential to affect, national security, and that 
                involves a specified biological, chemical, 
                radiological, or nuclear agent or agents, or a 
                specified disease or condition that may be attributable 
                to such agent or agents.
            ``(2) Termination of declaration.--
                    ``(A) In general.--A declaration under this 
                subsection shall terminate upon the earlier of--
                            ``(i) a determination by the Secretary, in 
                        consultation as appropriate with the Secretary 
                        of Homeland Security or the Secretary of 
                        Defense, that the circumstances described in 
                        paragraph (1) have ceased to exist; or
                            ``(ii) the expiration of the one-year 
                        period beginning on the date on which the 
                        declaration is made.
                    ``(B) Renewal.--Notwithstanding subparagraph (A), 
                the Secretary may renew a declaration under this 
                subsection, and this paragraph shall apply to any such 
                renewal.
                    ``(C) Disposition of product.--If an authorization 
                under this section with respect to an unapproved 
                product ceases to be effective as a result of a 
                termination under subparagraph (A) of this paragraph, 
                the Secretary shall consult with the manufacturer of 
                such product with respect to the appropriate 
                disposition of the product.
            ``(3) Advance notice of termination.--The Secretary shall 
        provide advance notice that a declaration under this subsection 
        will be terminated. The period of advance notice shall be a 
        period reasonably determined to provide--
                    ``(A) in the case of an unapproved product, a 
                sufficient period for disposition of the product, 
                including the return of such product (except such 
                quantities of product as are necessary to provide for 
                continued use consistent with subsection (f)(2)) to the 
                manufacturer (in the case of a manufacturer that 
                chooses to have such product returned); and
                    ``(B) in the case of an unapproved use of an 
                approved product, a sufficient period for the 
                disposition of any labeling, or any information under 
                subsection (e)(2)(B)(ii), as the case may be, that was 
                provided with respect to the emergency use involved.
            ``(4) Publication.--The Secretary shall promptly publish in 
        the Federal Register each declaration, determination, advance 
        notice of termination, and renewal under this subsection.
    ``(c) Criteria for Issuance of Authorization.--The Secretary may 
issue an authorization under this section with respect to the emergency 
use of a product only if, after consultation with the Director of the 
National Institutes of Health and the Director of the Centers for 
Disease Control and Prevention (to the extent feasible and appropriate 
given the circumstances of the emergency involved), the Secretary 
concludes--
            ``(1) that an agent specified in a declaration under 
        subsection (b) can cause a serious or life-threatening disease 
        or condition;
            ``(2) that, based on the totality of scientific evidence 
        available to the Secretary, including data from adequate and 
        well-controlled clinical trials, if available, it is reasonable 
        to believe that--
                    ``(A) the product may be effective in diagnosing, 
                treating, or preventing--
                            ``(i) such disease or condition; or
                            ``(ii) a serious or life-threatening 
                        disease or condition caused by a product 
                        authorized under this section, approved or 
                        cleared under this Act, or licensed under 
                        section 351 of the Public Health Service Act, 
                        for diagnosing, treating, or preventing such a 
                        disease or condition caused by such an agent; 
                        and
                    ``(B) the known and potential benefits of the 
                product, when used to diagnose, prevent, or treat such 
                disease or condition, outweigh the known and potential 
                risks of the product;
            ``(3) that there is no adequate, approved, and available 
        alternative to the product for diagnosing, preventing, or 
        treating such disease or condition; and
            ``(4) that such other criteria as the Secretary may by 
        regulation prescribe are satisfied.
    ``(d) Scope of Authorization.--An authorization of a product under 
this section shall state--
            ``(1) each disease or condition that the product may be 
        used to diagnose, prevent, or treat within the scope of the 
        authorization;
            ``(2) the Secretary's conclusions, made under subsection 
        (c)(2)(B), that the known and potential benefits of the 
        product, when used to diagnose, prevent, or treat such disease 
        or condition, outweigh the known and potential risks of the 
        product; and
            ``(3) the Secretary's conclusions, made under subsection 
        (c), concerning the safety and potential effectiveness of the 
        product in diagnosing, preventing, or treating such diseases or 
        conditions, including an assessment of the available scientific 
        evidence.
    ``(e) Conditions of Authorization.--
            ``(1) Unapproved product.--
                    ``(A) Required conditions.--With respect to the 
                emergency use of an unapproved product, the Secretary, 
                to the extent practicable given the circumstances of 
                the emergency, shall, for a person who carries out any 
                activity for which the authorization is issued, 
                establish such conditions on an authorization under 
                this section as the Secretary finds necessary or 
                appropriate to protect the public health, including the 
                following:
                            ``(i) Appropriate conditions designed to 
                        ensure that health care professionals 
                        administering the product are informed--
                                    ``(I) that the Secretary has 
                                authorized the emergency use of the 
                                product;
                                    ``(II) of the significant known and 
                                potential benefits and risks of the 
                                emergency use of the product, and of 
                                the extent to which such benefits and 
                                risks are unknown; and
                                    ``(III) of the alternatives to the 
                                product that are available, and of 
                                their benefits and risks.
                            ``(ii) Appropriate conditions designed to 
                        ensure that individuals to whom the product is 
                        administered are informed--
                                    ``(I) that the Secretary has 
                                authorized the emergency use of the 
                                product;
                                    ``(II) of the significant known and 
                                potential benefits and risks of such 
                                use, and of the extent to which such 
                                benefits and risks are unknown; and
                                    ``(III) of the option to accept or 
                                refuse administration of the product, 
                                of the consequences, if any, of 
                                refusing administration of the product, 
                                and of the alternatives to the product 
                                that are available and of their 
                                benefits and risks.
                            ``(iii) Appropriate conditions for the 
                        monitoring and reporting of adverse events 
                        associated with the emergency use of the 
                        product.
                            ``(iv) For manufacturers of the product, 
                        appropriate conditions concerning recordkeeping 
                        and reporting, including records access by the 
                        Secretary, with respect to the emergency use of 
                        the product.
                    ``(B) Authority for additional conditions.--With 
                respect to the emergency use of an unapproved product, 
                the Secretary may, for a person who carries out any 
                activity for which the authorization is issued, 
                establish such conditions on an authorization under 
                this section as the Secretary finds necessary or 
                appropriate to protect the public health, including the 
                following:
                            ``(i) Appropriate conditions on which 
                        entities may distribute the product with 
                        respect to the emergency use of the product 
                        (including limitation to distribution by 
                        government entities), and on how distribution 
                        is to be performed.
                            ``(ii) Appropriate conditions on who may 
                        administer the product with respect to the 
                        emergency use of the product, and on the 
                        categories of individuals to whom, and the 
                        circumstances under which, the product may be 
                        administered with respect to such use.
                            ``(iii) Appropriate conditions with respect 
                        to the collection and analysis of information, 
                        during the period when the authorization is in 
                        effect, concerning the safety and effectiveness 
                        of the product with respect to the emergency 
                        use of such product.
                            ``(iv) For persons other than manufacturers 
                        of the product, appropriate conditions 
                        concerning recordkeeping and reporting, 
                        including records access by the Secretary, with 
                        respect to the emergency use of the product.
            ``(2) Unapproved use.--With respect to the emergency use of 
        a product that is an unapproved use of an approved product:
                    ``(A) For a manufacturer of the product who carries 
                out any activity for which the authorization is issued, 
                the Secretary shall, to the extent practicable given 
                the circumstances of the emergency, establish 
                conditions described in clauses (i) and (ii) of 
                paragraph (1)(A), and may establish conditions 
                described in clauses (iii) and (iv) of such paragraph.
                    ``(B)(i) If the authorization under this section 
                regarding the emergency use authorizes a change in the 
                labeling of the product, but the manufacturer of the 
                product chooses not to make such change, such 
                authorization may not authorize distributors of the 
                product or any other person to alter or obscure the 
                labeling provided by the manufacturer.
                    ``(ii) In the circumstances described in clause 
                (i), for a person who does not manufacture the product 
                and who chooses to act under this clause, an 
                authorization under this section regarding the 
                emergency use shall, to the extent practicable given 
                the circumstances of the emergency, authorize such 
                person to provide appropriate information with respect 
                to such product in addition to the labeling provided by 
                the manufacturer, subject to compliance with clause 
                (i). While the authorization under this section is 
                effective, such additional information shall not be 
                considered labeling for purposes of section 502.
                    ``(C) The Secretary may establish with respect to 
                the distribution and administration of the product for 
                the unapproved use conditions no more restrictive than 
                those established by the Secretary with respect to the 
                distribution and administration of the product for the 
                approved use.
            ``(3) Good manufacturing practice.--With respect to the 
        emergency use of a product for which an authorization under 
        this section is issued (whether an unapproved product or an 
        unapproved use of an approved product), the Secretary may waive 
        or limit, to the extent appropriate given the circumstances of 
        the emergency, requirements regarding current good 
        manufacturing practice otherwise applicable to the manufacture, 
        processing, packing, or holding of products subject to 
        regulation under this Act, including such requirements 
        established under section 501.
            ``(4) Advertising.--The Secretary may establish conditions 
        on advertisements and other promotional descriptive printed 
        matter that relate to the emergency use of a product for which 
        an authorization under this section is issued (whether an 
        unapproved product or an unapproved use of an approved 
        product), including, as appropriate--
                    ``(A) with respect to drugs and biological 
                products, requirements applicable to prescription drugs 
                pursuant to section 502(n); or
                    ``(B) with respect to devices, requirements 
                applicable to restricted devices pursuant to section 
                502(r).
    ``(f) Duration of Authorization.--
            ``(1) In general.--Except as provided in paragraph (2), an 
        authorization under this section shall be effective until the 
        earlier of the termination of the declaration under subsection 
        (b) or a revocation under subsection (g).
            ``(2) Continued use after end of effective period.--
        Notwithstanding the termination of the declaration under 
        subsection (b) or a revocation under subsection (g), an 
        authorization shall continue to be effective to provide for 
        continued use of an unapproved product with respect to a 
        patient to whom it was administered during the period described 
        by paragraph (1), to the extent found necessary by such 
        patient's attending physician.
    ``(g) Revocation of Authorization.--
            ``(1) Review.--The Secretary shall periodically review the 
        circumstances and the appropriateness of an authorization under 
        this section.
            ``(2) Revocation.--The Secretary may revoke an 
        authorization under this section if the criteria under 
        subsection (c) for issuance of such authorization are no longer 
        met or other circumstances make such revocation appropriate to 
        protect the public health or safety.
    ``(h) Publication; Confidential Information.--
            ``(1) Publication.--The Secretary shall promptly publish in 
        the Federal Register a notice of each authorization, and each 
        termination or revocation of an authorization under this 
        section, and an explanation of the reasons therefor (which may 
        include a summary of data or information that has been 
        submitted to the Secretary in an application under section 
        505(i) or section 520(g), even if such summary may indirectly 
        reveal the existence of such application).
            ``(2) Confidential information.--Nothing in this section 
        alters or amends section 1905 of title 18, United States Code, 
        or section 552(b)(4) of title 5 of such Code.
    ``(i) Actions Committed to Agency Discretion.--Actions under the 
authority of this section by the Secretary, by the Secretary of 
Defense, or by the Secretary of Homeland Security are committed to 
agency discretion.
    ``(j) Rules of Construction.--The following applies with respect to 
this section:
            ``(1) Nothing in this section impairs the authority of the 
        President as Commander in Chief of the Armed Forces of the 
        United States under article II, section 2 of the United States 
        Constitution.
            ``(2) Nothing in this section impairs the authority of the 
        Secretary of Defense with respect to the Department of Defense, 
        including the armed forces, under other provisions of Federal 
        law.
            ``(3) Nothing in this section (including any exercise of 
        authority by a manufacturer under subsection (e)(2)) impairs 
        the authority of the United States to use or manage quantities 
        of a product that are owned or controlled by the United States 
        (including quantities in the stockpile maintained under section 
        319F-2 of the Public Health Service Act).
    ``(k) Relation to Other Provisions.--If a product is the subject of 
an authorization under this section, the use of such product within the 
scope of the authorization shall not be considered to constitute a 
clinical investigation for purposes of section 505(i), section 520(g), 
or any other provision of this Act or section 351 of the Public Health 
Service Act.
    ``(l) Option to Carry Out Authorized Activities.--Nothing in this 
section provides the Secretary any authority to require any person to 
carry out any activity that becomes lawful pursuant to an authorization 
under this section, and no person is required to inform the Secretary 
that the person will not be carrying out such activity, except that a 
manufacturer of a sole-source unapproved product authorized for 
emergency use shall report to the Secretary within a reasonable period 
of time after the issuance by the Secretary of such authorization if 
such manufacturer does not intend to carry out any activity under the 
authorization. This section only has legal effect on a person who 
carries out an activity for which an authorization under this section 
is issued. This section does not modify or affect activities carried 
out pursuant to other provisions of this Act or section 351 of the 
Public Health Service Act. Nothing in this subsection may be construed 
as restricting the Secretary from imposing conditions on persons who 
carry out any activity pursuant to an authorization under this 
section.''.
    (b) Repeal of Termination Provision.--Subsection (d) of section 
1603 of the National Defense Authorization Act for Fiscal Year 2004 (10 
U.S.C. 1107a note) is repealed.

SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

    (a) Secretary of Health and Human Services.--
            (1) Annual reports on particular exercises of authority.--
                    (A) Relevant authorities.--The Secretary of Health 
                and Human Services (referred to in this subsection as 
                the ``Secretary'') shall submit reports in accordance 
                with subparagraph (B) regarding the exercise of 
                authority under the following provisions of law:
                            (i) With respect to section 319F-1 of the 
                        Public Health Service Act (as added by section 
                        2 of this Act):
                                    (I) Subsection (b)(1) (relating to 
                                increased simplified acquisition 
                                threshold).
                                    (II) Subsection (b)(2) (relating to 
                                procedures other than full and open 
                                competition).
                                    (III) Subsection (c) (relating to 
                                expedited peer review procedures).
                            (ii) With respect to section 319F-2 of the 
                        Public Health Service Act (as added by section 
                        3 of this Act):
                                    (I) Subsection (c)(7)(C)(iii) 
                                (relating to simplified acquisition 
                                procedures).
                                    (II) Subsection (c)(7)(C)(iv) 
                                (relating to procedures other than full 
                                and open competition).
                                    (III) Subsection (c)(7)(C)(v) 
                                (relating to premium provision in 
                                multiple-award contracts).
                            (iii) With respect to section 564 of the 
                        Federal Food, Drug, and Cosmetic Act (as added 
                        by section 4 of this Act):
                                    (I) Subsection (a)(1) (relating to 
                                emergency uses of certain drugs and 
                                devices).
                                    (II) Subsection (b)(1) (relating to 
                                a declaration of an emergency).
                                    (III) Subsection (e) (relating to 
                                conditions on authorization).
                    (B) Contents of reports.--The Secretary shall 
                annually submit to the designated congressional 
                committees a report that summarizes--
                            (i) the particular actions that were taken 
                        under the authorities specified in subparagraph 
                        (A), including, as applicable, the 
                        identification of the threat agent, emergency, 
                        or the biomedical countermeasure with respect 
                        to which the authority was used;
                            (ii) the reasons underlying the decision to 
                        use such authorities, including, as applicable, 
                        the options that were considered and rejected 
                        with respect to the use of such authorities;
                            (iii) the number of, nature of, and other 
                        information concerning the persons and entities 
                        that received a grant, cooperative agreement, 
                        or contract pursuant to the use of such 
                        authorities, and the persons and entities that 
                        were considered and rejected for such a grant, 
                        cooperative agreement, or contract, except that 
                        the report need not disclose the identity of 
                        any such person or entity; and
                            (iv) whether, with respect to each 
                        procurement that is approved by the President 
                        under section 319F-2(c)(6) of the Public Health 
                        Service Act (as added by section 3 of this 
                        Act), a contract was entered into within one 
                        year after such approval by the President.
            (2) Annual summaries regarding certain activity.--The 
        Secretary shall annually submit to the designated congressional 
        committees a report that summarizes the activity undertaken 
        pursuant to the following authorities under section 319F-1 of 
        the Public Health Service Act (as added by section 2 of this 
        Act):
                    (A) Subsection (b)(3) (relating to increased 
                micropurchase threshold).
                    (B) Subsection (d) (relating to authority for 
                personal services contracts).
                    (C) Subsection (e) (relating to streamlined 
                personnel authority).
        With respect to subparagraph (B), the report shall include a 
        provision specifying, for the one-year period for which the 
        report is submitted, the number of persons who were paid 
        amounts greater than $100,000 and the number of persons who 
        were paid amounts between $50,000 and $100,000.
            (3) Report on additional barriers to procurement of 
        security countermeasures.--Not later than one year after the 
        date of the enactment of this Act, the Secretary, in 
        consultation with the Secretary of Homeland Security, shall 
        report to the designated congressional committees any potential 
        barriers to the procurement of security countermeasures that 
        have not been addressed by this Act.
    (b) General Accounting Office Review.--
            (1) In general.--Four years after the date of the enactment 
        of this Act, the Comptroller General of the United States shall 
        initiate a study--
                    (A)(i) to review the Secretary of Health and Human 
                Services' utilization of the authorities granted under 
                this Act with respect to simplified acquisition 
                procedures, procedures other than full and open 
                competition, increased micropurchase thresholds, 
                personal services contracts, streamlined personnel 
                authority, and the purchase of security countermeasures 
                under the special reserve fund; and
                    (ii) to make recommendations to improve the 
                utilization or effectiveness of such authorities in the 
                future;
                    (B)(i) to review and assess the adequacy of the 
                internal controls instituted by such Secretary with 
                respect to such authorities, where required by this 
                Act; and
                    (ii) to make recommendations to improve the 
                effectiveness of such controls;
                    (C)(i) to review such Secretary's utilization of 
                the authority granted under this Act to authorize an 
                emergency use of a biomedical countermeasure, including 
                the means by which the Secretary determines whether and 
                under what conditions any such authorizations should be 
                granted and the benefits and adverse impacts, if any, 
                resulting from the use of such authority; and
                    (ii) to make recommendations to improve the 
                utilization or effectiveness of such authority and to 
                enhance protection of the public health;
                    (D) to identify any purchases or procurements that 
                would not have been made or would have been 
                significantly delayed except for the authorities 
                described in subparagraph (A)(i); and
                    (E)(i) to determine whether and to what extent 
                activities undertaken pursuant to the biomedical 
                countermeasure research and development authorities 
                established in this Act have enhanced the development 
                of biomedical countermeasures affecting national 
                security; and
                    (ii) to make recommendations to improve the ability 
                of the Secretary to carry out these activities in the 
                future.
            (2) Additional provisions regarding determination on 
        development of biomedical countermeasures affecting national 
        security.--In the report under paragraph (1), the determination 
        under subparagraph (E) of such paragraph shall include--
                    (A) the Comptroller General's assessment of the 
                current availability of countermeasures to address 
                threats identified by the Secretary of Homeland 
                Security;
                    (B) the Comptroller General's assessment of the 
                extent to which programs and activities under this Act 
                will reduce any gap between the threat and the 
                availability of countermeasures to an acceptable level 
                of risk; and
                    (C)(i) the Comptroller General's assessment of 
                threats to national security that are posed by 
                technology that will enable, during the 10-year period 
                beginning on the date of the enactment of this Act, the 
                development of antibiotic resistant, mutated, or 
                bioengineered strains of biological agents; and
                    (ii) recommendations on short-term and long-term 
                governmental strategies for addressing such threats, 
                including recommendations for Federal policies 
                regarding research priorities, the development of 
                countermeasures, and investments in technology.
            (3) Report.--A report providing the results of the study 
        under paragraph (1) shall be submitted to the designated 
        congressional committees not later than five years after the 
        date of the enactment of this Act.
    (c) Report Regarding Biocontainment Facilities.--Not later than 120 
days after the date of the enactment of this Act, the Secretary of 
Homeland Security and the Secretary of Health and Human Services shall 
jointly report to the designated congressional committees whether there 
is a lack of adequate large-scale biocontainment facilities necessary 
for the testing of security countermeasures in accordance with Food and 
Drug Administration requirements.
    (d) Designated Congressional Committees.--For purposes of this 
section, the term ``designated congressional committees'' means the 
following committees of the Congress:
            (1) In the House of Representatives: the Committee on 
        Energy and Commerce, the Committee on Appropriations, the 
        Committee on Government Reform, and the Select Committee on 
        Homeland Security (or any successor to the Select Committee).
            (2) In the Senate: the appropriate committees.

SEC. 6. OUTREACH.

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

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

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

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

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

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

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

            Passed the Senate May 19, 2004.

            Attest:

                                                             Secretary.
108th CONGRESS

  2d Session

                                 S. 15

_______________________________________________________________________

                                 AN ACT

   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.