```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3678 Enrolled Bill (ENR)]

        S.3678

                       One Hundred Ninth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
             the third day of January, two thousand and six

                                 An Act

 
  To amend the Public Health Service Act with respect to public health 
   security and all-hazards preparedness and response, and for other 
                                purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.

 TITLE I--NATIONAL PREPAREDNESS AND RESPONSE, LEADERSHIP, ORGANIZATION, 
                              AND PLANNING

Sec. 101. Public health and medical preparedness and response functions 
          of the Secretary of Health and Human Services.
Sec. 102. Assistant Secretary for Preparedness and Response.
Sec. 103. National Health Security Strategy.

              TITLE II--PUBLIC HEALTH SECURITY PREPAREDNESS

Sec. 201. Improving State and local public health security.
Sec. 202. Using information technology to improve situational awareness 
          in public health emergencies.
Sec. 203. Public health workforce enhancements.
Sec. 204. Vaccine tracking and distribution.
Sec. 205. National Science Advisory Board for Biosecurity.
Sec. 206. Revitalization of Commissioned Corps.

              TITLE III--ALL-HAZARDS MEDICAL SURGE CAPACITY

Sec. 301. National disaster medical system.
Sec. 302. Enhancing medical surge capacity.
Sec. 303. Encouraging health professional volunteers.
Sec. 304. Core education and training.
Sec. 305. Partnerships for State and regional hospital preparedness to 
          improve surge capacity.
Sec. 306. Enhancing the role of the Department of Veterans Affairs.

     TITLE IV--PANDEMIC AND BIODEFENSE VACCINE AND DRUG DEVELOPMENT

Sec. 401. Biomedical Advanced Research and Development Authority.
Sec. 402. National Biodefense Science Board.
Sec. 403. Clarification of countermeasures covered by Project BioShield.
Sec. 404. Technical assistance.
Sec. 405. Collaboration and coordination.
Sec. 406. Procurement.

TITLE I--NATIONAL PREPAREDNESS AND RESPONSE, LEADERSHIP, ORGANIZATION, 
                              AND PLANNING

SEC. 101. PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE FUNCTIONS 
              OF THE SECRETARY OF HEALTH AND HUMAN SERVICES.

    Title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-11 
et seq.) is amended--
        (1) by striking the title heading and inserting the following:

  ``TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH 
                             EMERGENCIES'';

    and
        (2) by amending subtitle A to read as follows:

``Subtitle A--National All-Hazards Preparedness and Response Planning, 
                      Coordinating, and Reporting

``SEC. 2801. PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE 
              FUNCTIONS.

    ``(a) In General.--The Secretary of Health and Human Services shall 
lead all Federal public health and medical response to public health 
emergencies and incidents covered by the National Response Plan 
developed pursuant to section 502(6) of the Homeland Security Act of 
2002, or any successor plan.
    ``(b) Interagency Agreement.--The Secretary, in collaboration with 
the Secretary of Veterans Affairs, the Secretary of Transportation, the 
Secretary of Defense, the Secretary of Homeland Security, and the head 
of any other relevant Federal agency, shall establish an interagency 
agreement, consistent with the National Response Plan or any successor 
plan, under which agreement the Secretary of Health and Human Services 
shall assume operational control of emergency public health and medical 
response assets, as necessary, in the event of a public health 
emergency, except that members of the armed forces under the authority 
of the Secretary of Defense shall remain under the command and control 
of the Secretary of Defense, as shall any associated assets of the 
Department of Defense.''.

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

    (a) Assistant Secretary for Preparedness and Response.--Subtitle B 
of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-11 et 
seq.) is amended--
        (1) in the subtitle heading, by inserting ``All-Hazards'' 
    before ``Emergency Preparedness'';
        (2) by redesignating section 2811 as section 2812;
        (3) by inserting after the subtitle heading the following new 
    section:

``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-
              HAZARDS PUBLIC HEALTH EMERGENCIES.

    ``(a) In General.--There is established within the Department of 
Health and Human Services the position of the Assistant Secretary for 
Preparedness and Response. The President, with the advice and consent 
of the Senate, shall appoint an individual to serve in such position. 
Such Assistant Secretary shall report to the Secretary.
    ``(b) Duties.--Subject to the authority of the Secretary, the 
Assistant Secretary for Preparedness and Response shall carry out the 
following functions:
        ``(1) Leadership.--Serve as the principal advisor to the 
    Secretary on all matters related to Federal public health and 
    medical preparedness and response for public health emergencies.
        ``(2) Personnel.--Register, credential, organize, train, equip, 
    and have the authority to deploy Federal public health and medical 
    personnel under the authority of the Secretary, including the 
    National Disaster Medical System, and coordinate such personnel 
    with the Medical Reserve Corps and the Emergency System for Advance 
    Registration of Volunteer Health Professionals.
        ``(3) Countermeasures.--Oversee advanced research, development, 
    and procurement of qualified countermeasures (as defined in section 
    319F-1) and qualified pandemic or epidemic products (as defined in 
    section 319F-3).
        ``(4) Coordination.--
            ``(A) Federal integration.--Coordinate with relevant 
        Federal officials to ensure integration of Federal preparedness 
        and response activities for public health emergencies.
            ``(B) State, local, and tribal integration.--Coordinate 
        with State, local, and tribal public health officials, the 
        Emergency Management Assistance Compact, health care systems, 
        and emergency medical service systems to ensure effective 
        integration of Federal public health and medical assets during 
        a public health emergency.
            ``(C) Emergency medical services.--Promote improved 
        emergency medical services medical direction, system 
        integration, research, and uniformity of data collection, 
        treatment protocols, and policies with regard to public health 
        emergencies.
        ``(5) Logistics.--In coordination with the Secretary of 
    Veterans Affairs, the Secretary of Homeland Security, the General 
    Services Administration, and other public and private entities, 
    provide logistical support for medical and public health aspects of 
    Federal responses to public health emergencies.
        ``(6) Leadership.--Provide leadership in international 
    programs, initiatives, and policies that deal with public health 
    and medical emergency preparedness and response.
    ``(c) Functions.--The Assistant Secretary for Preparedness and 
Response shall--
        ``(1) have authority over and responsibility for--
            ``(A) the National Disaster Medical System (in accordance 
        with section 301 of the Pandemic and All-Hazards Preparedness 
        Act); and
            ``(B) the Hospital Preparedness Cooperative Agreement 
        Program pursuant to section 319C-2;
        ``(2) exercise the responsibilities and authorities of the 
    Secretary with respect to the coordination of--
            ``(A) the Medical Reserve Corps pursuant to section 2813;
            ``(B) the Emergency System for Advance Registration of 
        Volunteer Health Professionals pursuant to section 319I;
            ``(C) the Strategic National Stockpile; and
            ``(D) the Cities Readiness Initiative; and
        ``(3) assume other duties as determined appropriate by the 
    Secretary.''; and
        (4) by striking ``Assistant Secretary for Public Health 
    Emergency Preparedness'' each place it appears and inserting 
    ``Assistant Secretary for Preparedness and Response''.
    (b) Transfer of Functions; References.--
        (1) Transfer of functions.--There shall be transferred to the 
    Office of the Assistant Secretary for Preparedness and Response the 
    functions, personnel, assets, and liabilities of the Assistant 
    Secretary for Public Health Emergency Preparedness as in effect on 
    the day before the date of enactment of this Act.
        (2) References.--Any reference in any Federal law, Executive 
    order, rule, regulation, or delegation of authority, or any 
    document of or pertaining to the Assistant Secretary for Public 
    Health Emergency Preparedness as in effect the day before the date 
    of enactment of this Act, shall be deemed to be a reference to the 
    Assistant Secretary for Preparedness and Response.
    (c) Stockpile.--Section 319F-2(a)(1) of the Public Health Service 
Act (42 U.S.C. 247d-6b(a)(1)) is amended by--
        (1) inserting ``in collaboration with the Director of the 
    Centers for Disease Control and Prevention, and'' after 
    ``Secretary,''; and
        (2) inserting at the end the following: ``The Secretary shall 
    conduct an annual review (taking into account at-risk individuals) 
    of the contents of the stockpile, including non-pharmaceutical 
    supplies, and make necessary additions or modifications to the 
    contents based on such review.''.
    (d) At-Risk Individuals.--Title XXVIII of the Public Health Service 
Act (42 U.S.C. 300hh et seq.), as amended by section 303 of this Act, 
is amended by inserting after section 2813 the following:

``SEC. 2814. AT-RISK INDIVIDUALS.

    ``The Secretary, acting through such employee of the Department of 
Health and Human Services as determined by the Secretary and designated 
publicly (which may, at the discretion of the Secretary, involve the 
appointment or designation of an individual as the Director of At-Risk 
Individuals), shall--
        ``(1) oversee the implementation of the National Preparedness 
    goal of taking into account the public health and medical needs of 
    at-risk individuals in the event of a public health emergency, as 
    described in section 2802(b)(4);
        ``(2) assist other Federal agencies responsible for planning 
    for, responding to, and recovering from public health emergencies 
    in addressing the needs of at-risk individuals;
        ``(3) provide guidance to and ensure that recipients of State 
    and local public health grants include preparedness and response 
    strategies and capabilities that take into account the medical and 
    public health needs of at-risk individuals in the event of a public 
    health emergency, as described in section 319C-1(b)(2)(A)(iii);
        ``(4) ensure that the contents of the strategic national 
    stockpile take into account at-risk populations as described in 
    section 2811(b)(3)(B);
        ``(5) oversee the progress of the Advisory Committee on At-Risk 
    Individuals and Public Health Emergencies established under section 
    319F(b)(2) and make recommendations with a focus on opportunities 
    for action based on the work of the Committee;
        ``(6) oversee curriculum development for the public health and 
    medical response training program on medical management of 
    casualties, as it concerns at-risk individuals as described in 
    subparagraphs (A) through (C) of section 319F(a)(2);
        ``(7) disseminate novel and best practices of outreach to and 
    care of at-risk individuals before, during, and following public 
    health emergencies; and
        ``(8) not later than one year after the date of enactment of 
    the Pandemic and All-Hazards Preparedness Act, prepare and submit 
    to Congress a report describing the progress made on implementing 
    the duties described in this section.''.

SEC. 103. NATIONAL HEALTH SECURITY STRATEGY.

    Title XXVIII of the Public Health Service Act (300hh-11 et seq.), 
as amended by section 101, is amended by inserting after section 2801 
the following:

``SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.

    ``(a) In General.--
        ``(1) Preparedness and response regarding public health 
    emergencies.--Beginning in 2009 and every four years thereafter, 
    the Secretary shall prepare and submit to the relevant committees 
    of Congress a coordinated strategy (to be known as the National 
    Health Security Strategy) and any revisions thereof, and an 
    accompanying implementation plan for public health emergency 
    preparedness and response. Such National Health Security Strategy 
    shall identify the process for achieving the preparedness goals 
    described in subsection (b) and shall be consistent with the 
    National Preparedness Goal, the National Incident Management 
    System, and the National Response Plan developed pursuant to 
    section 502(6) of the Homeland Security Act of 2002, or any 
    successor plan.
        ``(2) Evaluation of progress.--The National Health Security 
    Strategy shall include an evaluation of the progress made by 
    Federal, State, local, and tribal entities, based on the evidence-
    based benchmarks and objective standards that measure levels of 
    preparedness established pursuant to section 319C-1(g). Such 
    evaluation shall include aggregate and State-specific breakdowns of 
    obligated funding spent by major category (as defined by the 
    Secretary) for activities funded through awards pursuant to 
    sections 319C-1 and 319C-2.
        ``(3) Public health workforce.--In 2009, the National Health 
    Security Strategy shall include a national strategy for 
    establishing an effective and prepared public health workforce, 
    including defining the functions, capabilities, and gaps in such 
    workforce, and identifying strategies to recruit, retain, and 
    protect such workforce from workplace exposures during public 
    health emergencies.
    ``(b) Preparedness Goals.--The National Health Security Strategy 
shall include provisions in furtherance of the following:
        ``(1) Integration.--Integrating public health and public and 
    private medical capabilities with other first responder systems, 
    including through--
            ``(A) the periodic evaluation of Federal, State, local, and 
        tribal preparedness and response capabilities through drills 
        and exercises; and
            ``(B) integrating public and private sector public health 
        and medical donations and volunteers.
        ``(2) Public health.--Developing and sustaining Federal, State, 
    local, and tribal essential public health security capabilities, 
    including the following:
            ``(A) Disease situational awareness domestically and 
        abroad, including detection, identification, and investigation.
            ``(B) Disease containment including capabilities for 
        isolation, quarantine, social distancing, and decontamination.
            ``(C) Risk communication and public preparedness.
            ``(D) Rapid distribution and administration of medical 
        countermeasures.
        ``(3) Medical.--Increasing the preparedness, response 
    capabilities, and surge capacity of hospitals, other health care 
    facilities (including mental health facilities), and trauma care 
    and emergency medical service systems, with respect to public 
    health emergencies, which shall include developing plans for the 
    following:
            ``(A) Strengthening public health emergency medical 
        management and treatment capabilities.
            ``(B) Medical evacuation and fatality management.
            ``(C) Rapid distribution and administration of medical 
        countermeasures.
            ``(D) Effective utilization of any available public and 
        private mobile medical assets and integration of other Federal 
        assets.
            ``(E) Protecting health care workers and health care first 
        responders from workplace exposures during a public health 
        emergency.
        ``(4) At-risk individuals.--
            ``(A) Taking into account the public health and medical 
        needs of at-risk individuals in the event of a public health 
        emergency.
            ``(B) For purpose of this section and sections 319C-1, 
        319F, and 319L, the term `at-risk individuals' means children, 
        pregnant women, senior citizens and other individuals who have 
        special needs in the event of a public health emergency, as 
        determined by the Secretary.
        ``(5) Coordination.--Minimizing duplication of, and ensuring 
    coordination between, Federal, State, local, and tribal planning, 
    preparedness, and response activities (including the State 
    Emergency Management Assistance Compact). Such planning shall be 
    consistent with the National Response Plan, or any successor plan, 
    and National Incident Management System and the National 
    Preparedness Goal.
        ``(6) Continuity of operations.--Maintaining vital public 
    health and medical services to allow for optimal Federal, State, 
    local, and tribal operations in the event of a public health 
    emergency.''.

             TITLE II--PUBLIC HEALTH SECURITY PREPAREDNESS

SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

    Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a) 
is amended--
        (1) by amending the heading to read as follows: ``improving 
    state and local public health security.'';
        (2) by striking subsections (a) through (i) and inserting the 
    following:
    ``(a) In General.--To enhance the security of the United States 
with respect to public health emergencies, the Secretary shall award 
cooperative agreements to eligible entities to enable such entities to 
conduct the activities described in subsection (d).
    ``(b) Eligible Entities.--To be eligible to receive an award under 
subsection (a), an entity shall--
        ``(1)(A) be a State;
        ``(B) be a political subdivision determined by the Secretary to 
    be eligible for an award under this section (based on criteria 
    described in subsection (i)(4)); or
        ``(C) be a consortium of entities described in subparagraph 
    (A); and
        ``(2) prepare and submit to the Secretary an application at 
    such time, and in such manner, and containing such information as 
    the Secretary may require, including--
            ``(A) an All-Hazards Public Health Emergency Preparedness 
        and Response Plan which shall include--
                ``(i) a description of the activities such entity will 
            carry out under the agreement to meet the goals identified 
            under section 2802;
                ``(ii) a pandemic influenza plan consistent with the 
            requirements of paragraphs (2) and (5) of subsection (g);
                ``(iii) preparedness and response strategies and 
            capabilities that take into account the medical and public 
            health needs of at-risk individuals in the event of a 
            public health emergency;
                ``(iv) a description of the mechanism the entity will 
            implement to utilize the Emergency Management Assistance 
            Compact or other mutual aid agreements for medical and 
            public health mutual aid; and
                ``(v) a description of how the entity will include the 
            State Unit on Aging in public health emergency 
            preparedness;
            ``(B) an assurance that the entity will report to the 
        Secretary on an annual basis (or more frequently as determined 
        by the Secretary) on the evidence-based benchmarks and 
        objective standards established by the Secretary to evaluate 
        the preparedness and response capabilities of such entity under 
        subsection (g);
            ``(C) an assurance that the entity will conduct, on at 
        least an annual basis, an exercise or drill that meets any 
        criteria established by the Secretary to test the preparedness 
        and response capabilities of such entity, and that the entity 
        will report back to the Secretary within the application of the 
        following year on the strengths and weaknesses identified 
        through such exercise or drill, and corrective actions taken to 
        address material weaknesses;
            ``(D) an assurance that the entity will provide to the 
        Secretary the data described under section 319D(d)(3) as 
        determined feasible by the Secretary;
            ``(E) an assurance that the entity will conduct activities 
        to inform and educate the hospitals within the jurisdiction of 
        such entity on the role of such hospitals in the plan required 
        under subparagraph (A);
            ``(F) an assurance that the entity, with respect to the 
        plan described under subparagraph (A), has developed and will 
        implement an accountability system to ensure that such entity 
        make satisfactory annual improvement and describe such system 
        in the plan under subparagraph (A);
            ``(G) a description of the means by which to obtain public 
        comment and input on the plan described in subparagraph (A) and 
        on the implementation of such plan, that shall include an 
        advisory committee or other similar mechanism for obtaining 
        comment from the public and from other State, local, and tribal 
        stakeholders; and
            ``(H) as relevant, a description of the process used by the 
        entity to consult with local departments of public health to 
        reach consensus, approval, or concurrence on the relative 
        distribution of amounts received under this section.
    ``(c) Limitation.--Beginning in fiscal year 2009, the Secretary may 
not award a cooperative agreement to a State unless such State is a 
participant in the Emergency System for Advance Registration of 
Volunteer Health Professionals described in section 319I.
    ``(d) Use of Funds.--
        ``(1) In general.--An award under subsection (a) shall be 
    expended for activities to achieve the preparedness goals described 
    under paragraphs (1), (2), (4), (5), and (6) of section 2802(b).
        ``(2) Effect of section.--Nothing in this subsection may be 
    construed as establishing new regulatory authority or as modifying 
    any existing regulatory authority.
    ``(e) Coordination With Local Response Capabilities.--An entity 
shall, to the extent practicable, ensure that activities carried out 
under an award under subsection (a) are coordinated with activities of 
relevant Metropolitan Medical Response Systems, local public health 
departments, the Cities Readiness Initiative, and local emergency 
plans.
    ``(f) Consultation With Homeland Security.--In making awards under 
subsection (a), the Secretary shall consult with the Secretary of 
Homeland Security to--
        ``(1) ensure maximum coordination of public health and medical 
    preparedness and response activities with the Metropolitan Medical 
    Response System, and other relevant activities;
        ``(2) minimize duplicative funding of programs and activities;
        ``(3) analyze activities, including exercises and drills, 
    conducted under this section to develop recommendations and 
    guidance on best practices for such activities; and
        ``(4) disseminate such recommendations and guidance, including 
    through expanding existing lessons learned information systems to 
    create a single Internet-based point of access for sharing and 
    distributing medical and public health best practices and lessons 
    learned from drills, exercises, disasters, and other emergencies.
    ``(g) Achievement of Measurable Evidence-Based Benchmarks and 
Objective Standards.--
        ``(1) In general.--Not later than 180 days after the date of 
    enactment of the Pandemic and All-Hazards Preparedness Act, the 
    Secretary shall develop or where appropriate adopt, and require the 
    application of, measurable evidence-based benchmarks and objective 
    standards that measure levels of preparedness with respect to the 
    activities described in this section and with respect to activities 
    described in section 319C-2. In developing such benchmarks and 
    standards, the Secretary shall consult with and seek comments from 
    State, local, and tribal officials and private entities, as 
    appropriate. Where appropriate, the Secretary shall incorporate 
    existing objective standards. Such benchmarks and standards shall--
            ``(A) include outcome goals representing operational 
        achievement of the National Preparedness Goals developed under 
        section 2802(b); and
            ``(B) at a minimum, require entities to--
                ``(i) measure progress toward achieving the outcome 
            goals; and
                ``(ii) at least annually, test, exercise, and 
            rigorously evaluate the public health and medical emergency 
            preparedness and response capabilities of the entity, and 
            report to the Secretary on such measured and tested 
            capabilities and measured and tested progress toward 
            achieving outcome goals, based on criteria established by 
            the Secretary.
        ``(2) Criteria for pandemic influenza plans.--
            ``(A) In general.--Not later than 180 days after the date 
        of enactment of the Pandemic and All-Hazards Preparedness Act, 
        the Secretary shall develop and disseminate to the chief 
        executive officer of each State criteria for an effective State 
        plan for responding to pandemic influenza.
            ``(B) Rule of construction.--Nothing in this section shall 
        be construed to require the duplication of Federal efforts with 
        respect to the development of criteria or standards, without 
        regard to whether such efforts were carried out prior to or 
        after the date of enactment of this section.
        ``(3) Technical assistance.--The Secretary shall, as determined 
    appropriate by the Secretary, provide to a State, upon request, 
    technical assistance in meeting the requirements of this section, 
    including the provision of advice by experts in the development of 
    high-quality assessments, the setting of State objectives and 
    assessment methods, the development of measures of satisfactory 
    annual improvement that are valid and reliable, and other relevant 
    areas.
        ``(4) Notification of failures.--The Secretary shall develop 
    and implement a process to notify entities that are determined by 
    the Secretary to have failed to meet the requirements of paragraph 
    (1) or (2). Such process shall provide such entities with the 
    opportunity to correct such noncompliance. An entity that fails to 
    correct such noncompliance shall be subject to paragraph (5).
        ``(5) Withholding of amounts from entities that fail to achieve 
    benchmarks or submit influenza plan.--Beginning with fiscal year 
    2009, and in each succeeding fiscal year, the Secretary shall--
            ``(A) withhold from each entity that has failed 
        substantially to meet the benchmarks and performance measures 
        described in paragraph (1) for the immediately preceding fiscal 
        year (beginning with fiscal year 2008), pursuant to the process 
        developed under paragraph (4), the amount described in 
        paragraph (6); and
            ``(B) withhold from each entity that has failed to submit 
        to the Secretary a plan for responding to pandemic influenza 
        that meets the criteria developed under paragraph (2), the 
        amount described in paragraph (6).
        ``(6) Amounts described.--
            ``(A) In general.--The amounts described in this paragraph 
        are the following amounts that are payable to an entity for 
        activities described in section 319C-1 or 319C-2:
                ``(i) For the fiscal year immediately following a 
            fiscal year in which an entity experienced a failure 
            described in subparagraph (A) or (B) of paragraph (5) by 
            the entity, an amount equal to 10 percent of the amount the 
            entity was eligible to receive for such fiscal year.
                ``(ii) For the fiscal year immediately following two 
            consecutive fiscal years in which an entity experienced 
            such a failure, an amount equal to 15 percent of the amount 
            the entity was eligible to receive for such fiscal year, 
            taking into account the withholding of funds for the 
            immediately preceding fiscal year under clause (i).
                ``(iii) For the fiscal year immediately following three 
            consecutive fiscal years in which an entity experienced 
            such a failure, an amount equal to 20 percent of the amount 
            the entity was eligible to receive for such fiscal year, 
            taking into account the withholding of funds for the 
            immediately preceding fiscal years under clauses (i) and 
            (ii).
                ``(iv) For the fiscal year immediately following four 
            consecutive fiscal years in which an entity experienced 
            such a failure, an amount equal to 25 percent of the amount 
            the entity was eligible to receive for such a fiscal year, 
            taking into account the withholding of funds for the 
            immediately preceding fiscal years under clauses (i), (ii), 
            and (iii).
            ``(B) Separate accounting.--Each failure described in 
        subparagraph (A) or (B) of paragraph (5) shall be treated as a 
        separate failure for purposes of calculating amounts withheld 
        under subparagraph (A).
        ``(7) Reallocation of amounts withheld.--
            ``(A) In general.--The Secretary shall make amounts 
        withheld under paragraph (6) available for making awards under 
        section 319C-2 to entities described in subsection (b)(1) of 
        such section.
            ``(B) Preference in reallocation.--In making awards under 
        section 319C-2 with amounts described in subparagraph (A), the 
        Secretary shall give preference to eligible entities (as 
        described in section 319C-2(b)(1)) that are located in whole or 
        in part in States from which amounts have been withheld under 
        paragraph (6).
        ``(8) Waive or reduce withholding.--The Secretary may waive or 
    reduce the withholding described in paragraph (6), for a single 
    entity or for all entities in a fiscal year, if the Secretary 
    determines that mitigating conditions exist that justify the waiver 
    or reduction.
    ``(h) Grants for Real-Time Disease Detection Improvement.--
        ``(1) In general.--The Secretary may award grants to eligible 
    entities to carry out projects described under paragraph (4).
        ``(2) Eligible entity.--For purposes of this section, the term 
    `eligible entity' means an entity that is--
            ``(A)(i) a hospital, clinical laboratory, university; or
            ``(ii) a poison control center or professional organization 
        in the field of poison control; and
            ``(B) a participant in the network established under 
        subsection 319D(d).
        ``(3) Application.--Each eligible entity desiring a grant under 
    this subsection shall submit to the Secretary an application at 
    such time, in such manner, and containing such information as the 
    Secretary may require.
        ``(4) Use of funds.--
            ``(A) In general.--An eligible entity described in 
        paragraph (2)(A)(i) that receives a grant under this subsection 
        shall use the funds awarded pursuant to such grant to carry out 
        a pilot demonstration project to purchase and implement the use 
        of advanced diagnostic medical equipment to analyze real-time 
        clinical specimens for pathogens of public health or 
        bioterrorism significance and report any results from such 
        project to State, local, and tribal public health entities and 
        the network established under section 319D(d).
            ``(B) Other entities.--An eligible entity described in 
        paragraph (2)(A)(ii) that receives a grant under this section 
        shall use the funds awarded pursuant to such grant to--
                ``(i) improve the early detection, surveillance, and 
            investigative capabilities of poison control centers for 
            chemical, biological, radiological, and nuclear events by 
            training poison information personnel to improve the 
            accuracy of surveillance data, improving the definitions 
            used by the poison control centers for surveillance, and 
            enhancing timely and efficient investigation of data 
            anomalies;
                ``(ii) improve the capabilities of poison control 
            centers to provide information to health care providers and 
            the public with regard to chemical, biological, 
            radiological, or nuclear threats or exposures, in 
            consultation with the appropriate State, local, and tribal 
            public health entities; or
                ``(iii) provide surge capacity in the event of a 
            chemical, biological, radiological, or nuclear event 
            through the establishment of alternative poison control 
            center worksites and the training of nontraditional 
            personnel.'';
        (3) by redesignating subsection (j) as subsection (i);
        (4) in subsection (i), as so redesignated--
            (A) by striking paragraphs (1) through (3)(A) and inserting 
        the following:
        ``(1) Authorization of appropriations.--
            ``(A) In general.--For the purpose of carrying out this 
        section, there is authorized to be appropriated $824,000,000 
        for fiscal year 2007, of which $35,000,000 shall be used to 
        carry out subsection (h), for awards pursuant to paragraph (3) 
        (subject to the authority of the Secretary to make awards 
        pursuant to paragraphs (4) and (5)), and such sums as may be 
        necessary for each of fiscal years 2008 through 2011.
            ``(B) Coordination.--There are authorized to be 
        appropriated, $10,000,000 for fiscal year 2007 to carry out 
        subsection (f)(4) of this section and section 2814.
            ``(C) Requirement for state matching funds.--Beginning in 
        fiscal year 2009, in the case of any State or consortium of two 
        or more States, the Secretary may not award a cooperative 
        agreement under this section unless the State or consortium of 
        States agree that, with respect to the amount of the 
        cooperative agreement awarded by the Secretary, the State or 
        consortium of States will make available (directly or through 
        donations from public or private entities) non-Federal 
        contributions in an amount equal to--
                ``(i) for the first fiscal year of the cooperative 
            agreement, not less than 5 percent of such costs ($1 for 
            each $20 of Federal funds provided in the cooperative 
            agreement); and
                ``(ii) for any second fiscal year of the cooperative 
            agreement, and for any subsequent fiscal year of such 
            cooperative agreement, not less than 10 percent of such 
            costs ($1 for each $10 of Federal funds provided in the 
            cooperative agreement).
            ``(D) Determination of amount of non-federal 
        contributions.--As determined by the Secretary, non-Federal 
        contributions required in subparagraph (C) may be provided 
        directly or through donations from public or private entities 
        and may be in cash or in kind, fairly evaluated, including 
        plant, equipment or services. Amounts provided by the Federal 
        government, or services assisted or subsidized to any 
        significant extent by the Federal government, may not be 
        included in determining the amount of such non-Federal 
        contributions.
        ``(2) Maintaining state funding.--
            ``(A) In general.--An entity that receives an award under 
        this section shall maintain expenditures for public health 
        security at a level that is not less than the average level of 
        such expenditures maintained by the entity for the preceding 2 
        year period.
            ``(B) Rule of construction.--Nothing in this section shall 
        be construed to prohibit the use of awards under this section 
        to pay salary and related expenses of public health and other 
        professionals employed by State, local, or tribal public health 
        agencies who are carrying out activities supported by such 
        awards (regardless of whether the primary assignment of such 
        personnel is to carry out such activities).
        ``(3) Determination of amount.--
            ``(A) In general.--The Secretary shall award cooperative 
        agreements under subsection (a) to each State or consortium of 
        2 or more States that submits to the Secretary an application 
        that meets the criteria of the Secretary for the receipt of 
        such an award and that meets other implementation conditions 
        established by the Secretary for such awards.'';
            (B) in paragraph (4)(A)--
                (i) by striking ``2003'' and inserting ``2007''; and
                (ii) by striking ``(A)(i)(I)'';
            (C) in paragraph (4)(D), by striking ``2002'' and inserting 
        ``2006'';
            (D) in paragraph (5)--
                (i) by striking ``2003'' and inserting ``2007''; and
                (ii) by striking ``(A)(i)(I)''; and
            (E) by striking paragraph (6) and inserting the following:
        ``(6) Funding of local entities.--The Secretary shall, in 
    making awards under this section, ensure that with respect to the 
    cooperative agreement awarded, the entity make available 
    appropriate portions of such award to political subdivisions and 
    local departments of public health through a process involving the 
    consensus, approval or concurrence with such local entities.''; and
        (5) by adding at the end the following:
    ``(j) Administrative and Fiscal Responsibility.--
        ``(1) Annual reporting requirements.--Each entity shall prepare 
    and submit to the Secretary annual reports on its activities under 
    this section and section 319C-2. Each such report shall be prepared 
    by, or in consultation with, the health department. In order to 
    properly evaluate and compare the performance of different entities 
    assisted under this section and section 319C-2 and to assure the 
    proper expenditure of funds under this section and section 319C-2, 
    such reports shall be in such standardized form and contain such 
    information as the Secretary determines and describes within 180 
    days of the date of enactment of the Pandemic and All-Hazards 
    Preparedness Act (after consultation with the States) to be 
    necessary to--
            ``(A) secure an accurate description of those activities;
            ``(B) secure a complete record of the purposes for which 
        funds were spent, and of the recipients of such funds;
            ``(C) describe the extent to which the entity has met the 
        goals and objectives it set forth under this section or section 
        319C-2;
            ``(D) determine the extent to which funds were expended 
        consistent with the entity's application transmitted under this 
        section or section 319C-2; and
            ``(E) publish such information on a Federal Internet 
        website consistent with subsection (k).
        ``(2) Audits; implementation.--
            ``(A) In general.--Each entity receiving funds under this 
        section or section 319C-2 shall, not less often than once every 
        2 years, audit its expenditures from amounts received under 
        this section or section 319C-2. Such audits shall be conducted 
        by an entity independent of the agency administering a program 
        funded under this section or section 319C-2 in accordance with 
        the Comptroller General's standards for auditing governmental 
        organizations, programs, activities, and functions and 
        generally accepted auditing standards. Within 30 days following 
        the completion of each audit report, the entity shall submit a 
        copy of that audit report to the Secretary.
            ``(B) Repayment.--Each entity shall repay to the United 
        States amounts found by the Secretary, after notice and 
        opportunity for a hearing to the entity, not to have been 
        expended in accordance with this section or section 319C-2 and, 
        if such repayment is not made, the Secretary may offset such 
        amounts against the amount of any allotment to which the entity 
        is or may become entitled under this section or section 319C-2 
        or may otherwise recover such amounts.
            ``(C) Withholding of payment.--The Secretary may, after 
        notice and opportunity for a hearing, withhold payment of funds 
        to any entity which is not using its allotment under this 
        section or section 319C-2 in accordance with such section. The 
        Secretary may withhold such funds until the Secretary finds 
        that the reason for the withholding has been removed and there 
        is reasonable assurance that it will not recur.
        ``(3) Maximum carryover amount.--
            ``(A) In general.--For each fiscal year, the Secretary, in 
        consultation with the States and political subdivisions, shall 
        determine the maximum percentage amount of an award under this 
        section that an entity may carryover to the succeeding fiscal 
        year.
            ``(B) Amount exceeded.--For each fiscal year, if the 
        percentage amount of an award under this section unexpended by 
        an entity exceeds the maximum percentage permitted by the 
        Secretary under subparagraph (A), the entity shall return to 
        the Secretary the portion of the unexpended amount that exceeds 
        the maximum amount permitted to be carried over by the 
        Secretary.
            ``(C) Action by secretary.--The Secretary shall make 
        amounts returned to the Secretary under subparagraph (B) 
        available for awards under section 319C-2(b)(1). In making 
        awards under section 319C-2(b)(1) with amounts collected under 
        this paragraph the Secretary shall give preference to entities 
        that are located in whole or in part in States from which 
        amounts have been returned under subparagraph (B).
            ``(D) Waiver.--An entity may apply to the Secretary for a 
        waiver of the maximum percentage amount under subparagraph (A). 
        Such an application for a waiver shall include an explanation 
        why such requirement should not apply to the entity and the 
        steps taken by such entity to ensure that all funds under an 
        award under this section will be expended appropriately.
            ``(E) Waive or reduce withholding.--The Secretary may waive 
        the application of subparagraph (B), or reduce the amount 
        determined under such subparagraph, for a single entity 
        pursuant to subparagraph (D) or for all entities in a fiscal 
        year, if the Secretary determines that mitigating conditions 
        exist that justify the waiver or reduction.
    ``(k) Compilation and Availability of Data.--The Secretary shall 
compile the data submitted under this section and make such data 
available in a timely manner on an appropriate Internet website in a 
format that is useful to the public and to other entities and that 
provides information on what activities are best contributing to the 
achievement of the outcome goals described in subsection (g).''.

SEC. 202. USING INFORMATION TECHNOLOGY TO IMPROVE SITUATIONAL AWARENESS 
              IN PUBLIC HEALTH EMERGENCIES.

    Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is 
amended--
        (1) in subsection (a)(1), by inserting ``domestically and 
    abroad'' after ``public health threats''; and
        (2) by adding at the end the following:
    ``(d) Public Health Situational Awareness.--
        ``(1) In general.--Not later than 2 years after the date of 
    enactment of the Pandemic and All-Hazards Preparedness Act, the 
    Secretary, in collaboration with State, local, and tribal public 
    health officials, shall establish a near real-time electronic 
    nationwide public health situational awareness capability through 
    an interoperable network of systems to share data and information 
    to enhance early detection of rapid response to, and management of, 
    potentially catastrophic infectious disease outbreaks and other 
    public health emergencies that originate domestically or abroad. 
    Such network shall be built on existing State situational awareness 
    systems or enhanced systems that enable such connectivity.
        ``(2) Strategic plan.--Not later than 180 days after the date 
    of enactment the Pandemic and All-Hazards Preparedness Act, the 
    Secretary shall submit to the appropriate committees of Congress, a 
    strategic plan that demonstrates the steps the Secretary will 
    undertake to develop, implement, and evaluate the network described 
    in paragraph (1), utilizing the elements described in paragraph 
    (3).
        ``(3) Elements.--The network described in paragraph (1) shall 
    include data and information transmitted in a standardized format 
    from--
            ``(A) State, local, and tribal public health entities, 
        including public health laboratories;
            ``(B) Federal health agencies;
            ``(C) zoonotic disease monitoring systems;
            ``(D) public and private sector health care entities, 
        hospitals, pharmacies, poison control centers or professional 
        organizations in the field of poison control, and clinical 
        laboratories, to the extent practicable and provided that such 
        data are voluntarily provided simultaneously to the Secretary 
        and appropriate State, local, and tribal public health 
        agencies; and
            ``(E) such other sources as the Secretary may deem 
        appropriate.
        ``(4) Rule of construction.--Paragraph (3) shall not be 
    construed as requiring separate reporting of data and information 
    from each source listed.
        ``(5) Required activities.--In establishing and operating the 
    network described in paragraph (1), the Secretary shall--
            ``(A) utilize applicable interoperability standards as 
        determined by the Secretary through a joint public and private 
        sector process;
            ``(B) define minimal data elements for such network;
            ``(C) in collaboration with State, local, and tribal public 
        health officials, integrate and build upon existing State, 
        local, and tribal capabilities, ensuring simultaneous sharing 
        of data, information, and analyses from the network described 
        in paragraph (1) with State, local, and tribal public health 
        agencies; and
            ``(D) in collaboration with State, local, and tribal public 
        health officials, develop procedures and standards for the 
        collection, analysis, and interpretation of data that States, 
        regions, or other entities collect and report to the network 
        described in paragraph (1).
    ``(e) State and Regional Systems To Enhance Situational Awareness 
in Public Health Emergencies.--
        ``(1) In general.--To implement the network described in 
    subsection (d), the Secretary may award grants to States or 
    consortia of States to enhance the ability of such States or 
    consortia of States to establish or operate a coordinated public 
    health situational awareness system for regional or Statewide early 
    detection of, rapid response to, and management of potentially 
    catastrophic infectious disease outbreaks and public health 
    emergencies, in collaboration with appropriate public health 
    agencies, sentinel hospitals, clinical laboratories, pharmacies, 
    poison control centers, other health care organizations, and animal 
    health organizations within such States.
        ``(2) Eligibility.--To be eligible to receive a grant under 
    paragraph (1), the State or consortium of States shall submit to 
    the Secretary an application at such time, in such manner, and 
    containing such information as the Secretary may require, including 
    an assurance that the State or consortium of States will submit to 
    the Secretary--
            ``(A) reports of such data, information, and metrics as the 
        Secretary may require;
            ``(B) a report on the effectiveness of the systems funded 
        under the grant; and
            ``(C) a description of the manner in which grant funds will 
        be used to enhance the timelines and comprehensiveness of 
        efforts to detect, respond to, and manage potentially 
        catastrophic infectious disease outbreaks and public health 
        emergencies.
        ``(3) Use of funds.--A State or consortium of States that 
    receives an award under this subsection--
            ``(A) shall establish, enhance, or operate a coordinated 
        public health situational awareness system for regional or 
        Statewide early detection of, rapid response to, and management 
        of potentially catastrophic infectious disease outbreaks and 
        public health emergencies;
            ``(B) may award grants or contracts to entities described 
        in paragraph (1) within or serving such State to assist such 
        entities in improving the operation of information technology 
        systems, facilitating the secure exchange of data and 
        information, and training personnel to enhance the operation of 
        the system described in subparagraph (A); and
            ``(C) may conduct a pilot program for the development of 
        multi-State telehealth network test beds that build on, 
        enhance, and securely link existing State and local telehealth 
        programs to prepare for, monitor, respond to, and manage the 
        events of public health emergencies, facilitate coordination 
        and communication among medical, public health, and emergency 
        response agencies, and provide medical services through 
        telehealth initiatives within the States that are involved in 
        such a multi-State telehealth network test bed.
        ``(4) Limitation.--Information technology systems acquired or 
    implemented using grants awarded under this section must be 
    compliant with--
            ``(A) interoperability and other technological standards, 
        as determined by the Secretary; and
            ``(B) data collection and reporting requirements for the 
        network described in subsection (d).
        ``(5) Independent evaluation.--Not later than 4 years after the 
    date of enactment of the Pandemic and All-Hazards Preparedness Act, 
    the Government Accountability Office shall conduct an independent 
    evaluation, and submit to the Secretary and the appropriate 
    committees of Congress a report concerning the activities conducted 
    under this subsection and subsection (d).
    ``(f) Telehealth Enhancements for Emergency Response.--
        ``(1) Evaluation.--The Secretary, in consultation with the 
    Federal Communications Commission and other relevant Federal 
    agencies, shall--
            ``(A) conduct an inventory of telehealth initiatives in 
        existence on the date of enactment of the Pandemic and All-
        Hazards Preparedness Act, including--
                ``(i) the specific location of network components;
                ``(ii) the medical, technological, and communications 
            capabilities of such components;
                ``(iii) the functionality of such components; and
                ``(iv) the capacity and ability of such components to 
            handle increased volume during the response to a public 
            health emergency;
            ``(B) identify methods to expand and interconnect the 
        regional health information networks funded by the Secretary, 
        the State and regional broadband networks funded through the 
        rural health care support mechanism pilot program funded by the 
        Federal Communications Commission, and other telehealth 
        networks;
            ``(C) evaluate ways to prepare for, monitor, respond 
        rapidly to, or manage the events of, a public health emergency 
        through the enhanced use of telehealth technologies, including 
        mechanisms for payment or reimbursement for use of such 
        technologies and personnel during public health emergencies;
            ``(D) identify methods for reducing legal barriers that 
        deter health care professionals from providing telemedicine 
        services, such as by utilizing State emergency health care 
        professional credentialing verification systems, encouraging 
        States to establish and implement mechanisms to improve 
        interstate medical licensure cooperation, facilitating the 
        exchange of information among States regarding investigations 
        and adverse actions, and encouraging States to waive the 
        application of licensing requirements during a public health 
        emergency;
            ``(E) evaluate ways to integrate the practice of 
        telemedicine within the National Disaster Medical System; and
            ``(F) promote greater coordination among existing Federal 
        interagency telemedicine and health information technology 
        initiatives.
        ``(2) Report.--Not later than 12 months after the date of 
    enactment of the Pandemic and All-Hazards Preparedness Act, the 
    Secretary shall prepare and submit a report to the Committee on 
    Health, Education, Labor, and Pensions of the Senate and the 
    Committee on Energy and Commerce of the House of Representatives 
    regarding the findings and recommendations pursuant to 
    subparagraphs (A) through (F) of paragraph (1).
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums as may be necessary 
in each of fiscal years 2007 through 2011.''.

SEC. 203. PUBLIC HEALTH WORKFORCE ENHANCEMENTS.

    (a) Demonstration Project.--Subpart III of part D of title III of 
the Public Health Service Act (42 U.S.C. 254l) is amended by adding at 
the end the following:

``SEC. 338M. PUBLIC HEALTH DEPARTMENTS.

    ``(a) In General.--To the extent that funds are appropriated under 
subsection (e), the Secretary shall establish a demonstration project 
to provide for the participation of individuals who are eligible for 
the Loan Repayment Program described in section 338B and who agree to 
complete their service obligation in a State health department that 
provides a significant amount of service to health professional 
shortage areas or areas at risk of a public health emergency, as 
determined by the Secretary, or in a local or tribal health department 
that serves a health professional shortage area or an area at risk of a 
public health emergency.
    ``(b) Procedure.--To be eligible to receive assistance under 
subsection (a), with respect to the program described in section 338B, 
an individual shall--
        ``(1) comply with all rules and requirements described in such 
    section (other than section 338B(f)(1)(B)(iv)); and
        ``(2) agree to serve for a time period equal to 2 years, or 
    such longer period as the individual may agree to, in a State, 
    local, or tribal health department, described in subsection (a).
    ``(c) Designations.--The demonstration project described in 
subsection (a), and any healthcare providers who are selected to 
participate in such project, shall not be considered by the Secretary 
in the designation of health professional shortage areas under section 
332 during fiscal years 2007 through 2010.
    ``(d) Report.--Not later than 3 years after the date of enactment 
of this section, the Secretary shall submit a report to the relevant 
committees of Congress that evaluates the participation of individuals 
in the demonstration project under subsection (a), the impact of such 
participation on State, local, and tribal health departments, and the 
benefit and feasibility of permanently allowing such placements in the 
Loan Repayment Program.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums as may be necessary 
for each of fiscal years 2007 through 2010.''.
    (b) Grants for Loan Repayment Program.--Section 338I of the Public 
Health Service Act (42 U.S.C. 254q-1) is amended by adding at the end 
the following:
    ``(j) Public Health Loan Repayment.--
        ``(1) In general.--The Secretary may award grants to States for 
    the purpose of assisting such States in operating loan repayment 
    programs under which such States enter into contracts to repay all 
    or part of the eligible loans borrowed by, or on behalf of, 
    individuals who agree to serve in State, local, or tribal health 
    departments that serve health professional shortage areas or other 
    areas at risk of a public health emergency, as designated by the 
    Secretary.
        ``(2) Loans eligible for repayment.--To be eligible for 
    repayment under this subsection, a loan shall be a loan made, 
    insured, or guaranteed by the Federal Government that is borrowed 
    by, or on behalf of, an individual to pay the cost of attendance 
    for a program of education leading to a degree appropriate for 
    serving in a State, local, or tribal health department as 
    determined by the Secretary and the chief executive officer of the 
    State in which the grant is administered, at an institution of 
    higher education (as defined in section 102 of the Higher Education 
    Act of 1965), including principal, interest, and related expenses 
    on such loan.
        ``(3) Applicability of existing requirements.--With respect to 
    awards made under paragraph (1)--
            ``(A) the requirements of subsections (b), (f), and (g) 
        shall apply to such awards; and
            ``(B) the requirements of subsection (c) shall apply to 
        such awards except that with respect to paragraph (1) of such 
        subsection, the State involved may assign an individual only to 
        public and nonprofit private entities that serve health 
        professional shortage areas or areas at risk of a public health 
        emergency, as determined by the Secretary.
        ``(4) Authorization of appropriations.--There are authorized to 
    be appropriated to carry out this subsection, such sums as may be 
    necessary for each of fiscal years 2007 through 2010.''.

SEC. 204. VACCINE TRACKING AND DISTRIBUTION.

    (a) In General.--Section 319A of the Public Health Service Act (42 
U.S.C. 247d-1) is amended to read as follows:

``SEC. 319A. VACCINE TRACKING AND DISTRIBUTION.

    ``(a) Tracking.--The Secretary, together with relevant 
manufacturers, wholesalers, and distributors as may agree to cooperate, 
may track the initial distribution of federally purchased influenza 
vaccine in an influenza pandemic. Such tracking information shall be 
used to inform Federal, State, local, and tribal decision makers during 
an influenza pandemic.
    ``(b) Distribution.--The Secretary shall promote communication 
between State, local, and tribal public health officials and such 
manufacturers, wholesalers, and distributors as agree to participate, 
regarding the effective distribution of seasonal influenza vaccine. 
Such communication shall include estimates of high priority 
populations, as determined by the Secretary, in State, local, and 
tribal jurisdictions in order to inform Federal, State, local, and 
tribal decision makers during vaccine shortages and supply disruptions.
    ``(c) Confidentiality.--The information submitted to the Secretary 
or its contractors, if any, under this section or under any other 
section of this Act related to vaccine distribution information shall 
remain confidential in accordance with the exception from the public 
disclosure of trade secrets, commercial or financial information, and 
information obtained from an individual that is privileged and 
confidential, as provided for in section 552(b)(4) of title 5, United 
States Code, and subject to the penalties and exceptions under sections 
1832 and 1833 of title 18, United States Code, relating to the 
protection and theft of trade secrets, and subject to privacy 
protections that are consistent with the regulations promulgated under 
section 264(c) of the Health Insurance Portability and Accountability 
Act of 1996. None of such information provided by a manufacturer, 
wholesaler, or distributor shall be disclosed without its consent to 
another manufacturer, wholesaler, or distributor, or shall be used in 
any manner to give a manufacturer, wholesaler, or distributor a 
proprietary advantage.
    ``(d) Guidelines.--The Secretary, in order to maintain the 
confidentiality of relevant information and ensure that none of the 
information contained in the systems involved may be used to provide 
proprietary advantage within the vaccine market, while allowing State, 
local, and tribal health officials access to such information to 
maximize the delivery and availability of vaccines to high priority 
populations, during times of influenza pandemics, vaccine shortages, 
and supply disruptions, in consultation with manufacturers, 
distributors, wholesalers and State, local, and tribal health 
departments, shall develop guidelines for subsections (a) and (b).
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, such sums for each of fiscal 
years 2007 through 2011.
    ``(f) Report to Congress.--As part of the National Health Security 
Strategy described in section 2802, the Secretary shall provide an 
update on the implementation of subsections (a) through (d).''.
    (b) Conforming Amendments.--
        (1) In general.--Title III of the Public Health Service Act (42 
    U.S.C. 241 et seq.) is amended by striking sections 319B and 319C.
        (2) Technical amendment.--Section 319D(a)(3) of the Public 
    Health Service Act (42 U.S.C. 247d-4(a)(3)) is amended by striking 
    ``, taking into account evaluations under section 319B(a),''.

SEC. 205. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.

    The National Science Advisory Board for Biosecurity shall, when 
requested by the Secretary of Health and Human Services, provide to 
relevant Federal departments and agencies, advice, guidance, or 
recommendations concerning--
        (1) a core curriculum and training requirements for workers in 
    maximum containment biological laboratories; and
        (2) periodic evaluations of maximum containment biological 
    laboratory capacity nationwide and assessments of the future need 
    for increased laboratory capacity.

SEC. 206. REVITALIZATION OF COMMISSIONED CORPS.

    (a) Purpose.--It is the purpose of this section to improve the 
force management and readiness of the Commissioned Corps to accomplish 
the following objectives:
        (1) To ensure the Corps is ready to respond rapidly to urgent 
    or emergency public health care needs and challenges.
        (2) To ensure the availability of the Corps for assignments 
    that address clinical and public health needs in isolated, 
    hardship, and hazardous duty positions, and, when required, to 
    address needs related to the well-being, security, and defense of 
    the United States.
        (3) To establish the Corps as a resource available to Federal 
    and State Government agencies for assistance in meeting public 
    health leadership and service roles.
    (b) Commissioned Corps Readiness.--Title II of the Public Health 
Service Act (42 U.S.C. 202 et seq.) is amended by inserting after 
section 203 the following:

``SEC. 203A. DEPLOYMENT READINESS.

    ``(a) Readiness Requirements for Commissioned Corps Officers.--
        ``(1) In general.--The Secretary, with respect to members of 
    the following Corps components, shall establish requirements, 
    including training and medical examinations, to ensure the 
    readiness of such components to respond to urgent or emergency 
    public health care needs that cannot otherwise be met at the 
    Federal, State, and local levels:
            ``(A) Active duty Regular Corps.
            ``(B) Active Reserves.
        ``(2) Annual assessment of members.--The Secretary shall 
    annually determine whether each member of the Corps meets the 
    applicable readiness requirements established under paragraph (1).
        ``(3) Failure to meet requirements.--A member of the Corps who 
    fails to meet or maintain the readiness requirements established 
    under paragraph (1) or who fails to comply with orders to respond 
    to an urgent or emergency public health care need shall, except as 
    provided in paragraph (4), in accordance with procedures 
    established by the Secretary, be subject to disciplinary action as 
    prescribed by the Secretary.
        ``(4) Waiver of requirements.--
            ``(A) In general.--The Secretary may waive one or more of 
        the requirements established under paragraph (1) for an 
        individual who is not able to meet such requirements because 
        of--
                ``(i) a disability;
                ``(ii) a temporary medical condition; or
                ``(iii) any other extraordinary limitation as 
            determined by the Secretary.
            ``(B) Regulations.--The Secretary shall promulgate 
        regulations under which a waiver described in subparagraph (A) 
        may be granted.
        ``(5) Urgent or emergency public health care need.--For 
    purposes of this section and section 214, the term `urgent or 
    emergency public health care need' means a health care need, as 
    determined by the Secretary, arising as the result of--
            ``(A) a national emergency declared by the President under 
        the National Emergencies Act (50 U.S.C. 1601 et seq.);
            ``(B) an emergency or major disaster declared by the 
        President under the Robert T. Stafford Disaster Relief and 
        Emergency Assistance Act (42 U.S.C. 5121 et seq.);
            ``(C) a public health emergency declared by the Secretary 
        under section 319 of this Act; or
            ``(D) any emergency that, in the judgment of the Secretary, 
        is appropriate for the deployment of members of the Corps.
    ``(b) Corps Management for Deployment.--The Secretary shall--
        ``(1) organize members of the Corps into units for rapid 
    deployment by the Secretary to respond to urgent or emergency 
    public health care needs;
        ``(2) establish appropriate procedures for the command and 
    control of units or individual members of the Corps that are 
    deployed at the direction of the President or the Secretary in 
    response to an urgent or emergency public health care need of 
    national, State or local significance;
        ``(3) ensure that members of the Corps are trained, equipped 
    and otherwise prepared to fulfill their public health and emergency 
    response roles; and
        ``(4) ensure that deployment planning takes into account--
            ``(A) any deployment exemptions that may be granted by the 
        Secretary based on the unique requirements of an agency and an 
        individual's functional role in such agency; and
            ``(B) the nature of the urgent or emergency public health 
        care need.
    ``(c) Deployment of Detailed or Assigned Officers.--For purposes of 
pay, allowances, and benefits of a Commissioned Corps officer who is 
detailed or assigned to a Federal entity, the deployment of such 
officer by the Secretary in response to an urgent or emergency public 
health care need shall be deemed to be an authorized activity of the 
Federal entity to which the officer is detailed or assigned.''.
    (c) Personnel Deployment Authority.--
        (1) Personnel detailed.--Section 214 of the Public Health 
    Service Act (42 U.S.C. 215) is amended by adding at the end the 
    following:
    ``(e) Except with respect to the United States Coast Guard and the 
Department of Defense, and except as provided in agreements negotiated 
with officials at agencies where officers of the Commissioned Corps may 
be assigned, the Secretary shall have the sole authority to deploy any 
Commissioned Corps officer assigned under this section to an entity 
outside of the Department of Health and Human Services for service 
under the Secretary's direction in response to an urgent or emergency 
public health care need (as defined in section 203A(a)(5)).''.
        (2) National health service corps.--Section 331(f) of the 
    Public Health Service Act (42 U.S.C. 254d(f)(1)) is amended by 
    inserting before the period the following: ``, except when such 
    members are Commissioned Corps officers who entered into a contract 
    with Secretary under section 338A or 338B after December 31, 2006 
    and when the Secretary determines that exercising the authority 
    provided under section 214 or 216 with respect to any such officer 
    to would not cause unreasonable disruption to health care services 
    provided in the community in which such officer is providing health 
    care services''.

             TITLE III--ALL-HAZARDS MEDICAL SURGE CAPACITY

SEC. 301. NATIONAL DISASTER MEDICAL SYSTEM.

    (a) National Disaster Medical System.--Section 2812 of subtitle B 
of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-11 et 
seq.), as redesignated by section 102, is amended--
        (1) by striking the section heading and inserting ``national 
    disaster medical system'';
        (2) by striking subsection (a);
        (3) by redesignating subsections (b) through (h) as subsections 
    (a) through (g);
        (4) in subsection (a), as so redesignated--
            (A) in paragraph (2)(B), by striking ``Federal Emergency 
        Management Agency'' and inserting ``Department of Homeland 
        Security''; and
            (B) in paragraph (3)(C), by striking ``Public Health 
        Security and Bioterrorism Preparedness and Response Act of 
        2002'' and inserting ``Pandemic and All-Hazards Preparedness 
        Act'';
        (5) in subsection (b), as so redesignated, by--
            (A) striking the subsection heading and inserting 
        ``Modifications'';
            (B) redesignating paragraph (2) as paragraph (3); and
            (C) striking paragraph (1) and inserting the following:
        ``(1) In general.--Taking into account the findings from the 
    joint review described under paragraph (2), the Secretary shall 
    modify the policies of the National Disaster Medical System as 
    necessary.
        ``(2) Joint review and medical surge capacity strategic plan.--
    Not later than 180 days after the date of enactment of the Pandemic 
    and All-Hazards Preparedness Act, the Secretary, in coordination 
    with the Secretary of Homeland Security, the Secretary of Defense, 
    and the Secretary of Veterans Affairs, shall conduct a joint review 
    of the National Disaster Medical System. Such review shall include 
    an evaluation of medical surge capacity, as described by section 
    2803(a). As part of the National Health Security Strategy under 
    section 2802, the Secretary shall update the findings from such 
    review and further modify the policies of the National Disaster 
    Medical System as necessary.'';
        (6) by striking ``subsection (b)'' each place it appears and 
    inserting ``subsection (a)'';
        (7) by striking ``subsection (d)'' each place it appears and 
    inserting ``subsection (c)''; and
        (8) in subsection (g), as so redesignated, by striking ``2002 
    through 2006'' and inserting ``2007 through 2011''.
    (b) Transfer of National Disaster Medical System to the Department 
of Health and Human Services.--There shall be transferred to the 
Secretary of Health and Human Services the functions, personnel, 
assets, and liabilities of the National Disaster Medical System of the 
Department of Homeland Security, including the functions of the 
Secretary of Homeland Security and the Under Secretary for Emergency 
Preparedness and Response relating thereto.
    (c) Conforming Amendments to the Homeland Security Act of 2002.--
The Homeland Security Act of 2002 (6 U.S.C. 312(3)(B), 313(5)) is 
amended--
        (1) in section 502(3)(B), by striking ``, the National Disaster 
    Medical System,''; and
        (2) in section 503(5), by striking ``, the National Disaster 
    Medical System''.
    (d) Update of Certain Provision.--Section 319F(b)(2) of the Public 
Health Service Act (42 U.S.C. 247d-6(b)(2)) is amended--
        (1) in the paragraph heading, by striking ``Children and 
    terrorism'' and inserting ``At-risk individuals and public health 
    emergencies'';
        (2) in subparagraph (A), by striking ``Children and Terrorism'' 
    and inserting ``At-Risk Individuals and Public Health 
    Emergencies'';
        (3) in subparagraph (B)--
            (A) in clause (i), by striking ``bioterrorism as it relates 
        to children'' and inserting ``public health emergencies as they 
        relate to at-risk individuals'';
            (B) in clause (ii), by striking ``children'' and inserting 
        ``at-risk individuals''; and
            (C) in clause (iii), by striking ``children'' and inserting 
        ``at-risk individuals'';
        (4) in subparagraph (C), by striking ``children'' and all that 
    follows through the period and inserting ``at-risk populations.''; 
    and
        (5) in subparagraph (D), by striking ``one year'' and inserting 
    ``six years''.
    (e) Conforming Amendment.--Section 319F(b)(3)(B) of the Public 
Health Service Act (42 U.S.C. 247d-6(b)(3)(B)) is amended by striking 
``and the working group under subsection (a)''.
    (f) Effective Date.--The amendments made by subsections (b) and (c) 
shall take effect on January 1, 2007.

SEC. 302. ENHANCING MEDICAL SURGE CAPACITY.

    (a) In General.--Title XXVIII of the Public Health Service Act 
(300hh-11 et seq.), as amended by section 103, is amended by inserting 
after section 2802 the following:

``SEC. 2803. ENHANCING MEDICAL SURGE CAPACITY.

    ``(a) Study of Enhancing Medical Surge Capacity.--As part of the 
joint review described in section 2812(b), the Secretary shall evaluate 
the benefits and feasibility of improving the capacity of the 
Department of Health and Human Services to provide additional medical 
surge capacity to local communities in the event of a public health 
emergency. Such study shall include an assessment of the need for and 
feasibility of improving surge capacity through--
        ``(1) acquisition and operation of mobile medical assets by the 
    Secretary to be deployed, on a contingency basis, to a community in 
    the event of a public health emergency;
        ``(2) integrating the practice of telemedicine within the 
    National Disaster Medical System; and
        ``(3) other strategies to improve such capacity as determined 
    appropriate by the Secretary.
    ``(b) Authority To Acquire and Operate Mobile Medical Assets.--In 
addition to any other authority to acquire, deploy, and operate mobile 
medical assets, the Secretary may acquire, deploy, and operate mobile 
medical assets if, taking into consideration the evaluation conducted 
under subsection (a), such acquisition, deployment, and operation is 
determined to be beneficial and feasible in improving the capacity of 
the Department of Health and Human Services to provide additional 
medical surge capacity to local communities in the event of a public 
health emergency.
    ``(c) Using Federal Facilities To Enhance Medical Surge Capacity.--
        ``(1) Analysis.--The Secretary shall conduct an analysis of 
    whether there are Federal facilities which, in the event of a 
    public health emergency, could practicably be used as facilities in 
    which to provide health care.
        ``(2) Memoranda of understanding.--If, based on the analysis 
    conducted under paragraph (1), the Secretary determines that there 
    are Federal facilities which, in the event of a public health 
    emergency, could be used as facilities in which to provide health 
    care, the Secretary shall, with respect to each such facility, seek 
    to conclude a memorandum of understanding with the head of the 
    Department or agency that operates such facility that permits the 
    use of such facility to provide health care in the event of a 
    public health emergency.''.
    (b) EMTALA.--
        (1) In general.--Section 1135(b) of the Social Security Act (42 
    U.S.C. 1320b-5(b)) is amended--
            (A) in paragraph (3), by striking subparagraph (B) and 
        inserting the following:
            ``(B) the direction or relocation of an individual to 
        receive medical screening in an alternative location--
                ``(i) pursuant to an appropriate State emergency 
            preparedness plan; or
                ``(ii) in the case of a public health emergency 
            described in subsection (g)(1)(B) that involves a pandemic 
            infectious disease, pursuant to a State pandemic 
            preparedness plan or a plan referred to in clause (i), 
            whichever is applicable in the State;'';
            (B) in the third sentence, by striking ``and shall be 
        limited to'' and inserting ``and, except in the case of a 
        waiver or modification to which the fifth sentence of this 
        subsection applies, shall be limited to''; and
            (C) by adding at the end the following: ``If a public 
        health emergency described in subsection (g)(1)(B) involves a 
        pandemic infectious disease (such as pandemic influenza), the 
        duration of a waiver or modification under paragraph (3) shall 
        be determined in accordance with subsection (e) as such 
        subsection applies to public health emergencies.''.
        (2) Effective date.--The amendments made by paragraph (1) shall 
    take effect on the date of the enactment of this Act and shall 
    apply to public health emergencies declared pursuant to section 319 
    of the Public Health Service Act (42 U.S.C. 247d) on or after such 
    date.

SEC. 303. ENCOURAGING HEALTH PROFESSIONAL VOLUNTEERS.

    (a) Volunteer Medical Reserve Corps.--Title XXVIII of the Public 
Health Service Act (42 U.S.C. 300hh-11 et seq.), as amended by this 
Act, is amended by inserting after section 2812 the following:

``SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.

    ``(a) In General.--Not later than 180 days after the date of 
enactment of the Pandemic and All-Hazards Preparedness Act, the 
Secretary, in collaboration with State, local, and tribal officials, 
shall build on State, local, and tribal programs in existence on the 
date of enactment of such Act to establish and maintain a Medical 
Reserve Corps (referred to in this section as the `Corps') to provide 
for an adequate supply of volunteers in the case of a Federal, State, 
local, or tribal public health emergency. The Corps shall be headed by 
a Director who shall be appointed by the Secretary and shall oversee 
the activities of the Corps chapters that exist at the State, local, 
and tribal levels.
    ``(b) State, Local, and Tribal Coordination.--The Corps shall be 
established using existing State, local, and tribal teams and shall not 
alter such teams.
    ``(c) Composition.--The Corps shall be composed of individuals 
who--
        ``(1)(A) are health professionals who have appropriate 
    professional training and expertise as determined appropriate by 
    the Director of the Corps; or
        ``(B) are non-health professionals who have an interest in 
    serving in an auxiliary or support capacity to facilitate access to 
    health care services in a public health emergency;
        ``(2) are certified in accordance with the certification 
    program developed under subsection (d);
        ``(3) are geographically diverse in residence;
        ``(4) have registered and carry out training exercises with a 
    local chapter of the Medical Reserve Corps; and
        ``(5) indicate whether they are willing to be deployed outside 
    the area in which they reside in the event of a public health 
    emergency.
    ``(d) Certification; Drills.--
        ``(1) Certification.--The Director, in collaboration with 
    State, local, and tribal officials, shall establish a process for 
    the periodic certification of individuals who volunteer for the 
    Corps, as determined by the Secretary, which shall include the 
    completion by each individual of the core training programs 
    developed under section 319F, as required by the Director. Such 
    certification shall not supercede State licensing or credentialing 
    requirements.
        ``(2) Drills.--In conjunction with the core training programs 
    referred to in paragraph (1), and in order to facilitate the 
    integration of trained volunteers into the health care system at 
    the local level, Corps members shall engage in periodic training 
    exercises to be carried out at the local level.
    ``(e) Deployment.--During a public health emergency, the Secretary 
shall have the authority to activate and deploy willing members of the 
Corps to areas of need, taking into consideration the public health and 
medical expertise required, with the concurrence of the State, local, 
or tribal officials from the area where the members reside.
    ``(f) Expenses and Transportation.--While engaged in performing 
duties as a member of the Corps pursuant to an assignment by the 
Secretary (including periods of travel to facilitate such assignment), 
members of the Corps who are not otherwise employed by the Federal 
Government shall be allowed travel or transportation expenses, 
including per diem in lieu of subsistence.
    ``(g) Identification.--The Secretary, in cooperation and 
consultation with the States, shall develop a Medical Reserve Corps 
Identification Card that describes the licensure and certification 
information of Corps members, as well as other identifying information 
determined necessary by the Secretary.
    ``(h) Intermittent Disaster-Response Personnel.--
        ``(1) In general.--For the purpose of assisting the Corps in 
    carrying out duties under this section, during a public health 
    emergency, the Secretary may appoint selected individuals to serve 
    as intermittent personnel of such Corps in accordance with 
    applicable civil service laws and regulations. In all other cases, 
    members of the Corps are subject to the laws of the State in which 
    the activities of the Corps are undertaken.
        ``(2) Applicable protections.--Subsections (c)(2), (d), and (e) 
    of section 2812 shall apply to an individual appointed under 
    paragraph (1) in the same manner as such subsections apply to an 
    individual appointed under section 2812(c).
        ``(3) Limitation.--State, local, and tribal officials shall 
    have no authority to designate a member of the Corps as Federal 
    intermittent disaster-response personnel, but may request the 
    services of such members.
    ``(i) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $22,000,000 for fiscal year 
2007, and such sums as may be necessary for each of fiscal years 2008 
through 2011.''.
    (b) Encouraging Health Professions Volunteers.--Section 319I of the 
Public Health Service Act (42 U.S.C. 247d-7b) is amended--
        (1) by redesignating subsections (e) and (f) as subsections (j) 
    and (k), respectively;
        (2) by striking subsections (a) and (b) and inserting the 
    following:
    ``(a) In General.--Not later than 12 months after the date of 
enactment of the Pandemic and All-Hazards Preparedness Act, the 
Secretary shall link existing State verification systems to maintain a 
single national interoperable network of systems, each system being 
maintained by a State or group of States, for the purpose of verifying 
the credentials and licenses of health care professionals who volunteer 
to provide health services during a public health emergency.
    ``(b) Requirements.--The interoperable network of systems 
established under subsection (a) (referred to in this section as the 
`verification network') shall include--
        ``(1) with respect to each volunteer health professional 
    included in the verification network--
            ``(A) information necessary for the rapid identification 
        of, and communication with, such professionals; and
            ``(B) the credentials, certifications, licenses, and 
        relevant training of such individuals; and
        ``(2) the name of each member of the Medical Reserve Corps, the 
    National Disaster Medical System, and any other relevant federally-
    sponsored or administered programs determined necessary by the 
    Secretary.'';
        (3) in subsection (c), strike ``system'' and insert 
    ``network''; and
        (4) by striking subsection (d) and inserting the following:
    ``(d) Accessibility.--The Secretary shall ensure that the 
verification network is electronically accessible by State, local, and 
tribal health departments and can be linked with the identification 
cards under section 2813.
    ``(e) Confidentiality.--The Secretary shall establish and require 
the application of and compliance with measures to ensure the effective 
security of, integrity of, and access to the data included in the 
verification network.
    ``(f) Coordination.--The Secretary shall coordinate with the 
Secretary of Veterans Affairs and the Secretary of Homeland Security to 
assess the feasibility of integrating the verification network under 
this section with the VetPro system of the Department of Veterans 
Affairs and the National Emergency Responder Credentialing System of 
the Department of Homeland Security. The Secretary shall, if feasible, 
integrate the verification network under this section with such VetPro 
system and the National Emergency Responder Credentialing System.
    ``(g) Updating of Information.--The States that are participants in 
the verification network shall, on at least a quarterly basis, work 
with the Director to provide for the updating of the information 
contained in the verification network.
    ``(h) Clarification.--Inclusion of a health professional in the 
verification network shall not constitute appointment of such 
individual as a Federal employee for any purpose, either under section 
2812(c) or otherwise. Such appointment may only be made under section 
2812 or 2813.
    ``(i) Health Care Provider Licenses.--The Secretary shall encourage 
States to establish and implement mechanisms to waive the application 
of licensing requirements applicable to health professionals, who are 
seeking to provide medical services (within their scope of practice), 
during a national, State, local, or tribal public health emergency upon 
verification that such health professionals are licensed and in good 
standing in another State and have not been disciplined by any State 
health licensing or disciplinary board.''; and
        (5) in subsection (k) (as so redesignated), by striking 
    ``2006'' and inserting ``2011''.

SEC. 304. CORE EDUCATION AND TRAINING.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended--
        (1) by striking subsection (a) and inserting the following:
    ``(a) All-Hazards Public Health and Medical Response Curricula and 
Training.--
        ``(1) In general.--The Secretary, in collaboration with the 
    Secretary of Defense, and in consultation with relevant public and 
    private entities, shall develop core health and medical response 
    curricula and trainings by adapting applicable existing curricula 
    and training programs to improve responses to public health 
    emergencies.
        ``(2) Curriculum.--The public health and medical response 
    training program may include course work related to--
            ``(A) medical management of casualties, taking into account 
        the needs of at-risk individuals;
            ``(B) public health aspects of public health emergencies;
            ``(C) mental health aspects of public health emergencies;
            ``(D) national incident management, including coordination 
        among Federal, State, local, tribal, international agencies, 
        and other entities; and
            ``(E) protecting health care workers and health care first 
        responders from workplace exposures during a public health 
        emergency.
        ``(3) Peer review.--On a periodic basis, products prepared as 
    part of the program shall be rigorously tested and peer-reviewed by 
    experts in the relevant fields.
        ``(4) Credit.--The Secretary and the Secretary of Defense 
    shall--
            ``(A) take into account continuing professional education 
        requirements of public health and healthcare professions; and
            ``(B) cooperate with State, local, and tribal accrediting 
        agencies and with professional associations in arranging for 
        students enrolled in the program to obtain continuing 
        professional education credit for program courses.
        ``(5) Dissemination and training.--
            ``(A) In general.--The Secretary may provide for the 
        dissemination and teaching of the materials described in 
        paragraphs (1) and (2) by appropriate means, as determined by 
        the Secretary.
            ``(B) Certain entities.--The education and training 
        activities described in subparagraph (A) may be carried out by 
        Federal public health or medical entities, appropriate 
        educational entities, professional organizations and societies, 
        private accrediting organizations, and other nonprofit 
        institutions or entities meeting criteria established by the 
        Secretary.
            ``(C) Grants and contracts.--In carrying out this 
        subsection, the Secretary may carry out activities directly or 
        through the award of grants and contracts, and may enter into 
        interagency agreements with other Federal agencies.''.
        (2) by striking subsections (c) through (g) and inserting the 
    following:
    ``(c) Expansion of Epidemic Intelligence Service Program.--The 
Secretary may establish 20 officer positions in the Epidemic 
Intelligence Service Program, in addition to the number of the officer 
positions offered under such Program in 2006, for individuals who agree 
to participate, for a period of not less than 2 years, in the Career 
Epidemiology Field Officer program in a State, local, or tribal health 
department that serves a health professional shortage area (as defined 
under section 332(a)), a medically underserved population (as defined 
under section 330(b)(3)), or a medically underserved area or area at 
high risk of a public health emergency as designated by the Secretary.
    ``(d) Centers for Public Health Preparedness; Core Curricula and 
Training.--
        ``(1) In general.--The Secretary may establish at accredited 
    schools of public health, Centers for Public Health Preparedness 
    (hereafter referred to in this section as the `Centers').
        ``(2) Eligibility.--To be eligible to receive an award under 
    this subsection to establish a Center, an accredited school of 
    public health shall agree to conduct activities consistent with the 
    requirements of this subsection.
        ``(3) Core curricula.--The Secretary, in collaboration with the 
    Centers and other public or private entities shall establish core 
    curricula based on established competencies leading to a 4-year 
    bachelor's degree, a graduate degree, a combined bachelor and 
    master's degree, or a certificate program, for use by each Center. 
    The Secretary shall disseminate such curricula to other accredited 
    schools of public health and other health professions schools 
    determined appropriate by the Secretary, for voluntary use by such 
    schools.
        ``(4) Core competency-based training program.--The Secretary, 
    in collaboration with the Centers and other public or private 
    entities shall facilitate the development of a competency-based 
    training program to train public health practitioners. The Centers 
    shall use such training program to train public health 
    practitioners. The Secretary shall disseminate such training 
    program to other accredited schools of public health, health 
    professions schools, and other public or private entities as 
    determined by the Secretary, for voluntary use by such entities.
        ``(5) Content of core curricula and training program.--The 
    Secretary shall ensure that the core curricula and training program 
    established pursuant to this subsection respond to the needs of 
    State, local, and tribal public health authorities and integrate 
    and emphasize essential public health security capabilities 
    consistent with section 2802(b)(2).
        ``(6) Academic-workforce communication.--As a condition of 
    receiving funding from the Secretary under this subsection, a 
    Center shall collaborate with a State, local, or tribal public 
    health department to--
            ``(A) define the public health preparedness and response 
        needs of the community involved;
            ``(B) assess the extent to which such needs are fulfilled 
        by existing preparedness and response activities of such school 
        or health department, and how such activities may be improved;
            ``(C) prior to developing new materials or trainings, 
        evaluate and utilize relevant materials and trainings developed 
        by others Centers; and
            ``(D) evaluate community impact and the effectiveness of 
        any newly developed materials or trainings.
        ``(7) Public health systems research.--In consultation with 
    relevant public and private entities, the Secretary shall define 
    the existing knowledge base for public health preparedness and 
    response systems, and establish a research agenda based on Federal, 
    State, local, and tribal public health preparedness priorities. As 
    a condition of receiving funding from the Secretary under this 
    subsection, a Center shall conduct public health systems research 
    that is consistent with the agenda described under this 
    paragraph.'';
        (3) by redesignating subsection (h) as subsection (e);
        (4) by inserting after subsection (e) (as so redesignated), the 
    following:
    ``(f) Authorization of Appropriations.--
        ``(1) Fiscal year 2007.--There are authorized to be 
    appropriated to carry out this section for fiscal year 2007--
            ``(A) to carry out subsection (a)--
                ``(i) $5,000,000 to carry out paragraphs (1) through 
            (4); and
                ``(ii) $7,000,000 to carry out paragraph (5);
            ``(B) to carry out subsection (c), $3,000,000; and
            ``(C) to carry out subsection (d), $31,000,000, of which 
        $5,000,000 shall be used to carry out paragraphs (3) through 
        (5) of such subsection.
        ``(2) Subsequent fiscal years.--There are authorized to be 
    appropriated such sums as may be necessary to carry out this 
    section for fiscal year 2008 and each subsequent fiscal year.''; 
    and
        (5) by striking subsections (i) and (j).

SEC. 305. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL PREPAREDNESS TO 
              IMPROVE SURGE CAPACITY.

    Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) 
is amended to read as follows:

``SEC. 319C-2. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL 
              PREPAREDNESS TO IMPROVE SURGE CAPACITY.

    ``(a) In General.--The Secretary shall award competitive grants or 
cooperative agreements to eligible entities to enable such entities to 
improve surge capacity and enhance community and hospital preparedness 
for public health emergencies.
    ``(b) Eligibility.--To be eligible for an award under subsection 
(a), an entity shall--
        ``(1)(A) be a partnership consisting of--
            ``(i) one or more hospitals, at least one of which shall be 
        a designated trauma center, consistent with section 1213(c);
            ``(ii) one or more other local health care facilities, 
        including clinics, health centers, primary care facilities, 
        mental health centers, mobile medical assets, or nursing homes; 
        and
            ``(iii)(I) one or more political subdivisions;
            ``(II) one or more States; or
            ``(III) one or more States and one or more political 
        subdivisions; and
        ``(B) prepare, in consultation with the Chief Executive Officer 
    and the lead health officials of the State, District, or territory 
    in which the hospital and health care facilities described in 
    subparagraph (A) are located, and submit to the Secretary, an 
    application at such time, in such manner, and containing such 
    information as the Secretary may require; or
        ``(2)(A) be an entity described in section 319C-1(b)(1); and
        ``(B) submit an application at such time, in such manner, and 
    containing such information as the Secretary may require, including 
    the information or assurances required under section 319C-1(b)(2) 
    and an assurance that the State will adhere to any applicable 
    guidelines established by the Secretary.
    ``(c) Use of Funds.--An award under subsection (a) shall be 
expended for activities to achieve the preparedness goals described 
under paragraphs (1), (3), (4), (5), and (6) of section 2802(b).
    ``(d) Preferences.--
        ``(1) Regional coordination.--In making awards under subsection 
    (a), the Secretary shall give preference to eligible entities that 
    submit applications that, in the determination of the Secretary--
            ``(A) will enhance coordination--
                ``(i) among the entities described in subsection 
            (b)(1)(A)(i); and
                ``(ii) between such entities and the entities described 
            in subsection (b)(1)(A)(ii); and
            ``(B) include, in the partnership described in subsection 
        (b)(1)(A), a significant percentage of the hospitals and health 
        care facilities within the geographic area served by such 
        partnership.
        ``(2) Other preferences.--In making awards under subsection 
    (a), the Secretary shall give preference to eligible entities that, 
    in the determination of the Secretary--
            ``(A) include one or more hospitals that are participants 
        in the National Disaster Medical System;
            ``(B) are located in a geographic area that faces a high 
        degree of risk, as determined by the Secretary in consultation 
        with the Secretary of Homeland Security; or
            ``(C) have a significant need for funds to achieve the 
        medical preparedness goals described in section 2802(b)(3).
    ``(e) Consistency of Planned Activities.--The Secretary may not 
award a cooperative agreement to an eligible entity described in 
subsection (b)(1) unless the application submitted by the entity is 
coordinated and consistent with an applicable State All-Hazards Public 
Health Emergency Preparedness and Response Plan and relevant local 
plans, as determined by the Secretary in consultation with relevant 
State health officials.
    ``(f) Limitation on Awards.--A political subdivision shall not 
participate in more than one partnership described in subsection 
(b)(1).
    ``(g) Coordination With Local Response Capabilities.--An eligible 
entity shall, to the extent practicable, ensure that activities carried 
out under an award under subsection (a) are coordinated with activities 
of relevant local Metropolitan Medical Response Systems, local Medical 
Reserve Corps, the Cities Readiness Initiative, and local emergency 
plans.
    ``(h) Maintenance of Funding.--
        ``(1) In general.--An entity that receives an award under this 
    section shall maintain expenditures for health care preparedness at 
    a level that is not less than the average level of such 
    expenditures maintained by the entity for the preceding 2 year 
    period.
        ``(2) Rule of construction.--Nothing in this section shall be 
    construed to prohibit the use of awards under this section to pay 
    salary and related expenses of public health and other 
    professionals employed by State, local, or tribal agencies who are 
    carrying out activities supported by such awards (regardless of 
    whether the primary assignment of such personnel is to carry out 
    such activities).
    ``(i) Performance and Accountability.--The requirements of section 
319C-1(g), (j), and (k) shall apply to entities receiving awards under 
this section (regardless of whether such entities are described under 
subsection (b)(1)(A) or (b)(2)(A)) in the same manner as such 
requirements apply to entities under section 319C-1. An entity 
described in subsection (b)(1)(A) shall make such reports available to 
the lead health official of the State in which such partnership is 
located.
    ``(j) Authorization of Appropriations.--
        ``(1) In general.--For the purpose of carrying out this 
    section, there is authorized to be appropriated $474,000,000 for 
    fiscal year 2007, and such sums as may be necessary for each of 
    fiscal years 2008 through 2011.
        ``(2) Reservation of amounts for partnerships.--Prior to making 
    awards described in paragraph (3), the Secretary may reserve from 
    the amount appropriated under paragraph (1) for a fiscal year, an 
    amount determined appropriate by the Secretary for making awards to 
    entities described in subsection (b)(1)(A).
        ``(3) Awards to states and political subdivisions.--
            ``(A) In general.--From amounts appropriated for a fiscal 
        year under paragraph (1) and not reserved under paragraph (2), 
        the Secretary shall make awards to entities described in 
        subsection (b)(2)(A) that have completed an application as 
        described in subsection (b)(2)(B).
            ``(B) Amount.--The Secretary shall determine the amount of 
        an award to each entity described in subparagraph (A) in the 
        same manner as such amounts are determined under section 319C-
        1(h).''.

SEC. 306. ENHANCING THE ROLE OF THE DEPARTMENT OF VETERANS AFFAIRS.

    (a) In General.--Section 8117 of title 38, United States Code, is 
amended--
        (1) in subsection (a)--
            (A) in paragraph (1), by--
                (i) striking ``chemical or biological attack'' and 
            inserting ``a public health emergency (as defined in 
            section 2801 of the Public Health Service Act)'';
                (ii) striking ``an attack'' and inserting ``such an 
            emergency''; and
                (iii) striking ``public health emergencies'' and 
            inserting ``such emergencies''; and
            (B) in paragraph (2)--
                (i) in subparagraph (A), by striking ``; and'' and 
            inserting a semicolon;
                (ii) in subparagraph (B), by striking the period and 
            inserting a semicolon; and
                (iii) by adding at the end the following:
            ``(C) organizing, training, and equipping the staff of such 
        centers to support the activities carried out by the Secretary 
        of Health and Human Services under section 2801 of the Public 
        Health Service Act in the event of a public health emergency 
        and incidents covered by the National Response Plan developed 
        pursuant to section 502(6) of the Homeland Security Act of 
        2002, or any successor plan; and
            ``(D) providing medical logistical support to the National 
        Disaster Medical System and the Secretary of Health and Human 
        Services as necessary, on a reimbursable basis, and in 
        coordination with other designated Federal agencies.'';
        (2) in subsection (c), by striking ``a chemical or biological 
    attack or other terrorist attack.'' and inserting ``a public health 
    emergency. The Secretary shall, through existing medical 
    procurement contracts, and on a reimbursable basis, make available 
    as necessary, medical supplies, equipment, and pharmaceuticals in 
    response to a public health emergency in support of the Secretary 
    of Health and Human Services.'';
        (3) in subsection (d), by--
            (A) striking ``develop and'';
            (B) striking ``biological, chemical, or radiological 
        attacks'' and inserting ``public health emergencies''; and
            (C) by inserting ``consistent with section 319F(a) of the 
        Public Health Service Act'' before the period; and
        (4) in subsection (e)--
            (A) in paragraph (1), by striking ``2811(b)'' and inserting 
        ``2812''; and
            (B) in paragraph (2)--
                (i) by striking ``bioterrorism and other''; and
                (ii) by striking ``319F(a)'' and inserting ``319F''.
    (b) Authorization of Appropriations.--Section 8117 of title 38, 
United States Code, is amended by adding at the end the following:
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated, such sums as may be necessary to carry out this section 
for each of fiscal years 2007 through 2011.''.

     TITLE IV--PANDEMIC AND BIODEFENSE VACCINE AND DRUG DEVELOPMENT

SEC. 401. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by inserting after section 319K the following:

``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

    ``(a) Definitions.--In this section:
        ``(1) BARDA.--The term `BARDA' means the Biomedical Advanced 
    Research and Development Authority.
        ``(2) Fund.--The term `Fund' means the Biodefense Medical 
    Countermeasure Development Fund established under subsection (d).
        ``(3) Other transactions.--The term `other transactions' means 
    transactions, other than procurement contracts, grants, and 
    cooperative agreements, such as the Secretary of Defense may enter 
    into under section 2371 of title 10, United States Code.
        ``(4) Qualified countermeasure.--The term `qualified 
    countermeasure' has the meaning given such term in section 319F-1.
        ``(5) Qualified pandemic or epidemic product.--The term 
    `qualified pandemic or epidemic product' has the meaning given the 
    term in section 319F-3.
        ``(6) Advanced research and development.--
            ``(A) In general.--The term `advanced research and 
        development' means, with respect to a product that is or may 
        become a qualified countermeasure or a qualified pandemic or 
        epidemic product, activities that predominantly--
                ``(i) are conducted after basic research and 
            preclinical development of the product; and
                ``(ii) are related to manufacturing the product on a 
            commercial scale and in a form that satisfies the 
            regulatory requirements under the Federal Food, Drug, and 
            Cosmetic Act or under section 351 of this Act.
            ``(B) Activities included.--The term under subparagraph (A) 
        includes--
                ``(i) testing of the product to determine whether the 
            product may be approved, cleared, or licensed under the 
            Federal Food, Drug, and Cosmetic Act or under section 351 
            of this Act for a use that is or may be the basis for such 
            product becoming a qualified countermeasure or qualified 
            pandemic or epidemic product, or to help obtain such 
            approval, clearance, or license;
                ``(ii) design and development of tests or models, 
            including animal models, for such testing;
                ``(iii) activities to facilitate manufacture of the 
            product on a commercial scale with consistently high 
            quality, as well as to improve and make available new 
            technologies to increase manufacturing surge capacity;
                ``(iv) activities to improve the shelf-life of the 
            product or technologies for administering the product; and
                ``(v) such other activities as are part of the advanced 
            stages of testing, refinement, improvement, or preparation 
            of the product for such use and as are specified by the 
            Secretary.
        ``(7) Security countermeasure.--The term `security 
    countermeasure' has the meaning given such term in section 319F-2.
        ``(8) Research tool.--The term `research tool' means a device, 
    technology, biological material (including a cell line or an 
    antibody), reagent, animal model, computer system, computer 
    software, or analytical technique that is developed to assist in 
    the discovery, development, or manufacture of qualified 
    countermeasures or qualified pandemic or epidemic products.
        ``(9) Program manager.--The term `program manager' means an 
    individual appointed to carry out functions under this section and 
    authorized to provide project oversight and management of strategic 
    initiatives.
        ``(10) Person.--The term `person' includes an individual, 
    partnership, corporation, association, entity, or public or private 
    corporation, and a Federal, State, or local government agency or 
    department.
    ``(b) Strategic Plan for Countermeasure Research, Development, and 
Procurement.--
        ``(1) In general.--Not later than 6 months after the date of 
    enactment of the Pandemic and All-Hazards Preparedness Act, the 
    Secretary shall develop and make public a strategic plan to 
    integrate biodefense and emerging infectious disease requirements 
    with the advanced research and development, strategic initiatives 
    for innovation, and the procurement of qualified countermeasures 
    and qualified pandemic or epidemic products. The Secretary shall 
    carry out such activities as may be practicable to disseminate the 
    information contained in such plan to persons who may have the 
    capacity to substantially contribute to the activities described in 
    such strategic plan. The Secretary shall update and incorporate 
    such plan as part of the National Health Security Strategy 
    described in section 2802.
        ``(2) Content.--The strategic plan under paragraph (1) shall 
    guide--
            ``(A) research and development, conducted or supported by 
        the Department of Health and Human Services, of qualified 
        countermeasures and qualified pandemic or epidemic products 
        against possible biological, chemical, radiological, and 
        nuclear agents and to emerging infectious diseases;
            ``(B) innovation in technologies that may assist advanced 
        research and development of qualified countermeasures and 
        qualified pandemic or epidemic products (such research and 
        development referred to in this section as `countermeasure and 
        product advanced research and development'); and
            ``(C) procurement of such qualified countermeasures and 
        qualified pandemic or epidemic products by such Department.
    ``(c) Biomedical Advanced Research and Development Authority.--
        ``(1) Establishment.--There is established within the 
    Department of Health and Human Services the Biomedical Advanced 
    Research and Development Authority.
        ``(2) In general.--Based upon the strategic plan described in 
    subsection (b), the Secretary shall coordinate the acceleration of 
    countermeasure and product advanced research and development by--
            ``(A) facilitating collaboration between the Department of 
        Health and Human Services and other Federal agencies, relevant 
        industries, academia, and other persons, with respect to such 
        advanced research and development;
            ``(B) promoting countermeasure and product advanced 
        research and development;
            ``(C) facilitating contacts between interested persons and 
        the offices or employees authorized by the Secretary to advise 
        such persons regarding requirements under the Federal Food, 
        Drug, and Cosmetic Act and under section 351 of this Act; and
            ``(D) promoting innovation to reduce the time and cost of 
        countermeasure and product advanced research and development.
        ``(3) Director.--The BARDA shall be headed by a Director 
    (referred to in this section as the `Director') who shall be 
    appointed by the Secretary and to whom the Secretary shall delegate 
    such functions and authorities as necessary to implement this 
    section.
        ``(4) Duties.--
            ``(A) Collaboration.--To carry out the purpose described in 
        paragraph (2)(A), the Secretary shall--
                ``(i) facilitate and increase the expeditious and 
            direct communication between the Department of Health and 
            Human Services and relevant persons with respect to 
            countermeasure and product advanced research and 
            development, including by--

                    ``(I) facilitating such communication regarding the 
                processes for procuring such advanced research and 
                development with respect to qualified countermeasures 
                and qualified pandemic or epidemic products of 
                interest; and
                    ``(II) soliciting information about and data from 
                research on potential qualified countermeasures and 
                qualified pandemic or epidemic products and related 
                technologies;

                ``(ii) at least annually--

                    ``(I) convene meetings with representatives from 
                relevant industries, academia, other Federal agencies, 
                international agencies as appropriate, and other 
                interested persons;
                    ``(II) sponsor opportunities to demonstrate the 
                operation and effectiveness of relevant biodefense 
                countermeasure technologies; and
                    ``(III) convene such working groups on 
                countermeasure and product advanced research and 
                development as the Secretary may determine are 
                necessary to carry out this section; and

                ``(iii) carry out the activities described in section 
            405 of the Pandemic and All-Hazards Preparedness Act.
            ``(B) Support advanced research and development.--To carry 
        out the purpose described in paragraph (2)(B), the Secretary 
        shall--
                ``(i) conduct ongoing searches for, and support calls 
            for, potential qualified countermeasures and qualified 
            pandemic or epidemic products;
                ``(ii) direct and coordinate the countermeasure and 
            product advanced research and development activities of the 
            Department of Health and Human Services;
                ``(iii) establish strategic initiatives to accelerate 
            countermeasure and product advanced research and 
            development and innovation in such areas as the Secretary 
            may identify as priority unmet need areas; and
                ``(iv) award contracts, grants, cooperative agreements, 
            and enter into other transactions, for countermeasure and 
            product advanced research and development.
            ``(C) Facilitating advice.--To carry out the purpose 
        described in paragraph (2)(C) the Secretary shall--
                ``(i) connect interested persons with the offices or 
            employees authorized by the Secretary to advise such 
            persons regarding the regulatory requirements under the 
            Federal Food, Drug, and Cosmetic Act and under section 351 
            of this Act related to the approval, clearance, or 
            licensure of qualified countermeasures or qualified 
            pandemic or epidemic products; and
                ``(ii) with respect to persons performing 
            countermeasure and product advanced research and 
            development funded under this section, enable such offices 
            or employees to provide to the extent practicable such 
            advice in a manner that is ongoing and that is otherwise 
            designed to facilitate expeditious development of qualified 
            countermeasures and qualified pandemic or epidemic products 
            that may achieve such approval, clearance, or licensure.
            ``(D) Supporting innovation.--To carry out the purpose 
        described in paragraph (2)(D), the Secretary may award 
        contracts, grants, and cooperative agreements, or enter into 
        other transactions, such as prize payments, to promote--
                ``(i) innovation in technologies that may assist 
            countermeasure and product advanced research and 
            development;
                ``(ii) research on and development of research tools 
            and other devices and technologies; and
                ``(iii) research to promote strategic initiatives, such 
            as rapid diagnostics, broad spectrum antimicrobials, and 
            vaccine manufacturing technologies.
        ``(5) Transaction authorities.--
            ``(A) Other transactions.--
                ``(i) In general.--The Secretary shall have the 
            authority to enter into other transactions under this 
            subsection in the same manner as the Secretary of Defense 
            enters into such transactions under section 2371 of title 
            10, United States Code.
                ``(ii) Limitations on authority.--

                    ``(I) In general.--Subsections (b), (c), and (h) of 
                section 845 of the National Defense Authorization Act 
                for Fiscal Year 1994 (10 U.S.C. 2371 note) shall apply 
                to other transactions under this subparagraph as if 
                such transactions were for prototype projects described 
                by subsection (a) of such section 845.
                    ``(II) Written determinations required.--The 
                authority of this subparagraph may be exercised for a 
                project that is expected to cost the Department of 
                Health and Human Services in excess of $20,000,000 only 
                upon a written determination by the senior procurement 
                executive for the Department (as designated for purpose 
                of section 16(c) of the Office of Federal Procurement 
                Policy Act (41 U.S.C. 414(c))), that the use of such 
                authority is essential to promoting the success of the 
                project. The authority of the senior procurement 
                executive under this subclause may not be delegated.

                ``(iii) Guidelines.--The Secretary shall establish 
            guidelines regarding the use of the authority under clause 
            (i). Such guidelines shall include auditing requirements.
            ``(B) Expedited authorities.--
                ``(i) In general.--In awarding contracts, grants, and 
            cooperative agreements, and in entering into other 
            transactions under subparagraph (B) or (D) of paragraph 
            (4), the Secretary shall have the expedited procurement 
            authorities, the authority to expedite peer review, and the 
            authority for personal services contracts, supplied by 
            subsections (b), (c), and (d) of section 319F-1.
                ``(ii) Application of provisions.--Provisions in such 
            section 319F-1 that apply to such authorities and that 
            require institution of internal controls, limit review, 
            provide for Federal Tort Claims Act coverage of personal 
            services contractors, and commit decisions to the 
            discretion of the Secretary shall apply to the authorities 
            as exercised pursuant to this paragraph.
                ``(iii) Authority to limit competition.--For purposes 
            of applying section 319F-1(b)(1)(D) to this paragraph, the 
            phrase `BioShield Program under the Project BioShield Act 
            of 2004' shall be deemed to mean the countermeasure and 
            product advanced research and development program under 
            this section.
                ``(iv) Availability of data.--The Secretary shall 
            require that, as a condition of being awarded a contract, 
            grant, cooperative agreement, or other transaction under 
            subparagraph (B) or (D) of paragraph (4), a person make 
            available to the Secretary on an ongoing basis, and submit 
            upon request to the Secretary, all data related to or 
            resulting from countermeasure and product advanced research 
            and development carried out pursuant to this section.
            ``(C) Advance payments; advertising.--The Secretary may 
        waive the requirements of section 3324(a) of title 31, United 
        States Code, or section 3709 of the Revised Statutes of the 
        United States (41 U.S.C. 5) upon the determination by the 
        Secretary that such waiver is necessary to obtain 
        countermeasures or products under this section.
            ``(D) Milestone-based payments allowed.--In awarding 
        contracts, grants, and cooperative agreements, and in entering 
        into other transactions, under this section, the Secretary may 
        use milestone-based awards and payments.
            ``(E) Foreign nationals eligible.--The Secretary may under 
        this section award contracts, grants, and cooperative 
        agreements to, and may enter into other transactions with, 
        highly qualified foreign national persons outside the United 
        States, alone or in collaboration with American participants, 
        when such transactions may inure to the benefit of the American 
        people.
            ``(F) Establishment of research centers.--The Secretary may 
        assess the feasibility and appropriateness of establishing, 
        through contract, grant, cooperative agreement, or other 
        transaction, an arrangement with an existing research center in 
        order to achieve the goals of this section. If such an 
        agreement is not feasible and appropriate, the Secretary may 
        establish one or more federally-funded research and development 
        centers, or university-affiliated research centers, in 
        accordance with section 303(c)(3) of the Federal Property and 
        Administrative Services Act of 1949 (41 U.S.C. 253(c)(3)).
        ``(6) At-risk individuals.--In carrying out the functions under 
    this section, the Secretary may give priority to the advanced 
    research and development of qualified countermeasures and qualified 
    pandemic or epidemic products that are likely to be safe and 
    effective with respect to children, pregnant women, elderly, and 
    other at-risk individuals.
        ``(7) Personnel authorities.--
            ``(A) Specially qualified scientific and professional 
        personnel.--
                ``(i) In general.--In addition to any other personnel 
            authorities, the Secretary may--

                    ``(I) without regard to those provisions of title 
                5, United States Code, governing appointments in the 
                competitive service, appoint highly qualified 
                individuals to scientific or professional positions in 
                BARDA, such as program managers, to carry out this 
                section; and
                    ``(II) compensate them in the same manner and 
                subject to the same terms and conditions in which 
                individuals appointed under section 9903 of such title 
                are compensated, 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.

                ``(ii) Manner of exercise of authority.--The authority 
            provided for in this subparagraph shall be exercised 
            subject to the same limitations described in section 319F-
            1(e)(2).
                ``(iii) Term of appointment.--The term limitations 
            described in section 9903(c) of title 5, United States 
            Code, shall apply to appointments under this subparagraph, 
            except that the references to the `Secretary' and to the 
            `Department of Defense's national security missions' shall 
            be deemed to be to the Secretary of Health and Human 
            Services and to the mission of the Department of Health and 
            Human Services under this section.
            ``(B) Special consultants.--In carrying out this section, 
        the Secretary may appoint special consultants pursuant to 
        section 207(f).
            ``(C) Limitation.--
                ``(i) In general.--The Secretary may hire up to 100 
            highly qualified individuals, or up to 50 percent of the 
            total number of employees, whichever is less, under the 
            authorities provided for in subparagraphs (A) and (B).
                ``(ii) Report.--The Secretary shall report to Congress 
            on a biennial basis on the implementation of this 
            subparagraph.
    ``(d) Fund.--
        ``(1) Establishment.--There is established the Biodefense 
    Medical Countermeasure Development Fund, which shall be available 
    to carry out this section in addition to such amounts as are 
    otherwise available for this purpose.
        ``(2) Funding.--To carry out the purposes of this section, 
    there are authorized to be appropriated to the Fund--
            ``(A) $1,070,000,000 for fiscal years 2006 through 2008, 
        the amounts to remain available until expended; and
            ``(B) such sums as may be necessary for subsequent fiscal 
        years, the amounts to remain available until expended.
    ``(e) Inapplicability of Certain Provisions.--
        ``(1) Disclosure.--
            ``(A) In general.--The Secretary shall withhold from 
        disclosure under section 552 of title 5, United States Code, 
        specific technical data or scientific information that is 
        created or obtained during the countermeasure and product 
        advanced research and development carried out under subsection 
        (c) that reveals significant and not otherwise publicly known 
        vulnerabilities of existing medical or public health defenses 
        against biological, chemical, nuclear, or radiological threats. 
        Such information shall be deemed to be information described in 
        section 552(b)(3) of title 5, United States Code.
            ``(B) Review.--Information subject to nondisclosure under 
        subparagraph (A) shall be reviewed by the Secretary every 5 
        years, or more frequently as determined necessary by the 
        Secretary, to determine the relevance or necessity of continued 
        nondisclosure.
            ``(C) Sunset.--This paragraph shall cease to have force or 
        effect on the date that is 7 years after the date of enactment 
        of the Pandemic and All-Hazards Preparedness Act.
        ``(2) Review.--Notwithstanding section 14 of the Federal 
    Advisory Committee Act, a working group of BARDA under this section 
    and the National Biodefense Science Board under section 319M shall 
    each terminate on the date that is 5 years after the date on which 
    each such group or Board, as applicable, was established. Such 5-
    year period may be extended by the Secretary for one or more 
    additional 5-year periods if the Secretary determines that any such 
    extension is appropriate.''.

SEC. 402. NATIONAL BIODEFENSE SCIENCE BOARD.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.), 
as amended by section 401, is further amended by inserting after 
section 319L the following:

``SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING GROUPS.

    ``(a) In General.--
        ``(1) Establishment and function.--The Secretary shall 
    establish the National Biodefense Science Board (referred to in 
    this section as the `Board') to provide expert advice and guidance 
    to the Secretary on scientific, technical and other matters of 
    special interest to the Department of Health and Human Services 
    regarding current and future chemical, biological, nuclear, and 
    radiological agents, whether naturally occurring, accidental, or 
    deliberate.
        ``(2) Membership.--The membership of the Board shall be 
    comprised of individuals who represent the Nation's preeminent 
    scientific, public health, and medical experts, as follows--
            ``(A) such Federal officials as the Secretary may determine 
        are necessary to support the functions of the Board;
            ``(B) four individuals representing the pharmaceutical, 
        biotechnology, and device industries;
            ``(C) four individuals representing academia; and
            ``(D) five other members as determined appropriate by the 
        Secretary, of whom--
                ``(i) one such member shall be a practicing healthcare 
            professional; and
                ``(ii) one such member shall be an individual from an 
            organization representing healthcare consumers.
        ``(3) Term of appointment.--A member of the Board described in 
    subparagraph (B), (C), or (D) of paragraph (2) shall serve for a 
    term of 3 years, except that the Secretary may adjust the terms of 
    the initial Board appointees in order to provide for a staggered 
    term of appointment for all members.
        ``(4) Consecutive appointments; maximum terms.--A member may be 
    appointed to serve not more than 3 terms on the Board and may serve 
    not more than 2 consecutive terms.
        ``(5) Duties.--The Board shall--
            ``(A) advise the Secretary on current and future trends, 
        challenges, and opportunities presented by advances in 
        biological and life sciences, biotechnology, and genetic 
        engineering with respect to threats posed by naturally 
        occurring infectious diseases and chemical, biological, 
        radiological, and nuclear agents;
            ``(B) at the request of the Secretary, review and consider 
        any information and findings received from the working groups 
        established under subsection (b); and
            ``(C) at the request of the Secretary, provide 
        recommendations and findings for expanded, intensified, and 
        coordinated biodefense research and development activities.
        ``(6) Meetings.--
            ``(A) Initial meeting.--Not later than one year after the 
        date of enactment of the Pandemic and All-Hazards Preparedness 
        Act, the Secretary shall hold the first meeting of the Board.
            ``(B) Subsequent meetings.--The Board shall meet at the 
        call of the Secretary, but in no case less than twice annually.
        ``(7) Vacancies.--Any vacancy in the Board shall not affect its 
    powers, but shall be filled in the same manner as the original 
    appointment.
        ``(8) Chairperson.--The Secretary shall appoint a chairperson 
    from among the members of the Board.
        ``(9) Powers.--
            ``(A) Hearings.--The Board may hold such hearings, sit and 
        act at such times and places, take such testimony, and receive 
        such evidence as the Board considers advisable to carry out 
        this subsection.
            ``(B) Postal services.--The Board may use the United States 
        mails in the same manner and under the same conditions as other 
        departments and agencies of the Federal Government.
        ``(10) Personnel.--
            ``(A) Employees of the federal government.--A member of the 
        Board that is an employee of the Federal Government may not 
        receive additional pay, allowances, or benefits by reason of 
        the member's service on the Board.
            ``(B) Other members.--A member of the Board that is not an 
        employee of the Federal Government may be compensated at a rate 
        not to exceed the daily equivalent of the annual rate of basic 
        pay prescribed for level IV of the Executive Schedule under 
        section 5315 of title 5, United States Code, for each day 
        (including travel time) during which the member is engaged in 
        the actual performance of duties as a member of the Board.
            ``(C) Travel expenses.--Each member of the Board shall 
        receive travel expenses, including per diem in lieu of 
        subsistence, in accordance with applicable provisions under 
        subchapter I of chapter 57 of title 5, United States Code.
            ``(D) Detail of government employees.--Any Federal 
        Government employee may be detailed to the Board with the 
        approval for the contributing agency without reimbursement, and 
        such detail shall be without interruption or loss of civil 
        service status or privilege.
    ``(b) Other Working Groups.--The Secretary may establish a working 
group of experts, or may use an existing working group or advisory 
committee, to--
        ``(1) identify innovative research with the potential to be 
    developed as a qualified countermeasure or a qualified pandemic or 
    epidemic product;
        ``(2) identify accepted animal models for particular diseases 
    and conditions associated with any biological, chemical, 
    radiological, or nuclear agent, any toxin, or any potential 
    pandemic infectious disease, and identify strategies to accelerate 
    animal model and research tool development and validation; and
        ``(3) obtain advice regarding supporting and facilitating 
    advanced research and development related to qualified 
    countermeasures and qualified pandemic or epidemic products that 
    are likely to be safe and effective with respect to children, 
    pregnant women, and other vulnerable populations, and other issues 
    regarding activities under this section that affect such 
    populations.
    ``(c) Definitions.--Any term that is defined in section 319L and 
that is used in this section shall have the same meaning in this 
section as such term is given in section 319L.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated $1,000,000 to carry out this section for fiscal year 2007 
and each fiscal year thereafter.''.

SEC. 403. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT 
              BIOSHIELD.

    (a) Qualified Countermeasure.--Section 319F-1(a) of the Public 
Health Service Act (42 U.S.C. 247d-6a(a)) is amended by striking 
paragraph (2) and inserting the following:
        ``(2) Definitions.--In this section:
            ``(A) Qualified countermeasure.--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--
                ``(i) diagnose, mitigate, prevent, or treat harm from 
            any biological agent (including organisms that cause an 
            infectious disease) or toxin, chemical, radiological, or 
            nuclear agent that may cause a public health emergency 
            affecting national security; or
                ``(ii) diagnose, mitigate, prevent, or treat 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 
            this subparagraph.
            ``(B) Infectious disease.--The term `infectious disease' 
        means a disease potentially caused by a pathogenic organism 
        (including a bacteria, virus, fungus, or parasite) that is 
        acquired by a person and that reproduces in that person.''.
    (b) Security Countermeasure.--Section 319F-2(c)(1)(B) is amended by 
striking ``treat, identify, or prevent'' each place it appears and 
inserting ``diagnose, mitigate, prevent, or treat''.
    (c) Limitation on Use of Funds.--Section 510(a) of the Homeland 
Security Act of 2002 (6 U.S.C. 320(a)) is amended by adding at the end 
the following: ``None of the funds made available under this subsection 
shall be used to procure countermeasures to diagnose, mitigate, 
prevent, or treat harm resulting from any naturally occurring 
infectious disease or other public health threat that are not security 
countermeasures under section 319F-2(c)(1)(B).''.

SEC. 404. TECHNICAL ASSISTANCE.

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

``SEC. 565. TECHNICAL ASSISTANCE.

    ``The Secretary, in consultation with the Commissioner of Food and 
Drugs, shall establish within the Food and Drug Administration a team 
of experts on manufacturing and regulatory activities (including 
compliance with current Good Manufacturing Practice) to provide both 
off-site and on-site technical assistance to the manufacturers of 
qualified countermeasures (as defined in section 319F-1 of the Public 
Health Service Act), security countermeasures (as defined in section 
319F-2 of such Act), or vaccines, at the request of such a manufacturer 
and at the discretion of the Secretary, if the Secretary determines 
that a shortage or potential shortage may occur in the United States in 
the supply of such vaccines or countermeasures and that the provision 
of such assistance would be beneficial in helping alleviate or avert 
such shortage.''.

SEC. 405. COLLABORATION AND COORDINATION.

    (a) Limited Antitrust Exemption.--
        (1) Meetings and consultations to discuss security 
    countermeasures, qualified countermeasures, or qualified pandemic 
    or epidemic product development.--
            (A) Authority to conduct meetings and consultations.--The 
        Secretary of Health and Human Services (referred to in this 
        subsection as the ``Secretary''), in coordination with the 
        Attorney General and the Secretary of Homeland Security, may 
        conduct meetings and consultations with persons engaged in the 
        development of a security countermeasure (as defined in section 
        319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)) 
        (as amended by this Act), a qualified countermeasure (as 
        defined in section 319F-1 of the Public Health Service Act (42 
        U.S.C. 247d-6a)) (as amended by this Act), or a qualified 
        pandemic or epidemic product (as defined in section 319F-3 of 
        the Public Health Service Act (42 U.S.C. 247d-6d)) for the 
        purpose of the development, manufacture, distribution, 
        purchase, or storage of a countermeasure or product. The 
        Secretary may convene such meeting or consultation at the 
        request of the Secretary of Homeland Security, the Attorney 
        General, the Chairman of the Federal Trade Commission (referred 
        to in this section as the ``Chairman''), or any interested 
        person, or upon initiation by the Secretary. The Secretary 
        shall give prior notice of any such meeting or consultation, 
        and the topics to be discussed, to the Attorney General, the 
        Chairman, and the Secretary of Homeland Security.
            (B) Meeting and consultation conditions.--A meeting or 
        consultation conducted under subparagraph (A) shall--
                (i) be chaired or, in the case of a consultation, 
            facilitated by the Secretary;
                (ii) be open to persons involved in the development, 
            manufacture, distribution, purchase, or storage of a 
            countermeasure or product, as determined by the Secretary;
                (iii) be open to the Attorney General, the Secretary of 
            Homeland Security, and the Chairman;
                (iv) be limited to discussions involving covered 
            activities; and
                (v) be conducted in such manner as to ensure that no 
            national security, confidential commercial, or proprietary 
            information is disclosed outside the meeting or 
            consultation.
            (C) Limitation.--The Secretary may not require participants 
        to disclose confidential commercial or proprietary information.
            (D) Transcript.--The Secretary shall maintain a complete 
        verbatim transcript of each meeting or consultation conducted 
        under this subsection. Such transcript (or a portion thereof) 
        shall not be disclosed under section 552 of title 5, United 
        States Code, to the extent that the Secretary, in consultation 
        with the Attorney General and the Secretary of Homeland 
        Security, determines that disclosure of such transcript (or 
        portion thereof) would pose a threat to national security. The 
        transcript (or portion thereof) with respect to which the 
        Secretary has made such a determination shall be deemed to be 
        information described in subsection (b)(3) of such section 552.
            (E) Exemption.--
                (i) In general.--Subject to clause (ii), it shall not 
            be a violation of the antitrust laws for any person to 
            participate in a meeting or consultation conducted in 
            accordance with this paragraph.
                (ii) Limitation.--Clause (i) shall not apply to any 
            agreement or conduct that results from a meeting or 
            consultation and that is not covered by an exemption 
            granted under paragraph (4).
        (2) Submission of written agreements.--The Secretary shall 
    submit each written agreement regarding covered activities that is 
    made pursuant to meetings or consultations conducted under 
    paragraph (1) to the Attorney General and the Chairman for 
    consideration. In addition to the proposed agreement itself, any 
    submission shall include--
            (A) an explanation of the intended purpose of the 
        agreement;
            (B) a specific statement of the substance of the agreement;
            (C) a description of the methods that will be utilized to 
        achieve the objectives of the agreement;
            (D) an explanation of the necessity for a cooperative 
        effort among the particular participating persons to achieve 
        the objectives of the agreement; and
            (E) any other relevant information determined necessary by 
        the Attorney General, in consultation with the Chairman and the 
        Secretary.
        (3) Exemption for conduct under approved agreement.--It shall 
    not be a violation of the antitrust laws for a person to engage in 
    conduct in accordance with a written agreement to the extent that 
    such agreement has been granted an exemption under paragraph (4), 
    during the period for which the exemption is in effect.
        (4) Action on written agreements.--
            (A) In general.--The Attorney General, in consultation with 
        the Chairman, shall grant, deny, grant in part and deny in 
        part, or propose modifications to an exemption request 
        regarding a written agreement submitted under paragraph (2), in 
        a written statement to the Secretary, within 15 business days 
        of the receipt of such request. An exemption granted under this 
        paragraph shall take effect immediately.
            (B) Extension.--The Attorney General may extend the 15-day 
        period referred to in subparagraph (A) for an additional period 
        of not to exceed 10 business days.
            (C) Determination.--An exemption shall be granted regarding 
        a written agreement submitted in accordance with paragraph (2) 
        only to the extent that the Attorney General, in consultation 
        with the Chairman and the Secretary, finds that the conduct 
        that will be exempted will not have any substantial 
        anticompetitive effect that is not reasonably necessary for 
        ensuring the availability of the countermeasure or product 
        involved.
        (5) Limitation on and renewal of exemptions.--An exemption 
    granted under paragraph (4) shall be limited to covered activities, 
    and such exemption shall be renewed (with modifications, as 
    appropriate, consistent with the finding described in paragraph 
    (4)(C)), on the date that is 3 years after the date on which the 
    exemption is granted unless the Attorney General in consultation 
    with the Chairman determines that the exemption should not be 
    renewed (with modifications, as appropriate) considering the 
    factors described in paragraph (4).
        (6) Authority to obtain information.--Consideration by the 
    Attorney General for granting or renewing an exemption submitted 
    under this section shall be considered an antitrust investigation 
    for purposes of the Antitrust Civil Process Act (15 U.S.C. 1311 et 
    seq.).
        (7) Limitation on parties.--The use of any information acquired 
    under an agreement for which an exemption has been granted under 
    paragraph (4), for any purpose other than specified in the 
    exemption, shall be subject to the antitrust laws and any other 
    applicable laws.
        (8) Report.--Not later than one year after the date of 
    enactment of this Act and biannually thereafter, the Attorney 
    General and the Chairman shall report to Congress on the use of the 
    exemption from the antitrust laws provided by this subsection.
    (b) Sunset.--The applicability of this section shall expire at the 
end of the 6-year period that begins on the date of enactment of this 
Act.
    (c) Definitions.--In this section:
        (1) Antitrust laws.--The term ``antitrust laws''--
            (A) has the meaning given such term in subsection (a) of 
        the first section of the Clayton Act (15 U.S.C. 12(a)), except 
        that such term includes section 5 of the Federal Trade 
        Commission Act (15 U.S.C. 45) to the extent such section 5 
        applies to unfair methods of competition; and
            (B) includes any State law similar to the laws referred to 
        in subparagraph (A).
        (2) Countermeasure or product.--The term ``countermeasure or 
    product'' refers to a security countermeasure, qualified 
    countermeasure, or qualified pandemic or epidemic product (as those 
    terms are defined in subsection (a)(1)).
        (3) Covered activities.--
            (A) In general.--Except as provided in subparagraph (B), 
        the term ``covered activities'' includes any activity relating 
        to the development, manufacture, distribution, purchase, or 
        storage of a countermeasure or product.
            (B) Exception.--The term ``covered activities'' shall not 
        include, with respect to a meeting or consultation conducted 
        under subsection (a)(1) or an agreement for which an exemption 
        has been granted under subsection (a)(4), the following 
        activities involving 2 or more persons:
                (i) Exchanging information among competitors relating 
            to costs, profitability, or distribution of any product, 
            process, or service if such information is not reasonably 
            necessary to carry out covered activities--

                    (I) with respect to a countermeasure or product 
                regarding which such meeting or consultation is being 
                conducted; or
                    (II) that are described in the agreement as 
                exempted.

                (ii) Entering into any agreement or engaging in any 
            other conduct--

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

                (iii) Entering into any agreement or engaging in any 
            other conduct allocating a market with a competitor that is 
            not expressly exempted from the antitrust laws under 
            subsection (a)(4).
                (iv) Exchanging information among competitors relating 
            to production (other than production by such covered 
            activities) of a product, process, or service if such 
            information is not reasonably necessary to carry out such 
            covered activities.
                (v) Entering into any agreement or engaging in any 
            other conduct restricting, requiring, or otherwise 
            involving the production of a product, process, or service 
            that is not expressly exempted from the antitrust laws 
            under subsection (a)(4).
                (vi) Except as otherwise provided in this subsection, 
            entering into any agreement or engaging in any other 
            conduct to restrict or require participation by any person 
            participating in such covered activities, in any unilateral 
            or joint activity that is not reasonably necessary to carry 
            out such covered activities.
                (vii) Entering into any agreement or engaging in any 
            other conduct restricting or setting the price at which a 
            countermeasure or product is offered for sale, whether by 
            bid or otherwise.

SEC. 406. PROCUREMENT.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
        (1) in the section heading, by inserting ``and security 
    countermeasure procurements'' before the period; and
        (2) in subsection (c)--
            (A) in the subsection heading, by striking ``Biomedical'';
            (B) in paragraph (3)--
                (i) by striking ``countermeasures.--The Secretary'' and 
            inserting the following: ``countermeasures.--
            ``(A) In general.--The Secretary''; and
                (ii) by adding at the end the following:
            ``(B) Information.--The Secretary shall institute a process 
        for making publicly available the results of assessments under 
        subparagraph (A) while withholding such information as--
                ``(i) would, in the judgment of the Secretary, tend to 
            reveal public health vulnerabilities; or
                ``(ii) would otherwise be exempt from disclosure under 
            section 552 of title 5, United States Code.'';
            (C) in paragraph (4)(A), by inserting ``not developed or'' 
        after ``currently'';
            (D) in paragraph (5)(B)(i), by striking ``to meet the needs 
        of the stockpile'' and inserting ``to meet the stockpile 
        needs'';
            (E) in paragraph (7)(B)--
                (i) by striking the subparagraph heading and all that 
            follows through ``Homeland Security Secretary'' and 
            inserting the following: ``Interagency agreement; cost.--
            The Homeland Security Secretary''; and
                (ii) by striking clause (ii);
            (F) in paragraph (7)(C)(ii)--
                (i) by amending subclause (I) to read as follows:

                    ``(I) Payment conditioned on delivery.--The 
                contract shall provide that no payment may be made 
                until delivery 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, partial payment for significant 
                milestones, or payment to increase manufacturing 
                capacity is necessary to ensure success of a project, 
                the Secretary shall pay an amount, not to exceed 10 
                percent of the contract amount, in advance of delivery. 
                The Secretary shall, to the extent practicable, make 
                the determination of advance payment at the same time 
                as the issuance of a solicitation. 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. The contract may also provide for 
                additional advance payments of 5 percent each for 
                meeting the milestones specified in such contract, 
                except that such payments shall not exceed 50 percent 
                of the total contract amount. If the specified 
                milestones are reached, the advanced payments of 5 
                percent shall not be required to be repaid. Nothing in 
                this subclause shall be construed as affecting the 
                rights of vendors under provisions of law or regulation 
                (including the Federal Acquisition Regulation) relating 
                to the termination of contracts for the convenience of 
                the Government.''; and

                (ii) by adding at the end the following:

                    ``(VII) Sales exclusivity.--The contract may 
                provide that the vendor is the exclusive supplier of 
                the product to the Federal Government for a specified 
                period of time, not to exceed the term of the contract, 
                on the condition that the vendor is able to satisfy the 
                needs of the Government. During the agreed period of 
                sales exclusivity, the vendor shall not assign its 
                rights of sales exclusivity to another entity or 
                entities without approval by the Secretary. Such a 
                sales exclusivity provision in such a contract shall 
                constitute a valid basis for a sole source procurement 
                under section 303(c)(1) of the Federal Property and 
                Administrative Services Act of 1949 (41 U.S.C. 
                253(c)(1)).
                    ``(VIII) Warm based surge capacity.--The contract 
                may provide that the vendor establish domestic 
                manufacturing capacity of the product to ensure that 
                additional production of the product is available in 
                the event that the Secretary determines that there is a 
                need to quickly purchase additional quantities of the 
                product. Such contract may provide a fee to the vendor 
                for establishing and maintaining such capacity in 
                excess of the initial requirement for the purchase of 
                the product. Additionally, the cost of maintaining the 
                domestic manufacturing capacity shall be an allowable 
                and allocable direct cost of the contract.
                    ``(IX) Contract terms.--The Secretary, in any 
                contract for procurement under this section, may 
                specify--

                        ``(aa) the dosing and administration 
                    requirements for countermeasures to be developed 
                    and procured;
                        ``(bb) the amount of funding that will be 
                    dedicated by the Secretary for development and 
                    acquisition of the countermeasure; and
                        ``(cc) the specifications the countermeasure 
                    must meet to qualify for procurement under a 
                    contract under this section.''; and
            (G) in paragraph (8)(A), by adding at the end the 
        following: ``Such agreements may allow other executive agencies 
        to order qualified and security countermeasures under 
        procurement contracts or other agreements established by the 
        Secretary. Such ordering process (including transfers of 
        appropriated funds between an agency and the Department of 
        Health and Human Services as reimbursements for such orders for 
        countermeasures) may be conducted under the authority of 
        section 1535 of title 31, United States Code, except that all 
        such orders shall be processed under the terms established 
        under this subsection for the procurement of 
        countermeasures.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```