```

[109th Congress Public Law 417]
[From the U.S. Government Printing Office]

[DOCID: f:publ417.109]

[[Page 120 STAT. 2831]]

Public Law 109-417
109th Congress

                                 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. <<NOTE: Dec. 19, 2006 -  [S. 3678]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Pandemic and All-Hazards 
Preparedness Act. 42 USC 201 note.>> 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.

[[Page 120 STAT. 2832]]

 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. <<NOTE: 42 USC 300hh.>> 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 <<NOTE: 42 USC 300hh-
        11.>> as section 2812;

[[Page 120 STAT. 2833]]

            (3) by inserting after the subtitle heading the following 
        new section:

``SEC. 2811. <<NOTE: 42 USC 300hh-10.>> COORDINATION OF PREPAREDNESS FOR 
            AND RESPONSE TO ALL-HAZARDS PUBLIC HEALTH EMERGENCIES.

    ``(a) <<NOTE: Government organization.>> In General.--There is 
established within the Department of Health and Human Services the 
position of the Assistant Secretary for Preparedness and Response. 
The <<NOTE: President.>> 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--

[[Page 120 STAT. 2834]]

                    ``(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) <<NOTE: 42 USC 300hh-11.>> by striking ``Assistant 
        Secretary for Public Health Emergency Preparedness'' each place 
        it appears and inserting ``Assistant Secretary for Preparedness 
        and Response''.

    (b) <<NOTE: 42 USC 300hh-10 note.>> 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. <<NOTE: 42 USC 300hh-16.>> 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);

[[Page 120 STAT. 2835]]

            ``(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) <<NOTE: Deadline. Reports.>> 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. <<NOTE: 42 USC 300hh-1.>> NATIONAL HEALTH SECURITY 
            STRATEGY.

    ``(a) In General.--
            ``(1) Preparedness and response regarding public health 
        emergencies.--Beginning <<NOTE: Effective date. Deadline.>> 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.

[[Page 120 STAT. 2836]]

            ``(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

[[Page 120 STAT. 2837]]

        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) <<NOTE: Contracts.>> 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

[[Page 120 STAT. 2838]]

                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) <<NOTE: Effective date.>> 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--

[[Page 120 STAT. 2839]]

            ``(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) <<NOTE: Website.>> 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) <<NOTE: Deadline.>> 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) <<NOTE: Deadline.>> 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

[[Page 120 STAT. 2840]]

        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 <<NOTE: Effective 
        date. Deadline.>> 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).

[[Page 120 STAT. 2841]]

                    ``(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

[[Page 120 STAT. 2842]]

                      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 <<NOTE: Effective date.>> 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

[[Page 120 STAT. 2843]]

                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) <<NOTE: Contracts.>> 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

[[Page 120 STAT. 2844]]

        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) <<NOTE: Publication. Website.>> 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. <<NOTE: Deadline.>> 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.

[[Page 120 STAT. 2845]]

                    ``(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) <<NOTE: Website.>> 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) <<NOTE: Deadline.>> 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) <<NOTE: Deadline.>> 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).

[[Page 120 STAT. 2846]]

            ``(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) <<NOTE: Reports.>> 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--

[[Page 120 STAT. 2847]]

                    ``(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) <<NOTE: Deadline. Reports.>> 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;

[[Page 120 STAT. 2848]]

                          ``(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. <<NOTE: 42 USC 254u.>> 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

[[Page 120 STAT. 2849]]

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

[[Page 120 STAT. 2850]]

                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).

[[Page 120 STAT. 2851]]

    ``(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 <<NOTE: 42 USC 247d-2, 247d-3.>> 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. <<NOTE: 42 USC 262a note.>> 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. <<NOTE: 42 USC 204a note.>> 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. <<NOTE: 42 USC 204a.>> 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

[[Page 120 STAT. 2852]]

        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) <<NOTE: Procedures.>> 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.

[[Page 120 STAT. 2853]]

    ``(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

[[Page 120 STAT. 2854]]

                    (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 <<NOTE: Deadline.>> 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) <<NOTE: 42 USC 300hh-11 note.>> 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), <<NOTE: 6 USC 314.>> by striking 
        ``, the National Disaster Medical System,''; and
            (2) in section 503(5), <<NOTE: 6 USC 313.>> 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

[[Page 120 STAT. 2855]]

            (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) <<NOTE: 6 USC 313 note.>> 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. <<NOTE: 42 USC 300hh-2.>> 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:

[[Page 120 STAT. 2856]]

                    ``(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) <<NOTE: Applicability.>> 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) <<NOTE: Applicability.>> 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) <<NOTE: 42 USC 1320b-5 note.>> 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. <<NOTE: Establishment. 42 USC 300hh-
            15. Deadline.>> 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

[[Page 120 STAT. 2857]]

            ``(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--

[[Page 120 STAT. 2858]]

            (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) <<NOTE: Deadline.>> 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

[[Page 120 STAT. 2859]]

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

[[Page 120 STAT. 2860]]

                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).

[[Page 120 STAT. 2861]]

            ``(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) <<NOTE: Grants. Contracts.>> 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--

[[Page 120 STAT. 2862]]

                    ``(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.

[[Page 120 STAT. 2863]]

    ``(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) <<NOTE: Applicability.>> 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)--

[[Page 120 STAT. 2864]]

                    (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.''.

[[Page 120 STAT. 2865]]

     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. <<NOTE: 42 USC 247d-7e.>> 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;

[[Page 120 STAT. 2866]]

                          ``(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) <<NOTE: Deadline. Public information.>> 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.

[[Page 120 STAT. 2867]]

    ``(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

[[Page 120 STAT. 2868]]

                          ``(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

[[Page 120 STAT. 2869]]

                      Defense enters into such transactions under 
                      section 2371 of title 10, United States Code.
                          ``(ii) Limitations on authority.--
                                    ``(I) <<NOTE: Applicability.>> 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) <<NOTE: Applicability.>> 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

[[Page 120 STAT. 2870]]

                      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.

[[Page 120 STAT. 2871]]

                          ``(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) <<NOTE: Applicability.>> 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

[[Page 120 STAT. 2872]]

                enactment of the Pandemic and All-Hazards Preparedness 
                Act.
            ``(2) <<NOTE: Termination date.>> 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. <<NOTE: 42 USC 247d-7f.>> 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;

[[Page 120 STAT. 2873]]

                    ``(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) <<NOTE: Deadline.>> 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;

[[Page 120 STAT. 2874]]

            ``(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 <<NOTE: 42 USC 247d-
6b.>> 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) <<NOTE: 42 USC 321j.>> 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 

[[Page 120 STAT. 2875]]

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. <<NOTE: Establishment. 21 USC 360bbb-4.>> 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. <<NOTE: 42 USC 247d-6a note.>> 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. <<NOTE: Notice.>> 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;

[[Page 120 STAT. 2876]]

                          (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

[[Page 120 STAT. 2877]]

        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) <<NOTE: Deadline.>> 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) <<NOTE: Applicability.>> 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 

[[Page 120 STAT. 2878]]

                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

[[Page 120 STAT. 2879]]

                      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) <<NOTE: Public information.>> 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

[[Page 120 STAT. 2880]]

                                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

[[Page 120 STAT. 2881]]

                                            ``(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.''.

    Approved December 19, 2006.

LEGISLATIVE HISTORY--S. 3678:
---------------------------------------------------------------------------

SENATE REPORTS: No. 109-319 (Comm. on Health, Education, Labor, and       
  Pensions).
CONGRESSIONAL RECORD, Vol. 152 (2006):
            Dec. 5, considered and passed Senate.
            Dec. 8, considered and passed House.

                                  <all>
```