```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3678 Engrossed in Senate (ES)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
109th CONGRESS
  2d Session
                                S. 3678

_______________________________________________________________________

                                 AN ACT

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

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
TITLE I--NATIONAL PREPAREDNESS AND RESPONSE, LEADERSHIP, ORGANIZATION, 
                              AND PLANNING

Sec. 101. Public health and medical preparedness and response functions 
                            of the Secretary of Health and Human 
                            Services.
Sec. 102. Assistant Secretary for Preparedness and Response.
Sec. 103. National Health Security Strategy.
             TITLE II--PUBLIC HEALTH SECURITY PREPAREDNESS

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

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

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

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

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

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

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

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

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

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

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

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

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

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

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

``SEC. 2814. AT-RISK INDIVIDUALS.

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

SEC. 103. NATIONAL HEALTH SECURITY STRATEGY.

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

``SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.

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

             TITLE II--PUBLIC HEALTH SECURITY PREPAREDNESS

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

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

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

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

SEC. 203. PUBLIC HEALTH WORKFORCE ENHANCEMENTS.

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

``SEC. 338M. PUBLIC HEALTH DEPARTMENTS.

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

SEC. 204. VACCINE TRACKING AND DISTRIBUTION.

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

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

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

SEC. 205. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.

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

SEC. 206. REVITALIZATION OF COMMISSIONED CORPS.

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

``SEC. 203A. DEPLOYMENT READINESS.

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

             TITLE III--ALL-HAZARDS MEDICAL SURGE CAPACITY

SEC. 301. NATIONAL DISASTER MEDICAL SYSTEM.

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

SEC. 302. ENHANCING MEDICAL SURGE CAPACITY.

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

``SEC. 2803. ENHANCING MEDICAL SURGE CAPACITY.

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

SEC. 303. ENCOURAGING HEALTH PROFESSIONAL VOLUNTEERS.

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

``SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.

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

SEC. 304. CORE EDUCATION AND TRAINING.

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

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

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

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

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

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

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

     TITLE IV--PANDEMIC AND BIODEFENSE VACCINE AND DRUG DEVELOPMENT

SEC. 401. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

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

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

    ``(a) Definitions.--In this section:
            ``(1) BARDA.--The term `BARDA' means the Biomedical 
        Advanced Research and Development Authority.
            ``(2) Fund.--The term `Fund' means the Biodefense Medical 
        Countermeasure Development Fund established under subsection 
        (d).
            ``(3) Other transactions.--The term `other transactions' 
        means transactions, other than procurement contracts, grants, 
        and cooperative agreements, such as the Secretary of Defense 
        may enter into under section 2371 of title 10, United States 
        Code.
            ``(4) Qualified countermeasure.--The term `qualified 
        countermeasure' has the meaning given such term in section 
        319F-1.
            ``(5) Qualified pandemic or epidemic product.--The term 
        `qualified pandemic or epidemic product' has the meaning given 
        the term in section 319F-3.
            ``(6) Advanced research and development.--
                    ``(A) In general.--The term `advanced research and 
                development' means, with respect to a product that is 
                or may become a qualified countermeasure or a qualified 
                pandemic or epidemic product, activities that 
                predominantly--
                            ``(i) are conducted after basic research 
                        and preclinical development of the product; and
                            ``(ii) are related to manufacturing the 
                        product on a commercial scale and in a form 
                        that satisfies the regulatory requirements 
                        under the Federal Food, Drug, and Cosmetic Act 
                        or under section 351 of this Act.
                    ``(B) Activities included.--The term under 
                subparagraph (A) includes--
                            ``(i) testing of the product to determine 
                        whether the product may be approved, cleared, 
                        or licensed under the Federal Food, Drug, and 
                        Cosmetic Act or under section 351 of this Act 
                        for a use that is or may be the basis for such 
                        product becoming a qualified countermeasure or 
                        qualified pandemic or epidemic product, or to 
                        help obtain such approval, clearance, or 
                        license;
                            ``(ii) design and development of tests or 
                        models, including animal models, for such 
                        testing;
                            ``(iii) activities to facilitate 
                        manufacture of the product on a commercial 
                        scale with consistently high quality, as well 
                        as to improve and make available new 
                        technologies to increase manufacturing surge 
                        capacity;
                            ``(iv) activities to improve the shelf-life 
                        of the product or technologies for 
                        administering the product; and
                            ``(v) such other activities as are part of 
                        the advanced stages of testing, refinement, 
                        improvement, or preparation of the product for 
                        such use and as are specified by the Secretary.
            ``(7) Security countermeasure.--The term `security 
        countermeasure' has the meaning given such term in section 
        319F-2.
            ``(8) Research tool.--The term `research tool' means a 
        device, technology, biological material (including a cell line 
        or an antibody), reagent, animal model, computer system, 
        computer software, or analytical technique that is developed to 
        assist in the discovery, development, or manufacture of 
        qualified countermeasures or qualified pandemic or epidemic 
        products.
            ``(9) Program manager.--The term `program manager' means an 
        individual appointed to carry out functions under this section 
        and authorized to provide project oversight and management of 
        strategic initiatives.
            ``(10) Person.--The term `person' includes an individual, 
        partnership, corporation, association, entity, or public or 
        private corporation, and a Federal, State, or local government 
        agency or department.
    ``(b) Strategic Plan for Countermeasure Research, Development, and 
Procurement.--
            ``(1) In general.--Not later than 6 months after the date 
        of enactment of the Pandemic and All-Hazards Preparedness Act, 
        the Secretary shall develop and make public a strategic plan to 
        integrate biodefense and emerging infectious disease 
        requirements with the advanced research and development, 
        strategic initiatives for innovation, and the procurement of 
        qualified countermeasures and qualified pandemic or epidemic 
        products. The Secretary shall carry out such activities as may 
        be practicable to disseminate the information contained in such 
        plan to persons who may have the capacity to substantially 
        contribute to the activities described in such strategic plan. 
        The Secretary shall update and incorporate such plan as part of 
        the National Health Security Strategy described in section 
        2802.
            ``(2) Content.--The strategic plan under paragraph (1) 
        shall guide--
                    ``(A) research and development, conducted or 
                supported by the Department of Health and Human 
                Services, of qualified countermeasures and qualified 
                pandemic or epidemic products against possible 
                biological, chemical, radiological, and nuclear agents 
                and to emerging infectious diseases;
                    ``(B) innovation in technologies that may assist 
                advanced research and development of qualified 
                countermeasures and qualified pandemic or epidemic 
                products (such research and development referred to in 
                this section as `countermeasure and product advanced 
                research and development'); and
                    ``(C) procurement of such qualified countermeasures 
                and qualified pandemic or epidemic products by such 
                Department.
    ``(c) Biomedical Advanced Research and Development Authority.--
            ``(1) Establishment.--There is established within the 
        Department of Health and Human Services the Biomedical Advanced 
        Research and Development Authority.
            ``(2) In general.--Based upon the strategic plan described 
        in subsection (b), the Secretary shall coordinate the 
        acceleration of countermeasure and product advanced research 
        and development by--
                    ``(A) facilitating collaboration between the 
                Department of Health and Human Services and other 
                Federal agencies, relevant industries, academia, and 
                other persons, with respect to such advanced research 
                and development;
                    ``(B) promoting countermeasure and product advanced 
                research and development;
                    ``(C) facilitating contacts between interested 
                persons and the offices or employees authorized by the 
                Secretary to advise such persons regarding requirements 
                under the Federal Food, Drug, and Cosmetic Act and 
                under section 351 of this Act; and
                    ``(D) promoting innovation to reduce the time and 
                cost of countermeasure and product advanced research 
                and development.
            ``(3) Director.--The BARDA shall be headed by a Director 
        (referred to in this section as the `Director') who shall be 
        appointed by the Secretary and to whom the Secretary shall 
        delegate such functions and authorities as necessary to 
        implement this section.
            ``(4) Duties.--
                    ``(A) Collaboration.--To carry out the purpose 
                described in paragraph (2)(A), the Secretary shall--
                            ``(i) facilitate and increase the 
                        expeditious and direct communication between 
                        the Department of Health and Human Services and 
                        relevant persons with respect to countermeasure 
                        and product advanced research and development, 
                        including by--
                                    ``(I) facilitating such 
                                communication regarding the processes 
                                for procuring such advanced research 
                                and development with respect to 
                                qualified countermeasures and qualified 
                                pandemic or epidemic products of 
                                interest; and
                                    ``(II) soliciting information about 
                                and data from research on potential 
                                qualified countermeasures and qualified 
                                pandemic or epidemic products and 
                                related technologies;
                            ``(ii) at least annually--
                                    ``(I) convene meetings with 
                                representatives from relevant 
                                industries, academia, other Federal 
                                agencies, international agencies as 
                                appropriate, and other interested 
                                persons;
                                    ``(II) sponsor opportunities to 
                                demonstrate the operation and 
                                effectiveness of relevant biodefense 
                                countermeasure technologies; and
                                    ``(III) convene such working groups 
                                on countermeasure and product advanced 
                                research and development as the 
                                Secretary may determine are necessary 
                                to carry out this section; and
                            ``(iii) carry out the activities described 
                        in section 405 of the Pandemic and All-Hazards 
                        Preparedness Act.
                    ``(B) Support advanced research and development.--
                To carry out the purpose described in paragraph (2)(B), 
                the Secretary shall--
                            ``(i) conduct ongoing searches for, and 
                        support calls for, potential qualified 
                        countermeasures and qualified pandemic or 
                        epidemic products;
                            ``(ii) direct and coordinate the 
                        countermeasure and product advanced research 
                        and development activities of the Department of 
                        Health and Human Services;
                            ``(iii) establish strategic initiatives to 
                        accelerate countermeasure and product advanced 
                        research and development and innovation in such 
                        areas as the Secretary may identify as priority 
                        unmet need areas; and
                            ``(iv) award contracts, grants, cooperative 
                        agreements, and enter into other transactions, 
                        for countermeasure and product advanced 
                        research and development.
                    ``(C) Facilitating advice.--To carry out the 
                purpose described in paragraph (2)(C) the Secretary 
                shall--
                            ``(i) connect interested persons with the 
                        offices or employees authorized by the 
                        Secretary to advise such persons regarding the 
                        regulatory requirements under the Federal Food, 
                        Drug, and Cosmetic Act and under section 351 of 
                        this Act related to the approval, clearance, or 
                        licensure of qualified countermeasures or 
                        qualified pandemic or epidemic products; and
                            ``(ii) with respect to persons performing 
                        countermeasure and product advanced research 
                        and development funded under this section, 
                        enable such offices or employees to provide to 
                        the extent practicable such advice in a manner 
                        that is ongoing and that is otherwise designed 
                        to facilitate expeditious development of 
                        qualified countermeasures and qualified 
                        pandemic or epidemic products that may achieve 
                        such approval, clearance, or licensure.
                    ``(D) Supporting innovation.--To carry out the 
                purpose described in paragraph (2)(D), the Secretary 
                may award contracts, grants, and cooperative 
                agreements, or enter into other transactions, such as 
                prize payments, to promote--
                            ``(i) innovation in technologies that may 
                        assist countermeasure and product advanced 
                        research and development;
                            ``(ii) research on and development of 
                        research tools and other devices and 
                        technologies; and
                            ``(iii) research to promote strategic 
                        initiatives, such as rapid diagnostics, broad 
                        spectrum antimicrobials, and vaccine 
                        manufacturing technologies.
            ``(5) Transaction authorities.--
                    ``(A) Other transactions.--
                            ``(i) In general.--The Secretary shall have 
                        the authority to enter into other transactions 
                        under this subsection in the same manner as the 
                        Secretary of Defense enters into such 
                        transactions under section 2371 of title 10, 
                        United States Code.
                            ``(ii) Limitations on authority.--
                                    ``(I) In general.--Subsections (b), 
                                (c), and (h) of section 845 of the 
                                National Defense Authorization Act for 
                                Fiscal Year 1994 (10 U.S.C. 2371 note) 
                                shall apply to other transactions under 
                                this subparagraph as if such 
                                transactions were for prototype 
                                projects described by subsection (a) of 
                                such section 845.
                                    ``(II) Written determinations 
                                required.--The authority of this 
                                subparagraph may be exercised for a 
                                project that is expected to cost the 
                                Department of Health and Human Services 
                                in excess of $20,000,000 only upon a 
                                written determination by the senior 
                                procurement executive for the 
                                Department (as designated for purpose 
                                of section 16(c) of the Office of 
                                Federal Procurement Policy Act (41 
                                U.S.C. 414(c))), that the use of such 
                                authority is essential to promoting the 
                                success of the project. The authority 
                                of the senior procurement executive 
                                under this subclause may not be 
                                delegated.
                            ``(iii) Guidelines.--The Secretary shall 
                        establish guidelines regarding the use of the 
                        authority under clause (i). Such guidelines 
                        shall include auditing requirements.
                    ``(B) Expedited authorities.--
                            ``(i) In general.--In awarding contracts, 
                        grants, and cooperative agreements, and in 
                        entering into other transactions under 
                        subparagraph (B) or (D) of paragraph (4), the 
                        Secretary shall have the expedited procurement 
                        authorities, the authority to expedite peer 
                        review, and the authority for personal services 
                        contracts, supplied by subsections (b), (c), 
                        and (d) of section 319F-1.
                            ``(ii) Application of provisions.--
                        Provisions in such section 319F-1 that apply to 
                        such authorities and that require institution 
                        of internal controls, limit review, provide for 
                        Federal Tort Claims Act coverage of personal 
                        services contractors, and commit decisions to 
                        the discretion of the Secretary shall apply to 
                        the authorities as exercised pursuant to this 
                        paragraph.
                            ``(iii) Authority to limit competition.--
                        For purposes of applying section 319F-
                        1(b)(1)(D) to this paragraph, the phrase 
                        `BioShield Program under the Project BioShield 
                        Act of 2004' shall be deemed to mean the 
                        countermeasure and product advanced research 
                        and development program under this section.
                            ``(iv) Availability of data.--The Secretary 
                        shall require that, as a condition of being 
                        awarded a contract, grant, cooperative 
                        agreement, or other transaction under 
                        subparagraph (B) or (D) of paragraph (4), a 
                        person make available to the Secretary on an 
                        ongoing basis, and submit upon request to the 
                        Secretary, all data related to or resulting 
                        from countermeasure and product advanced 
                        research and development carried out pursuant 
                        to this section.
                    ``(C) Advance payments; advertising.--The Secretary 
                may waive the requirements of section 3324(a) of title 
                31, United States Code, or section 3709 of the Revised 
                Statutes of the United States (41 U.S.C. 5) upon the 
                determination by the Secretary that such waiver is 
                necessary to obtain countermeasures or products under 
                this section.
                    ``(D) Milestone-based payments allowed.--In 
                awarding contracts, grants, and cooperative agreements, 
                and in entering into other transactions, under this 
                section, the Secretary may use milestone-based awards 
                and payments.
                    ``(E) Foreign nationals eligible.--The Secretary 
                may under this section award contracts, grants, and 
                cooperative agreements to, and may enter into other 
                transactions with, highly qualified foreign national 
                persons outside the United States, alone or in 
                collaboration with American participants, when such 
                transactions may inure to the benefit of the American 
                people.
                    ``(F) Establishment of research centers.--The 
                Secretary may assess the feasibility and 
                appropriateness of establishing, through contract, 
                grant, cooperative agreement, or other transaction, an 
                arrangement with an existing research center in order 
                to achieve the goals of this section. If such an 
                agreement is not feasible and appropriate, the 
                Secretary may establish one or more federally-funded 
                research and development centers, or university-
                affiliated research centers, in accordance with section 
                303(c)(3) of the Federal Property and Administrative 
                Services Act of 1949 (41 U.S.C. 253(c)(3)).
            ``(6) At-risk individuals.--In carrying out the functions 
        under this section, the Secretary may give priority to the 
        advanced research and development of qualified countermeasures 
        and qualified pandemic or epidemic products that are likely to 
        be safe and effective with respect to children, pregnant women, 
        elderly, and other at-risk individuals.
            ``(7) Personnel authorities.--
                    ``(A) Specially qualified scientific and 
                professional personnel.--
                            ``(i) In general.--In addition to any other 
                        personnel authorities, the Secretary may--
                                    ``(I) without regard to those 
                                provisions of title 5, United States 
                                Code, governing appointments in the 
                                competitive service, appoint highly 
                                qualified individuals to scientific or 
                                professional positions in BARDA, such 
                                as program managers, to carry out this 
                                section; and
                                    ``(II) compensate them in the same 
                                manner and subject to the same terms 
                                and conditions in which individuals 
                                appointed under section 9903 of such 
                                title are compensated, without regard 
                                to the provisions of chapter 51 and 
                                subchapter III of chapter 53 of such 
                                title relating to classification and 
                                General Schedule pay rates.
                            ``(ii) Manner of exercise of authority.--
                        The authority provided for in this subparagraph 
                        shall be exercised subject to the same 
                        limitations described in section 319F-1(e)(2).
                            ``(iii) Term of appointment.--The term 
                        limitations described in section 9903(c) of 
                        title 5, United States Code, shall apply to 
                        appointments under this subparagraph, except 
                        that the references to the `Secretary' and to 
                        the `Department of Defense's national security 
                        missions' shall be deemed to be to the 
                        Secretary of Health and Human Services and to 
                        the mission of the Department of Health and 
                        Human Services under this section.
                    ``(B) Special consultants.--In carrying out this 
                section, the Secretary may appoint special consultants 
                pursuant to section 207(f).
                    ``(C) Limitation.--
                            ``(i) In general.--The Secretary may hire 
                        up to 100 highly qualified individuals, or up 
                        to 50 percent of the total number of employees, 
                        whichever is less, under the authorities 
                        provided for in subparagraphs (A) and (B).
                            ``(ii) Report.--The Secretary shall report 
                        to Congress on a biennial basis on the 
                        implementation of this subparagraph.
    ``(d) Fund.--
            ``(1) Establishment.--There is established the Biodefense 
        Medical Countermeasure Development Fund, which shall be 
        available to carry out this section in addition to such amounts 
        as are otherwise available for this purpose.
            ``(2) Funding.--To carry out the purposes of this section, 
        there are authorized to be appropriated to the Fund--
                    ``(A) $1,070,000,000 for fiscal years 2006 through 
                2008, the amounts to remain available until expended; 
                and
                    ``(B) such sums as may be necessary for subsequent 
                fiscal years, the amounts to remain available until 
                expended.
    ``(e) Inapplicability of Certain Provisions.--
            ``(1) Disclosure.--
                    ``(A) In general.--The Secretary shall withhold 
                from disclosure under section 552 of title 5, United 
                States Code, specific technical data or scientific 
                information that is created or obtained during the 
                countermeasure and product advanced research and 
                development carried out under subsection (c) that 
                reveals significant and not otherwise publicly known 
                vulnerabilities of existing medical or public health 
                defenses against biological, chemical, nuclear, or 
                radiological threats. Such information shall be deemed 
                to be information described in section 552(b)(3) of 
                title 5, United States Code.
                    ``(B) Review.--Information subject to nondisclosure 
                under subparagraph (A) shall be reviewed by the 
                Secretary every 5 years, or more frequently as 
                determined necessary by the Secretary, to determine the 
                relevance or necessity of continued nondisclosure.
                    ``(C) Sunset.--This paragraph shall cease to have 
                force or effect on the date that is 7 years after the 
                date of enactment of the Pandemic and All-Hazards 
                Preparedness Act.
            ``(2) Review.--Notwithstanding section 14 of the Federal 
        Advisory Committee Act, a working group of BARDA under this 
        section and the National Biodefense Science Board under section 
        319M shall each terminate on the date that is 5 years after the 
        date on which each such group or Board, as applicable, was 
        established. Such 5-year period may be extended by the 
        Secretary for one or more additional 5-year periods if the 
        Secretary determines that any such extension is appropriate.''.

SEC. 402. NATIONAL BIODEFENSE SCIENCE BOARD.

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

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

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

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

    (a) Qualified Countermeasure.--Section 319F-1(a) of the Public 
Health Service Act (42 U.S.C. 247d-6a(a)) is amended by striking 
paragraph (2) and inserting the following:
            ``(2) Definitions.--In this section:
                    ``(A) Qualified countermeasure.--The term 
                `qualified countermeasure' means a drug (as that term 
                is defined by section 201(g)(1) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), 
                biological product (as that term is defined by section 
                351(i) of this Act (42 U.S.C. 262(i))), or device (as 
                that term is defined by section 201(h) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that 
                the Secretary determines to be a priority (consistent 
                with sections 302(2) and 304(a) of the Homeland 
                Security Act of 2002) to--
                            ``(i) diagnose, mitigate, prevent, or treat 
                        harm from any biological agent (including 
                        organisms that cause an infectious disease) or 
                        toxin, chemical, radiological, or nuclear agent 
                        that may cause a public health emergency 
                        affecting national security; or
                            ``(ii) diagnose, mitigate, prevent, or 
                        treat harm from a condition that may result in 
                        adverse health consequences or death and may be 
                        caused by administering a drug, biological 
                        product, or device that is used as described in 
                        this subparagraph.
                    ``(B) Infectious disease.--The term `infectious 
                disease' means a disease potentially caused by a 
                pathogenic organism (including a bacteria, virus, 
                fungus, or parasite) that is acquired by a person and 
                that reproduces in that person.''.
    (b) Security Countermeasure.--Section 319F-2(c)(1)(B) is amended by 
striking ``treat, identify, or prevent'' each place it appears and 
inserting ``diagnose, mitigate, prevent, or treat''.
    (c) Limitation on Use of Funds.--Section 510(a) of the Homeland 
Security Act of 2002 (6 U.S.C. 320(a)) is amended by adding at the end 
the following: ``None of the funds made available under this subsection 
shall be used to procure countermeasures to diagnose, mitigate, 
prevent, or treat harm resulting from any naturally occurring 
infectious disease or other public health threat that are not security 
countermeasures under section 319F-2(c)(1)(B).''.

SEC. 404. TECHNICAL ASSISTANCE.

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

``SEC. 565. TECHNICAL ASSISTANCE.

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

SEC. 405. COLLABORATION AND COORDINATION.

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

SEC. 406. PROCUREMENT.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
            (1) in the section heading, by inserting ``and security 
        countermeasure procurements'' before the period; and
            (2) in subsection (c)--
                    (A) in the subsection heading, by striking 
                ``Biomedical'';
                    (B) in paragraph (3)--
                            (i) by striking ``countermeasures.--The 
                        Secretary'' and inserting the following: 
                        ``countermeasures.--
                    ``(A) In general.--The Secretary''; and
                            (ii) by adding at the end the following:
                    ``(B) Information.--The Secretary shall institute a 
                process for making publicly available the results of 
                assessments under subparagraph (A) while withholding 
                such information as--
                            ``(i) would, in the judgment of the 
                        Secretary, tend to reveal public health 
                        vulnerabilities; or
                            ``(ii) would otherwise be exempt from 
                        disclosure under section 552 of title 5, United 
                        States Code.'';
                    (C) in paragraph (4)(A), by inserting ``not 
                developed or'' after ``currently'';
                    (D) in paragraph (5)(B)(i), by striking ``to meet 
                the needs of the stockpile'' and inserting ``to meet 
                the stockpile needs'';
                    (E) in paragraph (7)(B)--
                            (i) by striking the subparagraph heading 
                        and all that follows through ``Homeland 
                        Security Secretary'' and inserting the 
                        following: ``Interagency agreement; cost.--The 
                        Homeland Security Secretary''; and
                            (ii) by striking clause (ii);
                    (F) in paragraph (7)(C)(ii)--
                            (i) by amending subclause (I) to read as 
                        follows:
                                    ``(I) Payment conditioned on 
                                delivery.--The contract shall provide 
                                that no payment may be made until 
                                delivery of a portion, acceptable to 
                                the Secretary, of the total number of 
                                units contracted for, except that, 
                                notwithstanding any other provision of 
                                law, the contract may provide that, if 
                                the Secretary determines (in the 
                                Secretary's discretion) that an advance 
                                payment, partial payment for 
                                significant milestones, or payment to 
                                increase manufacturing capacity is 
                                necessary to ensure success of a 
                                project, the Secretary shall pay an 
                                amount, not to exceed 10 percent of the 
                                contract amount, in advance of 
                                delivery. The Secretary shall, to the 
                                extent practicable, make the 
                                determination of advance payment at the 
                                same time as the issuance of a 
                                solicitation. The contract shall 
                                provide that such advance payment is 
                                required to be repaid if there is a 
                                failure to perform by the vendor under 
                                the contract. The contract may also 
                                provide for additional advance payments 
                                of 5 percent each for meeting the 
                                milestones specified in such contract, 
                                except that such payments shall not 
                                exceed 50 percent of the total contract 
                                amount. If the specified milestones are 
                                reached, the advanced payments of 5 
                                percent shall not be required to be 
                                repaid. Nothing in this subclause shall 
                                be construed as affecting the rights of 
                                vendors under provisions of law or 
                                regulation (including the Federal 
                                Acquisition Regulation) relating to the 
                                termination of contracts for the 
                                convenience of the Government.''; and
                            (ii) by adding at the end the following:
                                    ``(VII) Sales exclusivity.--The 
                                contract may provide that the vendor is 
                                the exclusive supplier of the product 
                                to the Federal Government for a 
                                specified period of time, not to exceed 
                                the term of the contract, on the 
                                condition that the vendor is able to 
                                satisfy the needs of the Government. 
                                During the agreed period of sales 
                                exclusivity, the vendor shall not 
                                assign its rights of sales exclusivity 
                                to another entity or entities without 
                                approval by the Secretary. Such a sales 
                                exclusivity provision in such a 
                                contract shall constitute a valid basis 
                                for a sole source procurement under 
                                section 303(c)(1) of the Federal 
                                Property and Administrative Services 
                                Act of 1949 (41 U.S.C. 253(c)(1)).
                                    ``(VIII) Warm based surge 
                                capacity.--The contract may provide 
                                that the vendor establish domestic 
                                manufacturing capacity of the product 
                                to ensure that additional production of 
                                the product is available in the event 
                                that the Secretary determines that 
                                there is a need to quickly purchase 
                                additional quantities of the product. 
                                Such contract may provide a fee to the 
                                vendor for establishing and maintaining 
                                such capacity in excess of the initial 
                                requirement for the purchase of the 
                                product. Additionally, the cost of 
                                maintaining the domestic manufacturing 
                                capacity shall be an allowable and 
                                allocable direct cost of the contract.
                                    ``(IX) Contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this section, may 
                                specify--
                                            ``(aa) the dosing and 
                                        administration requirements for 
                                        countermeasures to be developed 
                                        and procured;
                                            ``(bb) the amount of 
                                        funding that will be dedicated 
                                        by the Secretary for 
                                        development and acquisition of 
                                        the countermeasure; and
                                            ``(cc) the specifications 
                                        the countermeasure must meet to 
                                        qualify for procurement under a 
                                        contract under this section.''; 
                                        and
                    (G) in paragraph (8)(A), by adding at the end the 
                following: ``Such agreements may allow other executive 
                agencies to order qualified and security 
                countermeasures under procurement contracts or other 
                agreements established by the Secretary. Such ordering 
                process (including transfers of appropriated funds 
                between an agency and the Department of Health and 
                Human Services as reimbursements for such orders for 
                countermeasures) may be conducted under the authority 
                of section 1535 of title 31, United States Code, except 
                that all such orders shall be processed under the terms 
                established under this subsection for the procurement 
                of countermeasures.''.

            Passed the Senate December 5, 2006.

            Attest:

                                                             Secretary.
109th CONGRESS

  2d Session

                                S. 3678

_______________________________________________________________________

                                 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.
```