[Congressional Record (Bound Edition), Volume 152 (2006), Part 18]
[House]
[Pages 23387-23402]
[From the U.S. Government Publishing Office, www.gpo.gov]




               PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT

  Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent to take 
from the Speaker's table the Senate bill (S. 3678) to amend the Public 
Health Service Act with respect to public health security and all-
hazards preparedness and response, and for other purposes, and ask for 
its immediate consideration in the House.
  The Clerk read the title of the Senate bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  The Clerk read the Senate bill, as follows:

                                S. 3678

       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.

[[Page 23388]]

       ``(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:

[[Page 23389]]

       ``(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

[[Page 23390]]

     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,

[[Page 23391]]

     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.--

[[Page 23392]]

       ``(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).''.

[[Page 23393]]

       (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--

[[Page 23394]]

       (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

[[Page 23395]]

     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

[[Page 23396]]

       ``(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

[[Page 23397]]

       (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

[[Page 23398]]

     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.''.

[[Page 23399]]



     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

[[Page 23400]]

     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.

[[Page 23401]]



     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.''.

  Mr. BARTON of Texas. Mr. Speaker, please insert this exchange of 
correspondence on 
S. 3678 into the Record.

                                    Congress of the United States,


                                     House of Representatives,

                                 Washington, DC, December 8, 2006.
     Hon. J. Dennis Hastert,
     Speaker, House of Representatives, Washington, DC.
       Dear Mr. Speaker: We write to clarify the intent of Title I 
     of S. 3678, the ``Pandemic and All-Hazards Preparedness 
     Act,'' regarding the respective roles and responsibilities of 
     the Secretary of Homeland Security and the Secretary of 
     Health and Human Services during Incidents of National 
     Significance under the National Response Plan (NRP). Title I 
     of S. 3678 should not be construed to designate the 
     Department of Health and Human Services as the lead Federal 
     agency under the NRP during incidents of National 
     Significance that require a medical and/or public health 
     response.
       The NRP is an all-discipline, all-hazards plan that 
     establishes a single, comprehensive framework for the 
     management of domestic incidents. Under the NRP, the 
     Department of Homeland Security (DHS) is the Federal 
     department responsible for coordinating Federal operations 
     and/or resources during Incidents of National Significance, 
     while the Department of Health and Human Services (DHHS) is 
     the Federal coordinator and primary agency for Emergency 
     Support Function 8, Public Health and Medical Services. 
     Nothing in Title I should be interpreted to change or affect 
     the existing relationship between DHS as the incident manager 
     and DHHS as the primary agency for medical services, as 
     currently defined by the NRP for Incidents of National 
     Significance.
       Rather than amending or otherwise diminishing the existing 
     responsibilities of the Secretary of Homeland Security under 
     the NRP, S. 3678 is intended to clarify and more specifically 
     define the medical preparedness and response authorities of 
     the Secretary of Health and Human Services with respect to 
     the Public Health Service Act.
       A copy of this letter will be included in the Record during 
     consideration of the bill on the House floor and should be 
     construed as a definitive expression of Congressional intent 
     on this matter.
           Sincerely,
     Peter T. King,
       Chairman, Committee on Homeland Security.
     Joe Barton,
       Chairman, Committee on Energy and Commerce.
                                  ____

         Congress of the United States, House of Representatives, 
           Committee on Government Reform,
                                 Washington, DC, December 8, 2006.
     Hon. Joe Barton,
     Chairman, House Committee on Energy and Commerce, Washington, 
         DC.
       Dear Mr. Chairman: The House is tentatively scheduled to 
     consider today S. 3678, the ``Pandemic and All-Hazards 
     Preparedness Act.'' The bill contains certain provisions 
     within the jurisdiction of the Committee on Government 
     Reform.
       In the interests of moving this important legislation to 
     the floor, I agree to waive sequential consideration of this 
     bill by the Committee on Government Reform. However, I did so 
     only with the understanding that this procedural route would 
     not be construed to prejudice the Committee on Government 
     Reform's jurisdictional interest and prerogatives on this 
     bill or any other similar legislation and will not be 
     considered as precedent for consideration of matters of 
     jurisdictional interest to my Committee in the future.
       I respectfully request that you include this letter and 
     your response in the Congressional Record during 
     consideration of the legislation on the House floor. Thank 
     you for your attention to these matters.
           Sincerely,
     Tom Davis.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                 Washington, DC, December 8, 2006.
     Hon. Tom Davis,
     Chairman, House Committee on Government Reform, Washington, 
         DC
       Dear Mr. Chairman, Thank you for your letter regarding S. 
     3678, the ``Pandemic and All-Hazards Preparedness Act,'' and 
     your willingness to forego consideration of S. 3678 by the 
     Government Reform Committee.
       In the interest of permitting the House to proceed 
     expeditiously to consider S. 3678, I appreciate your 
     willingness to support this legislation moving to the floor. 
     I understand that such a waiver only applies to this language 
     in this bill, and not to the underlying subject matter.

[[Page 23402]]

       I appreciate you willingness to allow us to proceed. I will 
     insert this exchange of letters into the Congressional Record 
     during the debate on this bill.
       Sincerely,
                                                       Joe Barton,
                                                         Chairman.

  Ms. ESHOO. Mr. Speaker, as the Democratic sponsor of the House 
version of this bill, H.R. 5533, I am proud to rise today in strong 
support of this legislation. This bill addresses an urgent issue which 
is critical to our Nation's security and public health: The threat of 
bioterror and pandemic disease.
  Last week the State Department issued a warning that the continuing 
spread of a highly contagious avian influenza (H5N1) virus among 
animals in Asia, Africa, the Middle East and Europe has the potential 
to significantly threaten human health. The virus has already caused 
nearly 150 human deaths around the world. If a virus such as H5N1 
mutates and spreads easily from one person to another, avian influenza 
could break out globally. While there are no reports of sustained 
human-to-human transmission of avian influenza, the U.S. government and 
international health agencies are scrambling to prepare for a possible 
pandemic.
  In hearings earlier this year on the Project Bioshield Act, it was 
apparent that gaps remain in our effort to address emerging threats to 
public health. In particular, we learned that very few companies are 
willing to risk their limited resources to develop the vaccines and 
antidotes to respond to chemical, biological, radiological or nuclear 
attacks or to a fast-spreading influenza such as H5N1. Put simply, 
there is little economic incentive for companies to conduct the vital 
research necessary in this field.
  The centerpiece of our legislation is a new office within HHS, the 
Biomedical Advanced Research and Development Authority (BARDA), which 
will be a single point of federal authority for the development of 
medical countermeasures.
  The bill enables the Secretary of HHS and the BARDA Director to 
collaborate and consult with agency leaders, academia, and industry on 
developing needed medical countermeasures and pandemic or epidemic 
products. This bill also empowers BARDA to make milestone payments to 
drug developers at key stages of their work, helping to reduce the 
financial risks of taking on such a great challenge.
  This legislation has broad bipartisan support in the House of 
Representatives and the Senate, and I thank the bill's many cosponsors 
for their support. I especially want to thank Congressman Mike Rogers 
for his leadership on this issue. This bill demonstrates the good that 
can come out of bipartisan teamwork and I'm proud to have worked with 
him to make this bill a reality.
  I also want to thank Chairmen Barton and Deal as well as Ranking 
Member Dingell for acknowledging the importance of this legislation and 
working with us every step of the way to get it done before the end of 
the year.
  I also want to thank the staff members who have put so much time and 
energy into this legislation: Kelly Childress with Representative 
Rogers, Nandan Kenkeremath with Chairman Barton, Brandon Clark with 
Chairman Deal, John Ford with Representative Dingell, and Jason Mahler 
and Jennifer Nieto of my staff.
  Mr. Speaker, this is a good bill that ensures our country is doing 
its best to prepare for the worst. Thank you for bringing this bill 
before the House today and I urge my colleagues to support it.
  Mr. ROGERS of Michigan. Mr. Speaker, I rise today in strong support 
of the Pandemic and All-Hazards Preparedness Act and specifically the 
Biodefense and Pandemic Vaccine and Drug Development Act.
  I would like to thank Chairman Barton, and the Energy and Commerce 
Committee staff for their support. I would also like to extend a 
special thanks to my colleague Congresswoman Anna Eshoo for her work on 
the issue.
  Biological weapons have been proven to work, are capable of causing 
massive disaster, are relatively cheap, and are increasingly easy to 
design, build and disseminate.
  The materials and technical know-how needed to make a bio-weapon that 
could infect hundreds of thousands of people are already widely 
distributed around the planet, and the number of people who possess the 
expertise needed to create bioweapons is rapidly growing as 
biotechnology and pharmaceutical research and production expand into 
developing countries.
  Preventing either a natural epidemic or a bioterrorist attack is, 
unfortunately, unlikely. Therefore, the Nation's ability to rapidly and 
effectively respond in the face of a bio-security crisis must be a 
central pillar in our bio-security strategy.
  Medicines and vaccines that can counter illnesses caused by exposure 
to bioterror agents are obviously an essential component of biodefense 
and would be critical to controlling the spread of contagious disease.
  This legislation will enable the government to better develop, 
procure, and make available countermeasures to chemical, biological, 
radiological and nuclear agents for use in a public health emergency.
  Bioterror countermeasures for agents of terrorism have no market 
other than the government. This legislation will provide assurance to 
companies that the government is fully engaged and a willing and able 
business partner.
  This legislation will speed up the development and procurement 
process by reorganizing and enhancing these responsibilities into the 
Biomedical Advanced Research and Development Agency, BARDA.
  1. BARDA would create a single point of authority within government.
  2. BARDA would streamline the approval and acquisition process to 
help bridge the ``valley of death'' for bio-pharmaceutical research.
  3. BARDA is an aggressive partnering with universities, research 
institutions and industry on the advanced development of promising 
drugs and vaccines and would of these countermeasures.
  As the Chairman and my colleagues on both sides of our aisle know, 
the House passed version of this legislation also included specific 
authority under BioShield for HHS to enter into procurement contracts 
with multiple companies for multiple products and technologies.
  We all know from lessons learned that this is a complicated and 
uncertain process. These vaccines and other medical countermeasures are 
only in the early stage of development and history suggests that most 
will not be successfully developed or only a few will receive FDA 
approval.
  That is why the House-passed bill included a provision intended to 
direct a risk mitigation strategy that the Department not put all their 
eggs in one basket.
  Is it the understanding that while the bill passed by the Senate had 
no similar provision, that currently the BioShield statute provides 
authority for the Department to enter into multiple procurement 
contracts for products and technologies for the development and 
acquisition of countermeasures and that this is an important risk 
mitigation strategy for the government.
  I have been in communication with Senator Burr and he agrees with 
this policy.
  I urge your support of this important piece of legislation.
  The Senate bill was ordered to be read a third time, was read the 
third time, and passed, and a motion to reconsider was laid on the 
table.

                          ____________________