[Congressional Record (Bound Edition), Volume 159 (2013), Part 1]
[House]
[Pages 258-271]
[From the U.S. Government Publishing Office, www.gpo.gov]




   PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2013

  Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 307) to reauthorize certain programs under the Public Health 
Service Act and the Federal Food, Drug, and Cosmetic Act with respect 
to public health security and all-hazards preparedness and response, 
and for other purposes.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                H.R. 307

       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 Reauthorization Act of 2013''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; table of contents.

 TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC 
                           HEALTH EMERGENCIES

Sec. 101. National Health Security Strategy.
Sec. 102. Assistant Secretary for Preparedness and Response.
Sec. 103. National Advisory Committee on Children and Disasters.
Sec. 104. Modernization of the National Disaster Medical System.
Sec. 105. Continuing the role of the Department of Veterans Affairs.

   TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND 
                                RESPONSE

Sec. 201. Temporary redeployment of federally funded personnel during a 
              public health emergency.
Sec. 202. Improving State and local public health security.
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 205. Eliminating duplicative Project Bioshield reports.

           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

Sec. 301. Special protocol assessment.
Sec. 302. Authorization for medical products for use in emergencies.
Sec. 303. Definitions.
Sec. 304. Enhancing medical countermeasure activities.
Sec. 305. Regulatory management plans.
Sec. 306. Report.
Sec. 307. Pediatric medical countermeasures.

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  TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND 
                              DEVELOPMENT

Sec. 401. BioShield.
Sec. 402. Biomedical Advanced Research and Development Authority.
Sec. 403. Strategic National Stockpile.
Sec. 404. National Biodefense Science Board.

 TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC 
                           HEALTH EMERGENCIES

     SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

       (a) In General.--Section 2802 of the Public Health Service 
     Act (42 U.S.C. 300hh-1) is amended--
       (1) in subsection (a)(1), by striking ``2009'' and 
     inserting ``2014''; and
       (2) in subsection (b)--
       (A) in paragraph (1)(A), by inserting ``, including drills 
     and exercises to ensure medical surge capacity for events 
     without notice'' after ``exercises''; and
       (B) in paragraph (3)--
       (i) in the matter preceding subparagraph (A)--

       (I) by striking ``facilities), and trauma care'' and 
     inserting ``and ambulatory care facilities and which may 
     include dental health facilities), and trauma care, critical 
     care,''; and
       (II) by inserting ``(including related availability, 
     accessibility, and coordination)'' after ``public health 
     emergencies'';

       (ii) in subparagraph (A), by inserting ``and trauma'' after 
     ``medical'';
       (iii) in subparagraph (B), by striking ``Medical evacuation 
     and fatality management'' and inserting ``Fatality 
     management'';
       (iv) by redesignating subparagraphs (C), (D), and (E) as 
     subparagraphs (D), (E), and (F), respectively;
       (v) by inserting after subparagraph (B), the following the 
     new subparagraph:
       ``(C) Coordinated medical triage and evacuation to 
     appropriate medical institutions based on patient medical 
     need, taking into account regionalized systems of care.'';
       (vi) in subparagraph (E), as redesignated by clause (iv), 
     by inserting ``(which may include such dental health 
     assets)'' after ``medical assets''; and
       (vii) by adding at the end the following:
       ``(G) Optimizing a coordinated and flexible approach to the 
     medical surge capacity of hospitals, other health care 
     facilities, critical care, and trauma care (which may include 
     trauma centers) and emergency medical systems.'';
       (C) in paragraph (4)--
       (i) in subparagraph (A), by inserting ``, including the 
     unique needs and considerations of individuals with 
     disabilities,'' after ``medical needs of at-risk 
     individuals''; and
       (ii) in subparagraph (B), by inserting ``the'' before 
     ``purpose of this section''; and
       (D) by adding at the end the following:
       ``(7) Countermeasures.--
       ``(A) Promoting strategic initiatives to advance 
     countermeasures to diagnose, mitigate, prevent, or treat harm 
     from any biological agent or toxin, chemical, radiological, 
     or nuclear agent or agents, whether naturally occurring, 
     unintentional, or deliberate.
       ``(B) For purposes of this paragraph, the term 
     `countermeasures' has the same meaning as the terms 
     `qualified countermeasures' under section 319F-1, `qualified 
     pandemic and epidemic products' under section 319F-3, and 
     `security countermeasures' under section 319F-2.
       ``(8) Medical and public health community resiliency.--
     Strengthening the ability of States, local communities, and 
     tribal communities to prepare for, respond to, and be 
     resilient in the event of public health emergencies, whether 
     naturally occurring, unintentional, or deliberate by--
       ``(A) optimizing alignment and integration of medical and 
     public health preparedness and response planning and 
     capabilities with and into routine daily activities; and
       ``(B) promoting familiarity with local medical and public 
     health systems.''.
       (b) At-Risk Individuals.--Section 2814 of the Public Health 
     Service Act (42 U.S.C. 300hh-16) is amended--
       (1) by striking paragraphs (5), (7), and (8);
       (2) in paragraph (4), by striking ``2811(b)(3)(B)'' and 
     inserting ``2802(b)(4)(B)'';
       (3) by redesignating paragraphs (1) through (4) as 
     paragraphs (2) through (5), respectively;
       (4) by inserting before paragraph (2) (as so redesignated), 
     the following:
       ``(1) monitor emerging issues and concerns as they relate 
     to medical and public health preparedness and response for 
     at-risk individuals in the event of a public health emergency 
     declared by the Secretary under section 319;'';
       (5) by amending paragraph (2) (as so redesignated) to read 
     as follows:
       ``(2) oversee the implementation of the preparedness goals 
     described in section 2802(b) with respect to 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);''; and
       (6) by inserting after paragraph (6), the following:
       ``(7) disseminate and, as appropriate, update novel and 
     best practices of outreach to and care of at-risk individuals 
     before, during, and following public health emergencies in as 
     timely a manner as is practicable, including from the time a 
     public health threat is identified; and
       ``(8) ensure that public health and medical information 
     distributed by the Department of Health and Human Services 
     during a public health emergency is delivered in a manner 
     that takes into account the range of communication needs of 
     the intended recipients, including at-risk individuals.''.

     SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

       (a) In General.--Section 2811 of the Public Health Service 
     Act (42 U.S.C. 300hh-10) is amended--
       (1) in subsection (b)--
       (A) in paragraph (3), by inserting ``, security 
     countermeasures (as defined in section 319F-2),'' after 
     ``qualified countermeasures (as defined in section 319F-1)'';
       (B) in paragraph (4), by adding at the end the following:
       ``(D) Policy coordination and strategic direction.--Provide 
     integrated policy coordination and strategic direction with 
     respect to all matters related to Federal public health and 
     medical preparedness and execution and deployment of the 
     Federal response for public health emergencies and incidents 
     covered by the National Response Plan developed pursuant to 
     section 504(6) of the Homeland Security Act of 2002, or any 
     successor plan, before, during, and following public health 
     emergencies.
       ``(E) Identification of inefficiencies.--Identify and 
     minimize gaps, duplication, and other inefficiencies in 
     medical and public health preparedness and response 
     activities and the actions necessary to overcome these 
     obstacles.
       ``(F) Coordination of grants and agreements.--Align and 
     coordinate medical and public health grants and cooperative 
     agreements as applicable to preparedness and response 
     activities authorized under this Act, to the extent possible, 
     including program requirements, timelines, and measurable 
     goals, and in consultation with the Secretary of Homeland 
     Security, to--
       ``(i) optimize and streamline medical and public health 
     preparedness and response capabilities and the ability of 
     local communities to respond to public health emergencies; 
     and
       ``(ii) gather and disseminate best practices among grant 
     and cooperative agreement recipients, as appropriate.
       ``(G) Drill and operational exercises.--Carry out drills 
     and operational exercises, in consultation with the 
     Department of Homeland Security, the Department of Defense, 
     the Department of Veterans Affairs, and other applicable 
     Federal departments and agencies, as necessary and 
     appropriate, to identify, inform, and address gaps in and 
     policies related to all-hazards medical and public health 
     preparedness and response, including exercises based on--
       ``(i) identified threats for which countermeasures are 
     available and for which no countermeasures are available; and
       ``(ii) unknown threats for which no countermeasures are 
     available.
       ``(H) National security priority.--On a periodic basis 
     consult with, as applicable and appropriate, the Assistant to 
     the President for National Security Affairs, to provide an 
     update on, and discuss, medical and public health 
     preparedness and response activities pursuant to this Act and 
     the Federal Food, Drug, and Cosmetic Act, including progress 
     on the development, approval, clearance, and licensure of 
     medical countermeasures.''; and
       (C) by adding at the end the following:
       ``(7) Countermeasures budget plan.--Develop, and update on 
     an annual basis, a coordinated 5-year budget plan based on 
     the medical countermeasure priorities described in subsection 
     (d). Each such plan shall--
       ``(A) include consideration of the entire medical 
     countermeasures enterprise, including--
       ``(i) basic research and advanced research and development;
       ``(ii) approval, clearance, licensure, and authorized uses 
     of products; and
       ``(iii) procurement, stockpiling, maintenance, and 
     replenishment of all products in the Strategic National 
     Stockpile;
       ``(B) inform prioritization of resources and include 
     measurable outputs and outcomes to allow for the tracking of 
     the progress made toward identified priorities;
       ``(C) identify medical countermeasure life-cycle costs to 
     inform planning, budgeting, and anticipated needs within the 
     continuum of the medical countermeasure enterprise consistent 
     with section 319F-2; and
       ``(D) be made available to the appropriate committees of 
     Congress upon request.'';
       (2) by striking subsection (c) and inserting the following:
       ``(c) Functions.--The Assistant Secretary for Preparedness 
     and Response shall--
       ``(1) have lead responsibility within the Department of 
     Health and Human Services for emergency preparedness and 
     response policy coordination and strategic direction;
       ``(2) have authority over and responsibility for--
       ``(A) the National Disaster Medical System pursuant to 
     section 2812;
       ``(B) the Hospital Preparedness Cooperative Agreement 
     Program pursuant to section 319C-2;

[[Page 260]]

       ``(C) the Biomedical Advanced Research and Development 
     Authority pursuant to section 319L;
       ``(D) the Medical Reserve Corps pursuant to section 2813;
       ``(E) the Emergency System for Advance Registration of 
     Volunteer Health Professionals pursuant to section 319I; and
       ``(F) administering grants and related authorities related 
     to trauma care under parts A through C of title XII, such 
     authority to be transferred by the Secretary from the 
     Administrator of the Health Resources and Services 
     Administration to such Assistant Secretary;
       ``(3) exercise the responsibilities and authorities of the 
     Secretary with respect to the coordination of--
       ``(A) the Public Health Emergency Preparedness Cooperative 
     Agreement Program pursuant to section 319C-1;
       ``(B) the Strategic National Stockpile pursuant to section 
     319F-2; and
       ``(C) the Cities Readiness Initiative; and
       ``(4) assume other duties as determined appropriate by the 
     Secretary.''; and
       (3) by adding at the end the following:
       ``(d) Public Health Emergency Medical Countermeasures 
     Enterprise Strategy and Implementation Plan.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this subsection, and every year thereafter, 
     the Assistant Secretary for Preparedness and Response shall 
     develop and submit to the appropriate committees of Congress 
     a coordinated strategy and accompanying implementation plan 
     for medical countermeasures to address chemical, biological, 
     radiological, and nuclear threats. In developing such a plan, 
     the Assistant Secretary for Preparedness and Response shall 
     consult with the Director of the Biomedical Advanced Research 
     and Development Authority, the Director of the National 
     Institutes of Health, the Director of the Centers for Disease 
     Control and Prevention, and the Commissioner of Food and 
     Drugs. Such strategy and plan shall be known as the `Public 
     Health Emergency Medical Countermeasures Enterprise Strategy 
     and Implementation Plan'.
       ``(2) Requirements.--The plan under paragraph (1) shall--
       ``(A) describe the chemical, biological, radiological, and 
     nuclear agent or agents that may present a threat to the 
     Nation and the corresponding efforts to develop qualified 
     countermeasures (as defined in section 319F-1), security 
     countermeasures (as defined in section 319F-2), or qualified 
     pandemic or epidemic products (as defined in section 319F-3) 
     for each threat;
       ``(B) evaluate the progress of all activities with respect 
     to such countermeasures or products, including research, 
     advanced research, development, procurement, stockpiling, 
     deployment, distribution, and utilization;
       ``(C) identify and prioritize near-, mid-, and long-term 
     needs with respect to such countermeasures or products to 
     address a chemical, biological, radiological, and nuclear 
     threat or threats;
       ``(D) identify, with respect to each category of threat, a 
     summary of all awards and contracts, including advanced 
     research and development and procurement, that includes--
       ``(i) the time elapsed from the issuance of the initial 
     solicitation or request for a proposal to the adjudication 
     (such as the award, denial of award, or solicitation 
     termination); and
       ``(ii) an identification of projected timelines, 
     anticipated funding allocations, benchmarks, and milestones 
     for each medical countermeasure priority under subparagraph 
     (C), including projected needs with regard to replenishment 
     of the Strategic National Stockpile;
       ``(E) be informed by the recommendations of the National 
     Biodefense Science Board pursuant to section 319M;
       ``(F) evaluate progress made in meeting timelines, 
     allocations, benchmarks, and milestones identified under 
     subparagraph (D)(ii);
       ``(G) report on the amount of funds available for 
     procurement in the special reserve fund as defined in section 
     319F-2(h) and the impact this funding will have on meeting 
     the requirements under section 319F-2;
       ``(H) incorporate input from Federal, State, local, and 
     tribal stakeholders;
       ``(I) identify the progress made in meeting the medical 
     countermeasure priorities for at-risk individuals (as defined 
     in 2802(b)(4)(B)), as applicable under subparagraph (C), 
     including with regard to the projected needs for related 
     stockpiling and replenishment of the Strategic National 
     Stockpile, including by addressing the needs of pediatric 
     populations with respect to such countermeasures and products 
     in the Strategic National Stockpile, including--
       ``(i) a list of such countermeasures and products necessary 
     to address the needs of pediatric populations;
       ``(ii) a description of measures taken to coordinate with 
     the Office of Pediatric Therapeutics of the Food and Drug 
     Administration to maximize the labeling, dosages, and 
     formulations of such countermeasures and products for 
     pediatric populations;
       ``(iii) a description of existing gaps in the Strategic 
     National Stockpile and the development of such 
     countermeasures and products to address the needs of 
     pediatric populations; and
       ``(iv) an evaluation of the progress made in addressing 
     priorities identified pursuant to subparagraph (C);
       ``(J) identify the use of authority and activities 
     undertaken pursuant to sections 319F-1(b)(1), 319F-1(b)(2), 
     319F-1(b)(3), 319F-1(c), 319F-1(d), 319F-1(e), 319F-
     2(c)(7)(C)(iii), 319F-2 (c)(7)(C)(iv), and 319F-2(c)(7)(C)(v) 
     of this Act, and subsections (a)(1), (b)(1), and (e) of 
     section 564 of the Federal Food, Drug, and Cosmetic Act, by 
     summarizing--
       ``(i) the particular actions that were taken under the 
     authorities specified, including, as applicable, the 
     identification of the threat agent, emergency, or the 
     biomedical countermeasure with respect to which the authority 
     was used;
       ``(ii) the reasons underlying the decision to use such 
     authorities, including, as applicable, the options that were 
     considered and rejected with respect to the use of such 
     authorities;
       ``(iii) the number of, nature of, and other information 
     concerning the persons and entities that received a grant, 
     cooperative agreement, or contract pursuant to the use of 
     such authorities, and the persons and entities that were 
     considered and rejected for such a grant, cooperative 
     agreement, or contract, except that the report need not 
     disclose the identity of any such person or entity;
       ``(iv) whether, with respect to each procurement that is 
     approved by the President under section 319F-2(c)(6), a 
     contract was entered into within one year after such approval 
     by the President; and
       ``(v) with respect to section 319F-1(d), for the one-year 
     period for which the report is submitted, the number of 
     persons who were paid amounts totaling $100,000 or greater 
     and the number of persons who were paid amounts totaling at 
     least $50,000 but less than $100,000; and
       ``(K) be made publicly available.
       ``(3) GAO report.--
       ``(A) In general.--Not later than 1 year after the date of 
     the submission to the Congress of the first Public Health 
     Emergency Medical Countermeasures Enterprise Strategy and 
     Implementation Plan, the Comptroller General of the United 
     States shall conduct an independent evaluation, and submit to 
     the appropriate committees of Congress a report, concerning 
     such Strategy and Implementation Plan.
       ``(B) Content.--The report described in subparagraph (A) 
     shall review and assess--
       ``(i) the near-term, mid-term, and long-term medical 
     countermeasure needs and identified priorities of the Federal 
     Government pursuant to paragraph (2)(C);
       ``(ii) the activities of the Department of Health and Human 
     Services with respect to advanced research and development 
     pursuant to section 319L; and
       ``(iii) the progress made toward meeting the timelines, 
     allocations, benchmarks, and milestones identified in the 
     Public Health Emergency Medical Countermeasures Enterprise 
     Strategy and Implementation Plan under this subsection.
       ``(e) Protection of National Security.--In carrying out 
     subsections (b)(7) and (d), the Secretary shall ensure that 
     information and items that could compromise national 
     security, contain confidential commercial information, or 
     contain proprietary information are not disclosed.''.
       (b) Interagency Coordination Plan.--In the first Public 
     Health Emergency Countermeasures Enterprise Strategy and 
     Implementation Plan submitted under subsection (d) of section 
     2811 of the Public Health Service Act (42 U.S.C. 300hh-10) 
     (as added by subsection (a)(3)), the Secretary of Health and 
     Human Services, in consultation with the Secretary of 
     Defense, shall include a description of the manner in which 
     the Department of Health and Human Services is coordinating 
     with the Department of Defense regarding countermeasure 
     activities to address chemical, biological, radiological, and 
     nuclear threats. Such report shall include information with 
     respect to--
       (1) the research, advanced research, development, 
     procurement, stockpiling, and distribution of countermeasures 
     to meet identified needs; and
       (2) the coordination of efforts between the Department of 
     Health and Human Services and the Department of Defense to 
     address countermeasure needs for various segments of the 
     population.

     SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 
                   DISASTERS.

       Subtitle B of title XXVIII of the Public Health Service Act 
     (42 U.S.C. 300hh et seq.) is amended by inserting after 
     section 2811 the following:

     ``SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 
                   DISASTERS.

       ``(a) Establishment.--The Secretary, in consultation with 
     the Secretary of Homeland Security, shall establish an 
     advisory committee to be known as the `National Advisory 
     Committee on Children and Disasters' (referred to in this 
     section as the `Advisory Committee').
       ``(b) Duties.--The Advisory Committee shall--
       ``(1) provide advice and consultation with respect to the 
     activities carried out pursuant to section 2814, as 
     applicable and appropriate;

[[Page 261]]

       ``(2) evaluate and provide input with respect to the 
     medical and public health needs of children as they relate to 
     preparation for, response to, and recovery from all-hazards 
     emergencies; and
       ``(3) provide advice and consultation with respect to State 
     emergency preparedness and response activities and children, 
     including related drills and exercises pursuant to the 
     preparedness goals under section 2802(b).
       ``(c) Additional Duties.--The Advisory Committee may 
     provide advice and recommendations to the Secretary with 
     respect to children and the medical and public health grants 
     and cooperative agreements as applicable to preparedness and 
     response activities authorized under this title and title 
     III.
       ``(d) Membership.--
       ``(1) In general.--The Secretary, in consultation with such 
     other Secretaries as may be appropriate, shall appoint not to 
     exceed 15 members to the Advisory Committee. In appointing 
     such members, the Secretary shall ensure that the total 
     membership of the Advisory Committee is an odd number.
       ``(2) Required members.--The Secretary, in consultation 
     with such other Secretaries as may be appropriate, may 
     appoint to the Advisory Committee under paragraph (1) such 
     individuals as may be appropriate to perform the duties 
     described in subsections (b) and (c), which may include--
       ``(A) the Assistant Secretary for Preparedness and 
     Response;
       ``(B) the Director of the Biomedical Advanced Research and 
     Development Authority;
       ``(C) the Director of the Centers for Disease Control and 
     Prevention;
       ``(D) the Commissioner of Food and Drugs;
       ``(E) the Director of the National Institutes of Health;
       ``(F) the Assistant Secretary of the Administration for 
     Children and Families;
       ``(G) the Administrator of the Federal Emergency Management 
     Agency;
       ``(H) at least two non-Federal health care professionals 
     with expertise in pediatric medical disaster planning, 
     preparedness, response, or recovery;
       ``(I) at least two representatives from State, local, 
     territorial, or tribal agencies with expertise in pediatric 
     disaster planning, preparedness, response, or recovery; and
       ``(J) representatives from such Federal agencies (such as 
     the Department of Education and the Department of Homeland 
     Security) as determined necessary to fulfill the duties of 
     the Advisory Committee, as established under subsections (b) 
     and (c).
       ``(e) Meetings.--The Advisory Committee shall meet not less 
     than biannually.
       ``(f) Sunset.--The Advisory Committee shall terminate on 
     the date that is 5 years after the date of enactment of the 
     Pandemic and All-Hazards Preparedness Reauthorization Act of 
     2013.''.

     SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL 
                   SYSTEM.

       Section 2812 of the Public Health Service Act (42 U.S.C. 
     300hh-11) is amended--
       (1) in subsection (a)(3)--
       (A) in subparagraph (A), in clause (i) by inserting ``, 
     including at-risk individuals as applicable'' after ``victims 
     of a public health emergency'';
       (B) by redesignating subparagraph (C) as subparagraph (E); 
     and
       (C) by inserting after subparagraph (B), the following:
       ``(C) Considerations for at-risk populations.--The 
     Secretary shall take steps to ensure that an appropriate 
     specialized and focused range of public health and medical 
     capabilities are represented in the National Disaster Medical 
     System, which take into account the needs of at-risk 
     individuals, in the event of a public health emergency.''.
       ``(D) Administration.--The Secretary may determine and pay 
     claims for reimbursement for services under subparagraph (A) 
     directly or through contracts that provide for payment in 
     advance or by way of reimbursement.''; and
       (2) in subsection (g), by striking ``such sums as may be 
     necessary for each of the fiscal years 2007 through 2011'' 
     and inserting ``$52,700,000 for each of fiscal years 2013 
     through 2017''.

     SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS 
                   AFFAIRS.

       Section 8117(g) of title 38, United States Code, is amended 
     by striking ``such sums as may be necessary to carry out this 
     section for each of fiscal years 2007 through 2011'' and 
     inserting ``$155,300,000 for each of fiscal years 2013 
     through 2017 to carry out this section''.

   TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND 
                                RESPONSE

     SEC. 201. TEMPORARY REDEPLOYMENT OF FEDERALLY FUNDED 
                   PERSONNEL DURING A PUBLIC HEALTH EMERGENCY.

       Section 319 of the Public Health Service Act (42 U.S.C. 
     247d) is amended by adding at the end the following:
       ``(e) Temporary Redeployment of Federally Funded Personnel 
     During a Public Health Emergency.--
       ``(1) Emergency redeployment of federally funded 
     personnel.--Notwithstanding any other provision of law, and 
     subject to paragraph (2), upon request by the Governor of a 
     State or the chief of a tribe or such Governor or chief's 
     designee, the Secretary may authorize the requesting State or 
     tribe to temporarily redeploy, for purposes of immediately 
     addressing a public health emergency in the State or tribe, 
     non-Federal personnel funded in whole or in part through, as 
     appropriate, programs under this Act.
       ``(2) Activation of emergency redeployment.--
       ``(A) Public health emergency.--The Secretary may authorize 
     a temporary redeployment of personnel under paragraph (1) 
     only during the period of a public health emergency 
     determined pursuant to subsection (a).
       ``(B) Contents of request.--To seek authority for a 
     temporary redeployment of personnel under paragraph (1), the 
     Governor of a State or the chief of a tribe shall submit to 
     the Secretary a request for such authority and shall include 
     in the request each of the following:
       ``(i) An assurance that the public health emergency in the 
     geographic area of the requesting State or tribe cannot be 
     adequately and appropriately addressed by the public health 
     workforce otherwise available.
       ``(ii) An assurance that the public health emergency would 
     be addressed more efficiently and effectively through the 
     requested temporary redeployment of personnel.
       ``(iii) An assurance that the requested temporary 
     redeployment of personnel is consistent with any applicable 
     All-Hazards Public Health Emergency Preparedness and Response 
     Plan under section 319C-1.
       ``(iv) An identification of--

       ``(I) each Federal program from which personnel would be 
     temporarily redeployed pursuant to the requested authority; 
     and
       ``(II) the number of personnel who would be so redeployed 
     from each such program.

       ``(v) Such other information and assurances as the 
     Secretary may require.
       ``(C) Consideration.--In reviewing a request for temporary 
     redeployment under paragraph (1) of personnel funded through 
     a Federal program, the Secretary shall consider the degree to 
     which the program would be adversely affected by the 
     redeployment.
       ``(D) Termination and extension.--
       ``(i) Termination.--A State or tribe's authority for a 
     temporary redeployment of personnel under paragraph (1) shall 
     terminate upon the earlier of the following:

       ``(I) The Secretary's determination that the public health 
     emergency no longer exists.
       ``(II) Subject to clause (ii), the expiration of the 30-day 
     period following the date on which the Secretary approved the 
     State or tribe's request for such authority.

       ``(ii) Extension authority.--The Secretary may extend the 
     authority to authorize a temporary redeployment of personnel 
     under paragraph (1) beyond the date otherwise applicable 
     under clause (i)(II) if the public health emergency still 
     exists as of such date, but only if--

       ``(I) the State or tribe that submitted the initial request 
     for authority for a temporary redeployment of personnel 
     submits a request for an extension of such authority; and
       ``(II) the request for an extension contains the same type 
     of information and assurances necessary for the approval of 
     an initial request for such authority.

       ``(3) Notice to personnel of possibility of redeployment.--
     The Secretary shall ensure that, if a State or tribe receives 
     Federal funds for personnel who are subject to the 
     Secretary's redeployment authority under this subsection, the 
     State or tribe gives notice to such personnel of the 
     possibility of redeployment--
       ``(A) at the time of hiring; or
       ``(B) in the case of personnel hired before the date of the 
     enactment of this subsection, as soon as practicable.
       ``(4) Notice to congress.--The Secretary shall give notice 
     to the Congress in conjunction with the approval under this 
     subsection of--
       ``(A) any initial request for authority for a temporary 
     redeployment of personnel; and
       ``(B) any request for an extension of such authority.
       ``(5) Guidance.--The Secretary shall--
       ``(A) not later than 6 months after the enactment of this 
     subsection, issue proposed guidance on the temporary 
     redeployment of personnel under this subsection; and
       ``(B) after providing notice and a 60-day period for public 
     comment, finalize such guidance.
       ``(6) Report to congress.--Not later than 4 years after the 
     date of enactment of the Pandemic and All-Hazards 
     Preparedness Reauthorization Act of 2013, the Comptroller 
     General of the United States shall conduct an independent 
     evaluation, and submit to the appropriate committees of the 
     Congress a report, on the Secretary's authority under this 
     subsection, including--
       ``(A) a description of how, and under what circumstances, 
     such authority has been used by States and tribes;
       ``(B) an analysis of how such authority has assisted States 
     and tribes in responding to public health emergencies;
       ``(C) an evaluation of how such authority has improved 
     operational efficiencies in responding to public health 
     emergencies;
       ``(D) an analysis of the extent to which, if any, Federal 
     programs from which personnel have been temporarily 
     redeployed pursuant to such authority have been adversely 
     affected by the redeployment; and

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       ``(E) recommendations on how such authority could be 
     improved to further assist in responding to public health 
     emergencies.
       ``(7) Definition.--In this subsection, the term `State' 
     includes, in addition to the entities listed in the 
     definition of such term in section 2, the Freely Associated 
     States.
       ``(8) Sunset.--The authority under this subsection shall 
     terminate on the date that is 5 years after the date of 
     enactment of the Pandemic and All-Hazards Preparedness 
     Reauthorization Act of 2013.''.

     SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

       (a) Cooperative Agreements.--Section 319C-1 of the Public 
     Health Service Act (42 U.S.C. 247d-3a) is amended--
       (1) in subsection (b)(1)(C), by striking ``consortium of 
     entities described in subparagraph (A)'' and inserting 
     ``consortium of States'';
       (2) in subsection (b)(2)--
       (A) in subparagraph (A)--
       (i) by striking clauses (i) and (ii) and inserting the 
     following:
       ``(i) a description of the activities such entity will 
     carry out under the agreement to meet the goals identified 
     under section 2802, including with respect to chemical, 
     biological, radiological, or nuclear threats, whether 
     naturally occurring, unintentional, or deliberate;
       ``(ii) a description of the activities such entity will 
     carry out with respect to pandemic influenza, as a component 
     of the activities carried out under clause (i), and 
     consistent with the requirements of paragraphs (2) and (5) of 
     subsection (g);'';
       (ii) in clause (iv), by striking ``and'' at the end; and
       (iii) by adding at the end the following:
       ``(vi) a description of how, as appropriate, the entity may 
     partner with relevant public and private stakeholders in 
     public health emergency preparedness and response;
       ``(vii) a description of how the entity, as applicable and 
     appropriate, will coordinate with State emergency 
     preparedness and response plans in public health emergency 
     preparedness, including State educational agencies (as 
     defined in section 9101(41) of the Elementary and Secondary 
     Education Act of 1965) and State child care lead agencies 
     (designated under section 658D of the Child Care and 
     Development Block Grant Act of 1990);
       ``(viii) in the case of entities that operate on the United 
     States-Mexico border or the United States-Canada border, a 
     description of the activities such entity will carry out 
     under the agreement that are specific to the border area 
     including disease detection, identification, investigation, 
     and preparedness and response activities related to emerging 
     diseases and infectious disease outbreaks whether naturally 
     occurring or due to bioterrorism, consistent with the 
     requirements of this section; and
       ``(ix) a description of any activities that such entity 
     will use to analyze real-time clinical specimens for 
     pathogens of public health or bioterrorism significance, 
     including any utilization of poison control centers;''; and
       (B) in subparagraph (C), by inserting ``, including 
     addressing the needs of at-risk individuals,'' after 
     ``capabilities of such entity'';
       (3) in subsection (f)--
       (A) in paragraph (2), by adding ``and'' at the end;
       (B) in paragraph (3), by striking ``; and'' and inserting a 
     period; and
       (C) by striking paragraph (4);
       (4) in subsection (g)--
       (A) in paragraph (1), by striking subparagraph (A) and 
     inserting the following:
       ``(A) include outcome goals representing operational 
     achievements of the National Preparedness Goals developed 
     under section 2802(b) with respect to all-hazards, including 
     chemical, biological, radiological, or nuclear threats; 
     and''; and
       (B) in paragraph (2)(A), by adding at the end the 
     following: ``The Secretary shall periodically update, as 
     necessary and appropriate, such pandemic influenza plan 
     criteria and shall require the integration of such criteria 
     into the benchmarks and standards described in paragraph 
     (1).'';
       (5) by striking subsection (h);
       (6) in subsection (i)--
       (A) in paragraph (1)--
       (i) in subparagraph (A)--

       (I) by striking ``$824,000,000 for fiscal year 2007, of 
     which $35,000,000 shall be used to carry out subsection 
     (h),'' and inserting ``$641,900,000 for fiscal year 2013''; 
     and
       (II) by striking ``such sums as may be necessary for each 
     of fiscal years 2008 through 2011'' and inserting 
     ``$641,900,000 for each of fiscal years 2014 through 2017'';

       (ii) by striking subparagraph (B);
       (iii) by redesignating subparagraphs (C) and (D) as 
     subparagraphs (B) and (C), respectively; and
       (iv) in subparagraph (C), as so redesignated, by striking 
     ``subparagraph (C)'' and inserting ``subparagraph (B)'';
       (B) in subparagraphs (C) and (D) of paragraph (3), by 
     striking ``(1)(A)(i)(I)'' each place it appears and inserting 
     ``(1)(A)'';
       (C) in paragraph (4)(B), by striking ``subsection (c)'' and 
     inserting ``subsection (b)''; and
       (D) by adding at the end the following:
       ``(7) Availability of cooperative agreement funds.--
       ``(A) In general.--Amounts provided to an eligible entity 
     under a cooperative agreement under subsection (a) for a 
     fiscal year and remaining unobligated at the end of such year 
     shall remain available to such entity for the next fiscal 
     year for the purposes for which such funds were provided.
       ``(B) Funds contingent on achieving benchmarks.--The 
     continued availability of funds under subparagraph (A) with 
     respect to an entity shall be contingent upon such entity 
     achieving the benchmarks and submitting the pandemic 
     influenza plan as described in subsection (g).''; and
       (7) in subsection (j), by striking paragraph (3).
       (b) Vaccine Tracking and Distribution.--Section 319A(e) of 
     the Public Health Service Act (42 U.S.C. 247d-1(e)) is 
     amended by striking ``such sums for each of fiscal years 2007 
     through 2011'' and inserting ``$30,800,000 for each of fiscal 
     years 2013 through 2017''.

     SEC. 203. HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY.

       (a) All-Hazards Public Health and Medical Response 
     Curricula and Training.--Section 319F(a)(5)(B) of the Public 
     Health Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by 
     striking ``public health or medical'' and inserting ``public 
     health, medical, or dental''.
       (b) Encouraging Health Professional Volunteers.--
       (1) Emergency system for advance registration of volunteer 
     health professionals.--Section 319I(k) of the Public Health 
     Service Act (42 U.S.C. 247d-7b(k)) is amended by striking 
     ``$2,000,000 for fiscal year 2002, and such sums as may be 
     necessary for each of the fiscal years 2003 through 2011'' 
     and inserting ``$5,000,000 for each of fiscal years 2013 
     through 2017''.
       (2) Volunteers.--Section 2813 of the Public Health Service 
     Act (42 U.S.C. 300hh-15) is amended--
       (A) in subsection (d)(2), by adding at the end the 
     following: ``Such training exercises shall, as appropriate 
     and applicable, incorporate the needs of at-risk individuals 
     in the event of a public health emergency.''; and
       (B) in subsection (i), by striking ``$22,000,000 for fiscal 
     year 2007, and such sums as may be necessary for each of 
     fiscal years 2008 through 2011'' and inserting ``$11,200,000 
     for each of fiscal years 2013 through 2017''.
       (c) Partnerships for State and Regional Preparedness To 
     Improve Surge Capacity.--Section 319C-2 of the Public Health 
     Service Act (42 U.S.C. 247d-3b) is amended--
       (1) in subsection (a), by inserting ``, including capacity 
     and preparedness to address the needs of pediatric and other 
     at-risk populations'' before the period at the end;
       (2) in subsection (b)(1)(A)(ii), by striking ``centers, 
     primary'' and inserting ``centers, community health centers, 
     primary'';
       (3) by striking subsection (c) and inserting the following:
       ``(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) with respect to all-hazards, including 
     chemical, biological, radiological, or nuclear threats.'';
       (4) by striking subsection (g) and inserting the following:
       ``(g) Coordination.--
       ``(1) 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 
     local Cities Readiness Initiative, and local emergency plans.
       ``(2) National collaboration.--Partnerships consisting of 
     one or more eligible entities under this section may, to the 
     extent practicable, collaborate with other partnerships 
     consisting of one or more eligible entities under this 
     section for purposes of national coordination and 
     collaboration with respect to activities to achieve the 
     preparedness goals described under paragraphs (1), (3), (4), 
     (5), and (6) of section 2802(b).'';
       (5) in subsection (i)--
       (A) by striking ``The requirements of'' and inserting the 
     following:
       ``(1) In general.--The requirements of''; and
       (B) by adding at the end the following:
       ``(2) Meeting goals of national health security strategy.--
     The Secretary shall implement objective, evidence-based 
     metrics to ensure that entities receiving awards under this 
     section are meeting, to the extent practicable, the 
     applicable goals of the National Health Security Strategy 
     under section 2802.''; and
       (6) in subsection (j)--
       (A) by amending paragraph (1) to read as follows:
       ``(1) In general.--For purposes of carrying out this 
     section, there is authorized to be appropriated $374,700,000 
     for each of fiscal years 2013 through 2017.''; and
       (B) by adding at the end the following:
       ``(4) Availability of cooperative agreement funds.--
       ``(A) In general.--Amounts provided to an eligible entity 
     under a cooperative agreement under subsection (a) for a 
     fiscal year and remaining unobligated at the end of such year 
     shall remain available to such entity

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     for the next fiscal year for the purposes for which such 
     funds were provided.
       ``(B) Funds contingent on achieving benchmarks.--The 
     continued availability of funds under subparagraph (A) with 
     respect to an entity shall be contingent upon such entity 
     achieving the benchmarks and submitting the pandemic 
     influenza plan as required under subsection (i).''.

     SEC. 204. ENHANCING SITUATIONAL AWARENESS AND 
                   BIOSURVEILLANCE.

       Section 319D of the Public Health Service Act (42 U.S.C. 
     247d-4) is amended--
       (1) in subsection (b)--
       (A) in paragraph (1)(B), by inserting ``poison control 
     centers,'' after ``hospitals,'';
       (B) in paragraph (2), by inserting before the period at the 
     end the following: ``, allowing for coordination to maximize 
     all-hazards medical and public health preparedness and 
     response and to minimize duplication of effort''; and
       (C) in paragraph (3), by inserting before the period at the 
     end the following: ``and update such standards as 
     necessary'';
       (2) by striking subsection (c); and
       (3) in subsection (d)--
       (A) in the subsection heading, by striking ``Public Health 
     Situational Awareness'' and inserting ``Modernizing Public 
     Health Situational Awareness and Biosurveillance'';
       (B) in paragraph (1)--
       (i) by striking ``Pandemic and All-Hazards Preparedness 
     Act'' and inserting ``Pandemic and All-Hazards Preparedness 
     Reauthorization Act of 2013''; and
       (ii) by inserting ``, novel emerging threats,'' after 
     ``disease outbreaks'';
       (C) by striking paragraph (2) and inserting the following:
       ``(2) Strategy and implementation plan.--Not later than 180 
     days after the date of enactment of the Pandemic and All-
     Hazards Preparedness Reauthorization Act of 2013, the 
     Secretary shall submit to the appropriate committees of 
     Congress a coordinated strategy and an accompanying 
     implementation plan that identifies and demonstrates the 
     measurable steps the Secretary will carry out to--
       ``(A) develop, implement, and evaluate the network 
     described in paragraph (1), utilizing the elements described 
     in paragraph (3);
       ``(B) modernize and enhance biosurveillance activities; and
       ``(C) improve information sharing, coordination, and 
     communication among disparate biosurveillance systems 
     supported by the Department of Health and Human Services.'';
       (D) in paragraph (3)(D), by inserting ``community health 
     centers, health centers'' after ``poison control,'';
       (E) in paragraph (5), by striking subparagraph (A) and 
     inserting the following:
       ``(A) utilize applicable interoperability standards as 
     determined by the Secretary, and in consultation with the 
     Office of the National Coordinator for Health Information 
     Technology, through a joint public and private sector 
     process;''; and
       (F) by adding at the end the following:
       ``(6) Consultation with the national biodefense science 
     board.--In carrying out this section and consistent with 
     section 319M, the National Biodefense Science Board shall 
     provide expert advice and guidance, including 
     recommendations, regarding the measurable steps the Secretary 
     should take to modernize and enhance biosurveillance 
     activities pursuant to the efforts of the Department of 
     Health and Human Services to ensure comprehensive, real-time, 
     all-hazards biosurveillance capabilities. In complying with 
     the preceding sentence, the National Biodefense Science Board 
     shall--
       ``(A) identify the steps necessary to achieve a national 
     biosurveillance system for human health, with international 
     connectivity, where appropriate, that is predicated on State, 
     regional, and community level capabilities and creates a 
     networked system to allow for two-way information flow 
     between and among Federal, State, and local government public 
     health authorities and clinical health care providers;
       ``(B) identify any duplicative surveillance programs under 
     the authority of the Secretary, or changes that are necessary 
     to existing programs, in order to enhance and modernize such 
     activities, minimize duplication, strengthen and streamline 
     such activities under the authority of the Secretary, and 
     achieve real-time and appropriate data that relate to disease 
     activity, both human and zoonotic; and
       ``(C) coordinate with applicable existing advisory 
     committees of the Director of the Centers for Disease Control 
     and Prevention, including such advisory committees consisting 
     of representatives from State, local, and tribal public 
     health authorities and appropriate public and private sector 
     health care entities and academic institutions, in order to 
     provide guidance on public health surveillance activities.'';
       (4) in subsection (e)(5), by striking ``4 years after the 
     date of enactment of the Pandemic and All-Hazards 
     Preparedness Act'' and inserting ``3 years after the date of 
     enactment of the Pandemic and All-Hazards Preparedness 
     Reauthorization Act of 2013'';
       (5) in subsection (g), by striking ``such sums as may be 
     necessary in each of fiscal years 2007 through 2011'' and 
     inserting ``$138,300,000 for each of fiscal years 2013 
     through 2017''; and
       (6) by adding at the end the following:
       ``(h) Definition.--For purposes of this section the term 
     `biosurveillance' means the process of gathering near real-
     time biological data that relates to human and zoonotic 
     disease activity and threats to human or animal health, in 
     order to achieve early warning and identification of such 
     health threats, early detection and prompt ongoing tracking 
     of health events, and overall situational awareness of 
     disease activity.''.

     SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.

       Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 
     247d-6c) is repealed.

           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

     SEC. 301. SPECIAL PROTOCOL ASSESSMENT.

       Section 505(b)(5)(B) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking 
     ``size of clinical trials intended'' and all that follows 
     through ``. The sponsor or applicant'' and inserting the 
     following: ``size--
       ``(i)(I) of clinical trials intended to form the primary 
     basis of an effectiveness claim; or
       ``(II) in the case where human efficacy studies are not 
     ethical or feasible, of animal and any associated clinical 
     trials which, in combination, are intended to form the 
     primary basis of an effectiveness claim; or
       ``(ii) with respect to an application for approval of a 
     biological product under section 351(k) of the Public Health 
     Service Act, of any necessary clinical study or studies.
     The sponsor or applicant''.

     SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
                   EMERGENCIES.

       (a) In General.--Section 564 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1), by striking ``sections 505, 510(k), 
     and 515 of this Act'' and inserting ``any provision of this 
     Act'';
       (B) in paragraph (2)(A), by striking ``under a provision of 
     law referred to in such paragraph'' and inserting ``under 
     section 505, 510(k), or 515 of this Act or section 351 of the 
     Public Health Service Act''; and
       (C) in paragraph (3), by striking ``a provision of law 
     referred to in such paragraph'' and inserting ``a section of 
     this Act or the Public Health Service Act referred to in 
     paragraph (2)(A)'';
       (2) in subsection (b)--
       (A) in the subsection heading, by striking ``Emergency'' 
     and inserting ``Emergency or Threat Justifying Emergency 
     Authorized Use'';
       (B) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``may declare an emergency'' and inserting ``may make a 
     declaration that the circumstances exist'';
       (ii) in subparagraph (A), by striking ``specified'';
       (iii) in subparagraph (B)--

       (I) by striking ``specified''; and
       (II) by striking ``; or'' and inserting a semicolon;

       (iv) by amending subparagraph (C) to read as follows:
       ``(C) a determination by the Secretary that there is a 
     public health emergency, or a significant potential for a 
     public health emergency, that affects, or has a significant 
     potential to affect, national security or the health and 
     security of United States citizens living abroad, and that 
     involves a biological, chemical, radiological, or nuclear 
     agent or agents, or a disease or condition that may be 
     attributable to such agent or agents; or''; and
       (v) by adding at the end the following:
       ``(D) the identification of a material threat pursuant to 
     section 319F-2 of the Public Health Service Act sufficient to 
     affect national security or the health and security of United 
     States citizens living abroad.'';
       (C) in paragraph (2)--
       (i) in subparagraph (A), by amending clause (ii) to read as 
     follows:
       ``(ii) a change in the approval status of the product such 
     that the circumstances described in subsection (a)(2) have 
     ceased to exist.'';
       (ii) by striking subparagraph (B); and
       (iii) by redesignating subparagraph (C) as subparagraph 
     (B);
       (D) in paragraph (4), by striking ``advance notice of 
     termination, and renewal under this subsection.'' and 
     inserting ``, and advance notice of termination under this 
     subsection.''; and
       (E) by adding at the end the following:
       ``(5) Explanation by secretary.--If an authorization under 
     this section with respect to an unapproved product or an 
     unapproved use of an approved product has been in effect for 
     more than 1 year, the Secretary shall provide in writing to 
     the sponsor of such product an explanation of the scientific, 
     regulatory, or other obstacles to approval, licensure, or 
     clearance of such product or use, including specific actions 
     to be taken by the Secretary and the sponsor to overcome such 
     obstacles.'';
       (3) in subsection (c)--
       (A) in the matter preceding paragraph (1)--

[[Page 264]]

       (i) by inserting ``the Assistant Secretary for Preparedness 
     and Response,'' after ``consultation with'';
       (ii) by striking ``Health and'' and inserting ``Health, 
     and''; and
       (iii) by striking ``circumstances of the emergency 
     involved'' and inserting ``applicable circumstances described 
     in subsection (b)(1)'';
       (B) in paragraph (1), by striking ``specified'' and 
     inserting ``referred to''; and
       (C) in paragraph (2)(B), by inserting ``, taking into 
     consideration the material threat posed by the agent or 
     agents identified in a declaration under subsection 
     (b)(1)(D), if applicable'' after ``risks of the product'';
       (4) in subsection (d)(3), by inserting ``, to the extent 
     practicable given the circumstances of the emergency,'' after 
     ``including'';
       (5) in subsection (e)--
       (A) in paragraph (1)(A), by striking ``circumstances of the 
     emergency'' and inserting ``applicable circumstances 
     described in subsection (b)(1)'';
       (B) in paragraph (1)(B), by amending clause (iii) to read 
     as follows:
       ``(iii) Appropriate conditions with respect to collection 
     and analysis of information concerning the safety and 
     effectiveness of the product with respect to the use of such 
     product during the period when the authorization is in effect 
     and a reasonable time following such period.'';
       (C) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) by striking ``manufacturer of the product'' and 
     inserting ``person'';
       (II) by striking ``circumstances of the emergency'' and 
     inserting ``applicable circumstances described in subsection 
     (b)(1)''; and
       (III) by inserting at the end before the period ``or in 
     paragraph (1)(B)'';

       (ii) in subparagraph (B)(i), by inserting before the period 
     at the end ``, except as provided in section 564A with 
     respect to authorized changes to the product expiration 
     date''; and
       (iii) by amending subparagraph (C) to read as follows:
       ``(C) In establishing conditions under this paragraph with 
     respect to the distribution and administration of the product 
     for the unapproved use, the Secretary shall not impose 
     conditions that would restrict distribution or administration 
     of the product when distributed or administered for the 
     approved use.''; and
       (D) by amending paragraph (3) to read as follows:
       ``(3) Good manufacturing practice; prescription.--With 
     respect to the emergency use of a product for which an 
     authorization under this section is issued (whether an 
     unapproved product or an unapproved use of an approved 
     product), the Secretary may waive or limit, to the extent 
     appropriate given the applicable circumstances described in 
     subsection (b)(1)--
       ``(A) requirements regarding current good manufacturing 
     practice otherwise applicable to the manufacture, processing, 
     packing, or holding of products subject to regulation under 
     this Act, including such requirements established under 
     section 501 or 520(f)(1), and including relevant conditions 
     prescribed with respect to the product by an order under 
     section 520(f)(2);
       ``(B) requirements established under section 503(b); and
       ``(C) requirements established under section 520(e).'';
       (6) in subsection (g)--
       (A) in the subsection heading, by inserting ``Review and'' 
     before ``Revocation'';
       (B) in paragraph (1), by inserting after the period at the 
     end the following: ``As part of such review, the Secretary 
     shall regularly review the progress made with respect to the 
     approval, licensure, or clearance of--
       ``(A) an unapproved product for which an authorization was 
     issued under this section; or
       ``(B) an unapproved use of an approved product for which an 
     authorization was issued under this section.''; and
       (C) by amending paragraph (2) to read as follows:
       ``(2) Revision and revocation.--The Secretary may revise or 
     revoke an authorization under this section if--
       ``(A) the circumstances described under subsection (b)(1) 
     no longer exist;
       ``(B) the criteria under subsection (c) for issuance of 
     such authorization are no longer met; or
       ``(C) other circumstances make such revision or revocation 
     appropriate to protect the public health or safety.'';
       (7) in subsection (h)(1), by adding after the period at the 
     end the following: ``The Secretary shall make any revisions 
     to an authorization under this section available on the 
     Internet Web site of the Food and Drug Administration.'';
       (8) by adding at the end of subsection (j) the following:
       ``(4) Nothing in this section shall be construed as 
     authorizing a delay in the review or other consideration by 
     the Secretary of any application or submission pending before 
     the Food and Drug Administration for a product for which an 
     authorization under this section is issued.''; and
       (9) by adding at the end the following:
       ``(m) Categorization of Laboratory Tests Associated With 
     Devices Subject to Authorization.--
       ``(1) In general.--In issuing an authorization under this 
     section with respect to a device, the Secretary may, subject 
     to the provisions of this section, determine that a 
     laboratory examination or procedure associated with such 
     device shall be deemed, for purposes of section 353 of the 
     Public Health Service Act, to be in a particular category of 
     examinations and procedures (including the category described 
     by subsection (d)(3) of such section) if, based on the 
     totality of scientific evidence available to the Secretary--
       ``(A) such categorization would be beneficial to protecting 
     the public health; and
       ``(B) the known and potential benefits of such 
     categorization under the circumstances of the authorization 
     outweigh the known and potential risks of the categorization.
       ``(2) Conditions of determination.--The Secretary may 
     establish appropriate conditions on the performance of the 
     examination or procedure pursuant to such determination.
       ``(3) Effective period.--A determination under this 
     subsection shall be effective for purposes of section 353 of 
     the Public Health Service Act notwithstanding any other 
     provision of that section during the effective period of the 
     relevant declaration under subsection (b).''.
       (b) Emergency Use of Medical Products.--Subchapter E of 
     chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb et seq.) is amended by inserting after section 
     564 the following:

     ``SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.

       ``(a) Definitions.--In this section:
       ``(1) Eligible product.--The term `eligible product' means 
     a product that--
       ``(A) is approved or cleared under this chapter or licensed 
     under section 351 of the Public Health Service Act;
       ``(B)(i) is intended for use to prevent, diagnose, or treat 
     a disease or condition involving a biological, chemical, 
     radiological, or nuclear agent or agents; or
       ``(ii) is intended for use to prevent, diagnose, or treat a 
     serious or life-threatening disease or condition caused by a 
     product described in clause (i); and
       ``(C) is intended for use during the circumstances under 
     which--
       ``(i) a determination described in subparagraph (A), (B), 
     or (C) of section 564(b)(1) has been made by the Secretary of 
     Homeland Security, the Secretary of Defense, or the 
     Secretary, respectively; or
       ``(ii) the identification of a material threat described in 
     subparagraph (D) of section 564(b)(1) has been made pursuant 
     to section 319F-2 of the Public Health Service Act.
       ``(2) Product.--The term `product' means a drug, device, or 
     biological product.
       ``(b) Expiration Dating.--
       ``(1) In general.--The Secretary may extend the expiration 
     date and authorize the introduction or delivery for 
     introduction into interstate commerce of an eligible product 
     after the expiration date provided by the manufacturer if--
       ``(A) the expiration date extension is intended to support 
     the United States ability to protect--
       ``(i) the public health; or
       ``(ii) military preparedness and effectiveness; and
       ``(B) the expiration date extension is supported by an 
     appropriate scientific evaluation that is conducted or 
     accepted by the Secretary.
       ``(2) Requirements and conditions.--Any extension of an 
     expiration date under paragraph (1) shall, as part of the 
     extension, identify--
       ``(A) each specific lot, batch, or other unit of the 
     product for which extended expiration is authorized;
       ``(B) the duration of the extension; and
       ``(C) any other requirements or conditions as the Secretary 
     may deem appropriate for the protection of the public health, 
     which may include requirements for, or conditions on, product 
     sampling, storage, packaging or repackaging, transport, 
     labeling, notice to product recipients, recordkeeping, 
     periodic testing or retesting, or product disposition.
       ``(3) Effect.--Notwithstanding any other provision of this 
     Act or the Public Health Service Act, an eligible product 
     shall not be considered an unapproved product (as defined in 
     section 564(a)(2)(A)) and shall not be deemed adulterated or 
     misbranded under this Act because, with respect to such 
     product, the Secretary has, under paragraph (1), extended the 
     expiration date and authorized the introduction or delivery 
     for introduction into interstate commerce of such product 
     after the expiration date provided by the manufacturer.
       ``(4) Expiration date.--For purposes of this subsection, 
     the term `expiration date' means the date established through 
     appropriate stability testing required by the regulations 
     issued by the Secretary to ensure that the product meets 
     applicable standards of identity, strength, quality, and 
     purity at the time of use.
       ``(c) Current Good Manufacturing Practice.--
       ``(1) In general.--The Secretary may, when the 
     circumstances of a domestic, military, or public health 
     emergency or material threat described in subsection 
     (a)(1)(C) so

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     warrant, authorize, with respect to an eligible product, 
     deviations from current good manufacturing practice 
     requirements otherwise applicable to the manufacture, 
     processing, packing, or holding of products subject to 
     regulation under this Act, including requirements under 
     section 501 or 520(f)(1) or applicable conditions prescribed 
     with respect to the eligible product by an order under 
     section 520(f)(2).
       ``(2) Effect.--Notwithstanding any other provision of this 
     Act or the Public Health Service Act, an eligible product 
     shall not be considered an unapproved product (as defined in 
     section 564(a)(2)(A)) and shall not be deemed adulterated or 
     misbranded under this Act because, with respect to such 
     product, the Secretary has authorized deviations from current 
     good manufacturing practices under paragraph (1).
       ``(d) Emergency Dispensing.--The requirements of sections 
     503(b) and 520(e) shall not apply to an eligible product, and 
     the product shall not be considered an unapproved product (as 
     defined in section 564(a)(2)(A)) and shall not be deemed 
     adulterated or misbranded under this Act because it is 
     dispensed without an individual prescription, if--
       ``(1) the product is dispensed during the circumstances 
     described in subsection (a)(1)(C); and
       ``(2) such dispensing without an individual prescription 
     occurs--
       ``(A) as permitted under the law of the State in which the 
     product is dispensed; or
       ``(B) in accordance with an order issued by the Secretary, 
     for the purposes and duration of the circumstances described 
     in subsection (a)(1)(C).
       ``(e) Emergency Use Instructions.--
       ``(1) In general.--The Secretary, acting through an 
     appropriate official within the Department of Health and 
     Human Services, may create and issue emergency use 
     instructions to inform health care providers or individuals 
     to whom an eligible product is to be administered concerning 
     such product's approved, licensed, or cleared conditions of 
     use.
       ``(2) Effect.--Notwithstanding any other provisions of this 
     Act or the Public Health Service Act, a product shall not be 
     considered an unapproved product and shall not be deemed 
     adulterated or misbranded under this Act because of the 
     issuance of emergency use instructions under paragraph (1) 
     with respect to such product or the introduction or delivery 
     for introduction of such product into interstate commerce 
     accompanied by such instructions--
       ``(A) during an emergency response to an actual emergency 
     that is the basis for a determination described in subsection 
     (a)(1)(C)(i); or
       ``(B) by a government entity (including a Federal, State, 
     local, or tribal government entity), or a person acting on 
     behalf of such a government entity, in preparation for an 
     emergency response.''.
       (c) Risk Evaluation and Mitigation Strategies.--Section 
     505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355-1), is amended--
       (1) in subsection (f), by striking paragraph (7); and
       (2) by adding at the end the following:
       ``(k) Waiver in Public Health Emergencies.--The Secretary 
     may waive any requirement of this section with respect to a 
     qualified countermeasure (as defined in section 319F-1(a)(2) 
     of the Public Health Service Act) to which a requirement 
     under this section has been applied, if the Secretary 
     determines that such waiver is required to mitigate the 
     effects of, or reduce the severity of, the circumstances 
     under which--
       ``(1) a determination described in subparagraph (A), (B), 
     or (C) of section 564(b)(1) has been made by the Secretary of 
     Homeland Security, the Secretary of Defense, or the 
     Secretary, respectively; or
       ``(2) the identification of a material threat described in 
     subparagraph (D) of section 564(b)(1) has been made pursuant 
     to section 319F-2 of the Public Health Service Act.''.
       (d) Products Held for Emergency Use.--The Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by 
     inserting after section 564A, as added by subsection (b), the 
     following:

     ``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.

       ``It is not a violation of any section of this Act or of 
     the Public Health Service Act for a government entity 
     (including a Federal, State, local, or tribal government 
     entity), or a person acting on behalf of such a government 
     entity, to introduce into interstate commerce a product (as 
     defined in section 564(a)(4)) intended for emergency use, if 
     that product--
       ``(1) is intended to be held and not used; and
       ``(2) is held and not used, unless and until that product--
       ``(A) is approved, cleared, or licensed under section 505, 
     510(k), or 515 of this Act or section 351 of the Public 
     Health Service Act;
       ``(B) is authorized for investigational use under section 
     505 or 520 of this Act or section 351 of the Public Health 
     Service Act; or
       ``(C) is authorized for use under section 564.''.

     SEC. 303. DEFINITIONS.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4) is amended by striking ``The Secretary, in 
     consultation'' and inserting the following:
       ``(a) Definitions.--In this section--
       ``(1) the term `countermeasure' means a qualified 
     countermeasure, a security countermeasure, and a qualified 
     pandemic or epidemic product;
       ``(2) the term `qualified countermeasure' has the meaning 
     given such term in section 319F-1 of the Public Health 
     Service Act;
       ``(3) the term `security countermeasure' has the meaning 
     given such term in section 319F-2 of such Act; and
       ``(4) the term `qualified pandemic or epidemic product' 
     means a product that meets the definition given such term in 
     section 319F-3 of the Public Health Service Act and--
       ``(A) that has been identified by the Department of Health 
     and Human Services or the Department of Defense as receiving 
     funding directly related to addressing chemical, biological, 
     radiological, or nuclear threats, including pandemic 
     influenza; or
       ``(B) is included under this paragraph pursuant to a 
     determination by the Secretary.
       ``(b) General Duties.--The Secretary, in consultation''.

     SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 303, is further 
     amended--
       (1) in the section heading, by striking ``TECHNICAL 
     ASSISTANCE'' and inserting ``COUNTERMEASURE DEVELOPMENT, 
     REVIEW, AND TECHNICAL ASSISTANCE'';
       (2) in subsection (b), by striking the subsection 
     enumerator and all that follows through ``shall establish'' 
     and inserting the following:
       ``(b) General Duties.--In order to accelerate the 
     development, stockpiling, approval, licensure, and clearance 
     of qualified countermeasures, security countermeasures, and 
     qualified pandemic or epidemic products, the Secretary, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response, shall--
       ``(1) ensure the appropriate involvement of Food and Drug 
     Administration personnel in interagency activities related to 
     countermeasure advanced research and development, consistent 
     with sections 319F, 319F-1, 319F-2, 319F-3, 319L, and 2811 of 
     the Public Health Service Act;
       ``(2) ensure the appropriate involvement and consultation 
     of Food and Drug Administration personnel in any flexible 
     manufacturing activities carried out under section 319L of 
     the Public Health Service Act, including with respect to 
     meeting regulatory requirements set forth in this Act;
       ``(3) promote countermeasure expertise within the Food and 
     Drug Administration by--
       ``(A) ensuring that Food and Drug Administration personnel 
     involved in reviewing countermeasures for approval, 
     licensure, or clearance are informed by the Assistant 
     Secretary for Preparedness and Response on the material 
     threat assessment conducted under section 319F-2 of the 
     Public Health Service Act for the agent or agents for which 
     the countermeasure under review is intended;
       ``(B) training Food and Drug Administration personnel 
     regarding review of countermeasures for approval, licensure, 
     or clearance;
       ``(C) holding public meetings at least twice annually to 
     encourage the exchange of scientific ideas; and
       ``(D) establishing protocols to ensure that countermeasure 
     reviewers have sufficient training or experience with 
     countermeasures;
       ``(4) maintain teams, composed of Food and Drug 
     Administration personnel with expertise on countermeasures, 
     including specific countermeasures, populations with special 
     clinical needs (including children and pregnant women that 
     may use countermeasures, as applicable and appropriate), 
     classes or groups of countermeasures, or other 
     countermeasure-related technologies and capabilities, that 
     shall--
       ``(A) consult with countermeasure experts, including 
     countermeasure sponsors and applicants, to identify and help 
     resolve scientific issues related to the approval, licensure, 
     or clearance of countermeasures, through workshops or public 
     meetings; and
       ``(B) improve and advance the science relating to the 
     development of new tools, standards, and approaches to 
     assessing and evaluating countermeasures--
       ``(i) in order to inform the process for countermeasure 
     approval, clearance, and licensure; and
       ``(ii) with respect to the development of countermeasures 
     for populations with special clinical needs, including 
     children and pregnant women, in order to meet the needs of 
     such populations, as necessary and appropriate; and
       ``(5) establish''; and
       (3) by adding at the end the following:
       ``(c) Final Guidance on Development of Animal Models.--
       ``(1) In general.--Not later than 1 year after the date of 
     the enactment of the Pandemic and All-Hazards Preparedness 
     Reauthorization Act of 2013, the Secretary shall provide 
     final guidance to industry regarding the development of 
     animal models to support approval, clearance, or licensure of 
     countermeasures referred to in subsection (a) when

[[Page 266]]

     human efficacy studies are not ethical or feasible.
       ``(2) Authority to extend deadline.--The Secretary may 
     extend the deadline for providing final guidance under 
     paragraph (1) by not more than 6 months upon submission by 
     the Secretary of a report on the status of such guidance to 
     the Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate.
       ``(d) Development and Animal Modeling Procedures.--
       ``(1) Availability of animal model meetings.--To facilitate 
     the timely development of animal models and support the 
     development, stockpiling, licensure, approval, and clearance 
     of countermeasures, the Secretary shall, not later than 180 
     days after the enactment of this subsection, establish a 
     procedure by which a sponsor or applicant that is developing 
     a countermeasure for which human efficacy studies are not 
     ethical or practicable, and that has an approved 
     investigational new drug application or investigational 
     device exemption, may request and receive--
       ``(A) a meeting to discuss proposed animal model 
     development activities; and
       ``(B) a meeting prior to initiating pivotal animal studies.
       ``(2) Pediatric models.--To facilitate the development and 
     selection of animal models that could translate to pediatric 
     studies, any meeting conducted under paragraph (1) shall 
     include discussion of animal models for pediatric 
     populations, as appropriate.
       ``(e) Review and Approval of Countermeasures.--
       ``(1) Material threat.--When evaluating an application or 
     submission for approval, licensure, or clearance of a 
     countermeasure, the Secretary shall take into account the 
     material threat posed by the chemical, biological, 
     radiological, or nuclear agent or agents identified under 
     section 319F-2 of the Public Health Service Act for which the 
     countermeasure under review is intended.
       ``(2) Review expertise.--When practicable and appropriate, 
     teams of Food and Drug Administration personnel reviewing 
     applications or submissions described under paragraph (1) 
     shall include a reviewer with sufficient training or 
     experience with countermeasures pursuant to the protocols 
     established under subsection (b)(3)(D).''.

     SEC. 305. REGULATORY MANAGEMENT PLANS.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 304, is further 
     amended by adding at the end the following:
       ``(f) Regulatory Management Plan.--
       ``(1) Definition.--In this subsection, the term `eligible 
     countermeasure' means--
       ``(A) a security countermeasure with respect to which the 
     Secretary has entered into a procurement contract under 
     section 319F-2(c) of the Public Health Service Act; or
       ``(B) a countermeasure with respect to which the Biomedical 
     Advanced Research and Development Authority has provided 
     funding under section 319L of the Public Health Service Act 
     for advanced research and development.
       ``(2) Regulatory management plan process.--The Secretary, 
     in consultation with the Assistant Secretary for Preparedness 
     and Response and the Director of the Biomedical Advanced 
     Research and Development Authority, shall establish a formal 
     process for obtaining scientific feedback and interactions 
     regarding the development and regulatory review of eligible 
     countermeasures by facilitating the development of written 
     regulatory management plans in accordance with this 
     subsection.
       ``(3) Submission of request and proposed plan by sponsor or 
     applicant.--
       ``(A) In general.--A sponsor or applicant of an eligible 
     countermeasure may initiate the process described under 
     paragraph (2) upon submission of a written request to the 
     Secretary. Such request shall include a proposed regulatory 
     management plan.
       ``(B) Timing of submission.--A sponsor or applicant may 
     submit a written request under subparagraph (A) after the 
     eligible countermeasure has an investigational new drug or 
     investigational device exemption in effect.
       ``(C) Response by secretary.--The Secretary shall direct 
     the Food and Drug Administration, upon submission of a 
     written request by a sponsor or applicant under subparagraph 
     (A), to work with the sponsor or applicant to agree on a 
     regulatory management plan within a reasonable time not to 
     exceed 90 days. If the Secretary determines that no plan can 
     be agreed upon, the Secretary shall provide to the sponsor or 
     applicant, in writing, the scientific or regulatory rationale 
     why such agreement cannot be reached.
       ``(4) Plan.--The content of a regulatory management plan 
     agreed to by the Secretary and a sponsor or applicant shall 
     include--
       ``(A) an agreement between the Secretary and the sponsor or 
     applicant regarding developmental milestones that will 
     trigger responses by the Secretary as described in 
     subparagraph (B);
       ``(B) performance targets and goals for timely and 
     appropriate responses by the Secretary to the triggers 
     described under subparagraph (A), including meetings between 
     the Secretary and the sponsor or applicant, written feedback, 
     decisions by the Secretary, and other activities carried out 
     as part of the development and review process; and
       ``(C) an agreement on how the plan shall be modified, if 
     needed.
       ``(5) Milestones and performance targets.--The 
     developmental milestones described in paragraph (4)(A) and 
     the performance targets and goals described in paragraph 
     (4)(B) shall include--
       ``(A) feedback from the Secretary regarding the data 
     required to support the approval, clearance, or licensure of 
     the eligible countermeasure involved;
       ``(B) feedback from the Secretary regarding the data 
     necessary to inform any authorization under section 564;
       ``(C) feedback from the Secretary regarding the data 
     necessary to support the positioning and delivery of the 
     eligible countermeasure, including to the Strategic National 
     Stockpile;
       ``(D) feedback from the Secretary regarding the data 
     necessary to support the submission of protocols for review 
     under section 505(b)(5)(B);
       ``(E) feedback from the Secretary regarding any gaps in 
     scientific knowledge that will need resolution prior to 
     approval, licensure, or clearance of the eligible 
     countermeasure and plans for conducting the necessary 
     scientific research;
       ``(F) identification of the population for which the 
     countermeasure sponsor or applicant seeks approval, 
     licensure, or clearance and the population for which desired 
     labeling would not be appropriate, if known; and
       ``(G) as necessary and appropriate, and to the extent 
     practicable, a plan for demonstrating safety and 
     effectiveness in pediatric populations, and for developing 
     pediatric dosing, formulation, and administration with 
     respect to the eligible countermeasure, provided that such 
     plan would not delay authorization under section 564, 
     approval, licensure, or clearance for adults.
       ``(6) Prioritization.--
       ``(A) Plans for security countermeasures.--The Secretary 
     shall establish regulatory management plans for all security 
     countermeasures for which a request is submitted under 
     paragraph (3)(A).
       ``(B) Plans for other eligible countermeasures.--The 
     Secretary shall determine whether resources are available to 
     establish regulatory management plans for eligible 
     countermeasures that are not security countermeasures. If 
     resources are available to establish regulatory management 
     plans for eligible countermeasures that are not security 
     countermeasures, and if resources are not available to 
     establish regulatory management plans for all eligible 
     countermeasures for which requests have been submitted, the 
     Director of the Biomedical Advanced Research and Development 
     Authority, in consultation with the Commissioner, shall 
     prioritize which eligible countermeasures may receive 
     regulatory management plans.''.

     SEC. 306. REPORT.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 305, is further 
     amended by adding at the end the following:
       ``(g) Annual Report.--Not later than 180 days after the 
     date of enactment of this subsection, and annually 
     thereafter, the Secretary shall make publicly available on 
     the Web site of the Food and Drug Administration a report 
     that details the countermeasure development and review 
     activities of the Food and Drug Administration, including--
       ``(1) with respect to the development of new tools, 
     standards, and approaches to assess and evaluate 
     countermeasures--
       ``(A) the identification of the priorities of the Food and 
     Drug Administration and the progress made on such priorities; 
     and
       ``(B) the identification of scientific gaps that impede the 
     development, approval, licensure, or clearance of 
     countermeasures for populations with special clinical needs, 
     including children and pregnant women, and the progress made 
     on resolving these challenges;
       ``(2) with respect to countermeasures for which a 
     regulatory management plan has been agreed upon under 
     subsection (f), the extent to which the performance targets 
     and goals set forth in subsection (f)(4)(B) and the 
     regulatory management plan have been met, including, for each 
     such countermeasure--
       ``(A) whether the regulatory management plan was completed 
     within the required timeframe, and the length of time taken 
     to complete such plan;
       ``(B) whether the Secretary adhered to the timely and 
     appropriate response times set forth in such plan; and
       ``(C) explanations for any failure to meet such performance 
     targets and goals;
       ``(3) the number of regulatory teams established pursuant 
     to subsection (b)(4), the number of products, classes of 
     products, or technologies assigned to each such team, and the 
     number of, type of, and any progress made as a result of 
     consultations carried out under subsection (b)(4)(A);
       ``(4) an estimate of resources obligated to countermeasure 
     development and regulatory assessment, including--
       ``(A) Center-specific objectives and accomplishments; and

[[Page 267]]

       ``(B) the number of full-time equivalent employees of the 
     Food and Drug Administration who directly support the review 
     of countermeasures;
       ``(5) the number of countermeasure applications and 
     submissions submitted, the number of countermeasures 
     approved, licensed, or cleared, the status of remaining 
     submitted applications and submissions, and the number of 
     each type of authorization issued pursuant to section 564;
       ``(6) the number of written requests for a regulatory 
     management plan submitted under subsection (f)(3)(A), the 
     number of regulatory management plans developed, and the 
     number of such plans developed for security countermeasures; 
     and
       ``(7) the number, type, and frequency of meetings between 
     the Food and Drug Administration and--
       ``(A) sponsors of a countermeasure as defined in subsection 
     (a); or
       ``(B) another agency engaged in development or management 
     of portfolios for such countermeasures, including the Centers 
     for Disease Control and Prevention, the Biomedical Advanced 
     Research and Development Authority, the National Institutes 
     of Health, and the appropriate agencies of the Department of 
     Defense.''.

     SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.

       (a) Pediatric Studies of Drugs.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended--
       (1) in subsection (d), by adding at the end the following:
       ``(5) Consultation.--With respect to a drug that is a 
     qualified countermeasure (as defined in section 319F-1 of the 
     Public Health Service Act), a security countermeasure (as 
     defined in section 319F-2 of the Public Health Service Act), 
     or a qualified pandemic or epidemic product (as defined in 
     section 319F-3 of the Public Health Service Act), the 
     Secretary shall solicit input from the Assistant Secretary 
     for Preparedness and Response regarding the need for and, 
     from the Director of the Biomedical Advanced Research and 
     Development Authority regarding the conduct of, pediatric 
     studies under this section.''; and
       (2) in subsection (n)(1), by adding at the end the 
     following:
       ``(C) For a drug that is a qualified countermeasure (as 
     defined in section 319F-1 of the Public Health Service Act), 
     a security countermeasure (as defined in section 319F-2 of 
     the Public Health Service Act), or a qualified pandemic or 
     epidemic product (as defined in section 319F-3 of such Act), 
     in addition to any action with respect to such drug under 
     subparagraph (A) or (B), the Secretary shall notify the 
     Assistant Secretary for Preparedness and Response and the 
     Director of the Biomedical Advanced Research and Development 
     Authority of all pediatric studies in the written request 
     issued by the Commissioner of Food and Drugs.''.
       (b) Addition to Priority List Considerations.--Section 409I 
     of the Public Health Service Act (42 U.S.C. 284m) is 
     amended--
       (1) by striking subsection (a)(2) and inserting the 
     following:
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary--
       ``(A) shall consider--
       ``(i) therapeutic gaps in pediatrics that may include 
     developmental pharmacology, pharmacogenetic determinants of 
     drug response, metabolism of drugs and biologics in children, 
     and pediatric clinical trials;
       ``(ii) particular pediatric diseases, disorders or 
     conditions where more complete knowledge and testing of 
     therapeutics, including drugs and biologics, may be 
     beneficial in pediatric populations; and
       ``(iii) the adequacy of necessary infrastructure to conduct 
     pediatric pharmacological research, including research 
     networks and trained pediatric investigators; and
       ``(B) may consider the availability of qualified 
     countermeasures (as defined in section 319F-1), security 
     countermeasures (as defined in section 319F-2), and qualified 
     pandemic or epidemic products (as defined in section 319F-3) 
     to address the needs of pediatric populations, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response, consistent with the purposes of this 
     section.''; and
       (2) in subsection (b), by striking ``subsection (a)'' and 
     inserting ``paragraphs (1) and (2)(A) of subsection (a)''.
       (c) Advice and Recommendations of the Pediatric Advisory 
     Committee Regarding Countermeasures for Pediatric 
     Populations.--Subsection (b)(2) of section 14 of the Best 
     Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 
     amended--
       (1) in subparagraph (C), by striking the period and 
     inserting ``; and''; and
       (2) by adding at the end the following:
       ``(D) the development of countermeasures (as defined in 
     section 565(a) of the Federal Food, Drug, and Cosmetic Act) 
     for pediatric populations.''.

  TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND 
                              DEVELOPMENT

     SEC. 401. BIOSHIELD.

       (a) Procurement of Countermeasures.--Section 319F-2(c) of 
     the Public Health Service Act (42 U.S.C. 247d-6b(c)) is 
     amended--
       (1) in paragraph (1)(B)(i)(III)(bb), by striking ``eight 
     years'' and inserting ``10 years'';
       (2) in paragraph (2)(C), by striking ``the designated 
     congressional committees (as defined in paragraph (10))'' and 
     inserting ``the appropriate committees of Congress'';
       (3) in paragraph (5)(B)(ii), by striking ``eight years'' 
     and inserting ``10 years'';
       (4) in subparagraph (C) of paragraph (6)--
       (A) in the subparagraph heading, by striking ``designated 
     congressional committees'' and inserting ``appropriate 
     congressional committees''; and
       (B) by striking ``the designated congressional committees'' 
     and inserting ``the appropriate congressional committees''; 
     and
       (5) in paragraph (7)(C)--
       (A) in clause (i)(I), by inserting ``including advanced 
     research and development,'' after ``as may reasonably be 
     required,'';
       (B) in clause (ii)--
       (i) in subclause (III), by striking ``eight years'' and 
     inserting ``10 years''; and
       (ii) by striking subclause (IX) and inserting the 
     following:

       ``(IX) Contract terms.--The Secretary, in any contract for 
     procurement under this section--

       ``(aa) may specify--
         ``(AA) the dosing and administration requirements for the 
     countermeasure to be developed and procured;
         ``(BB) the amount of funding that will be dedicated by 
     the Secretary for advanced research, development, and 
     procurement of the countermeasure; and
         ``(CC) the specifications the countermeasure must meet to 
     qualify for procurement under a contract under this section; 
     and
       ``(bb) shall provide a clear statement of defined 
     Government purpose limited to uses related to a security 
     countermeasure, as defined in paragraph (1)(B).''; and
       (C) by adding at the end the following:
       ``(viii) Flexibility.--In carrying out this section, the 
     Secretary may, consistent with the applicable provisions of 
     this section, enter into contracts and other agreements that 
     are in the best interest of the Government in meeting 
     identified security countermeasure needs, including with 
     respect to reimbursement of the cost of advanced research and 
     development as a reasonable, allowable, and allocable direct 
     cost of the contract involved.''.
       (b) Reauthorization of the Special Reserve Fund.--Section 
     319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
     is amended--
       (1) in subsection (c)--
       (A) by striking ``special reserve fund under paragraph 
     (10)'' each place it appears and inserting ``special reserve 
     fund as defined in subsection (h)''; and
       (B) by striking paragraphs (9) and (10); and
       (2) by adding at the end the following:
       ``(g) Special Reserve Fund.--
       ``(1) Authorization of appropriations.--In addition to 
     amounts appropriated to the special reserve fund prior to the 
     date of the enactment of this subsection, there is authorized 
     to be appropriated, for the procurement of security 
     countermeasures under subsection (c) and for carrying out 
     section 319L (relating to the Biomedical Advanced Research 
     and Development Authority), $2,800,000,000 for the period of 
     fiscal years 2014 through 2018. Amounts appropriated pursuant 
     to the preceding sentence are authorized to remain available 
     until September 30, 2019.
       ``(2) Use of special reserve fund for advanced research and 
     development.--The Secretary may utilize not more than 50 
     percent of the amounts authorized to be appropriated under 
     paragraph (1) to carry out section 319L (related to the 
     Biomedical Advanced Research and Development Authority). 
     Amounts authorized to be appropriated under this subsection 
     to carry out section 319L are in addition to amounts 
     otherwise authorized to be appropriated to carry out such 
     section.
       ``(3) Restrictions on use of funds.--Amounts in the special 
     reserve fund shall not be used to pay costs other than 
     payments made by the Secretary to a vendor for advanced 
     development (under section 319L) or for procurement of a 
     security countermeasure under subsection (c)(7).
       ``(4) Report.--Not later than 30 days after any date on 
     which the Secretary determines that the amount of funds in 
     the special reserve fund available for procurement is less 
     than $1,500,000,000, the Secretary shall submit to the 
     appropriate committees of Congress a report detailing the 
     amount of such funds available for procurement and the impact 
     such reduction in funding will have--
       ``(A) in meeting the security countermeasure needs 
     identified under this section; and
       ``(B) on the annual Public Health Emergency Medical 
     Countermeasures Enterprise and Strategy Implementation Plan 
     (pursuant to section 2811(d)).
       ``(h) Definitions.--In this section:
       ``(1) The term `advanced research and development' has the 
     meaning given such term in section 319L(a).
       ``(2) The term `special reserve fund' means the `Biodefense 
     Countermeasures' appropriations account, any appropriation 
     made available pursuant to section 521(a) of the Homeland 
     Security Act of 2002, and any appropriation made available 
     pursuant to subsection (g)(1).''.

[[Page 268]]



     SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
                   AUTHORITY.

       (a) Duties.--Section 319L(c)(4) of the Public Health 
     Service Act (42 U.S.C. 247d-7e(c)(4)) is amended--
       (1) in subparagraph (B)(iii), by inserting ``(which may 
     include advanced research and development for purposes of 
     fulfilling requirements under the Federal Food, Drug, and 
     Cosmetic Act or section 351 of this Act)'' after 
     ``development''; and
       (2) in subparagraph (D)(iii), by striking ``and vaccine 
     manufacturing technologies'' and inserting ``vaccine-
     manufacturing technologies, dose-sparing technologies, 
     efficacy-increasing technologies, and platform 
     technologies''.
       (b) Transaction Authorities.--Section 319L(c)(5) of the 
     Public Health Service Act (42 U.S.C. 247d-7e(c)(5)) is 
     amended by adding at the end the following:
       ``(G) Government purpose.--In awarding contracts, grants, 
     and cooperative agreements under this section, the Secretary 
     shall provide a clear statement of defined Government purpose 
     related to activities included in subsection (a)(6)(B) for a 
     qualified countermeasure or qualified pandemic or epidemic 
     product.''.
       (c) Fund.--Paragraph (2) of section 319L(d) of the Public 
     Health Service Act (42 U.S.C. 247d-7e(d)(2)) is amended to 
     read as follows:
       ``(2) Funding.--To carry out the purposes of this section, 
     there is authorized to be appropriated to the Fund 
     $415,000,000 for each of fiscal years 2013 through 2017, such 
     amounts to remain available until expended.''.
       (d) Continued Inapplicability of Certain Provisions.--
     Section 319L(e)(1)(C) of the Public Health Service Act (42 
     U.S.C. 247d-7e(e)(1)(C)) is amended by striking ``7 years'' 
     and inserting ``11 years''.
       (e) Extension of Limited Antitrust Exemption.--
       (1) In general.--Section 405(b) of the Pandemic and All-
     Hazards Preparedness Act (42 U.S.C. 247d-6a note) is amended 
     by striking ``6-year'' and inserting ``11-year''.
       (2) Effective date.--This subsection shall take effect as 
     if enacted on December 17, 2012.
       (f) Independent Evaluation.--Section 319L of the Public 
     Health Service Act (42 U.S.C. 247d-7e) is amended by adding 
     at the end the following:
       ``(f) Independent Evaluation.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this subsection, the Comptroller General of 
     the United States shall conduct an independent evaluation of 
     the activities carried out to facilitate flexible 
     manufacturing capacity pursuant to this section.
       ``(2) Report.--Not later than 1 year after the date of 
     enactment of this subsection, the Comptroller General of the 
     United States shall submit to the appropriate committees of 
     Congress a report concerning the results of the evaluation 
     conducted under paragraph (1). Such report shall review and 
     assess--
       ``(A) the extent to which flexible manufacturing capacity 
     under this section is dedicated to chemical, biological, 
     radiological, and nuclear threats;
       ``(B) the activities supported by flexible manufacturing 
     initiatives; and
       ``(C) the ability of flexible manufacturing activities 
     carried out under this section to--
       ``(i) secure and leverage leading technical expertise with 
     respect to countermeasure advanced research, development, and 
     manufacturing processes; and
       ``(ii) meet the surge manufacturing capacity needs 
     presented by novel and emerging threats, including chemical, 
     biological, radiological, and nuclear agents.''.
       (g) Definitions.--
       (1) Qualified countermeasure.--Section 319F-1(a)(2)(A) of 
     the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is 
     amended--
       (A) in the matter preceding clause (i), by striking ``to--
     '' and inserting ``--'';
       (B) in clause (i)--
       (i) by striking ``diagnose'' and inserting ``to diagnose''; 
     and
       (ii) by striking ``; or'' and inserting a semicolon;
       (C) in clause (ii)--
       (i) by striking ``diagnose'' and inserting ``to diagnose''; 
     and
       (ii) by striking the period at the end and inserting ``; 
     or''; and
       (D) by adding at the end the following:
       ``(iii) is a product or technology intended to enhance the 
     use or effect of a drug, biological product, or device 
     described in clause (i) or (ii).''.
       (2) Qualified pandemic or epidemic product.--Section 319F-
     3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d-
     6d(i)(7)(A)) is amended--
       (A) in clause (i)(II), by striking ``; or'' and inserting 
     ``;'';
       (B) in clause (ii), by striking ``; and'' and inserting ``; 
     or''; and
       (C) by adding at the end the following:
       ``(iii) a product or technology intended to enhance the use 
     or effect of a drug, biological product, or device described 
     in clause (i) or (ii); and''.
       (3) Technical amendments.--Section 319F-3(i) of the Public 
     Health Service Act (42 U.S.C. 247d-6d(i)) is amended--
       (A) in paragraph (1)(C), by inserting ``, 564A, or 564B'' 
     after ``564''; and
       (B) in paragraph (7)(B)(iii), by inserting ``, 564A, or 
     564B'' after ``564''.

     SEC. 403. STRATEGIC NATIONAL STOCKPILE.

       Section 319F-2 of the Public Health Service Act (42 U.S.C. 
     247d-6b) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) by inserting ``consistent with section 2811'' before 
     ``by the Secretary to be appropriate''; and
       (ii) by inserting before the period at the end of the 
     second sentence the following: ``and shall submit such review 
     annually to the appropriate congressional committees of 
     jurisdiction to the extent that disclosure of such 
     information does not compromise national security''; and
       (B) in paragraph (2)(D), by inserting before the semicolon 
     at the end the following: ``and that the potential depletion 
     of countermeasures currently in the stockpile is identified 
     and appropriately addressed, including through necessary 
     replenishment''; and
       (2) in subsection (f)(1), by striking ``$640,000,000 for 
     fiscal year 2002, and such sums as may be necessary for each 
     of fiscal years 2003 through 2006. Such authorization is in 
     addition to amounts in the special reserve fund referred to 
     in subsection (c)(10)(A).'' and inserting ``$533,800,000 for 
     each of fiscal years 2013 through 2017. Such authorization is 
     in addition to amounts in the special reserve fund referred 
     to in subsection (h).''.

     SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.

       Section 319M(a) of the Public Health Service Act (42 U.S.C. 
     247d-f(a)) is amended--
       (1) in paragraph (2)--
       (A) in subparagraph (D)--
       (i) in clause (i), by striking ``and'' at the end;
       (ii) in clause (ii), by striking the period and inserting a 
     semicolon; and
       (iii) by adding at the end the following:
       ``(iii) one such member shall be an individual with 
     pediatric subject matter expertise; and
       ``(iv) one such member shall be a State, tribal, 
     territorial, or local public health official.''; and
       (B) by adding at the end the following flush sentence:
     ``Nothing in this paragraph shall preclude a member of the 
     Board from satisfying two or more of the requirements 
     described in subparagraph (D).''; and
       (2) in paragraph (5)--
       (A) in subparagraph (B), by striking ``and'' at the end;
       (B) in subparagraph (C), by striking the period and 
     inserting ``; and''; and
       (C) by adding at the end the following:
       ``(D) provide any recommendation, finding, or report 
     provided to the Secretary under this paragraph to the 
     appropriate committees of Congress.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Pennsylvania (Mr. Pitts) and the gentleman from New Jersey (Mr. 
Pallone) each will control 20 minutes.
  The Chair recognizes the gentleman from Pennsylvania.


                             General Leave

  Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials into the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Pennsylvania?
  There was no objection.
  Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, H.R. 307, the Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2013, introduced by my colleague, Mike Rogers, 
from Michigan, would reauthorize programs designed to foster the 
development of chemical, biological, radioactive, and nuclear medical 
countermeasures and strengthen the Nation's preparedness 
infrastructure. It reauthorizes programs for 5 years at the fiscal year 
2012 appropriated level and does not create a new program nor increase 
the authorization for appropriations for an existing program.
  Congress originally enacted the programs reauthorized in PAHPRA 
through the Project BioShield Act of 2004 and Pandemic and All-Hazards 
Preparedness Act of 2006. Project BioShield authorized funds for the 
purchase of medical countermeasures through the Special Reserve Fund 
and enabled the Secretary of Health and Human Services to authorize the 
emergency use of medical products.
  PAHPRA created the Biodefense Advanced Research and Development 
Authority within HHS to help with the development of medical 
countermeasures and ensure communications between HHS and the 
developers of medical countermeasures. Reauthorizing these programs 
would help the

[[Page 269]]

Nation respond to a CBRN attack and is essential to addressing gaps in 
the Nation's flu preparedness.
  H.R. 307 is essentially the same as H.R. 6672, the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2012, which passed the 
House in December by a vote of 383-16.
  I would urge all Members to support this critical piece of 
legislation, and I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I am pleased to rise in support of H.R. 307, the 
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. 
Unfortunately, last month, before the end of the Congress, we were 
unable to get this final bill over the finish line, so I am grateful to 
Chairman Upton and Ranking Member Waxman for agreeing to move quickly 
to get this bill passed and sent over to the Senate without further 
delay.
  This bill is virtually identical to the House-passed bill last 
December. It reflects bipartisan work that took place between the House 
and Senate over several months late last year to resolve differences 
between the House- and Senate-passed PAHPA reauthorization bills.
  We all know very well that our Nation continues to face threats that 
require an ongoing commitment to public health and emergency 
preparedness. Of course, I think to my own district and State of New 
Jersey after we experienced a devastating storm that destroyed entire 
communities. The Federal Government's support, including through 
programs authorized by PAHPA, was critical in the wake of this 
hurricane disaster.
  The legislation before us today reauthorizes programs and activities 
first established as part of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002, the 2004 Project 
BioShield Act, and the 2006 Pandemic and All-Hazards Preparedness Act. 
Over the past decade, these programs have represented comprehensive 
efforts to prepare for and respond to public health emergencies. As a 
result of the investments that followed, our Nation is better equipped 
to respond to public health emergencies.
  I just want to take a few moments to highlight ways that H.R. 307 
will continue the progress we've made over the past decade:
  First, the bill further facilitates the development of medical 
countermeasures through emphasizing medical countermeasure advancement 
in the National Health Security Strategy, requiring the development of 
a 5-year budget analysis of the countermeasure enterprise, and calling 
for the development of a countermeasure strategy and implementation 
plan;
  Second, it bolsters the Nation's medical and public health 
preparedness and response infrastructure, including through a new 
authority that would allow States to deploy personnel funded through 
Federal programs to the areas within their State where they are most 
needed in the aftermath of a disaster;
  Third, it strengthens and clarifies the position of Assistant 
Secretary for Preparedness and Response as the lead for HHS on 
emergency preparedness and response and calls for streamlining and 
better coordinating HHS preparedness grants with those of other 
Departments;
  Finally, it places even greater emphasis on the special needs of 
pediatric and other at-risk populations in preparing for and responding 
to public health emergencies.
  Mr. Speaker, H.R. 307 improves FDA's emergency response capabilities. 
It will enable FDA to authorize the distribution and use of medical 
countermeasures in preparation for an emergency and to take actions 
during an emergency that will allow for the most effective use of 
medical countermeasures.
  I just wanted to thank the Congressmen. First, I want to thank my 
colleague, who is about to speak, Congresswoman Anna Eshoo, for all her 
work on this legislation over the years; also, obviously, Mike Rogers 
and Congressman Gene Green. These are different people who have 
authored the legislation over the years.
  I would also like to recognize the contributions of Chairman Upton, 
Chairman Pitts, Ranking Member Waxman, and Congressman Markey in 
strengthening the legislation as it moved through the committee process 
and in discussions with the Senate. They have all worked in a 
bipartisan fashion over the past 1\1/2\ years to accomplish the goals 
of our Members, and they should be commended for their work.
  I urge Members to join me in supporting passage of H.R. 307. I am 
hopeful that our Senate colleagues will move forward on this bill's 
passage so we can get it to the President's desk as quickly as 
possible.
  I reserve the balance of my time.
  Mr. PITTS. Mr. Speaker, I am pleased to yield 5 minutes to the 
gentleman from Michigan (Mr. Rogers), the prime sponsor of this 
legislation.
  Mr. ROGERS of Michigan. Thank you, Mr. Speaker and Ranking Member 
Pallone. I want to thank Anna Eshoo for being such a great partner in 
what is truly a collaborative effort to get this bill passed and 
protect our ability to protect so many Americans.
  It's been about 10 years, Mr. Speaker, since September 11 and the 
anthrax attacks that followed. The threat of bioterrorism remains a 
very real danger, indeed, to the American people. As we have seen in 
events across northern Africa, our adversaries in al Qaeda and others 
are still hell-bent on their terrorism acts, and we know that they are 
interested in chemical and radiological and biological elements to 
further their political gains.
  Fortunately, we have spent the last decade preparing for those 
chemical, biological, radiological, and nuclear threats by developing 
and stockpiling numerous medical countermeasures to protect Americans 
in the event of attack. As a result of these efforts, we now have 
numerous vaccines and treatments in the Strategic National Stockpile 
that will save thousands of lives if we're attacked. However, the work 
to protect Americans against bioterrorism is not finished, and we must 
pass this bill or the future of America's public health preparedness 
infrastructure will be in jeopardy.
  The Pandemic and All-Hazards Preparedness Reauthorization Act is a 
fiscally responsible bill that represents common ground between the 
bipartisan House- and Senate-passed preparedness bills in the 112th 
Congress.
  I'd like to take this opportunity again to thank the bipartisan 
cosponsors--first, Anna Eshoo for her long-term commitment and 
partnership in this, certainly Mr. Pallone from New Jersey as well, 
Chairman Upton and Ranking Member Waxman, and all of our great partners 
in the Senate--for their support in what has been a very productive 
process to ensure the health preparedness of our States and hospitals 
for the next flu outbreak or pandemic.

                              {time}  1240

  This bill will reauthorize critically important biodefense programs 
designed to promote the continued development of medical 
countermeasures against chemical, biological, radiological, and nuclear 
threats, and would strengthen the Nation's public health preparedness 
infrastructure. Reauthorizing these programs is essential to how the 
Nation would respond to these types of attacks.
  The bill would also reauthorize programs for 5 years at the fiscal 
year 2012 appropriated level. The bill would not create a new program 
nor increase authorization for appropriations for an existing program. 
This bill would reauthorize and improve certain provisions of Project 
BioShield and something we call PAHPA.
  Again, I want to thank you, Mr. Speaker. I wish this bill Godspeed 
for the safety of all of our first responders and those who might be 
exposed to what we know is a real threat when it comes to the safety, 
health, and national security of the United States.
  Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the 
gentlewoman from California (Ms. Eshoo). She is a longtime advocate and 
sponsor of this legislation.
  Ms. ESHOO. Mr. Speaker, I thank the ranking member, Mr. Pallone, for 
his

[[Page 270]]

leadership and legislative courtesies along the way. I'm very proud 
that as we begin a new year and a new Congress that this bill is on the 
floor. I think it's fitting that we begin a new Congress with this 
bill, the Pandemic and All-Hazards Preparedness Reauthorization. It is 
very important legislation, as you have already heard from those that 
have spoken.
  I first introduced this legislation with Congressman Mike Rogers, my 
friend, my colleague, at the committee, and we've done other bills 
together very successfully, as well. We began that particular effort in 
2006 to better help our country prepare for a chemical, biological, 
radiological, or nuclear attack--all words that none of us really wish 
to utter. But we need to be prepared.
  Developing and stockpiling appropriate countermeasures is essential 
for public safety. And these programs encourage American companies to 
invest in areas of critical need because we need the partnership of the 
private sector in this as well.
  The bill before us today includes new provisions that highlight the 
important needs of our Nation's children. Children are not just little 
adults. They need special care and medical attention. They're 
especially vulnerable to biological or chemical agents because of their 
size, their limited capacity to flush toxins out of their bodies, their 
underdeveloped motor skills, and their total reliance on their parents 
or other caregivers. And certainly the role of the Congress in this is 
to make sure that we have laws that really speak specifically to them.
  While the hope is that we will never need to use these 
countermeasures to combat an attack on our country, I'm proud that 
we've strengthened these programs for everyone in our country, 
especially children.
  This legislation is supported by the American Public Health 
Association, the Association of State and Territorial Health Officials, 
the National Association of County and City Health Officials, and Trust 
for America's Health, as well as, very importantly, the American 
Academy of Pediatrics.
  I'm very pleased that we're, once again, voting to pass the Pandemic 
and All-Hazards Preparedness Reauthorization Act, just as we did a 
month before the end of the last Congress, and I strongly urge my 
colleagues in the Senate to do the same. This is a bipartisan effort, 
and it's critical to our national preparedness and security strategies. 
We very often come to the floor about strategies relative to our 
military and strategies relative to our national intelligence 
community. This is about the public health element of that national 
security for our country.
  We need to move forward with this and bring the legislation to the 
President's desk for his signature.
  I thank Chairman Upton, the ranking member of the full Energy and 
Commerce Committee, Mr. Waxman, and certainly the distinguished 
chairman of the Health Subcommittee and, again, my wonderful partner, 
Congressman Mike Rogers.
  Mr. PITTS. I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I would like to include for the Record a 
joint letter from four public health organizations: the American Public 
Health Association, the Association of State and Territorial Health 
Officials, the National Association of County and City Health 
Officials, and Trust for America's Health.

                                                 January 22, 2013.
     Hon. Fred Upton, Chairman,
     House of Representatives,
     Washington, DC.
     Hon. Joseph R. Pitts, Chairman,
     House of Representatives,
     Washington, DC.
     Hon. Henry A. Waxman, Ranking Member,
     House of Representatives,
     Washington, DC.
     Hon. Frank Pallone, Jr., Ranking Member,
     House of Representatives,
     Washington, DC.
     Hon. Mike Rogers,
     House of Representatives,
     Washington, DC.
       Dear Chairmen Upton and Pitts, Ranking Members Waxman and 
     Pallone, and Representative Rogers: On behalf of the 
     undersigned organizations, dedicated to protecting the public 
     health of our nation, we write to express our support for the 
     Pandemic and All-Hazards Preparedness Reauthorization Act of 
     2013 (PAHPRA, H.R. 307). We urge swift passage in the House 
     as this legislation is critical to the safety of our nation. 
     We thank you for your leadership in moving PAHPRA though the 
     House in the 112th Congress and are eager to work with both 
     the House and Senate to ensure final passage in this session.
       PAHPRA is vital to state and local health and other public 
     health practitioners who are a critical part of any 
     community's first response to disease outbreaks, emergencies, 
     and acts of terrorism. The following provisions in particular 
     are essential to keeping communities healthy and safe:
       Temporary Redeployment of Federally Funded Personnel During 
     a Public Health Emergency (Section 201): The provision allows 
     states and tribes to request from the Department of Health 
     and Human Services (HHS) the authority to temporarily 
     reassign public health personnel from other HHS-funded grant 
     programs to respond to a major emergency. The authority would 
     allow state and local governments to meet the tremendous 
     staffing needs required by a disaster.
       Reauthorization of the Public Health and Emergency 
     Preparedness Grants (PHEP) (Section 202): The PHEP 
     cooperative agreement program provides funding to local and 
     state public health departments to strengthen their capacity 
     and capability to effectively respond to public health 
     emergencies including terrorist threats, infectious disease 
     outbreaks, natural disasters, and biological, chemical, 
     nuclear, and radiological emergencies. State and local health 
     departments work with federal government officials, law 
     enforcement, emergency management, health care, business, 
     education, and religious groups to plan, train, and prepare 
     for emergencies so that when disaster strikes, communities 
     are prepared.
       Reauthorization of the Hospital Preparedness Program (HPP) 
     (Section 203): HPP provides funding to state and local health 
     departments to enhance hospital preparedness and improve 
     overall surge capacity in the case of public health 
     emergencies. The preparedness activities carried out under 
     this program strengthen the capabilities of hospitals 
     throughout the country to respond to floods, hurricanes, or 
     wildfires, and also include training for a potential 
     influenza pandemic or terrorist attack.
       Carryover of Grant Use, Coordination (Section 202 and 203): 
     The bill updates the preparedness grant programs at HHS 
     giving grantees limited ability to carry over funds 
     encouraging flexibility and efficiency. The provisions 
     promote long-term planning currently impossible in an 
     unpredictable fiscal environment.
       Children's Preparedness (Sections 103, 307 and throughout): 
     The bill establishes the National Advisory Committee on 
     Children and Disasters to bring together federal and non-
     federal partners to provide guidance and recommendations on 
     medical and public health preparedness for children before, 
     during and after a disaster or public health emergency. The 
     bill takes significant steps to consider the particular needs 
     of pediatric populations in Medical Countermeasure (MCM) 
     research and development. The bill also calls for 
     consideration of the needs of children, as an at-risk 
     population, in the Public Health Emergency Medical 
     Countermeasures Enterprise Strategy and Implementation Plan, 
     PHEP, HPP, and Medical Reserve Corps.
       Enhancing Situational Awareness and Biosurveillance 
     (Section 204): The bill calls for planning and integration of 
     the current biosurveillance systems to strengthen the 
     nation's bioterrorism and disease outbreak response 
     capabilities. The bill also requires coordination with the 
     National Biodefense Science Board. HHS is required to provide 
     a report to Congress on their implementation plans and 
     progress.
       Individuals with Disabilities (Section 101): The bill calls 
     for the consideration of the needs individuals with 
     disabilities in the National Health Security Strategy.
       Thank you again for your work to reauthorize this important 
     legislation. We look forward to working with you and your 
     staff to move this bill to the President's desk.
           Sincerely,
     Georges C. Benjamin, MD, FACP, FACEP (E),
       Executive Director, American Public Health Association.
     Paul E. Jarris, MD, MBA,
       Executive Director, Association of State and Territorial 
     Health Officials.
     Robert M. Pestronk, MPH,
       Executive Director, National Association of County and City 
     Health Officials.
     Jeff Levi, Ph.D.,
       Executive Director, Trust For America's Health.

  Mr. PALLONE. I now would like to yield 3 minutes to another sponsor 
of the legislation, the gentleman from Texas (Mr. Green).
  Mr. GENE GREEN of Texas. Mr. Speaker, I rise in strong support of the

[[Page 271]]

Pandemic and All-Hazards Preparedness Reauthorization Act which will 
reauthorize certain provisions of the Project BioShield Act of 2004 and 
the Pandemic and All-Hazards Preparedness Act of 2006.
  This legislation was initially passed by Congress to help the U.S. 
develop medical countermeasures against chemical, biological, 
radiological, and nuclear terrorism agents, to provide a mechanism for 
Federal acquisition of these newly developed countermeasures.
  Our Nation remains vulnerable to these threats because many of the 
vaccines and medicines to protect our citizens do not exist. Developing 
and stockpiling these medical countermeasures require time, resources, 
and research, all of which will be provided under the legislation 
before us today. I'm pleased that the language I supported during the 
committee process aimed at increasing emphasis on regional trauma care 
centers was included.
  This bill is very important to me because the University of Texas 
Medical Branch's Galveston National Laboratory is near our district. 
The Galveston National Lab is the only BSL-4 lab located on a 
university campus. At the lab, scientists conduct research to develop 
therapies, vaccines, and diagnostic tests for naturally occurring 
emerging diseases such as SARS and avian influenza, as well as for 
microbes that might be employed by terrorists.
  This is exactly the type of research we hope to encourage under the 
Pandemic and All-Hazards Preparedness Reauthorization Act.
  As an original cosponsor of this bill with Mr. Rogers, I'm very 
pleased at how quickly we have moved this rare bipartisan piece of 
legislation. I would like to thank Chairman Rogers, Chairman Upton, 
Chairman Pitts, Ranking Member Waxman, Ranking Member Pallone, Mrs. 
Myrick and Ms. Eshoo for their work on this important legislation. The 
House passed this bill twice last year, and I hope the Senate acts 
quickly, and we will send it to the President.
  I strongly urge my colleagues to vote ``yes'' on this legislation.
  Mr. PALLONE. Mr. Speaker, I have no additional colleagues to speak, 
and I would simply urge Members to join me in supporting passage of 
H.R. 307 and hope that our Senate colleagues will move forward on the 
bill's passage so we can get the bill to the President's desk.
  I yield back the balance of my time.
  Mr. PITTS. Mr. Speaker, I have no other speakers.
  I urge my colleagues to support this legislation. It has strong 
bipartisan support. I yield back the balance of my time.
  Mr. WAXMAN. Mr. Speaker, I rise in support of H.R. 307, the Pandemic 
and All-Hazards Preparedness Reauthorization Act of 2013, and urge my 
colleagues to support this bill as well.
  Mr. Speaker, this bill has been a long time coming. In fact, it's the 
same one we passed just last month at the end of the 112th Congress. 
H.R. 307 reflects a lengthy, but extremely productive process with our 
Senate colleagues and their staff to come together to bridge the 
differences between earlier House and Senate bills. H.R. 307 is the 
product of that effort. It is our hope that this time around, the 
Senate will pass the bill as soon as possible after the House acts on 
the legislation today.
  Toward that end, H.R. 307 reauthorizes and makes minor--but 
important--improvements to various programs and activities first 
established in the 2002 Public Health Security and Bioterrorism 
Preparedness and Response Act; 2004 Project BioShield Act; and the 2006 
Pandemic and All-Hazards Preparedness Act, or as it is commonly 
referred to, ``PAHPA.'' These programs and activities are key in 
helping to ensure that our nation is well prepared to successfully 
manage the effects of natural disasters, infectious disease outbreaks, 
and acts of bioterrorism.
  H.R. 307 includes dozens of changes to these underlying authorities. 
Let me highlight just three provisions that deserve special attention:
  First, the bill will ensure that the Food and Drug Administration 
focuses on medical countermeasures of the highest importance. Medical 
countermeasures are products designed to combat chemical, biological, 
radiological, and nuclear agents. H.R. 307 will facilitate 
communication between the FDA and product sponsors--particularly on 
high priority countermeasures for which sponsors have developed 
regulatory management plans--to resolve scientific and regulatory 
questions and help make these products available more quickly. Just 
last month, FDA approved the first drug developed and procured under 
Project BioShield.
  The FDA provisions in H.R. 307 will also facilitate the rapid 
provision of existing medicines to people in need during an emergency. 
Taken together, these FDA provisions--along with the renewed emphasis 
in our countermeasure enterprise through other parts of the 
legislation--will make it possible for a greater number of drugs and 
devices to move from early development to procurement.
  Second, the legislation makes improvements to the nation's blueprint 
for public health preparedness and response activities that will 
enhance the ability of our diverse health care system to respond to 
mass casualty emergencies. Among such improvements are clarifying the 
role of the Assistant Secretary of Preparedness and Response as the 
lead office within the Department of Health and Human Services for 
emergency preparedness and response. H.R. 307 also establishes a new 
authority to permit the Secretary of the Department of Health and Human 
Services to approve a request of a state, territory, or an Indian tribe 
to redeploy certain federally-supported employees during the time of a 
national emergency to geographic areas where these employees are needed 
most.
  Finally, H.R. 307 continues support for investments in state and 
local public health departments. Such investments are necessary to make 
certain that we have the requisite public health infrastructure in 
place to respond immediately and appropriately to any public health 
threat that may arise.
  This legislation reflects the effort of a number of members--
Democrats and Republicans alike. On our side of the aisle, Congressman 
Green, Congresswoman Eshoo, Congressman Markey, and our Health 
Subcommittee Ranking Member, Congressman Pallone, have been deeply 
involved. I want to thank them and their staff for all the long and 
incredibly hard work they have put into this legislation and to the 
process of getting us here today.
  I urge my colleagues to vote in favor of H.R. 307.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the 
rules and pass the bill, H.R. 307.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. PITTS. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

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