[Congressional Record Volume 159, Number 28 (Wednesday, February 27, 2013)]
[Senate]
[Pages S948-S957]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




   PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2013

  Mr. REID. Mr. President, I ask unanimous consent that the Senate 
proceed to Calendar No. 14, H.R. 307.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A 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.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:

     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 reassignment of State and local 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.

  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, 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--

[[Page S949]]

       (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;
       ``(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

[[Page S950]]

     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;
       ``(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 
     September 30, 2018.''.

     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 2014 
     through 2018''.

     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 2014 
     through 2018 to carry out this section''.

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

     SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND LOCAL 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 Reassignment of State and Local Personnel 
     During a Public Health Emergency.--
       ``(1) Emergency reassignment of federally funded 
     personnel.--Notwithstanding any other provision of law, and 
     subject to paragraph (2), upon request by the Governor of a 
     State or a tribal organization or such Governor or tribal 
     organization's designee, the Secretary may authorize the 
     requesting State or Indian tribe to temporarily reassign, for 
     purposes of immediately addressing a public health emergency 
     in the State or Indian tribe, State and local public health 
     department or agency personnel funded in whole or in part 
     through programs authorized under this Act, as appropriate.
       ``(2) Activation of emergency reassignment.--
       ``(A) Public health emergency.--The Secretary may authorize 
     a temporary reassignment 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 reassignment of personnel under paragraph (1), the 
     Governor of a State or a tribal organization shall submit to 
     the Secretary a request for such reassignment flexibility 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 Indian 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 reassignment of State and local personnel 
     described in paragraph (1).
       ``(iii) An assurance that the requested temporary 
     reassignment 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 reassigned pursuant to the requested authority; 
     and
       ``(II) the number of personnel who would be so reassigned 
     from each such program.

       ``(v) Such other information and assurances upon which the 
     Secretary and Governor of a State or tribal organization 
     agree.
       ``(C) Consideration.--In reviewing a request for temporary 
     reassignment under paragraph (1), the Secretary shall 
     consider the degree to which the program or programs funded 
     in whole or in part by programs authorized under this Act 
     would be adversely affected by the reassignment.
       ``(D) Termination and extension.--
       ``(i) Termination.--A State or Indian tribe's temporary 
     reassignment 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 Indian tribe's request for such reassignment 
     flexibility.

       ``(ii) Extension of reassignment flexibility.--The 
     Secretary may extend reassignment flexibility 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 Indian tribe that submitted the initial 
     request for a temporary reassignment

[[Page S951]]

     of personnel submits a request for an extension of such 
     temporary reassignment; and
       ``(II) the request for an extension contains the same 
     information and assurances necessary for the approval of an 
     initial request for such temporary reassignment pursuant to 
     subparagraph (B).

       ``(3) Voluntary nature of temporary reassignment of state 
     and local personnel.--
       ``(A) In general.--Unless otherwise provided under the law 
     or regulation of the State or Indian tribe that receives 
     authorization for temporary reassignment of personnel under 
     paragraph (1), personnel eligible for reassignment pursuant 
     to such authorization--
       ``(i) shall have the opportunity to volunteer for temporary 
     reassignment; and
       ``(ii) shall not be required to agree to a temporary 
     reassignment.
       ``(B) Prohibition on conditioning federal awards.--The 
     Secretary may not condition the award of a grant, contract, 
     or cooperative agreement under this Act on the requirement 
     that a State or Indian tribe require that personnel eligible 
     for reassignment pursuant to an authorization under paragraph 
     (1) agree to such reassignment.
       ``(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 temporary reassignment of 
     personnel; and
       ``(B) any request for an extension of such temporary 
     reassignment.
       ``(5) Guidance.--The Secretary shall--
       ``(A) not later than 6 months after the enactment of this 
     subsection, issue proposed guidance on the temporary 
     reassignment 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 temporary reassignment under this 
     subsection, including--
       ``(A) a description of how, and under what circumstances, 
     such temporary reassignment has been used by States and 
     Indian tribes;
       ``(B) an analysis of how such temporary reassignment has 
     assisted States and Indian tribes in responding to public 
     health emergencies;
       ``(C) an evaluation of how such temporary reassignment 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 
     reassigned have been adversely affected by the reassignment; 
     and
       ``(E) recommendations on how medical surge capacity could 
     be improved in responding to public health emergencies and 
     the impact of the reassignment flexibility under this section 
     on such surge capacity.
       ``(7) Definitions.--In this subsection--
       ``(A) the terms `Indian tribe' and `tribal organization' 
     have the meanings given such terms in section 4 of the Indian 
     Self-Determination and Education Assistance Act; and
       ``(B) 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.--This subsection shall terminate on September 
     30, 2018.''.

     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) by redesignating subsections (i), (j), and (k) as 
     subsections (h), (i), and (j), respectively;
       (7) in subsection (h), as so redesignated--
       (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 2014''; 
     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 2015 through 2018'';

       (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
       (8) in subsection (i), as so redesignated--
       (A) in paragraph (1)(E), by striking ``subsection (k)'' and 
     inserting ``subsection (j)'';
       (B) 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 2014 through 2018''.
       (c) Technical and Conforming Amendments.--
       (1) Section 319C-1(b)(1)(B) of the Public Health Service 
     Act (42 U.S.C. 247d-3a(b)(1)(B)) is amended by striking 
     ``subsection (i)(4)'' and inserting ``subsection (h)(4)''.
       (2) Section 319C-2 of the Public Health Service Act (42 
     U.S.C. 247d-3b) is amended--
       (A) in subsection (i), by striking ``(j), and (k)'' and 
     inserting ``(i), and (j)''; and
       (B) in subsection (j)(3), by striking ``319C-1(i)'' and 
     inserting ``319C-1(h)''.

     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 2014 
     through 2018''.
       (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 2014 through 2018''.
       (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, as 
     appropriate, capacity and preparedness to address the needs 
     of children and other at-risk individuals'' before the period 
     at the end;
       (2) in subsection (b)(1)(A)(ii), by striking ``centers, 
     primary'' and inserting ``centers, community health centers, 
     primary'';

[[Page S952]]

       (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 2014 through 2018.''; 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 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.

       (a) In General.--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);
       (3) by redesignating subsections (d) through (g) as 
     subsections (c) through (f), respectively;
       (4) in subsection (c), as so redesignated--
       (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.'';
       (5) in subsection (d), as so redesignated--
       (A) in paragraph (1), by striking ``subsection (d)'' and 
     inserting ``subsection (c)'';
       (B) in paragraph (4)(B), by striking ``subsection (d)'' and 
     inserting ``subsection (c)''; and
       (C) in paragraph (5)--
       (i) 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''; and
       (ii) by striking ``subsection (d)'' and inserting 
     ``subsection (c)'';
       (6) in subsection (f), as so redesignated, 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 2014 through 2018''; and
       (7) by adding at the end the following:
       ``(g) 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.''.
       (b) Technical and Conforming Amendment.--Section 319C-
     1(b)(2)(D) of the Public Health Service Act (42 U.S.C. 247d-
     3a(b)(2)(D)) is amended by striking ``section 319D(d)(3)'' 
     and inserting ``section 319D(c)(3)''.

     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:

[[Page S953]]

       ``(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)--
       (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.

[[Page S954]]

       ``(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 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 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

[[Page S955]]

     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
       ``(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

[[Page S956]]

     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).''.

     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 2014 through 2018, 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 ``12 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 ``12-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

[[Page S957]]

     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 2014 through 2018. 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.''.

  Mr. REID. Mr. President, I ask unanimous consent that the committee-
reported substitute be agreed to, the bill, as amended, be read a third 
time and passed, and the motion to reconsider be made and laid upon the 
table with no intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee-reported substitute was agreed to.
  The amendment was ordered to be engrossed and the bill to be read the 
third time and passed.
  The bill (H.R. 307), as amended, was read the third time and passed.

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