[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1855 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1855

To amend the Public Health Service Act to reauthorize various programs 
          under the Pandemic and All-Hazards Preparedness Act.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 10, 2011

 Mr. Burr (for himself, Mr. Harkin, Mr. Enzi, Mr. Casey, Ms. Mikulski, 
Mr. Alexander, Mr. Lieberman, Ms. Collins, Mrs. Hagan, and Mr. Roberts) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to reauthorize various programs 
          under the Pandemic and All-Hazards Preparedness Act.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Act Reauthorization of 2011''.
    (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. Modernization of the National Disaster Medical System.
Sec. 104. Continuing the role of the Department of Veterans Affairs.
   TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND 
                                RESPONSE

Sec. 201. Improving State and local public health security.
Sec. 202. Hospital preparedness and medical surge capacity.
Sec. 203. Enhancing situational awareness and biosurveillance.
           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

Sec. 301. Special protocol assessment.
Sec. 302. Authorized use for medical products.
Sec. 303. Definitions.
Sec. 304. Enhancing medical countermeasure activities.
Sec. 305. Regulatory management plans.
Sec. 306. Report.
Sec. 307. Pediatric medical countermeasures.
Sec. 308. Technical and conforming amendments.
  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 (3)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``and which may include 
                        dental health facilities'' after ``mental 
                        health facilities''; and
                            (ii) in subparagraph (D), by inserting 
                        ``(which may include such dental health 
                        assets)'' after ``medical assets'';
                    (B) 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
                    (C) 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.
                    ``(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 State and local communities to 
        prepare for, respond to, and ensure resiliency 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 paragraph (7);
            (2) by redesignating paragraphs (1) through (6) and (8) as 
        paragraphs (2) through (7) and (10), respectively;
            (3) 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;''; and
            (4) by inserting after paragraph (7) (as so redesignated), 
        the following:
            ``(8) 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;
            ``(9) 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; and''.

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

    Section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10) 
is amended--
            (1) in subsection (b)(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 
                502(6) of the Homeland Security Act of 2002, or any 
                successor plan, before, during, and following public 
                health emergencies.'';
            (2) by striking subsection (c) and inserting the following:
    ``(c) Functions.--The Assistant Secretary for Preparedness and 
Response shall--
            ``(1) have authority over and responsibility for--
                    ``(A) the National Disaster Medical System (in 
                accordance with section 301 of the Pandemic and All-
                Hazards Preparedness Act);
                    ``(B) the Hospital Preparedness Cooperative 
                Agreement Program pursuant to section 319C-2;
                    ``(C) the Medical Reserve Corps pursuant to section 
                2813;
                    ``(D) the Emergency System for Advance Registration 
                of Volunteer Health Professionals pursuant to section 
                319I; and
                    ``(E) 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;
            ``(2) 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; and
                    ``(C) the Cities Readiness Initiative;
            ``(3) align and coordinate medical and public health 
        preparedness and response grants and cooperative agreements 
        authorized under this Act, to the extent possible, including 
        program requirements, timelines, and measurable goals, and in 
        coordination with the Secretary of Homeland Security, to--
                    ``(A) optimize and streamline medical and public 
                health preparedness capabilities and the ability of 
                local communities to respond to public health 
                emergencies;
                    ``(B) minimize duplication of efforts with regard 
                to medical and public health preparedness and response 
                programs; and
                    ``(C) gather and disseminate best practices among 
                grant and cooperative agreement recipients, as 
                appropriate;
            ``(4) carry out drills and operational exercises, in 
        coordination with the Department of Homeland Security, the 
        Department of Defense, 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, including exercises 
        based on--
                    ``(A) identified threats for which countermeasures 
                are available and for which no countermeasures are 
                available; and
                    ``(B) unknown threats for which no countermeasures 
                are available; and
            ``(5) assume other duties as determined appropriate by the 
        Secretary.''; and
            (3) by adding at the end the following:
    ``(d) National Security Priority.--The Secretary, acting through 
the Assistant Secretary for Preparedness and Response, shall on a 
periodic basis conduct meetings, as applicable and appropriate, with 
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.
    ``(e) 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 other year 
        thereafter, the Secretary, acting through the Assistant 
        Secretary for Preparedness and Response and in coordination 
        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 the Food and Drug 
        Administration, 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. 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) consider and reflect the full spectrum of 
                medical countermeasure-related activities, including 
                research, advanced research, development, procurement, 
                stockpiling, deployment, and distribution;
                    ``(B) identify and prioritize near-term, mid-term, 
                and long-term priority qualified and security 
                countermeasure (as defined in sections 319F-1 and 319F-
                2) needs and goals of the Federal Government according 
                to chemical, biological, radiological, and nuclear 
                threat or threats;
                    ``(C) identify projected timelines, anticipated 
                funding allocations, benchmarks, and milestones for 
                each medical countermeasure priority under subparagraph 
                (B), including projected needs with regard to 
                replenishment of the Strategic National Stockpile;
                    ``(D) be informed by the recommendations of the 
                National Biodefense Science Board pursuant to section 
                319M;
                    ``(E) report on advanced research and development 
                awards and the date of the issuance of contract awards, 
                including awards made through the special reserve fund 
                (as defined in section 319F-2(c)(10));
                    ``(F) identify progress made in meeting the goals, 
                benchmarks, and milestones identified under 
                subparagraph (C) in plans submitted subsequent to the 
                initial plan; and
                    ``(G) be made publically available.
            ``(3) GAO report.--
                    ``(A) In general.--Not later than 1 year after the 
                date on which a Public Health Emergency Medical 
                Countermeasures Enterprise Strategy and Implementation 
                Plan under this subsection is issued by the Secretary, 
                the Government Accountability Office 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)(B);
                            ``(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 goals, benchmarks, and milestones 
                        identified in the Public Health Emergency 
                        Medical Countermeasures Enterprise Strategy and 
                        Implementation Plan under this subsection.
    ``(f) Internal Multiyear Planning Process.--The Secretary shall 
develop, and update on an annual basis, a coordinated 5-year budget 
plan based on the medical countermeasure priorities and goals described 
in subsection (e). Each such plan shall--
            ``(1) include consideration of the entire medical 
        countermeasures enterprise, including--
                    ``(A) basic research, advanced research and 
                development;
                    ``(B) approval, clearance, licensure, and 
                authorized uses of products; and
                    ``(C) procurement, stockpiling, maintenance, and 
                replenishment of all products in the Strategic National 
                Stockpile;
            ``(2) include measurable outputs and outcomes to allow for 
        the tracking of the progress made toward identified goals;
            ``(3) 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
            ``(4) be made available to the appropriate committees of 
        Congress upon request.
    ``(g) Interagency Coordination Plan.--Not later than one year after 
the date of enactment of this subsection, the Secretary, in 
coordination with the Secretary of Defense, shall submit to the 
appropriate committees of Congress a report concerning 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.
    ``(h) Protection of National Security.--In carrying out subsections 
(e), (f), and (g), the Secretary shall ensure that information and 
items that could compromise national security are not disclosed.''.

SEC. 103. 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), by adding at the end the 
        following:
                    (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 ``$56,000,000 for each of fiscal years 2012 through 
        2016''.

SEC. 104. 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 ``$156,500,000 
for each of fiscal years 2012 through 2016 to carry out this section''.

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

SEC. 201. 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)(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;
                            ``(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;
                            (iii) in clause (v), by adding ``and'' 
                        after the semicolon; and
                            (iv) 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''; and
                    (B) in subparagraph (C), by inserting ``, including 
                addressing the needs of at-risk individuals,'' after 
                ``capabilities of such entity'';
            (2) 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
                    (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).''; and
            (3) in subsection (i)--
                    (A) in paragraph (1)(A)--
                            (i) by striking ``$824,000,000 for fiscal 
                        year 2007'' and inserting ``$632,900,000 for 
                        fiscal year 2012''; and
                            (ii) by striking ``such sums as may be 
                        necessary for each of fiscal years 2008 through 
                        2011'' and inserting ``$632,900,000 for each of 
                        fiscal years 2013 through 2016''; and
                    (B) 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).''.
    (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 2012 through 2016''.

SEC. 202. 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 ``$5,900,000 for each of fiscal years 2012 through 
        2016''.
            (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 ``$11,900,000 for each of fiscal years 2012 
                through 2016''.
    (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) 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.'';
            (2) 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).''; and
            (3) in subsection (j)--
                    (A) in paragraph (1), by striking ``$474,000,000 
                for fiscal year 2007, and such sums as may be necessary 
                for each of fiscal years 2008 through 2011'' and 
                inserting ``$378,000,000 for each of fiscal years 2012 
                through 2016''; 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. 203. ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE.

    Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is 
amended--
            (1) in subsection (b)--
                    (A) in paragraph (1)(B), by inserting ``poison 
                control centers,'' after ``hospitals,'';
                    (B) in paragraph (2), by inserting before the 
                period 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 the following: ``and update such standards as 
                necessary'';
            (2) in subsection (d)--
                    (A) in the subsection heading, by striking ``Public 
                Health Situational Awareness'' and inserting 
                ``Modernizing Public Health Situational Awareness and 
                BioSurveillance'';
                    (B) in paragraph (1)--
                            (i) by striking ``Pandemic and All-Hazards 
                        Preparedness Act'' and inserting ``Pandemic and 
                        All-Hazards Preparedness Act Reauthorization of 
                        2011''; 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 Act Reauthorization of 2011, 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); and
                    ``(B) modernize and enhance biosurveillance 
                activities.'';
                    (D) in paragraph (5), by striking subparagraph (A) 
                and inserting the following:
                    ``(A) utilize applicable interoperability standards 
                as determined by the Secretary, and in coordination 
                with the Office of the National Coordinator for Health 
                Information Technology, through a joint public and 
                private sector process;''; and
                    (E) by adding at the end the following:
            ``(6) Consultation with the national biodefense science 
        board.--In carrying out this section 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 Humans 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; and
                    ``(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.'';
            (3) in subsection (e)(5), by striking ``4 years after the 
        date of enactment of the Pandemic and All-Hazards Preparedness 
        Act, the Government Accountability Office'' and inserting ``3 
        years after the date of enactment of the Pandemic and All-
        Hazards Preparedness Act Reauthorization of 2011'';
            (4) in subsection (g), by striking ``such sums as may be 
        necessary in each of fiscal years 2007 through 2011'' and 
        inserting ``$160,121,000 for each of fiscal years 2012 through 
        2016''; and
            (5) by adding at the end the following:
    ``(h) Definition.--For purposes of this section the term 
`biosurveillance' means the process of gathering near real-time, 
biological data that relates to disease activity and threats to human 
or zoonotic health, in order to achieve early warning of such health 
threats, early detection of health events, and overall situational 
awareness of disease activity.''.

           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 practicable, of animal and 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. AUTHORIZED USE FOR MEDICAL PRODUCTS.

    Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3) is amended--
            (1) in the section heading, by striking ``for use in 
        emergencies'' and inserting ``for use in response to declared 
        emergency or identified material threat'';
            (2) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) in the paragraph heading, by striking 
                        ``Emergency'' and inserting ``Authorized''; and
                            (ii) by striking ``(referred to in this 
                        section as an `emergency use')'' and inserting 
                        ``or with respect to a material threat 
                        (referred to in this section as an `authorized 
                        use')'';
                    (B) in paragraph (2), by striking ``an emergency 
                use'' and inserting ``the use'';
                    (C) in paragraph (3), by striking ``An emergency 
                use authorized'' and inserting ``An authorized use'';
                    (D) by redesignating paragraph (4) as paragraph 
                (5);
                    (E) by inserting after paragraph (3) the following:
            ``(4) Extension of expiration date.--
                    ``(A) Authority to extend expiration date.--The 
                Secretary may extend the expiration date of an approved 
                product in accordance with this paragraph.
                    ``(B) Expiration date.--For purposes of this 
                paragraph, the term `expiration date' means the date 
                that appears on the label of an approved product to 
                reflect the results of stability testing and to ensure 
                that the product meets applicable standards of 
                identity, strength, quality, and purity at the time of 
                use.
                    ``(C) Effect of extension.--If the expiration date 
                of an approved product is extended by the Secretary 
                under this paragraph, then, notwithstanding any other 
                provision of this Act, the extended expiration date 
                shall not affect the approval status of the product or 
                the authorization of the product under this section.
                    ``(D) Eligibility.--A product shall be eligible for 
                extension of the expiration date of such product if--
                            ``(i)(I) the product is intended for use to 
                        prevent, diagnose, or treat a disease or 
                        condition involving a biological, chemical, 
                        radiological, or nuclear agent or agents, 
                        including a product intended to be used to 
                        prevent or treat pandemic influenza; or
                            ``(II) the product is intended for use to 
                        prevent, diagnose, or treat a serious or life-
                        threatening disease or condition caused by a 
                        product described in subclause (I); and
                            ``(ii) the product is intended for use 
                        during the circumstances of an emergency or a 
                        material threat described in subsection (b)(1).
                    ``(E) Determinations by secretary.--Before 
                extending the expiration date of an approved product 
                under this paragraph, the Secretary shall determine--
                            ``(i) that extension of the expiration date 
                        will help protect public health;
                            ``(ii) that any extension of expiration is 
                        supported by scientific evaluation; and
                            ``(iii) what changes to the product 
                        labeling, if any, are required or permitted, 
                        including whether and how any additional 
                        labeling communicating the extension of the 
                        expiration date may alter or obscure the 
                        labeling provided by the manufacturer.
                    ``(F) Scope of extension.--With respect to each 
                extension of an expiration date granted under this 
                paragraph, the Secretary shall determine--
                            ``(i) the batch, lot, or unit to which such 
                        extension shall apply;
                            ``(ii) the duration of such extension; and
                            ``(iii) any conditions to effectuate such 
                        extension that are necessary and appropriate to 
                        protect public health or safety.''; and
                    (F) in paragraph (5)(B), as so redesignated, by 
                striking ``emergency use'' and inserting ``authorized 
                use'';
            (3) in subsection (b)--
                    (A) in the subsection heading, by striking 
                ``Emergency'' and inserting ``Emergency or Threat 
                Justifying 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 (B), by striking ``; 
                        or'' and inserting a semicolon;
                            (iii) in subparagraph (C), by striking 
                        ``national security'' and all that follows 
                        through the period and inserting ``national 
                        security, or the health and security of United 
                        States citizens living abroad, and that 
                        involves a specified biological, chemical, 
                        radiological, or nuclear agent or agents, or a 
                        specified disease or condition that may be 
                        attributable to such agent or agents; or''; and
                            (iv) 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)(A)--
                            (i) in clause (i), by striking ``; or'' and 
                        inserting a semicolon;
                            (ii) by redesignating clause (ii) as clause 
                        (iii); and
                            (iii) by inserting after clause (i) the 
                        following:
                            ``(ii) a change in the regulatory status of 
                        the product such that the circumstances 
                        described in subsection (a)(2) have ceased to 
                        exist; or''; and
                    (D) in paragraph (3)(B), by striking ``emergency 
                use'' and inserting ``authorized use'';
            (4) in subsection (c)--
                    (A) in the matter preceding paragraph (1)--
                            (i) by striking ``emergency use'' and 
                        inserting ``authorized use'';
                            (ii) by inserting ``the Assistant Secretary 
                        for Preparedness and Response,'' after 
                        ``consultation with'';
                            (iii) by striking ``Health and'' and 
                        inserting ``Health, and''; and
                            (iv) by striking ``circumstances of the 
                        emergency involved'' and inserting ``applicable 
                        circumstances described in subsection (b)(1)''; 
                        and
                    (B) in paragraph (2)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``and the material threat 
                        posed by the agent or agents identified in a 
                        declaration under subsection (b)(1)(D), if 
                        applicable'' after ``if available,''; and
                            (ii) in subparagraph (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,'';
            (5) in subsection (e)(1)--
                    (A) in subparagraph (A), in the matter preceding 
                clause (i)--
                            (i) by striking ``emergency use'' and 
                        inserting ``authorized use''; and
                            (ii) by striking ``circumstances of the 
                        emergency'' and inserting ``applicable 
                        circumstances described in subsection (b)(1)'';
                    (B) in subparagraph (A)(i)--
                            (i) in subclause (I), by striking ``has 
                        authorized the emergency use'' and inserting 
                        ``has authorized under this section the use''; 
                        and
                            (ii) in subclause (II), by striking 
                        ``emergency use'' and inserting ``authorized 
                        use'';
                    (C) in subparagraph (A)(ii)(I), by striking 
                ``authorized the emergency use'' and inserting ``has 
                authorized under this section the use'';
                    (D) in clauses (iii) and (iv) of subparagraph (A), 
                by striking ``emergency use'' each place such term 
                appears and inserting ``authorized use'';
                    (E) in subparagraph (A), by adding at the end the 
                following:
                            ``(v) Appropriate conditions with respect 
                        to the collection and analysis of safety and 
                        effectiveness information useful to inform the 
                        approval, licensure, or clearance of the 
                        product, especially for a product for which 
                        human efficacy studies are not ethical or 
                        practicable.'';
                    (F) in subparagraph (B)--
                            (i) by striking ``emergency use'' each 
                        place such term appears and inserting 
                        ``authorized use'';
                            (ii) by striking clause (iii); and
                            (iii) by redesignating clause (iv) as 
                        clause (iii);
            (6) in subsection (e)--
                    (A) in paragraph (2)--
                            (i) by striking ``emergency use'' each 
                        place such term appears and inserting 
                        ``authorized use''; and
                            (ii) in subparagraph (A), by striking 
                        ``circumstances of the emergency'' and 
                        inserting ``applicable circumstances described 
                        in subsection (b)(1)'';
                    (B) in paragraph (3)--
                            (i) by striking ``emergency use'' and 
                        inserting ``use''; and
                            (ii) by striking ``circumstances of the 
                        emergency'' and inserting ``applicable 
                        circumstances described in subsection (b)(1)''; 
                        and
                    (C) in paragraph (4), by striking ``emergency use'' 
                and inserting ``use'';
            (7) 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.''; and
            (8) in subsection (h)(1), by inserting ``, revision,'' 
        after ``termination''.

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 `qualified pandemic or epidemic product' has 
        the meaning given such term in section 319F-3 of such Act; and
            ``(4) the term `security countermeasure' has the meaning 
        given such term in section 319F-2 of such Act.
    ``(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 heading 
        and all that follows through ``shall establish'' and inserting 
        the following:
    ``(b) General Duties.--The Secretary, in consultation with the 
Assistant Secretary for Preparedness and Response, shall accelerate the 
development, stockpiling, approval, licensure, and clearance of 
qualified countermeasures, security countermeasures, and qualified 
pandemic or epidemic products--
            ``(1) by ensuring 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, and 319L of the 
        Public Health Service Act;
            ``(2) by ensuring 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) by promoting 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; and
                    ``(C) establishing protocols to ensure that 
                countermeasure reviewers have sufficient training or 
                experience with countermeasures;
            ``(4) by maintaining teams, composed of Food and Drug 
        Administration personnel with expertise on countermeasures 
        (including specific countermeasures, classes or groups of 
        countermeasures, or other countermeasure-related technologies 
        and capabilities), that shall--
                    ``(A) work with countermeasure sponsors and 
                applicants to identify and help resolve scientific 
                issues related to the approval, licensure, or clearance 
                of countermeasures;
                    ``(B) encourage the exchange of scientific ideas by 
                holding public meetings at least twice annually; and
                    ``(C) 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) by establishing''; and
            (3) by adding at the end the following:
    ``(c) Development and Animal Modeling Procedures.--
            ``(1) Availability of animal model meetings.--To facilitate 
        the timely development of animal models and support the 
        development, stockpiling, licensure, approval, and clearance of 
        countermeasures, the Secretary shall, not later than 180 days 
        after the enactment of this subsection, establish a procedure 
        by which a sponsor or applicant that is developing a 
        countermeasure for which human efficacy studies are not ethical 
        or practicable, and that has an approved investigational new 
        drug application or investigational device exemption, may 
        request and receive--
                    ``(A) a meeting to discuss proposed animal model 
                development activities; and
                    ``(B) a meeting prior to initiating pivotal animal 
                studies.
            ``(2) Juvenile models.--To facilitate the development and 
        selection of animal models that could translate to juvenile 
        studies, any meeting conducted under paragraph (1) shall 
        include discussion of juvenile animal models, as appropriate.
    ``(d) 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)(C).''.

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:
    ``(e) Regulatory Management Plan.--
            ``(1) In general.--
                    ``(A) Initiation of process.--The Secretary, in 
                consultation with the Assistant Secretary for 
                Preparedness and Response and the product sponsor or 
                applicant, shall initiate a formal process for 
                obtaining scientific feedback and interactions 
                regarding the development and regulatory review of any 
                countermeasure.
                    ``(B) Content.--
                            ``(i) In general.--The process initiated 
                        under subparagraph (A) shall include the 
                        development of a written regulatory management 
                        plan that shall be made part of the 
                        administrative record. Except as provided in 
                        paragraph (2), such plan shall be completed not 
                        later than 45 days after the date on which an 
                        investigational new drug application or 
                        investigational device exemption is approved 
                        with respect to the countermeasure involved.
                            ``(ii) Content of plan.--The content of a 
                        regulatory management plan under clause (i) 
                        shall be consistent with sections 319L and 
                        319F-2 of the Public Health Service Act. Such 
                        plan shall include--
                                    ``(I) guidance from the Secretary 
                                regarding the data required to support 
                                the approval, clearance, or licensure 
                                of the countermeasure involved;
                                    ``(II) guidance from the Secretary 
                                regarding the data necessary to inform 
                                any authorization under section 564;
                                    ``(III) guidance from the Secretary 
                                regarding the data necessary to support 
                                the positioning and delivery of 
                                countermeasures, including to the 
                                Strategic National Stockpile;
                                    ``(IV) guidance from the Secretary 
                                regarding the data necessary to support 
                                the submission of protocols for review 
                                under section 505(b)(5)(B);
                                    ``(V) an agreement between the 
                                Secretary and the countermeasure 
                                sponsor or applicant regarding 
                                developmental milestones that will 
                                trigger responses by the Secretary as 
                                described in subclause (VI);
                                    ``(VI) performance targets and 
                                goals for timely and appropriate 
                                responses by the Secretary to the 
                                triggers described under subclause (V), 
                                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;
                                    ``(VII) guidance from the Secretary 
                                regarding any gaps in scientific 
                                knowledge that will need resolution 
                                prior to countermeasure approval, 
                                licensure, or clearance, and plans for 
                                conducting the necessary scientific 
                                research;
                                    ``(VIII) 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
                                    ``(IX) as necessary and 
                                appropriate, and to the extent 
                                practicable, a plan for developing 
                                pediatric dosing and administration 
                                with respect to the countermeasure.
                            ``(iii) Modification of plan.--Not later 
                        than 45 days after the Secretary becomes aware 
                        of a new substantial scientific issue essential 
                        to the review of a countermeasure, the 
                        Secretary shall--
                                    ``(I) determine, in consultation 
                                with the countermeasure sponsor or 
                                applicant, if such issue necessitates a 
                                modification to the regulatory 
                                management plan; and
                                    ``(II) if the Secretary so 
                                determines, make such modification.
            ``(2) Countermeasures under review.--
                    ``(A) In general.--Not later than 45 days after the 
                date of enactment of this subsection, the Secretary 
                shall establish a procedure for developing regulatory 
                management plans for countermeasures that are under 
                review by the Food and Drug Administration as of the 
                date of enactment of this subsection. Subject to 
                subparagraph (B), the regulatory management plans for 
                all such countermeasures shall be developed not later 
                than 274 days after the date of enactment of this 
                subsection.
                    ``(B) Exception.--The sponsor or applicant with 
                respect to a countermeasure described subparagraph (A) 
                may elect not to establish a regulatory management plan 
                under this subsection. Such sponsor or applicant shall 
                notify the Secretary of such an election not later than 
                30 days after the Secretary makes the procedures 
                established under subparagraph (A) publicly available. 
                If notification of such an election is not received by 
                the Secretary by such date, the procedures established 
                under subparagraph (A) shall apply to the 
                countermeasure.''.

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:
    ``(f) Annual Report.--Not later than 180 days after the date of 
enactment of this subsection, and annually thereafter, the Secretary 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives 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 or 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) the extent to which the performance targets and goals 
        set forth in subsection (e)(1)(B) and the regulatory management 
        plans established under such subsection have been met, 
        including, for each countermeasure reviewed--
                    ``(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) and the number of products, classes of 
        products, or technologies assigned to each such team;
            ``(4) an estimate of resources obligated to countermeasure 
        development and regulatory assessment, including Center 
        specific objectives and accomplishments; and
            ``(5) the number of countermeasure applications submitted, 
        the number of countermeasures approved, licensed, or cleared, 
        the status of remaining submitted applications, and the number 
        of each type of authorization issued pursuant to section 
        564.''.

SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.

    (a) Pediatric Studies of Drugs.--Section 505A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) in subsection (d), by adding at the end the following:
            ``(5) Consultation.--With respect to a drug that is a 
        qualified countermeasure (as defined in section 319F-1 of the 
        Public Health Service Act), a security countermeasure (as 
        defined in section 319F-2 of the Public Health Service Act), or 
        a qualified pandemic or epidemic product (as defined in section 
        319F-3 of the Public Health Service Act), the Secretary shall 
        solicit input from the Assistant Secretary for Preparedness and 
        Response regarding the need for and 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), prior to any action with 
                respect to such drug under subparagraph (A) or (B), the 
                Secretary shall refer all pediatric studies in the 
                written request to the Assistant Secretary for 
                Preparedness and Response and the Director of the 
                Biomedical Advanced Research and Development 
                Authority.''.
    (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.''.

SEC. 308. TECHNICAL AND CONFORMING AMENDMENTS.

    (a) Section 319F-2(c)(1)(B)(ii) of the Public Health Service Act 
(42 U.S.C. 247d-6b(c)(1)(B)(ii)) is amended by striking ``emergency''.
    (b) Section 319F-3(i) of such Act (42 U.S.C. 247d-6d(i)) is 
amended--
            (1) in paragraph (1)(C), by striking ``emergency''; and
            (2) in paragraph (7)(B)(iii), by striking ``emergency''.

  TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND 
                              DEVELOPMENT

SEC. 401. BIOSHIELD.

    (a) Reauthorization of the Special Reserve Fund.--Section 319F-2(c) 
of the Public Health Service Act (42 U.S.C. 247d-6b(c)) is amended by 
adding at the end the following:
            ``(11) Reauthorization of the special reserve fund.--In 
        addition to amounts otherwise appropriated, there are 
        authorized to be appropriated for the special reserve fund, 
        $2,800,000,000 for the fiscal years 2014 through 2018.
            ``(12) 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)).''.
    (b) 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 (5)(B)(ii), by striking ``eight years'' 
        and inserting ``10 years'';
            (3) 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 an 
                        allowable and allocable direct cost of the 
                        contract involved.'';
            (4) in paragraph (9)(B), by inserting before the period the 
        following: ``, except that this subparagraph shall not be 
        construed to prohibit the use of such amounts as otherwise 
        authorized in this title''; and
            (5) in paragraph (10), by adding at the end the following:
                    ``(C) Advanced research and development.--For 
                purposes of this paragraph, the term `advanced research 
                and development' shall have the meaning given such term 
                in section 319L(a).''.

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 2012 through 2016, 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 ``10 
years''.
    (e) Extension of Limited Antitrust Exemption.--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 ``10-year''.
    (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 Government Accountability 
        Office 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 Government Accountability 
        Office shall submit to the appropriate committees of Congress a 
        report concerning the results of the evaluation conducted under 
        paragraph (1). Such report shall review and assess--
                    ``(A) the extent to which flexible manufacturing 
                capacity under this section is dedicated to chemical, 
                biological, radiological, and nuclear threats;
                    ``(B) the activities supported by flexible 
                manufacturing initiatives; and
                    ``(C) the ability of flexible manufacturing 
                activities carried out under this section to--
                            ``(i) secure and leverage leading technical 
                        expertise with respect to countermeasure 
                        advanced research, development, and 
                        manufacturing processes; and
                            ``(ii) meet the surge manufacturing 
                        capacity needs presented by novel and emerging 
                        threats, including chemical, biological, 
                        radiological and nuclear agents.''.
    (g) Definitions.--
            (1) Qualified countermeasure.--Section 319F-1(a)(2)(A) of 
        the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is 
        amended--
                    (A) in the matter preceding clause (i), by striking 
                ``to--'' and inserting ``--'';
                    (B) in clause (i)--
                            (i) by striking ``diagnose'' and inserting 
                        ``to diagnose''; and
                            (ii) by striking ``; or'' and inserting a 
                        semicolon;
                    (C) in clause (ii)--
                            (i) by striking ``diagnose'' and inserting 
                        ``to diagnose''; and
                            (ii) by striking the period at the end and 
                        inserting ``; or''; and
                    (D) by adding at the end the following:
                            ``(iii) is a product or technology intended 
                        to enhance the purpose 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:
                    ``(B) a product or technology intended to enhance 
                the purpose of a drug, biological product, or device 
                described in clause (i) or (ii); and''.

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 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)--
                            (i) by redesignating subparagraphs (E) 
                        through (H) as subparagraphs (F) through (I), 
                        respectively; and
                            (ii) by inserting after subparagraph (D), 
                        the following:
                    ``(E) identify and address the potential depletion 
                and ensure appropriate replenishment of medical 
                countermeasures, including those currently in the 
                stockpile;''; 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'' and inserting ``$522,486,000 
        for each of fiscal years 2012 through 2016''.

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 the matter preceding clause (i), by 
                        striking ``five'' and inserting ``six'';
                            (ii) in clause (i), by striking ``and'' at 
                        the end;
                            (iii) in clause (ii), by striking the 
                        period and inserting a semicolon; and
                            (iv) 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).'';
            (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.''; and
            (3) in paragraph (8), by adding at the end the following: 
        ``Such chairperson shall serve as the deciding vote in the 
        event that a deciding vote is necessary with respect to voting 
        by members of the Board.''.
                                 <all>