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[House Report 114-42]
[From the U.S. Government Publishing Office]

114th Congress  }                                         {      Report
                        HOUSE OF REPRESENTATIVES
 1st Session    }                                         {      114-42

======================================================================

 
        ACCESS TO LIFE-SAVING TRAUMA CARE FOR ALL AMERICANS ACT

                                _______
                                

 March 16, 2015.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 647]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 647) to amend title XII of the Public Health 
Service Act to reauthorize certain trauma care programs, and 
for other purposes, having considered the same, report 
favorably thereon without amendment and recommend that the bill 
do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     2
Committee Consideration..........................................     2
Committee Votes..................................................     2
Committee Oversight Findings.....................................     3
Statement of General Performance Goals and Objectives............     3
New Budget Authority, Entitlement Authority, and Tax Expenditures     3
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     3
Committee Cost Estimate..........................................     3
Congressional Budget Office Estimate.............................     3
Federal Mandates Statement.......................................     4
Duplication of Federal Programs..................................     5
Disclosure of Directed Rule Makings..............................     5
Advisory Committee Statement.....................................     5
Applicability to Legislative Branch..............................     5
Section-by-Section Analysis of the Legislation...................     5
Changes in Existing Law Made by the Bill, as Reported............     5

                          Purpose and Summary

    H.R. 647, Access to Life-Saving Trauma Care for All 
Americans Act was introduced on February 2, 2015, by Rep. 
Michael Burgess (R-TX) and Rep. Gene Green (D-TX) and referred 
to the Committee on Energy and Commerce. The legislation is 
intended to support and prevent further trauma center closures 
and would amend the Public Health Service Act (PHSA) to 
establish three grant programs: (1) Substantial Uncompensated 
Care Awards; (2) Core Mission Awards; and (3) Emergency Awards.

                  Background and Need for Legislation

    Trauma centers should be available for all victims of 
traumatic injury. Getting a trauma victim to a trauma center 
right away is the first step in saving his or her life. 
Unfortunately, many trauma centers are at serious risk of 
closure and financial insolvency.
    In addition, the supply of trauma surgeons in the United 
States is rapidly declining, and the pipeline to replace 
retiring trauma surgeons and surgical specialists is limited. 
As a result of this shortage, and other factors, an increasing 
number of trauma centers are closing or downgrading their 
trauma center designation level due to factors that include a 
lack of access to on-call trauma specialists.
    The public's expectation that trauma care will always be 
available to them wherever they reside or travel has yet to be 
met. Nearly thirty trauma centers have closed in the past 
fifteen years, which has limited the availability of critical 
trauma care in several States.
    H.R. 647 will provide critically needed resources to offset 
uncompensated costs in trauma centers, support core mission 
trauma services, provide emergency funding to trauma centers, 
and address trauma center physician shortages in order to 
ensure the future availability of trauma care for all our 
citizens.

                                Hearings

    The Subcommittee on Health held a hearing on H.R. 647 on 
January 27, 2015, and the Subcommittee received testimony from 
Blaine L. Enderson, MD, Department of Surgery, University of 
Tennessee Medical Center.

                        Committee Consideration

    On February 4, 2015, the Subcommittee on Health met in open 
markup session to consider a Committee Print entitled ``Access 
to Life-Saving Trauma Care for All Americans Act'' and 
forwarded the Committee Print to the full Committee, without 
amendment, by a voice vote. On February 11 and 12, 2015, the 
full Committee met in open markup session to consider H.R. 647, 
which was substantially similar to the Committee Print 
forwarded by the Subcommittee, and ordered the bill favorably 
reported to the House, without amendment, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 647 reported. A motion by Mr. Upton to order H.R. 647 
reported to the House, without amendment, was agreed to by a 
voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a hearing and made 
findings, which are reflected throughout this report.

         Statement of General Performance Goals and Objectives

    H.R. 647 is intended to support and prevent trauma center 
grant closures by establishing three grant programs: 
Substantial Uncompensated Care Awards, Core Mission Awards; and 
Emergency Awards.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
647, would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 647 contains no earmarks, limited tax benefits, 
or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                    Washington, DC, March 11, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 647, the Access to 
Life-Saving Trauma Care for All Americans Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Zoee 
Williams.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 647--Access to Life-Saving Trauma Care for All Americans Act

    Summary: H.R. 647 would amend the Public Health Service Act 
to authorize funding for grant programs that support trauma 
care centers and trauma service availability. The bill also 
would clarify that public, nonprofit, Indian Health Service, 
Indian tribal, and urban Indian trauma centers are eligible to 
receive grants, and would change the administration of those 
grant programs to be the responsibility of the Assistant 
Secretary for Preparedness and Response.
    The bill would authorize the appropriation of $100 million 
a year for each of fiscal years 2016 through 2020. CBO 
estimates that implementing the bill would cost $401 million 
over the 2016-2020 period, assuming appropriation of the 
authorized amounts. Pay-as-you-go procedures do not apply to 
this legislation because it would not affect direct spending or 
revenues.
    H.R. 647 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
    Estimated cost to the Federal Government: For this 
estimate, CBO assumes that H.R. 647 will be enacted by the 
start of fiscal year 2016, the Congress will appropriate the 
authorized amounts for each year, and spending will follow 
historical patterns for similar programs. The estimated 
budgetary effects of H.R. 647 are shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                  By fiscal year, in millions of dollars--
                                                           -----------------------------------------------------
                                                                                                          2016-
                                                              2016     2017     2018     2019     2020     2020
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION
 
Authorization Level.......................................      100      100      100      100      100      500
Estimated Outlays.........................................       25       84       94       98      100      401
----------------------------------------------------------------------------------------------------------------

    Pay-As-You-Go considerations: None.
    Intergovernmental and private-sector impact: H.R. 647 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Estimate prepared by: Federal costs: Zoee Williams; Impact 
on state, local, and tribal governments: J'nell Blanco Suchy; 
Impact on the private sector: Amy Petz.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 647 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 647 specifically 
directs to be completed 0 rule makings within the meaning of 5 
U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    Section 1 provides the short title ``Access to Life-Saving 
Trauma Care for All Americans Act.''

Section 2. Reauthorization of Trauma and Emergency Care Programs

    Section 2 reauthorizes the Trauma Care Center Grants and 
the Trauma Service Availability Grants in section 1245 of the 
Public Health Service act at previously authorized levels.

Section 3. Alignment of programs under Assistant Secretary of 
        Preparedness and Response

    This section consolidates existing Federal trauma programs 
under the Assistant Secretary for Preparedness and Response.

Section 4. Technical clarifications relating to Trauma Center Grants

    This section clarifies that nonprofit trauma centers are 
eligible for the Trauma Care Center Grants.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *

TITLE XII--TRAUMA CARE

           *       *       *       *       *       *       *

 [Part D--Trauma Centers Operating in Areas Severely Affected by Drug-
                           Related Violence]

                         PART D--TRAUMA CENTERS

SEC. 1241. GRANTS FOR CERTAIN TRAUMA CENTERS.

  (a) In General.--The Secretary shall establish 3 programs to 
award grants to [qualified public, nonprofit Indian Health 
Service, Indian tribal, and urban Indian trauma centers] 
qualified public trauma centers, qualified nonprofit trauma 
centers, and qualified Indian Health Service, Indian tribal, 
and urban Indian trauma centers--
          (1) to assist in defraying substantial uncompensated 
        care costs;
          (2) to further the core missions of such trauma 
        centers, including by addressing costs associated with 
        patient stabilization and transfer, trauma education 
        and outreach, coordination with local and regional 
        trauma systems, essential personnel and other fixed 
        costs, and expenses associated with employee and non-
        employee physician services; and
          (3) to provide emergency relief to ensure the 
        continued and future availability of trauma services.
  (b) Minimum Qualifications of Trauma Centers.--
          (1) Participation in trauma care system operating 
        under certain professional guidelines.--Except as 
        provided in paragraph (2), the Secretary may not award 
        a grant to a trauma center under subsection (a) unless 
        the trauma center is a participant in a trauma system 
        that substantially complies with section 1213.
          (2) Exemption.--Paragraph (1) shall not apply to 
        trauma centers that are located in States with no 
        existing trauma care system.
          (3) Qualification for substantial uncompensated care 
        costs.--The Secretary shall award substantial 
        uncompensated care grants under subsection (a)(1) only 
        to trauma centers meeting at least 1 of the criteria in 
        1 of the following 3 categories:
                  (A) Category a.--The criteria for category A 
                are as follows:
                          (i) At least 40 percent of the visits 
                        in the emergency department of the 
                        hospital in which the trauma center is 
                        located were charity or self-pay 
                        patients.
                          (ii) At least 50 percent of the 
                        visits in such emergency department 
                        were Medicaid (under title XIX of the 
                        Social Security Act (42 U.S.C. 1396 et 
                        seq.)) and charity and self-pay 
                        patients combined.
                  (B) Category b.--The criteria for category B 
                are as follows:
                          (i) At least [35] 30 percent of the 
                        visits in the emergency department were 
                        charity or self-pay patients.
                          (ii) At least [50] 40 percent of the 
                        visits in the emergency department were 
                        Medicaid and charity and self-pay 
                        patients combined.
                  (C) Category c.--The criteria for category C 
                are as follows:
                          (i) At least 20 percent of the visits 
                        in the emergency department were 
                        charity or self-pay patients.
                          (ii) At least 30 percent of the 
                        visits in the emergency department were 
                        Medicaid and charity and self-pay 
                        patients combined.
          (4) Trauma centers in 1115 waiver states.--
        Notwithstanding paragraph (3), the Secretary may award 
        a substantial uncompensated care grant to a trauma 
        center under subsection (a)(1) if the trauma center 
        qualifies for funds under a Low Income Pool or Safety 
        Net Care Pool established through a waiver approved 
        under section 1115 of the Social Security Act (42 
        U.S.C. 1315).
          (5) Designation.--The Secretary may not award a grant 
        to a trauma center unless such trauma center is 
        verified by the American College of Surgeons or 
        designated by an equivalent State or local agency.
  (c) Additional Requirements.--The Secretary may not award a 
grant to a trauma center under subsection (a)(1) unless such 
trauma center--
          (1) submits to the Secretary a plan satisfactory to 
        the Secretary that demonstrates a continued commitment 
        to serving trauma patients regardless of their ability 
        to pay; and
          (2) has policies in place to assist patients who 
        cannot pay for part or all of the care they receive, 
        including a sliding fee scale, and to ensure fair 
        billing and collection practices.

           *       *       *       *       *       *       *

SEC. 1245. AUTHORIZATION OF APPROPRIATIONS.

  For the purpose of carrying out this part, there are 
authorized to be appropriated $100,000,000 for fiscal year 
[2009, and such] 2009, such sums as may be necessary for each 
of fiscal years 2010 through 2015, and $100,000,000 for each of 
fiscal years 2016 through 2020. Such authorization of 
appropriations is in addition to any other authorization of 
appropriations or amounts that are available for such purpose.

           *       *       *       *       *       *       *

PART H--TRAUMA SERVICE AVAILABILITY

           *       *       *       *       *       *       *

SEC. 1282. AUTHORIZATION OF APPROPRIATIONS.

  For the purpose of carrying out this part, there is 
authorized to be appropriated $100,000,000 for each of fiscal 
years 2010 through [2015] 2020.

           *       *       *       *       *       *       *

   TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH 
EMERGENCIES

           *       *       *       *       *       *       *

      Subtitle B--All-Hazards Emergency Preparedness and Response

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

  (a) In General.--There is established within the Department 
of Health and Human Services the position of the Assistant 
Secretary for Preparedness and Response. The President, with 
the advice and consent of the Senate, shall appoint an 
individual to serve in such position. Such Assistant Secretary 
shall report to the Secretary.
  (b) Duties.--Subject to the authority of the Secretary, the 
Assistant Secretary for Preparedness and Response shall carry 
out the following functions:
          (1) Leadership.--Serve as the principal advisor to 
        the Secretary on all matters related to Federal public 
        health and medical preparedness and response for public 
        health emergencies.
          (2) Personnel.--Register, credential, organize, 
        train, equip, and have the authority to deploy Federal 
        public health and medical personnel under the authority 
        of the Secretary, including the National Disaster 
        Medical System, and coordinate such personnel with the 
        Medical Reserve Corps and the Emergency System for 
        Advance Registration of Volunteer Health Professionals.
          (3) Countermeasures.--Oversee advanced research, 
        development, and procurement of qualified 
        countermeasures (as defined in section 319F-1), 
        security countermeasures (as defined in section 319F-
        2), and qualified pandemic or epidemic products (as 
        defined in section 319F-3).
          (4) Coordination.--
                  (A) Federal integration.--Coordinate with 
                relevant Federal officials to ensure 
                integration of Federal preparedness and 
                response activities for public health 
                emergencies.
                  (B) State, local, and tribal integration.--
                Coordinate with State, local, and tribal public 
                health officials, the Emergency Management 
                Assistance Compact, health care systems, and 
                emergency medical service systems to ensure 
                effective integration of Federal public health 
                and medical assets during a public health 
                emergency.
                  (C) Emergency medical services.--Promote 
                improved emergency medical services medical 
                direction, system integration, research, and 
                uniformity of data collection, treatment 
                protocols, and policies with regard to public 
                health emergencies.
                  (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.
          (5) Logistics.--In coordination with the Secretary of 
        Veterans Affairs, the Secretary of Homeland Security, 
        the General Services Administration, and other public 
        and private entities, provide logistical support for 
        medical and public health aspects of Federal responses 
        to public health emergencies.
          (6) Leadership.--Provide leadership in international 
        programs, initiatives, and policies that deal with 
        public health and medical emergency preparedness and 
        response.
          (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.
  (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] trauma care under 
                parts A through D of title XII and part H of 
                such title, 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.
  (d) Public Health Emergency Medical Countermeasures 
Enterprise Strategy and Implementation Plan.--
          (1) In general.--Not later than 180 days after the 
        date of enactment of this subsection, and every year 
        thereafter, the Assistant Secretary for Preparedness 
        and Response shall develop and submit to the 
        appropriate committees of Congress a coordinated 
        strategy and accompanying implementation plan for 
        medical countermeasures to address chemical, 
        biological, radiological, and nuclear threats. In 
        developing such a plan, the Assistant Secretary for 
        Preparedness and Response shall consult with the 
        Director of the Biomedical Advanced Research and 
        Development Authority, the Director of the National 
        Institutes of Health, the Director of the Centers for 
        Disease Control and Prevention, and the Commissioner of 
        Food and Drugs. Such strategy and plan shall be known 
        as the ``Public Health Emergency Medical 
        Countermeasures Enterprise Strategy and Implementation 
        Plan''.
          (2) Requirements.--The plan under paragraph (1) 
        shall--
                  (A) describe the chemical, biological, 
                radiological, and nuclear agent or agents that 
                may present a threat to the Nation and the 
                corresponding efforts to develop qualified 
                countermeasures (as defined in section 319F-1), 
                security countermeasures (as defined in section 
                319F-2), or qualified pandemic or epidemic 
                products (as defined in section 319F-3) for 
                each threat;
                  (B) evaluate the progress of all activities 
                with respect to such countermeasures or 
                products, including research, advanced 
                research, development, procurement, 
                stockpiling, deployment, distribution, and 
                utilization;
                  (C) identify and prioritize near-, mid-, and 
                long-term needs with respect to such 
                countermeasures or products to address a 
                chemical, biological, radiological, and nuclear 
                threat or threats;
                  (D) identify, with respect to each category 
                of threat, a summary of all awards and 
                contracts, including advanced research and 
                development and procurement, that includes--
                          (i) the time elapsed from the 
                        issuance of the initial solicitation or 
                        request for a proposal to the 
                        adjudication (such as the award, denial 
                        of award, or solicitation termination); 
                        and
                          (ii) an identification of projected 
                        timelines, anticipated funding 
                        allocations, benchmarks, and milestones 
                        for each medical countermeasure 
                        priority under subparagraph (C), 
                        including projected needs with regard 
                        to replenishment of the Strategic 
                        National Stockpile;
                  (E) be informed by the recommendations of the 
                National Biodefense Science Board pursuant to 
                section 319M;
                  (F) evaluate progress made in meeting 
                timelines, allocations, benchmarks, and 
                milestones identified under subparagraph 
                (D)(ii);
                  (G) report on the amount of funds available 
                for procurement in the special reserve fund as 
                defined in section 319F-2(h) and the impact 
                this funding will have on meeting the 
                requirements under section 319F-2;
                  (H) incorporate input from Federal, State, 
                local, and tribal stakeholders;
                  (I) identify the progress made in meeting the 
                medical countermeasure priorities for at-risk 
                individuals (as defined in 2802(b)(4)(B)), as 
                applicable under subparagraph (C), including 
                with regard to the projected needs for related 
                stockpiling and replenishment of the Strategic 
                National Stockpile, including by addressing the 
                needs of pediatric populations with respect to 
                such countermeasures and products in the 
                Strategic National Stockpile, including--
                          (i) a list of such countermeasures 
                        and products necessary to address the 
                        needs of pediatric populations;
                          (ii) a description of measures taken 
                        to coordinate with the Office of 
                        Pediatric Therapeutics of the Food and 
                        Drug Administration to maximize the 
                        labeling, dosages, and formulations of 
                        such countermeasures and products for 
                        pediatric populations;
                          (iii) a description of existing gaps 
                        in the Strategic National Stockpile and 
                        the development of such countermeasures 
                        and products to address the needs of 
                        pediatric populations; and
                          (iv) an evaluation of the progress 
                        made in addressing priorities 
                        identified pursuant to subparagraph 
                        (C);
                  (J) identify the use of authority and 
                activities undertaken pursuant to sections 
                319F-1(b)(1), 319F-1(b)(2), 319F-1(b)(3), 319F-
                1(c), 319F-1(d), 319F-1(e), 319F-
                2(c)(7)(C)(iii), 319F-2(c)(7)(C)(iv), and 319F-
                2(c)(7)(C)(v) of this Act, and subsections 
                (a)(1), (b)(1), and (e) of section 564 of the 
                Federal Food, Drug, and Cosmetic Act, by 
                summarizing--
                          (i) the particular actions that were 
                        taken under the authorities specified, 
                        including, as applicable, the 
                        identification of the threat agent, 
                        emergency, or the biomedical 
                        countermeasure with respect to which 
                        the authority was used;
                          (ii) the reasons underlying the 
                        decision to use such authorities, 
                        including, as applicable, the options 
                        that were considered and rejected with 
                        respect to the use of such authorities;
                          (iii) the number of, nature of, and 
                        other information concerning the 
                        persons and entities that received a 
                        grant, cooperative agreement, or 
                        contract pursuant to the use of such 
                        authorities, and the persons and 
                        entities that were considered and 
                        rejected for such a grant, cooperative 
                        agreement, or contract, except that the 
                        report need not disclose the identity 
                        of any such person or entity;
                          (iv) whether, with respect to each 
                        procurement that is approved by the 
                        President under section 319F-2(c)(6), a 
                        contract was entered into within one 
                        year after such approval by the 
                        President; and
                          (v) with respect to section 319F-
                        1(d), for the one-year period for which 
                        the report is submitted, the number of 
                        persons who were paid amounts totaling 
                        $100,000 or greater and the number of 
                        persons who were paid amounts totaling 
                        at least $50,000 but less than 
                        $100,000; and
                  (K) be made publicly available.
          (3) GAO report.--
                  (A) In general.--Not later than 1 year after 
                the date of the submission to the Congress of 
                the first Public Health Emergency Medical 
                Countermeasures Enterprise Strategy and 
                Implementation Plan, the Comptroller General of 
                the United States shall conduct an independent 
                evaluation, and submit to the appropriate 
                committees of Congress a report, concerning 
                such Strategy and Implementation Plan.
                  (B) Content.--The report described in 
                subparagraph (A) shall review and assess--
                          (i) the near-term, mid-term, and 
                        long-term medical countermeasure needs 
                        and identified priorities of the 
                        Federal Government pursuant to 
                        paragraph (2)(C);
                          (ii) the activities of the Department 
                        of Health and Human Services with 
                        respect to advanced research and 
                        development pursuant to section 319L; 
                        and
                          (iii) the progress made toward 
                        meeting the timelines, allocations, 
                        benchmarks, and milestones identified 
                        in the Public Health Emergency Medical 
                        Countermeasures Enterprise Strategy and 
                        Implementation Plan under this 
                        subsection.
  (e) Protection of National Security.--In carrying out 
subsections (b)(7) and (d), the Secretary shall ensure that 
information and items that could compromise national security, 
contain confidential commercial information, or contain 
proprietary information are not disclosed.

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                                  [all]
```