49–006 

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 


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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 


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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 LifeSaving Trauma Care for All Americans Act. 


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If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Zoe ̈ 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-asyou-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 2017 2018 2019 2020 2016- 

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: Zoe ̈ 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. 


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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): 


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PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE XII—TRAUMA CARE 

* * * * * * * 

øPART 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 øqualified 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: 


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(i) At least ø35¿ 30 percent of the visits in the emergency department were charity or self-pay patients. 

(ii) At least ø50¿ 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 ø2009, 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 

ø2015¿ 2020. 

* * * * * * * 


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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 

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ployment 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 


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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 øtrauma 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 


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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 

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fined 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 oneyear 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. 


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(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. 

* * * * * * * 

Æ 


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