59–006 

114TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 2d Session 114–735 

STRENGTHENING PUBLIC HEALTH EMERGENCY 

RESPONSE ACT OF 2016 

SEPTEMBER 9, 2016.—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 

together with 

DISSENTING VIEWS 

[To accompany H.R. 3299] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 3299) to amend the Public Health Service Act to ensure preparedness for chemical, radiological, biological, and nuclear 

threats, and for other purposes, having considered the same, report 

favorably thereon with an amendment and recommend that the bill 

as amended do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 7 

Background and Need for Legislation .................................................................... 7 

Hearings ................................................................................................................... 8 

Committee Consideration ........................................................................................ 8 

Committee Votes ...................................................................................................... 8 

Committee Oversight Findings ............................................................................... 12 

Statement of General Performance Goals and Objectives .................................... 12 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 12 

Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............................. 12 

Committee Cost Estimate ....................................................................................... 12 

Congressional Budget Office Estimate ................................................................... 12 

Federal Mandates Statement ................................................................................. 14 

Duplication of Federal Programs ............................................................................ 15 

Disclosure of Directed Rule Makings ..................................................................... 15 

Advisory Committee Statement .............................................................................. 15 

Applicability to Legislative Branch ........................................................................ 15 


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Section-by-Section Analysis of the Legislation ...................................................... 15 

Changes in Existing Law Made by the Bill, as Reported ..................................... 16 

Dissenting Views ..................................................................................................... 47 

The amendment is as follows: 

Strike all after the enacting clause and insert the following: 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘Strengthening Public Health 

Emergency Response Act of 2016’’. 

(b) TABLE OF CONTENTS.—The table of contents of this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. GAO report on State, local, and hospital preparedness programs. 

Sec. 3. Strategic national stockpile. 

Sec. 4. Project Bioshield procurement process. 

Sec. 5. BARDA transaction authorities. 

Sec. 6. Public health emergency medical countermeasures enterprise strategy and implementation plan. 

Sec. 7. Priority review to encourage treatments for agents that present national security threats. 

SEC. 2. GAO REPORT ON STATE, LOCAL, AND HOSPITAL PREPAREDNESS PROGRAMS. 

(a) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, 

the Comptroller General of the United States shall submit a report to the Congress 

on the programs for awarding cooperative agreements and grants under section 

319C–1 of the Public Health Service Act (42 U.S.C. 247d–3a; improving State and 

local public health security) and section 319C–2 of such Act (42 U.S.C. 247d–3b; 

partnerships for State and regional hospital preparedness to improve surge capacity). 

(b) CONTENTS.—The report under subsection (a) shall address each of the following: 

(1) The goals of the programs specified in subsection (a). 

(2) The extent to which such goals are being met, including performance 

metrics that could help to assess whether such programs are succeeding at the 

coalition and member level. 

(3) How such programs could be improved, including how such programs 

could be modified to improve the medical preparedness of hospitals, health care 

coalitions, and the continuity of health care delivery. 

(4) How such programs complement other preparedness programs of the Department of Health and Human Services. 

(5) How funds awarded through such programs should be allocated and 

whether that allocation should be based on risk. 

(6) Progress made toward State and local preparedness entities being self-sustaining. 

(7) Whether the level of funding for such programs is sufficient. 

(8) How funding for such programs is being used to ensure preparedness for 

at-risk populations including children, pregnant women, senior citizens, and 

other individuals who may have unique needs in the event of a public health 

emergency, such as individuals with disabilities. 

(9)(A) How, and to what extent, entities are using the funds awarded to such 

entities through section 319C–2 of the Public Health Service Act (42 U.S.C. 

247d–3b) to directly fund regional health care coalitions and members of such 

coalitions. 

(B) The amount each such entity retains for its own indirect and direct costs. 

(C) The purposes for which such retained funds are used and whether these 

uses provide value for the program under such section 319C–2, regional health 

care coalitions, and members of such coalitions. 

(10) The extent to which the funds awarded through the programs under sections 319C–1 and 319C–2 of the Public Health Service Act (42 U.S.C. 247d–3a, 

247d–3b) have been used for overlapping purposes. 

SEC. 3. STRATEGIC NATIONAL STOCKPILE. 

Section 319F–2(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(2)) is 

amended— 

(1) in subparagraph (G), by striking ‘‘and’’ at the end; 

(2) in subparagraph (H), by striking the period at the end and inserting ‘‘; 

and’’; and 

(3) by adding at the end the following: 

‘‘(I) ensure procedures are in place to coordinate the ongoing stockpiling 

by the Biomedical Advanced Research and Development Authority and Centers for Disease Control and Prevention of qualified countermeasures (as 

defined in section 319F–1) for which funds have been made available under 

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fied pandemic or epidemic products (as defined in section 319F–3) for which 

funds have been made available under section 319L in order to avoid any 

gaps in preparedness.’’. 

SEC. 4. PROJECT BIOSHIELD PROCUREMENT PROCESS. 

Section 319F–2(c) of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is 

amended— 

(1) in paragraph (4)(A)(ii), by striking ‘‘make a recommendation under paragraph (6) that the special reserve fund as defined in subsection (h) be made 

available for the procurement of such countermeasure’’ and inserting ‘‘make 

available the special reserve fund as defined in subsection (h) for procurement 

of such countermeasure’’; 

(2) in paragraph (6)— 

(A) by striking subparagraphs (A), (B), (C), and (E); and 

(B) by striking ‘‘(6) RECOMMENDATIONS FOR PRESIDENT’S APPROVAL’’ and 

all that follows through ‘‘(D) SUBSEQUENT SPECIFIC COUNTERMEASURES.—’’ 

and inserting ‘‘(6) SUBSEQUENT SPECIFIC COUNTERMEASURES.—’’; and 

(3) in paragraph (7)— 

(A) by striking subparagraph (A); 

(B) by redesignating subparagraph (B) as subparagraph (A) and amending such subparagraph (A), as redesignated, to read as follows: 

‘‘(A) PAYMENTS FROM SPECIAL RESERVE FUND.—The special reserve fund 

as defined in subsection (h) shall be available for payments made by the 

Secretary to a vendor for procurement of a security countermeasure in accordance with the provisions of this paragraph.’’; and 

(C) by redesignating subparagraph (C) as subparagraph (B). 

SEC. 5. BARDA 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: 

‘‘(H) CONTRACTING AUTHORITY CLARIFICATION.—The Secretary shall delegate authority for negotiating and entering into any contracts, grants, or cooperative agreements under this section to the Director.’’. 

SEC. 6. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE STRATEGY 

AND IMPLEMENTATION PLAN. 

Section 2811(d)(2) of the Public Health Service Act (42 U.S.C. 300hh–10(d)(2)) is 

amended— 

(1) in subparagraph (A), by inserting after ‘‘describe the chemical, biological, 

radiological, and nuclear agent or agents that may present a threat to the Nation’’ the following: ‘‘(which shall include pandemic influenza)’’; 

(2) by striking ‘‘and’’ at the end of subparagraph (J); 

(3) by redesignating subparagraph (K) as subparagraph (L); and 

(4) by inserting after subparagraph (J) the following: 

‘‘(K) report on the amount of time between the issuance of each request 

for a proposal or task order from the Biomedical Advanced Research and 

Development Authority and the award of a contract pursuant to such request for a proposal or task order; and’’. 

SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT PRESENT NATIONAL SECURITY THREATS. 

(a) IN GENERAL.—Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 565 the 

following: 

‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT PRESENT 

NATIONAL SECURITY THREATS. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) PRIORITY REVIEW.—The term ‘priority review’, with respect to a human 

drug application as defined in section 735(1), means review and action by the 

Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the manual of policies and procedures 

of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144). 

‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review voucher’ means a 

voucher issued by the Secretary to the sponsor of a material threat medical 

countermeasure application that entitles the holder of such voucher to priority 

review of a single human drug application submitted under section 505(b)(1) of 

this Act or section 351(a) of the Public Health Service Act after the date of approval of the material threat medical countermeasure application. 


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‘‘(3) MATERIAL THREAT MEDICAL COUNTERMEASURE APPLICATION.—The term 

‘material threat medical countermeasure application’ means an application 

that— 

‘‘(A) is a human drug application as defined in section 735(1) to prevent, 

or treat harm from, a biological, chemical, radiological, or nuclear agent 

identified as a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act; 

‘‘(B) the Secretary deems eligible for priority review; 

‘‘(C) is approved after the date of enactment of the Strengthening Public 

Health Emergency Response Act of 2016; and 

‘‘(D) is for a human drug, no active ingredient (including any ester or salt 

of the active ingredient) of which has been approved pursuant to any other 

application under section 505(b)(1) of this Act or section 351(a) of the Public 

Health Service Act. 

‘‘(b) PRIORITY REVIEW VOUCHER.— 

‘‘(1) IN GENERAL.—The Secretary shall award a priority review voucher to the 

sponsor of a material threat medical countermeasure application upon approval 

by the Secretary of such application. 

‘‘(2) TRANSFERABILITY.— 

‘‘(A) IN GENERAL.—The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a 

sponsor of a human drug for which an application under section 505(b)(1) 

of this Act or section 351(a) of the Public Health Service Act will be submitted after the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times a priority 

review voucher may be transferred before such voucher is used. 

‘‘(B) NOTIFICATION OF TRANSFER.—Each person to whom a voucher is 

transferred shall notify the Secretary of such change in ownership of the 

voucher not later than 30 days after the date of such transfer. 

‘‘(3) NOTIFICATION.— 

‘‘(A) IN GENERAL.—The sponsor of a human drug application shall notify 

the Secretary not later than 90 calendar days prior to submission of the 

human drug application that is the subject of a priority review voucher of 

an intent to submit the human drug application, including the date on 

which the sponsor intends to submit the application. Such notification shall 

be a legally binding commitment to pay for the user fee to be assessed in 

accordance with this section. 

‘‘(B) TRANSFER AFTER NOTICE.—The sponsor of a human drug application 

that provides notification of the intent of such sponsor to use the voucher 

for the human drug application under subparagraph (A) may transfer the 

voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification. 

‘‘(c) PRIORITY REVIEW USER FEE.— 

‘‘(1) IN GENERAL.—The Secretary shall establish a user fee program under 

which a sponsor of a human drug application that is the subject of a priority 

review voucher shall pay to the Secretary a fee determined under paragraph (2). 

Such fee shall be in addition to any fee required to be submitted by the sponsor 

under chapter VII. 

‘‘(2) FEE AMOUNT.—The amount of the priority review user fee shall be determined each fiscal year by the Secretary and based on the average cost incurred 

by the agency in the review of a human drug application subject to priority review in the previous fiscal year. 

‘‘(3) ANNUAL FEE SETTING.—The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2016, for that fiscal year, 

the amount of the priority review user fee. 

‘‘(4) PAYMENT.— 

‘‘(A) IN GENERAL.—The priority review user fee required by this subsection shall be due upon the notification by a sponsor of the intent of such 

sponsor to use the voucher, as specified in subsection (b)(3)(A). All other 

user fees associated with the human drug application shall be due as required by the Secretary or under applicable law. 

‘‘(B) COMPLETE APPLICATION.—An application described in subparagraph 

(A) for which the sponsor requests the use of a priority review voucher shall 

be considered incomplete if the fee required by this subsection and all other 

applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees. 


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‘‘(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR REFUNDS.—The Secretary 

may not grant a waiver, exemption, reduction, or refund of any fees due 

and payable under this section. 

‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to this subsection for 

any fiscal year— 

‘‘(A) shall be deposited and credited as offsetting collections to the account 

providing appropriations to the Food and Drug Administration; and 

‘‘(B) shall not be collected for any fiscal year except to the extent provided 

in advance in appropriation Acts. 

‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND APPROVAL OF PRODUCTS UNDER

VOUCHER.—The Secretary shall publish a notice in the Federal Register and on the 

public website of the Food and Drug Administration not later than 30 calendar days 

after the occurrence of each of the following: 

‘‘(1) The Secretary issues a priority review voucher under this section. 

‘‘(2) The Secretary approves a drug pursuant to an application submitted 

under section 505(b) of this Act or section 351(a) of the Public Health Service 

Act for which the sponsor of the application used a priority review voucher 

under this section. 

‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any 

other incentive program, including under this Act, except that no sponsor of a material threat medical countermeasure application may receive more than one priority 

review voucher issued under any section of this Act with respect to the drug that 

is the subject of such application. 

‘‘(f) RELATION TO OTHER PROVISIONS.—The provisions of this section shall supplement, not supplant, any other provisions of this Act or the Public Health Service 

Act that encourage the development of medical countermeasures. 

‘‘(g) MEDICAL COUNTERMEASURE POSTAPPROVAL REPORT.— 

‘‘(1) IN GENERAL.—Not later than 5 years after the date of approval of a material threat medical countermeasure application, the sponsor of such application 

shall submit a report to the Secretary on such medical countermeasure. 

‘‘(2) CONTENTS.—A report under paragraph (1) shall include, with respect to 

each of the first 2 years after approval of such material threat medical countermeasure application, a description of— 

‘‘(A) the sponsor’s activities with Federal agencies related to the procurement, including stockpiling, of the approved medical countermeasure; 

‘‘(B) the sponsor’s progress in fulfilling contracts entered into with Federal agencies, including the Biomedical Advanced Research and Development Authority, the Centers for Disease Control and Prevention, and the 

Department of Defense, related to such procurement; 

‘‘(C) the extent to which the Federal Government has fulfilled its stated 

medical countermeasure requirements for the threat intended to be treated 

by the approved medical countermeasure; and 

‘‘(D) the sponsor’s plans, if any, to develop additional material threat 

medical countermeasures. 

‘‘(3) AVAILABILITY TO CONGRESSIONAL COMMITTEES.—The Secretary shall make 

each report submitted under this subsection available to the Committee on Energy and Commerce of the House of Representatives and the Committee on 

Health, Education, Labor, and Pensions of the Senate upon request by either 

such Committee not later than 30 days after receipt of such request. 

‘‘(4) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed 

to permit the disclosure of confidential commercial or trade secret information 

or the disclosure of information that could compromise national security.’’. 

(b) GAO REPORT.— 

(1) STUDY.—The Comptroller General of the United States shall conduct a 

study on the effectiveness of priority review vouchers under section 565A of the 

Federal Food, Drug, and Cosmetic Act, as added by subsection (a), in providing 

incentives for the development of material threat medical countermeasure applications under such section 565A. In conducting such study, the Comptroller 

General shall examine the following: 

(A) The impact of such priority review on the development of material 

threat medical countermeasures and the impact of such investment, as applicable, on the development of such countermeasures. 

(B) How the drugs for which such priority review vouchers were awarded— 

(i) addressed identified medical countermeasure needs; and 

(ii) impacted United States preparedness against chemical, biological, 

radiological, and nuclear threats, including both identified threats and 

naturally occurring threats. 


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(C) How many material threat medical countermeasures were licensed or 

approved, or otherwise significantly advanced in clinical development, in 

the 15 years following the enactment of such section 565A compared to the 

15 years prior to the enactment of such section, including a comparative 

analysis of Federal advanced development and procurement dollars available in the 15 years following such enactment compared to the prior 15 

years. 

(D) How material threat medical countermeasures developed after the 

date of enactment of this Act impact— 

(i) the supply of products in the strategic national stockpile under 

section 319F–2 of the Public Health Service Act (42 U.S.C. 247d–6b); 

and 

(ii) national preparedness. 

(E) How the Federal Government supported sponsors of material threat 

medical countermeasures during the research, development, application review, and production of such drugs, including the use of government research, provision of resources through contracts or grants, and use of federally funded research facilities. 

(F) An analysis of the drugs for which such priority review vouchers were 

used, which shall include— 

(i) the indications for which such drugs were approved under section 

505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 

262(a)); 

(ii) whether unmet medical needs were addressed through the approval of such drugs, including, for each such drug— 

(I) if there was a currently marketed therapy approved to prevent or treat the same indication in the same patient population 

at the time the application was submitted to the Food and Drug 

Administration; and 

(II) if the drug provided a significant benefit or improvement in 

safety and effectiveness compared to such currently marketed product; 

(iii) the price of the priority review voucher if transferred or sold 

prior to redemption; and 

(iv) the length of time between the date on which a priority review 

voucher was awarded and the date on which it was used. 

(G) With respect to the priority review voucher program under such section 565A— 

(i) how many priority review vouchers were awarded under such section 565A and how many of such awarded vouchers were redeemed for 

priority review of a drug application in the 15 years following the date 

of enactment of such section; 

(ii) the resources associated with the Food and Drug Administration 

implementation of such section 565A and review of applications for 

which a voucher awarded under such section 565A is redeemed for priority review and if implementation of such section 565A prohibited the 

Food and Drug Administration from meeting drug application review 

goals; 

(iii) recommendations on whether appropriate Federal funding for advanced development and research would necessitate the priority review 

voucher program for medical countermeasures; 

(iv) the degree to which this incentive program impacts other priority 

review voucher programs; and 

(v) the degree to which guaranteed Federal funding for advanced development and research is a greater incentive for new investment in research and the development of medical countermeasures than the uncertain values of vouchers. 

(2) CONSULTATIONS.—In conducting the study under subsection (a), the Comptroller General of the United States shall consult with— 

(A) drug manufacturers involved in the research and development of medical countermeasures to address biological, chemical, radiological, and nuclear threats; 

(B) stakeholders involved in investing in the research and development 

of such medical countermeasures, including venture capitalists; 

(C) the Federal Government agencies responsible for advancing, reviewing, and procuring such medical countermeasures, including— 

(i) the Department of Health and Human Services, including the Office of the Assistant Secretary for Preparedness and Response, the BioVerDate Sep 11 2014 05:05 Sep 13, 2016 Jkt 059006 PO 00000 Frm 00006 Fmt 6659 Sfmt 6621 E:\HR\OC\HR735.XXX HR735

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medical Advanced Research and Development Authority, and the Food 

and Drug Administration; and 

(ii) the Department of Defense; 

(D) biodefense stakeholders, as applicable; and 

(E) drug manufacturers involved in the research and development of 

therapies that address— 

(i) tropical diseases (as defined in section 524(a) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360n(a))); or 

(ii) rare pediatric diseases (as defined in section 529(a) of such Act 

(21 U.S.C. 360ff(a))). 

(3) INITIAL ASSESSMENT.—Not later than 10 years after the date of enactment 

of this Act, the Comptroller General of the United States 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 an initial 

assessment of the effectiveness of the priority review voucher program set forth 

in section 565A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). 

(4) REPORT.—Not later than 16 years after the date of enactment of this Act, 

the Comptroller General of the United States 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 containing the 

results of the study conducted under paragraph (1). 

(5) PROTECTION OF NATIONAL SECURITY.—The Comptroller General of the 

United States shall conduct the study under paragraph (1) and issue the assessment and report under paragraphs (3) and (4) in a manner that does not compromise national security. 

PURPOSE AND SUMMARY

The purpose of H.R. 3299 is to enhance America’s preparedness 

for biological threats and resulting public health emergencies. H.R. 

3299 would improve and enhance our national preparedness in several ways: first, a Government Accountability Office (GAO) study 

would evaluate our current local and state emergency preparedness 

efforts to determine how to increase effectiveness; second, the bill 

would require coordination between Centers for Disease Control 

(CDC) and Biomedical Advanced Research and Development Authority (BARDA); third, the bill would increase the efficiency for 

contracting with companies to develop and procure products; 

fourth, the bill would amend an existing five year budget plan requirement to include pandemic influenza; and finally, the bill 

would provide a necessary and valuable incentive to ensure 

innovators develop medical products for national defense. 

H.R. 3299 also would establish a new priority review voucher 

(PRV) program at the Food and Drug Administration (FDA). Under 

this program, the Secretary would award a priority review voucher 

to sponsors of drugs that meet certain criteria, including that the 

drug prevent or treat harm from a biological, chemical, radiological, 

or nuclear agent that has been identified as a material threat by 

the Department of Homeland Security. 

BACKGROUND AND NEED FOR LEGISLATION

The past several years have demonstrated the global nature of 

biological threats. The Ebola outbreak in Western Africa and the 

emergence of Zika illustrate the importance of preparedness. A bipartisan report, issued on October 28, 2016, by the Blue Ribbon 

Study Panel on Biodefense, stated that ‘‘[t]he United States is 

underprepared for biological threats. . . . The Nation is dangerously vulnerable to a biological event. The root cause of this continuing vulnerability is the lack of strong centralized leadership at 


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1 A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts. Bipartisan Reform of the Blue Ribbon Study Panel on Biodefense. P. iv 2 Ibid. P. iv. 

the highest level of government.’’ 1 H.R. 3299 will address ‘‘serious 

gaps and inadequacies that continue to leave the Nation vulnerable 

to threats from nature and terrorists alike.’’ 2

HEARINGS

The Subcommittee on Health held a hearing on H.R. 3299 on 

May 19, 2016. The Subcommittee received testimony from: 

• Col. Russell Coleman, Ph.D., Joint Program Manager, 

Medical Countermeasures Systems, U.S. Department of Defense; 

• Richard Hatchett, M.D., Acting Director, Biomedical Advanced Research and Development Authority, U.S. Department 

of Health and Human Services; and, 

• Michael Mair, Director of Strategic Operations, Office of 

Counterterrorism and Emerging Threats, U.S. Food and Drug 

Administration. 

COMMITTEE CONSIDERATION

On June 7 and 8, 2016, the Subcommittee on Health met in open 

markup session and forwarded H.R. 3299 to the full Committee, as 

amended, by a voice vote. On July 12, 13, and 14, 2016, the full 

Committee on Energy and Commerce met in open markup session 

and ordered H.R. 3299 reported to the House, as amended, by a recorded vote of 36 yeas and 15 nays. 

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. The following reflects the record votes taken during the Committee consideration: 


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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 that are reflected in this report. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

H.R. 3299 would increase American emergency preparedness by 

increasing administrative efficiency within the Office of Assistant 

Secretary for Preparedness and Response (‘‘ASPR’’) in the U.S. Department of Health and Human Services (‘‘HHS’’) and provide incentives for companies to develop medical countermeasures for public health emergencies and biochemical attacks. 

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. 3299 

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. 3299 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, September 7, 2016. 

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. 3299, the Strengthening 

Public Health Emergency Response Act of 2016. 

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

to provide them. The CBO staff contact is Ellen Werble. 

Sincerely, 

KEITH HALL. 

Enclosure. 


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H.R. 3299—Strengthening Public Health Emergency Response Act 

of 2016 

Summary: H.R. 3299 would establish an incentive program that 

awards vouchers for priority review to companies that obtain approval from the Food and Drug Administration (FDA) for certain 

drugs that can be used to counter the effects of biological, chemical, 

radiological, or nuclear agents. The bill also would make several 

changes to the processes used to procure medical countermeasures 

in the Department of Health and Human Services (HHS). Finally, 

the Government Accountability Office (GAO) would be required to 

report on programs to improve state, local, and hospital preparedness. CBO estimates that implementing H.R. 3299 would cost $20 

million over the 2017–2021 period, assuming appropriation of the 

necessary amounts. Pay-as-you-go procedures do not apply to this 

legislation because it would not affect direct spending or revenues. 

CBO estimates that enacting H.R. 3299 would not increase net 

direct spending or on-budget deficits in any of the four consecutive 

10-year periods beginning in 2027. 

H.R. 3299 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA) 

and would not affect the budgets of state, local, or tribal governments. 

Estimated cost to the Federal Government: The estimated budgetary effect of H.R. 3299 is shown in the following table. The costs 

of this legislation fall primarily within budget function 550 

(health). 

By fiscal year, in millions of dollars— 

2017 2018 2019 2020 2021 2017– 

2021 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Estimated Authorization Level .......................................................................... 5 5 4 4 4 21 

Estimated Outlays ............................................................................................ 4 4 4 4 4 20 

Notes: Components do not sum to totals because of rounding. 

Basis of estimate: For this estimate, CBO assumes that the bill 

will be enacted near the beginning of fiscal year 2017 and that the 

necessary amounts will be appropriated. 

FDA: The bill would create an incentive program that awards 

vouchers for priority review to companies when they obtain FDA 

approval of certain drugs to counter the effects from biological, 

chemical, radiological, or nuclear agents. Such vouchers can be 

used to accelerate review of a future drug application. To redeem 

the voucher, a sponsor must pay an extra fee set by FDA each year 

to cover the agency’s cost for the accelerated review. Such fees 

would be collected and made available for obligation only to the extent and in the amounts provided in advance in appropriation acts. 

(Estimated collections and related spending offset each other in the 

year fees are paid by sponsors.) 

To establish the new voucher program, CBO expects FDA would 

issue guidance containing the definition of the types of products 

that would be eligible for a voucher. Based on an analysis of information from FDA for similar programs, CBO estimates that those 

activities would require about 10 employees to establish and to 

maintain the program. Assuming appropriation of the necessary 


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amounts, CBO estimates implementing the new voucher program 

would cost FDA $18 million over the 2017–2021 period. 

HHS: The Office of the Assistant Secretary for Preparedness and 

Response (ASPR) within HHS is required to work with other HHS 

agencies to issue a Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan (SIP) each 

year. The SIP outlines a strategy and an accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. H.R. 3299 would require 

ASPR to include specific information about pandemic influenza in 

the SIP. It also would require ASPR to report on the amount of 

time it takes the Biomedical Advanced Research and Development 

Authority (BARDA) to award contracts once requests for proposals 

are issued. Based on information from HHS, CBO estimates that 

including these new elements in the SIP would require one employee to implement. Assuming appropriation of the necessary 

amounts, CBO estimates this section would cost HHS about $1 million over the 2017–2021 period. 

GAO: H.R. 3299 would require GAO to report on programs to improve state, local, and hospital preparedness for public health 

emergencies. CBO estimates implementing that provision would 

cost about $500,000 over the 2017–2021 period; such spending 

would be subject to the availability of appropriated funds. 

Pay-As-You-Go considerations: None 

Increase in long-term direct spending and deficits: CBO estimates that enacting the legislation would not increase net direct 

spending or on-budget deficits in any of the four consecutive 10- 

year periods beginning in 2027. 

Intergovernmental and private-sector impact: H.R. 3299 contains 

no intergovernmental or private-sector mandates as defined in the 

UMRA and would not affect the budgets of state, local, or tribal 

governments. 

Previous CBO estimates: On August 8, 2016, CBO transmitted a 

cost estimate for S. 2055, the Medical Countermeasure Innovation 

Act of 2016, as reported by the Senate Committee on Health, Education, Labor, and Pensions on March 14, 2016. Several provisions 

are similar to provisions in H.R. 3299; however, S. 2055 would also 

authorize an additional program to invest in research and provide 

incentives for the development of medical countermeasures and 

would require HHS to prepare a five-year budget plan for such 

countermeasures. H.R. 3299 would authorize one program and 

modify existing requirements for an annual strategy and implementation plan. CBO’s estimate of the budgetary effects reflects 

those differences. 

Estimate prepared by: Federal costs: Andrea Noda, Ellen Werble, 

and Rebecca Yip; Impact on state, local, and tribal governments: 

Zachary Byrum; 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. 3299 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. 3299 specifically directs to be completed no 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; Table of contents 

Section 1 provides that this Act may be cited as the ‘‘Strengthening Public Health Emergency Response Act of 2016’’. 

Section 2. GAO report on state, local and hospital preparedness programs 

This section requires GAO to submit a report to Congress within 

one year of enactment regarding the programs for awarding cooperative agreements and grants and partnerships for State and regional hospital preparedness to improve surge capacity. 

Section 3. Strategic national stockpile 

This section requires that the Biomedical Advanced Research 

and Development Authority and Centers for Disease Control 

(BARDA) and Centers for Disease Control and Prevention (CDC) 

have procedures in place to coordinate ongoing stockpiling. 

Section 4. Project Bioshield procurement process 

This section removes the requirement for Office of Management 

and Budget (OMB) to review all BioShield contracts independently. 

This independent review is no longer necessary because the funds, 

which were originally housed at Department of Homeland Security 

(DHS) is now housed at HHS. This will remove an unnecessary 

level of bureaucracy and expedite the contracting process. 


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Section 5. BARDA transaction authority 

This section would give BARDA the sole authority to negotiate 

and award its own medical countermeasure research and development contracts. 

Section 6. Public health emergency medical countermeasures enterprise strategy and implementation plan 

The 2013 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) legislation required ASPR to create a 5-year 

medical countermeasure budget plan. The purpose of this plan was 

to anticipate countermeasure funding needs and spending plans 

across all chemical, biological, radiological and nuclear (CBRN) 

threats. In addition to CBRN, this section would require the 5-year 

budget to include planning for pandemic influenza, one of the largest public health threats we face today. 

Section 7. Priority review to encourage treatments for agents that 

present national security threats 

This section creates a new, permanent PRV program. This program would award a qualifying sponsor of a material threat medical countermeasures application a PRV, which entitles the sponsor 

to a second priority review of any other human drug application. 

To qualify for the award, a material threat medical countermeasure 

application must be for a human drug indicated to prevent, or treat 

harm from, a biological, chemical, radiological, or nuclear agent 

identified as a material threat. Additionally, the Secretary must 

deem the medical countermeasure application eligible for priority 

review and the medical countermeasure application must be approved after the date of enactment. The PRV is transferrable and 

there is no limit on how many times a voucher may be transferred 

or sold before it is used. The sponsor must notify FDA of its intent 

to transfer the voucher. Additionally, when a sponsor uses the 

PRV, it must notify FDA 90 days in advance of submitting an application for priority review and is required to pay an additional 

user fee, which shall be determined by the Secretary at the beginning of each fiscal year, starting after September 30, 2016. 

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, 

and existing law in which no change is proposed is shown in 

roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 


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PART B—FEDERAL-STATE COOPERATION

* * * * * * * 

SEC. 319F–2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE PROCUREMENTS. 

(a) STRATEGIC NATIONAL STOCKPILE.— 

(1) IN GENERAL.—The Secretary, in collaboration with the Director of the Centers for Disease Control and Prevention, and 

in coordination with the Secretary of Homeland Security (referred to in this section as the ‘‘Homeland Security Secretary’’), 

shall maintain a stockpile or stockpiles of drugs, vaccines and 

other biological products, medical devices, and other supplies 

in such numbers, types, and amounts as are determined consistent with section 2811 by the Secretary to be appropriate 

and practicable, taking into account other available sources, to 

provide for the emergency health security of the United States, 

including the emergency health security of children and other 

vulnerable populations, in the event of a bioterrorist attack or 

other public health emergency. The Secretary shall conduct an 

annual review (taking into account at-risk individuals) of the 

contents of the stockpile, including non-pharmaceutical supplies, and make necessary additions or modifications to the 

contents based on such review 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. 

(2) PROCEDURES.—The Secretary, in managing the stockpile 

under paragraph (1), shall— 

(A) consult with the working group under section 

319F(a); 

(B) ensure that adequate procedures are followed with 

respect to such stockpile for inventory management and 

accounting, and for the physical security of the stockpile; 

(C) in consultation with Federal, State, and local officials, take into consideration the timing and location of 

special events; 

(D) review and revise, as appropriate, the contents of the 

stockpile on a regular basis to ensure that emerging 

threats, advanced technologies, and new countermeasures 

are adequately considered and that the potential depletion 

of countermeasures currently in the stockpile is identified 

and appropriately addressed, including through necessary 

replenishment; 

(E) devise plans for the effective and timely supply-chain 

management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the public 

and private health care infrastructure; 

(F) deploy the stockpile as required by the Secretary of 

Homeland Security to respond to an actual or potential 

emergency; 

(G) deploy the stockpile at the discretion of the Secretary 

to respond to an actual or potential public health emergency or other situation in which deployment is necessary 

to protect the public health or safety; øand¿ 


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(H) ensure the adequate physical security of the 

stockpileø.¿; and 

(I) ensure procedures are in place to coordinate the ongoing stockpiling by the Biomedical Advanced Research and 

Development Authority and Centers for Disease Control 

and Prevention of qualified countermeasures (as defined in 

section 319F–1) for which funds have been made available 

under this part, security countermeasures (as defined in 

this section), and qualified pandemic or epidemic products 

(as defined in section 319F–3) for which funds have been 

made available under section 319L in order to avoid any 

gaps in preparedness. 

(b) SMALLPOX VACCINE DEVELOPMENT.— 

(1) IN GENERAL.—The Secretary shall award contracts, enter 

into cooperative agreements, or carry out such other activities 

as may reasonably be required in order to ensure that the 

stockpile under subsection (a) includes an amount of vaccine 

against smallpox as determined by such Secretary to be sufficient to meet the health security needs of the United States. 

(2) RULE OF CONSTRUCTION.—Nothing in this section shall be 

construed to limit the private distribution, purchase, or sale of 

vaccines from sources other than the stockpile described in 

subsection (a). 

(c) ADDITIONAL AUTHORITY REGARDING PROCUREMENT OF CER- TAIN COUNTERMEASURES; AVAILABILITY OF SPECIAL RESERVE

FUND.— 

(1) IN GENERAL.— (A) USE OF FUND.—A security countermeasure may, in 

accordance with this subsection, be procured with amounts 

in the special reserve fund as defined in subsection (h). 

(B) SECURITY COUNTERMEASURE.—For purposes of this 

subsection, the term ‘‘security countermeasure’’ means a 

drug (as that term is defined by section 201(g)(1) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

321(g)(1))), biological product (as that term is defined by 

section 351(i) of this Act (42 U.S.C. 262(i))), or device (as 

that term is defined by section 201(h) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 321(h))) that— 

(i)(I) the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material 

threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may 

result in adverse health consequences or death and 

may be caused by administering a drug, biological 

product, or device against such an agent; 

(II) the Secretary determines under paragraph 

(2)(B)(ii) to be a necessary countermeasure; and 

(III)(aa) is approved or cleared under chapter V of 

the Federal Food, Drug, and Cosmetic Act or licensed 

under section 351 of this Act; or 

(bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical expeVerDate Sep 11 2014 05:05 Sep 13, 2016 Jkt 059006 PO 00000 Frm 00018 Fmt 6659 Sfmt 6601 E:\HR\OC\HR735.XXX HR735

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rience or research data (including data, if available, 

from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify 

for approval or licensing within 10 years after the date 

of a determination under paragraph (5); or 

(ii) is authorized for emergency use under section 

564 of the Federal Food, Drug, and Cosmetic Act. 

(2) DETERMINATION OF MATERIAL THREATS.— (A) MATERIAL THREAT.—The Homeland Security Secretary, in consultation with the Secretary and the heads of 

other agencies as appropriate, shall on an ongoing basis— 

(i) assess current and emerging threats of chemical, 

biological, radiological, and nuclear agents; and 

(ii) determine which of such agents present a material threat against the United States population sufficient to affect national security. 

(B) PUBLIC HEALTH IMPACT; NECESSARY COUNTER- MEASURES.—The Secretary shall on an ongoing basis— 

(i) assess the potential public health consequences 

for the United States population of exposure to agents 

identified under subparagraph (A)(ii); and 

(ii) determine, on the basis of such assessment, the 

agents identified under subparagraph (A)(ii) for which 

countermeasures are necessary to protect the public 

health. 

(C) NOTICE TO CONGRESS.—The Secretary and the Homeland Security Secretary shall promptly notify the appropriate committees of Congress that a determination has 

been made pursuant to subparagraph (A) or (B). 

(D) ASSURING ACCESS TO THREAT INFORMATION.—In making the assessment and determination required under subparagraph (A), the Homeland Security Secretary shall use 

all relevant information to which such Secretary is entitled 

under section 202 of the Homeland Security Act of 2002, 

including but not limited to information, regardless of its 

level of classification, relating to current and emerging 

threats of chemical, biological, radiological, and nuclear 

agents. 

(3) ASSESSMENT OF AVAILABILITY AND APPROPRIATENESS OF

COUNTERMEASURES.— 

(A) IN GENERAL.—The Secretary, in consultation with 

the Homeland Security Secretary, shall assess on an ongoing basis the availability and appropriateness of specific 

countermeasures to address specific threats identified 

under paragraph (2). 

(B) INFORMATION.—The Secretary shall institute a process for making publicly available the results of assessments under subparagraph (A) while withholding such information as— 

(i) would, in the judgment of the Secretary, tend to 

reveal public health vulnerabilities; or 

(ii) would otherwise be exempt from disclosure 

under section 552 of title 5, United States Code. 

(4) CALL FOR DEVELOPMENT OF COUNTERMEASURES; COMMITMENT FOR RECOMMENDATION FOR PROCUREMENT.— 


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(A) PROPOSAL TO THE PRESIDENT.—If, pursuant to an assessment under paragraph (3), the Homeland Security Secretary and the Secretary make a determination that a 

countermeasure would be appropriate but is either 

currently not developed or unavailable for procurement as 

a security countermeasure or is approved, licensed, or 

cleared only for alternative uses, such Secretaries may 

jointly submit to the President a proposal to— 

(i) issue a call for the development of such countermeasure; and 

(ii) make a commitment that, upon the first development of such countermeasure that meets the conditions for procurement under paragraph (5), the Secretaries will, based in part on information obtained pursuant to such call, ømake a recommendation under 

paragraph (6) that the special reserve fund as defined 

in subsection (h) be made available for the procurement of such countermeasure¿ make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure. 

(B) COUNTERMEASURE SPECIFICATIONS.—The Homeland 

Security Secretary and the Secretary shall, to the extent 

practicable, include in the proposal under subparagraph 

(A)— 

(i) estimated quantity of purchase (in the form of 

number of doses or number of effective courses of 

treatments regardless of dosage form); 

(ii) necessary measures of minimum safety and effectiveness; 

(iii) estimated price for each dose or effective course 

of treatment regardless of dosage form; and 

(iv) other information that may be necessary to encourage and facilitate research, development, and 

manufacture of the countermeasure or to provide specifications for the countermeasure. 

(C) PRESIDENTIAL APPROVAL.—If the President approves 

a proposal under subparagraph (A), the Homeland Security Secretary and the Secretary shall make known to persons who may respond to a call for the countermeasure involved— 

(i) the call for the countermeasure; 

(ii) specifications for the countermeasure under subparagraph (B); and 

(iii) the commitment described in subparagraph 

(A)(ii). 

(5) SECRETARY’S DETERMINATION OF COUNTERMEASURES APPROPRIATE FOR FUNDING FROM SPECIAL RESERVE FUND.— 

(A) IN GENERAL.—The Secretary, in accordance with the 

provisions of this paragraph, shall identify specific security 

countermeasures that the Secretary determines, in consultation with the Homeland Security Secretary, to be appropriate for inclusion in the stockpile under subsection (a) 

pursuant to procurements made with amounts in the special reserve fund as defined in subsection (h) (referred to 


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in this subsection individually as a ‘‘procurement under 

this subsection’’). 

(B) REQUIREMENTS.—In making a determination under 

subparagraph (A) with respect to a security countermeasure, the Secretary shall determine and consider the 

following: 

(i) The quantities of the product that will be needed 

to meet the stockpile needs. 

(ii) The feasibility of production and delivery within 

10 years of sufficient quantities of the product. 

(iii) Whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure. 

(6) øRECOMMENDATION FOR PRESIDENT’S APPROVAL.—¿ SUBSEQUENT SPECIFIC COUNTERMEASURES.— 

ø(A) RECOMMENDATION FOR PROCUREMENT.—In the case 

of a security countermeasure that the Secretary has, in accordance with paragraphs (3) and (5), determined to be appropriate for procurement under this subsection, the 

Homeland Security Secretary and the Secretary shall jointly submit to the President, in coordination with the Director of the Office of Management and Budget, a recommendation that the special reserve fund as defined in 

subsection (h) be made available for the procurement of 

such countermeasure. 

ø(B) PRESIDENTIAL APPROVAL.—The special reserve fund 

as defined in subsection (h) is available for a procurement 

of a security countermeasure only if the President has approved a recommendation under subparagraph (A) regarding the countermeasure. 

ø(C) NOTICE TO APPROPRIATE CONGRESSIONAL COMMITTEES.—The Secretary and the Homeland Security Secretary shall notify the appropriate congressional committees of each decision of the President to approve a recommendation under subparagraph (A). Such notice shall 

include an explanation of the decision to make available 

the special reserve fund as defined in subsection (h) for 

procurement of such a countermeasure, including, where 

available, the number of, nature of, and other information 

concerning potential suppliers of such countermeasure, 

and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons therefor. 

ø(D) SUBSEQUENT SPECIFIC COUNTERMEASURES.— 

¿Procurement under this subsection of a security countermeasure for a particular purpose does not preclude the 

subsequent procurement under this subsection of any 

other security countermeasure for such purpose if the Secretary has determined under paragraph (5)(A) that such 

countermeasure is appropriate for inclusion in the stockpile and if, as determined by the Secretary, such countermeasure provides improved safety or effectiveness, or for 

other reasons enhances preparedness to respond to threats 

of use of a biological, chemical, radiological, or nuclear 


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agent. Such a determination by the Secretary is committed 

to agency discretion. 

ø(E) RULE OF CONSTRUCTION.—Recommendations and 

approvals under this paragraph apply solely to determinations that the special reserve fund as defined in subsection 

(h) will be made available for a procurement of a security 

countermeasure, and not to the substance of contracts for 

such procurement or other matters relating to awards of 

such contracts.¿ 

(7) PROCUREMENT.— ø(A) IN GENERAL.—For purposes of a procurement 

under this subsection that is approved by the President under paragraph (6), the Homeland Security Secretary and the Secretary shall have responsibilities in 

accordance with subparagraphs (B) and (C). 

ø(B) INTERAGENCY AGREEMENT; COST.—The Homeland Security Secretary shall enter into an agreement 

with the Secretary for procurement of a security countermeasure in accordance with the provisions of this 

paragraph. The special reserve fund as defined in subsection (h) shall be available for payments made by 

the Secretary to a vendor for such procurement.¿ 

(A) PAYMENTS FROM SPECIAL RESERVE FUND.—The 

special reserve fund as defined in subsection (h) shall 

be available for payments made by the Secretary to a 

vendor for procurement of a security countermeasure in 

accordance with the provisions of this paragraph. 

ø(C)¿ (B) PROCUREMENT.— (i) IN GENERAL.—The Secretary shall be responsible for— 

(I) arranging for procurement of a security 

countermeasure, including negotiating terms 

(including quantity, production schedule, and 

price) of, and entering into, contracts and cooperative agreements, and for carrying out 

such other activities as may reasonably be required, including advanced research and development, in accordance with the provisions 

of this subparagraph; and 

(II) promulgating such regulations as the 

Secretary determines necessary to implement 

the provisions of this subsection. 

(ii) CONTRACT TERMS.—A contract for procurements under this subsection shall (or, as specified 

below, may) include the following terms: 

(I) PAYMENT CONDITIONED ON DELIVERY.— 

The contract shall provide that no payment 

may be made until delivery of a portion, acceptable to the Secretary, of the total number 

of units contracted for, except that, notwithstanding any other provision of law, the contract may provide that, if the Secretary determines (in the Secretary’s discretion) that an 

advance payment, partial payment for significant milestones, or payment to increase manVerDate Sep 11 2014 05:05 Sep 13, 2016 Jkt 059006 PO 00000 Frm 00022 Fmt 6659 Sfmt 6601 E:\HR\OC\HR735.XXX HR735

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ufacturing capacity is necessary to ensure 

success of a project, the Secretary shall pay 

an amount, not to exceed 10 percent of the 

contract amount, in advance of delivery. The 

Secretary shall, to the extent practicable, 

make the determination of advance payment 

at the same time as the issuance of a solicitation. The contract shall provide that such advance payment is required to be repaid if 

there is a failure to perform by the vendor 

under the contract. The contract may also 

provide for additional advance payments of 5 

percent each for meeting the milestones specified in such contract, except that such payments shall not exceed 50 percent of the total 

contract amount. If the specified milestones 

are reached, the advanced payments of 5 percent shall not be required to be repaid. Nothing in this subclause shall be construed as affecting the rights of vendors under provisions 

of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the 

Government. 

(II) DISCOUNTED PAYMENT.—The contract 

may provide for a discounted price per unit of 

a product that is not licensed, cleared, or approved as described in paragraph 

(1)(B)(i)(III)(aa) at the time of delivery, and 

may provide for payment of an additional 

amount per unit if the product becomes so licensed, cleared, or approved before the expiration date of the contract (including an additional amount per unit of product delivered 

before the effective date of such licensing, 

clearance, or approval). 

(III) CONTRACT DURATION.—The contract 

shall be for a period not to exceed five years, 

except that, in first awarding the contract, the 

Secretary may provide for a longer duration, 

not exceeding 10 years, if the Secretary determines that complexities or other difficulties in 

performance under the contract justify such a 

period. The contract shall be renewable for 

additional periods, none of which shall exceed 

five years. 

(IV) STORAGE BY VENDOR.—The contract 

may provide that the vendor will provide storage for stocks of a product delivered to the 

ownership of the Federal Government under 

the contract, for such period and under such 

terms and conditions as the Secretary may 

specify, and in such case amounts from the 

special reserve fund as defined in subsection 

(h) shall be available for costs of shipping, 


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handling, storage, and related costs for such 

product. 

(V) PRODUCT APPROVAL.—The contract shall 

provide that the vendor seek approval, clearance, or licensing of the product from the Secretary; for a timetable for the development of 

data and other information to support such 

approval, clearance, or licensing; and that the 

Secretary may waive part or all of this contract term on request of the vendor or on the 

initiative of the Secretary. 

(VI) NON-STOCKPILE TRANSFERS OF SECURITY COUNTERMEASURES.—The contract shall 

provide that the vendor will comply with all 

applicable export-related controls with respect 

to such countermeasure. 

(VII) SALES EXCLUSIVITY.—The contract 

may provide that the vendor is the exclusive 

supplier of the product to the Federal Government for a specified period of time, not to exceed the term of the contract, on the condition 

that the vendor is able to satisfy the needs of 

the Government. During the agreed period of 

sales exclusivity, the vendor shall not assign 

its rights of sales exclusivity to another entity 

or entities without approval by the Secretary. 

Such a sales exclusivity provision in such a 

contract shall constitute a valid basis for a 

sole source procurement under section 

303(c)(1) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 

253(c)(1)). 

(VIII) WARM BASED SURGE CAPACITY.—The 

contract may provide that the vendor establish domestic manufacturing capacity of the 

product to ensure that additional production 

of the product is available in the event that 

the Secretary determines that there is a need 

to quickly purchase additional quantities of 

the product. Such contract may provide a fee 

to the vendor for establishing and maintaining such capacity in excess of the initial requirement for the purchase of the product. 

Additionally, the cost of maintaining the domestic manufacturing capacity shall be an allowable and allocable direct cost of the contract. 

(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


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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). 

(iii) AVAILABILITY OF SIMPLIFIED ACQUISITION

PROCEDURES.— (I) IN GENERAL.—If the Secretary determines that there is a pressing need for a procurement of a specific countermeasure, the 

amount of the procurement under this subsection shall be deemed to be below the 

threshold amount specified in section 4(11) of 

the Office of Federal Procurement Policy Act 

(41 U.S.C. 403(11)), for purposes of application to such procurement, pursuant to section 

302A(a) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 

252a(a)), of— 

(aa) section 303(g)(1)(A) of the Federal 

Property and Administrative Services Act 

of 1949 (41 U.S.C. 253(g)(1)(A)) and its 

implementing regulations; and 

(bb) section 302A(b) of such Act (41 

U.S.C. 252a(b)) and its implementing regulations. 

(II) APPLICATION OF CERTAIN PROVISIONS.— Notwithstanding subclause (I) and the provision of law and regulations referred to in such 

clause, each of the following provisions shall 

apply to procurements described in this clause 

to the same extent that such provisions would 

apply to such procurements in the absence of 

subclause (I): 

(aa) Chapter 37 of title 40, United 

States Code (relating to contract work 

hours and safety standards). 

(bb) Subsections (a) and (b) of section 7 

of the Anti-Kickback Act of 1986 (41 

U.S.C. 57(a) and (b)). 

(cc) Section 304C of the Federal Property and Administrative Services Act of 

1949 (41 U.S.C. 254d) (relating to the examination of contractor records). 


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(dd) Section 3131 of title 40, United 

States Code (relating to bonds of contractors of public buildings or works). 

(ee) Subsection (a) of section 304 of the 

Federal Property and Administrative 

Services Act of 1949 (41 U.S.C. 254(a)) 

(relating to contingent fees to middlemen). 

(ff) Section 6002 of the Solid Waste Disposal Act (42 U.S.C. 6962). 

(gg) Section 1354 of title 31, United 

States Code (relating to the limitation on 

the use of appropriated funds for contracts with entities not meeting veterans 

employment reporting requirements). 

(III) INTERNAL CONTROLS TO BE ESTABLISHED.—The Secretary shall establish appropriate internal controls for procurements 

made under this clause, including requirements with respect to documentation of the 

justification for the use of the authority provided under this paragraph with respect to 

the procurement involved. 

(IV) AUTHORITY TO LIMIT COMPETITION.—In 

conducting a procurement under this subparagraph, the Secretary may not use the authority provided for under subclause (I) to conduct 

a procurement on a basis other than full and 

open competition unless the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 

would be seriously impaired without such a 

limitation. 

(iv) PROCEDURES OTHER THAN FULL AND OPEN

COMPETITION.— (I) IN GENERAL.—In using the authority provided in section 303(c)(1) of title III of the 

Federal Property and Administrative Services 

Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive procedures in 

the case of a procurement under this subsection, the phrase ‘‘available from only one 

responsible source’’ in such section 303(c)(1) 

shall be deemed to mean ‘‘available from only 

one responsible source or only from a limited 

number of responsible sources’’. 

(II) RELATION TO OTHER AUTHORITIES.—The 

authority under subclause (I) is in addition to 

any other authority to use procedures other 

than competitive procedures. 

(III) APPLICABLE GOVERNMENT-WIDE REGU- LATIONS.—The Secretary shall implement this 

clause in accordance with government-wide 

regulations implementing such section 

303(c)(1) (including requirements that offers 


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be solicited from as many potential sources as 

is practicable under the circumstances, that 

required notices be published, and that submitted offers be considered), as such regulations apply to procurements for which an 

agency has authority to use procedures other 

than competitive procedures when the property or services needed by the agency are 

available from only one responsible source or 

only from a limited number of responsible 

sources and no other type of property or services will satisfy the needs of the agency. 

(v) PREMIUM PROVISION IN MULTIPLE AWARD

CONTRACTS.— 

(I) IN GENERAL.—If, under this subsection, 

the Secretary enters into contracts with more 

than one vendor to procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include 

in each of such contracts a provision that— 

(aa) identifies an increment of the total 

quantity of security countermeasure required, whether by percentage or by numbers of units; and 

(bb) promises to pay one or more specified premiums based on the priority of 

such vendors’ production and delivery of 

the increment identified under item (aa), 

in accordance with the terms and conditions of the contract. 

(II) DETERMINATION OF GOVERNMENT’S REQUIREMENT NOT REVIEWABLE.—If the Secretary includes in each of a set of contracts a 

provision as described in subclause (I), such 

Secretary’s determination of the total quantity 

of security countermeasure required, and any 

amendment of such determination, is committed to agency discretion. 

(vi) EXTENSION OF CLOSING DATE FOR RECEIPT

OF PROPOSALS NOT REVIEWABLE.—A decision by 

the Secretary to extend the closing date for receipt 

of proposals for a procurement under this subsection is committed to agency discretion. 

(vii) LIMITING COMPETITION TO SOURCES RESPONDING TO REQUEST FOR INFORMATION.—In conducting a procurement under this subsection, the 

Secretary may exclude a source that has not responded to a request for information under section 

303A(a)(1)(B) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 

253a(a)(1)(B)) if such request has given notice that 

the Secretary may so exclude such a source. 

(viii) FLEXIBILITY.—In carrying out this section, 

the Secretary may, consistent with the applicable 

provisions of this section, enter into contracts and 


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other agreements that are in the best interest of 

the Government in meeting identified security 

countermeasure needs, including with respect to 

reimbursement of the cost of advanced research 

and development as a reasonable, allowable, and 

allocable direct cost of the contract involved. 

(8) INTERAGENCY COOPERATION.— (A) IN GENERAL.—In carrying out activities under this 

section, the Homeland Security Secretary and the Secretary are authorized, subject to subparagraph (B), to 

enter into interagency agreements and other collaborative 

undertakings with other agencies of the United States 

Government. Such agreements may allow other executive 

agencies to order qualified and security countermeasures 

under procurement contracts or other agreements established by the Secretary. Such ordering process (including 

transfers of appropriated funds between an agency and the 

Department of Health and Human Services as reimbursements for such orders for countermeasures) may be conducted under the authority of section 1535 of title 31, 

United States Code, except that all such orders shall be 

processed under the terms established under this subsection for the procurement of countermeasures. 

(B) LIMITATION.—An agreement or undertaking under 

this paragraph shall not authorize another agency to exercise the authorities provided by this section to the Homeland Security Secretary or to the Secretary. 

(d) DISCLOSURES.—No Federal agency shall disclose under section 552 of title 5, United States Code, any information identifying 

the location at which materials in the stockpile under subsection 

(a) are stored. 

(e) DEFINITION.—For purposes of subsection (a), the term ‘‘stockpile’’ includes— 

(1) a physical accumulation (at one or more locations) of the 

supplies described in subsection (a); or 

(2) a contractual agreement between the Secretary and a 

vendor or vendors under which such vendor or vendors agree 

to provide to such Secretary supplies described in subsection 

(a). 

(f) AUTHORIZATION OF APPROPRIATIONS.— 

(1) STRATEGIC NATIONAL STOCKPILE.—For the purpose of carrying out subsection (a), there are authorized to be appropriated $533,800,000 for each of fiscal years 2014 through 

2018. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (h). 

(2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of 

carrying out subsection (b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as 

may be necessary for each of fiscal years 2003 through 2006. 

(g) SPECIAL RESERVE FUND.— (1) AUTHORIZATION OF APPROPRIATIONS.—In addition to 

amounts appropriated to the special reserve fund prior to the 

date of the enactment of this subsection, there is authorized to 

be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 


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319L (relating to the Biomedical Advanced Research and Development Authority), $2,800,000,000 for the period of fiscal 

years 2014 through 2018. Amounts appropriated pursuant to 

the preceding sentence are authorized to remain available until 

September 30, 2019. 

(2) USE OF SPECIAL RESERVE FUND FOR ADVANCED RESEARCH

AND DEVELOPMENT.—The Secretary may utilize not more than 

50 percent of the amounts authorized to be appropriated under 

paragraph (1) to carry out section 319L (related to the Biomedical Advanced Research and Development Authority). 

Amounts authorized to be appropriated under this subsection 

to carry out section 319L are in addition to amounts otherwise 

authorized to be appropriated to carry out such section. 

(3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the special 

reserve fund shall not be used to pay costs other than payments made by the Secretary to a vendor for advanced development (under section 319L) or for procurement of a security 

countermeasure under subsection (c)(7). 

(4) REPORT.—Not later than 30 days after any date on which 

the Secretary determines that the amount of funds in the special reserve fund available for procurement is less than 

$1,500,000,000, the Secretary shall submit to the appropriate 

committees of Congress a report detailing the amount of such 

funds available for procurement and the impact such reduction 

in funding will have— 

(A) in meeting the security countermeasure needs identified under this section; and 

(B) on the annual Public Health Emergency Medical 

Countermeasures Enterprise and Strategy Implementation 

Plan (pursuant to section 2811(d)). 

(h) DEFINITIONS.—In this section: 

(1) The term ‘‘advanced research and development’’ has the 

meaning given such term in section 319L(a). 

(2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense 

Countermeasures’’ appropriations account, any appropriation 

made available pursuant to section 521(a) of the Homeland Security Act of 2002, and any appropriation made available pursuant to subsection (g)(1). 

* * * * * * * 

SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 

AUTHORITY. 

(a) DEFINITIONS.—In this section: 

(1) BARDA.—The term ‘‘BARDA’’ means the Biomedical Advanced Research and Development Authority. 

(2) FUND.—The term ‘‘Fund’’ means the Biodefense Medical 

Countermeasure Development Fund established under subsection (d). 

(3) OTHER TRANSACTIONS.—The term ‘‘other transactions’’ 

means transactions, other than procurement contracts, grants, 

and cooperative agreements, such as the Secretary of Defense 

may enter into under section 2371 of title 10, United States 

Code. 


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(4) QUALIFIED COUNTERMEASURE.—The term ‘‘qualified countermeasure’’ has the meaning given such term in section 319F– 

1. 

(5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term 

‘‘qualified pandemic or epidemic product’’ has the meaning 

given the term in section 319F–3. 

(6) ADVANCED RESEARCH AND DEVELOPMENT.— (A) IN GENERAL.—The term ‘‘advanced research and development’’ means, with respect to a product that is or 

may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly— 

(i) are conducted after basic research and preclinical 

development of the product; and 

(ii) are related to manufacturing the product on a 

commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, 

and Cosmetic Act or under section 351 of this Act. 

(B) ACTIVITIES INCLUDED.—The term under subparagraph (A) includes— 

(i) testing of the product to determine whether the 

product may be approved, cleared, or licensed under 

the Federal Food, Drug, and Cosmetic Act or under 

section 351 of this Act for a use that is or may be the 

basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or 

to help obtain such approval, clearance, or license; 

(ii) design and development of tests or models, including animal models, for such testing; 

(iii) activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new 

technologies to increase manufacturing surge capacity; 

(iv) activities to improve the shelf-life of the product 

or technologies for administering the product; and 

(v) such other activities as are part of the advanced 

stages of testing, refinement, improvement, or preparation of the product for such use and as are specified 

by the Secretary. 

(7) SECURITY COUNTERMEASURE.—The term ‘‘security countermeasure’’ has the meaning given such term in section 319F– 

2. 

(8) RESEARCH TOOL.—The term ‘‘research tool’’ means a device, technology, biological material (including a cell line or an 

antibody), reagent, animal model, computer system, computer 

software, or analytical technique that is developed to assist in 

the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products. 

(9) PROGRAM MANAGER.—The term ‘‘program manager’’ 

means an individual appointed to carry out functions under 

this section and authorized to provide project oversight and 

management of strategic initiatives. 

(10) PERSON.—The term ‘‘person’’ includes an individual, 

partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government 

agency or department. 


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(b) STRATEGIC PLAN FOR COUNTERMEASURE RESEARCH, DEVELOPMENT, AND PROCUREMENT.— 

(1) IN GENERAL.—Not later than 6 months after the date of 

enactment of the Pandemic and All-Hazards Preparedness Act, 

the Secretary shall develop and make public a strategic plan 

to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. The Secretary shall carry out such activities as may be 

practicable to disseminate the information contained in such 

plan to persons who may have the capacity to substantially 

contribute to the activities described in such strategic plan. 

The Secretary shall update and incorporate such plan as part 

of the National Health Security Strategy described in section 

2802. 

(2) CONTENT.—The strategic plan under paragraph (1) shall 

guide— 

(A) research and development, conducted or supported 

by the Department of Health and Human Services, of 

qualified countermeasures and qualified pandemic or epidemic products against possible biological, chemical, radiological, and nuclear agents and to emerging infectious diseases; 

(B) innovation in technologies that may assist advanced 

research and development of qualified countermeasures 

and qualified pandemic or epidemic products (such research and development referred to in this section as 

‘‘countermeasure and product advanced research and development’’); and 

(C) procurement of such qualified countermeasures and 

qualified pandemic or epidemic products by such Department. 

(c) BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.— 

(1) ESTABLISHMENT.—There is established within the Department of Health and Human Services the Biomedical Advanced 

Research and Development Authority. 

(2) IN GENERAL.—Based upon the strategic plan described in 

subsection (b), the Secretary shall coordinate the acceleration 

of countermeasure and product advanced research and development by— 

(A) facilitating collaboration between the Department of 

Health and Human Services and other Federal agencies, 

relevant industries, academia, and other persons, with respect to such advanced research and development; 

(B) promoting countermeasure and product advanced research and development; 

(C) facilitating contacts between interested persons and 

the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act and under section 351 

of this Act; and 


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(D) promoting innovation to reduce the time and cost of 

countermeasure and product advanced research and development. 

(3) DIRECTOR.—The BARDA shall be headed by a Director 

(referred to in this section as the ‘‘Director’’) who shall be appointed by the Secretary and to whom the Secretary shall delegate such functions and authorities as necessary to implement 

this section. 

(4) DUTIES.— 

(A) COLLABORATION.—To carry out the purpose described 

in paragraph (2)(A), the Secretary shall— 

(i) facilitate and increase the expeditious and direct 

communication between the Department of Health and 

Human Services and relevant persons with respect to 

countermeasure and product advanced research and 

development, including by— 

(I) facilitating such communication regarding 

the processes for procuring such advanced research and development with respect to qualified 

countermeasures and qualified pandemic or epidemic products of interest; and 

(II) soliciting information about and data from 

research on potential qualified countermeasures 

and qualified pandemic or epidemic products and 

related technologies; 

(ii) at least annually— 

(I) convene meetings with representatives from 

relevant industries, academia, other Federal agencies, international agencies as appropriate, and 

other interested persons; 

(II) sponsor opportunities to demonstrate the 

operation and effectiveness of relevant biodefense 

countermeasure technologies; and 

(III) convene such working groups on countermeasure and product advanced research and development as the Secretary may determine are 

necessary to carry out this section; and 

(iii) carry out the activities described in section 405 

of the Pandemic and All-Hazards Preparedness Act. 

(B) SUPPORT ADVANCED RESEARCH AND DEVELOPMENT.— 

To carry out the purpose described in paragraph (2)(B), the 

Secretary shall— 

(i) conduct ongoing searches for, and support calls 

for, potential qualified countermeasures and qualified 

pandemic or epidemic products; 

(ii) direct and coordinate the countermeasure and 

product advanced research and development activities 

of the Department of Health and Human Services; 

(iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (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) and innovation in such areas 


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as the Secretary may identify as priority unmet need 

areas; and 

(iv) award contracts, grants, cooperative agreements, 

and enter into other transactions, for countermeasure 

and product advanced research and development. 

(C) FACILITATING ADVICE.—To carry out the purpose described in paragraph (2)(C) the Secretary shall— 

(i) connect interested persons with the offices or employees authorized by the Secretary to advise such 

persons regarding the regulatory requirements under 

the Federal Food, Drug, and Cosmetic Act and under 

section 351 of this Act related to the approval, clearance, or licensure of qualified countermeasures or 

qualified pandemic or epidemic products; and 

(ii) with respect to persons performing countermeasure and product advanced research and development funded under this section, enable such offices or 

employees to provide to the extent practicable such advice in a manner that is ongoing and that is otherwise 

designed to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure. 

(D) SUPPORTING INNOVATION.—To carry out the purpose 

described in paragraph (2)(D), the Secretary may award 

contracts, grants, and cooperative agreements, or enter 

into other transactions, such as prize payments, to promote— 

(i) innovation in technologies that may assist countermeasure and product advanced research and development; 

(ii) research on and development of research tools 

and other devices and technologies; and 

(iii) research to promote strategic initiatives, such as 

rapid diagnostics, broad spectrum antimicrobials, vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, and platform 

technologies. 

(5) TRANSACTION AUTHORITIES.— (A) OTHER TRANSACTIONS.— 

(i) IN GENERAL.—The Secretary shall have the authority to enter into other transactions under this subsection in the same manner as the Secretary of Defense enters into such transactions under section 2371 

of title 10, United States Code. 

(ii) LIMITATIONS ON AUTHORITY.— 

(I) IN GENERAL.—Subsections (b), (c), and (h) of 

section 845 of the National Defense Authorization 

Act for Fiscal Year 1994 (10 U.S.C. 2371 note) 

shall apply to other transactions under this subparagraph as if such transactions were for prototype projects described by subsection (a) of such 

section 845. 

(II) WRITTEN DETERMINATIONS REQUIRED.—The 

authority of this subparagraph may be exercised 


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for a project that is expected to cost the Department of Health and Human Services in excess of 

$20,000,000 only upon a written determination by 

the senior procurement executive for the Department (as designated for purpose of section 16(c) of 

the Office of Federal Procurement Policy Act (41 

U.S.C. 414(c))), that the use of such authority is 

essential to promoting the success of the project. 

The authority of the senior procurement executive 

under this subclause may not be delegated. 

(iii) GUIDELINES.—The Secretary shall establish 

guidelines regarding the use of the authority under 

clause (i). Such guidelines shall include auditing requirements. 

(B) EXPEDITED AUTHORITIES.— 

(i) IN GENERAL.—In awarding contracts, grants, and 

cooperative agreements, and in entering into other 

transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited procurement authorities, the authority to expedite peer 

review, and the authority for personal services contracts, supplied by subsections (b), (c), and (d) of section 319F–1. 

(ii) APPLICATION OF PROVISIONS.—Provisions in such 

section 319F–1 that apply to such authorities and that 

require institution of internal controls, limit review, 

provide for Federal Tort Claims Act coverage of personal services contractors, and commit decisions to the 

discretion of the Secretary shall apply to the authorities as exercised pursuant to this paragraph. 

(iii) AUTHORITY TO LIMIT COMPETITION.—For purposes of applying section 319F–1(b)(1)(D) to this paragraph, the phrase ‘‘BioShield Program under the 

Project BioShield Act of 2004’’ shall be deemed to 

mean the countermeasure and product advanced research and development program under this section. 

(iv) AVAILABILITY OF DATA.—The Secretary shall require that, as a condition of being awarded a contract, 

grant, cooperative agreement, or other transaction 

under subparagraph (B) or (D) of paragraph (4), a person make available to the Secretary on an ongoing 

basis, and submit upon request to the Secretary, all 

data related to or resulting from countermeasure and 

product advanced research and development carried 

out pursuant to this section. 

(C) ADVANCE PAYMENTS; ADVERTISING.—The Secretary 

may waive the requirements of section 3324(a) of title 31, 

United States Code, or section 3709 of the Revised Statutes of the United States (41 U.S.C. 5) upon the determination by the Secretary that such waiver is necessary to 

obtain countermeasures or products under this section. 

(D) MILESTONE-BASED PAYMENTS ALLOWED.—In awarding contracts, grants, and cooperative agreements, and in 

entering into other transactions, under this section, the 

Secretary may use milestone-based awards and payments. 


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(E) FOREIGN NATIONALS ELIGIBLE.—The Secretary may 

under this section award contracts, grants, and cooperative 

agreements to, and may enter into other transactions with, 

highly qualified foreign national persons outside the 

United States, alone or in collaboration with American 

participants, when such transactions may inure to the benefit of the American people. 

(F) ESTABLISHMENT OF RESEARCH CENTERS.—The Secretary may assess the feasibility and appropriateness of 

establishing, through contract, grant, cooperative agreement, or other transaction, an arrangement with an existing research center in order to achieve the goals of this 

section. If such an agreement is not feasible and appropriate, the Secretary may establish one or more federallyfunded research and development centers, or university-affiliated research centers, in accordance with section 

303(c)(3) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 253(c)(3)). 

(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. 

(H) CONTRACTING AUTHORITY CLARIFICATION.—The Secretary shall delegate authority for negotiating and entering 

into any contracts, grants, or cooperative agreements under 

this section to the Director. 

(6) AT-RISK INDIVIDUALS.—In carrying out the functions 

under this section, the Secretary may give priority to the advanced research and development of qualified countermeasures 

and qualified pandemic or epidemic products that are likely to 

be safe and effective with respect to children, pregnant women, 

elderly, and other at-risk individuals. 

(7) PERSONNEL AUTHORITIES.— 

(A) SPECIALLY QUALIFIED SCIENTIFIC AND PROFESSIONAL

PERSONNEL.— 

(i) IN GENERAL.—In addition to any other personnel 

authorities, the Secretary may— 

(I) without regard to those provisions of title 5, 

United States Code, governing appointments in 

the competitive service, appoint highly qualified 

individuals to scientific or professional positions in 

BARDA, such as program managers, to carry out 

this section; and 

(II) compensate them in the same manner and 

subject to the same terms and conditions in which 

individuals appointed under section 9903 of such 

title are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 

53 of such title relating to classification and General Schedule pay rates. 

(ii) MANNER OF EXERCISE OF AUTHORITY.—The authority provided for in this subparagraph shall be exVerDate Sep 11 2014 05:05 Sep 13, 2016 Jkt 059006 PO 00000 Frm 00035 Fmt 6659 Sfmt 6601 E:\HR\OC\HR735.XXX HR735

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ercised subject to the same limitations described in 

section 319F–1(e)(2). 

(iii) TERM OF APPOINTMENT.—The term limitations 

described in section 9903(c) of title 5, United States 

Code, shall apply to appointments under this subparagraph, except that the references to the ‘‘Secretary’’ 

and to the ‘‘Department of Defense’s national security 

missions’’ shall be deemed to be to the Secretary of 

Health and Human Services and to the mission of the 

Department of Health and Human Services under this 

section. 

(B) SPECIAL CONSULTANTS.—In carrying out this section, 

the Secretary may appoint special consultants pursuant to 

section 207(f). 

(C) LIMITATION.— 

(i) IN GENERAL.—The Secretary may hire up to 100 

highly qualified individuals, or up to 50 percent of the 

total number of employees, whichever is less, under 

the authorities provided for in subparagraphs (A) and 

(B). 

(ii) REPORT.—The Secretary shall report to Congress 

on a biennial basis on the implementation of this subparagraph. 

(d) FUND.— (1) ESTABLISHMENT.—There is established the Biodefense 

Medical Countermeasure Development Fund, which shall be 

available to carry out this section in addition to such amounts 

as are otherwise available for this purpose. 

(2) FUNDING.—To carry out the purposes of this section, 

there is authorized to be appropriated to the Fund 

$415,000,000 for each of fiscal years 2014 through 2018, such 

amounts to remain available until expended. 

(e) INAPPLICABILITY OF CERTAIN PROVISIONS.— (1) DISCLOSURE.— 

(A) IN GENERAL.—The Secretary shall withhold from disclosure under section 552 of title 5, United States Code, 

specific technical data or scientific information that is created or obtained during the countermeasure and product 

advanced research and development carried out under subsection (c) that reveals significant and not otherwise publicly known vulnerabilities of existing medical or public 

health defenses against biological, chemical, nuclear, or radiological threats. Such information shall be deemed to be 

information described in section 552(b)(3) of title 5, United 

States Code. 

(B) REVIEW.—Information subject to nondisclosure under 

subparagraph (A) shall be reviewed by the Secretary every 

5 years, or more frequently as determined necessary by the 

Secretary, to determine the relevance or necessity of continued nondisclosure. 

(C) SUNSET.—This paragraph shall cease to have force or 

effect on the date that is 12 years after the date of enactment of the Pandemic and All-Hazards Preparedness Act. 

(2) REVIEW.—Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA under this 


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section and the National Biodefense Science Board under section 319M shall each terminate on the date that is 5 years 

after the date on which each such group or Board, as applicable, was established. Such 5-year period may be extended by 

the Secretary for one or more additional 5-year periods if the 

Secretary determines that any such extension is appropriate. 

(f) INDEPENDENT EVALUATION.— 

(1) IN GENERAL.—Not later than 180 days after the date of 

enactment of this subsection, the Comptroller General of the 

United States shall conduct an independent evaluation of the 

activities carried out to facilitate flexible manufacturing capacity pursuant to this section. 

(2) REPORT.—Not later than 1 year after the date of enactment of this subsection, the Comptroller General of the United 

States shall submit to the appropriate committees of Congress 

a report concerning the results of the evaluation conducted 

under paragraph (1). Such report shall review and assess— 

(A) the extent to which flexible manufacturing capacity 

under this section is dedicated to chemical, biological, radiological, and nuclear threats; 

(B) the activities supported by flexible manufacturing 

initiatives; and 

(C) the ability of flexible manufacturing activities carried 

out under this section to— 

(i) secure and leverage leading technical expertise 

with respect to countermeasure advanced research, development, and manufacturing processes; and 

(ii) meet the surge manufacturing capacity needs 

presented by novel and emerging threats, including 

chemical, biological, radiological, and nuclear agents. 

* * * * * * * 

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: 


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(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 


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(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. 


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(c) FUNCTIONS.—The Assistant Secretary for Preparedness and 

Response shall— 

(1) have lead responsibility within the Department of Health 

and Human Services for emergency preparedness and response 

policy coordination and strategic direction; 

(2) have authority over and responsibility for— 

(A) the National Disaster Medical System pursuant to 

section 2812; 

(B) the Hospital Preparedness Cooperative Agreement 

Program pursuant to section 319C–2; 

(C) the Biomedical Advanced Research and Development 

Authority pursuant to section 319L; 

(D) the Medical Reserve Corps pursuant to section 2813; 

(E) the Emergency System for Advance Registration of 

Volunteer Health Professionals pursuant to section 319I; 

and 

(F) administering grants and related authorities related 

to trauma care under parts A through C of title XII, such 

authority to be transferred by the Secretary from the Administrator of the Health Resources and Services Administration to such Assistant Secretary; 

(3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of— 

(A) the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 319C–1; 

(B) the Strategic National Stockpile pursuant to section 

319F–2; and 

(C) the Cities Readiness Initiative; and 

(4) assume other duties as determined appropriate by the 

Secretary. 

(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 (which shall include pandemic influenza) 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 


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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 


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(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; øand¿ 

(K) report on the amount of time between the issuance of 

each request for a proposal or task order from the Biomedical Advanced Research and Development Authority 

and the award of a contract pursuant to such request for 

a proposal or task order; and 

ø(K)¿ (L) 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— 


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(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. 

* * * * * * * 

FEDERAL FOOD, DRUG, AND COSMETIC ACT 

* * * * * * * 

CHAPTER V—DRUGS AND DEVICES 

* * * * * * * 

SUBCHAPTER E—GENERAL PROVISIONS RELATING TO DRUGS AND

DEVICES

* * * * * * * 

SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 

AGENTS THAT PRESENT NATIONAL SECURITY THREATS. 

(a) DEFINITIONS.—In this section: 

(1) PRIORITY REVIEW.—The term ‘‘priority review’’, with respect to a human drug application as defined in section 735(1), 

means review and action by the Secretary on such application 

not later than 6 months after receipt by the Secretary of such 

application, as described in the manual of policies and procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and 

Drug Administration Safety and Innovation Act (Public Law 

112–144). 

(2) PRIORITY REVIEW VOUCHER.—The term ‘‘priority review 

voucher’’ means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application 

that entitles the holder of such voucher to priority review of a 

single human drug application submitted under section 

505(b)(1) of this Act or section 351(a) of the Public Health Service Act after the date of approval of the material threat medical 

countermeasure application. 

(3) MATERIAL THREAT MEDICAL COUNTERMEASURE APPLICA- TION.—The term ‘‘material threat medical countermeasure application’’ means an application that— 

(A) is a human drug application as defined in section 

735(1) to prevent, or treat harm from, a biological, chemVerDate Sep 11 2014 05:05 Sep 13, 2016 Jkt 059006 PO 00000 Frm 00043 Fmt 6659 Sfmt 6603 E:\HR\OC\HR735.XXX HR735

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ical, radiological, or nuclear agent identified as a material 

threat under section 319F–2(c)(2)(A)(ii) of the Public Health 

Service Act; 

(B) the Secretary deems eligible for priority review; 

(C) is approved after the date of enactment of the 

Strengthening Public Health Emergency Response Act of 

2016; and 

(D) is for a human drug, no active ingredient (including 

any ester or salt of the active ingredient) of which has been 

approved pursuant to any other application under section 

505(b)(1) of this Act or section 351(a) of the Public Health 

Service Act. 

(b) PRIORITY REVIEW VOUCHER.— 

(1) IN GENERAL.—The Secretary shall award a priority review 

voucher to the sponsor of a material threat medical countermeasure application upon approval by the Secretary of such application. 

(2) TRANSFERABILITY.— 

(A) IN GENERAL.—The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by 

sale) the entitlement to such voucher to a sponsor of a 

human drug for which an application under section 

505(b)(1) of this Act or section 351(a) of the Public Health 

Service Act will be submitted after the date of the approval 

of the material threat medical countermeasure application. 

There is no limit on the number of times a priority review 

voucher may be transferred before such voucher is used. 

(B) NOTIFICATION OF TRANSFER.—Each person to whom 

a voucher is transferred shall notify the Secretary of such 

change in ownership of the voucher not later than 30 days 

after the date of such transfer. 

(3) NOTIFICATION.— 

(A) IN GENERAL.—The sponsor of a human drug application shall notify the Secretary not later than 90 calendar 

days prior to submission of the human drug application 

that is the subject of a priority review voucher of an intent 

to submit the human drug application, including the date 

on which the sponsor intends to submit the application. 

Such notification shall be a legally binding commitment to 

pay for the user fee to be assessed in accordance with this 

section. 

(B) TRANSFER AFTER NOTICE.—The sponsor of a human 

drug application that provides notification of the intent of 

such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher 

after such notification is provided, if such sponsor has not 

yet submitted the human drug application described in the 

notification. 

(c) PRIORITY REVIEW USER FEE.— 

(1) IN GENERAL.—The Secretary shall establish a user fee program under which a sponsor of a human drug application that 

is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be 


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in addition to any fee required to be submitted by the sponsor 

under chapter VII. 

(2) FEE AMOUNT.—The amount of the priority review user fee 

shall be determined each fiscal year by the Secretary and based 

on the average cost incurred by the agency in the review of a 

human drug application subject to priority review in the previous fiscal year. 

(3) ANNUAL FEE SETTING.—The Secretary shall establish, before the beginning of each fiscal year beginning after September 

30, 2016, for that fiscal year, the amount of the priority review 

user fee. 

(4) PAYMENT.— 

(A) IN GENERAL.—The priority review user fee required by 

this subsection shall be due upon the notification by a 

sponsor of the intent of such sponsor to use the voucher, as 

specified in subsection (b)(3)(A). All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law. 

(B) COMPLETE APPLICATION.—An application described in 

subparagraph (A) for which the sponsor requests the use of 

a priority review voucher shall be considered incomplete if 

the fee required by this subsection and all other applicable 

user fees are not paid in accordance with the Secretary’s 

procedures for paying such fees. 

(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR RE- FUNDS.—The Secretary may not grant a waiver, exemption, 

reduction, or refund of any fees due and payable under this 

section. 

(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to 

this subsection for any fiscal year— 

(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food 

and Drug Administration; and 

(B) shall not be collected for any fiscal year except to the 

extent provided in advance in appropriation Acts. 

(d) NOTICE OF ISSUANCE OF VOUCHER AND APPROVAL OF PROD- UCTS UNDER VOUCHER.—The Secretary shall publish a notice in the 

Federal Register and on the public website of the Food and Drug 

Administration not later than 30 calendar days after the occurrence 

of each of the following: 

(1) The Secretary issues a priority review voucher under this 

section. 

(2) The Secretary approves a drug pursuant to an application 

submitted under section 505(b) of this Act or section 351(a) of 

the Public Health Service Act for which the sponsor of the application used a priority review voucher under this section. 

(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing in this section 

precludes a sponsor who seeks a priority review voucher under this 

section from participating in any other incentive program, including 

under this Act, except that no sponsor of a material threat medical 

countermeasure application may receive more than one priority review voucher issued under any section of this Act with respect to the 

drug that is the subject of such application. 

(f) RELATION TO OTHER PROVISIONS.—The provisions of this section shall supplement, not supplant, any other provisions of this Act 


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or the Public Health Service Act that encourage the development of 

medical countermeasures. 

(g) MEDICAL COUNTERMEASURE POSTAPPROVAL REPORT.— (1) IN GENERAL.—Not later than 5 years after the date of approval of a material threat medical countermeasure application, 

the sponsor of such application shall submit a report to the Secretary on such medical countermeasure. 

(2) CONTENTS.—A report under paragraph (1) shall include, 

with respect to each of the first 2 years after approval of such 

material threat medical countermeasure application, a description of— 

(A) the sponsor’s activities with Federal agencies related 

to the procurement, including stockpiling, of the approved 

medical countermeasure; 

(B) the sponsor’s progress in fulfilling contracts entered 

into with Federal agencies, including the Biomedical Advanced Research and Development Authority, the Centers 

for Disease Control and Prevention, and the Department of 

Defense, related to such procurement; 

(C) the extent to which the Federal Government has fulfilled its stated medical countermeasure requirements for 

the threat intended to be treated by the approved medical 

countermeasure; and 

(D) the sponsor’s plans, if any, to develop additional material threat medical countermeasures. 

(3) AVAILABILITY TO CONGRESSIONAL COMMITTEES.—The Secretary shall make each report submitted under this subsection 

available to the Committee on Energy and Commerce of the 

House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate upon request by either such Committee not later than 30 days after receipt of such 

request. 

(4) RULE OF CONSTRUCTION.—Nothing in this subsection 

shall be construed to permit the disclosure of confidential commercial or trade secret information or the disclosure of information that could compromise national security. 

* * * * * * * 


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1 Congressional Research Service, Federal Efforts to Address the Threat of Bioterrorism: Selected Issues and Options for Congress (Feb. 8, 2011) (R41123). 2 Id. 

3 Bipartisan Report of the Blue Ribbon Study Panel on Biodefense, A National Blueprint for 

Biodefense: Leadership and Major Reform Needed to Optimize Efforts (Oct. 2015). 

DISSENTING VIEWS 

We oppose the passage of H.R. 3299, the Strengthening Public 

Health Emergency Response Act of 2015, a bill that would make 

reforms to how the federal government acquires, procures, and develops medical countermeasures (MCMs) to prevent or treat biological threats. While this legislation attempts to address important recommendations on our nation’s biodefense preparedness, we 

are concerned that it would not improve our nation’s biodefense 

preparedness, includes policies that will undermine the Department of Health and Human Services’ (HHS) oversight over biodefense contracting, and would further burden the Food and Drug 

Administration (FDA) by creating a new, permanent, and unnecessary priority review voucher (PRV) program to incentivize the development of MCMs without addressing underlying flaws inherent 

in this incentive program. 

I. BACKGROUND

Following the September 11, 2001, terrorist attacks and the subsequent anthrax mailings, Congress passed legislation to address 

the threat of bioterrorism by increasing investments in research 

and preparedness to defend against biological weapons.1 Significant 

legislation included the Homeland Security Act of 2002 and the 

Pandemic and All-Hazards Preparedness Act (PAHPA) of 2006, 

which established new departments and agencies to address preparedness and bioterrorism response.2

Earlier this year the Subcommittee on Oversight and Investigations heard from members of the Blue Ribbon Panel on Biodefense 

and other experts about the current status of the United States’ 

biodefense preparedness. A report released by the Blue Ribbon 

Panel on October 28, 2015, found: 

The nation has not come to fully appreciate the severity 

of the biological threat and our leaders have not demonstrated the political will to fully address it. We must address these shortcomings by prioritizing the following 

areas: 1) coordination and accountability among federal departments and agencies; 2) collaboration between federal 

and non-federal stakeholders; and 3) innovation that addresses both lingering and novel problems.’’ 3

Further, the report found that the United States ‘‘does not afford 

the biological threat the same level of attention as it does other 


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48 

4 Id. 

threats.’’ 4 This comprehensive review also offered 33 recommendations about how Congress and the Administration can improve our 

preparedness. H.R. 3299 was introduced in response to this report 

and includes provisions meant to address these recommendations, 

such as: putting in place procedures to coordinate the ongoing 

stockpiling of medical countermeasures by the Biomedical Advanced Research and Development Authority (BARDA) and the 

Centers for Disease Control and Prevention; providing BARDA 

with direct contracting authority; requiring a report by the Government Accountability Office (GAO) on programs for public health 

emergency preparedness; and creating a PRV program, which 

would award a voucher to the sponsor of a new drug or biological 

product to treat a material threat that entitles the sponsor to a six 

month review of any future new drug or biological product application of the sponsor’s choosing. 

While legislative efforts to increase our nation’s preparedness 

and response to biological threats have historically enjoyed bipartisan support, H.R. 3299 fails to address concerns raised by the Administration regarding provisions that would limit oversight over 

contracting authority and would create a burdensome incentive 

program without addressing flaws in the underlying program’s 

structure. 

II. H.R. 3299: A MISGUIDED ATTEMPT TO REFORM BIODEFENSE

CONTRACTING AND MEDICAL COUNTERMEASURE DEVELOPMENT

A. H.R. 3299 REVISES BARDA TRANSACTION AUTHORITIES, 

UNDERMINING PROGRAM INTEGRITY

H.R. 3299 would grant BARDA the authority to directly negotiate and enter into contracts, grants, or cooperative agreements. 

The change to BARDA’s contracting structure proposed by H.R. 

3299 raises concerning program integrity issues. Currently, 

BARDA enters into contracts through the Office of Acquisition, 

Management, Contracts, and Grants (AMCG) and the Assistant 

Secretary for Preparedness and Response (ASPR) Office, its parent 

organization. This structure protects the integrity of the contracting process. The delegation of the function to negotiate and 

enter into contracts, grants, and cooperative agreements to the 

BARDA Director could result in the federal government not getting 

the best value for taxpayer dollars. 

After Secretary Sebelius provided Congress with notice and published the required announcement in the Federal Registrar in 

2010, contracting offices were removed from BARDA and other divisional entities within ASPR and consolidated into the AMCG 

along with other ASPR-wide reorganization efforts. The restructuring of the contract offices was done to streamline ASPR’s contracting activity, to bolster program integrity, and to ensure that 

ASPR and all of its operating divisions conduct their business without either the perception or potentially the reality of undue influence by program officials. The restructuring also allowed the 

AMCG to get Head of Contracting Activity (HCA)—an authority 

that allows a contracting office to be a self-fulfilling, self-managed 


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contracting office. This designation removed the need for the contracting office to go through an additional layer of approval at the 

departmental level before a contract could be completed. The current structure, which is consistent with procurement practices 

across the federal government, ensures the right balance between 

expert scientists that advance our national preparedness and expert contracting professionals that ensure the government is getting the best value for every taxpayer dollar. 

The integrity-minded structure established by the ASPR in 2010 

has not only contributed to a steadily improved contracting process 

but also one that has successfully withstood the few protests presented to the organization. The existence of undue influence could 

potentially compel a contracting officer to do something unethical 

or illegal at the direction of the BARDA director because they 

worry that the BARDA director, who would ultimately control their 

performance appraisal and promotions, might take adverse action 

against them. Overpaying for the research and development of 

medical countermeasures or for some products could limit our ability to enter into advanced development and procurement contracts 

for new medical countermeasures since only finite resources are 

available. This could weaken our preparedness for public health 

emergencies and protection against terrorist attacks by limiting the 

number of medical countermeasures we have in the pipeline to respond to chemical, biological, radiological, and nuclear (CBRN) 

threats as well as other public health threats. 

1. Potentially Slows Down the Contracting Process 

The changes proposed by H.R. 3299 could result in the contracting office losing its HCA designation, which would be consistent with the operation of the contracting office prior to its placement under ASPR. Since the reorganization of ASPR, which consolidated organization-wide contracting activities in the AMCG Office at ASPR, BARDA has experienced an acceleration in the delivery of medical countermeasures. For example, of the total 23 products that BARDA has supported that received FDA approval, licensure, or clearance, 14 of those approvals have occurred since 2011 

and five have occurred in the last 16 months. BARDA is also currently supporting a pipeline of over 100 more. 

If the contracting office loses that designation, BARDA contracts 

could be forced to go through an additional layer of approval at the 

department level that is not required by the current structure. As 

a result, the pace at which BARDA completes contracts is likely to 

slow down. This would be counter to the stated goals of this change 

and harm our ability to accelerate medical countermeasure development. 

B. H.R. 3299 EXTENDS AN UNNECESSARY, UNPROVEN, AND INHERENTLY

FLAWED INCENTIVE TO MEDICAL COUNTERMEASURES

As passed by the Committee, H.R. 3299 creates a new standalone 

and permanent PRV program for MCMs. The new permanent 

MCM PRV program would require FDA to review within six 

months any human drug application that is: (1) approved to prevent or treat harm from a material threat listed in section 319F– 


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5 H.R. 3299, Section 7. 

6 Congressional Research Service, The Project BioShield Act: Issues for the 113th Congress 

(June 18, 2014) (R43607). 7For example, in the 2015 President’s Budget, HHS reported it would spend over $830 million 

during the 2015 fiscal year to support medical countermeasure research, development, and procurement through BARDA and Project BioShield. Department of Health and Human Services, 

FY2015 Budget in Brief, (June 4, 2014) (www.hhs.gov/about/budget/fy2015/budget-in-brief/ 

phssef/index.html#). 8 House Committee on Energy and Commerce, Testimony of Michael Mair, Director of Strategic Operations, Food and Drug Administration, Hearing on Examining H.R. 3299, Strengthening Public Health Response Act, 114th Cong. (May 19, 2016) 9 Id. 

10Department of Health and Human Services, Department Of Health And Human Services’ 

Centers for Innovation in Advanced Development and Manufacturing (HHS–CIADM) 

(www.medicalcountermeasures.gov/barda/core-services/ciadm.aspx). 11 Nanotherapeutics Celebrates Groundbreaking of its Advanced Development and Manufacturing Center (NANO–ADM) in Copeland Park, Alachua, FL, Business Wire (Oct. 23, 2013) 

(www.businesswire.com/news/home/20131023005120/en/Nanotherapeutics-CelebratesGroundbreaking-Advanced-Development-Manufacturing-Center). 

2(c)(2)(A)(ii) of the Public Health Service Act; (2) eligible for priority review; (3) approved after the date of enactment of H.R. 3299; 

and, (4) includes no active ingredient previously approved by FDA.5

If FDA approves such an application, the agency must award the 

sponsor a PRV which entitles its holder to a second six-month priority review of any other human drug application (the standard 

drug review time is ten months). A company awarded a PRV can 

redeem the voucher for expedited review of its own product, or 

transfer or sell the PRV to another company. The only requirement 

is that a company redeeming a PRV must provide FDA with 90 

days advanced notice of its intent to redeem and pay FDA a priority review user fee to help offset the costly and resource-intensive 

priority review. The creation of this incentive is meant to spur continued and future development of MCMs. 

1. Existing Authorities and Incentives Sufficient to Encourage 

MCM Development 

While MCMs play an important role in our national security, 

H.R. 3299 extends an unnecessary incentive to drug companies. 

Companies that produce MCMs often receive significant federal 

support throughout the drug research and development, approval, 

and procurement process. A 2014 Congressional Research Service 

(CRS) report stated that, since 2004, the federal government has 

spent over $3 billion procuring MCMs.6 Further, in addition to the 

billions spent post-approval by the government to purchase these 

products for stockpiling, lucrative federal contracts often support 

research and development of these drugs.7

FDA also devotes significant taxpayer funded resources to assist 

MCM sponsors throughout the drug development and approval 

process. For example, in fiscal year 2015 alone, FDA held 84 formal 

meetings with MCM developers or applicants to provide technical 

assistance or clarify regulatory requirements.8 Since 2000, FDA 

has approved 89 medical countermeasures, 17 supplemental 

changes to already approved applications, and 71 modifications to 

diagnostic devices.9 Drug companies developing MCMs also often 

utilize existing government research and develop and produce 

MCMs in government-funded research facilities and production 

sites.10,11 The large number of approved MCMs and strong regulatory support demonstrate that sufficient incentives currently 


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12 House Committee on Energy and Commerce, Testimony of Michael Mair, Director of Strategic Operations, Food and Drug Administration, Hearing on Examining H.R. 3299, Strengthening Public Health Response Act, 114th Cong. (May 19, 2016) 13Tatum Anderson, Novartis Under Fire for Accepting New Reward for Old Drug, Lancet (Apr. 

25, 2009). 14 Aaron S. Kesselheim et al., Experience With the Priority Review Voucher Program for Drug 

Development, JAMA (Oct. 27, 2015) 15There is a set criteria FDA must adhere to when designating a drug as eligible for priority 

review and this should not be viewed as giving FDA significant discretion in determining PRV 

eligibility. To qualify for priority review, a drug must treat a serious condition (e.g., a material 

threat) and demonstrate only potential to be a significant improvement in safety or effectiveness. 

After receiving a request for a priority review designation, FDA only has 60 days to make this 

determination. 

exist for investments in MCM development. Providing an additional incentive of a PRV, the last of which sold for $350 million, 

is unnecessary and will amount to a windfall for many drug companies at the expense of American taxpayers. 

2. Lack of Evidence PRV Programs Work 

It is unclear if existing PRV programs are having the intended 

effect of incentivizing investment in new research and development 

of drugs. At the May 19, 2016 Subcommittee on Health hearing on 

H.R. 3299, FDA testified that, to date, there is no evidence that the 

two existing PRV programs (rare pediatric diseases and neglected 

tropical diseases) are incentivizing new research and drug development, or benefiting those Congress intended.12 For example, of the 

three PRVs awarded under the tropical disease PRV program, two 

were awarded to drugs that had been used for years outside the 

United States. One drug was approved in over 80 countries before 

the sponsor filed an application with FDA—an application that included only studies conducted before 2007 to obtain approval outside the United States.13 The second drug was registered outside 

the United States for over a decade before an application was filed 

with FDA and the filed application only included studies conducted 

by a company that previously owned the drug.14 However, under 

the terms of the program, FDA was forced to award two PRVs— 

one to a company that conducted no new research, and one to a 

company that conducted no research at all. Further, in the tropical 

disease PRV program, people afflicted with the disease have been 

unable to access approved drugs because, unlike the rare pediatric 

PRV program, there is no requirement that a sponsor market its 

drug after receiving the valuable PRV award in the tropical disease 

context. The underlying problems identified in the tropical disease 

PRV program have not been addressed in the creation of the MCM 

PRV program in H.R. 3299. H.R. 3299 does not limit a PRV award 

only to companies that invest in new drug research and development, and does not require a company that receives a PRV to 

produce and make the MCM available to the U.S. government for 

stockpiling purposes. 

3. Proposed New PRV Program Does Not Meaningfully Limit 

Eligibility 

Under H.R. 3299, FDA must approve a new drug application 

(NDA) for a drug to treat a material threat that: (1) qualifies for 

a six-month priority review; 15 (2) is approved after the date of enactment; and (3) contains no active ingredient previously approved 


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by FDA. If the sponsor’s NDA meets these qualifications and is approved by FDA, the sponsor is then eligible for a PRV. The program created in the H.R. 3299 AINS does not preclude PRV awards 

to drug companies: • With drug applications currently under review at FDA; • That previously received approval of the MCM outside the 

United States; and, • That are developing drugs that do not fulfill an existing 

federal government need (e.g., developing drugs for which 

there is an existing treatment in the strategic national stockpile). 

Without appropriate safeguards, it is unclear that H.R. 3299 

would appropriately award PRVs to new MCMs that are needed by 

the federal government, and could instead further flood the market 

with PRVs for products that may not be novel or necessary from 

a national preparedness perspective. This could have the unintended consequence of reducing the value of PRVs overall and 

thereby disincentivize development of new drugs under all PRV 

programs. 

4. Creation of a New PRV Program Could Undermine FDA’s Drug 

Review Process and Public Health Mission 

Generally, FDA will grant a six-month priority review to drug 

applications that have potential to improve public health, such as 

a drug that will address an unmet medical need. However, PRVs 

awarded under the tropical and rare pediatric disease programs 

can be used to expedite review of a drug application that otherwise 

would not qualify. PRV programs essentially allow a drug sponsor 

to purchase a priority review at the expense of other public health 

priorities. Increasing the burden on FDA to expedite review of 

more applications with limited public health value undermines 

FDA’s ability to fulfill its mission, manage its drug review workload, and threatens staff morale. 

FDA drug product reviewers are organized into divisions that 

specialize in reviewing specific drug classes. Drug reviewers cannot 

be ‘‘reassigned’’ to assist another division in reviewing an application submitted for expedited review (e.g., a reviewer trained to review oncology drugs cannot be reassigned to help expedite review 

of a weight loss drug submitted with a PRV). A drug company utilizing a PRV must only provide FDA with 90 days’ notice before 

submitting the new drug application for priority review, preventing 

FDA from hiring and training staff necessary to expedite review of 

applications submitted with a PRV. As a result, when a company 

redeems a PRV, FDA must divert resources from existing work to 

expedite review of a drug that may, under normal circumstances, 

be a lower priority. In addition, a new drug application that qualifies for the standard ten-month review generally is supported by 

large data sets that take FDA reviewers significant time to evaluate. When such an application is submitted with a PRV, it places 

a significant strain on FDA resources by reducing the time an FDA 

reviewer has to perform important work from ten to six months. 

Some supporters of the new PRV program included in H.R. 3299 

have suggested that this incentive comes at no cost to the taxpayer. 

However, expediting review of new drug applications that would 


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16Letter from Dr. David Ridley, Ph.D, Faculty Director, Health Sector Management, Duke 

University Fuqua School of Business, to Rep. Frank Pallone, Jr. and Rep. Gene Green, House 

Committee on Energy and Commerce (May 17, 2016). 17David B. Ridley and Stephane A. Regnier, The Commercial Market For Priority Review 

Vouchers, Health Affairs (May 1, 2016) (content.healthaffairs.org/content/35/5/776.full). 

not ordinarily qualify for priority review, places an enormous strain 

on FDA’s resources. This costs taxpayers money since it is tax dollars that fund this additional work. Additionally, it costs the American public when access to new drugs is delayed because a drug 

company ‘‘skipped the line’’ with a PRV and delayed FDA approval 

of other important drugs. 

5. Expanding Eligibility for PRVs to MCMs May Diminish the 

Value for Tropical Disease and Rare Pediatric PRVs 

David Ridley, the architect of the PRV program, cautioned 

against expanding the program to include MCMs. In a letter submitted for the record at the May 19, 2016, hearing on H.R. 3299, 

Mr. Ridley stated that such expansion could reduce the value of a 

PRV, as increasing the number of available PRVs would sharply 

decrease the expected price. This would make a PRV not only an 

ineffective incentive to develop MCMs, but also have the unintended consequence of disincentivizing development of drugs to 

treat rare pediatric and neglected tropical diseases as well. Mr. 

Ridley stated: 

Viewed in isolation, it makes perfect sense to add medical countermeasures to the diseases eligible for priority 

review vouchers. However, members of Congress should be 

aware that adding voucher-eligible diseases will drive 

down the price of vouchers and thus drive down the incentive to develop treatments for diseases already on the list. 

In the current issue of Health Affairs, my coauthor and I 

estimated that if one voucher is available in a year, it will 

be worth more than $200 million, but if four vouchers are 

available, then the price could fall below $100 million (Ridley and Re ́gnier 2006). If voucher prices fall below $100 

million, then the expected net present value of the voucher 

would fall below the typical cost of a Phase III clinical trial 

and FDA submission. Hence, the voucher would not provide sufficient incentive for drug development and additional incentives would be needed . . .16

Devaluation of a PRV can reduce the program’s effectiveness by 

undermining incentives to develop new medicines for tropical or 

rare pediatric diseases.17

6. The Unjustified and Unnecessary MCM PRV Program Would Be 

Permanent 

In other important areas, such as incentivizing development of 

drugs to help children, Congress thought it important to include a 

sunset date to allow for an opportunity to assess a program’s impacts and determine if reauthorization is in the best interest of the 

American public. For example, the rare pediatric disease PRV program, the Best Pharmaceuticals for Children Act (BPCA), and the 

Pediatric Research Equity Act (PREA) included initial sunset dates 


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18 BPCA was enacted in 1997, and PREA was enacted in 2003. Both programs were made permanent as a part of the Food and Drug Administration Safety and Innovation Act in 2012. 

so that we, as members of Congress, could determine if the legislation we enacted was working as intended. Both BPCA and PREA 

were later enacted on a permanent basis; however, this was only 

after Congress had the opportunity to assess if the program’s benefits outweighed its costs.18

There is no sunset in the MCM PRV program that would give 

Congress a similar opportunity to determine if the program is effective or working as intended. It is important to note that there has 

been only one study of existing priority review programs, which focused narrowly on one PRV program. In this study, the Government Accountability Office found a lack of evidence demonstrating 

that the rare pediatric disease program was incentivizing new investment in drug research and development. As there is no existing 

evidence—other than anecdotes from those that stand to gain from 

PRV programs—demonstrating that such programs are having the 

effect that Congress intended, it is unwise to create a new and permanent program for MCMs. 

FRANK PALLONE, Jr., 

Ranking Member. 

GENE GREEN, 

Ranking Member, Subcommittee on Health. 

Æ 


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