IB 
Union Calendar No. 571 
114TH CONGRESS 
2D SESSION 
H. R. 3299 
[Report No. 114–735] 
To amend the Public Health Service Act to ensure preparedness for chemical, 
radiological, biological, and nuclear threats, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 29, 2015 
Mrs. BROOKS of Indiana (for herself and Ms. ESHOO) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
SEPTEMBER 9, 2016 
Additional sponsors: Mr. FLORES, Mrs. ELLMERS of North Carolina, Mrs. 
BLACKBURN, Mr. MULLIN, Mr. HUNTER, Mrs. MIMI WALTERS of Cali-
fornia, Mr. BISHOP of Michigan, Mr. LONG, Mr. NUNES, Mr. TURNER, 
Mr. BURGESS, Mr. KNIGHT, Mr. CARTER of Georgia, Mr. BILIRAKIS, Mr. 
GARAMENDI, Mr. GRIFFITH, Mr. SWALWELL of California, Mr. COLLINS 
of New York, Mr. LANCE, Mrs. COMSTOCK, Mr. GUTHRIE, Mr. HAS-
TINGS, Mr. KINZINGER of Illinois, Mr. STEWART, Mr. VARGAS, Mr. 
BUCSHON, Mr. WALDEN, Mr. CRAMER, Mr. HUDSON, Mr. JOYCE, Mr. 
JOHNSON of Ohio, Mr. QUIGLEY, Mr. CRENSHAW, Mr. OLSON, Mr. 
DAVID SCOTT of Georgia, Mr. CA´RDENAS, Mr. WITTMAN, Mr. DENHAM, 
Mr. MESSER, Mr. RUPPERSBERGER, Mr. RUSH, Ms. SPEIER, Mr. SHIM-
KUS, Mrs. MCMORRIS RODGERS, Mr. RODNEY DAVIS of Illinois, and Mr. 
PASCRELL 
SEPTEMBER 9, 2016 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on July 29, 2015] 
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A BILL 
To amend the Public Health Service Act to ensure prepared-
ness for chemical, radiological, biological, and nuclear 
threats, and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘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 prepared-
ness to improve surge capacity). 
(b) CONTENTS.—The report under subsection (a) shall 
address each of the following: 
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(1) The goals of the programs specified in sub-
section (a). 
(2) The extent to which such goals are being met, 
including performance metrics that could help to as-
sess whether such programs are succeeding at the coa-
lition and member level. 
(3) How such programs could be improved, in-
cluding how such programs could be modified to im-
prove the medical preparedness of hospitals, health 
care coalitions, and the continuity of health care de-
livery. 
(4) How such programs complement other pre-
paredness 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 pre-
paredness entities being self-sustaining. 
(7) Whether the level of funding for such pro-
grams is sufficient. 
(8) How funding for such programs is being used 
to ensure preparedness for at-risk populations includ-
ing children, pregnant women, senior citizens, and 
other individuals who may have unique needs in the 
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event of a public health emergency, such as individ-
uals with disabilities. 
(9)(A) How, and to what extent, entities are 
using the funds awarded to such entities through sec-
tion 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 
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(3) by adding at the end the following: 
‘‘(I) ensure procedures are in place to co-
ordinate the ongoing stockpiling by the Bio-
medical Advanced Research and Development 
Authority and Centers for Disease Control and 
Prevention of qualified countermeasures (as de-
fined 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 de-
fined 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)— 
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(A) by striking subparagraphs (A), (B), (C), 
and (E); and 
(B) by striking ‘‘(6) RECOMMENDATIONS 
FOR PRESIDENT’S APPROVAL’’ and all that fol-
lows through ‘‘(D) SUBSEQUENT SPECIFIC COUN-
TERMEASURES.—’’ and inserting ‘‘(6) SUBSE-
QUENT SPECIFIC COUNTERMEASURES.—’’; and 
(3) in paragraph (7)— 
(A) by striking subparagraph (A); 
(B) by redesignating subparagraph (B) as 
subparagraph (A) and amending such subpara-
graph (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 procure-
ment 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: 
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‘‘(H) CONTRACTING AUTHORITY CLARIFICA-
TION.—The Secretary shall delegate authority for 
negotiating and entering into any contracts, 
grants, or cooperative agreements under this sec-
tion to the Director.’’. 
SEC. 6. PUBLIC HEALTH EMERGENCY MEDICAL COUNTER-
MEASURES ENTERPRISE STRATEGY AND IM-
PLEMENTATION 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 ‘‘de-
scribe the chemical, biological, radiological, and nu-
clear agent or agents that may present a threat to the 
Nation’’ the following: ‘‘(which shall include pan-
demic influenza)’’; 
(2) by striking ‘‘and’’ at the end of subpara-
graph (J); 
(3) by redesignating subparagraph (K) as sub-
paragraph (L); and 
(4) by inserting after subparagraph (J) the fol-
lowing: 
‘‘(K) report on the amount of time between 
the issuance of each request for a proposal or 
task order from the Biomedical Advanced Re-
search and Development Authority and the 
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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 SE-
CURITY 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 fol-
lowing: 
‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREAT-
MENTS FOR AGENTS THAT PRESENT NA-
TIONAL SECURITY THREATS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) PRIORITY REVIEW.—The term ‘priority re-
view’, 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 applica-
tion, as described in the manual of policies and proce-
dures 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 Inno-
vation Act (Public Law 112–144). 
‘‘(2) PRIORITY
REVIEW
VOUCHER.—The term 
‘priority review voucher’ means a voucher issued by 
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the Secretary to the sponsor of a material threat med-
ical countermeasure application that entitles the hold-
er 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
COUNTER-
MEASURE APPLICATION.—The term ‘material threat 
medical countermeasure application’ means an appli-
cation that— 
‘‘(A) is a human drug application as de-
fined in section 735(1) to prevent, or treat harm 
from, a biological, chemical, radiological, or nu-
clear 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 pri-
ority 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 ingre-
dient (including any ester or salt of the active 
ingredient) of which has been approved pursuant 
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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 ap-
proval by the Secretary of such application. 
‘‘(2) TRANSFERABILITY.— 
‘‘(A) IN GENERAL.—The sponsor of a mate-
rial 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 sec-
tion 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 
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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 Sec-
retary 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 spon-
sor 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 vouch-
er 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 
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‘‘(B) COMPLETE APPLICATION.—An appli-
cation 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 applica-
ble user fees are not paid in accordance with the 
Secretary’s procedures for paying such fees. 
‘‘(C) NO
WAIVERS, EXEMPTIONS, REDUC-
TIONS, 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 off-
setting collections to the account providing ap-
propriations to the Food and Drug Administra-
tion; 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 AP-
PROVAL 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 
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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 pri-
ority review voucher under this section. 
‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 
in this section precludes a sponsor who seeks a priority re-
view voucher under this section from participating in any 
other incentive program, including under this Act, except 
that no sponsor of a material threat medical counter-
measure 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 provi-
sions 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 counter-
measures. 
‘‘(g) MEDICAL COUNTERMEASURE POSTAPPROVAL RE-
PORT.— 
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‘‘(1) IN GENERAL.—Not later than 5 years after 
the date of approval of a material threat medical 
countermeasure application, the sponsor of such ap-
plication 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 coun-
termeasure application, a description of— 
‘‘(A) the sponsor’s activities with Federal 
agencies related to the procurement, including 
stockpiling, of the approved medical counter-
measure; 
‘‘(B) the sponsor’s progress in fulfilling con-
tracts entered into with Federal agencies, includ-
ing the Biomedical Advanced Research and De-
velopment Authority, the Centers for Disease 
Control and Prevention, and the Department of 
Defense, related to such procurement; 
‘‘(C) the extent to which the Federal Gov-
ernment has fulfilled its stated medical counter-
measure requirements for the threat intended to 
be treated by the approved medical counter-
measure; and 
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‘‘(D) the sponsor’s plans, if any, to develop 
additional material threat medical counter-
measures. 
‘‘(3) AVAILABILITY TO CONGRESSIONAL COMMIT-
TEES.—The Secretary shall make each report sub-
mitted under this subsection available to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate upon request by ei-
ther such Committee not later than 30 days after re-
ceipt 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 com-
promise national security.’’. 
(b) GAO REPORT.— 
(1) STUDY.—The Comptroller General of the 
United States shall conduct a study on the effective-
ness 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 counter-
measure applications under such section 565A. In 
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conducting such study, the Comptroller General shall 
examine the following: 
(A) The impact of such priority review on 
the development of material threat medical coun-
termeasures and the impact of such investment, 
as applicable, on the development of such coun-
termeasures. 
(B) How the drugs for which such priority 
review vouchers were awarded— 
(i) addressed identified medical coun-
termeasure needs; and 
(ii) impacted United States prepared-
ness against chemical, biological, radio-
logical, and nuclear threats, including both 
identified threats and naturally occurring 
threats. 
(C) How many material threat medical 
countermeasures were licensed or approved, or 
otherwise significantly advanced in clinical de-
velopment, in the 15 years following the enact-
ment of such section 565A compared to the 15 
years prior to the enactment of such section, in-
cluding a comparative analysis of Federal ad-
vanced development and procurement dollars 
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available in the 15 years following such enact-
ment compared to the prior 15 years. 
(D) How material threat medical counter-
measures developed after the date of enactment of 
this Act impact— 
(i) the supply of products in the stra-
tegic 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 counter-
measures during the research, development, ap-
plication review, and production of such drugs, 
including the use of government research, provi-
sion 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 sec-
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tion 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 mar-
keted therapy approved to prevent or 
treat the same indication in the same 
patient population at the time the ap-
plication was submitted to the Food 
and Drug Administration; and 
(II) if the drug provided a signifi-
cant benefit or improvement in safety 
and effectiveness compared to such cur-
rently marketed product; 
(iii) the price of the priority review 
voucher if transferred or sold prior to re-
demption; 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 
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how many of such awarded vouchers were 
redeemed for priority review of a drug ap-
plication in the 15 years following the date 
of enactment of such section; 
(ii) the resources associated with the 
Food and Drug Administration implemen-
tation 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 ap-
propriate Federal funding for advanced de-
velopment 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 
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of medical countermeasures than the uncer-
tain 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 re-
search and development of medical counter-
measures to address biological, chemical, radio-
logical, and nuclear threats; 
(B) stakeholders involved in investing in the 
research and development of such medical coun-
termeasures, including venture capitalists; 
(C) the Federal Government agencies re-
sponsible for advancing, reviewing, and pro-
curing such medical countermeasures, includ-
ing— 
(i) the Department of Health and 
Human Services, including the Office of the 
Assistant Secretary for Preparedness and 
Response, the Biomedical Advanced Re-
search and Development Authority, and the 
Food and Drug Administration; and 
(ii) the Department of Defense; 
(D) biodefense stakeholders, as applicable; 
and 
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(E) drug manufacturers involved in the re-
search and development of therapies that ad-
dress— 
(i) tropical diseases (as defined in sec-
tion 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 
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House of Representatives a report containing the re-
sults of the study conducted under paragraph (1). 
(5) PROTECTION OF NATIONAL SECURITY.—The 
Comptroller General of the United States shall con-
duct the study under paragraph (1) and issue the as-
sessment and report under paragraphs (3) and (4) in 
a manner that does not compromise national security. 
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Union Calendar No. 571 
114TH CONGRESS 
2D SESSION 
H. R. 3299 
[Report No. 114–735] 
A BILL 
To amend the Public Health Service Act to ensure 
preparedness for chemical, radiological, biologi-
cal, and nuclear threats, and for other purposes. 
SEPTEMBER 9, 2016 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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