I 
118TH CONGRESS 
1ST SESSION H. R. 4697 
To amend the Public Health Service Act to reauthorize certain programs 
with respect to public health security and all-hazards preparedness and 
response related to the Administration for Strategic Preparedness and 
Response and certain programs with respect to public health security 
and all-hazards preparedness and response related to the Centers for 
Disease Control and Prevention, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 18, 2023 
Ms. SCHRIER (for herself, Ms. ESHOO, Mr. PALLONE, Ms. DEGETTE, Ms. 
SCHAKOWSKY, Ms. MATSUI, Ms. CASTOR of Florida, Mr. SARBANES, Mr. 
TONKO, Ms. CLARKE of New York, Mr. CA´RDENAS, Mr. RUIZ, Mr. 
PETERS, Mrs. DINGELL, Mr. VEASEY, Ms. KUSTER, Ms. KELLY of Illi-
nois, Ms. BARRAGA´N, Ms. BLUNT ROCHESTER, Mr. SOTO, Ms. CRAIG, 
Mrs. TRAHAN, and Mrs. FLETCHER) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to reauthorize cer-
tain programs with respect to public health security and 
all-hazards preparedness and response related to the Ad-
ministration for Strategic Preparedness and Response 
and certain programs with respect to public health secu-
rity and all-hazards preparedness and response related 
to the Centers for Disease Control and Prevention, 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 
‘‘Protecting Pandemic and All-Hazards Preparedness Act 
of 2023’’ or the ‘‘Protecting PAHPA Act of 2023’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—PREPARING FOR AND RESPONDING TO PUBLIC 
HEALTH SECURITY THREATS 
Sec. 101. National health security strategy. 
Sec. 102. Protection of national security from threats. 
Sec. 103. Partnerships for State and regional hospital preparedness to improve 
surge capacity. 
Sec. 104. Guidelines for regional health care emergency preparedness and re-
sponse systems. 
Sec. 105. Strategic National Stockpile. 
Sec. 106. Diagnostic testing preparedness plan. 
Sec. 107. Biomedical Advanced Research and Development Authority. 
Sec. 108. Ensuring collaboration and coordination in medical countermeasure 
development. 
Sec. 109. Review of ASPR efforts to ensure supply chain resiliency and ac-
countability. 
Sec. 110. Review of HHS efforts To ensure rapid production and domestic 
manufacturing capacity of medical countermeasures. 
Sec. 111. Crisis standards of care. 
TITLE II—ENSURING WORKFORCE TO PREPARE FOR AND 
RESPOND TO PUBLIC HEALTH SECURITY THREATS 
Sec. 201. Emergency system for advance registration of volunteer health pro-
fessional. 
Sec. 202. Military and civilian partnership for trauma readiness. 
Sec. 203. National advisory committees on disasters. 
Sec. 204. National Disaster Medical System. 
Sec. 205. Volunteer Medical Reserve Corps. 
TITLE III—PREPARING FOR AND RESPONDING TO PUBLIC 
HEALTH SECURITY THREATS 
Sec. 301. Improving State and local public health security. 
Sec. 302. Facilities and capacities of the Centers for Disease Control and Pre-
vention to combat public health security threats. 
Sec. 303. Monitoring and distribution of certain medical countermeasures. 
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Sec. 304. Enhanced control of dangerous biological agents and toxins. 
Sec. 305. Mosquito-borne diseases. 
Sec. 306. Epidemiology-laboratory capacity. 
Sec. 307. Supporting public health data availability and access. 
TITLE IV—ENSURING WORKFORCE TO PREPARE FOR AND 
RESPOND TO PUBLIC HEALTH SECURITY THREATS 
Sec. 401. Temporary reassignment of State and local personnel during a public 
health emergency. 
Sec. 402. Epidemic Intelligence Service. 
TITLE V—ADDRESSING DRUG AND SUPPLY CHAIN SHORTAGES 
Subtitle A—Ensuring Access to Lifesaving Drugs 
Sec. 501. Extended expiration dates for life-saving drugs. 
Subtitle B—Drug Origin Transparency 
Sec. 511. Enhanced drug manufacturing amount information reporting. 
Sec. 512. Require drug labeling to include original manufacturer and supply 
chain information. 
Subtitle C—Medical Device Shortage Reduction 
Sec. 521. Clarifying device shortage notifications. 
Sec. 522. Supply chain risk management. 
Sec. 523. Clarifying voluntary notifications. 
Subtitle D—Drug Shortage Prevention 
Sec. 531. Improving notification procedures in case of increased demand for 
critical essential medicines. 
Subtitle E—Protecting Americans From Unsafe Drugs 
Sec. 541. Notification, nondistribution, and recall of drugs. 
TITLE I—PREPARING FOR AND 
RESPONDING 
TO 
PUBLIC 
HEALTH SECURITY THREATS 
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 
(a) 
PUBLIC
HEALTH
WORKFORCE.—Section 
2802(a)(3) of the Public Health Service Act (42 U.S.C. 
300hh–1(a)(3)) is amended by striking ‘‘In 2022, the’’ 
and inserting ‘‘The’’. 
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(b) MEDICAL
AND PUBLIC HEALTH COMMUNITY 
PREPAREDNESS GOAL.—Section 2802(b)(8)(A) of the 
Public Health Service Act (42 U.S.C. 300hh–1(b)(8)(A)) 
is amended by inserting before the semicolon the following: 
‘‘, including by protecting against cybersecurity threats’’. 
(c) CYBERSECURITY RESILIENCY OF HEALTH CARE 
DELIVERY SYSTEMS.—Section 2802(b) of the Public 
Health Service Act (42 U.S.C. 300hh–1(b)) is amended 
by adding at the end the following: 
‘‘(11) CYBERSECURITY RESILIENCY OF HEALTH 
CARE DELIVERY SYSTEMS.—Strengthening the abil-
ity of States, local communities, Tribal communities, 
and territorial entities to protect against, mitigate, 
or otherwise address the impact of cybersecurity 
risks or cybersecurity attacks that affect public 
health through mechanisms (including awards of 
grants or cooperative agreements under section 
319C–2) that encourage hospitals and other facili-
ties involved in the delivery of health care items and 
services to use recognized security practices meeting 
or exceeding the approaches promulgated under sec-
tion 405(d) of the Cybersecurity Act of 2015.’’. 
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SEC. 102. PROTECTION OF NATIONAL SECURITY FROM 
THREATS. 
Section 2811(f)(2)(A) of the Public Health Service 
Act (42 U.S.C. 300hh–10(f)(2)(A)) is amended by strik-
ing ‘‘$250,000,000 for each of fiscal years 2019 through 
2023’’ and inserting ‘‘$327,991,000 for each of fiscal 
years 2024 through 2028’’. 
SEC. 103. PARTNERSHIPS FOR STATE AND REGIONAL HOS-
PITAL PREPAREDNESS TO IMPROVE SURGE 
CAPACITY. 
(a) AUTHORIZATION OF APPROPRIATIONS.—Section 
319C–2(j)(1)(A) of the Public Health Service Act (42 
U.S.C. 247d–3b(j)(1)(A)) is amended— 
(1) by striking ‘‘is authorized to be appro-
priated’’ and inserting ‘‘are authorized to be appro-
priated’’; and 
(2) by inserting ‘‘ and $500,000,000 for each of 
fiscal years 2024 through 2028’’ before the period at 
the end. 
(b) SUNSET.—Section 319C–2(j)(1)(B)(iii) of the 
Public 
Health 
Service 
Act 
(42 
U.S.C. 
247d– 
3b(j)(1)(B)(iii)) is amended by striking ‘‘2023’’ and in-
serting ‘‘2028’’. 
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SEC. 104. GUIDELINES FOR REGIONAL HEALTH CARE 
EMERGENCY PREPAREDNESS AND RESPONSE 
SYSTEMS. 
(a) GUIDELINES.—Section 319C–3(b)(3) of the Pub-
lic Health Service Act (42 U.S.C. 247d–3c(b)(3)) is 
amended by striking ‘‘the Pandemic and All-Hazards Pre-
paredness and Advancing Innovation Act of 2019 (includ-
ing any amendments made by such Act)’’ and inserting 
‘‘the Pandemic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2019, the PREVENT 
Pandemics Act (title II of division FF of Public Law 117– 
328), and the Protecting Pandemic and All-Hazards Pre-
paredness Act of 2023’’. 
(b) DEMONSTRATION
PROJECT
FOR
REGIONAL 
HEALTH CARE PREPAREDNESS
AND RESPONSE SYS-
TEMS.—Section 319C–3(e)(2) of the Public Health Serv-
ice Act (42 U.S.C. 247d–3c(e)(2)) is amended by striking 
‘‘2023’’ and inserting ‘‘2028’’. 
SEC. 105. STRATEGIC NATIONAL STOCKPILE. 
(a) VENDOR-MANAGED
INVENTORY
AND
WARM- 
BASED SURGE CAPACITY CONTRACTS AND COOPERATIVE 
AGREEMENTS WITH CLINICAL LABORATORIES.—Section 
319F–2(a)(5)(A) of the Public Health Service Act (42 
U.S.C. 247d–6b(a)(5)(A)) is amended— 
(1) by inserting after ‘‘contracts or cooperative 
agreements with vendors, which may include manu-
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facturers or distributors of medical products,’’ the 
following: ‘‘as well as clinical laboratories,’’; and 
(2) in clause (ii), by striking ‘‘domestic manu-
facturing capacity’’ and inserting ‘‘domestic manu-
facturing and laboratory capacity’’. 
(b) AUTHORIZATION OF APPROPRIATIONS.— 
(1) IN
GENERAL.—Section 319F–2(f) of the 
Public Health Service Act (42 U.S.C. 247d–6b(f)) is 
amended— 
(A) 
in 
paragraph 
(1), 
by 
striking 
‘‘$610,000,000 for each of fiscal years 2019 
through 2021, and $750,000,000 for each of 
fiscal years 2022 and 2023’’ and inserting 
‘‘$1,963,000,000 for each of fiscal years 2024 
through 2028’’; 
(B) by striking paragraph (2); and 
(C) by striking ‘‘AUTHORIZATION OF AP-
PROPRIATIONS’’ and all that follows through 
‘‘For the purpose of carrying out subsection 
(a), there are authorized to be appropriated’’ 
and inserting ‘‘AUTHORIZATION OF APPROPRIA-
TIONS.—For the purpose of carrying out sub-
section (a), there is authorized to be appro-
priated’’. 
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(2) PILOT PROGRAM TO SUPPORT STATE MED-
ICAL
STOCKPILES.—Section 319F–2(i)(9) of the 
Public Health Service Act (42 U.S.C. 247d–6b(i)(9)) 
is amended by striking ‘‘2024’’ and inserting 
‘‘2028’’. 
SEC. 106. DIAGNOSTIC TESTING PREPAREDNESS PLAN. 
The Public Health Service Act (42 U.S.C. 201 et 
seq.) is amended by inserting after section 319F–5 of such 
Act (42 U.S.C. 247d–6f) the following: 
‘‘SEC. 319F–6. DIAGNOSTIC TESTING PREPAREDNESS PLAN. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Assistant Secretary for Preparedness and Response, 
and in consultation with the heads of relevant Federal 
agencies, shall develop not later than 1 year after the date 
of enactment of this section and update not less than every 
3 years thereafter a plan for rapid development, authoriza-
tion, scaling, procurement, and distribution of diagnostics 
and clinical and diagnostic laboratory testing capacity dur-
ing a public health emergency declared under section 319. 
‘‘(b) PURPOSES.—The purposes of the plan under 
subsection (a) shall be— 
‘‘(1) to facilitate the development and utiliza-
tion of diagnostics for use with respect to a novel 
chemical, biological, radiological, or nuclear threat or 
an emerging infectious disease, including any such 
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high-throughput laboratory diagnostic, point-of-care 
diagnostic, or rapid at-home or point-of-use diag-
nostic; and 
‘‘(2) to describe the processes for rapid develop-
ment, authorization, scaling, procurement, and dis-
tribution of diagnostics and clinical and diagnostic 
laboratory testing capacity. 
‘‘(c) PUBLIC-PRIVATE COORDINATION.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Assistant Secretary for Preparedness 
and Response, shall include within the plan under 
subsection (a) a plan for public-private coordination 
on national diagnostic testing during a public health 
emergency. 
‘‘(2) CONTENTS.—The plan under paragraph 
(1) shall be designed to facilitate coordination and 
collaboration among— 
‘‘(A) government agencies; and 
‘‘(B) critical private-sector diagnostic test-
ing stakeholders, including private-sector clin-
ical and diagnostic laboratories, diagnostic man-
ufacturers, health care product distributors, 
and research laboratories. 
‘‘(d) PUBLIC AVAILABILITY.—The Secretary, acting 
through the Assistant Secretary for Preparedness and Re-
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