[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4697 Introduced in House (IH)]
<DOC>
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. Cardenas, Mr. Ruiz, Mr. Peters, Mrs.
Dingell, Mr. Veasey, Ms. Kuster, Ms. Kelly of Illinois, Ms. Barragan,
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 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.
Be it enacted by the Senate and House of Representatives 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 response 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
accountability.
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
professional.
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 Prevention to combat public health
security threats.
Sec. 303. Monitoring and distribution of certain medical
countermeasures.
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''.
(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 ability 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 facilities involved in the delivery of
health care items and services to use recognized security
practices meeting or exceeding the approaches promulgated under
section 405(d) of the Cybersecurity Act of 2015.''.
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 striking ``$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 HOSPITAL 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 appropriated'' and
inserting ``are authorized to be appropriated''; 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 inserting ``2028''.
SEC. 104. GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS
AND RESPONSE SYSTEMS.
(a) Guidelines.--Section 319C-3(b)(3) of the Public Health Service
Act (42 U.S.C. 247d-3c(b)(3)) is amended by striking ``the Pandemic and
All-Hazards Preparedness and Advancing Innovation Act of 2019
(including any amendments made by such Act)'' and inserting ``the
Pandemic and All-Hazards Preparedness and Advancing 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 Preparedness Act
of 2023''.
(b) Demonstration Project for Regional Health Care Preparedness and
Response Systems.--Section 319C-3(e)(2) of the Public Health Service
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 manufacturers or
distributors of medical products,'' the following: ``as well as
clinical laboratories,''; and
(2) in clause (ii), by striking ``domestic manufacturing
capacity'' and inserting ``domestic manufacturing 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 Appropriations''
and all that follows through ``For the purpose of
carrying out subsection (a), there are authorized to be
appropriated'' and inserting ``Authorization of
Appropriations.--For the purpose of carrying out
subsection (a), there is authorized to be
appropriated''.
(2) Pilot program to support state medical 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, authorization,
scaling, procurement, and distribution of diagnostics and clinical and
diagnostic laboratory testing capacity during 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 utilization of
diagnostics for use with respect to a novel chemical,
biological, radiological, or nuclear threat or an emerging
infectious disease, including any such high-throughput
laboratory diagnostic, point-of-care diagnostic, or rapid at-
home or point-of-use diagnostic; and
``(2) to describe the processes for rapid development,
authorization, scaling, procurement, and distribution 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 testing
stakeholders, including private-sector clinical and
diagnostic laboratories, diagnostic manufacturers,
health care product distributors, and research
laboratories.
``(d) Public Availability.--The Secretary, acting through the
Assistant Secretary for Preparedness and Response, shall make the plan
under subsection (a) publicly available.
``(e) Reports to Congress.--Not later than 1 year after commencing
implementation of the plan under subsection (a) for a public health
emergency, the Secretary, acting through the Assistant Secretary for
Preparedness and Response, shall submit to the Congress a report
evaluating the effectiveness of activities implemented under the
plan.''.
SEC. 107. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
(a) Medical Countermeasures for Viral Threats With Pandemic
Potential.--Section 319L(c)(4) of the Public Health Service Act (42
U.S.C. 247d-7e(c)(4)) is amended--
(1) in subparagraph (D)--
(A) in clause (ii), by striking ``; and'' and
inserting a semicolon;
(B) by redesignating clause (iii) as clause (v);
and
(C) by inserting after clause (ii) the following:
``(iii) the identification and development
of platform manufacturing technologies needed
for advanced development and manufacturing of
medical countermeasures for viral families
which have significant potential to cause a
pandemic;
``(iv) advanced research and development of
flexible medical countermeasures against
priority respiratory virus families and other
respiratory viral pathogens with a significant
potential to cause a pandemic, with both
pathogen-specific and pathogen-agnostic
approaches; and''; and
(2) in subparagraph (F)--
(A) in clause (ii), by striking ``; and'' at the
end and inserting a semicolon;
(B) in clause (iii), by striking the period and
inserting ``; and''; and
(C) by adding at the end the following:
``(iv) priority virus families and other
viral pathogens with a significant potential to
cause a pandemic.''.
(b) Authorization of Appropriations.--Section 319L(d)(2) of the
Public Health Service Act (42 U.S.C. 247d-7e(d)(2)) is amended by
striking ``$611,700,000 for each of fiscal years 2019 through 2023''
and inserting ``$950,000,000 for each of fiscal years 2024 through
2028''.
(c) Inapplicability of Certain Provisions Sunset.--Section
319L(e)(1)(D) of the Public Health Service Act (42 U.S.C. 247d-
7e(e)(1)(D)) is amended by striking ``on the date that is 17 years
after the date of enactment of the Pandemic and All-Hazards
Preparedness Act'' and inserting ``on October 1, 2028''.
SEC. 108. ENSURING COLLABORATION AND COORDINATION IN MEDICAL
COUNTERMEASURE DEVELOPMENT.
Section 319L-1(b) of the Public Health Service Act (42 U.S.C. 274d-
7f(b)) is amended by striking ``at the end of the 17-year period that
begins on the date of enactment of this Act'' and inserting ``on
October 1, 2028''.
SEC. 109. REVIEW OF ASPR EFFORTS TO ENSURE SUPPLY CHAIN RESILIENCY AND
ACCOUNTABILITY.
(a) In General.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United States
shall complete a review of--
(1) the Supply Chain Control Tower Program (in this section
referred to as the ``SCCT Program'') under the Administration
for Strategic Preparedness and Response of the Department of
Health and Human Services; and
(2) any related efforts of the Administration for Strategic
Preparedness and Response--
(A) to create supply chain visibility into
inventory, capacity, and distribution flow of certain
products critical to preparedness and response efforts;
(B) to provide insights into demand forecasting and
modeling of certain products critical to preparedness
and response efforts; or
(C) to inform preparedness and response efforts by
targeting distribution and coordinating supply with
demand for certain products critical to preparedness
and response efforts.
(b) Issues.--The review under this section shall include
examination of--
(1) the data being collected and maintained pursuant to the
SCCT Program;
(2) how the Department of Health and Human Services, acting
through the Administration for Strategic Preparedness and
Response, uses such data to provide supply chain visibility and
address actual or potential supply gaps;
(3) the extent to which such data is provided and shared
with end users, including States, localities, Territories,
Tribes, and industry partners;
(4) the frequency and cadence of data reporting and sharing
by and among States, localities, Territories, Tribes, and
industry partners;
(5) information related to the type and number of States,
localities, Territories, Tribes, and industry partners
participating in the SCCT Program;
(6) the process by which States, localities, Territories,
Tribes, and industry partners voluntarily choose to participate
in the SCCT Program; and
(7) any inefficiencies, deficiencies, or challenges related
to the application or operation of the SCCT Program.
(c) Report to Congress.--Not later than the deadline described in
subsection (a) for the completion of the review under this section, the
Comptroller General shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the results of
such review.
SEC. 110. REVIEW OF HHS EFFORTS TO ENSURE RAPID PRODUCTION AND DOMESTIC
MANUFACTURING CAPACITY OF MEDICAL COUNTERMEASURES.
(a) In General.--Not later than 1 year after the date of the
enactment of this Act, the Comptroller General of the United States
shall conduct and complete a review examining the efforts of the
Secretary of Health and Human Services to ensure that the United States
is prepared to rapidly produce qualified countermeasures (as defined in
section 319F-1 of the Public Health Service Act (42 U.S.C. 247d-6a)) in
the event of a public health emergency declared under section 319 of
the Public Health Service Act (42 U.S.C. 274d).
(b) Contents.--The review conducted under subsection (a) shall
include a review of--
(1) the efforts described in such subsection, including the
Secretary's efforts to transition from the Centers for
Innovation and Advanced Drug Manufacturing program to any new
efforts, including the National Biopharmaceutical Manufacturing
Partnership and Industrial Base Expansion Connect;
(2) the progress made toward the implementation of such
efforts; and
(3) the planning within the Department of Health and Human
Services to assess risks and challenges associated with
advanced development and manufacturing of qualified
countermeasures.
(c) Report to Congress.--Not later than 1 year after completing the
review under subsection (a), the Comptroller General of the United
States shall submit to the Congress a report containing--
(1) the results of the review; and
(2) the Comptroller General's recommendations for ensuring
that the United States is prepared to rapidly produce qualified
countermeasures in the event of a public health emergency.
SEC. 111. CRISIS STANDARDS OF CARE.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services, acting through the Director of
the Office for Civil Rights of the Department of Health and Human
Services, shall issue guidance on how to develop or modify State and
local crisis standards of care for use during an emergency period (as
defined in section 1135(g)(1) of the Social Security Act (42 U.S.C.
1320b-5(g)(1)) so as to bring such standards of care into compliance
with the nondiscrimination requirements of section 504 of the
Rehabilitation Act of 1973 (29 U.S.C. 794).
TITLE II--ENSURING WORKFORCE TO PREPARE FOR AND RESPOND TO PUBLIC
HEALTH SECURITY THREATS
SEC. 201. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH
PROFESSIONAL.
(a) In General.--Section 319I(a) of the Public Health Service Act
(42 U.S.C. 247d-7b) is amended by striking ``Not later than 12 months
after the date of enactment of the Pandemic and All-Hazards
Preparedness Act, the Secretary shall link existing State verification
systems to maintain'' and inserting ``The Secretary shall continue to
maintain''.
(b) Authorization of Appropriations.--Section 319I(k) of the Public
Health Service Act (42 U.S.C. 247d-7b(k)) is amended by striking ``2019
through 2023'' and inserting ``2024 through 2028''.
SEC. 202. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS.
Section 1291(g) of the Public Health Service Act (42 U.S.C. 300d-
91(g)) is amended by striking ``2019 through 2023'' and inserting
``2024 through 2028''.
SEC. 203. NATIONAL ADVISORY COMMITTEES ON DISASTERS.
(a) National Advisory Committee on Children and Disasters.--
Subsection (g) of section 2811A of the Public Health Service Act (42
U.S.C. 300hh-10b) is amended to read as follows:
``(g) Sunset.--
``(1) In general.--The Advisory Committee shall terminate
on September 30, 2028.
``(2) Extension of committee.--Not later than October 1,
2027, the Secretary shall submit to Congress a recommendation
on whether the Advisory Committee should be extended.''.
(b) National Advisory Committee on Seniors and Disasters.--Section
2811B of the Public Health Service Act (42 U.S.C. 300hh-10c) is
amended--
(1) in subsection (d)--
(A) in paragraph (1), by striking ``in consultation
with such other heads of agencies as appropriate, shall
appoint not more than 17 members'' and inserting ``in
consultation with such other Secretaries as may be
appropriate, shall appoint not more than 23 members'';
(B) by redesignating paragraph (2) as paragraph
(3);
(C) by amending paragraph (3), as so redesignated--
(i) in the paragraph heading, by striking
``Required members'' and inserting ``Required
federal members'';
(ii) in the matter preceding subparagraph
(A), by striking ``and non-Federal members,'';
(iii) by striking subparagraphs (J) and
(K); and
(iv) by redesignating subparagraph (L) as
subparagraph (J);
(D) by inserting after paragraph (1) the following
new paragraph:
``(2) Required non-federal members.--The Secretary, in
consultation with such other heads of Federal agencies as may
be appropriate, shall appoint to the Advisory Committee under
paragraph (1) at least 13 individuals, including--
``(A) at least 4 non-Federal health care providers
with expertise in geriatric medical disaster planning,
preparedness, response, or recovery;
``(B) at least 3 representatives of State, local,
Tribal, or territorial agencies with expertise in
geriatric disaster planning, preparedness, response, or
recovery; and
``(C) at least 4 non-Federal professionals with
training in gerontology, including social workers,
scientists, human services specialists, or other non-
medical professionals, with experience in disaster
planning, preparedness, response, or recovery among
other adults.''; and
(E) by adding at the end the following new
paragraphs:
``(4) Term of appointment.--Each member of the Advisory
Committee appointed under paragraph (2) shall serve for a term
of 3 years, except that the Secretary may adjust the terms of
the Advisory Committee appointees serving on the date of
enactment of the Preparing for All Hazards and Pathogens
Reauthorization Act, or appointees who are initially appointed
after such date of enactment, in order to provide for a
staggered term of appointment for all members.
``(5) Consecutive appointments; maximum terms.--A member
appointed under paragraph (2) may serve not more than 3 terms
on the Advisory Committee, and not more than 2 of such terms
may be served consecutively.''; and
(2) in subsection (g)--
(A) in paragraph (1), by striking ``2023'' and
inserting ``2028''; and
(B) in paragraph (2), by striking ``2022'' and
inserting ``2027''.
(c) National Advisory Committee on Individuals With Disabilities.--
Section 2811C of the Public Health Service Act (42 U.S.C. 300hh-10d) is
amended--
(1) by redesignating subsections (c) through (g) as
subsections (d) through (h), respectively;
(2) by inserting after subsection (b) the following new
subsection:
``(c) Additional Duties.--The Advisory Committee may provide advice
and recommendations to the Secretary with respect to individuals with
disabilities, and medical and public health grants and cooperative
agreements, as applicable to preparedness and response activities under
this title and title III.'';
(3) in subsection (d), as so redesignated--
(A) in paragraph (1), by striking ``in consultation
with such other heads of agencies and departments as
appropriate, shall appoint not more than 17 members''
and inserting ``in consultation with such other
Secretaries as may be appropriate, shall appoint not
more than 23 members'';
(B) by redesignating paragraph (2) as paragraph
(3);
(C) by amending paragraph (3), as redesignated--
(i) in the paragraph heading, by striking
``Required members'' and inserting ``Required
federal members'';
(ii) in the matter preceding subparagraph
(A), by striking ``and non-Federal members,'';
(iii) by striking subparagraph (K) and
inserting the following:
``(K) Representatives of such other Federal
agencies as the Secretary determines necessary to
fulfill the duties of the Advisory Committee.''; and
(iv) by striking subparagraphs (L) and (M);
(D) by inserting after paragraph (1) the following
new paragraph:
``(2) Required non-federal members.--The Secretary, in
consultation with such other heads of Federal agencies as may
be appropriate, shall appoint to the Advisory Committee under
paragraph (1) at least 13 individuals, including--
``(A) at least 4 non-Federal health care
professionals with expertise in disability
accessibility before, during, and after disasters,
medical and mass care disaster planning, preparedness,
response, or recovery;
``(B) at least 3 representatives from State, local,
Tribal, or territorial agencies with expertise in
disaster planning, preparedness, response, or recovery
for individuals with disabilities; and
``(C) at least 4 individuals with a disability with
expertise in disaster planning, preparedness, response,
or recovery for individuals with disabilities.''; and
(E) by adding at the end the following new
paragraphs:
``(4) Term of appointment.--Each member of the Advisory
Committee appointed under paragraph (2) shall serve for a term
of 3 years, except that the Secretary may adjust the terms of
the Advisory Committee appointees serving on the date of
enactment of the Preparing for All Hazards and Pathogens
Reauthorization Act, or appointees who are initially appointed
after such date of enactment, in order to provide for a
staggered term of appointment for all members.
``(5) Consecutive appointments; maximum terms.--A member
appointed under paragraph (2) may serve not more than 3 terms
on the Advisory Committee, and not more than 2 of such terms
may be served consecutively.''; and
(4) in subsection (g)--
(A) in paragraph (1), by striking ``2023'' and
inserting ``2028''; and
(B) in paragraph (2), by striking ``2022'' and
inserting ``2027''.
SEC. 204. NATIONAL DISASTER MEDICAL SYSTEM.
(a) Elimination of Sunset of Authority To Make Certain Appointments
for National Disaster Medical System.--Section 2812(c)(4) of the Public
Health Service Act (42 U.S.C. 300hh-11(c)(4)) is amended--
(1) by striking ``(A) in general.--If the Secretary
determines'' and inserting ``If the Secretary determines''; and
(2) by striking subparagraph (B).
(b) Authorization of Appropriations.--Section 2812(g) of the Public
Health Service Act (42 U.S.C. 300hh-11(g)) is amended by striking
``$57,400,000 for each of fiscal years 2019 through 2023'' and
inserting ``$96,904,000 for each of fiscal years 2024 through 2028''.
SEC. 205. VOLUNTEER MEDICAL RESERVE CORPS.
Section 2813(i) of the Public Health Service Act (42 U.S.C. 300hh-
15(i)) is amended by striking ``2019 through 2023'' and inserting
``2024 through 2028''.
TITLE III--PREPARING FOR AND RESPONDING TO PUBLIC HEALTH SECURITY
THREATS
SEC. 301. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.
(a) Authorization of Appropriations.--Section 319C-1(h)(1)(A) of
the Public Health Service Act (42 U.S.C. 247d-3a(h)(1)(A)) is amended
by striking ``$685,000,000 for each of fiscal years 2019 through 2023''
and inserting ``$1,000,000,000 for each of fiscal years 2024 through
2028''.
(b) Elimination of Deadwood.--Section 319C-1(h) of the Public
Health Service Act (42 U.S.C. 247d-3a(h)) is amended--
(1) by striking paragraphs (4) and (5); and
(2) by redesignating paragraphs (6) and (7) as paragraphs
(4) and (5).
SEC. 302. FACILITIES AND CAPACITIES OF THE CENTERS FOR DISEASE CONTROL
AND PREVENTION TO COMBAT PUBLIC HEALTH SECURITY THREATS.
(a) Study.--Section 319D(a)(4) of the Public Health Service Act (42
U.S.C. 247d-4(a)(4)) is amended by striking ``Not later than June 1,
2022, the Comptroller General of the United States shall conduct a
study on Federal spending in fiscal years 2013 through 2018'' and
inserting ``Not later than June 1, 2027, the Comptroller General of the
United States shall conduct a study on Federal spending in fiscal years
2021 through 2026''.
(b) Authorization of Appropriations.--Section 319D(h) of the Public
Health Service Act (42 U.S.C. 247d-4(h)) is amended--
(1) in paragraph (1), by striking ``$25,000,000 for each of
fiscal years 2022 and 2023'' and inserting ``$40,000,000 for
each of fiscal years 2024 through 2028''; and
(2) in paragraph (2), by striking ``2022 and 2023'' and
inserting ``2024 through 2028''.
SEC. 303. MONITORING AND DISTRIBUTION OF CERTAIN MEDICAL
COUNTERMEASURES.
Section 319A(e) of the Public Health Service Act (42 U.S.C. 247d-
1(e)) is amended by striking ``2019 through 2023'' and inserting ``2024
through 2028''.
SEC. 304. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND TOXINS.
Section 351A(m) of the Public Health Service Act (42 U.S.C.
262a(m)) is amended by striking ``2027'' and inserting ``2028''.
SEC. 305. MOSQUITO-BORNE DISEASES.
Section 317S(f) of the Public Health Service Act (42 U.S.C. 247b-
21(f)) is amended--
(1) in paragraph (1), by striking ``2019 through 2023'' and
inserting ``2024 through 2028''; and
(2) by striking paragraph (3).
SEC. 306. EPIDEMIOLOGY-LABORATORY CAPACITY.
Section 2821(b) (42 U.S.C. 300hh-31(b)) is amended by striking
``2019 through 2023'' and inserting ``2024 through 2028''.
SEC. 307. SUPPORTING PUBLIC HEALTH DATA AVAILABILITY AND ACCESS.
(a) Designation of Public Health Data Standards.--Section
2823(a)(2) of the Public Health Service Act (42 U.S.C. 300hh-33(a)(2))
is amended by adding at the end the following:
``(D) Selection of data and technology standards.--
The standards designated as described in subparagraph
(A) may include standards to improve--
``(i) the exchange of electronic health
information for--
``(I) electronic case reporting;
``(II) syndromic surveillance;
``(III) reporting of vital
statistics; and
``(IV) reporting test orders and
results electronically, including from
laboratories;
``(ii) automated electronic reporting to
relevant public health data systems of the
Centers for Disease Control and Prevention; and
``(iii) such other uses as the Secretary
determines appropriate.
``(E) Considerations.--Standards designated under
this paragraph shall include standards and
implementation specifications necessary to ensure the
appropriate capture, exchange, access, and use of
information regarding race, ethnicity, sex (including
sexual orientation and gender identity), disability
status, veteran status, housing status, age, functional
status, and other elements.''.
(b) Improving Information Sharing and Availability of Public Health
Data.--Section 310B of the Public Health Service Act (42 U.S.C. 242u)
is amended to read as follows:
``SEC. 310B. IMPROVING INFORMATION SHARING AND AVAILABILITY OF PUBLIC
HEALTH DATA.
``(a) In General.--The Secretary acting through the Director of the
Centers for Disease Control and Prevention (in this section referred to
as the `Secretary') may require the reporting of public health and
health care data and information to the Centers for Disease Control and
Prevention by--
``(1) health care providers and facilities, including
pharmacies;
``(2) public health, clinical, and other laboratories and
diagnostic testing entities;
``(3) State, local, and Tribal health departments; and
``(4) other entities, as determined appropriate by the
Secretary.
``(b) Content, Form, Manner, and Frequency.--
``(1) Collaboration.--The Secretary shall collaborate with
representatives of State, local, and Tribal health departments
and other entities on determining the content, form, manner,
and frequency of the reporting of public health and health care
data and information required pursuant to subsection (a).
``(2) Simultaneous reporting.--In determining the content,
form, manner, and frequency of the reporting of public health
and health care data and information pursuant to subsection
(a), where a disease, condition, or related event is reportable
under applicable State or local law, the Secretary shall
require the data and information to be reported first or
simultaneously to the appropriate State or local jurisdiction.
``(3) Alignment with standards and implementation
specifications.--The content, form, manner, and frequency
requirements required pursuant to this section shall align with
the standards and implementation specifications adopted by the
Secretary under section 3004, where applicable.
``(4) Reasonable efforts to limit reporting.--The Secretary
shall make reasonable efforts to limit the public health and
health care data and information required to be reported under
this section to the minimum necessary to accomplish the
intended public health purpose.
``(5) Implementation and regulations.--The Secretary--
``(A) may promulgate by regulation the content,
form, manner, and frequency in which public health and
health care data and information is required to be
reported under this section; and
``(B) in the event of a public health emergency
declared under section 319, or where the Secretary
determines there is a significant potential for such an
emergency to exist, may issue such requirements--
``(i) by guidance in accordance with this
section; and
``(ii) without regard to the procedures
otherwise required by section 553 of title 5,
United States Code.
``(c) Ensuring That Data Is Accessible in a Timely Manner to State,
Local, and Tribal Health Authorities.--
``(1) Collaboration.--The Secretary shall collaborate with
representatives of State, local, and Tribal health departments,
and entities representing such departments, to ensure that data
and information that is collected by the Centers for Disease
Control and Prevention pursuant to this section are accessible,
as appropriate, in a timely manner, to State, local, and Tribal
health authorities.
``(2) Rules of construction.--Nothing in this section shall
be construed--
``(A) to prevent any Federal agency, State, local,
or Tribal health department, or other entity from
collecting data or information under other applicable
law; or
``(B) to limit the authority of the Centers for
Disease Control and Prevention to share public health
surveillance data with State, local, or Tribal health
authorities.
``(3) Reasonable efforts to reduce reporting burdens and
potential duplication.--The Secretary shall make reasonable
efforts to collaborate with representatives of Federal agencies
and State, local, and Tribal health departments to reduce
reporting burdens and potential duplication of reporting
requirements. Such efforts may include ensuring simultaneous
sharing of data and information described in subsection (b)
with State, local, and Tribal public health authorities.
``(d) Confidentiality and Protection of Data.--Any identifiable,
sensitive information reported to the Centers for Disease Control and
Prevention pursuant to this section shall not be further disclosed or
provided to any other individual or party, including any party involved
in civil, criminal, or administrative litigation, except--
``(1) as necessary for public health purposes, including
with relevant Federal, State, local, or tribal public health
authorities;
``(2) as required under section 552a(d)(1) of title 5,
United States Code;
``(3) as required by applicable Federal laws, excluding
instances of disclosure in any Federal, State, or local civil,
criminal, administrative, legislative, or other proceeding; or
``(4) with the consent of each individual to whom the
information pertains.
``(e) Exemption of Certain Public Health Data From Disclosure.--The
Secretary may exempt from disclosure under section 552(b)(3) of title
5, United States Code, public health and health care data and
information collected by the Centers for Disease Control and Prevention
pursuant to this section or any other authority under which the Centers
collects public health or health care data and information if--
``(1) an individual is identified through such data or
information; or
``(2) there is at least a very small risk, as determined by
current scientific practices or statistical methods, that some
combination of the data or information, the request for
disclosure under such section 552(b)(3), and other available
data sources or the application of technology could be used to
deduce the identity of the individuals to which such data or
information pertains.''.
(c) Public Health Information Sharing and Availability Advisory
Committee.--Part A of title III of the Public Health Service Act (42
U.S.C. 241 et seq.) is amended by adding at the end the following:
``SEC. 310C. PUBLIC HEALTH INFORMATION SHARING AND AVAILABILITY
ADVISORY COMMITTEE.
``(a) Establishment.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall establish an
advisory committee, to be known as the Public Health Information
Sharing and Availability Advisory Committee, to advise, and make
recommendations to, the Director with respect to the implementation of
public health and health care data and information reporting and
sharing under section 310B.
``(b) Membership.--The membership of the advisory committee
established pursuant to this section shall include--
``(1) individuals with subject matter expertise or
experience in the following areas of public health and health
care data and information, including--
``(A) State, territorial, local, and Tribal health
department data systems or practices; and
``(B) health care data;
``(2) ex officio members, including from relevant Federal
agencies such as the Office of the National Coordinator for
Health Information Technology, the Centers for Medicare &
Medicaid Services, the Centers for Disease Control and
Prevention, and the Office of the Assistant Secretary for
Health;
``(3) representatives of national organizations, including
the Council of State and Territorial Epidemiologists, the
Association of Public Health Laboratories, the Association of
State and Territorial Health Officials, the National
Association of County and City Health Officials, and the Big
Cities Health Coalition; and
``(4) such additional members as the Secretary determines
appropriate.
``(c) FACA Applicability.--The advisory committee established
pursuant to this section is deemed to be an advisory committee subject
to the Federal Advisory Committee Act.''.
(d) Improving Public Health Data Collection.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall
award grants, contracts, or cooperative agreements to eligible
entities for purposes of identifying, developing, or
disseminating best practices in the collection of electronic
health information and the use of designated data standards and
implementation specifications--
(A) to improve the quality and completeness of
data, including demographic data, collected, accessed,
or used for public health purposes; and
(B) to address health disparities and related
health outcomes.
(2) Eligible entities.--To be eligible to receive an award
under this subsection an entity shall--
(A) be a health care provider, academic medical
center, community-based organization, State, local
governmental entity, Indian Tribe or Tribal
organization (as such terms are defined in section 4 of
the Indian Self Determination and Education Assistance
Act (25 U.S.C. 5304)), Urban Indian organization (as
defined in section 4 of the Indian Health Care
Improvement Act (25 U.S.C. 1603)), or other appropriate
public or private nonprofit entity, or a consortia of
any such entities; and
(B) submit an application to the Secretary at such
time, in such manner, and containing such information
as the Secretary may require.
(3) Activities.--Entities receiving awards under this
subsection shall use such award to develop and test best
practices for training health care providers to use standards
and implementation specifications that assist in the capture,
access, exchange, and use of electronic health information,
including demographic information, disability status, veteran
status, housing status, functional status, and other data
elements. Such activities shall, at a minimum, include--
(A) improving, understanding, and using data
standards and implementation specifications;
(B) developing or identifying methods to improve
communication with patients in a culturally and
linguistically appropriate manner, including to better
capture information related to demographics of such
individuals;
(C) developing methods for accurately categorizing
and recording patient responses using available data
standards;
(D) educating providers regarding the utility of
such information for public health purposes and the
importance of accurate collection and recording of such
data; and
(E) other activities, as the Secretary determines
appropriate.
(4) Reporting.--
(A) Reporting by award recipients.--Each recipient
of an award under this subsection shall submit to the
Secretary a report on the results of best practices
identified, developed, or disseminated through such
award.
(B) Report to congress.--Not later than 1 year
after the completion of the program under this
subsection, the Secretary shall submit a report to
Congress on the success of the best practices developed
under such program, opportunities for further
dissemination of such best practices, and
recommendations for improving the capture, access,
exchange, and use of information to improve public
health and reduce health disparities.
(5) Nonduplication of efforts.--The Secretary shall ensure
that the activities and programs carried out under this
subsection are free of unnecessary duplication of effort.
(6) Authorization of appropriations.--There is authorized
to be appropriated $10,000,000 for each of fiscal years 2024
through 2026 to carry out this subsection.
(e) Information Collection.--Section 319D(a) of the Public Health
Service Act (42 U.S.C. 247d-4(a)) is amended by adding at the end the
following:
``(5) Information collection.--Subchapter I of chapter 35
of title 44, United States Code, shall not apply to information
collection by the Centers for Disease Control and Prevention,
including the Agency for Toxic Substances and Disease Registry,
that are part of investigations, research, surveillance, or
evaluations undertaken for public health purposes under any
available authority.''.
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.
(a) Report to Congress.--Section 319(e)(6) of the Public Health
Service Act (42 U.S.C. 247d(e)(6)) is amended by striking ``Not later
than 4 years after the date of enactment of the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013, the Comptroller
General of the United States shall'' and inserting ``Not later than 4
years after the date of enactment of the Protecting PAHPA Act of 2023,
the Comptroller General of the United States shall''.
(b) Sunset.--Section 319(e)(8) of the Public Health Service Act (42
U.S.C. 247d(e)(8)) is amended by striking ``2023'' and inserting
``2028''.
SEC. 402. EPIDEMIC INTELLIGENCE SERVICE.
Section 317F(c)(2) of the Public Health Service Act (42 U.S.C.
247b-7(c)(2)) is amended by striking ``2019 through 2023'' and
inserting ``2024 through 2028''.
TITLE V--ADDRESSING DRUG AND SUPPLY CHAIN SHORTAGES
Subtitle A--Ensuring Access to Lifesaving Drugs
SEC. 501. EXTENDED EXPIRATION DATES FOR LIFE-SAVING DRUGS.
(a) In General.--The Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) is amended by inserting after section 506L of such
Act (21 U.S.C. 356l) the following new section:
``SEC. 506M. EXTENDED EXPIRATION DATES FOR LIFE-SAVING DRUGS.
``(a) In General.--A manufacturer of a life-saving drug shall--
``(1) submit to the Secretary data and information as
required by subsection (b)(1);
``(2) conduct and submit the results, data, and information
generated by any studies required under subsection (b)(2); and
``(3) make any labeling change described in subsection (c)
by the date specified by the Secretary pursuant to such
subsection.
``(b) Data and Information.--
``(1) In general.--The Secretary may issue an order
requiring the manufacturer of a life-saving drug to submit, in
such manner as the Secretary may prescribe, data and
information from any stage of development of the drug that are
adequate to assess the stability of the drug to determine the
longest supported expiration date.
``(2) Lack of data and information.--If the data and
information required pursuant to an order issued under
paragraph (1) are not available or are insufficient, as
determined by the Secretary, the Secretary may issue an order
requiring the manufacturer of the drug--
``(A) to conduct studies, which may be a
continuation of ongoing studies, to provide data and
information adequate to assess the stability of the
drug and to determine the longest supported expiration
date; and
``(B) to submit such data and information to the
Secretary in such manner as the Secretary may prescribe
in the order.
``(c) Labeling.--The Secretary may issue an order requiring the
manufacturer of a life-saving drug, by a date determined by the
Secretary in consultation with the sponsor of the drug, to make any
labeling change regarding the expiration date or storage and handling
of the drug that the Secretary determines to be appropriate based on
the data and information required to be submitted under this section or
any other data and information available to the Secretary.
``(d) Definitions.--In this section:
``(1) Life-saving drug.--The term `life-saving drug' means
a drug, that is--
``(A)(i) a medical countermeasure; or
``(ii) on the drug shortage list under section 506E
or determined by the Secretary to be at risk of
shortage; and
``(B)(i) life-supporting;
``(ii) life-sustaining; or
``(iii) intended for use in the prevention or
treatment of a debilitating disease or condition in
humans or animals, including any such drug used in
emergency medical care or during surgery or any such
drug that is critical to the public health during a
public health emergency declared by the Secretary under
section 319 of the Public Health Service Act.
``(2) Medical countermeasure.--The term `medical
countermeasure' means a countermeasure as defined in section
565(a).
``(e) Confidentiality.--Nothing in this section shall be construed
as authorizing the Secretary to disclose any information that is a
trade secret or confidential information subject to section 552(b)(4)
of title 5, United States Code, or section 1905 of title 18, United
States Code.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section 3503(a)(1)(A) of
division FF of Public Law 117-328, is amended by inserting at the end
the following new subsection:
``(jjj) The failure to comply with any order issued under section
506M.''.
(c) Penalties.--Subsection (b) of section 303 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333) is amended by inserting at the
end the following:
``(9) If a manufacturer of a life-saving drug fails to submit data
and information as required under section 506M(b)(1), fails to conduct
or submit the data and information generated by studies as required
under section 506M(b)(2), or fails to make a labeling change as
required under section 506M(c), such manufacturer shall be subject to a
civil penalty of not more than $10,000 for the first day on which the
violation occurs and not more than $10,000 for each subsequent day on
which the violation is not corrected.''.
Subtitle B--Drug Origin Transparency
SEC. 511. ENHANCED DRUG MANUFACTURING AMOUNT INFORMATION REPORTING.
(a) In General.--Section 510(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(j)(3)) is amended--
(1) in subparagraph (A), by adding ``or (2)'' after
``paragraph (1)''; and
(2) by adding at the end the following:
``(C) Each report submitted pursuant to subparagraph (A)
with respect to a drug shall--
``(i) include additional information as may be
specified by the Secretary in regulation or guidance
regarding the supply chain for such drug, such as--
``(I) the identity of the respective
suppliers of each active pharmaceutical
ingredient, active pharmaceutical ingredient
intermediate, and in-process material used in
such manufacture, preparation, propagation,
compounding, or processing of the drug; and
``(II) the respective amounts of such drug
that were manufactured, prepared, propagated,
compounded, or processed using an active
pharmaceutical ingredient, active
pharmaceutical ingredient intermediate, and in-
process material from each such identified
supplier; and
``(ii) be submitted more frequently than annually,
in accordance with a reporting schedule as may be
specified by the Secretary in such regulation or
guidance, but not more frequently than 4 times per
year.
``(D) Any additional information specified in regulation or
guidance pursuant to subparagraph (C) shall be a required
element of reports under this paragraph not earlier than 6
months after the date on which such regulation or guidance is
issued in final form (and in no event shall the absence of any
regulation or guidance issued under subparagraph (C) affect the
requirement to report as described in subparagraph (A)).''.
(b) Conforming Amendment.--Section 510(j)(3)(B) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 510(j)(3)(B)) is amended by
striking ``subparagraph (A)'' and inserting ``this paragraph''.
SEC. 512. REQUIRE DRUG LABELING TO INCLUDE ORIGINAL MANUFACTURER AND
SUPPLY CHAIN INFORMATION.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) is amended--
(1) in paragraph (b)--
(A) by striking ``(b) If in a package'' and
inserting ``(b)(1) If in a package'';
(B) by striking ``a label containing (1) the name
and place'' and inserting ``a label containing--
``(A) the name and place'';
(C) by striking ``or distributor; and (2) an
accurate statement'' and inserting ``or distributor;
and
``(B) an accurate statement'';
(D) by striking ``under clause (2) of this
paragraph'' and inserting ``under this clause''; and
(E) by inserting at the end the following:
``(2)(A) Subject to clause (C), if it is a drug, including
an active pharmaceutical ingredient, unless it bears a label
containing the name and place of business, and unique facility
identifier of the original manufacturer of such drug or active
pharmaceutical ingredient, except that the Secretary may
provide, by regulation, for reasonable variations in the
implementation of such labeling requirements.
``(B) Subject to clause (C), if it is a drug that is an
active pharmaceutical ingredient, unless any accompanying
certificate of analysis contains the name and place of
business, and unique facility identifier of the original
manufacturer of the active pharmaceutical ingredient.
``(C) The Secretary may provide, by regulation, for
reasonable variations in the implementation of labeling
requirements specified in this subparagraph.''; and
(2) by inserting after paragraph (c) the following:
``(d)(1) Subject to subparagraph (2), if it is a drug, including an
active pharmaceutical ingredient, unless it bears labeling containing
the name and place of business of--
``(A) the original manufacturer of each active
pharmaceutical ingredient;
``(B) each manufacturer, if different from the original
manufacturer; and
``(C) the packer or distributor, if any.
``(2) The Secretary may provide, by regulation, for reasonable
variations or an alternative placement for the labeling requirements
specified in subparagraph (1), including by electronic means.''.
Subtitle C--Medical Device Shortage Reduction
SEC. 521. CLARIFYING DEVICE SHORTAGE NOTIFICATIONS.
Section 506J(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356j(a)) is amended--
(1) in paragraph (2), by striking ``during, or in advance
of, a public health emergency''; and
(2) in the matter following paragraph (2), by striking ``,
during, or in advance of, a public health emergency declared by
the Secretary under section 319 of the Public Health Service
Act,''.
SEC. 522. SUPPLY CHAIN RISK MANAGEMENT.
(a) Section 506J of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356j) is amended by striking subsection (h) and inserting the
following:
``(h) Risk Management Plans.--Each manufacturer of a device
described in subsection (a) shall develop, maintain, and, as
appropriate, implement a risk management plan that identifies and
evaluates risks to the supply of the device, as applicable, for each
establishment in which such device is manufactured. Such risk
management plan--
``(1) may identify and evaluate risks to the supply of more
than 1 device, or device category, manufactured at the same
establishment; and
``(2) shall be subject to inspection and copying by the
Secretary pursuant to section 704 or at the request of the
Secretary.''.
(b) Conforming Amendment.--Section 506J(f) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356j(f)) is amended by striking ``or
(h)'' after ``subsection (a)''.
SEC. 523. CLARIFYING VOLUNTARY NOTIFICATIONS.
Section 506J(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356j(i)) is amended by adding at the end the following:
``Nothing in this section shall be construed to limit the authority of
the Secretary to request that a manufacturer (or other person involved
in the device supply chain) provide, on a voluntary basis, information
to the Secretary or the authority of the Secretary to receive such
information.''.
Subtitle D--Drug Shortage Prevention
SEC. 531. IMPROVING NOTIFICATION PROCEDURES IN CASE OF INCREASED DEMAND
FOR CRITICAL ESSENTIAL MEDICINES.
(a) In General.--Section 506C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356c) is amended--
(1) in the section heading, by striking ``discontinuance or
interruption in the production of life-saving drugs'' and
inserting ``notification of issues affecting domestic supply of
critical essential medicines'';
(2) by striking subsections (a), (b), and (c), and
inserting the following:
``(a) Notification Required.--
``(1) In general.--A manufacturer of a critical essential
medicine shall notify the Secretary, in accordance with
subsection (b), of--
``(A)(i) a permanent discontinuance in the
manufacture of the drug or an interruption of the
manufacture of the drug that is likely to lead to a
meaningful disruption in the supply of such drug in the
United States;
``(ii) a permanent discontinuance in the
manufacture of an active pharmaceutical ingredient, an
excipient, or any other input in the final dosage form
of such drug or an interruption in the manufacture of
the active pharmaceutical ingredient, an excipient, or
any other input in the final dosage form of such drug
of such drug that is likely to lead to a meaningful
disruption in the supply of the active pharmaceutical
ingredient of such drug;
``(iii) an increased demand (other than an
anticipated seasonal surge) for such drug or an active
pharmaceutical ingredient, an excipient, or any other
input in the final dosage form of such drug that is
likely to lead to a shortage of the drug or the active
pharmaceutical ingredient, an excipient, or any other
input in the final dosage form of such drug; and
``(B) the reasons for such discontinuance,
interruption, or increased demand.
``(2) Contents.--Notification under this subsection with
respect to a critical essential medicine shall include--
``(A) with respect to the reasons for the
discontinuation, interruption, or increased demand
referred to in paragraph (1)(C), if an active
pharmaceutical ingredient, an excipient, or any other
input in the final dosage form of such drug is a reason
for, or risk factor in, such discontinuation,
interruption, or increased demand, the source of the
active pharmaceutical ingredient, excipient, or other
input and any alternative sources for the an active
pharmaceutical ingredient, an excipient, or any other
input by the manufacturer;
``(B) whether any associated device used for
preparation or administration included in the drug is a
reason for, or a risk factor in, such discontinuation,
interruption, or increased demand;
``(C) the expected duration of the interruption or
increased demand; and
``(D) such other information as the Secretary may
require.
``(b) Timing.--
``(1) In general.--A notice required under subsection (a)
shall be submitted to the Secretary--
``(A) at least 6 months prior to the date of the
discontinuance or interruption;
``(B) in the case of such a notice with respect to
increased demand for a critical essential medicine, not
later than 30 days after the submission of the initial
notification under paragraph (2); or
``(C) if compliance with subparagraph (A) or (B) is
not possible, as soon as practicable.
``(2) Initial notification with respect to increased
demand.--In the case a notification required under subsection
(a) with respect to increased demand for a critical essential
medicine, the manufacturer of the drug involved shall submit to
the Secretary an initial notification not later than 48 hours
after the date on which there has been increased demand for the
critical essential medicine for a period of at least 6
consecutive weeks.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute, through such means as the Secretary deems
appropriate, information on the discontinuance or interruption of the
manufacture of, or the increased demand for, critical essential
medicines to appropriate organizations, including physician, health
provider, and patient organizations, as described in section 506E.'';
(3) in subsection (g), in the matter preceding paragraph
(1), by striking ``drug described in subsection (a)'' and
inserting ``critical essential medicine''; and
(4) in subsection (j), by striking ``drug described in
subsection (a)'' and inserting ``critical essential medicine''.
(b) Application to Nonprescription Drugs.--Section 506C(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h)) is amended--
(1) by redesignating paragraphs (1), (2), and (3) as
paragraphs (2), (3), and (4), respectively;
(2) in paragraph (2)(A) (as so redesignated), by striking
``and that is subject to section 503(b)(1)'' and inserting ``,
including a drug that is not subject to section 503(b)(1)'';
and
(3) by inserting before paragraph (2) (as so redesignated)
the following:
``(1) the term `critical essential medicine' means a drug
that--
``(A) is--
``(i) life-supporting;
``(ii) life-sustaining; or
``(iii) intended for use in the prevention
or treatment of a debilitating disease or
condition, including any such drug used in
emergency medical care or during surgery or any
such drug that is critical to the public health
during a public health emergency declared by
the Secretary under section 319 of the Public
Health Service Act; and
``(B) is not a radio pharmaceutical drug product or
any other product as designated by the Secretary;''.
(c) Regulations.--Not later than 18 months after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
issue final regulations to implement the amendments made by subsections
(a) and (b).
(d) Guidance.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall issue guidance on the requirements for notifications
required to be submitted under section 506C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356c), as amended by
subsections (a) and (b), with respect to increased demand for
critical essential medicines (as defined in such section 506C).
Such guidance shall specifically address--
(A) the ways in which manufacturers of critical
essential medicines can improve demand predictability;
(B) what information manufacturers of critical
essential medicines should send to the Secretary; and
(C) what communications from the manufacturer the
Secretary would request with respect to increases in
demand following such notifications.
(2) Consultation.--In developing such guidance, the
Secretary shall consult with relevant stakeholders, including
manufacturers of critical essential medicines and local, State,
or Federal public health officials.
(3) Timing.--The Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, shall
issue--
(A) draft guidance under paragraph (1) not later
than 120 days after the date of the enactment of this
Act; and
(B) final guidance under such paragraph not later
than 180 days after the date of the enactment of this
Act.
Subtitle E--Protecting Americans From Unsafe Drugs
SEC. 541. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF DRUGS.
(a) Order To Cease Distribution and Recall.--Section 569D of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8d) is amended--
(1) in the section heading, by striking ``controlled
substances'' and inserting ``drugs'';
(2) by striking ``controlled substance'' each place such
term appears and inserting ``drug'';
(3) in subsection (b)--
(A) by striking ``controlled substances'' and
inserting ``drugs''; and
(B) by inserting ``of subsection (a)'' after ``an
order pursuant to paragraph (1) or an amended order
pursuant to subparagraph (B) or (C) of paragraph (3)'';
and
(4) in subsection (c), by striking ``or an official senior
to such Director'' and inserting ``or the Director of the
Center for Biologics Evaluation and Research (or an official
senior to either such Director)''.
(b) Imports and Exports.--Section 801(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(a)), as amended by section
3503(a)(4)(C) of division FF of Public Law 117-328, is amended by
striking ``is a controlled substance subject to an order under section
569D'' and inserting ``is a drug subject to an order under section
569D''.
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