[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''.
                                 <all>