[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2333 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  1st Session
                                S. 2333

  To reauthorize certain programs under the Public Health Service Act 
with respect to public health security and all-hazards preparedness and 
                   response, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 18, 2023

   Mr. Casey (for himself, Mr. Romney, Mr. Sanders, and Mr. Cassidy) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To reauthorize certain programs under the Public Health Service Act 
with respect to public health security and all-hazards preparedness and 
                   response, 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 ``Pandemic and All-
Hazards Preparedness and Response Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
            TITLE I--STATE AND LOCAL READINESS AND RESPONSE

Sec. 101. Temporary reassignment of State and local personnel during a 
                            public health emergency.
Sec. 102. Public Health Emergency Preparedness program.
Sec. 103. Improving and enhancing participation of EMS organizations in 
                            the hospital preparedness program.
Sec. 104. Improving medical readiness and response capabilities.
Sec. 105. Pilot program to support State medical stockpiles.
Sec. 106. Enhancing domestic wastewater surveillance for pathogen 
                            detection.
Sec. 107. Reauthorization of Mosquito Abatement for Safety and Health 
                            program.
              TITLE II--FEDERAL PLANNING AND COORDINATION

Sec. 201. All-Hazards Emergency Preparedness and Response.
Sec. 202. National Health Security Strategy.
Sec. 203. Improving development and distribution of diagnostic tests.
Sec. 204. Pilot program for public health data availability.
Sec. 205. Combating antimicrobial resistance.
Sec. 206. Strategic National Stockpile and material threats.
Sec. 207. Medical countermeasures for viral threats with pandemic 
                            potential.
Sec. 208. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 209. Strengthening public health communication.
Sec. 210. Fellowship and training programs.
Sec. 211. Assessment of COVID-19 mitigation policies.
           TITLE III--ADDRESSING THE NEEDS OF ALL INDIVIDUALS

Sec. 301. Transition of certain countermeasures between compensation 
                            programs.
Sec. 302. Accelerating injury compensation program administration and 
                            ensuring program integrity.
Sec. 303. Compensation for injuries relating to the public health 
                            emergency caused by SARS-CoV-2.
Sec. 304. Review of regulations.
Sec. 305. Supporting individuals with disabilities, older adults, and 
                            other at-risk individuals during emergency 
                            responses.
Sec. 306. National advisory committees.
Sec. 307. Research and coordination of activities concerning the long-
                            term health effects of SARS-CoV-2 
                            infection.
Sec. 308. National Academies study on prizes.
                  TITLE IV--STRENGTHENING BIOSECURITY

Sec. 401. Treatment of genetic variants and synthetic products of 
                            select agents and toxins.
Sec. 402. Establishment of no-fault reporting system.
Sec. 403. Evaluation of the Federal Select Agent Program and related 
                            policies.
Sec. 404. Supporting research and laboratory surge capacity.
Sec. 405. Gene synthesis.
Sec. 406. Limitation related to countries of concern conducting certain 
                            research.
Sec. 407. Assessment of artificial intelligence threats to health 
                            security.
                   TITLE V--PREVENTING DRUG SHORTAGES

Sec. 501. Improving notification procedures in case of increased demand 
                            for critical drugs.
Sec. 502. Reporting on supply chains.
Sec. 503. Reporting on use of new authorities and requirements with 
                            respect to drug shortages.
     TITLE VI--ADDITIONAL REAUTHORIZATIONS AND TECHNICAL AMENDMENTS

Sec. 601. Medical countermeasure priority review voucher.
Sec. 602. Epidemic Intelligence Service loan repayment program.
Sec. 603. Vaccine tracking and distribution.
Sec. 604. Regional health care emergency preparedness and response 
                            systems.
Sec. 605. Emergency system for advance registration of volunteer health 
                            professional.
Sec. 606. Limited antitrust exemption.
Sec. 607. Trauma care.
Sec. 608. Military and civilian partnership for trauma readiness.
Sec. 609. National Disaster Medical System.
Sec. 610. Volunteer Medical Reserve Corps.
Sec. 611. Epidemiology-laboratory capacity grants.
Sec. 612. Veterans Affairs.
Sec. 613. Technical amendments.

            TITLE I--STATE AND LOCAL READINESS AND RESPONSE

SEC. 101. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A 
              PUBLIC HEALTH EMERGENCY.

    Section 319(e) of the Public Health Service Act (42 U.S.C. 247d(e)) 
is amended--
            (1) in paragraph (1), by striking ``such Governor or tribal 
        organization's designee'' and inserting ``the designee of the 
        Governor or Tribal organization, or the State or Tribal health 
        official'';
            (2) in paragraph (2)(B)--
                    (A) in the matter preceding clause (i), by striking 
                ``tribal organization'' and inserting ``Tribal 
                organization, or the State or Tribal health official''; 
                and
                    (B) in clause (v), by striking ``tribal 
                organization'' and inserting ``Tribal organization or 
                State or Tribal health official'';
            (3) in paragraph (6)--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``Reauthorization Act of 
                        2013'' and inserting ``and Response Act''; and
                            (ii) by striking ``appropriate committees 
                        of the Congress'' and inserting ``Committee on 
                        Health, Education, Labor, and Pensions of the 
                        Senate and the Committee on Energy and Commerce 
                        of the House of Representatives''; and
                    (B) in subparagraph (A), by inserting ``, including 
                requests from State or Tribal health officials'' before 
                the semicolon;
            (4) in paragraph (7)(A), by striking ``tribal 
        organization'' and inserting ``Tribal organization''; and
            (5) in paragraph (8), by striking ``2023'' and inserting 
        ``2028''.

SEC. 102. PUBLIC HEALTH EMERGENCY PREPAREDNESS PROGRAM.

    Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a) 
is amended--
            (1) in subsection (b)(2)--
                    (A) in subparagraph (A)(ii), by striking 
                ``influenza'' and inserting ``response planning''; and
                    (B) in subparagraph (H), by inserting ``, such as 
                community-based organizations, including faith-based 
                organizations, and other public and private entities'' 
                after ``stakeholders'';
            (2) in subsection (g)--
                    (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by inserting ``and the ability of 
                each entity receiving an award under subsection (a) to 
                respond to all-hazards threats'' before the period at 
                the end of the first sentence;
                    (B) in paragraph (2)--
                            (i) in the paragraph heading, by striking 
                        ``influenza'' and inserting ``response''; and
                            (ii) in subparagraph (A)--
                                    (I) by striking ``to pandemic 
                                influenza'' and inserting ``to a 
                                pathogen causing a pandemic, including 
                                pandemic influenza''; and
                                    (II) by striking ``such pandemic 
                                influenza'' and inserting ``such 
                                pandemic response'';
                    (C) in paragraph (5)--
                            (i) in the paragraph heading, by striking 
                        ``influenza'' and inserting ``pandemic 
                        response'';
                            (ii) in the matter preceding subparagraph 
                        (A), by striking ``2019'' and inserting 
                        ``2025'';
                            (iii) in clause (i), by striking ``2018'' 
                        and inserting ``2024''; and
                            (iv) in subparagraph (B), by striking 
                        ``pandemic influenza'' and inserting ``a 
                        pathogen causing a pandemic''; and
                    (D) in paragraph (6)--
                            (i) in subparagraph (A), in the matter 
                        preceding clause (i), by striking ``The amounts 
                        described in this paragraph are the following 
                        amounts that are payable to an entity for 
                        activities described in this section of section 
                        319C-2'' and inserting ``The Secretary shall 
                        withhold from an entity pursuant to paragraph 
                        (5) for noncompliance with the requirements of 
                        this section or section 319C-2 as follows''; 
                        and
                            (ii) in subparagraph (B), by inserting 
                        ``with respect to the requirements of this 
                        section or section 319C-2'' after ``paragraph 
                        (5)''; and
            (3) in subsection (h)--
                    (A) in paragraph (1)(A), by striking ``$685,000,000 
                for each of fiscal years 2019 through 2023'' and 
                inserting ``$735,000,000 for each of fiscal years 2024 
                through 2028'';
                    (B) in paragraph (4)--
                            (i) in subparagraph (A), by striking ``For 
                        fiscal year 2027, the Secretary'' and inserting 
                        ``The Secretary''; and
                            (ii) in subparagraph (D), by striking ``for 
                        fiscal year 2026''; and
                    (C) in paragraph (5)(A), by striking ``For fiscal 
                year 2007, the Secretary'' and inserting ``The 
                Secretary''.

SEC. 103. IMPROVING AND ENHANCING PARTICIPATION OF EMS ORGANIZATIONS IN 
              THE HOSPITAL PREPAREDNESS PROGRAM.

    (a) Increasing Participation by EMS in the Hospital Preparedness 
Program.--Section 319C-2 of the Public Health Service Act (42 U.S.C. 
247d-3b) is amended--
            (1) in subsection (b)(1)(A)--
                    (A) in clause (iii)(III), by striking ``; and'' and 
                inserting semicolon; and
                    (B) by striking clause (iv) and inserting the 
                following:
                            ``(iv) one or more emergency medical 
                        service organizations; and
                            ``(v) to the extent practicable, one or 
                        more emergency management organizations; and''; 
                        and
            (2) in subsection (g)(1)--
                    (A) by striking the heading and inserting:
            ``(1) Local response capabilities.--
                    ``(A) Program coordination.--'';
                    (B) by striking ``extent practicable, ensure'' and 
                inserting the following: ``extent practicable--
                            ``(i) ensure'';
                    (C) by striking the period and inserting ``; and''; 
                and
                    (D) by adding at the end the following:
                            ``(ii) seek to increase participation of 
                        eligible entities described in subsection 
                        (b)(1)(A) with lower participation rates 
                        relative to coalitions of other eligible 
                        entities, such as coalitions that include 
                        emergency medical services organizations and 
                        health care facilities in underserved areas.''.
    (b) Preferences.--Section 319C-2(d)(1)(A)(iii) of the Public Health 
Service Act (42 U.S.C. 247d-3b(d)(1)(A)(iii)) is amended by striking 
``subsection (b)(1)(A)(ii)'' and inserting ``clauses (ii) and (iv) of 
subsection (b)(1)(A)''.

SEC. 104. IMPROVING MEDICAL READINESS AND RESPONSE CAPABILITIES.

    Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b) 
is amended--
            (1) in subsection (b)(2)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B), by striking the period and 
                inserting ``; and''; and
                    (C) by inserting at the end the following:
            ``(C) designate a lead entity to administer such award and 
        support coordination between entities described in this 
        subsection.'';
            (2) in subsection (g)(1), as amended by section 102(a)(2), 
        by adding at the end the following:
                    ``(B) Regional operations.--An eligible entity 
                shall establish and maintain, or leverage an existing, 
                capability to enable coordination of regional medical 
                operations, which may include systems to facilitate 
                information sharing and coordination, within a 
                coalition described under subsection (b)(1)(A) and, as 
                appropriate, between multiple coalitions that are in 
                close geographic proximity to each other.''; and
            (3) in subsection (j)(1)--
                    (A) in subparagraph (A), by striking ``2019 through 
                2023'' and inserting ``2024 through 2028''; and
                    (B) in subparagraph (B)(iii), by striking ``2023'' 
                and inserting ``2028''.

SEC. 105. PILOT PROGRAM TO SUPPORT STATE MEDICAL STOCKPILES.

    (a) In General.--Section 319F-2(i) of the Public Health Service Act 
(42 U.S.C. 247d-6b(i)) is amended--
            (1) in paragraph (2)(B)(i)--
                    (A) in subclause (I), by striking ``and 2024'' and 
                inserting ``through 2025''; and
                    (B) in subclause (II), by striking ``2025'' and 
                inserting ``2026'';
            (2) in paragraph (4)--
                    (A) in subparagraph (G), by striking ``; and'' at 
                the end and inserting a semicolon;
                    (B) by redesignating subparagraph (H) as 
                subparagraph (I);
                    (C) by inserting after subparagraph (G) the 
                following:
                    ``(H) facilitate the sharing of best practices 
                between States within a consortia of States in receipt 
                of funding related to establishing and maintaining a 
                stockpile of medical products; and''; and
                    (D) in subparagraph (I), as so redesignated, by 
                striking ``State efforts'' and inserting ``State or 
                regional efforts'';
            (3) by redesignating paragraphs (5) through (9) as 
        paragraphs (6) through (10), respectively;
            (4) by inserting after paragraph (4) the following:
            ``(5) Coordination.--An entity in receipt of an award under 
        paragraph (1), in carrying out the activities under this 
        subsection, shall coordinate with appropriate health care 
        entities, health officials, and emergency management officials 
        within the jurisdiction of such State or States.''; and
            (5) in paragraph (10), as so redesignated, by striking 
        ``$3,500,000,000 for each of fiscal years 2023 and 2024'' and 
        inserting ``such sums as may be necessary for each of fiscal 
        years 2024 through 2028''.
    (b) GAO Report.--Section 2409(b) of the PREVENT Pandemics Act 
(Public Law 117-328) is amended--
            (1) in paragraph (2), by striking ``; and'' and inserting a 
        semicolon;
            (2) in paragraph (3), by striking the period and inserting 
        ``; and''; and
            (3) by adding at the end the following:
            ``(4) the impact of any regional stockpiling approaches 
        carried out under such subsection (i)(1) of section 319F-2 of 
        the Public Health Service Act (42 U.S.C. 247d-6b).''.

SEC. 106. ENHANCING DOMESTIC WASTEWATER SURVEILLANCE FOR PATHOGEN 
              DETECTION.

    (a) In General.--Subtitle C of title XXVIII of the Public Health 
Service Act (42 U.S.C. 300hh-31 et seq.) is amended by adding at the 
end the following:

``SEC. 2827. WASTEWATER SURVEILLANCE FOR PATHOGEN DETECTION.

    ``(a) Wastewater Surveillance System.--The Secretary, acting 
through the Director of the Centers for Disease Control and Prevention 
and in coordination with other Federal departments and agencies, shall 
award grants, contracts, or cooperative agreements to eligible entities 
to establish, maintain, or improve activities related to the detection 
and monitoring of infectious diseases through wastewater for public 
health emergency preparedness and response purposes.
    ``(b) Eligible Entities.--To be eligible to receive an award under 
this section, an entity shall--
            ``(1) be a State, Tribal, or local health department, or a 
        partnership between such a health department and other public 
        and private entities; and
            ``(2) submit to the Secretary an application at such time, 
        in such manner, and containing such information as the 
        Secretary may reasonably require, which shall include--
                    ``(A) a description of activities proposed to be 
                carried out pursuant to an award under subsection (a);
                    ``(B) factors such entity proposes to use to select 
                wastewater sampling sites;
                    ``(C) a plan for responding, as appropriate, to 
                findings from such wastewater sampling, consistent with 
                applicable plans developed by such entity pursuant to 
                section 319C-1;
                    ``(D) a plan to sustain such wastewater 
                surveillance activities described in such application 
                following the conclusion of the award period; and
                    ``(E) any additional information the Secretary may 
                require.
    ``(c) Consideration.--In making awards under subsection (a), the 
Secretary may give priority to eligible entities that have submitted an 
application that--
            ``(1) details plans to provide public access to data 
        generated through such wastewater surveillance activities in a 
        manner that enables comparison to such data generated by other 
        recipients of an award under subsection (a); and
            ``(2) provides an assessment of community needs related to 
        ongoing infectious disease monitoring, including burden of 
        infectious diseases that can be detected in wastewater and 
        availability of other forms of infectious disease surveillance.
    ``(d) Use of Funds.--An eligible entity shall, as appropriate, use 
amounts awarded under this section to--
            ``(1) establish, or enhance existing, capacity and 
        capabilities to conduct wastewater sampling, testing, and 
        related analysis;
            ``(2) conduct wastewater surveillance, as appropriate, at 
        individual facilities, institutions, and locations in rural 
        areas, in which there is an increased risk of infectious 
        disease outbreaks, or areas in which wastewater is not treated 
        through the relevant local utility of the jurisdiction; and
            ``(3) implement projects that use evidence-based or 
        promising practices to conduct wastewater surveillance 
        activities.
    ``(e) Partnerships.--In carrying out activities under this section, 
eligible entities shall identify opportunities to partner with other 
public or private entities to leverage relevant capabilities maintained 
by such entities, as appropriate and consistent with this section.
    ``(f) Technical Assistance.--The Secretary, in consultation with 
the heads of other applicable Federal agencies and departments, as 
appropriate, shall provide technical assistance to recipients of awards 
under this section to facilitate the planning, development, and 
implementation of activities described in subsection (d).
    ``(g) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated such sums as may be necessary 
for each of fiscal years 2024 through 2028.''.
    (b) Wastewater Surveillance Research.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this subsection referred to as the ``Secretary'') shall 
        continue to conduct or support research on the use of 
        wastewater surveillance to detect and monitor emerging 
        infectious diseases, which may include--
                    (A) research to improve the efficiency of 
                wastewater sample collection and analysis and increase 
                the sensitivity and specificity of wastewater testing 
                methods; and
                    (B) implementation and development of evidence-
                based practices to facilitate the estimation of 
                population-level data within a community.
            (2) Non-duplication of effort.--The Secretary shall ensure 
        that activities carried out under this subsection do not 
        unnecessarily duplicate efforts of other agencies and offices 
        within the Department of Health and Human Services related to 
        wastewater surveillance.

SEC. 107. REAUTHORIZATION OF MOSQUITO ABATEMENT FOR SAFETY AND HEALTH 
              PROGRAM.

    Section 317S of the Public Health Service Act (42 U.S.C. 247b-21) 
is amended--
            (1) in subsection (a)(3)(A), by striking ``subsection 
        (b)(3)'' and inserting ``subsection (b)(4)'';
            (2) in subsection (b)--
                    (A) by redesignating paragraphs (3) through (6) as 
                paragraphs (4) through (7), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) Considerations.--The Secretary may consider the use 
        of innovative and novel technology for mosquito prevention and 
        control in making grants under paragraph (1).'';
            (3) by amending subsection (d) to read as follows:
    ``(d) Uses of Funds.--Amounts appropriated under subsection (f) may 
be used by the Secretary to provide training and technical assistance 
with respect to the planning, development, and operation of assessments 
and plans under subsection (a) and control programs under subsection 
(b). The Secretary may provide such training and technical assistance 
directly or through awards of grants or contracts to public and private 
entities.''; and
            (4) in subsection (f)(1), by striking ``2019 through 2023'' 
        and inserting ``2024 through 2028''.

              TITLE II--FEDERAL PLANNING AND COORDINATION

SEC. 201. ALL-HAZARDS EMERGENCY PREPAREDNESS AND RESPONSE.

    Section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10) 
is amended--
            (1) in subsection (b)--
                    (A) in paragraph (3)--
                            (i) by striking ``Oversee advanced'' and 
                        inserting the following:
                    ``(A) In general.--Oversee advanced''; and
                            (ii) by adding at the end following:
                    ``(B) Development of requirements.--Lead the 
                development and approval, and, on a routine basis, the 
                review and update, of requirements for such 
                countermeasures and products, including related 
                capabilities, to inform the advanced research, 
                development, procurement, and replenishment decisions 
                of the Department of Health and Human Services.'';
                    (B) in paragraph (4)--
                            (i) in subparagraph (F)--
                                    (I) in the matter preceding clause 
                                (i), by striking ``and in consultation 
                                with the Secretary of Homeland 
                                Security,''; and
                                    (II) in clause (i), by inserting 
                                ``enhance'' after ``capabilities and''; 
                                and
                            (ii) in subparagraph (G)--
                                    (I) in clause (i), by striking 
                                ``based on'' and inserting ``based on--
                                '';
                                    (II) in clause (ii), by striking 
                                ``; and'' at the end and inserting a 
                                semicolon;
                                    (III) in clause (iii), by striking 
                                the period and inserting ``; and''; and
                                    (IV) by adding at the end the 
                                following:
                            ``(iv) that include, as appropriate, 
                        participation by relevant industry, academia, 
                        professional societies, and other 
                        stakeholders.'';
                            (iii) in subparagraph (H)--
                                    (I) by inserting ``and the Director 
                                of the Office of Pandemic Preparedness 
                                and Response'' after ``Security 
                                Affairs''; and
                                    (II) by inserting ``and medical 
                                product and supply capacity planning 
                                pursuant to subparagraph (J), including 
                                discussion of any relevant identified 
                                supply chain vulnerabilities'' before 
                                the period at the end;
                            (iv) in subparagraph (I), by inserting 
                        ``the Director of the Office of Pandemic 
                        Preparedness and Response Policy,'' after 
                        ``Security Affairs,''; and
                            (v) in subparagraph (J)(i), in the matter 
                        preceding subclause (I), by inserting 
                        ``(including ancillary medical supplies and 
                        components of medical products, such as active 
                        pharmaceutical ingredients, key starting 
                        materials, and medical device components)'' 
                        after ``supply needs''; and
                    (C) in paragraph (7)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``and the requirements 
                        developed pursuant to paragraph (3)(B)'' after 
                        ``subsection (d)'';
                            (ii) by redesignating subparagraphs (E) and 
                        (F) as subparagraphs (F) and (G), respectively; 
                        and
                            (iii) by inserting after subparagraph (D) 
                        the following:
                    ``(E) include a professional judgment of 
                anticipated budget needs for each future fiscal year 
                accounted for in such plan to account for the full 
                range of anticipated medical countermeasure needs and 
                life-cycle costs to address such priorities and 
                requirements;'';
            (2) in subsection (d)--
                    (A) by amending paragraph (1) to read as follows:
            ``(1) In general.--Not later than March 15, 2020, and 
        biennially thereafter, the Assistant Secretary for Preparedness 
        and Response shall develop and submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives a coordinated strategy for medical 
        countermeasures to address chemical, biological, radiological, 
        and nuclear threats, informed by the requirements developed 
        pursuant to subsection (b)(3)(B). Not later than 180 days after 
        the submission of such strategy to such committees, the 
        Assistant Secretary for Preparedness and Response shall submit 
        an accompanying implementation plan to such committees. In 
        developing such a strategy and plan, the Assistant Secretary 
        for Preparedness and Response shall consult with the Public 
        Health Emergency Medical Countermeasures Enterprise established 
        under section 2811-1.''; and
                    (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by inserting ``strategy and'' before 
                ``plan''; and
            (3) in subsection (f)--
                    (A) in paragraph (1), in the matter preceding 
                subparagraph (A), by inserting ``, including an 
                emerging infectious disease,'' after ``any such 
                agent''; and
                    (B) in paragraph (2)(A), by striking ``$250,000,000 
                for each of fiscal years 2019 through 2023'' and 
                inserting ``$335,000,000 for each of fiscal years 2024 
                through 2028''.

SEC. 202. NATIONAL HEALTH SECURITY STRATEGY.

    Section 2802 of the Public Health Service Act is amended--
            (1) in subsection (a)(3)--
                    (A) by striking ``In 2022, the'' and inserting 
                ``The''; and
                    (B) by inserting ``, maintaining, and sustaining'' 
                after ``establishing''; and
            (2) in subsection (b)--
                    (A) in paragraph (2)--
                            (i) in subparagraph (A), by inserting 
                        ``that support interagency coordination and 
                        availability of information, as appropriate'' 
                        before the period;
                            (ii) in subparagraph (B), by inserting 
                        ``rapid testing,'' after ``and supplies,'';
                    (B) in paragraph (3)--
                            (i) in subparagraph (C), by inserting ``and 
                        current capacity of facilities within such 
                        systems, as applicable'' before the period;
                            (ii) in subparagraph (D), by inserting 
                        ``and other medical products and medical 
                        supplies directly related to responding to 
                        chemical, biological, radiological, or nuclear 
                        threats, including emerging infectious 
                        diseases, and incidents covered by the National 
                        Response Framework, as applicable and 
                        consistent with the activities carried out 
                        under section 2811(b)(4)(J)'' before the 
                        period; and
                            (iii) by adding at the end the following:
                    ``(H) Supporting the availability of blood and 
                blood products with respect to public health 
                emergencies.'';
                    (C) in paragraph (5), by inserting ``applicable 
                federally-funded activities and'' after ``(including'';
                    (D) in paragraph (8)--
                            (i) in subparagraph (A), by inserting 
                        ``public health and medical'' before 
                        ``activities''; and
                            (ii) in subparagraph (B), by striking 
                        ``familiarity with'' and inserting 
                        ``understanding of, and coordination 
                        between,'';
                    (E) by redesignating paragraphs (9) and (10) as 
                paragraphs (10) and (12), respectively;
                    (F) by inserting after paragraph (8) the following:
            ``(9) Other settings.--Supporting Federal, State, local, 
        and Tribal coordination and planning with respect to facilities 
        in which there is an increased risk of infectious disease 
        outbreaks, including such facilities that address the needs of 
        at-risk individuals, in the event of a public health emergency 
        declared under section 319.'';
                    (G) by inserting after subparagraph (10), as so 
                redesignated, the following:
            ``(11) Other hazards.--Assessing current and potential 
        health security threats from natural disasters or other extreme 
        weather events with respect to public health and medical 
        preparedness and response.''; and
                    (H) by striking ``tribal'' each place it appears 
                and inserting ``Tribal''.

SEC. 203. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC TESTS.

    Section 319B of the Public Health Service Act (42 U.S.C. 247d-2) is 
amended to read as follows:

``SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC 
              TESTS.

    ``(a) Framework.--The Secretary shall develop, make publicly 
available not later than 1 year after the date of enactment of the 
Pandemic and All-Hazards Preparedness and Response Act, and update not 
less frequently than every 3 years thereafter, a strategic framework 
for the rapid development, validation, authorization, manufacture, 
procurement, and distribution of diagnostic tests, and for rapid 
scaling of testing capacity, in response to chemical, biological, 
radiological, or nuclear threats, including infectious diseases for 
which a public health emergency is declared under section 319, or that 
has significant potential to cause such a public health emergency. Such 
strategic framework shall take into consideration--
            ``(1) domestic capacity, including any such capacity 
        established through partnerships with public and private 
        entities pursuant to subsection (c), to support the 
        development, validation, authorization, manufacture, 
        procurement, and distribution of tests;
            ``(2) novel technologies and platforms that may be used to 
        improve testing capabilities, including high-throughput 
        laboratory diagnostics, and point-of-care diagnostics, and any 
        such technologies to improve the accessibility of such tests, 
        and facilitate the development and manufacture of diagnostic 
        tests;
            ``(3) medical supply needs related to testing, including 
        diagnostic testing, equipment, supplies, and component parts, 
        and any potential vulnerabilities related to the availability 
        of such medical supplies and related planning, consistent with 
        section 2811(b)(4)(J);
            ``(4) strategies for the rapid and efficient distribution 
        of tests locally, regionally, or nationwide and scaling 
        laboratory testing capacity; and
            ``(5) assessing such strategies through drills and 
        operational exercises carried out under section 2811(b)(4)(G), 
        as appropriate.
    ``(b) Coordination.--To inform the development and update of the 
framework under subsection (a), and in carrying out activities to 
implement such framework, the Secretary shall coordinate with industry, 
States, local governmental entities, Indian Tribes and Tribal 
organizations, and other relevant public and private entities.
    ``(c) Capacity Building.--The Secretary may contract with public 
and private entities, as appropriate, to increase domestic capacity in 
the rapid development, validation, authorization, manufacture, 
procurement, and distribution of diagnostic tests, as appropriate, to 
State, local, and Tribal health departments and other appropriate 
entities for immediate public health response activities to address an 
infectious disease with respect to which a public health emergency is 
declared under section 319, or that has significant potential to cause 
such a public health emergency.''.

SEC. 204. PILOT PROGRAM FOR PUBLIC HEALTH DATA AVAILABILITY.

    (a) Situational Awareness System.--Section 319D of the Public 
Health Service Act (42 U.S.C. 247d-4) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (1), by inserting ``, and 
                facilitate the leveraging of relevant public health 
                data across the Department of Health and Human 
                Services'' after ``extent practicable''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``among agencies'' 
                                and inserting ``among, and direct 
                                communication between, agencies'';
                                    (II) by inserting ``the sharing of 
                                information from applicable public 
                                health data systems,'' after 
                                ``Technology),''; and
                                    (III) by striking ``; and'' at the 
                                end and inserting a semicolon;
                            (ii) in subparagraph (B), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following:
                    ``(C) facilitate communication, including 
                bidirectional communication or other means of 
                communication, to enable timely information sharing 
                with State, local, and Tribal public health officials, 
                between agencies and offices of the Department of 
                Health and Human Services, and with health care 
                providers, as applicable and appropriate.'';
            (2) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) by striking ``, the Secretary may'' and 
                        inserting ``and support the near real-time 
                        public availability of data, as appropriate, 
                        pursuant to section 319D-2, the Secretary shall 
                        establish a pilot program to''; and
                            (ii) by striking ``, in collaboration with 
                        appropriate'' and inserting ``. Such States or 
                        consortia of States shall carry out such 
                        activities in collaboration with appropriate 
                        stakeholders, such as health information 
                        exchanges, laboratory information systems,'';
                    (B) in paragraph (2)(A), by inserting ``pursuant to 
                paragraph (3)'' after ``may require'';
                    (C) by striking paragraph (6);
                    (D) by redesignating paragraphs (3) through (5) as 
                paragraphs (4) through (6), respectively;
                    (E) by inserting after paragraph (2) the following:
            ``(3) Data plan.--For purposes of this subsection, the 
        Secretary shall develop a plan for data elements to be reported 
        to the Secretary pertaining to potentially catastrophic 
        infectious disease outbreaks, in such form and manner and at 
        such timing and frequency as determined by the Secretary. When 
        developing the plan under this subsection, the Secretary 
        shall--
                    ``(A) align with the standards and implementation 
                specifications adopted by the Secretary under section 
                3004, where applicable, and update, as necessary and 
                consistent with applicable requirements of subsection 
                (b)(3) and section 2823, uniform standards for 
                applicable entities to report data elements;
                    ``(B) consider the use of technologies that enable 
                fast bulk exchange of data; and
                    ``(C) ensure the data elements reported under this 
                subsection and made publicly available pursuant to 
                section 319D-2 are made available consistent with 
                applicable Federal and State privacy law, at a 
                minimum.''; and
                    (F) in paragraph (4), as so redesignated--
                            (i) in subparagraph (A), by striking 
                        ``emergencies;'' and inserting ``emergencies, 
                        including such diseases recommended by the 
                        National Public Health Data Board established 
                        under section 319D-2; and'';
                            (ii) in subparagraph (B), by striking ``; 
                        and'' and inserting a period; and
                            (iii) by striking subparagraph (C); and
            (3) in subsection (h)--
                    (A) in paragraph (1), by striking ``2022 and 2023'' 
                and inserting ``2024 through 2028''; and
                    (B) in paragraph (2), by striking ``2022 and 2023'' 
                and inserting ``2024 through 2028''.
    (b) Data Selection and Access.--Title III of the Public Health 
Service Act (42 U.S.C. 241 et seq.) is amended by inserting after 
section 319D-1 the following:

``SEC. 319D-2. PUBLIC HEALTH DATA PILOT PROGRAM.

    ``(a) In General.--The Secretary shall--
            ``(1) establish and maintain a near real-time, open source, 
        public-facing, and publicly available website to provide 
        deidentified, aggregated data on potentially catastrophic 
        disease outbreaks, in accordance with subsection (b); and
            ``(2) collect the data elements pertaining to such diseases 
        recommended pursuant to subsection (b)(1)(B), using existing 
        processes or any new processes established pursuant to section 
        319D(d).
    ``(b) National Public Health Data Board.--
            ``(1) In general.--The Secretary shall establish a National 
        Public Health Data Board to advise, and make recommendations to 
        the Secretary with respect to potentially catastrophic 
        infectious diseases appropriate for inclusion in the public 
        health situational awareness system pilot program established 
        pursuant to section 319D(d) and the website established under 
        subsection (a)(1).
            ``(2) Membership.--The Board established under paragraph 
        (1) shall consist of the following members:
                    ``(A) Federal members.--The following Federal 
                members:
                            ``(i) The Secretary of Health and Human 
                        Services.
                            ``(ii) The Secretary of Defense.
                            ``(iii) The Secretary of Veterans Affairs.
                            ``(iv) The National Coordinator for Health 
                        Information Technology.
                            ``(v) The Director of the National 
                        Institutes of Health.
                            ``(vi) The Director of the Centers for 
                        Disease Control and Prevention.
                            ``(vii) The Assistant Secretary for 
                        Preparedness and Response.
                            ``(viii) The Director of the Indian Health 
                        Service.
                            ``(ix) The Administrator of the Centers for 
                        Medicare & Medicaid Services.
                            ``(x) The Commissioner of Food and Drugs.
                            ``(xi) Such other heads of departments, 
                        agencies, and offices as the Secretary 
                        determines appropriate.
                    ``(B) Non-federal members.--Such other individuals 
                appointed by the Secretary--
                            ``(i) who have relevant public health, 
                        medical, or scientific expertise, including--
                                    ``(I) individuals with expertise or 
                                experience in--
                                            ``(aa) State, local, or 
                                        Tribal health data systems or 
                                        practices; or
                                            ``(bb) health data 
                                        standards and technology 
                                        systems, which may include 
                                        hospital, pharmacy, laboratory 
                                        information systems and health 
                                        information exchanges; and
                                    ``(II) representatives of national 
                                public health organizations; and
                            ``(ii) individuals with such other specific 
                        expertise as the Secretary determines 
                        appropriate.
    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to alter existing obligations under regulations promulgated 
under section 264(c) of the Health Insurance Portability and 
Accountability Act of 1996, and this section shall be applied in a 
manner that is consistent with applicable Federal and State privacy 
law, at a minimum.
    ``(d) Nonduplication of Efforts.--The Secretary shall ensure that 
the activities carried out by the Board under this section do not 
duplicate the efforts of other Federal advisory committees that advise 
and make recommendations to the Secretary.
    ``(e) Sunset.--This section shall cease to have force or effect on 
September 30, 2028.''.

SEC. 205. COMBATING ANTIMICROBIAL RESISTANCE.

    Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is 
amended--
            (1) in subsection (a)--
                    (A) in paragraph (1), by inserting ``and 
                activities'' after ``Federal programs'';
                    (B) in paragraph (2)--
                            (i) by striking ``public health 
                        constituencies, manufacturers, veterinary and 
                        medical professional societies and others'' and 
                        inserting ``the Advisory Council described in 
                        subsection (b) and relevant public and private 
                        entities''; and
                            (ii) by inserting ``, pursuant to paragraph 
                        (4),'' after ``comprehensive plan'';
                    (C) by amending paragraph (3) to read as follow:
            ``(3) Agenda.--The task force described in paragraph (1) 
        shall consider factors the Secretary considers appropriate, 
        including factors to--
                    ``(A) slow the emergence of resistant bacteria and 
                fungi and prevent the spread of resistant infections;
                    ``(B) strengthen activities to combat resistance 
                with respect to zoonotic diseases;
                    ``(C) advance development and use of rapid and 
                innovative capabilities, including diagnostic tests, 
                for identification and characterization of resistant 
                bacteria and fungi;
                    ``(D) accelerate basic and applied research and 
                development for new antibiotics, antifungals, and other 
                related therapeutics and vaccines; and
                    ``(E) support international collaboration and 
                capacities for antimicrobial-resistance prevention, 
                detection, and control.'';
                    (D) by redesignating paragraph (4) as paragraph 
                (5); and
                    (E) by inserting after paragraph (3) the following:
            ``(4) Action plan.--Not later than October 1, 2025, and 
        every 5 years thereafter, the task force described in paragraph 
        (1) shall develop and submit to the Committee on Health, 
        Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate and the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives a plan regarding Federal programs and 
        activities to combat antimicrobial resistance, including 
        measurable outcomes, as appropriate, informed by the agenda 
        described in paragraph (3) and input provided by the Advisory 
        Council described in subsection (b) and other relevant 
        stakeholders provided pursuant to paragraph (2).'';
            (2) by redesignating subsections (b) through (o) as 
        subsections (c) through (p), respectively;
            (3) by inserting after subsection (a) the following:
    ``(b) Advisory Council.--
            ``(1) In general.--The Secretary may continue the 
        Presidential Advisory Council on Combating Antibiotic-Resistant 
        Bacteria, referred to in this subsection as the `Advisory 
        Council'.
            ``(2) Duties.--The Advisory Council shall advise and 
        provide information and recommendations to the Secretary, 
        acting through the Task Force established under subsection (a), 
        regarding Federal programs and activities intended to reduce or 
        combat antimicrobial-resistant bacteria or fungi that may 
        present a public health threat and improve capabilities to 
        prevent, diagnose, mitigate, or treat such resistance. Such 
        advice, information, and recommendations may be related to 
        improving Federal efforts related to factors described in 
        subsection (a)(3) and other topics related to antimicrobial 
        resistance, as appropriate.
            ``(3) Meetings and coordination.--
                    ``(A) Meetings.--The Advisory Council shall meet 
                not less than biannually and, to the extent 
                practicable, in coordination with meetings of the task 
                force established under subsection (a).
                    ``(B) Coordination.--The Advisory Council shall, to 
                the greatest extent practicable, coordinate activities 
                carried out by the Council with the task force 
                established under subsection (a).
            ``(4) FACA.--Chapter 10 of title 5, United States Code, 
        shall apply to the activities and duties of the Advisory 
        Council.''; and
            (4) in subsection (n), as so redesignated, by striking 
        ``(f) through (j)'' and inserting ``(g) through (k)''.

SEC. 206. STRATEGIC NATIONAL STOCKPILE AND MATERIAL THREATS.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2)(B)(i), by striking subclause 
                (IV) and inserting the following:
                                    ``(IV) the emergency health 
                                security threat or threats such 
                                countermeasure procurement is intended 
                                to address, including--
                                            ``(aa) whether such 
                                        procurement is consistent with 
                                        meeting emergency health 
                                        security needs associated with 
                                        such threat or threats; and
                                            ``(bb) in the case of a 
                                        countermeasure that addresses a 
                                        biological agent, whether such 
                                        agent has an increased 
                                        likelihood to become resistant 
                                        to, more resistant to, or 
                                        evade, such countermeasure 
                                        relative to other available 
                                        medical countermeasures;''; and
                    (B) in paragraph (3)--
                            (i) in subparagraph (B), by striking ``are 
                        followed, regularly reviewed, and updated with 
                        respect to such stockpile'' and inserting 
                        ``with respect to such stockpile are followed, 
                        regularly reviewed, and updated to reflect best 
                        practices'';
                            (ii) by redesignating subparagraphs (H) 
                        through (K) as subparagraphs (I) through (L), 
                        respectively; and
                            (iii) by inserting after subparagraph (G) 
                        the following:
                    ``(H) utilize tools to enable the timely and 
                accurate tracking, including the location and 
                geographic distribution and utilization, of the 
                contents of the stockpile throughout the deployment of 
                such contents;'';
            (2) in subsection (c)(2)(C)--
                    (A) by striking ``promptly''; and
                    (B) by inserting ``, not later than 60 days after 
                such determination'';
            (3) in subsection (f)(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 
        ``$965,000,000 for each of fiscal years 2024 through 2028''; 
        and
            (4) in subsection (g)(1), by striking ``2019 through 2028'' 
        and inserting ``2024 through 2033''.

SEC. 207. MEDICAL COUNTERMEASURES FOR VIRAL THREATS WITH PANDEMIC 
              POTENTIAL.

    Section 319L of the Public Health Service Act (42 U.S.C. 247d-7e) 
is amended--
            (1) in subsection (c)(4)--
                    (A) in subparagraph (D), by amending clause (iii) 
                to read as follows:
                            ``(iii) conduct research to promote 
                        strategic initiatives, such as--
                                    ``(I) rapid diagnostics;
                                    ``(II) broad spectrum 
                                antimicrobials;
                                    ``(III) medical countermeasures for 
                                virus families that have significant 
                                potential to cause a pandemic, 
                                including such countermeasures that 
                                take either pathogen-specific or broad 
                                spectrum approaches; and
                                    ``(IV) technologies to improve the 
                                production and use of medical 
                                countermeasures, which may include 
                                vaccine-manufacturing technologies, 
                                dose-sparing technologies, efficacy-
                                increasing technologies, platform 
                                technologies, technologies to 
                                administer countermeasures, and 
                                technologies to improve storage and 
                                transportation of countermeasures.''; 
                                and
                    (B) in subparagraph (F), by amending clause (ii) to 
                read as follows:
                            ``(ii) threats that--
                                    ``(I)(aa) consistently exist or 
                                continually circulate and have a 
                                significant potential to become a 
                                pandemic, such as pandemic influenza; 
                                or
                                    ``(bb) include priority virus 
                                families and other viral pathogens with 
                                a significant potential to cause a 
                                pandemic; and
                                    ``(II) may include the advanced 
                                research and development, 
                                manufacturing, and appropriate 
                                stockpiling of qualified pandemic or 
                                epidemic products, and products, 
                                technologies, or processes to support 
                                the advanced research and development 
                                of such countermeasures (including 
                                multiuse platform technologies for 
                                diagnostics, vaccines, and 
                                therapeutics; virus seeds; clinical 
                                trial lots; novel virus strains; and 
                                antigen and adjuvant material);'';
            (2) in subsection (d)(2), 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''; 
        and
            (3) in subsection (e)(1), by amending subparagraph (D) to 
        read as follows:
                    ``(D) Sunset.--This paragraph shall cease to have 
                force or effect after September 30, 2028.''.

SEC. 208. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.

    Section 2811-1(c) of the Public Health Service Act (42 U.S.C. 
300hh-10a(c)) is amended--
            (1) in paragraph (1)--
                    (A) by redesignating subparagraph (D) as 
                subparagraph (E); and
                    (B) by inserting after subparagraph (C) the 
                following:
                    ``(D) Assist the Secretary in developing strategies 
                for appropriate and evidence-based allocation and 
                distribution of countermeasures to jurisdictions, in a 
                manner that supports the availability and use of such 
                countermeasures, for public health and medical 
                preparedness and response needs.'';
            (2) in paragraph (2), by striking ``, as appropriate''; and
            (3) by adding at the end the following:
            ``(3) Information sharing.--The Secretary shall, as 
        appropriate and in a manner that does not compromise national 
        security, share information related to recommendations made and 
        strategies developed under subparagraphs (A) and (C) of 
        paragraph (1) with relevant stakeholders, including industry 
        and State, local, and Tribal public health departments.''.

SEC. 209. STRENGTHENING PUBLIC HEALTH COMMUNICATION.

    (a) Public Health Communications Advisory Committee.--The Secretary 
of Health and Human Services (referred to in this section as the 
``Secretary'') shall establish an advisory committee to be known as the 
Public Health Communications Advisory Committee (referred to in this 
subsection as the ``Advisory Committee'').
    (b) Duties.--The Advisory Committee shall make recommendations to 
the Secretary and report on--
            (1) critical aspects of communication and dissemination of 
        scientific and evidence-based public health information during 
        public health emergencies;
            (2) research from relevant external stakeholders related to 
        evidence-based or evidence-informed strategies and best 
        practices to effectively communicate and disseminate such 
        information; and
            (3) strategies to improve communication and dissemination 
        of scientific and evidence-based public health information to 
        the public and to improve communication between Federal, State, 
        local, and Tribal health officials.
    (c) Composition.--The Advisory Committee shall be composed of--
            (1) appropriate Federal officials, appointed by the 
        Secretary, who shall serve as nonvoting members; and
            (2) individuals, appointed by the Secretary, representing a 
        variety of States and rural and urban areas, and each of whom 
        that has--
                    (A) expertise in public health, including 
                individuals with experience in State, local, and Tribal 
                health departments, medicine, communications, related 
                technology, psychology, mental health and substance use 
                disorders, national security;
                    (B) experience in leading community outreach; or
                    (C) expertise in other areas, as the Secretary 
                determines appropriate.
    (d) Dissemination.--The Secretary shall review the recommendations 
of the Advisory Committee and, not later than 180 days after receipt of 
the report under subsection (b), shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives a report 
describing any actions planned by the Secretary related to this 
section.
    (e) Termination.--The Advisory Committee shall terminate 2 years 
after the date of enactment of this Act.

SEC. 210. FELLOWSHIP AND TRAINING PROGRAMS.

    Section 317G of the Public Health Service Act (42 U.S.C. 247b-8) is 
amended--
            (1) by striking ``The Secretary,'' and inserting the 
        following:
    ``(a) In General.--The Secretary,''; and
            (2) by adding at the end the following:
    ``(b) Noncompetitive Conversion.--
            ``(1) In general.--The Secretary may noncompetitively 
        convert an individual who has completed an epidemiology, 
        surveillance, or laboratory fellowship or training program 
        under subsection (a) to a career-conditional appointment 
        without regard to the provisions of subchapter I of chapter 33 
        of title 5, United States Code, provided that individual meets 
        qualification requirements for the appointment.''.

SEC. 211. ASSESSMENT OF COVID-19 MITIGATION POLICIES.

    (a) GAO Study.--The Comptroller General of the United States shall 
conduct a study on the economic impact and health outcomes associated 
with the response to the COVID-19 pandemic in the United States. Such 
study shall include--
            (1) a summary of strategies used by local governmental 
        entities, States, and the Federal Government to contain and 
        mitigate the spread of COVID-19 during the public health 
        emergency declared under section 319 of the Public Health 
        Service Act (42 U.S.C. 247d) on January 31, 2020, including--
                    (A) limitations on large gatherings of people;
                    (B) the closure of schools, businesses, houses of 
                worship, and other facilities;
                    (C) masking policies;
                    (D) testing policies; and
                    (E) vaccination policies;
            (2) an analysis and review of the scientific evidence 
        related to the effectiveness of such strategies in preventing 
        or mitigating the spread of COVID-19, including estimates of 
        the burden of disease and death that were avoided through such 
        interventions;
            (3) an analysis and review of the economic and health 
        impacts of such strategies, including impacts related to mental 
        and physical health and student learning loss; and
            (4) an accounting of Federal funding used to implement such 
        strategies.
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, the Comptroller General of the United States shall submit 
a report on the study under subsection (a) to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives. Such report shall 
include recommendations based on the findings of the study conducted 
under subsection (a) regarding the impact of such strategies during the 
COVID-19 public health emergency, including how to improve future 
responses.

           TITLE III--ADDRESSING THE NEEDS OF ALL INDIVIDUALS

SEC. 301. TRANSITION OF CERTAIN COUNTERMEASURES BETWEEN COMPENSATION 
              PROGRAMS.

    (a) Treatment of Certain Ineligible Requests Related to COVID-19 
Countermeasures.--
            (1) Requests initially submitted under cicp.--
                    (A) In general.--In the case of a request for 
                compensation submitted under section 319F-4 of the 
                Public Health Service Act (42 U.S.C. 247d-6e) for an 
                injury or death related to a COVID-19 vaccine that the 
                Secretary determines to be ineligible pursuant to 
                subparagraph (B) of such section 319F-4(b)(4), as added 
                by subsection (b)(1), the Secretary shall, not later 
                than 30 days after such determination, notify the 
                individual submitting the request of such 
                determination.
                    (B) Submission of petition.--An individual who 
                receives a notification described in subparagraph (A) 
                shall be eligible to submit a petition to the United 
                States Court of Federal Claims under section 2111 of 
                the Public Health Service Act (42 U.S.C. 300aa-11) with 
                respect to the same vaccine administration claimed in 
                the request submitted under section 319F-4 of such Act 
                (42 U.S.C. 247d-6e), provided that such petition is 
                submitted not later than the later of--
                            (i) 1 year after receiving such 
                        notification under subparagraph (A); or
                            (ii) the last date on which the individual 
                        otherwise would be eligible to submit a 
                        petition relating to such injury, as specified 
                        in section 2116 of the Public Health Service 
                        Act (42 U.S.C. 300aa-16).
                    (C) Eligibility.--To be eligible to submit a 
                petition in accordance with subparagraph (B), the 
                petitioner shall have submitted the request for 
                compensation under section 319F-4 of the Public Health 
                Service Act that was determined to be ineligible not 
                later than the deadline for filing a petition under 
                section 2116 of the Public Health Service Act (42 
                U.S.C. 300aa-16) that applies with respect to the 
                administration of such vaccine.
            (2) Requests initially submitted under vicp.--
                    (A) In general.--If a special master determines 
                that--
                            (i) a petition submitted under section 2111 
                        of the Public Health Service Act (42 U.S.C. 
                        300aa-11) related to a COVID-19 vaccine is 
                        ineligible for the National Vaccine Injury 
                        Compensation Program under subtitle 2 of title 
                        XXI of the Public Health Service Act (42 U.S.C. 
                        300aa-10 et seq.) because it relates to a 
                        vaccine administered at a time when the vaccine 
                        was not included in the Vaccine Injury Table 
                        under section 2114 of such Act (42 U.S.C. 
                        300aa-14); and
                            (ii) the vaccine was administered when it 
                        was a covered countermeasure subject to a 
                        declaration under section 319F-3(b) of such Act 
                        (42 U.S.C. 247d-6d(b)),
                the special master shall, not later than 30 days after 
                such determination, notify the petitioner of such 
                determination.
                    (B) Submission of request.--An individual who 
                receives a notification described in subparagraph (A) 
                shall be eligible to submit a request for compensation 
                under section 319F-4(b) of the Public Health Service 
                Act (42 U.S.C. 247d-6e) with respect to the same 
                vaccine administration claimed in the petition 
                submitted under section 2111 of such Act--
                            (i) not later than 1 year after receiving 
                        such notification; or
                            (ii) in the case that the notification is 
                        issued after judicial review of the petition 
                        under subsection (e) or (f) of section 2112 of 
                        such Act (42 U.S.C. 300aa-12), not later than 1 
                        year after the decision of the United States 
                        Court of Federal Claim or the mandate is issued 
                        by the United States Court of Appeals for the 
                        Federal Circuit pursuant to such subsection (e) 
                        or (f).
                    (C) Eligibility.--To be eligible to submit a 
                request for compensation in accordance with 
                subparagraph (B), the individual submitting the request 
                shall have submitted the petition under section 2111 of 
                the Public Health Service Act (42 U.S.C. 300aa-11) that 
                was determined to be ineligible not later than one year 
                after the date of administration of the vaccine.
    (b) Changes to Certain Programs.--
            (1) CICP.--Section 319F-4 of the Public Health Service Act 
        (42 U.S.C. 247d-6e) is amended--
                    (A) in subsection (b)(4)--
                            (i) by striking ``Except as provided'' and 
                        inserting the following:
                    ``(A) In general.--Except as provided''; and
                            (ii) by adding at the end the following:
                    ``(B) Exclusion of injuries caused by vaccines on 
                the vaccine injury table.--Notwithstanding any other 
                provision of this section, no individual may be 
                eligible for compensation under this section with 
                respect to a vaccine that, at the time it was 
                administered, was included in the Vaccine Injury Table 
                under section 2114.''; and
                    (B) in subsection (d)(3)--
                            (i) by striking ``This section'' and 
                        inserting the following:
                    ``(A) In general.--This section''; and
                            (ii) by adding at the end the following:
                    ``(B) Exhaustion of remedies.--A covered individual 
                shall not be considered to have exhausted remedies as 
                described in paragraph (1), nor be eligible to seek 
                remedy under section 319F-3(d), unless such individual 
                has provided to the Secretary all supporting 
                documentation necessary to facilitate the 
                determinations required under subsection (b)(4).''.
            (2) VICP.--Title XXI of the Public Health Service Act (42 
        U.S.C. 300aa-1 et seq.) is amended--
                    (A) in section 2111(a)(2)(A) (42 U.S.C. 300aa-
                11(a)(2)(A)), in the matter preceding clause (i), by 
                inserting ``containing the information required under 
                subsection (c)'' after ``unless a petition'';
                    (B) in section 2112(d) (42 U.S.C. 300aa-12(d))--
                            (i) by adding at the end of paragraph (1) 
                        the following: ``Such designation shall not 
                        occur until the petitioner has filed all 
                        materials required under section 2111(c).''; 
                        and
                            (ii) in paragraph (3)(A)(ii), by striking 
                        ``the petition was filed'' and inserting ``on 
                        which the chief special master makes the 
                        designation pursuant to paragraph (1)'';
                    (C) in section 2114(e) (42 U.S.C. 300aa-14(e))--
                            (i) in paragraph (2), in the matter 
                        preceding subparagraph (A), by striking ``2 
                        years'' and inserting ``6 months''; and
                            (ii) by adding at the end the following:
            ``(4) Licensure requirement.--Notwithstanding paragraphs 
        (2) and (3), the Secretary may not revise the Vaccine Injury 
        Table to include a vaccine for which the Centers for Disease 
        Control and Prevention has issued a recommendation for routine 
        use in children or pregnant women until at least one 
        application for such vaccine has been approved under section 
        351. Upon such revision of the Vaccine Injury Table, all 
        vaccines to prevent the same infectious disease, including 
        vaccines authorized under emergency use pursuant to section 564 
        of the Federal Food, Drug, and Cosmetic Act, shall be 
        considered included in the Vaccine Injury Table.''; and
                    (D) in section 2116 (42 U.S.C. 300aa-16), by adding 
                at the end the following:
    ``(d) Clarification.--Notwithstanding subsections (a) and (b), an 
injury or death related to a vaccine administered at a time when the 
vaccine was a covered countermeasure subject to a declaration under 
section 319F-3(b) shall not be eligible for compensation under the 
Program.''.

SEC. 302. ACCELERATING INJURY COMPENSATION PROGRAM ADMINISTRATION AND 
              ENSURING PROGRAM INTEGRITY.

    (a) In General.--Section 2112(c) of the Public Health Service Act 
(42 U.S.C. 300aa12(c)) is amended--
            (1) in paragraph (1), by striking ``not more than 8 special 
        masters'' and inserting ``not fewer than 10 special masters''; 
        and
            (2) in paragraph (4)--
                    (A) by striking ``a term of 4 years'' and inserting 
                ``an initial term of 4 years'';
                    (B) by striking the second and third sentences; and
                    (C) by adding at the end the following: ``An 
                individual appointed as special master may be 
                reappointed to serve one or more additional terms of up 
                to 8 years each, pursuant to paragraph (1), and subject 
                to termination under paragraphs (2) and (3).''.
    (b) Petitions for Compensation.--Section 2111(a)(2)(A)(i) of the 
Public Health Service Act (42 U.S.C. 300aa-11(a)(2)(A)(i)) is amended--
            (1) in subclause (I), by striking ``, and'' and inserting a 
        semicolon;
            (2) in subclause (II)--
                    (A) by moving the margin 2 ems to the right; and
                    (B) by striking ``, or'' and inserting ``; and''; 
                and
            (3) by adding at the end the following:
                    ``(III) the judgment described in subclause (I) 
                does not result from a petitioner's motion to dismiss 
                the case; or''.
    (c) Compensation.--Section 2115(e)(1) of the Public Health Service 
Act (42 U.S.C. 300aa-15(e)(1)) is amended by adding at the end the 
following: ``When making a determination of good faith under this 
paragraph, the special master or court may consider whether the 
petitioner demonstrated an intention to obtain compensation on such 
petition and was not merely seeking to satisfy the exhaustion 
requirement under section 2121(b).''.

SEC. 303. COMPENSATION FOR INJURIES RELATING TO THE PUBLIC HEALTH 
              EMERGENCY CAUSED BY SARS-COV-2.

    (a) In General.--With respect to claims filed under the 
Countermeasure Injury Compensation Program (referred to in this section 
as ``the Program'') under section 319F-4 of the Public Health Service 
Act (42 U.S.C. 247d-6e) alleging a covered injury caused by the 
administration or use of a covered countermeasure pursuant to a 
declaration under section 319F-3(b) of such Act (42 U.S.C. 247d-6d(b)) 
relating to COVID-19, the following shall apply:
            (1) Notwithstanding the filing deadline applicable under 
        section 319F-4, the claim shall be filed within 3 years of the 
        administration or use of the covered countermeasure, or one 
        year after enactment of this section, whichever is later, and, 
        if a claim filed under the Program with respect to such 
        administration or use was filed before the date of enactment of 
        this Act and denied on the basis of having not been filed 
        within the time period required under subsection (b)(4) of such 
        section 319F-4, such claim may be refiled pursuant to this 
        paragraph.
            (2) With respect to a claim relating to the administration 
        of a COVID-19 vaccine, such a claim may be filed under the 
        Program only if the administration of such vaccine occurred 
        prior to the addition of the vaccine to the Vaccine Injury 
        Table under section 2114 of the Public Health Service Act (42 
        U.S.C. 300aa-14).
            (3) Not later than 9 months after the date of enactment of 
        this section, the Secretary of Health and Human Services shall 
        promulgate a covered countermeasure injury table pursuant to 
        subsection (b)(5) of section 319F-4 of the Public Health 
        Service Act (42 U.S.C. 247d-6e(b)(5)).
    (b) Professional Judgment Budget.--
            (1) In general.--The Secretary of Health and Human 
        Services--
                    (A) in consultation with the Attorney General, 
                shall submit a budget outlining the resource needs for 
                each agency for purposes of carrying out the National 
                Vaccine Injury Compensation Program under subtitle 2 of 
                title XXI of such Act (42 U.S.C. 300aa-10 et seq.) for 
                fiscal years 2024 through 2028; and
                    (B) shall submit a budget outlining resource needs 
                for purposes of carrying out the Countermeasures Injury 
                Compensation Program under section 319F-4 of the Public 
                Health Service Act (42 U.S.C. 247d-6e) for fiscal years 
                2024 through 2028.
            (2) Inclusions.--The budgets described in subparagraphs (A) 
        and (B) of paragraph (1) shall include estimates of both the 
        resources necessary to process current backlogs and each 
        program's ability to reduce processing times with respect to 
        such professional judgments.
    (c) NASEM Report.--The Secretary of Health and Human Services shall 
seek to enter into a contract with the National Academies of Sciences, 
Engineering, and Medicine under which such National Academies shall 
report, not later than 3 years after the date of enactment of this Act, 
on the Countermeasure Injury Compensation Program under section 319F-4 
of the Public Health Service Act (42 U.S.C. 247d-6e), including 
recommendations to improve the administration of such program and 
whether Congress should adjust the compensation payments available 
under such program.

SEC. 304. REVIEW OF REGULATIONS.

    The Secretary of Health and Human Services shall update 
regulations, as needed for purposes of carrying out the amendments made 
by sections 301 and 302.

SEC. 305. SUPPORTING INDIVIDUALS WITH DISABILITIES, OLDER ADULTS, AND 
              OTHER AT-RISK INDIVIDUALS DURING EMERGENCY RESPONSES.

    (a) Technical Assistance Centers on At-Risk Individuals and 
Disasters.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary'') may, through 
        grants, contracts, or cooperative agreements to eligible 
        entities, establish more than one research, training, and 
        technical assistance centers to provide appropriate 
        information, training, and technical assistance to States, 
        localities, Tribes, and other applicable entities related to 
        addressing the unique needs and considerations of at-risk 
        individuals, as defined in section 2802(b)(4) of the Public 
        Health Service Act (42 U.S.C. 300hh-1(b)(4)), in the event of a 
        public health emergency declared by the Secretary pursuant to 
        section 319 of the Public Health Service Act (42 U.S.C. 247d).
            (2) Responsibilities of the centers.--The centers 
        established under paragraph (1) shall conduct activities for 
        the purpose of--
                    (A) developing, identifying, evaluating, and 
                disseminating evidence-based or evidence-informed 
                strategies to improve health and other related outcomes 
                for at-risk individuals related to public health 
                emergencies, including by addressing such unique needs 
                and considerations in carrying out public health and 
                medical activities to prepare for, respond to, and 
                recover from, such public health emergencies; and
                    (B) assisting applicable entities in the 
                implementation of such evidence-based strategies, 
                including through sub-grants, contracts, or cooperative 
                agreements.
            (3) Priority.--In awarding grants for activities described 
        in this subsection, the Secretary shall give priority to 
        eligible entities with demonstrated expertise in, and ability 
        to carry out, the activities described in paragraph (2).
            (4) Consultation.--In carrying out activities under 
        paragraph (2), the centers established under paragraph (1) 
        shall take into consideration relevant findings and 
        recommendations of, and, as appropriate, consult with, the 
        National Advisory Committee on Individuals with Disabilities 
        and Disasters established under section 2811C of the Public 
        Health Service Act (42 U.S.C. 300hh-10d), the National Advisory 
        Committee on Children and Disasters under section 2811A of such 
        Act (42 U.S.C. 300hh-10b), and the National Advisory Committee 
        on Seniors and Disasters under section 2811B of such Act (42 
        U.S.C. 300hh-10c).
            (5) Reports.--Not later than 2 years after the date of 
        enactment of this Act and every 2 years thereafter, the 
        Secretary shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a report 
        describing the activities carried out under this subsection 
        during the preceding 2 fiscal years.
            (6) Sunset.--This subsection shall cease to have force or 
        effort on September 30, 2028.
    (b) Crisis Standards of Care.--Not later than 2 years after the 
date of enactment of this Act, the Secretary, acting through the 
Director of the Office for Civil Rights of the Department of Health and 
Human Services, shall issue guidance to States and localities on the 
development or modification of State and local crisis standards of care 
for use during the response to a public health emergency declared by 
the governor of a State or by the Secretary under section 319 of the 
Public Health Service Act (42 U.S.C. 247d), or a major disaster or 
emergency declared by the President under section 401 or 501, 
respectively, of the Robert T. Stafford Disaster Relief and Emergency 
Assistance Act (42 U.S.C. 5170, 5191) to ensure that such standards of 
care are consistent with the nondiscrimination requirements of section 
504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), title II of the 
Americans with Disabilities Act of 1990 (42 U.S.C. 12131 et seq.), and 
the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.).

SEC. 306. NATIONAL ADVISORY COMMITTEES.

    (a) National Advisory Committee on Children and Disasters.--Section 
2811A of the Public Health Service Act (42 U.S.C. 300hh-10b) is 
amended--
            (1) in subsection (c)--
                    (A) by striking ``may provide advice'' and 
                inserting the following: ``may provide--
            ``(1) advice'';
                    (B) by striking the period and inserting ``; and''; 
                and
                    (C) by adding at the end the following:
            ``(2) recommendations to the Director of the Office of 
        Pandemic Preparedness and Response Policy and to Congress with 
        respect to the public health and emergency preparedness needs 
        of children.''; and
            (2) in subsection (g), by striking ``2023'' and inserting 
        ``2028''.
    (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 (c)--
                    (A) by striking ``may provide advice'' and 
                inserting the following: ``may provide--
            ``(1) advice'';
                    (B) by striking the period and inserting ``; and''; 
                and
                    (C) by adding at the end the following:
            ``(2) recommendations to the Director of the Office of 
        Pandemic Preparedness and Response Policy and to Congress with 
        respect to the public health and emergency preparedness needs 
        of seniors.'';
            (2) in subsection (d)--
                    (A) in paragraph (1), by striking ``17 members'' 
                and inserting ``25 members''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (J), by striking ``2'' 
                        and inserting ``3'';
                            (ii) in subparagraph (K), by striking ``2'' 
                        and inserting ``3'';
                            (iii) by redesignating subparagraphs (K) 
                        through (L) as subparagraphs (L) through (M), 
                        respectively; and
                            (iv) by inserting after subparagraph (J) 
                        the following:
                    ``(K) At least 2 non-Federal health care 
                professionals with expertise in gerontology.''; and
            (3) by amending subsection (g) to read as follows:
    ``(g) Sunset.--The Advisory Committee shall terminate on September 
30, 2028.''.
    (c) National Advisory Committee on Individuals With Disabilities 
and Disasters.--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:
    ``(c) Additional Duties.--The Advisory Committee may provide--
            ``(1) advice and recommendations to the Secretary and to 
        Congress with respect to individuals with disabilities and the 
        medical and public health grants and cooperative agreements as 
        applicable to preparedness and response activities under this 
        title and title III; and
            ``(2) recommendations to the Director of the Office of 
        Pandemic Preparedness and Response Policy and to Congress with 
        respect to the public health and emergency preparedness needs 
        of individuals with disabilities.'';
            (3) in subsection (d), as so redesignated--
                    (A) in paragraph (1), by striking ``17 members'' 
                and inserting ``25 members'';
                    (B) in paragraph (2)--
                            (i) by striking subparagraphs (K) through 
                        (M); and
                            (ii) by inserting after subparagraph (J) 
                        the following:
                    ``(K) 15 non-Federal members (at least 4 of whom 
                shall be individuals with disabilities) from diverse 
                backgrounds, including the following:
                            ``(i) One representative from each of the 
                        following:
                                    ``(I) A nongovernmental 
                                organization that provides disaster 
                                preparedness and response services.
                                    ``(II) A community-based 
                                organization that represents 
                                individuals with multiple types of 
                                disabilities.
                                    ``(III) A State-based organization 
                                that represents individuals with 
                                multiple types of disabilities.
                                    ``(IV) A national organization that 
                                represents individuals with multiple 
                                types of disabilities.
                                    ``(V) A national organization that 
                                represents older adults.
                                    ``(VI) An organization that 
                                provides relevant housing services, 
                                including during the response to, and 
                                recovery from, disasters.
                                    ``(VII) An organization that 
                                represents disabled veterans.
                            ``(ii) Four individuals with geographically 
                        diverse expertise in emergency management.
                            ``(iii) Two 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.''; and
                    (C) by adding at the end the following:
            ``(3) Consideration.--In appointing members, including the 
        Chair, to the Committee under this subsection, the Secretary 
        may give consideration to disability status.''; and
            (4) by amending subsection (h), as so redesignated, to read 
        as follows:
    ``(h) Sunset.--The Advisory Committee shall terminate on September 
30, 2028.''.

SEC. 307. RESEARCH AND COORDINATION OF ACTIVITIES CONCERNING THE LONG-
              TERM HEALTH EFFECTS OF SARS-COV-2 INFECTION.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall, as 
appropriate--
            (1) coordinate activities among relevant Federal 
        departments and agencies with respect to addressing the long-
        term health effects of SARS-CoV-2 infection, which may include 
        conditions that arise as a result of such infection;
            (2) continue to conduct or support basic, clinical, 
        epidemiological, behavioral, and translational research and 
        public health surveillance related to the pathogenesis, 
        prevention, diagnosis, and treatment of the long-term health 
        effects of SARS-CoV-2 infection and re-infection, which may 
        include conditions and any effects on development, cognition, 
        and neural structure and function that arise as a result of 
        such infection; and
            (3) consistent with the findings of studies and research 
        under paragraph (1), in consultation with health and public 
        health professional associations, scientific and medical 
        researchers, and other relevant experts, develop and inform 
        recommendations, guidance, and educational materials on the 
        long-term effects of SARS-CoV-2 infection, which may include 
        conditions that arise as a result of such infection, and 
        provide such recommendations, guidance, and educational 
        materials to health care providers and the general public.
    (b) Considerations.--In conducting or supporting research under 
this section, the Secretary shall consider the diversity of research 
participants or cohorts to ensure inclusion of a broad range of 
participants, as applicable and appropriate.
    (c) Additional Activities.--The Secretary may--
            (1) acting through the Director of the Agency for 
        Healthcare Research and Quality, conduct or support research 
        related to--
                    (A) the improvement of health care delivery for 
                individuals experiencing long-term health effects of 
                SARS-CoV-2, which may include conditions that arise as 
                a result of such infection;
                    (B) the identification of any trends associated 
                with differences in diagnosis and treatment of the 
                long-term health effects of SARS-CoV-2 infection and 
                related conditions; and
                    (C) the development or identification of tools and 
                strategies to help health care entities and providers 
                care for such populations, which may include addressing 
                any differences identified pursuant to subparagraph 
                (B);
            (2) publicly disseminate the results of such research; and
            (3) establish a primary care technical assistance 
        initiative to convene primary care providers and organizations, 
        which may include support for continuing training and education 
        for such providers, as applicable and appropriate, in order to 
        collect and disseminate best practices related to the care of 
        individuals with long-term health effects of SARS-CoV-2 
        infection, which may include conditions that arise as a result 
        of such infection.
    (d) Annual Reports.--Not later than 1 year after the date of 
enactment of this Act, and annually thereafter for the next 4 years, 
the Secretary shall prepare and submit a report to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives regarding an 
overview of the research conducted or supported under this section and 
any relevant findings. Such reports may include information about how 
the research and relevant findings under this section relate to other 
research efforts supported by other public or private entities.
    (e) Public Availability of Information.--In making information or 
reports publicly available under this section, the Secretary shall take 
into consideration the delivery of such information in a manner that 
takes into account the range of communication needs of the intended 
recipients, including at-risk individuals.

SEC. 308. NATIONAL ACADEMIES STUDY ON PRIZES.

    (a) In General.--Not later than 90 days after the date of enactment 
of this Act, the Secretary of Health and Human Services shall seek to 
enter into an agreement with the National Academies of Sciences, 
Engineering, and Medicine (referred to in this section as the 
``National Academies'') to conduct a study to examine--
            (1) alternative models for directly funding, or stimulating 
        investment in, biomedical research and development that delink 
        research and development costs from the prices of drugs, 
        including the progressive replacement of patents and regulatory 
        exclusivities on new drugs with a combination of expanded 
        support for research and innovation prizes to reward the 
        successful development of drugs or achievement of related 
        milestones;
            (2) the dollar amount of innovation prizes for different 
        stages of research and development of different classes or 
        types of drugs, and total annual funding, that would be 
        necessary to stimulate investment sufficient to achieve such 
        successful drug development and related milestones;
            (3) the relative effectiveness and efficiency of such 
        alternative models in stimulating innovation, compared to the 
        status quo that includes patents and regulatory exclusivities;
            (4) strategies to implement such alternative models 
        described in paragraph (1), including a phased transition over 
        time; and
            (5) the anticipated economic and societal impacts of such 
        alternative models, including an assessment of impact on--
                    (A) the number and variety of new drugs that would 
                be developed, approved, and marketed in the United 
                States, including such new drugs intended to prevent, 
                diagnose, or treat a rare disease or condition;
                    (B) the rate at which new drugs would be developed, 
                approved, and marketed in the United States;
                    (C) access to medication and health outcomes;
                    (D) average lifespan and disease burden in the 
                United States;
                    (E) the number of manufacturers that would be 
                seeking approval for a drug or bringing a drug to 
                market for the first time;
                    (F) Federal discretionary and mandatory spending; 
                and
                    (G) public and private insurance markets.
    (b) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $3,000,000 for fiscal year 2024.
    (c) Requirements.--In conducting the study pursuant to subsection 
(a), the National Academies shall hold not fewer than 2 public 
listening sessions to solicit feedback from interested parties, 
including representatives of academia, professional societies, patient 
advocates, public health organizations, relevant Federal departments 
and agencies, drug developers, representatives of other relevant 
industries, and subject matter experts.
    (d) Report.--Not later than 2 years after the date of enactment of 
this Act, the National Academies shall submit to the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate and the Committee on Energy and Commerce 
and the Committee on Appropriations of the House of Representatives a 
report on the study conducted pursuant to subsection (a).

                  TITLE IV--STRENGTHENING BIOSECURITY

SEC. 401. TREATMENT OF GENETIC VARIANTS AND SYNTHETIC PRODUCTS OF 
              SELECT AGENTS AND TOXINS.

    Section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 
262a(a)(1)) is amended by adding at the end the following:
                    ``(C) Inclusions.--
                            ``(i) In general.--For purposes of the list 
                        under this paragraph, the following shall be 
                        considered to be a biological agent or toxin 
                        included on the list:
                                    ``(I) Any biological agent that 
                                incorporates nucleic acids coding for a 
                                virulence factor from a listed agent or 
                                toxin.
                                    ``(II) Any biological agent or 
                                toxin that is genetically homologous to 
                                a listed agent or toxin with respect to 
                                nucleotides coding for virulence 
                                factors or toxicity.
                                    ``(III) Any biological agent or 
                                toxin that is synthetically derived 
                                with virulence or toxicity 
                                characteristics of a listed agent or 
                                toxin.
                                    ``(IV) Any nucleic acid that 
                                encodes for components contributing to 
                                pathogenicity, transmissibility, or 
                                toxicity of a listed agent or toxin.
                            ``(ii) Exemptions.--The Secretary may 
                        exempt from inclusion on the list under this 
                        paragraph any biological agent, toxin, or 
                        nucleic acid described in clause (i), if such 
                        agent, toxin, or nucleic acid does not meet the 
                        criteria under subparagraph (B).''.

SEC. 402. ESTABLISHMENT OF NO-FAULT REPORTING SYSTEM.

    Title III of the Public Health Service Act is amended by inserting 
after section 351A (42 U.S.C. 262a) the following:

``SEC. 351B. NO-FAULT REPORTING SYSTEM.

    ``(a) Definitions.--In this section:
            ``(1) The term `listed agents and toxins' has the meaning 
        given the term in section 351A(l).
            ``(2) The term `reporting system' means the reporting 
        system established under subsection (b)(1).
    ``(b) Establishment.--
            ``(1) In general.--Not later than 3 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Response Act, the Secretary shall establish a confidential, 
        anonymous, voluntary, no-fault reporting system related to 
        accidents, near-accidents, or other safety incidents involving 
        biological agents and toxins, in order to support continuous 
        improvement and sharing of lessons learned related to such 
        incidents.
            ``(2) Availability.--The ability to submit reports on a 
        voluntary basis to the reporting system shall be made available 
        to individuals affiliated with laboratories located in the 
        United States, or at federally-funded entities outside the 
        United States, that conduct research involving biological 
        agents and toxins.
            ``(3) Data.--Not later than 2 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Response Act, the Secretary shall publish a notice in the 
        Federal Register on plans for the reporting system, including--
                    ``(A) data elements that will be included in the 
                submission of reports;
                    ``(B) procedures and processes for the submission 
                of reports;
                    ``(C) criteria for incidents that may be reported 
                to such system; and
                    ``(D) procedures for privacy and anonymization.
            ``(4) Prototyping and testing.--The Secretary shall test 
        and prototype the reporting system for not less than 1 year 
        before finalizing the reporting system.
            ``(5) External feedback.--The Secretary shall seek feedback 
        on development of the reporting system from external 
        stakeholders, including prior to publication of the information 
        under paragraph (3) and prior to introduction of prototypes and 
        finalization of such system under paragraph (4).
    ``(c) FOIA.--
            ``(1) In general.--Information submitted to, or derived 
        from, the reporting system shall be exempt from disclosure 
        under section 552 of title 5, United States Code.
            ``(2) Applicability.--For purposes of paragraph (1), this 
        section shall be considered a statute described in section 
        552(b)(3)(B) of title 5, United States Code.
    ``(d) Prohibition on Use as Evidence.--Information submitted to, or 
derived from, the reporting system shall not be used in any Federal or 
State enforcement action or criminal prosecution.
    ``(e) Privacy; Disciplinary Action for Unauthorized Disclosure.--An 
individual or entity that submits information to the reporting system 
under subsection (b) shall not be required to provide their name.
    ``(f) Relationship to Other Reporting Systems.--The voluntary 
reporting system established under this section shall supplement, and 
not supplant, any other requirements to submit reports under any other 
reporting system.''.

SEC. 403. EVALUATION OF THE FEDERAL SELECT AGENT PROGRAM AND RELATED 
              POLICIES.

    (a) In General.--Not later than 4 years after the date of enactment 
of this Act, the National Science Advisory Board for Biosecurity 
(referred to in this section as the ``Board'') established pursuant to 
section 404O of the Public Health Service Act (42 U.S.C. 283r) shall be 
charged with assessing the framework for biosafety and biosecurity 
oversight, particularly with respect to mitigating risks to the United 
States population with respect to biological threats. The findings of 
the Board shall address scientific advancements and integration of the 
Program and other related Federal policies and frameworks for biosafety 
and biosecurity. The findings of the Board shall be transmitted to the 
President.
    (b) Framework.--
            (1) In general.--The recommendations developed under 
        subsection (a) shall include a proposed framework for an 
        integrated approach to the oversight of biological research 
        that raises significant biosafety and biosecurity concerns, 
        which may include proposals to harmonize and modernize relevant 
        Federal policies such as the following:
                    (A) The Federal Select Agent Program.
                    (B) Federal policies relating to dual-use research 
                of concern.
                    (C) Federal policies related to federally funded 
                research involving enhanced pathogens of pandemic 
                potential.
                    (D) The Biosafety in Microbiological and Biomedical 
                Laboratories Manual of the Department of Health and 
                Human Services, and other related guidance documents.
                    (E) The Guidelines for Research Involving 
                Recombinant or Synthetic Nucleic Acid Molecules of the 
                National Institutes of Health.
            (2) Requirements for framework.--The framework proposed 
        under paragraph (1) shall--
                    (A) be developed in consultation with stakeholders 
                and experts from institutions of higher education, 
                industry, and other government agencies; and
                    (B) make recommendations related to mitigating any 
                identified risks associated with existing gaps in 
                oversight of such research, which may include research 
                that does not receive Federal funding, taking into 
                consideration any national security concerns, the 
                potential benefits of such research, considerations 
                related to the research community, transparency, and 
                public availability of information, and international 
                research collaboration.
    (c) Reorganization.--In carrying out this section, the Board may 
make recommendations related to the clarification of the authorities 
and responsibilities of relevant Federal departments and agencies and 
any necessary reorganization of such authorities and responsibilities 
among such departments and agencies.
    (d) Report.--Not later than 1 year after the issuance of 
recommendations under subsection (a), the President shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives, 
and, as applicable, other appropriate committees of Congress, a report 
that describes plans to consider and implement such recommendations, 
including the identification of--
            (1) any barriers to implementation; and
            (2) any areas in which the President disagrees with the 
        findings or recommendations of the Board.

SEC. 404. SUPPORTING RESEARCH AND LABORATORY SURGE CAPACITY.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall make awards to 
establish or maintain, as applicable, not fewer than 12 regional 
biocontainment laboratories, for purposes of--
            (1) conducting biomedical research to support public health 
        and medical preparedness for, and rapid response to, biological 
        agents, including emerging infectious diseases;
            (2) ensuring the availability of surge capacity for 
        purposes of responding to such biological agents;
            (3) supporting information-sharing between, and the 
        dissemination of findings to, researchers and other relevant 
        individuals to facilitate collaboration between industry and 
        academia; and
            (4) providing, as appropriate and applicable, technical 
        assistance and training to researchers and other relevant 
        individuals to support the biomedical research workforce in 
        improving the management and mitigation of safety and security 
        risks in the conduct of research involving such biological 
        agents.
    (b) Requirements.--As a condition of receiving a grant under this 
section, a regional biocontainment laboratory shall agree--
            (1) to such oversight activities as the Secretary 
        determines appropriate, including periodic meetings with 
        relevant officials of the Department of Health and Human 
        Services, facility inspections, and other activities as 
        necessary and appropriate to ensure compliance with the terms 
        and conditions of such award; and
            (2) to report accidents, near-accidents, or other safety 
        incidents involving biological agents and toxins into the no-
        fault reporting system established pursuant to section 351B of 
        the Public Health Service Act, as added by section 402.
    (c) Board.--The Secretary shall establish a Board consisting of a 
representative from each entity in receipt of an award under subsection 
(a), which shall be headed by an executive committee of 3 members 
elected upon an affirmative vote from a majority of such 
representatives. The Board shall make recommendations to the Secretary 
in administering awards under this section, for purposes of--
            (1) improving the quality and consistency of applicable 
        procedures and practices within laboratories funded pursuant to 
        subsection (a); and
            (2) ensuring coordination, as appropriate, of federally 
        funded activities carried out at such laboratories.
    (d) Definition.--In this section, the term ``regional 
biocontainment laboratory'' means a Biosafety or Animal Biosafety 
Level-3 and Level-2 facility located at an institution in the United 
States that is designated by the Secretary to carry out the activities 
described in subsection (a).
    (e) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $52,000,000 for each of fiscal 
years 2024 through 2028.
    (f) Administrative Expenses.--Of the amount available to carry out 
this section for a fiscal year, the Secretary may use not more than 5 
percent for the administrative expenses of carrying out this section, 
including expenses related to carrying out subsection (c).
    (g) Report to Congress.--Not later than 1 year after the date of 
the enactment of this Act, and biannually thereafter, the Secretary, in 
consultation with the heads of applicable Federal departments and 
agencies shall report to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and Commerce of the 
House of Representatives on--
            (1) the activities and accomplishments of the regional 
        biocontainment laboratories;
            (2) any published or disseminated research findings based 
        on research conducted in such laboratories in the applicable 
        year;
            (3) oversight activities carried out by the Secretary 
        pursuant to subsection (b);
            (4) activities undertaken by the Secretary to take into 
        consideration the capacity and capabilities of the network of 
        regional biocontainment laboratories in activities to prepare 
        for and respond to biological agents, which may include 
        leveraging such capacity and capabilities to support the 
        Laboratory Response Network, as applicable and appropriate;
            (5) plans for the maintenance and sustainment of federally 
        funded activities conducted at the regional biocontainment 
        laboratories, consistent with the strategy required under 
        section 2312 of the PREVENT Pandemics Act (Public Law 117-328); 
        and
            (6) activities undertaken by the Secretary to coordinate 
        with applicable agencies to ensure work carried out by such 
        facilities is prioritized and complementary to one another, and 
        avoiding unnecessary duplication.

SEC. 405. GENE SYNTHESIS.

    (a) Guidance.--Not later than 1 year after the date of enactment of 
this Act, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall update the Screening Framework 
Guidance for Providers of Synthetic Double-Stranded DNA to account for 
scientific and technological advancements with respect to mitigating 
risk of unauthorized individuals or individuals with malicious intent 
from using nucleic acid synthesis technologies to obtain biological 
agents or toxins of concern. Such guidance shall include 
recommendations related to--
            (1) screening for sequences that the Secretary determines 
        may contribute to toxicity, pathogenicity, or virulence;
            (2) screening and verification of the identity and 
        legitimacy of customers;
            (3) the identification, evaluation, and use of appropriate 
        software or other tools to enable the screening described in 
        paragraphs (1) and (2);
            (4) ensuring nucleic acid synthesis activities are carried 
        out in compliance with existing regulations under part 73 of 
        title 42, Code of Federal Regulations, part 331 of title 7, 
        Code of Federal Regulations, part 121 of title 9, Code of 
        Federal Regulations, and part 774 of title 15 Code of Federal 
        Regulations (or successor regulations);
            (5) implementing appropriate safeguards, which may include 
        the use of such software or other tools, in gene synthesis 
        equipment to facilitate screening of nucleic acid sequences 
        and, as applicable, customers;
            (6) maintaining records of customer orders, metadata, and 
        screening system or protocol performance in specified formats, 
        which may include standardized machine-readable and 
        interoperable data formats; and
            (7) other recommendations as determined appropriate by the 
        Secretary.
    (b) Sequences of Concern.--The Secretary shall maintain a public 
docket to solicit recommendations on potential sequences of concern 
and, in consultation with other Federal departments and agencies and 
non-Federal experts, as appropriate, review and update, on a regular 
basis, a list of sequences of concern to facilitate screening under 
subsection (a)(1).
    (c) Landscape Review.--The Secretary, in coordination with other 
Federal departments and agencies, as appropriate, shall conduct a 
landscape review of providers and manufacturers of gene synthesis 
equipment, products, software, and other tools with the purpose of 
understanding the number, types, and capabilities of products and 
equipment that exist domestically and to inform the development of any 
updates to the guidance under subsection (a).
    (d) Technical Assistance.--The Secretary, in consultation with 
other Federal departments and agencies, shall provide technical 
assistance upon request of a gene synthesis provider, manufacturer of 
gene synthesis equipment, or developer of software or other screening 
tools to support implementation of the recommendations included in the 
guidance under subsection (a).
    (e) Definitions.--For purposes of this section:
            (1) The term ``gene synthesis equipment'' means equipment 
        needed to produce gene synthesis products.
            (2) The term ``gene synthesis product''--
                    (A) means custom single-stranded or double-stranded 
                DNA, or single-stranded or double-stranded RNA, which 
                has been chemically or enzymatically synthesized or 
                otherwise manufactured de novo and is of a length 
                exceeding the screening threshold, as determined by the 
                Secretary; and
                    (B) does not include--
                            (i) base chemical subunits, such as 
                        individual nucleotides or nucleosides, or 
                        oligonucleotides shorter than the screening 
                        threshold typically used as polymerase chain 
                        reaction primers, as determined by the 
                        Secretary;
                            (ii) by-products generated during 
                        sequencing that are not useful for assembly or 
                        cloning, as determined by the Secretary; or
                            (iii) products generated from cloning or 
                        assembling of existing gene or gene fragment 
                        material, in circumstances in which the gene 
                        synthesis provider has no access or notice to 
                        the sequence design, as determined by the 
                        Secretary.
            (3) The term ``gene synthesis provider'' means an entity 
        that synthesizes and distributes gene synthesis products, 
        including bacteria, viruses, or fungi containing recombinant or 
        synthetic nucleic acid molecules, for delivery to a customer.
            (4) The term ``manufacturers of gene synthesis equipment'' 
        means an entity that produces and sells equipment for 
        synthesizing gene synthesis products.

SEC. 406. LIMITATION RELATED TO COUNTRIES OF CONCERN CONDUCTING CERTAIN 
              RESEARCH.

    Section 2315(c) of the PREVENT Pandemics Act (Public Law 117-328) 
is amended--
            (1) in paragraph (1)--
                    (A) by inserting ``that may reasonably be 
                anticipated to involve the creation, transfer, and use 
                of enhanced pathogens of pandemic potential or 
                biological agents or toxins listed pursuant to section 
                351A(a)(1) if such research is'' after ``not fund 
                research''; and
                    (B) by striking ``, involving pathogens of pandemic 
                potential'' and all that follows through the period at 
                the end and inserting a period;
            (2) in paragraph (2)--
                    (A) in the heading, by striking ``Conditions for 
                listing or suspending prohibition'' and inserting 
                ``Limitations''; and
                    (B) in the matter preceding subparagraph (A)--
                            (i) by striking ``The Secretary'' and 
                        inserting ``Beginning 5 years after an initial 
                        determination of a country of concern, the 
                        Director of National Intelligence or the 
                        Secretary''; and
                            (ii) by inserting ``with respect to such 
                        country of concern'' after ``paragraph (1)''; 
                        and
            (3) by adding at the end the following:
            ``(3) Clarification.--
                    ``(A) In general.--The requirement of paragraph (1) 
                may be waived by the President for the duration of the 
                initial response to an outbreak of a novel emerging 
                infectious disease if the President determines that 
                such requirement impedes the ability of the Federal 
                Government to immediately respond to such outbreak.
                    ``(B) Notification.--The President shall notify 
                Congress not later than 48 hours after exercising the 
                waiver under subparagraph (A), and shall provide 
                updates to Congress related to the use of such waiver 
                every 15 days thereafter.''.

SEC. 407. ASSESSMENT OF ARTIFICIAL INTELLIGENCE THREATS TO HEALTH 
              SECURITY.

    (a) In General.--Not later than 45 days after the date of enactment 
of this Act, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall seek to enter into a contract 
with the National Academies of Sciences, Engineering, and Medicine 
(referred to in this section as the ``National Academies'') to conduct 
a study assessing the potential vulnerabilities to health security 
presented by the current or prospective use or misuse of artificial 
intelligence, including with respect to open-source artificial 
intelligence models, such as large language models.
    (b) Inclusions.--The study conducted pursuant to the contract under 
subsection (a) shall include--
            (1) an assessment of the potential vulnerabilities posed by 
        technical advancements in artificial intelligence to health 
        security, including any risks related to the development of, 
        enhancement of, or protection from, chemical, biological, 
        radiological, or nuclear threats;
            (2) a description of roles, responsibilities, and 
        capabilities of agencies and offices of the Department of 
        Health and Human Services, and, as applicable and appropriate, 
        other Federal departments and agencies, with respect to the 
        identification and mitigation of such potential 
        vulnerabilities;
            (3) a summary of any ongoing Federal activities related to 
        the identification, understanding, and mitigation of such 
        potential risks;
            (4) the identification of any potential gaps, whether 
        current or anticipated, related to such roles, 
        responsibilities, and capabilities; and
            (5) recommendations to improve Federal efforts to identify, 
        prepare for, and mitigate such potential vulnerabilities.
    (c) Reports.--
            (1) National academies report.--Not later than 2 years 
        after the date of the contract under subsection (a), the 
        National Academies shall submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives a report 
        on the study conducted pursuant to subsection (a).
            (2) HHS report.--Not later than 1 year after the issuance 
        of the report required under paragraph (1), the Secretary shall 
        submit to the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives a report detailing actions 
        taken to mitigate and monitor risks to health security posed by 
        misuse of artificial intelligence, as detailed in the report 
        under paragraph (1).

                   TITLE V--PREVENTING DRUG SHORTAGES

SEC. 501. IMPROVING NOTIFICATION PROCEDURES IN CASE OF INCREASED DEMAND 
              FOR CRITICAL DRUGS.

    (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 drugs'';
            (2) by striking subsections (a), (b), and (c), and 
        inserting the following:
    ``(a) Notification Required.--
            ``(1) In general.--A manufacturer of a covered drug 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 of 
                such drug, or an interruption in the manufacture of an 
                active pharmaceutical ingredient of such drug that is 
                likely to lead to a meaningful disruption in the supply 
                of the active pharmaceutical ingredient of such drug; 
                or
                    ``(iii) any other circumstance, such as an increase 
                in demand or export restriction, that is likely to 
                leave the manufacturer unable to meet demand for the 
                drug without a meaningful shortfall or delay; and
                    ``(B) the reasons for such discontinuance, 
                interruption, or other circumstance, if known.
            ``(2) Contents.--Notification under this subsection with 
        respect to a covered drug shall include--
                    ``(A) with respect to the reasons for the 
                discontinuation, interruption, or other circumstance 
                described in paragraph (1)(A)(iii), if an active 
                pharmaceutical ingredient is a reason for, or risk 
                factor in, such discontinuation, interruption, or other 
                circumstance, the source of the active pharmaceutical 
                ingredient and any alternative sources for the active 
                pharmaceutical ingredient known to 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 other circumstance described in 
                paragraph (1)(A)(iii);
                    ``(C) the expected duration of the interruption; 
                and
                    ``(D) such other information as the Secretary may 
                require.
    ``(b) Timing.--A notice required under subsection (a) shall be 
submitted to the Secretary--
            ``(1) at least 6 months prior to the date of the 
        discontinuance or interruption;
            ``(2) in the case of such a notice with respect to a 
        circumstance described in subsection (a)(1)(A)(iii), as soon as 
        practicable, or not later than 10 business days after the onset 
        of the circumstance; or
            ``(3) if compliance with paragraph (1) or (2) is not 
        possible, as soon as practicable.
    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute, through such means as the Secretary 
determines appropriate, information on the discontinuance or 
interruption of the manufacture of, or other circumstance described in 
subsection (a)(1)(A)(iii) that is likely to lead to a shortage or 
meaningful disruption in the supply of, covered drugs 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 ``covered drug''; and
            (4) in subsection (j), by striking ``drug described in 
        subsection (a)'' and inserting ``covered drug''.
    (b) Definitions.--Paragraph (1) of section 506C(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h)) is amended to read as 
follows:
            ``(1) the term `covered drug' means a drug that is intended 
        for human use and 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;
                    ``(B) is not a radio pharmaceutical drug product or 
                any other product as designated by the Secretary; and
                    ``(C) is not a biological product (as defined in 
                section 351(i) of the Public Health Service Act), 
                unless otherwise provided by the Secretary in the 
                regulations promulgated under subsection (i);''.

SEC. 502. REPORTING ON SUPPLY CHAINS.

    Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(j)(3)(A)) is amended--
            (1) by inserting ``, and the names and unique facility 
        identifiers of the manufacturers of the active pharmaceutical 
        ingredients such person used for the manufacture, preparation, 
        propagation, compounding, or processing of such drug, and the 
        amount of such drug manufactured, prepared, propagated, 
        compounded, or processed using each such active pharmaceutical 
        ingredient from each such manufacturer'' before the period at 
        the end of the first sentence; and
            (2) by inserting after the first sentence the following: 
        ``In addition to the reporting required under the preceding 
        sentence, the Secretary may receive voluntary submissions of 
        such information at more frequent intervals.''.

SEC. 503. REPORTING ON USE OF NEW AUTHORITIES AND REQUIREMENTS WITH 
              RESPECT TO DRUG SHORTAGES.

    Not later than 90 days after the date of enactment of this Act, the 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary'') shall report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives on--
            (1) the extent to which the Secretary has implemented the 
        authorities and requirements under sections 506C(g), 506C(j), 
        506E(d), 510(j)(3), and 704(b)(2) (21 U.S.C. 356c(g), 356c(j), 
        356e(d), 360(j)(3), 374(b)(2)) of the Federal Food, Drug, and 
        Cosmetic Act, as amended by section 3111 and 3112 of the 
        Coronavirus Aid, Relief, and Economic Security Act (Public Law 
        116-136), including--
                    (A) specific examples of uses of such authorities 
                and requirements; and
                    (B) an assessment of the extent to which such 
                authorities and requirements have helped mitigate drug 
                shortages; and
            (2) the status of the guidance documents that the Secretary 
        intends to issue with respect to reporting and risk management 
        plan requirements applicable to manufacturers of drugs and 
        active pharmaceutical ingredients, pursuant to the amendments 
        made to section 506C of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 356c) by subsections (a) and (b) of section 3112 
        of the Coronavirus Aid, Relief, and Economic Security Act 
        (Public Law 116-136).

     TITLE VI--ADDITIONAL REAUTHORIZATIONS AND TECHNICAL AMENDMENTS

SEC. 601. MEDICAL COUNTERMEASURE PRIORITY REVIEW VOUCHER.

    Section 565A(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-4a) is amended by striking ``2023'' and inserting 
``2028''.

SEC. 602. EPIDEMIC INTELLIGENCE SERVICE LOAN REPAYMENT PROGRAM.

    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''.

SEC. 603. VACCINE TRACKING AND DISTRIBUTION.

    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. 604. REGIONAL HEALTH CARE EMERGENCY 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. 605. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH 
              PROFESSIONAL.

    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. 606. LIMITED ANTITRUST EXEMPTION.

    Section 319L-1(b) of the Public Health Service Act (42 U.S.C. 247d-
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 
September 30, 2028''.

SEC. 607. TRAUMA CARE.

    Section 1232(a) of the Public Health Service Act (42 U.S.C. 300d-
32(a)) is amended by striking ``$24,000,000 for each of fiscal years 
2023 through 2027'' and inserting ``$39,000,000 for each of fiscal 
years 2024 through 2028''.

SEC. 608. 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. 609. NATIONAL DISASTER MEDICAL SYSTEM.

    (a) In General.--Section 2812 of the Public Health Service Act (42 
U.S.C. 300hh-11) is amended--
            (1) in subsection (c)(4)(B), by striking ``2023'' and 
        inserting ``2028''; and
            (2) in subsection (g), by striking ``$57,400,000 for each 
        of fiscal years 2019 through 2023'' and inserting ``$65,900,000 
        for each of fiscal years 2024 through 2028''.
    (b) Repeal of Sunset.--
            (1) In general.--Section 301(d)(3) of the Pandemic and All-
        Hazards Preparedness and Advancing Innovation Act of 2019 
        (Public Law 116-22; 34 U.S.C. 10284 note) is repealed.
            (2) Effective date.-- Paragraph (1) shall take effect as if 
        enacted on September 30, 2021.

SEC. 610. 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''.

SEC. 611. EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS.

    Section 2821(b) of the Public Health Service Act (42 U.S.C. 300hh-
31(b)) is amended, in the matter preceding paragraph (1), by striking 
``2019 through 2023'' and inserting ``2024 through 2028''.

SEC. 612. VETERANS AFFAIRS.

    Section 8117(g) of title 38, United States Code is amended by 
striking ``2019 through 2023'' and inserting ``2024 through 2028''.

SEC. 613. TECHNICAL AMENDMENTS.

    (a) Title XXI of the Public Health Service Act (42 U.S.C. 300aa-1 
et seq.) is amended--
            (1) in section 2105(b), by striking ``, 2103, and 2104'' 
        each place it appears and inserting ``and 2103'';
            (2) in section 2110(b), by striking ``the program'' and 
        inserting ``The Program'';
            (3) in section 2111(a)--
                    (A) in paragraph (6), by striking ``1988 for'' and 
                inserting ``1988, for''; and
                    (B) in paragraph (10), by striking ``United States 
                Claims Court'' and inserting ``United States Court of 
                Federal Claims'';
            (4) in section 2112--
                    (A) in subsection (c)(6)(A), by striking ``United 
                States Claims Courts'' and inserting ``United States 
                Court of Federal Claims''; and
                    (B) in subsection (f)--
                            (i) by striking ``United States Claims 
                        Court on'' and inserting ``United States Court 
                        of Federal Claims on''; and
                            (ii) by striking ``United States Claims 
                        Court's judgment'' and inserting ``judgment of 
                        the United States Court of Federal Claims'';
            (5) in section 2115(b)(3), by striking ``subsection (e)'' 
        and inserting ``subsection (e))'';
            (6) in section 2117--
                    (A) in the section heading, by striking 
                ``subrogration'' and inserting ``subrogation''; and
                    (B) in subsection (a), by striking ``subrograted'' 
                and inserting ``subrogated''; and
            (7) in section 2127--
                    (A) in subsection (b)(1), by inserting ``and 
                Prevention'' before the period; and
                    (B) in subsection (c), by striking ``Committee on 
                Labor and Human Resources'' and inserting ``Committee 
                on Health, Education, Labor, and Pensions''.
    (b) Section 319F-3 of the Public Health Service Act (42 U.S.C. 
247d-6d) is amended--
            (1) in subsection (c)(5)(B)(ii)(I), by striking ``chapter 
        5'' and inserting ``chapter V''; and
            (2) in subsection (i)(7)--
                    (A) by striking ``321(g)(1))'' and inserting 
                ``321(g)(1)))''; and
                    (B) by striking ``321(h))'' and inserting 
                ``321(h)))''.
    (c) Section 319F-4 of the Public Health Service Act (42 U.S.C. 
247d-6e) is amended--
            (1) in subsection (b)(1), by striking ``under 319F-3(b)'' 
        and inserting ``under section 319F-3(b)''; and
            (2) in subsection (d)(5), by striking ``under subsection 
        (a) the Secretary determines that a covered individual 
        qualifies for compensation'' and inserting ``a covered 
        individual is determined under subsection (a) to be eligible 
        for compensation under this section''.
    (d) Part C of title II of the Public Health Service Act (42 U.S.C. 
239 et seq.) is amended--
            (1) in section 261(a)(2)(A), by striking ``specialities'' 
        and inserting ``specialties'';
            (2) in section 265(c)(5), by striking ``involves'' and 
        inserting ``involved'';
            (3) in section 266(b)(3)(B)(ii), by striking ``to with 
        respect to an eligible'' and inserting ``with respect to an 
        eligible''; and
            (4) in section 267(b), by striking ``such Act'' and 
        inserting ``such part''.
    (e) Section 351A(e)(7)(B)(ii) is amended by striking ``judical'' 
and inserting ``judicial''.
                                 <all>