PREVENT Pandemics Act
Bill: S.3799 | Sponsor: Sen. Murray, Patty (D-WA)
Policy area: Health

Summary:
Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or the PREVENT Pandemics Act
This bill sets out programs and activities primarily to address public health preparedness and response.
Specifically, the bill establishes a legislative task force to investigate the COVID-19 pandemic and a White House office to advise on pandemic preparedness and response. It also revises authorities, programs, and other aspects of the Department of Health and Human Services and associated agencies to support preparedness and response activities at all levels of government.
Other matters addressed in the bill include
The bill also modifies the regulation of medical products with a particular focus on expediting the development and approval of medical countermeasures. Additional areas of focus include strengthening medical product supply chains and supporting innovation in, for example, clinical trial designs.

To prepare for, and respond to, existing viruses, emerging new threats, 
                             and pandemics.

    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 ``Prepare for and 
Respond to Existing Viruses, Emerging New Threats, and Pandemics Act'' 
or the ``PREVENT Pandemics Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
         TITLE I--STRENGTHENING FEDERAL AND STATE PREPAREDNESS

           Subtitle A--Federal Leadership and Accountability

Sec. 101. Comprehensive review of the COVID-19 response.
Sec. 102. Appointment and authority of the Director of the Centers for 
                            Disease Control and Prevention.
Sec. 103. Additional provisions related to the Centers for Disease 
                            Control and Prevention.
Sec. 104. Public health and medical preparedness and response 
                            coordination.
Sec. 105. Strengthening public health communication.
Sec. 106. Office of Pandemic Preparedness and Response Policy.
                 Subtitle B--State and Local Readiness

Sec. 111. Improving State and local public health security.
Sec. 112. Supporting access to mental health and substance use disorder 
                            services during public health emergencies.
Sec. 113. Trauma care reauthorization.
Sec. 114. Assessment of containment and mitigation of infectious 
                            diseases.
  TITLE II--IMPROVING PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPACITY

    Subtitle A--Addressing Disparities and Improving Public Health 
                          Emergency Responses

Sec. 201. Addressing social determinants of health and improving health 
                            outcomes.
Sec. 202. National Academies of Sciences, Engineering, and Medicine 
                            report.
                Subtitle B--Improving Public Health Data

Sec. 211. Modernizing biosurveillance capabilities and infectious 
                            disease data collection.
Sec. 212. Genomic sequencing, analytics, and public health surveillance 
                            of pathogens.
Sec. 213. Supporting public health data availability and access.
Sec. 214. Epidemic forecasting and outbreak analytics.
Sec. 215. Report on CDC data portal.
Sec. 216. Public health data transparency.
          Subtitle C--Revitalizing the Public Health Workforce

Sec. 221. Improving recruitment and retention of the frontline public 
                            health workforce.
Sec. 222. Awards to support community health workers and community 
                            health.
Sec. 223. Improving public health emergency response capacity.
Sec. 224. Extension of authorities to support health professional 
                            volunteers at community health centers.
Sec. 225. Increasing educational opportunities for allied health 
                            professions.
Sec. 226. Public Health Service Corps annual and sick leave.
             Subtitle D--Improving Public Health Responses

Sec. 231. Centers for public health preparedness and response.
Sec. 232. Vaccine distribution plans.
Sec. 233. Coordination and collaboration regarding blood supply.
     TITLE III--ACCELERATING RESEARCH AND COUNTERMEASURE DISCOVERY

     Subtitle A--Fostering Research and Development and Improving 
                              Coordination

Sec. 301. Research and activities related to long-term health effects 
                            of SARS-CoV-2 infection.
Sec. 302. Research centers for pathogens of pandemic concern.
Sec. 303. Improving medical countermeasure research coordination.
Sec. 304. Accessing specimen samples and diagnostic tests.
            Subtitle B--Improving Biosafety and Biosecurity

Sec. 311. Improving control and oversight of select biological agents 
                            and toxins.
Sec. 312. Strategy for Federal high-containment laboratories.
Sec. 313. National Science Advisory Board for Biosecurity.
Sec. 314. Research to improve biosafety.
Sec. 315. Federally-funded research with enhanced pathogens of pandemic 
                            potential.
 Subtitle C--Preventing Undue Foreign Influence in Biomedical Research

Sec. 321. Foreign talent programs.
Sec. 322. Securing identifiable, sensitive information.
Sec. 323. Duties of the Director.
Sec. 324. Protecting America's biomedical research enterprise.
Sec. 325. GAO Study.
Sec. 326. Report on progress to address undue foreign influence.
  TITLE IV--MODERNIZING AND STRENGTHENING THE SUPPLY CHAIN FOR VITAL 
                            MEDICAL PRODUCTS

Sec. 401. Warm base manufacturing capacity for medical countermeasures.
Sec. 402. Supply chain considerations for the Strategic National 
                            Stockpile.
Sec. 403. Strategic National Stockpile equipment maintenance.
Sec. 404. Improving transparency and predictability of processes of the 
                            Strategic National Stockpile.
Sec. 405. Improving supply chain flexibility for the Strategic National 
                            Stockpile.
Sec. 406. Reimbursement for certain supplies.
Sec. 407. Action reporting on stockpile depletion.
Sec. 408. Provision of medical countermeasures to Indian programs and 
                            facilities.
Sec. 409. Grants for State strategic stockpiles.
   TITLE V--ENHANCING DEVELOPMENT AND COMBATING SHORTAGES OF MEDICAL 
                                PRODUCTS

                   Subtitle A--Development and Review

Sec. 501. Advancing qualified infectious disease product innovation.
Sec. 502. Modernizing clinical trials.
Sec. 503. Accelerating countermeasure development and review.
Sec. 504. Third party test evaluation during emergencies.
Sec. 505. Facilitating the use of real world evidence.
Sec. 506. Platform technologies.
Sec. 507. Increasing EUA decision transparency.
Sec. 508. Improving FDA guidance and communication.
Sec. 509. GAO study and report on hiring challenges at FDA.
                    Subtitle B--Mitigating Shortages

Sec. 511. Ensuring registration of foreign drug and device 
                            manufacturers.
Sec. 512. Extending expiration dates for certain drugs.
Sec. 513. Unannounced foreign facility inspections pilot program.
Sec. 514. Combating counterfeit devices.
Sec. 515. Strengthening medical device supply chains.
Sec. 516. Preventing medical device shortages.
Sec. 517. Remote records assessments for medical devices.
Sec. 518. Advanced manufacturing technologies designation pilot 
                            program.
Sec. 519. Technical corrections.

         TITLE I--STRENGTHENING FEDERAL AND STATE PREPAREDNESS

           Subtitle A--Federal Leadership and Accountability

SEC. 101. COMPREHENSIVE REVIEW OF THE COVID-19 RESPONSE.

    (a) Establishment of Task Force.--There is established in the 
legislative branch a task force to be known as the ``National Task 
Force on the Response of the United States to the COVID-19 Pandemic'' 
(referred to in this section as the ``Task Force'').
    (b) Purposes.--The purposes of the Task Force are to--
            (1) examine, assess, and report upon the United States' 
        preparedness for, and response to, the COVID-19 pandemic, 
        including--
                    (A) the initial Federal, State, local, and 
                territorial responses in the United States;
                    (B) the ongoing Federal, State, local, and 
                territorial responses in the United States, including 
                the activities, policies, and decisions of the Trump 
                Administration and the Biden Administration;
                    (C) the impact of the pandemic on public health and 
                health care systems; and
                    (D) the initial outbreak in Wuhan, China, including 
                efforts to determine the potential causes for the 
                emergence of the SARS-CoV-2 virus, and Federal actions 
                to mitigate its spread internationally;
            (2) build upon existing or ongoing evaluations and avoid 
        unnecessary duplication, by reviewing the findings, 
        conclusions, and recommendations of other appropriate task 
        forces, committees, commissions, or entities established by 
        other public or nonprofit private entities related to the 
        United States' preparedness for, and response to, the COVID-19 
        pandemic;
            (3) identify gaps in public health preparedness and medical 
        response policies, processes, and activities, including 
        disparities in COVID-19 infection and mortality rates among 
        people of color, older adults, people with disabilities, and 
        other vulnerable or at-risk groups, and how such gaps impacted 
        the ability of the United States to respond to the COVID-19 
        pandemic; and
            (4) submit a report to the President and to Congress on its 
        findings, conclusions, and recommendations to improve the 
        United States preparedness for, and response to, future public 
        health emergencies, including a public health emergency 
        resulting from an emerging infectious disease.
    (c) Composition of Task Force; Meetings.--
            (1) Members.--The Task Force shall be composed of 12 
        members, of whom--
                    (A) 1 member shall be appointed by the majority 
                leader of the Senate;
                    (B) 1 member shall be appointed by the minority 
                leader of the Senate;
                    (C) 2 members shall be appointed by the chair of 
                the Committee on Health, Education, Labor, and Pensions 
                of the Senate;
                    (D) 2 members shall be appointed by the ranking 
                member of the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    (E) 1 member shall be appointed by the Speaker of 
                the House of Representatives;
                    (F) 1 member shall be appointed by the minority 
                leader of the House of Representatives;
                    (G) 2 members shall be appointed by the chair of 
                the Committee on Energy and Commerce of the House of 
                Representatives; and
                    (H) 2 members shall be appointed by the ranking 
                member of the Committee on Energy and Commerce of the 
                House of Representatives.
            (2) Chair and vice chair.--Not later than 30 days after the 
        date on which all members of the Task Force are appointed under 
        paragraph (1), such members shall meet to elect a Chair and 
        Vice Chair from among such members. The Chair and Vice Chair 
        shall each be elected to serve upon an affirmative vote from 8 
        members of the Task Force. The Chair and Vice Chair shall not 
        be registered members of the same political party.
            (3) Qualifications.--
                    (A) Political party affiliation.--Not more than 6 
                members of the Task Force shall be registered members 
                of the same political party.
                    (B) Nongovernmental appointees.--An individual 
                appointed to the Task Force may not be an officer or 
                employee of the Federal Government or any State, local, 
                Tribal, or territorial government.
                    (C) Qualifications.--It is the sense of Congress 
                that individuals appointed to the Task Force should be 
                highly qualified citizens of the United States. Members 
                appointed under paragraph (1) may include individuals 
                with expertise in--
                            (i) public health, health disparities and 
                        at-risk populations, medicine, and related 
                        fields;
                            (ii) State, local, Tribal, or territorial 
                        government, including public health and medical 
                        preparedness and response and emergency 
                        management and other relevant public 
                        administration;
                            (iii) research regarding, or the 
                        development, manufacturing, distribution, and 
                        regulation of, medical products;
                            (iv) national security and foreign 
                        relations, including global health; and
                            (v) commerce, including transportation, 
                        supply chains, and small business.
            (4) Deadline for appointment.--All members of the Task 
        Force shall be appointed not later than 90 days after the date 
        of enactment of this Act.
            (5) Meetings.--The Task Force shall meet and begin the 
        operations of the Task Force as soon as practicable. After its 
        initial meeting, the Task Force shall meet upon the call of the 
        Chair and Vice Chair or 8 of its members.
            (6) Quorum; vacancies.--
                    (A) Quorum.--Eight members of the Task Force shall 
                constitute a quorum.
                    (B) Vacancies.--Any vacancy in the Task Force shall 
                not affect its powers, but shall be filled in the same 
                manner in which the original appointment was made.
    (d) Functions of Task Force.--The functions of the Task Force are 
to--
            (1) conduct a review that--
                    (A) examines the initial outbreak of the SARS-CoV-2 
                virus in Wuhan, China, including--
                            (i) engaging with willing partner 
                        governments and global experts;
                            (ii) seeking access to relevant records; 
                        and
                            (iii) examining the potential causes of the 
                        emergence and source of the virus;
                    (B) examines the United States preparation for, and 
                response to, the COVID-19 pandemic, including--
                            (i) relevant laws, policies, regulations, 
                        and processes that were in place prior to, or 
                        put into place during, the public health 
                        emergency declared by the Secretary of Health 
                        and Human Services under section 319 of the 
                        Public Health Service Act (42 U.S.C. 247d) with 
                        respect to COVID-19, including any that are put 
                        into place related to such public health 
                        emergency after the date of enactment of this 
                        Act and prior to the issuance of the final 
                        report pursuant to subsection (j)(2);
                            (ii) relevant actions taken by, and 
                        coordination between, Federal, State, local, 
                        Tribal, and territorial governments, 
                        nongovernmental organizations, and 
                        international organizations on preparedness and 
                        response efforts, including coordination 
                        between governments and other public and 
                        private entities, during the--
                                    (I) initial response in the United 
                                States;
                                    (II) response during the Trump 
                                Administration; and
                                    (III) ongoing response during the 
                                Biden Administration;
                            (iii) communication of public health and 
                        scientific information related to the COVID-19 
                        pandemic, including processes for the 
                        development, approval, and dissemination of 
                        Federal public health and other relevant public 
                        health or scientific guidance;
                            (iv) actions taken to support the 
                        development, manufacturing, and distribution of 
                        medical countermeasures and related medical 
                        supplies to prevent, detect, and treat COVID-
                        19; and
                    (C) may include assessments relating to--
                            (i) the capacity and capabilities of 
                        Federal, State, local, Tribal, and territorial 
                        governments to respond to the COVID-19 
                        pandemic;
                            (ii) the capacity and capabilities of 
                        health care facilities and the health care 
                        workforce to respond to the COVID-19 pandemic;
                            (iii) medical countermeasure research and 
                        development and the supply chains of medical 
                        products necessary to respond to the COVID-19 
                        pandemic;
                            (iv) international preparedness for and 
                        response to COVID-19, and Federal decision-
                        making processes related to new global health 
                        threats;
                            (v) containment and mitigation measures 
                        related to domestic and international travel in 
                        response to COVID-19; and
                            (vi) the impact of the COVID-19 pandemic 
                        and related mitigation efforts on hard-to-reach 
                        and at-risk or underserved populations, 
                        including related health disparities;
            (2) identify, review, and evaluate the lessons learned from 
        the COVID-19 pandemic, including activities to prepare for, and 
        respond to, future potential pandemics and related public 
        health emergencies; and
            (3) submit to the President and Congress such reports as 
        are required by this Act containing such findings, conclusions, 
        and recommendations as the Task Force shall determine.
    (e) Powers of Task Force.--
            (1) Hearings.--The Task Force may--
                    (A) hold such hearings and sit and act at such 
                times and places, take such testimony, receive such 
                evidence as determined by the Chair and Vice Chair, and 
                administer such oaths as the Task Force or a designated 
                member, as determined by the Chair or Vice Chair, may 
                determine advisable to be necessary to carry out the 
                functions of the Task Force; and
                    (B) subject to paragraph (2)(A), require, by 
                subpoena or otherwise, the attendance and testimony of 
                such witnesses and the production of such books, 
                records, correspondence, memoranda, papers, and 
                documents, as the person described in paragraph 
                (2)(A)(i) may determine advisable.
            (2) Subpoenas.--
                    (A) Issuance.--
                            (i) In general.--A subpoena may be issued 
                        under this subsection only--
                                    (I) by the agreement of the Chair 
                                and the Vice Chair; or
                                    (II) by the affirmative vote of 9 
                                members of the Task Force.
                            (ii) Signature.--Subpoenas issued under 
                        this subsection may be issued under the 
                        signature of the Chair or any member designated 
                        by a majority of the Task Force, and may be 
                        served by any person designated by the Chair or 
                        by a member designated by agreement of the 
                        majority of the Task Force.
                    (B) Enforcement.--In the case of contumacy or 
                failure to obey a subpoena issued under subsection, the 
                United States district court for the judicial district 
                in which the subpoenaed person resides, is served, or 
                may be found, or where the subpoena is returnable, may 
                issue an order requiring such person to appear at any 
                designated place to testify or to produce documentary 
                or other evidence. Any failure to obey the order of the 
                court may be punished by the court as a contempt of 
                that court.
            (3) Contracting.--The Task Force may, to such extent and in 
        such amounts as are provided in appropriation Acts, enter into 
        contracts to enable the Task Force to discharge its duties 
        under this Act.
            (4) Information from federal agencies.--
                    (A) In general.--The Task Force may access from any 
                executive department, bureau, agency, board, 
                commission, office, independent establishment, or 
                instrumentality of the Federal Government, such 
                information, documents, suggestions, estimates, and 
                statistics as the Task Force considers necessary to 
                carry out this section.
                    (B) Provision of information.--On written request 
                of the Chair, each department, bureau, agency, board, 
                commission, office, independent establishment, or 
                instrumentality shall, to the extent authorized by law, 
                provide such information to the Task Force.
                    (C) Receipt, handling, storage, and 
                dissemination.--Information shall only be received, 
                handled, stored, and disseminated by members of the 
                Task Force and its staff consistent with all applicable 
                statutes, regulations, and executive orders.
            (5) Assistance from federal agencies.--
                    (A) General services administration.--On request of 
                the Chair and Vice Chair, the Administrator of General 
                Services Administration shall provide to the Task 
                Force, on a reimbursable basis, administrative support 
                and other assistance necessary for the Task Force to 
                carry out its duties.
                    (B) Other departments and agencies.--In addition to 
                the assistance provided for in subparagraph (A), 
                departments and agencies of the United States may 
                provide to the Task Force such assistance as such 
                departments and agencies may determine advisable and as 
                authorized by law.
            (6) Donations.--The Task Force may accept, use, and dispose 
        of gifts or donations of services or property. Not later than 5 
        days after the acceptance of a donation under this subsection, 
        the Task Force shall publicly disclose--
                    (A) the name of the entity that provided such 
                donation;
                    (B) the service or property provided through such 
                donation;
                    (C) the value of such donation; and
                    (D) how the Task Force plans to use such donation.
            (7) Postal services.--The Task Force may use the United 
        States mails in the same manner and under the same conditions 
        as a department or agency of the United States.
    (f) Applicability of Federal Advisory Committee Act.--
            (1) In general.--The Federal Advisory Committee Act (5 
        U.S.C. App.) shall apply to the Task Force.
            (2) Public meetings and release of public versions of 
        reports.--The Task Force shall--
                    (A) hold public hearings and meetings to the extent 
                appropriate; and
                    (B) release public versions of the reports required 
                under paragraph (1) and (2) of subsection (j).
            (3) Public hearings.--Any public hearings of the Task Force 
        shall be conducted in a manner consistent with the protection 
        of information provided to or developed for or by the Task 
        Force as required by any applicable statute, regulation, or 
        Executive order.
    (g) Staff of Task Force.--
            (1) In general.--
                    (A) Appointment and compensation.--The Chair of the 
                Task Force, in agreement with the Vice Chair, in 
                accordance with rules agreed upon by the Task Force, 
                may appoint and fix the compensation of a staff 
                director and such other personnel as may be necessary 
                to enable the Task Force to carry out its functions, 
                without regard to the provisions of title 5, United 
                States Code, governing appointments in the competitive 
                service, and without regard to the provisions of 
                chapter 51 and subchapter III of chapter 53 of such 
                title relating to classification and General Schedule 
                pay rates, except that no rate of pay fixed under this 
                subsection may exceed the equivalent of that payable 
                for a position at level V of the Executive Schedule 
                under section 5316 of title 5, United States Code.
                    (B) Personnel as federal employees.--
                            (i) In general.--The staff director and any 
                        personnel of the Task Force who are employees 
                        shall be employees under section 2105 of title 
                        5, United States Code, for purposes of chapters 
                        63, 81, 83, 84, 85, 87, 89, and 90 of that 
                        title.
                            (ii) Members of task force.--Clause (i) 
                        shall not be construed to apply to members of 
                        the Task Force.
            (2) Detailees.--Upon request of the Chair and Vice Chair of 
        the Task Force, the head of any executive department, bureau, 
        agency, board, commission, office, independent establishment, 
        or instrumentality of the Federal Government employee may 
        detail, without reimbursement, any of its personnel to the Task 
        Force to assist in carrying out its duties under this section. 
        Any such detailee shall be without interruption or loss of 
        civil service status or privilege.
            (3) Consultant services.--The Task Force is authorized to 
        procure the services of experts and consultants in accordance 
        with section 3109 of title 5, United States Code, but at rates 
        not to exceed the daily rate paid a person occupying a position 
        at level IV of the Executive Schedule under section 5315 of 
        title 5, United States Code.
    (h) Compensation and Travel Expenses.--Each member of the Task 
Force shall serve without compensation, but shall receive travel 
expenses, including per diem in lieu of subsistence, at rates 
authorized for an employee of an agency under subchapter I of chapter 
57 of title 5, United States Code.
    (i) Security Clearances for Task Force Members and Staff.--The 
appropriate Federal agencies or departments shall cooperate with the 
Task Force in expeditiously providing to the Task Force members and 
staff appropriate security clearances, consistent with existing 
procedures and requirements. No person shall be provided with access to 
classified information under this section without the appropriate 
security clearances.
    (j) Reports of Task Force; Termination.--
            (1) Interim report.--Not later than 180 days after the date 
        of enactment of this Act, the Task Force shall submit to the 
        President, the Committee on Health, Education, Labor, and 
        Pensions of the Senate, and the Committee on Energy and 
        Commerce of the House of Representatives an interim report 
        containing such findings, conclusions, and recommendations as 
        have been agreed to by 8 members of the Task Force. Such 
        interim report shall be made available online in a manner that 
        does not compromise national security.
            (2) Final report.--
                    (A) In general.--Not later than 18 months after the 
                date on which the last member of the Task Force is 
                appointed, the Task Force shall submit to the 
                President, the Committee on Health, Education, Labor, 
                and Pensions of the Senate, and the Committee on Energy 
                and Commerce of the House of Representatives a final 
                report containing such findings, conclusions, and 
                recommendations as have been agreed to by 8 members of 
                the Task Force. The final report shall be made 
                available online in a manner that does not compromise 
                national security.
                    (B) Extensions.--
                            (i) In general.--The submission and 
                        publication of the final report, as described 
                        in subparagraph (A), may be delayed by 6 months 
                        upon the agreement of 8 members of the Task 
                        Force.
                            (ii) Notification.--The Task Force shall 
                        notify the President, the Committee on Health, 
                        Education, Labor, and Pensions of the Senate, 
                        the Committee on Energy and Commerce of the 
                        House of Representatives, and the public of any 
                        extension granted under clause (i).
                    (C) Special rules and considerations.--
                            (i) Rule of construction.--Nothing in this 
                        subsection shall be construed as authorizing 
                        the Task Force to publicly disclose information 
                        otherwise prohibited from disclosure by law.
                            (ii) Special timing considerations.--
                        Notwithstanding any other provision of this 
                        section, the Task Force shall not publish or 
                        make available any interim or final report 
                        during the during the 60-day periods ending 
                        November 8, 2022, and November 5, 2024.
            (3) Termination.--
                    (A) In general.--The Task Force, and all the 
                authorities of this section, shall terminate 60 days 
                after the date on which the final report is submitted 
                under paragraph (2).
                    (B) Administrative activities before termination.--
                The Task Force may use the 60-day period referred to in 
                subparagraph (A) for the purpose of concluding its 
                activities, including providing testimony to committees 
                of Congress concerning its reports and disseminating 
                the final report.
    (k) Funding.--
            (1) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this section, a total of 
        $3,000,000 for fiscal years 2023 and 2024.
            (2) Duration of availability.--Amounts made available to 
        the Task Force under paragraph (1) shall remain available until 
        the termination of the Task Force.

SEC. 102. APPOINTMENT AND AUTHORITY OF THE DIRECTOR OF THE CENTERS FOR 
              DISEASE CONTROL AND PREVENTION.

    (a) In General.--Part A of title III of the Public Health Service 
Act (42 U.S.C. 241 et seq.) is amended by inserting after section 304 
the following:

``SEC. 305. APPOINTMENT AND AUTHORITY OF THE DIRECTOR OF THE CENTERS 
              FOR DISEASE CONTROL AND PREVENTION.

    ``(a) In General.--The Centers for Disease Control and Prevention 
(referred to in this section as the `CDC') shall be headed by the 
Director of the Centers for Disease Control and Prevention (referred to 
in this section as the `Director'), who shall be appointed by the 
President, by and with the advice and consent of the Senate. Such 
individual shall also serve as the Administrator of the Agency for 
Toxic Substances and Disease Registry consistent with section 104(i) of 
the Comprehensive Environmental Response, Compensation, and Liability 
Act. The Director shall perform functions provided for in subsection 
(b) and such other functions as the Secretary may prescribe.
    ``(b) Functions.--The Secretary, acting through the Director, 
shall--
            ``(1) implement and exercise applicable authorities and 
        responsibilities provided for in this Act or other applicable 
        law related to the investigation, detection, identification, 
        prevention, or control of diseases or conditions to preserve 
        and improve public health domestically and globally and address 
        injuries and occupational and environmental hazards, as 
        appropriate;
            ``(2) be responsible for the overall direction of the CDC 
        and for the establishment and implementation of policies 
        related to the management and operation of programs and 
        activities within the CDC;
            ``(3) coordinate and oversee the operation of centers, 
        institutes, and offices within the CDC;
            ``(4) support, in consultation with the heads of such 
        centers, institutes, and offices, program coordination across 
        such centers, institutes, and offices, including through 
        priority setting reviews and the development of strategic 
        plans, to reduce unnecessary duplication and encourage 
        collaboration between programs;
            ``(5) oversee the development, implementation, and updating 
        of the strategic plan established pursuant to subsection (c);
            ``(6) ensure that appropriate strategic planning, including 
        the use of performance metrics, is conducted by such centers, 
        institutes, and offices to facilitate and improve CDC programs 
        and activities;
            ``(7) communicate, including through convening annual 
        meetings, with public and private entities regarding relevant 
        public health programs and activities, and, as applicable, the 
        strategic plan established pursuant to subsection (c).
    ``(c) Strategic Plan.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the PREVENT Pandemics Act, and at least every 4 
        years thereafter, the Director 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, and post on the website of the CDC, a 
        coordinated strategy to provide strategic direction and 
        facilitate collaboration across the centers, institutes, and 
        offices within the CDC. Such strategy shall be known as the 
        `CDC Strategic Plan'.
            ``(2) Requirements.--The CDC Strategic Plan shall--
                    ``(A) identify strategic priorities and objectives 
                related to--
                            ``(i) preventing, reducing, and eliminating 
                        the spread of communicable and noncommunicable 
                        diseases or conditions, and addressing 
                        injuries, and occupational and environmental 
                        hazards;
                            ``(ii) supporting the efforts of State, 
                        local, and Tribal health departments to prevent 
                        and reduce the prevalence of the diseases or 
                        conditions under clause (i);
                            ``(iii) containing, mitigating, and ending 
                        disease outbreaks;
                            ``(iv) enhancing global and domestic public 
                        health capacity, capabilities, and 
                        preparedness, including public health data, 
                        surveillance, workforce, and laboratory 
                        capacity and safety; and
                            ``(v) other priorities, as established by 
                        the Director;
                    ``(B) describe the capacity and capabilities 
                necessary to achieve the priorities and objectives 
                under subparagraph (A), and progress towards achieving 
                such capacity and capabilities, as appropriate; and
                    ``(C) include a description of how the CDC 
                Strategic Plan incorporates--
                            ``(i) strategic communications;
                            ``(ii) partnerships with private sector 
                        entities, and State, local, and Tribal health 
                        departments, and other public sector entities, 
                        as appropriate; and
                            ``(iii) coordination with other agencies 
                        and offices of the Department of Health and 
                        Human Services and other Federal departments 
                        and agencies, as appropriate.
            ``(3) Use of plans.--Strategic plans developed and updated 
        by the centers, institutes, and offices of the CDC shall be 
        prepared regularly and in such a manner that such plans will be 
        informed by the CDC Strategic Plan developed and updated under 
        this subsection.
    ``(d) Appearances Before Congress.--
            ``(1) In general.--Each fiscal year, the Director shall 
        appear before the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives at hearings on topics such as--
                    ``(A) support for State, local, and Tribal public 
                health preparedness and responses to any recent or 
                ongoing public health emergency, including--
                            ``(i) any objectives, activities, or 
                        initiatives that have been carried out, or are 
                        planned, by the Director to prepare for, or 
                        respond to, the public health emergency, 
                        including relevant strategic communications or 
                        partnerships and any gaps or challenges 
                        identified in such objectives, activities, or 
                        initiatives;
                            ``(ii) any objectives and planned 
                        activities for the upcoming fiscal year to 
                        address gaps in, or otherwise improve, State, 
                        local, and Tribal public health preparedness; 
                        and
                            ``(iii) other potential all-hazard threats 
                        that the Director is preparing to address;
                    ``(B) activities related to public health and 
                functions of the Director described in subsection (b); 
                and
                    ``(C) updates on other relevant activities 
                supported or conducted by the CDC, or in collaboration 
                or coordination with the heads of other Federal 
                departments, agencies, or stakeholders, as appropriate.
            ``(2) Clarifications.--
                    ``(A) Waiver authority.--The Chair of the Committee 
                on Health, Education, Labor, and Pensions of the Senate 
                or the Chair of the Committee on Energy and Commerce of 
                the House of Representatives may waive the requirements 
                of paragraph (1) for the applicable fiscal year with 
                respect to the applicable Committee.
                    ``(B) Scope of requirements.--The requirements of 
                this subsection shall not be construed to impact the 
                appearance of other Federal officials or the Director 
                at hearings of either Committee described in paragraph 
                (1) at other times and for purposes other than the 
                times and purposes described in paragraph (1).
            ``(3) Closed hearings.--Information that is not appropriate 
        for disclosure during an open hearing under paragraph (1) in 
        order to protect national security may instead be discussed in 
        a closed hearing that immediately follows the open hearing.''.
    (b) Application.--The first sentence of section 305(a) of the 
Public Health Service Act, as added by subsection (a), shall not apply 
to the Director of the Centers for Disease Control and Prevention who 
is serving on the date of enactment of this Act.

SEC. 103. ADDITIONAL PROVISIONS RELATED TO THE CENTERS FOR DISEASE 
              CONTROL AND PREVENTION.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by inserting after section 305, as added by section 102, the 
following:

``SEC. 305A. ADDITIONAL PROVISIONS RELATED TO THE CENTERS FOR DISEASE 
              CONTROL AND PREVENTION.

    ``(a) Appointments.--
            ``(1) In general.--Unless otherwise specified in statute, 
        the heads of the centers or institutes of the Centers for 
        Disease Control and Prevention shall be appointed by the 
        Secretary, acting through the Director of the Centers for 
        Disease Control and Prevention (referred to in this section as 
        the `Director'). Each such individual shall be appointed for 5 
        years.
            ``(2) Reappointments.--At the end of a 5-year term, an 
        individual appointed under paragraph (1) shall be reappointed 
        in accordance with standards applicable to the relevant 
        appointment mechanism and as determined by the Secretary, as 
        applicable.
            ``(3) No limit on terms.--There shall be no limit on the 
        number of terms that any individual appointed under this 
        subsection may serve.
            ``(4) Vacancies.--If the position of a head of a center or 
        institute described in paragraph (1) becomes vacant before the 
        end of a term, the head of such center or institute appointed 
        to fill the vacancy shall be appointed for a 5-year term 
        starting on the date of such appointment.
            ``(5) Current positions and exemptions.--
                    ``(A) In general.--Each such individual who is 
                serving on the date of enactment of the PREVENT 
                Pandemics Act shall be deemed to be appointed for a 5-
                year term under this subsection beginning on such date 
                of enactment.
                    ``(B) Exemptions.--The Secretary may exempt the 
                head of a center or institute from the 5-year term 
                described in subparagraph (A) if such Secretary 
                determines such exemption is necessary in order to hire 
                or retain talented individuals.
            ``(6) Rule of construction.--Nothing in this subsection 
        shall be construed to limit the authority of the Secretary or 
        the Director to terminate the appointment of a head of a center 
        or institute described in paragraph (1) before the expiration 
        of such individual's 5-year term.
            ``(7) Nature of appointment.--Appointments and 
        reappointments under this subsection shall be made on the basis 
        of ability and experience as it relates to the mission of the 
        Centers for Disease Control and Prevention and its components, 
        including compliance with relevant legal requirements.
    ``(b) Other Transactions.--
            ``(1) In general.--In carrying out activities of the 
        Centers for Disease Control and Prevention, the Director may 
        enter into transactions other than a contract, grant, or 
        cooperative agreement for purposes of biosurveillance, 
        infectious disease modeling, and public health preparedness and 
        response, including related research.
            ``(2) Written determination.--With respect to a project 
        that is expected to cost the Centers for Disease Control and 
        Prevention more than $5,000,000, the Director may exercise the 
        authority under paragraph (1) only upon a written determination 
        by the Assistant Secretary for Financial Resources of the 
        Department of Health and Human Services, that the use of such 
        authority is essential to promoting the success of the project. 
        The authority of the Assistant Secretary for Financial 
        Resources under this paragraph may not be delegated.
            ``(3) Guidelines.--The Director, in consultation with the 
        Secretary, shall establish guidelines regarding the use of the 
        authority under paragraph (1). Such guidelines shall include 
        auditing requirements.''.

SEC. 104. PUBLIC HEALTH AND MEDICAL PREPAREDNESS AND RESPONSE 
              COORDINATION.

    (a) Public Health Emergency Fund.--Section 319(b) of the Public 
Health Service Act (42 U.S.C. 247d(b)) is amended--
            (1) in paragraph (2)--
                    (A) in subparagraph (E), by striking ``and'' at the 
                end;
                    (B) by redesignating subparagraph (F) as 
                subparagraph (G); and
                    (C) by inserting after subparagraph (E), the 
                following:
                    ``(F) support the initial deployment and 
                distribution of contents of the Strategic National 
                Stockpile, as appropriate; and''; and
            (2) by amending paragraph (3)(A) to read as follows:
                    ``(A) the expenditures made from the Public Health 
                Emergency Fund in such fiscal year, including--
                            ``(i) the amount obligated;
                            ``(ii) the recipient or recipients of such 
                        obligated funds;
                            ``(iii) the specific response activities 
                        such obligated funds will support; and
                            ``(iv) the declared or potential public 
                        health emergency for which such funds were 
                        obligated; and''.
    (b) Improving Public Health and Medical Preparedness and Response 
Coordination.--
            (1) Coordination with federal agencies.--Section 2801 of 
        the Public Health Service Act (42 U.S.C. 300hh) is amended by 
        adding at the end the following:
    ``(c) Coordination With Federal Agencies.--In leading the Federal 
public health and medical response to a declared or potential public 
health emergency, consistent with this section, the Secretary shall 
coordinate with, and may request support from, other Federal 
departments and agencies, as appropriate in order to carry out 
necessary activities and leverage the expertise of such departments and 
agencies, which may include the provision of assistance at the 
direction of the Secretary related to supporting the public health and 
medical response for States, localities, and Tribes.''.
            (2) ASPR duties.--Section 2811(b) of the Public Health 
        Service Act (42 U.S.C. 300hh-10(b)) is amended--
                    (A) in paragraph (1), by inserting ``and, 
                consistent with the National Response Framework and 
                other applicable provisions of law, assist the 
                Secretary in carrying out the functions under section 
                2801'' before the period; and
                    (B) in paragraph (4)--
                            (i) in subparagraph (E) by striking ``the 
                        actions necessary to overcome these 
                        obstacles.'' and inserting ``recommend actions 
                        necessary to overcome these obstacles, such 
                        as--
                            ``(i) improving coordination with relevant 
                        Federal officials;
                            ``(ii) partnering with other public or 
                        private entities to leverage capabilities 
                        maintained by such entities, as appropriate and 
                        consistent with this subsection; and
                            ``(iii) coordinating efforts to support or 
                        establish new capabilities, as appropriate.''; 
                        and
                            (ii) in subparagraph (G)--
                                    (I) by redesignating clauses (i) 
                                and (ii) as subclauses (I) and (II) and 
                                adjusting the margins accordingly;
                                    (II) in the matter preceding 
                                subclause (I), as so redesignated--
                                            (aa) by inserting ``each 
                                        year, including national-level 
                                        and State-level full-scale 
                                        exercises not less than once 
                                        every 5 years'' after 
                                        ``operational exercises''; and
                                            (bb) by striking 
                                        ``exercises based on--'' and 
                                        inserting ``exercises--
                            ``(i) based on'';
                                    (III) by striking the period and 
                                inserting a semicolon; and
                                    (IV) by adding at the end the 
                                following:
                            ``(ii) that assess the ability of the 
                        Strategic National Stockpile, as appropriate, 
                        to provide medical countermeasures, medical 
                        products, and other supplies, including 
                        ancillary medical supplies, to support the 
                        response to a public health emergency or 
                        potential public health emergency, including a 
                        threat that requires the large-scale and 
                        simultaneous deployment of stockpiles and a 
                        long-term public health and medical response; 
                        and
                            ``(iii) conducted in coordination with 
                        State and local health officials.''.
    (c) Appearances Before and Reports to Congress.--Section 2811 of 
the Public Health Service Act (42 U.S.C. 300hh-10) is amended by adding 
at the end the following:
    ``(g) Appearances Before Congress.--
            ``(1) In general.--Each fiscal year, the Assistant 
        Secretary for Preparedness and Response shall appear before the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives at hearings, on topics such as--
                    ``(A) coordination of Federal activities to prepare 
                for, and respond to, public health emergencies;
                    ``(B) activities and capabilities of the Strategic 
                National Stockpile, including whether, and the degree 
                to which, recommendations made pursuant to section 
                2811-1(c)(1)(A) have been met;
                    ``(C) support for State, local, and Tribal public 
                health and medical preparedness;
                    ``(D) activities implementing the countermeasures 
                budget plan described under subsection (b)(7), 
                including--
                            ``(i) any challenges in meeting the full 
                        range of identified medical countermeasure 
                        needs; and
                            ``(ii) progress in supporting advanced 
                        research, development, and procurement of 
                        medical countermeasures, pursuant to subsection 
                        (b)(3);
                    ``(E) the strategic direction of, and activities 
                related to, the sustainment of manufacturing surge 
                capacity and capabilities for medical countermeasures 
                pursuant to section 319L and the distribution and 
                deployment of such countermeasures;
                    ``(F) any additional objectives, activities, or 
                initiatives that have been carried out or are planned 
                by the Assistant Secretary for Preparedness and 
                Response and associated challenges, as appropriate;
                    ``(G) the specific all-hazards threats that the 
                Assistant Secretary for Preparedness and Response is 
                preparing to address, or that are being addressed, 
                through the activities described in subparagraphs (A) 
                through (F); and
                    ``(H) objectives, activities, or initiatives 
                related to the coordination and consultation required 
                under subsections (b)(4)(H) and (b)(4)(I), in a manner 
                consistent with paragraph (3), as appropriate.
            ``(2) Clarifications.--
                    ``(A) Waiver authority.--The Chair of the Committee 
                on Health, Education, Labor, and Pensions of the Senate 
                or the Chair of the Committee on Energy and Commerce of 
                the House of Representatives may waive the requirements 
                of paragraph (1) for the applicable fiscal year with 
                respect to the applicable Committee.
                    ``(B) Scope of requirements.--The requirements of 
                this subsection shall not be construed to impact the 
                appearance of other Federal officials or the Assistant 
                Secretary at hearings of either Committee described in 
                paragraph (1) at other times and for purposes other 
                than the times and purposes described in paragraph (1).
            ``(3) Closed hearings.--Information that is not appropriate 
        for disclosure during an open hearing under paragraph (1) in 
        order to protect national security may instead be discussed in 
        a closed hearing that immediately follows such open hearing.''.
    (d) Annual Report on Emergency Response and Preparedness.--Section 
2801 of the Public Health Service Act (42 U.S.C. 300hh), as amended by 
subsection (b), is further amended by adding at the end the following:
    ``(d) Annual Report on Emergency Response and Preparedness.--The 
Secretary shall submit a written report each fiscal year to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives, 
containing--
            ``(1) updated information related to an assessment of the 
        response to any public health emergency declared, or otherwise 
        in effect, during the previous fiscal year;
            ``(2) findings related to drills and operational exercises 
        completed in the previous fiscal year pursuant to section 
        2811(b)(4)(G);
            ``(3) the state of public health preparedness and response 
        capabilities for chemical, biological, radiological, and 
        nuclear threats, including emerging infectious diseases; and
            ``(4) any challenges in preparing for or responding to such 
        threats, as appropriate.''.
    (e) GAO Report on Interagency Agreements and Coordination.--Not 
later than 3 years after the date of enactment of this Act, the 
Comptroller General of the United States shall--
            (1) conduct a review of previous and current interagency 
        agreements established between the Secretary of Health and 
        Human Services and the heads of other relevant Federal 
        departments or agencies pursuant to section 2801(b) of the 
        Public Health Service Act (42 U.S.C. 300hh(b)), including--
                    (A) the specific roles and responsibilities of each 
                Federal department or agency that is a party to any 
                such interagency agreement;
                    (B) the manner in which specific capabilities of 
                each such Federal department or agency may be utilized 
                under such interagency agreements;
                    (C) the frequency with which such interagency 
                agreements have been utilized;
                    (D) gaps, if any, in interagency agreements that 
                prevent the Secretary from carrying out the goals under 
                section 2802 of the Public Health Service Act (42 
                U.S.C. 300hh-1);
                    (E) barriers, if any, to establishing or utilizing 
                such interagency agreements; and
                    (F) recommendations, if any, on the ways in which 
                such interagency agreements can be improved to address 
                the gaps and barriers identified under subparagraphs 
                (D) and (E);
            (2) conduct a review of the implementation and utilization 
        of the authorities described under section 2801(c) of the 
        Public Health Service Act (42 U.S.C. 300hh(c)); and
            (3) 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 
        reviews under paragraphs (1) and (2), including related 
        recommendations, as applicable.

SEC. 105. STRENGTHENING PUBLIC HEALTH COMMUNICATION.

    Subsection (b) of section 319F of the Public Health Service Act (42 
U.S.C. 247d-6) is amended to read as follows:
    ``(b) Public Health Information and Communications Advisory 
Committee.--
            ``(1) In general.--The Secretary shall establish an 
        advisory committee to be known as the Public Health Information 
        and Communications Advisory Committee (referred to in this 
        subsection as the `Advisory Committee').
            ``(2) Duties.--The Advisory Committee shall make 
        recommendations to the Secretary and report on--
                    ``(A) critical aspects of communication and 
                dissemination of scientific and evidence-based public 
                health information during public health emergencies, 
                including--
                            ``(i) the role and impact of misinformation 
                        on the response to such public health 
                        emergencies;
                            ``(ii) the role of risk communication 
                        before and during such public health 
                        emergencies; and
                            ``(iii) other relevant factors, as the 
                        Secretary determines appropriate;
                    ``(B) information from academic institutions, 
                community-based organizations, and other 
                nongovernmental organizations related to evidence-based 
                or evidence-informed strategies and best practices to 
                effectively communicate and disseminate such 
                information;
                    ``(C) strategies to improve communication and 
                dissemination of scientific and evidence-based public 
                health information to the public, to improve such 
                communication between Federal, State, local, and Tribal 
                health officials, and, as appropriate, to address 
                misinformation during public health emergencies, 
                including strategies to--
                            ``(i) identify the most effective methods 
                        for the dissemination of information during a 
                        public health emergency, with consideration of 
                        the needs of at-risk populations;
                            ``(ii) determine best practices and 
                        communicate information to populations that may 
                        be impacted by such misinformation; and
                            ``(iii) adapt approaches for the 
                        dissemination of information, as appropriate, 
                        to address emerging trends related to 
                        misinformation.
            ``(3) Composition.--The Advisory Committee shall be 
        composed of--
                    ``(A) appropriate Federal officials, appointed by 
                the Secretary, who shall serve as nonvoting members; 
                and
                    ``(B) individuals, appointed by the Secretary, with 
                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, and other areas, as the 
                Secretary determines appropriate, who shall serve as 
                voting members.
            ``(4) Dissemination.--The Secretary shall review the 
        recommendations of the Advisory Committee and, not later than 
        180 days after receipt of the report under paragraph (2), 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 the communication and 
        dissemination of scientific and evidence-based public health 
        information, including addressing misinformation, as 
        appropriate.
            ``(5) Termination.--The Advisory Committee shall terminate 
        4 years after the date of enactment of the PREVENT Pandemics 
        Act.''.

SEC. 106. OFFICE OF PANDEMIC PREPAREDNESS AND RESPONSE POLICY.

    (a) In General.--There is established in the Executive Office of 
the President an Office of Pandemic Preparedness and Response Policy 
(referred to in this section as the ``Office''), which shall be headed 
by a Director (referred to in this section as the ``Director'') 
appointed by the President and who shall be compensated at the rate 
provided for level II of the Executive Schedule in section 5313 of 
title 5, United States Code. The President is authorized to appoint not 
more than 2 Associate Directors, who shall be compensated at a rate not 
to exceed that provided for level III of the Executive Schedule in 
section 5314 of such title. Associate Directors shall perform such 
functions as the Director may prescribe.
    (b) Functions of the Director.--The primary function of the 
Director is to provide advice, within the Executive Office of the 
President, on pandemic preparedness and response policy, and support 
strategic coordination and communication with respect to relevant 
activities across the Federal Government. In addition to such other 
functions and activities as the President may assign, the Director, 
consistent with applicable laws and the National Response Framework, 
shall--
            (1) serve as the principal advisor to the President on all 
        matters related to pandemic preparedness and response policy 
        and make recommendations to the President regarding pandemic 
        and other biological threats that may impact national security;
            (2) coordinate Federal activities to prepare for, and 
        respond to, pandemic and other biological threats, by--
                    (A) providing strategic direction to the heads of 
                applicable Federal departments, agencies, and offices, 
                including--
                            (i) the establishment, implementation, 
                        prioritization, and assessment of policy goals 
                        and objectives across the Executive Office of 
                        the President and such departments, agencies, 
                        and offices;
                            (ii) supporting the assessment and 
                        clarification of roles and responsibilities 
                        related to such Federal activities; and
                            (iii) supporting the development and 
                        implementation of metrics and performance 
                        measures to evaluate the extent to which 
                        applicable activities meet such goals and 
                        objectives;
                    (B) providing, in consultation with the Secretary 
                of Health and Human Services and the heads of other 
                relevant Federal departments, agencies, and offices, 
                leadership with respect to the National Biodefense 
                Strategy and related activities pursuant to section 
                1086 of the National Defense Authorization Act for 
                Fiscal Year 2017 (6 U.S.C. 104) and section 363 of the 
                William M. (Mac) Thornberry National Defense 
                Authorization Act for Fiscal Year 2021 (6 U.S.C. 105);
                    (C) facilitating coordination and communication 
                between such Federal departments, agencies, and offices 
                to improve preparedness for, and response to, such 
                threats;
                    (D) ensuring that the authorities, capabilities, 
                and expertise of each such department, agency, and 
                office are appropriately leveraged to facilitate the 
                whole-of-Government response to such threats;
                    (E) overseeing coordination of Federal efforts to 
                prepare for and support the production, supply, and 
                distribution of relevant medical products and supplies 
                during a response to a pandemic or other biological 
                threat, as applicable and appropriate, including 
                supporting Federal efforts to assess any relevant 
                vulnerabilities in the supply chain of such products 
                and supplies;
                    (F) overseeing coordination of Federal efforts for 
                the basic and advanced research, development, 
                manufacture, and procurement of medical 
                countermeasures, including by--
                            (i) serving, with the Secretary of Health 
                        and Human Services, as co-Chair of the Public 
                        Health Emergency Medical Countermeasures 
                        Enterprise established pursuant to section 
                        2811-1 of the Public Health Service Act (42 
                        U.S.C. 300hh-10a); and
                            (ii) promoting coordination between the 
                        medical countermeasure research, development, 
                        and procurement activities of respective 
                        Federal departments and agencies, including to 
                        advance the discovery and development of new 
                        medical products and technologies;
                    (G) convening heads of Federal departments and 
                agencies, as appropriate, on topics related to 
                capabilities to prepare for, and respond to, such 
                threats;
                    (H) assessing and advising on international 
                cooperation in preparing for, and responding to, such 
                threats to advance the national security objectives of 
                the United States; and
                    (I) overseeing other Federal activities to assess 
                preparedness for, and responses to, such threats, 
                including--
                            (i) drills and operational exercises 
                        conducted pursuant to applicable provisions of 
                        law; and
                            (ii) Federal after-action reports developed 
                        following such drills and exercises or a 
                        response to a pandemic or other biological 
                        threat;
            (3) promote and support the development of relevant 
        expertise and capabilities within the Federal Government to 
        ensure that the United States can quickly detect, identify, and 
        respond to such threats, and provide recommendations, as 
        appropriate, to the President;
            (4) consult with the Director of the Office of Management 
        and Budget and other relevant officials within the Executive 
        Office of the President, including the Assistant to the 
        President for National Security Affairs and the Director of the 
        Office of Science and Technology Policy, regarding activities 
        related to preparing for, and responding to, such threats and 
        relevant research and emerging technologies that may advance 
        the biosecurity and preparedness and response goals of the 
        Federal Government;
            (5) identify opportunities to leverage current and emerging 
        technologies, including through public-private partnerships, as 
        appropriate, to address such threats and advance the 
        preparedness and response goals of the Federal Government; and
            (6) ensure that findings of Federal after-action reports 
        conducted pursuant to paragraph (2)(I)(ii) are implemented to 
        the maximum extent feasible within the Federal Government.
    (c) Support From Other Agencies.--Each department, agency, and 
instrumentality of the executive branch of the Federal Government, 
including any independent agency, is authorized to support the Director 
by providing the Director such information as the Director determines 
necessary to carry out the functions of the Director under this 
section.
    (d) Preparedness Outlook Report.--
            (1) In general.--Within its first year of operation, the 
        Director, in consultation with the heads of relevant Federal 
        departments and agencies and other officials within the 
        Executive Office of the President, shall through a report 
        submitted to the President and made available to the public, to 
        the extent practicable, identify and describe situations and 
        conditions which warrant special attention within the next 5 
        years, involving current and emerging problems of national 
        significance related to pandemic or other biological threats, 
        and opportunities for, and the barriers to, the research, 
        development, and procurement of medical countermeasures to 
        adequately respond to such threats.
            (2) Revisions.--The Office shall revise the report under 
        paragraph (1) not less than once every 5 years and work with 
        relevant Federal officials to address the problems, barriers, 
        opportunities, and actions identified under this report through 
        the development of the President's Budgets and programs.
    (e) Interdepartmental Working Group.--The Director shall lead an 
interdepartmental working group that will meet on a regular basis to 
evaluate national biosecurity and pandemic preparedness issues and make 
recommendations to the heads of applicable Federal departments, 
agencies and offices. The working group shall consist of 
representatives from--
            (1) the Office of Pandemic Preparedness and Response 
        Policy, to serve as the chair;
            (2) the Department of Health and Human Services;
            (3) the Department of Homeland Security;
            (4) the Department of Defense;
            (5) the Office of Management and Budget; and
            (6) other Federal Departments and agencies.
    (f) Additional Functions of the Director.--The Director, in 
addition to the other duties and functions set forth in this section--
            (1) shall--
                    (A) serve as a member of the Domestic Policy 
                Council and the National Security Council;
                    (B) serve as a member of the Intergovernmental 
                Science, Engineering, and Technology Advisory Panel 
                under section 205(b) of the National Science and 
                Technology Policy, Organization, and Priorities Act of 
                1976 (42 U.S.C. 6614(b)) and the Federal Coordinating 
                Council for Science, Engineering and Technology under 
                section 401 of such Act (42 U.S.C. 6651);
                    (C) consult with State, Tribal, local, and 
                territorial governments, industry, academia, 
                professional societies, and other stakeholders, as 
                appropriate;
                    (D) use for administrative purposes, on a 
                reimbursable basis, the available services, equipment, 
                personnel, and facilities of Federal, State, and local 
                agencies; and
                    (E) at the President's request, perform such other 
                duties and functions and enter into contracts and other 
                arrangements for studies, analyses, and related 
                services with public or private entities, as applicable 
                and appropriate; and
            (2) may hold such hearings in various parts of the United 
        States as necessary to determine the views of the entities and 
        individuals referred to in paragraph (1) and of the general 
        public, concerning national needs and trends in pandemic 
        preparedness and response.
    (g) Staffing and Detailees.--In carrying out functions under this 
section, the Director may--
            (1) appoint not more than 25 individuals to serve as 
        employees of the Office as necessary to carry out this section;
            (2) fix the compensation of such personnel at a rate to be 
        determined by the Director, up to the amount of annual 
        compensation (excluding expenses) specified in section 102 of 
        title 3, United States Code;
            (3) utilize the services of consultants, which may include 
        by obtaining services described under section 3109(b) of title 
        5, United States Code, at rates not to exceed the rate of basic 
        pay for level IV of the Executive Schedule; and
            (4) direct, with the concurrence of the Secretary of a 
        department or head of an agency, the temporary reassignment 
        within the Federal Government of personnel employed by such 
        department or agency, in order to carry out the functions of 
        the Office.
    (h) Preparedness Review and Report.--The Director, in consultation 
with the heads of applicable Federal departments, agencies, and 
offices, shall--
            (1) not later than 1 year after the date of enactment of 
        this Act, conduct a review of applicable Federal strategies, 
        policies, procedures, and after-action reports to identify gaps 
        and inefficiencies related to pandemic preparedness and 
        response;
            (2) not later than 18 months after the date of enactment of 
        this Act, and every 2 years thereafter, submit to the President 
        and 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--
                    (A) current and emerging pandemic and other 
                biological threats that pose a significant level of 
                risk to national security;
                    (B) the roles and responsibilities of the Federal 
                Government in preparing for, and responding to, such 
                threats;
                    (C) the findings of the review conducted under 
                paragraph (1);
                    (D) any barriers or limitations related to 
                addressing such findings;
                    (E) current and planned activities to update 
                Federal strategies, policies, and procedures to address 
                such findings, consistent with applicable laws and the 
                National Response Framework;
                    (F) current and planned activities to support the 
                development of expertise within the Federal Government 
                pursuant to subsection (b)(3); and
                    (G) opportunities to improve Federal preparedness 
                and response capacities and capabilities through the 
                use of current and emerging technologies.
    (i) Nonduplication of Effort.--The Director shall ensure that 
activities carried out under this section do not unnecessarily 
duplicate the efforts of other Federal departments, agencies, and 
offices.
    (j) Conforming Amendments.--
            (1) Section 2811-1 of the Public Health Service Act (42 
        U.S.C. 300hh-10a) is amended--
                    (A) in the second sentence of subsection (a), by 
                striking ``shall serve as chair'' and inserting ``and 
                the Director of the Office of Pandemic Preparedness and 
                Response Policy shall serve as co-chairs''; and
                    (B) in subsection (b)--
                            (i) by redesignating paragraph (10) as 
                        paragraph (11); and
                            (ii) by inserting after paragraph (9) the 
                        following:
            ``(10) The Director of the Office of Pandemic Preparedness 
        and Response Policy.''.
            (2) Section 101(c)(1) of the National Security Act of 1947 
        (50 U.S.C. 3021(c)(1)) is amended by inserting ``the Director 
        of the Office of Pandemic Preparedness and Response Policy'' 
        after ``Treasury,''.
            (3) The National Science and Technology Policy, 
        Organization, and Priorities Act of 1976 (42 U.S.C. 6601 et 
        seq.) is amended--
                    (A) in section 205(b)(2) (42 U.S.C. 6614(b)(2))--
                            (i) by striking ``and (C)'' and inserting 
                        ``(C)''; and
                            (ii) by striking the period at the end and 
                        inserting ``; and (D) the Director of the 
                        Office of Pandemic Preparedness and Response 
                        Policy.''; and
                    (B) in section 401(b) (42 U.S.C. 6651(b)), by 
                inserting ``, the Director of the Office of Pandemic 
                Preparedness and Response Policy,'' after ``Technology 
                Policy''.

                 Subtitle B--State and Local Readiness

SEC. 111. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

    (a) In General.--Section 319C-1(b)(2) of the Public Health Service 
Act (42 U.S.C. 247d-3a(b)(2)) is amended--
            (1) in subparagraph (A)--
                    (A) in clause (vii), by inserting ``during and'' 
                before ``following a public health emergency'';
                    (B) by amending clause (viii) to read as follows:
                            ``(viii) a description of how the entity, 
                        as applicable and appropriate, will coordinate 
                        with State emergency preparedness and response 
                        plans in public health emergency preparedness, 
                        including State education agencies (as defined 
                        in section 8101 of the Elementary and Secondary 
                        Education Act of 1965), State child care lead 
                        agencies (designated under section 658D of the 
                        Child Care and Development Block Grant Act of 
                        1990), and other relevant State agencies'';
                    (C) in clause (xi), by striking ``; and'' and 
                inserting a semicolon;
                    (D) by redesignating clause (xii) as clause (xiii); 
                and
                    (E) by inserting after clause (xi) the following:
                            ``(xii) a description of how the entity 
                        will provide technical assistance to improve 
                        public health preparedness and response, as 
                        appropriate, to agencies or other entities that 
                        operate facilities within the entity's 
                        jurisdiction in which there is an increased 
                        risk of infectious disease outbreaks in the 
                        event of a public health emergency declared 
                        under section 319, such as residential care 
                        facilities, group homes, and other similar 
                        settings; and'';
            (2) by redesignating subparagraphs (D) through (H) as 
        subparagraphs (E) through (I), respectively; and
            (3) by inserting after subparagraph (C) the following:
                    ``(D) an assurance that the entity will require 
                relevant staff to complete relevant preparedness and 
                response trainings, including trainings related to 
                efficient and effective operation during an incident or 
                event within an Incident Command System;''.
    (b) Applicability.--The amendments made by subsection (a) shall not 
apply with respect to any cooperative agreement entered into prior to 
the date of enactment of this Act.

SEC. 112. SUPPORTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER 
              SERVICES DURING PUBLIC HEALTH EMERGENCIES.

    (a) Authorities.--Section 501(d) of the Public Health Service Act 
(42 U.S.C. 290aa(d)) is amended--
            (1) by redesignating paragraphs (24) and (25) as paragraphs 
        (25) and (26), respectively; and
            (2) by inserting after paragraph (23) the following:
            ``(24) support the continued access to, or availability of, 
        mental health and substance use disorder services during, or in 
        response to, a public health emergency declared under section 
        319, including in consultation with, as appropriate, the 
        Assistant Secretary for Preparedness and Response and the heads 
        of other relevant agencies, in preparing for, and responding 
        to, a public health emergency;''.
    (b) Strategic Plan.--Section 501(l)(4) of the Public Health Service 
Act (42 U.S.C. 290aa(l)(4)) is amended--
            (1) in subparagraph (E), by striking ``and'' at the end;
            (2) in subparagraph (F), by striking the period and 
        inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(G) specify a strategy to support the continued 
                access to, or availability of, mental health and 
                substance use disorder services, including to at-risk 
                individuals (as defined in section 2802(b)(4)), during, 
                or in response to, public health emergencies declared 
                pursuant to section 319.''.
    (c) Biennial Report Concerning Activities and Progress.--Section 
501(m) of the Public Health Service Act (42 U.S.C. 290aa(m)) is 
amended--
            (1) by redesignating paragraphs (4) through (7) as 
        paragraphs (5) through (8), respectively;
            (2) by inserting after paragraph (3) the following:
            ``(4) a description of the Administration's activities to 
        support the continued provision of mental health and substance 
        use disorder services, as applicable, in response to public 
        health emergencies declared pursuant to section 319;''; and
            (3) in paragraph (5), as so redesignated--
                    (A) by redesignating subparagraphs (D) and (E) as 
                subparagraphs (E) and (F), respectively; and
                    (B) by inserting after subparagraph (C) the 
                following:
                    ``(D) relevant preparedness and response 
                activities;''.
    (d) Advisory Councils.--Not later than 1 year after the date of 
enactment of this Act, the Assistant Secretary for Mental Health and 
Substance Use shall issue 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, reflecting the 
feedback of the advisory councils for the Center for Substance Abuse 
Treatment, the Center for Substance Abuse Prevention, and the Center 
for Mental Health Services, pursuant to section 502 of the Public 
Health Service Act (42 U.S.C. 290aa-1), with recommendations to improve 
the continued provision of mental health and substance use disorder 
services during a public health emergency declared under section 319 of 
such Act (42 U.S.C. 247d), and the provision of such services as part 
of the public health and medical response to such an emergency, 
consistent with title XXVIII of such Act (42 U.S.C. 300hh et seq.), 
including related to the capacity of the mental health and substance 
use disorder workforce and flexibilities provided to awardees of mental 
health and substance use disorder programs.
    (e) GAO Report.--Not later than 3 years after the date of enactment 
of this Act, the Comptroller General of the United States shall submit 
to the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on programs and activities of the Substance 
Abuse and Mental Health Services Administration to support the 
provision of mental health and substance use disorder services and 
related activities during the COVID-19 pandemic, including the 
provision of such services as part of the medical and public health 
response to such pandemic. Such report shall--
            (1) examine the role played by the advisory councils 
        described in section 502 of the Public Health Service Act (42 
        U.S.C. 290aa-1) and the National Mental Health and Substance 
        Use Policy Laboratory established under section 501A of such 
        Act (42 U.S.C. 290aa-0) in providing technical assistance and 
        recommendations to the Substance Abuse and Mental Health 
        Services Administration to support the response of such agency 
        to the public health emergency declared under section 319 of 
        the Public Health Service Act (42 U.S.C. 247d) with respect to 
        COVID-19;
            (2) describe the manner in which existing awardees of 
        mental health and substance use disorder programs provided and 
        altered delivery of services during such public health 
        emergency, including information on the populations served by 
        such awardees and any barriers faced in delivering services; 
        and
            (3) describe activities of the Substance Abuse and Mental 
        Health Services Administration to support the response to such 
        public health emergency, including through technical 
        assistance, provision of services, and any flexibilities 
        provided to such existing awardees, and any barriers faced in 
        implementing such activities.

SEC. 113. TRAUMA CARE REAUTHORIZATION.

    (a) In General.--Section 1201 of the Public Health Service Act (42 
U.S.C. 300d) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (3)--
                            (i) by inserting ``analyze,'' after 
                        ``compile,''; and
                            (ii) by inserting ``and medically 
                        underserved areas'' before the semicolon;
                    (B) in paragraph (4), by adding ``and'' after the 
                semicolon;
                    (C) by striking paragraph (5); and
                    (D) by redesignating paragraph (6) as paragraph 
                (5);
            (2) by redesignating subsection (b) as subsection (c); and
            (3) by inserting after subsection (a) the following:
    ``(b) Trauma Care Readiness and Coordination.--The Secretary, 
acting through the Assistant Secretary for Preparedness and Response, 
shall support the efforts of States and consortia of States to 
coordinate and improve emergency medical services and trauma care 
during a public health emergency declared by the Secretary pursuant to 
section 319 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. Such support may 
include--
            ``(1) developing, issuing, and updating guidance, as 
        appropriate, to support the coordinated medical triage and 
        evacuation to appropriate medical institutions based on patient 
        medical need, taking into account regionalized systems of care;
            ``(2) disseminating, as appropriate, information on 
        evidence-based or evidence-informed trauma care practices, 
        taking into consideration emergency medical services and trauma 
        care systems, including such practices identified through 
        activities conducted under subsection (a) and which may include 
        the identification and dissemination of performance metrics, as 
        applicable and appropriate; and
            ``(3) other activities, as appropriate, to optimize a 
        coordinated and flexible approach to the emergency response and 
        medical surge capacity of hospitals, other health care 
        facilities, critical care, and emergency medical systems.''.
    (b) Grants To Improve Trauma Care in Rural Areas.--Section 1202 of 
the Public Health Service Act (42 U.S.C. 300d-3) is amended--
            (1) by amending the section heading to read as follows: 
        ``grants to improve trauma care in rural areas'';
            (2) by amending subsections (a) and (b) to read as follows:
    ``(a) In General.--The Secretary shall award grants to eligible 
entities for the purpose of carrying out research and demonstration 
projects to support the improvement of emergency medical services and 
trauma care in rural areas through the development of innovative uses 
of technology, training and education, transportation of seriously 
injured patients for the purposes of receiving such emergency medical 
services, access to prehospital care, evaluation of protocols for the 
purposes of improvement of outcomes and dissemination of any related 
best practices, activities to facilitate clinical research, as 
applicable and appropriate, and increasing communication and 
coordination with applicable State or Tribal trauma systems.
    ``(b) Eligible Entities.--
            ``(1) In general.--To be eligible to receive a grant under 
        this section, an entity shall be a public or private entity 
        that provides trauma care in a rural area.
            ``(2) Priority.--In awarding grants under this section, the 
        Secretary shall give priority to eligible entities that will 
        provide services under the grant in any rural area identified 
        by a State under section 1214(d)(1).''; and
            (3) by adding at the end the following:
    ``(d) Reports.--An entity that receives a grant under this section 
shall submit to the Secretary such reports as the Secretary may require 
to inform administration of the program under this section.''.
    (c) Pilot Grants for Trauma Centers.--Section 1204 of the Public 
Health Service Act (42 U.S.C. 300d-6) is amended--
            (1) by amending the section heading to read as follows: 
        ``pilot grants for trauma centers'';
            (2) in subsection (a)--
                    (A) by striking ``not fewer than 4'' and inserting 
                ``10'';
                    (B) by striking ``that design, implement, and 
                evaluate'' and inserting ``to design, implement, and 
                evaluate new or existing'';
                    (C) by striking ``emergency care'' and inserting 
                ``emergency medical''; and
                    (D) by inserting ``, and improve access to trauma 
                care within such systems'' before the period;
            (3) in subsection (b)(1), by striking subparagraphs (A) and 
        (B) and inserting the following:
                    ``(A) a State or consortia of States;
                    ``(B) an Indian Tribe or Tribal organization (as 
                defined in section 4 of the Indian Self-Determination 
                and Education Assistance Act);
                    ``(C) a consortium of level I, II, or III trauma 
                centers designated by applicable State or local 
                agencies within an applicable State or region, and, as 
                applicable, other emergency services providers; or
                    ``(D) a consortium or partnership of nonprofit 
                Indian Health Service, Indian Tribal, and urban Indian 
                trauma centers.'';
            (4) in subsection (c)--
                    (A) in the matter preceding paragraph (1)--
                            (i) by striking ``that proposes a pilot 
                        project'';
                            (ii) by striking ``an emergency medical and 
                        trauma system that--'' and inserting ``a new or 
                        existing emergency medical and trauma system. 
                        Such eligible entity shall use amounts awarded 
                        under this subsection to carry out 2 or more of 
                        the following activities:'';
                    (B) in paragraph (1) --
                            (i) by striking ``coordinates'' and 
                        inserting ``Strengthening coordination and 
                        communication''; and
                            (ii) by striking ``an approach to emergency 
                        medical and trauma system access throughout the 
                        region, including 9-1-1 Public Safety Answering 
                        Points and emergency medical dispatch;'' and 
                        inserting ``approaches to improve situational 
                        awareness and emergency medical and trauma 
                        system access, including distribution of 
                        patients during a mass casualty incident, 
                        throughout the region.'';
                    (C) in paragraph (2)--
                            (i) by striking ``includes'' and inserting 
                        ``Providing'';
                            (ii) by inserting ``support patient 
                        movement to'' after ``region to''; and
                            (iii) by striking the semicolon and 
                        inserting a period;
                    (D) in paragraph (3)--
                            (i) by striking ``allows for'' and 
                        inserting ``Improving''; and
                            (ii) by striking ``; and'' and inserting a 
                        period;
                    (E) in paragraph (4), by striking ``includes a 
                consistent'' and inserting ``Supporting a consistent''; 
                and
                    (F) by adding at the end the following:
            ``(5) Establishing, implementing, and disseminating, or 
        utilizing existing, as applicable, evidence-based or evidence-
        informed practices across facilities within such emergency 
        medical and trauma system to improve health outcomes, including 
        such practices related to management of injuries, and the 
        ability of such facilities to surge.
            ``(6) Conducting activities to facilitate clinical 
        research, as applicable and appropriate.'';
            (5) in subsection (d)(2)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``the proposed'' and inserting ``the 
                        applicable emergency medical and trauma 
                        system'';
                            (ii) in clause (i), by inserting ``or 
                        Tribal entity'' after ``equivalent State 
                        office''; and
                            (iii) in clause (vi), by striking ``; and'' 
                        and inserting a semicolon;
                    (B) by redesignating subparagraph (B) as 
                subparagraph (C); and
                    (C) by inserting after subparagraph (A) the 
                following:
                    ``(B) for eligible entities described in 
                subparagraph (C) or (D) of subsection (b)(1), a 
                description of, and evidence of, coordination with the 
                applicable State Office of Emergency Medical Services 
                (or equivalent State Office) or applicable such office 
                for a Tribe or Tribal organization; and'';
            (6) in subsection (e)--
                    (A) in paragraph (1), by striking ``$1 for each 
                $3'' and inserting ``$1 for each $5''; and
                    (B) by adding at the end the following:
            ``(3) Waiver.--The Secretary may waive all or part of the 
        matching requirement described in paragraph (1) for any fiscal 
        year for a State, consortia of States, Indian Tribe or Tribal 
        organization, or trauma center, if the Secretary determines 
        that applying such matching requirement would result in serious 
        hardship or an inability to carry out the purposes of the pilot 
        program.'';
            (7) in subsection (f), by striking ``population in a 
        medically underserved area'' and inserting ``medically 
        underserved population'';
            (8) in subsection (g)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``described in'';
                    (B) in paragraph (2), by striking ``the system 
                characteristics that contribute to'' and inserting 
                ``opportunities for improvement, including 
                recommendations for how to improve'';
                    (C) by striking paragraph (4);
                    (D) by redesignating paragraphs (5) and (6) as 
                paragraphs (4) and (5), respectively;
                    (E) in paragraph (4), as so redesignated, by 
                striking ``; and'' and inserting a semicolon;
                    (F) in paragraph (5), as so redesignated, by 
                striking the period and inserting ``; and''; and
                    (G) by adding at the end the following:
            ``(6) any evidence-based or evidence-informed strategies 
        developed or utilized pursuant to subsection (c)(5).''; and
            (9) by amending subsection (h) to read as follows:
    ``(h) Dissemination of Findings.--Not later than 1 year after the 
completion of the final project under subsection (a), 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 information contained in each 
report submitted pursuant to subsection (g) and any additional actions 
planned by the Secretary related to regionalized emergency care and 
trauma systems.''.
    (d) Program Funding.--Section 1232(a) of the Public Health Service 
Act (42 U.S.C. 300d-32(a)) is amended by striking ``2010 through 2014'' 
and inserting ``2023 through 2027''.

SEC. 114. ASSESSMENT OF CONTAINMENT AND MITIGATION OF INFECTIOUS 
              DISEASES.

    (a) GAO Study.--The Comptroller General of the United States shall 
conduct a study that reviews a geographically diverse sample of States 
and territories that, in response to the COVID-19 pandemic, implemented 
preparedness and response plans that included isolation and quarantine 
recommendations or requirements. Such study shall include--
            (1) a review of such State and territorial preparedness and 
        response plans in place during the COVID-19 pandemic, an 
        assessment of the extent to which such plans facilitated or 
        presented challenges to State and territorial responses to such 
        public health emergency, including response activities relating 
        to isolation and quarantine to prevent the spread of COVID-19; 
        and
            (2) a description of the technical assistance provided by 
        the Federal Government to help States and territories 
        facilitate such response activities during responses to 
        relevant public health emergencies declared by the Secretary of 
        Health and Human Services pursuant to section 319 of the Public 
        Health Service Act, including the public health emergency with 
        respect to COVID-19, and a review of the degree to which such 
        State and territorial plans were implemented and subsequently 
        revised in response to the COVID-19 pandemic to address any 
        challenges.
    (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.

  TITLE II--IMPROVING PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPACITY

    Subtitle A--Addressing Disparities and Improving Public Health 
                          Emergency Responses

SEC. 201. ADDRESSING SOCIAL DETERMINANTS OF HEALTH AND IMPROVING HEALTH 
              OUTCOMES.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended--
            (1) by inserting after section 317U the following:

``SEC. 317V. ADDRESSING SOCIAL DETERMINANTS OF HEALTH AND IMPROVING 
              HEALTH OUTCOMES.

    ``(a) In General.--The Secretary shall, as appropriate, award 
grants, contracts, or cooperative agreements to eligible entities for 
the conduct of evidence-based or evidence-informed projects, which may 
include the development of networks to improve health outcomes and 
reduce health disparities by improving the capacity of such entities to 
address social determinants of health in communities.
    ``(b) Eligible Entities.--To be eligible to receive an award under 
this section, an entity shall--
            ``(1)(A) be a State, local, or Tribal health department, 
        community-based organization, Indian Tribe or Tribal 
        organization (as such terms are defined in section 4 of the 
        Indian Self-Determination and Education Assistance Act), urban 
        Indian organization (as defined in section 4 of the Indian 
        Health Care Improvement Act), or other public or private 
        entity, as the Secretary determines appropriate; or
            ``(B) be a consortia or public-private partnership of 
        entities described in subparagraph (A);
            ``(2) submit to the Secretary an application at such time, 
        in such manner, and containing such information as the 
        Secretary shall require;
            ``(3) in the case of an entity other than a community-based 
        organization, demonstrate a history of successfully working 
        with an established community-based organization to address 
        health disparities;
            ``(4) submit a plan to conduct activities described in 
        subsection (a) based on a community needs assessment that takes 
        into account community input; and
            ``(5) demonstrate the capacity to effectively implement 
        evidence-based or evidence-informed strategies to address 
        health disparities among underserved populations, which may 
        include rural, racial, and ethnic minority populations and 
        people with disabilities, in a timely manner.
    ``(c) Use of Funds.--An entity described in subsection (b) shall 
use funds received under subsection (a), in consultation with State, 
local, and Tribal health departments, community-based organizations, 
and other entities with experience addressing social determinants of 
health or reducing health disparities, as applicable, for one or more 
of the following purposes:
            ``(1) Supporting the implementation, evaluation, and 
        dissemination of strategies, including culturally-appropriate 
        strategies, to address social determinants of health, based on 
        the identified needs of the community that is the subject of 
        the assessment submitted under subsection (b)(4), through 
        evidence-informed or evidence-based programs and through the 
        support and use of public health and health care professionals 
        to address such social determinants of health.
            ``(2) Establishing, maintaining, or improving, in 
        consultation with State, local, or Tribal health departments, 
        technology platforms or networks to support coordination among 
        appropriate entities, and providing information on health and 
        related social services, which may include activities to 
        improve data collection for public health purposes, in a manner 
        that is consistent with applicable Federal and State privacy 
        law.
            ``(3) Implementing best practices for improving health 
        outcomes and reducing disease among underserved populations, 
        including rural or racial and ethnic minority populations.
            ``(4) Supporting consideration of social determinants of 
        health in preparing for, and responding to, public health 
        emergencies, through outreach, education, research, and other 
        relevant activities.
    ``(d) Best Practices and Technical Assistance.--The Secretary, in 
consultation with the Director of the Office of Minority Health, may 
award grants, contracts, and cooperative agreements to public or 
nonprofit private entities, including minority serving institutions 
(defined, for purposes of this subsection, as institutions and programs 
described in section 326(e)(1) of the Higher Education Act of 1965 and 
institutions described in section 371(a) of such Act of 1965), to--
            ``(1) identify or facilitate the development of best 
        practices to support improved health outcomes and reduce health 
        disparities by addressing social determinants of health;
            ``(2) provide technical assistance, training, and 
        evaluation assistance to award recipients under subsection (a);
            ``(3) disseminate best practices, including to award 
        recipients under subsection (a); and
            ``(4) establish or operate regional centers to develop, 
        evaluate, and disseminate effective strategies on the 
        utilization of preventive health care services to address 
        social determinants of health, including supporting research 
        and training related to such strategies.
    ``(e) Award Periods.--The Secretary shall issue awards under this 
section for periods of not more than 5 years and may issue extensions 
of such award periods for an additional period of up to 3 years.
    ``(f) Report.--Not later than September 30, 2026, 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 that includes information on activities funded 
under this section. Such report shall include a description of--
            ``(1) changes in the capacity of public health entities to 
        address social determinants of health in communities, including 
        any applicable platforms or networks developed or utilized to 
        coordinate health and related social services and any changes 
        in workforce capacity or capabilities;
            ``(2) improvements in health outcomes and in reducing 
        health disparities in medically underserved communities;
            ``(3) activities conducted to support consideration of 
        social determinants of health in preparing for, and responding 
        to, public health emergencies, through outreach, education, and 
        other relevant activities;
            ``(4) communities and populations served by recipients of 
        awards under subsection (a);
            ``(5) activities supported under subsection (e); and
            ``(6) other relevant activities and outcomes, as determined 
        by the Secretary.
    ``(g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $70,000,000 for each of fiscal 
years 2023 through 2027.''; and
            (2) by striking section 330D (42 U.S.C. 254c-4).
    (b) GAO Study and Report.--Not later than 4 years after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Energy and Committee on Energy and Commerce of 
the House of Representatives a report on the program authorized under 
section 317V of the Public Health Service Act, as added by subsection 
(a), including a review of the outcomes and effectiveness of the 
program and coordination with other programs in the Department of 
Health and Human Services with similar goals to ensure that there was 
no unnecessary duplication of efforts.

SEC. 202. NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE 
              REPORT.

    (a) In General.--Not later than 45 days after the date of enactment 
of this Act, the Secretary of Health and Human Services 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 to examine health 
disparities and the effect of such disparities on health outcomes, 
which may include health outcomes related to pandemic and other public 
health emergencies.
    (b) Report.--Pursuant to the contract under subsection (a), the 
National Academies shall, not later than 3 years after the date of 
enactment of this Act, issue a report informed by the study conducted 
under such subsection that includes--
            (1) consideration of previous recommendations made by the 
        National Academies related to health disparities, including in 
        the report titled ``Unequal Treatment: Confronting Racial and 
        Ethnic Disparities in Healthcare'';
            (2) recommendations for strategies to improve health 
        outcomes by reducing health disparities, which may include 
        education and training; and
            (3) an assessment of ongoing research and strategies to 
        reduce health disparities and improve health outcomes, 
        including effective service delivery models.
    (c) Clarification.--In completing the requirements of the contract 
under this section, the National Academies may leverage relevant 
ongoing work of the National Academies, including ongoing work related 
to the impact of Federal policies on health disparities.
    (d) Authorization of Appropriations.--There is authorized to be 
appropriated $2,000,000 for fiscal year 2023 to carry out this section.

                Subtitle B--Improving Public Health Data

SEC. 211. MODERNIZING BIOSURVEILLANCE CAPABILITIES AND INFECTIOUS 
              DISEASE DATA COLLECTION.

    Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is 
amended--
            (1) in subsection (b)(1)(A), by striking ``, and local'' 
        and inserting ``, local, and Tribal'';
            (2) in subsection (c)--
                    (A) in paragraph (1), by inserting ``modernize,'' 
                after ``establish,'';
                    (B) in paragraph (3)(B), by inserting ``, and make 
                recommendations to improve the quality of data 
                collected pursuant to subparagraph (A) to ensure 
                complete, accurate, and timely sharing of such data, as 
                appropriate, across such elements as described in 
                subparagraph (A)'' after ``under subparagraph (A)'';
                    (C) in paragraph (5)--
                            (i) in subparagraph (A)--
                                    (I) in the matter preceding clause 
                                (i), by striking ``and operating'' and 
                                inserting ``, operating, and updating, 
                                as appropriate,'';
                                    (II) in clause (iv), by striking 
                                ``and'' at the end;
                                    (III) in clause (v), by striking 
                                the period and inserting ``; and''; and
                                    (IV) by adding at the end the 
                                following:
                            ``(vi) in collaboration with State, local, 
                        and Tribal public health officials, integrate 
                        and update applicable existing public health 
                        data systems and networks of the Department of 
                        Health and Human Services to reflect 
                        technological advancements, consistent with 
                        section 2823, as applicable.''; and
                            (ii) in subparagraph (B)--
                                    (I) in clause (i), by inserting 
                                ``and 180 days after the date of 
                                enactment of the PREVENT Pandemics 
                                Act,'' after ``Innovation Act of 
                                2019,'';
                                    (II) in clause (ii), by inserting 
                                ``experts in privacy and data 
                                security;'' after ``forecasting);''; 
                                and
                                    (III) in clause (iii)--
                                            (aa) in subclause (V), by 
                                        striking ``and'' at the end;
                                            (bb) in subclause (VI), by 
                                        striking the period and 
                                        inserting a semicolon; and
                                            (cc) by adding at the end 
                                        the following:
                                    ``(VII) strategies to integrate 
                                laboratory and public health data 
                                systems and capabilities to support 
                                rapid and accurate reporting of 
                                laboratory test results and associated 
                                relevant data;
                                    ``(VIII) strategies to improve the 
                                collection and reporting of relevant, 
                                aggregated, deidentified demographic 
                                data to inform responses to public 
                                health emergencies, including 
                                identification of at-risk populations 
                                and to address potential health 
                                disparities; and
                                    ``(IX) strategies to improve the 
                                electronic exchange of health 
                                information between State and local 
                                health departments and health care 
                                providers and facilities to improve 
                                public health surveillance.''; and
                    (D) in paragraph (6)(A)--
                            (i) in the matter preceding clause (i), by 
                        inserting ``and every 5 years thereafter,'' 
                        after ``Innovation Act of 2019,''
                            (ii) in clause (iii)--
                                    (I) in subclause (III), by striking 
                                ``and'' at the end; and
                                    (II) by adding at the end the 
                                following:
                                    ``(V) improve coordination and 
                                collaboration, as appropriate, with 
                                other Federal departments; and
                                    ``(VI) implement applicable lessons 
                                learned from recent public health 
                                emergencies to address gaps in 
                                situational awareness and 
                                biosurveillance capabilities;'';
                            (iii) in clause (iv), by striking ``and'' 
                        at the end;
                            (iv) in clause (v), by striking the period 
                        and inserting ``, including a description of 
                        how such steps will further the goals of the 
                        network, consistent with paragraph (1); and''; 
                        and
                            (v) by adding at the end the following:
                            ``(vi) identifies and demonstrates 
                        measurable steps the Secretary will take to 
                        further develop and integrate infectious 
                        disease detection, support rapid and accurate 
                        reporting of laboratory test results during a 
                        public health emergency, and improve 
                        coordination and collaboration with State, 
                        local, and Tribal public health officials, 
                        clinical laboratories, and other entities with 
                        expertise in public health surveillance.'';
            (3) in subsection (d)--
                    (A) in paragraph (1), by inserting ``, acting 
                through the Director of the Centers for Disease Control 
                and Prevention and in coordination with the heads of 
                other appropriate agencies and offices within the 
                Department of Health and Human Services,'' after ``the 
                Secretary'';
                    (B) in paragraph (2)(C), by inserting ``, including 
                any public-private partnerships or other partnerships 
                entered into to improve such capacity'' before the 
                semicolon; and
                    (C) by adding at the end the following:
            ``(6) Non-duplication of effort.--The Secretary shall 
        ensure that activities carried out under an award under this 
        subsection do not unnecessarily duplicate efforts of other 
        agencies and offices within the Department of Health and Human 
        Services.'';
            (4) by amending subsection (i) to read as follows:
    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated--
            ``(1) to carry out subsection (a), $25,000,000 for each of 
        fiscal years 2022 and 2023; and
            ``(2) to carry out subsections (b), (c), and (d), 
        $136,800,000 for each of fiscal years 2022 and 2023.''; and
            (5) by striking ``tribal'' each place it appears and 
        inserting ``Tribal''.

SEC. 212. GENOMIC SEQUENCING, ANALYTICS, AND PUBLIC HEALTH SURVEILLANCE 
              OF PATHOGENS.

    (a) Guidance Supporting Genomic Sequencing of Pathogens 
Collaboration.--The Secretary of Health and Human Services (referred to 
in this section as the ``Secretary''), in consultation with the heads 
of other Federal departments or agencies, as appropriate, shall issue 
guidance to support collaboration relating to genomic sequencing of 
pathogens, including the use of new and innovative approaches and 
technology for the detection, characterization, and sequencing of 
pathogens, to improve public health surveillance and preparedness and 
response activities, consistent with section 2824 of the Public Health 
Service Act, as added by subsection (b). Such guidance shall address 
the secure sharing, for public health surveillance purposes, of 
specimens of such pathogens, between appropriate entities and public 
health authorities, consistent with the regulations promulgated under 
section 264(c) of the Health Insurance Portability and Accountability 
Act of 1996 (42 U.S.C. 1320d-2 note), as applicable, and in a manner 
that protects personal privacy to the extent required by applicable 
privacy law, at a minimum, and the appropriate use of sequence data 
derived from such specimens.
    (b) Genomic Sequencing Program.--Title XXVIII of the Public Health 
Service Act (42 U.S.C. 300hh et seq.) is amended by adding at the end 
the following

``SEC. 2824. GENOMIC SEQUENCING, ANALYTICS, AND PUBLIC HEALTH 
              SURVEILLANCE OF PATHOGENS PROGRAM.

    ``(a) Genomic Sequencing, Analytics, and Public Health Surveillance 
of Pathogens Program.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in consultation with 
the Director of the National Institutes of Health and heads of other 
departments and agencies, as appropriate, shall strengthen and expand 
activities related to genomic sequencing of pathogens, including new 
and innovative approaches and technology for the detection, 
characterization, and sequencing of pathogens, analytics, and public 
health surveillance, including--
            ``(1) continuing and expanding activities, which may 
        include existing genomic sequencing activities related to 
        advanced molecular detection, to--
                    ``(A) identify and respond to emerging infectious 
                disease threats; and
                    ``(B) identify the potential use of genomic 
                sequencing technologies, advanced computing, and other 
                advanced technology to inform surveillance activities 
                and incorporate the use of such technologies, as 
                appropriate, into related activities;
            ``(2) providing technical assistance and guidance to State, 
        Tribal, local, and territorial public health departments to 
        increase the capacity of such departments to perform genomic 
        sequencing of pathogens, including recipients of funding under 
        section 2821;
            ``(3) carrying out activities to enhance the capabilities 
        of the public health workforce with respect to pathogen 
        genomics, epidemiology, and bioinformatics, including through 
        training; and
            ``(4) continuing and expanding activities, as applicable, 
        with public and private entities, including relevant 
        departments and agencies, laboratories, academic institutions, 
        and industry.
    ``(b) Partnerships.--For the purposes of carrying out the 
activities described in subsection (a), the Secretary, acting through 
the Director of the Centers for Disease Control and Prevention, may 
award grants, contracts, or cooperative agreements to entities, 
including academic and other laboratories, with expertise in genomic 
sequencing for public health purposes, including new and innovative 
approaches to, and related technology for, the detection, 
characterization, and sequencing of pathogens.
    ``(c) Centers of Excellence.--
            ``(1) In general.--The Secretary shall, as appropriate, 
        award grants, contracts, or cooperative agreements to public 
        health agencies for the establishment or operation of centers 
        of excellence to promote innovation in pathogen genomics and 
        molecular epidemiology to improve the control of and response 
        to pathogens that may cause a public health emergency. Such 
        centers shall, as appropriate--
                    ``(A) identify and evaluate the use of genomics, or 
                other related technologies that may advance public 
                health preparedness and response;
                    ``(B) improve the identification, development, and 
                use of tools for integrating and analyzing genomic and 
                epidemiologic data;
                    ``(C) assist with genomic surveillance of, and 
                response to, infectious diseases, including analysis of 
                pathogen genomic data;
                    ``(D) conduct applied research to improve public 
                health surveillance of, and response to, infectious 
                diseases through innovation in pathogen genomics and 
                molecular epidemiology; and
                    ``(E) develop and provide training materials for 
                experts in the fields of genomics, microbiology, 
                bioinformatics, epidemiology, and other fields, as 
                appropriate.
            ``(2) Requirements.--To be eligible for an award under 
        paragraph (1), an entity shall submit to the Secretary an 
        application containing such information as the Secretary may 
        require, including a description of how the entity will 
        partner, as applicable, with academic institutions or a 
        consortium of academic partners that have relevant expertise, 
        such as microbial genomics, molecular epidemiology, or the 
        application of bioinformatics or statistics.
    ``(d) Authorization.--For purposes of carrying out this section, 
there are authorized to be appropriated $175,000,000 for each of fiscal 
years 2023 through 2027.''.

SEC. 213. SUPPORTING PUBLIC HEALTH DATA AVAILABILITY AND ACCESS.

    (a) Designation of Public Health Data Standards.--Section 
2823(a)(2) of the Public Health Service Act (42 U.S.C. 300hh-33(a)(2)) 
is amended--
            (1) by striking ``In carrying out'' and inserting the 
        following:
                    ``(A) In general.--In carrying out''; and
            (2) by striking ``shall, as appropriate and'' and inserting 
        ``shall, not later than 2 years after the date of enactment of 
        the PREVENT Pandemics Act,''; and
            (3) by adding at the end the following:
                    ``(B) Selection of data and technology standards.--
                The standards designated as described in subparagraph 
                (A) may include standards to improve--
                            ``(i) the exchange of electronic health 
                        information for--
                                    ``(I) electronic case reporting;
                                    ``(II) syndromic surveillance;
                                    ``(III) reporting of vital 
                                statistics; and
                                    ``(IV) reporting test orders and 
                                results electronically, including from 
                                laboratories;
                            ``(ii) automated electronic reporting to 
                        relevant public health data systems of the 
                        Centers for Disease Control and Prevention; and
                            ``(iii) such other use cases as the 
                        Secretary determines appropriate.
                    ``(C) No duplicative efforts.--
                            ``(i) In general.--In carrying out the 
                        requirements of this paragraph, the Secretary, 
                        in consultation with the Office of the National 
                        Coordinator for Health Information Technology, 
                        may use input gathered (including input and 
                        recommendations gathered from the Health 
                        Information Technology Advisory Committee), and 
                        materials developed, prior to the date of 
                        enactment of the PREVENT Pandemics Act.
                            ``(ii) Previously adopted standards.--The 
                        data and technology standards designated 
                        pursuant to this paragraph may include the 
                        adoption of standards previously adopted by the 
                        Secretary pursuant to section 3004.
                    ``(D) Privacy and security.--Nothing in this 
                paragraph shall be construed as modifying applicable 
                Federal or State information privacy or security 
                law.''.
    (b) Study on Laboratory Information Standards.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Office of the National Coordinator 
        for Health Information Technology shall conduct a study to 
        review the use of standards for electronic ordering and 
        reporting of laboratory test results.
            (2) Areas of concentration.--In conducting the study under 
        paragraph (1), the Office of the National Coordinator for 
        Health Information Technology shall--
                    (A) determine the extent to which clinical 
                laboratories are using standards for electronic 
                ordering and reporting of laboratory test results;
                    (B) assess trends in laboratory compliance with 
                standards for ordering and reporting laboratory test 
                results and the effect of such trends on the 
                interoperability of laboratory data with public health 
                data systems;
                    (C) identify challenges related to collection and 
                reporting of demographic and other data elements with 
                respect to laboratory test results;
                    (D) identify any challenges associated with using 
                or complying with standards and reporting laboratory 
                test results with data elements identified in standards 
                for electronic ordering and reporting of such results; 
                and
                    (E) review other relevant areas determined 
                appropriate by the Office of the National Coordinator 
                for Health Information Technology.
            (3) Report.--Not later than 2 years after the date of 
        enactment of this Act, the Office of the National Coordinator 
        for Health Information Technology 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 concerning the findings of the study 
        conducted under paragraph (1).
    (c) Supporting Information Sharing Through Data Use Agreements.--
            (1) Interagency data use agreements within the department 
        of health and human services for public health emergencies.--
                    (A) In general.--The Secretary of Health and Human 
                Services (referred to in this subsection as the 
                ``Secretary'') shall, as appropriate, facilitate the 
                development of, or updates to, memoranda of 
                understanding, data use agreements, or other applicable 
                interagency agreements regarding appropriate access, 
                exchange, and use of public health data between the 
                Centers for Disease Control and Prevention, the Office 
                of the Assistant Secretary for Preparedness and 
                Response, other relevant agencies or offices within the 
                Department of Health and Human Services, and other 
                relevant Federal agencies, in order to prepare for, 
                identify, monitor, and respond to declared or potential 
                public health emergencies.
                    (B) Requirements.--In carrying out activities 
                pursuant to subparagraph (A), the Secretary shall--
                            (i) ensure that the agreements and 
                        memoranda of understanding described in such 
                        subparagraph--
                                    (I) address the methods of granting 
                                access to data held by one agency or 
                                office with another to support the 
                                respective missions of such agencies or 
                                offices;
                                    (II) consider minimum necessary 
                                principles of data sharing for 
                                appropriate use;
                                    (III) include appropriate privacy 
                                and cybersecurity protections; and
                                    (IV) are subject to regular 
                                updates, as appropriate;
                            (ii) collaborate with the Centers for 
                        Disease Control and Prevention, the Office of 
                        the Assistant Secretary for Preparedness and 
                        Response, the Office of the Chief Information 
                        Officer, and, as appropriate, the Office of the 
                        National Coordinator for Health Information 
                        Technology, and other entities within the 
                        Department of Health and Human Services; and
                            (iii) consider the terms and conditions of 
                        any existing data use agreements with other 
                        public or private entities and any need for 
                        updates to such existing agreements, consistent 
                        with paragraph (2).
            (2) Data use agreements with external entities.--The 
        Secretary, acting through the Director of the Centers for 
        Disease Control and Prevention and the Assistant Secretary for 
        Preparedness and Response, may update memoranda of 
        understanding, data use agreements, or other applicable 
        agreements and contracts to improve appropriate access, 
        exchange, and use of public health data between the Centers for 
        Disease Control and Prevention and the Office of the Assistant 
        Secretary for Preparedness and Response and external entities, 
        including State, Tribal, and territorial health departments, 
        laboratories, hospitals and other health care providers, 
        electronic health records vendors, and other entities, as 
        applicable and appropriate, in order to prepare for, identify, 
        monitor, and respond to declared or potential public health 
        emergencies.
            (3) Report.--Not later than 90 days after the date of 
        enactment of this Act, 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 the status of the agreements under this 
        subsection.
    (d) Improving Information Sharing and Availability of Public Health 
Data.--Part A of title III of the Public Health Service Act (42 U.S.C. 
241 et seq.) is amended by adding at the end the following:

``SEC. 310B. IMPROVING INFORMATION SHARING AND AVAILABILITY OF PUBLIC 
              HEALTH DATA.

    ``(a) In General.--The Secretary may, in consultation with State, 
local, and Tribal public health officials, carry out activities to 
improve the availability of appropriate and applicable public health 
data related to communicable diseases, and information sharing between, 
the Director of the Centers for Disease Control and Prevention, the 
Assistant Secretary for Preparedness and Response, and such State, 
local, and Tribal public health officials, which may include such data 
from--
            ``(1) health care providers and facilities;
            ``(2) public health and clinical laboratories; and
            ``(3) State, local, and Tribal health departments.
    ``(b) Content, Form, and Manner.--The Secretary shall, consistent 
with the requirements of this section, work with such officials and 
relevant stakeholders to provide information on the content, form, and 
manner in which such data may most effectively support the ability of 
State, local, and Tribal health departments to respond to such 
communicable diseases, including related to the collection and 
reporting of demographic and other relevant data elements.
    ``(c) Decreased Burden.--In facilitating the coordination of 
efforts under subsection (a), the Secretary shall make reasonable 
efforts to limit reported public health data to the minimum necessary 
information needed to accomplish the intended public health 
surveillance purpose.
    ``(d) Exemption of Certain Public Health Data From Disclosure.--The 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention, may exempt from disclosure under section 
552(b)(3) of title 5, United States Code, public health data that are 
gathered under this section if--
            ``(1) an individual is identified through such data; or
            ``(2) there is at least a very small risk, as determined by 
        current scientific practices or statistical methods, that some 
        combination of the information, the request, and other 
        available data sources or the application of technology could 
        be used to deduce the identity of an individual.''.
    (e) Improving Public Health Data Collection.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this subsection as the ``Secretary'') shall 
        award grants, contracts, or cooperative agreements to eligible 
        entities for purposes of identifying, developing, or 
        disseminating best practices in the collection of electronic 
        health information and the use of designated data standards and 
        implementation specifications to improve the quality and 
        completeness of data, including demographic data, collected, 
        accessed, or used for public health purposes and to address 
        health disparities and related health outcomes.
            (2) Eligible entities.--To be eligible to receive an award 
        under this subsection an entity shall--
                    (A) be a health care provider, academic medical 
                center, community-based organization, State, local 
                governmental entity, Indian Tribe or Tribal 
                organization (as such terms are defined in section 4 of 
                the Indian Self Determination and Education Assistance 
                Act (25 U.S.C. 5304)), urban Indian organization (as 
                defined in section 4 of the Indian Health Care 
                Improvement Act (25 U.S.C. 1603)), or other appropriate 
                public or private nonprofit entity, or a consortia of 
                any such entities; and
                    (B) submit an application to the Secretary at such 
                time, in such manner, and containing such information 
                as the Secretary may require.
            (3) Activities.--Entities receiving awards under this 
        subsection shall use such award to develop and test best 
        practices for training health care providers to use standards 
        and implementation specifications that assist in the capture, 
        access, exchange, and use of electronic health information, 
        including demographic information, disability status, veteran 
        status, housing status, functional status, and other data 
        elements. Such activities shall include, at a minimum--
                    (A) improving, understanding, and using data 
                standards and implementation specifications;
                    (B) developing or identifying methods to improve 
                communication with patients in a culturally- and 
                linguistically-appropriate manner, including to better 
                capture information related to demographics of such 
                individuals;
                    (C) developing methods for accurately categorizing 
                and recording patient responses using available data 
                standards;
                    (D) educating providers regarding the utility of 
                such information for public health purposes and the 
                importance of accurate collection and recording of such 
                data; and
                    (E) other activities, as the Secretary determines 
                appropriate.
            (4) Reporting.--
                    (A) Reporting by award recipients.--Each recipient 
                of an award under this subsection shall submit to the 
                Secretary a report on the results of best practices 
                identified, developed, or disseminated through such 
                award.
                    (B) Report to congress.--Not later than 1 year 
                after the completion of the program under this 
                subsection, the Secretary shall submit a report to 
                Congress on the success of best practices developed 
                under such program, opportunities for further 
                dissemination of such best practices, and 
                recommendations for improving the capture, access, 
                exchange, and use of information to improve public 
                health and reduce health disparities.
            (5) Non-duplication of efforts.--The Secretary shall ensure 
        that the activities and programs carried out under this 
        subsection are free of unnecessary duplication of effort.
            (6) Authorization of appropriations.--There are authorized 
        to be appropriated $10,000,000 for each of fiscal years 2023 
        through 2025 to carry out this subsection.

SEC. 214. EPIDEMIC FORECASTING AND OUTBREAK ANALYTICS.

    Title XXVIII of the Public Health Service Act (42 U.S.C. 300hh et 
seq.), as amended by section 212, is further amended by adding at the 
end the following:

``SEC. 2825. EPIDEMIC FORECASTING AND OUTBREAK ANALYTICS.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall continue 
activities related to the development of infectious disease outbreak 
analysis capabilities to enhance the prediction, modeling, and 
forecasting of potential public health emergencies and other infectious 
disease outbreaks, which may include activities to support preparedness 
for, and response to, such emergencies and outbreaks. In carrying out 
this subsection, the Secretary shall identify strategies to include and 
leverage, as appropriate, the capabilities to public and private 
entities, which may include conducting such activities through 
collaborative partnerships with public and private entities, including 
academic institutions, and other Federal agencies, consistent with 
section 319D, as applicable.
    ``(b) Considerations.--In carrying out subsection (a), the 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention, may consider public health data and, as 
appropriate, other data sources related to the transmission of such 
infectious diseases that affect preparedness for, or response to, 
public health emergencies and infectious disease outbreaks.
    ``(c) Annual Reports.--Not later than 1 year after the date of 
enactment of this section, and annually thereafter for each of the 
subsequent 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 update on progress on activities 
conducted under this section to develop infectious disease outbreak 
analysis capabilities and any additional information relevant to such 
efforts.''.

SEC. 215. REPORT ON CDC DATA PORTAL.

    (a) In General.--Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Director of the Centers for Disease Control and Prevention, shall 
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 public health data modernization 
initiatives, surveillance investments, and public health data reporting 
modernization initiatives under this Act (including the amendments made 
by this Act) and the Public Health Service Act (42 U.S.C. 201 et seq.), 
and provide recommendations on the feasibility of the use of a web-
based information technology platform (referred to in this section as 
the ``platform'') for the streamlining of existing voluntary 
submissions of public health data for all State, local, Tribal, and 
territorial entities that report such data to the Centers for Disease 
Control and Prevention, and whether such platform would reduce the 
reporting burden for such entities.
    (b) Requirements.--The report under subsection (a) shall address 
the extent to which the submission of such data to the platform may--
            (1) support coordination within the Department of Health 
        and Human Services;
            (2) provide appropriate information among and between 
        State, Tribal, local, and territorial public health officials;
            (3) leverage private sector technologies; and
            (4) provide for the streamlining of data reporting to the 
        greatest extent possible.

SEC. 216. PUBLIC HEALTH DATA TRANSPARENCY.

    (a) Report.--Not later than 1 year after the date of enactment of 
this Act, the Secretary of Health and Human Services shall issue a 
report assessing practices, objectives, and associated progress and 
challenges in achieving such objectives, of the Centers of Disease 
Control and Prevention with respect to the collection and dissemination 
of public health data related to a public health emergency declared 
under section 319 of the Public Health Service Act (42 U.S.C. 247d) or 
a potential public health emergency.
    (b) Plan.--Not later than 180 days following the issuance of the 
report pursuant to paragraph (1), the Director of the Centers for 
Disease Control and Prevention 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 plan that shall 
include--
            (1) steps to improve the timely reporting and dissemination 
        of public health data related to a public health emergency 
        declared under section 319 of the Public Health Service Act (42 
        U.S.C. 247d) or a potential public health emergency that is 
        collected by the Centers for Disease Control and Prevention, 
        including any associated barriers;
            (2) recommendations to Congress regarding gaps in such 
        practices and objectives described in subsection (a); and
            (3) considerations regarding the requirements and 
        limitations of data use agreements for such purposes, as 
        applicable.

          Subtitle C--Revitalizing the Public Health Workforce

SEC. 221. IMPROVING RECRUITMENT AND RETENTION OF THE FRONTLINE PUBLIC 
              HEALTH WORKFORCE.

    (a) In General.--Section 776 of the Public Health Service Act (42 
U.S.C. 295f-1) is amended--
            (1) in subsection (a)--
                    (A) by striking ``supply of'' and inserting 
                ``supply of, and encourage recruitment and retention 
                of,''; and
                    (B) by striking ``Federal,'';
            (2) in subsection (b)--
                    (A) by amending paragraph (1)(A) to read as 
                follows:
            ``(1)(A)(i) be accepted for enrollment, or be enrolled, as 
        a student in an accredited institution of higher education or 
        school of public health in the final semester (or equivalent) 
        of a program leading to a certificate or degree, including a 
        master's or doctoral degree, in public health, epidemiology, 
        laboratory sciences, data systems, data science, data 
        analytics, informatics, statistics, or another subject matter 
        related to public health; and
            ``(ii) be employed by, or have accepted employment with, a 
        State, local, or Tribal public health agency, or a related 
        training fellowship at such State, local, or Tribal public 
        health agency, as recognized by the Secretary, to commence upon 
        graduation; or''; and
                    (B) in paragraph (1)(B)--
                            (i) in clause (i)--
                                    (I) by striking ``accredited 
                                educational institution in a State or 
                                territory'' and inserting ``accredited 
                                institution of higher education or 
                                school of public health''; and
                                    (II) by striking ``a public health 
                                or health professions degree or 
                                certificate'' and inserting ``a 
                                certificate or degree, including a 
                                master's or doctoral degree, in public 
                                health, epidemiology, laboratory 
                                sciences, data systems, data science, 
                                data analytics, informatics, 
                                statistics, or another subject matter 
                                related to public health''; and
                            (ii) in clause (ii)--
                                    (I) by striking ``Federal,''; and
                                    (II) by striking ``fellowship,'' 
                                and inserting ``fellowship at such 
                                State, local, or Tribal public health 
                                agency,'';
            (3) in subsection (c)(2)--
                    (A) by striking ``Federal,''; and
                    (B) by striking ``equal to the greater of--'' and 
                all that follows through the end of subparagraph (B) 
                and inserting ``of at least 3 consecutive years;'';
            (4) in subsection (d)--
                    (A) by amending paragraph (1) to read as follows:
            ``(1) In general.--A loan repayment provided for an 
        individual under a written contract under the Program shall 
        consist of payment, in accordance with paragraph (2), for the 
        individual toward the outstanding principal and interest on 
        education loans incurred by the individual in the pursuit of 
        the relevant degree or certificate described in subsection 
        (b)(1) in accordance with the terms of the contract.''; and
                    (B) in paragraph (2)--
                            (i) by striking ``For each year'' and 
                        inserting the following:
                    ``(A) In general.--For each year'';
                            (ii) by striking ``$35,000'' and inserting 
                        ``$50,000'';
                            (iii) by striking ``$105,000'' and 
                        inserting ``$150,000''; and
                            (iv) by adding at the end the following:
                    ``(B) Considerations.--The Secretary may take 
                action in making awards under this section to ensure 
                that--
                            ``(i) an appropriate proportion of 
                        contracts are awarded to individuals who are 
                        eligible to participate in the program pursuant 
                        to subsection (b)(1)(A); and
                            ``(ii) contracts awarded under this section 
                        are equitably distributed among--
                                    ``(I) the geographical regions of 
                                the United States;
                                    ``(II) local, State, and Tribal 
                                public health departments; and
                                    ``(III) such public health 
                                departments under subclause (II) 
                                serving rural and urban areas.'';
            (5) in subsection (e), by striking ``receiving a degree or 
        certificate from a health professions or other related school'' 
        and inserting ``with a contract to serve under subsection 
        (c)'';
            (6) in subsection (f), by adding at the end the following: 
        ``In the event that a participant fails to either begin or 
        complete the obligated service requirement of the loan 
        repayment contract under this section, the Secretary may waive 
        or suspend either the unfulfilled service or the assessed 
        damages as provided for under section 338E(d), as 
        appropriate.'';
            (7) by redesignating subsection (g) as subsection (h);
            (8) by inserting after subsection (f) the following:
    ``(g) Eligible Loans.--The loans eligible for repayment under this 
section are each of the following:
            ``(1) Any loan for education or training for employment by 
        a health department.
            ``(2) Any loan under part E of title VIII (relating to 
        nursing student loans).
            ``(3) Any Federal Direct Stafford Loan, Federal Direct PLUS 
        Loan, Federal Direct Unsubsidized Stafford Loan, or Federal 
        Direct Consolidation Loan (as such terms are used in section 
        455 of the Higher Education Act of 1965).
            ``(4) Any Federal Perkins Loan under part E of title I of 
        the Higher Education Act of 1965.
            ``(5) Any other Federal loan, as the Secretary determines 
        appropriate.'';
            (9) in subsection (h), as so redesignated, by striking 
        ``$195,000,000 for fiscal year 2010, and such sums as may be 
        necessary for each of fiscal years 2011 through 2015'' and 
        inserting ``such sums as may be necessary for each of fiscal 
        years 2022 through 2025''; and
            (10) by striking ``tribal'' each place such term appears 
        and inserting ``Tribal''.
    (b) GAO Study on Public Health Workforce .--Not later than 2 years 
after the date of enactment of this Act, the Comptroller General of the 
United States shall--
            (1) conduct an evaluation of what is known about the public 
        health workforce in the United States, which shall address--
                    (A) existing gaps in the Federal, State, local, 
                Tribal, and territorial public health workforce, 
                including positions that may be required to prepare 
                for, and respond to, a public health emergency such as 
                COVID-19;
                    (B) challenges associated with the hiring, 
                recruitment, and retention of the Federal, State, 
                local, Tribal, and territorial public health workforce; 
                and
                    (C) Federal efforts to improve hiring, recruitment, 
                and retention of the public health workforce; and
            (2) 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 such 
        review.

SEC. 222. AWARDS TO SUPPORT COMMUNITY HEALTH WORKERS AND COMMUNITY 
              HEALTH.

    (a) In General.--Section 399V of the Public Health Service Act (42 
U.S.C. 280g-11) is amended--
            (1) by amending the section heading to read as follows: 
        ``awards to support community health workers and community 
        health'';
            (2) by amending subsection (a) to read as follows:
    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in coordination with 
the Administrator of the Health Resources and Services Administration, 
shall award grants, contracts, or cooperative agreements to eligible 
entities to promote positive health behaviors and outcomes for 
populations in medically underserved communities by leveraging 
community health workers, including by addressing ongoing and longer-
term community health needs, and by building the capacity of the 
community health worker workforce. Such grants, contracts, and 
cooperative agreements shall be awarded in alignment and coordination 
with existing funding arrangements supporting community health 
workers.'';
            (3) in subsection (b)--
                    (A) in the matter preceding paragraph (1)--
                            (i) by striking ``Grants awarded'' and 
                        inserting ``Subject to any requirements for the 
                        scope of licensure, registration, or 
                        certification of a community health worker 
                        under applicable State law, grants, contracts, 
                        and cooperative agreements awarded''; and
                            (ii) by striking ``support community health 
                        workers'';
                    (B) by redesignating paragraphs (3) through (5) as 
                paragraphs (4) through (6), respectively;
                    (C) by striking paragraphs (1) and (2) and 
                inserting the following:
            ``(1) recruit, hire, train, and retain community health 
        workers that reflect the needs of the community;
            ``(2) support community health workers in providing 
        education and outreach, in a community setting, regarding--
                    ``(A) health conditions prevalent in--
                            ``(i) medically underserved communities (as 
                        defined in section 799B), particularly racial 
                        and ethnic minority populations; and
                            ``(ii) other such at-risk populations or 
                        geographic areas that may require additional 
                        support during public health emergencies, which 
                        may include counties identified by the 
                        Secretary using applicable measures developed 
                        by the Centers for Disease Control and 
                        Prevention or other Federal agencies; and
                    ``(B) addressing social determinants of health and 
                eliminating health disparities, including by--
                            ``(i) promoting awareness of services and 
                        resources to increase access to health care, 
                        mental health and substance use disorder 
                        services, child services, technology, housing 
                        services, educational services, nutrition 
                        services, employment services, and other 
                        services; and
                            ``(ii) assisting in conducting individual 
                        and community needs assessments;
            ``(3) educate community members, including regarding 
        effective strategies to promote healthy behaviors;'';
                    (D) in paragraph (4), as so redesignated, by 
                striking ``to educate'' and inserting ``educate'';
                    (E) in paragraph (5), as so redesignated--
                            (i) by striking ``to identify'' and 
                        inserting ``identify'';
                            (ii) by striking ``healthcare agencies'' 
                        and inserting ``health care agencies''; and
                            (iii) by striking ``healthcare services and 
                        to eliminate duplicative care; or'' and 
                        inserting ``health care services and to 
                        streamline care, including serving as a liaison 
                        between communities and health care agencies; 
                        and''; and
                    (F) in paragraph (6), as so redesignated--
                            (i) by striking ``to educate, guide, and 
                        provide'' and inserting ``support community 
                        health workers in educating, guiding, or 
                        providing''; and
                            (ii) by striking ``maternal health and 
                        prenatal care'' and inserting ``chronic 
                        diseases, maternal health, prenatal, and 
                        postpartum care in order to improve maternal 
                        and infant health outcomes'';
            (4) in subsection (c), by striking ``Each eligible entity'' 
        and all that follows through ``accompanied by'' and inserting 
        ``To be eligible to receive an award under subsection (a), an 
        entity shall prepare and submit to the Secretary an application 
        at such time, in such manner, and containing'';
            (5) in subsection (d)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``awarding grants'' and inserting ``making 
                awards'';
                    (B) by amending paragraph (1) to read as follows:
            ``(1) propose to serve--
                    ``(A) areas with populations that have a high rate 
                of chronic disease, infant mortality, or maternal 
                morbidity and mortality;
                    ``(B) low-income populations, including medically 
                underserved populations (as defined in section 
                330(b)(3));
                    ``(C) populations residing in health professional 
                shortage areas (as defined in section 332(a));
                    ``(D) populations residing in maternity care health 
                professional target areas identified under section 
                332(k); or
                    ``(E) rural or traditionally underserved 
                populations, including racial and ethnic minority 
                populations or low-income populations;'';
                    (C) in paragraph (2), by striking ``; and'' and 
                inserting ``, including rural populations and racial 
                and ethnic minority populations;'';
                    (D) in paragraph (3), by striking ``with community 
                health workers.'' and inserting ``and established 
                relationships with community health workers in the 
                communities expected to be served by the program;'' and
                    (E) by adding at the end the following:
            ``(4) develop a plan for providing services to the extent 
        practicable, in the language and cultural context most 
        appropriate to individuals expected to be served by the 
        program; and
            ``(5) propose to use evidence-informed or evidence-based 
        practices, as applicable and appropriate.'';
            (6) in subsection (e)--
                    (A) by striking ``community health worker 
                programs'' and inserting ``eligible entities''; and
                    (B) by striking ``and one-stop delivery systems 
                under section 121(e)'' and inserting ``, health 
                professions schools, minority-serving institutions 
                (defined, for purposes of this subsection, as 
                institutions and programs described in section 
                326(e)(1) of the Higher Education Act of 1965 and 
                institutions described in section 371(a) of such Act), 
                area health education centers under section 751 of this 
                Act, and one-stop delivery systems under section 121'';
            (7) by striking subsections (f), (g), (h), (i), and (j) and 
        inserting the following:
    ``(f) Technical Assistance.--The Secretary may provide to eligible 
entities that receive awards under subsection (a) technical assistance 
with respect to planning, development, and operation of community 
health worker programs authorized or supported under this section.
    ``(g) Dissemination of Best Practices.--Not later than 4 years 
after the date of enactment of the PREVENT Pandemics Act, the Secretary 
shall, based on activities carried out under this section and in 
consultation with relevant stakeholders, identify and disseminate 
evidence-based or evidence-informed practices regarding recruitment and 
retention of community health workers and paraprofessionals to address 
ongoing public health and community health needs, and to prepare for, 
and respond to, future public health emergencies.
    ``(h) Report to Congress.--Not later than 4 years after the date of 
enactment of the PREVENT Pandemics Act, 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 concerning the effectiveness of the program 
under this section in addressing ongoing public health and community 
health needs. Such report shall include recommendations regarding any 
improvements to such program, including recommendations for how to 
improve recruitment, training, and retention of the community health 
workforce.
    ``(i) Authorization of Appropriations.--For purposes of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of fiscal years 2023 through 2027.'';
            (8) by redesignating subsection (k) as subsection (j); and
            (9) in subsection (j), as so redesignated--
                    (A) by striking paragraphs (1), (2), and (4);
                    (B) by redesignating paragraph (3) as paragraph 
                (1);
                    (C) in paragraph (1), as so redesignated--
                            (i) by striking ``entity (including a State 
                        or public subdivision of a State'' and 
                        inserting ``entity, including a State or 
                        political subdivision of a State, an Indian 
                        Tribe or Tribal organization, an urban Indian 
                        organization, a community-based organization''; 
                        and
                            (ii) by striking ``as defined in section 
                        1861(aa) of the Social Security Act))'' and 
                        inserting ``(as defined in section 1861(aa)(4) 
                        of the Social Security Act)''; and
                    (D) by adding at the end the following:
            ``(2) Indian tribe; tribal organization.--The terms `Indian 
        Tribe' and `Tribal organization' have the meanings given the 
        terms `Indian tribe' and `tribal organization', respectively, 
        in section 4 of the Indian Self-Determination and Education 
        Assistance Act.
            ``(3) Urban indian organization.--The term `urban Indian 
        organization' has the meaning given such term in section 4 of 
        the Indian Health Care Improvement Act.''.
    (b) GAO Study and Report.--Not later than 1 year after the date of 
submission of the report under subsection (h) of section 399V of the 
Public Health Service Act (42 U.S.C. 280g-11), as amended by subsection 
(a), the Comptroller General of the United States shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the program authorized under such section 399V, including a 
review of the efforts of the Secretary of Health and Human Services to 
coordinate such program with applicable programs of the Health 
Resources and Services Administration to ensure there is no unnecessary 
duplication of efforts among such programs, and identification of any 
areas of duplication.

SEC. 223. IMPROVING PUBLIC HEALTH EMERGENCY RESPONSE CAPACITY.

    (a) Certain Appointments to Support Public Health Emergency 
Responses.--Section 319 of the Public Health Service Act (42 U.S.C. 
247d) is amended by adding at the end the following:
    ``(g) Certain Appointments To Support Public Health Emergency 
Responses.--
            ``(1) In general.--In order to support the initial response 
        to a public health emergency declared by the Secretary under 
        this section, the Secretary may, subject to paragraph (2) and 
        without regard to sections 3309 through 3318 of title 5, United 
        States Code, appoint individuals directly to positions in the 
        Department of Health and Human Services for which the Secretary 
        has provided public notice in order to--
                    ``(A) address a critical hiring need directly 
                related to responding to a public health emergency 
                declared by the Secretary under this section; or
                    ``(B) address a severe shortage of candidates that 
                impacts the operational capacity of the Department of 
                Health and Human Services to respond in the event of a 
                public health emergency declared by the Secretary under 
                this section.
            ``(2) Number of appointments.--Each fiscal year in which 
        the Secretary makes a determination of a public health 
        emergency under subsection (a) (not including a renewal), the 
        Secretary may directly appoint not more than--
                    ``(A) 400 individuals under paragraph (1)(A); and
                    ``(B) 100 individuals under paragraph (1)(B).
            ``(3) Compensation.--The annual rate of basic pay of an 
        individual appointed under this subsection shall be determined 
        in accordance with chapter 51 and subchapter III of chapter 53 
        of title 5, United States Code.
            ``(4) Reporting.--The Secretary shall establish and 
        maintain records regarding the use of the authority under this 
        subsection, including--
                    ``(A) the number of positions filled through such 
                authority;
                    ``(B) the types of appointments of such positions;
                    ``(C) the titles, occupational series, and grades 
                of such positions;
                    ``(D) the number of positions publicly noticed to 
                be filled under such authority;
                    ``(E) the number of qualified applicants who apply 
                for such positions;
                    ``(F) the qualification criteria for such 
                positions; and
                    ``(G) the demographic information of individuals 
                appointed to such positions.
            ``(5) Notification to congress.--In the event the 
        Secretary, within a single fiscal year, directly appoints more 
        than 50 percent of the individuals allowable under either 
        subparagraph (A) or (B) of paragraph (2), the Secretary shall, 
        not later than 15 days after the date of such action, notify 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives. Such notification shall, in a manner that 
        protects personal privacy, to the extent required by applicable 
        Federal and State privacy law, at a minimum, include--
                    ``(A) information on each such appointment within 
                such fiscal year;
                    ``(B) a description of how each such position 
                relates to the requirements of subparagraph (A) or (B) 
                of paragraph (1); and
                    ``(C) the additional number of personnel, if any, 
                the Secretary anticipates to be necessary to adequately 
                support a response to a public health emergency 
                declared under this section using the authorities 
                described in paragraph (1) within such fiscal year.
            ``(6) Reports to congress.--Not later than September 30, 
        2023, and annually thereafter for each fiscal year in which the 
        authority under this subsection is used, 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 total 
        number of appointments filled under this subsection within the 
        fiscal year and a description of how the positions relate to 
        the requirements of subparagraph (A) or (B) of paragraph (1).
            ``(7) Sunset.--The authority under this subsection shall 
        expire on September 30, 2028.''.
    (b) GAO Report.--Not later than 1 year after the issuance of the 
initial report under subsection (g)(6) of section 319 of the Public 
Health Service Act (42 U.S.C. 247d), as added by subsection (a), and 
again 180 days after the date on which the authority provided under 
section 319(g) of such Act expires pursuant to paragraph (7) of such 
section, the Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report on the use of the authority provided under 
such section. Such report shall, in a manner that protects personal 
privacy, at a minimum, include information on--
            (1) the number of positions publicly noticed and filled 
        under the authority of each of subparagraphs (A) and (B) of 
        such section 319(g)(1);
            (2) the occupational series, grades, and types of 
        appointments of such positions;
            (3) how such positions related to addressing a need or 
        shortage described in subparagraph (A) or (B) of such section;
            (4) how the Secretary of Health and Human Services made 
        appointment decisions under each of subparagraphs (A) and (B) 
        of such section;
            (5) sources used to identify candidates for filling such 
        positions;
            (6) the number of individuals appointed under each such 
        subparagraph;
            (7) aggregated demographic information related to 
        individuals appointed under each such subparagraph; and
            (8) any challenges, limitations, or gaps related to the use 
        of the authority under each such subparagraph and any related 
        recommendations to address such challenges, limitations, or 
        gaps.

SEC. 224. EXTENSION OF AUTHORITIES TO SUPPORT HEALTH PROFESSIONAL 
              VOLUNTEERS AT COMMUNITY HEALTH CENTERS.

    Section 224(q) of the Public Health Service Act (42 U.S.C. 233(q)) 
is amended by striking paragraph (6).

SEC. 225. INCREASING EDUCATIONAL OPPORTUNITIES FOR ALLIED HEALTH 
              PROFESSIONS.

    Section 755(b) of the Public Health Service Act (42 U.S.C. 294e(b)) 
is amended by adding at the end the following:
            ``(4) Increasing educational opportunities in physical 
        therapy, occupational therapy, respiratory therapy, audiology, 
        and speech-language pathology professions, which may include 
        offering scholarships or stipends and carrying out other 
        activities to improve retention, for individuals from 
        disadvantaged backgrounds or individuals who are 
        underrepresented in such professions.''.

SEC. 226. PUBLIC HEALTH SERVICE CORPS ANNUAL AND SICK LEAVE.

    (a) In General.--Section 219 of the Public Health Service Act (42 
U.S.C. 210-1) is amended--
            (1) in subsection (a)--
                    (A) by striking ``Reserve Corps'' and inserting 
                ``Ready Reserve Corps''; and
                    (B) by striking ``: Provided, That such regulations 
                shall not authorize annual leave to be accumulated in 
                excess of sixty days'';
            (2) by inserting after subsection (a) the following:
    ``(b) The regulations described in subsection (a) may authorize 
accumulated annual leave of not more than 120 days for any commissioned 
officer of the Regular Corps or officer of the Ready Reserve Corps on 
active duty.''; and
            (3) by redesignating subsection (d) as subsection (c).
    (b) Application.--The amendments made by subsection (a) shall apply 
with respect to accumulated annual leave (as defined in section 219 of 
the Public Health Service Act (42 U.S.C. 210-1)) that a commissioned 
officer of the Regular Corps or officer of the Ready Reserve Corps on 
active duty would, but for the regulations described in such section, 
lose at the end of fiscal year 2022 or a subsequent fiscal year.

             Subtitle D--Improving Public Health Responses

SEC. 231. CENTERS FOR PUBLIC HEALTH PREPAREDNESS AND RESPONSE.

    (a) In General.--Section 319F of the Public Health Service Act (42 
U.S.C. 247d-6) is amended--
            (1) by striking subsection (d) and inserting the following:
    ``(d) Centers for Public Health Preparedness and Response.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, may 
        award grants, contracts, or cooperative agreements to 
        institutions of higher education, including accredited schools 
        of public health, or other nonprofit private entities to 
        establish or maintain a network of Centers for Public Health 
        Preparedness and Response (referred to in this subsection as 
        `Centers').
            ``(2) Eligibility.--To be eligible to receive an award 
        under this subsection, an entity shall submit to the Secretary 
        an application containing such information as the Secretary may 
        require, including a description of how the entity will--
                    ``(A) coordinate relevant activities with 
                applicable State, local, and Tribal health departments 
                and officials, health care facilities, and health care 
                coalitions to improve public health preparedness and 
                response, as informed by the public health preparedness 
                and response needs of the community, or communities, 
                involved;
                    ``(B) prioritize efforts to implement evidence-
                informed or evidence-based practices to improve public 
                health preparedness and response, including by helping 
                to reduce the transmission of emerging infectious 
                diseases; and
                    ``(C) use funds awarded under this subsection, 
                including by carrying out any activities described in 
                paragraph (3).
            ``(3) Use of funds.--The Centers established or maintained 
        under this subsection shall use funds awarded under this 
        subsection to carry out activities to advance public health 
        preparedness and response capabilities, which may include--
                    ``(A) identifying, translating, and disseminating 
                promising research findings or strategies into 
                evidence-informed or evidence-based practices to inform 
                preparedness for, and responses to, chemical, 
                biological, radiological, or nuclear threats, including 
                emerging infectious diseases, and other public health 
                emergencies, which may include conducting research 
                related to public health preparedness and response 
                systems;
                    ``(B) improving awareness of such evidence-informed 
                or evidence-based practices and other relevant 
                scientific or public health information among health 
                care professionals, public health professionals, other 
                stakeholders, and the public, including through the 
                development, evaluation, and dissemination of trainings 
                and training materials, consistent with section 
                2802(b)(2), as applicable and appropriate, and with 
                consideration given to existing training materials, to 
                support preparedness for, and responses to, such 
                threats;
                    ``(C) utilizing and expanding relevant 
                technological and analytical capabilities to inform 
                public health and medical preparedness and response 
                efforts;
                    ``(D) expanding activities, including through 
                public-private partnerships, related to public health 
                preparedness and response, including participation in 
                drills and exercises and training public health 
                experts, as appropriate; and
                    ``(E) providing technical assistance and expertise 
                that relies on evidence-based practices, as applicable, 
                related to responses to public health emergencies, as 
                appropriate, to State, local, and Tribal health 
                departments and other entities pursuant to paragraph 
                (2)(A).
            ``(4) Distribution of awards.--In awarding grants, 
        contracts, or cooperative agreements under this subsection, the 
        Secretary shall support not fewer than 10 Centers, subject to 
        the availability of appropriations, and ensure that such awards 
        are equitably distributed among the geographical regions of the 
        United States.''; and
            (2) in subsection (f)(1)(C), by striking ``, of which 
        $5,000,000 shall be used to carry out paragraphs (3) through 
        (5) of such subsection''.
    (b) Repeal.--Section 319G of the Public Health Service Act (42 
U.S.C. 247d-7) is repealed.

SEC. 232. VACCINE DISTRIBUTION PLANS.

    Section 319A of the Public Health Service Act (42 U.S.C. 247d-1) is 
amended--
            (1) in subsection (a)--
                    (A) by inserting ``, or other federally purchased 
                vaccine to address another pandemic'' before the period 
                at the end of the first sentence; and
                    (B) by inserting ``or other pandemic'' before the 
                period at the end of the second sentence; and
            (2) in subsection (d), by inserting ``or other pandemics'' 
        after ``influenza pandemics''.

SEC. 233. COORDINATION AND COLLABORATION REGARDING BLOOD SUPPLY.

    (a) In General.--The Secretary of Health and Human Services, or the 
Secretary's designee, shall--
            (1) ensure coordination and collaboration between relevant 
        Federal departments and agencies related to the safety and 
        availability of the blood supply, including--
                    (A) the Department of Health and Human Services, 
                including the Office of the Assistant Secretary for 
                Health, the Centers for Disease Control and Prevention, 
                the Food and Drug Administration, the Office of the 
                Assistant Secretary for Preparedness and Response, the 
                National Institutes of Health, the Centers for Medicare 
                & Medicaid Services, and the Health Resources and 
                Services Administration;
                    (B) the Department of Defense; and
                    (C) the Department of Veterans Affairs; and
            (2) consult and communicate with private stakeholders, 
        including blood collection establishments, health care 
        providers, accreditation organizations, researchers, and 
        patients, regarding issues related to the safety and 
        availability of the blood supply.
    (b) Streamlining Blood Donor Input.--Chapter 35 of title 44, United 
States Code, shall not apply to the collection of information to which 
a response is voluntary and that is initiated by the Secretary of 
Health and Human Services to solicit information from blood donors or 
potential blood donors to support the development of recommendations by 
the Secretary concerning blood donation.

     TITLE III--ACCELERATING RESEARCH AND COUNTERMEASURE DISCOVERY

     Subtitle A--Fostering Research and Development and Improving 
                              Coordination

SEC. 301. RESEARCH AND ACTIVITIES RELATED TO 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) 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
            (2) in consultation with health professional associations, 
        researchers, and other relevant experts, develop and inform 
        recommendations, guidance, and provide educational materials 
        for health care providers and the general public on the long-
        term effects of SARS-CoV-2 infection, consistent with the 
        findings of studies and research under paragraph (1).
    (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) 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.

SEC. 302. RESEARCH CENTERS FOR PATHOGENS OF PANDEMIC CONCERN.

    Subpart 6 of part C of title IV of the Public Health Service Act is 
amended by inserting after section 447C (42 U.S.C. 285f-4) the 
following:

``SEC. 447D. RESEARCH CENTERS FOR PATHOGENS OF PANDEMIC CONCERN.

    ``(a) In General.--The Director of the Institute, in collaboration, 
as appropriate, with the directors of applicable institutes, centers, 
and divisions of the National Institutes of Health, the Assistant 
Secretary for Preparedness and Response, and the Director of the 
Biomedical Advanced Research and Development Authority, shall establish 
or continue a multidisciplinary research program to advance the 
discovery and preclinical development of medical products for priority 
virus families and other viral pathogens with a significant potential 
to cause a pandemic, through support for research centers.
    ``(b) Uses of Funds.--The Director of the Institute shall award 
funding through grants, contracts, or cooperative agreements to public 
or private entities to provide support for research centers described 
in subsection (a) for the purpose of--
            ``(1) conducting basic research through preclinical 
        development of new medical products or technologies, including 
        platform technologies, to address pathogens of pandemic 
        concern;
            ``(2) identifying potential targets for therapeutic 
        candidates, including antivirals, to treat such pathogens;
            ``(3) identifying existing medical products with the 
        potential to address such pathogens, including candidates that 
        could be used in outpatient settings; and
            ``(4) carrying out or supporting other research related to 
        medical products to address such pathogens, as determined 
        appropriate by the Director.
    ``(c) Coordination.--The Director of the Institute shall, as 
appropriate, provide for the coordination of activities among the 
centers described in subsection (a), including through--
            ``(1) facilitating the exchange of information and regular 
        communication among the centers, as appropriate; and
            ``(2) requiring the periodic preparation and submission to 
        the Director of reports on the activities of each center.
    ``(d) Priority.--In awarding funding through grants, contracts, or 
cooperative agreements under subsection (a), the Director of the 
Institute shall, as appropriate, give priority to applicants with 
existing frameworks and partnerships, as applicable, to support the 
advancement of such research.
    ``(e) Collaboration.--The Director of the Institute shall--
            ``(1) collaborate with the heads of other appropriate 
        Federal departments, agencies, and offices with respect to the 
        identification of additional priority virus families and other 
        viral pathogens with a significant potential to cause a 
        pandemic; and
            ``(2) collaborate with the Director of the Biomedical 
        Advanced Research and Development Authority with respect to the 
        research conducted by centers described in subsection (a), 
        including, as appropriate, providing any updates on the 
        research advancements made by such centers, identifying any 
        advanced research and development needs for such 
        countermeasures, consistent with section 319L(a)(6), and taking 
        into consideration existing manufacturing capacity and future 
        capacity needs for such medical products or technologies, 
        including platform technologies, supported by the centers 
        described in subsection (a).
    ``(f) Supplement, Not Supplant.--Any support received by a center 
described in subsection (a) under this section shall be used to 
supplement, and not supplant, other public or private support for 
activities authorized to be supported.''.

SEC. 303. IMPROVING MEDICAL COUNTERMEASURE RESEARCH COORDINATION.

    Section 402(b) in the Public Health Service Act (42 U.S.C. 282(b)) 
is amended--
            (1) in paragraph (24), by striking ``and'' at the end;
            (2) in paragraph (25), by striking the period and inserting 
        a semicolon; and
            (3) by inserting after paragraph (25) the following:
            ``(26) shall consult with the Assistant Secretary for 
        Preparedness and Response, the Director of the Biomedical 
        Advanced Research and Development Authority, the Director of 
        the Centers for Disease Control and Prevention, and the heads 
        of other Federal agencies and offices, as appropriate, 
        regarding research needs to advance medical countermeasures to 
        diagnose, mitigate, prevent, or treat harm from any biological 
        agent or toxin, including emerging infectious diseases, 
        chemical, radiological, or nuclear agent that may cause a 
        public health emergency or other research needs related to 
        emerging public health threats;''.

SEC. 304. ACCESSING SPECIMEN SAMPLES AND DIAGNOSTIC TESTS.

    (a) Improving Research and Development of Medical Countermeasures 
for Novel Pathogens.--
            (1) Sample access.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this subsection as the ``Secretary'') 
        shall make publicly available policies and procedures related 
        to public and private entities accessing specimens of, or 
        specimens containing, pathogens or suitable surrogates for, or 
        alternatives to, such pathogens as the Secretary determines 
        appropriate to support public health preparedness and response 
        activities or biomedical research for purposes of the 
        development and validation, as applicable, of medical products 
        to address emerging infectious diseases and for use to 
        otherwise respond to emerging infectious diseases. Such 
        policies and procedures shall take into account, as 
        appropriate, any applicable existing Federal resources.
            (2) Guidance.--The Secretary shall issue guidance regarding 
        the procedures for carrying out paragraph (1), including--
                    (A) the method for requesting such samples;
                    (B) considerations for sample availability and use 
                of suitable surrogates or alternatives to such 
                pathogens, as appropriate, including applicable 
                safeguard and security measures; and
                    (C) information required to be provided in order to 
                receive such samples or suitable surrogates or 
                alternatives.
    (b) Earlier Development of Diagnostic Tests.--Title III of the 
Public Health Service Act is amended by inserting after section 319A 
(42 U.S.C. 247d-1) the following:

``SEC. 319B. EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS.

    ``The Secretary may contract with public and private entities, as 
appropriate, to increase capacity in the rapid development, validation, 
manufacture, and dissemination 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 
emerging 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.''.

            Subtitle B--Improving Biosafety and Biosecurity

SEC. 311. IMPROVING CONTROL AND OVERSIGHT OF SELECT BIOLOGICAL AGENTS 
              AND TOXINS.

    Section 351A of the Public Health Service Act (42 U.S.C. 262a) is 
amended--
            (1) in subsection (b)(1), by amending subparagraph (A) to 
        read as follows:
                    ``(A) proper training, including with respect to 
                notification requirements under this section, of--
                            ``(i) individuals who are involved in the 
                        handling and use of such agents and toxins, 
                        including appropriate skills to handle such 
                        agents and toxins;
                            ``(ii) individuals whose responsibilities 
                        routinely place them in close proximity to 
                        laboratory facilities in which such agents and 
                        toxins are being transferred, possessed, or 
                        used; and
                            ``(iii) individuals who perform 
                        administrative or oversight functions of the 
                        facility related to the transfer, possession, 
                        or use of such agents and toxins on behalf of 
                        registered persons;'';
            (2) in subsection (e)(1), by striking ``(including the risk 
        of use in domestic or international terrorism)'' and inserting 
        ``(including risks posed by the release, theft, or loss of such 
        agent or toxin, or use in domestic or international 
        terrorism)'';
            (3) in subsection (k)--
                    (A) by redesignating paragraphs (1) and (2) as 
                paragraphs (2) and (3), respectively;
                    (B) by inserting before paragraph (2), as so 
                redesignated, the following:
            ``(1) Notification with respect to federal facilities.--In 
        the event of the release, loss, or theft of an agent or toxin 
        listed by the Secretary pursuant to subsection (a)(1), or by 
        the Secretary of Agriculture pursuant to section 212(a)(1) of 
        the Agricultural Bioterrorism Protection Act of 2002, from or 
        within a laboratory facility owned or operated by the 
        Department of Health and Human Services, or other Federal 
        laboratory facility subject to the requirements of this 
        section, the Secretary, in a manner that does not compromise 
        national security, shall--
                    ``(A) not later than 72 hours after such event is 
                reported to the Secretary, notify the Committee on 
                Health, Education, Labor, and Pensions of the Senate 
                and the Committee on Energy and Commerce of the House 
                of Representatives of such event, including--
                            ``(i) the Federal laboratory facility in 
                        which such release, loss, or theft occurred; 
                        and
                            ``(ii) the circumstances of such release, 
                        loss, or theft; and
                    ``(B) not later than 14 days after such 
                notification, update such Committees on--
                            ``(i) any actions taken or planned by the 
                        Secretary to mitigate any potential threat such 
                        release, loss, or theft may pose to public 
                        health and safety; and
                            ``(ii) any actions taken or planned by the 
                        Secretary to review the circumstances of such 
                        release, loss, or theft, and prevent similar 
                        events.''; and
                    (C) by amending paragraph (2), as so redesignated, 
                to read as follows:
            ``(2) Annual report.--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 on an annual basis a report--
                    ``(A) summarizing the number and nature of 
                notifications received under subsection (e)(8) 
                (relating to theft or loss) and subsection (j) 
                (relating to releases), during the preceding fiscal 
                year;
                    ``(B) describing actions taken by the Secretary to 
                address such incidents, such as any corrective action 
                plans required and steps taken to promote adherence to, 
                and compliance with, safety and security best 
                practices, standards, and regulations; and
                    ``(C) describing any gaps, challenges, or 
                limitations with respect to ensuring that such safety 
                and security practices are consistently applied and 
                adhered to, and actions taken to address such gaps, 
                challenges, or limitations.''; and
            (4) in subsection (m), by striking ``fiscal years 2002 
        through 2007'' and inserting ``fiscal years 2023 through 
        2027''.

SEC. 312. STRATEGY FOR FEDERAL HIGH-CONTAINMENT LABORATORIES.

    (a) Strategy for Federal High-Containment Laboratories.--Not later 
than 1 year after the date of enactment of this Act, the Director of 
the Office of Science and Technology Policy, in consultation with 
relevant Federal agencies and departments, shall establish a strategy 
for the management, maintenance, and oversight of federally-owned 
laboratory facilities capable of operating at Biosafety Level 3 or 4, 
including equivalent classification levels. Such strategy shall 
include--
            (1) a description of the roles and responsibilities of 
        relevant Federal departments and agencies with respect to the 
        management, maintenance, and oversight of Biosafety Level 3 or 
        4 laboratory facilities;
            (2) an assessment of the needs of the Federal Government 
        with respect to Biosafety Level 3 or 4 laboratory facilities;
            (3) a summary of existing federally-owned Biosafety Level 3 
        or 4 laboratory facility capacity;
            (4) a summary of other Biosafety Level 3 or 4 laboratory 
        facility capacity established through Federal funds;
            (5) a description of how the capacity described in 
        paragraphs (3) and (4) addresses the needs of the Federal 
        Government, including--
                    (A) how relevant Federal departments and agencies 
                coordinate to provide access to appropriate laboratory 
                facilities to reduce unnecessary duplication; and
                    (B) any gaps in such capacity related to such 
                needs;
            (6) a summary of plans that are in place for the 
        maintenance of such capacity, as applicable and appropriate, 
        including processes for determining whether to maintain or 
        expand such capacity, and a description of how the Federal 
        Government will address rapid changes in the need for such 
        capacity during a public health emergency; and
            (7) a description of how the heads of relevant Federal 
        departments and agencies will coordinate to ensure appropriate 
        oversight of federally-owned laboratory facility capacity and 
        leverage such capacity, as appropriate, to fulfill the needs of 
        multiple Federal departments and agencies in order to reduce 
        unnecessary duplication and improve collaboration within the 
        Federal Government.

SEC. 313. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.

    (a) In General.--Part A of title IV of the Public Health Service 
Act (42 U.S.C. 281 et seq.) is amended by adding at the end the 
following:

``SEC. 404O. NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY.

    ``(a) Establishment.--The Secretary, acting through the Director of 
NIH, shall establish an advisory committee, to be known as the 
`National Science Advisory Board for Biosecurity' (referred to in this 
section as the `Board').
    ``(b) Duties.--
            ``(1) In general.--The National Science Advisory Board for 
        Biosecurity referred to in section 205 of the Pandemic and All-
        Hazards Preparedness Act (Public Law 109-417) (referred to in 
        this section as the `Board') shall provide technical advice, 
        guidance, or recommendations, to relevant Federal departments 
        and agencies related to biosafety and biosecurity oversight of 
        biomedical research, including--
                    ``(A) oversight of federally-conducted or 
                federally-supported dual use biomedical research, such 
                as the review of policies or frameworks used to assess 
                and appropriately manage safety and security risks 
                associated with such research, taking into 
                consideration 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; and
                    ``(B) continuing to carry out the activities 
                required under section 205 of the Pandemic and All-
                Hazards Preparedness Act (Public Law 109-417).
    ``(c) Considerations.--In carrying out the duties under subsection 
(b), the Board may consider strategies to improve the safety and 
security of biomedical research, including through--
            ``(1) leveraging or using new technologies and scientific 
        advancements to reduce safety and security risks associated 
        with such research and improve containment of pathogens; and
            ``(2) outreach to, and education and training of, 
        researchers, laboratory personnel, and other appropriate 
        individuals with respect to safety and security risks 
        associated with such research and mitigation of such risks.
    ``(d) Membership.--The Board shall be composed of the following:
            ``(1) Non-voting, ex officio members, including the 
        following:
                    ``(A) At least one representative of each of the 
                following:
                            ``(i) The Department of Health and Human 
                        Services.
                            ``(ii) The Department of Defense.
                            ``(iii) The Department of Agriculture.
                            ``(iv) The Department of Homeland Security.
                            ``(v) The Department of Energy.
                            ``(vi) The Department of State.
                            ``(vii) The Office of Science and 
                        Technology Policy.
                            ``(viii) The Office of the Director of 
                        National Intelligence.
                    ``(B) Representatives of such other Federal 
                departments or agencies as the Secretary determines 
                appropriate to carry out the requirements of this 
                section.
            ``(2) Individuals, appointed by the Secretary, with 
        expertise in biology, infectious diseases, public health, 
        ethics, national security, and other fields, as the Secretary 
        determines appropriate, who shall serve as voting members.''.
    (b) Orderly Transition.--The Secretary of Health and Human Services 
shall take such steps as are necessary to provide for the orderly 
transition to the authority of the National Science Advisory Board for 
Biosecurity established under section 404O of the Public Health Service 
Act, as added by subsection (a), from any authority of the Board 
described in section 205 of the Pandemic and All-Hazards Preparedness 
Act (Public Law 109-417), as in effect on the day before the date of 
enactment of this Act.
    (c) Application.--The requirements under section 404O of the Public 
Health Service Act, as added by subsection (a), related to the mission, 
activities, or functions of the National Science Advisory Board for 
Biosecurity shall not apply until the completion of any work undertaken 
by such Board before the date of enactment of this Act.

SEC. 314. RESEARCH TO IMPROVE BIOSAFETY.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall, as 
appropriate, conduct or support research to improve the safe conduct of 
biomedical research activities involving pathogens of pandemic 
potential or biological agents or toxins listed pursuant to section 
351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).
    (b) Report.--Not later than 5 years after the date of enactment of 
this Act, 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 any research conducted or supported under this 
section, any relevant findings, and steps the Secretary is taking to 
disseminate any such findings to support the reduction of risks 
associated with biomedical research involving pathogens of pandemic 
potential or biological agents or toxins listed pursuant to section 
351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)).

SEC. 315. FEDERALLY-FUNDED RESEARCH WITH ENHANCED PATHOGENS OF PANDEMIC 
              POTENTIAL.

    (a) Review and Oversight of Enhanced Pathogens of Pandemic 
Potential.--
            (1) In general.--The Director of the Office of Science and 
        Technology Policy (referred to in this section as the 
        ``Director''), in consultation with the heads of relevant 
        Federal departments and agencies, shall--
                    (A) not later than 1 years after the date of 
                enactment of this Act--
                            (i) continue or conduct a review of 
                        existing Federal policies related to research 
                        proposed for Federal funding that may be 
                        reasonably anticipated to involve the creation, 
                        transfer, or use of pathogens of pandemic 
                        potential; and
                            (ii) establish or update a Federal policy 
                        for the consistent review and oversight of such 
                        proposed research that appropriately considers 
                        the risks associated with, and potential 
                        benefits of, such research; and
                    (B) not less than every 4 years thereafter, review 
                and update such policy, as necessary and appropriate, 
                to ensure that such policy fully accounts for relevant 
                research that may be reasonably anticipated to involve 
                the creation, transfer, or use of enhanced pathogens of 
                pandemic potential, takes into consideration the 
                benefits of such research, and supports the mitigation 
                of related risks.
            (2) Requirements.--The policy established pursuant to 
        paragraph (1) shall include--
                    (A) a clear scope to support the consistent 
                identification of research proposals subject to such 
                policy by relevant Federal departments and agencies;
                    (B) a framework for such reviews that accounts for 
                safety, security, and ethical considerations related to 
                the creation, transfer, or use of enhanced pathogens of 
                pandemic potential;
                    (C) measures to enhance the transparency and public 
                availability of information related to such research 
                activities in a manner that does not compromise 
                national security, the safety and security of such 
                research activities, or any identifiable, sensitive 
                information of relevant individuals; and
                    (D) consistent procedures across relevant Federal 
                department and agencies to ensure that--
                            (i) proposed research that has been 
                        determined to have scientific and technical 
                        merit and may be subject to such policy is 
                        identified and referred for review;
                            (ii) subjected research activities 
                        conducted under an award, including activities 
                        undertaken by any subrecipients of such award, 
                        are monitored regularly throughout the project 
                        period to ensure compliance with such policy 
                        and the terms and conditions of such award; and
                            (iii) in the event that federally-funded 
                        research activities not subject to such policy 
                        produce unanticipated results related to the 
                        creation, transfer, or use of enhanced 
                        pathogens of pandemic potential, such research 
                        activities are identified and appropriately 
                        reviewed under such policy.
            (3) Clarification.--Reviews required pursuant to this 
        section shall be in addition to any applicable requirements for 
        research project applications required under the Public Health 
        Service Act, including reviews required under section 492 of 
        such Act (42 U.S.C. 289a), as applicable, or other applicable 
        laws.
    (b) Implementation.--
            (1) In general.--The Director shall direct all heads of 
        relevant Federal departments and agencies to update, modernize, 
        or promulgate applicable implementing regulations and guidance 
        to implement the requirements of this section.
            (2) Updates.--Consistent with the requirements under 
        subsection (a)(1)(B), the Director shall require all heads of 
        relevant Federal departments and agencies to update such 
        policies consistent with any changes to the policy established 
        pursuant to subsection (a)(1).

 Subtitle C--Preventing Undue Foreign Influence in Biomedical Research

SEC. 321. FOREIGN TALENT PROGRAMS.

    The Secretary of Health and Human Services shall require disclosure 
of participation in foreign talent programs, including the provision of 
copies of all grants, contracts, or other agreements related to such 
programs, and other supporting documentation related to such programs, 
as a condition of receipt of Federal extramural biomedical research 
funding awarded through the Department of Health and Human Services.

SEC. 322. SECURING IDENTIFIABLE, SENSITIVE INFORMATION.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), in consultation 
with the Director of National Intelligence, the Secretary of State, the 
Secretary of Defense, and other national security experts, as 
appropriate, shall ensure that biomedical research supported or 
conducted by the National Institutes of Health and other relevant 
agencies and offices within the Department of Health and Human Services 
involving the sequencing of human genomic information, and collection, 
analysis, or storage of identifiable, sensitive information, as defined 
in section 301(d)(4) of the Public Health Service Act (42 U.S.C. 
241(d)(4)), is conducted in a manner that appropriately considers 
national security risks, including national security implications 
related to potential misuse of such data. Not later than 1 year after 
the date of enactment of this Act, the Secretary shall ensure that the 
National Institutes of Health and other relevant agencies and offices 
within the Department of Health and Human Services, working with the 
heads of agencies and national security experts, including the Office 
of the National Security within the Department of Health and Human 
Services--
            (1) develop a comprehensive framework for assessing and 
        managing such national security risks that includes--
                    (A) criteria for how and when to conduct risk 
                assessments for projects that may have national 
                security implications;
                    (B) security controls and training for researchers 
                or entities, including peer reviewers, that manage or 
                have access to such data; and
                    (C) methods to incorporate risk-reduction in the 
                process for funding such projects that may have 
                national security implications;
            (2) not later than 1 year after the risk framework is 
        developed under paragraph (1), develop and implement controls 
        to--
                    (A) ensure that researchers or entities that manage 
                or have access to such data have complied with the 
                requirements of paragraph (1) and ongoing requirements 
                with such paragraph; and
                    (B) ensure that data access committees reviewing 
                data access requests for projects that may have 
                national security risks, as appropriate, include 
                members with expertise in current and emerging national 
                security threats, in order to make appropriate 
                decisions related to access to such identifiable, 
                sensitive information; and
            (3) not later than 2 years after the risk framework is 
        developed under paragraph (1), update data access and sharing 
        policies related to human genomic data, as appropriate, based 
        on current and emerging national security threats.
    (b) Congressional Briefing.--Not later than 1 year after the date 
of enactment of this Act, the Secretary shall provide a briefing to the 
Committee on Health, Education, Labor, and Pensions and the Select 
Committee on Intelligence of the Senate and the Committee on Energy and 
Commerce and the Permanent Select Committee on Intelligence of the 
House of Representatives on the activities required under subsection 
(a).

SEC. 323. DUTIES OF THE DIRECTOR.

    Section 402(b) in the Public Health Service Act (42 U.S.C. 282(b)), 
as amended by section 303, is further amended by inserting after 
paragraph (26) (as added by section 303) the following:
            ``(27) shall consult with the Director of the Office of 
        National Security within the Department of Health and Human 
        Services, the Assistant Secretary for Preparedness and 
        Response, the Director of National Intelligence, the Director 
        of the Federal Bureau of Investigation, and the heads of other 
        appropriate agencies on a regular basis, regarding biomedical 
        research conducted or supported by the National Institutes of 
        Health that may affect or be affected by matters of national 
        security;
            ``(28) shall ensure that recipients of awards from the 
        National Institutes of Health, and, as appropriate and 
        practicable, entities collaborating with such recipients, have 
        in place and are adhering to appropriate technology practices 
        and policies for the security of identifiable, sensitive 
        information, including information collected, stored, or 
        analyzed by domestic and non-domestic entities; and
            ``(29) shall ensure that recipients of awards from the 
        National Institutes of Health are in compliance with the terms 
        and conditions of such award, which may include activities to 
        support awareness of, and compliance with, such terms and 
        conditions by any subrecipients of the award.''.

SEC. 324. PROTECTING AMERICA'S BIOMEDICAL RESEARCH ENTERPRISE.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), in collaboration 
with Assistant to the President for National Security Affairs, the 
Director of National Intelligence, the Director of the Federal Bureau 
of Investigation, and the heads of other relevant departments and 
agencies, and in consultation with research institutions and research 
advocacy organizations or other relevant experts, as appropriate, 
shall--
            (1) identify ways to improve the protection of intellectual 
        property and other proprietary information, as well as 
        identifiable, sensitive information of participants in 
        biomedical research and development, from national security 
        risks and other applicable threats, including the 
        identification of gaps in policies and procedures in such areas 
        related to biomedical research and development supported by the 
        Department of Health and Human Services and biomedical research 
        supported by other agencies as applicable, and make 
        recommendations to institutions of higher education or other 
        entities that have traditionally received Federal funding for 
        biomedical research to protect such information;
            (2) identify or develop strategies to prevent, mitigate, 
        and address national security threats in biomedical research 
        and development supported by the Federal Government, including 
        such threats associated with foreign talent programs, by 
        countries seeking to exploit United States technology and other 
        proprietary information as it relates to such biomedical 
        research and development;
            (3) identify national security risks and potential misuse 
        of proprietary information, and identifiable, sensitive 
        information of biomedical research participants and other 
        applicable risks, including with respect to peer review, and 
        make recommendations for additional policies and procedures to 
        protect such information;
            (4) develop a framework to identify areas of biomedical 
        research and development supported by the Federal Government 
        that are emerging areas of interest for state actors and would 
        compromise national security if they were to be subjected to 
        undue foreign influence; and
            (5) regularly review recommendations or policies developed 
        under this section and make additional recommendations or 
        updates, as appropriate.
    (b) Report to President and to Congress.--Not later than 1 year 
after the date of enactment of this Act, the Secretary shall prepare 
and submit, in a manner that does not compromise national security, to 
the President and the Committee on Health, Education, Labor, and 
Pensions and the Select Committee on Intelligence of the Senate, the 
Committee on Energy and Commerce and the Permanent Select Committee on 
Intelligence of the House of Representatives, and other congressional 
committees as appropriate, a report on the findings and recommendations 
pursuant to subsection (a).

SEC. 325. GAO STUDY.

    (a) In General.--The Comptroller General of the United States 
(referred to in this section as the ``Comptroller General'') shall 
conduct a study to assess the extent to which the Department of Health 
and Human Services (referred to in this section as the ``Department'') 
utilizes or provides funding to entities that utilize such funds for 
human genomic sequencing services or genetic services (as such term is 
defined in section 201(6) of the Genetic Information Nondiscrimination 
Act of 2008 (42 U.S.C. 2000ff(6))) provided by entities, or 
subsidiaries of such entities, organized under the laws of a country or 
countries of concern, in the estimation of the Director of National 
Intelligence or the head of another Federal department or agency, as 
appropriate.
    (b) Considerations.--In carrying out the study under this section, 
the Comptroller General shall--
            (1) consider--
                    (A) the extent to which the country or countries of 
                concern could obtain human genomic information of 
                citizens and residents of the United States from such 
                entities that sequence, analyze, collect, or store 
                human genomic information and which the Director of 
                National Intelligence or the head of another Federal 
                department or agency reasonably anticipates may use 
                such information in a manner inconsistent with the 
                national security interests of the United States;
                    (B) whether the Department or recipient of such 
                funds from the Department sought to provide funding to, 
                or to use, domestic entities with no such ties to the 
                country or countries of concern for such purposes and 
                any barriers to the use of domestic entities; and
                    (C) whether data use agreements, data security 
                measures, and other such measures taken by the 
                Department or recipient of such funds from the 
                Department are sufficient to protect the identifiable, 
                sensitive information of the people of the United 
                States and the national security interests of the 
                United States; and
            (2) make recommendations to address any vulnerabilities to 
        the United States national security identified, as appropriate.
    (c) Estimation.--In conducting the study under this section, the 
Comptroller General may, as appropriate and necessary to complete such 
study, investigate specific instances of such utilization of genetic 
sequencing services or genetic services, as described in subsection 
(a), to produce estimates of the potential prevalence of such 
utilization among entities in receipt of Departmental funds.
    (d) Report.--Not later than 2 years after the date of enactment of 
this Act, the Comptroller General shall submit a report on the study 
under this section, in a manner that does not compromise national 
security, to the Committee on Health, Education, Labor, and Pensions 
and the Select Committee on Intelligence of the Senate, and the 
Committee on Energy and Commerce and the Permanent Select Committee on 
Intelligence of the House of Representatives. The report shall be 
submitted in unclassified form, to the extent practicable, but may 
include a classified annex.

SEC. 326. REPORT ON PROGRESS TO ADDRESS UNDUE FOREIGN INFLUENCE.

    Not later than 1 year after the date of enactment of this Act and 
annually thereafter, the Secretary of Health and Human Services shall 
prepare and submit to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and Commerce in the 
House of Representatives, in a manner that does not compromise national 
security, a report on actions taken by such Secretary--
            (1) to address cases of noncompliance with disclosure 
        requirements or research misconduct related to foreign 
        influence, including--
                    (A) the number of potential noncompliance cases 
                investigated by the National Institutes of Health or 
                reported to the National Institutes of Health by a 
                research institution, including relating to undisclosed 
                research support, undisclosed conflicts of interest or 
                other conflicts of commitment, and peer review 
                violations;
                    (B) the number of cases referred to the Office of 
                Inspector General of the Department of Health and Human 
                Services, the Office of National Security of the 
                Department of Health and Human Services, the Federal 
                Bureau of Investigation, or other law enforcement 
                agencies;
                    (C) a description of enforcement actions taken for 
                noncompliance related to undue foreign influence; and
                    (D) any other relevant information; and
            (2) to prevent, address, and mitigate instances of 
        noncompliance with disclosure requirements or research 
        misconduct related to foreign influence.

  TITLE IV--MODERNIZING AND STRENGTHENING THE SUPPLY CHAIN FOR VITAL 
                            MEDICAL PRODUCTS

SEC. 401. WARM BASE MANUFACTURING CAPACITY FOR MEDICAL COUNTERMEASURES.

    (a) In General.--Section 319L of the Public Health Service Act (42 
U.S.C. 247d-7e) is amended--
            (1) in subsection (a)(6)(B)--
                    (A) by redesignating clauses (iv) and (v) as 
                clauses (v) and (vi), respectively;
                    (B) by inserting after clause (iii), the following:
                            ``(iv) activities to support, maintain, and 
                        improve domestic manufacturing surge capacity 
                        and capabilities, as appropriate, including 
                        through the utilization of advanced 
                        manufacturing and platform technologies, to 
                        increase the availability of products that are 
                        or may become qualified countermeasures or 
                        qualified pandemic or epidemic products;''; and
                    (C) in clause (vi) (as so redesignated), by 
                inserting ``manufacturing,'' after ``improvement,'';
            (2) in subsection (b)--
                    (A) in the first sentence of paragraph (1), by 
                inserting ``support for domestic manufacturing surge 
                capacity and capabilities,'' after ``initiatives for 
                innovation,''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (B), by striking 
                        ``and'' at the end;
                            (ii) by redesignating subparagraph (C) as 
                        subparagraph (D); and
                            (iii) by inserting after subparagraph (B), 
                        the following:
                    ``(C) activities to support, maintain, and improve 
                domestic manufacturing surge capacity and capabilities, 
                as appropriate, including through the utilization of 
                advanced manufacturing and platform technologies, to 
                increase the availability of products that are or may 
                become qualified countermeasures or qualified pandemic 
                or epidemic products; and'';
            (3) in subsection (c)--
                    (A) in paragraph (2)(B), by inserting before the 
                semicolon ``, including through the establishment and 
                maintenance of domestic manufacturing surge capacity 
                and capabilities, consistent with subsection 
                (a)(6)(B)(iv)'';
                    (B) in paragraph (4)--
                            (i) in subparagraph (A)--
                                    (I) in clause (i)--
                                            (aa) in subclause (I), by 
                                        striking ``and'' at the end; 
                                        and
                                            (bb) by adding at the end 
                                        the following:
                                    ``(III) facilitating such 
                                communication, as appropriate, 
                                regarding manufacturing surge capacity 
                                and capabilities with respect to 
                                qualified countermeasures and qualified 
                                pandemic or epidemic products to 
                                prepare for, or respond to, a public 
                                health emergency or potential public 
                                health emergency; and
                                    ``(IV) facilitating such 
                                communication, as appropriate and in a 
                                manner that does not compromise 
                                national security, with respect to 
                                potential eligibility for the material 
                                threat medical countermeasure priority 
                                review voucher program under section 
                                565A of the Federal Food, Drug, and 
                                Cosmetic Act;'';
                                    (II) in clause (ii)(III), by 
                                striking ``and'' at the end;
                                    (III) by redesignating clause (iii) 
                                as clause (iv); and
                                    (IV) by inserting after clause 
                                (ii), the following:
                            ``(iii) communicate regularly with entities 
                        in receipt of an award pursuant to subparagraph 
                        (B)(v), and facilitate communication between 
                        such entities and other entities in receipt of 
                        an award pursuant to subparagraph (B)(iv), as 
                        appropriate, for purposes of planning and 
                        response regarding the availability of 
                        countermeasures and the maintenance of domestic 
                        manufacturing surge capacity and capabilities, 
                        including any planned uses of such capacity and 
                        capabilities in the near- and mid-term, and 
                        identification of any significant challenges 
                        related to the long-term maintenance of such 
                        capacity and capabilities; and'';
                            (ii) in subparagraph (B)--
                                    (I) in clause (iii), by striking 
                                ``and'' at the end;
                                    (II) in clause (iv), by striking 
                                the period and inserting ``; and''; and
                                    (III) by adding at the end the 
                                following:
                            ``(v) award contracts, grants, and 
                        cooperative agreements and enter into other 
                        transactions to support, maintain, and improve 
                        domestic manufacturing surge capacity and 
                        capabilities, including through supporting 
                        flexible or advanced manufacturing, to ensure 
                        that additional capacity is available to 
                        rapidly manufacture products that are or may 
                        become qualified countermeasures or qualified 
                        pandemic or epidemic products in the event of a 
                        public health emergency declaration or 
                        significant potential for a public health 
                        emergency.'';
                            (iii) in subparagraph (C)--
                                    (I) in clause (i), by striking 
                                ``and'' at the end;
                                    (II) in clause (ii), by striking 
                                the period at the end and inserting ``; 
                                and''; and
                                    (III) by adding at the end the 
                                following:
                            ``(iii) consult with the Commissioner of 
                        Food and Drugs, pursuant to section 565(b)(2) 
                        of the Federal Food, Drug, and Cosmetic Act, to 
                        ensure that facilities performing 
                        manufacturing, pursuant to an award under 
                        subparagraph (B)(v), are in compliance with 
                        applicable requirements under such Act and this 
                        Act, as appropriate, including current good 
                        manufacturing practice pursuant to section 
                        501(a)(2)(B) of the Food, Drug, and Cosmetic 
                        Act; and'';
                            (iv) in subparagraph (D)(i), by inserting 
                        ``, including to improve manufacturing 
                        capacities and capabilities for medical 
                        countermeasures'' before the semicolon;
                            (v) in subparagraph (E)(ix), by striking 
                        ``2023'' and inserting ``2028''; and
                            (vi) by adding at the end the following:
                    ``(G) Annual reports by award recipients.--As a 
                condition of receiving an award under subparagraph 
                (B)(v), a recipient shall develop and submit to the 
                Secretary annual reports related to the maintenance of 
                such capacity and capabilities, including ensuring that 
                such capacity and capabilities are able to support the 
                rapid manufacture of countermeasures as required by the 
                Secretary.''; and
                    (C) in paragraph (5), by adding at the end the 
                following:
                    ``(H) Supporting warm-base and surge capacity and 
                capabilities.--Pursuant to an award under subparagraph 
                (B)(v), the Secretary may make payments for activities 
                necessary to maintain domestic manufacturing surge 
                capacity and capabilities supported under such award to 
                ensure that such capacity and capabilities are able to 
                support the rapid manufacture of countermeasures as 
                required by the Secretary to prepare for, or respond 
                to, an existing or potential public health emergency or 
                otherwise address threats that pose a significant level 
                of risk to national security. The Secretary may support 
                the utilization of such capacity and capabilities under 
                awards for countermeasure and product advanced research 
                and development, as appropriate, to provide for the 
                maintenance of such capacity and capabilities.''; and
            (4) in subsection (f)--
                    (A) in paragraph (1), by striking ``Not later than 
                180 days after the date of enactment of this 
                subsection'' and inserting ``Not later than 180 days 
                after the date of enactment of the PREVENT Pandemics 
                Act'';
                    (B) in paragraph (2)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``this subsection'' and 
                        inserting ``the PREVENT Pandemics Act'';
                            (ii) in subparagraph (B), by striking 
                        ``and'' at the end; and
                            (iii) in subparagraph (C), by striking the 
                        period and inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(D) plans for the near-, mid-, and long-term 
                sustainment of manufacturing activities carried out 
                under this section, including such activities pursuant 
                to subsection (c)(5)(H), specific actions to regularly 
                assess the ability of recipients of an award under 
                subsection (c)(4)(B)(v) to rapidly manufacture 
                countermeasures as required by the Secretary, and 
                recommendations to address challenges, if any, related 
                to such activities.''.

SEC. 402. SUPPLY CHAIN CONSIDERATIONS FOR THE STRATEGIC NATIONAL 
              STOCKPILE.

    Subclause (II) of section 319F-2(a)(2)(B)(i) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)(2)(B)(i)) is amended to read as 
follows:
                                    ``(II) planning considerations for 
                                appropriate manufacturing capacity and 
                                capability to meet the goals of such 
                                additions or modifications (without 
                                disclosing proprietary information), 
                                including--
                                            ``(aa) consideration of the 
                                        effect such additions or 
                                        modifications may have on the 
                                        availability of such products 
                                        and ancillary medical supplies 
                                        on the health care system; and
                                            ``(bb) an assessment of the 
                                        current supply chain for such 
                                        products, including information 
                                        on supply chain redundancies, 
                                        any known domestic 
                                        manufacturing capacity for such 
                                        products, and any related 
                                        vulnerabilities;''.

SEC. 403. STRATEGIC NATIONAL STOCKPILE EQUIPMENT MAINTENANCE.

    Subparagraph (D) of section 319F-2(a)(3) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)(3)) is amended to read as follows:
                    ``(D) review and revise, as appropriate, the 
                contents of the stockpile on a regular basis to ensure 
                that--
                            ``(i) emerging threats, advanced 
                        technologies, and new countermeasures are 
                        adequately considered;
                            ``(ii) the potential depletion of 
                        countermeasures currently in the stockpile is 
                        identified and appropriately addressed, 
                        including through necessary replenishment; and
                            ``(iii) such contents are in working 
                        condition or usable, as applicable, and are 
                        ready for deployment, which may include 
                        conducting maintenance services on such 
                        contents of the stockpile and disposing of such 
                        contents that are no longer in working 
                        condition, or usable, as applicable;''.

SEC. 404. IMPROVING TRANSPARENCY AND PREDICTABILITY OF PROCESSES OF THE 
              STRATEGIC NATIONAL STOCKPILE.

    (a) Guidance.--Not later than 60 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 issue guidance describing the 
processes by which the Secretary deploys the contents of the Strategic 
National Stockpile under section 319F-2(a) of the Public Health Service 
Act (42 U.S.C. 247d-6b(a)), or otherwise distributes medical 
countermeasures, as applicable, to States, territories, Indian Tribes 
and Tribal organizations (as such terms are defined under section 4 of 
the Indian Self-Determination and Education Assistance Act), and other 
applicable entities. Such guidance shall include information related to 
processes by which to request access to the contents of the Strategic 
National Stockpile, factors considered by the Secretary when making 
deployment or distribution decisions, and processes and points of 
contact through which entities may contact the Secretary to address any 
issues related to products requested or received by such entity from 
the stockpile, and on other relevant topics.
    (b) Annual Meetings.--Section 319F-2(a)(3) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)(3)) is amended--
            (1) in subparagraph (I), by striking ``and'' at the end;
            (2) in subparagraph (J), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(K) convene meetings, not less than once per 
                year, with representatives from State, local, and 
                Tribal health departments or officials, relevant 
                industries, other Federal agencies, and other 
                appropriate stakeholders, in a manner that does not 
                compromise national security, to coordinate and share 
                information related to maintenance and use of the 
                stockpile, including a description of future 
                countermeasure needs and additions, modifications, and 
                replenishments of the contents of the stockpile, and 
                considerations related to the manufacturing and 
                procurement of products consistent with the 
                requirements of the Buy American Act of 1933, as 
                appropriate.''.

SEC. 405. IMPROVING SUPPLY CHAIN FLEXIBILITY FOR THE STRATEGIC NATIONAL 
              STOCKPILE.

    (a) In General.--Section 319F-2 of the Public Health Service Act 
(42 U.S.C. 247d-6b) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (3)(F), by striking ``as required 
                by the Secretary of Homeland Security'' and inserting 
                ``at the discretion of the Secretary, in consultation 
                with, or at the request of, the Secretary of Homeland 
                Security,'';
                    (B) by redesignating paragraphs (5) and (6) as 
                paragraphs (6) and (7), respectively;
                    (C) by inserting after paragraph (4) the following:
            ``(5) Vendor-managed inventory and warm-base surge 
        capacity.--
                    ``(A) In general.--For the purposes of maintaining 
                the stockpile under paragraph (1) and carrying out 
                procedures under paragraph (3), the Secretary may enter 
                into contracts or cooperative agreements with vendors, 
                which may include manufacturers or distributors of 
                medical products, with respect to medical products 
                intended to be delivered to the ownership of the 
                Federal Government. Each such contract or cooperative 
                agreement shall be subject to such terms and conditions 
                as the Secretary may specify, including terms and 
                conditions with respect to--
                            ``(i) procurement, maintenance, storage, 
                        and delivery of reserve amounts of products 
                        under such contract or cooperative agreement, 
                        which may consider, as appropriate, costs of 
                        transporting and handling such products; and
                            ``(ii) maintenance of domestic 
                        manufacturing capacity and capabilities of such 
                        products to ensure additional reserved 
                        production capacity and capabilities are 
                        available, and that such capacity and 
                        capabilities are able to support the rapid 
                        manufacture, purchase, storage, and delivery of 
                        such products, as required by the Secretary to 
                        prepare for, or respond to, an existing or 
                        potential public health emergency.
                    ``(B) Report.--Not later than 2 years after the 
                date of enactment of the PREVENT Pandemics Act, and 
                annually 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 on any contracts 
                or cooperative agreements entered into under 
                subparagraph (A) for purposes of establishing and 
                maintaining vendor-managed inventory or reserve 
                manufacturing capacity and capabilities for products 
                intended for the stockpile, including a description 
                of--
                            ``(i) the amount of each award;
                            ``(ii) the recipient of each award;
                            ``(iii) the product or products covered 
                        through each award; and
                            ``(iv) how the Secretary works with each 
                        recipient to ensure situational awareness 
                        related to the manufacturing capacity for, or 
                        inventory of, such products and coordinates the 
                        distribution and deployment of such products, 
                        as appropriate and applicable.''; and
                    (D) in subparagraph (A) of paragraph (6), as so 
                redesignated--
                            (i) in clause (viii), by striking ``; and'' 
                        and inserting a semicolon;
                            (ii) in clause (ix), by striking the period 
                        and inserting ``; and''; and
                            (iii) by adding at the end the following:
                            ``(x) with respect to reports issued in 
                        2027 or any subsequent year, an assessment of 
                        selected contracts or cooperative agreements 
                        entered into pursuant to paragraph (5).''; and
            (2) in subsection (c)(2)(C), by striking ``on an annual 
        basis'' and inserting ``not later than March 15 of each year''.
    (b) Authorization of Appropriations.--Section 319F-2(f)(1) of the 
Public Health Service Act (42 U.S.C. 247d-6b(f)(1)) is amended by 
striking ``$610,000,000 for each of fiscal years 2019 through 2023'' 
and inserting ``$610,000,000 for each of fiscal year 2019 through 2021, 
and $750,000,000 for each of fiscal years 2022 and 2023''.

SEC. 406. REIMBURSEMENT FOR CERTAIN SUPPLIES.

    Paragraph (7) of section 319F-2(a) of the Public Health Service Act 
(42 U.S.C. 247d-6b(a)), as so redesignated by section 405(a)(1)(B), is 
amended to read as follows:
            ``(7) Reimbursement for certain supplies.--
                    ``(A) In general.--The Secretary may, at 
                appropriate intervals, make available for purchase 
                excess contents procured for, and maintained within, 
                the stockpile under paragraph (1) to any Federal agency 
                or State, local, or Tribal government. The Secretary 
                shall make such contents available for purchase only 
                if--
                            ``(i) such contents are in excess of what 
                        is required for appropriate maintenance of such 
                        stockpile;
                            ``(ii) the Secretary determines that the 
                        costs for maintaining such excess contents are 
                        not appropriate to expend to meet the needs of 
                        the stockpile; and
                            ``(iii) the Secretary determines that such 
                        action does not compromise national security 
                        and is in the national interest.
                    ``(B) Reimbursement and collection.--The Secretary 
                may require reimbursement for contents that are made 
                available under subparagraph (A), in an amount that 
                reflects the cost of acquiring and maintaining such 
                contents and the costs incurred to make available such 
                contents in the time and manner specified by the 
                Secretary. Amounts collected under this subsection 
                shall be credited to the appropriations account or fund 
                that incurred the costs to procure such contents, and 
                shall remain available, without further appropriation, 
                until expended, for the purposes of the appropriation 
                account or fund so credited.
                    ``(C) Rule of construction.--This paragraph shall 
                not be construed to preclude transfers of contents in 
                the stockpile under other authorities.
                    ``(D) Report.--Not later than 2 years after the 
                date of enactment of the PREVENT Pandemics Act, and 
                annually thereafter, the Secretary 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 use of the authority provided under this 
                paragraph, including details of each action taken 
                pursuant to this paragraph, the account or fund to 
                which any collected amounts have been credited, and how 
                the Secretary has used such amounts.
                    ``(E) Sunset.--The authority under this paragraph 
                shall terminate on September 30, 2025.''.

SEC. 407. ACTION REPORTING ON STOCKPILE DEPLETION.

    Section 319 of the Public Health Service Act (42 U.S.C. 247d), as 
amended by section 223, is further amended by adding at the end the 
following:
    ``(h) Stockpile Depletion Reporting.--The Secretary shall, not 
later than 30 days after the deployment of contents of the Strategic 
National Stockpile under section 319F-2(a) to respond to a public 
health emergency declared by the Secretary under this section or an 
emergency or major disaster declared by the President under the Robert 
T. Stafford Disaster Relief and Emergency Assistance Act, and every 30 
days thereafter until the expiration or termination of such public 
health emergency, emergency, or major disaster, submit a report 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 on--
            ``(1) the deployment of the contents of the stockpile in 
        response to State, local, and Tribal requests;
            ``(2) the amount of such products that remain within the 
        stockpile following such deployment; and
            ``(3) plans to replenish such products, as appropriate, 
        including related timeframes and any barriers or limitations to 
        replenishment.''.

SEC. 408. PROVISION OF MEDICAL COUNTERMEASURES TO INDIAN PROGRAMS AND 
              FACILITIES.

    (a) Clarification.--Section 319F-2(a)(3) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)(3)) is amended--
            (1) in subparagraph (C), by striking ``and local'' and 
        inserting ``local, and Tribal''; and
            (2) in subparagraph ( J), by striking ``and local'' and 
        inserting ``local, and Tribal''.
    (b) Distribution of Medical Countermeasures to Indian Tribes.--
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is 
amended by inserting after section 319F-4 the following:

``SEC. 319F-5. PROVISION OF MEDICAL COUNTERMEASURES TO INDIAN PROGRAMS 
              AND FACILITIES.

    ``In the event that the Secretary deploys the contents of the 
Strategic National Stockpile under section 319F-2(a), or otherwise 
distributes medical countermeasures to States to respond to a public 
health emergency declared by the Secretary under section 319, the 
Secretary shall, in consultation with the applicable States, make such 
contents or countermeasures directly available to Indian Tribes and 
Tribal organizations (as such terms are defined in section 4 of the 
Indian Self-Determination and Education Assistance Act (25 U.S.C. 
5304), which may include through health programs or facilities operated 
by the Indian Health Service, that are affected by such public health 
emergency.''.

SEC. 409. GRANTS FOR STATE STRATEGIC STOCKPILES.

    (a) Section 319F-2 of the Public Health Service Act (42 U.S.C. 
247d-6b) is amended by adding at the end the following:
    ``(i) Pilot Program To Support State Medical Stockpiles.--
            ``(1) In general.--The Secretary, in consultation with the 
        Assistant Secretary for Preparedness and Response and the 
        Director of the Centers for Disease Control and Prevention, 
        shall award grants or cooperative agreements to not fewer than 
        5 States, or consortia of States, with consideration given to 
        distribution among the geographical regions of the United 
        States, to establish, expand, or maintain a stockpile of 
        appropriate drugs, vaccines and other biological products, 
        medical devices, and other medical supplies determined by the 
        State to be necessary to respond to a public health emergency 
        declared by the Governor of a State or by the Secretary under 
        section 319, 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, in 
        order to support the preparedness goals described in paragraphs 
        (2) through (6) and (8) of section 2802(b).
            ``(2) Requirements.--
                    ``(A) Application.--To be eligible to receive an 
                award under paragraph (1), an entity shall prepare, in 
                consultation with appropriate health care entities and 
                health officials within the jurisdiction of such State 
                or States, and submit to the Secretary an application 
                that contains such information as the Secretary may 
                require, including--
                            ``(i) a plan for such stockpile, consistent 
                        with paragraph (4), including a description of 
                        the activities such entity will carry out under 
                        the agreement and an outline of proposed 
                        expenses; and
                            ``(ii) a description of how such entity 
                        will coordinate with relevant entities in 
                        receipt of an award under section 319C-1 or 
                        319C-2 pursuant to paragraph (4), including 
                        through promoting alignment between the 
                        stockpile plan established pursuant to clause 
                        (i) and applicable plans that are established 
                        by such entity pursuant to section 319C-1 or 
                        319C-2.
                    ``(B) Matching funds.--
                            ``(i) Subject to clause (ii), the Secretary 
                        may not make an award under this subsection 
                        unless the applicant agrees, with respect to 
                        the costs to be incurred by the applicant in 
                        carrying out the purpose described in this 
                        subsection, to make available non-Federal 
                        contributions toward such costs in an amount 
                        equal to--
                                    ``(I) for each of fiscal years 2023 
                                and 2024, not less than $1 for each $20 
                                of Federal funds provided in the award; 
                                and
                                    ``(II) for fiscal year 2025 and 
                                each fiscal year thereafter, not less 
                                than $1 for each $10 of Federal funds 
                                provided in the award.
                            ``(ii) Waiver.--The Secretary may, upon the 
                        request of a State, waive the requirement under 
                        clause (i), in whole or in part, if the 
                        Secretary determines that extraordinary 
                        economic conditions in the State in the fiscal 
                        year involved or in the previous fiscal year 
                        justify the waiver. A waiver provided by the 
                        Secretary under this subparagraph shall apply 
                        only to the fiscal year involved.
                    ``(C) Administrative expenses.--Not more than 10 
                percent of amounts received by an entity pursuant to an 
                award under this subsection may be used for 
                administrative expenses.
            ``(3) Lead entity.--An entity in receipt of an award under 
        paragraph (1) may designate a lead entity, which may be a 
        public or private entity, as appropriate, to manage the 
        stockpile at the direction of the State or consortium of 
        States.
            ``(4) Use of funds.--An entity in receipt of an award under 
        paragraph (1) shall use such funds to--
                    ``(A) purchase, store, and maintain a stockpile of 
                appropriate drugs, vaccines and other biological 
                products, medical devices, and other medical supplies 
                to be used during a public health emergency, major 
                disaster, or emergency described in paragraph (1), in 
                such numbers, types, and amounts as the entity 
                determines necessary, consistent with such entity's 
                stockpile plan established pursuant to paragraph 
                (2)(A)(i);
                    ``(B) deploy the stockpile as required by the 
                entity to respond to an actual or potential public 
                health emergency, major disaster, or other emergency 
                described in paragraph (1);
                    ``(C) replenish and make necessary additions or 
                modifications to the contents of such stockpile, 
                including to address potential depletion;
                    ``(D) in consultation with Federal, State, and 
                local officials, take into consideration the 
                availability, deployment, dispensing, and 
                administration requirements of medical products within 
                the stockpile;
                    ``(E) ensure that procedures are followed for 
                inventory management and accounting, and for the 
                physical security of the stockpile, as appropriate;
                    ``(F) review and revise, as appropriate, the 
                contents of the stockpile on a regular basis to ensure 
                that, to the extent practicable, new technologies and 
                medical products are considered;
                    ``(G) carry out exercises, drills, and other 
                training for purposes of stockpile deployment, 
                dispensing, and administration of medical products, and 
                for purposes of assessing the capability of such 
                stockpile to address the medical supply needs of public 
                health emergencies, major disasters, or other 
                emergencies described in paragraph (1) of varying types 
                and scales, which may be conducted in accordance with 
                requirements related to exercises, drills, and other 
                training for recipients of awards under section 319C-1 
                or 319C-2, as applicable; and
                    ``(H) carry out other activities related to the 
                State strategic stockpile as the entity determines 
                appropriate, to support State efforts to prepare for, 
                and respond to, public health threats.
            ``(5) Supplement not supplant.--Awards under paragraph (1) 
        shall supplement, not supplant, the maintenance and use of the 
        Strategic National Stockpile by the Secretary under subsection 
        (a).
            ``(6) Guidance for states.--Not later than 180 days after 
        the date of enactment of this subsection, the Secretary, in 
        consultation with States, health officials, and other relevant 
        stakeholders, as appropriate, shall issue guidance, and update 
        such guidance as appropriate, for States related to maintaining 
        and replenishing a stockpile of medical products, which may 
        include strategies and best practices related to--
                    ``(A) types of medical products and medical 
                supplies that are critical to respond to public health 
                emergencies, and may be appropriate for inclusion in a 
                stockpile by States, with consideration of threats that 
                require the large-scale and simultaneous deployment of 
                stockpiles, including the stockpile maintained by the 
                Secretary pursuant to subsection (a), and long-term 
                public health and medical response needs;
                    ``(B) appropriate management of the contents of a 
                stockpile, including management by vendors of reserve 
                amounts of medical products and supplies intended to be 
                delivered to the ownership of the State and appropriate 
                disposition of excess products, as applicable; and
                    ``(C) the procurement of medical products and 
                medical supplies consistent with the Buy American Act 
                of 1933.
            ``(7) Technical assistance.--The Secretary shall provide 
        assistance to States, including technical assistance, as 
        appropriate, in establishing, maintaining, improving, and 
        utilizing a medical stockpile, including appropriate inventory 
        management and disposition of products.
            ``(8) Reporting.--
                    ``(A) State reports.--Each entity receiving an 
                award under paragraph (1) shall update, as appropriate, 
                the plan established pursuant to paragraph (2)(A)(i) 
                and submit to the Secretary an annual report on 
                implementation of such plan, including any changes to 
                the contents of the stockpile supported under such 
                award. The Secretary shall use information obtained 
                from such reports to inform the maintenance and 
                management of the Strategic National Stockpile pursuant 
                to subsection (a).
                    ``(B) Reports to congress.--Not later than 1 year 
                after the initial issuance of awards pursuant to 
                paragraph (1), and annually thereafter for the duration 
                of the program established under this subsection, 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 on such program, including--
                            ``(i) Federal and State expenditures to 
                        support stockpiles under such program;
                            ``(ii) activities conducted pursuant to 
                        paragraph (4); and
                            ``(iii) any additional information from the 
                        States that the Secretary determines relevant.
            ``(9) Authorization of appropriations.--To carry out this 
        subsection, there is authorized to be appropriated such sums as 
        may be necessary for each of fiscal years 2023 through 2028.''.
    (b) GAO Report.--Not later than 3 years after the date on which 
awards are first issued pursuant to subsection (i)(1) of section 319F-2 
of the Public Health Service Act (42 U.S.C. 247d-6b), as added by 
subsection (a), the Comptroller General of the United States shall 
submit to the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on the State stockpiles established or 
maintained pursuant to this section. Such report shall include an 
assessment of--
            (1) coordination and communication between the Secretary of 
        Health and Human Services and entities in receipt of an award 
        under this section, or a lead entity designated by such entity;
            (2) technical assistance provided by the Secretary of 
        Health and Human Services to such entities; and
            (3) the impact of such stockpiles on the ability of the 
        State to prepare for and respond to a public health emergency, 
        major disaster, or other emergency described in subsection 
        (i)(1) of section 319F-2 of the Public Health Service Act (42 
        U.S.C. 247d-6b), as added by subsection (a), including the 
        availability and distribution of items from such State 
        stockpile to health care entities and other applicable 
        entities.

   TITLE V--ENHANCING DEVELOPMENT AND COMBATING SHORTAGES OF MEDICAL 
                                PRODUCTS

                   Subtitle A--Development and Review

SEC. 501. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.

    (a) In General.--Section 505E of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355f) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (2), by striking ``; or'' and 
                inserting ``;'';
                    (B) in paragraph (3), by striking the period and 
                inserting ``; or''; and
                    (C) by adding at the end the following:
            ``(4) an application pursuant to section 351(a) of the 
        Public Health Service Act.'';
            (2) in subsection (d)(1), by inserting ``of this Act or 
        section 351(a) of the Public Health Service Act'' after 
        ``section 505(b)''; and
            (3) by amending subsection (g) to read as follows:
    ``(g) Qualified Infectious Disease Product.--The term `qualified 
infectious disease product' means a drug, including an antibacterial or 
antifungal drug or a biological product, for human use that--
            ``(1) acts directly on bacteria or fungi or on substances 
        produced by such bacteria or fungi; and
            ``(2) is intended to treat a serious or life-threatening 
        infection, including such an infection caused by--
                    ``(A) an antibacterial or antifungal resistant 
                pathogen, including novel or emerging infectious 
                pathogens; or
                    ``(B) qualifying pathogens listed by the Secretary 
                under subsection (f).''.
    (b) Priority Review.--Section 524A(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by inserting ``of 
this Act, or section 351(a) of the Public Health Service Act, that 
requires clinical data (other than bioavailability studies) to 
demonstrate safety or effectiveness'' before the period.

SEC. 502. MODERNIZING CLINICAL TRIALS.

    (a) Clarifying the Use of Digital Health Technologies in Clinical 
Trials.--
            (1) In general.--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 issue or revise draft guidance regarding the appropriate 
        use of validated digital health technologies in clinical trials 
        to help improve recruitment for, retention in, participation 
        in, and data collection during, clinical trials, and provide 
        for novel clinical trial designs utilizing such technology for 
        purposes of supporting the development of, and review of 
        applications for, drugs and devices. Not later than 18 months 
        after the public comment period on such draft guidance ends, 
        the Secretary shall issue a revised draft guidance or final 
        guidance.
            (2) Content.--The guidance described in paragraph (1) shall 
        include--
                    (A) recommendations for data collection 
                methodologies by which sponsors may incorporate the use 
                of digital health technologies in clinical trials to 
                collect data remotely from trial participants;
                    (B) considerations for privacy and security 
                protections for data collected during a clinical trial, 
                including--
                            (i) recommendations for the protection of 
                        trial participant data that is collected or 
                        used in research, using digital health 
                        technologies;
                            (ii) compliance with the regulations 
                        promulgated under section 264(c) of the Health 
                        Insurance Portability and Accountability Act of 
                        1996 (42 U.S.C. 1320d-2 note), subpart B of 
                        part 50 of title 21, Code of Federal 
                        Regulations, subpart C of part 56 of title 21, 
                        Code of Federal Regulations, the Federal policy 
                        for the protection of human subjects under 
                        subpart A of part 46 of title 45, Code of 
                        Federal Regulations (commonly known as the 
                        ``Common Rule''), and part 2 of title 42, Code 
                        of Federal Regulations (or any successor 
                        regulations); and
                            (iii) recommendations for protection of 
                        clinical trial participant data against 
                        cybersecurity threats, as applicable;
                    (C) considerations on data collection methods to 
                help increase recruitment of clinical trial 
                participants and the level of participation of such 
                participants, reduce burden on clinical trial 
                participants, and optimize data quality;
                    (D) recommendations for the use of electronic 
                methods to obtain informed consent from clinical trial 
                participants, taking into consideration applicable 
                Federal law, including subpart B of part 50 of title 
                21, Code of Federal Regulations (or successor 
                regulations), and, as appropriate, State law;
                    (E) best practices for communication and early 
                engagement between sponsors and the Secretary on the 
                development of data collection methods;
                    (F) the appropriate format to submit such data to 
                the Secretary;
                    (G) a description of the manner in which the 
                Secretary may assess or evaluate data collected through 
                digital health technologies to support the development 
                of the drug or device;
                    (H) recommendations regarding the data and 
                information needed to demonstrate that a digital health 
                technology is fit-for-purpose for a clinical trial, and 
                a description of how the Secretary will evaluate such 
                data and information; and
                    (I) recommendations for increasing access to, and 
                the use of, digital health technologies in clinical 
                trials to facilitate the inclusion of diverse and 
                underrepresented populations, as appropriate, including 
                considerations for access to, and the use of, digital 
                health technologies in clinical trials by people with 
                disabilities and pediatric populations.
    (b) Advancing Decentralized Clinical Trials.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall issue or revise 
        draft guidance to provide recommendations to clarify and 
        advance the use of decentralized clinical trials to support the 
        development of drugs and devices and help improve trial 
        participant engagement and advance the use of flexible and 
        novel clinical trial designs. Not later than 18 months after 
        the public comment period on such draft guidance ends, the 
        Secretary shall issue a revised draft guidance or final 
        guidance.
            (2) Content.--The guidance described in paragraph (1) shall 
        include--
                    (A) recommendations for methods of remote data 
                collection, including trial participant experience 
                data, though the use of digital health technologies, 
                telemedicine, local laboratories, local health care 
                providers, or other options for data collection;
                    (B) considerations for sponsors to minimize or 
                reduce burdens for clinical trial participants 
                associated with participating in a clinical trial, such 
                as the use of digital technologies, telemedicine, local 
                laboratories, local health care providers, or other 
                data collection or assessment options, health care 
                provider home visits, direct-to-participant shipping of 
                investigational drugs and devices, and electronic 
                informed consent, as appropriate;
                    (C) recommendations regarding conducting 
                decentralized clinical trials to facilitate and 
                encourage diversity among the clinical trial 
                participants, as appropriate;
                    (D) recommendations for strategies and methods for 
                recruiting, retaining, and engaging with clinical trial 
                participants, including communication regarding the 
                role of trial participants and community partners to 
                facilitate clinical trial recruitment and engagement, 
                including with respect to diverse and underrepresented 
                populations, as appropriate;
                    (E) considerations for review and oversight by 
                sponsors and institutional review boards, including 
                remote trial oversight;
                    (F) recommendations for decentralized clinical 
                trial protocol designs and processes for evaluating 
                such proposed trial designs;
                    (G) recommendations for digital health technology 
                and other remote assessment tools that may support 
                decentralized clinical trials, including guidance on 
                appropriate technological platforms and tools, data 
                collection and use, data integrity, and communication 
                to clinical trial participants through such technology;
                    (H) a description of the manner in which the 
                Secretary will assess or evaluate data collected within 
                a decentralized clinical trial to support the 
                development of the drug or device, if the manner is 
                different from that used for a non-decentralized trial;
                    (I) considerations for sponsors to validate digital 
                technologies and establish appropriate clinical 
                endpoints for use in decentralized trials;
                    (J) considerations for privacy and security of 
                personally identifiable information of trial 
                participants; and
                    (K) considerations for conducting clinical trials 
                using centralized approaches in conjunction with 
                decentralized approaches.
    (c) Seamless and Concurrent Clinical Trials.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall issue or revise 
        draft guidance on the use of seamless, concurrent, and other 
        innovative clinical trial designs to support the expedited 
        development and review of applications for drugs, as 
        appropriate. Not later than 18 months after the public comment 
        period on such draft guidance ends, the Secretary shall issue a 
        revised draft guidance or final guidance.
            (2) Content.--The guidance described in paragraph (1) shall 
        include--
                    (A) recommendations on the use of expansion cohorts 
                and other seamless clinical trial designs to assess 
                different aspects of product candidates in one 
                continuous trial, including how such clinical trial 
                designs can be used as part of meeting the substantial 
                evidence standard under section 505(d) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
                    (B) recommendations on the use of clinical trial 
                designs that involve the concurrent conduct of 
                different or multiple clinical trial phases, and the 
                concurrent conduct of preclinical testing, to expedite 
                the development of new drugs and facilitate the timely 
                collection of data;
                    (C) recommendations for how to streamline trial 
                logistics and facilitate the efficient collection and 
                analysis of clinical trial data, including any planned 
                interim analyses and how such analyses could be used to 
                streamline the product development and review 
                processes;
                    (D) considerations to assist sponsors in ensuring 
                the rights, safety, and welfare of clinical trial 
                participants, maintaining compliance with good clinical 
                practice regulations, minimizing risks to clinical 
                trial data integrity, and ensuring the reliability of 
                clinical trial results;
                    (E) recommendations for communication and early 
                engagement between sponsors and the Food and Drug 
                Administration on the development of seamless, 
                concurrent, or other adaptive trial designs, including 
                review of, and feedback on, clinical trial protocols; 
                and
                    (F) a description of the manner in which the 
                Secretary will assess or evaluate data collected 
                through seamless, concurrent, or other adaptive trial 
                designs to support the development of the drug.
    (d) International Harmonization.--The Secretary shall work with 
foreign regulators pursuant to memoranda of understanding or other 
arrangements governing the exchange of information to facilitate 
international harmonization of the regulation and use of decentralized 
clinical trials, digital technology in clinical trials, and seamless, 
concurrent, and other adaptive or innovative clinical trial designs.

SEC. 503. ACCELERATING COUNTERMEASURE DEVELOPMENT AND REVIEW.

    Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-4) is amended by adding at the end the following:
    ``(h) Accelerating Countermeasure Development and Review During an 
Emergency.--
            ``(1) Acceleration of countermeasure development and 
        review.--The Secretary may, at the request of the sponsor of a 
        countermeasure, during a domestic, military, or public health 
        emergency or material threat described in section 
        564A(a)(1)(C), expedite the development and review of 
        countermeasures that are intended to address such domestic, 
        military, or public health emergency or material threat for 
        approval, licensure, clearance, or authorization under this 
        title or section 351 of the Public Health Service Act.
            ``(2) Actions.--The actions to expedite the development and 
        review of a countermeasure under paragraph (1) may include the 
        following:
                    ``(A) Expedited review of submissions made by 
                sponsors of countermeasures to the Food and Drug 
                Administration, including rolling submissions of 
                countermeasure applications and other submissions.
                    ``(B) Expedited and increased engagement with 
                sponsors regarding countermeasure development and 
                manufacturing, including--
                            ``(i) holding meetings with the sponsor and 
                        the review team and providing timely advice to, 
                        and interactive communication with, the sponsor 
                        regarding the development of the countermeasure 
                        to ensure that the development program to 
                        gather the nonclinical and clinical data 
                        necessary for approval, licensure, clearance, 
                        or authorization is as efficient as 
                        practicable;
                            ``(ii) involving senior managers and 
                        experienced review staff, as appropriate, in a 
                        collaborative, cross-disciplinary review;
                            ``(iii) assigning a cross-disciplinary 
                        project lead for the review team to facilitate;
                            ``(iv) taking steps to ensure that the 
                        design of the clinical trials is as efficient 
                        as practicable, when scientifically 
                        appropriate, such as by minimizing the number 
                        of patients exposed to a potentially less 
                        efficacious treatment; and
                            ``(v) streamlining the review of approved, 
                        licensed, cleared, or authorized 
                        countermeasures to treat or prevent new or 
                        emerging threats, including the review of any 
                        changes to such countermeasures.
                    ``(C) Expedited issuance of guidance documents and 
                publication of other regulatory information regarding 
                countermeasure development and manufacturing.
                    ``(D) Other steps to expedite the development and 
                review of a countermeasure application submitted for 
                approval, licensure, clearance, or authorization, as 
                the Secretary determines appropriate.
            ``(3) Limitation of effect.--Nothing in this subsection 
        shall be construed to require the Secretary to grant, or take 
        any other action related to, a request of a sponsor to expedite 
        the development and review of a countermeasure for approval, 
        licensure, clearance, or authorization under paragraph (1).''.

SEC. 504. THIRD PARTY TEST EVALUATION DURING EMERGENCIES.

    (a) In General.--Section 565 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-4), as amended by section 503, is 
further amended by adding at the end the following:
    ``(i) Third Party Evaluation of Tests Used During an Emergency.--
            ``(1) In general.--For purposes of conducting evaluations 
        regarding whether an in vitro diagnostic product (as defined in 
        section 809.3 of title 21, Code of Federal Regulations (or any 
        successor regulations)) for which a request for emergency use 
        authorization is submitted under section 564 meets the criteria 
        for issuance of such authorization, the Secretary may, as 
        appropriate, consult with persons with appropriate expertise 
        with respect to such evaluations or enter into cooperative 
        agreements or contracts with such persons under which such 
        persons conduct such evaluations and make such recommendations, 
        including, as appropriate, evaluations and recommendations 
        regarding the scope of authorization and conditions of 
        authorization.
            ``(2) Requirements regarding evaluations and 
        recommendations.--
                    ``(A) In general.--In evaluating and making 
                recommendations to the Secretary regarding the 
                validity, accuracy, and reliability of in vitro 
                diagnostic products, as described in paragraph (1), a 
                person shall consider and document whether the relevant 
                criteria under subsection (c)(2) of section 564 for 
                issuance of authorization under such section are met 
                with respect to the in vitro diagnostic product.
                    ``(B) Written recommendations.--Recommendations 
                made by a person under this subsection shall be 
                submitted to the Secretary in writing, and shall 
                include the reasons for such recommendation and other 
                information that may be requested by the Secretary.
            ``(3) Rule of construction.-- Nothing in this subsection 
        shall be construed to require the Secretary to consult with, or 
        enter into cooperative agreements or contracts with, persons as 
        described in paragraph (1) for purposes of authorizing an in 
        vitro diagnostic product or otherwise affecting the emergency 
        use authorization authorities under this section or section 
        564.''.
    (b) 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 subsection as the ``Secretary'') shall issue draft guidance on 
consultations with persons under subsection (i) of section 565 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4), as added by 
subsection (a), including considerations concerning conflicts of 
interest, compensation arrangements, and information sharing. Not later 
than 1 year after the public comment period on such draft guidance 
ends, the Secretary shall issue a revised draft guidance or final 
guidance.

SEC. 505. FACILITATING THE USE OF REAL WORLD EVIDENCE.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue or revise existing 
guidance on considerations for the use of real world data and real 
world evidence to support regulatory decision-making, as follows:
            (1) With respect to drugs, such guidance shall address the 
        use of such data and evidence to support the approval of a drug 
        application under section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) or a biological product 
        application under section 351 of the Public Health Service Act 
        (42 U.S.C. 262), or to support an investigational use exemption 
        under section 505(i) of the Federal Food, Drug, and Cosmetic 
        Act or section 351(a)(3) of the Public Health Service Act. Such 
        guidance shall include considerations for the inclusion, in 
        such applications, of real world data and real world evidence 
        obtained as a result of the use of drugs authorized for 
        emergency use under section 564 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360bbb-3), and considerations for 
        standards and methodologies for collection and analysis of real 
        world evidence included in such applications, submissions, or 
        requests, as appropriate.
            (2) With respect to devices, such guidance shall address 
        the use of such data and evidence to support the approval, 
        clearance, or classification of a device pursuant to an 
        application or submission submitted under section 510(k), 
        513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360(k), 360c(f)(2), 360e), or to support an 
        investigational use exemption under section 520(g) of such Act 
        (21 U.S.C. 360j(g)). Such guidance shall include considerations 
        for the inclusion, in such applications, submissions, or 
        requests, of real world data and real world evidence obtained 
        as a result of the use of devices authorized for emergency use 
        under section 564 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360bbb-3), and considerations for standards and 
        methodologies for collection and analysis of real world 
        evidence included in such applications, submissions, or 
        requests, as appropriate.

SEC. 506. PLATFORM TECHNOLOGIES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 506J of such Act (21 U.S.C. 
356j) the following:

``SEC. 506K. PLATFORM TECHNOLOGIES.

    ``(a) In General.--The Secretary shall establish a process for the 
designation of platform technologies that meet the criteria described 
in subsection (b).
    ``(b) Criteria.--A platform technology incorporated within or 
utilized by a drug is eligible for designation as a designated platform 
technology under this section if--
            ``(1) the platform technology is incorporated in, or 
        utilized by, a drug approved under section 505 of this Act or a 
        biological product licensed under section 351 of the Public 
        Health Service Act;
            ``(2) preliminary evidence submitted by the sponsor of the 
        approved or licensed drug described in paragraph (1), or a 
        sponsor that has been granted a right of reference to data 
        submitted in the application for such drug, demonstrates that 
        the platform technology has the potential to be incorporated 
        in, or utilized by, more than one drug without an adverse 
        effect on quality, manufacturing, or safety; and
            ``(3) data or information submitted by the applicable 
        person under paragraph (2) indicates that incorporation or 
        utilization of the platform technology has a reasonable 
        likelihood to bring significant efficiencies to the drug 
        development or manufacturing process and to the review 
        processes.
    ``(c) Request for Designation.--A person may request the Secretary 
designate a platform technology as a designated platform technology 
concurrently with, or at any time after, submission under section 
505(i) of this Act or section 351(a)(3) of the Public Health Service 
Act for the investigation of a drug that incorporates or utilizes the 
platform technology that is the subject of the request.
    ``(d) Designation.--
            ``(1) In general.--Not later than 60 calendar days after 
        the receipt of a request under subsection (c), the Secretary 
        shall determine whether the platform technology that is the 
        subject of the request meets the criteria described in 
        subsection (b).
            ``(2) Designation.--If the Secretary determines that the 
        platform technology meets the criteria described in subsection 
        (b), the Secretary shall designate the platform technology as a 
        designated platform technology and may expedite the development 
        and review of any subsequent application submitted under 
        section 505(b) of this Act or section 351(a) of the Public 
        Health Service Act for a drug that uses or incorporates the 
        platform technology pursuant to subsection (e), as appropriate.
            ``(3) Determination not to designate.--If the Secretary 
        determines that the platform technology does not meet the 
        criteria under subsection (b), the Secretary shall include with 
        the determination not to designate the technology a written 
        description of the rationale for such determination.
            ``(4) Revocation of designation.--The Secretary may revoke 
        a designation made under paragraph (2), if the Secretary 
        determines that the designated platform technology no longer 
        meets the criteria described in subsection (b). The Secretary 
        shall communicate the determination to revoke a designation to 
        the requesting sponsor in writing, including a description of 
        the rationale for such determination.
            ``(5) Applicability.--Nothing in this section shall prevent 
        a product that uses or incorporates a designated platform 
        technology from being eligible for expedited approval pathways 
        if it is otherwise eligible under this Act or the Public Health 
        Service Act.
    ``(e) Actions.--The Secretary may take actions to expedite the 
development and review of an application for a drug that incorporates 
or utilizes a designated platform technology, including--
            ``(1) engaging in early interactions with the sponsor to 
        discuss the use of the designated platform technology and what 
        is known about such technology, including data previously 
        submitted that is relevant to establishing, as applicable, 
        safety or efficacy under section 505(b) of this Act or safety, 
        purity, or potency under section 351(a) of the Public Health 
        Service Act;
            ``(2) providing timely advice to, and interactive 
        communication with, the sponsor regarding the development of 
        the drug that proposes to use the designated platform 
        technology to ensure that the development program designed to 
        gather data necessary for approval or licensure is as efficient 
        as practicable, which may include holding meetings with the 
        sponsor and the review team throughout the development of the 
        drug; and
            ``(3) considering inspectional findings, including prior 
        findings, related to the manufacture of a drug that 
        incorporates or utilizes the designated platform technology.
    ``(f) Leveraging Data From Designated Platform Technologies.--The 
Secretary shall, consistent with applicable standards for approval, 
authorization, or licensure under this Act and section 351(a) of the 
Public Health Service Act, allow the sponsor of an application under 
section 505(b) of this Act or section 351(a) of the Public Health 
Service Act or a request for emergency use authorization under section 
564, in order to support approval, licensure, or authorization, to 
reference or rely upon data and information within such application or 
request that incorporates or utilizes the same or substantially similar 
platform technology designated under subsection (d), provided that--
            ``(1) such data and information was submitted by the same 
        sponsor, pursuant to the application for the drug with respect 
        to which designation of the designated platform technology 
        under subsection (d) was granted; or
            ``(2) the sponsor relying on such data and information 
        received a right of reference to such data and information from 
        the sponsor described in paragraph (1).
    ``(g) Changes to a Designated Platform Technology.--A sponsor of 
one or more applications approved under section 505(b) of this Act or 
section 351(a) of the Public Health Service Act for a drug or 
biological product that incorporates or utilizes the same designated 
platform technology may submit a single supplemental application for 
the same proposed changes to the designated platform technology that is 
applicable to more than one drug or biological product that 
incorporates or utilizes such designated platform technology that may 
be cross referenced in other applications incorporating such change. 
Such application may include one or more comparability protocols 
regarding how such changes to the platform technology would be made for 
each applicable application.
    ``(h) Guidance.--Not later than 1 year after the date of enactment 
of this section, the Secretary shall issue draft guidance on the 
implementation of this section. Such guidance shall include examples of 
drugs that can be manufactured using platform technologies, including 
drugs that contain or consist of vectors and nucleic acids, information 
about the Secretary's review of platform technologies, information 
regarding submitting for designation, consideration for persons 
submitting a request for designation who has been granted a right of 
reference, the implementation of the designated platform technology 
designation program, efficiencies that may be achieved in the 
development and review of products that incorporate or utilize 
designated platform technologies, and recommendations and requirements 
for making and reporting manufacturing changes to a designated platform 
technology in accordance with section 506A.
    ``(i) Definitions.--For purposes of this section:
            ``(1) The term `platform technology' means--
                    ``(A) a technology incorporated into a drug or 
                biological product, such as a nucleic acid sequence, 
                molecular structure, mechanism of action, delivery 
                method, or other technology the Secretary determines to 
                be appropriate, or combination of any such 
                technologies, that--
                            ``(i) is essential to the characterization 
                        of the drug or biological product; and
                            ``(ii) can be adapted for, or incorporated 
                        or utilized in, more than one drug or 
                        biological product sharing common structural 
                        elements; or
                    ``(B) a standardized production or manufacturing 
                process that is used to create or develop more than one 
                drug sharing common structural elements that can be 
                incorporated into multiple different drugs.
            ``(2) The term `designated platform technology' means a 
        platform technology that is designated as a platform technology 
        under subsection (d).
    ``(j) Rule of Construction.--Nothing in this section shall be 
construed to--
            ``(1) alter the authority of the Secretary to approve drugs 
        pursuant to section 505 of this Act or license biological 
        products pursuant to section 351 of the Public Health Service 
        Act, including standards of evidence and applicable conditions 
        for approval or licensure under the applicable Act; or
            ``(2) confer any new rights with respect to the 
        permissibility of a sponsor of an application for a drug 
        product or biological product referencing information contained 
        in another application submitted by the holder of an approved 
        application under section 505(c) of this Act or of a license 
        under section 351(a) of the Public Health Service Act.''.
    (b) Report.--Not later than 2 years after the date of enactment of 
this Act, the Secretary of Health and Human Services shall issue 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, on the platform technology designation program under 
section 506K of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a). Such report shall include--
            (1) the number of requests for designation under such 
        program;
            (2) the number of designations under such program issued, 
        active, and revoked;
            (3) the resources required to carry out such program 
        (including the review time used for full-time equivalent 
        employees);
            (4) any efficiencies gained in the development, 
        manufacturing, and review processes associated with such 
        designations; and
            (5) recommendations, if any, to strengthen the program to 
        better leverage platform technologies that can be used in more 
        than one drug and meet patient needs in a manner as timely as 
        possible, taking into consideration the resources available to 
        the Secretary of Health and Human Services for carrying out 
        such program.

SEC. 507. INCREASING EUA DECISION TRANSPARENCY.

    Section 564(h)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-3(h)(1)) is amended--
            (1) by inserting ``on the internet website of the Food and 
        Drug Administration and'' after ``promptly publish''; and
            (2) by striking ``application under section 505(i), 512(j), 
        or 520(g), even if such summary may indirectly reveal the 
        existence of such application'' and inserting ``application, 
        request, or submission under this section or section 505(b), 
        505(i), 505(j), 512(b), 512(j), 512(n), 515, 510(k), 513(f)(2), 
        520(g), 520(m), 571, or 572 of this Act, or section 351(a) or 
        351(k) of the Public Health Service Act, even if such summary 
        may reveal the existence of such an application, request, or 
        submission, or data contained in such application, request, or 
        submission''.

SEC. 508. IMPROVING FDA GUIDANCE AND COMMUNICATION.

    (a) FDA Report and Implementation of Good Guidance Practices.--The 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary'') shall develop, and publish on the website of the 
Food and Drug Administration--
            (1) a report identifying best practices for the efficient 
        prioritization, development, issuance, and use of guidance 
        documents, within centers, across the Food and Drug 
        Administration, and across other applicable agencies; and
            (2) a plan for implementation of such best practices, 
        including across other applicable agencies, which shall 
        address--
                    (A) streamlining development and review of guidance 
                documents within centers and across the Food and Drug 
                Administration;
                    (B) streamlining processes for regulatory 
                submissions to the Food and Drug Administration, 
                including through the revision or issuance of guidance 
                documents; and
                    (C) implementing innovative guidance development 
                processes and practices and transitioning or updating 
                guidance issued during the COVID-19 public health 
                emergency, as appropriate.
    (b) Report and Implementation of FDA Best Practices for 
Communicating With External Stakeholders.--The Secretary, acting 
through the Commissioner of Food and Drugs, shall develop and publish 
on the website of the Food and Drug Administration a report on the 
practices of the Food and Drug Administration to broadly communicate 
with external stakeholders, other than through guidance documents, 
which shall include--
            (1) a review of the types and methods of public 
        communication that the Food and Drug Administration uses to 
        communicate and interact with medical product sponsors and 
        other external stakeholders;
            (2) the identification of best practices for the efficient 
        development, issuance, and use of such communications; and
            (3) a plan for implementation of best practices for 
        communication with external stakeholders, which shall address--
                    (A) advancing the use of innovative forms of 
                communication, including novel document types and 
                formats, to provide increased regulatory clarity to 
                product sponsors and other stakeholders, and advancing 
                methods of communicating and interacting with medical 
                product sponsors and other external stakeholders, 
                including the use of tools such as product submission 
                templates, webinars, and frequently asked questions 
                communications;
                    (B) streamlining processes for regulatory 
                submissions; and
                    (C) implementing innovative communication 
                development processes and transitioning or updating 
                communication practices used during the COVID-19 public 
                health emergency, as appropriate.
    (c) Consultation.--In developing and publishing the report and 
implementation plan under this section, the Secretary shall consult 
with stakeholders, including researchers, academic organizations, 
pharmaceutical, biotechnology, and medical device developers, clinical 
research organizations, clinical laboratories, health care providers, 
patient groups, and other appropriate stakeholders.
    (d) Manner of Issuance.--For purposes of carrying out this section, 
the Secretary may update an existing report or plan, and may combine 
the reports and implementation plans described in subsections (a) and 
(b) into one or more documents.
    (e) Timing.--The Secretary shall--
            (1) not later than 1 year after the date of enactment of 
        this Act, publish a draft of the reports and plans required 
        under this section; and
            (2) not later than 180 days after publication of the draft 
        reports and plans under paragraph (1)--
                    (A) publish a final report and plan; and
                    (B) begin implementation of the best practices 
                pursuant to such final plan.

SEC. 509. GAO STUDY AND REPORT ON HIRING CHALLENGES AT FDA.

    (a) In General.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report assessing the policies, practices, processes, 
and programs of the Food and Drug Administration with respect to 
hiring, recruiting, and retention, and the impact of such policies, 
practices, processes, and programs on the agency's ability to carry out 
its public health mission, including the agency's ability to respond to 
the COVID-19 public health emergency. Such report may involve policies, 
practices, processes, and programs of the Department of Health and 
Human Services and other agencies, as applicable.
    (b) Content of Report.--The report required under subsection (a) 
shall include an assessment of--
            (1) challenges related to the efficient hiring, recruiting, 
        professional development, and retention of the Food and Drug 
        Administration workforce, including, as applicable, the end-to-
        end hiring process, time to hire, multiple hiring authorities, 
        salary levels, vacancy rates, and identification and 
        availability of candidates with necessary expertise;
            (2) causes of the challenges identified under paragraph 
        (1), including an analysis of relevant policies, practices, 
        processes, programs, organizational structure, resources, 
        training, remote work capabilities, and data systems;
            (3) challenges facing the Food and Drug Administration 
        workforce, including with respect to workload, diversity, 
        employee engagement, and morale;
            (4) the impact of challenges identified under paragraphs 
        (1) and (3) on operations of the Food and Drug Administration, 
        including on meeting user fee agreement performance goals and 
        inspection activities;
            (5) any hiring or retention plans of the Food and Drug 
        Administration, and progress towards implementation and the 
        metrics to measure success of such plans;
            (6) successful or efficient hiring policies or authorities, 
        including any relevant hiring authorities that resulted in 
        efficient hiring for vacant positions, such as temporary direct 
        hiring authorities during the COVID-19 public health emergency 
        response;
            (7) whether policies, practices, processes, and programs 
        related to hiring, recruiting, professional development, and 
        retention are implemented consistently across the Food and Drug 
        Administration;
            (8) recommendations to address challenges identified, 
        including recommendations regarding improvements to policies, 
        practices, processes, and programs of the Food and Drug 
        Administration with respect to hiring, recruiting, professional 
        development, and retention; and
            (9) challenges related to hiring, recruiting, and retaining 
        a qualified workforce to meet public health emergency response 
        needs, including any such challenges identified during the 
        COVID-19 public health emergency.

                    Subtitle B--Mitigating Shortages

SEC. 511. ENSURING REGISTRATION OF FOREIGN DRUG AND DEVICE 
              MANUFACTURERS.

    (a) Registration of Certain Foreign Establishments.--Section 510(i) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
amended by adding at the end the following:
    ``(5) The requirements of paragraphs (1) and (2) shall apply 
regardless of whether the drug or device undergoes further manufacture, 
preparation, propagation, compounding, or processing at a separate 
establishment outside the United States prior to being imported or 
offered for import into the United States.''.
    (b) Updating Regulations.--Not later than 2 years after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
update regulations, as appropriate, to implement the amendment made by 
subsection (a).

SEC. 512. EXTENDING EXPIRATION DATES FOR CERTAIN DRUGS.

    (a) In General.--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 issue draft guidance, or 
revise existing guidance, to address recommendations for sponsors of 
applications submitted under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health 
Service Act (42 U.S.C. 262) regarding--
            (1) the submission of stability testing data in such 
        applications, including considerations for data requirements 
        that could be streamlined or reduced to facilitate faster 
        review of longer proposed expiration dates;
            (2) establishing in the labeling of drugs the longest 
        feasible expiration date scientifically supported by such data, 
        taking into consideration how extended expiration dates may--
                    (A) help prevent or mitigate drug shortages; and
                    (B) affect product quality; and
            (3) the use of innovative approaches for drug and 
        combination product stability modeling to support initial 
        product expiration dates and expiration date extensions.
    (b) Report.--Not later than 2 years after the date of enactment of 
this Act, and again 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 that includes--
            (1) the number of drugs for which the Secretary has 
        requested the manufacturer make a labeling change regarding the 
        expiration date; and
            (2) for each drug for which the Secretary has requested a 
        labeling change with respect to the expiration date, 
        information regarding the circumstances of such request, 
        including--
                    (A) the name and dose of such drug;
                    (B) the rationale for the request;
                    (C) whether the drug, at the time of the request, 
                was listed on the drug shortage list under section 506E 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                356e), or was at risk of shortage;
                    (D) whether the request was made during a public 
                health emergency declared under section 319 of the 
                Public Health Service Act (42 U.S.C. 247d); and
                    (E) whether the manufacturer made the requested 
                change by the requested date, and for instances where 
                the manufacturer does not make the requested change, 
                the manufacturer's justification for not making the 
                change, if the manufacturer agrees to provide such 
                justification for inclusion in the report.

SEC. 513. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT PROGRAM.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall conduct a 
pilot program under which the Secretary increases the conduct of 
unannounced inspections of foreign human drug facilities and evaluates 
the differences between inspections of domestic and foreign human drug 
facilities, including the impact of announcing inspections to persons 
who own or operate foreign human drug facilities in advance of an 
inspection. Such pilot program shall evaluate--
            (1) differences in the number and type of violations of 
        section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 351(a)(2)(B)) identified during unannounced and 
        announced inspections of foreign human drug facilities and any 
        other significant differences between each type of inspection;
            (2) costs and benefits associated with conducting announced 
        and unannounced inspections of foreign human drug facilities;
            (3) barriers to conducting unannounced inspections of 
        foreign human drug facilities and any challenges to achieving 
        parity between domestic and foreign human drug facility 
        inspections; and
            (4) approaches for mitigating any negative effects of 
        conducting announced inspections of foreign human drug 
        facilities.
    (b) Pilot Program Initiation.--The Secretary shall initiate the 
pilot program under this section not later than 180 days after the date 
of enactment of this Act.
    (c) Report.--The Secretary shall, not later than 180 days following 
the completion of the pilot program, make available on the website of 
the Food and Drug Administration a final report on the pilot program 
under this section, including--
            (1) findings and any associated recommendations with 
        respect to the evaluation under subsection (a), including any 
        recommendations to address identified barriers to conducting 
        unannounced inspections of foreign human drug facilities;
            (2) findings and any associated recommendations regarding 
        how the Secretary may achieve parity between domestic and 
        foreign human drug inspections; and
            (3) the number of unannounced inspections during the pilot 
        that would not be unannounced under existing practices.

SEC. 514. COMBATING COUNTERFEIT DEVICES.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(fff)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, stamp, tag, 
label, or other identification upon any device or container, packaging, 
or labeling thereof so as to render such device a counterfeit device.
    ``(2) Making, selling, disposing of, or keeping in possession, 
control, or custody, or concealing any punch, die, plate, stone, or 
other thing designed to print, imprint, or reproduce the trademark, 
trade name, or other identifying mark or imprint of another or any 
likeness of any of the foregoing upon any device or container, 
packaging, or labeling thereof so as to render such device a 
counterfeit device.
    ``(3) The doing of any act which causes a device to be a 
counterfeit device, or the sale or dispensing, or the holding for sale 
or dispensing, of a counterfeit device.''.
    (b) Penalties.--Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333) is amended--
            (1) in subsection (b)(8), by inserting ``, or who violates 
        section 301(fff)(3) by knowingly making, selling or dispensing, 
        or holding for sale or dispensing, a counterfeit device,'' 
        after ``a counterfeit drug''; and
            (2) in subsection (c), by inserting ``; or (6) for having 
        violated section 301(fff)(2) if such person acted in good faith 
        and had no reason to believe that use of the punch, die, plate, 
        stone, or other thing involved would result in a device being a 
        counterfeit device, or for having violated section 301(fff)(3) 
        if the person doing the act or causing it to be done acted in 
        good faith and had no reason to believe that the device was a 
        counterfeit device'' before the period.
    (c) Seizure.--Section 304(a)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334(a)(2)) is amended--
            (1) by striking ``, and (E)'' and inserting ``, (E)''; and
            (2) by inserting ``, (F) Any device that is a counterfeit 
        device, (G) Any container, packaging, or labeling of a 
        counterfeit device, and (H) Any punch, die, plate, stone, 
        labeling, container, or other thing used or designed for use in 
        making a counterfeit device or devices'' before the period.

SEC. 515. STRENGTHENING MEDICAL DEVICE SUPPLY CHAINS.

    (a) In General.--Section 506J of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356j) is amended--
            (1) by redesignating subsections (h) and (i) as subsections 
        (j) and (k), respectively; and
            (2) by inserting after subsection (g) the following:
    ``(h) Risk Management Plans.--Each manufacturer of a device that is 
critical to public health, including devices that are life-supporting, 
life-sustaining, or intended for use in emergency medical care, shall 
develop, maintain, and, as appropriate, implement a redundancy risk 
management plan that identifies and evaluates risks to the supply of 
the device, as applicable, for each establishment in which such device 
is manufactured. A risk management plan under this subsection--
            ``(1) may identify and evaluate risks to the supply of more 
        than one device, or device category, manufactured at the same 
        establishment; and
            ``(2) shall be subject to inspection and copying by the 
        Secretary pursuant to section 704 or at the request of the 
        Secretary.''.
    (b) Report.--Not later than 2 years after the date of enactment of 
this Act, and annually for 4 years thereafter, the Secretary of Health 
and Human Services shall prepare 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 report on the use 
of information manufacturers submit pursuant to section 506J of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j) and applicable 
guidance issued with respect to such section.

SEC. 516. PREVENTING MEDICAL DEVICE SHORTAGES.

    (a) Notifications.--Section 506J of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356j), as amended by section 515, is further 
amended--
            (1) in the flush text at the end of subsection (a), by 
        inserting ``or of any other circumstance that is likely to lead 
        to a meaningful disruption in the supply of the device or a 
        shortage of the device, and there is no other available device 
        that could reasonably be substituted for that device in the 
        United States'' before the period;
            (2) in subsection (f), by inserting ``or (i)'' after 
        ``subsection (a)''; and
            (3) by inserting after subsection (h), as added by section 
        515, the following:
    ``(i) Additional Notifications.--The Secretary may receive 
notifications from a manufacturers of a device that is life-supporting, 
life-sustaining, or intended for use in emergency medical care or 
during surgery, or any other device the Secretary determines to be 
critical to the public health, pertaining to a permanent discontinuance 
in the manufacture of the device (except for any discontinuance as a 
result of an approved modification of the device) or an interruption of 
the manufacture of the device that is likely to lead to a meaningful 
disruption in the supply of that device in the United States, and the 
reasons for such discontinuance or interruption.''.
    (b) Guidance on Voluntary Notifications of Discontinuance or 
Interruption of Device Manufacture.--Not later than 1 year after the 
date of enactment of this Act, the Secretary shall issue draft guidance 
to facilitate voluntary notifications under subsection (i) of section 
506J of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356j), as 
added by subsection (a). Such guidance shall include a description of 
circumstances in which a voluntary notification under such subsection 
(i) may be appropriate, recommended timeframes within which sponsors 
should submit such a notification, the process for receiving such 
notifications, and actions the Secretary may take to mitigate or 
prevent a shortage resulting from a discontinuance or interruption in 
the manufacture of a device for which such notification is received. 
The Secretary shall issue final guidance not later than 1 year after 
the close of the comment period for the draft guidance.

SEC. 517. REMOTE RECORDS ASSESSMENTS FOR MEDICAL DEVICES.

    (a) Factory Inspection.--Section 704(a)(4)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended--
            (1) in the first sentence, by inserting ``or device'' after 
        ``processing of a drug''; and
            (2) in the second sentence, by striking ``shall include'' 
        and all that follows through the period at the end and 
        inserting the following: ``shall include--
                    ``(A) a description of the records requested; and
                    ``(B) a rationale for requesting such information 
                in advance of, or in lieu of, an inspection.''.
    (b) Guidance.--Not later than 1 year after the date of enactment of 
this Act, the Secretary shall issue draft guidance describing 
circumstances in which the Secretary intends to issue requests for 
records or other information in advance of, or in lieu of, an 
inspection, processes for responding to such requests electronically or 
in physical form, and factors the Secretary intends to consider in 
evaluating whether such records are provided within a reasonable 
timeframe, within reasonable limits, and in a reasonable manner, 
accounting for resource and other limitations that may exist, including 
for small businesses. The Secretary shall issue final guidance not 
later than 1 year after the close of the comment period for the draft 
guidance.

SEC. 518. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT 
              PROGRAM.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.), as amended by section 506, is further 
amended by inserting after section 506K the following:

``SEC. 506L. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PILOT 
              PROGRAM.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of this section, the Secretary shall initiate a pilot program 
under which persons may request designation of an advanced 
manufacturing technology as described in subsection (b).
    ``(b) Designation Process.--The Secretary shall establish a process 
for the designation under this section of methods of manufacturing 
drugs, including biological products, and active pharmaceutical 
ingredients of such drugs, as advanced manufacturing technologies. A 
method of manufacturing, or a combination of manufacturing methods, is 
eligible for designation as an advanced manufacturing technology if 
such method or combination of methods incorporates a novel technology, 
or uses an established technique or technology in a novel way, that 
will substantially--
            ``(1) enhance drug quality; or
            ``(2) improve the manufacturing process for a drug and 
        maintain drug quality, including by--
                    ``(A) reducing development time for a drug using 
                the designated manufacturing method; or
                    ``(B) increasing or maintaining the supply of--
                            ``(i) a drug that is life-supporting, life-
                        sustaining, or of critical importance to 
                        providing health care; or
                            ``(ii) a drug that is on the drug shortage 
                        list under section 506E.
    ``(c) Evaluation and Designation of an Advanced Manufacturing 
Technology.--
            ``(1) Submission.--A person who requests designation of a 
        method of manufacturing as an advanced manufacturing technology 
        under this section shall submit to the Secretary data or 
        information demonstrating that the method of manufacturing 
        meets the criteria described in subsection (b) in a particular 
        context of use. The Secretary may facilitate the development 
        and review of such data or information by--
                    ``(A) providing timely advice to, and interactive 
                communication with, such person regarding the 
                development of the method of manufacturing; and
                    ``(B) involving senior managers and experienced 
                staff of the Food and Drug Administration, as 
                appropriate, in a collaborative, cross-disciplinary 
                review of the method of manufacturing, as applicable.
            ``(2) Evaluation and designation.--Not later than 180 
        calendar days after the receipt of a request under paragraph 
        (1), the Secretary shall determine whether to designate such 
        method of manufacturing as an advanced manufacturing 
        technology, in a particular context of use, based on the data 
        and information submitted under paragraph (1) and the criteria 
        described in subsection (b).
    ``(d) Review of Advanced Manufacturing Technologies.--If the 
Secretary designates a method of manufacturing as an advanced 
manufacturing technology, the Secretary shall--
            ``(1) expedite the development and review of an application 
        submitted under section 505 of this Act or section 351 of the 
        Public Health Service Act, including supplemental applications, 
        for drugs that are manufactured using a designated advanced 
        manufacturing technology; and
            ``(2) allow the holder of an advanced technology 
        designation, or a person authorized by the advanced 
        manufacturing technology designation holder, to reference or 
        rely upon, in an application submitted under section 505 of 
        this Act or section 351 of the Public Health Service Act, 
        including a supplemental application, data and information 
        about the designated advanced manufacturing technology for use 
        in manufacturing drugs in the same context of use for which the 
        designation was granted.
    ``(e) Implementation and Evaluation of Advanced Manufacturing 
Technologies Pilot.--
            ``(1) Public meeting.--The Secretary shall publish in the 
        Federal Register a notice of a public meeting, to be held not 
        later than 180 days after the date of enactment of this 
        section, to discuss, and obtain input and recommendations from 
        relevant stakeholders regarding--
                    ``(A) the goals and scope of the pilot program, and 
                a suitable framework, procedures, and requirements for 
                such program; and
                    ``(B) ways in which the Food and Drug 
                Administration will support the use of advanced 
                manufacturing technologies and other innovative 
                manufacturing approaches for drugs.
            ``(2) Pilot program guidance.--
                    ``(A) In general.--The Secretary shall--
                            ``(i) not later than 180 days after the 
                        public meeting under paragraph (1), issue draft 
                        guidance regarding the goals and implementation 
                        of the pilot program under this section; and
                            ``(ii) not later than 2 years after the 
                        date of enactment of this section, issue final 
                        guidance regarding the implementation of such 
                        program.
                    ``(B) Content.--The guidance described in 
                subparagraph (A) shall address--
                            ``(i) the process by which a person may 
                        request a designation under subsection (b);
                            ``(ii) the data and information that a 
                        person requesting such a designation is 
                        required to submit under subsection (c), and 
                        how the Secretary intends to evaluate such 
                        submissions;
                            ``(iii) the process to expedite the 
                        development and review of applications under 
                        subsection (d); and
                            ``(iv) the criteria described in subsection 
                        (b) for eligibility for such a designation.
            ``(3) Report.--Not later than 3 years after the date of 
        enactment of this section and annually thereafter, the 
        Secretary shall publish on the website of the Food and Drug 
        Administration 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 report 
        containing a description and evaluation of the pilot program 
        being conducted under this section, including the types of 
        innovative manufacturing approaches supported under the 
        program. Such report shall include the following:
                    ``(A) The number of persons that have requested 
                designations and that have been granted designations.
                    ``(B) The number of methods of manufacturing that 
                have been the subject of designation requests and that 
                have been granted designations.
                    ``(C) The average number of calendar days for 
                completion of evaluations under subsection (c)(2).
                    ``(D) An analysis of the factors in data 
                submissions that result in determinations to designate 
                and not to designate after evaluation under subsection 
                (c)(2).
                    ``(E) The number of applications received under 
                section 505 of this Act or section 351 of the Public 
                Health Service Act, including supplemental 
                applications, that have included an advanced 
                manufacturing technology designated under this section, 
                and the number of such applications approved.
    ``(f) Sunset.--The Secretary--
            ``(1) may not consider any requests for designation 
        submitted under subsection (c) after October 1, 2029; and
            ``(2) may continue all activities under this section with 
        respect to advanced manufacturing technologies that were 
        designated pursuant to subsection (d) prior to such date, if 
        the Secretary determines such activities are in the interest of 
        the public health.''.

SEC. 519. TECHNICAL CORRECTIONS.

    (a) Technical Corrections to the CARES Act.--Division A of the 
CARES Act (Public Law 116-136) is amended--
            (1) in section 3111(1), by striking ``in paragraph (1)'' 
        and inserting ``in the matter preceding paragraph (1)'';
            (2) in section 3112(d)(1), by striking ``and subparagraphs 
        (A) and (B)'' and inserting ``as subparagraphs (A) and (B)''; 
        and
            (3) in section 3112(e), by striking ``Federal Food, Drug, 
        Cosmetic Act'' and inserting ``Federal Food, Drug, and Cosmetic 
        Act''.
    (b) Technical Corrections to the Federal Food, Drug, and Cosmetic 
Act Related to the CARES Act.--
            (1) Section 506c.--Section 506C(a) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 356c(a)) is amended, in the 
        flush text at the end, by striking the second comma after ``in 
        the United States''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect as if included in section 3112 of division A 
        of the CARES Act (Public Law 116-136).
    (c) Other Technical Correction to the Federal Food, Drug, and 
Cosmetic Act.--Section 505B(f)(6)(I) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c(f)(6)(I)) is amended by striking 
``subsection (a)(3)(B)'' and inserting ``subsection (a)(4)(C)''.
                                 <all>