[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7328 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 7328

To reauthorize certain programs under the Public Health Service Act and 
the Federal Food, Drug, and Cosmetic Act with respect to public health 
  security and all-hazards preparedness and response, to clarify the 
regulatory framework with respect to certain nonprescription drugs that 
   are marketed without an approved drug application, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 19, 2018

Mrs. Brooks of Indiana (for herself, Ms. Eshoo, Mr. Latta, Ms. DeGette, 
Mr. Guthrie, and Mrs. Dingell) introduced the following bill; which was 
 referred to the Committee on Energy and Commerce, and in addition to 
   the Committees on Veterans' Affairs, the Judiciary, and Homeland 
Security, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To reauthorize certain programs under the Public Health Service Act and 
the Federal Food, Drug, and Cosmetic Act with respect to public health 
  security and all-hazards preparedness and response, to clarify the 
regulatory framework with respect to certain nonprescription drugs that 
   are marketed without an approved drug application, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
    DIVISION A--PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING 
                               INNOVATION

Sec. 100. References in division.
      TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

Sec. 101. National Health Security Strategy.
             TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

Sec. 201. Improving benchmarks and standards for preparedness and 
                            response.
Sec. 202. Amendments to preparedness and response programs.
Sec. 203. Regional health care emergency preparedness and response 
                            systems.
Sec. 204. Military and civilian partnership for trauma readiness.
Sec. 205. Public health and health care system situational awareness 
                            and biosurveillance capabilities.
Sec. 206. Strengthening and supporting the public health emergency 
                            rapid response fund.
Sec. 207. Improving all-hazards preparedness and response by public 
                            health emergency volunteers.
Sec. 208. Clarifying State liability law for volunteer health care 
                            professionals.
Sec. 209. Report on adequate national blood supply.
Sec. 210. Report on the public health preparedness and response 
                            capabilities and capacities of hospitals, 
                            long-term care facilities, and other health 
                            care facilities.
                  TITLE III--REACHING ALL COMMUNITIES

Sec. 301. Strengthening and assessing the emergency response workforce.
Sec. 302. Health system infrastructure to improve preparedness and 
                            response.
Sec. 303. Considerations for at-risk individuals.
Sec. 304. Improving emergency preparedness and response considerations 
                            for children.
Sec. 305. National advisory committees on disasters.
Sec. 306. Guidance for participation in exercises and drills.
             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, 
                            and other significant threats.
Sec. 405. Reporting on the Federal Select Agent Program.
 TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED 
                        RESEARCH AND DEVELOPMENT

Sec. 501. Medical countermeasure budget plan.
Sec. 502. Material threat and medical countermeasure notifications.
Sec. 503. Availability of regulatory management plans.
Sec. 504. The Biomedical Advanced Research and Development Authority 
                            and the BioShield Special Reserve Fund.
Sec. 505. Additional strategies for combating antibiotic resistance.
      TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

Sec. 601. Administration of countermeasures.
Sec. 602. Updating definitions of other transactions.
Sec. 603. Medical countermeasure master files.
Sec. 604. Animal rule report.
Sec. 605. Review of the benefits of genomic engineering technologies 
                            and their potential role in national 
                            security.
Sec. 606. Report on vaccines development.
Sec. 607. Strengthening mosquito abatement for safety and health.
                  TITLE VII--MISCELLANEOUS PROVISIONS

Sec. 701. Reauthorizations and extensions.
Sec. 702. Location of materials in the stockpile.
Sec. 703. Cybersecurity.
Sec. 704. Strategy and report.
Sec. 705. Technical amendments.
 DIVISION B--OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM

Sec. 1000. Short title; references in division.
                        TITLE I--OTC DRUG REVIEW

Sec. 1001. Regulation of certain nonprescription drugs that are 
                            marketed without an approved drug 
                            application.
Sec. 1002. Misbranding.
Sec. 1003. Drugs excluded from the over-the-counter drug review.
Sec. 1004. Treatment of Sunscreen Innovation Act.
Sec. 1005. Annual update to Congress on appropriate pediatric 
                            indication for certain OTC cough and cold 
                            drugs.
Sec. 1006. Technical corrections.
                          TITLE II--USER FEES

Sec. 2001. Short title; finding.
Sec. 2002. Fees relating to over-the-counter drugs.

    DIVISION A--PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING 
                               INNOVATION

SEC. 100. REFERENCES IN DIVISION.

    Except as otherwise specified--
            (1) amendments made by this division to a section or other 
        provision of law are amendments to such section or other 
        provision of the Public Health Service Act (42 U.S.C. 201 et 
        seq.); and
            (2) any reference to ``this Act'' contained in this 
        division shall be treated as referring only to the provisions 
        of this division.

      TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

    Section 2802 (42 U.S.C. 300hh-1) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) by striking ``2014'' and inserting 
                        ``2018''; and
                            (ii) by striking the second sentence and 
                        inserting the following: ``Such National Health 
                        Security Strategy shall describe potential 
                        emergency health security threats and identify 
                        the process for achieving the preparedness 
                        goals described in subsection (b) to be 
                        prepared to identify and respond to such 
                        threats and shall be consistent with the 
                        national preparedness goal (as described in 
                        section 504(a)(19) of the Homeland Security Act 
                        of 2002), the National Incident Management 
                        System (as defined in section 501(7) of such 
                        Act), and the National Response Plan developed 
                        pursuant to section 504 of such Act, or any 
                        successor plan.'';
                    (B) in paragraph (2), by inserting before the 
                period at the end of the second sentence the following: 
                ``, and an analysis of any changes to the evidence-
                based benchmarks and objective standards under sections 
                319C-1 and 319C-2''; and
                    (C) in paragraph (3)--
                            (i) by striking ``2009'' and inserting 
                        ``2022'';
                            (ii) by inserting ``(including gaps in the 
                        environmental health and animal health 
                        workforces, as applicable), describing the 
                        status of such workforce'' after ``gaps in such 
                        workforce'';
                            (iii) by striking ``and identifying 
                        strategies'' and inserting ``identifying 
                        strategies''; and
                            (iv) by inserting before the period at the 
                        end ``, and identifying current capabilities to 
                        meet the requirements of section 2803''; and
            (2) in subsection (b)--
                    (A) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``and 
                        investigation'' and inserting ``investigation, 
                        and related information technology 
                        activities'';
                            (ii) in subparagraph (B), by striking ``and 
                        decontamination'' and inserting 
                        ``decontamination, relevant health care 
                        services and supplies, and transportation and 
                        disposal of medical waste''; and
                            (iii) by adding at the end the following:
                    ``(E) Response to environmental hazards.'';
                    (B) in paragraph (3)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``including mental health'' 
                        and inserting ``including pharmacies, mental 
                        health facilities,''; and
                            (ii) in subparagraph (F), by inserting ``or 
                        exposures to agents that could cause a public 
                        health emergency'' before the period;
                    (C) in paragraph (5), by inserting ``and other 
                applicable compacts'' after ``Compact''; and
                    (D) by adding at the end the following:
            ``(9) Zoonotic disease, food, and agriculture.--Improving 
        coordination among Federal, State, local, tribal, and 
        territorial entities (including through consultation with the 
        Secretary of Agriculture) to prevent, detect, and respond to 
        outbreaks of plant or animal disease (including zoonotic 
        disease) that could compromise national security resulting from 
        a deliberate attack, a naturally occurring threat, the 
        intentional adulteration of food, or other public health 
        threats, taking into account interactions between animal 
        health, human health, and animals' and humans' shared 
        environment as directly related to public health emergency 
        preparedness and response capabilities, as applicable.
            ``(10) Global health security.--Assessing current or 
        potential health security threats from abroad to inform 
        domestic public health preparedness and response 
        capabilities.''.

             TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR PREPAREDNESS AND 
              RESPONSE.

    (a) Evaluating Measurable Evidence-Based Benchmarks and Objective 
Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is amended by inserting 
after subsection (j) the following:
    ``(k) Evaluation.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018 and every 2 years thereafter, 
        the Secretary shall conduct an evaluation of the evidence-based 
        benchmarks and objective standards required under subsection 
        (g). Such evaluation shall be submitted to the congressional 
        committees of jurisdiction together with the National Health 
        Security Strategy under section 2802, at such time as such 
        strategy is submitted.
            ``(2) Content.--The evaluation under this paragraph shall 
        include--
                    ``(A) a review of evidence-based benchmarks and 
                objective standards, and associated metrics and 
                targets;
                    ``(B) a discussion of changes to any evidence-based 
                benchmarks and objective standards, and the effect of 
                such changes on the ability to track whether entities 
                are meeting or making progress toward the goals under 
                this section and, to the extent practicable, the 
                applicable goals of the National Health Security 
                Strategy under section 2802;
                    ``(C) a description of amounts received by eligible 
                entities described in subsection (b) and section 319C-
                2(b), and amounts received by subrecipients and the 
                effect of such funding on meeting evidence-based 
                benchmarks and objective standards; and
                    ``(D) recommendations, as applicable and 
                appropriate, to improve evidence-based benchmarks and 
                objective standards to more accurately assess the 
                ability of entities receiving awards under this section 
                to better achieve the goals under this section and 
                section 2802.''.
    (b) Evaluating the Partnership for State and Regional Hospital 
Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-3b(i)(1)) is amended 
by striking ``section 319C-1(g), (i), and (j)'' and inserting ``section 
319C-1(g), (i), (j), and (k)''.

SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS.

    (a) Cooperative Agreement Applications for Improving State and 
Local Public Health Security.--Section 319C-1 (42 U.S.C. 247d-3a) is 
amended--
            (1) in subsection (a), by inserting ``, acting through the 
        Director of the Centers for Disease Control and Prevention,'' 
        after ``the Secretary''; and
            (2) in subsection (b)(2)(A)--
                    (A) in clause (vi), by inserting ``, including 
                public health agencies with specific expertise that may 
                be relevant to public health security, such as 
                environmental health agencies,'' after 
                ``stakeholders'';
                    (B) by redesignating clauses (vii) through (ix) as 
                clauses (viii) through (x);
                    (C) by inserting after clause (vi) the following:
                            ``(vii) a description of how, as 
                        applicable, such entity may integrate 
                        information to account for individuals with 
                        behavioral health needs following a public 
                        health emergency;'';
                    (D) in clause (ix), as so redesignated, by striking 
                ``; and'' and inserting a semicolon; and
                    (E) by adding at the end the following:
                            ``(xi) a description of how the entity will 
                        partner with health care facilities, including 
                        hospitals and nursing homes and other long-term 
                        care facilities, to promote and improve public 
                        health preparedness and response; and
                            ``(xii) a description of how, as 
                        appropriate and practicable, the entity will 
                        include critical infrastructure partners, such 
                        as utility companies within the entity's 
                        jurisdiction, in planning pursuant to this 
                        subparagraph to help ensure that critical 
                        infrastructure will remain functioning during, 
                        or return to function as soon as practicable 
                        after, a public health emergency;''.
    (b) Exception Relating to Application of Certain Requirements.--
            (1) In general.--Section 319C-1(g) (42 U.S.C. 247d-3a(g)) 
        is amended--
                    (A) in paragraph (5)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``Beginning with fiscal year 
                        2009'' and inserting ``Beginning with fiscal 
                        year 2019''; and
                            (ii) in subparagraph (A)--
                                    (I) by striking ``for the 
                                immediately preceding fiscal year'' and 
                                inserting ``for either of the 2 
                                immediately preceding fiscal years''; 
                                and
                                    (II) by striking ``2008'' and 
                                inserting ``2018''; and
                    (B) in paragraph (6), by amending subparagraph (A) 
                to read as follows:
                    ``(A) In general.--The amounts described in this 
                paragraph are the following amounts that are payable to 
                an entity for activities described in this section or 
                section 319C-2:
                            ``(i) For no more than 1 of each of the 
                        first 2 fiscal years immediately following a 
                        fiscal year in which an entity experienced a 
                        failure described in subparagraph (A) or (B) of 
                        paragraph (5), an amount equal to 10 percent of 
                        the amount the entity was eligible to receive 
                        for the respective fiscal year.
                            ``(ii) For no more than 1 of the first 2 
                        fiscal years immediately following the third 
                        consecutive fiscal year in which an entity 
                        experienced such a failure, in lieu of applying 
                        clause (i), an amount equal to 15 percent of 
                        the amount the entity was eligible to receive 
                        for the respective fiscal year.''.
            (2) Effective date.--The amendments made by paragraph (1) 
        shall apply with respect to cooperative agreements awarded on 
        or after the date of enactment of this Act.
    (c) Partnership for State and Regional Hospital Preparedness to 
Improve Surge Capacity.--Section 319C-2 (42 U.S.C. 247d-3b) is 
amended--
            (1) in subsection (a)--
                    (A) by inserting ``, acting through the Assistant 
                Secretary for Preparedness and Response,'' after ``The 
                Secretary''; and
                    (B) by striking ``preparedness for public health 
                emergencies'' and inserting ``preparedness for, and 
                response to, public health emergencies in accordance 
                with subsection (c)'';
            (2) in subsection (b)(1)(A)--
                    (A) by striking ``partnership consisting of'' and 
                inserting ``coalition that includes'';
                    (B) in clause (ii), by striking ``; and'' and 
                inserting a semicolon; and
                    (C) by adding at the end the following:
                    ``(iv) one or more emergency medical service 
                organizations or emergency management organizations; 
                and'';
            (3) in subsection (d)--
                    (A) in paragraph (1)(B), by striking 
                ``partnership'' each place it appears and inserting 
                ``coalition''; and
                    (B) in paragraph (2)(C), by striking ``medical 
                preparedness'' and inserting ``preparedness and 
                response'';
            (4) in subsection (f), by striking ``partnership'' and 
        inserting ``coalition'';
            (5) in subsection (g)(2)--
                    (A) by striking ``Partnerships'' and inserting 
                ``Coalitions'';
                    (B) by striking ``partnerships'' and inserting 
                ``coalitions''; and
                    (C) by inserting ``and response'' after 
                ``preparedness''; and
            (6) in subsection (i)(1)--
                    (A) by striking ``An entity'' and inserting ``A 
                coalition''; and
                    (B) by striking ``such partnership'' and inserting 
                ``such coalition''.
    (d) Public Health Security Grants Authorization of 
Appropriations.--Section 319C-1(h)(1)(A) (42 U.S.C. 247d-3a(h)(1)(A)) 
is amended by striking ``$641,900,000 for fiscal year 2014'' and all 
that follows through the period at the end and inserting ``$685,000,000 
for each of fiscal years 2019 through 2023 for awards pursuant to 
paragraph (3) (subject to the authority of the Secretary to make awards 
pursuant to paragraphs (4) and (5)).''.
    (e) Partnership for State and Regional Hospital Preparedness 
Authorization of Appropriations.--Section 319C-2(j) (42 U.S.C. 247d-
3b(j)) is amended--
            (1) by amending paragraph (1) to read as follows:
            ``(1) In general.--
                    ``(A) Authorization of appropriations.--For 
                purposes of carrying out this section and section 319C-
                3, in accordance with subparagraph (B), there is 
                authorized to be appropriated $385,000,000 for each of 
                fiscal years 2019 through 2023.
                    ``(B) Reservation of amounts for regional 
                systems.--
                            ``(i) In general.--Subject to clause (ii), 
                        of the amount appropriated under subparagraph 
                        (A) for a fiscal year, the Secretary may 
                        reserve up to 5 percent for the purpose of 
                        carrying out section 319C-3.
                            ``(ii) Reservation contingent on continued 
                        appropriations for this section.--If for fiscal 
                        year 2019 or a subsequent fiscal year, the 
                        amount appropriated under subparagraph (A) is 
                        such that, after application of clause (i), the 
                        amount remaining for the purpose of carrying 
                        out this section would be less than the amount 
                        available for such purpose for the previous 
                        fiscal year, the amount that may be reserved 
                        under clause (i) shall be reduced such that the 
                        amount remaining for the purpose of carrying 
                        out this section is not less than the amount 
                        available for such purpose for the previous 
                        fiscal year.
                            ``(iii) Sunset.--The authority to reserve 
                        amounts under clause (i) shall expire on 
                        September 30, 2023.'';
            (2) in paragraph (2), by striking ``paragraph (1) for a 
        fiscal year'' and inserting ``paragraph (1)(A) for a fiscal 
        year and not reserved for the purpose described in paragraph 
        (1)(B)(i)''; and
            (3) in paragraph (3)(A), by striking ``paragraph (1) and 
        not reserved under paragraph (2)'' and inserting ``paragraph 
        (1)(A) and not reserved under paragraph (1)(B)(i) or (2)''.

SEC. 203. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE 
              SYSTEMS.

    (a) In General.--Part B of title III (42 U.S.C. 243 et seq.) is 
amended by inserting after section 319C-2 the following:

``SEC. 319C-3. GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY 
              PREPAREDNESS AND RESPONSE SYSTEMS.

    ``(a) Purpose.--It is the purpose of this section to identify and 
provide guidelines for regional systems of hospitals, health care 
facilities, and other public and private sector entities, with varying 
levels of capability to treat patients and increase medical surge 
capacity during, in advance of, and immediately following a public 
health emergency, including threats posed by one or more chemical, 
biological, radiological, or nuclear agents, including emerging 
infectious diseases.
    ``(b) Guidelines.--The Assistant Secretary for Preparedness and 
Response, in consultation with the Director of the Centers for Disease 
Control and Prevention, the Administrator of the Centers for Medicare & 
Medicaid Services, the Administrator of the Health Resources and 
Services Administration, the Commissioner of Food and Drugs, the 
Assistant Secretary for Mental Health and Substance Use, the Assistant 
Secretary of Labor for Occupational Safety and Health, the Secretary of 
Veterans Affairs, the heads of such other Federal agencies as the 
Secretary determines to be appropriate, and State, local, tribal, and 
territorial public health officials, shall, not later than 2 years 
after the date of enactment of this section--
            ``(1) identify and develop a set of guidelines relating to 
        practices and protocols for all-hazards public health emergency 
        preparedness and response for hospitals and health care 
        facilities to provide appropriate patient care during, in 
        advance of, or immediately following, a public health 
        emergency, resulting from one or more chemical, biological, 
        radiological, or nuclear agents, including emerging infectious 
        diseases (which may include existing practices, such as trauma 
        care and medical surge capacity and capabilities), with respect 
        to--
                    ``(A) a regional approach to identifying hospitals 
                and health care facilities based on varying 
                capabilities and capacity to treat patients affected by 
                such emergency, including--
                            ``(i) the manner in which the system will 
                        coordinate with and integrate the partnerships 
                        and health care coalitions established under 
                        section 319C-2(b); and
                            ``(ii) informing and educating appropriate 
                        first responders and health care supply chain 
                        partners of the regional emergency preparedness 
                        and response capabilities and medical surge 
                        capacity of such hospitals and health care 
                        facilities in the community;
                    ``(B) physical and technological infrastructure, 
                laboratory capacity, staffing, blood supply, and other 
                supply chain needs, taking into account resiliency, 
                geographic considerations, and rural considerations;
                    ``(C) protocols or best practices for the safety 
                and personal protection of workers who handle human 
                remains and health care workers (including with respect 
                to protective equipment and supplies, waste management 
                processes, and decontamination), sharing of specialized 
                experience among the health care workforce, behavioral 
                health, psychological resilience, and training of the 
                workforce, as applicable;
                    ``(D) in a manner that allows for disease 
                containment (within the meaning of section 
                2802(b)(2)(B)), coordinated medical triage, treatment, 
                and transportation of patients, based on patient 
                medical need (including patients in rural areas), to 
                the appropriate hospitals or health care facilities 
                within the regional system or, as applicable and 
                appropriate, between systems in different States or 
                regions; and
                    ``(E) the needs of children and other at-risk 
                individuals;
            ``(2) make such guidelines available on the internet 
        website of the Department of Health and Human Services in a 
        manner that does not compromise national security; and
            ``(3) update such guidelines as appropriate, including 
        based on input received pursuant to subsections (c) and (e) and 
        information resulting from applicable reports required under 
        the Pandemic and All-Hazards Preparedness and Advancing 
        Innovation Act of 2018 (including any amendments made by such 
        Act), to address new and emerging public health threats.
    ``(c) Considerations.--In identifying, developing, and updating 
guidelines under subsection (b), the Assistant Secretary for 
Preparedness and Response shall--
            ``(1) include input from hospitals and health care 
        facilities (including health care coalitions under section 
        319C-2), State, local, tribal, and territorial public health 
        departments, and health care or subject matter experts 
        (including experts with relevant expertise in chemical, 
        biological, radiological, or nuclear threats, including 
        emerging infectious diseases), as the Assistant Secretary 
        determines appropriate, to meet the goals under section 
        2802(b)(3);
            ``(2) consult and engage with appropriate health care 
        providers and professionals, including physicians, nurses, 
        first responders, health care facilities (including hospitals, 
        primary care clinics, community health centers, mental health 
        facilities, ambulatory care facilities, and dental health 
        facilities), pharmacies, emergency medical providers, trauma 
        care providers, environmental health agencies, public health 
        laboratories, poison control centers, blood banks, tissue 
        banks, and other experts that the Assistant Secretary 
        determines appropriate, to meet the goals under section 
        2802(b)(3);
            ``(3) consider feedback related to financial implications 
        for hospitals, health care facilities, public health agencies, 
        laboratories, blood banks, tissue banks, and other entities 
        engaged in regional preparedness planning to implement and 
        follow such guidelines, as applicable; and
            ``(4) consider financial requirements and potential 
        incentives for entities to prepare for, and respond to, public 
        health emergencies as part of the regional health care 
        emergency preparedness and response system.
    ``(d) Technical Assistance.--The Assistant Secretary for 
Preparedness and Response, in consultation with the Director of the 
Centers for Disease Control and Prevention and the Assistant Secretary 
of Labor for Occupational Safety and Health, may provide technical 
assistance and consultation toward meeting the guidelines described in 
subsection (b).
    ``(e) Demonstration Project for Regional Health Care Preparedness 
and Response Systems.--
            ``(1) In general.--The Assistant Secretary for Preparedness 
        and Response may establish a demonstration project pursuant to 
        the development and implementation of guidelines under 
        subsection (b) to award grants to improve medical surge 
        capacity for all hazards, build and integrate regional medical 
        response capabilities, improve specialty care expertise for 
        all-hazards response, and coordinate medical preparedness and 
        response across State, local, tribal, territorial, and regional 
        jurisdictions.
            ``(2) Sunset.--The authority under this subsection shall 
        expire on September 30, 2023.''.
    (b) GAO Report to Congress.--
            (1) Report.--Not later than 3 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States (referred to in this subsection as the ``Comptroller 
        General'') shall submit to the Committee on Health, Education, 
        Labor, and Pensions and the Committee on Finance of the Senate 
        and the Committee on Energy and Commerce and the Committee on 
        Ways and Means of the House of Representatives, a report on the 
        extent to which hospitals and health care facilities have 
        implemented the recommended guidelines under section 319C-3(b) 
        of the Public Health Service Act (as added by subsection (a)), 
        including an analysis and evaluation of any challenges 
        hospitals or health care facilities experienced in implementing 
        such guidelines.
            (2) Content.--The Comptroller General shall include in the 
        report under paragraph (1)--
                    (A) data on the preparedness and response 
                capabilities that have been informed by the guidelines 
                under section 319C-3(b) of the Public Health Service 
                Act to improve regional emergency health care 
                preparedness and response capability, including 
                hospital and health care facility capacity and medical 
                surge capabilities to prepare for, and respond to, 
                public health emergencies; and
                    (B) recommendations to reduce gaps in incentives 
                for regional health partners, including hospitals and 
                health care facilities, to improve capacity and medical 
                surge capabilities to prepare for, and respond to, 
                public health emergencies, consistent with subsection 
                (a), which may include consideration of facilities 
                participating in programs under section 319C-2 of the 
                Public Health Service Act (42 U.S.C. 247d-3b) or in 
                programs under the Centers for Medicare & Medicaid 
                Services (including innovative health care delivery and 
                payment models), and input from private sector 
                financial institutions.
            (3) Consultation.--In carrying out paragraphs (1) and (2), 
        the Comptroller General shall consult with the heads of 
        appropriate Federal agencies, including--
                    (A) the Assistant Secretary for Preparedness and 
                Response;
                    (B) the Director of the Centers for Disease Control 
                and Prevention;
                    (C) the Administrator of the Centers for Medicare & 
                Medicaid Services;
                    (D) the Assistant Secretary for Mental Health and 
                Substance Use;
                    (E) the Assistant Secretary of Labor for 
                Occupational Safety and Health; and
                    (F) the Secretary of Veterans Affairs.
    (c) Annual Reports.--Section 319C-2(i)(1) (42 U.S.C. 247d-3b(i)(1)) 
is amended by inserting after the first sentence the following: ``In 
submitting reports under this paragraph, a coalition shall include 
information on the progress that the coalition has made toward the 
implementation of section 319C-3 (or barriers to progress, if any).''.
    (d) National Health Security Strategy Incorporation of Regionalized 
Emergency Preparedness and Response.--Subparagraph (G) of section 
2802(b)(3) (42 U.S.C. 300hh-1(b)(3)) is amended to read as follows:
                    ``(G) Optimizing a coordinated and flexible 
                approach to the emergency response and medical surge 
                capacity of hospitals, other health care facilities, 
                critical care, trauma care (which may include trauma 
                centers), and emergency medical systems.''.
    (e) Improving State and Local Public Health Security.--
            (1) State and local security.--Section 319C-1(e) (42 U.S.C. 
        247d-3a(e)) is amended by striking ``, and local emergency 
        plans.'' and inserting ``, local emergency plans, and any 
        regional health care emergency preparedness and response system 
        established pursuant to the applicable guidelines under section 
        319C-3.''.
            (2) Partnerships.--Section 319C-2(d)(1)(A) (42 U.S.C. 247d-
        3b(d)(1)(A)) is amended--
                    (A) in clause (i), by striking ``; and'' and 
                inserting ``;'';
                    (B) by redesignating clause (ii) as clause (iii); 
                and
                    (C) inserting after clause (i), the following:
                            ``(ii) among one or more facilities in a 
                        regional health care emergency system under 
                        section 319C-3; and''.

SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS.

    Title XII (42 U.S.C. 300d et seq.) is amended by adding at the end 
the following new part:

``PART I--MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT 
                                PROGRAM

``SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS 
              GRANT PROGRAM.

    ``(a) Military Trauma Team Placement Program.--
            ``(1) In general.--The Secretary, acting through the 
        Assistant Secretary for Preparedness and Response and in 
        consultation with the Secretary of Defense, shall award grants 
        to not more than 20 eligible high acuity trauma centers to 
        enable military trauma teams to provide, on a full-time basis, 
        trauma care and related acute care at such trauma centers.
            ``(2) Limitations.--In the case of a grant awarded under 
        paragraph (1) to an eligible high acuity trauma center, such 
        grant--
                    ``(A) shall be for a period of at least 3 years and 
                not more than 5 years (and may be renewed at the end of 
                such period); and
                    ``(B) shall be in an amount that does not exceed 
                $1,000,000 per year.
            ``(3) Availability of funds.--Notwithstanding section 1552 
        of title 31, United States Code, or any other provision of law, 
        funds available to the Secretary for obligation for a grant 
        under this subsection shall remain available for expenditure 
        for 100 days after the last day of the performance period of 
        such grant.
    ``(b) Military Trauma Care Provider Placement Program.--
            ``(1) In general.--The Secretary, acting through the 
        Assistant Secretary for Preparedness and Response and in 
        consultation with the Secretary of Defense, shall award grants 
        to eligible trauma centers to enable military trauma care 
        providers to provide trauma care and related acute care at such 
        trauma centers.
            ``(2) Limitations.--In the case of a grant awarded under 
        paragraph (1) to an eligible trauma center, such grant--
                    ``(A) shall be for a period of at least 1 year and 
                not more than 3 years (and may be renewed at the end of 
                such period); and
                    ``(B) shall be in an amount that does not exceed, 
                in a year--
                            ``(i) $100,000 for each military trauma 
                        care provider that is a physician at such 
                        eligible trauma center; and
                            ``(ii) $50,000 for each other military 
                        trauma care provider at such eligible trauma 
                        center.
    ``(c) Grant Requirements.--
            ``(1) Deployment and public health emergencies.--As a 
        condition of receipt of a grant under this section, a grant 
        recipient shall agree to allow military trauma care providers 
        providing care pursuant to such grant to--
                    ``(A) be deployed by the Secretary of Defense for 
                military operations, for training, or for response to a 
                mass casualty incident; and
                    ``(B) be deployed by the Secretary of Defense, in 
                consultation with the Secretary of Health and Human 
                Services, for response to a public health emergency 
                pursuant to section 319.
            ``(2) Use of funds.--Grants awarded under this section to 
        an eligible trauma center may be used to train and incorporate 
        military trauma care providers into such trauma center, 
        including incorporation into operational exercises and training 
        drills related to public health emergencies, expenditures for 
        malpractice insurance, office space, information technology, 
        specialty education and supervision, trauma programs, research, 
        and applicable license fees for such military trauma care 
        providers.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to affect any other provision of law that preempts State 
licensing requirements for health care professionals, including with 
respect to military trauma care providers.
    ``(e) Reporting Requirements.--
            ``(1) Report to the secretary and the secretary of 
        defense.--Each eligible trauma center or eligible high acuity 
        trauma center awarded a grant under subsection (a) or (b) for a 
        year shall submit to the Secretary and the Secretary of Defense 
        a report for such year that includes information on--
                    ``(A) the number and types of trauma cases managed 
                by military trauma teams or military trauma care 
                providers pursuant to such grant during such year;
                    ``(B) the ability to maintain the integration of 
                the military trauma providers or teams of providers as 
                part of the trauma center, including the financial 
                effect of such grant on the trauma center;
                    ``(C) the educational effect on resident trainees 
                in centers where military trauma teams are assigned;
                    ``(D) any research conducted during such year 
                supported by such grant; and
                    ``(E) any other information required by the 
                Secretaries for the purpose of evaluating the effect of 
                such grant.
            ``(2) Report to congress.--Not less than once every 2 
        years, the Secretary, in consultation with the Secretary of 
        Defense, shall submit a report to the congressional committees 
        of jurisdiction that includes information on the effect of 
        placing military trauma care providers in trauma centers 
        awarded grants under this section on--
                    ``(A) maintaining military trauma care providers' 
                readiness and ability to respond to and treat 
                battlefield injuries;
                    ``(B) providing health care to civilian trauma 
                patients in urban and rural settings;
                    ``(C) the capability of trauma centers and military 
                trauma care providers to increase medical surge 
                capacity, including as a result of a large scale event;
                    ``(D) the ability of grant recipients to maintain 
                the integration of the military trauma providers or 
                teams of providers as part of the trauma center;
                    ``(E) efforts to incorporate military trauma care 
                providers into operational exercises and training and 
                drills for public health emergencies; and
                    ``(F) the capability of military trauma care 
                providers to participate as part of a medical response 
                during or in advance of a public health emergency, as 
                determined by the Secretary, or a mass casualty 
                incident.
    ``(f) Definitions.--For purposes of this part:
            ``(1) Eligible trauma center.--The term `eligible trauma 
        center' means a Level I, II, or III trauma center that 
        satisfies each of the following:
                    ``(A) Such trauma center has an agreement with the 
                Secretary of Defense to enable military trauma care 
                providers to provide trauma care and related acute care 
                at such trauma center.
                    ``(B) Such trauma center utilizes a risk-adjusted 
                benchmarking system and metrics to measure performance, 
                quality, and patient outcomes.
                    ``(C) Such trauma center demonstrates a need for 
                integrated military trauma care providers to maintain 
                or improve the trauma clinical capability of such 
                trauma center.
            ``(2) Eligible high acuity trauma center.--The term 
        `eligible high acuity trauma center' means a Level I trauma 
        center that satisfies each of the following:
                    ``(A) Such trauma center has an agreement with the 
                Secretary of Defense to enable military trauma teams to 
                provide trauma care and related acute care at such 
                trauma center.
                    ``(B) At least 20 percent of patients treated at 
                such trauma center in the most recent 3-month period 
                for which data are available are treated for a major 
                trauma at such trauma center.
                    ``(C) Such trauma center utilizes a risk-adjusted 
                benchmarking system and metrics to measure performance, 
                quality, and patient outcomes.
                    ``(D) Such trauma center is an academic training 
                center--
                            ``(i) affiliated with a medical school;
                            ``(ii) that maintains residency programs 
                        and fellowships in critical trauma specialties 
                        and subspecialties, and provides education and 
                        supervision of military trauma team members 
                        according to those specialties and 
                        subspecialties; and
                            ``(iii) that undertakes research in the 
                        prevention and treatment of traumatic injury.
                    ``(E) Such trauma center serves as a medical and 
                public health preparedness and response leader for its 
                community, such as by participating in a partnership 
                for State and regional hospital preparedness 
                established under section 319C-2 or 319C-3.
            ``(3) Major trauma.--The term `major trauma' means an 
        injury that is greater than or equal to 15 on the injury 
        severity score.
            ``(4) Military trauma team.--The term `military trauma 
        team' means a complete military trauma team consisting of 
        military trauma care providers.
            ``(5) Military trauma care provider.--The term `military 
        trauma care provider' means a member of the Armed Forces who 
        furnishes emergency, critical care, and other trauma acute care 
        services (including a physician, surgeon, physician assistant, 
        nurse, nurse practitioner, respiratory therapist, flight 
        paramedic, combat medic, or enlisted medical technician) or 
        other military trauma care provider as the Secretary determines 
        appropriate.
    ``(g) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $11,500,000 for each of fiscal 
years 2019 through 2023.''.

SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL AWARENESS 
              AND BIOSURVEILLANCE CAPABILITIES.

    (a) Facilities, Capacities, and Biosurveillance Capabilities.--
Section 319D (42 U.S.C. 247d-4) is amended--
            (1) in the section heading, by striking ``revitalizing'' 
        and inserting ``facilities and capacities of'';
            (2) in subsection (a)--
                    (A) in the subsection heading, by striking 
                ``Facilities; Capacities'' and inserting ``In 
                General'';
                    (B) in paragraph (1), by striking ``and improved'' 
                and inserting ``, improved, and appropriately 
                maintained'';
                    (C) in paragraph (3), in the matter preceding 
                subparagraph (A), by striking ``expand, enhance, and 
                improve'' and inserting ``expand, improve, enhance, and 
                appropriately maintain''; and
                    (D) by adding at the end the following:
            ``(4) Study of resources for facilities and capacities.--
        Not later than June 1, 2022, the Comptroller General of the 
        United States shall conduct a study on Federal spending in 
        fiscal years 2013 through 2018 for activities authorized under 
        this subsection. Such study shall include a review and 
        assessment of obligations and expenditures directly related to 
        each activity under paragraphs (2) and (3), including a 
        specific accounting of, and delineation between, obligations 
        and expenditures incurred for the construction, renovation, 
        equipping, and security upgrades of facilities and associated 
        contracts under this subsection, and the obligations and 
        expenditures incurred to establish and improve the situational 
        awareness and biosurveillance network under subsection (b), and 
        shall identify the agency or agencies incurring such 
        obligations and expenditures.'';
            (3) in subsection (b)--
                    (A) in the subsection heading, by striking 
                ``National'' and inserting ``Establishment of Systems 
                of Public Health'';
                    (B) in paragraph (1)(B), by inserting 
                ``immunization information systems,'' after 
                ``centers,''; and
                    (C) in paragraph (2)--
                            (i) by inserting ``develop a plan to, and'' 
                        after ``The Secretary shall''; and
                            (ii) by inserting ``and in a form readily 
                        usable for analytical approaches'' after ``in a 
                        secure manner''; and
                    (D) by amending paragraph (3) to read as follows:
            ``(3) Standards.--
                    ``(A) In general.--Not later than 1 year after the 
                date of the enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary, in cooperation with health care providers, 
                State, local, tribal, and territorial public health 
                officials, and relevant Federal agencies (including the 
                Office of the National Coordinator for Health 
                Information Technology and the National Institute of 
                Standards and Technology), shall, as necessary, adopt 
                technical and reporting standards, including standards 
                for interoperability as defined by section 3000, for 
                networks under paragraph (1) and update such standards 
                as necessary. Such standards shall be made available on 
                the internet website of the Department of Health and 
                Human Services, in a manner that does not compromise 
                national security.
                    ``(B) Deference to standards development 
                organizations.--In adopting and implementing standards 
                under this subsection and subsection (c), the Secretary 
                shall give deference to standards published by 
                standards development organizations and voluntary 
                consensus-based standards entities.'';
            (4) in subsection (c)--
                    (A) in paragraph (1)--
                            (i) by striking ``Not later than 2 years 
                        after the date of enactment of the Pandemic and 
                        All-Hazards Preparedness Reauthorization Act of 
                        2013, the Secretary'' and inserting ``The 
                        Secretary'';
                            (ii) by inserting ``, and improve as 
                        applicable and appropriate,'' after ``shall 
                        establish'';
                            (iii) by striking ``of rapid'' and 
                        inserting ``of, rapid''; and
                            (iv) by striking ``such connectivity'' and 
                        inserting ``such interoperability'';
                    (B) by amending paragraph (2) to read as follows:
            ``(2) Coordination and consultation.--In establishing and 
        improving the network under paragraph (1) the Secretary shall--
                    ``(A) facilitate coordination among agencies within 
                the Department of Health and Human Services that 
                provide, or have the potential to provide, information 
                and data to, and analyses for, the situational 
                awareness and biosurveillance network under paragraph 
                (1), including coordination among relevant agencies 
                related to health care services, the facilitation of 
                health information exchange (including the Office of 
                the National Coordinator for Health Information 
                Technology), and public health emergency preparedness 
                and response; and
                    ``(B) consult with the Secretary of Agriculture, 
                the Secretary of Commerce (and the Director of the 
                National Institute of Standards and Technology), the 
                Secretary of Defense, the Secretary of Homeland 
                Security, the Secretary of Veterans Affairs, and the 
                heads of other Federal agencies, as the Secretary 
                determines appropriate.'';
                    (C) in paragraph (3)--
                            (i) by redesignating subparagraphs (A) 
                        through (E) as clauses (i) through (v), 
                        respectively, and adjusting the margins 
                        accordingly;
                            (ii) in clause (iv), as so redesignated--
                                    (I) by inserting ``immunization 
                                information systems,'' after ``poison 
                                control,''; and
                                    (II) by striking ``and clinical 
                                laboratories'' and inserting ``, 
                                clinical laboratories, and public 
                                environmental health agencies'';
                            (iii) by striking ``The network'' and 
                        inserting the following:
                    ``(A) In general.--The network''; and
                            (iv) by adding at the end the following:
                    ``(B) Review.--Not later than 2 years after the 
                date of the enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018 and 
                every 6 years thereafter, the Secretary shall conduct a 
                review of the elements described in subparagraph (A). 
                Such review shall include a discussion of the addition 
                of any elements pursuant to clause (v), including 
                elements added to advancing new technologies, and 
                identify any challenges in the incorporation of 
                elements under subparagraph (A). The Secretary shall 
                provide such review to the congressional committees of 
                jurisdiction.'';
                    (D) in paragraph (5)--
                            (i) by redesignating subparagraphs (A) 
                        through (D) as clauses (i) through (iv), 
                        respectively, and adjusting the margins 
                        accordingly;
                            (ii) by striking ``In establishing'' and 
                        inserting the following:
                    ``(A) In general.--In establishing'';
                            (iii) by adding at the end the following:
                    ``(B) Public meeting.--
                            ``(i) In general.--Not later than 180 days 
                        after the date of enactment of the Pandemic and 
                        All-Hazards Preparedness and Advancing 
                        Innovation Act of 2018, the Secretary shall 
                        convene a public meeting for purposes of 
                        discussing and providing input on the potential 
                        goals, functions, and uses of the network 
                        described in paragraph (1) and incorporating 
                        the elements described in paragraph (3)(A).
                            ``(ii) Experts.--The public meeting shall 
                        include representatives of relevant Federal 
                        agencies (including representatives from the 
                        Office of the National Coordinator for Health 
                        Information Technology and the National 
                        Institute of Standards and Technology); State, 
                        local, tribal, and territorial public health 
                        officials; stakeholders with expertise in 
                        biosurveillance and situational awareness; 
                        stakeholders with expertise in capabilities 
                        relevant to biosurveillance and situational 
                        awareness, such as experts in informatics and 
                        data analytics (including experts in 
                        prediction, modeling, or forecasting); and 
                        other representatives as the Secretary 
                        determines appropriate.
                            ``(iii) Topics.--Such public meeting shall 
                        include a discussion of--
                                    ``(I) data elements, including 
                                minimal or essential data elements, 
                                that are voluntarily provided for such 
                                network, which may include elements 
                                from public health and public and 
                                private health care entities, to the 
                                extent practicable;
                                    ``(II) standards and implementation 
                                specifications that may improve the 
                                collection, analysis, and 
                                interpretation of data during a public 
                                health emergency;
                                    ``(III) strategies to encourage the 
                                access, exchange, and use of 
                                information;
                                    ``(IV) considerations for State, 
                                local, tribal, and territorial 
                                capabilities and infrastructure related 
                                to data exchange and interoperability;
                                    ``(V) privacy and security 
                                protections provided at the Federal, 
                                State, local, tribal, and territorial 
                                levels, and by nongovernmental 
                                stakeholders; and
                                    ``(VI) opportunities for the 
                                incorporation of innovative 
                                technologies to improve the network.''; 
                                and
                            (iv) in subparagraph (A), as so designated 
                        by clause (ii)--
                                    (I) in clause (i), as so 
                                redesignated--
                                            (aa) by striking ``as 
                                        determined'' and inserting ``as 
                                        adopted''; and
                                            (bb) by inserting ``and the 
                                        National Institute of Standards 
                                        and Technology'' after ``Office 
                                        of the National Coordinator for 
                                        Health Information 
                                        Technology'';
                                    (II) in clause (iii), as so 
                                redesignated, by striking ``; and'' and 
                                inserting a semicolon;
                                    (III) in clause (iv), as so 
                                redesignated, by striking the period 
                                and inserting ``; and''; and
                                    (IV) by adding at the end the 
                                following:
                            ``(v) pilot test standards and 
                        implementation specifications, consistent with 
                        the process described in section 3002(b)(3)(C), 
                        which State, local, tribal, and territorial 
                        public health entities may utilize, on a 
                        voluntary basis, as a part of the network.'';
                    (E) by redesignating paragraph (6) as paragraph 
                (7);
                    (F) by inserting after paragraph (5) the following:
            ``(6) Strategy and implementation plan.--
                    ``(A) In general.--Not later than 18 months after 
                the date of enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary shall submit to the congressional committees 
                of jurisdiction a coordinated strategy and an 
                accompanying implementation plan that--
                            ``(i) is informed by the public meeting 
                        under paragraph (5)(B);
                            ``(ii) includes a review and assessment of 
                        existing capabilities of the network and 
                        related infrastructure, including input 
                        provided by the public meeting under paragraph 
                        (5)(B);
                            ``(iii) identifies and demonstrates the 
                        measurable steps the Secretary will carry out 
                        to--
                                    ``(I) develop, implement, and 
                                evaluate the network described in 
                                paragraph (1), utilizing elements 
                                described in paragraph (3)(A);
                                    ``(II) modernize and enhance 
                                biosurveillance activities, including 
                                strategies to include innovative 
                                technologies and analytical approaches 
                                (including prediction and forecasting 
                                for pandemics and all-hazards) from 
                                public and private entities;
                                    ``(III) improve information 
                                sharing, coordination, and 
                                communication among disparate 
                                biosurveillance systems supported by 
                                the Department of Health and Human 
                                Services, including the identification 
                                of methods to improve accountability, 
                                better utilize resources and workforce 
                                capabilities, and incorporate 
                                innovative technologies within and 
                                across agencies; and
                                    ``(IV) test and evaluate 
                                capabilities of the interoperable 
                                network of systems to improve 
                                situational awareness and 
                                biosurveillance capabilities;
                            ``(iv) includes performance measures and 
                        the metrics by which performance measures will 
                        be assessed with respect to the measurable 
                        steps under clause (iii); and
                            ``(v) establishes dates by which each 
                        measurable step under clause (iii) will be 
                        implemented.
                    ``(B) Annual budget plan.--Not later than 2 years 
                after the date of enactment of the Pandemic and All-
                Hazards Preparedness and Advancing Innovation Act of 
                2018 and on an annual basis thereafter, in accordance 
                with the strategy and implementation plan under this 
                paragraph, the Secretary shall, taking into account 
                recommendations provided by the National Biodefense 
                Science Board, develop a budget plan based on the 
                strategy and implementation plan under this section. 
                Such budget plan shall include--
                            ``(i) a summary of resources previously 
                        expended to establish, improve, and utilize the 
                        nationwide public health situational awareness 
                        and biosurveillance network under paragraph 
                        (1);
                            ``(ii) estimates of costs and resources 
                        needed to establish and improve the network 
                        under paragraph (1) according to the strategy 
                        and implementation plan under subparagraph (A);
                            ``(iii) the identification of gaps and 
                        inefficiencies in nationwide public health 
                        situational awareness and biosurveillance 
                        capabilities, resources, and authorities needed 
                        to address such gaps; and
                            ``(iv) a strategy to minimize and address 
                        such gaps and improve inefficiencies.'';
                    (G) in paragraph (7), as so redesignated--
                            (i) in subparagraph (A), by inserting 
                        ``(taking into account zoonotic disease, 
                        including gaps in scientific understanding of 
                        the interactions between human, animal, and 
                        environmental health)'' after ``human health'';
                            (ii) in subparagraph (B)--
                                    (I) by inserting ``and gaps in 
                                surveillance programs'' after 
                                ``surveillance programs''; and
                                    (II) by striking ``; and'' and 
                                inserting a semicolon;
                            (iii) in subparagraph (C)--
                                    (I) by inserting ``, animal health 
                                organizations related to zoonotic 
                                disease,'' after ``health care 
                                entities''; and
                                    (II) by striking the period and 
                                inserting ``; and''; and
                            (iv) by adding at the end the following:
                    ``(D) provide recommendations to the Secretary on 
                policies and procedures to complete the steps described 
                in this paragraph in a manner that is consistent with 
                section 2802.''; and
                    (H) by adding at the end the following:
            ``(8) Situational awareness and biosurveillance as a 
        national security priority.--The Secretary, on a periodic basis 
        as applicable and appropriate, shall meet with the Director of 
        National Intelligence to inform the development and 
        capabilities of the nationwide public health situational 
        awareness and biosurveillance network.'';
            (5) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) by inserting ``environmental health 
                        agencies,'' after ``public health agencies,''; 
                        and
                            (ii) by inserting ``immunization 
                        programs,'' after ``poison control centers,''; 
                        and
                    (B) in paragraph (2)--
                            (i) in subparagraph (B), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (C), by striking the 
                        period and inserting ``; and''; and
                            (iii) by adding after subparagraph (C) the 
                        following:
                    ``(D) an implementation plan that may include 
                measurable steps to achieve the purposes described in 
                paragraph (1).''; and
                    (C) by striking paragraph (5) and inserting the 
                following:
            ``(5) Technical assistance.--The Secretary may provide 
        technical assistance to States, localities, tribes, and 
        territories or a consortium of States, localities, tribes, and 
        territories receiving an award under this subsection regarding 
        interoperability and the technical standards set forth by the 
        Secretary.'';
            (6) by redesignating subsections (f) and (g) as subsections 
        (i) and (j), respectively; and
            (7) by inserting after subsection (e) the following:
    ``(f) Personnel Authorities.--
            ``(1) Specially qualified personnel.--In addition to any 
        other personnel authorities, to carry out subsections (b) and 
        (c), the Secretary may--
                    ``(A) appoint highly qualified individuals to 
                scientific or professional positions at the Centers for 
                Disease Control and Prevention, not to exceed 30 such 
                employees at any time (specific to positions authorized 
                by this subsection), with expertise in capabilities 
                relevant to biosurveillance and situational awareness, 
                such as experts in informatics and data analytics 
                (including experts in prediction, modeling, or 
                forecasting), and other related scientific or technical 
                fields; and
                    ``(B) compensate individuals appointed under 
                subparagraph (A) in the same manner and subject to the 
                same terms and conditions in which individuals 
                appointed under 9903 of title 5, United States Code, 
                are compensated, 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.
            ``(2) Limitations.--The Secretary shall exercise the 
        authority under paragraph (1) in a manner that is consistent 
        with the limitations described in section 319F-1(e)(2).
    ``(g) Timeline.--The Secretary shall accomplish the purposes under 
subsections (b) and (c) no later than September 30, 2023, and shall 
provide a justification to the congressional committees of jurisdiction 
for any missed or delayed implementation of measurable steps identified 
under subsection (c)(6)(A)(iii).
    ``(h) Independent Evaluation.--Not later than 3 years after the 
date of enactment of the Pandemic and All-Hazards Preparedness and 
Advancing Innovation Act of 2018, the Comptroller General of the United 
States shall conduct an independent evaluation and submit to the 
Secretary and the congressional committees of jurisdiction a report 
concerning the activities conducted under subsections (b) and (c), and 
provide recommendations, as applicable and appropriate, on necessary 
improvements to the biosurveillance and situational awareness 
network.''.
    (b) Authorization of Appropriations.--Subsection (i) of section 
319D (42 U.S.C. 247d-4), as redesignated by subsection (a)(6), is 
amended by striking ``$138,300,000 for each of fiscal years 2014 
through 2018'' and inserting ``$161,800,000 for each of fiscal years 
2019 through 2023''.
    (c) Biological Threat Detection Report.--The Secretary of Health 
and Human Services shall, in coordination with the Secretary of Defense 
and the Secretary of Homeland Security, not later than 180 days after 
the date of enactment of this Act, report to the Committee on Energy 
and Commerce, the Committee on Armed Services, and the Committee on 
Homeland Security of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions, the Committee on Armed 
Services, and the Committee on Homeland Security and Governmental 
Affairs of the Senate on the state of Federal biological threat 
detection efforts, including the following--
            (1) an identification of technological, operational, and 
        programmatic successes and failures of domestic detection 
        programs supported by Federal departments and agencies for 
        intentionally-introduced or accidentally-released biological 
        threat agents and naturally occurring infectious diseases;
            (2) a description of Federal efforts to facilitate the 
        exchange of information related to the information described in 
        paragraph (1) among Federal departments and agencies that 
        utilize biological threat detection technology;
            (3) a description of the capabilities of detection systems 
        in use by Federal departments and agencies including the 
        capability to--
                    (A) rapidly detect, identify, characterize, and 
                confirm the presence of biological threat agents;
                    (B) recover live biological agents from collection 
                devices;
                    (C) determine the geographical distribution of 
                biological agents;
                    (D) determine the extent of environmental 
                contamination and persistence of biological agents; and
                    (E) provide advanced molecular diagnostics to 
                State, local, tribal, and territorial public health and 
                other laboratories that support biological threat 
                detection activities;
            (4) a description of Federal interagency coordination 
        related to biological threat detection;
            (5) a description of efforts by Federal departments and 
        agencies that utilize biological threat detection technology to 
        collaborate with State, local, tribal, and territorial public 
        health laboratories and other users of biological threat 
        detection systems, including collaboration regarding the 
        development of--
                    (A) biological threat detection requirements or 
                standards;
                    (B) a standardized integration strategy;
                    (C) training requirements or guidelines;
                    (D) guidelines for a coordinated public health 
                response, including preparedness capabilities, and, as 
                applicable, for coordination with public health 
                surveillance systems; and
                    (E) a coordinated environmental remediation plan, 
                as applicable; and
            (6) recommendations related to research, advanced research, 
        development, and procurement for Federal departments and 
        agencies to improve and enhance biological threat detection 
        systems, including recommendations on the transfer of 
        biological threat detection technology among Federal 
        departments and agencies, as necessary and appropriate.

SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH EMERGENCY 
              RAPID RESPONSE FUND.

    Section 319 (42 U.S.C. 247d) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1)--
                            (i) in the first sentence, by inserting 
                        ``or if the Secretary determines there is the 
                        significant potential for a public health 
                        emergency, to allow the Secretary to rapidly 
                        respond to the immediate needs resulting from 
                        such public health emergency or potential 
                        public health emergency'' before the period; 
                        and
                            (ii) by inserting ``The Secretary shall 
                        plan for the expedited distribution of funds to 
                        appropriate agencies and entities.'' after the 
                        first sentence;
                    (B) by redesignating paragraph (2) as paragraph 
                (3);
                    (C) by inserting after paragraph (1) the following:
            ``(2) Uses.--The Secretary may use amounts in the Fund 
        established under paragraph (1), to--
                    ``(A) facilitate coordination between and among 
                Federal, State, local, tribal, and territorial entities 
                and public and private health care entities that the 
                Secretary determines may be affected by a public health 
                emergency or potential public health emergency referred 
                to in paragraph (1) (including communication of such 
                entities with relevant international entities, as 
                applicable);
                    ``(B) make grants, provide for awards, enter into 
                contracts, and conduct supportive investigations 
                pertaining to a public health emergency or potential 
                public health emergency, including further supporting 
                programs under section 319C-1, 319C-2, or 319C-3;
                    ``(C) facilitate and accelerate, as applicable, 
                advanced research and development of security 
                countermeasures (as defined in section 319F-2), 
                qualified countermeasures (as defined in section 319F-
                1), or qualified pandemic or epidemic products (as 
                defined in section 319F-3), that are applicable to the 
                public health emergency or potential public health 
                emergency under paragraph (1);
                    ``(D) strengthen biosurveillance capabilities and 
                laboratory capacity to identify, collect, and analyze 
                information regarding such public health emergency or 
                potential public health emergency, including the 
                systems under section 319D;
                    ``(E) support initial emergency operations and 
                assets related to preparation and deployment of 
                intermittent disaster response personnel under section 
                2812 and the Medical Reserve Corps under section 2813; 
                and
                    ``(F) carry out other activities, as the Secretary 
                determines applicable and appropriate.''; and
                    (D) by inserting after paragraph (3), as so 
                redesignated, the following:
            ``(4) Review.--Not later than 2 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018, the Secretary, in 
        coordination with the Assistant Secretary for Preparedness and 
        Response, shall conduct a review of the Fund under this section 
        and provide recommendations 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 policies to improve such Fund for the uses 
        described in paragraph (2).
            ``(5) GAO report.--Not later than 4 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018, the Comptroller General of 
        the United States shall--
                    ``(A) conduct a review of the Fund under this 
                section, including its uses and the resources available 
                in the Fund; and
                    ``(B) 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, including recommendations 
                related to such review, as applicable.''; and
            (2) in subsection (c)--
                    (A) by inserting ``rapidly respond to public health 
                emergencies or potential public health emergencies 
                and'' after ``used to''; and
                    (B) by striking ``section.'' and inserting ``Act or 
                funds otherwise provided for emergency response.''.

SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND RESPONSE BY PUBLIC 
              HEALTH EMERGENCY VOLUNTEERS.

    (a) In General.--Section 319I (42 U.S.C. 247d-7b) is amended--
            (1) in the section heading, by striking ``health 
        professions volunteers'' and inserting ``volunteer health 
        professional'';
            (2) in subsection (a), by adding at the end the following: 
        ``Such health care professionals may include members of the 
        National Disaster Medical System, members of the Medical 
        Reserve Corps, and individual health care professionals.'';
            (3) in subsection (i) by adding at the end ``In order to 
        inform the development of such mechanisms by States, the 
        Secretary shall make available information and material 
        provided by States that have developed mechanisms to waive the 
        application of licensing requirements to applicable health 
        professionals seeking to provide medical services during a 
        public health emergency. Such information shall be made 
        publicly available in a manner that does not compromise 
        national security.''; and
            (4) in subsection (k) by striking ``2014 through 2018'' and 
        inserting ``2019 through 2023''.
    (b) All-Hazards Public Health Emergency Preparedness and Response 
Plan.--Section 319C-1(b)(2)(A)(iv) (42 U.S.C. 247d-3a(b)(2)(A)(iv)) is 
amended to read as follows:
                    ``(iv) a description of the mechanism the entity 
                will implement to utilize the Emergency Management 
                Assistance Compact, or other mutual aid agreement, for 
                medical and public health mutual aid, and, as 
                appropriate, the activities such entity will implement 
                pursuant to section 319I to improve enrollment and 
                coordination of volunteer health care professionals 
                seeking to provide medical services during a public 
                health emergency, which may include--
                            ``(I) providing a public method of 
                        communication for purposes of volunteer 
                        coordination (such as a phone number);
                            ``(II) providing for optional registration 
                        to participate in volunteer services during 
                        processes related to State medical licensing, 
                        registration, or certification or renewal of 
                        such licensing, registration or certification; 
                        or
                            ``(III) other mechanisms as the State 
                        determines appropriate;''.

SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUNTEER HEALTH CARE 
              PROFESSIONALS.

    (a) In General.--Title II (42 U.S.C. 202 et seq.) is amended by 
inserting after section 224 the following:

``SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DURING A PUBLIC HEALTH 
              EMERGENCY.

    ``(a) Limitation on Liability.--Notwithstanding any other provision 
of law, a health care professional who is a member of the Medical 
Reserve Corps under section 2813 or who is included in the Emergency 
System for Advance Registration of Volunteer Health Professionals under 
section 319I and who--
            ``(1) is responding--
                    ``(A) to a public health emergency determined under 
                section 319(a), during the initial period of not more 
                than 90 days (as determined by the Secretary) of the 
                public health emergency determination (excluding any 
                period covered by a renewal of such determination); or
                    ``(B) to a major disaster or an emergency as 
                declared by the President under section 401 of the 
                Robert T. Stafford Disaster Relief and Emergency 
                Assistance Act (42 U.S.C. 5170) or under section 201 of 
                the National Emergencies Act (50 U.S.C.1621) during the 
                initial period of such declaration; and
            ``(2) is alleged to be liable for an act or omission--
                    ``(A) during the initial period of a determination 
                or declaration described in paragraph (1) and related 
                to the treatment of individuals in need of health care 
                services due to such public health emergency, major 
                disaster, or emergency;
                    ``(B) in the State or States for which such 
                determination or declaration is made;
                    ``(C) in the health care professional's capacity as 
                a member of the Medical Reserve Corps or a professional 
                included in the Emergency System for Advance 
                Registration of Volunteer Health Professionals under 
                section 319I; and
                    ``(D) in the course of providing services that are 
                within the scope of the license, registration, or 
                certification of the professional, as defined by the 
                State of licensure, registration, or certification; and
            ``(3) prior to the rendering of such act or omission, was 
        authorized by the State's authorization of deploying such 
        State's Emergency System for Advance Registration of Volunteer 
        Health Professionals described in section 319I or the Medical 
        Reserve Corps established under section 2813, to provide health 
        care services,
shall be subject only to the State liability laws of the State in which 
such act or omission occurred, in the same manner and to the same 
extent as a similar health care professional who is a resident of such 
State would be subject to such State laws, except with respect to the 
licensure, registration, and certification of such individual.
    ``(b) Volunteer Protection Act.--Nothing in this section shall be 
construed to affect an individual's right to protections under the 
Volunteer Protection Act of 1997.
    ``(c) Preemption.--This section shall supersede the laws of any 
State that would subject a health care professional described in 
subsection (a) to the liability laws of any State other than the State 
liability laws to which such individual is subject pursuant to such 
subsection.
    ``(d) Definitions.--In this section:
            ``(1) The term `health care professional' means an 
        individual licensed, registered, or certified under Federal or 
        State laws or regulations to provide health care services.
            ``(2) The term `health care services' means any services 
        provided by a health care professional, or by any individual 
        working under the supervision of a health care professional, 
        that relate to--
                    ``(A) the diagnosis, prevention, or treatment of 
                any human disease or impairment; or
                    ``(B) the assessment or care of the health of human 
                beings.
    ``(e) Effective Date.--
            ``(1) In general.--This section shall take effect 90 days 
        after the date of the enactment of the Pandemic and All-Hazards 
        Preparedness and Advancing Innovation Act of 2018.
            ``(2) Application.--This section shall apply to a claim for 
        harm only if the act or omission that caused such harm occurred 
        on or after the effective date described in paragraph (1).''.
    (b) GAO Study.--Not later than one year after the date of enactment 
of this Act, the Comptroller General of the United States shall conduct 
a review of--
            (1) the number of health care providers who register under 
        the Emergency System for Advance Registration of Volunteer 
        Health Professionals under section 319I of the Public Health 
        Service Act (42 U.S.C. 247d-7b) in advance to provide services 
        during a public health emergency;
            (2) the number of health care providers who are 
        credentialed to provide services during the period of a public 
        health emergency declaration, including those who are 
        credentialed though programs established in the Emergency 
        System for Advance Registration of Volunteer Health 
        Professionals under such section 319I and those credentialed by 
        authorities within the State in which the emergency occurred;
            (3) the average time to verify the credentials of a health 
        care provider during the period of a public health emergency 
        declaration, including the average time pursuant to the 
        Emergency System for Advance Registration of Volunteer Health 
        Professionals under such section 319I and for an individual's 
        credentials to be verified by an authority within the State; 
        and
            (4) the Emergency System for Advance Registration of 
        Volunteer Health Professionals program in States, including 
        whether physician or medical groups, associations, or other 
        relevant provider organizations utilize such program for 
        purposes of volunteering during public health emergencies.

SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUPPLY.

    Not later than 1 year after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall submit to Congress a 
report containing recommendations related to maintaining an adequate 
national blood supply, including--
            (1) challenges associated with the continuous recruitment 
        of blood donors (including those newly eligible to donate);
            (2) ensuring the adequacy of the blood supply in the case 
        of public health emergencies;
            (3) implementation of the transfusion transmission 
        monitoring system; and
            (4) other measures to promote safety and innovation, such 
        as the development, use, or implementation of new technologies, 
        processes, and procedures to improve the safety and reliability 
        of the blood supply.

SEC. 210. REPORT ON THE PUBLIC HEALTH PREPAREDNESS AND RESPONSE 
              CAPABILITIES AND CAPACITIES OF HOSPITALS, LONG-TERM CARE 
              FACILITIES, AND OTHER HEALTH CARE FACILITIES.

    (a) Study.--
            (1) In general.--Not later than one year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall enter into an agreement with an appropriate 
        entity to conduct a study regarding the public health 
        preparedness and response capabilities and medical surge 
        capacities of hospitals, long-term care facilities, and other 
        health care facilities to prepare for, and respond to, public 
        health emergencies, including natural disasters.
            (2) Consultation.--In conducting the study under paragraph 
        (1), the entity shall consult with Federal, State, local, 
        tribal, and territorial public health officials (as 
        appropriate), and health care providers and facilities with 
        experience in public health preparedness and response 
        activities.
            (3) Evaluation.--The study under paragraph (1) shall 
        include--
                    (A) an evaluation of the current benchmarks and 
                objective standards, as applicable, related to programs 
                that support hospitals, long-term care facilities, and 
                other health care facilities, and their effect on 
                improving public health preparedness and response 
                capabilities and medical surge capacities, including 
                the Hospital Preparedness Program, the Public Health 
                Emergency Preparedness cooperative agreements, and the 
                Regional Health Care Emergency Preparedness and 
                Response Systems under section 319C-3 of the Public 
                Health Service Act (as added by section 203);
                    (B) the identification of gaps in preparedness, 
                including with respect to such benchmarks and objective 
                standards, such as those identified during recent 
                public health emergencies, for hospitals, long-term 
                care facilities, and other health care facilities to 
                address future potential public health threats;
                    (C) an evaluation of coordination efforts between 
                the recipients of Federal funding for programs 
                described in subparagraph (A) and entities with 
                expertise in emergency power systems and other critical 
                infrastructure partners during a public health 
                emergency, to ensure a functioning critical 
                infrastructure, to the greatest extent practicable, 
                during a public health emergency;
                    (D) an evaluation of coordination efforts between 
                the recipients of Federal funding for programs 
                described in subparagraph (A) and environmental health 
                agencies with expertise in emergency preparedness and 
                response planning for hospitals, long-term care 
                facilities, and other health care facilities; and
                    (E) an evaluation of current public health 
                preparedness and response capabilities and medical 
                surge capacities related to at-risk individuals during 
                public health emergencies, including an identification 
                of gaps in such preparedness as they relate to such 
                individuals.
    (b) Report.--
            (1) In general.--The agreement under subsection (a) shall 
        require the entity to submit to the Secretary of Health and 
        Human Services and the congressional committees of 
        jurisdiction, not later than 3 years after the date of 
        enactment of this Act, a report on the results of the study 
        conducted pursuant to this section.
            (2) Contents.--The report under paragraph (1) shall--
                    (A) describe the findings and conclusions of the 
                evaluation conducted pursuant to subsection (a); and
                    (B) provide recommendations for improving public 
                health preparedness and response capability and medical 
                surge capacity for hospitals, long-term care 
                facilities, and other health care facilities, 
                including--
                            (i) improving the existing benchmarks and 
                        objective standards for the Federal grant 
                        programs described in subsection (a)(3)(A) or 
                        developing new benchmarks and standards for 
                        such programs; and
                            (ii) identifying best practices for 
                        improving public health preparedness and 
                        response programs and medical surge capacity at 
                        hospitals, long-term care facilities, and other 
                        health care facilities, including 
                        recommendations for the evaluation under 
                        subparagraphs (C) and (D) of subsection (a)(3).

                  TITLE III--REACHING ALL COMMUNITIES

SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY RESPONSE WORKFORCE.

    (a) National Disaster Medical System.--
            (1) Strengthening the national disaster medical system.--
        Clause (ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh-
        11(a)(3)(A)) is amended to read as follows:
                            ``(ii) be present at locations, and for 
                        limited periods of time, specified by the 
                        Secretary on the basis that the Secretary has 
                        determined that a location is at risk of a 
                        public health emergency during the time 
                        specified, or there is a significant potential 
                        for a public health emergency.''.
            (2) Review of the national disaster medical system.--
        Section 2812(b)(2) (42 U.S.C. 300hh-11(b)(2)) is amended to 
        read as follows:
            ``(2) Joint review and medical surge capacity strategic 
        plan.--
                    ``(A) Review.--Not later than 180 days after the 
                date of enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary, in coordination with the Secretary of 
                Homeland Security, the Secretary of Defense, and the 
                Secretary of Veterans Affairs, shall conduct a joint 
                review of the National Disaster Medical System. Such 
                review shall include--
                            ``(i) an evaluation of medical surge 
                        capacity, as described in section 2803(a);
                            ``(ii) an assessment of the available 
                        workforce of the intermittent disaster response 
                        personnel described in subsection (c);
                            ``(iii) the capacity of the workforce 
                        described in clause (ii) to respond to all 
                        hazards, including capacity to simultaneously 
                        respond to multiple public health emergencies 
                        and the capacity to respond to a nationwide 
                        public health emergency;
                            ``(iv) the effectiveness of efforts to 
                        recruit, retain, and train such workforce; and
                            ``(v) gaps that may exist in such workforce 
                        and recommendations for addressing such gaps.
                    ``(B) Updates.--As part of the National Health 
                Security Strategy under section 2802, the Secretary 
                shall update the findings from the review under 
                subparagraph (A) and provide recommendations to modify 
                the policies of the National Disaster Medical System as 
                necessary.''.
            (3) Notification of shortage.--Section 2812(c) (42 U.S.C. 
        300hh-11(c)) is amended by adding at the end the following:
            ``(3) Notification.--Not later than 30 days after the date 
        on which the Secretary determines the number of intermittent 
        disaster-response personnel of the National Disaster Medical 
        System is insufficient to address a public health emergency or 
        potential public health emergency, the Secretary shall submit 
        to the congressional committees of jurisdiction a notification 
        detailing--
                    ``(A) the impact such shortage could have on 
                meeting public health needs and emergency medical 
                personnel needs during a public health emergency; and
                    ``(B) any identified measures to address such 
                shortage.
            ``(4) Certain appointments.--
                    ``(A) In general.--If the Secretary determines that 
                the number of intermittent disaster response personnel 
                within the National Disaster Medical System under this 
                section is insufficient to address a public health 
                emergency or potential public health emergency, the 
                Secretary may appoint candidates directly to personnel 
                positions for intermittent disaster response within 
                such system. The Secretary shall provide updates on the 
                number of vacant or unfilled positions within such 
                system to the congressional committees of jurisdiction 
                each quarter for which this authority is in effect.
                    ``(B) Sunset.--The authority under this paragraph 
                shall expire on September 30, 2021.''.
            (4) Authorization of appropriations.--Section 2812(g) (42 
        U.S.C. 300hh-11(g)) is amended by striking ``$52,700,000 for 
        each of fiscal years 2014 through 2018'' and inserting 
        ``$57,400,000 for each of fiscal years 2019 through 2023''.
    (b) Volunteer Medical Reserve Corps.--
            (1) In general.--Section 2813(a) (42 U.S.C. 42 U.S.C. 
        300hh-15(a)) is amended by striking the second sentence and 
        inserting ``The Secretary may appoint a Director to head the 
        Corps and oversee the activities of the Corps chapters that 
        exist at the State, local, tribal, and territorial levels.''.
            (2) Authorization of appropriations.--Section 2813(i) (42 
        U.S.C. 300hh-15(i)) is amended by striking ``2014 through 
        2018'' and inserting ``2019 through 2023''.
    (c) Strengthening the Epidemic Intelligence Service.--Section 317F 
(42 U.S.C. Sec. 247b-7) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) by inserting ``or preparedness and 
                        response activities, including rapid response 
                        to public health emergencies and significant 
                        public health threats'' after ``conduct 
                        prevention activities''; and
                            (ii) by striking ``$35,000'' and inserting 
                        ``$50,000''; and
                    (B) in paragraph (2)(B), by striking ``3 years'' 
                and inserting ``2 years''; and
            (2) in subsection (c)--
                    (A) by striking ``For the purpose of carrying out 
                this section'' and inserting the following:
            ``(1) In general.--For the purpose of carrying out this 
        section, except as described in paragraph (2)''; and
                    (B) by adding at the end the following:
            ``(2) Epidemic intelligence service program.--For purposes 
        of carrying out this section with respect to qualified health 
        professionals serving in the Epidemic Intelligence Service, as 
        authorized under section 317G, there are authorized to be 
        appropriated $1,000,000 for each of fiscal years 2019 through 
        2023.''.
    (d) Service Benefit for National Disaster Medical System 
Volunteers.--
            (1) In general.--Section 2812(c) (42 U.S.C. 300hh-11(c)), 
        as amended by subsection (a)(3), is further amended by adding 
        at the end the following:
            ``(5) Service benefit.--Individuals appointed to serve 
        under this subsection shall be considered eligible for benefits 
        under part L of title I of the Omnibus Crime Control and Safe 
        Streets Act of 1968. The Secretary shall provide notification 
        to any eligible individual of any effect such designation may 
        have on other benefits for which such individual is eligible, 
        including benefits from private entities.''.
            (2) Public safety officer benefits.--Section 1204(9) of 
        title I of the Omnibus Crime Control and Safe Streets Act of 
        1968 (34 U.S.C. 10284(9)) is amended--
                    (A) in subparagraph (C)(ii), by striking ``or'' at 
                the end;
                    (B) in subparagraph (D), by striking the period and 
                inserting ``; or''; and
                    (C) by inserting after subparagraph (D) the 
                following:
                    ``(E) an individual appointed to the National 
                Disaster Medical System under section 2812 of the 
                Public Health Service Act (42 U.S.C. 300hh-11) who is 
                performing official duties of the Department of Health 
                and Human Services, if those official duties are--
                            ``(i) related to responding to a public 
                        health emergency or potential public health 
                        emergency, or other activities for which the 
                        Secretary of Health and Human Services has 
                        activated such National Disaster Medical 
                        System; and
                            ``(ii) determined by the Secretary of 
                        Health and Human Services to be hazardous.''.
            (3) Sunset.--The amendments made by paragraphs (1) and (2) 
        shall cease to have force or effect on October 1, 2021.
    (e) Mission Readiness Report to Congress.--
            (1) Report.--Not later than one year after the date of 
        enactment of this section, the Comptroller General of the 
        United States (referred to in this subsection as the 
        ``Comptroller General'') 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 medical surge capacity of the 
        United States in the event of a public health emergency, 
        including the capacity and capability of the current health 
        care workforce to prepare for, and respond to the full range of 
        public health emergencies or potential public health 
        emergencies, and recommendations to address any gaps identified 
        in such workforce.
            (2) Contents.--The Comptroller General shall include in the 
        report under paragraph (1)--
                    (A) the number of health care providers who have 
                volunteered to provide health care services during a 
                public health emergency, including members of the 
                National Disaster Medical System, the Disaster Medical 
                Assistant Teams, the Medical Reserve Corps, and other 
                volunteer health care professionals in the verification 
                network pursuant to section 319I of the Public Health 
                Service Act (42 U.S.C. 247d-7b);
                    (B) the capacity of the workforce described in 
                subparagraph (A) to respond to a public health 
                emergency or potential public health emergency, 
                including the capacity to respond to multiple 
                concurrent public health emergencies and the capacity 
                to respond to a nationwide public health emergency;
                    (C) the preparedness and response capabilities and 
                mission readiness of the workforce described in 
                subparagraph (A) taking into account areas of health 
                care expertise and considerations for at-risk 
                individuals (as defined in section 2802(b)(4)(B) of the 
                Public Health Service Act (42 U.S.C. 300hh-
                1(b)(4)(B)));
                    (D) an assessment of the effectiveness of efforts 
                to recruit, retain, and train such workforce; and
                    (E) identification of gaps that may exist in such 
                workforce and recommendations for addressing such gaps, 
                the extent to which the Assistant Secretary for 
                Preparedness and Response plans to address such gaps, 
                and any recommendations from the Comptroller General to 
                address such gaps.

SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE PREPAREDNESS AND 
              RESPONSE.

    (a) Coordination of Preparedness.--Section 2811(b)(5) (42 U.S.C. 
300hh-10(b)(5)) is amended by adding at the end the following: ``Such 
logistical support shall include working with other relevant Federal, 
State, local, tribal, and territorial public health officials and 
private sector entities to identify the critical infrastructure assets, 
systems, and networks needed for the proper functioning of the health 
care and public health sectors that need to be maintained through any 
emergency or disaster, including entities capable of assisting with, 
responding to, and mitigating the effect of a public health emergency, 
including a public health emergency determined by the Secretary 
pursuant to section 319(a) or an emergency or major disaster declared 
by the President under the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act or the National Emergencies Act, including by 
establishing methods to exchange critical information and deliver 
products consumed or used to preserve, protect, or sustain life, 
health, or safety, and sharing of specialized expertise.''.
    (b) Manufacturing Capacity.--Section 2811(d)(2)(C) (42 U.S.C. 
300hh-10(d)(2)(C)) is amended by inserting ``, and ancillary medical 
supplies to assist with the utilization of such countermeasures or 
products,'' after ``products''.
    (c) Evaluation of Barriers to Rapid Delivery of Medical 
Countermeasures.--
            (1) Rapid delivery study.--The Assistant Secretary for 
        Preparedness and Response may conduct a study on issues that 
        have the potential to adversely affect the handling and rapid 
        delivery of medical countermeasures to individuals during 
        public health emergencies occurring in the United States.
            (2) Notice to congress.--Not later than 9 months after the 
        date of the enactment of this Act, the Assistant Secretary for 
        Preparedness and Response shall notify the Committee on Energy 
        and Commerce of the House of Representatives and the Committee 
        on Health, Education, Labor, and Pensions of the Senate if the 
        Assistant Secretary for Preparedness and Response does not plan 
        to conduct the study under paragraph (1) and shall provide such 
        committees a summary explanation for such decision.
            (3) Report to congress.--Not later than 1 year after the 
        Assistant Secretary for Preparedness and Response conducts the 
        study under paragraph (1), such Assistant Secretary shall 
        submit a report to the Committee on Energy and Commerce of the 
        House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate containing the 
        findings of such study.

SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS.

    (a) At-Risk Individuals in the National Health Security Strategy.--
Section 2802(b)(4)(B) (42 U.S.C. 300hh-1(b)(4)(B)) is amended--
            (1) by striking ``this section and sections 319C-1, 319F, 
        and 319L,'' and inserting ``this Act,''; and
            (2) by striking ``special'' and inserting ``access or 
        functional''.
    (b) Countermeasure Considerations.--Section 319L(c)(6) (42 U.S.C. 
247d-7e(c)(6)) is amended--
            (1) by striking ``elderly'' and inserting ``older adults''; 
        and
            (2) by inserting ``with relevant characteristics that 
        warrant consideration during the process of researching and 
        developing such countermeasures and products'' before the 
        period.
    (c) Biosurveillance of Emerging Public Health Threats.--Section 
2814 is amended--
            (1) in paragraph (7), by striking ``; and'' and inserting a 
        semicolon;
            (2) in paragraph (8), by striking the period and inserting 
        ``; and''; and
            (3) by adding at the end the following:
            ``(9) facilitate coordination to ensure that, in 
        implementing the situational awareness and biosurveillance 
        network under section 319D, the Secretary considers 
        incorporating data and information from Federal, State, local, 
        tribal, and territorial public health officials and entities 
        relevant to detecting emerging public health threats that may 
        affect at-risk individuals, such as pregnant and postpartum 
        women and infants, including adverse health outcomes of such 
        populations related to such emerging public health threats.''.

SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RESPONSE CONSIDERATIONS 
              FOR CHILDREN.

    Part B of title III (42 U.S.C. 243 et seq.) is amended by inserting 
after section 319D the following:

``SEC. 319D-1. CHILDREN'S PREPAREDNESS UNIT.

    ``(a) Enhancing Emergency Preparedness for Children.--The 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention (referred to in this subsection as the 
`Director'), shall maintain an internal team of experts, to be known as 
the Children's Preparedness Unit (referred to in this subsection as the 
`Unit'), to work collaboratively to provide guidance on the 
considerations for, and the specific needs of, children before, during, 
and after public health emergencies. The Unit shall inform the Director 
regarding emergency preparedness and response efforts pertaining to 
children at the Centers for Disease Control and Prevention.
    ``(b) Expertise.--The team described in subsection (a) shall 
include one or more pediatricians, which may be a developmental-
behavioral pediatrician, and may also include behavioral scientists, 
child psychologists, epidemiologists, biostatisticians, health 
communications staff, and individuals with other areas of expertise, as 
the Secretary determines appropriate.
    ``(c) Duties.--The team described in subsection (a) may--
            ``(1) assist State, local, tribal, and territorial 
        emergency planning and response activities related to children, 
        which may include developing, identifying, and sharing best 
        practices;
            ``(2) provide technical assistance, training, and 
        consultation to Federal, State, local, tribal, and territorial 
        public health officials to improve preparedness and response 
        capabilities with respect to the needs of children, including 
        providing such technical assistance, training, and consultation 
        to eligible entities in order to support the achievement of 
        measurable evidence-based benchmarks and objective standards 
        applicable to sections 319C-1 and 319C-2;
            ``(3) improve the utilization of methods to incorporate the 
        needs of children in planning for and responding to a public 
        health emergency, including public awareness of such methods;
            ``(4) coordinate with, and improve, public-private 
        partnerships, such as health care coalitions pursuant to 
        sections 319C-2 and 319C-3, to address gaps and inefficiencies 
        in emergency preparedness and response efforts for children;
            ``(5) provide expertise and input during the development of 
        guidance and clinical recommendations to address the needs of 
        children when preparing for, and responding to, public health 
        emergencies, including pursuant to section 319C-3; and
            ``(6) carry out other duties related to preparedness and 
        response activities for children, as the Secretary determines 
        appropriate.''.

SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISASTERS.

    (a) Reauthorizing the National Advisory Committee on Children and 
Disasters.--Section 2811A (42 U.S.C. 300hh-10a) is amended--
            (1) in subsection (b)(2), by inserting ``, mental and 
        behavioral,'' after ``medical'';
            (2) in subsection (d)--
                    (A) in paragraph (1), by striking ``15'' and 
                inserting ``25''; and
                    (B) by striking paragraph (2) and inserting the 
                following:
            ``(2) Required non-federal members.--The Secretary, in 
        consultation with such other heads of Federal agencies as may 
        be appropriate, shall appoint to the Advisory Committee under 
        paragraph (1) at least 13 individuals, including--
                    ``(A) at least 2 non-Federal professionals with 
                expertise in pediatric medical disaster planning, 
                preparedness, response, or recovery;
                    ``(B) at least 2 representatives from State, local, 
                tribal, or territorial agencies with expertise in 
                pediatric disaster planning, preparedness, response, or 
                recovery;
                    ``(C) at least 4 members representing health care 
                professionals, which may include members with expertise 
                in pediatric emergency medicine; pediatric trauma, 
                critical care, or surgery; the treatment of pediatric 
                patients affected by chemical, biological, 
                radiological, or nuclear agents, including emerging 
                infectious diseases; pediatric mental or behavioral 
                health related to children affected by a public health 
                emergency; or pediatric primary care; and
                    ``(D) other members as the Secretary determines 
                appropriate, of whom--
                            ``(i) at least one such member shall 
                        represent a children's hospital;
                            ``(ii) at least one such member shall be an 
                        individual with expertise in schools or child 
                        care settings;
                            ``(iii) at least one such member shall be 
                        an individual with expertise in children and 
                        youth with special health care needs; and
                            ``(iv) at least one such member shall be an 
                        individual with expertise in the needs of 
                        parents or family caregivers, including the 
                        parents or caregivers of children with 
                        disabilities.''.
            ``(3) Federal members.--The Advisory Committee under 
        paragraph (1) shall include the following Federal members or 
        their designees (who may be non-voting members, as determined 
        by the Secretary):
                    ``(A) The Assistant Secretary for Preparedness and 
                Response.
                    ``(B) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(C) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(D) The Commissioner of Food and Drugs.
                    ``(E) The Director of the National Institutes of 
                Health.
                    ``(F) The Assistant Secretary of the Administration 
                for Children and Families.
                    ``(G) The Administrator of the Health Resources and 
                Services Administration.
                    ``(H) The Administrator of the Federal Emergency 
                Management Agency.
                    ``(I) The Administrator of the Administration for 
                Community Living.
                    ``(J) The Secretary of Education.
                    ``(K) Representatives from such Federal agencies 
                (such as the Substance Abuse and Mental Health Services 
                Administration and the Department of Homeland Security) 
                as the Secretary determines appropriate to fulfill the 
                duties of the Advisory Committee under subsections (b) 
                and (c).''.
            ``(4) Term of appointment.--Each member of the Advisory 
        Committee appointed under paragraph (2) shall serve for a term 
        of 3 years, except that the Secretary may adjust the terms of 
        the Advisory Committee appointees serving on the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018, or appointees who are 
        initially appointed after such date of enactment, in order to 
        provide for a staggered term of appointment for all members.
            ``(5) Consecutive appointments; maximum terms.--A member 
        appointed under paragraph (2) may serve not more than 3 terms 
        on the Advisory Committee, and not more than 2 of such terms 
        may be served consecutively.'';
            (3) in subsection (e), by adding at the end ``At least one 
        meeting per year shall be an in-person meeting.'';
            (4) by redesignating subsection (f) as subsection (g);
            (5) by inserting after subsection (e) the following:
    ``(f) Coordination.--The Secretary shall coordinate duties and 
activities authorized under this section in accordance with section 
2811D.''; and
            (6) in subsection (g), as so redesignated, by striking 
        ``2018'' and inserting ``2023''.
    (b) Authorizing the National Advisory Committee on Seniors and 
Disasters.--Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.) is 
amended by inserting after section 2811A the following:

``SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SENIORS AND DISASTERS.

    ``(a) Establishment.--The Secretary, in consultation with the 
Secretary of Homeland Security and the Secretary of Veterans Affairs, 
shall establish an advisory committee to be known as the National 
Advisory Committee on Seniors and Disasters (referred to in this 
section as the `Advisory Committee').
    ``(b) Duties.--The Advisory Committee shall--
            ``(1) provide advice and consultation with respect to the 
        activities carried out pursuant to section 2814, as applicable 
        and appropriate;
            ``(2) evaluate and provide input with respect to the 
        medical and public health needs of seniors related to 
        preparation for, response to, and recovery from all-hazards 
        emergencies; and
            ``(3) provide advice and consultation with respect to State 
        emergency preparedness and response activities relating to 
        seniors, including related drills and exercises pursuant to the 
        preparedness goals under section 2802(b).
    ``(c) Additional Duties.--The Advisory Committee may provide advice 
and recommendations to the Secretary with respect to seniors and the 
medical and public health grants and cooperative agreements as 
applicable to preparedness and response activities under this title and 
title III.
    ``(d) Membership.--
            ``(1) In general.--The Secretary, in consultation with such 
        other heads of agencies as appropriate, shall appoint not more 
        than 17 members to the Advisory Committee. In appointing such 
        members, the Secretary shall ensure that the total membership 
        of the Advisory Committee is an odd number.
            ``(2) Required members.--The Advisory Committee shall 
        include Federal members or their designees (who may be non-
        voting members, as determined by the Secretary) and non-Federal 
        members, as follows:
                    ``(A) The Assistant Secretary for Preparedness and 
                Response.
                    ``(B) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(C) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(D) The Commissioner of Food and Drugs.
                    ``(E) The Director of the National Institutes of 
                Health.
                    ``(F) The Administrator of the Centers for Medicare 
                & Medicaid Services.
                    ``(G) The Administrator of the Administration for 
                Community Living.
                    ``(H) The Administrator of the Federal Emergency 
                Management Agency.
                    ``(I) The Under Secretary for Health of the 
                Department of Veterans Affairs.
                    ``(J) At least 2 non-Federal health care 
                professionals with expertise in geriatric medical 
                disaster planning, preparedness, response, or recovery.
                    ``(K) At least 2 representatives of State, local, 
                tribal, or territorial agencies with expertise in 
                geriatric disaster planning, preparedness, response, or 
                recovery.
                    ``(L) Representatives of such other Federal 
                agencies (such as the Department of Energy and the 
                Department of Homeland Security) as the Secretary 
                determines necessary to fulfill the duties of the 
                Advisory Committee.
    ``(e) Meetings.--The Advisory Committee shall meet not less 
frequently than biannually. At least one meeting per year shall be an 
in-person meeting.
    ``(f) Coordination.--The Secretary shall coordinate duties and 
activities authorized under this section in accordance with section 
2811D.
    ``(g) Sunset.--
            ``(1) In general.--The Advisory Committee shall terminate 
        on September 30, 2023.
            ``(2) Extension of committee.--Not later than October 1, 
        2022, the Secretary shall submit to Congress a recommendation 
        on whether the Advisory Committee should be extended.''.
    (c) National Advisory Committee on Individuals With Disabilities 
and Disasters.--Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.), 
as amended by subsection (b), is further amended by inserting after 
section 2811B the following:

``SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH 
              DISABILITIES AND DISASTERS.

    ``(a) Establishment.--The Secretary, in consultation with the 
Secretary of Homeland Security, shall establish a national advisory 
committee to be known as the National Advisory Committee on Individuals 
with Disabilities and Disasters (referred to in this section as the 
`Advisory Committee').
    ``(b) Duties.--The Advisory Committee shall--
            ``(1) provide advice and consultation with respect to 
        activities carried out pursuant to section 2814, as applicable 
        and appropriate;
            ``(2) evaluate and provide input with respect to the 
        medical, public health, and accessibility needs of individuals 
        with disabilities related to preparation for, response to, and 
        recovery from all-hazards emergencies; and
            ``(3) provide advice and consultation with respect to State 
        emergency preparedness and response activities, including 
        related drills and exercises pursuant to the preparedness goals 
        under section 2802(b).
    ``(c) Membership.--
            ``(1) In general.--The Secretary, in consultation with such 
        other heads of agencies and departments as appropriate, shall 
        appoint not more than 17 members to the Advisory Committee. In 
        appointing such members, the Secretary shall ensure that the 
        total membership of the Advisory Committee is an odd number.
            ``(2) Required members.--The Advisory Committee shall 
        include Federal members or their designees (who may be non-
        voting members, as determined by the Secretary) and non-Federal 
        members, as follows:
                    ``(A) The Assistant Secretary for Preparedness and 
                Response.
                    ``(B) The Administrator of the Administration for 
                Community Living.
                    ``(C) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(D) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(E) The Commissioner of Food and Drugs.
                    ``(F) The Director of the National Institutes of 
                Health.
                    ``(G) The Administrator of the Federal Emergency 
                Management Agency.
                    ``(H) The Chair of the National Council on 
                Disability.
                    ``(I) The Chair of the United States Access Board.
                    ``(J) The Under Secretary for Health of the 
                Department of Veterans Affairs.
                    ``(K) At least 2 non-Federal health care 
                professionals with expertise in disability 
                accessibility before, during, and after disasters, 
                medical and mass care disaster planning, preparedness, 
                response, or recovery.
                    ``(L) At least 2 representatives from State, local, 
                tribal, or territorial agencies with expertise in 
                disaster planning, preparedness, response, or recovery 
                for individuals with disabilities.
                    ``(M) At least 2 individuals with a disability with 
                expertise in disaster planning, preparedness, response, 
                or recovery for individuals with disabilities.
    ``(d) Meetings.--The Advisory Committee shall meet not less 
frequently than biannually. At least one meeting per year shall be an 
in-person meeting.
    ``(e) Disability Defined.--For purposes of this section, the term 
`disability' has the meaning given such term in section 3 of the 
Americans with Disabilities Act of 1990.
    ``(f) Coordination.--The Secretary shall coordinate duties and 
activities authorized under this section in accordance with section 
2811D.
    ``(g) Sunset.--
            ``(1) In general.--The Advisory Committee shall terminate 
        on September 30, 2023.
            ``(2) Recommendation.--Not later than October 1, 2022, the 
        Secretary shall submit to Congress a recommendation on whether 
        the Advisory Committee should be extended.''.
    (d) Advisory Committee Coordination.--Subtitle B of title XXVIII 
(42 U.S.C. 300hh et seq.), as amended by subsection (c), is further 
amended by inserting after section 2811C the following:

``SEC. 2811D. ADVISORY COMMITTEE COORDINATION.

    ``(a) In General.--The Secretary shall coordinate duties and 
activities authorized under sections 2811A, 2811B, and 2811C, and make 
efforts to reduce unnecessary or duplicative reporting, or unnecessary 
duplicative meetings and recommendations under such sections, as 
practicable. Members of the advisory committees authorized under such 
sections, or their designees, shall annually meet to coordinate any 
recommendations, as appropriate, that may be similar, duplicative, or 
overlapping with respect to addressing the needs of children, seniors, 
and individuals with disabilities during public health emergencies. If 
such coordination occurs through an in-person meeting, it shall not be 
considered the required in-person meetings under any of sections 
2811A(e), 2811B(e), or 2811C(d).
    ``(b) Coordination and Alignment.--The Secretary, acting through 
the employee designated pursuant to section 2814, shall align 
preparedness and response programs or activities to address similar, 
dual, or overlapping needs of children, seniors, and individuals with 
disabilities, and any challenges in preparing for and responding to 
such needs.
    ``(c) Notification.--The Secretary shall annually notify the 
congressional committees of jurisdiction regarding the steps taken to 
coordinate, as appropriate, the recommendations under this section, and 
provide a summary description of such coordination.''.

SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES AND DRILLS.

    Not later than 2 years after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue final guidance 
regarding the ability of personnel funded by programs authorized under 
this Act (including the amendments made by this Act) to participate in 
drills and operational exercises related to all-hazards medical and 
public health preparedness and response. Such drills and operational 
exercises may include activities that incorporate medical surge 
capacity planning, medical countermeasure distribution and 
administration, and preparing for and responding to identified threats 
for that region. Such personnel may include State, local, tribal, and 
territorial public health department or agency personnel funded under 
this Act (including the amendments made by this Act). The Secretary 
shall consult with the Department of Homeland Security, the Department 
of Defense, the Department of Veterans Affairs, and other applicable 
Federal departments and agencies as necessary and appropriate in the 
development of such guidance. The Secretary shall make the guidance 
available on the internet website of the Department of Health and Human 
Services.

             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

    Section 2811(b) (42 U.S.C. 300hh-10(b)) is amended--
            (1) in the matter preceding paragraph (1) by inserting 
        ``utilize experience related to public health emergency 
        preparedness and response, biodefense, medical countermeasures, 
        and other relevant topics to'' after ``shall''; and
            (2) in paragraph (4) by adding at the end the following:
                    ``(I) Threat awareness.--Coordinate with the 
                Director of the Centers for Disease Control and 
                Prevention, the Director of National Intelligence, the 
                Secretary of Homeland Security, the Assistant to the 
                President for National Security Affairs, the Secretary 
                of Defense, and other relevant Federal officials, such 
                as the Secretary of Agriculture, to maintain a current 
                assessment of national security threats and inform 
                preparedness and response capabilities based on the 
                range of the threats that have the potential to result 
                in a public health emergency.''.

SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.

    (a) In General.--Title XXVIII is amended by inserting after section 
2811 (42 U.S.C. 300hh-10) the following:

``SEC. 2811-1. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES 
              ENTERPRISE.

    ``(a) In General.--The Secretary shall establish the Public Health 
Emergency Medical Countermeasures Enterprise (referred to in this 
section as the `PHEMCE'). The Assistant Secretary for Preparedness and 
Response shall serve as chair of the PHEMCE.
    ``(b) Members.--The PHEMCE shall include each of the following 
members, or the designee of such members:
            ``(1) The Assistant Secretary for Preparedness and 
        Response.
            ``(2) The Director of the Centers for Disease Control and 
        Prevention.
            ``(3) The Director of the National Institutes of Health.
            ``(4) The Commissioner of Food and Drugs.
            ``(5) The Secretary of Defense.
            ``(6) The Secretary of Homeland Security.
            ``(7) The Secretary of Agriculture.
            ``(8) The Secretary of Veterans Affairs.
            ``(9) The Director of National Intelligence.
            ``(10) Representatives of any other Federal agency, which 
        may include the Director of the Biomedical Advanced Research 
        and Development Authority, the Director of the Strategic 
        National Stockpile, the Director of the National Institute of 
        Allergy and Infectious Diseases, and the Director of the Office 
        of Public Health Preparedness and Response, as the Secretary 
        determines appropriate.
    ``(c) Functions.--
            ``(1) In general.--The functions of the PHEMCE shall 
        include the following:
                    ``(A) Utilize a process to make recommendations to 
                the Secretary regarding research, advanced research, 
                development, procurement, stockpiling, deployment, 
                distribution, and utilization with respect to 
                countermeasures, as defined in section 319F-2(c), 
                including prioritization based on the health security 
                needs of the United States. Such recommendations shall 
                be informed by, when available and practicable, the 
                National Health Security Strategy pursuant to section 
                2802, the Strategic National Stockpile needs pursuant 
                to section 319F-2, and assessments of current national 
                security threats, including chemical, biological, 
                radiological, and nuclear threats, including emerging 
                infectious diseases. In the event that members of the 
                PHEMCE do not agree upon a recommendation, the 
                Secretary shall provide a determination regarding such 
                recommendation.
                    ``(B) Identify national health security needs, 
                including gaps in public health preparedness and 
                response related to countermeasures and challenges to 
                addressing such needs (including any regulatory 
                challenges), and support alignment of countermeasure 
                procurement with recommendations to address such needs 
                under subparagraph (A).
                    ``(C) Assist the Secretary in developing strategies 
                related to logistics, deployment, distribution, 
                dispensing, and use of countermeasures that may be 
                applicable to the activities of the strategic national 
                stockpile under section 319F-2(a).
                    ``(D) Provide consultation for the development of 
                the strategy and implementation plan under section 
                2811(d).
            ``(2) Input.--In carrying out subparagraphs (B) and (C) of 
        paragraph (1), the PHEMCE shall solicit and consider input from 
        State, local, tribal, and territorial public health departments 
        or officials, as appropriate.''.
    (b) Public Health Emergency Medical Countermeasures Enterprise 
Strategy and Implementation Plan.--Section 2811(d) (42 U.S.C. 300hh-
10(d)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``Not later than 180 days after the 
                date of enactment of this subsection, and every year 
                thereafter'' and inserting ``Not later than March 15, 
                2020, and biennially thereafter''; and
                    (B) by striking ``Director of the Biomedical'' and 
                all that follows through ``Food and Drugs'' and 
                inserting ``Public Health Emergency Medical 
                Countermeasures Enterprise established under section 
                2811-1''; and
            (2) in paragraph (2)(J)(v), by striking ``one-year period'' 
        and inserting ``2-year period''.

SEC. 403. STRATEGIC NATIONAL STOCKPILE.

    (a) In General.--Section 319F-2(a) (42 U.S.C. 247d-6b(a)) is 
amended--
            (1) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively; and
            (2) in paragraph (1)--
                    (A) by inserting ``the Assistant Secretary for 
                Preparedness and Response and'' after ``collaboration 
                with'';
                    (B) by inserting ``and optimize'' after ``provide 
                for'';
                    (C) by inserting ``and, as informed by existing 
                recommendations of, or consultations with, the Public 
                Health Emergency Medical Countermeasure Enterprise 
                established under section 2811-1, make necessary 
                additions or modifications to the contents of such 
                stockpile or stockpiles based on the review conducted 
                under paragraph (2)'' before the period of the first 
                sentence; and
                    (D) by striking the second sentence;
            (3) by inserting after paragraph (1) the following:
            ``(2) Threat-based review.--
                    ``(A) In general.--The Secretary shall conduct an 
                annual threat-based review (taking into account at-risk 
                individuals) of the contents of the stockpile under 
                paragraph (1), including non-pharmaceutical supplies, 
                and, in consultation with the Public Health Emergency 
                Medical Countermeasures Enterprise established under 
                section 2811-1, review contents within the stockpile 
                and assess whether such contents are consistent with 
                the recommendations made pursuant to section 2811-
                1(c)(1)(A). Such review shall be submitted on June 15, 
                2019, and on March 15 of each year thereafter, 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, in a 
                manner that does not compromise national security.
                    ``(B) Additions, modifications, and 
                replenishments.--Each annual threat-based review under 
                subparagraph (A) shall, for each new or modified 
                countermeasure procurement or replenishment, provide--
                            ``(i) information regarding--
                                    ``(I) the quantities of the 
                                additional or modified countermeasure 
                                procured for, or contracted to be 
                                procured for, the stockpile;
                                    ``(II) planning considerations for 
                                appropriate manufacturing capacity and 
                                capability to meet the goals of such 
                                additions or modifications (without 
                                disclosing proprietary information), 
                                including consideration of the effect 
                                such additions or modifications may 
                                have on the availability of such 
                                products and ancillary medical supplies 
                                in the health care system;
                                    ``(III) the presence or lack of a 
                                commercial market for the 
                                countermeasure at the time of 
                                procurement;
                                    ``(IV) the emergency health 
                                security threat or threats such 
                                countermeasure procurement is intended 
                                to address, including whether such 
                                procurement is consistent with meeting 
                                emergency health security needs 
                                associated with such threat or threats;
                                    ``(V) an assessment of whether the 
                                emergency health security threat or 
                                threats described in subclause (IV) 
                                could be addressed in a manner that 
                                better utilizes the resources of the 
                                stockpile and permits the greatest 
                                possible increase in the level of 
                                emergency preparedness to address such 
                                threats;
                                    ``(VI) whether such countermeasure 
                                is replenishing an expiring or expired 
                                countermeasure, is a different 
                                countermeasure with the same indication 
                                that is replacing an expiring or 
                                expired countermeasure, or is a new 
                                addition to the stockpile;
                                    ``(VII) a description of how such 
                                additions or modifications align with 
                                projected investments under previous 
                                countermeasures budget plans under 
                                section 2811(b)(7), including expected 
                                life-cycle costs, expenditures related 
                                to countermeasure procurement to 
                                address the threat or threats described 
                                in subclause (IV), replenishment dates 
                                (including the ability to extend the 
                                maximum shelf life of a 
                                countermeasure), and the manufacturing 
                                capacity required to replenish such 
                                countermeasure; and
                                    ``(VIII) appropriate protocols and 
                                processes for the deployment, 
                                distribution, or dispensing of the 
                                countermeasure at the State and local 
                                level, including plans for relevant 
                                capabilities of State and local 
                                entities to dispense, distribute, and 
                                administer the countermeasure; and
                            ``(ii) an assurance, which need not be 
                        provided in advance of procurement, that for 
                        each countermeasure procured or replenished 
                        under this subsection, the Secretary completed 
                        a review addressing each item listed under this 
                        subsection in advance of such procurement or 
                        replenishment.'';
            (4) in paragraph (3), as so redesignated--
                    (A) in subparagraph (A), by inserting ``and the 
                Public Health Emergency Medical Countermeasures 
                Enterprise established under section 2811-1'' before 
                the semicolon;
                    (B) in subparagraph (C), by inserting ``, and the 
                availability, deployment, dispensing, and 
                administration of countermeasures'' before the 
                semicolon;
                    (C) by amending subparagraph (E) to read as 
                follows:
                    ``(E) devise plans for effective and timely supply-
                chain management of the stockpile, in consultation with 
                the Director of the Centers for Disease Control and 
                Prevention, the Assistant Secretary for Preparedness 
                and Response, the Secretary of Transportation, the 
                Secretary of Homeland Security, the Secretary of 
                Veterans Affairs, and the heads of other appropriate 
                Federal agencies; State, local, tribal, and territorial 
                agencies; and the public and private health care 
                infrastructure, as applicable, taking into account the 
                manufacturing capacity and other available sources of 
                products and appropriate alternatives to supplies in 
                the stockpile;'';
                    (D) in subparagraph (G), by striking ``; and'' and 
                inserting a semicolon;
                    (E) in subparagraph (H), by striking the period and 
                inserting a semicolon; and
                    (F) by adding at the end the following:
                    ``(I) ensure that each countermeasure or product 
                under consideration for procurement pursuant to this 
                subsection receives the same consideration regardless 
                of whether such countermeasure or product receives or 
                had received funding under section 319L, including with 
                respect to whether the countermeasure or product is 
                most appropriate to meet the emergency health security 
                needs of the United States; and
                    ``(J) provide assistance, including technical 
                assistance, to maintain and improve State and local 
                public health preparedness capabilities to distribute 
                and dispense medical countermeasures and products from 
                the stockpile, as appropriate.''; and
            (5) by adding at the end the following:
            ``(5) GAO report.--
                    ``(A) In general.--Not later than 3 years after the 
                date of enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, and 
                every 5 years thereafter, the Comptroller General of 
                the United States shall conduct a review of any changes 
                to the contents or management of the stockpile since 
                January 1, 2015. Such review shall include--
                            ``(i) an assessment of the 
                        comprehensiveness and completeness of each 
                        annual threat-based review under paragraph (2), 
                        including whether all newly procured or 
                        replenished countermeasures within the 
                        stockpile were described in each annual review, 
                        and whether, consistent with paragraph (2)(B), 
                        the Secretary conducted the necessary internal 
                        review in advance of such procurement or 
                        replenishment;
                            ``(ii) an assessment of whether the 
                        Secretary established health security and 
                        science-based justifications, and a description 
                        of such justifications for procurement 
                        decisions related to health security needs with 
                        respect to the identified threat, for additions 
                        or modifications to the stockpile based on the 
                        information provided in such reviews under 
                        paragraph (2)(B), including whether such review 
                        was conducted prior to procurement, 
                        modification, or replenishment;
                            ``(iii) an assessment of the plans 
                        developed by the Secretary for the deployment, 
                        distribution, and dispensing of countermeasures 
                        procured, modified, or replenished under 
                        paragraph (1), including whether such plans 
                        were developed prior to procurement, 
                        modification, or replenishment;
                            ``(iv) an accounting of countermeasures 
                        procured, modified, or replenished under 
                        paragraph (1) that received advanced research 
                        and development funding from the Biomedical 
                        Advanced Research and Development Authority;
                            ``(v) an analysis of how such procurement 
                        decisions made progress toward meeting 
                        emergency health security needs related to the 
                        identified threats for countermeasures added, 
                        modified, or replenished under paragraph (1);
                            ``(vi) a description of the resources 
                        expended related to the procurement of 
                        countermeasures (including additions, 
                        modifications, and replenishments) in the 
                        stockpile, and how such expenditures relate to 
                        the ability of the stockpile to meet emergency 
                        health security needs;
                            ``(vii) an assessment of the extent to 
                        which additions, modifications, and 
                        replenishments reviewed under paragraph (2) 
                        align with previous relevant reports or reviews 
                        by the Secretary or the Comptroller General;
                            ``(viii) with respect to any change in the 
                        Federal organizational management of the 
                        stockpile, an assessment and comparison of the 
                        processes affected by such change, including 
                        planning for potential countermeasure 
                        deployment, distribution, or dispensing 
                        capabilities and processes related to 
                        procurement decisions, use of stockpiled 
                        countermeasures, and use of resources for such 
                        activities; and
                            ``(ix) an assessment of whether the 
                        processes and procedures described by the 
                        Secretary pursuant to section 403(b) of the 
                        Pandemic and All-Hazards Preparedness and 
                        Advancing Innovation Act of 2018 are sufficient 
                        to ensure countermeasures and products under 
                        consideration for procurement pursuant to 
                        subsection (a) receive the same consideration 
                        regardless of whether such countermeasures and 
                        products receive or had received funding under 
                        section 319L, including with respect to whether 
                        such countermeasures and products are most 
                        appropriate to meet the emergency health 
                        security needs of the United States.
                    ``(B) Submission.--Not later than 6 months after 
                completing a classified version of the review under 
                subparagraph (A), the Comptroller General shall submit 
                an unclassified version of the review to the 
                congressional committees of jurisdiction.''.
    (b) Additional Reporting.--In the first threat-based review 
submitted after the date of enactment of this Act pursuant to paragraph 
(2) of section 319F-2(a) of the Public Health Service Act (42 U.S.C. 
247d-6b(a)), as amended by subsection (a), the Secretary shall include 
a description of the processes and procedures through which the 
Director of Strategic National Stockpile and the Director of the 
Biomedical Advanced Research and Development Authority coordinate with 
respect to countermeasures and products procured under such section 
319F-2(a), including such processes and procedures in place to ensure 
countermeasures and products under consideration for procurement 
pursuant to such section 319F-2(a) receive the same consideration 
regardless of whether such countermeasures or products receive or had 
received funding under section 319L of the Public Health Service Act 
(42 U.S.C. 247d-7e), and whether such countermeasures and products are 
the most appropriate to meet the emergency health security needs of the 
United States.
    (c) Authorization of Appropriations, Strategic National 
Stockpile.--Section 319F-2(f)(1) (42 U.S.C. 247d-6b(f)(1)) is amended 
by striking ``$533,800,000 for each of fiscal years 2014 through 2018'' 
and inserting ``$610,000,000 for each of fiscal years 2019 through 
2023, to remain available until expended''.

SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL RESISTANCE, 
              AND OTHER SIGNIFICANT THREATS.

    (a) Strategic Initiatives.--Section 319L(c)(4) (247d-7e(c)(4)) is 
amended by adding at the end the following:
                    ``(F) Strategic initiatives.--The Secretary, acting 
                through the Director of BARDA, may implement strategic 
                initiatives, including by building on existing programs 
                and by awarding contracts, grants, and cooperative 
                agreements, or entering into other transactions, to 
                support innovative candidate products in preclinical 
                and clinical development that address priority, 
                naturally occurring and man-made threats that, as 
                determined by the Secretary, pose a significant level 
                of risk to national security based on the 
                characteristics of a chemical, biological, radiological 
                or nuclear threat, or existing capabilities to respond 
                to such a threat (including medical response and 
                treatment capabilities and manufacturing 
                infrastructure). Such initiatives shall accelerate and 
                support the advanced research, development, and 
                procurement of, countermeasures and products, as 
                applicable, to address areas including--
                            ``(i) chemical, biological, radiological, 
                        or nuclear threats, including emerging 
                        infectious diseases, for which insufficient 
                        approved, licensed, or authorized 
                        countermeasures exist, or for which such 
                        threat, or the result of an exposure to such 
                        threat, may become resistant to countermeasures 
                        or existing countermeasures may be rendered 
                        ineffective;
                            ``(ii) threats that consistently exist or 
                        continually circulate and have a significant 
                        potential to become a pandemic, such as 
                        pandemic influenza, which may include the 
                        advanced research and development, 
                        manufacturing, and appropriate stockpiling of 
                        qualified pandemic or epidemic products, and 
                        products, technologies, or processes to support 
                        the advanced research and development of such 
                        countermeasures (including multiuse platform 
                        technologies for diagnostics, vaccines, and 
                        therapeutics; virus seeds; clinical trial lots; 
                        novel virus strains; and antigen and adjuvant 
                        material); and
                            ``(iii) threats that may result primarily 
                        or secondarily from a chemical, biological, 
                        radiological, or nuclear agent, or emerging 
                        infectious diseases, and which may present 
                        increased treatment complications such as the 
                        occurrence of resistance to available 
                        countermeasures or potential countermeasures, 
                        including antimicrobial resistant pathogens.''.
    (b) Protection of National Security From Threats.--Section 2811 (42 
U.S.C. 300hh-10) is amended by adding at the end the following:
    ``(f) Protection of National Security From Threats.--
            ``(1) In general.--In carrying out subsection (b)(3), the 
        Assistant Secretary for Preparedness and Response shall 
        implement strategic initiatives or activities to address 
        threats, including pandemic influenza and which may include a 
        chemical, biological, radiological, or nuclear agent (including 
        any such agent with a significant potential to become a 
        pandemic), that pose a significant level of risk to public 
        health and national security based on the characteristics of 
        such threat. Such initiatives shall include activities to--
                    ``(A) accelerate and support the advanced research, 
                development, manufacturing capacity, procurement, and 
                stockpiling of countermeasures, including initiatives 
                under section 319L(c)(4)(F);
                    ``(B) support the development and manufacturing of 
                virus seeds, clinical trial lots, and stockpiles of 
                novel virus strains; and
                    ``(C) maintain or improve preparedness activities, 
                including for pandemic influenza.
            ``(2) Authorization of appropriations.--
                    ``(A) In general.--To carry out this subsection, 
                there is authorized to be appropriated $250,000,000 for 
                each of fiscal years 2019 through 2023.
                    ``(B) Supplement, not supplant.--Amounts 
                appropriated under this paragraph shall be used to 
                supplement and not supplant funds provided under 
                sections 319L(d) and 319F-2(g).
                    ``(C) Documentation required.--The Assistant 
                Secretary for Preparedness and Response, in accordance 
                with subsection (b)(7), shall document amounts expended 
                for purposes of carrying out this subsection, including 
                amounts appropriated under the heading `Public Health 
                and Social Services Emergency Fund' under the heading 
                `Office of the Secretary' under title II of division H 
                of the Consolidated Appropriations Act, 2018 (Public 
                Law 115-141) and allocated to carrying out section 
                319L(c)(4)(F).''.

SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM.

    Section 351A(k) (42 U.S.C. 262a(k)) is amended--
            (1) by striking ``The Secretary'' and inserting the 
        following:
            ``(1) In general.--The Secretary''; and
            (2) by adding at the end the following:
            ``(2) Implementation of recommendations of the federal 
        experts security advisory panel and the fast track action 
        committee on select agent regulations.--
                    ``(A) In general.--Not later than 1 year after the 
                date of the enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary shall report to the congressional committees 
                of jurisdiction on the implementation of 
                recommendations of the Federal Experts Security 
                Advisory Panel concerning the select agent program.
                    ``(B) Continued updates.--The Secretary shall 
                report to the congressional committees of jurisdiction 
                annually following the submission of the report under 
                subparagraph (A) until the recommendations described in 
                such subparagraph are fully implemented, or a 
                justification is provided for the delay in, or lack of, 
                implementation.''.

 TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED 
                        RESEARCH AND DEVELOPMENT

SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN.

    Section 2811(b)(7) (42 U.S.C. 300hh-10(b)(7)) is amended--
            (1) in the matter preceding subparagraph (A), by striking 
        ``March 1'' and inserting ``March 15'';
            (2) in subparagraph (A)--
                    (A) in clause (ii), by striking ``; and'' and 
                inserting ``;''; and
                    (B) by striking clause (iii) and inserting the 
                following:
                            ``(iii) procurement, stockpiling, 
                        maintenance, and potential replenishment 
                        (including manufacturing capabilities) of all 
                        products in the Strategic National Stockpile;
                            ``(iv) the availability of technologies 
                        that may assist in the advanced research and 
                        development of countermeasures and 
                        opportunities to use such technologies to 
                        accelerate and navigate challenges unique to 
                        countermeasure research and development; and
                            ``(v) potential deployment, distribution, 
                        and utilization of medical countermeasures; 
                        development of clinical guidance and emergency 
                        use instructions for the use of medical 
                        countermeasures; and, as applicable, potential 
                        post-deployment activities related to medical 
                        countermeasures;'';
            (3) by redesignating subparagraphs (D) and (E) as 
        subparagraphs (E) and (F), respectively; and
            (4) by inserting after subparagraph (C), the following:
                    ``(D) identify the full range of anticipated 
                medical countermeasure needs related to research and 
                development, procurement, and stockpiling, including 
                the potential need for indications, dosing, and 
                administration technologies, and other countermeasure 
                needs as applicable and appropriate;''.

SEC. 502. MATERIAL THREAT AND MEDICAL COUNTERMEASURE NOTIFICATIONS.

    (a) Congressional Notification of Material Threat Determination.--
Section 319F-2(c)(2)(C) (42 U.S.C. 247d-6b(c)(2)(C)) is amended by 
striking ``The Secretary and the Homeland Security Secretary shall 
promptly notify the appropriate committees of Congress'' and inserting 
``The Secretary and the Secretary of Homeland Security shall send to 
Congress, on an annual basis, all current material threat 
determinations and shall promptly notify the Committee on Health, 
Education, Labor, and Pensions and the Committee on Homeland Security 
and Governmental Affairs of the Senate and the Committee on Energy and 
Commerce and the Committee on Homeland Security of the House of 
Representatives''.
    (b) Contracting Communication.--Section 319F-2(c)(7)(B)(ii)(III) 
(42 U.S.C. 247d-6b(c)(7)(B)(ii)(III)) is amended by adding at the end 
the following: ``The Secretary shall notify the vendor within 90 days 
of a determination by the Secretary to renew, extend, or terminate such 
contract.''.

SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS.

    Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-4(f)) is amended--
            (1) by redesignating paragraphs (3) through (6) as 
        paragraphs (4) through (7), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) Publication.--The Secretary shall make available on 
        the internet website of the Food and Drug Administration 
        information regarding regulatory management plans, including--
                    ``(A) the process by which an applicant may submit 
                a request for a regulatory management plan;
                    ``(B) the timeframe by which the Secretary is 
                required to respond to such request;
                    ``(C) the information required for the submission 
                of such request;
                    ``(D) a description of the types of development 
                milestones and performance targets that could be 
                discussed and included in such plans; and
                    ``(E) contact information for beginning the 
                regulatory management plan process.'';
            (3) in paragraph (6), as so redesignated, in the matter 
        preceding subparagraph (A)--
                    (A) by striking ``paragraph (4)(A)'' and inserting 
                ``paragraph (5)(A)''; and
                    (B) by striking ``paragraph (4)(B)'' and inserting 
                ``paragraph (5)(B)''; and
            (4) in paragraph (7)(A), as so redesignated, by striking 
        ``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''.

SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY 
              AND THE BIOSHIELD SPECIAL RESERVE FUND.

    (a) BioShield Special Reserve Fund.--Section 319F-2(g)(1) (42 
U.S.C. 247d-6b(g)(1)) is amended--
            (1) by striking ``$2,800,000,000 for the period of fiscal 
        years 2014 through 2018'' and inserting ``$7,100,000,000 for 
        the period of fiscal years 2019 through 2028, to remain 
        available until expended''; and
            (2) by striking the second sentence.
    (b) The Biomedical Advanced Research and Development Authority.--
Section 319L(d)(2) (42 U.S.C. 247d-7e(d)(2)) is amended by striking 
``$415,000,000 for each of fiscal years 2014 through 2018'' and 
inserting ``$611,700,000 for each of fiscal years 2019 through 2023''.

SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTIBIOTIC RESISTANCE.

    (a) Advisory Council.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') may continue the 
Presidential Advisory Council on Combating Antibiotic-Resistant 
Bacteria, referred to in this section as the ``Advisory Council''.
    (b) Duties.--The Advisory Council shall advise and provide 
information and recommendations to the Secretary regarding programs and 
policies intended to reduce or combat antibiotic-resistant bacteria 
that may present a public health threat and improve capabilities to 
prevent, diagnose, mitigate, or treat such resistance. Such advice, 
information, and recommendations may be related to improving--
            (1) the effectiveness of antibiotics;
            (2) research and advanced research on, and the development 
        of, improved and innovative methods for combating or reducing 
        antibiotic resistance, including new treatments, rapid point-
        of-care diagnostics, alternatives to antibiotics, including 
        alternatives to animal antibiotics, and antimicrobial 
        stewardship activities;
            (3) surveillance of antibiotic-resistant bacterial 
        infections, including publicly available and up-to-date 
        information on resistance to antibiotics;
            (4) education for health care providers and the public with 
        respect to up-to-date information on antibiotic resistance and 
        ways to reduce or combat such resistance to antibiotics related 
        to humans and animals;
            (5) methods to prevent or reduce the transmission of 
        antibiotic-resistant bacterial infections, including 
        stewardship programs; and
            (6) coordination with respect to international efforts in 
        order to inform and advance United States capabilities to 
        combat antibiotic resistance.
    (c) Meetings and Coordination.--
            (1) Meetings.--The Advisory Council shall meet not less 
        than biannually and, to the extent practicable, in coordination 
        with meetings of the Antimicrobial Resistance Task Force 
        established in section 319E(a) of the Public Health Service 
        Act.
            (2) Coordination.--The Advisory Council shall, to the 
        greatest extent practicable, coordinate activities carried out 
        by the Council with the Antimicrobial Resistance Task Force 
        established under section 319E(a) of the Public Health Service 
        Act (42 U.S.C. 247d-5(a)).
    (d) FACA.--The Federal Advisory Committee Act (5 U.S.C. App.) shall 
apply to the activities and duties of the Advisory Council.
    (e) Extension of Advisory Council.--Not later than October 1, 2022, 
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 recommendation on whether 
the Advisory Council should be extended, and in addition, identify 
whether there are other committees, councils, or task forces that have 
overlapping or similar duties to that of the Advisory Council, and 
whether such committees, councils, or task forces should be combined, 
including with respect to section 319E(a) of the Public Health Service 
Act (42 U.S.C. 247d-5(a)).

      TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

SEC. 601. ADMINISTRATION OF COUNTERMEASURES.

    Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d-7e(c)(4)(D)(iii)) is 
amended by striking ``and platform technologies'' and inserting 
``platform technologies, technologies to administer countermeasures, 
and technologies to improve storage and transportation of 
countermeasures''.

SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS.

    Section 319L (42 U.S.C. 247d-7e) is amended--
            (1) in subsection (a)(3), by striking ``, such as'' and all 
        that follows through ``Code''; and
            (2) in subsection (c)(5)(A)--
                    (A) in clause (i), by striking ``under this 
                subsection'' and all that follows through ``Code'' and 
                inserting ``(as defined in subsection (a)(3)) under 
                this subsection''; and
                    (B) in clause (ii)--
                            (i) by amending subclause (I) to read as 
                        follows:
                                    ``(I) In general.--To the maximum 
                                extent practicable, competitive 
                                procedures shall be used when entering 
                                into transactions to carry out projects 
                                under this subsection.''; and
                            (ii) in subclause (II)--
                                    (I) by striking ``$20,000,000'' and 
                                inserting ``$100,000,000'';
                                    (II) by striking ``senior 
                                procurement executive for the 
                                Department (as designated for purpose 
                                of section 16(c) of the Office of 
                                Federal Procurement Policy Act (41 
                                U.S.C. 414(c)))'' and inserting 
                                ``Assistant Secretary for Financial 
                                Resources''; and
                                    (III) by striking ``senior 
                                procurement executive under'' and 
                                inserting ``Assistant Secretary for 
                                Financial Resources under''.

SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES.

    (a) In General.--The purpose of this section (including section 
565B of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (b)) is to support and advance the development or 
manufacture of security countermeasures, qualified countermeasures, and 
qualified pandemic or epidemic products by facilitating and encouraging 
submission of data and information to support the development of such 
products, and through clarifying the authority to cross-reference to 
data and information previously submitted to the Secretary of Health 
and Human Services (referred to in this section as the ``Secretary''), 
including data and information submitted to medical countermeasure 
master files or other master files.
    (b) Medical Countermeasure Master Files.--Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 565A the following:

``SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES.

    ``(a) Applicability of Reference.--
            ``(1) In general.--A person may submit data and information 
        in a master file to the Secretary with the intent to reference, 
        or to authorize, in writing, another person to reference, such 
        data or information to support a medical countermeasure 
        submission (including a supplement or amendment to any such 
        submission), without requiring the master file holder to 
        disclose the data and information to any such persons 
        authorized to reference the master file. Such data and 
        information shall be available for reference by the master file 
        holder or by a person authorized by the master file holder, in 
        accordance with applicable privacy and confidentiality 
        protocols and regulations.
            ``(2) Reference of certain master files.--In the case that 
        data or information within a medical countermeasure master file 
        is used only to support the conditional approval of an 
        application filed under section 571, such master file may be 
        relied upon to support the effectiveness of a product that is 
        the subject of a subsequent medical countermeasure submission 
        only if such application is supplemented by additional data or 
        information to support review and approval in a manner 
        consistent with the standards applicable to such review and 
        approval for such countermeasure, qualified countermeasure, or 
        qualified pandemic or epidemic product.
    ``(b) Medical Countermeasure Master File Content.--
            ``(1) In general.--A master file under this section may 
        include data or information to support--
                    ``(A) the development of medical countermeasure 
                submissions to support the approval, licensure, 
                classification, clearance, conditional approval, or 
                authorization of one or more security countermeasures, 
                qualified countermeasures, or qualified pandemic or 
                epidemic products; and
                    ``(B) the manufacture of security countermeasures, 
                qualified countermeasures, or qualified pandemic or 
                epidemic products.
            ``(2) Required updates.--The Secretary may require, as 
        appropriate, that the master file holder ensure that the 
        contents of such master file are updated during the time such 
        master file is referenced for a medical countermeasure 
        submission.
    ``(c) Sponsor Reference.--
            ``(1) In general.--Each incorporation of data or 
        information within a medical countermeasure master file shall 
        describe the incorporated material in a manner in which the 
        Secretary determines appropriate and that permits the review of 
        such information within such master file without necessitating 
        re-submission of such data or information. Master files shall 
        be submitted in an electronic format in accordance with 
        sections 512(b)(4), 571(a)(4), and 745A, as applicable, and as 
        specified in applicable guidance.
            ``(2) Reference by a master file holder.--A master file 
        holder that is the sponsor of a medical countermeasure 
        submission shall notify the Secretary in writing of the intent 
        to reference the medical countermeasure master file as a part 
        of the submission.
            ``(3) Reference by an authorized person.--A person 
        submitting an application for review may, where the Secretary 
        determines appropriate, incorporate by reference all or part of 
        the contents of a medical countermeasure master file, if the 
        master file holder authorizes the incorporation in writing.
    ``(d) Acknowledgment of and Reliance Upon a Master File by the 
Secretary.--
            ``(1) In general.--The Secretary shall provide the master 
        file holder with a written notification indicating that the 
        Secretary has reviewed and relied upon specified data or 
        information within a master file and the purposes for which 
        such data or information was incorporated by reference if the 
        Secretary has reviewed and relied upon such specified data or 
        information to support the approval, classification, 
        conditional approval, clearance, licensure, or authorization of 
        a security countermeasure, qualified countermeasure, or 
        qualified pandemic or epidemic product. The Secretary may rely 
        upon the data and information within the medical countermeasure 
        master file for which such written notification was provided in 
        additional applications, as applicable and appropriate and upon 
        the request of the master file holder so notified in writing or 
        by an authorized person of such holder.
            ``(2) Certain applications.--If the Secretary has reviewed 
        and relied upon specified data or information within a medical 
        countermeasure master file to support the conditional approval 
        of an application under section 571 to subsequently support the 
        approval, clearance, licensure, or authorization of a security 
        countermeasure, qualified countermeasure, or qualified pandemic 
        or epidemic product, the Secretary shall provide a brief 
        written description to the master file holder regarding the 
        elements of the application fulfilled by the data or 
        information within the master file and how such data or 
        information contained in such application meets the standards 
        of evidence under subsection (c) or (d) of section 505, 
        subsection (d) of section 512, or section 351 of the Public 
        Health Service Act (as applicable), which shall not include any 
        trade secret or confidential commercial information.
    ``(e) Rules of Construction.--Nothing in this section shall be 
construed to--
            ``(1) limit the authority of the Secretary to approve, 
        license, clear, conditionally approve, or authorize drugs, 
        biological products, or devices pursuant to, as applicable, 
        this Act or section 351 of the Public Health Service Act (as 
        such applicable Act is in effect on the day before the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018), including the standards of 
        evidence, and applicable conditions, for approval under the 
        applicable Act;
            ``(2) alter the standards of evidence with respect to 
        approval, licensure, or clearance, as applicable, of drugs, 
        biological products, or devices under this Act or section 351 
        of the Public Health Service Act, including, as applicable, the 
        substantial evidence standards under sections 505(d) and 512(d) 
        or this Act and section 351(a) of the Public Health Service 
        Act; or
            ``(3) alter the authority of the Secretary under this Act 
        or the Public Health Service Act to determine the types of data 
        or information previously submitted by a sponsor or any other 
        person that may be incorporated by reference in an application, 
        request, or notification for a drug, biological product, or 
        device submitted under sections 505(i), 505(b), 505(j), 
        512(b)(1), 512(b)(2), 512(j), 564, 571, 520(g), 515(c), 
        513(f)(2), or 510(k) of this Act, or subsection (a) or (k) of 
        section 351 of the Public Health Service Act, including a 
        supplement or amendment to any such submission, and the 
        requirements associated with such reference.
    ``(f) Definitions.--In this section:
            ``(1) The term `master file holder' means a person who 
        submits data and information to the Secretary with the intent 
        to reference or authorize another person to reference such data 
        or information to support a medical countermeasure submission, 
        as described in subsection (a).
            ``(2) The term `medical countermeasure submission' means an 
        investigational new drug application under section 505(i), a 
        new drug application under section 505(b), or an abbreviated 
        new drug application under section 505(j) of this Act, a 
        biological product license application under section 351(a) of 
        the Public Health Service Act or a biosimilar biological 
        product license application under section 351(k) of the Public 
        Health Service Act, a new animal drug application under section 
        512(b)(1) or abbreviated new animal drug application under 
        section 512(b)(2), an application for conditional approval of a 
        new animal drug under section 571, an investigational device 
        application under section 520(g), an application with respect 
        to a device under section 515(c), a request for classification 
        of a device under section 513(f)(2), a notification with 
        respect to a device under section 510(k), or a request for an 
        emergency use authorization under section 564 to support--
                    ``(A) the approval, licensure, classification, 
                clearance, conditional approval, or authorization of a 
                security countermeasure, qualified countermeasure, or 
                qualified pandemic or epidemic product; or
                    ``(B) a new indication to an approved security 
                countermeasure, qualified countermeasure, or qualified 
                pandemic or epidemic product.
            ``(3) The terms `qualified countermeasure', `security 
        countermeasure', and `qualified pandemic or epidemic product' 
        have the meanings given such terms in sections 319F-1, 319F-2, 
        and 319F-3, respectively, of the Public Health Service Act.''.
    (c) Stakeholder Input.--Not later than 18 months after the date of 
enactment of this Act, the Secretary, acting through the Commissioner 
of Food and Drugs and in consultation with the Assistant Secretary for 
Preparedness and Response, shall solicit input from stakeholders, 
including stakeholders developing security countermeasures, qualified 
countermeasures, or qualified pandemic or epidemic products, and 
stakeholders developing technologies to assist in the development of 
such countermeasures with respect to how the Food and Drug 
Administration can advance the use of tools and technologies to support 
and advance the development or manufacture of security countermeasures, 
qualified countermeasures, and qualified pandemic or epidemic products, 
including through reliance on cross-referenced data and information 
contained within master files and submissions previously submitted to 
the Secretary as set forth in section 565B of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (b).
    (d) Guidance.--Not later than 2 years after the date of enactment 
of this Act, the Secretary, acting through the Commissioner of Food and 
Drugs, shall publish draft guidance about how reliance on cross-
referenced data and information contained within master files under 
section 565B of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (b) or submissions otherwise submitted to the Secretary may 
be used for specific tools or technologies (including platform 
technologies) that have the potential to support and advance the 
development or manufacture of security countermeasures, qualified 
countermeasures, and qualified pandemic or epidemic products. The 
Secretary, acting through the Commissioner of Food and Drugs, shall 
publish the final guidance not later than 3 years after the enactment 
of this Act.

SEC. 604. ANIMAL RULE REPORT.

    (a) Study.--The Comptroller General of the United States shall 
conduct a study on the application of the requirements under 
subsections (c) and (d) of section 565 of the of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) (referred to in this 
section as the ``animal rule'') as a component of medical 
countermeasure advanced development under the Biomedical Advanced 
Research and Development Authority and regulatory review by the Food 
and Drug Administration. In conducting such study, the Comptroller 
General shall examine the following:
            (1) The extent to which advanced development and review of 
        a medical countermeasure are coordinated between the Biomedical 
        Advanced Research and Development Authority and the Food and 
        Drug Administration, including activities that facilitate 
        appropriate and efficient design of studies to support 
        approval, licensure, and authorization under the animal rule, 
        consistent with the recommendations in the animal rule 
        guidance, issued pursuant to section 565(c) of the Federal Food 
        Drug and Cosmetic Act (21 U.S.C. 360bbb-4(c)) and entitled 
        ``Product Development Under the Animal Rule: Guidance for 
        Industry'' (issued in October 2015), to resolve discrepancies 
        in the design of adequate and well-controlled efficacy studies 
        conducted in animal models related to the provision of 
        substantial evidence of effectiveness for the product approved, 
        licensed, or authorized under the animal rule.
            (2) The consistency of the application of the animal rule 
        among and between review divisions within the Food and Drug 
        Administration.
            (3) The flexibility pursuant to the animal rule to address 
        variations in countermeasure development and review processes, 
        including the extent to which qualified animal models are 
        adopted and used within the Food and Drug Administration in 
        regulatory decisionmaking with respect to medical 
        countermeasures.
            (4) The extent to which the guidance issued under section 
        565(c) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 
        360bbb-4(c)), entitled, ``Product Development Under the Animal 
        Rule: Guidance for Industry'' (issued in October 2015), has 
        assisted in achieving the purposes described in paragraphs (1), 
        (2), and (3).
    (b) Consultations.--In conducting the study under subsection (a), 
the Comptroller General of the United States shall consult with--
            (1) the Federal agencies responsible for advancing, 
        reviewing, and procuring medical countermeasures, including the 
        Office of the Assistant Secretary for Preparedness and 
        Response, the Biomedical Advanced Research and Development 
        Authority, the Food and Drug Administration, and the Department 
        of Defense;
            (2) manufacturers involved in the research and development 
        of medical countermeasures to address biological, chemical, 
        radiological, or nuclear threats; and
            (3) other biodefense stakeholders, as applicable.
    (c) 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 containing the results of the study conducted 
under subsection (a) and recommendations to improve the application and 
consistency of the requirements under subsections (c) and (d) of 
section 565 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
360bbb-4) to support and expedite the research and development of 
medical countermeasures, as applicable.
    (d) Protection of National Security.--The Comptroller General of 
the United States shall conduct the study and issue the assessment and 
report under this section in a manner that does not compromise national 
security.

SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING TECHNOLOGIES 
              AND THEIR POTENTIAL ROLE IN NATIONAL SECURITY.

    (a) Meeting.--
            (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 convene a meeting to discuss the potential role 
        advancements in genomic engineering technologies (including 
        genome editing technologies) may have in advancing national 
        health security. Such meeting shall be held in a manner that 
        does not compromise national security.
            (2) Attendees.--The attendees of the meeting under 
        paragraph (1)--
                    (A) shall include--
                            (i) representatives from the Office of the 
                        Assistant Secretary for Preparedness and 
                        Response, the National Institutes of Health, 
                        the Centers for Disease Control and Prevention, 
                        and the Food and Drug Administration; and
                            (ii) representatives from academic, 
                        private, and nonprofit entities with expertise 
                        in genome engineering technologies, 
                        biopharmaceuticals, medicine, or biodefense, 
                        and other relevant stakeholders; and
                    (B) may include--
                            (i) other representatives from the 
                        Department of Health and Human Services, as the 
                        Secretary determines appropriate; and
                            (ii) representatives from the Department of 
                        Homeland Security, the Department of Defense, 
                        the Department of Agriculture, and other 
                        departments, as the Secretary may request for 
                        the meeting.
            (3) Topics.--The meeting under paragraph (1) shall include 
        a discussion of--
                    (A) the current state of the science of genomic 
                engineering technologies related to national health 
                security, including--
                            (i) medical countermeasure development, 
                        including potential efficiencies in the 
                        development pathway and detection technologies; 
                        and
                            (ii) the international and domestic 
                        regulation of products utilizing genome editing 
                        technologies; and
                    (B) national security implications, including--
                            (i) capabilities of the United States to 
                        leverage genomic engineering technologies as a 
                        part of the medical countermeasure enterprise, 
                        including current applicable research, 
                        development, and application efforts underway 
                        within the Department of Defense;
                            (ii) the potential for state and non-state 
                        actors to utilize genomic engineering 
                        technologies as a national health security 
                        threat; and
                            (iii) security measures to monitor and 
                        assess the potential threat that may result 
                        from utilization of genomic engineering 
                        technologies and related technologies for the 
                        purpose of compromising national health 
                        security.
    (b) Report.--Not later than 270 days after the meeting described in 
subsection (a) is held, the Assistant Secretary for Preparedness and 
Response shall issue a report to the congressional committees of 
jurisdiction on the topics discussed at such meeting, and provide 
recommendations, as applicable, to utilize innovations in genomic 
engineering (including genome editing) and related technologies as a 
part of preparedness and response activities to advance national health 
security. Such report shall be issued in a manner that does not 
compromise national security.

SEC. 606. REPORT ON VACCINES DEVELOPMENT.

    Not later than one year after the date of the enactment of this 
Act, the Secretary of Health and Human Services 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 efforts and activities to coordinate with other 
countries and international partners during recent public health 
emergencies with respect to the research and advanced research on, and 
development of, qualified pandemic or epidemic products (as defined in 
section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)). 
Such report may include information regarding relevant work carried out 
under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C. 
247d-7e(c)(5)(E)), through public-private partnerships, and through 
collaborations with other countries to assist with or expedite the 
research and development of qualified pandemic or epidemic products. 
Such report shall not include information that may compromise national 
security.

SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND HEALTH.

    (a) Reauthorization of Mosquito Abatement for Safety and Health 
Program.--Section 317S (42 U.S.C. 247b-21) is amended--
            (1) in subsection (a)(1)(B)--
                    (A) by inserting ``including programs to address 
                emerging infectious mosquito-borne diseases,'' after 
                ``subdivisions for control programs,''; and
                    (B) by inserting ``or improving existing control 
                programs'' before the period at the end;
            (2) in subsection (b)--
                    (A) in paragraph (1), by inserting ``, including 
                improvement,'' after ``operation'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (A)--
                                    (I) in clause (ii), by striking 
                                ``or'' at the end;
                                    (II) in clause (iii), by striking 
                                the semicolon at the end and inserting 
                                ``, including an emerging infectious 
                                mosquito-borne disease that presents a 
                                serious public health threat; or''; and
                                    (III) by adding at the end the 
                                following:
                            ``(iv) a public health emergency due to the 
                        incidence or prevalence of a mosquito-borne 
                        disease that presents a serious public health 
                        threat;''; and
                            (ii) by amending subparagraph (D) to read 
                        as follows:
                    ``(D)(i) is located in a State that has received a 
                grant under subsection (a); or
                    ``(ii) that demonstrates to the Secretary that the 
                control program is consistent with existing State 
                mosquito control plans or policies, or other applicable 
                State preparedness plans.'';
                    (C) in paragraph (4)(C), by striking ``that 
                extraordinary'' and all that follows through the period 
                at the end and inserting the following: ``that--
                            ``(i) extraordinary economic conditions in 
                        the political subdivision or consortium of 
                        political subdivisions involved justify the 
                        waiver; or
                            ``(ii) the geographical area covered by a 
                        political subdivision or consortium for a grant 
                        under paragraph (1) has an extreme mosquito 
                        control need due to--
                                    ``(I) the size or density of the 
                                potentially impacted human population;
                                    ``(II) the size or density of a 
                                mosquito population that requires 
                                heightened control; or
                                    ``(III) the severity of the 
                                mosquito-borne disease, such that 
                                expected serious adverse health 
                                outcomes for the human population 
                                justify the waiver.''; and
                    (D) by amending paragraph (6) to read as follows:
            ``(6) Number of grants.--A political subdivision or a 
        consortium of political subdivisions may not receive more than 
        one grant under paragraph (1).''; and
            (3) in subsection (f)--
                    (A) in paragraph (1) by striking ``for fiscal year 
                2003, and such sums as may be necessary for each of 
                fiscal years 2004 through 2007'' and inserting ``for 
                each of fiscal years 2019 through 2023'';
                    (B) in paragraph (2), by striking ``the Public 
                Health Security and Bioterrorism Preparedness and 
                Response Act of 2002'' and inserting ``this Act and 
                other medical and public health preparedness and 
                response laws''; and
                    (C) in paragraph (3)--
                            (i) in the paragraph heading, by striking 
                        ``2004'' and inserting ``2019''; and
                            (ii) by striking ``2004,'' and inserting 
                        ``2019,''.
    (b) Epidemiology-Laboratory Capacity Grants.--Section 2821 (42 
U.S.C. 300hh-31) is amended--
            (1) in subsection (a)(1), by inserting ``, including 
        mosquito and other vector-borne diseases,'' after ``infectious 
        diseases''; and
            (2) in subsection (b), by striking ``2010 through 2013'' 
        and inserting ``2019 through 2023''.

                  TITLE VII--MISCELLANEOUS PROVISIONS

SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.

    (a) Veterans Affairs.--Section 8117(g) of title 38, United States 
Code, is amended by striking ``2014 through 2018'' and inserting ``2019 
through 2023''.
    (b) Vaccine Tracking and Distribution.--Section 319A(e) (42 U.S.C. 
247d-1(e)) is amended by striking ``2014 through 2018'' and inserting 
``2019 through 2023''.
    (c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C. 
247d(e)(8)) is amended by striking ``2018'' and inserting ``2023''.
    (d) Strategic Innovation Partner.--Section 319L(c)(4)(E)(ix) (42 
U.S.C. 247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and 
inserting ``2023''.
    (e) Limited Antitrust Exemption.--
            (1) In general.--Section 405 of the Pandemic and All-
        Hazards Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-6a 
        note) is amended--
                    (A) in subsection (a)(1)(A)--
                            (i) by striking ``Secretary of Health and 
                        Human Services (referred to in this subsection 
                        as the `Secretary')'' and inserting 
                        ``Secretary'';
                            (ii) by striking ``of the Public Health 
                        Service Act (42 U.S.C. 247d-6b)) (as amended by 
                        this Act'';
                            (iii) by striking ``of the Public Health 
                        Service Act (42 U.S.C. 247d-6a)) (as amended by 
                        this Act''; and
                            (iv) by striking ``of the Public Health 
                        Service Act (42 U.S.C. 247d-6d)'';
                    (B) in subsection (b), by striking ``12-year'' and 
                inserting ``17-year'';
                    (C) by redesignating such section 405 as section 
                319L-1; and
                    (D) by transferring such section 319L-1, as 
                redesignated, to the Public Health Service Act (42 
                U.S.C. 201 et seq.), to appear after section 319L of 
                such Act (42 U.S.C. 247d-7e).
            (2) Conforming amendment.--The table of contents in section 
        1(b) of the Pandemic and All-Hazards Preparedness Act (Public 
        Law 109-417) is amended by striking the item related to section 
        405.
    (f) Inapplicability of Certain Provisions.--Subsection (e)(1) of 
section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
            (1) by amending subparagraph (A) to read as follows:
                    ``(A) Non-disclosure of information.--
                            ``(i) In general.--Information described in 
                        clause (ii) shall be deemed to be information 
                        described in section 552(b)(3) of title 5, 
                        United States Code.
                            ``(ii) Information described.--The 
                        information described in this clause is 
                        information relevant to programs of the 
                        Department of Health and Human Services that 
                        could compromise national security and reveal 
                        significant and not otherwise publicly known 
                        vulnerabilities of existing medical or public 
                        health defenses against chemical, biological, 
                        radiological, or nuclear threats, and is 
                        comprised of--
                                    ``(I) specific technical data or 
                                scientific information that is created 
                                or obtained during the countermeasure 
                                and product advanced research and 
                                development carried out under 
                                subsection (c);
                                    ``(II) information pertaining to 
                                the location security, personnel, and 
                                research materials and methods of high-
                                containment laboratories conducting 
                                research with select agents, toxins, or 
                                other agents with a material threat 
                                determination under section 319F-
                                2(c)(2); or
                                    ``(III) security and vulnerability 
                                assessments.'';
            (2) by redesignating subparagraph (C) as subparagraph (D);
            (3) by inserting after subparagraph (B) the following:
                    ``(C) Reporting.--One year after the date of 
                enactment of the Pandemic and All-Hazards Preparedness 
                and Advancing Innovation Act of 2018, and annually 
                thereafter, 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 number of instances in which 
                the Secretary has used the authority under this 
                subsection to withhold information from disclosure, as 
                well as the nature of any request under section 552 of 
                title 5, United States Code that was denied using such 
                authority.''; and
            (4) in subparagraph (D), as so redesignated, by striking 
        ``12'' and inserting ``17''.

SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE.

    Subsection (d) of section 319F-2 (42 U.S.C. 247d-6b) is amended to 
read as follows:
    ``(d) Disclosures.--No Federal agency may disclose under section 
552 of title 5, United States Code any information identifying the 
location at which materials in the stockpile described in subsection 
(a) are stored, or other information regarding the contents or 
deployment capability of the stockpile that could compromise national 
security.''.

SEC. 703. CYBERSECURITY.

    (a) Strategy for Public Health Preparedness and Response to 
Cybersecurity Threats.--
            (1) Strategy.--Not later than 18 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary'') 
        shall prepare and submit to the relevant committees of Congress 
        a strategy for public health preparedness and response to 
        address cybersecurity threats (as defined in section 102 of 
        Cybersecurity Information Sharing Act of 2015 (6 U.S.C. 1501)) 
        that present a threat to national health security. Such 
        strategy shall include--
                    (A) identifying the duties, functions, and 
                preparedness goals for which the Secretary is 
                responsible in order to prepare for and respond to such 
                cybersecurity threats, including metrics by which to 
                measure success in meeting preparedness goals;
                    (B) identifying gaps in public health capabilities 
                to achieve such preparedness goals; and
                    (C) strategies to address identified gaps and 
                strengthen public health emergency preparedness and 
                response capabilities to address such cybersecurity 
                threats.
            (2) Protection of national security.--The Secretary shall 
        make such strategy available to the Committee on Health, 
        Education, Labor, and Pensions of the Senate, the Committee on 
        Energy and Commerce of the House of Representatives, and other 
        congressional committees of jurisdiction, in a manner that does 
        not compromise national security.
    (b) Coordination of Preparedness for and Response to All-hazards 
Public Health Emergencies.--Subparagraph (D) of section 2811(b)(4) (42 
U.S.C. 300hh-10(b)(4)) is amended to read as follows:
                    ``(D) Policy coordination and strategic 
                direction.--Provide integrated policy coordination and 
                strategic direction, before, during, and following 
                public health emergencies, with respect to all matters 
                related to Federal public health and medical 
                preparedness and execution and deployment of the 
                Federal response for public health emergencies and 
                incidents covered by the National Response Plan 
                described in section 504(a)(6) of the Homeland Security 
                Act of 2002 (6 U.S.C. 314(a)(6)), or any successor 
                plan; and such Federal responses covered by the 
                National Cybersecurity Incident Response Plan developed 
                under section 228(c) of the Homeland Security Act of 
                2002 (6 U.S.C. 149(c)), including public health 
                emergencies or incidents related to cybersecurity 
                threats that present a threat to national health 
                security.''.

SEC. 704. STRATEGY AND REPORT.

    Not later than 14 days after the date of the enactment of this Act, 
the Secretary of Health and Human Services, in coordination with the 
Assistant Secretary for Preparedness and Response and the Assistant 
Secretary for the Administration on Children and Families or other 
appropriate office, and in collaboration with other departments, as 
appropriate, shall submit to the Committee on Energy and Commerce of 
the House of Representatives, the Committee on Health, Education, 
Labor, and Pensions of the Senate, and other relevant congressional 
committees--
            (1) a formal strategy, including interdepartmental actions 
        and efforts to reunify children with their parents or 
        guardians, in all cases in which such children have been 
        separated from their parents or guardians as a result of the 
        initiative announced on April 6, 2018, and due to prosecution 
        under section 275(a) of the Immigration and Nationality Act (8 
        U.S.C. 1325(a)), if the parent or guardian chooses such 
        reunification and the child--
                    (A) was separated from a parent or guardian and 
                placed into a facility funded by the Department of 
                Health and Human Services;
                    (B) as of the date of the enactment of this Act, 
                remains in the care of the Department of Health and 
                Human Services; and
                    (C) can be safely reunited with such parent or 
                guardian; and
            (2) a report on challenges and deficiencies related to the 
        oversight of, and care for, unaccompanied alien children and 
        appropriately reuniting such children with their parents or 
        guardians, and the actions taken to address any challenges and 
        deficiencies related to unaccompanied alien children in the 
        custody of the Department of Health and Human Services, 
        including deficiencies identified and publicly reported by 
        Congress, the Government Accountability Office, or the 
        Inspectors General of the Department of Health and Human 
        Services or other Federal departments.

SEC. 705. TECHNICAL AMENDMENTS.

    (a) Public Health Service Act.--Title III (42 U.S.C. 241 et seq.) 
is amended--
            (1) in paragraphs (1) and (5) of section 319F-1(a) (42 
        U.S.C. 247d-6a(a)), by striking ``section 319F(h)'' each place 
        such term appears and inserting ``section 319F(e)''; and
            (2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking 
        ``section 319F(h)(4)'' and inserting ``section 319F(e)(4)''.
    (b) Public Health Security Grants.--Section 319C-1(b)(2) (42 U.S.C. 
247d-3a(b)(2)) is amended--
            (1) in subparagraph (C), by striking ``individuals,,'' and 
        inserting ``individuals,''; and
            (2) in subparagraph (F), by striking ``make satisfactory 
        annual improvement and describe'' and inserting ``makes 
        satisfactory annual improvement and describes''.
    (c) Emergency Use Instructions.--Subparagraph (A) of section 
564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3a(e)(2)) is amended by striking ``subsection (a)(1)(C)(i)'' and 
inserting ``subsection (a)(1)(C)''.
    (d) Products Held for Emergency Use.--Section 564B(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b) is amended--
            (1) in subparagraph (B), by inserting a comma after 
        ``505''; and
            (2) in subparagraph (C), by inserting ``or section 564A'' 
        before the period at the end.
    (e) Transparency.--Section 507(c)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 357(c)(3)) is amended--
            (1) by striking ``Nothing in'' and inserting the following:
                    ``(A) In general.--Nothing in'';
            (2) by inserting ``or directing'' after ``authorizing'';
            (3) by striking ``disclose any'' and inserting ``disclose--
                            ``(i) any'';
            (4) by striking the period and inserting ``; or''; and
            (5) by adding at the end the following:
                            ``(ii) in the case of a drug development 
                        tool that may be used to support the 
                        development of a qualified countermeasure, 
                        security countermeasure, or qualified pandemic 
                        or epidemic product, as defined in sections 
                        319F-1, 319F-2, and 319F-3, respectively, of 
                        the Public Health Service Act, any information 
                        that the Secretary determines has a significant 
                        potential to affect national security.
                    ``(B) Public acknowledgment.--In the case that the 
                Secretary, pursuant to subparagraph (A)(ii), does not 
                make information publicly available, the Secretary 
                shall provide on the internet website of the Food and 
                Drug Administration an acknowledgment of the 
                information that has not been disclosed, pursuant to 
                subparagraph (A)(ii).''.

 DIVISION B--OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM

SEC. 1000. SHORT TITLE; REFERENCES IN DIVISION.

    (a) Short Title.--This division may be cited as the ``Over-the-
Counter Monograph Safety, Innovation, and Reform Act of 2018''.
    (b) References.--Except as otherwise specified, any reference to 
``this Act'' contained in this division shall be treated as referring 
only to the provisions of this division.

                        TITLE I--OTC DRUG REVIEW

SEC. 1001. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE 
              MARKETED WITHOUT AN APPROVED DRUG APPLICATION.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 505F of such Act (21 U.S.C. 
355g) the following:

``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE 
              MARKETED WITHOUT AN APPROVED DRUG APPLICATION.

    ``(a) Nonprescription Drugs Marketed Without an Approved 
Application.--Nonprescription drugs marketed without an approved drug 
application under section 505, as of the date of the enactment of this 
section, shall be treated in accordance with this subsection.
            ``(1) Drugs subject to a final monograph; category i drugs 
        subject to a tentative final monograph.--A drug is deemed to be 
        generally recognized as safe and effective under section 
        201(p)(1), not a new drug under section 201(p), and not subject 
        to section 503(b)(1), if--
                    ``(A) the drug is--
                            ``(i) in conformity with the requirements 
                        for nonprescription use of a final monograph 
                        issued under part 330 of title 21, Code of 
                        Federal Regulations (except as provided in 
                        paragraph (2)), the general requirements for 
                        nonprescription drugs, and conditions or 
                        requirements under subsections (b), (c), and 
                        (k); and
                            ``(ii) except as permitted by an order 
                        issued under subsection (b) or, in the case of 
                        a minor change in the drug, in conformity with 
                        an order issued under subsection (c), in a 
                        dosage form that, immediately prior to the date 
                        of the enactment of this section, has been used 
                        to a material extent and for a material time 
                        under section 201(p)(2); or
                    ``(B) the drug is--
                            ``(i) classified in category I for safety 
                        and effectiveness under a tentative final 
                        monograph that is the most recently applicable 
                        proposal or determination issued under part 330 
                        of title 21, Code of Federal Regulations;
                            ``(ii) in conformity with the proposed 
                        requirements for nonprescription use of such 
                        tentative final monograph, any applicable 
                        subsequent determination by the Secretary, the 
                        general requirements for nonprescription drugs, 
                        and conditions or requirements under 
                        subsections (b), (c), and (k); and
                            ``(iii) except as permitted by an order 
                        issued under subsection (b) or, in the case of 
                        a minor change in the drug, in conformity with 
                        an order issued under subsection (c), in a 
                        dosage form that, immediately prior to the date 
                        of the enactment of this section, has been used 
                        to a material extent and for a material time 
                        under section 201(p)(2).
            ``(2) Treatment of sunscreen drugs.--With respect to 
        sunscreen drugs subject to this section, the applicable 
        requirements in terms of conformity with a final monograph, for 
        purposes of paragraph (1)(A)(i), shall be the requirements 
        specified in part 352 of title 21, Code of Federal Regulations, 
        as published on May 21, 1999, beginning on page 27687 of volume 
        64 of the Federal Register, except that the applicable 
        requirements governing effectiveness and labeling shall be 
        those specified in section 201.327 of title 21, Code of Federal 
        Regulations.
            ``(3) Category iii drugs subject to a tentative final 
        monograph; category i drugs subject to proposed monograph or 
        advance notice of proposed rulemaking.--A drug that is not 
        described in paragraph (1), (2), or (4) is not required to be 
        the subject of an application approved under section 505, and 
        is not subject to section 503(b)(1), if--
                    ``(A) the drug is--
                            ``(i) classified in category III for safety 
                        or effectiveness in the preamble of a proposed 
                        rule establishing a tentative final monograph 
                        that is the most recently applicable proposal 
                        or determination for such drug issued under 
                        part 330 of title 21, Code of Federal 
                        Regulations;
                            ``(ii) in conformity with--
                                    ``(I) the conditions of use, 
                                including indication and dosage 
                                strength, if any, described for such 
                                category III drug in such preamble or 
                                in an applicable subsequent proposed 
                                rule;
                                    ``(II) the proposed requirements 
                                for drugs classified in such tentative 
                                final monograph in category I in the 
                                most recently proposed rule 
                                establishing requirements related to 
                                such tentative final monograph and in 
                                any final rule establishing 
                                requirements that are applicable to the 
                                drug; and
                                    ``(III) the general requirements 
                                for nonprescription drugs and 
                                conditions or requirements under 
                                subsection (b) or (k); and
                            ``(iii) in a dosage form that, immediately 
                        prior to the date of the enactment of this 
                        section, had been used to a material extent and 
                        for a material time under section 201(p)(2); or
                    ``(B) the drug is--
                            ``(i) classified in category I for safety 
                        and effectiveness under a proposed monograph or 
                        advance notice of proposed rulemaking that is 
                        the most recently applicable proposal or 
                        determination for such drug issued under part 
                        330 of title 21, Code of Federal Regulations;
                            ``(ii) in conformity with the requirements 
                        for nonprescription use of such proposed 
                        monograph or advance notice of proposed 
                        rulemaking, any applicable subsequent 
                        determination by the Secretary, the general 
                        requirements for nonprescription drugs, and 
                        conditions or requirements under subsection (b) 
                        or (k); and
                            ``(iii) in a dosage form that, immediately 
                        prior to the date of the enactment of this 
                        section, has been used to a material extent and 
                        for a material time under section 201(p)(2).
            ``(4) Category ii drugs deemed new drugs.--A drug that is 
        classified in category II for safety or effectiveness under a 
        tentative final monograph or that is subject to a determination 
        to be not generally recognized as safe and effective in a 
        proposed rule that is the most recently applicable proposal 
        issued under part 330 of title 21, Code of Federal Regulations, 
        shall be deemed to be a new drug under section 201(p), 
        misbranded under section 502(ee), and subject to the 
        requirement for an approved new drug application under section 
        505 beginning on the day that is 180 calendar days after the 
        date of the enactment of this section, unless, before such day, 
        the Secretary determines that it is in the interest of public 
        health to extend the period during which the drug may be 
        marketed without such an approved new drug application.
            ``(5) Drugs not grase deemed new drugs.--A drug that the 
        Secretary has determined not to be generally recognized as safe 
        and effective under section 201(p)(1) under a final 
        determination issued under part 330 of title 21, Code of 
        Federal Regulations, shall be deemed to be a new drug under 
        section 201(p), misbranded under section 502(ee), and subject 
        to the requirement for an approved new drug application under 
        section 505.
            ``(6) Other drugs deemed new drugs.--Except as provided in 
        subsection (m), a drug is deemed to be a new drug under section 
        201(p) and misbranded under section 502(ee) if the drug--
                    ``(A) is not subject to section 503(b)(1); and
                    ``(B) is not described in paragraph (1), (2), (3), 
                (4), or (5), or subsection (b)(1)(B).
    ``(b) Administrative Orders.--
            ``(1) In general.--
                    ``(A) Determination.--The Secretary may, on the 
                initiative of the Secretary or at the request of one or 
                more requestors, issue an administrative order 
                determining whether there are conditions under which a 
                specific drug, a class of drugs, or a combination of 
                drugs, is determined to be--
                            ``(i) not subject to section 503(b)(1); and
                            ``(ii) generally recognized as safe and 
                        effective under section 201(p)(1).
                    ``(B) Effect.--A drug or combination of drugs shall 
                be deemed to not require approval under section 505 if 
                such drug or combination of drugs--
                            ``(i) is determined by the Secretary to 
                        meet the conditions specified in clauses (i) 
                        and (ii) of subparagraph (A);
                            ``(ii) is marketed in conformity with an 
                        administrative order under this subsection;
                            ``(iii) meets the general requirements for 
                        nonprescription drugs; and
                            ``(iv) meets the requirements under 
                        subsections (c) and (k).
                    ``(C) Standard.--The Secretary shall find that a 
                drug is not generally recognized as safe and effective 
                under section 201(p)(1) if--
                            ``(i) the evidence shows that the drug is 
                        not generally recognized as safe and effective 
                        under section 201(p)(1); or
                            ``(ii) the evidence is inadequate to show 
                        that the drug is generally recognized as safe 
                        and effective under section 201(p)(1).
            ``(2) Administrative orders initiated by the secretary.--
                    ``(A) In general.--In issuing an administrative 
                order under paragraph (1) upon the Secretary's 
                initiative, the Secretary shall--
                            ``(i) make reasonable efforts to notify 
                        informally, not later than 2 business days 
                        before the issuance of the proposed order, the 
                        sponsors of drugs who have a listing in effect 
                        under section 510(j) for the drugs or 
                        combination of drugs that will be subject to 
                        the administrative order;
                            ``(ii) after any such reasonable efforts of 
                        notification--
                                    ``(I) issue a proposed 
                                administrative order by publishing it 
                                on the website of the Food and Drug 
                                Administration and include in such 
                                order the reasons for the issuance of 
                                such order; and
                                    ``(II) publish a notice of 
                                availability of such proposed order in 
                                the Federal Register;
                            ``(iii) except as provided in subparagraph 
                        (B), provide for a public comment period with 
                        respect to such proposed order of not less than 
                        45 calendar days; and
                            ``(iv) if, after completion of the 
                        proceedings specified in clauses (i) through 
                        (iii), the Secretary determines that it is 
                        appropriate to issue a final administrative 
                        order--
                                    ``(I) issue the final 
                                administrative order, together with a 
                                detailed statement of reasons, which 
                                order shall not take effect until the 
                                time for requesting judicial review 
                                under paragraph (3)(D)(ii) has expired;
                                    ``(II) publish a notice of such 
                                final administrative order in the 
                                Federal Register;
                                    ``(III) afford requestors of drugs 
                                that will be subject to such order the 
                                opportunity for formal dispute 
                                resolution up to the level of the 
                                Director of the Center for Drug 
                                Evaluation and Research, which 
                                initially must be requested within 45 
                                calendar days of the issuance of the 
                                order, and, for subsequent levels of 
                                appeal, within 30 calendar days of the 
                                prior decision; and
                                    ``(IV) except with respect to drugs 
                                described in paragraph (3)(B), upon 
                                completion of the formal dispute 
                                resolution procedure, inform the 
                                persons which sought such dispute 
                                resolution of their right to request a 
                                hearing.
                    ``(B) Exceptions.--When issuing an administrative 
                order under paragraph (1) on the Secretary's initiative 
                proposing to determine that a drug described in 
                subsection (a)(3) is not generally recognized as safe 
                and effective under section 201(p)(1), the Secretary 
                shall follow the procedures in subparagraph (A), except 
                that--
                            ``(i) the proposed order shall include 
                        notice of--
                                    ``(I) the general categories of 
                                data the Secretary has determined 
                                necessary to establish that the drug is 
                                generally recognized as safe and 
                                effective under section 201(p)(1); and
                                    ``(II) the format for submissions 
                                by interested persons;
                            ``(ii) the Secretary shall provide for a 
                        public comment period of no less than 180 
                        calendar days with respect to such proposed 
                        order, except when the Secretary determines, 
                        for good cause, that a shorter period is in the 
                        interest of public health; and
                            ``(iii) any person who submits data in such 
                        comment period shall include a certification 
                        that the person has submitted all evidence 
                        created, obtained, or received by that person 
                        that is both within the categories of data 
                        identified in the proposed order and relevant 
                        to a determination as to whether the drug is 
                        generally recognized as safe and effective 
                        under section 201(p)(1).
            ``(3) Hearings; judicial review.--
                    ``(A) In general.--Only a person who participated 
                in each stage of formal dispute resolution under 
                subclause (III) of paragraph (2)(A)(iv) of an 
                administrative order with respect to a drug may request 
                a hearing concerning a final administrative order 
                issued under such paragraph with respect to such drug. 
                If a hearing is sought, such person must submit a 
                request for a hearing, which shall be based solely on 
                information in the administrative record, to the 
                Secretary not later than 30 calendar days after 
                receiving notice of the final decision of the formal 
                dispute resolution procedure.
                    ``(B) No hearing required with respect to orders 
                relating to certain drugs.--
                            ``(i) In general.--The Secretary shall not 
                        be required to provide notice and an 
                        opportunity for a hearing pursuant to paragraph 
                        (2)(A)(iv) if the final administrative order 
                        involved relates to a drug--
                                    ``(I) that is described in 
                                subsection (a)(3)(A); and
                                    ``(II) with respect to which no 
                                human or non-human data studies 
                                relevant to the safety or effectiveness 
                                of such drug have been submitted to the 
                                administrative record since the 
                                issuance of the most recent tentative 
                                final monograph relating to such drug.
                            ``(ii) Human data studies and non-human 
                        data defined.--In this subparagraph:
                                    ``(I) The term `human data studies' 
                                means clinical trials of safety or 
                                effectiveness (including actual use 
                                studies), pharmacokinetics studies, or 
                                bioavailability studies.
                                    ``(II) The term `non-human data' 
                                means data from testing other than with 
                                human subjects which provides 
                                information concerning safety or 
                                effectiveness.
                    ``(C) Hearing procedures.--
                            ``(i) Denial of request for hearing.--If 
                        the Secretary determines that information 
                        submitted in a request for a hearing under 
                        subparagraph (A) with respect to a final 
                        administrative order issued under paragraph 
                        (2)(A)(iv), does not identify the existence of 
                        a genuine and substantial question of material 
                        fact, the Secretary may deny such request. In 
                        making such a determination, the Secretary may 
                        consider only information and data that are 
                        based on relevant and reliable scientific 
                        principles and methodologies.
                            ``(ii) Single hearing for multiple related 
                        requests.--If more than one request for a 
                        hearing is submitted with respect to the same 
                        administrative order under subparagraph (A), 
                        the Secretary may direct that a single hearing 
                        be conducted in which all persons whose hearing 
                        requests were granted may participate.
                            ``(iii) Presiding officer.--The presiding 
                        officer of a hearing requested under 
                        subparagraph (A) shall--
                                    ``(I) be designated by the 
                                Secretary;
                                    ``(II) not be an employee of the 
                                Center for Drug Evaluation and 
                                Research; and
                                    ``(III) not have been previously 
                                involved in the development of the 
                                administrative order involved or 
                                proceedings relating to that 
                                administrative order.
                            ``(iv) Rights of parties to hearing.--The 
                        parties to a hearing requested under 
                        subparagraph (A) shall have the right to 
                        present testimony, including testimony of 
                        expert witnesses, and to cross-examine 
                        witnesses presented by other parties. Where 
                        appropriate, the presiding officer may require 
                        that cross-examination by parties representing 
                        substantially the same interests be 
                        consolidated to promote efficiency and avoid 
                        duplication.
                            ``(v) Final decision.--
                                    ``(I) At the conclusion of a 
                                hearing requested under subparagraph 
                                (A), the presiding officer of the 
                                hearing shall issue a decision 
                                containing findings of fact and 
                                conclusions of law. The decision of the 
                                presiding officer shall be final.
                                    ``(II) The final decision may not 
                                take effect until the period under 
                                subparagraph (D)(ii) for submitting a 
                                request for judicial review of such 
                                decision expires.
                    ``(D) Judicial review of final administrative 
                order.--
                            ``(i) In general.--The procedures described 
                        in section 505(h) shall apply with respect to 
                        judicial review of final administrative orders 
                        issued under this subsection in the same manner 
                        and to the same extent as such section applies 
                        to an order described in such section except 
                        that the judicial review shall be taken by 
                        filing in an appropriate district court of the 
                        United States in lieu of the appellate courts 
                        specified in such section.
                            ``(ii) Period to submit a request for 
                        judicial review.--A person eligible to request 
                        a hearing under this paragraph and seeking 
                        judicial review of a final administrative order 
                        issued under this subsection shall file such 
                        request for judicial review not later than 60 
                        calendar days after the latest of--
                                    ``(I) the date on which notice of 
                                such order is published;
                                    ``(II) the date on which a hearing 
                                with respect to such order is denied 
                                under subparagraph (B) or (C)(i);
                                    ``(III) the date on which a final 
                                decision is made following a hearing 
                                under subparagraph (C)(v); or
                                    ``(IV) if no hearing is requested, 
                                the date on which the time for 
                                requesting a hearing expires.
            ``(4) Expedited procedure with respect to administrative 
        orders initiated by the secretary.--
                    ``(A) Imminent hazard to the public health.--
                            ``(i) In general.--In the case of a 
                        determination by the Secretary that a drug, 
                        class of drugs, or combination of drugs subject 
                        to this section poses an imminent hazard to the 
                        public health, the Secretary, after first 
                        making reasonable efforts to notify, not later 
                        than 48 hours before issuance of such order 
                        under this subparagraph, sponsors who have a 
                        listing in effect under section 510(j) for such 
                        drug or combination of drugs--
                                    ``(I) may issue an interim final 
                                administrative order for such drug, 
                                class of drugs, or combination of drugs 
                                under paragraph (1), together with a 
                                detailed statement of the reasons for 
                                such order;
                                    ``(II) shall publish in the Federal 
                                Register a notice of availability of 
                                any such order; and
                                    ``(III) shall provide for a public 
                                comment period of at least 45 calendar 
                                days with respect to such interim final 
                                order.
                            ``(ii) Nondelegation.--The Secretary may 
                        not delegate the authority to issue an interim 
                        final administrative order under this 
                        subparagraph.
                    ``(B) Safety labeling changes.--
                            ``(i) In general.--In the case of a 
                        determination by the Secretary that a change in 
                        the labeling of a drug, class of drugs, or 
                        combination of drugs subject to this section is 
                        reasonably expected to mitigate a significant 
                        or unreasonable risk of a serious adverse event 
                        associated with use of the drug, the Secretary 
                        may--
                                    ``(I) make reasonable efforts to 
                                notify informally, not later than 48 
                                hours before the issuance of the 
                                interim final order, the sponsors of 
                                drugs who have a listing in effect 
                                under section 510(j) for such drug or 
                                combination of drugs;
                                    ``(II) after reasonable efforts of 
                                notification, issue an interim final 
                                administrative order in accordance with 
                                paragraph (1) to require such change, 
                                together with a detailed statement of 
                                the reasons for such order;
                                    ``(III) publish in the Federal 
                                Register a notice of availability of 
                                such order; and
                                    ``(IV) provide for a public comment 
                                period of at least 45 calendar days 
                                with respect to such interim final 
                                order.
                            ``(ii) Content of order.--An interim final 
                        order issued under this subparagraph with 
                        respect to the labeling of a drug may provide 
                        for new warnings and other information required 
                        for safe use of the drug.
                    ``(C) Effective date.--An order under subparagraph 
                (A) or (B) shall take effect on a date specified by the 
                Secretary.
                    ``(D) Final order.--After the completion of the 
                proceedings in subparagraph (A) or (B), the Secretary 
                shall--
                            ``(i) issue a final order in accordance 
                        with paragraph (1);
                            ``(ii) publish a notice of availability of 
                        such final administrative order in the Federal 
                        Register; and
                            ``(iii) afford sponsors of such drugs that 
                        will be subject to such an order the 
                        opportunity for formal dispute resolution up to 
                        the level of the Director of the Center for 
                        Drug Evaluation and Research, which must 
                        initially be within 45 calendar days of the 
                        issuance of the order, and for subsequent 
                        levels of appeal, within 30 calendar days of 
                        the prior decision.
                    ``(E) Hearings.--A sponsor of a drug subject to a 
                final order issued under subparagraph (D) and that 
                participated in each stage of formal dispute resolution 
                under clause (iii) of such subparagraph may request a 
                hearing on such order. The provisions of subparagraphs 
                (A), (B), and (C) of paragraph (3), other than 
                paragraph (3)(C)(v)(II), shall apply with respect to a 
                hearing on such order in the same manner and to the 
                same extent as such provisions apply with respect to a 
                hearing on an administrative order issued under 
                paragraph (2)(A)(iv).
                    ``(F) Timing.--
                            ``(i) Final order and hearing.--The 
                        Secretary shall--
                                    ``(I) not later than 6 months after 
                                the date on which the comment period 
                                closes under subparagraph (A) or (B), 
                                issue a final order in accordance with 
                                paragraph (1); and
                                    ``(II) not later than 12 months 
                                after the date on which such final 
                                order is issued, complete any hearing 
                                under subparagraph (E).
                            ``(ii) Dispute resolution request.--The 
                        Secretary shall specify in an interim final 
                        order issued under subparagraph (A) or (B) such 
                        shorter periods for requesting dispute 
                        resolution under subparagraph (D)(iii) as are 
                        necessary to meet the requirements of this 
                        subparagraph.
                    ``(G) Judicial review.--A final order issued 
                pursuant to subparagraph (F) shall be subject to 
                judicial review in accordance with paragraph (3)(D).
            ``(5) Administrative order initiated at the request of a 
        requestor.--
                    ``(A) In general.--In issuing an administrative 
                order under paragraph (1) at the request of a requestor 
                with respect to certain drugs, classes of drugs, or 
                combinations of drugs--
                            ``(i) the Secretary shall, after receiving 
                        a request under this subparagraph, determine 
                        whether the request is sufficiently complete 
                        and formatted to permit a substantive review;
                            ``(ii) if the Secretary determines that the 
                        request is sufficiently complete and formatted 
                        to permit a substantive review, the Secretary 
                        shall--
                                    ``(I) file the request; and
                                    ``(II) initiate proceedings with 
                                respect to issuing an administrative 
                                order in accordance with paragraphs (2) 
                                and (3); and
                            ``(iii) except as provided in paragraph 
                        (6), if the Secretary determines that a request 
                        does not meet the requirements for filing or is 
                        not sufficiently complete and formatted to 
                        permit a substantive review, the requestor may 
                        demand that the request be filed over protest, 
                        and the Secretary shall initiate proceedings to 
                        review the request in accordance with paragraph 
                        (2)(A).
                    ``(B) Request to initiate proceedings.--
                            ``(i) In general.--A requestor seeking an 
                        administrative order under paragraph (1) with 
                        respect to certain drugs, classes of drugs, or 
                        combinations of drugs, shall submit to the 
                        Secretary a request to initiate proceedings for 
                        such order in the form and manner as specified 
                        by the Secretary. Such requestor may submit a 
                        request under this subparagraph for the 
                        issuance of an administrative order--
                                    ``(I) determining whether a drug is 
                                generally recognized as safe and 
                                effective under section 201(p)(1), 
                                exempt from section 503(b)(1), and not 
                                required to be the subject of an 
                                approved application under section 505; 
                                or
                                    ``(II) determining whether a change 
                                to a condition of use of a drug is 
                                generally recognized as safe and 
                                effective under section 201(p)(1), 
                                exempt from section 503(b)(1), and not 
                                required to be the subject of an 
                                approved application under section 505, 
                                if, absent such a changed condition of 
                                use, such drug is--
                                            ``(aa) generally recognized 
                                        as safe and effective under 
                                        section 201(p)(1) in accordance 
                                        with subsection (a)(1), (a)(2), 
                                        or an order under this 
                                        subsection; or
                                            ``(bb) subject to 
                                        subsection (a)(3), but only if 
                                        such requestor initiates such 
                                        request in conjunction with a 
                                        request for the Secretary to 
                                        determine whether such drug is 
                                        generally recognized as safe 
                                        and effective under section 
                                        201(p)(1), which is filed by 
                                        the Secretary under 
                                        subparagraph (A)(ii).
                            ``(ii) Exception.--The Secretary is not 
                        required to complete review of a request for a 
                        change described in clause (i)(II) if the 
                        Secretary determines that there is an 
                        inadequate basis to find the drug is generally 
                        recognized as safe and effective under section 
                        201(p)(1) under paragraph (1) and issues a 
                        final order announcing that determination.
                            ``(iii) Withdrawal.--The requestor may 
                        withdraw a request under this paragraph, 
                        according to the procedures set forth pursuant 
                        to subsection (d)(2)(B). Notwithstanding any 
                        other provision of this section, if such 
                        request is withdrawn, the Secretary may cease 
                        proceedings under this subparagraph.
                    ``(C) Exclusivity.--
                            ``(i) In general.--A final administrative 
                        order issued in response to a request under 
                        this section shall have the effect of 
                        authorizing solely the order requestor (or the 
                        licensees, assignees, or successors in interest 
                        of such requestor with respect to the subject 
                        of such order), for a period of 18 months 
                        following the effective date of such final 
                        order and beginning on the date the requestor 
                        may lawfully market such drugs pursuant to the 
                        order, to market drugs--
                                    ``(I) incorporating changes 
                                described in clause (ii); and
                                    ``(II) subject to the limitations 
                                under clause (iv).
                            ``(ii) Changes described.--A change 
                        described in this clause is a change subject to 
                        an order specified in clause (i), which--
                                    ``(I) provides for a drug to 
                                contain an active ingredient (including 
                                any ester or salt of the active 
                                ingredient) not previously incorporated 
                                in a drug described in clause (iii); or
                                    ``(II) provides for a change in the 
                                conditions of use of a drug, for which 
                                new human data studies conducted or 
                                sponsored by the requestor (or for 
                                which the requestor has an exclusive 
                                right of reference) were essential to 
                                the issuance of such order.
                            ``(iii) Drugs described.--The drugs 
                        described in this clause are drugs--
                                    ``(I) specified in subsection 
                                (a)(1), (a)(2), or (a)(3);
                                    ``(II) subject to a final order 
                                issued under this section;
                                    ``(III) subject to a final 
                                sunscreen order (as defined in section 
                                586(2)(A)); or
                                    ``(IV) described in subsection 
                                (m)(1), other than drugs subject to an 
                                active enforcement action under chapter 
                                III of this Act.
                            ``(iv) Limitations on exclusivity.--
                                    ``(I) In general.--Only one 18-
                                month period under this subparagraph 
                                shall be granted, under each order 
                                described in clause (i), with respect 
                                to changes (to the drug subject to such 
                                order) which are either--
                                            ``(aa) changes described in 
                                        clause (ii)(I), relating to 
                                        active ingredients; or
                                            ``(bb) changes described in 
                                        clause (ii)(II), relating to 
                                        conditions of use.
                                    ``(II) No exclusivity allowed.--No 
                                exclusivity shall apply to changes to a 
                                drug which are--
                                            ``(aa) the subject of a 
                                        Tier 2 OTC monograph order 
                                        request (as defined in section 
                                        744L);
                                            ``(bb) safety-related 
                                        changes, as defined by the 
                                        Secretary, or any other changes 
                                        the Secretary considers 
                                        necessary to assure safe use; 
                                        or
                                            ``(cc) changes related to 
                                        methods of testing safety or 
                                        efficacy.
                            ``(v) New human data studies defined.--In 
                        this subparagraph, the term `new human data 
                        studies' means clinical trials of safety or 
                        effectiveness (including actual use studies), 
                        pharmacokinetics studies, or bioavailability 
                        studies, the results of which--
                                    ``(I) have not been relied on by 
                                the Secretary to support--
                                            ``(aa) a proposed or final 
                                        determination that a drug 
                                        described in subclause (I), 
                                        (II), or (III) of clause (iii) 
                                        is generally recognized as safe 
                                        and effective under section 
                                        201(p)(1); or
                                            ``(bb) approval of a drug 
                                        that was approved under section 
                                        505; and
                                    ``(II) do not duplicate the results 
                                of another study that was relied on by 
                                the Secretary to support--
                                            ``(aa) a proposed or final 
                                        determination that a drug 
                                        described in subclause (I), 
                                        (II), or (III) of clause (iii) 
                                        is generally recognized as safe 
                                        and effective under section 
                                        201(p)(1); or
                                            ``(bb) approval of a drug 
                                        that was approved under section 
                                        505.
            ``(6) Information regarding safe nonprescription marketing 
        and use as condition for filing a generally recognized as safe 
        and effective request.--
                    ``(A) In general.--In response to a request under 
                this section that a drug described in subparagraph (B) 
                be generally recognized as safe and effective, the 
                Secretary--
                            ``(i) may file such request, if the request 
                        includes information specified under 
                        subparagraph (C) with respect to safe 
                        nonprescription marketing and use of such drug; 
                        or
                            ``(ii) if the request fails to include 
                        information specified under subparagraph (C), 
                        shall refuse to file such request and require 
                        that nonprescription marketing of the drug be 
                        pursuant to a new drug application as described 
                        in subparagraph (D).
                    ``(B) Drug described.--A drug described in this 
                subparagraph is a nonprescription drug which contains 
                an active ingredient not previously incorporated in a 
                drug--
                            ``(i) specified in subsection (a)(1), 
                        (a)(2), or (a)(3);
                            ``(ii) subject to a final order under this 
                        section; or
                            ``(iii) subject to a final sunscreen order 
                        (as defined in section 586(2)(A)).
                    ``(C) Information demonstrating prima facie safe 
                nonprescription marketing and use.--Information 
                specified in this subparagraph, with respect to a 
                request described in subparagraph (A)(i), is--
                            ``(i) information sufficient for a prima 
                        facie demonstration that the drug subject to 
                        such request has a verifiable history of being 
                        marketed and safely used by consumers in the 
                        United States as a nonprescription drug under 
                        comparable conditions of use;
                            ``(ii) if the drug has not been previously 
                        marketed in the United States as a 
                        nonprescription drug, information sufficient 
                        for a prima facie demonstration that the drug 
                        was marketed and safely used under comparable 
                        conditions of marketing and use in a country 
                        listed in section 802(b)(1)(A) or designated by 
                        the Secretary in accordance with section 
                        802(b)(1)(B)--
                                    ``(I) for such period as needed to 
                                provide reasonable assurances 
                                concerning the safe nonprescription use 
                                of the drug; and
                                    ``(II) during such time was subject 
                                to sufficient monitoring by a 
                                regulatory body considered acceptable 
                                by the Secretary for such monitoring 
                                purposes, including for adverse events 
                                associated with nonprescription use of 
                                the drug; or
                            ``(iii) if the Secretary determines that 
                        information described in clause (i) or (ii) is 
                        not needed to provide a prima facie 
                        demonstration that the drug can be safely 
                        marketed and used as a nonprescription drug, 
                        such other information the Secretary determines 
                        is sufficient for such purposes.
                    ``(D) Marketing pursuant to new drug application.--
                In the case of a request described in subparagraph 
                (A)(ii), the drug subject to such request may be re-
                submitted for filing only if--
                            ``(i) the drug is marketed as a 
                        nonprescription drug, under conditions of use 
                        comparable to the conditions specified in the 
                        request, for such period as the Secretary 
                        determines appropriate (not to exceed 5 
                        consecutive years) pursuant to an application 
                        approved under section 505; and
                            ``(ii) during such period, 1,000,000 retail 
                        packages of the drug, or an equivalent quantity 
                        as determined by the Secretary, were 
                        distributed for retail sale, as determined in 
                        such manner as the Secretary finds appropriate.
                    ``(E) Rule of application.--Except in the case of a 
                request involving a drug described in section 586(9), 
                as in effect on January 1, 2017, if the Secretary 
                refuses to file a request under this paragraph, the 
                requestor may not file such request over protest under 
                paragraph (5)(A)(iii).
            ``(7) Packaging.--An administrative order issued under 
        paragraph (2), (4)(A), or (5) may include requirements for the 
        packaging of a drug to encourage use in accordance with 
        labeling. Such requirements may include unit dose packaging, 
        requirements for products intended for use by pediatric 
        populations, requirements to reduce risk of harm from 
        unsupervised ingestion, and other appropriate requirements. 
        This paragraph does not authorize the Food and Drug 
        Administration to require standards or testing procedures as 
        described in part 1700 of title 16, Code of Federal 
        Regulations.
            ``(8) Final and tentative final monographs for category i 
        drugs deemed final administrative orders.--
                    ``(A) In general.--A final monograph or tentative 
                final monograph described in subparagraph (B) shall be 
                deemed to be a final administrative order under this 
                subsection and may be amended, revoked, or otherwise 
                modified in accordance with the procedures of this 
                subsection.
                    ``(B) Monographs described.--For purposes of 
                subparagraph (A), a final monograph or tentative final 
                monograph is described in this subparagraph if it--
                            ``(i) establishes conditions of use for a 
                        drug described in paragraph (1) or (2) of 
                        subsection (a); and
                            ``(ii) represents the most recently 
                        promulgated version of such conditions, 
                        including as modified, in whole or in part, by 
                        any proposed or final rule.
                    ``(C) Deemed orders include harmonizing technical 
                amendments.--The deemed establishment of a final 
                administrative order under subparagraph (A) shall be 
                construed to include any technical amendments to such 
                order as the Secretary determines necessary to ensure 
                that such order is appropriately harmonized, in terms 
                of terminology or cross-references, with the applicable 
                provisions of this Act (and regulations thereunder) and 
                any other orders issued under this section.
    ``(c) Procedure for Minor Changes.--
            ``(1) In general.--Minor changes in the dosage form of a 
        drug that is described in paragraph (1) or (2) of subsection 
        (a) or the subject of an order issued under subsection (b) may 
        be made by a requestor without the issuance of an order under 
        subsection (b) if--
                    ``(A) the requestor maintains such information as 
                is necessary to demonstrate that the change--
                            ``(i) will not affect the safety or 
                        effectiveness of the drug; and
                            ``(ii) will not materially affect the 
                        extent of absorption or other exposure to the 
                        active ingredient in comparison to a suitable 
                        reference product; and
                    ``(B) the change is in conformity with the 
                requirements of an applicable administrative order 
                issued by the Secretary under paragraph (3).
            ``(2) Additional information.--
                    ``(A) Access to records.--A sponsor shall submit 
                records requested by the Secretary relating to such a 
                minor change under section 704(a)(4), within 15 
                business days of receiving such a request, or such 
                longer period as the Secretary may provide.
                    ``(B) Insufficient information.--If the Secretary 
                determines that the information contained in such 
                records is not sufficient to demonstrate that the 
                change does not affect the safety or effectiveness of 
                the drug or materially affect the extent of absorption 
                or other exposure to the active ingredient, the 
                Secretary--
                            ``(i) may so inform the sponsor of the drug 
                        in writing; and
                            ``(ii) if the Secretary so informs the 
                        sponsor, shall provide the sponsor of the drug 
                        with a reasonable opportunity to provide 
                        additional information.
                    ``(C) Failure to submit sufficient information.--If 
                the sponsor fails to provide such additional 
                information within a time prescribed by the Secretary, 
                or if the Secretary determines that such additional 
                information does not demonstrate that the change does 
                not--
                            ``(i) affect the safety or effectiveness of 
                        the drug; or
                            ``(ii) materially affect the extent of 
                        absorption or other exposure to the active 
                        ingredient in comparison to a suitable 
                        reference product,
                the drug as modified is a new drug under section 201(p) 
                and shall be deemed to be misbranded under section 
                502(ee).
            ``(3) Determining whether a change will affect safety or 
        effectiveness.--
                    ``(A) In general.--The Secretary shall issue one or 
                more administrative orders specifying requirements for 
                determining whether a minor change made by a sponsor 
                pursuant to this subsection will affect the safety or 
                effectiveness of a drug or materially affect the extent 
                of absorption or other exposure to an active ingredient 
                in the drug in comparison to a suitable reference 
                product, together with guidance for applying those 
                orders to specific dosage forms.
                    ``(B) Standard practices.--The orders and guidance 
                issued by the Secretary under subparagraph (A) shall 
                take into account relevant public standards and 
                standard practices for evaluating the quality of drugs, 
                and may take into account the special needs of 
                populations, including children.
    ``(d) Confidentiality of Information Submitted to the Secretary.--
            ``(1) In general.--Subject to paragraph (2), any 
        information, including reports of testing conducted on the drug 
        or drugs involved, that is submitted by a requestor in 
        connection with proceedings on an order under this section 
        (including any minor change under subsection (c)) and is a 
        trade secret or confidential information subject to section 
        552(b)(4) of title 5, United States Code, or section 1905 of 
        title 18, United States Code, shall not be disclosed to the 
        public unless the requestor consents to that disclosure.
            ``(2) Public availability.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the Secretary shall--
                            ``(i) make any information submitted by a 
                        requestor in support of a request under 
                        subsection (b)(5)(A) available to the public 
                        not later than the date on which the proposed 
                        order is issued; and
                            ``(ii) make any information submitted by 
                        any other person with respect to an order 
                        requested (or initiated by the Secretary) under 
                        subsection (b), available to the public upon 
                        such submission.
                    ``(B) Limitations on public availability.--
                Information described in subparagraph (A) shall not be 
                made public if--
                            ``(i) the information pertains to 
                        pharmaceutical quality information, unless such 
                        information is necessary to establish standards 
                        under which a drug is generally recognized as 
                        safe and effective under section 201(p)(1);
                            ``(ii) the information is submitted in a 
                        requestor-initiated request, but the requestor 
                        withdraws such request, in accordance with 
                        withdrawal procedures established by the 
                        Secretary, before the Secretary issues the 
                        proposed order;
                            ``(iii) the Secretary requests and obtains 
                        the information under subsection (c) and such 
                        information is not submitted in relation to an 
                        order under subsection (b); or
                            ``(iv) the information is of the type 
                        contained in raw datasets.
    ``(e) Updates to Drug Listing Information.--A sponsor who makes a 
change to a drug subject to this section shall submit updated drug 
listing information for the drug in accordance with section 510(j) 
within 30 calendar days of the date when the drug is first commercially 
marketed, except that a sponsor who was the order requestor with 
respect to an order subject to subsection (b)(5)(C) (or a licensee, 
assignee, or successor in interest of such requestor) shall submit 
updated drug listing information on or before the date when the drug is 
first commercially marketed.
    ``(f) Approvals Under Section 505.--The provisions of this section 
shall not be construed to preclude a person from seeking or maintaining 
the approval of an application for a drug under sections 505(b)(1), 
505(b)(2), and 505(j). A determination under this section that a drug 
is not subject to section 503(b)(1), is generally recognized as safe 
and effective under section 201(p)(1), and is not a new drug under 
section 201(p) shall constitute a finding that the drug is safe and 
effective that may be relied upon for purposes of an application under 
section 505(b)(2), so that the applicant shall be required to submit 
for purposes of such application only information needed to support any 
modification of the drug that is not covered by such determination 
under this section.
    ``(g) Public Availability of Administrative Orders.--The Secretary 
shall establish, maintain, update (as determined necessary by the 
Secretary but no less frequently than annually), and make publicly 
available, with respect to orders issued under this section--
            ``(1) a repository of each final order and interim final 
        order in effect, including the complete text of the order; and
            ``(2) a listing of all orders proposed and under 
        development under subsection (b)(2), including--
                    ``(A) a brief description of each such order; and
                    ``(B) the Secretary's expectations, if resources 
                permit, for issuance of proposed orders over a 3-year 
                period.
    ``(h) Development Advice to Sponsors or Requestors.--The Secretary 
shall establish procedures under which sponsors or requestors may meet 
with appropriate officials of the Food and Drug Administration to 
obtain advice on the studies and other information necessary to support 
submissions under this section and other matters relevant to the 
regulation of nonprescription drugs and the development of new 
nonprescription drugs under this section.
    ``(i) Participation of Multiple Sponsors or Requestors.--The 
Secretary shall establish procedures to facilitate efficient 
participation by multiple sponsors or requestors in proceedings under 
this section, including provision for joint meetings with multiple 
sponsors or requestors or with organizations nominated by sponsors or 
requestors to represent their interests in a proceeding.
    ``(j) Electronic Format.--All submissions under this section shall 
be in electronic format.
    ``(k) Effect on Existing Regulations Governing Nonprescription 
Drugs.--
            ``(1) Regulations of general applicability to 
        nonprescription drugs.--Except as provided in this subsection, 
        nothing in this section supersedes regulations establishing 
        general requirements for nonprescription drugs, including 
        regulations of general applicability contained in parts 201, 
        250, and 330 of title 21, Code of Federal Regulations, or any 
        successor regulations. The Secretary shall establish or modify 
        such regulations by means of rulemaking in accordance with 
        section 553 of title 5, United States Code.
            ``(2) Regulations establishing requirements for specific 
        nonprescription drugs.--
                    ``(A) The provisions of section 310.545 of title 
                21, Code of Federal Regulations, as in effect on the 
                day before the date of the enactment of this section, 
                shall be deemed to be a final order under subsection 
                (b).
                    ``(B) Regulations in effect on the day before the 
                date of the enactment of this section, establishing 
                requirements for specific nonprescription drugs 
                marketed pursuant to this section (including such 
                requirements in parts 201 and 250 of title 21, Code of 
                Federal Regulations), shall be deemed to be final 
                orders under subsection (b), only as they apply to 
                drugs--
                            ``(i) subject to paragraph (1), (2), (3), 
                        or (4) of subsection (a); or
                            ``(ii) otherwise subject to an order under 
                        this section.
            ``(3) Withdrawal of regulations.--The Secretary shall 
        withdraw regulations establishing final monographs and the 
        procedures governing the over-the-counter drug review under 
        part 330 and other relevant parts of title 21, Code of Federal 
        Regulations (as in effect on the day before the date of the 
        enactment of this section), or make technical changes to such 
        regulations to ensure conformity with appropriate terminology 
        and cross references. Notwithstanding subchapter II of chapter 
        5 of title 5, United States Code, any such withdrawal or 
        technical changes shall be made without public notice and 
        comment and shall be effective upon publication through notice 
        in the Federal Register (or upon such date as specified in such 
        notice).
    ``(l) Guidance.--The Secretary shall issue guidance that 
specifies--
            ``(1) the procedures and principles for formal meetings 
        between the Secretary and sponsors or requestors for drugs 
        subject to this section;
            ``(2) the format and content of data submissions to the 
        Secretary under this section;
            ``(3) the format of electronic submissions to the Secretary 
        under this section;
            ``(4) consolidated proceedings for appeal and the 
        procedures for such proceedings where appropriate; and
            ``(5) for minor changes in drugs, recommendations on how to 
        comply with the requirements in orders issued under subsection 
        (c)(3).
    ``(m) Rule of Construction.--
            ``(1) In general.--This section shall not affect the 
        treatment or status of a nonprescription drug--
                    ``(A) that is marketed without an application 
                approved under section 505 as of the date of the 
                enactment of this section;
                    ``(B) that is not subject to an order issued under 
                this section; and
                    ``(C) to which paragraphs (1), (2), (3), (4), or 
                (5) of subsection (a) do not apply.
            ``(2) Treatment of products previously found to be subject 
        to time and extent requirements.--
                    ``(A) Notwithstanding subsection (a), a drug 
                described in subparagraph (B) may only be lawfully 
                marketed, without an application approved under section 
                505, pursuant to an order issued under this section.
                    ``(B) A drug described in this subparagraph is a 
                drug which, prior to the date of the enactment of this 
                section, the Secretary determined in a proposed or 
                final rule to be ineligible for review under the OTC 
                drug review (as such phrase `OTC drug review' was used 
                in section 330.14 of title 21, Code of Federal 
                Regulations, as in effect on the day before the date of 
                the enactment of this section).
            ``(3) Preservation of authority.--
                    ``(A) Nothing in paragraph (1) shall be construed 
                to preclude or limit the applicability of any provision 
                of this Act other than this section.
                    ``(B) Nothing in subsection (a) shall be construed 
                to prohibit the Secretary from issuing an order under 
                this section finding a drug to be not generally 
                recognized as safe and effective under section 
                201(p)(1), as the Secretary determines appropriate.
    ``(n) Investigational New Drugs.--A drug is not subject to this 
section if an exemption for investigational use under section 505(i) is 
in effect for such drug.
    ``(o) Inapplicability of Paperwork Reduction Act.--Chapter 35 of 
title 44, United States Code, shall not apply to collections of 
information made under this section.
    ``(p) Inapplicability of Notice and Comment Rulemaking and Other 
Requirements.--The requirements of subsection (b) shall apply with 
respect to orders issued under this section instead of the requirements 
of subchapter II of chapter 5 of title 5, United States Code.
    ``(q) Definitions.--In this section:
            ``(1) The term `nonprescription drug' refers to a drug not 
        subject to the requirements of section 503(b)(1).
            ``(2) The term `sponsor' refers to any person marketing, 
        manufacturing, or processing a drug that--
                    ``(A) is listed pursuant to section 510(j); and
                    ``(B) is or will be subject to an administrative 
                order under this section of the Food and Drug 
                Administration.
            ``(3) The term `requestor' refers to any person or group of 
        persons marketing, manufacturing, processing, or developing a 
        drug.''.
    (b) GAO Study.--Not later than 4 years after the date of enactment 
of this Act, the Comptroller General of the United States shall submit 
a study to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate addressing the effectiveness and overall impact 
of exclusivity under section 505G of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), and section 586C of such Act 
(21 U.S.C. 360fff-3), including the impact of such exclusivity on 
consumer access. Such study shall include--
            (1) an analysis of the impact of exclusivity under such 
        section 505G for nonprescription drug products, including--
                    (A) the number of nonprescription drug products 
                that were granted exclusivity and the indication for 
                which the nonprescription drug products were determined 
                to be generally recognized as safe and effective;
                    (B) whether the exclusivity for such drug products 
                was granted for--
                            (i) a new active ingredient (including any 
                        ester or salt of the active ingredient); or
                            (ii) changes in the conditions of use of a 
                        drug, for which new human data studies 
                        conducted or sponsored by the requestor were 
                        essential;
                    (C) whether, and to what extent, the exclusivity 
                impacted the requestor's or sponsor's decision to 
                develop the drug product;
                    (D) an analysis of the implementation of the 
                exclusivity provision in such section 505G, including--
                            (i) the resources used by the Food and Drug 
                        Administration;
                            (ii) the impact of such provision on 
                        innovation, as well as research and development 
                        in the nonprescription drug market;
                            (iii) the impact of such provision on 
                        competition in the nonprescription drug market;
                            (iv) the impact of such provision on 
                        consumer access to nonprescription drug 
                        products;
                            (v) the impact of such provision on the 
                        prices of nonprescription drug products; and
                            (vi) whether the administrative orders 
                        initiated by requestors under such section 505G 
                        have been sufficient to encourage the 
                        development of nonprescription drug products 
                        that would likely not be otherwise developed, 
                        or developed in as timely a manner; and
                    (E) whether the administrative orders initiated by 
                requestors under such section 505G have been sufficient 
                incentive to encourage innovation in the 
                nonprescription drug market; and
            (2) an analysis of the impact of exclusivity under such 
        section 586C for sunscreen ingredients, including--
                    (A) the number of sunscreen ingredients that were 
                granted exclusivity and the specific ingredient that 
                was determined to be generally recognized as safe and 
                effective;
                    (B) whether, and to what extent, the exclusivity 
                impacted the requestor's or sponsor's decision to 
                develop the sunscreen ingredient;
                    (C) whether, and to what extent, the sunscreen 
                ingredient granted exclusivity had previously been 
                available outside of the United States;
                    (D) an analysis of the implementation of the 
                exclusivity provision in such section 586C, including--
                            (i) the resources used by the Food and Drug 
                        Administration;
                            (ii) the impact of such provision on 
                        innovation, as well as research and development 
                        in the sunscreen market;
                            (iii) the impact of such provision on 
                        competition in the sunscreen market;
                            (iv) the impact of such provision on 
                        consumer access to sunscreen products;
                            (v) the impact of such provision on the 
                        prices of sunscreen products; and
                            (vi) whether the administrative orders 
                        initiated by requestors under such section 505G 
                        have been utilized by sunscreen ingredient 
                        sponsors and whether such process has been 
                        sufficient to encourage the development of 
                        sunscreen ingredients that would likely not be 
                        otherwise developed, or developed in as timely 
                        a manner; and
                    (E) whether the administrative orders initiated by 
                requestors under such section 586C have been sufficient 
                incentive to encourage innovation in the sunscreen 
                market.
    (c) Conforming Amendment.--Section 751(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379r(d)(1)) is amended--
            (1) in the matter preceding subparagraph (A)--
                    (A) by striking ``final regulation promulgated'' 
                and inserting ``final order under section 505G''; and
                    (B) by striking ``and not misbranded''; and
            (2) in subparagraph (A), by striking ``regulation in 
        effect'' and inserting ``regulation or order in effect''.

SEC. 1002. MISBRANDING.

    Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352) is amended by adding at the end the following:
    ``(ee) If it is a nonprescription drug that is subject to section 
505G, is not the subject of an application approved under section 505, 
and does not comply with the requirements under section 505G.
    ``(ff) If it is a drug and it was manufactured, prepared, 
propagated, compounded, or processed in a facility for which fees have 
not been paid as required by section 744M.''.

SEC. 1003. DRUGS EXCLUDED FROM THE OVER-THE-COUNTER DRUG REVIEW.

    (a) In General.--Nothing in this Act (or the amendments made by 
this Act) shall apply to any nonprescription drug (as defined in 
section 505G(q) of the Federal Food, Drug, and Cosmetic Act, as added 
by section 1001 of this Act) which was excluded by the Food and Drug 
Administration from the Over-the-Counter Drug Review in accordance with 
the paragraph numbered 25 on page 9466 of volume 37 of the Federal 
Register, published on May 11, 1972.
    (b) Rule of Construction.--Nothing in this section shall be 
construed to preclude or limit the applicability of any other provision 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 1004. TREATMENT OF SUNSCREEN INNOVATION ACT.

    (a) Review of Nonprescription Sunscreen Active Ingredients.--
            (1) Applicability of section 505g for pending 
        submissions.--
                    (A) In general.--A sponsor of a nonprescription 
                sunscreen active ingredient or combination of 
                nonprescription sunscreen active ingredients that, as 
                of the date of enactment of this Act, is subject to a 
                proposed sunscreen order under section 586C of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-
                3) may elect, by means of giving written notification 
                to the Secretary of Health and Human Services within 
                180 calendar days of the enactment of this Act, to 
                transition into the review of such ingredient or 
                combination of ingredients pursuant to the process set 
                out in section 505G of the Federal Food, Drug, and 
                Cosmetic Act, as added by section 1001 of this Act.
                    (B) Election exercised.--Upon receipt by the 
                Secretary of Health and Human Services of a timely 
                notification under subparagraph (A)--
                            (i) the proposed sunscreen order involved 
                        is deemed to be a request for an order under 
                        subsection (b) of section 505G of the Federal 
                        Food, Drug, and Cosmetic Act, as added by 
                        section 1001 of this Act; and
                            (ii) such order is deemed to have been 
                        accepted for filing under subsection 
                        (b)(6)(A)(i) of such section 505G.
                    (C) Election not exercised.--If a notification 
                under subparagraph (A) is not received by the Secretary 
                of Health and Human Services within 180 calendar days 
                of the date of enactment of this Act, the review of the 
                proposed sunscreen order described in subparagraph 
                (A)--
                            (i) shall continue under section 586C of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 360fff-3); and
                            (ii) shall not be eligible for review under 
                        section 505G, added by section 1001 of this 
                        Act.
            (2) Definitions.--In this subsection, the terms 
        ``sponsor'', ``nonprescription'', ``sunscreen active 
        ingredient'', and ``proposed sunscreen order'' have the 
        meanings given to those terms in section 586 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).
    (b) Amendments to Sunscreen Provisions.--
            (1) Final sunscreen orders.--Paragraph (3) of section 
        586C(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360fff-3(e)) is amended to read as follows:
            ``(3) Relationship to orders under section 505g.--A final 
        sunscreen order shall be deemed to be a final order under 
        section 505G.''.
            (2) Meetings.--Paragraph (7) of section 586C(b) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) is 
        amended--
                    (A) by striking ``A sponsor may request'' and 
                inserting the following:
                    ``(A) In general.--A sponsor may request''; and
                    (B) by adding at the end the following:
                    ``(B) Confidential meetings.--A sponsor may request 
                one or more confidential meetings with respect to a 
                proposed sunscreen order, including a letter deemed to 
                be a proposed sunscreen order under paragraph (3), to 
                discuss matters relating to data requirements to 
                support a general recognition of safety and 
                effectiveness involving confidential information and 
                public information related to such proposed sunscreen 
                order, as appropriate. The Secretary shall convene a 
                confidential meeting with such sponsor in a reasonable 
                time period. If a sponsor requests more than one 
                confidential meeting for the same proposed sunscreen 
                order, the Secretary may refuse to grant an additional 
                confidential meeting request if the Secretary 
                determines that such additional confidential meeting is 
                not reasonably necessary for the sponsor to advance its 
                proposed sunscreen order, or if the request for a 
                confidential meeting fails to include sufficient 
                information upon which to base a substantive 
                discussion. The Secretary shall publish a post-meeting 
                summary of each confidential meeting under this 
                subparagraph that does not disclose confidential 
                commercial information or trade secrets. This 
                subparagraph does not authorize the disclosure of 
                confidential commercial information or trade secrets 
                subject to 552(b)(4) of title 5, United States Code, or 
                section 1905 of title 18, United States Code.''.
            (3) Exclusivity.--Section 586C of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding at 
        the end the following:
    ``(f) Exclusivity.--
            ``(1) In general.--A final sunscreen order shall have the 
        effect of authorizing solely the order requestor (or the 
        licensees, assignees, or successors in interest of such 
        requestor with respect to the subject of such request and 
        listed under paragraph (5)) for a period of 18 months, to 
        market a sunscreen ingredient under this section incorporating 
        changes described in paragraph (2) subject to the limitations 
        under paragraph (4), beginning on the date the requestor (or 
        any licensees, assignees, or successors in interest of such 
        requestor with respect to the subject of such request and 
        listed under paragraph (5)) may lawfully market such sunscreen 
        ingredient pursuant to the order.
            ``(2) Changes described.--A change described in this 
        paragraph is a change subject to an order specified in 
        paragraph (1) that permits a sunscreen to contain an active 
        sunscreen ingredient not previously incorporated in a marketed 
        sunscreen listed in paragraph (3).
            ``(3) Marketed sunscreen.--The marketed sunscreen 
        ingredients described in this paragraph are sunscreen 
        ingredients--
                    ``(A) marketed in accordance with a final monograph 
                for sunscreen drug products set forth at part 352 of 
                title 21, Code of Federal Regulations (as published at 
                64 Fed. Reg. 27687); or
                    ``(B) marketed in accordance with a final order 
                issued under this section.
            ``(4) Limitations on exclusivity.--Only one 18-month period 
        may be granted per ingredient under paragraph (1).
            ``(5) Listing of licensees, assignees, or successors in 
        interest.--Requestors shall submit to the Secretary at the time 
        when a drug subject to such request is introduced or delivered 
        for introduction into interstate commerce, a list of licensees, 
        assignees, or successors in interest under paragraph (1).''.
            (4) Sunset provision.--Subchapter I of chapter V of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.) 
        is amended by adding at the end the following:

``SEC. 586H. SUNSET.

    ``This subchapter shall cease to be effective at the end of fiscal 
year 2022.''.
            (5) Treatment of final sunscreen order.--The Federal Food, 
        Drug, and Cosmetic Act is amended by striking section 586E of 
        such Act (21 U.S.C. 360fff-5).
    (c) Treatment of Authority Regarding Finalization of Sunscreen 
Monograph.--
            (1) In general.--
                    (A) Revision of final sunscreen order.--Not later 
                than November 26, 2019, the Secretary of Health and 
                Human Services (referred to in this subsection as the 
                ``Secretary'') shall amend and revise the final 
                administrative order concerning nonprescription 
                sunscreen (referred to in this subsection as the 
                ``sunscreen order'') for which the content, prior to 
                the date of enactment of this Act, was represented by 
                the final monograph for sunscreen drug products set 
                forth in part 352 of title 21, Code of Federal 
                Regulations (as in effect on May 21, 1999).
                    (B) Issuance of revised sunscreen order; effective 
                date.--A revised sunscreen order described in 
                subparagraph (A) shall be--
                            (i) issued in accordance with the 
                        procedures described in section 505G(c)(2) of 
                        the Federal Food, Drug, and Cosmetic Act;
                            (ii) issued in proposed form not later than 
                        May 28, 2019;
                            (iii) effective not later than November 26, 
                        2020; and
                            (iv) issued by the Secretary at least 1 
                        year prior to the effective date of the revised 
                        order.
            (2) Reports.--If a revised sunscreen order issued under 
        paragraph (1) does not include provisions related to the 
        effectiveness of various sun protection factor levels, and does 
        not address all dosage forms known to the Secretary to be used 
        in sunscreens marketed in the United States without a new drug 
        application approved under section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall 
        submit a report to the Committee on Energy and Commerce of the 
        House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate on the rationale 
        for omission of such provisions from such order, and a plan and 
        timeline to compile any information necessary to address such 
        provisions through such order.
    (d) Treatment of Non-Sunscreen Time and Extent Applications.--
            (1) In general.--Any application described in section 586F 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-
        6) that was submitted to the Secretary pursuant to section 
        330.14 of title 21, Code of Federal Regulations, as such 
        provisions were in effect immediately prior to the date of 
        enactment date of this Act, shall be extinguished as of such 
        date of enactment, subject to paragraph (2).
            (2) Order request.--Nothing in paragraph (1) precludes the 
        submission of an order request under section 505G(b) of the 
        Federal Food, Drug, and Cosmetic Act, as added by section 1001 
        of this Act, with respect to a drug that was the subject of an 
        application extinguished under paragraph (1).

SEC. 1005. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC 
              INDICATION FOR CERTAIN OTC COUGH AND COLD DRUGS.

    (a) In General.--Subject to subsection (c), the Secretary of Health 
and Human Services shall, beginning not later than 1 year after the 
date of enactment of this Act, annually submit to the Committee on 
Energy and Commerce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate a letter 
describing the progress of the Food and Drug Administration--
            (1) in evaluating the cough and cold monograph described in 
        subsection (b) with respect to children under age 6; and
            (2) as appropriate, revising such cough and cold monograph 
        to address such children through the order process under 
        section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as 
        added by section 1001 of this Act.
    (b) Cough and Cold Monograph Described.--The cough and cold 
monograph described in this subsection consists of the conditions under 
which nonprescription drugs containing antitussive, expectorant, nasal 
decongestant, or antihistamine active ingredients (or combinations 
thereof) are generally recognized as safe and effective, as specified 
in part 341 of title 21, Code of Federal Regulations (as in effect 
immediately prior to the date of enactment of this Act), and included 
in an order deemed to be established under section 505G(b) of the 
Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this 
Act.
    (c) Duration of Authority.--The requirement under subsection (a) 
shall terminate as of the date of a letter submitted by the Secretary 
of Health and Human Services pursuant to such subsection in which the 
Secretary indicates that the Food and Drug Administration has completed 
its evaluation and revised, in a final order, as applicable, the cough 
and cold monograph as described in subsection (a)(2).

SEC. 1006. TECHNICAL CORRECTIONS.

    (a) Imports and Exports.--Section 801(e)(4)(E)(iii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended 
by striking ``subparagraph'' each place such term appears and inserting 
``paragraph''.
    (b) FDA Reauthorization Act of 2017.--
            (1) In general.--Section 905(b)(4) of the FDA 
        Reauthorization Act of 2017 (Public Law115-52) is amended by 
        striking ``Section 744H(e)(2)(B)'' and inserting ``Section 
        744H(f)(2)(B)''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall take effect as of the enactment of the FDA 
        Reauthorization Act of 2017 (Public Law 115-52).

                          TITLE II--USER FEES

SEC. 2001. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Over-the-Counter 
Monograph User Fee Act of 2018''.
    (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to OTC monograph drug 
activities, as set forth in the goals identified for purposes of part 
10 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, in the letters from the Secretary of Health and Human 
Services to the Chairman of the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Chairman of the Committee on Energy 
and Commerce of the House of Representatives, as set forth in the 
Congressional Record.

SEC. 2002. FEES RELATING TO OVER-THE-COUNTER DRUGS.

    Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379f et seq.) is amended by inserting after part 9 the 
following:

           ``PART 10--FEES RELATING TO OVER-THE-COUNTER DRUGS

``SEC. 744L. DEFINITIONS.

    ``In this part:
            ``(1) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) one business entity controls, or has the 
                power to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control, both of the business entities.
            ``(2) The term `contract manufacturing organization 
        facility' means an OTC monograph drug facility where neither 
        the owner of such manufacturing facility nor any affiliate of 
        such owner or facility sells the OTC monograph drug produced at 
        such facility directly to wholesalers, retailers, or consumers 
        in the United States.
            ``(3) The term `costs of resources allocated for OTC 
        monograph drug activities' means the expenses in connection 
        with OTC monograph drug activities for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees and costs 
                related to contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies; and
                    ``(D) collecting fees under section 744M and 
                accounting for resources allocated for OTC monograph 
                drug activities.
            ``(4) The term `FDA establishment identifier' is the unique 
        number automatically generated by Food and Drug 
        Administration's Field Accomplishments and Compliance Tracking 
        System (FACTS) (or any successor system).
            ``(5) The term `OTC monograph drug' means a nonprescription 
        drug without an approved new drug application which is governed 
        by the provisions of section 505G.
            ``(6) The term `OTC monograph drug activities' means 
        activities of the Secretary associated with OTC monograph drugs 
        and inspection of facilities associated with such products, 
        including the following activities:
                    ``(A) The activities necessary for review and 
                evaluation of OTC monographs and OTC monograph order 
                requests, including--
                            ``(i) orders proposing or finalizing 
                        applicable conditions of use for OTC monograph 
                        drugs;
                            ``(ii) orders affecting status regarding 
                        general recognition of safety and effectiveness 
                        of an OTC monograph ingredient or combination 
                        of ingredients under specified conditions of 
                        use;
                            ``(iii) all OTC monograph drug development 
                        and review activities, including intra-agency 
                        collaboration;
                            ``(iv) regulation and policy development 
                        activities related to OTC monograph drugs;
                            ``(v) development of product standards for 
                        products subject to review and evaluation;
                            ``(vi) meetings referred to in section 
                        505G(i);
                            ``(vii) review of labeling prior to 
                        issuance of orders related to OTC monograph 
                        drugs or conditions of use; and
                            ``(viii) regulatory science activities 
                        related to OTC monograph drugs.
                    ``(B) Inspections related to OTC monograph drugs.
                    ``(C) Monitoring of clinical and other research 
                conducted in connection with OTC monograph drugs.
                    ``(D) Safety activities with respect to OTC 
                monograph drugs, including--
                            ``(i) collecting, developing, and reviewing 
                        safety information on OTC monograph drugs, 
                        including adverse event reports;
                            ``(ii) developing and using improved 
                        adverse event data-collection systems, 
                        including information technology systems; and
                            ``(iii) developing and using improved 
                        analytical tools to assess potential safety 
                        risks, including access to external databases.
                    ``(E) Other activities necessary for implementation 
                of section 505G.
            ``(7) The term `OTC monograph order request' means a 
        request for an order submitted under section 505G(b)(5).
            ``(8) The term `Tier 1 OTC monograph order request' means 
        any OTC monograph order request not determined to be a Tier 2 
        OTC monograph order request.
            ``(9)(A) The term `Tier 2 OTC monograph order request' 
        means, subject to subparagraph (B), an OTC monograph order 
        request for--
                    ``(i) the reordering of existing information in the 
                drug facts label of an OTC monograph drug;
                    ``(ii) the addition of information to the other 
                information section of the drug facts label of an OTC 
                monograph drug, as limited by section 201.66(c)(7) of 
                title 21, Code of Federal Regulations (or any successor 
                regulations);
                    ``(iii) modification to the directions for use 
                section of the drug facts label of an OTC monograph 
                drug, if such changes conform to changes made pursuant 
                to section 505G(c)(3)(A);
                    ``(iv) the standardization of the concentration or 
                dose of a specific finalized ingredient within a 
                particular finalized monograph;
                    ``(v) a change to ingredient nomenclature to align 
                with nomenclature of a standards-setting organization; 
                or
                    ``(vi) addition of an interchangeable term in 
                accordance with section 330.1 of title 21, Code of 
                Federal Regulations (or any successor regulations).
            ``(B) The Secretary may, based on program implementation 
        experience or other factors found appropriate by the Secretary, 
        characterize any OTC monograph order request as a Tier 2 OTC 
        monograph order request (including recharacterizing a request 
        from Tier 1 to Tier 2) and publish such determination in a 
        proposed order issued pursuant to section 505G.
            ``(10)(A) The term `OTC monograph drug facility' means a 
        foreign or domestic business or other entity that--
                    ``(i) is--
                            ``(I) under one management, either direct 
                        or indirect; and
                            ``(II) at one geographic location or 
                        address engaged in manufacturing or processing 
                        the finished dosage form of an OTC monograph 
                        drug;
                    ``(ii) includes a finished dosage form manufacturer 
                facility in a contractual relationship with the sponsor 
                of one or more OTC monograph drugs to manufacture or 
                process such drugs; and
                    ``(iii) does not include a business or other entity 
                whose only manufacturing or processing activities are 
                one or more of the following: production of clinical 
                research supplies, testing, or placement of outer 
                packaging on packages containing multiple products, for 
                such purposes as creating multipacks, when each 
                monograph drug product contained within the 
                overpackaging is already in a final packaged form prior 
                to placement in the outer overpackaging.
            ``(B) For purposes of subparagraph (A)(i)(II), separate 
        buildings or locations within close proximity are considered to 
        be at one geographic location or address if the activities 
        conducted in such buildings or locations are--
                    ``(i) closely related to the same business 
                enterprise;
                    ``(ii) under the supervision of the same local 
                management; and
                    ``(iii) under a single FDA establishment identifier 
                and capable of being inspected by the Food and Drug 
                Administration during a single inspection.
            ``(C) If a business or other entity would meet criteria 
        specified in subparagraph (A), but for being under multiple 
        management, the business or other entity is deemed to 
        constitute multiple facilities, one per management entity, for 
        purposes of this paragraph.
            ``(11) The term `OTC monograph drug meeting' means any 
        meeting regarding the content of a proposed OTC monograph order 
        request.
            ``(12) The term `person' includes an affiliate of a person.
            ``(13) The terms `requestor' and `sponsor' have the 
        meanings given such terms in section 505G.

``SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.

    ``(a) Types of Fees.--Beginning with fiscal year 2019, the 
Secretary shall assess and collect fees in accordance with this section 
as follows:
            ``(1) Facility fee.--
                    ``(A) In general.--Each person that owns a facility 
                identified as an OTC monograph drug facility on 
                December 31 of the fiscal year or at any time during 
                the preceding 12-month period shall be assessed an 
                annual fee for each such facility as determined under 
                subsection (c).
                    ``(B) Exceptions.--
                            ``(i) A fee shall not be assessed under 
                        subparagraph (A) if the identified OTC 
                        monograph drug facility--
                                    ``(I) has ceased all activities 
                                related to OTC monograph drugs prior to 
                                January 31, 2019, for the first program 
                                year, and December 31 of the fiscal 
                                year for subsequent fiscal years; and
                                    ``(II) has updated its registration 
                                to reflect such change under the 
                                requirements for drug establishment 
                                registration set forth in section 510.
                            ``(ii) The amount of the fee for a contract 
                        manufacturing organization facility shall be 
                        equal to two-thirds of the amount of the fee 
                        for an OTC monograph drug facility that is not 
                        a contract manufacturing organization facility.
                    ``(C) Amount.--The amount of fees established under 
                subparagraph (A) shall be established under subsection 
                (c).
                    ``(D) Due date.--
                            ``(i) For first program year.--For fiscal 
                        year 2019, the facility fees required under 
                        subparagraph (A) shall be due 45 calendar days 
                        after publication of the Federal Register 
                        notice provided for under subsection (c)(4)(A).
                            ``(ii) Subsequent fiscal years.--For each 
                        fiscal year after fiscal year 2019, the 
                        facility fees required under subparagraph (A) 
                        shall be due on the later of--
                                    ``(I) the first business day of 
                                June of such year; or
                                    ``(II) the first business day after 
                                the enactment of an appropriations Act 
                                providing for the collection and 
                                obligation of fees under this section 
                                for such year.
            ``(2) OTC monograph order request fee.--
                    ``(A) In general.--Each person that submits an OTC 
                monograph order request shall be subject to a fee for 
                an OTC monograph order request. The amount of such fee 
                shall be--
                            ``(i) for a Tier 1 OTC monograph order 
                        request, $500,000, adjusted for inflation for 
                        the fiscal year (as determined under subsection 
                        (c)(1)(B)); and
                            ``(ii) for a Tier 2 OTC monograph order 
                        request, $100,000 adjusted for inflation for 
                        the fiscal year (as determined under subsection 
                        (c)(1)(B)).
                    ``(B) Due date.--The OTC monograph order request 
                fees required under subparagraph (A) shall be due on 
                the date of submission of the OTC monograph order 
                request.
                    ``(C) Exception for certain safety changes.--A 
                person who is named as the requestor in an OTC 
                monograph order shall not be subject to a fee under 
                subparagraph (A) if the Secretary finds that the OTC 
                monograph order request seeks to change the drug facts 
                labeling of an OTC monograph drug in a way that would 
                add to or strengthen--
                            ``(i) a contraindication, warning, or 
                        precaution;
                            ``(ii) a statement about risk associated 
                        with misuse or abuse; or
                            ``(iii) an instruction about dosage and 
                        administration that is intended to increase the 
                        safe use of the OTC monograph drug.
                    ``(D) Refund of fee if order request is 
                recategorized as a tier 2 otc monograph order 
                request.--If the Secretary determines that an OTC 
                monograph request initially characterized as Tier 1 
                shall be re-characterized as a Tier 2 OTC monograph 
                order request, and the requestor has paid a Tier 1 fee 
                in accordance with subparagraph (A)(i), the Secretary 
                shall refund the requestor the difference between the 
                Tier 1 and Tier 2 fees determined under subparagraphs 
                (A)(i) and (A)(ii), respectively.
                    ``(E) Refund of fee if order request refused for 
                filing or withdrawn before filing.--The Secretary shall 
                refund 75 percent of the fee paid under subparagraph 
                (B) for any order request which is refused for filing 
                or was withdrawn before being accepted or refused for 
                filing.
                    ``(F) Fees for order requests previously refused 
                for filing or withdrawn before filing.--An OTC 
                monograph order request that was submitted but was 
                refused for filing, or was withdrawn before being 
                accepted or refused for filing, shall be subject to the 
                full fee under subparagraph (A) upon being resubmitted 
                or filed over protest.
                    ``(G) Refund of fee if order request withdrawn.--If 
                an order request is withdrawn after the order request 
                was filed, the Secretary may refund the fee or a 
                portion of the fee if no substantial work was performed 
                on the order request after the application was filed. 
                The Secretary shall have the sole discretion to refund 
                a fee or a portion of the fee under this subparagraph. 
                A determination by the Secretary concerning a refund 
                under this subparagraph shall not be reviewable.
            ``(3) Refunds.--
                    ``(A) In general.--Other than refunds provided 
                pursuant to any of subparagraphs (D) through (G) of 
                paragraph (2), the Secretary shall not refund any fee 
                paid under paragraph (1) except as provided in 
                subparagraph (B).
                    ``(B) Disputes concerning fees.--To qualify for the 
                return of a fee claimed to have been paid in error 
                under paragraph (1) or (2), a person shall submit to 
                the Secretary a written request justifying such return 
                within 180 calendar days after such fee was paid.
            ``(4) Notice.--Within the timeframe specified in subsection 
        (c), the Secretary shall publish in the Federal Register the 
        amount of the fees under paragraph (1) for such fiscal year.
    ``(b) Fee Revenue Amounts.--
            ``(1) Fiscal year 2019.--For fiscal year 2019, fees under 
        subsection (a)(1) shall be established to generate a total 
        facility fee revenue amount equal to the sum of--
                    ``(A) the annual base revenue for fiscal year 2019 
                (as determined under paragraph (3));
                    ``(B) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(2)); and
                    ``(C) additional direct cost adjustments (as 
                determined under subsection (c)(3)).
            ``(2) Subsequent fiscal years.--For each of the fiscal 
        years 2020 through 2023, fees under subsection (a)(1) shall be 
        established to generate a total facility fee revenue amount 
        equal to the sum of--
                    ``(A) the annual base revenue for the fiscal year 
                (as determined under paragraph (3));
                    ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                    ``(C) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(2));
                    ``(D) additional direct cost adjustments (as 
                determined under subsection (c)(3)); and
                    ``(E) additional dollar amounts for each fiscal 
                year as follows:
                            ``(i) $7,000,000 for fiscal year 2020.
                            ``(ii) $6,000,000 for fiscal year 2021.
                            ``(iii) $7,000,000 for fiscal year 2022.
                            ``(iv) $3,000,000 for fiscal year 2023.
            ``(3) Annual base revenue.--For purposes of paragraphs 
        (1)(A) and (2)(A), the dollar amount of the annual base revenue 
        for a fiscal year shall be--
                    ``(A) for fiscal year 2019, $8,000,000; and
                    ``(B) for fiscal years 2020 through 2023, the 
                dollar amount of the total revenue amount established 
                under this subsection for the previous fiscal year, not 
                including any adjustments made under subsection (c)(2) 
                or (c)(3).
    ``(c) Adjustments; Annual Fee Setting.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--For purposes of subsection 
                (b)(2)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for fiscal year 
                2020 and each subsequent fiscal year shall be equal to 
                the product of--
                            ``(i) such annual base revenue for the 
                        fiscal year under subsection (b)(2); and
                            ``(ii) the inflation adjustment percentage 
                        under subparagraph (C).
                    ``(B) OTC monograph order request fees.--For 
                purposes of subsection (a)(2), the dollar amount of the 
                inflation adjustment to the fee for OTC monograph order 
                requests for fiscal year 2020 and each subsequent 
                fiscal year shall be equal to the product of--
                            ``(i) the applicable fee under subsection 
                        (a)(2) for the preceding fiscal year; and
                            ``(ii) the inflation adjustment percentage 
                        under subparagraph (C).
                    ``(C) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this subparagraph 
                for a fiscal year is equal to--
                            ``(i) for each of fiscal years 2020 and 
                        2021, the average annual percent change that 
                        occurred in the Consumer Price Index for urban 
                        consumers (Washington-Baltimore, DC-MD-VA-WV; 
                        Not Seasonally Adjusted; All items; Annual 
                        Index) for the first 3 years of the preceding 4 
                        years of available data; and
                            ``(ii) for each of fiscal years 2022 and 
                        2023, the sum of--
                                    ``(I) the average annual percent 
                                change in the cost, per full-time 
                                equivalent position of the Food and 
                                Drug Administration, of all personnel 
                                compensation and benefits paid with 
                                respect to such positions for the first 
                                3 years of the preceding 4 fiscal 
                                years, multiplied by the proportion of 
                                personnel compensation and benefits 
                                costs to total costs of OTC monograph 
                                drug activities for the first 3 years 
                                of the preceding 4 fiscal years; and
                                    ``(II) the average annual percent 
                                change that occurred in the Consumer 
                                Price Index for urban consumers 
                                (Washington-Baltimore, DC-MD-VA-WV; Not 
                                Seasonally Adjusted; All items; Annual 
                                Index) for the first 3 years of the 
                                preceding 4 years of available data 
                                multiplied by the proportion of all 
                                costs other than personnel compensation 
                                and benefits costs to total costs of 
                                OTC monograph drug activities for the 
                                first 3 years of the preceding 4 fiscal 
                                years.
            ``(2) Operating reserve adjustment.--
                    ``(A) In general.--For fiscal year 2019 and 
                subsequent fiscal years, for purposes of subsections 
                (b)(1)(B) and (b)(2)(C), the Secretary may, in addition 
                to adjustments under paragraph (1), further increase 
                the fee revenue and fees if such an adjustment is 
                necessary to provide operating reserves of carryover 
                user fees for OTC monograph drug activities for not 
                more than the number of weeks specified in subparagraph 
                (B).
                    ``(B) Number of weeks.--The number of weeks 
                specified in this subparagraph is--
                            ``(i) 3 weeks for fiscal year 2019;
                            ``(ii) 7 weeks for fiscal year 2020;
                            ``(iii) 10 weeks for fiscal year 2021;
                            ``(iv) 10 weeks for fiscal year 2022; and
                            ``(v) 10 weeks for fiscal year 2023.
                    ``(C) Decrease.--If the Secretary has carryover 
                balances for such process in excess of 10 weeks of the 
                operating reserves referred to in subparagraph (A), the 
                Secretary shall decrease the fee revenue and fees 
                referred to in such subparagraph to provide for not 
                more than 10 weeks of such operating reserves.
                    ``(D) Rationale for adjustment.--If an adjustment 
                under this paragraph is made, the rationale for the 
                amount of the increase or decrease (as applicable) in 
                fee revenue and fees shall be contained in the annual 
                Federal Register notice under paragraph (4) 
                establishing fee revenue and fees for the fiscal year 
                involved.
            ``(3) Additional direct cost adjustment.--The Secretary 
        shall, in addition to adjustments under paragraphs (1) and (2), 
        further increase the fee revenue and fees for purposes of 
        subsection (b)(2)(D) by an amount equal to--
                    ``(A) $14,000,000 for fiscal year 2019;
                    ``(B) $7,000,000 for fiscal year 2020;
                    ``(C) $4,000,000 for fiscal year 2021;
                    ``(D) $3,000,000 for fiscal year 2022; and
                    ``(E) $3,000,000 for fiscal year 2023.
            ``(4) Annual fee setting.--
                    ``(A) Fiscal year 2019.--The Secretary shall, not 
                later than the second Monday in March of 2019--
                            ``(i) establish OTC monograph drug facility 
                        fees for fiscal year 2019 under subsection (a), 
                        based on the revenue amount for such year under 
                        subsection (b) and the adjustments provided 
                        under this subsection; and
                            ``(ii) publish fee revenue, facility fees, 
                        and OTC monograph order requests in the Federal 
                        Register.
                    ``(B) Subsequent fiscal years.--The Secretary 
                shall, not later than the second Monday in March of 
                each fiscal year that begins after September 30, 2019--
                            ``(i) establish for each such fiscal year, 
                        based on the revenue amounts under subsection 
                        (b) and the adjustments provided under this 
                        subsection--
                                    ``(I) OTC monograph drug facility 
                                fees under subsection (a)(1); and
                                    ``(II) OTC monograph order request 
                                fees under subsection (a)(2); and
                            ``(ii) publish such fee revenue amounts, 
                        facility fees, and OTC monograph order request 
                        fees in the Federal Register.
    ``(d) Identification of Facilities.--Each person that owns an OTC 
monograph drug facility shall submit to the Secretary the information 
required under this subsection each year. Such information shall, for 
each fiscal year--
            ``(1) be submitted as part of the requirements for drug 
        establishment registration set forth in section 510; and
            ``(2) include for each such facility, at a minimum, 
        identification of the facility's business operation as that of 
        an OTC monograph drug facility.
    ``(e) Effect of Failure To Pay Fees.--
            ``(1) OTC monograph drug facility fee.--
                    ``(A) In general.--Failure to pay the fee under 
                subsection (a)(1) within 20 calendar days of the due 
                date as specified in subparagraph (D) of such 
                subsection shall result in the following:
                            ``(i) The Secretary shall place the 
                        facility on a publicly available arrears list.
                            ``(ii) All OTC monograph drugs manufactured 
                        in such a facility or containing an ingredient 
                        manufactured in such a facility shall be deemed 
                        misbranded under section 502(ff).
                    ``(B) Application of penalties.--The penalties 
                under this paragraph shall apply until the fee 
                established by subsection (a)(1) is paid.
            ``(2) Order requests.--An OTC monograph order request 
        submitted by a person subject to fees under subsection (a) 
        shall be considered incomplete and shall not be accepted for 
        filing by the Secretary until all fees owed by such person 
        under this section have been paid.
            ``(3) Meetings.--A person subject to fees under this 
        section shall be considered ineligible for OTC monograph drug 
        meetings until all such fees owed by such person have been 
        paid.
    ``(f) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for OTC monograph drug activities.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--Subject to subparagraph (C), the 
                fees authorized by this section shall be collected and 
                available in each fiscal year in an amount not to 
                exceed the amount specified in appropriation Acts, or 
                otherwise made available for obligation, for such 
                fiscal year.
                    ``(B) Use of fees and limitation.--The fees 
                authorized by this section shall be available to defray 
                increases in the costs of the resources allocated for 
                OTC monograph drug activities (including increases in 
                such costs for an additional number of full-time 
                equivalent positions in the Department of Health and 
                Human Services to be engaged in such activities), only 
                if the Secretary allocates for such purpose an amount 
                for such fiscal year (excluding amounts from fees 
                collected under this section) no less than $12,000,000, 
                multiplied by the adjustment factor applicable to the 
                fiscal year involved under subsection (c)(1).
                    ``(C) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (B) in any fiscal year if the costs funded by 
                appropriations and allocated for OTC monograph drug 
                activities are not more than 15 percent below the level 
                specified in such subparagraph.
                    ``(D) Provision for early payments in subsequent 
                years.--Payment of fees authorized under this section 
                for a fiscal year (after fiscal year 2019), prior to 
                the due date for such fees, may be accepted by the 
                Secretary in accordance with authority provided in 
                advance in a prior year appropriations Act.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2019 through 2023, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total amount of fees assessed for such fiscal year under this 
        section.
    ``(g) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 calendar days after it is due, such fee shall be treated as a claim 
of the United States Government subject to subchapter II of chapter 37 
of title 31, United States Code.
    ``(h) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employers, and advisory 
committees not engaged in OTC monograph drug activities, be reduced to 
offset the number of officers, employees, and advisory committees so 
engaged.

``SEC. 744N. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Report.--Beginning with fiscal year 2019, and not 
later than 120 calendar days after the end of each fiscal year 
thereafter for which fees are collected under this part, the Secretary 
shall prepare and submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report concerning the progress of the Food 
and Drug Administration in achieving the goals identified in the 
letters described in section 2001(b) of the Over-the-Counter Monograph 
Safety, Innovation, and Reform Act of 2018 during such fiscal year and 
the future plans of the Food and Drug Administration for meeting such 
goals.
    ``(b) Fiscal Report.--Not later than 120 calendar days after the 
end of fiscal year 2019 and each subsequent fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report on the implementation of the authority for such fees 
during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
internet website of the Food and Drug Administration.
    ``(d) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals described in 
        subsection (a), and plans for meeting the goals, for OTC 
        monograph drug activities for the first 5 fiscal years after 
        fiscal year 2023, and for the reauthorization of this part for 
        such fiscal years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 calendar days for 
                the public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2023, the Secretary shall transmit to the Congress 
        the revised recommendations under paragraph (2), a summary of 
        the views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.''.
                                 <all>