[Congressional Record Volume 164, Number 201 (Thursday, December 20, 2018)]
[House]
[Pages H10366-H10393]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING INNOVATION ACT OF 
                                  2018

  Mr. BURGESS. Mr. Speaker, I move to suspend the rules and pass the 
bill (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.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 7328

       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''

[[Page H10367]]

     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

[[Page H10368]]

     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.--

[[Page H10369]]

       (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

[[Page H10370]]

     ``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

[[Page H10371]]

     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

[[Page H10372]]

     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

[[Page H10373]]

       (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,

[[Page H10374]]

     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;

[[Page H10375]]

       ``(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

[[Page H10376]]

     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''.

[[Page H10377]]

  


     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

[[Page H10378]]

     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)--

[[Page H10379]]

       (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,

[[Page H10380]]

     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.--

[[Page H10381]]

       (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--

[[Page H10382]]

       ``(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

     SECTION 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--

[[Page H10383]]

       ``(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).

[[Page H10384]]

       ``(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

[[Page H10385]]

     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

[[Page H10386]]

     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).

[[Page H10387]]

       ``(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.

[[Page H10388]]

       (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).

[[Page H10389]]

  


                          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.--

[[Page H10390]]

       ``(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
  


[[Page H10391]]

  

       ``(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.''.
  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Texas (Mr. Burgess) and the gentlewoman from California (Ms. Eshoo) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Texas.


                             General Leave

  Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
  H.R. 7328 includes both the Pandemic and All-Hazards Preparedness Act 
and the Over-the-Counter Monograph reform language. Both of these bills 
have passed this House separately, and this today in front of us 
includes bipartisan, bicameral agreements on these programs. Passage of 
this bill is critical to our national security; and on this 100-year 
anniversary of the Spanish flu, I can think of no more appropriate 
piece of legislation to be considering.
  I urge all Members to support the bill, and I yield back the balance 
of my time.
  Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 7328. This is a good bill. I 
think it is an

[[Page H10392]]

important one. It is the Over-the-Counter Monograph Safety, Innovation, 
and Reform Act of 2018. Kind of a mouthful, but what it does is it 
streamlines how over-the-counter drugs are regulated. This will enable 
the FDA, the Food and Drug Administration, to act faster to address 
safety issues associated with over-the-counter drugs and bring 
innovative over-the-counter drugs to market.
  The legislation will also establish a new user fee program to provide 
the FDA with reliable and stable funding to implement the reforms in 
this bill. These user fees are already in place with the pharmaceutical 
industry, with others. It works very well, and it allows hiring the 
necessary additional staff to oversee the over-the-counter market.
  This updated legislation, very importantly, reflects that it is both 
bipartisan and bicameral, and I urge the entire House to support the 
bill.
  I also want to point out that, rolled into this bill, H.R. 7328, is 
what we call PAHPA, the Pandemic and All-Hazards Preparedness and 
Advancing Innovation Act. I am very proud to have authored this 
originally in a past Congress. But also my partner in this Congress has 
been Congresswoman Susan Brooks. I couldn't ask for a finer partner.
  The legislation really reflects months of negotiations and compromise 
reached by both the House and the Senate, and the bill makes important 
updates to, as I said, the over-the-counter monograph program.
  What we are considering in terms of this particular bill is an 
update, and it directs Federal agencies to respond to new and emerging 
threats and strengthens our Nation's existing preparedness and response 
programs. This has a great deal to do with our national security, and 
that is why it is so important.
  The legislation not only reauthorizes critical programs to allow our 
country to be prepared to respond to naturally occurring and manmade 
disasters--and we know these threats are real--but it also meets the 
challenges that we face today and those that we anticipate facing in 
the future.
  I am very glad that this legislation was rolled into H.R. 7328, and I 
once again want to salute the work that Congresswoman Susan Brooks did 
on this particular bill that is part of H.R. 7328.
  Mr. Speaker, I have two speakers on my side, but I will reserve the 
balance of my time.
  The SPEAKER pro tempore. The gentlewoman from California has the only 
time remaining. The gentleman from Texas has yielded back the balance 
of his time.
  Ms. ESHOO. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Michigan (Mrs. Dingell), my friend and colleague.
  Mrs. DINGELL. Mr. Speaker, I rise in strong support of H.R. 7328, and 
I thank all of my colleagues for the very hard work that has gone into 
this.
  This important bill reauthorizes the Pandemics and All-Hazards 
Preparedness Act, and it also gives the FDA revenue and authority to 
improve their oversight of the over-the-counter drugs.
  Although the hour is late, I am very glad we are sending this bill to 
the Senate today, and I urge my colleagues to quickly pass this bill 
before the 115th Congress expires. I know we all want it to expire, but 
we can do some good things before it does.
  Today, 60 percent of all medicines sold in the U.S. are over the 
counter; yet the FDA has only 18 full-time employees overseeing that 
entire market. That is not reflective of the way that our healthcare 
systems run, and it is putting patients at risk every single day.
  Our bill reforms the system for the better by creating a new user fee 
program to give the FDA resources it needs to improve public health, 
and it allows the agency to update OTC monographs by administrative 
order rather than the ineffective rulemaking process we have been 
watching. This will be a big win for patients, who will benefit from 
the improved safety of their products, as well as the industry, as they 
will have a reliable pathway to bring new, innovative products to 
market. We haven't seen a new sunscreen on the market in more than a 
decade.
  I want to thank all of my colleagues on both sides of the aisle in 
the Energy and Commerce Committee for all of the time and the effort 
they put into this legislation. I especially want to thank Kim Trzeciak 
of the committee staff for all of her hard work.
  Let's get this done before we go home for the holidays. I urge my 
colleagues to support H.R. 7328.
  Ms. ESHOO. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Colorado (Ms. DeGette).
  Ms. DeGETTE. Mr. Speaker, today we have an opportunity, as well as 
the wonderful items in this bil that Mrs. Dingell talked about, to make 
long overdue reforms to the way that the Food and Drug Administration 
reviews over-the-counter medicines.

  Nearly 7 in 10 parents report giving their children an OTC medicine 
to help treat a sudden medical symptom. Similarly, 81 percent of adults 
use OTC drugs as a first response to a minor ailment.
  Despite the widespread use of these medicines, though, the FDA is 
forced to use a cumbersome and archaic monograph pathway for review and 
approval. This antiquated, 40-year review system does not keep pace 
with recent medical advances and the burgeoning of the OTC market, 
which now has over 300,000 drugs. As a result, the current monograph 
fails to respond to OTC safety issues in a timely and effective manner.
  During the 2 years between 2004 and 2005, the CDC reported 1,500 
cases of children under the age of 2 visiting emergency rooms due to 
serious side effects of over-the-counter drugs of cough and cold 
products. Since this finding, the FDA has been trying to revise the 
cough and cold monograph to warn parents about the risks that these 
common drugs can cause. But the FDA can't do that because they are 
hamstrung due to the burdensome process it has to undergo to revise 
these monographs.
  This bill, H.R. 7328, which I worked on with my colleagues, Mr. 
Latta, Mrs. Dingell, Mr. Green, Mr. Burgess, and Mr. Guthrie, is a rare 
triple win because it helps regulators, consumers, and industry:
  It modernizes an outdated FDA process;
  It ensures consumers get access to safe and effective over-the-
counter drugs;
  It provides industry with the certainty to innovate and develop 
cutting-edge OTC products; and
  It gives the FDA the tools and resources to remove dangerous and 
ineffective products from the market.
  Let's pass this bill right now, and let's urge the Senate to get 
something done and pass this before the Congress ends.
  Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
  I don't have any other speakers, but let me just close by saying I 
think that, between the chairman of our subcommittee and my two 
colleagues and their remarks--and mine included--that these are very 
good bills that are going to accomplish good things for the American 
people. So whether it is what was rolled into H.R. 7328--PAHPA and the 
underlying bill, the Over-the-Counter Monograph Safety, Innovation, and 
Reform Act--I feel very confident that, with its passage, we will have 
accomplished something that is excellent for the American people.
  Mr. Speaker, I yield back the balance of my time.
  Mr. LATTA. Mr. Speaker, I rise today in support of H.R. 7328, which 
includes the bill I authored, H.R. 5333, the Over-the-Counter Monograph 
Safety, Innovation, and Reform Act.
  With more than 240 million Americans using OTC products every year, 
it is time to update and complete the outdated regulatory framework 
used for oversight of these medicines.
  This bill will modernize the broken monograph system, strengthen 
consumer protection, spur innovation, and increase consumer choice.
  Mrs. BROOKS of Indiana. Mr. Speaker, I rise today to speak in support 
of my bill--the Pandemic and All-Hazards Preparedness and Advancing 
Innovation Act of 2018 or PAHPA. I'm proud to have introduced this 
important bill with my good friend Representative Anna Eshoo who was 
one of the original authors of the 2006 PAHPA bill and lead author of 
the last reauthorization in 2013.
  This bipartisan public health and national security effort will 
ensure our nation is better prepared to respond to natural disasters 
like hurricanes, emerging infectious diseases like

[[Page H10393]]

Zika or Ebola, and chemical, biological, radiological or nuclear 
attacks whether from terrorist groups or from nation states.
  The threats we face are not hypothetical.
  Since August of this year, 315 people in the Democratic Republic of 
Congo have died from Ebola. The ongoing Ebola outbreak in the 
Democratic Republic of Congo is now the second largest outbreak in 
history. More than 530 cases have been reported with 18 new confirmed 
cases over the weekend.
  Thanks to PAHPA and the 21st Century Cures Act, we are more prepared 
for biological threats and attacks. In July, the FDA approved the first 
drug to treat smallpox--TPOXX. But, TPOXX is not the only recent 
approval at the FDA. On July 10th, the FDA approved an autoinjector 
which provides a one-time dose of an antidote to block effects of a 
nerve agent. This new antidote and TPOXX will help protect Americans 
from biological attacks.
  But, PAHPA is much more than just a biodefense bill. It also helps 
ensure a coordinated health care response to hurricanes. During the 
2017 hurricane season, Hurricanes Florence, Harvey, Irma, Jose, and 
Maria killed hundreds of Americans and showed us that we need to do 
better to prioritize the needs of every person in our communities. The 
PAHPA bill we are considering today does that by prioritizing our 
nation's most vulnerable populations--our children, senior citizens, 
and people with disabilities. It reauthorizes the advisory committee 
focused on the specific needs of children, and creates NEW advisory 
committees to ensure the needs of the elderly and people with 
disabilities are considered.
  The bill provides liability protections for doctors who volunteer 
after a medical disaster. In addition to these Good Samaritan 
provisions, the bill also ensures more health care professionals like 
nurses and doctors can be hired and trained when facing a public health 
crisis by strengthening the National Disaster Medical System, which 
provides grants to our regional health care network. It also ensures we 
have a robust supply of vaccines, basic equipment like gloves, hazmat 
suits, masks and more in our Strategic National Stockpiles located all 
across the country, so these professionals have the equipment they 
need.
  PAHPA ensures our preparedness and response capabilities will include 
a robust pipeline of medical countermeasures by reauthorizing and 
increasing funding for the BioShield Special Reserve Fund and BARDA--
the Biomedical Advanced Research and Development Authority. BARDA's 
work over the last decade has resulted in FDA approvals for more than 
42 different medical countermeasures. The development of medical 
countermeasures is a lengthy and often risky endeavor, which is why 
sending a clear signal that BARDA remains a strong and committed 
partner with academic institutions and the private sector in these 
efforts is so important.
  In September, we saw another example of the success of research 
funded by BARDA when the FDA approved ReCell--the first spray on skin 
product ever approved for use in the United States. This new treatment 
will help treat burn victims so that they can heal faster and with less 
risk of infection from painful skin grafts. By using a piece of a 
patient's skin about the size of a credit card, a doctor can turn it 
into a single cell based solution that can be sprayed over the 
patient's burns so that new skin can grow and replace the damaged and 
burnt skin.
  While the investments BARDA is making into innovative research and 
new treatments are critical, it is also important that we continue to 
address threats that have been around for years. It has been 100 years 
since the 1918 pandemic influenza killed millions of people around the 
globe including 675,000 in the United States. Some experts predict that 
we are due for another global pandemic influenza. To address that 
threat, the bill we are considering today authorizes $250 million for 
the Assistant Secretary for Preparedness and Response (the ASPR) to 
address threats like pandemic influenza. Specifically, the bill directs 
the ASPR to work to increase manufacturing capacity and stockpile 
medical countermeasures. While the PAHPA bill we are considering today 
authorizes funding for research into known threats like pandemic 
influenza it also maintains the flexibility that is the foundation of 
our medical countermeasure enterprise to deal with unknown threats for 
which we may have no defense today.
  The PAHPA reauthorization bill we are considering is the process of 
months of committee work in both the House and Senate. I cannot 
emphasize enough how critically important it is to reauthorize PAHPA 
this year, and I encourage the Senate to quickly take up and pass H.R. 
7328.
  I would urge all Members to support this critical piece of 
legislation.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Texas (Mr. Burgess) that the House suspend the rules and 
pass the bill, H.R. 7328.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. MASSIE. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

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