[Congressional Record Volume 165, Number 3 (Tuesday, January 8, 2019)]
[House]
[Pages H237-H266]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING INNOVATION ACT OF
2019
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 269) 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. 269
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
2019''.
(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 H238]]
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 2019 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 H239]]
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 2019 (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 H240]]
(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) by 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 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.
``(2) 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.
``(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 is 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'';
[[Page H241]]
(C) in paragraph (3), in the matter preceding subparagraph
(A), by striking ``expand, enhance, and improve'' and
inserting ``expand, improve, enhance, and appropriately
maintain''; and
(D) by adding at the end the following:
``(4) Study of resources for facilities and capacities.--
Not later than June 1, 2022, the Comptroller General of the
United States shall conduct a study on Federal spending in
fiscal years 2013 through 2018 for activities authorized
under this subsection. Such study shall include a review and
assessment of obligations and expenditures directly related
to each activity under paragraphs (2) and (3), including a
specific accounting of, and delineation between, obligations
and expenditures incurred for the construction, renovation,
equipping, and security upgrades of facilities and associated
contracts under this subsection, and the obligations and
expenditures incurred to establish and improve the
situational awareness and biosurveillance network under
subsection (b), and shall identify the agency or agencies
incurring such obligations and expenditures.'';
(3) in subsection (b)--
(A) in the subsection heading, by striking ``National'' and
inserting ``Establishment of Systems of Public Health'';
(B) in paragraph (1)(B), by inserting ``immunization
information systems,'' after ``centers,'';
(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 2019, 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 2019 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 2019, 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 2019, 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
[[Page H242]]
situational awareness and biosurveillance capabilities;
``(iv) includes performance measures and the metrics by
which performance measures will be assessed with respect to
the measurable steps under clause (iii); and
``(v) establishes dates by which each measurable step under
clause (iii) will be implemented.
``(B) Annual budget plan.--Not later than 2 years after the
date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019 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,'';
(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 2019, 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.
(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--
[[Page H243]]
``(A) facilitate coordination between and among Federal,
State, local, Tribal, and territorial entities and public and
private health care entities that the Secretary determines
may be affected by a public health emergency or potential
public health emergency referred to in paragraph (1)
(including communication of such entities with relevant
international entities, as applicable);
``(B) make grants, provide for awards, enter into
contracts, and conduct supportive investigations pertaining
to a public health emergency or potential public health
emergency, including further supporting programs under
section 319C-1, 319C-2, or 319C-3;
``(C) facilitate and accelerate, as applicable, advanced
research and development of security countermeasures (as
defined in section 319F-2), qualified countermeasures (as
defined in section 319F-1), or qualified pandemic or epidemic
products (as defined in section 319F-3), that are applicable
to the public health emergency or potential public health
emergency under paragraph (1);
``(D) strengthen biosurveillance capabilities and
laboratory capacity to identify, collect, and analyze
information regarding such public health emergency or
potential public health emergency, including the systems
under section 319D;
``(E) support initial emergency operations and assets
related to preparation and deployment of intermittent
disaster response personnel under section 2812 and the
Medical Reserve Corps under section 2813; and
``(F) carry out other activities, as the Secretary
determines applicable and appropriate.''; and
(D) by inserting after paragraph (3), as so redesignated,
the following:
``(4) Review.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, 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 2019, 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 the following:
``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;
``(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 2019.
``(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
[[Page H244]]
under such section 319I and for an individual's credentials
to be verified by an authority within the State; and
(4) the Emergency System for Advance Registration of
Volunteer Health Professionals program in States, including
whether physician or medical groups, associations, or other
relevant provider organizations utilize such program for
purposes of volunteering during public health emergencies.
SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUPPLY.
Not later than 1 year after the date of the enactment of
this Act, the Secretary of Health and Human Services shall
submit to Congress a report containing recommendations
related to maintaining an adequate national blood supply,
including--
(1) challenges associated with the continuous recruitment
of blood donors (including those newly eligible to donate);
(2) ensuring the adequacy of the blood supply in the case
of public health emergencies;
(3) implementation of the transfusion transmission
monitoring system; and
(4) other measures to promote safety and innovation, such
as the development, use, or implementation of new
technologies, processes, and procedures to improve the safety
and reliability of the blood supply.
SEC. 210. REPORT ON THE PUBLIC HEALTH PREPAREDNESS AND
RESPONSE CAPABILITIES AND CAPACITIES OF
HOSPITALS, LONG-TERM CARE FACILITIES, AND OTHER
HEALTH CARE FACILITIES.
(a) Study.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall enter into an agreement with an appropriate
entity to conduct a study regarding the public health
preparedness and response capabilities and medical surge
capacities of hospitals, long-term care facilities, and other
health care facilities to prepare for, and respond to, public
health emergencies, including natural disasters.
(2) Consultation.--In conducting the study under paragraph
(1), the entity shall consult with Federal, State, local,
Tribal, and territorial public health officials (as
appropriate), and health care providers and facilities with
experience in public health preparedness and response
activities.
(3) Evaluation.--The study under paragraph (1) shall
include--
(A) an evaluation of the current benchmarks and objective
standards, as applicable, related to programs that support
hospitals, long-term care facilities, and other health care
facilities, and their effect on improving public health
preparedness and response capabilities and medical surge
capacities, including the Hospital Preparedness Program, the
Public Health Emergency Preparedness cooperative agreements,
and the Regional Health Care Emergency Preparedness and
Response Systems under section 319C-3 of the Public Health
Service Act (as added by section 203);
(B) the identification of gaps in preparedness, including
with respect to such benchmarks and objective standards, such
as those identified during recent public health emergencies,
for hospitals, long-term care facilities, and other health
care facilities to address future potential public health
threats;
(C) an evaluation of coordination efforts between the
recipients of Federal funding for programs described in
subparagraph (A) and entities with expertise in emergency
power systems and other critical infrastructure partners
during a public health emergency, to ensure a functioning
critical infrastructure, to the greatest extent practicable,
during a public health emergency;
(D) an evaluation of coordination efforts between the
recipients of Federal funding for programs described in
subparagraph (A) and environmental health agencies with
expertise in emergency preparedness and response planning for
hospitals, long-term care facilities, and other health care
facilities; and
(E) an evaluation of current public health preparedness and
response capabilities and medical surge capacities related to
at-risk individuals during public health emergencies,
including an identification of gaps in such preparedness as
they relate to such individuals.
(b) Report.--
(1) In general.--The agreement under subsection (a) shall
require the entity to submit to the Secretary of Health and
Human Services and the congressional committees of
jurisdiction, not later than 3 years after the date of
enactment of this Act, a report on the results of the study
conducted pursuant to this section.
(2) Contents.--The report under paragraph (1) shall--
(A) describe the findings and conclusions of the evaluation
conducted pursuant to subsection (a); and
(B) provide recommendations for improving public health
preparedness and response capability and medical surge
capacity for hospitals, long-term care facilities, and other
health care facilities, including--
(i) improving the existing benchmarks and objective
standards for the Federal grant programs described in
subsection (a)(3)(A) or developing new benchmarks and
standards for such programs; and
(ii) identifying best practices for improving public health
preparedness and response programs and medical surge capacity
at hospitals, long-term care facilities, and other health
care facilities, including recommendations for the evaluation
under subparagraphs (C) and (D) of subsection (a)(3).
TITLE III--REACHING ALL COMMUNITIES
SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY RESPONSE
WORKFORCE.
(a) National Disaster Medical System.--
(1) Strengthening the national disaster medical system.--
Clause (ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh-
11(a)(3)(A)) is amended to read as follows:
``(ii) be present at locations, and for limited periods of
time, specified by the Secretary on the basis that the
Secretary has determined that a location is at risk of a
public health emergency during the time specified, or there
is a significant potential for a public health emergency.''.
(2) Review of the national disaster medical system.--
Section 2812(b)(2) (42 U.S.C. 300hh-11(b)(2)) is amended to
read as follows:
``(2) Joint review and medical surge capacity strategic
plan.--
``(A) Review.--Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, 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:
[[Page H245]]
``(2) Epidemic intelligence service program.--For purposes
of carrying out this section with respect to qualified health
professionals serving in the Epidemic Intelligence Service,
as authorized under section 317G, there is 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;
[[Page H246]]
``(3) improve the utilization of methods to incorporate the
needs of children in planning for and responding to a public
health emergency, including public awareness of such methods;
``(4) coordinate with, and improve, public-private
partnerships, such as health care coalitions pursuant to
sections 319C-2 and 319C-3, to address gaps and
inefficiencies in emergency preparedness and response efforts
for children;
``(5) provide expertise and input during the development of
guidance and clinical recommendations to address the needs of
children when preparing for, and responding to, public health
emergencies, including pursuant to section 319C-3; and
``(6) carry out other duties related to preparedness and
response activities for children, as the Secretary determines
appropriate.''.
SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISASTERS.
(a) Reauthorizing the National Advisory Committee on
Children and Disasters.--Section 2811A (42 U.S.C. 300hh-10a)
is amended--
(1) in subsection (b)(2), by inserting ``, mental and
behavioral,'' after ``medical'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``15'' and inserting
``25''; and
(B) by striking paragraph (2) and inserting the following:
``(2) Required non-federal members.--The Secretary, in
consultation with such other heads of Federal agencies as may
be appropriate, shall appoint to the Advisory Committee under
paragraph (1) at least 13 individuals, including--
``(A) at least 2 non-Federal professionals with expertise
in pediatric medical disaster planning, preparedness,
response, or recovery;
``(B) at least 2 representatives from State, local, Tribal,
or territorial agencies with expertise in pediatric disaster
planning, preparedness, response, or recovery;
``(C) at least 4 members representing health care
professionals, which may include members with expertise in
pediatric emergency medicine; pediatric trauma, critical
care, or surgery; the treatment of pediatric patients
affected by chemical, biological, radiological, or nuclear
agents, including emerging infectious diseases; pediatric
mental or behavioral health related to children affected by a
public health emergency; or pediatric primary care; and
``(D) other members as the Secretary determines
appropriate, of whom--
``(i) at least one such member shall represent a children's
hospital;
``(ii) at least one such member shall be an individual with
expertise in schools or child care settings;
``(iii) at least one such member shall be an individual
with expertise in children and youth with special health care
needs; and
``(iv) at least one such member shall be an individual with
expertise in the needs of parents or family caregivers,
including the parents or caregivers of children with
disabilities.
``(3) Federal members.--The Advisory Committee under
paragraph (1) shall include the following Federal members or
their designees (who may be nonvoting 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 2019, 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
nonvoting 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
[[Page H247]]
response activities, including related drills and exercises
pursuant to the preparedness goals under section 2802(b).
``(c) Membership.--
``(1) In general.--The Secretary, in consultation with such
other heads of agencies and departments as appropriate, shall
appoint not more than 17 members to the Advisory Committee.
In appointing such members, the Secretary shall ensure that
the total membership of the Advisory Committee is an odd
number.
``(2) Required members.--The Advisory Committee shall
include Federal members or their designees (who may be
nonvoting 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
[[Page H248]]
(B) by striking ``Director of the Biomedical'' and all that
follows through ``Food and Drugs'' and inserting ``Public
Health Emergency Medical Countermeasures Enterprise
established under section 2811-1''; and
(2) in paragraph (2)(J)(v), by striking ``one-year period''
and inserting ``2-year period''.
SEC. 403. STRATEGIC NATIONAL STOCKPILE.
(a) In General.--Section 319F-2(a) (42 U.S.C. 247d-6b(a))
is amended--
(1) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(2) in paragraph (1)--
(A) by inserting ``the Assistant Secretary for Preparedness
and Response and'' after ``collaboration with'';
(B) by inserting ``and optimize'' after ``provide for'';
(C) by inserting ``and, as informed by existing
recommendations of, or consultations with, the Public Health
Emergency Medical Countermeasure Enterprise established under
section 2811-1, make necessary additions or modifications to
the contents of such stockpile or stockpiles based on the
review conducted under paragraph (2)'' before the period of
the first sentence; and
(D) by striking the second sentence;
(3) by inserting after paragraph (1) the following:
``(2) Threat-based review.--
``(A) In general.--The Secretary shall conduct an annual
threat-based review (taking into account at-risk individuals)
of the contents of the stockpile under paragraph (1),
including non-pharmaceutical supplies, and, in consultation
with the Public Health Emergency Medical Countermeasures
Enterprise established under section 2811-1, review contents
within the stockpile and assess whether such contents are
consistent with the recommendations made pursuant to section
2811-1(c)(1)(A). Such review shall be submitted on June 15,
2019, and on March 15 of each year thereafter, to the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of
the House of Representatives, in a manner that does not
compromise national security.
``(B) Additions, modifications, and replenishments.--Each
annual threat-based review under subparagraph (A) shall, for
each new or modified countermeasure procurement or
replenishment, provide--
``(i) information regarding--
``(I) the quantities of the additional or modified
countermeasure procured for, or contracted to be procured
for, the stockpile;
``(II) planning considerations for appropriate
manufacturing capacity and capability to meet the goals of
such additions or modifications (without disclosing
proprietary information), including consideration of the
effect such additions or modifications may have on the
availability of such products and ancillary medical supplies
in the health care system;
``(III) the presence or lack of a commercial market for the
countermeasure at the time of procurement;
``(IV) the emergency health security threat or threats such
countermeasure procurement is intended to address, including
whether such procurement is consistent with meeting emergency
health security needs associated with such threat or threats;
``(V) an assessment of whether the emergency health
security threat or threats described in subclause (IV) could
be addressed in a manner that better utilizes the resources
of the stockpile and permits the greatest possible increase
in the level of emergency preparedness to address such
threats;
``(VI) whether such countermeasure is replenishing an
expiring or expired countermeasure, is a different
countermeasure with the same indication that is replacing an
expiring or expired countermeasure, or is a new addition to
the stockpile;
``(VII) a description of how such additions or
modifications align with projected investments under previous
countermeasures budget plans under section 2811(b)(7),
including expected life-cycle costs, expenditures related to
countermeasure procurement to address the threat or threats
described in subclause (IV), replenishment dates (including
the ability to extend the maximum shelf life of a
countermeasure), and the manufacturing capacity required to
replenish such countermeasure; and
``(VIII) appropriate protocols and processes for the
deployment, distribution, or dispensing of the countermeasure
at the State and local level, including plans for relevant
capabilities of State and local entities to dispense,
distribute, and administer the countermeasure; and
``(ii) an assurance, which need not be provided in advance
of procurement, that for each countermeasure procured or
replenished under this subsection, the Secretary completed a
review addressing each item listed under this subsection in
advance of such procurement or replenishment.'';
(4) in paragraph (3), as so redesignated--
(A) in subparagraph (A), by inserting ``and the Public
Health Emergency Medical Countermeasures Enterprise
established under section 2811-1'' before the semicolon;
(B) in subparagraph (C), by inserting ``, and the
availability, deployment, dispensing, and administration of
countermeasures'' before the semicolon;
(C) by amending subparagraph (E) to read as follows:
``(E) devise plans for effective and timely supply-chain
management of the stockpile, in consultation with the
Director of the Centers for Disease Control and Prevention,
the Assistant Secretary for Preparedness and Response, the
Secretary of Transportation, the Secretary of Homeland
Security, the Secretary of Veterans Affairs, and the heads of
other appropriate Federal agencies; State, local, Tribal, and
territorial agencies; and the public and private health care
infrastructure, as applicable, taking into account the
manufacturing capacity and other available sources of
products and appropriate alternatives to supplies in the
stockpile;'';
(D) in subparagraph (G), by striking ``; and'' and
inserting a semicolon;
(E) in subparagraph (H), by striking the period and
inserting a semicolon; and
(F) by adding at the end the following:
``(I) ensure that each countermeasure or product under
consideration for procurement pursuant to this subsection
receives the same consideration regardless of whether such
countermeasure or product receives or had received funding
under section 319L, including with respect to whether the
countermeasure or product is most appropriate to meet the
emergency health security needs of the United States; and
``(J) provide assistance, including technical assistance,
to maintain and improve State and local public health
preparedness capabilities to distribute and dispense medical
countermeasures and products from the stockpile, as
appropriate.''; and
(5) by adding at the end the following:
``(5) GAO report.--
``(A) In general.--Not later than 3 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, 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 2019 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
[[Page H249]]
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
the Strategic National Stockpile and the Director of the
Biomedical Advanced Research and Development Authority
coordinate with respect to countermeasures and products
procured under such section 319F-2(a), including such
processes and procedures in place to ensure countermeasures
and products under consideration for procurement pursuant to
such section 319F-2(a) receive the same consideration
regardless of whether such countermeasures or products
receive or had received funding under section 319L of the
Public Health Service Act (42 U.S.C. 247d-7e), and whether
such countermeasures and products are the most appropriate to
meet the emergency health security needs of the United
States.
(c) Authorization of Appropriations, Strategic National
Stockpile.--Section 319F-2(f)(1) (42 U.S.C. 247d-6b(f)(1)) is
amended by striking ``$533,800,000 for each of fiscal years
2014 through 2018'' and inserting ``$610,000,000 for each of
fiscal years 2019 through 2023, to remain available until
expended''.
SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL
RESISTANCE, AND OTHER SIGNIFICANT THREATS.
(a) Strategic Initiatives.--Section 319L(c)(4) (247d-
7e(c)(4)) is amended by adding at the end the following:
``(F) Strategic initiatives.--The Secretary, acting through
the Director of BARDA, may implement strategic initiatives,
including by building on existing programs and by awarding
contracts, grants, and cooperative agreements, or entering
into other transactions, to support innovative candidate
products in preclinical and clinical development that address
priority, naturally occurring and man-made threats that, as
determined by the Secretary, pose a significant level of risk
to national security based on the characteristics of a
chemical, biological, radiological or nuclear threat, or
existing capabilities to respond to such a threat (including
medical response and treatment capabilities and manufacturing
infrastructure). Such initiatives shall accelerate and
support the advanced research, development, and procurement
of countermeasures and products, as applicable, to address
areas including--
``(i) chemical, biological, radiological, or nuclear
threats, including emerging infectious diseases, for which
insufficient approved, licensed, or authorized
countermeasures exist, or for which such threat, or the
result of an exposure to such threat, may become resistant to
countermeasures or existing countermeasures may be rendered
ineffective;
``(ii) threats that consistently exist or continually
circulate and have a significant potential to become a
pandemic, such as pandemic influenza, which may include the
advanced research and development, manufacturing, and
appropriate stockpiling of qualified pandemic or epidemic
products, and products, technologies, or processes to support
the advanced research and development of such countermeasures
(including multiuse platform technologies for diagnostics,
vaccines, and therapeutics; virus seeds; clinical trial lots;
novel virus strains; and antigen and adjuvant material); and
``(iii) threats that may result primarily or secondarily
from a chemical, biological, radiological, or nuclear agent,
or emerging infectious diseases, and which may present
increased treatment complications such as the occurrence of
resistance to available countermeasures or potential
countermeasures, including antimicrobial resistant
pathogens.''.
(b) Protection of National Security From Threats.--Section
2811 (42 U.S.C. 300hh-10) is amended by adding at the end the
following:
``(f) Protection of National Security From Threats.--
``(1) In general.--In carrying out subsection (b)(3), the
Assistant Secretary for Preparedness and Response shall
implement strategic initiatives or activities to address
threats, including pandemic influenza and which may include a
chemical, biological, radiological, or nuclear agent
(including any such agent with a significant potential to
become a pandemic), that pose a significant level of risk to
public health and national security based on the
characteristics of such threat. Such initiatives shall
include activities to--
``(A) accelerate and support the advanced research,
development, manufacturing capacity, procurement, and
stockpiling of countermeasures, including initiatives under
section 319L(c)(4)(F);
``(B) support the development and manufacturing of virus
seeds, clinical trial lots, and stockpiles of novel virus
strains; and
``(C) maintain or improve preparedness activities,
including for pandemic influenza.
``(2) Authorization of appropriations.--
``(A) In general.--To carry out this subsection, there is
authorized to be appropriated $250,000,000 for each of fiscal
years 2019 through 2023.
``(B) Supplement, not supplant.--Amounts appropriated under
this paragraph shall be used to supplement and not supplant
funds provided under sections 319L(d) and 319F-2(g).
``(C) Documentation required.--The Assistant Secretary for
Preparedness and Response, in accordance with subsection
(b)(7), shall document amounts expended for purposes of
carrying out this subsection, including amounts appropriated
under the heading `Public Health and Social Services
Emergency Fund' under the heading `Office of the Secretary'
under title II of division H of the Consolidated
Appropriations Act, 2018 (Public Law 115-141) and allocated
to carrying out section 319L(c)(4)(F).''.
SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM.
Section 351A(k) (42 U.S.C. 262a(k)) is amended--
(1) by striking ``The Secretary'' and inserting the
following:
``(1) In general.--The Secretary''; and
(2) by adding at the end the following:
``(2) Implementation of recommendations of the federal
experts security advisory panel and the fast track action
committee on select agent regulations.--
``(A) In general.--Not later than 1 year after the date of
the enactment of the Pandemic and All-Hazards Preparedness
and Advancing Innovation Act of 2019, 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 postdeployment
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--
[[Page H250]]
``(A) the process by which an applicant may submit a
request for a regulatory management plan;
``(B) the timeframe by which the Secretary is required to
respond to such request;
``(C) the information required for the submission of such
request;
``(D) a description of the types of development milestones
and performance targets that could be discussed and included
in such plans; and
``(E) contact information for beginning the regulatory
management plan process.'';
(3) in paragraph (6), as so redesignated, in the matter
preceding subparagraph (A)--
(A) by striking ``paragraph (4)(A)'' and inserting
``paragraph (5)(A)''; and
(B) by striking ``paragraph (4)(B)'' and inserting
``paragraph (5)(B)''; and
(4) in paragraph (7)(A), as so redesignated, by striking
``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''.
SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY AND THE BIOSHIELD SPECIAL RESERVE
FUND.
(a) BioShield Special Reserve Fund.--Section 319F-2(g)(1)
(42 U.S.C. 247d-6b(g)(1)) is amended--
(1) by striking ``$2,800,000,000 for the period of fiscal
years 2014 through 2018'' and inserting ``$7,100,000,000 for
the period of fiscal years 2019 through 2028, to remain
available until expended''; and
(2) by striking the second sentence.
(b) The Biomedical Advanced Research and Development
Authority.--Section 319L(d)(2) (42 U.S.C. 247d-7e(d)(2)) is
amended by striking ``$415,000,000 for each of fiscal years
2014 through 2018'' and inserting ``$611,700,000 for each of
fiscal years 2019 through 2023''.
SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTIBIOTIC
RESISTANCE.
(a) Advisory Council.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
may continue the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria, referred to in this section as
the ``Advisory Council''.
(b) Duties.--The Advisory Council shall advise and provide
information and recommendations to the Secretary regarding
programs and policies intended to reduce or combat
antibiotic-resistant bacteria that may present a public
health threat and improve capabilities to prevent, diagnose,
mitigate, or treat such resistance. Such advice, information,
and recommendations may be related to improving--
(1) the effectiveness of antibiotics;
(2) research and advanced research on, and the development
of, improved and innovative methods for combating or reducing
antibiotic resistance, including new treatments, rapid point-
of-care diagnostics, alternatives to antibiotics, including
alternatives to animal antibiotics, and antimicrobial
stewardship activities;
(3) surveillance of antibiotic-resistant bacterial
infections, including publicly available and up-to-date
information on resistance to antibiotics;
(4) education for health care providers and the public with
respect to up-to-date information on antibiotic resistance
and ways to reduce or combat such resistance to antibiotics
related to humans and animals;
(5) methods to prevent or reduce the transmission of
antibiotic-resistant bacterial infections, including
stewardship programs; and
(6) coordination with respect to international efforts in
order to inform and advance United States capabilities to
combat antibiotic resistance.
(c) Meetings and Coordination.--
(1) Meetings.--The Advisory Council shall meet not less
than biannually and, to the extent practicable, in
coordination with meetings of the Antimicrobial Resistance
Task Force established in section 319E(a) of the Public
Health Service Act.
(2) Coordination.--The Advisory Council shall, to the
greatest extent practicable, coordinate activities carried
out by the Council with the Antimicrobial Resistance Task
Force established under section 319E(a) of the Public Health
Service Act (42 U.S.C. 247d-5(a)).
(d) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall apply to the activities and duties of the
Advisory Council.
(e) Extension of Advisory Council.--Not later than October
1, 2022, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a recommendation on whether the Advisory
Council should be extended, and in addition, identify whether
there are other committees, councils, or task forces that
have overlapping or similar duties to that of the Advisory
Council, and whether such committees, councils, or task
forces should be combined, including with respect to section
319E(a) of the Public Health Service Act (42 U.S.C. 247d-
5(a)).
TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES
SEC. 601. ADMINISTRATION OF COUNTERMEASURES.
Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d-
7e(c)(4)(D)(iii)) is amended by striking ``and platform
technologies'' and inserting ``platform technologies,
technologies to administer countermeasures, and technologies
to improve storage and transportation of countermeasures''.
SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS.
Section 319L (42 U.S.C. 247d-7e) is amended--
(1) in subsection (a)(3), by striking ``, such as'' and all
that follows through ``Code''; and
(2) in subsection (c)(5)(A)--
(A) in clause (i), by striking ``under this subsection''
and all that follows through ``Code'' and inserting ``(as
defined in subsection (a)(3)) under this subsection''; and
(B) in clause (ii)--
(i) by amending subclause (I) to read as follows:
``(I) In general.--To the maximum extent practicable,
competitive procedures shall be used when entering into
transactions to carry out projects under this subsection.'';
and
(ii) in subclause (II)--
(I) by striking ``$20,000,000'' and inserting
``$100,000,000'';
(II) by striking ``senior procurement executive for the
Department (as designated for purpose of section 16(c) of the
Office of Federal Procurement Policy Act (41 U.S.C.
414(c)))'' and inserting ``Assistant Secretary for Financial
Resources''; and
(III) by striking ``senior procurement executive under''
and inserting ``Assistant Secretary for Financial Resources
under''.
SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES.
(a) In General.--The purpose of this section (including
section 565B of the Federal Food, Drug, and Cosmetic Act, as
added by subsection (b)) is to support and advance the
development or manufacture of security countermeasures,
qualified countermeasures, and qualified pandemic or epidemic
products by facilitating and encouraging submission of data
and information to support the development of such products,
and through clarifying the authority to cross-reference to
data and information previously submitted to the Secretary of
Health and Human Services (referred to in this section as the
``Secretary''), including data and information submitted to
medical countermeasure master files or other master files.
(b) Medical Countermeasure Master Files.--Chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.)
is amended by inserting after section 565A the following:
``SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES.
``(a) Applicability of Reference.--
``(1) In general.--A person may submit data and information
in a master file to the Secretary with the intent to
reference, or to authorize, in writing, another person to
reference, such data or information to support a medical
countermeasure submission (including a supplement or
amendment to any such submission), without requiring the
master file holder to disclose the data and information to
any such persons authorized to reference the master file.
Such data and information shall be available for reference by
the master file holder or by a person authorized by the
master file holder, in accordance with applicable privacy and
confidentiality protocols and regulations.
``(2) Reference of certain master files.--In the case that
data or information within a medical countermeasure master
file is used only to support the conditional approval of an
application filed under section 571, such master file may be
relied upon to support the effectiveness of a product that is
the subject of a subsequent medical countermeasure submission
only if such application is supplemented by additional data
or information to support review and approval in a manner
consistent with the standards applicable to such review and
approval for such countermeasure, qualified countermeasure,
or qualified pandemic or epidemic product.
``(b) Medical Countermeasure Master File Content.--
``(1) In general.--A master file under this section may
include data or information to support--
``(A) the development of medical countermeasure submissions
to support the approval, licensure, classification,
clearance, conditional approval, or authorization of one or
more security countermeasures, qualified countermeasures, or
qualified pandemic or epidemic products; and
``(B) the manufacture of security countermeasures,
qualified countermeasures, or qualified pandemic or epidemic
products.
``(2) Required updates.--The Secretary may require, as
appropriate, that the master file holder ensure that the
contents of such master file are updated during the time such
master file is referenced for a medical countermeasure
submission.
``(c) Sponsor Reference.--
``(1) In general.--Each incorporation of data or
information within a medical countermeasure master file shall
describe the incorporated material in a manner in which the
Secretary determines appropriate and that permits the review
of such information within such master file without
necessitating resubmission 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
[[Page H251]]
review may, where the Secretary determines appropriate,
incorporate by reference all or part of the contents of a
medical countermeasure master file, if the master file holder
authorizes the incorporation in writing.
``(d) Acknowledgment of and Reliance Upon a Master File by
the Secretary.--
``(1) In general.--The Secretary shall provide the master
file holder with a written notification indicating that the
Secretary has reviewed and relied upon specified data or
information within a master file and the purposes for which
such data or information was incorporated by reference if the
Secretary has reviewed and relied upon such specified data or
information to support the approval, classification,
conditional approval, clearance, licensure, or authorization
of a security countermeasure, qualified countermeasure, or
qualified pandemic or epidemic product. The Secretary may
rely upon the data and information within the medical
countermeasure master file for which such written
notification was provided in additional applications, as
applicable and appropriate and upon the request of the master
file holder so notified in writing or by an authorized person
of such holder.
``(2) Certain applications.--If the Secretary has reviewed
and relied upon specified data or information within a
medical countermeasure master file to support the conditional
approval of an application under section 571 to subsequently
support the approval, clearance, licensure, or authorization
of a security countermeasure, qualified countermeasure, or
qualified pandemic or epidemic product, the Secretary shall
provide a brief written description to the master file holder
regarding the elements of the application fulfilled by the
data or information within the master file and how such data
or information contained in such application meets the
standards of evidence under subsection (c) or (d) of section
505, subsection (d) of section 512, or section 351 of the
Public Health Service Act (as applicable), which shall not
include any trade secret or confidential commercial
information.
``(e) Rules of Construction.--Nothing in this section shall
be construed to--
``(1) limit the authority of the Secretary to approve,
license, clear, conditionally approve, or authorize drugs,
biological products, or devices pursuant to, as applicable,
this Act or section 351 of the Public Health Service Act (as
such applicable Act is in effect on the day before the date
of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019), 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)
[[Page H252]]
to support and expedite the research and development of
medical countermeasures, as applicable.
(d) Protection of National Security.--The Comptroller
General of the United States shall conduct the study and
issue the assessment and report under this section in a
manner that does not compromise national security.
SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING
TECHNOLOGIES AND THEIR POTENTIAL ROLE IN
NATIONAL SECURITY.
(a) Meeting.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall convene a meeting to discuss the potential role
advancements in genomic engineering technologies (including
genome editing technologies) may have in advancing national
health security. Such meeting shall be held in a manner that
does not compromise national security.
(2) Attendees.--The attendees of the meeting under
paragraph (1)--
(A) shall include--
(i) representatives from the Office of the Assistant
Secretary for Preparedness and Response, the National
Institutes of Health, the Centers for Disease Control and
Prevention, and the Food and Drug Administration; and
(ii) representatives from academic, private, and nonprofit
entities with expertise in genome engineering technologies,
biopharmaceuticals, medicine, or biodefense, and other
relevant stakeholders; and
(B) may include--
(i) other representatives from the Department of Health and
Human Services, as the Secretary determines appropriate; and
(ii) representatives from the Department of Homeland
Security, the Department of Defense, the Department of
Agriculture, and other departments, as the Secretary may
request for the meeting.
(3) Topics.--The meeting under paragraph (1) shall include
a discussion of--
(A) the current state of the science of genomic engineering
technologies related to national health security, including--
(i) medical countermeasure development, including potential
efficiencies in the development pathway and detection
technologies; and
(ii) the international and domestic regulation of products
utilizing genome editing technologies; and
(B) national security implications, including--
(i) capabilities of the United States to leverage genomic
engineering technologies as a part of the medical
countermeasure enterprise, including current applicable
research, development, and application efforts underway
within the Department of Defense;
(ii) the potential for state and non-state actors to
utilize genomic engineering technologies as a national health
security threat; and
(iii) security measures to monitor and assess the potential
threat that may result from utilization of genomic
engineering technologies and related technologies for the
purpose of compromising national health security.
(b) Report.--Not later than 270 days after the meeting
described in subsection (a) is held, the Assistant Secretary
for Preparedness and Response shall issue a report to the
congressional committees of jurisdiction on the topics
discussed at such meeting, and provide recommendations, as
applicable, to utilize innovations in genomic engineering
(including genome editing) and related technologies as a part
of preparedness and response activities to advance national
health security. Such report shall be issued in a manner that
does not compromise national security.
SEC. 606. REPORT ON VACCINES DEVELOPMENT.
Not later than one year after the date of the enactment of
this Act, the Secretary of Health and Human Services shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report describing
efforts and activities to coordinate with other countries and
international partners during recent public health
emergencies with respect to the research and advanced
research on, and development of, qualified pandemic or
epidemic products (as defined in section 319F-3 of the Public
Health Service Act (42 U.S.C. 247d-6d)). Such report may
include information regarding relevant work carried out under
section 319L(c)(5)(E) of the Public Health Service Act (42
U.S.C. 247d-7e(c)(5)(E)), through public-private
partnerships, and through collaborations with other countries
to assist with or expedite the research and development of
qualified pandemic or epidemic products. Such report shall
not include information that may compromise national
security.
SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND
HEALTH.
(a) Reauthorization of Mosquito Abatement for Safety and
Health Program.--Section 317S (42 U.S.C. 247b-21) is
amended--
(1) in subsection (a)(1)(B)--
(A) by inserting ``including programs to address emerging
infectious mosquito-borne diseases,'' after ``subdivisions
for control programs,''; and
(B) by inserting ``or improving existing control programs''
before the period at the end;
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``, including
improvement,'' after ``operation'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in clause (ii), by striking ``or'' at the end;
(II) in clause (iii), by striking the semicolon at the end
and inserting ``, including an emerging infectious mosquito-
borne disease that presents a serious public health threat;
or''; and
(III) by adding at the end the following:
``(iv) a public health emergency due to the incidence or
prevalence of a mosquito-borne disease that presents a
serious public health threat;''; and
(ii) by amending subparagraph (D) to read as follows:
``(D)(i) is located in a State that has received a grant
under subsection (a); or
``(ii) that demonstrates to the Secretary that the control
program is consistent with existing State mosquito control
plans or policies, or other applicable State preparedness
plans.'';
(C) in paragraph (4)(C), by striking ``that extraordinary''
and all that follows through the period at the end and
inserting the following: ``that--
``(i) extraordinary economic conditions in the political
subdivision or consortium of political subdivisions involved
justify the waiver; or
``(ii) the geographical area covered by a political
subdivision or consortium for a grant under paragraph (1) has
an extreme mosquito control need due to--
``(I) the size or density of the potentially impacted human
population;
``(II) the size or density of a mosquito population that
requires heightened control; or
``(III) the severity of the mosquito-borne disease, such
that expected serious adverse health outcomes for the human
population justify the waiver.''; and
(D) by amending paragraph (6) to read as follows:
``(6) Number of grants.--A political subdivision or a
consortium of political subdivisions may not receive more
than one grant under paragraph (1).''; and
(3) in subsection (f)--
(A) in paragraph (1) by striking ``for fiscal year 2003,
and such sums as may be necessary for each of fiscal years
2004 through 2007'' and inserting ``for each of fiscal years
2019 through 2023'';
(B) in paragraph (2), by striking ``the Public Health
Security and Bioterrorism Preparedness and Response Act of
2002'' and inserting ``this Act and other medical and public
health preparedness and response laws''; and
(C) in paragraph (3)--
(i) in the paragraph heading, by striking ``2004'' and
inserting ``2019''; and
(ii) by striking ``2004,'' and inserting ``2019,''.
(b) Epidemiology-Laboratory Capacity Grants.--Section 2821
(42 U.S.C. 300hh-31) is amended--
(1) in subsection (a)(1), by inserting ``, including
mosquito and other vector-borne diseases,'' after
``infectious diseases''; and
(2) in subsection (b), by striking ``2010 through 2013''
and inserting ``2019 through 2023''.
TITLE VII--MISCELLANEOUS PROVISIONS
SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.
(a) Veterans Affairs.--Section 8117(g) of title 38, United
States Code, is amended by striking ``2014 through 2018'' and
inserting ``2019 through 2023''.
(b) Vaccine Tracking and Distribution.--Section 319A(e) (42
U.S.C. 247d-1(e)) is amended by striking ``2014 through
2018'' and inserting ``2019 through 2023''.
(c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C.
247d(e)(8)) is amended by striking ``2018'' and inserting
``2023''.
(d) Strategic Innovation Partner.--Section
319L(c)(4)(E)(ix) (42 U.S.C. 247d-7e(c)(4)(E)(ix)) is amended
by striking ``2022'' and inserting ``2023''.
(e) Limited Antitrust Exemption.--
(1) In general.--Section 405 of the Pandemic and All-
Hazards Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-
6a note) is amended--
(A) in subsection (a)(1)(A)--
(i) by striking ``Secretary of Health and Human Services
(referred to in this subsection as the `Secretary')'' and
inserting ``Secretary'';
(ii) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6b)) (as amended by this Act'';
(iii) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6a)) (as amended by this Act''; and
(iv) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6d)'';
(B) in subsection (b), by striking ``12-year'' and
inserting ``17-year'';
(C) by redesignating such section 405 as section 319L-1;
and
(D) by transferring such section 319L-1, as redesignated,
to the Public Health Service Act (42 U.S.C. 201 et seq.), to
appear after section 319L of such Act (42 U.S.C. 247d-7e).
(2) Conforming amendment.--The table of contents in section
1(b) of the Pandemic and All-Hazards Preparedness Act (Public
Law 109-417) is amended by striking the item related to
section 405.
(f) Inapplicability of Certain Provisions.--Subsection
(e)(1) of section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
(1) by amending subparagraph (A) to read as follows:
[[Page H253]]
``(A) Nondisclosure of information.--
``(i) In general.--Information described in clause (ii)
shall be deemed to be information described in section
552(b)(3) of title 5, United States Code.
``(ii) Information described.--The information described in
this clause is information relevant to programs of the
Department of Health and Human Services that could compromise
national security and reveal significant and not otherwise
publicly known vulnerabilities of existing medical or public
health defenses against chemical, biological, radiological,
or nuclear threats, and is comprised of--
``(I) specific technical data or scientific information
that is created or obtained during the countermeasure and
product advanced research and development carried out under
subsection (c);
``(II) information pertaining to the location security,
personnel, and research materials and methods of high-
containment laboratories conducting research with select
agents, toxins, or other agents with a material threat
determination under section 319F-2(c)(2); or
``(III) security and vulnerability assessments.'';
(2) by redesignating subparagraph (C) as subparagraph (D);
(3) by inserting after subparagraph (B) the following:
``(C) Reporting.--One year after the date of enactment of
the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2019, and annually thereafter, the
Secretary shall report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives on the number of
instances in which the Secretary has used the authority under
this subsection to withhold information from disclosure, as
well as the nature of any request under section 552 of title
5, United States Code that was denied using such
authority.''; and
(4) in subparagraph (D), as so redesignated, by striking
``12'' and inserting ``17''.
SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE.
Subsection (d) of section 319F-2 (42 U.S.C. 247d-6b) is
amended to read as follows:
``(d) Disclosures.--No Federal agency may disclose under
section 552 of title 5, United States Code any information
identifying the location at which materials in the stockpile
described in subsection (a) are stored, or other information
regarding the contents or deployment capability of the
stockpile that could compromise national security.''.
SEC. 703. CYBERSECURITY.
(a) Strategy for Public Health Preparedness and Response to
Cybersecurity Threats.--
(1) Strategy.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall prepare and submit to the relevant committees of
Congress a strategy for public health preparedness and
response to address cybersecurity threats (as defined in
section 102 of Cybersecurity Information Sharing Act of 2015
(6 U.S.C. 1501)) that present a threat to national health
security. Such strategy shall include--
(A) identifying the duties, functions, and preparedness
goals for which the Secretary is responsible in order to
prepare for and respond to such cybersecurity threats,
including metrics by which to measure success in meeting
preparedness goals;
(B) identifying gaps in public health capabilities to
achieve such preparedness goals; and
(C) strategies to address identified gaps and strengthen
public health emergency preparedness and response
capabilities to address such cybersecurity threats.
(2) Protection of national security.--The Secretary shall
make such strategy available to the Committee on Health,
Education, Labor, and Pensions of the Senate, the Committee
on Energy and Commerce of the House of Representatives, and
other congressional committees of jurisdiction, in a manner
that does not compromise national security.
(b) Coordination of Preparedness for and Response to All-
Hazards Public Health Emergencies.--Subparagraph (D) of
section 2811(b)(4) (42 U.S.C. 300hh-10(b)(4)) is amended to
read as follows:
``(D) Policy coordination and strategic direction.--Provide
integrated policy coordination and strategic direction,
before, during, and following public health emergencies, with
respect to all matters related to Federal public health and
medical preparedness and execution and deployment of the
Federal response for public health emergencies and incidents
covered by the National Response Plan described in section
504(a)(6) of the Homeland Security Act of 2002 (6 U.S.C.
314(a)(6)), or any successor plan; and such Federal responses
covered by the National Cybersecurity Incident Response Plan
developed under section 228(c) of the Homeland Security Act
of 2002 (6 U.S.C. 149(c)), including public health
emergencies or incidents related to cybersecurity threats
that present a threat to national health security.''.
SEC. 704. STRATEGY AND REPORT.
Not later than 14 days after the date of the enactment of
this Act, the Secretary of Health and Human Services, in
coordination with the Assistant Secretary for Preparedness
and Response and the Assistant Secretary for the
Administration on Children and Families or other appropriate
office, and in collaboration with other departments, as
appropriate, shall submit to the Committee on Energy and
Commerce of the House of Representatives, the Committee on
Health, Education, Labor, and Pensions of the Senate, and
other relevant congressional committees--
(1) a formal strategy, including interdepartmental actions
and efforts to reunify children with their parents or
guardians, in all cases in which such children have been
separated from their parents or guardians as a result of the
initiative announced on April 6, 2018, and due to prosecution
under section 275(a) of the Immigration and Nationality Act
(8 U.S.C. 1325(a)), if the parent or guardian chooses such
reunification and the child--
(A) was separated from a parent or guardian and placed into
a facility funded by the Department of Health and Human
Services;
(B) as of the date of the enactment of this Act, remains in
the care of the Department of Health and Human Services; and
(C) can be safely reunited with such parent or guardian;
and
(2) a report on challenges and deficiencies related to the
oversight of, and care for, unaccompanied alien children and
appropriately reuniting such children with their parents or
guardians, and the actions taken to address any challenges
and deficiencies related to unaccompanied alien children in
the custody of the Department of Health and Human Services,
including deficiencies identified and publicly reported by
Congress, the Government Accountability Office, or the
inspectors general of the Department of Health and Human
Services or other Federal departments.
SEC. 705. TECHNICAL AMENDMENTS.
(a) Public Health Service Act.--Title III (42 U.S.C. 241 et
seq.) is amended--
(1) in paragraphs (1) and (5) of section 319F-1(a) (42
U.S.C. 247d-6a(a)), by striking ``section 319F(h)'' each
place such term appears and inserting ``section 319F(e)'';
and
(2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking
``section 319F(h)(4)'' and inserting ``section 319F(e)(4)''.
(b) Public Health Security Grants.--Section 319C-1(b)(2)
(42 U.S.C. 247d-3a(b)(2)) is amended--
(1) in subparagraph (C), by striking ``individuals,,'' and
inserting ``individuals,''; and
(2) in subparagraph (F), by striking ``make satisfactory
annual improvement and describe'' and inserting ``makes
satisfactory annual improvement and describes''.
(c) Emergency Use Instructions.--Subparagraph (A) of
section 564A(e)(2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-3a(e)(2)) is amended by striking
``subsection (a)(1)(C)(i)'' and inserting ``subsection
(a)(1)(C)''.
(d) Products Held for Emergency Use.--Section 564B(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
3b) is amended--
(1) in subparagraph (B), by inserting a comma after
``505''; and
(2) in subparagraph (C), by inserting ``or section 564A''
before the period at the end.
(e) Transparency.--Section 507(c)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) is amended--
(1) by striking ``Nothing in'' and inserting the following:
``(A) In general.--Nothing in'';
(2) by inserting ``or directing'' after ``authorizing'';
(3) by striking ``disclose any'' and inserting ``disclose--
``(i) any'';
(4) by striking the period and inserting ``; or''; and
(5) by adding at the end the following:
``(ii) in the case of a drug development tool that may be
used to support the development of a qualified
countermeasure, security countermeasure, or qualified
pandemic or epidemic product, as defined in sections 319F-1,
319F-2, and 319F-3, respectively, of the Public Health
Service Act, any information that the Secretary determines
has a significant potential to affect national security.
``(B) Public acknowledgment.--In the case that the
Secretary, pursuant to subparagraph (A)(ii), does not make
information publicly available, the Secretary shall provide
on the internet website of the Food and Drug Administration
an acknowledgment of the information that has not been
disclosed, pursuant to subparagraph (A)(ii).''.
DIVISION B--OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM
SEC. 1000. SHORT TITLE; REFERENCES IN DIVISION.
(a) Short Title.--This division may be cited as the ``Over-
the-Counter Monograph Safety, Innovation, and Reform Act of
2019''.
(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:
[[Page H254]]
``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT
ARE MARKETED WITHOUT AN APPROVED DRUG
APPLICATION.
``(a) Nonprescription Drugs Marketed Without an Approved
Application.--Nonprescription drugs marketed without an
approved drug application under section 505, as of the date
of the enactment of this section, shall be treated in
accordance with this subsection.
``(1) Drugs subject to a final monograph; category i drugs
subject to a tentative final monograph.--A drug is deemed to
be generally recognized as safe and effective under section
201(p)(1), not a new drug under section 201(p), and not
subject to section 503(b)(1), if--
``(A) the drug is--
``(i) in conformity with the requirements for
nonprescription use of a final monograph issued under part
330 of title 21, Code of Federal Regulations (except as
provided in paragraph (2)), the general requirements for
nonprescription drugs, and conditions or requirements under
subsections (b), (c), and (k); and
``(ii) except as permitted by an order issued under
subsection (b) or, in the case of a minor change in the drug,
in conformity with an order issued under subsection (c), in a
dosage form that, immediately prior to the date of the
enactment of this section, has been used to a material extent
and for a material time under section 201(p)(2); or
``(B) the drug is--
``(i) classified in category I for safety and effectiveness
under a tentative final monograph that is the most recently
applicable proposal or determination issued under part 330 of
title 21, Code of Federal Regulations;
``(ii) in conformity with the proposed requirements for
nonprescription use of such tentative final monograph, any
applicable subsequent determination by the Secretary, the
general requirements for nonprescription drugs, and
conditions or requirements under subsections (b), (c), and
(k); and
``(iii) except as permitted by an order issued under
subsection (b) or, in the case of a minor change in the drug,
in conformity with an order issued under subsection (c), in a
dosage form that, immediately prior to the date of the
enactment of this section, has been used to a material extent
and for a material time under section 201(p)(2).
``(2) Treatment of sunscreen drugs.--With respect to
sunscreen drugs subject to this section, the applicable
requirements in terms of conformity with a final monograph,
for purposes of paragraph (1)(A)(i), shall be the
requirements specified in part 352 of title 21, Code of
Federal Regulations, as published on May 21, 1999, beginning
on page 27687 of volume 64 of the Federal Register, except
that the applicable requirements governing effectiveness and
labeling shall be those specified in section 201.327 of title
21, Code of Federal Regulations.
``(3) Category iii drugs subject to a tentative final
monograph; category i drugs subject to proposed monograph or
advance notice of proposed rulemaking.--A drug that is not
described in paragraph (1), (2), or (4) is not required to be
the subject of an application approved under section 505, and
is not subject to section 503(b)(1), if--
``(A) the drug is--
``(i) classified in category III for safety or
effectiveness in the preamble of a proposed rule establishing
a tentative final monograph that is the most recently
applicable proposal or determination for such drug issued
under part 330 of title 21, Code of Federal Regulations;
``(ii) in conformity with--
``(I) the conditions of use, including indication and
dosage strength, if any, described for such category III drug
in such preamble or in an applicable subsequent proposed
rule;
``(II) the proposed requirements for drugs classified in
such tentative final monograph in category I in the most
recently proposed rule establishing requirements related to
such tentative final monograph and in any final rule
establishing requirements that are applicable to the drug;
and
``(III) the general requirements for nonprescription drugs
and conditions or requirements under subsection (b) or (k);
and
``(iii) in a dosage form that, immediately prior to the
date of the enactment of this section, had been used to a
material extent and for a material time under section
201(p)(2); or
``(B) the drug is--
``(i) classified in category I for safety and effectiveness
under a proposed monograph or advance notice of proposed
rulemaking that is the most recently applicable proposal or
determination for such drug issued under part 330 of title
21, Code of Federal Regulations;
``(ii) in conformity with the requirements for
nonprescription use of such proposed monograph or advance
notice of proposed rulemaking, any applicable subsequent
determination by the Secretary, the general requirements for
nonprescription drugs, and conditions or requirements under
subsection (b) or (k); and
``(iii) in a dosage form that, immediately prior to the
date of the enactment of this section, has been used to a
material extent and for a material time under section
201(p)(2).
``(4) Category ii drugs deemed new drugs.--A drug that is
classified in category II for safety or effectiveness under a
tentative final monograph or that is subject to a
determination to be not generally recognized as safe and
effective in a proposed rule that is the most recently
applicable proposal issued under part 330 of title 21, Code
of Federal Regulations, shall be deemed to be a new drug
under section 201(p), misbranded under section 502(ee), and
subject to the requirement for an approved new drug
application under section 505 beginning on the day that is
180 calendar days after the date of the enactment of this
section, unless, before such day, the Secretary determines
that it is in the interest of public health to extend the
period during which the drug may be marketed without such an
approved new drug application.
``(5) Drugs not grase deemed new drugs.--A drug that the
Secretary has determined not to be generally recognized as
safe and effective under section 201(p)(1) under a final
determination issued under part 330 of title 21, Code of
Federal Regulations, shall be deemed to be a new drug under
section 201(p), misbranded under section 502(ee), and subject
to the requirement for an approved new drug application under
section 505.
``(6) Other drugs deemed new drugs.--Except as provided in
subsection (m), a drug is deemed to be a new drug under
section 201(p) and misbranded under section 502(ee) if the
drug--
``(A) is not subject to section 503(b)(1); and
``(B) is not described in paragraph (1), (2), (3), (4), or
(5), or subsection (b)(1)(B).
``(b) Administrative Orders.--
``(1) In general.--
``(A) Determination.--The Secretary may, on the initiative
of the Secretary or at the request of one or more requestors,
issue an administrative order determining whether there are
conditions under which a specific drug, a class of drugs, or
a combination of drugs, is determined to be--
``(i) not subject to section 503(b)(1); and
``(ii) generally recognized as safe and effective under
section 201(p)(1).
``(B) Effect.--A drug or combination of drugs shall be
deemed to not require approval under section 505 if such drug
or combination of drugs--
``(i) is determined by the Secretary to meet the conditions
specified in clauses (i) and (ii) of subparagraph (A);
``(ii) is marketed in conformity with an administrative
order under this subsection;
``(iii) meets the general requirements for nonprescription
drugs; and
``(iv) meets the requirements under subsections (c) and
(k).
``(C) Standard.--The Secretary shall find that a drug is
not generally recognized as safe and effective under section
201(p)(1) if--
``(i) the evidence shows that the drug is not generally
recognized as safe and effective under section 201(p)(1); or
``(ii) the evidence is inadequate to show that the drug is
generally recognized as safe and effective under section
201(p)(1).
``(2) Administrative orders initiated by the secretary.--
``(A) In general.--In issuing an administrative order under
paragraph (1) upon the Secretary's initiative, the Secretary
shall--
``(i) make reasonable efforts to notify informally, not
later than 2 business days before the issuance of the
proposed order, the sponsors of drugs who have a listing in
effect under section 510(j) for the drugs or combination of
drugs that will be subject to the administrative order;
``(ii) after any such reasonable efforts of notification--
``(I) issue a proposed administrative order by publishing
it on the website of the Food and Drug Administration and
include in such order the reasons for the issuance of such
order; and
``(II) publish a notice of availability of such proposed
order in the Federal Register;
``(iii) except as provided in subparagraph (B), provide for
a public comment period with respect to such proposed order
of not less than 45 calendar days; and
``(iv) if, after completion of the proceedings specified in
clauses (i) through (iii), the Secretary determines that it
is appropriate to issue a final administrative order--
``(I) issue the final administrative order, together with a
detailed statement of reasons, which order shall not take
effect until the time for requesting judicial review under
paragraph (3)(D)(ii) has expired;
``(II) publish a notice of such final administrative order
in the Federal Register;
``(III) afford requestors of drugs that will be subject to
such order the opportunity for formal dispute resolution up
to the level of the Director of the Center for Drug
Evaluation and Research, which initially must be requested
within 45 calendar days of the issuance of the order, and,
for subsequent levels of appeal, within 30 calendar days of
the prior decision; and
``(IV) except with respect to drugs described in paragraph
(3)(B), upon completion of the formal dispute resolution
procedure, inform the persons which sought such dispute
resolution of their right to request a hearing.
``(B) Exceptions.--When issuing an administrative order
under paragraph (1) on the Secretary's initiative proposing
to determine that a drug described in subsection (a)(3) is
not generally recognized as safe and effective under section
201(p)(1), the Secretary shall follow the procedures in
subparagraph (A), except that--
``(i) the proposed order shall include notice of--
``(I) the general categories of data the Secretary has
determined necessary to establish that the drug is generally
recognized as safe and effective under section 201(p)(1); and
[[Page H255]]
``(II) the format for submissions by interested persons;
``(ii) the Secretary shall provide for a public comment
period of no less than 180 calendar days with respect to such
proposed order, except when the Secretary determines, for
good cause, that a shorter period is in the interest of
public health; and
``(iii) any person who submits data in such comment period
shall include a certification that the person has submitted
all evidence created, obtained, or received by that person
that is both within the categories of data identified in the
proposed order and relevant to a determination as to whether
the drug is generally recognized as safe and effective under
section 201(p)(1).
``(3) Hearings; judicial review.--
``(A) In general.--Only a person who participated in each
stage of formal dispute resolution under subclause (III) of
paragraph (2)(A)(iv) of an administrative order with respect
to a drug may request a hearing concerning a final
administrative order issued under such paragraph with respect
to such drug. If a hearing is sought, such person must submit
a request for a hearing, which shall be based solely on
information in the administrative record, to the Secretary
not later than 30 calendar days after receiving notice of the
final decision of the formal dispute resolution procedure.
``(B) No hearing required with respect to orders relating
to certain drugs.--
``(i) In general.--The Secretary shall not be required to
provide notice and an opportunity for a hearing pursuant to
paragraph (2)(A)(iv) if the final administrative order
involved relates to a drug--
``(I) that is described in subsection (a)(3)(A); and
``(II) with respect to which no human or non-human data
studies relevant to the safety or effectiveness of such drug
have been submitted to the administrative record since the
issuance of the most recent tentative final monograph
relating to such drug.
``(ii) Human data studies and non-human data defined.--In
this subparagraph:
``(I) The term `human data studies' means clinical trials
of safety or effectiveness (including actual use studies),
pharmacokinetics studies, or bioavailability studies.
``(II) The term `non-human data' means data from testing
other than with human subjects which provides information
concerning safety or effectiveness.
``(C) Hearing procedures.--
``(i) Denial of request for hearing.--If the Secretary
determines that information submitted in a request for a
hearing under subparagraph (A) with respect to a final
administrative order issued under paragraph (2)(A)(iv) does
not identify the existence of a genuine and substantial
question of material fact, the Secretary may deny such
request. In making such a determination, the Secretary may
consider only information and data that are based on relevant
and reliable scientific principles and methodologies.
``(ii) Single hearing for multiple related requests.--If
more than one request for a hearing is submitted with respect
to the same administrative order under subparagraph (A), the
Secretary may direct that a single hearing be conducted in
which all persons whose hearing requests were granted may
participate.
``(iii) Presiding officer.--The presiding officer of a
hearing requested under subparagraph (A) shall--
``(I) be designated by the Secretary;
``(II) not be an employee of the Center for Drug Evaluation
and Research; and
``(III) not have been previously involved in the
development of the administrative order involved or
proceedings relating to that administrative order.
``(iv) Rights of parties to hearing.--The parties to a
hearing requested under subparagraph (A) shall have the right
to present testimony, including testimony of expert
witnesses, and to cross-examine witnesses presented by other
parties. Where appropriate, the presiding officer may require
that cross-examination by parties representing substantially
the same interests be consolidated to promote efficiency and
avoid duplication.
``(v) Final decision.--
``(I) At the conclusion of a hearing requested under
subparagraph (A), the presiding officer of the hearing shall
issue a decision containing findings of fact and conclusions
of law. The decision of the presiding officer shall be final.
``(II) The final decision may not take effect until the
period under subparagraph (D)(ii) for submitting a request
for judicial review of such decision expires.
``(D) Judicial review of final administrative order.--
``(i) In general.--The procedures described in section
505(h) shall apply with respect to judicial review of final
administrative orders issued under this subsection in the
same manner and to the same extent as such section applies to
an order described in such section except that the judicial
review shall be taken by filing in an appropriate district
court of the United States in lieu of the appellate courts
specified in such section.
``(ii) Period to submit a request for judicial review.--A
person eligible to request a hearing under this paragraph and
seeking judicial review of a final administrative order
issued under this subsection shall file such request for
judicial review not later than 60 calendar days after the
latest of--
``(I) the date on which notice of such order is published;
``(II) the date on which a hearing with respect to such
order is denied under subparagraph (B) or (C)(i);
``(III) the date on which a final decision is made
following a hearing under subparagraph (C)(v); or
``(IV) if no hearing is requested, the date on which the
time for requesting a hearing expires.
``(4) Expedited procedure with respect to administrative
orders initiated by the secretary.--
``(A) Imminent hazard to the public health.--
``(i) In general.--In the case of a determination by the
Secretary that a drug, class of drugs, or combination of
drugs subject to this section poses an imminent hazard to the
public health, the Secretary, after first making reasonable
efforts to notify, not later than 48 hours before issuance of
such order under this subparagraph, sponsors who have a
listing in effect under section 510(j) for such drug or
combination of drugs--
``(I) may issue an interim final administrative order for
such drug, class of drugs, or combination of drugs under
paragraph (1), together with a detailed statement of the
reasons for such order;
``(II) shall publish in the Federal Register a notice of
availability of any such order; and
``(III) shall provide for a public comment period of at
least 45 calendar days with respect to such interim final
order.
``(ii) Nondelegation.--The Secretary may not delegate the
authority to issue an interim final administrative order
under this subparagraph.
``(B) Safety labeling changes.--
``(i) In general.--In the case of a determination by the
Secretary that a change in the labeling of a drug, class of
drugs, or combination of drugs subject to this section is
reasonably expected to mitigate a significant or unreasonable
risk of a serious adverse event associated with use of the
drug, the Secretary may--
``(I) make reasonable efforts to notify informally, not
later than 48 hours before the issuance of the interim final
order, the sponsors of drugs who have a listing in effect
under section 510(j) for such drug or combination of drugs;
``(II) after reasonable efforts of notification, issue an
interim final administrative order in accordance with
paragraph (1) to require such change, together with a
detailed statement of the reasons for such order;
``(III) publish in the Federal Register a notice of
availability of such order; and
``(IV) provide for a public comment period of at least 45
calendar days with respect to such interim final order.
``(ii) Content of order.--An interim final order issued
under this subparagraph with respect to the labeling of a
drug may provide for new warnings and other information
required for safe use of the drug.
``(C) Effective date.--An order under subparagraph (A) or
(B) shall take effect on a date specified by the Secretary.
``(D) Final order.--After the completion of the proceedings
in subparagraph (A) or (B), the Secretary shall--
``(i) issue a final order in accordance with paragraph (1);
``(ii) publish a notice of availability of such final
administrative order in the Federal Register; and
``(iii) afford sponsors of such drugs that will be subject
to such an order the opportunity for formal dispute
resolution up to the level of the Director of the Center for
Drug Evaluation and Research, which must initially be within
45 calendar days of the issuance of the order, and for
subsequent levels of appeal, within 30 calendar days of the
prior decision.
``(E) Hearings.--A sponsor of a drug subject to a final
order issued under subparagraph (D) and that participated in
each stage of formal dispute resolution under clause (iii) of
such subparagraph may request a hearing on such order. The
provisions of subparagraphs (A), (B), and (C) of paragraph
(3), other than paragraph (3)(C)(v)(II), shall apply with
respect to a hearing on such order in the same manner and to
the same extent as such provisions apply with respect to a
hearing on an administrative order issued under paragraph
(2)(A)(iv).
``(F) Timing.--
``(i) Final order and hearing.--The Secretary shall--
``(I) not later than 6 months after the date on which the
comment period closes under subparagraph (A) or (B), issue a
final order in accordance with paragraph (1); and
``(II) not later than 12 months after the date on which
such final order is issued, complete any hearing under
subparagraph (E).
``(ii) Dispute resolution request.--The Secretary shall
specify in an interim final order issued under subparagraph
(A) or (B) such shorter periods for requesting dispute
resolution under subparagraph (D)(iii) as are necessary to
meet the requirements of this subparagraph.
``(G) Judicial review.--A final order issued pursuant to
subparagraph (F) shall be subject to judicial review in
accordance with paragraph (3)(D).
``(5) Administrative order initiated at the request of a
requestor.--
``(A) In general.--In issuing an administrative order under
paragraph (1) at the request of a requestor with respect to
certain drugs, classes of drugs, or combinations of drugs--
``(i) the Secretary shall, after receiving a request under
this subparagraph, determine
[[Page H256]]
whether the request is sufficiently complete and formatted to
permit a substantive review;
``(ii) if the Secretary determines that the request is
sufficiently complete and formatted to permit a substantive
review, the Secretary shall--
``(I) file the request; and
``(II) initiate proceedings with respect to issuing an
administrative order in accordance with paragraphs (2) and
(3); and
``(iii) except as provided in paragraph (6), if the
Secretary determines that a request does not meet the
requirements for filing or is not sufficiently complete and
formatted to permit a substantive review, the requestor may
demand that the request be filed over protest, and the
Secretary shall initiate proceedings to review the request in
accordance with paragraph (2)(A).
``(B) Request to initiate proceedings.--
``(i) In general.--A requestor seeking an administrative
order under paragraph (1) with respect to certain drugs,
classes of drugs, or combinations of drugs, shall submit to
the Secretary a request to initiate proceedings for such
order in the form and manner as specified by the Secretary.
Such requestor may submit a request under this subparagraph
for the issuance of an administrative order--
``(I) determining whether a drug is generally recognized as
safe and effective under section 201(p)(1), exempt from
section 503(b)(1), and not required to be the subject of an
approved application under section 505; or
``(II) determining whether a change to a condition of use
of a drug is generally recognized as safe and effective under
section 201(p)(1), exempt from section 503(b)(1), and not
required to be the subject of an approved application under
section 505, if, absent such a changed condition of use, such
drug is--
``(aa) generally recognized as safe and effective under
section 201(p)(1) in accordance with subsection (a)(1),
(a)(2), or an order under this subsection; or
``(bb) subject to subsection (a)(3), but only if such
requestor initiates such request in conjunction with a
request for the Secretary to determine whether such drug is
generally recognized as safe and effective under section
201(p)(1), which is filed by the Secretary under subparagraph
(A)(ii).
``(ii) Exception.--The Secretary is not required to
complete review of a request for a change described in clause
(i)(II) if the Secretary determines that there is an
inadequate basis to find the drug is generally recognized as
safe and effective under section 201(p)(1) under paragraph
(1) and issues a final order announcing that determination.
``(iii) Withdrawal.--The requestor may withdraw a request
under this paragraph, according to the procedures set forth
pursuant to subsection (d)(2)(B). Notwithstanding any other
provision of this section, if such request is withdrawn, the
Secretary may cease proceedings under this subparagraph.
``(C) Exclusivity.--
``(i) In general.--A final administrative order issued in
response to a request under this section shall have the
effect of authorizing solely the order requestor (or the
licensees, assignees, or successors in interest of such
requestor with respect to the subject of such order), for a
period of 18 months following the effective date of such
final order and beginning on the date the requestor may
lawfully market such drugs pursuant to the order, to market
drugs--
``(I) incorporating changes described in clause (ii); and
``(II) subject to the limitations under clause (iv).
``(ii) Changes described.--A change described in this
clause is a change subject to an order specified in clause
(i), which--
``(I) provides for a drug to contain an active ingredient
(including any ester or salt of the active ingredient) not
previously incorporated in a drug described in clause (iii);
or
``(II) provides for a change in the conditions of use of a
drug, for which new human data studies conducted or sponsored
by the requestor (or for which the requestor has an exclusive
right of reference) were essential to the issuance of such
order.
``(iii) Drugs described.--The drugs described in this
clause are drugs--
``(I) specified in subsection (a)(1), (a)(2), or (a)(3);
``(II) subject to a final order issued under this section;
``(III) subject to a final sunscreen order (as defined in
section 586(2)(A)); or
``(IV) described in subsection (m)(1), other than drugs
subject to an active enforcement action under chapter III of
this Act.
``(iv) Limitations on exclusivity.--
``(I) In general.--Only one 18-month period under this
subparagraph shall be granted, under each order described in
clause (i), with respect to changes (to the drug subject to
such order) which are either--
``(aa) changes described in clause (ii)(I), relating to
active ingredients; or
``(bb) changes described in clause (ii)(II), relating to
conditions of use.
``(II) No exclusivity allowed.--No exclusivity shall apply
to changes to a drug which are--
``(aa) the subject of a Tier 2 OTC monograph order request
(as defined in section 744L);
``(bb) safety-related changes, as defined by the Secretary,
or any other changes the Secretary considers necessary to
assure safe use; or
``(cc) changes related to methods of testing safety or
efficacy.
``(v) New human data studies defined.--In this
subparagraph, the term `new human data studies' means
clinical trials of safety or effectiveness (including actual
use studies), pharmacokinetics studies, or bioavailability
studies, the results of which--
``(I) have not been relied on by the Secretary to support--
``(aa) a proposed or final determination that a drug
described in subclause (I), (II), or (III) of clause (iii) is
generally recognized as safe and effective under section
201(p)(1); or
``(bb) approval of a drug that was approved under section
505; and
``(II) do not duplicate the results of another study that
was relied on by the Secretary to support--
``(aa) a proposed or final determination that a drug
described in subclause (I), (II), or (III) of clause (iii) is
generally recognized as safe and effective under section
201(p)(1); or
``(bb) approval of a drug that was approved under section
505.
``(6) Information regarding safe nonprescription marketing
and use as condition for filing a generally recognized as
safe and effective request.--
``(A) In general.--In response to a request under this
section that a drug described in subparagraph (B) be
generally recognized as safe and effective, the Secretary--
``(i) may file such request, if the request includes
information specified under subparagraph (C) with respect to
safe nonprescription marketing and use of such drug; or
``(ii) if the request fails to include information
specified under subparagraph (C), shall refuse to file such
request and require that nonprescription marketing of the
drug be pursuant to a new drug application as described in
subparagraph (D).
``(B) Drug described.--A drug described in this
subparagraph is a nonprescription drug which contains an
active ingredient not previously incorporated in a drug--
``(i) specified in subsection (a)(1), (a)(2), or (a)(3);
``(ii) subject to a final order under this section; or
``(iii) subject to a final sunscreen order (as defined in
section 586(2)(A)).
``(C) Information demonstrating prima facie safe
nonprescription marketing and use.--Information specified in
this subparagraph, with respect to a request described in
subparagraph (A)(i), is--
``(i) information sufficient for a prima facie
demonstration that the drug subject to such request has a
verifiable history of being marketed and safely used by
consumers in the United States as a nonprescription drug
under comparable conditions of use;
``(ii) if the drug has not been previously marketed in the
United States as a nonprescription drug, information
sufficient for a prima facie demonstration that the drug was
marketed and safely used under comparable conditions of
marketing and use in a country listed in section 802(b)(1)(A)
or designated by the Secretary in accordance with section
802(b)(1)(B)--
``(I) for such period as needed to provide reasonable
assurances concerning the safe nonprescription use of the
drug; and
``(II) during such time was subject to sufficient
monitoring by a regulatory body considered acceptable by the
Secretary for such monitoring purposes, including for adverse
events associated with nonprescription use of the drug; or
``(iii) if the Secretary determines that information
described in clause (i) or (ii) is not needed to provide a
prima facie demonstration that the drug can be safely
marketed and used as a nonprescription drug, such other
information the Secretary determines is sufficient for such
purposes.
``(D) Marketing pursuant to new drug application.--In the
case of a request described in subparagraph (A)(ii), the drug
subject to such request may be resubmitted 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.--
[[Page H257]]
``(A) In general.--A final monograph or tentative final
monograph described in subparagraph (B) shall be deemed to be
a final administrative order under this subsection and may be
amended, revoked, or otherwise modified in accordance with
the procedures of this subsection.
``(B) Monographs described.--For purposes of subparagraph
(A), a final monograph or tentative final monograph is
described in this subparagraph if it--
``(i) establishes conditions of use for a drug described in
paragraph (1) or (2) of subsection (a); and
``(ii) represents the most recently promulgated version of
such conditions, including as modified, in whole or in part,
by any proposed or final rule.
``(C) Deemed orders include harmonizing technical
amendments.--The deemed establishment of a final
administrative order under subparagraph (A) shall be
construed to include any technical amendments to such order
as the Secretary determines necessary to ensure that such
order is appropriately harmonized, in terms of terminology or
cross-references, with the applicable provisions of this Act
(and regulations thereunder) and any other orders issued
under this section.
``(c) Procedure for Minor Changes.--
``(1) In general.--Minor changes in the dosage form of a
drug that is described in paragraph (1) or (2) of subsection
(a) or the subject of an order issued under subsection (b)
may be made by a requestor without the issuance of an order
under subsection (b) if--
``(A) the requestor maintains such information as is
necessary to demonstrate that the change--
``(i) will not affect the safety or effectiveness of the
drug; and
``(ii) will not materially affect the extent of absorption
or other exposure to the active ingredient in comparison to a
suitable reference product; and
``(B) the change is in conformity with the requirements of
an applicable administrative order issued by the Secretary
under paragraph (3).
``(2) Additional information.--
``(A) Access to records.--A sponsor shall submit records
requested by the Secretary relating to such a minor change
under section 704(a)(4), within 15 business days of receiving
such a request, or such longer period as the Secretary may
provide.
``(B) Insufficient information.--If the Secretary
determines that the information contained in such records is
not sufficient to demonstrate that the change does not affect
the safety or effectiveness of the drug or materially affect
the extent of absorption or other exposure to the active
ingredient, the Secretary--
``(i) may so inform the sponsor of the drug in writing; and
``(ii) if the Secretary so informs the sponsor, shall
provide the sponsor of the drug with a reasonable opportunity
to provide additional information.
``(C) Failure to submit sufficient information.--If the
sponsor fails to provide such additional information within a
time prescribed by the Secretary, or if the Secretary
determines that such additional information does not
demonstrate that the change does not--
``(i) affect the safety or effectiveness of the drug; or
``(ii) materially affect the extent of absorption or other
exposure to the active ingredient in comparison to a suitable
reference product,
the drug as modified is a new drug under section 201(p) and
shall be deemed to be misbranded under section 502(ee).
``(3) Determining whether a change will affect safety or
effectiveness.--
``(A) In general.--The Secretary shall issue one or more
administrative orders specifying requirements for determining
whether a minor change made by a sponsor pursuant to this
subsection will affect the safety or effectiveness of a drug
or materially affect the extent of absorption or other
exposure to an active ingredient in the drug in comparison to
a suitable reference product, together with guidance for
applying those orders to specific dosage forms.
``(B) Standard practices.--The orders and guidance issued
by the Secretary under subparagraph (A) shall take into
account relevant public standards and standard practices for
evaluating the quality of drugs, and may take into account
the special needs of populations, including children.
``(d) Confidentiality of Information Submitted to the
Secretary.--
``(1) In general.--Subject to paragraph (2), any
information, including reports of testing conducted on the
drug or drugs involved, that is submitted by a requestor in
connection with proceedings on an order under this section
(including any minor change under subsection (c)) and is a
trade secret or confidential information subject to section
552(b)(4) of title 5, United States Code, or section 1905 of
title 18, United States Code, shall not be disclosed to the
public unless the requestor consents to that disclosure.
``(2) Public availability.--
``(A) In general.--Except as provided in subparagraph (B),
the Secretary shall--
``(i) make any information submitted by a requestor in
support of a request under subsection (b)(5)(A) available to
the public not later than the date on which the proposed
order is issued; and
``(ii) make any information submitted by any other person
with respect to an order requested (or initiated by the
Secretary) under subsection (b), available to the public upon
such submission.
``(B) Limitations on public availability.--Information
described in subparagraph (A) shall not be made public if--
``(i) the information pertains to pharmaceutical quality
information, unless such information is necessary to
establish standards under which a drug is generally
recognized as safe and effective under section 201(p)(1);
``(ii) the information is submitted in a requestor-
initiated request, but the requestor withdraws such request,
in accordance with withdrawal procedures established by the
Secretary, before the Secretary issues the proposed order;
``(iii) the Secretary requests and obtains the information
under subsection (c) and such information is not submitted in
relation to an order under subsection (b); or
``(iv) the information is of the type contained in raw
datasets.
``(e) Updates to Drug Listing Information.--A sponsor who
makes a change to a drug subject to this section shall submit
updated drug listing information for the drug in accordance
with section 510(j) within 30 calendar days of the date when
the drug is first commercially marketed, except that a
sponsor who was the order requestor with respect to an order
subject to subsection (b)(5)(C) (or a licensee, assignee, or
successor in interest of such requestor) shall submit updated
drug listing information on or before the date when the drug
is first commercially marketed.
``(f) Approvals Under Section 505.--The provisions of this
section shall not be construed to preclude a person from
seeking or maintaining the approval of an application for a
drug under sections 505(b)(1), 505(b)(2), and 505(j). A
determination under this section that a drug is not subject
to section 503(b)(1), is generally recognized as safe and
effective under section 201(p)(1), and is not a new drug
under section 201(p) shall constitute a finding that the drug
is safe and effective that may be relied upon for purposes of
an application under section 505(b)(2), so that the applicant
shall be required to submit for purposes of such application
only information needed to support any modification of the
drug that is not covered by such determination under this
section.
``(g) Public Availability of Administrative Orders.--The
Secretary shall establish, maintain, update (as determined
necessary by the Secretary but no less frequently than
annually), and make publicly available, with respect to
orders issued under this section--
``(1) a repository of each final order and interim final
order in effect, including the complete text of the order;
and
``(2) a listing of all orders proposed and under
development under subsection (b)(2), including--
``(A) a brief description of each such order; and
``(B) the Secretary's expectations, if resources permit,
for issuance of proposed orders over a 3-year period.
``(h) Development Advice to Sponsors or Requestors.--The
Secretary shall establish procedures under which sponsors or
requestors may meet with appropriate officials of the Food
and Drug Administration to obtain advice on the studies and
other information necessary to support submissions under this
section and other matters relevant to the regulation of
nonprescription drugs and the development of new
nonprescription drugs under this section.
``(i) Participation of Multiple Sponsors or Requestors.--
The Secretary shall establish procedures to facilitate
efficient participation by multiple sponsors or requestors in
proceedings under this section, including provision for joint
meetings with multiple sponsors or requestors or with
organizations nominated by sponsors or requestors to
represent their interests in a proceeding.
``(j) Electronic Format.--All submissions under this
section shall be in electronic format.
``(k) Effect on Existing Regulations Governing
Nonprescription Drugs.--
``(1) Regulations of general applicability to
nonprescription drugs.--Except as provided in this
subsection, nothing in this section supersedes regulations
establishing general requirements for nonprescription drugs,
including regulations of general applicability contained in
parts 201, 250, and 330 of title 21, Code of Federal
Regulations, or any successor regulations. The Secretary
shall establish or modify such regulations by means of
rulemaking in accordance with section 553 of title 5, United
States Code.
``(2) Regulations establishing requirements for specific
nonprescription drugs.--
``(A) The provisions of section 310.545 of title 21, Code
of Federal Regulations, as in effect on the day before the
date of the enactment of this section, shall be deemed to be
a final order under subsection (b).
``(B) Regulations in effect on the day before the date of
the enactment of this section, establishing requirements for
specific nonprescription drugs marketed pursuant to this
section (including such requirements in parts 201 and 250 of
title 21, Code of Federal Regulations), shall be deemed to be
final orders under subsection (b), only as they apply to
drugs--
``(i) subject to paragraph (1), (2), (3), or (4) of
subsection (a); or
``(ii) otherwise subject to an order under this section.
[[Page H258]]
``(3) Withdrawal of regulations.--The Secretary shall
withdraw regulations establishing final monographs and the
procedures governing the over-the-counter drug review under
part 330 and other relevant parts of title 21, Code of
Federal Regulations (as in effect on the day before the date
of the enactment of this section), or make technical changes
to such regulations to ensure conformity with appropriate
terminology and cross references. Notwithstanding subchapter
II of chapter 5 of title 5, United States Code, any such
withdrawal or technical changes shall be made without public
notice and comment and shall be effective upon publication
through notice in the Federal Register (or upon such date as
specified in such notice).
``(l) Guidance.--The Secretary shall issue guidance that
specifies--
``(1) the procedures and principles for formal meetings
between the Secretary and sponsors or requestors for drugs
subject to this section;
``(2) the format and content of data submissions to the
Secretary under this section;
``(3) the format of electronic submissions to the Secretary
under this section;
``(4) consolidated proceedings for appeal and the
procedures for such proceedings where appropriate; and
``(5) for minor changes in drugs, recommendations on how to
comply with the requirements in orders issued under
subsection (c)(3).
``(m) Rule of Construction.--
``(1) In general.--This section shall not affect the
treatment or status of a nonprescription drug--
``(A) that is marketed without an application approved
under section 505 as of the date of the enactment of this
section;
``(B) that is not subject to an order issued under this
section; and
``(C) to which paragraphs (1), (2), (3), (4), or (5) of
subsection (a) do not apply.
``(2) Treatment of products previously found to be subject
to time and extent requirements.--
``(A) Notwithstanding subsection (a), a drug described in
subparagraph (B) may only be lawfully marketed, without an
application approved under section 505, pursuant to an order
issued under this section.
``(B) A drug described in this subparagraph is a drug
which, prior to the date of the enactment of this section,
the Secretary determined in a proposed or final rule to be
ineligible for review under the OTC drug review (as such
phrase `OTC drug review' was used in section 330.14 of title
21, Code of Federal Regulations, as in effect on the day
before the date of the enactment of this section).
``(3) Preservation of authority.--
``(A) Nothing in paragraph (1) shall be construed to
preclude or limit the applicability of any provision of this
Act other than this section.
``(B) Nothing in subsection (a) shall be construed to
prohibit the Secretary from issuing an order under this
section finding a drug to be not generally recognized as safe
and effective under section 201(p)(1), as the Secretary
determines appropriate.
``(n) Investigational New Drugs.--A drug is not subject to
this section if an exemption for investigational use under
section 505(i) is in effect for such drug.
``(o) Inapplicability of Paperwork Reduction Act.--Chapter
35 of title 44, United States Code, shall not apply to
collections of information made under this section.
``(p) Inapplicability of Notice and Comment Rulemaking and
Other Requirements.--The requirements of subsection (b) shall
apply with respect to orders issued under this section
instead of the requirements of subchapter II of chapter 5 of
title 5, United States Code.
``(q) Definitions.--In this section:
``(1) The term `nonprescription drug' refers to a drug not
subject to the requirements of section 503(b)(1).
``(2) The term `sponsor' refers to any person marketing,
manufacturing, or processing a drug that--
``(A) is listed pursuant to section 510(j); and
``(B) is or will be subject to an administrative order
under this section of the Food and Drug Administration.
``(3) The term `requestor' refers to any person or group of
persons marketing, manufacturing, processing, or developing a
drug.''.
(b) GAO Study.--Not later than 4 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit a study to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate
addressing the effectiveness and overall impact of
exclusivity under section 505G of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), and section 586C of
such Act (21 U.S.C. 360fff-3), including the impact of such
exclusivity on consumer access. Such study shall include--
(1) an analysis of the impact of exclusivity under such
section 505G for nonprescription drug products, including--
(A) the number of nonprescription drug products that were
granted exclusivity and the indication for which the
nonprescription drug products were determined to be generally
recognized as safe and effective;
(B) whether the exclusivity for such drug products was
granted for--
(i) a new active ingredient (including any ester or salt of
the active ingredient); or
(ii) changes in the conditions of use of a drug, for which
new human data studies conducted or sponsored by the
requestor were essential;
(C) whether, and to what extent, the exclusivity impacted
the requestor's or sponsor's decision to develop the drug
product;
(D) an analysis of the implementation of the exclusivity
provision in such section 505G, including--
(i) the resources used by the Food and Drug Administration;
(ii) the impact of such provision on innovation, as well as
research and development in the nonprescription drug market;
(iii) the impact of such provision on competition in the
nonprescription drug market;
(iv) the impact of such provision on consumer access to
nonprescription drug products;
(v) the impact of such provision on the prices of
nonprescription drug products; and
(vi) whether the administrative orders initiated by
requestors under such section 505G have been sufficient to
encourage the development of nonprescription drug products
that would likely not be otherwise developed, or developed in
as timely a manner; and
(E) whether the administrative orders initiated by
requestors under such section 505G have been sufficient
incentive to encourage innovation in the nonprescription drug
market; and
(2) an analysis of the impact of exclusivity under such
section 586C for sunscreen ingredients, including--
(A) the number of sunscreen ingredients that were granted
exclusivity and the specific ingredient that was determined
to be generally recognized as safe and effective;
(B) whether, and to what extent, the exclusivity impacted
the requestor's or sponsor's decision to develop the
sunscreen ingredient;
(C) whether, and to what extent, the sunscreen ingredient
granted exclusivity had previously been available outside of
the United States;
(D) an analysis of the implementation of the exclusivity
provision in such section 586C, including--
(i) the resources used by the Food and Drug Administration;
(ii) the impact of such provision on innovation, as well as
research and development in the sunscreen market;
(iii) the impact of such provision on competition in the
sunscreen market;
(iv) the impact of such provision on consumer access to
sunscreen products;
(v) the impact of such provision on the prices of sunscreen
products; and
(vi) whether the administrative orders initiated by
requestors under such section 505G have been utilized by
sunscreen ingredient sponsors and whether such process has
been sufficient to encourage the development of sunscreen
ingredients that would likely not be otherwise developed, or
developed in as timely a manner; and
(E) whether the administrative orders initiated by
requestors under such section 586C have been sufficient
incentive to encourage innovation in the sunscreen market.
(c) Conforming Amendment.--Section 751(d)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379r(d)(1)) is
amended--
(1) in the matter preceding subparagraph (A)--
(A) by striking ``final regulation promulgated'' and
inserting ``final order under section 505G''; and
(B) by striking ``and not misbranded''; and
(2) in subparagraph (A), by striking ``regulation in
effect'' and inserting ``regulation or order in effect''.
SEC. 1002. MISBRANDING.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352) is amended by adding at the end the following:
``(ee) If it is a nonprescription drug that is subject to
section 505G, is not the subject of an application approved
under section 505, and does not comply with the requirements
under section 505G.
``(ff) If it is a drug and it was manufactured, prepared,
propagated, compounded, or processed in a facility for which
fees have not been paid as required by section 744M.''.
SEC. 1003. DRUGS EXCLUDED FROM THE OVER-THE-COUNTER DRUG
REVIEW.
(a) In General.--Nothing in this Act (or the amendments
made by this Act) shall apply to any nonprescription drug (as
defined in section 505G(q) of the Federal Food, Drug, and
Cosmetic Act, as added by section 1001 of this Act) which was
excluded by the Food and Drug Administration from the Over-
the-Counter Drug Review in accordance with the paragraph
numbered 25 on page 9466 of volume 37 of the Federal
Register, published on May 11, 1972.
(b) Rule of Construction.--Nothing in this section shall be
construed to preclude or limit the applicability of any other
provision of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
SEC. 1004. TREATMENT OF SUNSCREEN INNOVATION ACT.
(a) Review of Nonprescription Sunscreen Active
Ingredients.--
(1) Applicability of section 505g for pending
submissions.--
(A) In general.--A sponsor of a nonprescription sunscreen
active ingredient or combination of nonprescription sunscreen
active ingredients that, as of the date of enactment of this
Act, is subject to a proposed sunscreen order under section
586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360fff-3) may elect, by means of giving
[[Page H259]]
written notification to the Secretary of Health and Human
Services within 180 calendar days of the enactment of this
Act, to transition into the review of such ingredient or
combination of ingredients pursuant to the process set out in
section 505G of the Federal Food, Drug, and Cosmetic Act, as
added by section 1001 of this Act.
(B) Election exercised.--Upon receipt by the Secretary of
Health and Human Services of a timely notification under
subparagraph (A)--
(i) the proposed sunscreen order involved is deemed to be a
request for an order under subsection (b) of section 505G of
the Federal Food, Drug, and Cosmetic Act, as added by section
1001 of this Act; and
(ii) such order is deemed to have been accepted for filing
under subsection (b)(6)(A)(i) of such section 505G.
(C) Election not exercised.--If a notification under
subparagraph (A) is not received by the Secretary of Health
and Human Services within 180 calendar days of the date of
enactment of this Act, the review of the proposed sunscreen
order described in subparagraph (A)--
(i) shall continue under section 586C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360fff-3); and
(ii) shall not be eligible for review under section 505G,
added by section 1001 of this Act.
(2) Definitions.--In this subsection, the terms
``sponsor'', ``nonprescription'', ``sunscreen active
ingredient'', and ``proposed sunscreen order'' have the
meanings given to those terms in section 586 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).
(b) Amendments to Sunscreen Provisions.--
(1) Final sunscreen orders.--Paragraph (3) of section
586C(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360fff-3(e)) is amended to read as follows:
``(3) Relationship to orders under section 505g.--A final
sunscreen order shall be deemed to be a final order under
section 505G.''.
(2) Meetings.--Paragraph (7) of section 586C(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b))
is amended--
(A) by striking ``A sponsor may request'' and inserting the
following:
``(A) In general.--A sponsor may request''; and
(B) by adding at the end the following:
``(B) Confidential meetings.--A sponsor may request one or
more confidential meetings with respect to a proposed
sunscreen order, including a letter deemed to be a proposed
sunscreen order under paragraph (3), to discuss matters
relating to data requirements to support a general
recognition of safety and effectiveness involving
confidential information and public information related to
such proposed sunscreen order, as appropriate. The Secretary
shall convene a confidential meeting with such sponsor in a
reasonable time period. If a sponsor requests more than one
confidential meeting for the same proposed sunscreen order,
the Secretary may refuse to grant an additional confidential
meeting request if the Secretary determines that such
additional confidential meeting is not reasonably necessary
for the sponsor to advance its proposed sunscreen order, or
if the request for a confidential meeting fails to include
sufficient information upon which to base a substantive
discussion. The Secretary shall publish a post-meeting
summary of each confidential meeting under this subparagraph
that does not disclose confidential commercial information or
trade secrets. This subparagraph does not authorize the
disclosure of confidential commercial information or trade
secrets subject to 552(b)(4) of title 5, United States Code,
or section 1905 of title 18, United States Code.''.
(3) Exclusivity.--Section 586C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding at
the end the following:
``(f) Exclusivity.--
``(1) In general.--A final sunscreen order shall have the
effect of authorizing solely the order requestor (or the
licensees, assignees, or successors in interest of such
requestor with respect to the subject of such request and
listed under paragraph (5)) for a period of 18 months, to
market a sunscreen ingredient under this section
incorporating changes described in paragraph (2) subject to
the limitations under paragraph (4), beginning on the date
the requestor (or any licensees, assignees, or successors in
interest of such requestor with respect to the subject of
such request and listed under paragraph (5)) may lawfully
market such sunscreen ingredient pursuant to the order.
``(2) Changes described.--A change described in this
paragraph is a change subject to an order specified in
paragraph (1) that permits a sunscreen to contain an active
sunscreen ingredient not previously incorporated in a
marketed sunscreen listed in paragraph (3).
``(3) Marketed sunscreen.--The marketed sunscreen
ingredients described in this paragraph are sunscreen
ingredients--
``(A) marketed in accordance with a final monograph for
sunscreen drug products set forth at part 352 of title 21,
Code of Federal Regulations (as published at 64 Fed. Reg.
27687); or
``(B) marketed in accordance with a final order issued
under this section.
``(4) Limitations on exclusivity.--Only one 18-month period
may be granted per ingredient under paragraph (1).
``(5) Listing of licensees, assignees, or successors in
interest.--Requestors shall submit to the Secretary at the
time when a drug subject to such request is introduced or
delivered for introduction into interstate commerce, a list
of licensees, assignees, or successors in interest under
paragraph (1).''.
(4) Sunset provision.--Subchapter I of chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et
seq.) is amended by adding at the end the following:
``SEC. 586H. SUNSET.
``This subchapter shall cease to be effective at the end of
fiscal year 2022.''.
(5) Treatment of final sunscreen order.--The Federal Food,
Drug, and Cosmetic Act is amended by striking section 586E of
such Act (21 U.S.C. 360fff-5).
(c) Treatment of Authority Regarding Finalization of
Sunscreen Monograph.--
(1) In general.--
(A) Revision of final sunscreen order.--Not later than
November 26, 2019, the Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall
amend and revise the final administrative order concerning
nonprescription sunscreen (referred to in this subsection as
the ``sunscreen order'') for which the content, prior to the
date of enactment of this Act, was represented by the final
monograph for sunscreen drug products set forth in part 352
of title 21, Code of Federal Regulations (as in effect on May
21, 1999).
(B) Issuance of revised sunscreen order; effective date.--A
revised sunscreen order described in subparagraph (A) shall
be--
(i) issued in accordance with the procedures described in
section 505G(c)(2) of the Federal Food, Drug, and Cosmetic
Act;
(ii) issued in proposed form not later than May 28, 2019;
(iii) effective not later than November 26, 2020; and
(iv) issued by the Secretary at least 1 year prior to the
effective date of the revised order.
(2) Reports.--If a revised sunscreen order issued under
paragraph (1) does not include provisions related to the
effectiveness of various sun protection factor levels, and
does not address all dosage forms known to the Secretary to
be used in sunscreens marketed in the United States without a
new drug application approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the
Secretary shall submit a report to the Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate on the rationale for omission of such provisions from
such order, and a plan and timeline to compile any
information necessary to address such provisions through such
order.
(d) Treatment of Non-sunscreen Time and Extent
Applications.--
(1) In general.--Any application described in section 586F
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360fff-6) that was submitted to the Secretary pursuant to
section 330.14 of title 21, Code of Federal Regulations, as
such provisions were in effect immediately prior to the date
of enactment date of this Act, shall be extinguished as of
such date of enactment, subject to paragraph (2).
(2) Order request.--Nothing in paragraph (1) precludes the
submission of an order request under section 505G(b) of the
Federal Food, Drug, and Cosmetic Act, as added by section
1001 of this Act, with respect to a drug that was the subject
of an application extinguished under paragraph (1).
SEC. 1005. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC
INDICATION FOR CERTAIN OTC COUGH AND COLD
DRUGS.
(a) In General.--Subject to subsection (c), the Secretary
of Health and Human Services shall, beginning not later than
1 year after the date of enactment of this Act, annually
submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a letter describing the
progress of the Food and Drug Administration--
(1) in evaluating the cough and cold monograph described in
subsection (b) with respect to children under age 6; and
(2) as appropriate, revising such cough and cold monograph
to address such children through the order process under
section 505G(b) of the Federal Food, Drug, and Cosmetic Act,
as added by section 1001 of this Act.
(b) Cough and Cold Monograph Described.--The cough and cold
monograph described in this subsection consists of the
conditions under which nonprescription drugs containing
antitussive, expectorant, nasal decongestant, or
antihistamine active ingredients (or combinations thereof)
are generally recognized as safe and effective, as specified
in part 341 of title 21, Code of Federal Regulations (as in
effect immediately prior to the date of enactment of this
Act), and included in an order deemed to be established under
section 505G(b) of the Federal Food, Drug, and Cosmetic Act,
as added by section 1001 of this Act.
(c) Duration of Authority.--The requirement under
subsection (a) shall terminate as of the date of a letter
submitted by the Secretary of Health and Human Services
pursuant to such subsection in which the Secretary indicates
that the Food and Drug Administration has completed its
evaluation and revised, in a final order, as applicable, the
cough and cold monograph as described in subsection (a)(2).
[[Page H260]]
SEC. 1006. TECHNICAL CORRECTIONS.
(a) Imports and Exports.--Section 801(e)(4)(E)(iii) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(e)(4)(E)(iii)) is amended by striking ``subparagraph''
each place such term appears and inserting ``paragraph''.
(b) FDA Reauthorization Act of 2017.--
(1) In general.--Section 905(b)(4) of the FDA
Reauthorization Act of 2017 (Public Law115-52) is amended by
striking ``Section 744H(e)(2)(B)'' and inserting ``Section
744H(f)(2)(B)''.
(2) Effective date.--The amendment made by paragraph (1)
shall take effect as of the enactment of the FDA
Reauthorization Act of 2017 (Public Law 115-52).
TITLE II--USER FEES
SEC. 2001. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Over-
the-Counter Monograph User Fee Act of 2019''.
(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,
[[Page H261]]
2019, for the first program year, and December 31 of the
fiscal year for subsequent fiscal years; and
``(II) has updated its registration to reflect such change
under the requirements for drug establishment registration
set forth in section 510.
``(ii) The amount of the fee for a contract manufacturing
organization facility shall be equal to two-thirds of the
amount of the fee for an OTC monograph drug facility that is
not a contract manufacturing organization facility.
``(C) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection (c).
``(D) Due date.--
``(i) For first program year.--For fiscal year 2019, the
facility fees required under subparagraph (A) shall be due 45
calendar days after publication of the Federal Register
notice provided for under subsection (c)(4)(A).
``(ii) Subsequent fiscal years.--For each fiscal year after
fiscal year 2019, the facility fees required under
subparagraph (A) shall be due on the later of--
``(I) the first business day of June of such year; or
``(II) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees under this section for such year.
``(2) OTC monograph order request fee.--
``(A) In general.--Each person that submits an OTC
monograph order request shall be subject to a fee for an OTC
monograph order request. The amount of such fee shall be--
``(i) for a Tier 1 OTC monograph order request, $500,000,
adjusted for inflation for the fiscal year (as determined
under subsection (c)(1)(B)); and
``(ii) for a Tier 2 OTC monograph order request, $100,000
adjusted for inflation for the fiscal year (as determined
under subsection (c)(1)(B)).
``(B) Due date.--The OTC monograph order request fees
required under subparagraph (A) shall be due on the date of
submission of the OTC monograph order request.
``(C) Exception for certain safety changes.--A person who
is named as the requestor in an OTC monograph order shall not
be subject to a fee under subparagraph (A) if the Secretary
finds that the OTC monograph order request seeks to change
the drug facts labeling of an OTC monograph drug in a way
that would add to or strengthen--
``(i) a contraindication, warning, or precaution;
``(ii) a statement about risk associated with misuse or
abuse; or
``(iii) an instruction about dosage and administration that
is intended to increase the safe use of the OTC monograph
drug.
``(D) Refund of fee if order request is recategorized as a
tier 2 otc monograph order request.--If the Secretary
determines that an OTC monograph request initially
characterized as Tier 1 shall be re-characterized as a Tier 2
OTC monograph order request, and the requestor has paid a
Tier 1 fee in accordance with subparagraph (A)(i), the
Secretary shall refund the requestor the difference between
the Tier 1 and Tier 2 fees determined under subparagraphs
(A)(i) and (A)(ii), respectively.
``(E) Refund of fee if order request refused for filing or
withdrawn before filing.--The Secretary shall refund 75
percent of the fee paid under subparagraph (B) for any order
request which is refused for filing or was withdrawn before
being accepted or refused for filing.
``(F) Fees for order requests previously refused for filing
or withdrawn before filing.--An OTC monograph order request
that was submitted but was refused for filing, or was
withdrawn before being accepted or refused for filing, shall
be subject to the full fee under subparagraph (A) upon being
resubmitted or filed over protest.
``(G) Refund of fee if order request withdrawn.--If an
order request is withdrawn after the order request was filed,
the Secretary may refund the fee or a portion of the fee if
no substantial work was performed on the order request after
the application was filed. The Secretary shall have the sole
discretion to refund a fee or a portion of the fee under this
subparagraph. A determination by the Secretary concerning a
refund under this subparagraph shall not be reviewable.
``(3) Refunds.--
``(A) In general.--Other than refunds provided pursuant to
any of subparagraphs (D) through (G) of paragraph (2), the
Secretary shall not refund any fee paid under paragraph (1)
except as provided in subparagraph (B).
``(B) Disputes concerning fees.--To qualify for the return
of a fee claimed to have been paid in error under paragraph
(1) or (2), a person shall submit to the Secretary a written
request justifying such return within 180 calendar days after
such fee was paid.
``(4) Notice.--Within the timeframe specified in subsection
(c), the Secretary shall publish in the Federal Register the
amount of the fees under paragraph (1) for such fiscal year.
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2019.--For fiscal year 2019, fees under
subsection (a)(1) shall be established to generate a total
facility fee revenue amount equal to the sum of--
``(A) the annual base revenue for fiscal year 2019 (as
determined under paragraph (3));
``(B) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(2)); and
``(C) additional direct cost adjustments (as determined
under subsection (c)(3)).
``(2) Subsequent fiscal years.--For each of the fiscal
years 2020 through 2023, fees under subsection (a)(1) shall
be established to generate a total facility fee revenue
amount equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(2));
``(D) additional direct cost adjustments (as determined
under subsection (c)(3)); and
``(E) additional dollar amounts for each fiscal year as
follows:
``(i) $7,000,000 for fiscal year 2020.
``(ii) $6,000,000 for fiscal year 2021.
``(iii) $7,000,000 for fiscal year 2022.
``(iv) $3,000,000 for fiscal year 2023.
``(3) Annual base revenue.--For purposes of paragraphs
(1)(A) and (2)(A), the dollar amount of the annual base
revenue for a fiscal year shall be--
``(A) for fiscal year 2019, $8,000,000; and
``(B) for fiscal years 2020 through 2023, the dollar amount
of the total revenue amount established under this subsection
for the previous fiscal year, not including any adjustments
made under subsection (c)(2) or (c)(3).
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection (b)(2)(B),
the dollar amount of the inflation adjustment to the annual
base revenue for fiscal year 2020 and each subsequent fiscal
year shall be equal to the product of--
``(i) such annual base revenue for the fiscal year under
subsection (b)(2); and
``(ii) the inflation adjustment percentage under
subparagraph (C).
``(B) OTC monograph order request fees.--For purposes of
subsection (a)(2), the dollar amount of the inflation
adjustment to the fee for OTC monograph order requests for
fiscal year 2020 and each subsequent fiscal year shall be
equal to the product of--
``(i) the applicable fee under subsection (a)(2) for the
preceding fiscal year; and
``(ii) the inflation adjustment percentage under
subparagraph (C).
``(C) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a fiscal
year is equal to--
``(i) for each of fiscal years 2020 and 2021, the average
annual percent change that occurred in the Consumer Price
Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All items; Annual Index) for the
first 3 years of the preceding 4 years of available data; and
``(ii) for each of fiscal years 2022 and 2023, the sum of--
``(I) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years, multiplied by the proportion of
personnel compensation and benefits costs to total costs of
OTC monograph drug activities for the first 3 years of the
preceding 4 fiscal years; and
``(II) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data multiplied by the proportion of all costs
other than personnel compensation and benefits costs to total
costs of OTC monograph drug activities for the first 3 years
of the preceding 4 fiscal years.
``(2) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2019 and subsequent
fiscal years, for purposes of subsections (b)(1)(B) and
(b)(2)(C), the Secretary may, in addition to adjustments
under paragraph (1), further increase the fee revenue and
fees if such an adjustment is necessary to provide operating
reserves of carryover user fees for OTC monograph drug
activities for not more than the number of weeks specified in
subparagraph (B).
``(B) Number of weeks.--The number of weeks specified in
this subparagraph is--
``(i) 3 weeks for fiscal year 2019;
``(ii) 7 weeks for fiscal year 2020;
``(iii) 10 weeks for fiscal year 2021;
``(iv) 10 weeks for fiscal year 2022; and
``(v) 10 weeks for fiscal year 2023.
``(C) Decrease.--If the Secretary has carryover balances
for such process in excess of 10 weeks of the operating
reserves referred to in subparagraph (A), the Secretary shall
decrease the fee revenue and fees referred to in such
subparagraph to provide for not more than 10 weeks of such
operating reserves.
``(D) Rationale for adjustment.--If an adjustment under
this paragraph is made, the rationale for the amount of the
increase or decrease (as applicable) in fee revenue and fees
shall be contained in the annual Federal Register notice
under paragraph (4) establishing fee revenue and fees for the
fiscal year involved.
``(3) Additional direct cost adjustment.--The Secretary
shall, in addition to adjustments under paragraphs (1) and
(2), further increase the fee revenue and fees for purposes
of subsection (b)(2)(D) by an amount equal to--
[[Page H262]]
``(A) $14,000,000 for fiscal year 2019;
``(B) $7,000,000 for fiscal year 2020;
``(C) $4,000,000 for fiscal year 2021;
``(D) $3,000,000 for fiscal year 2022; and
``(E) $3,000,000 for fiscal year 2023.
``(4) Annual fee setting.--
``(A) Fiscal year 2019.--The Secretary shall, not later
than the second Monday in March of 2019--
``(i) establish OTC monograph drug facility fees for fiscal
year 2019 under subsection (a), based on the revenue amount
for such year under subsection (b) and the adjustments
provided under this subsection; and
``(ii) publish fee revenue, facility fees, and OTC
monograph order requests in the Federal Register.
``(B) Subsequent fiscal years.--The Secretary shall, not
later than the second Monday in March of each fiscal year
that begins after September 30, 2019--
``(i) establish for each such fiscal year, based on the
revenue amounts under subsection (b) and the adjustments
provided under this subsection--
``(I) OTC monograph drug facility fees under subsection
(a)(1); and
``(II) OTC monograph order request fees under subsection
(a)(2); and
``(ii) publish such fee revenue amounts, facility fees, and
OTC monograph order request fees in the Federal Register.
``(d) Identification of Facilities.--Each person that owns
an OTC monograph drug facility shall submit to the Secretary
the information required under this subsection each year.
Such information shall, for each fiscal year--
``(1) be submitted as part of the requirements for drug
establishment registration set forth in section 510; and
``(2) include for each such facility, at a minimum,
identification of the facility's business operation as that
of an OTC monograph drug facility.
``(e) Effect of Failure To Pay Fees.--
``(1) OTC monograph drug facility fee.--
``(A) In general.--Failure to pay the fee under subsection
(a)(1) within 20 calendar days of the due date as specified
in subparagraph (D) of such subsection shall result in the
following:
``(i) The Secretary shall place the facility on a publicly
available arrears list.
``(ii) All OTC monograph drugs manufactured in such a
facility or containing an ingredient manufactured in such a
facility shall be deemed misbranded under section 502(ff).
``(B) Application of penalties.--The penalties under this
paragraph shall apply until the fee established by subsection
(a)(1) is paid.
``(2) Order requests.--An OTC monograph order request
submitted by a person subject to fees under subsection (a)
shall be considered incomplete and shall not be accepted for
filing by the Secretary until all fees owed by such person
under this section have been paid.
``(3) Meetings.--A person subject to fees under this
section shall be considered ineligible for OTC monograph drug
meetings until all such fees owed by such person have been
paid.
``(f) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums
transferred shall be available solely for OTC monograph drug
activities.
``(2) Collections and appropriation acts.--
``(A) In general.--Subject to subparagraph (C), the fees
authorized by this section shall be collected and available
in each fiscal year in an amount not to exceed the amount
specified in appropriation Acts, or otherwise made available
for obligation, for such fiscal year.
``(B) Use of fees and limitation.--The fees authorized by
this section shall be available to defray increases in the
costs of the resources allocated for OTC monograph drug
activities (including increases in such costs for an
additional number of full-time equivalent positions in the
Department of Health and Human Services to be engaged in such
activities), only if the Secretary allocates for such purpose
an amount for such fiscal year (excluding amounts from fees
collected under this section) no less than $12,000,000,
multiplied by the adjustment factor applicable to the fiscal
year involved under subsection (c)(1).
``(C) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (B) in any fiscal
year if the costs funded by appropriations and allocated for
OTC monograph drug activities are not more than 15 percent
below the level specified in such subparagraph.
``(D) Provision for early payments in subsequent years.--
Payment of fees authorized under this section for a fiscal
year (after fiscal year 2019), prior to the due date for such
fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations
Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2019 through 2023, there is authorized to be
appropriated for fees under this section an amount equal to
the total amount of fees assessed for such fiscal year under
this section.
``(g) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such
fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title
31, United States Code.
``(h) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in OTC
monograph drug activities, be reduced to offset the number of
officers, employees, and advisory committees so engaged.
``SEC. 744N. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2019,
and not later than 120 calendar days after the end of each
fiscal year thereafter for which fees are collected under
this part, the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report concerning the
progress of the Food and Drug Administration in achieving the
goals identified in the letters described in section 2001(b)
of the Over-the-Counter Monograph Safety, Innovation, and
Reform Act of 2019 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 New
Jersey (Mr. Pallone) and the gentleman from Texas (Mr. Burgess) each
will control 20 minutes.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
have 5 legislative days to revise and extend their remarks and include
extraneous materials on H.R. 269.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
{time} 1615
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
I rise to voice my support for the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019. This legislation
will help strengthen our Nation's emergency preparedness and response
efforts. It will also modernize the regulatory
[[Page H263]]
framework for over-the-counter drugs and provide FDA with stable and
consistent funding to oversee the over-the-counter market.
This bill would ensure our Nation is prepared and can respond to
emerging infectious disease threats, including Zika and Ebola. It will
also prepare us so we can better respond to health security events,
like bioterrorism and natural disasters such as hurricanes and
wildfires.
The importance of this law cannot be overstated, Mr. Speaker. That is
why our committee committed to working together in the last Congress on
a bipartisan basis to ensure that the important authorities granted to
the FDA in this law did not lapse.
I want to especially thank Representatives Eshoo and Brooks for their
work on this legislation and their leadership in promoting the
importance of strengthening our Nation's emergency preparedness and
response infrastructure.
While the House passed legislation that would have prevented this
authorization from expiring, the Senate then refused to act and,
instead, allowed these important authorities to expire on September 30.
While we were disappointed that we were unable to reauthorize PAHPA
before that occurred, we continued to work with our Senate colleagues
on moving this important legislation forward before the end of the
115th Congress. That effort led to the passage of H.R. 7328 on December
20, legislation developed as a result of bipartisan, bicameral
negotiations to reach agreement on a PAHPA reauthorization bill that we
could all support.
Unfortunately, just like before, the Senate did not act; and, thus,
we are on the floor again today, Mr. Speaker, moving legislation to
reauthorize the Pandemic All-Hazards Preparedness Act and pass historic
legislation to streamline and fund the regulation of over-the-counter
drugs. I hope that the third time will be the charm and that our Senate
colleagues will act quickly to pass this legislation.
In addition to reauthorizing our public health preparedness and
response programs, this legislation also contains a bipartisan and
bicameral agreement reforming our over-the-counter drug program.
The Over-the-Counter Monograph Safety, Innovation, and Reform Act of
2018 has also twice previously passed the House with overwhelming
bipartisan support. It modernizes the way the FDA reviews over-the-
counter products for colds, allergies, and other common health issues.
The bill streamlines the review process for future monograph changes,
allows for expedited safety label changes, and establishes a user fee
program to provide reasonable or sustainable resources to implement
these reforms.
These are all critical changes that I am very proud to support.
While this is not a perfect bill and still contains unnecessary and
unwarranted exclusivity for over-the-counter drugs and sunscreens,
reform of our over-the-counter drug program is long overdue. This
reform will pave the way for innovation in the over-the-counter market,
allow the agency to respond to safety events, and finally provide the
agency with the resources needed to properly oversee this growing
market.
This legislation has the broad support of industry, public health
groups, and the FDA, and it deserves the support of both the House and
the Senate.
I want to thank the bill's authors, Representatives Eshoo, Brooks,
DeGette, Latta, Dingell, Guthrie, and Burgess, for their hard work on
this legislation.
It is my hope that the Senate will now take swift action and move
this legislation to the President's desk. I urge my colleagues to vote
in support of this legislation.
Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
We often hear it said that life is a multiple of threes, and here we
are, the third time, passing this important legislation.
One hundred years ago, this country was in the midst of the worst
pandemic in its history, claiming the lives of almost 700,000 Americans
and killing more than 50 million people worldwide.
As we discuss the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2019, it is paramount that we remember the
significance of the centennial anniversary of the 1918 influenza
pandemic.
I must also note, again, the third time the House has passed this
legislation. We have clearly done our work, and it is time for the
other body to do their work and send this bill to the President's desk.
The creation of the Assistant Secretary for Preparedness and Response
under the original legislation in 2006 has helped us to make monumental
strides in preparedness, coordination, and response.
Close collaboration and efforts between the Centers for Disease
Control and Prevention, the Food and Drug Administration, and our
State, local, Tribal, and territorial public health partners have been
vital in making this progress.
Like politics, much of public health is local and executed on the
ground by our hospitals, by our health departments and our emergency
responders, who are our front lines in addressing infectious diseases,
disasters, and threats.
We hear each and every year of the dangers of the influenza as flu
season wreaks havoc on communities across the country. Last year, in
north Texas, some schools had to close in order to contain the spread
of the flu. This bill includes an important provisio dedicated to
preparing for pandemic influenza to protect our Nation against the
terror of a pandemic.
Mr. Speaker, I would just parenthetically add that if anyone has not
yet had their influenza immunization this year, it is still a good idea
to avail yourself of that protective measure. The flu vaccine not only
can prevent the flu, but if someone gets the flu after having had the
flu vaccine, their clinical course is likely to be more benign.
This reauthorization includes an important provision, the MISSION
ZERO Act. The MISSION ZERO Act seeks to connect American patients with
battle-tested trauma care through the craft of military trauma care
providers.
The bill provides grants to integrate military trauma care providers
and teams into the Nation's leading trauma centers and systems. This
will also ensure that our military can maintain battlefield-ready
trauma care providers in between periods of active engagement. The need
for top-notch trauma care extends across our Nation, far removed from
the battlefield.
We must also remember that infectious diseases are a much more
serious threat in the global community, and we must continue to ensure
that we are prepared and ready to respond. Frontline facilities and
responders in Dallas, Texas, experienced this firsthand in 2014 when a
patient presented with Ebola in a DFW emergency department.
Today, currently, right now, there is an Ebola outbreak in the
Democratic Republic of the Congo that has been deemed the second worst
on record, with more than 600 cases. This legislation equips our Nation
with the tools to respond in a timely and effective manner when the
public health and safety are at risk, such as if Ebola were to hit the
United States again.
Additionally, this bill will also help to bring domestic biologic
surveillance systems up to date so that they are operating with the
most efficient capabilities and technologies.
We must also look for innovative ways to continue to advance medical
countermeasures, ensuring that Americans can access medications that
will provide critical protection in the future.
Another portion of this legislation would modernize the regulation of
over-the-counter medicines. To date, consumers have access to more than
300,000 nonprescription items, from cough to cold medicines to
antiperspirants, antacids, and sunscreens. Pharmacy aisles and medicine
cabinets are filled with over-the-counter products, and American
consumers rely on these each and every day.
This bill would make the over-the-counter regulatory framework more
science-based and responsive to public health concerns, and it would
encourage the development of more innovative products and provide
resources to the Food and Drug Administration to bolster the agency's
ability to review over-the-counter applications and to regulate this
sector in a consistent manner.
[[Page H264]]
This Pandemic and All-Hazards Preparedness reauthorization is
critical to protecting the lives of all Americans and providing the
necessary tools and infrastructure are in place when disaster strikes.
I want to thank Representatives Susan Brooks and Anna Eshoo for their
work and Representatives Bob Latta and Diana DeGette for their work on
the over-the-counter monograph reform.
I strongly support this legislation, urge Members to do the same, and
I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Michigan (Mrs. Dingell).
Mrs. DINGELL. Mr. Speaker, I thank the chairman for yielding me the
time.
I rise in strong support of H.R. 269. This important bill
reauthorizes the Pandemic and All-Hazards Preparedness Act and provides
FDA with needed revenue and authority to improve oversight of over-the-
counter drugs.
The House of Representatives overwhelmingly passed this bipartisan
legislation at the end of the 115th Congress, and I am pleased that we
are acting on this bill once again at the beginning of the 116th
Congress. I am proud to have helped introduce this legislation, and I
urge my Senate colleagues to quickly pass this bill into law.
My chairman, Mr. Pallone and Representative Burgess have talked and
spoken well of why we must address the Pandemic and All-Hazards
Preparedness Act. Headlines in the Detroit paper today talking about a
death in an area hospital because of a power outage is why we must
prepare these institutions to be ready for crises, but I want to speak
about the over-the-counter part of this bill.
Today, 60 percent of all medicines sold in the United States are over
the counter. Americans trust that they are safe, yet the FDA has only
18 full-time employees--only 18--to oversee the entire market of drugs
sold across this country.
This outdated system has the potential to put patients at risk and
does not match the realities of our modern healthcare system.
The bill we are discussing today reforms this system for the better.
It creates a new user fee program to give FDA the resources it needs to
improve public health. It also improves the efficiency by allowing the
agency to update OTC monographs through administrative order rather
than the rulemaking process.
These changes are a big win for patients, who will benefit from
improved product safety, and for industry, as they will have a reliable
pathway to bring new, innovative products to market. It has been years
since a new sunscreen product has been brought to market simply because
of this outdated system.
I want to thank my colleagues on the Energy and Commerce Committee
for all the time and effort they put into this legislation; to
Representatives Eshoo and Brooks, who worked so hard on the Pandemic
and All-Hazards Preparedness Act; and to my colleague, Representative
DeGette, and my Republican colleagues, Representatives Latta, Guthrie,
and Burgess, for all the work that they did.
We need to get this important bill passed and into law. I urge my
colleagues to support H.R. 269.
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from
Ohio (Mr. Latta).
Mr. LATTA. Mr. Speaker, I rise today in support of H.R. 269, the
PAHPA OTC legislation, which includes a bill I authored last Congress,
the Over-the-Counter Monograph Safety, Innovation, and Reform Act.
More than 240 million Americans use over-the-counter medications for
relief of common ailments, such as headaches, colds, and seasonal
allergies. We trust and depend on these affordable remedies to get us
well and stay well.
Despite the success and high utilization of these medicines, the Food
and Drug Administration's regulatory structure for oversight of OTC
products, referred to as the monograph system, is outdated and
incomplete. The system was created more than 45 years ago, yet movement
on unfinished items has ground to a halt due to cumbersome notice and
comment rulemaking processes.
Without process modernization, it is nearly impossible for
manufacturers to address safety concerns and offers little incentive to
develop new products. This bill would provide meaningful and long
overdue reform to the FDA's monograph system. The reform will create a
more flexible framework that accounts for advances in science, allows
timely updates to safety label changes, and creates a workable process
for completing unfinished monographs.
This bill would also create a pathway to market for new and
innovative products, which would help to reduce strain on our
healthcare system by giving consumers more options to treat common
ailments at home. Furthermore, this legislation will improve regulatory
certainty for manufacturers. Over time, we would see increase
investment in research and development, leading to new OTC medicines on
our shelves, and providing greater self-care options to consumers.
Again, I thank my colleagues--Ms. DeGette, Mr. Guthrie, Mrs. Dingell,
Dr. Burgess, and former Member Mr. Gene Green from Texas--the FDA, and
stakeholders for working so closely with me over the last 3 years to
ensure that this modernization effort appropriately addresses and
resolves this complex issue.
{time} 1630
I believe modernization of the broken monograph system will
strengthen consumer protections, spur innovation, and expand consumer
choice. It is long overdue to fix this regulatory framework that
oversees 60 percent of the medicines sold in the United States.
Mr. Speaker, I strongly urge my colleagues to support passage of our
bipartisan bill, H.R. 269, PAHPA OTC.
Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I
reserve the balance my time.
Mr. BURGESS. Mr. Speaker, I yield 4 minutes to the gentlewoman from
Indiana (Mrs. Brooks), the principal author of the bill.
Mrs. BROOKS of Indiana. Mr. Speaker, I rise today in support of H.R.
269, the Pandemic and All-Hazards Preparedness and Advancing Innovation
Act, or PAHPA.
I am proud to have introduced this important bill with my very good
friend, Representative Anna Eshoo, who is one of the original authors
of the 2006 PAHPA bill and the lead author of the last reauthorization
in 2013.
Mr. Speaker, I want to thank Energy and Commerce Committee Chair
Representative Pallone and Ranking Member Representative Walden, as
well as Representative Burgess for his work on the Health Subcommittee,
and the committee staff for working to get this bill back on the House
floor so quickly as we begin the 116th Congress.
PAHPA is a bipartisan public health national security effort which
works to ensure our Nation is better prepared to respond, whether it is
to natural disasters like hurricanes, emerging infectious diseases like
Zika or Ebola, or chemical, biological, radiological, or nuclear
attacks, whether they might come from a terrorist group or from a
nation-state.
The reality is that these threats we face are not just hypothetical.
The ongoing Ebola outbreak is now, as you have already heard, the
second largest outbreak in history. Since August of 2018, 374 people in
the Democratic Republic of the Congo have died from Ebola, bringing the
total to 623 cases. Nine new cases have been confirmed in just the last
week alone.
Thanks to PAHPA and the 21st Century Cures Act, we are more prepared
for biological threats and attacks. Last year, the FDA approved the
first drug to treat smallpox and also an auto injector which provides a
one-time dose of an antidote to block effects of a nerve agent.
But PAHPA is much more than what we think of as just a biodefense
bill. It helps ensure a coordinated healthcare response, whether it is
to hurricanes and other natural disasters, by prioritizing our Nation's
most vulnerable populations: children, senior citizens, and people with
disabilities.
PAHPA provides liability protection for physicians who volunteer
after medical disasters. It ensures more healthcare professionals,
nurses and doctors and others, can be hired and trained when facing a
public health crisis. It ensures we have a robust supply of vaccines
and equipment like gloves,
[[Page H265]]
hazmat suits, and masks in our Strategic National Stockpiles so our
medical professionals and our first responders have what they need.
The bill ensures our preparedness and response capabilities will
include a robust pipeline of medical countermeasures by increasing
funding for the BioShield Special Reserve Fund and BARDA, whose work
over the last decade has resulted in FDA approvals for more than 42
different medical countermeasures.
While the investments BARDA is making into innovative research and
treatments are critical, we have to address the threats that have been
around for years.
As Mr. Burgess talked about, the 1918 influenza outbreak killed
675,000 Americans and millions worldwide. Many experts predict that we
are due for another global pandemic influenza. The bill today
authorizes $250 million to address threats like pan flu.
This bill is the result of months of committee work in both the House
and the Senate. I can't emphasize enough how critically important it is
that we reauthorize PAHPA.
Mr. Speaker, I encourage the Senate to quickly pass H.R. 269. I urge
all Members to support this critical piece of public health and
national security legislation.
Mr. PALLONE. Mr. Speaker, I have no additional speakers and am
prepared to close. I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from
Kentucky (Mr. Guthrie).
Mr. GUTHRIE. Mr. Speaker, I rise today in support of the Pandemic and
All-Hazards Preparedness and Advancing Innovation Act of 2019, which
includes legislation to update the over-the-counter monograph system.
Our healthcare system is innovating rapidly, and the Food and Drug
Administration can't keep up. The FDA's approval system for over-the-
counter medications has not been updated since the 1970s. By updating
the monograph approval system, we make it easier for over-the-counter
medicines to reach the market, providing an affordable way for
Americans to access healthcare treatment.
I was proud to work on over-the-counter monograph reform last
Congress with a number of my colleagues on the Energy and Commerce
Committee, with the efforts being led by Congressman Bob Latta, and it
was bipartisan.
Mr. Speaker, I urge my colleagues to support this bill on the floor
today.
Mr. BURGESS. Mr. Speaker, I urge all Members to support the bill
before us today, and I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, again, I would ask support for this
bipartisan bill. It is very important legislation, and I hope that we
can send it to the Senate and have the President quickly sign it.
Mr. Speaker, I yield back the balance of my time.
Ms. ESHOO. Mr. Speaker, I rise in support of this bipartisan
legislation, the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act. I've worked on this legislation with my partner
Representative Susan Brooks for almost a year and it reflects months of
negotiations and compromise reached by the House and Senate. This bill
also includes important updates to the Over-the-Counter Monograph
program at the Food and Drug Administration. I am proud to reintroduce
this bill in the 116th Congress and pleased the House is taking it up
so quickly.
The Pandemic and All-Hazards Preparedness and Advancing Innovation
Act we're considering today is critical to our national security. The
legislation updates the original Pandemic and All-Hazards Preparedness
Act I authored with then-Representativelichard Burr in 2006, by
directing federal agencies to respond to new and emerging threats, and
strengthen our nation's existing preparedness and response programs.
This legislation reauthorizes critical programs that ensure our nation
is prepared to respond to naturally occurring and manmade disasters.
These threats are real and our country must be prepared to adequately
respond to them. This reauthorization meets the challenges that we face
today and those we anticipate facing in the future. The policies in
this bill are almost identical to those passed under suspension by the
House in September 2018 with small changes made at the request of the
Senate. The House passed an identical bill at the end of the 115th
Congress by a vote of 367 to 9.
This bill also includes overdue updates to the Over-the-Counter
Monograph program which will streamline the process by which over-the-
counter products are regulated and approved by FDA and will improve
patient safety. It establishes a new user fee program that will enable
FDA to act faster to address safety issues associated with over-the-
counter drugs and bring innovative over-the-counter drugs to market.
It's imperative that after the House passes this legislation today
that the Senate take it up quickly and send it to the President's desk
as soon as possible. PAHPA expired on September 30th and reauthorizing
these programs is critical to our national security.
I'm proud of this legislation and I urge my colleagues to support the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
Ms. JACKSON LEE. Mr. Speaker, I rise today in support of H.R. 269,
the ``Pandemic and All-Hazards Preparedness and Advancing Innovation
Act of 2019.''
H.R. 269 reauthorizes and strengthens emergency preparedness and
response programs and efforts Health and Human Services (HHS) and
modernizes the regulatory framework at the Federal Drug Administration
(FDA) for over-the-counter (OTC) drugs and provide the FDA with stable
funding to do so through a new user fee program.
H.R. 269 strengthens HHS's emergency preparedness and response by
improving benchmarks and standards, addressing military and civilian
partnerships for trauma readiness, and clarifying state liability law
for volunteer health care professionals.
Additionally, H.R. 269 calls for reporting on the national blood
supply and public health preparedness and response capabilities and
capacities of hospitals, long-term care facilities, and other health
care facilities.
H.R. 269 also allows for the regulation of certain nonprescription
drugs that are marketed without an approved drug application, addresses
the misbranding of OTC drugs, and calls for an annual update to
Congress on the conditions under which certain OTC cough and cold drugs
are generally recognized as safe and effective for children.
H.R. 269 grants authority to assess and use OTC monograph fees as a
source of stable funding to the FDA for its use to modernize the
regulatory framework.
This legislation will benefit all communities by strengthening and
assessing the emergency response workforce, improving the preparedness
and response of health system infrastructure, taking into consideration
at-risk individuals and children, providing guidance for participation
in exercises and drills, and create national advisory committees on
disasters.
In 2014, Dallas, Texas was faced with an Ebola virus outbreak, one of
the world's most deadly viruses.
Howard Duncan was visiting family in Dallas when he became the first
person diagnosed with Ebola in the United States.
In addition to Duncan, two nurses who provided care to him also
became infected.
Zika made its first appearance in Texas in 2015.
In 2016 Texas had 315 cases of Zika, and in 2017, 55 cases were
confirmed.
2017 brought a high severity flu season along with Hurricane Harvey.
80,000 people died of the flu during the 2017 through 2018 season and
over 30,000 people, or 9 percent of the population, were hospitalized.
The severity of the 2017-2018 flu season was in part due to the flu
vaccine, unfortunately, only being effective against only 30 percent of
the viruses circulating.
Also in 2017, the 18th District of Texas and the Gulf Coast saw the
devastation of Hurricane Harvey.
The economic cost of Hurricane Harvey was $125 billion, tying it with
Hurricane Katrina as the most costly storm in U.S. history.
More importantly, 107 people lost their lives due to Hurricane
Harvey.
Then there is the ongoing shortage of medical supplies, specifically
saline solution.
Since 2014 there has been an ongoing shortage of saline, and when
Hurricane Maria hit Puerto Rico in 2017, the country's largest supplier
was damaged causing an even larger shortage.
The saline shortage coupled with a severe flu season in 2017-2018 has
some worried that the demand will quickly outpace the supply.
H.R. 269 will help address these and other local, state, and national
emergencies.
Not only does H.R. 269 address HHS emergency preparedness, but it
also allows the FDA to better do its job to keep Americans safe.
In 2018, the FDA issued at least 1,412 warning letters regarding the
misbranding of products under its jurisdiction.
An alarming number of these letters regard OTC drugs and supplements.
H.R. 269 provides the FDA a stable funding source so that it may
continue its regulation of
[[Page H266]]
certain nonprescription drugs that are marketed without an approved
drug application and address the misbranding of OTC drugs.
For these reasons, I ask my colleagues to join me in supporting H.R.
269.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 269.
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. PALLONE. 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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