[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 269 Engrossed in House (EH)]
<DOC>
116th CONGRESS
1st Session
H. R. 269
_______________________________________________________________________
AN ACT
To reauthorize certain programs under the Public Health Service Act and
the Federal Food, Drug, and Cosmetic Act with respect to public health
security and all-hazards preparedness and response, to clarify the
regulatory framework with respect to certain nonprescription drugs that
are marketed without an approved drug application, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 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''
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 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.--
(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'';
(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
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--
``(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 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:
``(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;
``(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 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
(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 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--
``(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 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) to support and expedite the research and development of
medical countermeasures, as applicable.
(d) Protection of National Security.--The Comptroller General of
the United States shall conduct the study and issue the assessment and
report under this section in a manner that does not compromise national
security.
SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING TECHNOLOGIES
AND THEIR POTENTIAL ROLE IN NATIONAL SECURITY.
(a) Meeting.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall convene a meeting to discuss the potential role
advancements in genomic engineering technologies (including
genome editing technologies) may have in advancing national
health security. Such meeting shall be held in a manner that
does not compromise national security.
(2) Attendees.--The attendees of the meeting under
paragraph (1)--
(A) shall include--
(i) representatives from the Office of the
Assistant Secretary for Preparedness and
Response, the National Institutes of Health,
the Centers for Disease Control and Prevention,
and the Food and Drug Administration; and
(ii) representatives from academic,
private, and nonprofit entities with expertise
in genome engineering technologies,
biopharmaceuticals, medicine, or biodefense,
and other relevant stakeholders; and
(B) may include--
(i) other representatives from the
Department of Health and Human Services, as the
Secretary determines appropriate; and
(ii) representatives from the Department of
Homeland Security, the Department of Defense,
the Department of Agriculture, and other
departments, as the Secretary may request for
the meeting.
(3) Topics.--The meeting under paragraph (1) shall include
a discussion of--
(A) the current state of the science of genomic
engineering technologies related to national health
security, including--
(i) medical countermeasure development,
including potential efficiencies in the
development pathway and detection technologies;
and
(ii) the international and domestic
regulation of products utilizing genome editing
technologies; and
(B) national security implications, including--
(i) capabilities of the United States to
leverage genomic engineering technologies as a
part of the medical countermeasure enterprise,
including current applicable research,
development, and application efforts underway
within the Department of Defense;
(ii) the potential for state and non-state
actors to utilize genomic engineering
technologies as a national health security
threat; and
(iii) security measures to monitor and
assess the potential threat that may result
from utilization of genomic engineering
technologies and related technologies for the
purpose of compromising national health
security.
(b) Report.--Not later than 270 days after the meeting described in
subsection (a) is held, the Assistant Secretary for Preparedness and
Response shall issue a report to the congressional committees of
jurisdiction on the topics discussed at such meeting, and provide
recommendations, as applicable, to utilize innovations in genomic
engineering (including genome editing) and related technologies as a
part of preparedness and response activities to advance national health
security. Such report shall be issued in a manner that does not
compromise national security.
SEC. 606. REPORT ON VACCINES DEVELOPMENT.
Not later than one year after the date of the enactment of this
Act, the Secretary of Health and Human Services shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a
report describing efforts and activities to coordinate with other
countries and international partners during recent public health
emergencies with respect to the research and advanced research on, and
development of, qualified pandemic or epidemic products (as defined in
section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)).
Such report may include information regarding relevant work carried out
under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C.
247d-7e(c)(5)(E)), through public-private partnerships, and through
collaborations with other countries to assist with or expedite the
research and development of qualified pandemic or epidemic products.
Such report shall not include information that may compromise national
security.
SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND HEALTH.
(a) Reauthorization of Mosquito Abatement for Safety and Health
Program.--Section 317S (42 U.S.C. 247b-21) is amended--
(1) in subsection (a)(1)(B)--
(A) by inserting ``including programs to address
emerging infectious mosquito-borne diseases,'' after
``subdivisions for control programs,''; and
(B) by inserting ``or improving existing control
programs'' before the period at the end;
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``, including
improvement,'' after ``operation'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in clause (ii), by striking
``or'' at the end;
(II) in clause (iii), by striking
the semicolon at the end and inserting
``, including an emerging infectious
mosquito-borne disease that presents a
serious public health threat; or''; and
(III) by adding at the end the
following:
``(iv) a public health emergency due to the
incidence or prevalence of a mosquito-borne
disease that presents a serious public health
threat;''; and
(ii) by amending subparagraph (D) to read
as follows:
``(D)(i) is located in a State that has received a
grant under subsection (a); or
``(ii) that demonstrates to the Secretary that the
control program is consistent with existing State
mosquito control plans or policies, or other applicable
State preparedness plans.'';
(C) in paragraph (4)(C), by striking ``that
extraordinary'' and all that follows through the period
at the end and inserting the following: ``that--
``(i) extraordinary economic conditions in
the political subdivision or consortium of
political subdivisions involved justify the
waiver; or
``(ii) the geographical area covered by a
political subdivision or consortium for a grant
under paragraph (1) has an extreme mosquito
control need due to--
``(I) the size or density of the
potentially impacted human population;
``(II) the size or density of a
mosquito population that requires
heightened control; or
``(III) the severity of the
mosquito-borne disease, such that
expected serious adverse health
outcomes for the human population
justify the waiver.''; and
(D) by amending paragraph (6) to read as follows:
``(6) Number of grants.--A political subdivision or a
consortium of political subdivisions may not receive more than
one grant under paragraph (1).''; and
(3) in subsection (f)--
(A) in paragraph (1) by striking ``for fiscal year
2003, and such sums as may be necessary for each of
fiscal years 2004 through 2007'' and inserting ``for
each of fiscal years 2019 through 2023'';
(B) in paragraph (2), by striking ``the Public
Health Security and Bioterrorism Preparedness and
Response Act of 2002'' and inserting ``this Act and
other medical and public health preparedness and
response laws''; and
(C) in paragraph (3)--
(i) in the paragraph heading, by striking
``2004'' and inserting ``2019''; and
(ii) by striking ``2004,'' and inserting
``2019,''.
(b) Epidemiology-Laboratory Capacity Grants.--Section 2821 (42
U.S.C. 300hh-31) is amended--
(1) in subsection (a)(1), by inserting ``, including
mosquito and other vector-borne diseases,'' after ``infectious
diseases''; and
(2) in subsection (b), by striking ``2010 through 2013''
and inserting ``2019 through 2023''.
TITLE VII--MISCELLANEOUS PROVISIONS
SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.
(a) Veterans Affairs.--Section 8117(g) of title 38, United States
Code, is amended by striking ``2014 through 2018'' and inserting ``2019
through 2023''.
(b) Vaccine Tracking and Distribution.--Section 319A(e) (42 U.S.C.
247d-1(e)) is amended by striking ``2014 through 2018'' and inserting
``2019 through 2023''.
(c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C.
247d(e)(8)) is amended by striking ``2018'' and inserting ``2023''.
(d) Strategic Innovation Partner.--Section 319L(c)(4)(E)(ix) (42
U.S.C. 247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and
inserting ``2023''.
(e) Limited Antitrust Exemption.--
(1) In general.--Section 405 of the Pandemic and All-
Hazards Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-6a
note) is amended--
(A) in subsection (a)(1)(A)--
(i) by striking ``Secretary of Health and
Human Services (referred to in this subsection
as the `Secretary')'' and inserting
``Secretary'';
(ii) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6b)) (as amended by
this Act'';
(iii) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6a)) (as amended by
this Act''; and
(iv) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6d)'';
(B) in subsection (b), by striking ``12-year'' and
inserting ``17-year'';
(C) by redesignating such section 405 as section
319L-1; and
(D) by transferring such section 319L-1, as
redesignated, to the Public Health Service Act (42
U.S.C. 201 et seq.), to appear after section 319L of
such Act (42 U.S.C. 247d-7e).
(2) Conforming amendment.--The table of contents in section
1(b) of the Pandemic and All-Hazards Preparedness Act (Public
Law 109-417) is amended by striking the item related to section
405.
(f) Inapplicability of Certain Provisions.--Subsection (e)(1) of
section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
(1) by amending subparagraph (A) to read as follows:
``(A) 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:
``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE
MARKETED WITHOUT AN APPROVED DRUG APPLICATION.
``(a) Nonprescription Drugs Marketed Without an Approved
Application.--Nonprescription drugs marketed without an approved drug
application under section 505, as of the date of the enactment of this
section, shall be treated in accordance with this subsection.
``(1) Drugs subject to a final monograph; category i drugs
subject to a tentative final monograph.--A drug is deemed to be
generally recognized as safe and effective under section
201(p)(1), not a new drug under section 201(p), and not subject
to section 503(b)(1), if--
``(A) the drug is--
``(i) in conformity with the requirements
for nonprescription use of a final monograph
issued under part 330 of title 21, Code of
Federal Regulations (except as provided in
paragraph (2)), the general requirements for
nonprescription drugs, and conditions or
requirements under subsections (b), (c), and
(k); and
``(ii) except as permitted by an order
issued under subsection (b) or, in the case of
a minor change in the drug, in conformity with
an order issued under subsection (c), in a
dosage form that, immediately prior to the date
of the enactment of this section, has been used
to a material extent and for a material time
under section 201(p)(2); or
``(B) the drug is--
``(i) classified in category I for safety
and effectiveness under a tentative final
monograph that is the most recently applicable
proposal or determination issued under part 330
of title 21, Code of Federal Regulations;
``(ii) in conformity with the proposed
requirements for nonprescription use of such
tentative final monograph, any applicable
subsequent determination by the Secretary, the
general requirements for nonprescription drugs,
and conditions or requirements under
subsections (b), (c), and (k); and
``(iii) except as permitted by an order
issued under subsection (b) or, in the case of
a minor change in the drug, in conformity with
an order issued under subsection (c), in a
dosage form that, immediately prior to the date
of the enactment of this section, has been used
to a material extent and for a material time
under section 201(p)(2).
``(2) Treatment of sunscreen drugs.--With respect to
sunscreen drugs subject to this section, the applicable
requirements in terms of conformity with a final monograph, for
purposes of paragraph (1)(A)(i), shall be the requirements
specified in part 352 of title 21, Code of Federal Regulations,
as published on May 21, 1999, beginning on page 27687 of volume
64 of the Federal Register, except that the applicable
requirements governing effectiveness and labeling shall be
those specified in section 201.327 of title 21, Code of Federal
Regulations.
``(3) Category iii drugs subject to a tentative final
monograph; category i drugs subject to proposed monograph or
advance notice of proposed rulemaking.--A drug that is not
described in paragraph (1), (2), or (4) is not required to be
the subject of an application approved under section 505, and
is not subject to section 503(b)(1), if--
``(A) the drug is--
``(i) classified in category III for safety
or effectiveness in the preamble of a proposed
rule establishing a tentative final monograph
that is the most recently applicable proposal
or determination for such drug issued under
part 330 of title 21, Code of Federal
Regulations;
``(ii) in conformity with--
``(I) the conditions of use,
including indication and dosage
strength, if any, described for such
category III drug in such preamble or
in an applicable subsequent proposed
rule;
``(II) the proposed requirements
for drugs classified in such tentative
final monograph in category I in the
most recently proposed rule
establishing requirements related to
such tentative final monograph and in
any final rule establishing
requirements that are applicable to the
drug; and
``(III) the general requirements
for nonprescription drugs and
conditions or requirements under
subsection (b) or (k); and
``(iii) in a dosage form that, immediately
prior to the date of the enactment of this
section, had been used to a material extent and
for a material time under section 201(p)(2); or
``(B) the drug is--
``(i) classified in category I for safety
and effectiveness under a proposed monograph or
advance notice of proposed rulemaking that is
the most recently applicable proposal or
determination for such drug issued under part
330 of title 21, Code of Federal Regulations;
``(ii) in conformity with the requirements
for nonprescription use of such proposed
monograph or advance notice of proposed
rulemaking, any applicable subsequent
determination by the Secretary, the general
requirements for nonprescription drugs, and
conditions or requirements under subsection (b)
or (k); and
``(iii) in a dosage form that, immediately
prior to the date of the enactment of this
section, has been used to a material extent and
for a material time under section 201(p)(2).
``(4) Category ii drugs deemed new drugs.--A drug that is
classified in category II for safety or effectiveness under a
tentative final monograph or that is subject to a determination
to be not generally recognized as safe and effective in a
proposed rule that is the most recently applicable proposal
issued under part 330 of title 21, Code of Federal Regulations,
shall be deemed to be a new drug under section 201(p),
misbranded under section 502(ee), and subject to the
requirement for an approved new drug application under section
505 beginning on the day that is 180 calendar days after the
date of the enactment of this section, unless, before such day,
the Secretary determines that it is in the interest of public
health to extend the period during which the drug may be
marketed without such an approved new drug application.
``(5) Drugs not grase deemed new drugs.--A drug that the
Secretary has determined not to be generally recognized as safe
and effective under section 201(p)(1) under a final
determination issued under part 330 of title 21, Code of
Federal Regulations, shall be deemed to be a new drug under
section 201(p), misbranded under section 502(ee), and subject
to the requirement for an approved new drug application under
section 505.
``(6) Other drugs deemed new drugs.--Except as provided in
subsection (m), a drug is deemed to be a new drug under section
201(p) and misbranded under section 502(ee) if the drug--
``(A) is not subject to section 503(b)(1); and
``(B) is not described in paragraph (1), (2), (3),
(4), or (5), or subsection (b)(1)(B).
``(b) Administrative Orders.--
``(1) In general.--
``(A) Determination.--The Secretary may, on the
initiative of the Secretary or at the request of one or
more requestors, issue an administrative order
determining whether there are conditions under which a
specific drug, a class of drugs, or a combination of
drugs, is determined to be--
``(i) not subject to section 503(b)(1); and
``(ii) generally recognized as safe and
effective under section 201(p)(1).
``(B) Effect.--A drug or combination of drugs shall
be deemed to not require approval under section 505 if
such drug or combination of drugs--
``(i) is determined by the Secretary to
meet the conditions specified in clauses (i)
and (ii) of subparagraph (A);
``(ii) is marketed in conformity with an
administrative order under this subsection;
``(iii) meets the general requirements for
nonprescription drugs; and
``(iv) meets the requirements under
subsections (c) and (k).
``(C) Standard.--The Secretary shall find that a
drug is not generally recognized as safe and effective
under section 201(p)(1) if--
``(i) the evidence shows that the drug is
not generally recognized as safe and effective
under section 201(p)(1); or
``(ii) the evidence is inadequate to show
that the drug is generally recognized as safe
and effective under section 201(p)(1).
``(2) Administrative orders initiated by the secretary.--
``(A) In general.--In issuing an administrative
order under paragraph (1) upon the Secretary's
initiative, the Secretary shall--
``(i) make reasonable efforts to notify
informally, not later than 2 business days
before the issuance of the proposed order, the
sponsors of drugs who have a listing in effect
under section 510(j) for the drugs or
combination of drugs that will be subject to
the administrative order;
``(ii) after any such reasonable efforts of
notification--
``(I) issue a proposed
administrative order by publishing it
on the website of the Food and Drug
Administration and include in such
order the reasons for the issuance of
such order; and
``(II) publish a notice of
availability of such proposed order in
the Federal Register;
``(iii) except as provided in subparagraph
(B), provide for a public comment period with
respect to such proposed order of not less than
45 calendar days; and
``(iv) if, after completion of the
proceedings specified in clauses (i) through
(iii), the Secretary determines that it is
appropriate to issue a final administrative
order--
``(I) issue the final
administrative order, together with a
detailed statement of reasons, which
order shall not take effect until the
time for requesting judicial review
under paragraph (3)(D)(ii) has expired;
``(II) publish a notice of such
final administrative order in the
Federal Register;
``(III) afford requestors of drugs
that will be subject to such order the
opportunity for formal dispute
resolution up to the level of the
Director of the Center for Drug
Evaluation and Research, which
initially must be requested within 45
calendar days of the issuance of the
order, and, for subsequent levels of
appeal, within 30 calendar days of the
prior decision; and
``(IV) except with respect to drugs
described in paragraph (3)(B), upon
completion of the formal dispute
resolution procedure, inform the
persons which sought such dispute
resolution of their right to request a
hearing.
``(B) Exceptions.--When issuing an administrative
order under paragraph (1) on the Secretary's initiative
proposing to determine that a drug described in
subsection (a)(3) is not generally recognized as safe
and effective under section 201(p)(1), the Secretary
shall follow the procedures in subparagraph (A), except
that--
``(i) the proposed order shall include
notice of--
``(I) the general categories of
data the Secretary has determined
necessary to establish that the drug is
generally recognized as safe and
effective under section 201(p)(1); and
``(II) the format for submissions
by interested persons;
``(ii) the Secretary shall provide for a
public comment period of no less than 180
calendar days with respect to such proposed
order, except when the Secretary determines,
for good cause, that a shorter period is in the
interest of public health; and
``(iii) any person who submits data in such
comment period shall include a certification
that the person has submitted all evidence
created, obtained, or received by that person
that is both within the categories of data
identified in the proposed order and relevant
to a determination as to whether the drug is
generally recognized as safe and effective
under section 201(p)(1).
``(3) Hearings; judicial review.--
``(A) In general.--Only a person who participated
in each stage of formal dispute resolution under
subclause (III) of paragraph (2)(A)(iv) of an
administrative order with respect to a drug may request
a hearing concerning a final administrative order
issued under such paragraph with respect to such drug.
If a hearing is sought, such person must submit a
request for a hearing, which shall be based solely on
information in the administrative record, to the
Secretary not later than 30 calendar days after
receiving notice of the final decision of the formal
dispute resolution procedure.
``(B) No hearing required with respect to orders
relating to certain drugs.--
``(i) In general.--The Secretary shall not
be required to provide notice and an
opportunity for a hearing pursuant to paragraph
(2)(A)(iv) if the final administrative order
involved relates to a drug--
``(I) that is described in
subsection (a)(3)(A); and
``(II) with respect to which no
human or non-human data studies
relevant to the safety or effectiveness
of such drug have been submitted to the
administrative record since the
issuance of the most recent tentative
final monograph relating to such drug.
``(ii) Human data studies and non-human
data defined.--In this subparagraph:
``(I) The term `human data studies'
means clinical trials of safety or
effectiveness (including actual use
studies), pharmacokinetics studies, or
bioavailability studies.
``(II) The term `non-human data'
means data from testing other than with
human subjects which provides
information concerning safety or
effectiveness.
``(C) Hearing procedures.--
``(i) Denial of request for hearing.--If
the Secretary determines that information
submitted in a request for a hearing under
subparagraph (A) with respect to a final
administrative order issued under paragraph
(2)(A)(iv) does not identify the existence of a
genuine and substantial question of material
fact, the Secretary may deny such request. In
making such a determination, the Secretary may
consider only information and data that are
based on relevant and reliable scientific
principles and methodologies.
``(ii) Single hearing for multiple related
requests.--If more than one request for a
hearing is submitted with respect to the same
administrative order under subparagraph (A),
the Secretary may direct that a single hearing
be conducted in which all persons whose hearing
requests were granted may participate.
``(iii) Presiding officer.--The presiding
officer of a hearing requested under
subparagraph (A) shall--
``(I) be designated by the
Secretary;
``(II) not be an employee of the
Center for Drug Evaluation and
Research; and
``(III) not have been previously
involved in the development of the
administrative order involved or
proceedings relating to that
administrative order.
``(iv) Rights of parties to hearing.--The
parties to a hearing requested under
subparagraph (A) shall have the right to
present testimony, including testimony of
expert witnesses, and to cross-examine
witnesses presented by other parties. Where
appropriate, the presiding officer may require
that cross-examination by parties representing
substantially the same interests be
consolidated to promote efficiency and avoid
duplication.
``(v) Final decision.--
``(I) At the conclusion of a
hearing requested under subparagraph
(A), the presiding officer of the
hearing shall issue a decision
containing findings of fact and
conclusions of law. The decision of the
presiding officer shall be final.
``(II) The final decision may not
take effect until the period under
subparagraph (D)(ii) for submitting a
request for judicial review of such
decision expires.
``(D) Judicial review of final administrative
order.--
``(i) In general.--The procedures described
in section 505(h) shall apply with respect to
judicial review of final administrative orders
issued under this subsection in the same manner
and to the same extent as such section applies
to an order described in such section except
that the judicial review shall be taken by
filing in an appropriate district court of the
United States in lieu of the appellate courts
specified in such section.
``(ii) Period to submit a request for
judicial review.--A person eligible to request
a hearing under this paragraph and seeking
judicial review of a final administrative order
issued under this subsection shall file such
request for judicial review not later than 60
calendar days after the latest of--
``(I) the date on which notice of
such order is published;
``(II) the date on which a hearing
with respect to such order is denied
under subparagraph (B) or (C)(i);
``(III) the date on which a final
decision is made following a hearing
under subparagraph (C)(v); or
``(IV) if no hearing is requested,
the date on which the time for
requesting a hearing expires.
``(4) Expedited procedure with respect to administrative
orders initiated by the secretary.--
``(A) Imminent hazard to the public health.--
``(i) In general.--In the case of a
determination by the Secretary that a drug,
class of drugs, or combination of drugs subject
to this section poses an imminent hazard to the
public health, the Secretary, after first
making reasonable efforts to notify, not later
than 48 hours before issuance of such order
under this subparagraph, sponsors who have a
listing in effect under section 510(j) for such
drug or combination of drugs--
``(I) may issue an interim final
administrative order for such drug,
class of drugs, or combination of drugs
under paragraph (1), together with a
detailed statement of the reasons for
such order;
``(II) shall publish in the Federal
Register a notice of availability of
any such order; and
``(III) shall provide for a public
comment period of at least 45 calendar
days with respect to such interim final
order.
``(ii) Nondelegation.--The Secretary may
not delegate the authority to issue an interim
final administrative order under this
subparagraph.
``(B) Safety labeling changes.--
``(i) In general.--In the case of a
determination by the Secretary that a change in
the labeling of a drug, class of drugs, or
combination of drugs subject to this section is
reasonably expected to mitigate a significant
or unreasonable risk of a serious adverse event
associated with use of the drug, the Secretary
may--
``(I) make reasonable efforts to
notify informally, not later than 48
hours before the issuance of the
interim final order, the sponsors of
drugs who have a listing in effect
under section 510(j) for such drug or
combination of drugs;
``(II) after reasonable efforts of
notification, issue an interim final
administrative order in accordance with
paragraph (1) to require such change,
together with a detailed statement of
the reasons for such order;
``(III) publish in the Federal
Register a notice of availability of
such order; and
``(IV) provide for a public comment
period of at least 45 calendar days
with respect to such interim final
order.
``(ii) Content of order.--An interim final
order issued under this subparagraph with
respect to the labeling of a drug may provide
for new warnings and other information required
for safe use of the drug.
``(C) Effective date.--An order under subparagraph
(A) or (B) shall take effect on a date specified by the
Secretary.
``(D) Final order.--After the completion of the
proceedings in subparagraph (A) or (B), the Secretary
shall--
``(i) issue a final order in accordance
with paragraph (1);
``(ii) publish a notice of availability of
such final administrative order in the Federal
Register; and
``(iii) afford sponsors of such drugs that
will be subject to such an order the
opportunity for formal dispute resolution up to
the level of the Director of the Center for
Drug Evaluation and Research, which must
initially be within 45 calendar days of the
issuance of the order, and for subsequent
levels of appeal, within 30 calendar days of
the prior decision.
``(E) Hearings.--A sponsor of a drug subject to a
final order issued under subparagraph (D) and that
participated in each stage of formal dispute resolution
under clause (iii) of such subparagraph may request a
hearing on such order. The provisions of subparagraphs
(A), (B), and (C) of paragraph (3), other than
paragraph (3)(C)(v)(II), shall apply with respect to a
hearing on such order in the same manner and to the
same extent as such provisions apply with respect to a
hearing on an administrative order issued under
paragraph (2)(A)(iv).
``(F) Timing.--
``(i) Final order and hearing.--The
Secretary shall--
``(I) not later than 6 months after
the date on which the comment period
closes under subparagraph (A) or (B),
issue a final order in accordance with
paragraph (1); and
``(II) not later than 12 months
after the date on which such final
order is issued, complete any hearing
under subparagraph (E).
``(ii) Dispute resolution request.--The
Secretary shall specify in an interim final
order issued under subparagraph (A) or (B) such
shorter periods for requesting dispute
resolution under subparagraph (D)(iii) as are
necessary to meet the requirements of this
subparagraph.
``(G) Judicial review.--A final order issued
pursuant to subparagraph (F) shall be subject to
judicial review in accordance with paragraph (3)(D).
``(5) Administrative order initiated at the request of a
requestor.--
``(A) In general.--In issuing an administrative
order under paragraph (1) at the request of a requestor
with respect to certain drugs, classes of drugs, or
combinations of drugs--
``(i) the Secretary shall, after receiving
a request under this subparagraph, determine
whether the request is sufficiently complete
and formatted to permit a substantive review;
``(ii) if the Secretary determines that the
request is sufficiently complete and formatted
to permit a substantive review, the Secretary
shall--
``(I) file the request; and
``(II) initiate proceedings with
respect to issuing an administrative
order in accordance with paragraphs (2)
and (3); and
``(iii) except as provided in paragraph
(6), if the Secretary determines that a request
does not meet the requirements for filing or is
not sufficiently complete and formatted to
permit a substantive review, the requestor may
demand that the request be filed over protest,
and the Secretary shall initiate proceedings to
review the request in accordance with paragraph
(2)(A).
``(B) Request to initiate proceedings.--
``(i) In general.--A requestor seeking an
administrative order under paragraph (1) with
respect to certain drugs, classes of drugs, or
combinations of drugs, shall submit to the
Secretary a request to initiate proceedings for
such order in the form and manner as specified
by the Secretary. Such requestor may submit a
request under this subparagraph for the
issuance of an administrative order--
``(I) determining whether a drug is
generally recognized as safe and
effective under section 201(p)(1),
exempt from section 503(b)(1), and not
required to be the subject of an
approved application under section 505;
or
``(II) determining whether a change
to a condition of use of a drug is
generally recognized as safe and
effective under section 201(p)(1),
exempt from section 503(b)(1), and not
required to be the subject of an
approved application under section 505,
if, absent such a changed condition of
use, such drug is--
``(aa) generally recognized
as safe and effective under
section 201(p)(1) in accordance
with subsection (a)(1), (a)(2),
or an order under this
subsection; or
``(bb) subject to
subsection (a)(3), but only if
such requestor initiates such
request in conjunction with a
request for the Secretary to
determine whether such drug is
generally recognized as safe
and effective under section
201(p)(1), which is filed by
the Secretary under
subparagraph (A)(ii).
``(ii) Exception.--The Secretary is not
required to complete review of a request for a
change described in clause (i)(II) if the
Secretary determines that there is an
inadequate basis to find the drug is generally
recognized as safe and effective under section
201(p)(1) under paragraph (1) and issues a
final order announcing that determination.
``(iii) Withdrawal.--The requestor may
withdraw a request under this paragraph,
according to the procedures set forth pursuant
to subsection (d)(2)(B). Notwithstanding any
other provision of this section, if such
request is withdrawn, the Secretary may cease
proceedings under this subparagraph.
``(C) Exclusivity.--
``(i) In general.--A final administrative
order issued in response to a request under
this section shall have the effect of
authorizing solely the order requestor (or the
licensees, assignees, or successors in interest
of such requestor with respect to the subject
of such order), for a period of 18 months
following the effective date of such final
order and beginning on the date the requestor
may lawfully market such drugs pursuant to the
order, to market drugs--
``(I) incorporating changes
described in clause (ii); and
``(II) subject to the limitations
under clause (iv).
``(ii) Changes described.--A change
described in this clause is a change subject to
an order specified in clause (i), which--
``(I) provides for a drug to
contain an active ingredient (including
any ester or salt of the active
ingredient) not previously incorporated
in a drug described in clause (iii); or
``(II) provides for a change in the
conditions of use of a drug, for which
new human data studies conducted or
sponsored by the requestor (or for
which the requestor has an exclusive
right of reference) were essential to
the issuance of such order.
``(iii) Drugs described.--The drugs
described in this clause are drugs--
``(I) specified in subsection
(a)(1), (a)(2), or (a)(3);
``(II) subject to a final order
issued under this section;
``(III) subject to a final
sunscreen order (as defined in section
586(2)(A)); or
``(IV) described in subsection
(m)(1), other than drugs subject to an
active enforcement action under chapter
III of this Act.
``(iv) Limitations on exclusivity.--
``(I) In general.--Only one 18-
month period under this subparagraph
shall be granted, under each order
described in clause (i), with respect
to changes (to the drug subject to such
order) which are either--
``(aa) changes described in
clause (ii)(I), relating to
active ingredients; or
``(bb) changes described in
clause (ii)(II), relating to
conditions of use.
``(II) No exclusivity allowed.--No
exclusivity shall apply to changes to a
drug which are--
``(aa) the subject of a
Tier 2 OTC monograph order
request (as defined in section
744L);
``(bb) safety-related
changes, as defined by the
Secretary, or any other changes
the Secretary considers
necessary to assure safe use;
or
``(cc) changes related to
methods of testing safety or
efficacy.
``(v) New human data studies defined.--In
this subparagraph, the term `new human data
studies' means clinical trials of safety or
effectiveness (including actual use studies),
pharmacokinetics studies, or bioavailability
studies, the results of which--
``(I) have not been relied on by
the Secretary to support--
``(aa) a proposed or final
determination that a drug
described in subclause (I),
(II), or (III) of clause (iii)
is generally recognized as safe
and effective under section
201(p)(1); or
``(bb) approval of a drug
that was approved under section
505; and
``(II) do not duplicate the results
of another study that was relied on by
the Secretary to support--
``(aa) a proposed or final
determination that a drug
described in subclause (I),
(II), or (III) of clause (iii)
is generally recognized as safe
and effective under section
201(p)(1); or
``(bb) approval of a drug
that was approved under section
505.
``(6) Information regarding safe nonprescription marketing
and use as condition for filing a generally recognized as safe
and effective request.--
``(A) In general.--In response to a request under
this section that a drug described in subparagraph (B)
be generally recognized as safe and effective, the
Secretary--
``(i) may file such request, if the request
includes information specified under
subparagraph (C) with respect to safe
nonprescription marketing and use of such drug;
or
``(ii) if the request fails to include
information specified under subparagraph (C),
shall refuse to file such request and require
that nonprescription marketing of the drug be
pursuant to a new drug application as described
in subparagraph (D).
``(B) Drug described.--A drug described in this
subparagraph is a nonprescription drug which contains
an active ingredient not previously incorporated in a
drug--
``(i) specified in subsection (a)(1),
(a)(2), or (a)(3);
``(ii) subject to a final order under this
section; or
``(iii) subject to a final sunscreen order
(as defined in section 586(2)(A)).
``(C) Information demonstrating prima facie safe
nonprescription marketing and use.--Information
specified in this subparagraph, with respect to a
request described in subparagraph (A)(i), is--
``(i) information sufficient for a prima
facie demonstration that the drug subject to
such request has a verifiable history of being
marketed and safely used by consumers in the
United States as a nonprescription drug under
comparable conditions of use;
``(ii) if the drug has not been previously
marketed in the United States as a
nonprescription drug, information sufficient
for a prima facie demonstration that the drug
was marketed and safely used under comparable
conditions of marketing and use in a country
listed in section 802(b)(1)(A) or designated by
the Secretary in accordance with section
802(b)(1)(B)--
``(I) for such period as needed to
provide reasonable assurances
concerning the safe nonprescription use
of the drug; and
``(II) during such time was subject
to sufficient monitoring by a
regulatory body considered acceptable
by the Secretary for such monitoring
purposes, including for adverse events
associated with nonprescription use of
the drug; or
``(iii) if the Secretary determines that
information described in clause (i) or (ii) is
not needed to provide a prima facie
demonstration that the drug can be safely
marketed and used as a nonprescription drug,
such other information the Secretary determines
is sufficient for such purposes.
``(D) Marketing pursuant to new drug application.--
In the case of a request described in subparagraph
(A)(ii), the drug subject to such request may be
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.--
``(A) In general.--A final monograph or tentative
final monograph described in subparagraph (B) shall be
deemed to be a final administrative order under this
subsection and may be amended, revoked, or otherwise
modified in accordance with the procedures of this
subsection.
``(B) Monographs described.--For purposes of
subparagraph (A), a final monograph or tentative final
monograph is described in this subparagraph if it--
``(i) establishes conditions of use for a
drug described in paragraph (1) or (2) of
subsection (a); and
``(ii) represents the most recently
promulgated version of such conditions,
including as modified, in whole or in part, by
any proposed or final rule.
``(C) Deemed orders include harmonizing technical
amendments.--The deemed establishment of a final
administrative order under subparagraph (A) shall be
construed to include any technical amendments to such
order as the Secretary determines necessary to ensure
that such order is appropriately harmonized, in terms
of terminology or cross-references, with the applicable
provisions of this Act (and regulations thereunder) and
any other orders issued under this section.
``(c) Procedure for Minor Changes.--
``(1) In general.--Minor changes in the dosage form of a
drug that is described in paragraph (1) or (2) of subsection
(a) or the subject of an order issued under subsection (b) may
be made by a requestor without the issuance of an order under
subsection (b) if--
``(A) the requestor maintains such information as
is necessary to demonstrate that the change--
``(i) will not affect the safety or
effectiveness of the drug; and
``(ii) will not materially affect the
extent of absorption or other exposure to the
active ingredient in comparison to a suitable
reference product; and
``(B) the change is in conformity with the
requirements of an applicable administrative order
issued by the Secretary under paragraph (3).
``(2) Additional information.--
``(A) Access to records.--A sponsor shall submit
records requested by the Secretary relating to such a
minor change under section 704(a)(4), within 15
business days of receiving such a request, or such
longer period as the Secretary may provide.
``(B) Insufficient information.--If the Secretary
determines that the information contained in such
records is not sufficient to demonstrate that the
change does not affect the safety or effectiveness of
the drug or materially affect the extent of absorption
or other exposure to the active ingredient, the
Secretary--
``(i) may so inform the sponsor of the drug
in writing; and
``(ii) if the Secretary so informs the
sponsor, shall provide the sponsor of the drug
with a reasonable opportunity to provide
additional information.
``(C) Failure to submit sufficient information.--If
the sponsor fails to provide such additional
information within a time prescribed by the Secretary,
or if the Secretary determines that such additional
information does not demonstrate that the change does
not--
``(i) affect the safety or effectiveness of
the drug; or
``(ii) materially affect the extent of
absorption or other exposure to the active
ingredient in comparison to a suitable
reference product,
the drug as modified is a new drug under section 201(p)
and shall be deemed to be misbranded under section
502(ee).
``(3) Determining whether a change will affect safety or
effectiveness.--
``(A) In general.--The Secretary shall issue one or
more administrative orders specifying requirements for
determining whether a minor change made by a sponsor
pursuant to this subsection will affect the safety or
effectiveness of a drug or materially affect the extent
of absorption or other exposure to an active ingredient
in the drug in comparison to a suitable reference
product, together with guidance for applying those
orders to specific dosage forms.
``(B) Standard practices.--The orders and guidance
issued by the Secretary under subparagraph (A) shall
take into account relevant public standards and
standard practices for evaluating the quality of drugs,
and may take into account the special needs of
populations, including children.
``(d) Confidentiality of Information Submitted to the Secretary.--
``(1) In general.--Subject to paragraph (2), any
information, including reports of testing conducted on the drug
or drugs involved, that is submitted by a requestor in
connection with proceedings on an order under this section
(including any minor change under subsection (c)) and is a
trade secret or confidential information subject to section
552(b)(4) of title 5, United States Code, or section 1905 of
title 18, United States Code, shall not be disclosed to the
public unless the requestor consents to that disclosure.
``(2) Public availability.--
``(A) In general.--Except as provided in
subparagraph (B), the Secretary shall--
``(i) make any information submitted by a
requestor in support of a request under
subsection (b)(5)(A) available to the public
not later than the date on which the proposed
order is issued; and
``(ii) make any information submitted by
any other person with respect to an order
requested (or initiated by the Secretary) under
subsection (b), available to the public upon
such submission.
``(B) Limitations on public availability.--
Information described in subparagraph (A) shall not be
made public if--
``(i) the information pertains to
pharmaceutical quality information, unless such
information is necessary to establish standards
under which a drug is generally recognized as
safe and effective under section 201(p)(1);
``(ii) the information is submitted in a
requestor-initiated request, but the requestor
withdraws such request, in accordance with
withdrawal procedures established by the
Secretary, before the Secretary issues the
proposed order;
``(iii) the Secretary requests and obtains
the information under subsection (c) and such
information is not submitted in relation to an
order under subsection (b); or
``(iv) the information is of the type
contained in raw datasets.
``(e) Updates to Drug Listing Information.--A sponsor who makes a
change to a drug subject to this section shall submit updated drug
listing information for the drug in accordance with section 510(j)
within 30 calendar days of the date when the drug is first commercially
marketed, except that a sponsor who was the order requestor with
respect to an order subject to subsection (b)(5)(C) (or a licensee,
assignee, or successor in interest of such requestor) shall submit
updated drug listing information on or before the date when the drug is
first commercially marketed.
``(f) Approvals Under Section 505.--The provisions of this section
shall not be construed to preclude a person from seeking or maintaining
the approval of an application for a drug under sections 505(b)(1),
505(b)(2), and 505(j). A determination under this section that a drug
is not subject to section 503(b)(1), is generally recognized as safe
and effective under section 201(p)(1), and is not a new drug under
section 201(p) shall constitute a finding that the drug is safe and
effective that may be relied upon for purposes of an application under
section 505(b)(2), so that the applicant shall be required to submit
for purposes of such application only information needed to support any
modification of the drug that is not covered by such determination
under this section.
``(g) Public Availability of Administrative Orders.--The Secretary
shall establish, maintain, update (as determined necessary by the
Secretary but no less frequently than annually), and make publicly
available, with respect to orders issued under this section--
``(1) a repository of each final order and interim final
order in effect, including the complete text of the order; and
``(2) a listing of all orders proposed and under
development under subsection (b)(2), including--
``(A) a brief description of each such order; and
``(B) the Secretary's expectations, if resources
permit, for issuance of proposed orders over a 3-year
period.
``(h) Development Advice to Sponsors or Requestors.--The Secretary
shall establish procedures under which sponsors or requestors may meet
with appropriate officials of the Food and Drug Administration to
obtain advice on the studies and other information necessary to support
submissions under this section and other matters relevant to the
regulation of nonprescription drugs and the development of new
nonprescription drugs under this section.
``(i) Participation of Multiple Sponsors or Requestors.--The
Secretary shall establish procedures to facilitate efficient
participation by multiple sponsors or requestors in proceedings under
this section, including provision for joint meetings with multiple
sponsors or requestors or with organizations nominated by sponsors or
requestors to represent their interests in a proceeding.
``(j) Electronic Format.--All submissions under this section shall
be in electronic format.
``(k) Effect on Existing Regulations Governing Nonprescription
Drugs.--
``(1) Regulations of general applicability to
nonprescription drugs.--Except as provided in this subsection,
nothing in this section supersedes regulations establishing
general requirements for nonprescription drugs, including
regulations of general applicability contained in parts 201,
250, and 330 of title 21, Code of Federal Regulations, or any
successor regulations. The Secretary shall establish or modify
such regulations by means of rulemaking in accordance with
section 553 of title 5, United States Code.
``(2) Regulations establishing requirements for specific
nonprescription drugs.--
``(A) The provisions of section 310.545 of title
21, Code of Federal Regulations, as in effect on the
day before the date of the enactment of this section,
shall be deemed to be a final order under subsection
(b).
``(B) Regulations in effect on the day before the
date of the enactment of this section, establishing
requirements for specific nonprescription drugs
marketed pursuant to this section (including such
requirements in parts 201 and 250 of title 21, Code of
Federal Regulations), shall be deemed to be final
orders under subsection (b), only as they apply to
drugs--
``(i) subject to paragraph (1), (2), (3),
or (4) of subsection (a); or
``(ii) otherwise subject to an order under
this section.
``(3) Withdrawal of regulations.--The Secretary shall
withdraw regulations establishing final monographs and the
procedures governing the over-the-counter drug review under
part 330 and other relevant parts of title 21, Code of Federal
Regulations (as in effect on the day before the date of the
enactment of this section), or make technical changes to such
regulations to ensure conformity with appropriate terminology
and cross references. Notwithstanding subchapter II of chapter
5 of title 5, United States Code, any such withdrawal or
technical changes shall be made without public notice and
comment and shall be effective upon publication through notice
in the Federal Register (or upon such date as specified in such
notice).
``(l) Guidance.--The Secretary shall issue guidance that
specifies--
``(1) the procedures and principles for formal meetings
between the Secretary and sponsors or requestors for drugs
subject to this section;
``(2) the format and content of data submissions to the
Secretary under this section;
``(3) the format of electronic submissions to the Secretary
under this section;
``(4) consolidated proceedings for appeal and the
procedures for such proceedings where appropriate; and
``(5) for minor changes in drugs, recommendations on how to
comply with the requirements in orders issued under subsection
(c)(3).
``(m) Rule of Construction.--
``(1) In general.--This section shall not affect the
treatment or status of a nonprescription drug--
``(A) that is marketed without an application
approved under section 505 as of the date of the
enactment of this section;
``(B) that is not subject to an order issued under
this section; and
``(C) to which paragraphs (1), (2), (3), (4), or
(5) of subsection (a) do not apply.
``(2) Treatment of products previously found to be subject
to time and extent requirements.--
``(A) Notwithstanding subsection (a), a drug
described in subparagraph (B) may only be lawfully
marketed, without an application approved under section
505, pursuant to an order issued under this section.
``(B) A drug described in this subparagraph is a
drug which, prior to the date of the enactment of this
section, the Secretary determined in a proposed or
final rule to be ineligible for review under the OTC
drug review (as such phrase `OTC drug review' was used
in section 330.14 of title 21, Code of Federal
Regulations, as in effect on the day before the date of
the enactment of this section).
``(3) Preservation of authority.--
``(A) Nothing in paragraph (1) shall be construed
to preclude or limit the applicability of any provision
of this Act other than this section.
``(B) Nothing in subsection (a) shall be construed
to prohibit the Secretary from issuing an order under
this section finding a drug to be not generally
recognized as safe and effective under section
201(p)(1), as the Secretary determines appropriate.
``(n) Investigational New Drugs.--A drug is not subject to this
section if an exemption for investigational use under section 505(i) is
in effect for such drug.
``(o) Inapplicability of Paperwork Reduction Act.--Chapter 35 of
title 44, United States Code, shall not apply to collections of
information made under this section.
``(p) Inapplicability of Notice and Comment Rulemaking and Other
Requirements.--The requirements of subsection (b) shall apply with
respect to orders issued under this section instead of the requirements
of subchapter II of chapter 5 of title 5, United States Code.
``(q) Definitions.--In this section:
``(1) The term `nonprescription drug' refers to a drug not
subject to the requirements of section 503(b)(1).
``(2) The term `sponsor' refers to any person marketing,
manufacturing, or processing a drug that--
``(A) is listed pursuant to section 510(j); and
``(B) is or will be subject to an administrative
order under this section of the Food and Drug
Administration.
``(3) The term `requestor' refers to any person or group of
persons marketing, manufacturing, processing, or developing a
drug.''.
(b) GAO Study.--Not later than 4 years after the date of enactment
of this Act, the Comptroller General of the United States shall submit
a study to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate addressing the effectiveness and overall impact
of exclusivity under section 505G of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), and section 586C of such Act
(21 U.S.C. 360fff-3), including the impact of such exclusivity on
consumer access. Such study shall include--
(1) an analysis of the impact of exclusivity under such
section 505G for nonprescription drug products, including--
(A) the number of nonprescription drug products
that were granted exclusivity and the indication for
which the nonprescription drug products were determined
to be generally recognized as safe and effective;
(B) whether the exclusivity for such drug products
was granted for--
(i) a new active ingredient (including any
ester or salt of the active ingredient); or
(ii) changes in the conditions of use of a
drug, for which new human data studies
conducted or sponsored by the requestor were
essential;
(C) whether, and to what extent, the exclusivity
impacted the requestor's or sponsor's decision to
develop the drug product;
(D) an analysis of the implementation of the
exclusivity provision in such section 505G, including--
(i) the resources used by the Food and Drug
Administration;
(ii) the impact of such provision on
innovation, as well as research and development
in the nonprescription drug market;
(iii) the impact of such provision on
competition in the nonprescription drug market;
(iv) the impact of such provision on
consumer access to nonprescription drug
products;
(v) the impact of such provision on the
prices of nonprescription drug products; and
(vi) whether the administrative orders
initiated by requestors under such section 505G
have been sufficient to encourage the
development of nonprescription drug products
that would likely not be otherwise developed,
or developed in as timely a manner; and
(E) whether the administrative orders initiated by
requestors under such section 505G have been sufficient
incentive to encourage innovation in the
nonprescription drug market; and
(2) an analysis of the impact of exclusivity under such
section 586C for sunscreen ingredients, including--
(A) the number of sunscreen ingredients that were
granted exclusivity and the specific ingredient that
was determined to be generally recognized as safe and
effective;
(B) whether, and to what extent, the exclusivity
impacted the requestor's or sponsor's decision to
develop the sunscreen ingredient;
(C) whether, and to what extent, the sunscreen
ingredient granted exclusivity had previously been
available outside of the United States;
(D) an analysis of the implementation of the
exclusivity provision in such section 586C, including--
(i) the resources used by the Food and Drug
Administration;
(ii) the impact of such provision on
innovation, as well as research and development
in the sunscreen market;
(iii) the impact of such provision on
competition in the sunscreen market;
(iv) the impact of such provision on
consumer access to sunscreen products;
(v) the impact of such provision on the
prices of sunscreen products; and
(vi) whether the administrative orders
initiated by requestors under such section 505G
have been utilized by sunscreen ingredient
sponsors and whether such process has been
sufficient to encourage the development of
sunscreen ingredients that would likely not be
otherwise developed, or developed in as timely
a manner; and
(E) whether the administrative orders initiated by
requestors under such section 586C have been sufficient
incentive to encourage innovation in the sunscreen
market.
(c) Conforming Amendment.--Section 751(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379r(d)(1)) is amended--
(1) in the matter preceding subparagraph (A)--
(A) by striking ``final regulation promulgated''
and inserting ``final order under section 505G''; and
(B) by striking ``and not misbranded''; and
(2) in subparagraph (A), by striking ``regulation in
effect'' and inserting ``regulation or order in effect''.
SEC. 1002. MISBRANDING.
Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352) is amended by adding at the end the following:
``(ee) If it is a nonprescription drug that is subject to section
505G, is not the subject of an application approved under section 505,
and does not comply with the requirements under section 505G.
``(ff) If it is a drug and it was manufactured, prepared,
propagated, compounded, or processed in a facility for which fees have
not been paid as required by section 744M.''.
SEC. 1003. DRUGS EXCLUDED FROM THE OVER-THE-COUNTER DRUG REVIEW.
(a) In General.--Nothing in this Act (or the amendments made by
this Act) shall apply to any nonprescription drug (as defined in
section 505G(q) of the Federal Food, Drug, and Cosmetic Act, as added
by section 1001 of this Act) which was excluded by the Food and Drug
Administration from the Over-the-Counter Drug Review in accordance with
the paragraph numbered 25 on page 9466 of volume 37 of the Federal
Register, published on May 11, 1972.
(b) Rule of Construction.--Nothing in this section shall be
construed to preclude or limit the applicability of any other provision
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 1004. TREATMENT OF SUNSCREEN INNOVATION ACT.
(a) Review of Nonprescription Sunscreen Active Ingredients.--
(1) Applicability of section 505g for pending
submissions.--
(A) In general.--A sponsor of a nonprescription
sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients that, as
of the date of enactment of this Act, is subject to a
proposed sunscreen order under section 586C of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-
3) may elect, by means of giving written notification
to the Secretary of Health and Human Services within
180 calendar days of the enactment of this Act, to
transition into the review of such ingredient or
combination of ingredients pursuant to the process set
out in section 505G of the Federal Food, Drug, and
Cosmetic Act, as added by section 1001 of this Act.
(B) Election exercised.--Upon receipt by the
Secretary of Health and Human Services of a timely
notification under subparagraph (A)--
(i) the proposed sunscreen order involved
is deemed to be a request for an order under
subsection (b) of section 505G of the Federal
Food, Drug, and Cosmetic Act, as added by
section 1001 of this Act; and
(ii) such order is deemed to have been
accepted for filing under subsection
(b)(6)(A)(i) of such section 505G.
(C) Election not exercised.--If a notification
under subparagraph (A) is not received by the Secretary
of Health and Human Services within 180 calendar days
of the date of enactment of this Act, the review of the
proposed sunscreen order described in subparagraph
(A)--
(i) shall continue under section 586C of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360fff-3); and
(ii) shall not be eligible for review under
section 505G, added by section 1001 of this
Act.
(2) Definitions.--In this subsection, the terms
``sponsor'', ``nonprescription'', ``sunscreen active
ingredient'', and ``proposed sunscreen order'' have the
meanings given to those terms in section 586 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360fff).
(b) Amendments to Sunscreen Provisions.--
(1) Final sunscreen orders.--Paragraph (3) of section
586C(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360fff-3(e)) is amended to read as follows:
``(3) Relationship to orders under section 505g.--A final
sunscreen order shall be deemed to be a final order under
section 505G.''.
(2) Meetings.--Paragraph (7) of section 586C(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) is
amended--
(A) by striking ``A sponsor may request'' and
inserting the following:
``(A) In general.--A sponsor may request''; and
(B) by adding at the end the following:
``(B) Confidential meetings.--A sponsor may request
one or more confidential meetings with respect to a
proposed sunscreen order, including a letter deemed to
be a proposed sunscreen order under paragraph (3), to
discuss matters relating to data requirements to
support a general recognition of safety and
effectiveness involving confidential information and
public information related to such proposed sunscreen
order, as appropriate. The Secretary shall convene a
confidential meeting with such sponsor in a reasonable
time period. If a sponsor requests more than one
confidential meeting for the same proposed sunscreen
order, the Secretary may refuse to grant an additional
confidential meeting request if the Secretary
determines that such additional confidential meeting is
not reasonably necessary for the sponsor to advance its
proposed sunscreen order, or if the request for a
confidential meeting fails to include sufficient
information upon which to base a substantive
discussion. The Secretary shall publish a post-meeting
summary of each confidential meeting under this
subparagraph that does not disclose confidential
commercial information or trade secrets. This
subparagraph does not authorize the disclosure of
confidential commercial information or trade secrets
subject to 552(b)(4) of title 5, United States Code, or
section 1905 of title 18, United States Code.''.
(3) Exclusivity.--Section 586C of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding at
the end the following:
``(f) Exclusivity.--
``(1) In general.--A final sunscreen order shall have the
effect of authorizing solely the order requestor (or the
licensees, assignees, or successors in interest of such
requestor with respect to the subject of such request and
listed under paragraph (5)) for a period of 18 months, to
market a sunscreen ingredient under this section incorporating
changes described in paragraph (2) subject to the limitations
under paragraph (4), beginning on the date the requestor (or
any licensees, assignees, or successors in interest of such
requestor with respect to the subject of such request and
listed under paragraph (5)) may lawfully market such sunscreen
ingredient pursuant to the order.
``(2) Changes described.--A change described in this
paragraph is a change subject to an order specified in
paragraph (1) that permits a sunscreen to contain an active
sunscreen ingredient not previously incorporated in a marketed
sunscreen listed in paragraph (3).
``(3) Marketed sunscreen.--The marketed sunscreen
ingredients described in this paragraph are sunscreen
ingredients--
``(A) marketed in accordance with a final monograph
for sunscreen drug products set forth at part 352 of
title 21, Code of Federal Regulations (as published at
64 Fed. Reg. 27687); or
``(B) marketed in accordance with a final order
issued under this section.
``(4) Limitations on exclusivity.--Only one 18-month period
may be granted per ingredient under paragraph (1).
``(5) Listing of licensees, assignees, or successors in
interest.--Requestors shall submit to the Secretary at the time
when a drug subject to such request is introduced or delivered
for introduction into interstate commerce, a list of licensees,
assignees, or successors in interest under paragraph (1).''.
(4) Sunset provision.--Subchapter I of chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.)
is amended by adding at the end the following:
``SEC. 586H. SUNSET.
``This subchapter shall cease to be effective at the end of fiscal
year 2022.''.
(5) Treatment of final sunscreen order.--The Federal Food,
Drug, and Cosmetic Act is amended by striking section 586E of
such Act (21 U.S.C. 360fff-5).
(c) Treatment of Authority Regarding Finalization of Sunscreen
Monograph.--
(1) In general.--
(A) Revision of final sunscreen order.--Not later
than November 26, 2019, the Secretary of Health and
Human Services (referred to in this subsection as the
``Secretary'') shall amend and revise the final
administrative order concerning nonprescription
sunscreen (referred to in this subsection as the
``sunscreen order'') for which the content, prior to
the date of enactment of this Act, was represented by
the final monograph for sunscreen drug products set
forth in part 352 of title 21, Code of Federal
Regulations (as in effect on May 21, 1999).
(B) Issuance of revised sunscreen order; effective
date.--A revised sunscreen order described in
subparagraph (A) shall be--
(i) issued in accordance with the
procedures described in section 505G(c)(2) of
the Federal Food, Drug, and Cosmetic Act;
(ii) issued in proposed form not later than
May 28, 2019;
(iii) effective not later than November 26,
2020; and
(iv) issued by the Secretary at least 1
year prior to the effective date of the revised
order.
(2) Reports.--If a revised sunscreen order issued under
paragraph (1) does not include provisions related to the
effectiveness of various sun protection factor levels, and does
not address all dosage forms known to the Secretary to be used
in sunscreens marketed in the United States without a new drug
application approved under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall
submit a report to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate on the rationale
for omission of such provisions from such order, and a plan and
timeline to compile any information necessary to address such
provisions through such order.
(d) Treatment of Non-sunscreen Time and Extent Applications.--
(1) In general.--Any application described in section 586F
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-
6) that was submitted to the Secretary pursuant to section
330.14 of title 21, Code of Federal Regulations, as such
provisions were in effect immediately prior to the date of
enactment date of this Act, shall be extinguished as of such
date of enactment, subject to paragraph (2).
(2) Order request.--Nothing in paragraph (1) precludes the
submission of an order request under section 505G(b) of the
Federal Food, Drug, and Cosmetic Act, as added by section 1001
of this Act, with respect to a drug that was the subject of an
application extinguished under paragraph (1).
SEC. 1005. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC
INDICATION FOR CERTAIN OTC COUGH AND COLD DRUGS.
(a) In General.--Subject to subsection (c), the Secretary of Health
and Human Services shall, beginning not later than 1 year after the
date of enactment of this Act, annually submit to the Committee on
Energy and Commerce of the House of Representatives and the Committee
on Health, Education, Labor, and Pensions of the Senate a letter
describing the progress of the Food and Drug Administration--
(1) in evaluating the cough and cold monograph described in
subsection (b) with respect to children under age 6; and
(2) as appropriate, revising such cough and cold monograph
to address such children through the order process under
section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as
added by section 1001 of this Act.
(b) Cough and Cold Monograph Described.--The cough and cold
monograph described in this subsection consists of the conditions under
which nonprescription drugs containing antitussive, expectorant, nasal
decongestant, or antihistamine active ingredients (or combinations
thereof) are generally recognized as safe and effective, as specified
in part 341 of title 21, Code of Federal Regulations (as in effect
immediately prior to the date of enactment of this Act), and included
in an order deemed to be established under section 505G(b) of the
Federal Food, Drug, and Cosmetic Act, as added by section 1001 of this
Act.
(c) Duration of Authority.--The requirement under subsection (a)
shall terminate as of the date of a letter submitted by the Secretary
of Health and Human Services pursuant to such subsection in which the
Secretary indicates that the Food and Drug Administration has completed
its evaluation and revised, in a final order, as applicable, the cough
and cold monograph as described in subsection (a)(2).
SEC. 1006. TECHNICAL CORRECTIONS.
(a) Imports and Exports.--Section 801(e)(4)(E)(iii) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended
by striking ``subparagraph'' each place such term appears and inserting
``paragraph''.
(b) FDA Reauthorization Act of 2017.--
(1) In general.--Section 905(b)(4) of the FDA
Reauthorization Act of 2017 (Public Law115-52) is amended by
striking ``Section 744H(e)(2)(B)'' and inserting ``Section
744H(f)(2)(B)''.
(2) Effective date.--The amendment made by paragraph (1)
shall take effect as of the enactment of the FDA
Reauthorization Act of 2017 (Public Law 115-52).
TITLE II--USER FEES
SEC. 2001. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Over-the-Counter
Monograph User Fee Act of 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, 2019, for the first program
year, and December 31 of the fiscal
year for subsequent fiscal years; and
``(II) has updated its registration
to reflect such change under the
requirements for drug establishment
registration set forth in section 510.
``(ii) The amount of the fee for a contract
manufacturing organization facility shall be
equal to two-thirds of the amount of the fee
for an OTC monograph drug facility that is not
a contract manufacturing organization facility.
``(C) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection
(c).
``(D) Due date.--
``(i) For first program year.--For fiscal
year 2019, the facility fees required under
subparagraph (A) shall be due 45 calendar days
after publication of the Federal Register
notice provided for under subsection (c)(4)(A).
``(ii) Subsequent fiscal years.--For each
fiscal year after fiscal year 2019, the
facility fees required under subparagraph (A)
shall be due on the later of--
``(I) the first business day of
June of such year; or
``(II) the first business day after
the enactment of an appropriations Act
providing for the collection and
obligation of fees under this section
for such year.
``(2) OTC monograph order request fee.--
``(A) In general.--Each person that submits an OTC
monograph order request shall be subject to a fee for
an OTC monograph order request. The amount of such fee
shall be--
``(i) for a Tier 1 OTC monograph order
request, $500,000, adjusted for inflation for
the fiscal year (as determined under subsection
(c)(1)(B)); and
``(ii) for a Tier 2 OTC monograph order
request, $100,000 adjusted for inflation for
the fiscal year (as determined under subsection
(c)(1)(B)).
``(B) Due date.--The OTC monograph order request
fees required under subparagraph (A) shall be due on
the date of submission of the OTC monograph order
request.
``(C) Exception for certain safety changes.--A
person who is named as the requestor in an OTC
monograph order shall not be subject to a fee under
subparagraph (A) if the Secretary finds that the OTC
monograph order request seeks to change the drug facts
labeling of an OTC monograph drug in a way that would
add to or strengthen--
``(i) a contraindication, warning, or
precaution;
``(ii) a statement about risk associated
with misuse or abuse; or
``(iii) an instruction about dosage and
administration that is intended to increase the
safe use of the OTC monograph drug.
``(D) Refund of fee if order request is
recategorized as a tier 2 otc monograph order
request.--If the Secretary determines that an OTC
monograph request initially characterized as Tier 1
shall be re-characterized as a Tier 2 OTC monograph
order request, and the requestor has paid a Tier 1 fee
in accordance with subparagraph (A)(i), the Secretary
shall refund the requestor the difference between the
Tier 1 and Tier 2 fees determined under subparagraphs
(A)(i) and (A)(ii), respectively.
``(E) Refund of fee if order request refused for
filing or withdrawn before filing.--The Secretary shall
refund 75 percent of the fee paid under subparagraph
(B) for any order request which is refused for filing
or was withdrawn before being accepted or refused for
filing.
``(F) Fees for order requests previously refused
for filing or withdrawn before filing.--An OTC
monograph order request that was submitted but was
refused for filing, or was withdrawn before being
accepted or refused for filing, shall be subject to the
full fee under subparagraph (A) upon being resubmitted
or filed over protest.
``(G) Refund of fee if order request withdrawn.--If
an order request is withdrawn after the order request
was filed, the Secretary may refund the fee or a
portion of the fee if no substantial work was performed
on the order request after the application was filed.
The Secretary shall have the sole discretion to refund
a fee or a portion of the fee under this subparagraph.
A determination by the Secretary concerning a refund
under this subparagraph shall not be reviewable.
``(3) Refunds.--
``(A) In general.--Other than refunds provided
pursuant to any of subparagraphs (D) through (G) of
paragraph (2), the Secretary shall not refund any fee
paid under paragraph (1) except as provided in
subparagraph (B).
``(B) Disputes concerning fees.--To qualify for the
return of a fee claimed to have been paid in error
under paragraph (1) or (2), a person shall submit to
the Secretary a written request justifying such return
within 180 calendar days after such fee was paid.
``(4) Notice.--Within the timeframe specified in subsection
(c), the Secretary shall publish in the Federal Register the
amount of the fees under paragraph (1) for such fiscal year.
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2019.--For fiscal year 2019, fees under
subsection (a)(1) shall be established to generate a total
facility fee revenue amount equal to the sum of--
``(A) the annual base revenue for fiscal year 2019
(as determined under paragraph (3));
``(B) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(2)); and
``(C) additional direct cost adjustments (as
determined under subsection (c)(3)).
``(2) Subsequent fiscal years.--For each of the fiscal
years 2020 through 2023, fees under subsection (a)(1) shall be
established to generate a total facility fee revenue amount
equal to the sum of--
``(A) the annual base revenue for the fiscal year
(as determined under paragraph (3));
``(B) the dollar amount equal to the inflation
adjustment for the fiscal year (as determined under
subsection (c)(1));
``(C) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(2));
``(D) additional direct cost adjustments (as
determined under subsection (c)(3)); and
``(E) additional dollar amounts for each fiscal
year as follows:
``(i) $7,000,000 for fiscal year 2020.
``(ii) $6,000,000 for fiscal year 2021.
``(iii) $7,000,000 for fiscal year 2022.
``(iv) $3,000,000 for fiscal year 2023.
``(3) Annual base revenue.--For purposes of paragraphs
(1)(A) and (2)(A), the dollar amount of the annual base revenue
for a fiscal year shall be--
``(A) for fiscal year 2019, $8,000,000; and
``(B) for fiscal years 2020 through 2023, the
dollar amount of the total revenue amount established
under this subsection for the previous fiscal year, not
including any adjustments made under subsection (c)(2)
or (c)(3).
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection
(b)(2)(B), the dollar amount of the inflation
adjustment to the annual base revenue for fiscal year
2020 and each subsequent fiscal year shall be equal to
the product of--
``(i) such annual base revenue for the
fiscal year under subsection (b)(2); and
``(ii) the inflation adjustment percentage
under subparagraph (C).
``(B) OTC monograph order request fees.--For
purposes of subsection (a)(2), the dollar amount of the
inflation adjustment to the fee for OTC monograph order
requests for fiscal year 2020 and each subsequent
fiscal year shall be equal to the product of--
``(i) the applicable fee under subsection
(a)(2) for the preceding fiscal year; and
``(ii) the inflation adjustment percentage
under subparagraph (C).
``(C) Inflation adjustment percentage.--The
inflation adjustment percentage under this subparagraph
for a fiscal year is equal to--
``(i) for each of fiscal years 2020 and
2021, the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4
years of available data; and
``(ii) for each of fiscal years 2022 and
2023, the sum of--
``(I) the average annual percent
change in the cost, per full-time
equivalent position of the Food and
Drug Administration, of all personnel
compensation and benefits paid with
respect to such positions for the first
3 years of the preceding 4 fiscal
years, multiplied by the proportion of
personnel compensation and benefits
costs to total costs of OTC monograph
drug activities for the first 3 years
of the preceding 4 fiscal years; and
``(II) the average annual percent
change that occurred in the Consumer
Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not
Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the
preceding 4 years of available data
multiplied by the proportion of all
costs other than personnel compensation
and benefits costs to total costs of
OTC monograph drug activities for the
first 3 years of the preceding 4 fiscal
years.
``(2) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2019 and
subsequent fiscal years, for purposes of subsections
(b)(1)(B) and (b)(2)(C), the Secretary may, in addition
to adjustments under paragraph (1), further increase
the fee revenue and fees if such an adjustment is
necessary to provide operating reserves of carryover
user fees for OTC monograph drug activities for not
more than the number of weeks specified in subparagraph
(B).
``(B) Number of weeks.--The number of weeks
specified in this subparagraph is--
``(i) 3 weeks for fiscal year 2019;
``(ii) 7 weeks for fiscal year 2020;
``(iii) 10 weeks for fiscal year 2021;
``(iv) 10 weeks for fiscal year 2022; and
``(v) 10 weeks for fiscal year 2023.
``(C) Decrease.--If the Secretary has carryover
balances for such process in excess of 10 weeks of the
operating reserves referred to in subparagraph (A), the
Secretary shall decrease the fee revenue and fees
referred to in such subparagraph to provide for not
more than 10 weeks of such operating reserves.
``(D) Rationale for adjustment.--If an adjustment
under this paragraph is made, the rationale for the
amount of the increase or decrease (as applicable) in
fee revenue and fees shall be contained in the annual
Federal Register notice under paragraph (4)
establishing fee revenue and fees for the fiscal year
involved.
``(3) Additional direct cost adjustment.--The Secretary
shall, in addition to adjustments under paragraphs (1) and (2),
further increase the fee revenue and fees for purposes of
subsection (b)(2)(D) by an amount equal to--
``(A) $14,000,000 for fiscal year 2019;
``(B) $7,000,000 for fiscal year 2020;
``(C) $4,000,000 for fiscal year 2021;
``(D) $3,000,000 for fiscal year 2022; and
``(E) $3,000,000 for fiscal year 2023.
``(4) Annual fee setting.--
``(A) Fiscal year 2019.--The Secretary shall, not
later than the second Monday in March of 2019--
``(i) establish OTC monograph drug facility
fees for fiscal year 2019 under subsection (a),
based on the revenue amount for such year under
subsection (b) and the adjustments provided
under this subsection; and
``(ii) publish fee revenue, facility fees,
and OTC monograph order requests in the Federal
Register.
``(B) Subsequent fiscal years.--The Secretary
shall, not later than the second Monday in March of
each fiscal year that begins after September 30, 2019--
``(i) establish for each such fiscal year,
based on the revenue amounts under subsection
(b) and the adjustments provided under this
subsection--
``(I) OTC monograph drug facility
fees under subsection (a)(1); and
``(II) OTC monograph order request
fees under subsection (a)(2); and
``(ii) publish such fee revenue amounts,
facility fees, and OTC monograph order request
fees in the Federal Register.
``(d) Identification of Facilities.--Each person that owns an OTC
monograph drug facility shall submit to the Secretary the information
required under this subsection each year. Such information shall, for
each fiscal year--
``(1) be submitted as part of the requirements for drug
establishment registration set forth in section 510; and
``(2) include for each such facility, at a minimum,
identification of the facility's business operation as that of
an OTC monograph drug facility.
``(e) Effect of Failure To Pay Fees.--
``(1) OTC monograph drug facility fee.--
``(A) In general.--Failure to pay the fee under
subsection (a)(1) within 20 calendar days of the due
date as specified in subparagraph (D) of such
subsection shall result in the following:
``(i) The Secretary shall place the
facility on a publicly available arrears list.
``(ii) All OTC monograph drugs manufactured
in such a facility or containing an ingredient
manufactured in such a facility shall be deemed
misbranded under section 502(ff).
``(B) Application of penalties.--The penalties
under this paragraph shall apply until the fee
established by subsection (a)(1) is paid.
``(2) Order requests.--An OTC monograph order request
submitted by a person subject to fees under subsection (a)
shall be considered incomplete and shall not be accepted for
filing by the Secretary until all fees owed by such person
under this section have been paid.
``(3) Meetings.--A person subject to fees under this
section shall be considered ineligible for OTC monograph drug
meetings until all such fees owed by such person have been
paid.
``(f) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be available
solely for OTC monograph drug activities.
``(2) Collections and appropriation acts.--
``(A) In general.--Subject to subparagraph (C), the
fees authorized by this section shall be collected and
available in each fiscal year in an amount not to
exceed the amount specified in appropriation Acts, or
otherwise made available for obligation, for such
fiscal year.
``(B) Use of fees and limitation.--The fees
authorized by this section shall be available to defray
increases in the costs of the resources allocated for
OTC monograph drug activities (including increases in
such costs for an additional number of full-time
equivalent positions in the Department of Health and
Human Services to be engaged in such activities), only
if the Secretary allocates for such purpose an amount
for such fiscal year (excluding amounts from fees
collected under this section) no less than $12,000,000,
multiplied by the adjustment factor applicable to the
fiscal year involved under subsection (c)(1).
``(C) Compliance.--The Secretary shall be
considered to have met the requirements of subparagraph
(B) in any fiscal year if the costs funded by
appropriations and allocated for OTC monograph drug
activities are not more than 15 percent below the level
specified in such subparagraph.
``(D) Provision for early payments in subsequent
years.--Payment of fees authorized under this section
for a fiscal year (after fiscal year 2019), prior to
the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in
advance in a prior year appropriations Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2019 through 2023, there is authorized to be
appropriated for fees under this section an amount equal to the
total amount of fees assessed for such fiscal year under this
section.
``(g) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 calendar days after it is due, such fee shall be treated as a claim
of the United States Government subject to subchapter II of chapter 37
of title 31, United States Code.
``(h) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employers, and advisory
committees not engaged in OTC monograph drug activities, be reduced to
offset the number of officers, employees, and advisory committees so
engaged.
``SEC. 744N. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2019, and not
later than 120 calendar days after the end of each fiscal year
thereafter for which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning the progress of the Food
and Drug Administration in achieving the goals identified in the
letters described in section 2001(b) of the Over-the-Counter Monograph
Safety, Innovation, and Reform Act of 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.''.
Passed the House of Representatives January 8, 2019.
Attest:
Clerk.
116th CONGRESS
1st Session
H. R. 269
_______________________________________________________________________
AN ACT
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.