[117th Congress Public Law 180]
[From the U.S. Government Publishing Office]
[[Page 2113]]
CONTINUING APPROPRIATIONS
AND UKRAINE SUPPLEMENTAL
APPROPRIATIONS ACT, 2023
[[Page 136 STAT. 2114]]
Public Law 117-180
117th Congress
An Act
Making continuing appropriations for fiscal year 2023, and for other
purposes. <<NOTE: Sept. 30, 2022 - [H.R. 6833]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Continuing
Appropriations and Ukraine Supplemental Appropriations Act, 2023.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Continuing Appropriations and Ukraine
Supplemental Appropriations Act, 2023''.
SEC. 2. TABLE OF CONTENTS.
Sec. 1. Short Title.
Sec. 2. Table of Contents.
Sec. 3. References.
Sec. 4. Payment to Widows and Heirs of Deceased Members of Congress.
DIVISION A--CONTINUING APPROPRIATIONS ACT, 2023
DIVISION B--UKRAINE SUPPLEMENTAL APPROPRIATIONS ACT, 2023
DIVISION C--OTHER MATTERS
Title I--Extensions, Technical Corrections, and Other Matters
Title II--Budgetary Effects
DIVISION D--HEALTH AND HUMAN SERVICES EXTENSIONS
Title I--Medicare and Medicaid
Title II--Human Services
Title III--Public Health
Title IV--Indian Health
DIVISION E--VETERANS AFFAIRS EXTENSIONS
Title I--Extensions of authorities relating to health care
Title II--Extensions of authorities relating to benefits
Title III--Extensions of authorities relating to homeless veterans
Title IV--Extensions of other authorities
DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022
DIVISION G--HERMIT'S PEAK/CALF CANYON FIRE ASSISTANCE ACT
SEC. 3. REFERENCES.
Except as expressly provided otherwise, any reference to ``this
Act'' contained in any division of this Act shall be treated as
referring only to the provisions of that division.
SEC. 4. <<NOTE: Dean Swihart.>> PAYMENT TO WIDOWS AND HEIRS OF
DECEASED MEMBERS OF CONGRESS.
There is hereby appropriated for fiscal year 2023, out of any money
in the Treasury not otherwise appropriated, for payment to Dean Swihart,
beneficiary of Jacqueline Walorski-Swihart, late a Representative from
the State of Indiana, $174,000.
[[Page 136 STAT. 2115]]
DIVISION A <<NOTE: Continuing Appropriations Act, 2023.>> --CONTINUING
APPROPRIATIONS ACT, 2023
The following sums are hereby appropriated, out of any money in the
Treasury not otherwise appropriated, and out of applicable corporate or
other revenues, receipts, and funds, for the several departments,
agencies, corporations, and other organizational units of Government for
fiscal year 2023, and for other purposes, namely:
Sec. 101. Such amounts as may be necessary, at a rate for
operations as provided in the applicable appropriations Acts for fiscal
year 2022 and under the authority and conditions provided in such Acts,
for continuing projects or activities (including the costs of direct
loans and loan guarantees) that are not otherwise specifically provided
for in this Act, that were conducted in fiscal year 2022, and for which
appropriations, funds, or other authority were made available in the
following appropriations Acts:
(1) <<NOTE: Applicability.>> The Agriculture, Rural
Development, Food and Drug Administration, and Related Agencies
Appropriations Act, 2022 (division A of Public Law 117-103),
except section 783, and except that section 785 shall be applied
by substituting ``$125,000,000'' for ``$250,000,000''.
(2) The Commerce, Justice, Science, and Related Agencies
Appropriations Act, 2022 (division B of Public Law 117-103),
except section 521(c)(1).
(3) The Department of Defense Appropriations Act, 2022
(division C of Public Law 117-103).
(4) The Energy and Water Development and Related Agencies
Appropriations Act, 2022 (division D of Public Law 117-103).
(5) The Financial Services and General Government
Appropriations Act, 2022 (division E of Public Law 117-103),
except the matter under the heading ``Postal Regulatory
Commission'' in title V.
(6) The Department of Homeland Security Appropriations Act,
2022 (division F of Public Law 117-103), except sections 544 and
545, and including title II of division O of Public Law 117-103.
(7) The Department of the Interior, Environment, and Related
Agencies Appropriations Act, 2022 (division G of Public Law 117-
103).
(8) The Departments of Labor, Health and Human Services, and
Education, and Related Agencies Appropriations Act, 2022
(division H of Public Law 117-103), and section 162 of division
A of Public Law 117-43.
(9) The Legislative Branch Appropriations Act, 2022
(division I of Public Law 117-103), and section 6 in the matter
preceding division A of Public Law 117-103.
(10) The Military Construction, Veterans Affairs, and
Related Agencies Appropriations Act, 2022 (division J of Public
Law 117-103).
(11) The Department of State, Foreign Operations, and
Related Programs Appropriations Act, 2022 (division K of Public
Law 117-103), except the first proviso of section 7069(e).
(12) The Transportation, Housing and Urban Development, and
Related Agencies Appropriations Act, 2022 (division L of Public
Law 117-103).
[[Page 136 STAT. 2116]]
Sec. 102. (a) No appropriation or funds made available or authority
granted pursuant to section 101 for the Department of Defense shall be
used for:
(1) the new production of items not funded for production in
fiscal year 2022 or prior years;
(2) the increase in production rates above those sustained
with fiscal year 2022 funds; or
(3) the initiation, resumption, or continuation of any
project, activity, operation, or organization (defined as any
project, subproject, activity, budget activity, program element,
and subprogram within a program element, and for any investment
items defined as a P-1 line item in a budget activity within an
appropriation account and an R-1 line item that includes a
program element and subprogram element within an appropriation
account) for which appropriations, funds, or other authority
were not available during fiscal year 2022.
(b) No appropriation or funds made available or authority granted
pursuant to section 101 for the Department of Defense shall be used to
initiate multi-year procurements utilizing advance procurement funding
for economic order quantity procurement unless specifically appropriated
later.
Sec. 103. Appropriations made by section 101 shall be available to
the extent and in the manner that would be provided by the pertinent
appropriations Act.
Sec. 104. Except as otherwise provided in section 102, no
appropriation or funds made available or authority granted pursuant to
section 101 shall be used to initiate or resume any project or activity
for which appropriations, funds, or other authority were not available
during fiscal year 2022.
Sec. 105. Appropriations made and authority granted pursuant to
this Act shall cover all obligations or expenditures incurred for any
project or activity during the period for which funds or authority for
such project or activity are available under this Act.
Sec. 106. Unless otherwise provided for in this Act or in the
applicable appropriations Act for fiscal year 2023, appropriations and
funds made available and authority granted pursuant to this Act shall be
available until whichever of the following first occurs:
(1) The enactment into law of an appropriation for any
project or activity provided for in this Act.
(2) The enactment into law of the applicable appropriations
Act for fiscal year 2023 without any provision for such project
or activity.
(3) <<NOTE: Expiration date.>> December 16, 2022.
Sec. 107. Expenditures made pursuant to this Act shall be charged
to the applicable appropriation, fund, or authorization whenever a bill
in which such applicable appropriation, fund, or authorization is
contained is enacted into law.
Sec. 108. Appropriations made and funds made available by or
authority granted pursuant to this Act may be used without regard to the
time limitations for submission and approval of apportionments set forth
in section 1513 of title 31, United States Code, but nothing in this Act
may be construed to waive any other provision of law governing the
apportionment of funds.
Sec. 109. Notwithstanding any other provision of this Act, except
section 106, for those programs that would otherwise have high initial
rates of operation or complete distribution of appropriations at the
beginning of fiscal year 2023 because of distributions
[[Page 136 STAT. 2117]]
of funding to States, foreign countries, grantees, or others, such high
initial rates of operation or complete distribution shall not be made,
and no grants shall be awarded for such programs funded by this Act that
would impinge on final funding prerogatives.
Sec. 110. This Act shall be implemented so that only the most
limited funding action of that permitted in the Act shall be taken in
order to provide for continuation of projects and activities.
Sec. 111. (a) <<NOTE: Extension.>> For entitlements and other
mandatory payments whose budget authority was provided in appropriations
Acts for fiscal year 2022, and for activities under the Food and
Nutrition Act of 2008, activities shall be continued at the rate to
maintain program levels under current law, under the authority and
conditions provided in the applicable appropriations Act for fiscal year
2022, to be continued through the date specified in section 106(3).
(b) <<NOTE: Time period. Deadline.>> Notwithstanding section 106,
obligations for mandatory payments due on or about the first day of any
month that begins after October 2022 but not later than 30 days after
the date specified in section 106(3) may continue to be made, and funds
shall be available for such payments.
Sec. 112. Amounts made available under section 101 for civilian
personnel compensation and benefits in each department and agency may be
apportioned up to the rate for operations necessary to avoid furloughs
within such department or agency, consistent with the applicable
appropriations Act for fiscal year 2022, except that such authority
provided under this section shall not be used until after the department
or agency has taken all necessary actions to reduce or defer non-
personnel-related administrative expenses.
Sec. 113. Funds appropriated by this Act may be obligated and
expended notwithstanding section 10 of Public Law 91-672 (22 U.S.C.
2412), section 15 of the State Department Basic Authorities Act of 1956
(22 U.S.C. 2680), section 313 of the Foreign Relations Authorization
Act, Fiscal Years 1994 and 1995 (22 U.S.C. 6212), and section 504(a)(1)
of the National Security Act of 1947 (50 U.S.C. 3094(a)(1)).
Sec. 114. Each amount incorporated by reference in this Act that
was previously designated by the Congress as an emergency requirement
pursuant to sections 4001(a)(1) and 4001(b) of S. Con. Res. 14 (117th
Congress), the concurrent resolution on the budget for fiscal year 2022,
or as being for disaster relief pursuant to section 4005(f) of such
concurrent resolution, is designated as being an emergency requirement
pursuant to section 4001(a)(1) of such concurrent resolution and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022, or as being for disaster relief
pursuant to section 1(f) of such House resolution, respectively.
Sec. 115. <<NOTE: Rescissions.>> (a) Rescissions or cancellations
of discretionary budget authority that continue pursuant to section 101
in Treasury Appropriations Fund Symbols (TAFS)--
(1) to which other appropriations are not provided by this
Act, but for which there is a current applicable TAFS that does
receive an appropriation in this Act; or
(2) which are no-year TAFS and receive other appropriations
in this Act,
may be continued instead by reducing the rate for operations otherwise
provided by section 101 for such current applicable TAFS,
[[Page 136 STAT. 2118]]
as long as doing so does not impinge on the final funding prerogatives
of the Congress.
(b) Rescissions or cancellations described in subsection (a) shall
continue in an amount equal to the lesser of--
(1) the amount specified for rescission or cancellation in
the applicable appropriations Act referenced in section 101 of
this Act; or
(2) the <<NOTE: Effective date.>> amount of balances
available, as of October 1, 2022, from the funds specified for
rescission or cancellation in the applicable appropriations Act
referenced in section 101 of this Act.
(c) No <<NOTE: Deadline. List.>> later than November 21, 2022, the
Director of the Office of Management and Budget shall provide to the
Committees on Appropriations of the House of Representatives and the
Senate a comprehensive list of the rescissions or cancellations that
will continue pursuant to section 101:
Provided, <<NOTE: Updates. Effective date.>> That the information in
such comprehensive list shall be periodically updated to reflect any
subsequent changes in the amount of balances available, as of October 1,
2022, from the funds specified for rescission or cancellation in the
applicable appropriations Act referenced in section 101, and such
updates shall be transmitted to the Committees on Appropriations of the
House of Representatives and the Senate upon request.
Sec. 116. Amounts made available by section 101 for ``Farm Service
Agency--Agricultural Credit Insurance Fund Program Account'' may be
apportioned up to the rate for operations necessary to accommodate
approved applications for direct and guaranteed farm ownership loans, as
authorized by 7 U.S.C. 1922 et seq.
Sec. 117. Amounts made available by section 101 to the Department
of Agriculture for ``Rural Business--Cooperative Service--Rural
Microentrepreneur Assistance Program'' may be used for the costs of
loans, including the cost of modifying such loans, as defined in section
502 of the Congressional Budget Act of 1974, under the same terms and
conditions as authorized by section 379E of the Consolidated Farm and
Rural Development Act (7 U.S.C. 2008s).
Sec. 118. <<NOTE: Applicability.>> Section 260 of the Agricultural
Marketing Act of 1946 (7 U.S.C. 1636i) and section 942 of the Livestock
Mandatory Reporting Act of 1999 (7 U.S.C. 1635 note; Public Law 106-78)
shall be applied by substituting the date specified in section 106(3) of
this Act for ``September 30, 2022''.
Sec. 119. Amounts made available by section 101 to the Department
of Commerce for ``Economic Development Administration--Salaries and
Expenses'' may be apportioned up to the rate for operations necessary to
maintain agency operations.
Sec. 120. Amounts made available by section 101 for ``Department of
Commerce--National Telecommunications and Information Administration--
Salaries and Expenses'' may be apportioned up to the rate for operations
necessary to ensure continued oversight of public safety communications
programs.
Sec. 121. In addition to amounts otherwise provided by section 101,
for ``Department of Justice--Federal Bureau of Investigation--Salaries
and Expenses'', there is appropriated $15,300,000, for an additional
amount for fiscal year 2023, to remain available until September 30,
2023, for investigative activities associated with Afghan resettlement
operations: Provided, That such amount is designated by the Congress as
being for an emergency requirement
[[Page 136 STAT. 2119]]
pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the
concurrent resolution on the budget for fiscal year 2022, and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022.
Sec. 122. <<NOTE: Expiration date.>> (a) Notwithstanding sections
101 and 106, through September 30, 2023, the Secretary of Defense may
transfer up to $3,000,000,000 from unobligated balances from amounts
made available under the heading ``Department of Defense--Operation and
Maintenance--Overseas Humanitarian, Disaster, and Civic Aid'' in
division C of Public Law 117-43 and division B of Public Law 117-70 to
any appropriation account under the headings ``Department of State and
Related Agency--Department of State--Administration of Foreign
Affairs'', ``Bilateral Economic Assistance--Department of State--
Migration and Refugee Assistance'', and ``Bilateral Economic
Assistance--Department of State--United States Emergency Refugee and
Migration Assistance Fund'' for support of Operation Allies Welcome or
any successor operation: Provided, That upon transfer, such funds shall
be merged with the appropriation to which such funds are transferred
except that such funds may be made available for such purposes
notwithstanding any requirement or limitation applicable to the
appropriation to which transferred, including sections 2(c)(1) and
2(c)(2) of the Migration and Refugee Assistance Act of 1962 with respect
to the United States Emergency Refugee and Migration Assistance Fund and
in sections 4(a) and 4(b) of the State Department Basic Authorities Act
of 1956 with respect to funds transferred to the Emergencies in the
Diplomatic and Consular Service account: Provided further, That section
2215 of title 10, United States Code, shall not apply to a transfer of
funds under this subsection: Provided
further, <<NOTE: Consultation. Notification.>> That the exercise of the
authority of this subsection shall be subject to prior consultation
with, and the regular notification procedures of, the Committees on
Appropriations of the House of Representatives and the Senate: Provided
further, That any funds transferred pursuant to this subsection that
were previously designated by the Congress as an emergency requirement
pursuant to the concurrent resolution on the budget are designated by
the Congress as being for an emergency requirement pursuant to section
4001(a)(1) of S. Con. Res. 14 (117th Congress), the concurrent
resolution on the budget for fiscal year 2022, and section 1(e) of H.
Res. 1151 (117th Congress), as engrossed in the House of Representatives
on June 8, 2022.
(b) <<NOTE: Reports.>> Not later than November 1, 2022 and prior to
any transfer of funds pursuant to subsection (a), the Director of the
Office of Management and Budget shall provide to the Committees on
Appropriations of the House of Representatives and the Senate a written
report on Operation Allies Welcome or any successor operation:
Provided, <<NOTE: Afghans. Relocation. Strategy. Plan. Timeline. Spend
plan. Cost estimate.>> That such report shall describe the number and
status of Afghans residing at Department of Defense and Department of
State-managed facilities and any anticipated future arrivals at such
facilities; the strategy and plan, including timeline, for adjudicating
and relocating all Afghans residing at Department of Defense or overseas
civilian facilities and for the transition of operations and
responsibilities under Operation Allies Welcome or any successor
operation from the Department of Defense to the Department of State
during fiscal year 2023; the activities and responsibilities assigned to
each Federal agency involved in such strategy and plan; and a spend
plan, containing an estimate
[[Page 136 STAT. 2120]]
of the costs, including additional construction and security costs, to
be incurred by each such agency for carrying out such strategy and plan,
and the sources of funds: Provided further, That prior to the initial
obligation of funds transferred to the Department of State pursuant to
subsection (a), the Secretary of State shall submit a report to such
Committees detailing the roles and responsibilities of Department of
State bureaus and offices in Operation Allies Welcome or any successor
operation.
Sec. 123. <<NOTE: Applicability.>> During the period covered by this
Act, section 714(b)(2)(B) of title 10, United States Code, shall be
applied by substituting ``three years'' for ``two years''.
Sec. 124. (a) <<NOTE: Rescission.>> Of the remaining unobligated
balances, as of September 30, 2022, from amounts provided under the
heading ``Afghanistan Security Forces Fund'' in title IX of division C
of Public Law 116-260, $100,000,000 is hereby permanently rescinded, and
in addition to amounts otherwise provided by section 101, an amount of
additional new budget authority equivalent to the amount rescinded
pursuant to this subsection is hereby appropriated on September 30,
2022, for an additional amount for fiscal year 2022, to remain available
until September 30, 2025, for the same purposes and under the same
authorities provided under such heading in Public Law 116-260, in
addition to other funds as may be available for such purposes.
(b)(1) <<NOTE: Effective date.>> Subject to paragraph (2), this
section shall become effective immediately upon enactment of this Act.
(2) <<NOTE: Applicability.>> If this Act is enacted after
September 30, 2022, this section shall be applied as if it were
in effect on September 30, 2022.
Sec. 125. In addition to amounts otherwise provided by section 101,
for ``Corps of Engineers--Civil--Construction'', there is appropriated
$20,000,000, for an additional amount for fiscal year 2023, to remain
available until expended, for necessary expenses related to water and
wastewater infrastructure under section 219 of the Water Resources
Development Act of 1992 (106 Stat. 4835): Provided, That such amount is
designated by the Congress as being for an emergency requirement
pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the
concurrent resolution on the budget for fiscal year 2022, and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022.
Sec. 126. <<NOTE: Applicability.>> (a) During the period covered by
this Act, title I of Public Law 108-361 (the Calfed Bay-Delta
Authorization Act) (118 Stat. 1681), as amended by section 204 of
division D of Public Law 117-103, shall be applied by substituting
``2023'' for ``2022'' each place it appears.
(b) During the period covered by this Act, section 103(f)(4)(A) of
title I of Public Law 108-361 (the Calfed Bay-Delta Authorization Act)
(118 Stat. 1696) shall be applied by substituting ``$25,650,000'' for
``$25,000,000''.
Sec. 127. <<NOTE: Applicability.>> (a) During the period covered by
this Act, section 9106(g)(2) of Public Law 111-11 (Omnibus Public Land
Management Act of 2009) shall be applied by substituting ``2023'' for
``2022''.
(b) During the period covered by this Act, section 104(c) of the
Reclamation States Emergency Drought Relief Act of 1991 (43 U.S.C.
2214(c)) shall be applied by substituting ``2023'' for ``2022''.
[[Page 136 STAT. 2121]]
(c) During the period covered by this Act, section 301 of the
Reclamation States Emergency Drought Relief Act of 1991 (43 U.S.C. 2241)
shall be applied by substituting ``2023'' for ``2022''.
Sec. 128. In addition to amounts otherwise provided by section 101,
amounts are provided for ``Department of the Treasury--Alcohol and
Tobacco Tax and Trade Bureau--Salaries and Expenses'' at a rate for
operations of $14,929,000, for an additional amount to administer the
Craft Beverage Modernization Act import claims program, as required by
the Taxpayer Certainty and Disaster Tax Relief Act of 2020, and such
amounts may be apportioned up to the rate for operations necessary to
establish and implement a new import claims program.
Sec. 129. <<NOTE: Applicability.>> Notwithstanding section 101,
title II of division E of Public Law 117-103 shall be applied by adding
the following new heading and appropriation language under the heading
``Executive Office of the President and Funds Appropriated to the
President'':
``Office of the National Cyber Director
``salaries and expenses
``For necessary expenses of the Office of the National Cyber
Director, as authorized by section 1752 of the William M. (Mac)
Thornberry National Defense Authorization Act for Fiscal Year 2021
(Public Law 116-283), $21,000,000, of which not to exceed $5,000 shall
be available for official reception and representation expenses.''.
Sec. 130. Notwithstanding section 101, amounts are provided for
``The Judiciary--Courts of Appeals, District Courts, and Other Judicial
Services--Fees of Jurors and Commissioners'' at a rate for operations of
$59,565,000.
Sec. 131. In addition to amounts otherwise provided by section 101,
for ``The Judiciary--Courts of Appeals, District Courts, and Other
Judicial Services--Court Security'', there is appropriated $112,500,000,
for an additional amount for fiscal year 2023, to remain available until
expended, for security improvements at United States courthouses and
Federal court facilities: <<NOTE: Reports. Time period.>> Provided,
That not later than 90 days after the date of enactment of this Act, and
every 90 days thereafter until all funds provided by this section have
been expended, the Director of the Administrative Office of the United
States Courts shall provide, in an appropriate format, quarterly reports
on the obligations and expenditures of the funds provided under this
section to the Committees on Appropriations of the House of
Representatives and the Senate: Provided further, That such amount is
designated by the Congress as being for an emergency requirement
pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the
concurrent resolution on the budget for fiscal year 2022, and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022.
Sec. 132. Notwithstanding any other provision of this Act, except
section 106, the District of Columbia may expend local funds made
available under the heading ``District of Columbia--District of Columbia
Funds'' for such programs and activities under the District of Columbia
Appropriations Act, 2022 (title IV of division E of Public Law 117-103)
at the rate set forth in the Fiscal Year
[[Page 136 STAT. 2122]]
2023 Local Budget Act of 2022 (D.C. Act 24-486), as modified as of the
date of enactment of this Act.
Sec. 133. In addition to amounts otherwise provided by section 101,
amounts are provided for ``Small Business Administration--Salaries and
Expenses'' at a rate for operations of $20,000,000, for an additional
amount for costs associated with the establishment and implementation of
a Government-wide service-disabled veteran-owned small business
certification program within the Small Business Administration, as
required by section 36 of the Small Business Act (15 U.S.C. 657f) and
section 862 of Public Law 116-283:
Provided, <<NOTE: Apportionment. Certification.>> That such amounts may
be apportioned up to the rate for operations necessary to establish and
implement such certification program: Provided further, That such
amounts may be obligated in the account and budget structure set forth
in H.R. 8294, as passed by the House of Representatives on July 20,
2022.
Sec. 134. Amounts made available by section 101 for ``Small
Business Administration--Business Loans Program Account'' may be
apportioned up to the rate for operations necessary to accommodate
increased demand for commitments for general business loans authorized
under paragraphs (1) through (35) of section 7(a) of the Small Business
Act (15 U.S.C. 636(a)), for guarantees of trust certificates authorized
by section 5(g) of the Small Business Act (15 U.S.C. 634(g)), for
commitments to guarantee loans under section 503 of the Small Business
Investment Act of 1958 (15 U.S.C. 697), and for commitments to guarantee
loans for debentures under section 303(b) of the Small Business
Investment Act of 1958 (15 U.S.C. 683(b)).
Sec. 135. Amounts made available by section 101 to the Department
of Homeland Security under the heading ``Federal Emergency Management
Agency--Disaster Relief Fund'' may be apportioned up to the rate for
operations necessary to carry out response and recovery activities under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42
U.S.C. 5121 et seq.).
Sec. 136. Notwithstanding sections 101, 104, and 106, to carry out
the Hermit's Peak/Calf Canyon Fire Assistance Act, there is appropriated
$2,500,000,000, to remain available until expended, to the Department of
Homeland Security for ``Federal Emergency Management Agency--Hermit's
Peak/Calf Canyon Fire Assistance Account'', which shall be derived by
transfer from amounts made available under the heading ``Federal
Emergency Management Agency--Disaster Relief Fund'' in title VI of
division B of the Coronavirus Aid, Relief, and Economic Security Act
(Public Law 116-136), of which $1,000,000 shall be transferred to
``Office of the Inspector General--Operations and Support'' for
oversight of activities authorized by the Hermit's Peak/Calf Canyon Fire
Assistance Act: Provided, That no amounts may be derived from amounts
made available for major disasters declared pursuant to the Robert T.
Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 et
seq.): Provided further, That amounts provided by this section shall be
subject to the same authorities and conditions as if such amounts were
provided by title III of the Department of Homeland Security
Appropriations Act, 2022 (division F of Public Law 117-103): Provided
further, <<NOTE: Reports. Time period.>> That not later than 90 days
after the date of enactment of this Act, and every 90 days thereafter
until all funds provided by this section have been expended, the
Administrator of the Federal Emergency Management Agency shall
[[Page 136 STAT. 2123]]
provide, in an appropriate format, quarterly reports to the Committees
on Appropriations of the Senate and the House of Representatives on the
obligations and expenditures of the funds made available by this
section: Provided further, That amounts transferred by this section
that were previously designated by the Congress as an emergency
requirement pursuant to the Balanced Budget and Emergency Deficit
Control Act of 1985 or a concurrent resolution on the budget are
designated as an emergency requirement pursuant to section 4001(a)(1) of
S. Con. Res. 14 (117th Congress), the concurrent resolution on the
budget for fiscal year 2022, and section 1(e) of H. Res. 1151 (117th
Congress), as engrossed in the House of Representatives on June 8, 2022.
Sec. 137. <<NOTE: Applicability.>> Section 708(b)(13) of the
Homeland Security Act of 2002 (6 U.S.C. 348(b)(13)) shall be applied by
substituting the date specified in section 106(3) of this Act for
``September 30, 2022''.
Sec. 138. <<NOTE: Applicability.>> During the period covered by
this Act, section 822(a) of the Homeland Security Act of 2002 (6 U.S.C.
383(a)) shall be applied by substituting ``2023'' for ``2022''.
Sec. 139. <<NOTE: Applicability.>> (a) Sections 1309(a) and 1319 of
the National Flood Insurance Act of 1968 (42 U.S.C. 4016(a) and 4026)
shall be applied by substituting the date specified in section 106(3) of
this Act for ``September 30, 2022''.
(b)(1) <<NOTE: Effective date.>> Subject to paragraph (2), this
section shall become effective immediately upon enactment of this Act.
(2) If <<NOTE: Applicability.>> this Act is enacted after
September 30, 2022, this section shall be applied as if it were
in effect on September 30, 2022.
Sec. 140. <<NOTE: Applicability.>> Section 880(g) of the National
Defense Authorization Act for Fiscal Year 2017 (Public Law 114-328)
shall be applied by substituting the date specified in section 106(3) of
this Act for ``September 30, 2022''.
Sec. 141. <<NOTE: Applicability. Time period.>> Section 210G(i) of
the Homeland Security Act of 2002 (6 U.S.C. 124n(i)) shall be applied by
substituting the date specified in section 106(3) of this Act for ``the
date that is 4 years after the date of enactment of this section''.
Sec. 142. Amounts made available by section 101 for ``Department of
the Interior--National Park Service--National Recreation and
Preservation'' for heritage partnership programs may be used to provide
financial assistance to any national heritage area, national heritage
corridor, cultural heritage corridor, national heritage partnership,
national heritage route, national heritage canalway, and battlefields
national historic district established as of September 1, 2022,
notwithstanding any statutory sunset provision terminating the
Secretary's authority to provide assistance to any such area and
notwithstanding any limitation on amounts authorized to be appropriated
with respect to any such area.
Sec. 143. Amounts made available by section 101 to the Department
of the Interior under the heading ``Working Capital Fund'' may be
apportioned up to the rate for operations necessary to implement
enterprise cybersecurity safeguards.
Sec. 144. (a) In addition to amounts otherwise provided by section
101, amounts are provided for ``Department of Health and Human
Services--Indian Health Service--Indian Health Services'' at a rate for
operations of $16,721,000, for an additional amount for costs of
staffing and operating facilities that were opened, renovated, or
expanded in fiscal years 2022 and 2023, and such
[[Page 136 STAT. 2124]]
amounts may be apportioned up to the rate for operations necessary to
staff and operate such facilities.
(b) In addition to amounts otherwise provided by section 101,
amounts are provided for ``Department of Health and Human Services--
Indian Health Service--Indian Health Facilities'' at a rate for
operations of $1,201,000, for an additional amount for costs of staffing
and operating facilities that were opened, renovated, or expanded in
fiscal years 2022 and 2023, and such amounts may be apportioned up to
the rate for operations necessary to staff and operate such facilities.
Sec. 145. In addition to amounts otherwise provided by section 101,
for ``Department of Health and Human Services--Substance Abuse and
Mental Health Services Administration--Mental Health'', there is
appropriated $62,000,000, for an additional amount for fiscal year 2023,
to remain available until September 30, 2023, for carrying out 988
Suicide Lifeline activities and behavioral health crisis services.
Sec. 146. In addition to amounts otherwise provided by section 101,
for ``Department of Health and Human Services--Administration for
Children and Families--Low Income Home Energy Assistance'', there is
appropriated $1,000,000,000, for an additional amount for fiscal year
2023, to remain available until September 30, 2023, for making payments
under subsection (b) of section 2602 of the Low-Income Home Energy
Assistance Act of 1981 (42 U.S.C. 8621 et seq.): Provided, That of the
funds made available by this section, $500,000,000 shall be allocated as
though the total appropriation for such payments for fiscal year 2023
was less than $1,975,000,000: Provided further, That such amount is
designated by the Congress as being for an emergency requirement
pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the
concurrent resolution on the budget for fiscal year 2022, and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022.
Sec. 147. In addition to amounts otherwise provided by section 101,
for ``Department of Health and Human Services--Administration for
Children and Families--Refugee and Entrant Assistance'', there is
appropriated $1,775,000,000, for an additional amount for fiscal year
2023, to remain available until September 30, 2025, to carry out section
462 of the Homeland Security Act of 2002 and section 235 of the William
Wilberforce Trafficking Victims Protection Reauthorization Act of 2008,
and for refugee and entrant assistance activities authorized by section
414 of the Immigration and Nationality Act and section 501 of the
Refugee Education Assistance Act of 1980: Provided, That such amount is
designated by the Congress as being for an emergency requirement
pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the
concurrent resolution on the budget for fiscal year 2022, and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022.
Sec. 148. <<NOTE: Applicability.>> Notwithstanding section 101, the
first paragraph under the heading ``Social Security Administration--
Limitation on Administrative Expenses'' in title IV of division H of
Public Law 117-103 shall be applied by substituting ``$13,602,945,000''
for ``$13,202,945,000''.
Sec. 149. <<NOTE: Applicability.>> (a) During the period covered by
this Act, subsection (a)(1)(A) of section 2502 of the Afghanistan
Supplemental Appropriations Act, 2022 (division C of Public Law 117-43)
shall be
[[Page 136 STAT. 2125]]
applied by substituting the date specified in section 106(3) for
``September 30, 2022''.
(b) The amount provided by this section is designated as an
emergency requirement pursuant to section 4001(a)(1) of S. Con. Res. 14
(117th Congress), the concurrent resolution on the budget for fiscal
year 2022, and section 1(e) of H. Res. 1151 (117th Congress), as
engrossed in the House of Representatives on June 8, 2022.
Sec. 150. <<NOTE: Extension.>> Activities authorized by part A of
title IV (other than under section 403(c) or 418) and section 1108(b) of
the Social Security Act shall continue through the date specified in
section 106(3), in the manner authorized for fiscal year 2022, and out
of any money in the Treasury of the United States not otherwise
appropriated, there are hereby appropriated such sums as may be
necessary for such purpose.
Sec. 151. <<NOTE: Applicability.>> Notwithstanding section 101,
section 126 of division J of Public Law 117-103 shall be applied during
the period covered by this Act by substituting ``fiscal year 2017 and
fiscal year 2018'' for ``fiscal year 2017''.
Sec. 152. Notwithstanding section 101, amounts are provided for--
(1) ``Department of State and Related Agency--Department of
State--Administration of Foreign Affairs--Diplomatic Programs''
at a rate for operations of $9,228,789,000;
(2) ``Bilateral Economic Assistance--Funds Appropriated to
the President--International Disaster Assistance'' at a rate for
operations of $4,555,460,000;
(3) ``Bilateral Economic Assistance--Funds Appropriated to
the President--Transition Initiatives'' at a rate for operations
of $100,000,000;
(4) ``Bilateral Economic Assistance--Funds Appropriated to
the President--Assistance for Europe, Eurasia and Central Asia''
at a rate for operations of $850,000,000;
(5) ``Bilateral Economic Assistance--Department of State--
Migration and Refugee Assistance'' at a rate for operations of
$3,562,188,000;
(6) ``International Security Assistance--Department of
State--International Narcotics Control and Law Enforcement'' at
a rate for operations of $1,421,004,000; and
(7) ``International Security Assistance--Funds Appropriated
to the President--Foreign Military Financing Program'' at a rate
for operations of $6,190,424,000.
Sec. 153. <<NOTE: Applicability.>> During the period covered by
this Act, section 579 of the Multifamily Assisted Housing Reform and
Affordability Act of 1997 (42 U.S.C. 1437f note) shall be applied by
substituting ``2023'' for ``2022'' each place it appears.
Sec. 154. Amounts made available by section 101 to the Department
of Housing and Urban Development for ``Public and Indian Housing--Native
Hawaiian Housing Loan Guarantee Fund Program Account'' may be
apportioned up to the rate for operations necessary to accommodate
demand for commitments to guarantee loans as authorized by section 184A
of the Housing and Community Development Act of 1992 (12 U.S.C. 1715z-
13b).
Sec. 155. In addition to amounts otherwise provided by section 101,
for ``Department of Housing and Urban Development--Community Planning
and Development--Community Development Fund'', there is appropriated
$2,000,000,000, for an additional amount for
[[Page 136 STAT. 2126]]
fiscal year 2023, to remain available until expended, for the same
purposes and under the same terms and conditions as funds appropriated
under such heading in title VIII of the Disaster Relief Supplemental
Appropriations Act, 2022 (division B of Public Law 117-43), except that
such amounts shall be for major disasters that occurred in 2021 or 2022
and the fourth, twentieth, and twenty-first provisos under such heading
in such Act shall not apply: Provided, That amounts made available
under this section and under such heading in such Act may be used by a
grantee to assist utilities as part of a disaster-related eligible
activity under section 105(a) of the Housing and Community Development
Act of 1974 (42 U.S.C. 5305(a)): Provided further, That such amount is
designated by the Congress as being for an emergency requirement
pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the
concurrent resolution on the budget for fiscal year 2022, and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022.
Sec. 156. Notwithstanding section 106 of this Act, at any time
during fiscal year 2023, the Secretary of Housing and Urban Development
may transfer up to $1,300,000 in unobligated balances from amounts made
available in prior Acts under the heading ``Housing Programs--Project-
Based Rental Assistance'' to Treasury Appropriation Fund Symbol 86 X
0148 for the liquidation of obligations incurred in fiscal year 2018 in
connection with the continued provision of interest reduction payments
authorized under section 236 of the National Housing Act (12 U.S.C.
1715z-1).
Sec. 157. <<NOTE: Effective date. Rescissions.>> (a) The remaining
unobligated balances, as of September 30, 2022, from amounts made
available for ``Department of Transportation--Office of the Secretary--
National Infrastructure Investments'' in title I of division H of the
Further Consolidated Appropriations Act, 2020 (Public Law 116-94) are
hereby permanently rescinded, and in addition to amounts otherwise
provided by section 101, an amount of additional new budget authority
equivalent to the amount rescinded pursuant to this subsection is hereby
appropriated on September 30, 2022, for an additional amount for fiscal
year 2022, to remain available until September 30, 2023, and shall be
available, without additional competition, for completing the funding of
awards made pursuant to the fiscal year 2020 national infrastructure
investments program, in addition to other funds as may be available for
such purposes.
(b) <<NOTE: Rescission.>> The remaining unobligated balances, as of
September 30, 2022, from amounts made available to the Department of
Transportation in section 105 of division L of the Consolidated
Appropriations Act, 2021 (Public Law 116-260) are hereby permanently
rescinded, and in addition to amounts otherwise provided by section 101,
an amount of additional new budget authority equivalent to the amount
rescinded pursuant to this subsection is hereby appropriated on
September 30, 2022, for an additional amount for fiscal year 2022, to
remain available until September 30, 2023, and shall be available,
without additional competition, for completing the funding of awards
made pursuant to the fiscal year 2019 national infrastructure
investments program, in addition to other funds as may be available for
such purposes.
(c)(1) <<NOTE: Effective date.>> Subject to paragraph (2), this
section shall become effective immediately upon enactment of this Act.
[[Page 136 STAT. 2127]]
(2) <<NOTE: Applicability.>> If this Act is enacted after
September 30, 2022, this section shall be applied as if it were
in effect on September 30, 2022.
This division may be cited as the ``Continuing Appropriations Act,
2023''.
DIVISION B <<NOTE: Ukraine Supplemental Appropriations Act, 2023.>> --
UKRAINE SUPPLEMENTAL APPROPRIATIONS ACT, 2023
The following sums are appropriated, out of any money in the
Treasury not otherwise appropriated, for the fiscal year ending
September 30, 2023, and for other purposes, namely:
TITLE I
DEPARTMENT OF DEFENSE
Military Personnel
Military Personnel, Army
For an additional amount for ``Military Personnel, Army'',
$110,107,000, to remain available until September 30, 2023, to respond
to the situation in Ukraine and for related expenses.
Military Personnel, Navy
For an additional amount for ``Military Personnel, Navy'', $462,000,
to remain available until September 30, 2023, to respond to the
situation in Ukraine and for related expenses.
Military Personnel, Marine Corps
For an additional amount for ``Military Personnel, Marine Corps'',
$600,000, to remain available until September 30, 2023, to respond to
the situation in Ukraine and for related expenses.
Military Personnel, Air Force
For an additional amount for ``Military Personnel, Air Force'',
$11,582,000, to remain available until September 30, 2023, to respond to
the situation in Ukraine and for related expenses.
OPERATION AND MAINTENANCE
Operation and Maintenance, Army
For an additional amount for ``Operation and Maintenance, Army'',
$654,696,000, to remain available until September 30, 2023, to respond
to the situation in Ukraine and for related expenses.
Operation and Maintenance, Navy
For an additional amount for ``Operation and Maintenance, Navy'',
$433,035,000, to remain available until September 30, 2023, to respond
to the situation in Ukraine and for related expenses.
[[Page 136 STAT. 2128]]
Operation and Maintenance, Marine Corps
For an additional amount for ``Operation and Maintenance, Marine
Corps'', $34,984,000, to remain available until September 30, 2023, to
respond to the situation in Ukraine and for related expenses.
Operation and Maintenance, Air Force
For an additional amount for ``Operation and Maintenance, Air
Force'', $267,084,000, to remain available until September 30, 2023, to
respond to the situation in Ukraine and for related expenses.
Operation and Maintenance, Space Force
For an additional amount for ``Operation and Maintenance, Space
Force'', $1,771,000, to remain available until September 30, 2023, to
respond to the situation in Ukraine and for related expenses.
Operation and Maintenance, Defense-Wide
(including transfer of funds)
For an additional amount for ``Operation and Maintenance, Defense-
Wide'', $4,713,544,000, to remain available until September 30, 2023, to
respond to the situation in Ukraine and for related expenses: Provided,
That of the total amount provided under this heading in this Act,
$3,000,000,000, to remain available until September 30, 2024, shall be
for the Ukraine Security Assistance Initiative: Provided further, That
such funds for the Ukraine Security Assistance Initiative shall be
available to the Secretary of Defense under the same terms and
conditions as are provided for in section 8139 of the Department of
Defense Appropriations Act, 2022 (division C of Public Law 117-103):
Provided further, That of the total amount provided under this heading
in this Act, up to $1,500,000,000, to remain available until September
30, 2024, may be transferred to accounts under the headings ``Operation
and Maintenance'' and ``Procurement'' for replacement of defense
articles from the stocks of the Department of Defense, and for
reimbursement for defense services of the Department of Defense and
military education and training, provided to the government of Ukraine
or to foreign countries that have provided support to Ukraine at the
request of the United States: Provided further, That funds transferred
pursuant to a transfer authority provided under this heading in this Act
shall be merged with and available for the same purposes and for the
same time period as the appropriations to which the funds are
transferred: Provided further, <<NOTE: Notification. Deadline.>> That
the Secretary of Defense shall notify the congressional defense
committees of the details of such transfers not less than 15 days before
any such transfer: Provided further, <<NOTE: Determination.>> That upon
a determination that all or part of the funds transferred from this
appropriation are not necessary for the purposes provided herein, such
amounts may be transferred back and merged with this appropriation:
Provided further, That the transfer authority provided under this
heading in this Act is in addition to any other transfer authority
provided by law.
[[Page 136 STAT. 2129]]
PROCUREMENT
Missile Procurement, Army
For an additional amount for ``Missile Procurement, Army'',
$450,000,000, to remain available until September 30, 2025, to respond
to the situation in Ukraine and for related expenses.
Procurement of Ammunition, Army
For an additional amount for ``Procurement of Ammunition, Army'',
$540,000,000, to remain available until September 30, 2025, for
expansion of public and private plants, including the land necessary
therefor, and procurement and installation of equipment, appliances, and
machine tools in such plants, for the purpose of increasing production
of critical munitions to replace defense articles provided to the
Government of Ukraine or foreign countries that have provided support to
Ukraine at the request of the United States.
Other Procurement, Army
For an additional amount for ``Other Procurement, Army'',
$3,890,000, to remain available until September 30, 2025, to respond to
the situation in Ukraine and for related expenses.
Other Procurement, Navy
For an additional amount for ``Other Procurement, Navy'',
$2,170,000, to remain available until September 30, 2025, to respond to
the situation in Ukraine and for related expenses.
Other Procurement, Air Force
For an additional amount for ``Other Procurement, Air Force'',
$437,991,000, to remain available until September 30, 2025, to respond
to the situation in Ukraine and for other expenses.
Procurement, Defense-Wide
For an additional amount for ``Procurement, Defense-Wide'',
$9,770,000, to remain available until September 30, 2025, to respond to
the situation in Ukraine and for related expenses.
RESEARCH, DEVELOPMENT, TEST AND EVALUATION
Research, Development, Test and Evaluation, Army
For an additional amount for ``Research, Development, Test and
Evaluation, Army'', $3,300,000, to remain available until September 30,
2024, to respond to the situation in Ukraine and for related expenses.
Research, Development, Test and Evaluation, Navy
For an additional amount for ``Research, Development, Test and
Evaluation, Navy'', $2,077,000, to remain available until September 30,
2024, to respond to the situation in Ukraine and for related expenses.
[[Page 136 STAT. 2130]]
Research, Development, Test and Evaluation, Air Force
For an additional amount for ``Research, Development, Test and
Evaluation, Air Force'', $99,704,000, to remain available until
September 30, 2024, to respond to the situation in Ukraine and for
related expenses.
Research, Development, Test and Evaluation, Defense-Wide
For an additional amount for ``Research, Development, Test and
Evaluation, Defense-Wide'', $31,230,000, to remain available until
September 30, 2024, to respond to the situation in Ukraine and for
related expenses.
OTHER DEPARTMENT OF DEFENSE PROGRAMS
Office of the Inspector General
For an additional amount for ``Office of the Inspector General'',
$2,000,000, to remain available until September 30, 2023, to carry out
reviews of the activities of the Department of Defense to execute funds
appropriated in this title, including assistance provided to Ukraine:
Provided, <<NOTE: Briefing. Deadline.>> That the Inspector General of
the Department of Defense shall provide to the congressional defense
committees a briefing not later than 90 days after the date of enactment
of this Act.
RELATED AGENCIES
Intelligence Community Management Account
For an additional amount for ``Intelligence Community Management
Account'', $500,000, to remain available until September 30, 2023, to
respond to the situation in Ukraine and for related expenses.
GENERAL PROVISIONS--THIS TITLE
Sec. 1101. <<NOTE: Reports. Coordination.>> Not later than 60 days
after the date of enactment of this Act, the Secretary of Defense, in
coordination with the Secretary of State, shall submit a report to the
Committees on Appropriations, Armed Services, and Foreign Affairs of the
House of Representatives and the Committees on Appropriations, Armed
Services, and Foreign Relations of the Senate on measures being taken to
account for United States defense articles designated for Ukraine since
the February 24, 2022, Russian invasion of Ukraine, particularly
measures with regard to such articles that require enhanced end-use
monitoring; measures to ensure that such articles reach their intended
recipients and are used for their intended purposes; and any other
measures to promote accountability for the use of such articles:
Provided, That such report shall include a description of any
occurrences of articles not reaching their intended recipients or used
for their intended purposes and a description of any remedies taken:
Provided further, That such report shall be submitted in unclassified
form, but may be accompanied by a classified annex.
Sec. 1102. <<NOTE: Reports. Time periods. Coordination.>> Not later
than 30 days after the date of enactment of this Act, and every 30 days
thereafter through fiscal year 2023,
[[Page 136 STAT. 2131]]
the Secretary of Defense, in coordination with the Secretary of State,
shall provide a written report to the Committees on Appropriations,
Armed Services, and Foreign Affairs of the House of Representatives and
the Committees on Appropriations, Armed Services, and Foreign Relations
of the Senate describing United States security assistance provided to
Ukraine since the February 24, 2022, Russian invasion of Ukraine,
including a comprehensive list of the defense articles and services
provided to Ukraine and the associated authority and funding used to
provide such articles and services: Provided, That such report shall be
submitted in unclassified form, but may be accompanied by a classified
annex.
TITLE II
DEPARTMENT OF ENERGY
ATOMIC ENERGY DEFENSE ACTIVITIES
NATIONAL NUCLEAR SECURITY ADMINISTRATION
Defense Nuclear Nonproliferation
For an additional amount for ``Defense Nuclear Nonproliferation'',
$35,000,000, to remain available until expended, to respond to the
situation in Ukraine and for related expenses.
TITLE III
BILATERAL ECONOMIC ASSISTANCE
Funds Appropriated to the President
economic support fund
For an additional amount for ``Economic Support Fund'',
$4,500,000,000, to remain available until September 30, 2024, for
assistance for Ukraine: Provided, That funds appropriated under this
heading in this Act may be made available notwithstanding any other
provision of law that restricts assistance to foreign countries and may
be made available as contributions.
GENERAL PROVISIONS--THIS TITLE
Sec. 1301. <<NOTE: Applicability.>> During fiscal year 2023,
section 506(a)(1) of the Foreign Assistance Act of 1961 (22 U.S.C.
2318(a)(1)) shall be applied by substituting ``$3,700,000,000'' for
``$100,000,000''.
Sec. 1302. <<NOTE: Requirements.>> (a) Funds appropriated by this
title shall be made available for direct financial support for the
Government of Ukraine, including for Ukrainian first responders, and may
be made available as a cash transfer subject to the requirements of
subsection (b): Provided, <<NOTE: Reimbursement.>> That such funds
shall be provided on a reimbursable basis and matched by sources other
than the United States Government, to the maximum extent practicable:
Provided further, That the Secretary of State or the Administrator of
the United States Agency for International Development, as appropriate,
shall ensure third-party monitoring of such funds: Provided
further, <<NOTE: Deadline. Consultation. Certification. Reports.>> That
at least 15 days prior to the initial obligation of such funds, the
Secretary of State, following consultation with the Administrator
[[Page 136 STAT. 2132]]
of the United States Agency for International Development, shall certify
and report to the appropriate congressional committees that mechanisms
for monitoring and oversight of such funds are in place and functioning
and that the Government of Ukraine has in place substantial safeguards
to prevent corruption and ensure accountability of such funds: Provided
further, <<NOTE: Reports. Assessments.>> That not less than 45 days
after the initial obligation of such funds, the Inspectors General of
the Department of State and the United States Agency for International
Development shall submit a report to the appropriate congressional
committees detailing and assessing the mechanisms for monitoring and
safeguards described in the previous proviso.
(b) <<NOTE: Memorandum.>> Funds made available to the Government of
Ukraine as a cash transfer under subsection (a) shall be subject to a
memorandum of understanding between the Governments of the United States
and Ukraine that describes how the funds proposed to be made available
will be used and the appropriate safeguards to ensure transparency and
accountability: Provided, That such assistance shall be maintained in a
separate, auditable account and may not be comingled with any other
funds.
(c) <<NOTE: Reports. Time period.>> The Secretary of State or the
Administrator of the United States Agency for International Development,
as appropriate, shall report to the appropriate congressional committees
on the uses of funds provided for direct financial support to the
Government of Ukraine pursuant to subsection (a) not later than 45 days
after the date of enactment of this Act and every 45 days thereafter
until all such funds have been expended: Provided, <<NOTE: Summary.>>
That such report shall include a detailed description of the use of such
funds, including categories and amounts, the intended results and the
results achieved, a summary of other donor contributions, and a
description of the efforts undertaken by the Secretary and Administrator
to increase other donor contributions for direct financial support:
Provided further, That such report shall also include the metrics
established to measure such results.
(d) <<NOTE: Notification.>> Funds made available for the purposes
of subsection (a) shall be subject to the regular notification
procedures of the Committees on Appropriations of the House of
Representatives and the Senate.
TITLE IV
GENERAL PROVISIONS--THIS ACT
Sec. 1401. Each amount appropriated or made available by this Act
is in addition to amounts otherwise appropriated for the fiscal year
involved.
Sec. 1402. No part of any appropriation contained in this Act shall
remain available for obligation beyond the current fiscal year unless
expressly so provided herein.
Sec. 1403. Unless otherwise provided for by this Act, the
additional amounts appropriated by this Act to appropriations accounts
shall be available under the authorities and conditions applicable to
such appropriations accounts for fiscal year 2023.
Sec. 1404. Each amount provided by this division is designated by
the Congress as being for an emergency requirement pursuant to section
4001(a)(1) of S. Con. Res. 14 (117th Congress), the concurrent
resolution on the budget for fiscal year 2022, and section
[[Page 136 STAT. 2133]]
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of
Representatives on June 8, 2022.
This division may be cited as the ``Ukraine Supplemental
Appropriations Act, 2023''.
DIVISION C--OTHER MATTERS
TITLE I--EXTENSIONS, TECHNICAL CORRECTIONS, AND OTHER MATTERS
SEC. 101. EXTENSION OF FCC AUCTION AUTHORITY.
Section 309(j)(11) of the Communications Act of 1934 (47 U.S.C.
309(j)(11)) is amended by striking ``September 30, 2022'' and inserting
``December 16, 2022''.
SEC. 102. EXTENSION OF AUTHORIZATION FOR SPECIAL ASSESSMENT FOR
DOMESTIC TRAFFICKING VICTIMS' FUND.
Section 3014(a) of title 18, United States Code, is amended, in the
matter preceding paragraph (1), by striking ``September 30, 2022'' and
inserting ``December 16, 2022''.
SEC. 103. <<NOTE: United States Parole Commission Extension Act of
2022.>> UNITED STATES PAROLE COMMISSION
EXTENSION.
(a) <<NOTE: 18 USC 1 note.>> Short Title.--This section may be
cited as the ``United States Parole Commission Extension Act of 2022''.
(b) <<NOTE: 18 USC 3551 note.>> Amendment of Sentencing Reform Act
of 1984.--For purposes of section 235(b) of the Sentencing Reform Act of
1984 (18 U.S.C. 3551 note; Public Law 98-473; 98 Stat. 2032), as such
section relates to chapter 311 of title 18, United States Code, and the
United States Parole Commission, each reference in such section to ``35
years'' or ``35-year period'' shall be deemed a reference to ``35 years
and 46 days'' or ``35-year and 46-day period'', respectively.
SEC. 104. EXTENSION OF COMMODITY FUTURES TRADING COMMISSION
CUSTOMER PROTECTION FUND EXPENSES ACCOUNT.
Section 1(b) of Public Law 117-25 (135 Stat. 297) is amended by
striking ``October 1, 2022'' each place it appears and inserting
``December 16, 2022''.
TITLE II--BUDGETARY EFFECTS
SEC. 201. BUDGETARY EFFECTS.
(a) Statutory PAYGO Scorecards.--The budgetary effects of this
division and each succeeding division shall not be entered on either
PAYGO scorecard maintained pursuant to section 4(d) of the Statutory
Pay-As-You-Go Act of 2010.
(b) Senate PAYGO Scorecards.--The budgetary effects of this division
and each succeeding division shall not be entered on any PAYGO scorecard
maintained for purposes of section 4106 of H. Con. Res. 71 (115th
Congress).
(c) Classification of Budgetary Effects.--Notwithstanding Rule 3 of
the Budget Scorekeeping Guidelines set forth in the joint explanatory
statement of the committee of conference accompanying Conference Report
105-217 and section 250(c)(8) of the Balanced Budget and Emergency
Deficit Control Act of 1985, the
[[Page 136 STAT. 2134]]
budgetary effects of this division and each succeeding division shall
not be estimated--
(1) for purposes of section 251 of such Act;
(2) for purposes of an allocation to the Committee on
Appropriations pursuant to section 302(a) of the Congressional
Budget Act of 1974; and
(3) for purposes of paragraph (4)(C) of section 3 of the
Statutory Pay-As-You-Go Act of 2010 as being included in an
appropriation Act.
DIVISION D--HEALTH AND HUMAN SERVICES EXTENSIONS
TITLE I--MEDICARE AND MEDICAID
SEC. 101. EXTENSION OF INCREASED INPATIENT HOSPITAL PAYMENT
ADJUSTMENT FOR CERTAIN LOW-VOLUME
HOSPITALS.
(a) <<NOTE: Time periods.>> In General.--Section 1886(d)(12) of the
Social Security Act (42 U.S.C. 1395ww(d)(12)) is amended--
(1) in subparagraph (B), in the matter preceding clause (i),
by striking ``in fiscal year 2023 and subsequent fiscal years''
and inserting ``during the portion of fiscal year 2023 beginning
on December 17, 2022, and ending on September 30, 2023, and in
fiscal year 2024 and subsequent fiscal years'';
(2) in subparagraph (C)(i)--
(A) in the matter preceding subclause (I)--
(i) by inserting ``or portion of a fiscal
year'' after ``for a fiscal year''; and
(ii) by inserting ``and the portion of fiscal
year 2023 beginning on October 1, 2022, and ending
on December 16, 2022'' after ``through 2022'';
(B) in subclause (III), by inserting ``and the
portion of fiscal year 2023 beginning on October 1,
2022, and ending on December 16, 2022'' after ``through
2022''; and
(C) in subclause (IV), by striking ``fiscal year
2023'' and inserting ``the portion of fiscal year 2023
beginning on December 17, 2022, and ending on September
30, 2023, and fiscal year 2024''; and
(3) in subparagraph (D)--
(A) in the matter preceding clause (i), by inserting
``or during the portion of fiscal year 2023 beginning on
October 1, 2022, and ending on December 16, 2022'' after
``through 2022''; and
(B) in clause (ii), by inserting ``and the portion
of fiscal year 2023 beginning on October 1, 2022, and
ending on December 16, 2022'' after ``through 2022''.
(b) <<NOTE: 42 USC 1395ww note.>> Implementation.--Notwithstanding
any other provision of law, the Secretary of Health and Human Services
may implement the provisions of, including the amendments made by, this
section by program instruction or otherwise.
SEC. 102. EXTENSION OF THE MEDICARE-DEPENDENT HOSPITAL (MDH)
PROGRAM.
(a) In General.--Section 1886(d)(5)(G) of the Social Security Act
(42 U.S.C. 1395ww(d)(5)(G)) is amended--
[[Page 136 STAT. 2135]]
(1) in clause (i), by striking ``October 1, 2022'' and
inserting ``December 17, 2022''; and
(2) in clause (ii)(II), by striking ``October 1, 2022'' and
inserting ``December 17, 2022''.
(b) Conforming Amendments.--
(1) Extension of target amount.--Section 1886(b)(3)(D) of
the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is amended--
(A) in the matter preceding clause (i), by striking
``October 1, 2022'' and inserting ``December 17, 2022'';
and
(B) <<NOTE: Time period.>> in clause (iv), by
inserting ``and the portion of fiscal year 2023
beginning on October 1, 2022, and ending on December 16,
2022,'' after ``through fiscal year 2022''.
(2) <<NOTE: Time periods.>> Permitting hospitals to decline
reclassification.--Section 13501(e)(2) of the Omnibus Budget
Reconciliation Act of 1993 (42 U.S.C. 1395ww note) is amended by
striking ``or fiscal year 2000 through fiscal year 2022,'' and
inserting ``fiscal year 2000 through fiscal year 2022, or the
portion of fiscal year 2023 beginning on October 1, 2022, and
ending on December 16, 2022''.
SEC. 103. EXTENSION OF INCREASED FMAPS FOR THE TERRITORIES.
Section 1905(ff) of the Social Security Act (42 U.S.C. 1396d(ff)) is
amended by striking ``December 13'' each place it appears and inserting
``December 16'' in each such place.
SEC. 104. REDUCTION OF MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``$7,500,000,000'' and inserting
``$7,308,000,000''.
TITLE II--HUMAN SERVICES
SEC. 201. EXTENSION OF MATERNAL, INFANT, AND EARLY CHILDHOOD HOME
VISITING PROGRAMS.
Activities authorized by section 511 of the Social Security Act
shall continue through December 16, 2022, in the manner authorized for
fiscal year 2022, and out of any money in the Treasury of the United
States not otherwise appropriated, there is hereby appropriated for such
purpose an amount equal to the pro rata portion of the amount
appropriated for such activities for fiscal year 2022.
SEC. 202. EXTENSION OF CHILD AND FAMILY SERVICES PROGRAMS.
Activities authorized by part B of title IV of the Social Security
Act shall continue through December 16, 2022, in the manner authorized
for fiscal year 2022, and out of any money in the Treasury of the United
States not otherwise appropriated, there are hereby appropriated such
sums as may be necessary for such purpose.
[[Page 136 STAT. 2136]]
TITLE III--PUBLIC HEALTH
SEC. 301. EXTENSION OF THE PROGRAM TO DEEM CERTAIN HEALTH
PROFESSIONAL VOLUNTEERS EMPLOYEES OF THE
PUBLIC HEALTH SERVICE UNDER CERTAIN
CIRCUMSTANCES.
(a) In General.--Section 224(q) of the Public Health Service Act (42
U.S.C. 233(q)) is amended by striking paragraph (6).
(b) Technical Corrections.--Section 224 of the Public Health Service
Act (42 U.S.C. 233) is amended--
(1) in subsection (g)(1)(H)(iv), by striking ``this
section.'' and inserting ``this section).'';
(2) in subsection (k)(3), by inserting ``governing board
members,'' after ``officers,'';
(3) in subsection (p)(7)(A)(i), by moving the margin of
subclause (II) 2 ems to the left; and
(4) in subsection (q)(5)(A), by striking ``and paragraph
(6)''.
SEC. 302. <<NOTE: Applicability. 42 USC 210-1 note.>> EXTENSION
OF AUTHORIZATION FOR A COMMISSIONED
OFFICER OF THE PUBLIC HEALTH SERVICE TO
ACCUMULATE EXCESS ANNUAL LEAVE.
For purposes of annual leave accumulated in fiscal year 2022, the
authority provided in section 2106 of division C of Public Law 116-159
(42 U.S.C. 210-1 note) shall apply to such leave by substituting
``2022'' for ``2020'' in subsections (a) and (d)(2).
TITLE IV--INDIAN HEALTH
SEC. 401. EXTENSION OF MORATORIUM.
Section 424(a) of title IV of division G of Public Law 113-
76 <<NOTE: 128 Stat. 343.>> is amended by striking ``October 1, 2019''
and inserting ``December 16, 2022''.
DIVISION E--VETERANS AFFAIRS EXTENSIONS
TITLE I--EXTENSIONS OF AUTHORITIES RELATING TO HEALTH CARE
SEC. 101. EXTENSION OF AUTHORITY FOR COLLECTION OF COPAYMENTS FOR
HOSPITAL CARE AND NURSING HOME CARE.
Section 1710(f)(2)(B) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2024''.
SEC. 102. EXTENSION OF REQUIREMENT TO PROVIDE NURSING HOME CARE TO
CERTAIN VETERANS WITH SERVICE-CONNECTED
DISABILITIES.
Section 1710A(d) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2024''.
[[Page 136 STAT. 2137]]
SEC. 103. EXTENSION OF AUTHORITY TO CONTINUE DOD-VA HEALTH CARE
SHARING INCENTIVE FUND.
Section 8111(d)(3) of title 38, United States Code, is amended by
striking ``September 30, 2023'' and inserting ``September 30, 2026''.
SEC. 104. EXTENSION OF AUTHORITY FOR JOINT DEPARTMENT OF DEFENSE-
DEPARTMENT OF VETERANS AFFAIRS MEDICAL
FACILITY DEMONSTRATION FUND.
Section 1704(e) of the National Defense Authorization Act for Fiscal
Year 2010 (Public Law 111-84; 123 Stat. 2573), as most recently amended
by section 715 of the National Defense Authorization Act for Fiscal Year
2022 (Public Law 117-81; 135 Stat. 1787), is amended by striking
``September 30, 2023'' and inserting ``September 30, 2024''.
SEC. 105. EXTENSION OF TEMPORARY EXPANSION OF PAYMENTS AND
ALLOWANCES FOR BENEFICIARY TRAVEL IN
CONNECTION WITH VETERANS RECEIVING CARE
FROM VET CENTERS.
Section 104(a) of the Honoring America's Veterans and Caring for
Camp Lejeune Families Act of 2012 (Public Law 112-154; 126 Stat. 1169),
as most recently amended by section 3 of the Department of Veterans
Affairs Expiring Authorities Act of 2021 (Public Law 117-42; 135 Stat.
342), is amended by striking ``September 30, 2022'' and inserting
``September 30, 2023''.
TITLE II--EXTENSIONS OF AUTHORITIES RELATING TO BENEFITS
SEC. 201. EXTENSION OF AUTHORITY TO TRANSPORT INDIVIDUALS TO AND
FROM DEPARTMENT OF VETERANS AFFAIRS
FACILITIES.
Section 111A(a)(2) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2024''.
SEC. 202. EXTENSION OF AUTHORITY TO MAINTAIN REGIONAL OFFICE IN
THE REPUBLIC OF THE PHILIPPINES.
Section 315(b) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2024''.
SEC. 203. EXTENSION OF AUTHORITY FOR REPORT ON EQUITABLE RELIEF
PROVIDED DUE TO ADMINISTRATIVE ERROR.
Section 503(c) of title 38, United States Code, is amended by
striking ``December 31, 2022'' and inserting ``December 31, 2024''.
SEC. 204. EXTENSION OF AUTHORITY TO PROVIDE ASSISTANCE FOR
SPECIALLY ADAPTED HOUSING FOR DISABLED
VETERANS RESIDING TEMPORARILY IN HOUSING
OWNED BY A FAMILY MEMBER.
Section 2102A(e) of title 38, United States Code, is amended by
striking ``December 31, 2022'' and inserting ``December 31, 2024''.
[[Page 136 STAT. 2138]]
SEC. 205. EXTENSION OF SPECIALLY ADAPTED HOUSING ASSISTIVE
TECHNOLOGY GRANT PROGRAM.
Section 2108(g) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2024''.
TITLE III--EXTENSIONS OF AUTHORITIES RELATING TO HOMELESS VETERANS
SEC. 301. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR
HOMELESS VETERANS REINTEGRATION PROGRAMS.
Section 2021(e)(1)(F) of title 38, United States Code, is amended by
striking ``2022'' and inserting ``2024''.
SEC. 302. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR
HOMELESS WOMEN VETERANS AND HOMELESS
VETERANS WITH CHILDREN REINTEGRATION GRANT
PROGRAM.
Section 2021A(f)(1) of title 38, United States Code, is amended by
striking ``2022'' and inserting ``2024''.
SEC. 303. EXTENSION OF AUTHORITY FOR TREATMENT AND REHABILITATION
FOR SERIOUSLY MENTALLY ILL AND HOMELESS
VETERANS.
(a) General Treatment.--Section 2031(b) of title 38, United States
Code, is amended by striking ``September 30, 2022'' and inserting
``September 30, 2024''.
(b) Additional Services at Certain Locations.--Section 2033(d) of
such title is amended by striking ``September 30, 2022'' and inserting
``September 30, 2024''.
SEC. 304. EXTENSION OF FUNDING FOR FINANCIAL ASSISTANCE FOR
SUPPORTIVE SERVICES FOR VERY LOW-INCOME
VETERAN FAMILIES IN PERMANENT HOUSING.
Section 2044(e)(1)(H) of title 38, United States Code, is amended by
striking ``and 2022'' and inserting ``through 2024''.
SEC. 305. EXTENSION OF FUNDING FOR GRANT PROGRAM FOR HOMELESS
VETERANS WITH SPECIAL NEEDS.
Section 2061(d)(1) of title 38, United States Code, is amended by
striking ``2022'' and inserting ``2024''.
SEC. 306. EXTENSION OF AUTHORITY FOR THE ADVISORY COMMITTEE ON
HOMELESS VETERANS.
Section 2066(d) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2026''.
[[Page 136 STAT. 2139]]
TITLE IV--EXTENSIONS OF OTHER AUTHORITIES
SEC. 401. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR MONTHLY
ASSISTANCE ALLOWANCE UNDER THE OFFICE OF
NATIONAL VETERANS SPORTS PROGRAMS AND
SPECIAL EVENTS.
Section 322(d)(4) of title 38, United States Code, is amended by
striking ``2022'' and inserting ``2026''.
SEC. 402. EXTENSION AND AUTHORIZATION OF APPROPRIATIONS FOR
ADAPTIVE SPORTS PROGRAMS FOR DISABLED
VETERANS AND MEMBERS OF THE ARMED FORCES.
(a) Authorization of Appropriations.--Subsection (g)(1)(B) of
section 521A of title 38, United States Code, is amended by striking
``and 2022'' and inserting ``through 2026''.
(b) Extension.--Subsection (l) of such section is amended by
striking ``2022'' and inserting ``2026''.
(c) Technical Correction.--Subsection (g)(1)(A) of such section is
amended by striking ``. for each of fiscal years 2010 through 2020''.
SEC. 403. EXTENSION OF ADVISORY COMMITTEE ON MINORITY VETERANS.
Section 544(e) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2026''.
SEC. 404. EXTENSION OF VETERANS' ADVISORY COMMITTEE ON EDUCATION.
Section 3692(c) of title 38, United States Code, is amended by
striking ``December 31, 2022'' and inserting ``December 31, 2026''.
SEC. 405. EXTENSION OF AUTHORITY FOR TRANSFER OF REAL PROPERTY.
Section 8118(a)(5) of title 38, United States Code, is amended by
striking ``September 30, 2022'' and inserting ``September 30, 2024''.
DIVISION F <<NOTE: FDA User Fee Reauthorization Act of 2022.>> --FDA
USER FEE REAUTHORIZATION ACT OF 2022
SEC. 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This division may be cited as the ``FDA User Fee Reauthorization Act
of 2022''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this division is as follows:
DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 1001. Short title; finding.
Sec. 1002. Definitions.
[[Page 136 STAT. 2140]]
Sec. 1003. Authority to assess and use drug fees.
Sec. 1004. Reauthorization; reporting requirements.
Sec. 1005. Sunset dates.
Sec. 1006. Effective date.
Sec. 1007. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 2001. Short title; finding.
Sec. 2002. Definitions.
Sec. 2003. Authority to assess and use device fees.
Sec. 2004. Reauthorization; reporting requirements.
Sec. 2005. Conformity assessment pilot program.
Sec. 2006. Reauthorization of third-party review program.
Sec. 2007. Sunset dates.
Sec. 2008. Effective date.
Sec. 2009. Savings clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 3001. Short title; finding.
Sec. 3002. Authority to assess and use human generic drug fees.
Sec. 3003. Reauthorization; reporting requirements.
Sec. 3004. Sunset dates.
Sec. 3005. Effective date.
Sec. 3006. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 4001. Short title; finding.
Sec. 4002. Definitions.
Sec. 4003. Authority to assess and use biosimilar biological product
fees.
Sec. 4004. Reauthorization; reporting requirements.
Sec. 4005. Sunset dates.
Sec. 4006. Effective date.
Sec. 4007. Savings clause.
TITLE V--REAUTHORIZATION OF OTHER PROVISIONS
Sec. 5001. Reauthorization of the best pharmaceuticals for children
program.
Sec. 5002. Reauthorization of the humanitarian device exemption
incentive.
Sec. 5003. Reauthorization of the pediatric device consortia program.
Sec. 5004. Reauthorization of provision pertaining to drugs containing
single enantiomers.
Sec. 5005. Reauthorization of the critical path public-private
partnership.
Sec. 5006. Reauthorization of orphan drug grants.
Sec. 5007. Reauthorization of certain device inspections.
Sec. 5008. Reauthorization of reporting requirements related to pending
generic drug applications and priority review applications.
TITLE I <<NOTE: Prescription Drug User Fee Amendments of 2022.>> --FEES
RELATING TO DRUGS
SEC. 1001. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Prescription Drug User Fee Amendments of 2022''.
(b) <<NOTE: 21 USC 379g note.>> Finding.--Congress finds that the
fees authorized by the amendments made by this title will be dedicated
toward expediting the drug development process and the process for the
review of human drug applications, including postmarket drug safety
activities, as set forth in the goals identified for purposes of part 2
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379g et seq.), 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. 1002. DEFINITIONS.
(a) Human Drug Application.--Section 735(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended,
[[Page 136 STAT. 2141]]
in the matter following subparagraph (B), by striking ``an allergenic
extract product, or'' and inserting ``does not include an application
with respect to an allergenic extract product licensed before October 1,
2022, does not include an application with respect to a standardized
allergenic extract product submitted pursuant to a notification to the
applicant from the Secretary regarding the existence of a potency test
that measures the allergenic activity of an allergenic extract product
licensed by the applicant before October 1, 2022, does not include an
application with respect to''.
(b) Prescription Drug Product.--Section 735(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended--
(1) by redesignating subparagraphs (A), (B), and (C) as
clauses (i), (ii), and (iii), respectively;
(2) by striking ``(3) The term'' and inserting ``(3)(A) The
term'';
(3) by striking ``Such term does not include whole blood''
and inserting the following:
``(B) Such term does not include whole blood'';
(4) by striking ``an allergenic extract product,'' and
inserting ``an allergenic extract product licensed before
October 1, 2022, a standardized allergenic extract product
submitted pursuant to a notification to the applicant from the
Secretary regarding the existence of a potency test that
measures the allergenic activity of an allergenic extract
product licensed by the applicant before October 1, 2022,'' ;
and
(5) by adding at the end the following:
``(C)(i) <<NOTE: Assessment. Effective date.>> If a
written request to place a product in the discontinued
section of either of the lists referenced in
subparagraph (A)(iii) is submitted to the Secretary on
behalf of an applicant, and the request identifies the
date the product is, or will be, withdrawn from sale,
then for purposes of assessing the prescription drug
program fee under section 736(a)(2), the Secretary shall
consider such product to have been included in the
discontinued section on the later of--
``(I) the date such request was received; or
``(II) if the product will be withdrawn from
sale on a future date, such future date when the
product is withdrawn from sale.
``(ii) For purposes of this subparagraph, a product
shall be considered withdrawn from sale once the
applicant has ceased its own distribution of the
product, whether or not the applicant has ordered recall
of all previously distributed lots of the product,
except that a routine, temporary interruption in supply
shall not render a product withdrawn from sale.''.
(c) Skin-Test Diagnostic Product.--Section 735 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g) is amended by adding at the end
the following:
``(12) The term `skin-test diagnostic product'--
``(A) means a product--
``(i) for prick, scratch, intradermal, or
subcutaneous administration;
``(ii) expected to produce a limited, local
reaction at the site of administration (if
positive), rather than a systemic effect;
[[Page 136 STAT. 2142]]
``(iii) not intended to be a preventive or
therapeutic intervention; and
``(iv) intended to detect an immediate- or
delayed-type skin hypersensitivity reaction to aid
in the diagnosis of--
``(I) an allergy to an antimicrobial
agent;
``(II) <<NOTE: Time period.>> an
allergy that is not to an antimicrobial
agent, if the diagnostic product was
authorized for marketing prior to
October 1, 2022; or
``(III) infection with fungal or
mycobacterial pathogens; and
``(B) includes positive and negative controls
required to interpret the results of a product described
in subparagraph (A).''.
SEC. 1003. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--
(1) Human drug application fee.--Section 736(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is
amended--
(A) in the matter preceding paragraph (1), by
striking ``fiscal year 2018'' and inserting ``fiscal
year 2023'';
(B) in paragraph (1)(A), by striking ``(c)(5)'' each
place it appears and inserting ``(c)(6)'';
(C) in paragraph (1)(C), by inserting ``prior to
approval'' after ``or was withdrawn''; and
(D) in paragraph (1), by adding at the end the
following:
``(H) Exception for skin-test diagnostic products.--
A human drug application for a skin-test diagnostic
product shall not be subject to a fee under subparagraph
(A).''.
(2) Prescription drug program fee.--Section 736(a)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(2)) is
amended--
(A) in subparagraph (A)--
(i) by striking ``Except as provided in
subparagraphs (B) and (C)'' and inserting the
following:
``(i) Payment of fees.--Except as provided in
subparagraphs (B) and (C)'';
(ii) by striking ``subsection (c)(5)'' and
inserting ``subsection (c)(6)''; and
(iii) by adding at the end the following:
``(ii) Special rule for previously
discontinued drug products. <<NOTE: Effective
date. Time period. Payment fee.>> --If a drug
product that is identified in a human drug
application approved as of October 1 of a fiscal
year is not a prescription drug product as of that
date because the drug product is in the
discontinued section of a list referenced in
section 735(3)(A)(iii), and on any subsequent day
during such fiscal year the drug product is a
prescription drug product, then except as provided
in subparagraphs (B) and (C), each person who is
named as the applicant in a human drug application
with respect to such product, and who, after
September 1, 1992, had pending before the
Secretary a human drug application or supplement,
shall pay the annual prescription drug
[[Page 136 STAT. 2143]]
program fee established for a fiscal year under
subsection (c)(6) for such prescription drug
product. <<NOTE: Deadline.>> Such fee shall be
due on the last business day of such fiscal year
and shall be paid only once for each such product
for a fiscal year in which the fee is payable.'';
and
(B) by amending subparagraph (B) to read as follows:
``(B) Exception for certain prescription drug
products.--A prescription drug program fee shall not be
assessed for a prescription drug product under
subparagraph (A) if such product is--
``(i) a large volume parenteral product (a
sterile aqueous drug product packaged in a single-
dose container with a volume greater than or equal
to 100 mL, not including powders for
reconstitution or pharmacy bulk packages)
identified on the list compiled under section
505(j)(7);
``(ii) pharmaceutically equivalent (as defined
in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulation)) to
another product on the list of products compiled
under section 505(j)(7) (not including the
discontinued section of such list); or
``(iii) a skin-test diagnostic product.''.
(b) <<NOTE: Time period.>> Fee Revenue Amounts.--
(1) In general.--Paragraph (1) of section 736(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
amended to read as follows:
``(1) In general.--For each of the fiscal years 2023 through
2027, fees under subsection (a) shall, except as provided in
subsections (c), (d), (f), and (g), be established to generate a
total revenue amount under such subsection that is 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 strategic
hiring and retention adjustment for the fiscal year (as
determined under subsection (c)(2));
``(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(3));
``(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(4));
``(F) the dollar amount equal to the additional
direct cost adjustment for the fiscal year (as
determined under subsection (c)(5)); and
``(G) additional dollar amounts for each fiscal year
as follows:
``(i) $65,773,693 for fiscal year 2023.
``(ii) $25,097,671 for fiscal year 2024.
``(iii) $14,154,169 for fiscal year 2025.
``(iv) $4,864,860 for fiscal year 2026.
``(v) $1,314,620 for fiscal year 2027.''.
[[Page 136 STAT. 2144]]
(2) Annual base revenue.--Paragraph (3) of section 736(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
amended to read as follows:
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
``(A) for fiscal year 2023, $1,151,522,958; and
``(B) for fiscal years 2024 through 2027, the dollar
amount of the total revenue amount established under
paragraph (1) for the previous fiscal year, not
including any adjustments made under subsection (c)(4)
or (c)(5).''.
(c) <<NOTE: Time periods.>> Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)(1)(B)(ii)) is amended by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-Arlington-
Alexandria, DC-VA-MD-WV''.
(2) Strategic hiring and retention adjustment.--Section
736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)) is amended--
(A) by redesignating paragraphs (2) through (6) as
paragraphs (3) through (7), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, after the annual base revenue established in
subsection (b)(1)(A) is adjusted for inflation in accordance
with paragraph (1), the Secretary shall further increase the fee
revenue and fees by the following amounts:
``(A) For fiscal year 2023, $9,000,000.
``(B) For each of fiscal years 2024 through 2027,
$4,000,000.''.
(3) Capacity planning adjustment.--Paragraph (3), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, after the
annual base revenue established in subsection (b)(1)(A)
is adjusted in accordance with paragraphs (1) and (2),
such revenue shall be adjusted further for such fiscal
year, in accordance with this paragraph, to reflect
changes in the resource capacity needs of the Secretary
for the process for the review of human drug
applications.
``(B) Methodology.--For purposes of this paragraph,
the Secretary shall employ the capacity planning
methodology utilized by the Secretary in setting fees
for fiscal year 2021, as described in the notice titled
`Prescription Drug User Fee Rates for Fiscal Year 2021'
published in the Federal Register on August 3, 2020 (85
Fed. Reg. 46651). The workload categories used in
applying such methodology in forecasting shall include
only the activities described in that notice and, as
feasible, additional activities that are directly
related to the direct review of applications and
supplements, including additional formal meeting types,
the direct review of postmarketing commitments and
requirements, the direct review of risk evaluation and
mitigation strategies, and the direct review of annual
reports for approved prescription drug products. Subject
[[Page 136 STAT. 2145]]
to the exceptions in the preceding sentence, the
Secretary shall not include as workload categories in
applying such methodology in forecasting any non-core
review activities, including those activities that the
Secretary referenced for potential future use in such
notice but did not utilize in setting fees for fiscal
year 2021.
``(C) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
for a fiscal year that is less than the sum of the
amounts under subsections (b)(1)(A) (the annual base
revenue for the fiscal year), (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal year),
and (b)(1)(C) (the dollar amount of the strategic hiring
and retention adjustment for the fiscal year).
``(D) <<NOTE: Notice.>> Publication in federal
register.--The Secretary shall publish in the Federal
Register notice under paragraph (6) of the fee revenue
and fees resulting from the adjustment and the
methodologies under this paragraph.''.
(4) Operating reserve adjustment.--Paragraph (4), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(A) by amending subparagraph (A) to read as follows:
``(A) Increase.--For fiscal year 2023 and subsequent
fiscal years, the Secretary shall, in addition to
adjustments under paragraphs (1), (2), and (3), further
increase the fee revenue and fees if such an adjustment
is necessary to provide for operating reserves of
carryover user fees for the process for the review of
human drug applications for each fiscal year in at least
the following amounts:
``(i) For fiscal year 2023, at least 8 weeks
of operating reserves.
``(ii) For fiscal year 2024, at least 9 weeks
of operating reserves.
``(iii) For fiscal year 2025 and subsequent
fiscal years, at least 10 weeks of operating
reserves.''; and
(B) in subparagraph (C), by striking ``paragraph
(5)'' and inserting ``paragraph (6)''.
(5) Additional direct cost adjustment.--Paragraph (5), as
redesignated, of section 736(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows:
``(5) Additional direct cost adjustment.--
``(A) Increase.--The Secretary shall, in addition to
adjustments under paragraphs (1), (2), (3), and (4),
further increase the fee revenue and fees--
``(i) for fiscal year 2023, by $44,386,150;
and
``(ii) for each of fiscal years 2024 through
2027, by the amount set forth in clauses (i)
through (iv) of subparagraph (B), as applicable,
multiplied by the Consumer Price Index for urban
consumers (Washington-Arlington-Alexandria, DC-VA-
MD-WV; Not Seasonally Adjusted; All Items; Annual
Index) for the most recent year of available data,
divided by such Index for 2021.
``(B) Applicable amounts.--The amounts referred to
in subparagraph (A)(ii) are the following:
[[Page 136 STAT. 2146]]
``(i) For fiscal year 2024, $60,967,993.
``(ii) For fiscal year 2025, $35,799,314.
``(iii) For fiscal year 2026, $35,799, 314.
``(iv) For fiscal year 2027, $35,799,314.''.
(6) Annual fee setting.--Paragraph (6), as redesignated, of
section 736(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h(c)) is amended by striking ``September 30, 2017''
and inserting ``September 30, 2022''.
(d) Crediting and Availability of Fees.--Section 736(g)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended
by striking ``fiscal years 2018 through 2022'' and inserting ``fiscal
years 2023 through 2027''.
(e) Written Requests for Waivers, Reductions, Exemptions, and
Returns; Disputes Concerning Fees.--Section 736(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is amended to read as
follows:
``(i) Written Requests for Waivers, Reductions, Exemptions, and
Returns; Disputes Concerning Fees.--To qualify for consideration for a
waiver or reduction under subsection (d), an exemption under subsection
(k), or the return of any fee paid under this section, including if the
fee is claimed to have been paid in error, a person shall--
``(1) <<NOTE: Deadline.>> not later than 180 days after
such fee is due, submit to the Secretary a written request
justifying such waiver, reduction, exemption, or return; and
``(2) include in the request any legal authorities under
which the request is made.''.
(f) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(k)) is amended--
(1) in paragraph (1)(B), by striking ``during the previous
year'' and inserting ``as determined under paragraph (2)''; and
(2) by amending paragraph (2) to read as follows:
``(2) <<NOTE: Applicability. Certification.>> Evidence of
qualification.--An exemption under paragraph (1) applies with
respect to a drug only if the applicant involved submits a
certification that the applicant's gross annual revenues did not
exceed $50,000,000 for the last calendar year ending prior to
the fiscal year for which the exemption is requested. Such
certification shall be supported by--
``(A) tax returns submitted to the United States
Internal Revenue Service; or
``(B) as necessary, other appropriate financial
information.''.
SEC. 1004. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h-2) is amended--
(1) in subsection (a)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(2) by striking ``Prescription Drug User Fee Amendments of
2017'' each place it appears and inserting ``Prescription Drug
User Fee Amendments of 2022'';
(3) in subsection (a)(3)(A), by striking ``Not later than 30
calendar days after the end of the second quarter of fiscal year
2018, and not later than 30 calendar days after the end of each
quarter of each fiscal year thereafter'' and inserting ``Not
later than 30 calendar days after the end of each quarter
[[Page 136 STAT. 2147]]
of each fiscal year for which fees are collected under this
part'';
(4) in subsection (a)(4), by striking ``Beginning with
fiscal year 2020, the'' and inserting ``The'';
(5) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (5), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 1005. SUNSET DATES.
(a) <<NOTE: 21 USC 379g note.>> Authorization.--Sections 735 and
736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h)
shall cease to be effective October 1, 2027.
(b) <<NOTE: 21 USC 379h-2 note.>> Reporting Requirements.--Section
736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2)
shall cease to be effective January 31, 2028.
(c) <<NOTE: Repeal. 21 USC 379g note.>> Previous Sunset
Provision.--Effective October 1, 2022, subsections (a) and (b) of
section 104 of the FDA Reauthorization Act of 2017 (Public Law 115-52)
are repealed.
SEC. 1006. <<NOTE: Assessment. 21 USC 379g note.>> EFFECTIVE
DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be
assessed for all human drug applications received on or after October 1,
2022, regardless of the date of the enactment of this Act.
SEC. 1007. <<NOTE: Extension. Time period. 21 USC 379g note.>>
SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379g et seq.), as in effect on the day before the date of the
enactment of this title, shall continue to be in effect with respect to
human drug applications and supplements (as defined in such part as of
such day) that were accepted by the Food and Drug Administration for
filing on or after October 1, 2017, but before October 1, 2022, with
respect to assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2023.
TITLE II-- <<NOTE: Medical Device User Fee Amendments of 2022.>> FEES
RELATING TO DEVICES
SEC. 2001. SHORT TITLE; FINDING.
(a) Short <<NOTE: 21 USC 301 note.>> Title.--This title may be
cited as the ``Medical Device User Fee Amendments of 2022''.
(b) <<NOTE: 21 USC 379i note.>> Finding.--Congress finds that the
fees authorized under the amendments made by this title will be
dedicated toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of devices,
as set forth in the goals identified for purposes of part 3 of
subchapter C of
[[Page 136 STAT. 2148]]
chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i
et seq.), 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. DEFINITIONS.
Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379i) is amended--
(1) in paragraph (9)--
(A) in the matter preceding subparagraph (A), by
striking ``and premarket notification submissions'' and
inserting ``premarket notification submissions, and de
novo classification requests'';
(B) in subparagraph (D), by striking ``and
submissions'' and inserting ``submissions, and de novo
classification requests'';
(C) in subparagraph (F), by striking ``and premarket
notification submissions'' and inserting ``premarket
notification submissions, and de novo classification
requests'';
(D) in each of subparagraphs (G) and (H), by
striking ``or submissions'' and inserting ``submissions,
or requests''; and
(E) in subparagraph (K), by striking ``or premarket
notification submissions'' and inserting ``premarket
notification submissions, or de novo classification
requests''; and
(2) in paragraph (11), by striking ``2016'' and inserting
``2021''.
SEC. 2003. <<NOTE: Time periods.>> AUTHORITY TO ASSESS AND USE
DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2018'' and
inserting ``fiscal year 2023''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``October 1, 2017'' and inserting
``October 1, 2022'';
(ii) in clause (iii), by striking ``75
percent'' and inserting ``80 percent''; and
(iii) in clause (viii), by striking ``3.4
percent'' and inserting ``4.5 percent'';
(B) in subparagraph (B)(iii), by striking ``or
premarket notification submission'' and inserting
``premarket notification submission, or de novo
classification request''; and
(C) in subparagraph (C), by striking ``or periodic
reporting concerning a class III device'' and inserting
``periodic reporting concerning a class III device, or
de novo classification request''.
(b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(b)) is amended--
(1) in paragraph (1), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(2) by amending paragraph (2) to read as follows:
``(2) Base fee amounts specified.--For purposes of paragraph
(1), the base fee amounts specified in this paragraph are as
follows:
[[Page 136 STAT. 2149]]
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2023 Year 2024 Year 2025 Year 2026 Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $425,000 $435,000 $445,000 $455,000 $470,000
Establishment Registration............................... $6,250 $6,875 $7,100 $7,575 $8,465'';
and
----------------------------------------------------------------------------------------------------------------
''; and (3) by amending paragraph (3) to read as follows:
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $312,606,000 for fiscal year 2023.
``(B) $335,750,000 for fiscal year 2024.
``(C) $350,746,400 for fiscal year 2025.
``(D) $366,486,300 for fiscal year 2026.
``(E) $418,343,000 for fiscal year 2027.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2018'' and
inserting ``2023'';
(B) in subparagraph (B)--
(i) in the matter preceding clause (i), by
striking ``fiscal year 2018'' and inserting
``fiscal year 2023''; and
(ii) in clause (ii), by striking ``fiscal year
2016'' and inserting ``fiscal year 2022'';
(C) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''; and
(D) in subparagraph (D), in the matter preceding
clause (i), by striking ``fiscal years 2018 through
2022'' and inserting ``fiscal years 2023 through 2027'';
(3) in paragraph (3), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(4) by redesignating paragraphs (4) and (5) as paragraphs
(7) and (8), respectively; and
(5) by inserting after paragraph (3) the following:
``(4) Performance improvement adjustment.--
``(A) <<NOTE: Determination.>> In general.--For
each of fiscal years 2025 through 2027, after the
adjustments under paragraphs (2) and (3), the base
establishment registration fee amounts for such fiscal
year shall be increased to reflect changes in the
resource needs of the Secretary due to improved review
performance goals for the process for the review of
device applications identified in the letters described
in section 2001(b) of the Medical Device User Fee
Amendments of 2022, as the Secretary determines
necessary to achieve an increase in total fee
collections for such fiscal year equal to the following
amounts, as applicable:
``(i) For fiscal year 2025, the product of--
``(I) the amount determined under
subparagraph (B)(i)(I); and
[[Page 136 STAT. 2150]]
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(ii) For fiscal year 2026, the product of--
``(I) the sum of the amounts
determined under subparagraphs
(B)(i)(II), (B)(ii)(I), and (B)(iii)(I);
and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(iii) For fiscal year 2027, the product of--
``(I) the sum of the amounts
determined under subparagraphs
(B)(i)(III), (B)(ii)(II), and
(B)(iii)(II); and
``(II) the applicable inflation
adjustment under paragraph (2)(B) for
such fiscal year.
``(B) Amounts.--
``(i) Presubmission amount.--For purposes of
subparagraph (A), with respect to the
Presubmission Written Feedback goal, the amounts
determined under this subparagraph are as follows:
``(I) For fiscal year 2025,
$15,396,600 if such goal for fiscal year
2023 is met.
``(II) For fiscal year 2026:
``(aa) $15,396,600 if such
goal for fiscal year 2023 is met
and such goal for fiscal year
2024 is not met.
``(bb) $36,792,200 if such
goal for fiscal year 2024 is
met.
``(III) For fiscal year 2027:
``(aa) $15,396,600 if such
goal for fiscal year 2023 is met
and such goal for each of fiscal
years 2024 and 2025 is not met.
``(bb) $36,792,200 if such
goal for fiscal year 2024 is met
and such goal for fiscal year
2025 is not met.
``(cc) $40,572,600 if such
goal for fiscal year 2025 is
met.
``(ii) De novo classification request
amount.--For purposes of subparagraph (A), with
respect to the De Novo Decision goal, the amounts
determined under this subparagraph are as follows:
``(I) For fiscal year 2026,
$6,323,500 if such goal for fiscal year
2023 is met.
``(II) For fiscal year 2027:
``(aa) $6,323,500 if such
goal for fiscal year 2023 is met
and such goal for fiscal year
2024 is not met.
``(bb) $11,765,400 if such
goal for fiscal year 2024 is
met.
``(iii) Premarket notification and premarket
approval amount.--For purposes of subparagraph
(A), with respect to the 510(k) decision goal,
510(k) Shared Outcome Total Time to Decision goal,
PMA decision goal, and PMA Shared Outcome Total
Time to Decision goal, the amounts determined
under this subparagraph are as follows:
``(I) For fiscal year 2026,
$1,020,000 if the 4 goals for fiscal
year 2023 are met.
[[Page 136 STAT. 2151]]
``(II) For fiscal year 2027:
``(aa) $1,020,000 if the 4
goals for fiscal year 2023 are
met and one or more of the 4
goals for fiscal year 2024 are
not met.
``(bb) $3,906,000 if the 4
goals for fiscal year 2024 are
met.
``(C) <<NOTE: Determination.>> Performance
calculation.--For purposes of this paragraph,
performance of the following goals shall be determined
as specified in the letters described in section 2001(b)
of the Medical Device User Fee Amendments of 2022 and
based on data available, as follows:
``(i) <<NOTE: Data.>> The performance of the
Presubmission Written Feedback goal shall be based
on data available as of--
``(I) for fiscal year 2023, March
31, 2024;
``(II) for fiscal year 2024, March
31, 2025; and
``(III) for fiscal year 2025, March
31, 2026.
``(ii) The performance of the De Novo Decision
goal, 510(k) decision goal, 510(k) Shared Outcome
Total Time to Decision goal, PMA decision goal,
and PMA Shared Outcome Total Time to Decision goal
shall be based on data available as of--
``(I) for fiscal year 2023, March
31, 2025; and
``(II) for fiscal year 2024, March
31, 2026.
``(D) Goals defined.--For purposes of this
paragraph, the terms `Presubmission Written Feedback
goal', `De Novo Decision goal', `510(k) decision goal',
`510(k) Shared Outcome Total Time to Decision goal',
`PMA decision goal', and `PMA Shared Outcome Total Time
to Decision goal' refer to the goals identified by the
same names in the letters described in section 2001(b)
of the Medical Device User Fee Amendments of 2022.
``(5) Hiring adjustment.--
``(A) <<NOTE: Determination.>> In general.--For
each of fiscal years 2025 through 2027, after the
adjustments under paragraphs (2), (3), and (4), if
applicable, if the number of hires to support the
process for the review of device applications falls
below the thresholds specified in subparagraph (B) for
the applicable fiscal years, the base establishment
registration fee amounts shall be decreased as the
Secretary determines necessary to achieve a reduction in
total fee collections equal to the hiring adjustment
amount under subparagraph (C).
``(B) Thresholds.--The thresholds specified in this
subparagraph are as follows:
``(i) For fiscal year 2025, the threshold is
123 hires for fiscal year 2023.
``(ii) For fiscal year 2026, the threshold is
38 hires for fiscal year 2024.
``(iii) For fiscal year 2027, the threshold
is--
``(I) 22 hires for fiscal year 2025
if the base establishment registration
fees are not increased by the amount
determined under paragraph (4)(A)(i); or
``(II) 75 hires for fiscal year 2025
if such fees are so increased.
[[Page 136 STAT. 2152]]
``(C) Hiring adjustment amount.--The hiring
adjustment amount for fiscal year 2025 and each
subsequent fiscal year is the product of--
``(i) the number of hires by which the hiring
goal specified in subparagraph (D) for the fiscal
year before the prior fiscal year was not met;
``(ii) $72,877; and
``(iii) the applicable inflation adjustment
under paragraph (2)(B) for the fiscal year for
which the hiring goal was not met.
``(D) Hiring goals.--The hiring goals for each of
fiscal years 2023 through 2025 are as follows:
``(i) For fiscal year 2023, 144 hires.
``(ii) For fiscal year 2024, 42 hires.
``(iii) For fiscal year 2025:
``(I) 24 hires if the base
establishment registration fees are not
increased by the amount determined under
paragraph (4)(A)(i).
``(II) 83 hires if the base
establishment registration fees are
increased by the amount determined under
paragraph (4)(A)(i).
``(E) <<NOTE: Determination.>> Number of hires.--
For purposes of this paragraph, the number of hires for
a fiscal year shall be determined by the Secretary as
set forth in the letters described in section 2001(b) of
the Medical Device User Fee Amendments of 2022.
``(6) Operating reserve adjustment.--
``(A) In general.--For each of fiscal years 2023
through 2027, after the adjustments under paragraphs
(2), (3), (4), and (5), if applicable, if the Secretary
has operating reserves of carryover user fees for the
process for the review of device applications in excess
of the designated amount in subparagraph (B), the
Secretary shall decrease the base establishment
registration fee amounts to provide for not more than
such designated amount of operating reserves.
``(B) Designated amount.--Subject to subparagraph
(C), for each fiscal year, the designated amount in this
subparagraph is equal to the sum of--
``(i) 13 weeks of operating reserves of
carryover user fees; and
``(ii) 1 month of operating reserves
maintained pursuant to paragraph (8).
``(C) Excluded amount.--For the period of fiscal
years 2023 through 2026, a total amount equal to
$118,000,000 shall not be considered part of the
designated amount under subparagraph (B) and shall not
be subject to the decrease under subparagraph (A).''.
(d) Conditions.--Section 738(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(g)) is amended--
(1) in paragraph (1)(A), by striking ``$320,825,000'' and
inserting ``$398,566,000''; and
(2) in paragraph (2), by inserting ``de novo classification
requests,'' after ``class III device,''.
(e) Crediting and Availability of Fees.--Section 738(h)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended
to read as follows:
``(3) Authorization of appropriations.--
[[Page 136 STAT. 2153]]
``(A) In general.--For each of fiscal years 2023
through 2027, there is authorized to be appropriated for
fees under this section an amount equal to the revenue
amount determined under subparagraph (B), less the
amount of reductions determined under subparagraph (C).
``(B) Revenue amount.--For purposes of this
paragraph, the revenue amount for each fiscal year is
the sum of--
``(i) the total revenue amount under
subsection (b)(3) for the fiscal year, as adjusted
under paragraphs (2) and (3) of subsection (c);
and
``(ii) the performance improvement adjustment
amount for the fiscal year under subsection
(c)(4), if applicable.
``(C) Amount of reductions.--For purposes of this
paragraph, the amount of reductions for each fiscal year
is the sum of--
``(i) the hiring adjustment amount for the
fiscal year under subsection (c)(5), if
applicable; and
``(ii) the operating reserve adjustment amount
for the fiscal year under subsection (c)(6), if
applicable.''.
SEC. 2004. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
(1) by striking ``fiscal year 2018'' each place it appears
and inserting ``fiscal year 2023'';
(2) by striking ``Medical Device User Fee Amendments of
2017'' each place it appears and inserting ``Medical Device User
Fee Amendments of 2022'';
(3) in paragraph (1)--
(A) in subparagraph (A), by redesignating the second
clause (iv) (relating to analysis) as clause (v); and
(B) in subparagraph (A)(iv), by striking ``fiscal
year 2020'' and inserting ``fiscal year 2023''; and
(4) in paragraph (4), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
(b) Reauthorization.--Section 738A(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2022'' and inserting
``2027''; and
(2) in paragraph (5), by striking ``2022'' and inserting
``2027''.
SEC. 2005. CONFORMITY ASSESSMENT PILOT PROGRAM.
Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360d(d)) is amended to read as follows:
``(d) Accreditation Scheme for Conformity Assessment.--
``(1) In general.--The Secretary shall establish a program
under which--
``(A) <<NOTE: Guidelines.>> testing laboratories
meeting criteria specified in guidance by the Secretary
may be accredited, by accreditation bodies meeting
criteria specified in guidance by the Secretary, to
conduct testing to support the assessment of the
conformity of a device to certain standards recognized
under this section; and
``(B) subject to paragraph (2), results from tests
conducted to support the assessment of conformity of
devices
[[Page 136 STAT. 2154]]
as described in subparagraph (A) conducted by testing
laboratories accredited pursuant to this subsection
shall be accepted by the Secretary for purposes of
demonstrating such conformity unless the Secretary finds
that certain results of such tests should not be so
accepted.
``(2) Secretarial review of accredited laboratory results.--
The Secretary may--
``(A) review the results of tests conducted by
testing laboratories accredited pursuant to this
subsection, including by conducting periodic audits of
such results or of the processes of accredited bodies or
testing laboratories;
``(B) following such review, take additional
measures under this Act, as the Secretary determines
appropriate, such as--
``(i) suspension or withdrawal of
accreditation of a testing laboratory or
recognition of an accreditation body under
paragraph (1)(A); or
``(ii) requesting additional information with
respect to a device; and
``(C) if the Secretary becomes aware of information
materially bearing on the safety or effectiveness of a
device for which an assessment of conformity was
supported by testing conducted by a testing laboratory
accredited under this subsection, take such additional
measures under this Act, as the Secretary determines
appropriate, such as--
``(i) suspension or withdrawal of
accreditation of a testing laboratory or
recognition of an accreditation body under
paragraph (1)(A); or
``(ii) requesting additional information with
regard to such device.
``(3) <<NOTE: Public information. Website.>> Report.--The
Secretary shall make available on the internet website of the
Food and Drug Administration an annual report on the progress of
the program under this subsection.''.
SEC. 2006. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.
Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360m(c)) is amended by striking ``October 1'' and inserting
``December 17''.
SEC. 2007. SUNSET DATES.
(a) <<NOTE: 21 USC 379i note.>> Authorization.--Sections 737 and
738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j)
shall cease to be effective October 1, 2027.
(b) <<NOTE: 21 USC 379j-1 note.>> Reporting Requirements.--Section
738A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1)
shall cease to be effective January 31, 2028.
(c) <<NOTE: Repeal. 21 USC 379i note.>> Previous Sunset
Provisions.--Effective October 1, 2022, subsections (a) and (b) of
section 210 of the FDA Reauthorization Act of 2017 (Public Law 115-52)
are repealed.
SEC. 2008. <<NOTE: Assessment. 21 USC 360d note.>> EFFECTIVE
DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.) shall be
assessed for all submissions listed in section
[[Page 136 STAT. 2155]]
738(a)(2)(A) of such Act received on or after October 1, 2022,
regardless of the date of the enactment of this Act.
SEC. 2009. <<NOTE: Extension. Time period. 21 USC 379i note.>>
SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379i et seq.), as in effect on the day before the date of the
enactment of this title, shall continue to be in effect with respect to
the submissions listed in section 738(a)(2)(A) of such Act (as defined
in such part as of such day) that on or after October 1, 2017, but
before October 1, 2022, were received by the Food and Drug
Administration with respect to assessing and collecting any fee required
by such part for a fiscal year prior to fiscal year 2023.
TITLE III-- <<NOTE: Generic Drug User Fee Amendments of 2022.>> FEES
RELATING TO GENERIC DRUGS
SEC. 3001. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Generic Drug User Fee Amendments of 2022''.
(b) <<NOTE: 21 USC 379j-41 note.>> Finding.--Congress finds that
the fees authorized by the amendments made by this title will be
dedicated to human generic drug activities, as set forth in the goals
identified for purposes of part 7 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41 et seq.), 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. 3002. <<NOTE: Time periods.>> AUTHORITY TO ASSESS AND USE
HUMAN GENERIC DRUG FEES.
(a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``2018'' and inserting ``2023'';
(2) in paragraph (2)(C), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(3) in paragraph (3)(B), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(4) in paragraph (4)(D), by striking ``2018 through 2022''
and inserting ``2023 through 2027''; and
(5) in paragraph (5)(D), by striking ``2018 through 2022''
and inserting ``2023 through 2027''.
(b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the heading, by striking ``2018'' and
inserting ``2023'';
(ii) by striking ``2018'' and inserting
``2023''; and
(iii) by striking ``$493,600,000'' and
inserting ``$582,500,000''; and
(B) by amending subparagraph (B) to read as follows:
[[Page 136 STAT. 2156]]
``(B) Fiscal years 2024 through 2027.--
``(i) In general.--For each of the fiscal
years 2024 through 2027, fees under paragraphs (2)
through (5) of subsection (a) shall be established
to generate a total estimated revenue amount under
such subsection that is equal to the base revenue
amount for the fiscal year under clause (ii), as
adjusted pursuant to subsection (c).
``(ii) Base revenue amount.--The base revenue
amount for a fiscal year referred to in clause (i)
is equal to the total revenue amount established
under this paragraph for the previous fiscal year,
not including any adjustments made for such
previous fiscal year under subsection (c)(3).'';
and
(2) in paragraph (2)--
(A) in subparagraph (C), by striking ``one-third the
amount'' and inserting ``twenty-four percent'';
(B) in subparagraph (D), by striking ``Seven
percent'' and inserting ``Six percent''; and
(C) in subparagraph (E)(i), by striking ``Thirty-
five percent'' and inserting ``Thirty-six percent''.
(c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``2019'' and inserting
``2024''; and
(ii) by striking ``to equal the product of the
total revenues established in such notice for the
prior fiscal year multiplied'' and inserting ``to
equal the base revenue amount for the fiscal year
(as specified in subsection (b)(1)(B)(ii))
multiplied''; and
(B) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''; and
(2) by striking paragraph (2) and inserting the following:
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with fiscal year 2024,
the Secretary shall, in addition to the adjustment under
paragraph (1), further increase the fee revenue and fees
under this section for a fiscal year, in accordance with
this paragraph, to reflect changes in the resource
capacity needs of the Secretary for human generic drug
activities.
``(B) Capacity planning methodology.--The Secretary
shall establish a capacity planning methodology for
purposes of this paragraph, which shall--
``(i) be derived from the methodology and
recommendations made in the report titled
`Independent Evaluation of the GDUFA Resource
Capacity Planning Adjustment Methodology:
Evaluation and Recommendations' announced in the
Federal Register on August 3, 2020 (85 Fed. Reg.
46658); and
``(ii) incorporate approaches and attributes
determined appropriate by the Secretary, including
approaches and attributes made in such report,
except that in incorporating such approaches and
attributes the workload categories used in
forecasting resources
[[Page 136 STAT. 2157]]
shall only be the workload categories specified in
section VIII.B.2.e. of the letters described in
section 3001(b) of the Generic Drug User Fee
Amendments of 2022.
``(C) Limitations.--
``(i) In general.--Under no circumstances
shall an adjustment under this paragraph result in
fee revenue for a fiscal year that is less than
the sum of the amounts under subsection
(b)(1)(B)(ii) (the base revenue amount for the
fiscal year) and paragraph (1) (the dollar amount
of the inflation adjustment for the fiscal year).
``(ii) <<NOTE: Determinations.>> Additional
limitation.--An adjustment under this paragraph
shall not exceed 3 percent of the sum described in
clause (i) for the fiscal year, except that such
limitation shall be 4 percent if--
``(I) for purposes of a fiscal year
2024 adjustment, the Secretary
determines that during the period from
April 1, 2021, through March 31, 2023--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,000;
or
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as that
term is defined in section XI of
the letters described in section
3001(b) of the Generic Drug User
Fee Amendments of 2022);
``(II) for purposes of a fiscal year
2025 adjustment, the Secretary
determines that during the period from
April 1, 2022, through March 31, 2024--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as so
defined);
``(III) for purposes of a fiscal
year 2026 adjustment, the Secretary
determines that during the period from
April 1, 2023, through March 31, 2025--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as so
defined); and
``(IV) for purposes of a fiscal year
2027 adjustment, the Secretary
determines that during the period from
April 1, 2024, through March 31, 2026--
``(aa) the total number of
abbreviated new drug
applications submitted was
greater than or equal to 2,300;
or
[[Page 136 STAT. 2158]]
``(bb) thirty-five percent
or more of abbreviated new drug
applications submitted related
to complex products (as so
defined).
``(D) <<NOTE: Notice.>> Publication in federal
register.--The Secretary shall publish in the Federal
Register notice referred to in subsection (a) the fee
revenue and fees resulting from the adjustment and the
methodology under this paragraph.
``(3) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2024 and each
subsequent fiscal year, the Secretary may, in addition
to adjustments under paragraphs (1) and (2), further
increase the fee revenue and fees under this section for
such fiscal year if such an adjustment is necessary to
provide operating reserves of carryover user fees for
human generic drug activities for not more than the
number of weeks specified in subparagraph (B) with
respect to that fiscal year.
``(B) Number of weeks.--The number of weeks
specified in this subparagraph is--
``(i) 8 weeks for fiscal year 2024;
``(ii) 9 weeks for fiscal year 2025; and
``(iii) 10 weeks for each of fiscal year 2026
and 2027.
``(C) Decrease.--If the Secretary has carryover
balances for human generic drug activities in excess of
12 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 12 weeks of such operating
reserves.
``(D) <<NOTE: Notice. Federal Register,
publication.>> 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 subsection
(a) publishing the fee revenue and fees for the fiscal
year involved.''.
(d) Annual Fee Setting.--Section 744B(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is amended--
(1) in the paragraph heading, by striking ``2018 through
2022'' and inserting ``2023 through 2027''; and
(2) by striking ``more than 60 days before the first day of
each of fiscal years 2018 through 2022'' and inserting ``later
than 60 days before the first day of each of fiscal years 2023
through 2027''.
(e) Effect of Failure to Pay Fees.--The heading of paragraph (3) of
section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-42(g)) is amended by striking ``and prior approval supplement
fee''.
(f) Crediting and Availability of Fees.--Section 744B(i)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)(3)) is
amended by striking ``fiscal years 2018 through 2022'' and inserting
``fiscal years 2023 through 2027''.
SEC. 3003. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-43) is amended--
[[Page 136 STAT. 2159]]
(1) in subsection (a)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(2) by striking ``Generic Drug User Fee Amendments of 2017''
each place it appears and inserting ``Generic Drug User Fee
Amendments of 2022'';
(3) <<NOTE: Deadline.>> in subsection (a)(2), by striking
``Not later than 30 calendar days after the end of the second
quarter of fiscal year 2018, and not later than 30 calendar days
after the end of each quarter of each fiscal year thereafter''
and inserting ``Not later than 30 calendar days after the end of
each quarter of each fiscal year for which fees are collected
under this part'';
(4) in subsection (a)(3), by striking ``Beginning with
fiscal year 2020, the'' and inserting ``The'';
(5) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (5), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 3004. SUNSET DATES.
(a) <<NOTE: 21 USC 379j-41 note.>> Authorization.--Sections 744A
and 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41;
379j-42) shall cease to be effective October 1, 2027.
(b) <<NOTE: 21 USC 379j-43 note.>> Reporting Requirements.--Section
744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43)
shall cease to be effective January 31, 2028.
(c) <<NOTE: Repeal. 21 USC 379j-41 note.>> Previous Sunset
Provision.--Effective October 1, 2022, subsections (a) and (b) of
section 305 of the FDA Reauthorization Act of 2017 (Public Law 115-52)
are repealed.
SEC. 3005. <<NOTE: Assessment. 21 USC 379j-41 note.>> EFFECTIVE
DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 7 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41 et seq.) shall
be assessed for all abbreviated new drug applications received on or
after October 1, 2022, regardless of the date of the enactment of this
Act.
SEC. 3006. <<NOTE: Extension. Time period. 21 USC 379j-41 note.>>
SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-41 et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with respect
to abbreviated new drug applications (as defined in such part as of such
day) that were received by the Food and Drug Administration within the
meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)),
prior approval supplements that were submitted, and drug master files
for Type II active pharmaceutical ingredients that were first referenced
on or after October 1, 2017, but before October 1, 2022, with respect
[[Page 136 STAT. 2160]]
to assessing and collecting any fee required by such part for a fiscal
year prior to fiscal year 2023.
TITLE IV-- <<NOTE: Biosimilar User Fee Amendments of 2022.>> FEES
RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 4001. SHORT TITLE; FINDING.
(a) <<NOTE: 21 USC 301 note.>> Short Title.--This title may be
cited as the ``Biosimilar User Fee Amendments of 2022''.
(b) <<NOTE: 21 USC 379j-51 note.>> Finding.--Congress finds that
the fees authorized by the amendments made by this title will be
dedicated to expediting the process for the review of biosimilar
biological product applications, including postmarket safety activities,
as set forth in the goals identified for purposes of part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-51 et seq.), 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. 4002. DEFINITIONS.
(a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for urban consumers
(Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally
Adjusted; All items) for September of the preceding fiscal year
divided by such Index for September 2011.''.
(b) Biosimilar Biological Product Application.--Section
744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-51(4)(B)(iii)) is amended--
(1) by striking subclause (II) (relating to an allergenic
extract product); and
(2) by redesignating subclauses (III) and (IV) as subclauses
(II) and (III), respectively.
SEC. 4003. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL
PRODUCT FEES.
(a) Types of Fees.--
(1) In general.--The matter preceding paragraph (1) in
section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)) is amended by striking ``fiscal year 2018''
and inserting ``fiscal year 2023''.
(2) Initial biosimilar biological product development fee.--
Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(A)) are each amended by striking ``5 days'' and
inserting ``7 days''.
(3) Annual biosimilar biological product development fee.--
Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
(A) <<NOTE: Notice.>> in clause (i), by inserting
before the period at the end the following: ``, except
that, in the case that such product (including, where
applicable, ownership of
[[Page 136 STAT. 2161]]
the relevant investigational new drug application) is
transferred to a licensee, assignee, or successor of
such person, and written notice of such transfer is
provided to the Secretary, such licensee, assignee, or
successor shall pay the annual biosimilar biological
product development fee'';
(B) in clause (iii)--
(i) in subclause (I), by striking ``or'' at
the end;
(ii) in subclause (II), by striking the period
at the end and inserting ``; or''; and
(iii) by adding at the end the following:
``(III) been administratively
removed from the biosimilar biological
product development program for the
product under subparagraph (E)(v).'';
and
(C) in clause (iv), by striking ``is accepted for
filing on or after October 1 of such fiscal year'' and
inserting ``is subsequently accepted for filing''.
(4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is
amended to read as follows:
``(D) Reactivation fee.--
``(i) In general.--A person that has
discontinued participation in the biosimilar
biological product development program for a
product under subparagraph (C), or who has been
administratively removed from such program for a
product under subparagraph (E)(v), shall, if the
person seeks to resume participation in such
program, pay all annual biosimilar biological
product development fees previously assessed for
such product and still owed and a fee (referred to
in this section as `reactivation fee') by the
earlier of the following:
``(I) <<NOTE: Deadline.>> Not later
than 7 days after the Secretary grants a
request by such person for a biosimilar
biological product development meeting
for the product (after the date on which
such participation was discontinued or
the date of administrative removal, as
applicable).
``(II) <<NOTE: Determination.>>
Upon the date of submission (after the
date on which such participation was
discontinued or the date of
administrative removal, as applicable)
by such person of an investigational new
drug application describing an
investigation that the Secretary
determines is intended to support a
biosimilar biological product
application for that product.
``(ii) <<NOTE: Notice.>> Application of
annual fee.--A person that pays a reactivation fee
for a product shall pay for such product,
beginning in the next fiscal year, the annual
biosimilar biological product development fee
under subparagraph (B), except that, in the case
that such product (including, where applicable,
ownership of the relevant investigational new drug
application) is transferred to a licensee,
assignee, or successor of such person, and written
notice of such transfer is provided to the
Secretary, such licensee, assignee, or successor
shall pay the annual biosimilar biological product
development fee.''.
[[Page 136 STAT. 2162]]
(5) Effect of failure to pay fees.--Section 744H(a)(1)(E) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(E)) is amended by adding at the end the following:
``(v) <<NOTE: Time periods.>> Administrative
removal from the biosimilar biological product
development program.--If a person has failed to
pay an annual biosimilar biological product
development fee for a product as required under
subparagraph (B) for a period of 2 consecutive
fiscal years, the Secretary may administratively
remove such person from the biosimilar biological
product development program for the
product. <<NOTE: Notice.>> At least 30 days prior
to administratively removing a person from the
biosimilar biological product development program
for a product under this clause, the Secretary
shall provide written notice to such person of the
intended administrative removal.''.
(6) Biosimilar biological product application fee.--Section
744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or was
withdrawn'' the following: ``prior to approval''.
(7) Biosimilar biological product program fee.--Section
744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(3)) is amended--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``and'' at the
end;
(ii) by redesignating clause (ii) as clause
(iii); and
(iii) by inserting after clause (i) the
following:
``(ii) may be dispensed only under
prescription pursuant to section 503(b); and'';
and
(B) by adding at the end the following:
``(E) Movement to discontinued list.--
``(i) Date of inclusion.--If a written request
to place a product on the list referenced in
subparagraph (A) of discontinued biosimilar
biological products is submitted to the Secretary
on behalf of an applicant, and the request
identifies the date the product is, or will be,
withdrawn from sale, then for purposes of
assessing the biosimilar biological product
program fee, the Secretary shall consider such
product to have been included on such list on the
later of--
``(I) the date such request was
received; or
``(II) if the product will be
withdrawn from sale on a future date,
such future date when the product is
withdrawn from sale.
``(ii) Treatment as withdrawn from sale.--For
purposes of clause (i), a product shall be
considered withdrawn from sale once the applicant
has ceased its own distribution of the product,
whether or not the applicant has ordered recall of
all previously distributed lots of the product,
except that a routine, temporary interruption in
supply shall not render a product withdrawn from
sale.
``(iii) Special rule for products removed from
discontinued list.--If a biosimilar biological
product that is identified in a biosimilar
biological product application approved as of
October 1 of a fiscal year appears, as of October
1 of such fiscal year, on the
[[Page 136 STAT. 2163]]
list referenced in subparagraph (A) of
discontinued biosimilar biological products, and
on any subsequent day during such fiscal year the
biosimilar biological product does not appear on
such list, except as provided in subparagraph (D),
each person who is named as the applicant in a
biosimilar biological product application with
respect to such product shall pay the annual
biosimilar biological product program fee
established for a fiscal year under subsection
(c)(5) for such biosimilar biological product.
Notwithstanding subparagraph (B), such fee shall
be due on the last business day of such fiscal
year and shall be paid only once for each such
product for each fiscal year.''.
(8) Biosimilar biological product fee.--Section 744H(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a))
is amended by striking paragraph (4).
(b) Fee Revenue Amounts.--Subsection (b) of section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as
paragraphs (1) through (3), respectively;
(3) by amending paragraph (1) (as so redesignated) to read
as follows:
``(1) In <<NOTE: Time periods.>> general.--For each of the
fiscal years 2023 through 2027, fees under subsection (a) shall,
except as provided in subsection (c), be established to generate
a total 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 strategic
hiring and retention adjustment (as determined under
subsection (c)(2));
``(D) the dollar amount equal to the capacity
planning adjustment for the fiscal year (as determined
under subsection (c)(3));
``(E) the dollar amount equal to the operating
reserve adjustment for the fiscal year, if applicable
(as determined under subsection (c)(4));
``(F) for fiscal year 2023 an additional amount of
$4,428,886; and
``(G) for fiscal year 2024 an additional amount of
$320,569.'';
(4) in paragraph (2) (as so redesignated)--
(A) in the paragraph heading, by striking ``;
limitations on fee amounts'';
(B) by striking subparagraph (B); and
(C) by redesignating subparagraphs (C) and (D) as
subparagraphs (B) and (C), respectively; and
(5) by amending paragraph (3) (as so redesignated) to read
as follows:
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal year
shall be--
[[Page 136 STAT. 2164]]
``(A) for fiscal year 2023, $43,376,922; and
``(B) <<NOTE: Time period.>> for fiscal years 2024
through 2027, the dollar amount of the total revenue
amount established under paragraph (1) for the previous
fiscal year, excluding any adjustments to such revenue
amount under subsection (c)(4).''.
(c) Adjustments; Annual Fee Setting.--Section 744H(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(c)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by
striking ``subsection (b)(2)(B)'' and inserting
``subsection (b)(1)(B)''; and
(ii) in clause (i), by striking ``subsection
(b)'' and inserting ``subsection (b)(1)(A)''; and
(B) in subparagraph (B)(ii), by striking
``Washington-Baltimore, DC-MD-VA-WV'' and inserting
``Washington-Arlington-Alexandria, DC-VA-MD-WV'';
(2) by striking paragraphs (2) through (4) and inserting the
following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, after the annual base revenue under subsection
(b)(1)(A) is adjusted for inflation in accordance with paragraph
(1), the Secretary shall further increase the fee revenue and
fees by $150,000.
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, the
Secretary shall, in addition to the adjustments under
paragraphs (1) and (2), further adjust the fee revenue
and fees under this section for a fiscal year to reflect
changes in the resource capacity needs of the Secretary
for the process for the review of biosimilar biological
product applications.
``(B) Methodology.--For purposes of this paragraph,
the Secretary shall employ the capacity planning
methodology utilized by the Secretary in setting fees
for fiscal year 2021, as described in the notice titled
`Biosimilar User Fee Rates for Fiscal Year 2021'
published in the Federal Register on August 4, 2020 (85
Fed. Reg. 47220). The workload categories used in
applying such methodology in forecasting shall include
only the activities described in that notice and, as
feasible, additional activities that are directly
related to the direct review of biosimilar biological
product applications and supplements, including
additional formal meeting types, the direct review of
postmarketing commitments and requirements, the direct
review of risk evaluation and mitigation strategies, and
the direct review of annual reports for approved
biosimilar biological products. Subject to the
exceptions in the preceding sentence, the Secretary
shall not include as workload categories in applying
such methodology in forecasting any non-core review
activities, including those activities that the
Secretary referenced for potential future use in such
notice but did not utilize in setting fees for fiscal
year 2021.
``(C) Limitations.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue
[[Page 136 STAT. 2165]]
for a fiscal year that is less than the sum of the
amounts under subsections (b)(1)(A) (the annual base
revenue for the fiscal year), (b)(1)(B) (the dollar
amount of the inflation adjustment for the fiscal year),
and (b)(1)(C) (the dollar amount of the strategic hiring
and retention adjustment).
``(D) <<NOTE: Notice.>> Publication in federal
register.--The Secretary shall publish in the Federal
Register notice under paragraph (5) the fee revenue and
fees resulting from the adjustment and the methodologies
under this paragraph.
``(4) <<NOTE: Time periods.>> Operating reserve
adjustment.--
``(A) <<NOTE: Review.>> Increase.--For fiscal year
2023 and subsequent fiscal years, the Secretary shall,
in addition to adjustments under paragraphs (1), (2),
and (3), further increase the fee revenue and fees if
such an adjustment is necessary to provide for at least
10 weeks of operating reserves of carryover user fees
for the process for the review of biosimilar biological
product applications.
``(B) Decrease.--
``(i) Fiscal year 2023.--For fiscal year 2023,
if the Secretary has carryover balances for such
process in excess of 33 weeks of such operating
reserves, the Secretary shall decrease such fee
revenue and fees to provide for not more than 33
weeks of such operating reserves.
``(ii) Fiscal year 2024.--For fiscal year
2024, if the Secretary has carryover balances for
such process in excess of 27 weeks of such
operating reserves, the Secretary shall decrease
such fee revenue and fees to provide for not more
than 27 weeks of such operating reserves.
``(iii) Fiscal year 2025 and subsequent fiscal
years.--For fiscal year 2025 and subsequent fiscal
years, if the Secretary has carryover balances for
such process in excess of 21 weeks of such
operating reserves, the Secretary shall decrease
such fee revenue and fees to provide for not more
than 21 weeks of such operating reserves.
``(C) Federal register notice.--If an adjustment
under subparagraph (A) or (B) 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 (5)(B)
establishing fee revenue and fees for the fiscal year
involved.''; and
(3) in paragraph (5), in the matter preceding subparagraph
(A), by striking ``2018'' and inserting ``2023''.
(d) Crediting and Availability of Fees.--Subsection (f)(3) of
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-52(f)(3)) is amended by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
(e) Written Requests for Waivers and Returns; Disputes Concerning
Fees.--Section 744H(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(h)) is amended to read as follows:
``(h) Written Requests for Waivers and Returns; Disputes Concerning
Fees.-- <<NOTE: Deadline.>> To qualify for consideration for a waiver
under subsection (d), or for the return of any fee paid under this
section, including if the fee is claimed to have been paid in error, a
person
[[Page 136 STAT. 2166]]
shall submit to the Secretary a written request justifying such waiver
or return and, except as otherwise specified in this section, such
written request shall be submitted to the Secretary not later than 180
days after such fee is due. A request submitted under this paragraph
shall include any legal authorities under which the request is made.''.
SEC. 4004. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-53) is amended--
(1) in subsection (a)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(2) by striking ``Biosimilar User Fee Amendments of 2017''
each place it appears and inserting ``Biosimilar User Fee
Amendments of 2022'';
(3) in subsection (a)(2), by striking ``Beginning with
fiscal year 2018, the'' and inserting ``The'';
(4) in subsection (a)(3)(A), by striking ``Not later than 30
calendar days after the end of the second quarter of fiscal year
2018, and not later than 30 calendar days after the end of each
quarter of each fiscal year thereafter'' and inserting ``Not
later than 30 calendar days after the end of each quarter of
each fiscal year for which fees are collected under this part'';
(5) in subsection (b), by striking ``Not later than 120 days
after the end of fiscal year 2018 and each subsequent fiscal
year for which fees are collected under this part'' and
inserting ``Not later than 120 days after the end of each fiscal
year for which fees are collected under this part'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, and for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by striking ``fiscal year 2022'' and
inserting ``fiscal year 2027''; and
(B) in paragraph (3), by striking ``January 15,
2022'' and inserting ``January 15, 2027''.
SEC. 4005. SUNSET DATES.
(a) <<NOTE: 21 USC 379j-51 note.>> Authorization.--Sections 744G
and 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51,
379j-52) shall cease to be effective October 1, 2027.
(b) <<NOTE: 21 USC 379j-53 note.>> Reporting Requirements.--Section
744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53)
shall cease to be effective January 31, 2028.
(c) <<NOTE: Repeal. 21 USC 379j-51 note.>> Previous Sunset
Provision.--Effective October 1, 2022, subsections (a) and (b) of
section 405 of the FDA Reauthorization Act of 2017 (Public Law 115-52)
are repealed.
SEC. 4006. <<NOTE: Assessment. 21 USC 379j-51 note.>> EFFECTIVE
DATE.
The amendments made by this title shall take effect on October 1,
2022, or the date of the enactment of this Act, whichever is later,
except that fees under part 8 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51 et seq.) shall
be assessed for all biosimilar biological product applications received
on or after October 1, 2022, regardless of the date of the enactment of
this Act.
[[Page 136 STAT. 2167]]
SEC. 4007. <<NOTE: Extension. Time period. 21 USC 379j-51 note.>>
SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-51 et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with respect
to biosimilar biological product applications and supplements (as
defined in such part as of such day) that were accepted by the Food and
Drug Administration for filing on or after October 1, 2017, but before
October 1, 2022, with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2023.
TITLE V-- <<NOTE: Time periods.>> REAUTHORIZATION OF OTHER PROVISIONS
SEC. 5001. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR
CHILDREN PROGRAM.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m(d)(1)) is amended by striking ``$25,000,000 for each of fiscal
years 2018 through 2022'' and inserting ``$5,273,973 for the period
beginning on October 1, 2022 and ending on December 16, 2022''.
SEC. 5002. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION
INCENTIVE.
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``October 1'' and
inserting ``December 17''.
SEC. 5003. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA
PROGRAM.
Section 305(e) of the Food and Drug Administration Amendments Act of
2007 (Public Law 110-85; 42 U.S.C. 282 note) is amended by striking
``$5,250,000 for each of fiscal years 2018 through 2022'' and inserting
``$1,107,534 for the period beginning on October 1, 2022, and ending on
December 16, 2022''.
SEC. 5004. REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS
CONTAINING SINGLE ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(u)(4)) is amended by striking ``October 1'' and inserting
``December 17''.
SEC. 5005. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIP.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-5(f)) is amended by striking ``$6,000,000 for each of
fiscal years 2018 through 2022'' and inserting ``$1,265,753 for the
period beginning on October 1, 2022 and ending on December 16, 2022''.
SEC. 5006. REAUTHORIZATION OF ORPHAN DRUG GRANTS.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended
by striking ``$30,000,000 for each of fiscal years 2018 through 2022''
and inserting ``$6,328,767 for the period beginning on October 1, 2022,
and ending on December 16, 2022''.
[[Page 136 STAT. 2168]]
SEC. 5007. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374(g)(11)) is amended by striking ``October 1'' and inserting
``December 17''.
SEC. 5008. REAUTHORIZATION OF REPORTING REQUIREMENTS RELATED TO
PENDING GENERIC DRUG APPLICATIONS AND
PRIORITY REVIEW APPLICATIONS.
Section 807 of the FDA Reauthorization Act of 2017 (Public Law 115-
52) is amended, in the matter preceding paragraph (1), by striking
``October 1'' and inserting ``December 16''.
DIVISION G-- <<NOTE: Hermit's Peak/Calf Canyon Fire Assistance
Act. Claims.>> HERMIT'S PEAK/CALF CANYON FIRE ASSISTANCE ACT
SEC. 101. SHORT TITLE.
This division may be cited as the ``Hermit's Peak/Calf Canyon Fire
Assistance Act''.
SEC. 102. FINDINGS AND PURPOSES.
(a) Findings.--Congress finds that--
(1) on April 6, 2022, the Forest Service initiated the Las
Dispensas-Gallinas prescribed burn on Federal land in the Santa
Fe National Forest in San Miguel County, New Mexico, when
erratic winds were prevalent in the area that was also suffering
from severe drought after many years of insufficient
precipitation;
(2) on April 6, 2022, the prescribed burn, which became
known as the ``Hermit's Peak Fire'', exceeded the containment
capabilities of the Forest Service, was declared a wildfire, and
spread to other Federal and non-Federal land;
(3) on April 19, 2022, the Calf Canyon Fire, also in San
Miguel County, New Mexico, began burning on Federal land and was
later identified as the result of a pile burn in January 2022
that remained dormant under the surface before reemerging;
(4) on April 27, 2022, the Hermit's Peak Fire and the Calf
Canyon Fire merged, and both fires were reported as the Hermit's
Peak Fire or the Hermit's Peak/Calf Canyon Fire, which shall be
referred to hereafter as the Hermit's Peak/Calf Canyon Fire;
(5) by May 2, 2022, the fire had grown in size and caused
evacuations in multiple villages and communities in San Miguel
County and Mora County, including in the San Miguel county jail,
the State's psychiatric hospital, the United World College, and
New Mexico Highlands University;
(6) on May 4, 2022, the President issued a major disaster
declaration for the counties of Colfax, Mora, and San Miguel,
New Mexico;
(7) on May 20, 2022, U.S. Forest Service Chief Randy Moore
ordered a 90-day review of prescribed burn policies to reduce
the risk of wildfires and ensure the safety of the communities
involved;
(8) the U.S. Forest Service has assumed responsibility for
the Hermit's Peak/Calf Canyon Fire;
[[Page 136 STAT. 2169]]
(9) the fire resulted in the loss of Federal, State, local,
Tribal, and private property; and
(10) the United States should compensate the victims of the
Hermit's Peak/Calf Canyon Fire.
(b) Purposes.--The purposes of this Act are--
(1) to compensate victims of the Hermit's Peak/Calf Canyon
Fire, for injuries resulting from the fire; and
(2) to provide for the expeditious consideration and
settlement of claims for those injuries.
SEC. 103. DEFINITIONS.
In this Act:
(1) Administrator.--The term ``Administrator'' means--
(A) the Administrator of the Federal Emergency
Management Agency; or
(B) if a Manager is appointed under section
104(a)(3), the Manager.
(2) Hermit's peak/calf canyon fire.--The term ``Hermit's
Peak/Calf Canyon Fire'' means--
(A) the fire resulting from the initiation by the
Forest Service of a prescribed burn in the Santa Fe
National Forest in San Miguel County, New Mexico, on
April 6, 2022;
(B) the pile burn holdover resulting from the
prescribed burn by the Forest Service, which reemerged
on April 19, 2022; and
(C) the merger of the two fires described in
subparagraphs (A) and (B), reported as the Hermit's Peak
Fire or the Hermit's Peak Fire/Calf Canyon Fire.
(3) Indian tribe.--The term ``Indian Tribe'' means the
recognized governing body of any Indian or Alaska Native Tribe,
band, nation, pueblo, village, community, component band, or
component reservation individually identified (including
parenthetically) in the list published most recently as of the
date of enactment of this Act pursuant to section 104 of the
Federally Recognized Indian Tribe List Act of 1994 (25 U.S.C.
5131).
(4) Injured person.--The term ``injured person'' means--
(A) an individual, regardless of the citizenship or
alien status of the individual; or
(B) an Indian Tribe, corporation, Tribal
corporation, partnership, company, association, county,
township, city, State, school district, or other non-
Federal entity (including a legal representative) that
suffered injury resulting from the Hermit's Peak/Calf
Canyon Fire.
(5) Injury.--The term ``injury'' has the same meaning as the
term ``injury or loss of property, or personal injury or death''
as used in section 1346(b)(1) of title 28, United States Code.
(6) Manager.--The term ``Manager'' means an Independent
Claims Manager appointed under section 104(a)(3).
(7) Office.--The term ``Office'' means the Office of
Hermit's Peak/Calf Canyon Fire Claims established by section
104(a)(2).
(8) Tribal entity.--The term ``Tribal entity'' includes any
Indian Tribe, tribal organization, Indian-controlled
organization serving Indians, Native Hawaiian organization, or
Alaska Native entity, as such terms are defined or used in
section
[[Page 136 STAT. 2170]]
166 of the Workforce Innovation and Opportunity Act (29 U.S.C.
3221).
SEC. 104. COMPENSATION FOR VICTIMS OF HERMIT'S PEAK/CALF CANYON
FIRE.
(a) In General.--
(1) Compensation.--Each injured person shall be eligible to
receive from the United States compensation for injury suffered
by the injured person as a result of the Hermit's Peak/Calf
Canyon Fire, subject to the availability of appropriations and
subject to the Administrator making the determinations required
under subsection (d).
(2) <<NOTE: Establishment.>> Office of hermit's peak/calf
canyon fire claims.--
(A) In general.--There is established within the
Federal Emergency Management Agency an Office of
Hermit's Peak/Calf Canyon Fire Claims.
(B) Purpose.--The Office shall receive, process, and
pay claims in accordance with this Act.
(C) Funding.--The Office--
(i) shall be funded from funds made available
to the Administrator for carrying out this
section;
(ii) <<NOTE: Appointment.>> may appoint and
fix the compensation of such temporary personnel
as may be necessary, without regard to the
provisions of title 5, United States Code,
governing appointments in competitive service; and
(iii) <<NOTE: Reimbursement.>> may reimburse
other Federal agencies for claims processing
support and assistance.
(3) Option to appoint independent claims manager.--The
Administrator may appoint an Independent Claims Manager to--
(A) head the Office; and
(B) assume the duties of the Administrator under
this Act.
(4) <<NOTE: Reimbursement.>> Detail.--Upon the request of
the Administrator, the head of any Federal department or agency
may detail, on a reimbursable basis, any of the personnel of
that department or agency to the Federal Emergency Management
Agency to assist the Agency in carrying out the duties under
this Act.
(b) <<NOTE: Deadline. Requirements. Determination.>> Submission of
Claims.--Not later than 2 years after the date on which regulations are
first promulgated under subsection (f), an injured person may submit to
the Administrator a written claim for 1 or more injuries suffered by the
injured person in accordance with such requirements as the Administrator
determines to be appropriate.
(c) Investigation of Claims.--
(1) In general.--In accordance with subsection (d), the
Administrator shall, on behalf of the United States,
investigate, consider, ascertain, adjust, determine, grant,
deny, or settle any claim for money damages asserted under
subsection (b).
(2) Applicability of state law.--Except as otherwise
provided in this Act, the laws of the State of New Mexico shall
apply to the calculation of damages under subsection (d)(4).
(3) Extent of damages.--Any payment under this Act--
(A) shall be limited to actual compensatory damages
measured by injuries suffered; and
(B) shall not include--
[[Page 136 STAT. 2171]]
(i) interest before settlement or payment of a
claim; or
(ii) punitive damages.
(d) Payment of Claims.--
(1) Determination and payment of amount.--
(A) In general.--
(i) <<NOTE: Deadline.>> Payment.--Not later
than 180 days after the date on which a claim is
submitted under this Act, the Administrator shall
determine and fix the amount, if any, to be paid
for the claim.
(ii) Priority.--The Administrator, to the
maximum extent practicable, shall pay subrogation
claims submitted under this Act only after paying
claims submitted by injured parties that are not
insurance companies seeking payment as subrogees.
(B) Parameters of determination.--In determining and
settling a claim under this Act, the Administrator shall
determine only--
(i) whether the claimant is an injured person;
(ii) whether the injury that is the subject of
the claim resulted from the Hermit's Peak/Calf
Canyon Fire;
(iii) whether the person or persons are
otherwise eligible to receive any amount
determined under clause (iv); and
(iv) whether sufficient funds are available
for payment and, if so, the amount, if any, to be
allowed and paid under this Act.
(C) Insurance and other benefits.--
(i) In general.--In determining the amount of,
and paying, a claim under this Act, to prevent
recovery by a claimant in excess of actual
compensatory damages, the Administrator shall
reduce the amount to be paid for the claim by an
amount that is equal to the total of insurance
benefits (excluding life insurance benefits) or
other payments or settlements of any nature that
were paid, or will be paid, with respect to the
claim.
(ii) Government loans.--This subparagraph
shall not apply to the receipt by a claimant of
any government loan that is required to be repaid
by the claimant.
(2) Partial payment.--
(A) In general.--At the request of a claimant, the
Administrator may make 1 or more advance or partial
payments, subject to the determination required under
paragraph (1)(B), before the final settlement of a
claim, including final settlement on any portion or
aspect of a claim that is determined to be severable.
(B) Judicial decision.--If a claimant receives a
partial payment on a claim under this Act, but further
payment on the claim is subsequently denied by the
Administrator, the claimant may--
(i) <<NOTE: Determination.>> seek judicial
review under subsection (i); and
(ii) keep any partial payment that the
claimant received, unless the Administrator
determines that the claimant--
[[Page 136 STAT. 2172]]
(I) was not eligible to receive the
compensation; or
(II) fraudulently procured the
compensation.
(3) Rights of insurer or other third party.--If an insurer
or other third party pays any amount to a claimant to compensate
for an injury described in subsection (a), the insurer or other
third party shall be subrogated to any right that the claimant
has to receive any payment under this Act or any other law.
(4) Allowable damages.--
(A) Loss of property.--A claim that is paid for loss
of property under this Act may include otherwise
uncompensated damages resulting from the Hermit's Peak/
Calf Canyon Fire for--
(i) an uninsured or underinsured property
loss;
(ii) a decrease in the value of real property;
(iii) damage to physical infrastructure,
including irrigation infrastructure such as
acequia systems;
(iv) a cost resulting from lost subsistence
from hunting, fishing, firewood gathering,
timbering, grazing, or agricultural activities
conducted on land damaged by the Hermit's Peak/
Calf Canyon Fire;
(v) a cost of reforestation or revegetation on
Tribal or non-Federal land, to the extent that the
cost of reforestation or revegetation is not
covered by any other Federal program; and
(vi) any other loss that the Administrator
determines to be appropriate for inclusion as loss
of property.
(B) Business loss.--A claim that is paid for injury
under this Act may include damages resulting from the
Hermit's Peak/Calf Canyon Fire for the following types
of otherwise uncompensated business loss:
(i) Damage to tangible assets or inventory,
including natural resources.
(ii) Business interruption losses.
(iii) Overhead costs.
(iv) Employee wages for work not performed.
(v) Loss of business net income.
(vi) Any other loss that the Administrator
determines to be appropriate for inclusion as
business loss.
(C) Financial loss.--A claim that is paid for injury
under this Act may include damages resulting from the
Hermit's Peak/Calf Canyon Fire for the following types
of otherwise uncompensated financial loss:
(i) Increased mortgage interest costs.
(ii) An insurance deductible.
(iii) A temporary living or relocation
expense.
(iv) Lost wages or personal income.
(v) Emergency staffing expenses.
(vi) Debris removal and other cleanup costs.
(vii) <<NOTE: Determination. Deadlines.>>
Costs of reasonable efforts, as determined by the
Administrator, to reduce the risk of wildfire,
flood, or other natural disaster in the counties
impacted by the Hermit's Peak/Calf Canyon Fire to
risk levels prevailing in those counties before
the Hermit's Peak/Calf Canyon Fire, that are
incurred not later than
[[Page 136 STAT. 2173]]
the date that is 3 years after the date on which
the regulations under subsection (f) are first
promulgated.
(viii) A premium for flood insurance that is
required to be paid on or before May 31, 2024, if,
as a result of the Hermit's Peak/Calf Canyon Fire,
a person that was not required to purchase flood
insurance before the Hermit's Peak/Calf Canyon
Fire is required to purchase flood insurance.
(ix) A disaster assistance loan received from
the Small Business Administration.
(x) Any other loss that the Administrator
determines to be appropriate for inclusion as
financial loss.
(e) Acceptance of Award.--The acceptance by a claimant of any
payment under this Act, except an advance or partial payment made under
subsection (d)(2), shall--
(1) be final and conclusive on the claimant, with respect to
all claims arising out of or relating to the same subject
matter; and
(2) constitute a complete release of all claims against the
United States (including any agency or employee of the United
States) under chapter 171 of title 28, United States Code
(commonly known as the ``Federal Tort Claims Act''), or any
other Federal or State law, arising out of or relating to the
same subject matter.
(f) Regulations and Public Information.--
(1) <<NOTE: Deadline. Federal Register, publication.>>
Regulations.--Notwithstanding any other provision of law, not
later than 45 days after the date of enactment of this Act, the
Administrator shall promulgate and publish in the Federal
Register interim final regulations for the processing and
payment of claims under this Act.
(2) Public information.--
(A) <<NOTE: Web posting. Newspapers. New Mexico.>>
In general.--At the time at which the Administrator
promulgates regulations under paragraph (1), the
Administrator shall publish, online and in print, in
newspapers of general circulation in the State of New
Mexico, a clear, concise, and easily understandable
explanation, in English and Spanish, of--
(i) the rights conferred under this Act; and
(ii) the procedural and other requirements of
the regulations promulgated under paragraph (1).
(B) Dissemination through other media.--The
Administrator shall disseminate the explanation
published under subparagraph (A) through websites,
blogs, social media, brochures, pamphlets, radio,
television, and other media that the Administrator
determines are likely to reach prospective claimants.
(g) Consultation.--In administering this Act, the Administrator
shall consult with the Secretary of the Interior, the Secretary of
Energy, the Secretary of Agriculture, the Administrator of the Small
Business Administration, other Federal agencies, and State, local, and
Tribal authorities, as determined to be necessary by the Administrator,
to--
(1) ensure the efficient administration of the claims
process; and
(2) provide for local concerns.
(h) Election of Remedy.--
[[Page 136 STAT. 2174]]
(1) In general.--An injured person may elect to seek
compensation from the United States for 1 or more injuries
resulting from the Hermit's Peak/Calf Canyon Fire by--
(A) submitting a claim under this Act;
(B) filing a claim or bringing a civil action under
chapter 171 of title 28, United States Code (commonly
known as the ``Federal Tort Claims Act''); or
(C) bringing an authorized civil action under any
other provision of law.
(2) Effect of election.--In accordance with subsection (e),
an election by an injured person to seek compensation in any
manner described in paragraph (1) shall be final and conclusive
on the claimant with respect to all injuries resulting from the
Hermit's Peak/Calf Canyon Fire that are suffered by the claimant
upon acceptance of an award.
(3) Arbitration.--
(A) <<NOTE: Deadline. Regulations. Procedures.>> In
general.--Not later than 45 days after the date of
enactment of this Act, the Administrator shall establish
by regulation procedures under which a dispute regarding
a claim submitted under this Act may be settled by
arbitration.
(B) Arbitration as remedy.--On establishment of
arbitration procedures under subparagraph (A), an
injured person that submits a disputed claim under this
Act may elect to settle the claim through arbitration.
(C) Binding effect.--An election by an injured
person to settle a claim through arbitration under this
paragraph shall--
(i) be binding; and
(ii) preclude any exercise by the injured
person of the right to judicial review of a claim
described in subsection (i).
(4) No effect on entitlements.--The value of compensation
that may be provided under this Act shall not be considered
income or resources for any purpose under any Federal, State, or
local laws, including laws relating to taxation, welfare, and
public assistance programs, and no State or political
subdivision thereof shall decrease any assistance otherwise
provided to an injured person because of the receipt of benefits
under this Act.
(i) Judicial Review.--
(1) <<NOTE: Deadline.>> In general.--Any claimant aggrieved
by a final decision of the Administrator under this Act may, not
later than 60 days after the date on which the decision is
issued, bring a civil action in the United States District Court
for the District of New Mexico, to modify or set aside the
decision, in whole or in part.
(2) Record.--The court shall hear a civil action under
paragraph (1) on the record made before the Administrator.
(3) Standard.--The decision of the Administrator
incorporating the findings of the Administrator shall be upheld
if the decision is supported by substantial evidence on the
record considered as a whole.
(j) Attorney's and Agent's Fees.--
(1) In general.--No attorney or agent, acting alone or in
combination with any other attorney or agent, shall charge,
demand, receive, or collect, for services rendered in connection
[[Page 136 STAT. 2175]]
with a claim submitted under this Act, fees in excess of the
limitations established under section 2678 of title 28, United
States Code.
(2) Violation.--An attorney or agent who violates paragraph
(1) shall be fined not more than $10,000.
(k) <<NOTE: Determinations.>> Waiver of Requirement for Matching
Funds.--
(1) State and local project.--
(A) In general.--Notwithstanding any other provision
of law, a State or local project that is determined by
the Administrator to be carried out in response to the
Hermit's Peak/Calf Canyon Fire under any Federal program
that applies to an area affected by the Hermit's Peak/
Calf Canyon Fire shall not be subject to any requirement
for State or local matching funds to pay the cost of the
project under the Federal program.
(B) Federal share.--The Federal share of the costs
of a project described in subparagraph (A) shall be 100
percent.
(2) Other needs program assistance.--Notwithstanding section
408(g)(2) of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act (42 U.S.C. 5174(g)(2)), for any
emergency or major disaster declared by the President under that
Act for the Hermit's Peak/Calf Canyon Fire, the Federal share of
assistance provided under that section shall be 100 percent.
(3) Agricultural program assistance.--
(A) In general.--Notwithstanding any other provision
of law, a State, local, or individual project that is
determined by the Secretary of Agriculture to be carried
out in response to the Hermit's Peak/Calf Canyon Fire
under any Federal program that applies to an area
affected by the Hermit's Peak/Calf Canyon Fire shall not
be subject to any requirement for State, local, or
individual matching funds to pay the cost of the project
under the Federal program.
(B) Federal share.--The Federal share of the costs
of a project described in subparagraph (A) shall be 100
percent.
(l) Applicability of Debt Collection Requirements.--Section 3711(a)
of title 31, United States Code, shall not apply to any payment under
this Act, unless--
(1) there is evidence of civil or criminal fraud,
misrepresentation, presentation of a false claim; or
(2) a claimant was not eligible under subsection (d)(2) of
this Act to any partial payment.
(m) Indian Compensation.--Notwithstanding any other provision of
law, in the case of an Indian Tribe, a Tribal entity, or a member of an
Indian Tribe that submits a claim under this Act--
(1) the Bureau of Indian Affairs shall have no authority
over, or any trust obligation regarding, any aspect of the
submission of, or any payment received for, the claim;
(2) the Indian Tribe, Tribal entity, or member of an Indian
Tribe shall be entitled to proceed under this Act in the same
manner and to the same extent as any other injured person; and
(3) except with respect to land damaged by the Hermit's
Peak/Calf Canyon Fire that is the subject of the claim, the
[[Page 136 STAT. 2176]]
Bureau of Indian Affairs shall have no responsibility to restore
land damaged by the Hermit's Peak/Calf Canyon Fire.
(n) Report.--Not later than 1 year after the date of promulgation of
regulations under subsection (f)(1), and annually thereafter, the
Administrator shall submit to Congress a report that describes the
claims submitted under this Act during the year preceding the date of
submission of the report, including, for each claim--
(1) the amount claimed;
(2) a brief description of the nature of the claim; and
(3) the status or disposition of the claim, including the
amount of any payment under this Act.
(o) Authorization of Appropriations.--There are authorized to be
appropriated such sums as are necessary to carry out this Act.
Approved September 30, 2022.
LEGISLATIVE HISTORY--H.R. 6833:
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CONGRESSIONAL RECORD, Vol. 168 (2022):
Mar. 31, considered and passed House.
Sept. 28, 29, considered and passed Senate, amended.
Sept. 30, House concurred in Senate amendment.
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