[Congressional Record Volume 168, Number 159 (Friday, September 30, 2022)]
[House]
[Pages H8330-H8351]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
AFFORDABLE INSULIN NOW ACT
Ms. DeLAURO. Mr. Speaker, pursuant to House Resolution 1404, I call
up the bill (H.R. 6833) to amend title XXVII of the Public Health
Service Act, the Internal Revenue Code of 1986, and the Employee
Retirement Income
[[Page H8331]]
Security Act of 1974 to establish requirements with respect to cost-
sharing for certain insulin products, and for other purposes, with the
Senate amendment thereto, and ask for its immediate consideration.
The Clerk read the title of the bill.
The SPEAKER pro tempore. The Clerk will designate the Senate
amendment.
Senate amendment:
Strike all after the enacting clause and insert the
following:
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. 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.
DIVISION A--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) 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).
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) 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 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) 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) 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)).
[[Page H8332]]
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. (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, 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 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 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, 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. 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 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. (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, 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) 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, 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 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. 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) 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) Subject to paragraph (2), this section shall become
effective immediately upon enactment of this Act.
(2) 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. (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. (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''.
(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
[[Page H8333]]
$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. 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: 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 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, 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, 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 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. 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. 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. (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) Subject to paragraph (2), this section shall become
effective immediately upon enactment of this Act.
(2) 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. 140. 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. 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 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.
[[Page H8334]]
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. 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. (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 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. 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. 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. 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 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. (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) 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) Subject to paragraph (2), this section shall become
effective immediately upon enactment of this Act.
(2) 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--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.
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,
[[Page H8335]]
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, 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, 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.
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.
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,
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. 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. Not later than 30 days after the date of
enactment of this Act, and every 30 days thereafter through
fiscal year 2023, 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. 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. (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,
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, That at least 15 days prior to the initial
obligation of such funds, the Secretary of State, following
consultation with the Administrator 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, 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) 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) 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
[[Page H8336]]
have been expended: Provided, 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) 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 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. UNITED STATES PAROLE COMMISSION EXTENSION.
(a) Short Title.--This section may be cited as the ``United
States Parole Commission Extension Act of 2022''.
(b) 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 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) 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) 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--
(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) 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) 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.
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. 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 is amended by striking ``October 1, 2019'' and inserting
``December 16, 2022''.
[[Page H8337]]
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''.
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''.
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''.
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--FDA USER FEE REAUTHORIZATION ACT OF 2022
SECTION 1. 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.
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--FEES RELATING TO DRUGS
SEC. 1001. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2022''.
(b) Finding.--Congress finds that the fees authorized by
the amendments made by this title
[[Page H8338]]
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,
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) 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;
``(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) 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.--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 program fee established for
a fiscal year under subsection (c)(6) for such prescription
drug product. 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) 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.''.
(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) 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
[[Page H8339]]
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 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) 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:
``(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) 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) 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 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) 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) 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) 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. 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. 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--FEES RELATING TO DEVICES
SEC. 2001. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2022''.
(b) 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 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. 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'';
[[Page H8340]]
(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:
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
(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) 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
``(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.
``(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) 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) 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) 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.
``(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) 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
[[Page H8341]]
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.--
``(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) 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
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) 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) 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) 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) 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. 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 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. 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--FEES RELATING TO GENERIC DRUGS
SEC. 3001. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Generic
Drug User Fee Amendments of 2022''.
(b) 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. 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:
``(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''.
[[Page H8342]]
(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 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) 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
``(bb) thirty-five percent or more of abbreviated new drug
applications submitted related to complex products (as so
defined).
``(D) 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) 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--
(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) 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) 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) 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) 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. 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. 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 to assessing and collecting any fee required by such
part for a fiscal year prior to fiscal year 2023.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 4001. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the
``Biosimilar User Fee Amendments of 2022''.
(b) 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:
[[Page H8343]]
``(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) 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 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) 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) 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) 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.''.
(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) 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. 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 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 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--
``(A) for fiscal year 2023, $43,376,922; 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, 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
[[Page H8344]]
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 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) 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) Operating reserve adjustment.--
``(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 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.--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 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) 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) 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) 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. 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.
SEC. 4007. 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--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''.
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--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;
[[Page H8345]]
(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;
(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 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) 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) 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) 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) 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) 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--
(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) 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) seek judicial review under subsection (i); and
(ii) keep any partial payment that the claimant received,
unless the Administrator determines that the claimant--
(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
[[Page H8346]]
(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) 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 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) 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) 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.--
(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) 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) 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 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) 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
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.
Motion to Concur
Ms. DeLAURO. Mr. Speaker, I have a motion at the desk.
The SPEAKER pro tempore. The Clerk will designate the motion.
[[Page H8347]]
The text of the motion is as follows:
Ms. DeLauro of Connecticut moves that the House concur in
the Senate amendment to H.R. 6833.
The SPEAKER pro tempore. Pursuant to House Resolution 1404, the
motion shall be debatable for 1 hour equally divided and controlled by
the chair and ranking minority member of the Committee on
Appropriations or their respective designees.
The gentlewoman from Connecticut (Ms. DeLauro) and the gentlewoman
from Texas (Ms. Granger) each will control 30 minutes.
The Chair recognizes the gentlewoman from Connecticut.
general leave
Ms. DeLAURO. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and include extraneous material on the Senate amendment to H.R.
6833.
The SPEAKER pro tempore. Is there objection to the request of the
gentlewoman from Connecticut?
There was no objection.
Ms. DeLAURO. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of the Continuing Appropriations and
Ukraine Supplemental Appropriations Act, which extends funding for
Federal programs and services through December 16.
With a 72-25 vote, the United States Senate approved this legislation
with the support of all Democrats and 22 Republicans, including
Senators Shelby and McConnell.
Before I begin, I want to acknowledge the millions of people in
Florida, Puerto Rico, Alaska, and elsewhere reeling from recent
disasters, stranded without power and other necessary resources, and
mourning the loss of loved ones. This institution will stand with
communities across America as they rebuild and recover.
With the many challenges facing our Nation and the world, including
devastating natural disasters and the high cost of living, we cannot
wait any longer to pass this bill.
This bill guarantees that we have the means to continue the important
work we are doing to help middle class and working families with the
cost of living, support vulnerable Americans by keeping roofs over the
heads of millions of families and food on their tables, uphold our
commitment to our veterans, and strengthen our national security. But
this is not enough, and this solution is only a short-term one.
The Appropriations Committee and House Democrats worked to clear all
12 government funding bills out of committee and pass six on the floor
of the House this summer. These are transformational bills needed to
meet the moment and tackle our Nation's biggest challenges.
The legislation before us allows additional time for bipartisan,
bicameral negotiations to enact final 2023 funding bills.
The bill also includes $12.35 billion in necessary emergency funding
to support the Ukrainian people and global democracy in the face of
Russia's grievous invasion of Ukraine. This body came together twice
earlier this year to deliver on our commitment to the courageous people
of Ukraine, but most of those resources have already been disbursed or
committed.
For that reason, this bill includes necessary security assistance for
Ukraine, including $3 billion for the Ukraine Security Assistance
Initiative to keep weapons and ammunition flowing without interruption,
and $1.5 billion to replenish U.S. stocks of equipment sent through
drawdown authority.
We also help Ukraine protect its democracy by supporting the
continuity of its democratic government and delivery of citizen
services with $4.5 billion. This contribution ensures we continue
upholding our moral responsibility to support the people of Ukraine in
the face of a vicious invasion that continues to demand decisive action
from us.
The bill also includes safeguards over these funds, such as a
requirement of third-party monitoring and a certification by the
Secretary of State that protects against corruption.
With $2 million for the DOD Inspector General to monitor funds and
provide Congress with a report inventorying security assistance, we
ensure weapons are used for their intended purpose by their intended
recipients.
At the same time, this bill responds to the devastation that recent
natural disasters and extreme weather events have left behind. As the
climate crisis wreaks havoc on communities all over our Nation, this
legislation provides significant support for disaster response and
recovery efforts.
Included in this is a critical $20 million in funding to complete
previously authorized Army Corps of Engineers projects that will help
address the water crisis in Jackson, Mississippi, and upgrade its water
and wastewater infrastructure.
In the wealthiest Nation in the world, the bare minimum every person
deserves is drinking water that is clean and safe, and this bill gets
us one step closer to that minimum.
By fully funding the Disaster Relief Fund, this bill responds to
Hurricane Ian in Florida; to the crisis left behind in Puerto Rico
after the devastating Hurricane Fiona; and to the severe storm,
flooding, and landslides in Alaska, helping with recovery and disaster
relief efforts.
We also provide $1 billion in funding for the Low Income Home Energy
Assistance Program to help lower-income families cover the rising
energy costs of home heating and cooling; including $2.5 billion to
address the largest wildfire in New Mexico, in their history, that
started from prescribed burns on Federal land; and support these and
other communities all over the Nation, including Kentucky, California,
Louisiana, and Texas, by providing $2 billion to help address unmet
housing, infrastructure, and economic recovery needs in communities
recovering from recent wildfires, major storms, droughts, floods, and
extreme heat.
While this legislation provides a bridge to an omnibus, it is not
perfect. I am saddened that the continuing resolution does not fully
meet some of our country's most urgent needs, including the ongoing
COVID-19 pandemic and monkey pox outbreak. I will continue working to
provide the resources to combat these public health crises and support
the areas in need of additional resources to recover from natural
disasters.
Despite these shortcomings, the investments included in this bill are
urgent and necessary to avoid disruptions to vital Federal agencies, to
help communities get back on their feet, and to ensure we have the time
needed to negotiate a final funding agreement that meets the needs of
hardworking people.
I urge my colleagues to support this bill, and I reserve the balance
of my time.
Ms. GRANGER. Mr. Speaker, I yield myself such time as I may consume.
I rise today in opposition to the Senate amendment to H.R. 6833, a
short-term continuing resolution extending government funding through
December 16. I oppose this CR for several reasons.
First, we should be here addressing the border crisis, the energy
crisis, and the inflation crisis. This bill does nothing to fix any of
these issues. In fact, this bill actually bails out the Biden
administration for their failures and provides additional
appropriations to put a Band-Aid on some of these problems for a few
more months.
For example, this bill includes nearly $2 billion in funding for
children and families flooding the border. Providing more funding
without changing the policies that led to this crisis will only
encourage more migrants to come.
Second, it is unfortunate this bill will be rushed through the House
today with just hours to spare to avoid a government shutdown. The
American people continue to wonder why Congress can't get its job done
until the very last minute and why we don't have more time to review
legislation.
For these reasons, I urge my colleagues to vote ``no.'' I reserve the
balance of my time.
Ms. DeLAURO. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Florida (Ms. Wasserman Schultz), the chair of the Military
Construction, Veterans Affairs, and Related Agencies Subcommittee.
Ms. WASSERMAN SCHULTZ. Mr. Speaker, I thank the chairwoman for
yielding.
I rise to support this continuing resolution that will keep our
Federal Government open and deliver the vital services that impact us
all.
Look no further than Southwest Florida, in my home State, where
Hurricane Ian inflicted tragic human loss
[[Page H8348]]
and massive property damage. While we pray for those who endured Ian's
wrath and those who still face it, let's pass this continuing
resolution and offer more than well wishes.
Thankfully, President Biden declared a major disaster, unleashing
extensive Federal aid and assistance for the counties hit by Ian. But
this CR will allow FEMA and other Federal partners to keep assistance
flowing to Florida in our time of need, while also aiding those hurting
in Puerto Rico, Alaska, New Mexico, and Mississippi.
We cannot leave communities behind that are still picking up the
pieces from disastrous floods, wildfires, and hurricanes, and even
basic water system failures. This Federal funding bill comes to their
rescue by helping to meet long-term housing, infrastructure, and
recovery needs.
This CR also extends funding for vital Federal education, health,
housing, and public safety programs. It keeps up school, job training,
and child nutritional investments, and it keeps funds flowing to
address badly needed affordable housing problems which plague so many
families in Florida.
Anyone who understands the housing struggles that millions of
Americans face cannot possibly ignore the relief that this CR offers.
This legislation also keeps America's security intact, while also
supporting those brave veterans who defended us.
This CR also confronts Russia's fake elections to annex parts of
Ukraine, whose families urgently need our support to defend global
democracy and turn back a murderous communist tyrant.
I am pleased that this continuing resolution before us reflects that
vanishing breed of bipartisan, bicameral, negotiated compromise.
I hope our colleagues on the other side of the aisle respect that and
honor the trust that Americans hand us to maintain an orderly economy
and state of affairs. This CR provides that basic test of governance.
Americans want our government funding bills to help reduce their cost
of living, support their families, create good jobs, and combat climate
change. This continuing funding legislation gives us the time we need
to ensure our 2023 bills will do exactly that.
Let's keep America running so Congress can complete America's
critical fiscal work.
Ms. GRANGER. Mr. Speaker, I yield 2 minutes to the gentleman from
Virginia (Mr. Cline), a member of the Appropriations Committee.
Mr. CLINE. Mr. Speaker, I rise on behalf of the people of the Sixth
District of Virginia who are contacting my office right now expressing
their outrage at this failed, do-nothing Democratic majority who has
brought us to the brink of a government shutdown. They are furious,
furious because Democrats control the House, the Senate, the White
House, and still, here we are at the point where we have to keep the
government running, and instead of confronting these crises that are
leading us to this shutdown, this Democratic majority is kicking the
can down the road until after the elections in November.
The American people are furious at a broken, business-as-usual
Washington that refuses to confront the crises. In fact, it exacerbates
the crises created by President Biden and the Democratic majority.
This continuing resolution we are voting on today, once again, makes
clear that the Democrats' business-as-usual Washington must end.
Just look at some of these policies that Democrats have stuffed in
this bill, thrown taxpayer dollars at Biden's wide-open border crisis,
the raging inflation crisis, and the skyrocketing energy crisis.
$57.5 billion for DHS to continue wide-open border and amnesty
policies that have allowed illegal migrants to pour across our southern
border and drug cartels to smuggle deadly fentanyl into our communities
under Secretary Mayorkas' failed leadership.
$10.8 billion for the FBI that the Biden administration has
weaponized against Americans who disagree with its policies, including
parents concerned about their kids in schools.
$12.6 billion for the IRS, on top of the $80 billion that Democrats
just gave to hire 87,000 new agents to spy into the bank accounts of
Americans and conduct more audits on small businesses.
$728 billion to a Department of Defense that is more focused on
promoting the radical left's woke ideology than protecting our national
security here at home and abroad.
$3.8 billion for a Low Income Housing Energy Assistance Program that
pays for the increased energy costs for those that live in anti-
fracking States like New York, without addressing the real cause of the
energy crisis, which is the Democrats' socialist Green New Deal agenda.
Americans are hurting and their paychecks are declining in value, but
Democrats continue to fund these out-of-touch policies, and that is why
I am voting ``no.''
The SPEAKER pro tempore. The time of the gentleman has expired.
Ms. GRANGER. Mr. Speaker, I yield an additional 1 minute to the
gentleman from Virginia.
Mr. CLINE. Mr. Speaker, Americans are hurting. Their paychecks are
declining in value, but Democrats continue to fund these out-of-touch
policies with billions of taxpayer dollars from hardworking Americans.
That is why I am voting ``no.'' I hope my colleagues will join me.
Ms. DeLAURO. Mr. Speaker, I yield 2 minutes to the gentleman from New
Jersey (Mr. Pallone), the chairman of the Energy and Commerce
Committee.
{time} 1130
Mr. PALLONE. Mr. Speaker, I thank the chairwoman of the Committee on
Appropriations for all she has done to get us to the point where we are
able to pass this continuing resolution today.
In June, House Democrats and Republicans came together to pass, by an
overwhelming supermajority, a sweeping package of reforms at the Food
and Drug Administration. That bipartisan legislation would strengthen
the integrity of the accelerated approval program, foster innovation,
improve clinical trial diversity, and reauthorize the agency's medical
product user fee programs. Those user fee programs help fund FDA
reviews for safety and efficacy of drugs and medical devices.
While the House concluded its work in June, the Senate failed to act.
As soon as we passed our legislation through the House, I reached out
to Ranking Member Rodgers and the Democratic and Republican leaders of
the Senate HELP Committee to begin bipartisan, bicameral conversations
to come to an agreement on a package of mutually agreeable FDA reforms.
After weeks of negotiations, our talks hit a temporary roadblock with
Senator Burr, the Republican ranking member of the Senate HELP
Committee, but we stayed at the table, and eventually, the negotiations
were fruitful. We were able to come together to find common ground
across several meaningful policy areas.
Unfortunately, despite this progress, Senate Minority Leader
McConnell decided to stand in the way of enacting bipartisan policies
to improve public health. Senator McConnell threatened to hold up
government funding if our FDA reforms were included in the continuing
resolution we are debating today.
While I am pleased that we are reauthorizing user fees, which will
prevent layoffs at the agency and allow the FDA to continue its
mission, I will continue pushing for the widely supported improvements
at the agency.
I have secured commitments from Senators Murray and Burr, as well as
Ranking Member Rodgers, to continue working to finalize a package of
FDA reforms before the continuing resolution expires in December, and I
look forward to taking meaningful action in the near future. For now, I
encourage Members to support continuing the work at the FDA by voting
in favor of the continuing resolution.
Ms. GRANGER. Mr. Speaker, I yield 2 minutes to the gentleman from
Virginia (Mr. Good).
Mr. GOOD of Virginia. Mr. Speaker, the preamble to the Constitution
states that its purpose is, in part, to ``secure the blessings of
liberty to ourselves and our posterity.'' Are we doing that today?
This legislation represents Congress at its worst. We are voting to
let government funding expire on December 16, just days after dozens of
Democrats are fired by the voters on November 8. But before this
Congress adjourns and new courageous conservatives are sworn in,
Congress wants to stick it to the American people one more time.
[[Page H8349]]
The funding for 2023 and beyond should reflect the will of the people
and how they vote on November 8 when they reject the policies under
which they are suffering today.
No Republican in the Senate should have, and no Republican in this
House, and even those on the other side, should give one more cent to a
government that doesn't care about our border but wants to send $12
billion more to secure the border of Ukraine.
We should not fund a government that is allowing an invasion across
our southern border and is giving hundreds of millions of dollars to
the countries that are facilitating that just south of our border.
We should be cutting our spending and not increasing inflation by
more massive spending, as reflected in this package today.
We should support American energy production, not subsidize
unreliable energy and Biden's gas price hike.
We should not be funding the hiring of 87,000 new IRS agents to go
after regular, hardworking Americans.
We should end the vaccine mandate and the COVID China virus emergency
and not fund an administration that wants to fire healthcare workers
because they don't get a vaccine.
All Republicans should oppose this CR, not give one more vote for one
more cent for this tyrannical government that is hurting all Americans.
Ms. DeLAURO. Mr. Speaker, I yield 1 minute to the gentleman from
Rhode Island (Mr. Cicilline).
Mr. CICILLINE. Mr. Speaker, I rise today in support of this
continuing resolution.
In addition to averting a disastrous government shutdown, this
legislation provides critical funding to continue our support for
Ukraine, resettle Afghan refugees, support communities impacted by
natural disasters, and help low-income families heat their homes this
winter.
However, we still have work to do as this package lacks funding to
support our public health response to COVID-19 and monkeypox, also
known as MPV.
Our public health workforce is depleted and exhausted from battling
the COVID-19 pandemic over the last 2 years. They cannot stop the
spread of these outbreaks without additional Federal support.
Both viruses disproportionately impact low-income communities and
communities of color. Congressional inaction will deepen these
disparities.
Mr. Speaker, I urge my colleagues to vote today to avert a government
shutdown and then join us in working on long-term funding bills that
address these public health crises and the other priorities of the
American people.
I want to end by thanking the extraordinary chairwoman of the
Committee on Appropriations, Rosa DeLauro, for her leadership in
negotiating today's legislation and thanking her for all she has done.
Ms. GRANGER. Mr. Speaker, I reserve the balance of my time.
Ms. DeLAURO. Mr. Speaker, I yield 1 minute to the gentlewoman from
Texas (Ms. Jackson Lee).
Ms. JACKSON LEE. Mr. Speaker, I thank the gentlewoman for her
leadership.
I am very glad to say that there is something that responsibility
calls you to do: save lives. This CR indicates that we will not shut
the government down in the face of disasters around the world. We will
not freeze out low-income families by not providing them with the home
energy assistance program. And, yes, we will ensure that agencies like
housing and health and public safety, to reduce the crime across
America, to respond to the needs of our police officers and victims of
crime, will not shut down.
But, yes, we will also recognize that we are good neighbors. In
Pakistan, 33 million people have been dislocated because of
catastrophic floods of Biblical proportions. Mothers are about to
deliver babies, 70,000 of them, and we can help them as USAID goes and
does its work internationally.
I am glad that we are putting a stop sign on closing the government
down. I wish our friends on the other side would join us.
Finally, I want us to give more money to the hostage section of the
Department of State because people like Brittney Griner are in cages in
Russia, and we have to get our hostages out. Americans are looking for
America to stand by their side.
The SPEAKER pro tempore. The time of the gentlewoman has expired.
Ms. DeLAURO. Mr. Speaker, I yield an additional 1 minute to the
gentlewoman from Texas.
Ms. JACKSON LEE. Mr. Speaker, I thank the chairwoman very much and
again applaud her persistence in helping the American people.
As I finish, on the issue of Brittney Griner, introducing this to
many of our colleagues that don't know, she is a hostage in Putin's
Russia. Playing basketball there was her only crime, if you will. There
she is, in a cage in Russia, a hostage since February.
We have a department that works on this issue inside the Department
of State. I want to implore them and make sure they have the resources
for the many Americans who are innocently held by countries around the
world. It is a tragedy and a shame that we have a circumstance where
Americans cannot travel. I am grateful for that support.
I am also grateful to acknowledge, if you will, the Disaster Relief
Fund for our domestic crises. As I said earlier, a man was interviewed
in Florida and said: I have lost everything, my house and everything in
it.
There are a million people with no access to power, so this is a
crucial and important CR. Puerto Rico is in need. It is a crucial and
important CR. We always stand to hand out to our friends around the
Nation and around the world. That is the United States of America. That
is why we are passing the CR.
Mr. Speaker, I rise in support of the Senate amendment to H.R. 6833:
the Continuing Resolution to fund the federal government through
December 16, 2022.
I commend our colleagues in the Senate and the House for crafting
this bipartisan, bicameral agreement that keeps the federal government
fully operational without any interruption.
The agreement that led to this Continuing Resolution reflects our
commitment to the policies on which Americans rely.
It reassures the American people that our government will continue to
deliver all services while negotiations continue on funding federal
agencies, programs, activities, and services for the remainder of
Fiscal Year 2023.
Passing this continuing resolution might appear to be a basic
ministerial act; but it is actually much more than that and highly
consequential.
Throughout my 27 years of service in Congress, I have never lost
sight of my principal responsibilities to my constituents and to the
American people.
Paramount among them are two priorities: to do everything we can to
keep our country and our people safe, and to provide the vitally
necessary services and activities that preserve and enhance quality-of-
life standards for all Americans.
Keeping our country safe includes protecting Americans from:
domestic terrorism and violent extremism,
public health pandemics,
aggression from adversarial countries and non-country actors,
environmental hazards to our air and water,
food and drug contamination,
racially based hate crimes, and
gun violence, which we advanced this summer by enacting the
Bipartisan Safer Communities Act.
Maintaining vital services includes providing:
health care and public health programs,
food stamps and SNAP funding,
clean air and water standards,
weather forecasting to enable resilience against natural disasters
and FEMA funding to help rebuild lives and communities after they
strike,
child nutrition and immunizations,
education programs and funding,
economic and business support programs that help create jobs and
entrepreneurial opportunities,
workplace safety protections and safeguards for employee rights,
prosecution of crimes and protections of civil rights,
housing assistance and homelessness prevention assistance,
broadband and other communication services,
medical research and healthcare innovation,
American leadership in the world community, and
myriad other services and programs that are synonymous with service
to all Americans, especially those who are most in need of a helping
hand to uplift themselves and thrive.
Both of these goals--keeping Americans safe and providing vital
services--require that the federal government and all of its programs
remain fully operational at all times without any interruption,
especially a disruption due to political discord.
[[Page H8350]]
It is incumbent upon Congress to pass appropriations bills that
enable the federal government to fulfill its diverse mandates.
With 535 members of the House and Senate, is essential that we
negotiate, compromise, and reach agreements to ensure that the
government will deliver for the American people on all activities that
we are entrusted to perform.
Failure is not an option because the consequences on peoples' lives
and livelihoods would be far too great to bear.
Failure would debilitate our economy, eliminate jobs, and devastate
family finances.
Failure would mean that:
the health of Americans would suffer,
more people would become homeless,
production of food would be limited and its safety put at risk,
public safety would be impaired,
rebuilding from natural disasters would grind to a halt,
veterans and Social Security recipients would not receive their
checks, and
the global stature of the United States would be diminished, among
many other unacceptable outcomes.
These are just some of the reasons why I support passage of this
Continuing Resolution.
It is imperative that we keep the federal government open and fully
functional over the next few months as we continue to craft
appropriations legislation that will fuel the federal government for
the remainder of this fiscal year.
During this time, we will be able to craft language to improve
government operations, address urgent needs, and accelerate forward-
looking initiatives that will strengthen our country, ensure equity,
and enhance opportunity for all Americans.
Yet, some needs are already well recognized. That is why I am
particularly pleased that this bill not only continues funding for
government programs and services at their current rate, but also
includes funding for critically necessary activities, and extends
programs that would have expired.
Some of the many provisions in the bill that would achieve these aims
and which I fully support are the:
$1 billion in aid to Jackson Mississippi to help them resolve their
water crisis,
$1 billion in Low Income Home Energy Assistance Program support to
help low income families afford heat during the upcoming cold weather
months,
funding for victims of natural disasters that is needed to help them
restore their homes and rebuild their lives,
maintenance of social security customer service systems,
$2 billion for the Community Development Block Grant Disaster
Recovery program,
extension of child and family services programs,
extension of veterans' health care and housing supports,
fortification of cybersecurity by funding the newly created Office of
the National Cyber Director,
enhancement of the Judiciary's court security program,
extension of the national flood insurance program,
funding of the FDA to continue its activities, and
$12.35 billion in aid to Ukraine that will enable them to combat
Russia's hegemony.
Mr. Speaker, this continuing resolution is crucial for the sustenance
and resilience of the American people.
I urge all my colleagues to support the Continuing Resolution so that
we can keep the government operating while we negotiate a comprehensive
bill to maintain programs, services, and activities through the
remainder of this fiscal year.
Ms. GRANGER. Mr. Speaker, I reserve the balance of my time.
Ms. DeLAURO. Mr. Speaker, I yield 1 minute to the gentleman from New
York (Mr. Nadler).
Mr. NADLER. Mr. Speaker, there are many good things about this CR.
One of the best is that it won't shut down the government.
It is shocking to me that our Republican colleagues seem to want to
shut down the government, with all of these services and necessary
things it does for the people of the United States.
This CR does many good things. I want to focus on one of them, the
87,000 extra new agents to be hired for enforcement by the Internal
Revenue Service. That is an excellent thing because what will they do?
They will go after the rich people.
By the terms of the statute, by the terms of the CR, they cannot be
used for enforcement of taxes against anybody earning less than
$400,000, so we are not talking about the middle class.
The rich people in this country are cheating. They are cheating
tremendously. They are cheating to the tune of tens of billions of
dollars because they know they can get away with it and because there
is no manpower or womanpower to enforce the law. This will give us the
manpower to enforce the law.
The SPEAKER pro tempore. The time of the gentleman has expired.
Ms. DeLAURO. Mr. Speaker, I yield an additional 30 seconds to the
gentleman from New York.
Mr. NADLER. Mr. Speaker, this will give us the manpower to enforce
the law and to make sure that the rich pay their fair share, and,
therefore, there can be more services for the middle class and for low-
income people in this country, which is exactly what the government is
for.
This is one of the best things it does. Mr. Speaker, I urge everyone
to vote for the CR, in particular, because of the 87,000 extra agents
that the Internal Revenue Service will have to enforce taxes against
rich tax cheats.
Ms. GRANGER. Mr. Speaker, I reserve the balance of my time.
Ms. DeLAURO. Mr. Speaker, I yield myself such time as I may consume.
We need this bill. We need this bill to continue negotiating final
2023 funding bills.
With the bill before us, what is in this bill, and why is it so
onerous to some?
We provide relief to working families, our schools, our children,
small businesses, and communities across this Nation.
We support the people of Ukraine. We support them in what is the
fight for their lives, for their democracy, and for world democracy
against Russian aggression.
We protect communities everywhere in need of safe water. We help to
rebuild them from crushing natural disasters.
This bill will make a very real difference in the lives of Americans
everywhere, and I am proud to support it.
Mr. Speaker, I urge all of my colleagues to join me in supporting
these bills, and I reserve the balance of my time.
Ms. GRANGER. Mr. Speaker, I yield myself the balance of my time for
closing.
Mr. Speaker, as I said before, we all know we must pass the CR to
keep the government open. But this bill is a wasted opportunity.
Mr. Speaker, I urge my colleagues to vote against this bill, and I
yield back the balance of my time.
Ms. DeLAURO. Mr. Speaker, I yield back the balance of my time.
Ms. KAPTUR. Mr. Speaker, first I want to thank Chair DeLauro for her
diligent work to bring this CR to the floor in order to fund the
essential services of the federal government at a time when our Nation
needs stable governance.
As Chair of the House Energy and Water Appropriations Subcommittee, I
am pleased that this bill provides $20 million in emergency funding to
the Corps of Engineers for previously authorized water and wastewater
infrastructure improvements, which can be used in Jackson, Mississippi.
I also appreciate the inclusion of $1 billion for the Low-Income Home
Energy Assistance Program to help address pressure on low-income
households' pocketbooks due to inflation caused by pandemic-related
supply chain backups and global energy disruption due to Russia's war
on Ukraine.
As Co-Chair of the bipartisan Congressional Ukraine Caucus, I am
grateful for the inclusion of a new U.S. funding package that will
deliver urgently-needed weapons, equipment, aid, and support to
America's friend and ally Ukraine in her valiant battle for Liberty
against Putin's tyranny.
We have more work ahead of us to pass the full slate of
appropriations bills--including our Energy and Water bill to invest in
American progress, American jobs, American families, and the future of
American communities.
Today, we take a responsible step forward to keep the government
open--and we continue our work to deliver for the American people.
The SPEAKER pro tempore. All time for debate has expired.
Pursuant to House Resolution 1404, the previous question is ordered.
The question is on the motion by the gentlewoman from Connecticut
(Ms. DeLauro).
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Ms. GRANGER. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this question will be postponed.
[[Page H8351]]
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