Act — H. R. 6833, Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (117th Congress)
Summary
H. R. 6833 is an Act making continuing appropriations for fiscal year 2023, and for other purposes, with the short title Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023. Its table of contents lists Division A (Continuing Appropriations Act, 2023), Division B (Ukraine Supplemental Appropriations Act, 2023), and further divisions on extensions, FDA user fee reauthorization and the Hermit’s Peak/Calf Canyon Fire Assistance Act. Section 4 appropriates $174,000 for payment to Dean Swihart, beneficiary of Jacqueline Walorski-Swihart, late a Representative from the State of Indiana. Division A funds continuing projects and activities at a rate for operations provided in the applicable appropriations Acts for fiscal year 2022.
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Cite this document
“Act — H. R. 6833, Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (117th Congress).”
Original at www.govinfo.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/bills-bills-117hr6833enr-bills-117hr6833enr/
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H. R. 6833
One Hundred Seventeenth Congress
of the
United States of America
AT T H E S E C O N D S E S S I O N
Begun and held at the City of Washington on Monday,
the third day of January, two thousand and twenty-two
An Act
Making continuing appropriations for fiscal year 2023, and for other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
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.
H. R. 6833—2
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 Agen-
cies Appropriations Act, 2022 (division D of Public Law 117–
103).
(5) The Financial Services and General Government Appro-
priations 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 (divi-
sion 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).
H. R. 6833—3
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 invest-
ment 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 pursu-
ant 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 appor-
tionments 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 appropria-
tions at the beginning of fiscal year 2023 because of distributions
H. R. 6833—4
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 activi-
ties.
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 condi-
tions 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 pay-
ments 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 Authori-
ties Act of 1956 (22 U.S.C. 2680), section 313 of the Foreign Rela-
tions Authorization Act, Fiscal Years 1994 and 1995 (22 U.S.C.
6212), and section 504(a)(1) of the National Security Act of 1947
(50 U.S.C. 3094(a)(1)).
SEC. 114. Each amount incorporated by reference in this Act
that was previously designated by the Congress as an emergency
requirement pursuant to sections 4001(a)(1) and 4001(b) of S. Con.
Res. 14 (117th Congress), the concurrent resolution on the budget
for fiscal year 2022, or as being for disaster relief pursuant to
section 4005(f) of such concurrent resolution, is designated as being
an emergency requirement pursuant to section 4001(a)(1) of such
concurrent resolution and section 1(e) of H. Res. 1151 (117th Con-
gress), 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 Appro-
priations 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 appropria-
tions in this Act,
may be continued instead by reducing the rate for operations other-
wise provided by section 101 for such current applicable TAFS,
H. R. 6833—5
as long as doing so does not impinge on the final funding preroga-
tives 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 can-
cellation 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 Depart-
ment 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 Depart-
ment 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 ‘‘Depart-
ment 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
H. R. 6833—6
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 Assist-
ance—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 notwith-
standing any requirement or limitation applicable to the appropria-
tion 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: Pro-
vided 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
H. R. 6833—7
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 respon-
sibilities 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 appro-
priated 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 effec-
tive 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 appro-
priated $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): Pro-
vided, 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 Manage-
ment 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’’.
H. R. 6833—8
(c) During the period covered by this Act, section 301 of the
Reclamation States Emergency Drought Relief Act of 1991 (43
U.S.C. 2241) shall be applied by substituting ‘‘2023’’ for ‘‘2022’’.
SEC. 128. In addition to amounts otherwise provided by section
101, amounts are provided for ‘‘Department of the Treasury—
Alcohol and Tobacco Tax and Trade Bureau—Salaries and
Expenses’’ at a rate for operations of $14,929,000, for an additional
amount to administer the Craft Beverage Modernization Act import
claims program, as required by the Taxpayer Certainty and Disaster
Tax Relief Act of 2020, and such amounts may be apportioned
up to the rate for operations necessary to establish and implement
a new import claims program.
SEC. 129. 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 ‘‘Execu-
tive Office of the President and Funds Appropriated to the Presi-
dent’’:
‘‘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 Appro-
priations 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
H. R. 6833—9
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 Busi-
ness Administration, as required by section 36 of the Small Business
Act (15 U.S.C. 657f) and section 862 of Public Law 116–283: Pro-
vided, 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 accommo-
date 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 sec-
tion 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 Depart-
ment 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 Assist-
ance 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
H. R. 6833—10
provide, in an appropriate format, quarterly reports to the Commit-
tees on Appropriations of the Senate and the House of Representa-
tives on the obligations and expenditures of the funds made avail-
able 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 resolu-
tion 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 effec-
tive 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 ‘‘Depart-
ment 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 herit-
age partnership, national heritage route, national heritage
canalway, and battlefields national historic district established as
of September 1, 2022, notwithstanding any statutory sunset provi-
sion 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 Depart-
ment 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, ren-
ovated, or expanded in fiscal years 2022 and 2023, and such
H. R. 6833—11
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 Serv-
ices—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 behav-
ioral health crisis services.
SEC. 146. In addition to amounts otherwise provided by section
101, for ‘‘Department of Health and Human Services—Administra-
tion for Children and Families—Low Income Home Energy Assist-
ance’’, 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 concur-
rent resolution on the budget for fiscal year 2022, and section
1(e) of H. Res. 1151 (117th Congress), as engrossed in the House
of Representatives on June 8, 2022.
SEC. 147. In addition to amounts otherwise provided by section
101, for ‘‘Department of Health and Human Services—Administra-
tion 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 concur-
rent 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 Appro-
priations Act, 2022 (division C of Public Law 117–43) shall be
H. R. 6833—12
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 Con-
gress), 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 Pro-
grams’’ 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 Appro-
priated 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 Depart-
ment 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 Develop-
ment 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—Commu-
nity Planning and Development—Community Development Fund’’,
there is appropriated $2,000,000,000, for an additional amount for
H. R. 6833—13
fiscal year 2023, to remain available until expended, for the same
purposes and under the same terms and conditions as funds appro-
priated 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 require-
ment 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 obliga-
tions 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 Sep-
tember 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 perma-
nently 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 Transpor-
tation 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 appro-
priated 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 effec-
tive immediately upon enactment of this Act.
H. R. 6833—14
(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.
H. R. 6833—15
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 Sep-
tember 30, 2024, shall be for the Ukraine Security Assistance
Initiative: Provided further, That such funds for the Ukraine Secu-
rity 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 ‘‘Oper-
ation 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.
H. R. 6833—16
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 nec-
essary 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 arti-
cles 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 Sep-
tember 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 Sep-
tember 30, 2024, to respond to the situation in Ukraine and for
related expenses.
H. R. 6833—17
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 Manage-
ment 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 accom-
panied 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,
H. R. 6833—18
the Secretary of Defense, in coordination with the Secretary of
State, shall provide a written report to the Committees on Appro-
priations, 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 Nonprolifera-
tion’’, $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 coun-
tries 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 Govern-
ment, 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
H. R. 6833—19
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 appro-
priate congressional committees detailing and assessing the mecha-
nisms 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 memo-
randum 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 assist-
ance 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 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 Adminis-
trator 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 addi-
tional 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 concur-
rent resolution on the budget for fiscal year 2022, and section
H. R. 6833—20
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 Appro-
priations 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’’, respec-
tively.
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 accom-
panying Conference Report 105–217 and section 250(c)(8) of the
Balanced Budget and Emergency Deficit Control Act of 1985, the
H. R. 6833—21
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 Appro-
priations 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—
H. R. 6833—22
(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 author-
ized 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.
H. R. 6833—23
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 mem-
bers,’’ after ‘‘officers,’’;
(3) in subsection (p)(7)(A)(i), by moving the margin of sub-
clause (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 ACCUMU-
LATE 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 sub-
stituting ‘‘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’’.
DIVISION E—VETERANS AFFAIRS
EXTENSIONS
TITLE I—EXTENSIONS OF AUTHORITIES
RELATING TO HEALTH CARE
SEC. 101. EXTENSION OF AUTHORITY FOR COLLECTION OF COPAY-
MENTS 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’’.
H. R. 6833—24
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 Authoriza-
tion Act for Fiscal Year 2022 (Public Law 117–81; 135 Stat. 1787),
is amended by striking ‘‘September 30, 2023’’ and inserting ‘‘Sep-
tember 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 Depart-
ment 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’’.
H. R. 6833—25
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 AUTHORI-
TIES RELATING TO HOMELESS VET-
ERANS
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 HOME-
LESS 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’’.
H. R. 6833—26
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 SPE-
CIAL 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 sec-
tion is amended by striking ‘‘. for each of fiscal years 2010 through
2020’’.
SEC. 403. EXTENSION OF ADVISORY COMMITTEE ON MINORITY VET-
ERANS.
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 EDU-
CATION.
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 PROP-
ERTY.
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
SEC. 1. SHORT TITLE.
This division may be cited as the ‘‘FDA User Fee Reauthoriza-
tion 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.
H. R. 6833—27
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 will be dedicated toward expediting
the drug development process and the process for the review of
human drug applications, including postmarket drug safety activi-
ties, 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,
H. R. 6833—28
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 standard-
ized 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 Fed-
eral 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 with-
drawn from sale.’’.
(c) SKIN-TEST DIAGNOSTIC PRODUCT.—Section 735 of the Fed-
eral 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;
H. R. 6833—29
‘‘(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 diag-
nosis 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 subpara-
graph (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 fol-
lowing:
‘‘(H) EXCEPTION FOR SKIN-TEST DIAGNOSTIC PROD-
UCTS.—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 subpara-
graphs (B) and (C)’’ and inserting the following:
‘‘(i) PAYMENT OF FEES.—Except as provided in sub-
paragraphs (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
H. R. 6833—30
program fee established for a fiscal year under sub-
section (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 PROD-
UCTS.—A prescription drug program fee shall not be
assessed for a prescription drug product under subpara-
graph (A) if such product is—
‘‘(i) a large volume parenteral product (a sterile
aqueous drug product packaged in a single-dose con-
tainer with a volume greater than or equal to 100
mL, not including powders for reconstitution or phar-
macy bulk packages) identified on the list compiled
under section 505(j)(7);
‘‘(ii) pharmaceutically equivalent (as defined in sec-
tion 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 adjust-
ment 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 sub-
section (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.’’.
H. R. 6833—31
(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-Balti-
more, DC–MD–VA–WV’’ and inserting ‘‘Washington-Arlington-
Alexandria, DC–VA–MD–WV’’.
(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—Sec-
tion 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 method-
ology utilized by the Secretary in setting fees for fiscal
year 2021, as described in the notice titled ‘Prescription
Drug User Fee Rates for Fiscal Year 2021’ published in
the Federal Register on August 3, 2020 (85 Fed. Reg.
46651). The workload categories used in applying such
methodology in forecasting shall include only the activities
described in that notice and, as feasible, additional activi-
ties that are directly related to the direct review of applica-
tions 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
H. R. 6833—32
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 Sec-
retary 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 para-
graph.’’.
(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 oper-
ating reserves.
‘‘(ii) For fiscal year 2024, at least 9 weeks of oper-
ating 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 (Wash-
ington-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:
H. R. 6833—33
‘‘(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, EXEMP-
TIONS, 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, EXEMP-
TIONS, 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, reduc-
tion, 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 informa-
tion.’’.
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
H. R. 6833—34
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 subpara-
graph (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 supple-
ments (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 expe-
diting 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
H. R. 6833—35
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 Rep-
resentatives, 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 notifica-
tion 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 notifica-
tion 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’’;
(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 notifica-
tion submission, or de novo classification request’’; and
(C) in subparagraph (C), by striking ‘‘or periodic
reporting concerning a class III device’’ and inserting ‘‘peri-
odic 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 para-
graph (1), the base fee amounts specified in this paragraph
are as follows:
H. R. 6833—36
Fiscal Fiscal Fiscal Fiscal Fiscal
‘‘Fee Type Year Year Year Year Year
2023 2024 2025 2026 2027
Premarket Application .... $425,000 $435,000 $445,000 $455,000 $470,000
Establishment Registra-
tion ................................ $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 Amend-
ments 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 subpara-
graph (B)(i)(I); and
H. R. 6833—37
‘‘(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.
H. R. 6833—38
‘‘(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 Out-
come 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.
H. R. 6833—39
‘‘(C) HIRING ADJUSTMENT AMOUNT.—The hiring adjust-
ment 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 registra-
tion fees are not increased by the amount deter-
mined under paragraph (4)(A)(i).
‘‘(II) 83 hires if the base establishment reg-
istration fees are increased by the amount deter-
mined under paragraph (4)(A)(i).
‘‘(E) NUMBER OF HIRES.—For purposes of this para-
graph, the number of hires for a fiscal year shall be deter-
mined by the Secretary as set forth in the letters described
in section 2001(b) of the Medical Device User Fee Amend-
ments of 2022.
‘‘(6) OPERATING RESERVE ADJUSTMENT.—
‘‘(A) IN GENERAL.—For each of fiscal years 2023
through 2027, after the adjustments under paragraphs (2),
(3), (4), and (5), if applicable, if the Secretary has operating
reserves of carryover user fees for the process for the review
of device applications in excess of the designated amount
in subparagraph (B), the Secretary shall decrease the base
establishment registration fee amounts to provide for not
more than such designated amount of operating reserves.
‘‘(B) DESIGNATED AMOUNT.—Subject to subparagraph
(C), for each fiscal year, the designated amount in this
subparagraph is equal to the sum of—
‘‘(i) 13 weeks of operating reserves of carryover
user fees; and
‘‘(ii) 1 month of operating reserves maintained
pursuant to paragraph (8).
‘‘(C) EXCLUDED AMOUNT.—For the period of fiscal years
2023 through 2026, a total amount equal to $118,000,000
shall not be considered part of the designated amount
under subparagraph (B) and shall not be subject to the
decrease under subparagraph (A).’’.
(d) CONDITIONS.—Section 738(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(g)) is amended—
(1) in paragraph (1)(A), by striking ‘‘$320,825,000’’ and
inserting ‘‘$398,566,000’’; and
(2) in paragraph (2), by inserting ‘‘de novo classification
requests,’’ after ‘‘class III device,’’.
(e) CREDITING AND AVAILABILITY OF FEES.—Section 738(h)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3))
is amended to read as follows:
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—
H. R. 6833—40
‘‘(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 para-
graph, 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 accredita-
tion 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 con-
ducted to support the assessment of conformity of devices
H. R. 6833—41
as described in subparagraph (A) conducted by testing lab-
oratories 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 sub-
section.’’.
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
H. R. 6833—42
738(a)(2)(A) of such Act received on or after October 1, 2022, regard-
less 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:
H. R. 6833—43
‘‘(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 sub-
section (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 per-
cent’’ and inserting ‘‘Thirty-six percent’’.
(c) ADJUSTMENTS.—Section 744B(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended—
(1) in paragraph (1)—
(A) in the matter preceding subparagraph (A)—
(i) by striking ‘‘2019’’ and inserting ‘‘2024’’; and
(ii) by striking ‘‘to equal the product of the total
revenues established in such notice for the prior fiscal
year multiplied’’ and inserting ‘‘to equal the base rev-
enue amount for the fiscal year (as specified in sub-
section (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 Sec-
retary shall establish a capacity planning methodology for
purposes of this paragraph, which shall—
‘‘(i) be derived from the methodology and rec-
ommendations made in the report titled ‘Independent
Evaluation of the GDUFA Resource Capacity Planning
Adjustment Methodology: Evaluation and Rec-
ommendations’ announced in the Federal Register on
August 3, 2020 (85 Fed. Reg. 46658); and
‘‘(ii) incorporate approaches and attributes deter-
mined 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
H. R. 6833—44
shall only be the workload categories specified in sec-
tion 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 rev-
enue 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 adjust-
ment, 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 abbre-
viated 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 adjust-
ment, 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 abbre-
viated new drug applications submitted
related to complex products (as so defined);
‘‘(III) for purposes of a fiscal year 2026 adjust-
ment, 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 abbre-
viated new drug applications submitted
related to complex products (as so defined);
and
‘‘(IV) for purposes of a fiscal year 2027 adjust-
ment, 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
H. R. 6833—45
‘‘(bb) thirty-five percent or more of abbre-
viated new drug applications submitted
related to complex products (as so defined).
‘‘(D) PUBLICATION IN FEDERAL REGISTER.—The Sec-
retary 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 para-
graph.
‘‘(3) OPERATING RESERVE ADJUSTMENT.—
‘‘(A) IN GENERAL.—For fiscal year 2024 and each subse-
quent fiscal year, the Secretary may, in addition to adjust-
ments 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 speci-
fied 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 bal-
ances 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 para-
graph (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—
H. R. 6833—46
(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 subpara-
graph (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 applica-
tions 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
H. R. 6833—47
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 applica-
tions, 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 Com-
mittee on Energy and Commerce of the House of Representatives,
as set forth in the Congressional Record.
SEC. 4002. DEFINITIONS.
(a) ADJUSTMENT FACTOR.—Section 744G(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read
as follows:
‘‘(1) The term ‘adjustment factor’ applicable to a fiscal
year is the Consumer Price Index for urban consumers (Wash-
ington-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
H. R. 6833—48
the relevant investigational new drug application) is trans-
ferred to a licensee, assignee, or successor of such person,
and written notice of such transfer is provided to the Sec-
retary, 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 Fed-
eral 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 subpara-
graph (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 fol-
lowing:
‘‘(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 sup-
port 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.’’.
H. R. 6833—49
(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 BIO-
SIMILAR BIOLOGICAL PRODUCT DEVELOPMENT PRO-
GRAM.—If a person has failed to pay an annual bio-
similar biological product development fee for a product
as required under subparagraph (B) for a period of
2 consecutive fiscal years, the Secretary may adminis-
tratively 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.—Sec-
tion 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
H. R. 6833—50
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 applica-
tion 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 bio-
similar biological product. Notwithstanding subpara-
graph (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 para-
graphs (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 adjust-
ment 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 sub-
section (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 ‘‘; LIMITA-
TIONS 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—
H. R. 6833—51
‘‘(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 the review of biosimilar biological product applications.
‘‘(B) METHODOLOGY.—For purposes of this paragraph,
the Secretary shall employ the capacity planning method-
ology 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 post-
marketing 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 pre-
ceding sentence, the Secretary shall not include as work-
load 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
H. R. 6833—52
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 Sec-
retary 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 bio-
similar 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
H. R. 6833—53
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 subpara-
graph (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.
H. R. 6833—54
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 EXEMP-
TION INCENTIVE.
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cos-
metic 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 Amend-
ments 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-PRI-
VATE 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’’.
H. R. 6833—55
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;
(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 re-
emerging;
(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 commu-
nities involved;
(8) the U.S. Forest Service has assumed responsibility for
the Hermit’s Peak/Calf Canyon Fire;
H. R. 6833—56
(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 settle-
ment 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 subpara-
graphs (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
H. R. 6833—57
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 suf-
fered 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 Fed-
eral 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 Man-
ager 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 pro-
vided 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—
H. R. 6833—58
(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 max-
imum extent practicable, shall pay subrogation claims
submitted under this Act only after paying claims sub-
mitted by injured parties that are not insurance compa-
nies 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 pay-
ment 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 dam-
ages, 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 insur-
ance 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 govern-
ment 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—
H. R. 6833—59
(I) was not eligible to receive the compensa-
tion; or
(II) fraudulently procured the compensation.
(3) RIGHTS OF INSURER OR OTHER THIRD PARTY.—If an
insurer or other third party pays any amount to a claimant
to compensate for an injury described in subsection (a), the
insurer or other third party shall be subrogated to any right
that the claimant has to receive any payment under this Act
or any other law.
(4) ALLOWABLE DAMAGES.—
(A) LOSS OF PROPERTY.—A claim that is paid for loss
of property under this Act may include otherwise
uncompensated damages resulting from the Hermit’s Peak/
Calf Canyon Fire for—
(i) an uninsured or underinsured property loss;
(ii) a decrease in the value of real property;
(iii) damage to physical infrastructure, including
irrigation infrastructure such as acequia systems;
(iv) a cost resulting from lost subsistence from
hunting, fishing, firewood gathering, timbering,
grazing, or agricultural activities conducted on land
damaged by the Hermit’s Peak/Calf Canyon Fire;
(v) a cost of reforestation or revegetation on Tribal
or non-Federal land, to the extent that the cost of
reforestation or revegetation is not covered by any
other Federal program; and
(vi) any other loss that the Administrator deter-
mines to be appropriate for inclusion as loss of prop-
erty.
(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 deter-
mines 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 pre-
vailing in those counties before the Hermit’s Peak/
Calf Canyon Fire, that are incurred not later than
H. R. 6833—60
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 insur-
ance 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 deter-
mines 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 pay-
ment 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 (com-
monly 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 Adminis-
trator promulgates regulations under paragraph (1), the
Administrator shall publish, online and in print, in news-
papers 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 Adminis-
trator 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.—
H. R. 6833—61
(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 compensa-
tion 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 deci-
sion 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 incor-
porating 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
H. R. 6833—62
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 para-
graph (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 emer-
gency 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 deter-
mined 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.—Sec-
tion 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, misrepresen-
tation, 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 provi-
sion 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
H. R. 6833—63
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 promulga-
tion 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.
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