Congressional Record, Senate, September 27, 2022 — Amendments Including Continuing Appropriations Act, 2023
Summary
Page S5094 of the Senate section of the Congressional Record for September 27, 2022, in interleaved columns. A list of amendments submitted includes SA 5742 from Mr. Padilla for himself and Mrs. Feinstein, intended to be proposed to SA 5499 submitted by Mr. Reed for himself and Mr. Inhofe, and SA 5745 from Mr. Schumer to the bill H.R. 6833. Bill text covers a memorandum of understanding between the Secretary of Agriculture and the Karuk Tribe on river values of components of the National Wild and Scenic Rivers System, a requirement for a report to Congress on claims, and a limit on attorney and agent fees for services in connection with a claim.
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“Congressional Record, Senate, September 27, 2022 — Amendments Including Continuing Appropriations Act, 2023.”
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S5094 CONGRESSIONAL RECORD — SENATE September 27, 2022
for Fiscal Year 2014 (Public Law 113–66; 127 component of the National Wild and Scenic (B) by striking paragraph (3);
Stat. 881).’’; and Rivers System, including any component (C) by redesignating paragraphs (4) and (5)
(10) by redesignating subsections (d) that flows through the land taken into trust as paragraphs (3) and (4), respectively; and
through (h) as subsections (c) through (g), re- under subsection (d). (D) in paragraph (4), as redesignated, by
spectively. (2) MEMORANDUM OF UNDERSTANDING.—The striking ‘‘paragraph (4)’’ and inserting
Secretary of Agriculture shall enter into a ‘‘paragraph (3)’’; and
SA 5742. Mr. PADILLA (for himself memorandum of understanding with the (2) in subsection (d), by striking ‘‘, except
and Mrs. FEINSTEIN) submitted an Karuk Tribe, consistent with the obligations with respect to allegations described in sub-
amendment intended to be proposed to of the Secretary of Agriculture under sub- section (b)(3),’’.
amendment SA 5499 submitted by Mr. section (c), to establish mutual goals for the
REED (for himself and Mr. INHOFE) and protection and enhancement of the river val- SA 5745. Mr. SCHUMER submitted an
intended to be proposed to the bill H.R. ues of any component of the National Wild amendment intended to be proposed by
and Scenic Rivers System that flows through him to the bill H.R. 6833, to amend title
7900, to authorize appropriations for the land taken into trust under subsection
fiscal year 2023 for military activities XXVII of the Public Health Service
(d).
of the Department of Defense, for mili- Act, the Internal Revenue Code of 1986,
tary construction, and for defense ac- SA 5743. Mr. PADILLA (for himself and the Employee Retirement Income
tivities of the Department of Energy, and Mrs. FEINSTEIN) submitted an Security Act of 1974 to establish re-
to prescribe military personnel amendment intended to be proposed to quirements with respect to cost-shar-
strengths for such fiscal year, and for amendment SA 5499 submitted by Mr. ing for certain insulin products, and for
other purposes; which was ordered to REED (for himself and Mr. INHOFE) and other purposes; which was ordered to
lie on the table; as follows: intended to be proposed to the bill H.R. lie on the table; as follows:
At the end of subtitle G of title X, add the 7900, to authorize appropriations for Strike all after the enacting clause and in-
following: fiscal year 2023 for military activities sert the following:
SECTION 1. SHORT TITLE.
SEC. 10ll. LAND HELD IN TRUST FOR THE of the Department of Defense, for mili-
KARUK TRIBE. This Act may be cited as the ‘‘Continuing
tary construction, and for defense ac-
(a) FINDINGS.—Congress finds that— Appropriations and Ukraine Supplemental
tivities of the Department of Energy, Appropriations Act, 2023’’.
(1) the Katimiı̂n and Ameekyáaraam land
is located in the ancestral territory of the
to prescribe military personnel SEC. 2. TABLE OF CONTENTS.
Karuk Tribe; and strengths for such fiscal year, and for
Sec. 1. Short Title.
(2) the Karuk Tribe has historically used, other purposes; which was ordered to Sec. 2. Table of Contents.
and has an ongoing relationship with, the lie on the table; as follows: Sec. 3. References.
Katimiı̂n and Ameekyáaraam land. At the end of subtitle G of title X, add the Sec. 4. Payment to Widows and Heirs of De-
(b) DEFINITIONS.—In this section: following: ceased Members of Congress.
(1) KATIMIÎN AND AMEEKYÁARAAM LAND.— SEC. 10ll. LAND TO BE TAKEN INTO TRUST FOR DIVISION A—CONTINUING
The term ‘‘Katimiı̂n and Ameekyáaraam THE BENEFIT OF THE AGUA APPROPRIATIONS ACT, 2023
land’’ means the approximately 1,031 acres of CALIENTE BAND OF CAHUILLA INDI-
ANS. DIVISION B—UKRAINE SUPPLEMENTAL
Federal land, including improvements and
(a) IN GENERAL.—The approximately 2,560 APPROPRIATIONS ACT, 2023
appurtenances to the Federal land, located
in Siskiyou County, California, and Hum- acres of land owned by the Agua Caliente DIVISION C—OTHER MATTERS
boldt County, California, and generally de- Band of Cahuilla Indians generally depicted Title I—Extensions, Technical Corrections,
picted as ‘‘Proposed Area’’ on the map of the as ‘‘Lands to be Taken into Trust’’ on the and Other Matters
Forest Service entitled ‘‘Katimiı̂n Area map entitled ‘‘Agua Caliente Band of Title II—Budgetary Effects
Boundary Proposal’’ and dated August 9, Cahuilla Indians Land to be Taken into DIVISION D—HEALTH AND HUMAN
2021. Trust’’ and dated November 17, 2021, is here- SERVICES EXTENSIONS
(2) SECRETARY.—The term ‘‘Secretary’’ by taken into trust by the United States for Title I—Medicare and Medicaid
means the Secretary of the Interior. the benefit of the Agua Caliente Band of Title II—Human Services
(c) ADMINISTRATIVE TRANSFER.—Adminis- Cahuilla Indians. Title III—Public Health
trative jurisdiction of the Katimiı̂n and (b) ADMINISTRATION.—Land taken into Title IV—Indian Health
Ameekyáaraam land is hereby transferred trust by subsection (a) shall be—
DIVISION E—VETERANS AFFAIRS
from the Secretary of Agriculture to the (1) part of the reservation of the Agua
EXTENSIONS
Secretary, subject to the condition that the Caliente Band of Cahuilla Indians; and
Chief of the Forest Service shall continue to (2) administered in accordance with the Title I—Extensions of authorities relating to
manage the component of the National Wild laws and regulations generally applicable to health care
and Scenic Rivers System that flows through property held in trust by the United States Title II—Extensions of authorities relating
the Katimiı̂n and Ameekyáaraam land. for the benefit of an Indian Tribe. to benefits
(d) LAND HELD IN TRUST.—The Katimiı̂n (c) GAMING PROHIBITED.—Land taken into Title III—Extensions of authorities relating
and Ameekyáaraam land is hereby taken trust by subsection (a) shall not be eligible to homeless veterans
into trust by the Secretary for the benefit of for gaming under the Indian Gaming Regu- Title IV—Extensions of other authorities
the Karuk Tribe, subject to— latory Act (25 U.S.C. 2701 et seq.). DIVISION F—FDA USER FEE
(1) valid existing rights, contracts, and REAUTHORIZATION ACT OF 2022
management agreements relating to ease- SA 5744. Mr. DURBIN (for himself DIVISION G—HERMIT’S PEAK/CALF
ments and rights-of-way; and and Mr. LEE) submitted an amendment CANYON FIRE ASSISTANCE ACT
(2) continued access by the Chief of the intended to be proposed to amendment SEC. 3. REFERENCES.
Forest Service for the purpose of managing SA 5499 submitted by Mr. REED (for Except as expressly provided otherwise,
the component of the National Wild and Sce- himself and Mr. INHOFE) and intended any reference to ‘‘this Act’’ contained in any
nic Rivers System that flows through the division of this Act shall be treated as refer-
to be proposed to the bill H.R. 7900, to
Katimiı̂n and Ameekyáaraam land. ring only to the provisions of that division.
(e) SURVEY.—Not later than 180 days after authorize appropriations for fiscal year
2023 for military activities of the De- SEC. 4. PAYMENT TO WIDOWS AND HEIRS OF DE-
the date of enactment of this Act, the Sec- CEASED MEMBERS OF CONGRESS.
retary of Agriculture shall provide to the partment of Defense, for military con-
There is hereby appropriated for fiscal year
Secretary a complete survey of the land struction, and for defense activities of 2023, out of any money in the Treasury not
taken into trust under subsection (d). the Department of Energy, to prescribe otherwise appropriated, for payment to Dean
(f) USE OF LAND.— military personnel strengths for such Swihart, beneficiary of Jacqueline Walorski-
(1) IN GENERAL.—Land taken into trust
fiscal year, and for other purposes; Swihart, late a Representative from the
under subsection (d) may be used for tradi-
which was ordered to lie on the table; State of Indiana, $174,000.
tional and customary uses for the benefit of
the Karuk Tribe. as follows: DIVISION A—CONTINUING
(2) GAMING.—Class II and class III gaming At the appropriate place, insert the fol- APPROPRIATIONS ACT, 2023
under the Indian Gaming Regulatory Act (25 lowing: The following sums are hereby appro-
ctelli on DSK11ZRN23PROD with SENATE
U.S.C. 2701 et seq.) shall not be allowed on SEC. ll. INVESTIGATIONS OF DEPARTMENT OF priated, out of any money in the Treasury
the land taken into trust under subsection JUSTICE PERSONNEL. not otherwise appropriated, and out of appli-
(d). Section 8E of the Inspector General Act of cable corporate or other revenues, receipts,
(g) WILD AND SCENIC RIVERS MANAGE- 1978 (5 U.S.C. App.) is amended— and funds, for the several departments, agen-
MENT.— (1) in subsection (b)— cies, corporations, and other organizational
(1) IN GENERAL.—Nothing in this section af- (A) in paragraph (2), by striking ‘‘and para- units of Government for fiscal year 2023, and
fects the status or administration of any graph (3)’’; for other purposes, namely:
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5095
SEC. 101. Such amounts as may be nec- (b) No appropriation or funds made avail- SEC. 112. Amounts made available under
essary, at a rate for operations as provided able or authority granted pursuant to sec- section 101 for civilian personnel compensa-
in the applicable appropriations Acts for fis- tion 101 for the Department of Defense shall tion and benefits in each department and
cal year 2022 and under the authority and be used to initiate multi-year procurements agency may be apportioned up to the rate for
conditions provided in such Acts, for con- utilizing advance procurement funding for operations necessary to avoid furloughs
tinuing projects or activities (including the economic order quantity procurement unless within such department or agency, con-
costs of direct loans and loan guarantees) specifically appropriated later. sistent with the applicable appropriations
that are not otherwise specifically provided SEC. 103. Appropriations made by section Act for fiscal year 2022, except that such au-
for in this Act, that were conducted in fiscal 101 shall be available to the extent and in the thority provided under this section shall not
year 2022, and for which appropriations, manner that would be provided by the perti- be used until after the department or agency
funds, or other authority were made avail- nent appropriations Act. has taken all necessary actions to reduce or
able in the following appropriations Acts: SEC. 104. Except as otherwise provided in defer non-personnel-related administrative
(1) The Agriculture, Rural Development, section 102, no appropriation or funds made expenses.
Food and Drug Administration, and Related available or authority granted pursuant to SEC. 113. Funds appropriated by this Act
Agencies Appropriations Act, 2022 (division A section 101 shall be used to initiate or re- may be obligated and expended notwith-
of Public Law 117–103), except section 783, sume any project or activity for which ap- standing section 10 of Public Law 91–672 (22
and except that section 785 shall be applied propriations, funds, or other authority were U.S.C. 2412), section 15 of the State Depart-
by substituting ‘‘$125,000,000’’ for not available during fiscal year 2022. ment Basic Authorities Act of 1956 (22 U.S.C.
‘‘$250,000,000’’. SEC. 105. Appropriations made and author- 2680), section 313 of the Foreign Relations
(2) The Commerce, Justice, Science, and ity granted pursuant to this Act shall cover Authorization Act, Fiscal Years 1994 and 1995
Related Agencies Appropriations Act, 2022 all obligations or expenditures incurred for (22 U.S.C. 6212), and section 504(a)(1) of the
(division B of Public Law 117–103), except sec- any project or activity during the period for National Security Act of 1947 (50 U.S.C.
tion 521(c)(1). which funds or authority for such project or 3094(a)(1)).
(3) The Department of Defense Appropria- activity are available under this Act.
SEC. 106. Unless otherwise provided for in SEC. 114. Each amount incorporated by ref-
tions Act, 2022 (division C of Public Law 117– erence in this Act that was previously des-
103). this Act or in the applicable appropriations
Act for fiscal year 2023, appropriations and ignated by the Congress as an emergency re-
(4) The Energy and Water Development and quirement pursuant to sections 4001(a)(1) and
Related Agencies Appropriations Act, 2022 funds made available and authority granted
pursuant to this Act shall be available until 4001(b) of S. Con. Res. 14 (117th Congress), the
(division D of Public Law 117–103). concurrent resolution on the budget for fis-
(5) The Financial Services and General whichever of the following first occurs:
(1) The enactment into law of an appro- cal year 2022, or as being for disaster relief
Government Appropriations Act, 2022 (divi- pursuant to section 4005(f) of such concur-
sion E of Public Law 117–103), except the priation for any project or activity provided
for in this Act. rent resolution, is designated as being an
matter under the heading ‘‘Postal Regu- emergency requirement pursuant to section
latory Commission’’ in title V. (2) The enactment into law of the applica-
ble appropriations Act for fiscal year 2023 4001(a)(1) of such concurrent resolution and
(6) The Department of Homeland Security section 1(e) of H. Res. 1151 (117th Congress),
Appropriations Act, 2022 (division F of Public without any provision for such project or ac-
tivity. as engrossed in the House of Representatives
Law 117–103), except sections 544 and 545, and on June 8, 2022, or as being for disaster relief
including title II of division O of Public Law (3) December 16, 2022.
SEC. 107. Expenditures made pursuant to pursuant to section 1(f) of such House resolu-
117–103. tion, respectively.
(7) The Department of the Interior, Envi- this Act shall be charged to the applicable
appropriation, fund, or authorization when- SEC. 115. (a) Rescissions or cancellations of
ronment, and Related Agencies Appropria-
ever a bill in which such applicable appro- discretionary budget authority that con-
tions Act, 2022 (division G of Public Law 117–
priation, fund, or authorization is contained tinue pursuant to section 101 in Treasury Ap-
103).
is enacted into law. propriations Fund Symbols (TAFS)—
(8) The Departments of Labor, Health and
SEC. 108. Appropriations made and funds (1) to which other appropriations are not
Human Services, and Education, and Related
made available by or authority granted pur- provided by this Act, but for which there is
Agencies Appropriations Act, 2022 (division H
suant to this Act may be used without re- a current applicable TAFS that does receive
of Public Law 117–103), and section 162 of di-
gard to the time limitations for submission an appropriation in this Act; or
vision A of Public Law 117–43.
and approval of apportionments set forth in (2) which are no-year TAFS and receive
(9) The Legislative Branch Appropriations
section 1513 of title 31, United States Code, other appropriations in this Act,
Act, 2022 (division I of Public Law 117–103),
but nothing in this Act may be construed to may be continued instead by reducing the
and section 6 in the matter preceding divi-
waive any other provision of law governing rate for operations otherwise provided by
sion A of Public Law 117–103.
the apportionment of funds. section 101 for such current applicable TAFS,
(10) The Military Construction, Veterans
SEC. 109. Notwithstanding any other provi- as long as doing so does not impinge on the
Affairs, and Related Agencies Appropriations
sion of this Act, except section 106, for those final funding prerogatives of the Congress.
Act, 2022 (division J of Public Law 117–103).
programs that would otherwise have high (b) Rescissions or cancellations described
(11) The Department of State, Foreign Op-
initial rates of operation or complete dis- in subsection (a) shall continue in an amount
erations, and Related Programs Appropria-
tribution of appropriations at the beginning equal to the lesser of—
tions Act, 2022 (division K of Public Law 117–
of fiscal year 2023 because of distributions of (1) the amount specified for rescission or
103), except the first proviso of section
funding to States, foreign countries, grant- cancellation in the applicable appropriations
7069(e).
ees, or others, such high initial rates of oper- Act referenced in section 101 of this Act; or
(12) The Transportation, Housing and
ation or complete distribution shall not be (2) the amount of balances available, as of
Urban Development, and Related Agencies
made, and no grants shall be awarded for October 1, 2022, from the funds specified for
Appropriations Act, 2022 (division L of Public
such programs funded by this Act that would rescission or cancellation in the applicable
Law 117–103).
impinge on final funding prerogatives. appropriations Act referenced in section 101
SEC. 102. (a) No appropriation or funds SEC. 110. This Act shall be implemented so
made available or authority granted pursu- of this Act.
that only the most limited funding action of
ant to section 101 for the Department of De- that permitted in the Act shall be taken in (c) No later than November 21, 2022, the Di-
fense shall be used for: order to provide for continuation of projects rector of the Office of Management and
(1) the new production of items not funded and activities. Budget shall provide to the Committees on
for production in fiscal year 2022 or prior SEC. 111. (a) For entitlements and other Appropriations of the House of Representa-
years; mandatory payments whose budget author- tives and the Senate a comprehensive list of
(2) the increase in production rates above ity was provided in appropriations Acts for the rescissions or cancellations that will
those sustained with fiscal year 2022 funds; fiscal year 2022, and for activities under the continue pursuant to section 101: Provided,
or Food and Nutrition Act of 2008, activities That the information in such comprehensive
(3) the initiation, resumption, or continu- shall be continued at the rate to maintain list shall be periodically updated to reflect
ation of any project, activity, operation, or program levels under current law, under the any subsequent changes in the amount of
organization (defined as any project, sub- authority and conditions provided in the ap- balances available, as of October 1, 2022, from
project, activity, budget activity, program plicable appropriations Act for fiscal year the funds specified for rescission or cancella-
element, and subprogram within a program 2022, to be continued through the date speci- tion in the applicable appropriations Act ref-
element, and for any investment items de- fied in section 106(3). erenced in section 101, and such updates shall
ctelli on DSK11ZRN23PROD with SENATE
fined as a P–1 line item in a budget activity (b) Notwithstanding section 106, obliga- be transmitted to the Committees on Appro-
within an appropriation account and an R–1 tions for mandatory payments due on or priations of the House of Representatives
line item that includes a program element about the first day of any month that begins and the Senate upon request.
and subprogram element within an appro- after October 2022 but not later than 30 days SEC. 116. Amounts made available by sec-
priation account) for which appropriations, after the date specified in section 106(3) may tion 101 for ‘‘Farm Service Agency—Agricul-
funds, or other authority were not available continue to be made, and funds shall be tural Credit Insurance Fund Program Ac-
during fiscal year 2022. available for such payments. count’’ may be apportioned up to the rate for
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S5096 CONGRESSIONAL RECORD — SENATE September 27, 2022
operations necessary to accommodate ap- apply to a transfer of funds under this sub- water and wastewater infrastructure under
proved applications for direct and guaran- section: Provided further, That the exercise of section 219 of the Water Resources Develop-
teed farm ownership loans, as authorized by the authority of this subsection shall be sub- ment Act of 1992 (106 Stat. 4835): Provided,
7 U.S.C. 1922 et seq. ject to prior consultation with, and the reg- That such amount is designated by the Con-
SEC. 117. Amounts made available by sec- ular notification procedures of, the Commit- gress as being for an emergency requirement
tion 101 to the Department of Agriculture for tees on Appropriations of the House of Rep- pursuant to section 4001(a)(1) of S. Con. Res.
‘‘Rural Business—Cooperative Service— resentatives and the Senate: Provided further, 14 (117th Congress), the concurrent resolu-
Rural Microentrepreneur Assistance Pro- That any funds transferred pursuant to this tion on the budget for fiscal year 2022, and
gram’’ may be used for the costs of loans, in- subsection that were previously designated section 1(e) of H. Res. 1151 (117th Congress),
cluding the cost of modifying such loans, as by the Congress as an emergency require- as engrossed in the House of Representatives
defined in section 502 of the Congressional ment pursuant to the concurrent resolution on June 8, 2022.
Budget Act of 1974, under the same terms and on the budget are designated by the Congress SEC. 126. (a) During the period covered by
conditions as authorized by section 379E of as being for an emergency requirement pur- this Act, title I of Public Law 108–361 (the
the Consolidated Farm and Rural Develop- suant to section 4001(a)(1) of S. Con. Res. 14 Calfed Bay-Delta Authorization Act) (118
ment Act (7 U.S.C. 2008s). (117th Congress), the concurrent resolution Stat. 1681), as amended by section 204 of divi-
SEC. 118. Section 260 of the Agricultural on the budget for fiscal year 2022, and section sion D of Public Law 117–103, shall be applied
Marketing Act of 1946 (7 U.S.C. 1636i) and 1(e) of H. Res. 1151 (117th Congress), as en- by substituting ‘‘2023’’ for ‘‘2022’’ each place
section 942 of the Livestock Mandatory Re- grossed in the House of Representatives on it appears.
porting Act of 1999 (7 U.S.C. 1635 note; Public June 8, 2022. (b) During the period covered by this Act,
Law 106–78) shall be applied by substituting (b) Not later than November 1, 2022 and section 103(f)(4)(A) of title I of Public Law
the date specified in section 106(3) of this Act prior to any transfer of funds pursuant to 108–361 (the Calfed Bay-Delta Authorization
for ‘‘September 30, 2022’’. subsection (a), the Director of the Office of Act) (118 Stat. 1696) shall be applied by sub-
SEC. 119. Amounts made available by sec- Management and Budget shall provide to the stituting ‘‘$25,650,000’’ for ‘‘$25,000,000’’.
tion 101 to the Department of Commerce for SEC. 127. (a) During the period covered by
Committees on Appropriations of the House
‘‘Economic Development Administration— this Act, section 9106(g)(2) of Public Law 111–
of Representatives and the Senate a written
Salaries and Expenses’’ may be apportioned 11 (Omnibus Public Land Management Act of
report on Operation Allies Welcome or any
up to the rate for operations necessary to 2009) shall be applied by substituting ‘‘2023’’
successor operation: Provided, That such re-
for ‘‘2022’’.
maintain agency operations. port shall describe the number and status of (b) During the period covered by this Act,
SEC. 120. Amounts made available by sec- Afghans residing at Department of Defense section 104(c) of the Reclamation States
tion 101 for ‘‘Department of Commerce—Na- and Department of State-managed facilities Emergency Drought Relief Act of 1991 (43
tional Telecommunications and Information and any anticipated future arrivals at such U.S.C. 2214(c)) shall be applied by sub-
Administration—Salaries and Expenses’’ facilities; the strategy and plan, including stituting ‘‘2023’’ for ‘‘2022’’.
may be apportioned up to the rate for oper- timeline, for adjudicating and relocating all (c) During the period covered by this Act,
ations necessary to ensure continued over- Afghans residing at Department of Defense section 301 of the Reclamation States Emer-
sight of public safety communications pro- or overseas civilian facilities and for the gency Drought Relief Act of 1991 (43 U.S.C.
grams. transition of operations and responsibilities 2241) shall be applied by substituting ‘‘2023’’
SEC. 121. In addition to amounts otherwise under Operation Allies Welcome or any suc- for ‘‘2022’’.
provided by section 101, for ‘‘Department of cessor operation from the Department of De- SEC. 128. In addition to amounts otherwise
Justice—Federal Bureau of Investigation— fense to the Department of State during fis- provided by section 101, amounts are pro-
Salaries and Expenses’’, there is appro- cal year 2023; the activities and responsibil- vided for ‘‘Department of the Treasury—Al-
priated $15,300,000, for an additional amount ities assigned to each Federal agency in- cohol and Tobacco Tax and Trade Bureau—
for fiscal year 2023, to remain available until volved in such strategy and plan; and a spend Salaries and Expenses’’ at a rate for oper-
September 30, 2023, for investigative activi- plan, containing an estimate of the costs, in- ations of $14,929,000, for an additional
ties associated with Afghan resettlement op- cluding additional construction and security amount to administer the Craft Beverage
erations: Provided, That such amount is des- costs, to be incurred by each such agency for Modernization Act import claims program,
ignated by the Congress as being for an carrying out such strategy and plan, and the as required by the Taxpayer Certainty and
emergency requirement pursuant to section sources of funds: Provided further, That prior Disaster Tax Relief Act of 2020, and such
4001(a)(1) of S. Con. Res. 14 (117th Congress), to the initial obligation of funds transferred amounts may be apportioned up to the rate
the concurrent resolution on the budget for to the Department of State pursuant to sub- for operations necessary to establish and im-
fiscal year 2022, and section 1(e) of H. Res. section (a), the Secretary of State shall sub- plement a new import claims program.
1151 (117th Congress), as engrossed in the mit a report to such Committees detailing SEC. 129. Notwithstanding section 101, title
House of Representatives on June 8, 2022. the roles and responsibilities of Department II of division E of Public Law 117–103 shall be
SEC. 122. (a) Notwithstanding sections 101 of State bureaus and offices in Operation Al- applied by adding the following new heading
and 106, through September 30, 2023, the Sec- lies Welcome or any successor operation. and appropriation language under the head-
retary of Defense may transfer up to SEC. 123. During the period covered by this ing ‘‘Executive Office of the President and
$3,000,000,000 from unobligated balances from Act, section 714(b)(2)(B) of title 10, United Funds Appropriated to the President’’:
amounts made available under the heading States Code, shall be applied by substituting ‘‘OFFICE OF THE NATIONAL CYBER DIRECTOR
‘‘Department of Defense—Operation and ‘‘three years’’ for ‘‘two years’’. ‘‘SALARIES AND EXPENSES
Maintenance—Overseas Humanitarian, Dis- SEC. 124. (a) Of the remaining unobligated ‘‘For necessary expenses of the Office of
aster, and Civic Aid’’ in division C of Public balances, as of September 30, 2022, from the National Cyber Director, as authorized
Law 117–43 and division B of Public Law 117– amounts provided under the heading ‘‘Af- by section 1752 of the William M. (Mac)
70 to any appropriation account under the ghanistan Security Forces Fund’’ in title IX Thornberry National Defense Authorization
headings ‘‘Department of State and Related of division C of Public Law 116–260, Act for Fiscal Year 2021 (Public Law 116–283),
Agency—Department of State—Administra- $100,000,000 is hereby permanently rescinded, $21,000,000, of which not to exceed $5,000 shall
tion of Foreign Affairs’’, ‘‘Bilateral Eco- and in addition to amounts otherwise pro- be available for official reception and rep-
nomic Assistance—Department of State—Mi- vided by section 101, an amount of additional resentation expenses.’’.
gration and Refugee Assistance’’, and ‘‘Bilat- new budget authority equivalent to the SEC. 130. Notwithstanding section 101,
eral Economic Assistance—Department of amount rescinded pursuant to this sub- amounts are provided for ‘‘The Judiciary—
State—United States Emergency Refugee section is hereby appropriated on September Courts of Appeals, District Courts, and Other
and Migration Assistance Fund’’ for support 30, 2022, for an additional amount for fiscal Judicial Services—Fees of Jurors and Com-
of Operation Allies Welcome or any suc- year 2022, to remain available until Sep- missioners’’ at a rate for operations of
cessor operation: Provided, That upon trans- tember 30, 2025, for the same purposes and $59,565,000.
fer, such funds shall be merged with the ap- under the same authorities provided under SEC. 131. In addition to amounts otherwise
propriation to which such funds are trans- such heading in Public Law 116–260, in addi- provided by section 101, for ‘‘The Judiciary—
ferred except that such funds may be made tion to other funds as may be available for Courts of Appeals, District Courts, and Other
available for such purposes notwithstanding such purposes. Judicial Services—Court Security’’, there is
any requirement or limitation applicable to (b)(1) Subject to paragraph (2), this section appropriated $112,500,000, for an additional
the appropriation to which transferred, in- shall become effective immediately upon en- amount for fiscal year 2023, to remain avail-
cluding sections 2(c)(1) and 2(c)(2) of the Mi- actment of this Act. able until expended, for security improve-
gration and Refugee Assistance Act of 1962 (2) If this Act is enacted after September ments at United States courthouses and Fed-
with respect to the United States Emergency 30, 2022, this section shall be applied as if it eral court facilities: Provided, That not later
ctelli on DSK11ZRN23PROD with SENATE
Refugee and Migration Assistance Fund and were in effect on September 30, 2022. than 90 days after the date of enactment of
in sections 4(a) and 4(b) of the State Depart- SEC. 125. In addition to amounts otherwise this Act, and every 90 days thereafter until
ment Basic Authorities Act of 1956 with re- provided by section 101, for ‘‘Corps of Engi- all funds provided by this section have been
spect to funds transferred to the Emer- neers—Civil—Construction’’, there is appro- expended, the Director of the Administrative
gencies in the Diplomatic and Consular Serv- priated $20,000,000, for an additional amount Office of the United States Courts shall pro-
ice account: Provided further, That section for fiscal year 2023, to remain available until vide, in an appropriate format, quarterly re-
2215 of title 10, United States Code, shall not expended, for necessary expenses related to ports on the obligations and expenditures of
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5097
the funds provided under this section to the be derived from amounts made available for provided for ‘‘Department of Health and
Committees on Appropriations of the House major disasters declared pursuant to the Human Services—Indian Health Service—In-
of Representatives and the Senate: Provided Robert T. Stafford Disaster Relief and Emer- dian Health Services’’ at a rate for oper-
further, That such amount is designated by gency Assistance Act (42 U.S.C. 5121 et seq.): ations of $16,721,000, for an additional
the Congress as being for an emergency re- Provided further, That amounts provided by amount for costs of staffing and operating
quirement pursuant to section 4001(a)(1) of S. this section shall be subject to the same au- facilities that were opened, renovated, or ex-
Con. Res. 14 (117th Congress), the concurrent thorities and conditions as if such amounts panded in fiscal years 2022 and 2023, and such
resolution on the budget for fiscal year 2022, were provided by title III of the Department amounts may be apportioned up to the rate
and section 1(e) of H. Res. 1151 (117th Con- of Homeland Security Appropriations Act, for operations necessary to staff and operate
gress), as engrossed in the House of Rep- 2022 (division F of Public Law 117–103): Pro- such facilities.
resentatives on June 8, 2022. vided further, That not later than 90 days (b) In addition to amounts otherwise pro-
SEC. 132. Notwithstanding any other provi- after the date of enactment of this Act, and vided by section 101, amounts are provided
sion of this Act, except section 106, the Dis- every 90 days thereafter until all funds pro- for ‘‘Department of Health and Human Serv-
trict of Columbia may expend local funds vided by this section have been expended, the ices—Indian Health Service—Indian Health
made available under the heading ‘‘District Administrator of the Federal Emergency Facilities’’ at a rate for operations of
of Columbia—District of Columbia Funds’’ Management Agency shall provide, in an ap- $1,201,000, for an additional amount for costs
for such programs and activities under the propriate format, quarterly reports to the of staffing and operating facilities that were
District of Columbia Appropriations Act, Committees on Appropriations of the Senate opened, renovated, or expanded in fiscal
2022 (title IV of division E of Public Law 117– and the House of Representatives on the ob- years 2022 and 2023, and such amounts may
103) at the rate set forth in the Fiscal Year ligations and expenditures of the funds made be apportioned up to the rate for operations
2023 Local Budget Act of 2022 (D.C. Act 24– available by this section: Provided further, necessary to staff and operate such facilities.
486), as modified as of the date of enactment That amounts transferred by this section SEC. 145. In addition to amounts otherwise
of this Act. that were previously designated by the Con- provided by section 101, for ‘‘Department of
SEC. 133. In addition to amounts otherwise gress as an emergency requirement pursuant Health and Human Services—Substance
provided by section 101, amounts are pro- to the Balanced Budget and Emergency Def- Abuse and Mental Health Services Adminis-
vided for ‘‘Small Business Administration— icit Control Act of 1985 or a concurrent reso- tration—Mental Health’’, there is appro-
Salaries and Expenses’’ at a rate for oper- lution on the budget are designated as an priated $62,000,000, for an additional amount
ations of $20,000,000, for an additional emergency requirement pursuant to section for fiscal year 2023, to remain available until
amount for costs associated with the estab- 4001(a)(1) of S. Con. Res. 14 (117th Congress), September 30, 2023, for carrying out 988 Sui-
lishment and implementation of a Govern- the concurrent resolution on the budget for cide Lifeline activities and behavioral health
ment-wide service-disabled veteran-owned fiscal year 2022, and section 1(e) of H. Res. crisis services.
small business certification program within 1151 (117th Congress), as engrossed in the SEC. 146. In addition to amounts otherwise
the Small Business Administration, as re- House of Representatives on June 8, 2022. provided by section 101, for ‘‘Department of
quired by section 36 of the Small Business SEC. 137. Section 708(b)(13) of the Homeland Health and Human Services—Administration
Act (15 U.S.C. 657f) and section 862 of Public Security Act of 2002 (6 U.S.C. 348(b)(13)) shall for Children and Families—Low Income
Law 116–283: Provided, That such amounts be applied by substituting the date specified Home Energy Assistance’’, there is appro-
may be apportioned up to the rate for oper- in section 106(3) of this Act for ‘‘September priated $1,000,000,000, for an additional
ations necessary to establish and implement 30, 2022’’. amount for fiscal year 2023, to remain avail-
such certification program: Provided further, SEC. 138. During the period covered by this able until September 30, 2023, for making
That such amounts may be obligated in the Act, section 822(a) of the Homeland Security payments under subsection (b) of section 2602
Act of 2002 (6 U.S.C. 383(a)) shall be applied of the Low-Income Home Energy Assistance
account and budget structure set forth in
by substituting ‘‘2023’’ for ‘‘2022’’. Act of 1981 (42 U.S.C. 8621 et seq.): Provided,
H.R. 8294, as passed by the House of Rep-
SEC. 139. (a) Sections 1309(a) and 1319 of the That of the funds made available by this sec-
resentatives on July 20, 2022.
SEC. 134. Amounts made available by sec- National Flood Insurance Act of 1968 (42 tion, $500,000,000 shall be allocated as though
tion 101 for ‘‘Small Business Administra- U.S.C. 4016(a) and 4026) shall be applied by the total appropriation for such payments
tion—Business Loans Program Account’’ substituting the date specified in section for fiscal year 2023 was less than
may be apportioned up to the rate for oper- 106(3) of this Act for ‘‘September 30, 2022’’. $1,975,000,000: Provided further, That such
ations necessary to accommodate increased (b)(1) Subject to paragraph (2), this section amount is designated by the Congress as
demand for commitments for general busi- shall become effective immediately upon en- being for an emergency requirement pursu-
actment of this Act. ant to section 4001(a)(1) of S. Con. Res. 14
ness loans authorized under paragraphs (1)
(2) If this Act is enacted after September (117th Congress), the concurrent resolution
through (35) of section 7(a) of the Small Busi-
30, 2022, this section shall be applied as if it on the budget for fiscal year 2022, and section
ness Act (15 U.S.C. 636(a)), for guarantees of
were in effect on September 30, 2022. 1(e) of H. Res. 1151 (117th Congress), as en-
trust certificates authorized by section 5(g)
SEC. 140. Section 880(g) of the National De- grossed in the House of Representatives on
of the Small Business Act (15 U.S.C. 634(g)),
fense Authorization Act for Fiscal Year 2017 June 8, 2022.
for commitments to guarantee loans under SEC. 147. In addition to amounts otherwise
(Public Law 114–328) shall be applied by sub-
section 503 of the Small Business Investment provided by section 101, for ‘‘Department of
stituting the date specified in section 106(3)
Act of 1958 (15 U.S.C. 697), and for commit- of this Act for ‘‘September 30, 2022’’. Health and Human Services—Administration
ments to guarantee loans for debentures SEC. 141. Section 210G(i) of the Homeland for Children and Families—Refugee and En-
under section 303(b) of the Small Business In- Security Act of 2002 (6 U.S.C. 124n(i)) shall be trant Assistance’’, there is appropriated
vestment Act of 1958 (15 U.S.C. 683(b)). applied by substituting the date specified in $1,775,000,000, for an additional amount for
SEC. 135. Amounts made available by sec- section 106(3) of this Act for ‘‘the date that is fiscal year 2023, to remain available until
tion 101 to the Department of Homeland Se- 4 years after the date of enactment of this September 30, 2025, to carry out section 462 of
curity under the heading ‘‘Federal Emer- section’’. the Homeland Security Act of 2002 and sec-
gency Management Agency—Disaster Relief SEC. 142. Amounts made available by sec- tion 235 of the William Wilberforce Traf-
Fund’’ may be apportioned up to the rate for tion 101 for ‘‘Department of the Interior—Na- ficking Victims Protection Reauthorization
operations necessary to carry out response tional Park Service—National Recreation Act of 2008, and for refugee and entrant as-
and recovery activities under the Robert T. and Preservation’’ for heritage partnership sistance activities authorized by section 414
Stafford Disaster Relief and Emergency As- programs may be used to provide financial of the Immigration and Nationality Act and
sistance Act (42 U.S.C. 5121 et seq.). assistance to any national heritage area, na- section 501 of the Refugee Education Assist-
SEC. 136. Notwithstanding sections 101, 104, tional heritage corridor, cultural heritage ance Act of 1980: Provided, That such amount
and 106, to carry out the Hermit’s Peak/Calf corridor, national heritage partnership, na- is designated by the Congress as being for an
Canyon Fire Assistance Act, there is appro- tional heritage route, national heritage emergency requirement pursuant to section
priated $2,500,000,000, to remain available canalway, and battlefields national historic 4001(a)(1) of S. Con. Res. 14 (117th Congress),
until expended, to the Department of Home- district established as of September 1, 2022, the concurrent resolution on the budget for
land Security for ‘‘Federal Emergency Man- notwithstanding any statutory sunset provi- fiscal year 2022, and section 1(e) of H. Res.
agement Agency—Hermit’s Peak/Calf Can- sion terminating the Secretary’s authority 1151 (117th Congress), as engrossed in the
yon Fire Assistance Account’’, which shall to provide assistance to any such area and House of Representatives on June 8, 2022.
be derived by transfer from amounts made notwithstanding any limitation on amounts SEC. 148. Notwithstanding section 101, the
available under the heading ‘‘Federal Emer- authorized to be appropriated with respect to first paragraph under the heading ‘‘Social
gency Management Agency—Disaster Relief any such area. Security Administration—Limitation on Ad-
Fund’’ in title VI of division B of the SEC. 143. Amounts made available by sec- ministrative Expenses’’ in title IV of divi-
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Coronavirus Aid, Relief, and Economic Secu- tion 101 to the Department of the Interior sion H of Public Law 117–103 shall be applied
rity Act (Public Law 116–136), of which under the heading ‘‘Working Capital Fund’’ by substituting ‘‘$13,602,945,000’’ for
$1,000,000 shall be transferred to ‘‘Office of may be apportioned up to the rate for oper- ‘‘$13,202,945,000’’.
the Inspector General—Operations and Sup- ations necessary to implement enterprise cy- SEC. 149. (a) During the period covered by
port’’ for oversight of activities authorized bersecurity safeguards. this Act, subsection (a)(1)(A) of section 2502
by the Hermit’s Peak/Calf Canyon Fire As- SEC. 144. (a) In addition to amounts other- of the Afghanistan Supplemental Appropria-
sistance Act: Provided, That no amounts may wise provided by section 101, amounts are tions Act, 2022 (division C of Public Law 117–
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S5098 CONGRESSIONAL RECORD — SENATE September 27, 2022
43) shall be applied by substituting the date curred in 2021 or 2022 and the fourth, twen- TITLE I
specified in section 106(3) for ‘‘September 30, tieth, and twenty-first provisos under such DEPARTMENT OF DEFENSE
2022’’. heading in such Act shall not apply: Pro- MILITARY PERSONNEL
(b) The amount provided by this section is vided, That amounts made available under
designated as an emergency requirement this section and under such heading in such MILITARY PERSONNEL, ARMY
pursuant to section 4001(a)(1) of S. Con. Res. Act may be used by a grantee to assist utili- For an additional amount for ‘‘Military
14 (117th Congress), the concurrent resolu- ties as part of a disaster-related eligible ac- Personnel, Army’’, $110,107,000, to remain
tion on the budget for fiscal year 2022, and tivity under section 105(a) of the Housing available until September 30, 2023, to respond
section 1(e) of H. Res. 1151 (117th Congress), and Community Development Act of 1974 (42 to the situation in Ukraine and for related
as engrossed in the House of Representatives U.S.C. 5305(a)): Provided further, That such expenses.
on June 8, 2022. amount is designated by the Congress as MILITARY PERSONNEL, NAVY
SEC. 150. Activities authorized by part A of being for an emergency requirement pursu- For an additional amount for ‘‘Military
title IV (other than under section 403(c) or ant to section 4001(a)(1) of S. Con. Res. 14 Personnel, Navy’’, $462,000, to remain avail-
418) and section 1108(b) of the Social Security (117th Congress), the concurrent resolution able until September 30, 2023, to respond to
Act shall continue through the date specified on the budget for fiscal year 2022, and section the situation in Ukraine and for related ex-
in section 106(3), in the manner authorized 1(e) of H. Res. 1151 (117th Congress), as en- penses.
for fiscal year 2022, and out of any money in grossed in the House of Representatives on MILITARY PERSONNEL, MARINE CORPS
the Treasury of the United States not other- June 8, 2022.
wise appropriated, there are hereby appro- SEC. 156. Notwithstanding section 106 of For an additional amount for ‘‘Military
priated such sums as may be necessary for this Act, at any time during fiscal year 2023, Personnel, Marine Corps’’, $600,000, to remain
such purpose. the Secretary of Housing and Urban Develop- available until September 30, 2023, to respond
SEC. 151. Notwithstanding section 101, sec- ment may transfer up to $1,300,000 in unobli- to the situation in Ukraine and for related
tion 126 of division J of Public Law 117–103 gated balances from amounts made available expenses.
shall be applied during the period covered by in prior Acts under the heading ‘‘Housing MILITARY PERSONNEL, AIR FORCE
this Act by substituting ‘‘fiscal year 2017 and Programs—Project-Based Rental Assist- For an additional amount for ‘‘Military
fiscal year 2018’’ for ‘‘fiscal year 2017’’. ance’’ to Treasury Appropriation Fund Sym- Personnel, Air Force’’, $11,582,000, to remain
SEC. 152. Notwithstanding section 101, bol 86 X 0148 for the liquidation of obliga- available until September 30, 2023, to respond
amounts are provided for— tions incurred in fiscal year 2018 in connec- to the situation in Ukraine and for related
(1) ‘‘Department of State and Related tion with the continued provision of interest expenses.
Agency—Department of State—Administra- reduction payments authorized under section OPERATION AND MAINTENANCE
tion of Foreign Affairs—Diplomatic Pro- 236 of the National Housing Act (12 U.S.C.
1715z–1). OPERATION AND MAINTENANCE, ARMY
grams’’ at a rate for operations of
$9,228,789,000; SEC. 157. (a) The remaining unobligated For an additional amount for ‘‘Operation
(2) ‘‘Bilateral Economic Assistance—Funds balances, as of September 30, 2022, from and Maintenance, Army’’, $654,696,000, to re-
Appropriated to the President—Inter- amounts made available for ‘‘Department of main available until September 30, 2023, to
national Disaster Assistance’’ at a rate for Transportation—Office of the Secretary—Na- respond to the situation in Ukraine and for
operations of $4,555,460,000; tional Infrastructure Investments’’ in title I related expenses.
(3) ‘‘Bilateral Economic Assistance—Funds of division H of the Further Consolidated Ap- OPERATION AND MAINTENANCE, NAVY
Appropriated to the President—Transition propriations Act, 2020 (Public Law 116–94) are For an additional amount for ‘‘Operation
Initiatives’’ at a rate for operations of hereby permanently rescinded, and in addi- and Maintenance, Navy’’, $433,035,000, to re-
$100,000,000; tion to amounts otherwise provided by sec- main available until September 30, 2023, to
(4) ‘‘Bilateral Economic Assistance—Funds tion 101, an amount of additional new budget respond to the situation in Ukraine and for
Appropriated to the President—Assistance authority equivalent to the amount re- related expenses.
for Europe, Eurasia and Central Asia’’ at a scinded pursuant to this subsection is hereby
OPERATION AND MAINTENANCE, MARINE CORPS
rate for operations of $850,000,000; appropriated on September 30, 2022, for an
additional amount for fiscal year 2022, to re- For an additional amount for ‘‘Operation
(5) ‘‘Bilateral Economic Assistance—De- and Maintenance, Marine Corps’’, $34,984,000,
partment of State—Migration and Refugee main available until September 30, 2023, and
shall be available, without additional com- to remain available until September 30, 2023,
Assistance’’ at a rate for operations of to respond to the situation in Ukraine and
$3,562,188,000; petition, for completing the funding of
awards made pursuant to the fiscal year 2020 for related expenses.
(6) ‘‘International Security Assistance—
Department of State—International Nar- national infrastructure investments pro- OPERATION AND MAINTENANCE, AIR FORCE
cotics Control and Law Enforcement’’ at a gram, in addition to other funds as may be For an additional amount for ‘‘Operation
rate for operations of $1,421,004,000; and available for such purposes. and Maintenance, Air Force’’, $267,084,000, to
(7) ‘‘International Security Assistance— (b) The remaining unobligated balances, as remain available until September 30, 2023, to
Funds Appropriated to the President—For- of September 30, 2022, from amounts made respond to the situation in Ukraine and for
eign Military Financing Program’’ at a rate available to the Department of Transpor- related expenses.
for operations of $6,190,424,000. tation in section 105 of division L of the Con- OPERATION AND MAINTENANCE, SPACE FORCE
SEC. 153. During the period covered by this solidated Appropriations Act, 2021 (Public
For an additional amount for ‘‘Operation
Act, section 579 of the Multifamily Assisted Law 116–260) are hereby permanently re-
and Maintenance, Space Force’’, $1,771,000, to
Housing Reform and Affordability Act of 1997 scinded, and in addition to amounts other-
remain available until September 30, 2023, to
(42 U.S.C. 1437f note) shall be applied by sub- wise provided by section 101, an amount of
respond to the situation in Ukraine and for
stituting ‘‘2023’’ for ‘‘2022’’ each place it ap- additional new budget authority equivalent
related expenses.
pears. to the amount rescinded pursuant to this
subsection is hereby appropriated on Sep- OPERATION AND MAINTENANCE, DEFENSE-WIDE
SEC. 154. Amounts made available by sec-
tion 101 to the Department of Housing and tember 30, 2022, for an additional amount for (INCLUDING TRANSFER OF FUNDS)
Urban Development for ‘‘Public and Indian fiscal year 2022, to remain available until For an additional amount for ‘‘Operation
Housing—Native Hawaiian Housing Loan September 30, 2023, and shall be available, and Maintenance, Defense-Wide’’,
Guarantee Fund Program Account’’ may be without additional competition, for com- $4,713,544,000, to remain available until Sep-
apportioned up to the rate for operations pleting the funding of awards made pursuant tember 30, 2023, to respond to the situation in
necessary to accommodate demand for com- to the fiscal year 2019 national infrastruc- Ukraine and for related expenses: Provided,
mitments to guarantee loans as authorized ture investments program, in addition to That of the total amount provided under this
by section 184A of the Housing and Commu- other funds as may be available for such pur- heading in this Act, $3,000,000,000, to remain
nity Development Act of 1992 (12 U.S.C. poses. available until September 30, 2024, shall be
1715z–13b). (c)(1) Subject to paragraph (2), this section for the Ukraine Security Assistance Initia-
SEC. 155. In addition to amounts otherwise shall become effective immediately upon en- tive: Provided further, That such funds for the
provided by section 101, for ‘‘Department of actment of this Act. Ukraine Security Assistance Initiative shall
Housing and Urban Development—Commu- (2) If this Act is enacted after September be available to the Secretary of Defense
nity Planning and Development—Commu- 30, 2022, this section shall be applied as if it under the same terms and conditions as are
nity Development Fund’’, there is appro- were in effect on September 30, 2022. provided for in section 8139 of the Depart-
priated $2,000,000,000, for an additional This division may be cited as the ‘‘Con- ment of Defense Appropriations Act, 2022 (di-
amount for fiscal year 2023, to remain avail- tinuing Appropriations Act, 2023’’. vision C of Public Law 117–103): Provided fur-
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able until expended, for the same purposes DIVISION B—UKRAINE SUPPLEMENTAL ther, That of the total amount provided
and under the same terms and conditions as APPROPRIATIONS ACT, 2023 under this heading in this Act, up to
funds appropriated under such heading in The following sums are appropriated, out $1,500,000,000, to remain available until Sep-
title VIII of the Disaster Relief Supple- of any money in the Treasury not otherwise tember 30, 2024, may be transferred to ac-
mental Appropriations Act, 2022 (division B appropriated, for the fiscal year ending Sep- counts under the headings ‘‘Operation and
of Public Law 117–43), except that such tember 30, 2023, and for other purposes, Maintenance’’ and ‘‘Procurement’’ for re-
amounts shall be for major disasters that oc- namely: placement of defense articles from the
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5099
stocks of the Department of Defense, and for $2,077,000, to remain available until Sep- TITLE II
reimbursement for defense services of the tember 30, 2024, to respond to the situation in DEPARTMENT OF ENERGY
Department of Defense and military edu- Ukraine and for related expenses. ATOMIC ENERGY DEFENSE ACTIVITIES
cation and training, provided to the govern- RESEARCH, DEVELOPMENT, TEST AND
ment of Ukraine or to foreign countries that NATIONAL NUCLEAR SECURITY
EVALUATION, AIR FORCE
have provided support to Ukraine at the re- ADMINISTRATION
For an additional amount for ‘‘Research,
quest of the United States: Provided further, DEFENSE NUCLEAR NONPROLIFERATION
Development, Test and Evaluation, Air
That funds transferred pursuant to a transfer Force’’, $99,704,000, to remain available until For an additional amount for ‘‘Defense Nu-
authority provided under this heading in this September 30, 2024, to respond to the situa- clear Nonproliferation’’, $35,000,000, to re-
Act shall be merged with and available for tion in Ukraine and for related expenses. main available until expended, to respond to
the same purposes and for the same time pe- RESEARCH, DEVELOPMENT, TEST AND the situation in Ukraine and for related ex-
riod as the appropriations to which the funds EVALUATION, DEFENSE-WIDE penses.
are transferred: Provided further, That the TITLE III
For an additional amount for ‘‘Research,
Secretary of Defense shall notify the con- BILATERAL ECONOMIC ASSISTANCE
Development, Test and Evaluation, Defense-
gressional defense committees of the details
Wide’’, $31,230,000, to remain available until FUNDS APPROPRIATED TO THE PRESIDENT
of such transfers not less than 15 days before
September 30, 2024, to respond to the situa- ECONOMIC SUPPORT FUND
any such transfer: Provided further, That
tion in Ukraine and for related expenses.
upon a determination that all or part of the For an additional amount for ‘‘Economic
funds transferred from this appropriation are OTHER DEPARTMENT OF DEFENSE Support Fund’’, $4,500,000,000, to remain
not necessary for the purposes provided here- PROGRAMS available until September 30, 2024, for assist-
in, such amounts may be transferred back OFFICE OF THE INSPECTOR GENERAL ance for Ukraine: Provided, That funds appro-
and merged with this appropriation: Provided For an additional amount for ‘‘Office of the priated under this heading in this Act may
further, That the transfer authority provided Inspector General’’, $2,000,000, to remain be made available notwithstanding any other
under this heading in this Act is in addition available until September 30, 2023, to carry provision of law that restricts assistance to
to any other transfer authority provided by out reviews of the activities of the Depart- foreign countries and may be made available
law. ment of Defense to execute funds appro- as contributions.
PROCUREMENT priated in this title, including assistance GENERAL PROVISIONS—THIS TITLE
provided to Ukraine: Provided, That the In-
MISSILE PROCUREMENT, ARMY SEC. 1301. During fiscal year 2023, section
spector General of the Department of De-
For an additional amount for ‘‘Missile Pro- fense shall provide to the congressional de- 506(a)(1) of the Foreign Assistance Act of 1961
curement, Army’’, $450,000,000, to remain fense committees a briefing not later than 90 (22 U.S.C. 2318(a)(1)) shall be applied by sub-
available until September 30, 2025, to respond days after the date of enactment of this Act. stituting ‘‘$3,700,000,000’’ for ‘‘$100,000,000’’.
to the situation in Ukraine and for related SEC. 1302. (a) Funds appropriated by this
RELATED AGENCIES title shall be made available for direct finan-
expenses.
INTELLIGENCE COMMUNITY MANAGEMENT cial support for the Government of Ukraine,
PROCUREMENT OF AMMUNITION, ARMY ACCOUNT including for Ukrainian first responders, and
For an additional amount for ‘‘Procure- For an additional amount for ‘‘Intelligence may be made available as a cash transfer
ment of Ammunition, Army’’, $540,000,000, to Community Management Account’’, $500,000, subject to the requirements of subsection (b):
remain available until September 30, 2025, for to remain available until September 30, 2023, Provided, That such funds shall be provided
expansion of public and private plants, in- to respond to the situation in Ukraine and on a reimbursable basis and matched by
cluding the land necessary therefor, and pro- for related expenses. sources other than the United States Gov-
curement and installation of equipment, ap-
GENERAL PROVISIONS—THIS TITLE ernment, to the maximum extent prac-
pliances, and machine tools in such plants,
SEC. 1101. Not later than 60 days after the ticable: Provided further, That the Secretary
for the purpose of increasing production of
date of enactment of this Act, the Secretary of State or the Administrator of the United
critical munitions to replace defense articles
of Defense, in coordination with the Sec- States Agency for International Develop-
provided to the Government of Ukraine or
retary of State, shall submit a report to the ment, as appropriate, shall ensure third-
foreign countries that have provided support
Committees on Appropriations, Armed Serv- party monitoring of such funds: Provided fur-
to Ukraine at the request of the United
ices, and Foreign Affairs of the House of Rep- ther, That at least 15 days prior to the initial
States.
resentatives and the Committees on Appro- obligation of such funds, the Secretary of
OTHER PROCUREMENT, ARMY priations, Armed Services, and Foreign Rela- State, following consultation with the Ad-
For an additional amount for ‘‘Other Pro- tions of the Senate on measures being taken ministrator of the United States Agency for
curement, Army’’, $3,890,000, to remain avail- to account for United States defense articles International Development, shall certify and
able until September 30, 2025, to respond to designated for Ukraine since the February report to the appropriate congressional com-
the situation in Ukraine and for related ex- 24, 2022, Russian invasion of Ukraine, par- mittees that mechanisms for monitoring and
penses. ticularly measures with regard to such arti- oversight of such funds are in place and func-
OTHER PROCUREMENT, NAVY cles that require enhanced end-use moni- tioning and that the Government of Ukraine
For an additional amount for ‘‘Other Pro- toring; measures to ensure that such articles has in place substantial safeguards to pre-
curement, Navy’’, $2,170,000, to remain avail- reach their intended recipients and are used vent corruption and ensure accountability of
able until September 30, 2025, to respond to for their intended purposes; and any other such funds: Provided further, That not less
the situation in Ukraine and for related ex- measures to promote accountability for the than 45 days after the initial obligation of
penses. use of such articles: Provided, That such re- such funds, the Inspectors General of the De-
OTHER PROCUREMENT, AIR FORCE port shall include a description of any occur- partment of State and the United States
rences of articles not reaching their intended Agency for International Development shall
For an additional amount for ‘‘Other Pro- recipients or used for their intended purposes submit a report to the appropriate congres-
curement, Air Force’’, $437,991,000, to remain and a description of any remedies taken: Pro- sional committees detailing and assessing
available until September 30, 2025, to respond vided further, That such report shall be sub- the mechanisms for monitoring and safe-
to the situation in Ukraine and for other ex- mitted in unclassified form, but may be ac- guards described in the previous proviso.
penses. companied by a classified annex. (b) Funds made available to the Govern-
PROCUREMENT, DEFENSE-WIDE SEC. 1102. Not later than 30 days after the ment of Ukraine as a cash transfer under
For an additional amount for ‘‘Procure- date of enactment of this Act, and every 30 subsection (a) shall be subject to a memo-
ment, Defense-Wide’’, $9,770,000, to remain days thereafter through fiscal year 2023, the randum of understanding between the Gov-
available until September 30, 2025, to respond Secretary of Defense, in coordination with ernments of the United States and Ukraine
to the situation in Ukraine and for related the Secretary of State, shall provide a writ- that describes how the funds proposed to be
expenses. ten report to the Committees on Appropria- made available will be used and the appro-
RESEARCH, DEVELOPMENT, TEST AND tions, Armed Services, and Foreign Affairs of priate safeguards to ensure transparency and
EVALUATION the House of Representatives and the Com- accountability: Provided, That such assist-
RESEARCH, DEVELOPMENT, TEST AND mittees on Appropriations, Armed Services, ance shall be maintained in a separate,
EVALUATION, ARMY and Foreign Relations of the Senate describ- auditable account and may not be comingled
ing United States security assistance pro- with any other funds.
For an additional amount for ‘‘Research, vided to Ukraine since the February 24, 2022, (c) The Secretary of State or the Adminis-
Development, Test and Evaluation, Army’’, Russian invasion of Ukraine, including a trator of the United States Agency for Inter-
ctelli on DSK11ZRN23PROD with SENATE
$3,300,000, to remain available until Sep- comprehensive list of the defense articles national Development, as appropriate, shall
tember 30, 2024, to respond to the situation in and services provided to Ukraine and the as- report to the appropriate congressional com-
Ukraine and for related expenses. sociated authority and funding used to pro- mittees on the uses of funds provided for di-
RESEARCH, DEVELOPMENT, TEST AND vide such articles and services: Provided, rect financial support to the Government of
EVALUATION, NAVY That such report shall be submitted in un- Ukraine pursuant to subsection (a) not later
For an additional amount for ‘‘Research, classified form, but may be accompanied by than 45 days after the date of enactment of
Development, Test and Evaluation, Navy’’, a classified annex. this Act and every 45 days thereafter until
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S5100 CONGRESSIONAL RECORD — SENATE September 27, 2022
all such funds have been expended: Provided, succeeding division shall not be entered on (2) in clause (ii)(II), by striking ‘‘October 1,
That such report shall include a detailed de- either PAYGO scorecard maintained pursu- 2022’’ and inserting ‘‘December 17, 2022’’.
scription of the use of such funds, including ant to section 4(d) of the Statutory Pay-As- (b) CONFORMING AMENDMENTS.—
categories and amounts, the intended results You-Go Act of 2010. (1) EXTENSION OF TARGET AMOUNT.—Section
and the results achieved, a summary of other (b) SENATE PAYGO SCORECARDS.—The 1886(b)(3)(D) of the Social Security Act (42
donor contributions, and a description of the budgetary effects of this division and each U.S.C. 1395ww(b)(3)(D)) is amended—
efforts undertaken by the Secretary and Ad- succeeding division shall not be entered on (A) in the matter preceding clause (i), by
ministrator to increase other donor con- any PAYGO scorecard maintained for pur- striking ‘‘October 1, 2022’’ and inserting ‘‘De-
tributions for direct financial support: Pro- poses of section 4106 of H. Con. Res. 71 (115th cember 17, 2022’’; and
vided further, That such report shall also in- Congress). (B) in clause (iv), by inserting ‘‘and the
clude the metrics established to measure (c) CLASSIFICATION OF BUDGETARY EF- portion of fiscal year 2023 beginning on Octo-
such results. FECTS.—Notwithstanding Rule 3 of the Budg- ber 1, 2022, and ending on December 16, 2022,’’
(d) Funds made available for the purposes et Scorekeeping Guidelines set forth in the after ‘‘through fiscal year 2022’’.
of subsection (a) shall be subject to the reg- joint explanatory statement of the com- (2) PERMITTING HOSPITALS TO DECLINE RE-
ular notification procedures of the Commit- mittee of conference accompanying Con- CLASSIFICATION.—Section 13501(e)(2) of the
tees on Appropriations of the House of Rep- ference Report 105–217 and section 250(c)(8) of Omnibus Budget Reconciliation Act of 1993
resentatives and the Senate. the Balanced Budget and Emergency Deficit (42 U.S.C. 1395ww note) is amended by strik-
TITLE IV Control Act of 1985, the budgetary effects of ing ‘‘or fiscal year 2000 through fiscal year
GENERAL PROVISIONS—THIS ACT this division and each succeeding division 2022,’’ and inserting ‘‘fiscal year 2000 through
shall not be estimated— fiscal year 2022, or the portion of fiscal year
SEC. 1401. Each amount appropriated or
(1) for purposes of section 251 of such Act; 2023 beginning on October 1, 2022, and ending
made available by this Act is in addition to
(2) for purposes of an allocation to the on December 16, 2022’’.
amounts otherwise appropriated for the fis-
Committee on Appropriations pursuant to SEC. 103. EXTENSION OF INCREASED FMAPS FOR
cal year involved.
SEC. 1402. No part of any appropriation section 302(a) of the Congressional Budget THE TERRITORIES.
contained in this Act shall remain available Act of 1974; and Section 1905(ff) of the Social Security Act
for obligation beyond the current fiscal year (3) for purposes of paragraph (4)(C) of sec- (42 U.S.C. 1396d(ff)) is amended by striking
unless expressly so provided herein. tion 3 of the Statutory Pay-As-You-Go Act ‘‘December 13’’ each place it appears and in-
SEC. 1403. Unless otherwise provided for by of 2010 as being included in an appropriation serting ‘‘December 16’’ in each such place.
this Act, the additional amounts appro- Act. SEC. 104. REDUCTION OF MEDICARE IMPROVE-
priated by this Act to appropriations ac- DIVISION D—HEALTH AND HUMAN MENT FUND.
counts shall be available under the authori- SERVICES EXTENSIONS Section 1898(b)(1) of the Social Security
ties and conditions applicable to such appro- TITLE I—MEDICARE AND MEDICAID Act (42 U.S.C. 1395iii(b)(1)) is amended by
priations accounts for fiscal year 2023. striking ‘‘$7,500,000,000’’ and inserting
SEC. 101. EXTENSION OF INCREASED INPATIENT
SEC. 1404. Each amount provided by this di- HOSPITAL PAYMENT ADJUSTMENT
‘‘$7,308,000,000’’.
vision is designated by the Congress as being FOR CERTAIN LOW-VOLUME HOS- TITLE II—HUMAN SERVICES
for an emergency requirement pursuant to PITALS. SEC. 201. EXTENSION OF MATERNAL, INFANT,
section 4001(a)(1) of S. Con. Res. 14 (117th (a) IN GENERAL.—Section 1886(d)(12) of the AND EARLY CHILDHOOD HOME VIS-
Congress), the concurrent resolution on the Social Security Act (42 U.S.C. 1395ww(d)(12)) ITING PROGRAMS.
budget for fiscal year 2022, and section 1(e) of is amended— Activities authorized by section 511 of the
H. Res. 1151 (117th Congress), as engrossed in (1) in subparagraph (B), in the matter pre- Social Security Act shall continue through
the House of Representatives on June 8, 2022. ceding clause (i), by striking ‘‘in fiscal year December 16, 2022, in the manner authorized
This division may be cited as the ‘‘Ukraine 2023 and subsequent fiscal years’’ and insert- for fiscal year 2022, and out of any money in
Supplemental Appropriations Act, 2023’’. ing ‘‘during the portion of fiscal year 2023 be- the Treasury of the United States not other-
DIVISION C—OTHER MATTERS ginning on December 17, 2022, and ending on wise appropriated, there is hereby appro-
TITLE I—EXTENSIONS, TECHNICAL September 30, 2023, and in fiscal year 2024 priated for such purpose an amount equal to
CORRECTIONS, AND OTHER MATTERS and subsequent fiscal years’’; the pro rata portion of the amount appro-
SEC. 101. EXTENSION OF FCC AUCTION AUTHOR- (2) in subparagraph (C)(i)— priated for such activities for fiscal year
ITY. (A) in the matter preceding subclause (I)— 2022.
Section 309(j)(11) of the Communications (i) by inserting ‘‘or portion of a fiscal SEC. 202. EXTENSION OF CHILD AND FAMILY
Act of 1934 (47 U.S.C. 309(j)(11)) is amended by year’’ after ‘‘for a fiscal year’’; and SERVICES PROGRAMS.
striking ‘‘September 30, 2022’’ and inserting (ii) by inserting ‘‘and the portion of fiscal Activities authorized by part B of title IV
‘‘December 16, 2022’’. year 2023 beginning on October 1, 2022, and of the Social Security Act shall continue
SEC. 102. EXTENSION OF AUTHORIZATION FOR ending on December 16, 2022’’ after ‘‘through through December 16, 2022, in the manner au-
SPECIAL ASSESSMENT FOR DOMES- 2022’’; thorized for fiscal year 2022, and out of any
TIC TRAFFICKING VICTIMS’ FUND. (B) in subclause (III), by inserting ‘‘and the money in the Treasury of the United States
Section 3014(a) of title 18, United States portion of fiscal year 2023 beginning on Octo- not otherwise appropriated, there are hereby
Code, is amended, in the matter preceding ber 1, 2022, and ending on December 16, 2022’’ appropriated such sums as may be necessary
paragraph (1), by striking ‘‘September 30, after ‘‘through 2022’’; and for such purpose.
2022’’ and inserting ‘‘December 16, 2022’’. (C) in subclause (IV), by striking ‘‘fiscal TITLE III—PUBLIC HEALTH
SEC. 103. UNITED STATES PAROLE COMMISSION year 2023’’ and inserting ‘‘the portion of fis-
EXTENSION. SEC. 301. EXTENSION OF THE PROGRAM TO DEEM
cal year 2023 beginning on December 17, 2022, CERTAIN HEALTH PROFESSIONAL
(a) SHORT TITLE.—This section may be and ending on September 30, 2023, and fiscal VOLUNTEERS EMPLOYEES OF THE
cited as the ‘‘United States Parole Commis- year 2024’’; and PUBLIC HEALTH SERVICE UNDER
sion Extension Act of 2022’’. (3) in subparagraph (D)— CERTAIN CIRCUMSTANCES.
(b) AMENDMENT OF SENTENCING REFORM (A) in the matter preceding clause (i), by (a) IN GENERAL.—Section 224(q) of the Pub-
ACT OF 1984.—For purposes of section 235(b) inserting ‘‘or during the portion of fiscal lic Health Service Act (42 U.S.C. 233(q)) is
of the Sentencing Reform Act of 1984 (18 year 2023 beginning on October 1, 2022, and amended by striking paragraph (6).
U.S.C. 3551 note; Public Law 98–473; 98 Stat. ending on December 16, 2022’’ after ‘‘through (b) TECHNICAL CORRECTIONS.—Section 224 of
2032), as such section relates to chapter 311 of 2022’’; and the Public Health Service Act (42 U.S.C. 233)
title 18, United States Code, and the United (B) in clause (ii), by inserting ‘‘and the por- is amended—
States Parole Commission, each reference in tion of fiscal year 2023 beginning on October (1) in subsection (g)(1)(H)(iv), by striking
such section to ‘‘35 years’’ or ‘‘35-year pe- 1, 2022, and ending on December 16, 2022’’ ‘‘this section.’’ and inserting ‘‘this sec-
riod’’ shall be deemed a reference to ‘‘35 after ‘‘through 2022’’. tion).’’;
years and 46 days’’ or ‘‘35-year and 46-day pe- (b) IMPLEMENTATION.—Notwithstanding (2) in subsection (k)(3), by inserting ‘‘gov-
riod’’, respectively. any other provision of law, the Secretary of erning board members,’’ after ‘‘officers,’’;
SEC. 104. EXTENSION OF COMMODITY FUTURES Health and Human Services may implement (3) in subsection (p)(7)(A)(i), by moving the
TRADING COMMISSION CUSTOMER the provisions of, including the amendments margin of subclause (II) 2 ems to the left;
PROTECTION FUND EXPENSES AC-
made by, this section by program instruction and
COUNT.
or otherwise. (4) in subsection (q)(5)(A), by striking ‘‘and
Section 1(b) of Public Law 117–25 (135 Stat.
297) is amended by striking ‘‘October 1, 2022’’
SEC. 102. EXTENSION OF THE MEDICARE-DE- paragraph (6)’’.
ctelli on DSK11ZRN23PROD with SENATE
PENDENT HOSPITAL (MDH) PRO- SEC. 302. EXTENSION OF AUTHORIZATION FOR A
each place it appears and inserting ‘‘Decem- GRAM. COMMISSIONED OFFICER OF THE
ber 16, 2022’’. (a) IN GENERAL.—Section 1886(d)(5)(G) of PUBLIC HEALTH SERVICE TO ACCU-
TITLE II—BUDGETARY EFFECTS the Social Security Act (42 U.S.C. MULATE EXCESS ANNUAL LEAVE.
SEC. 201. BUDGETARY EFFECTS. 1395ww(d)(5)(G)) is amended— For purposes of annual leave accumulated
(a) STATUTORY PAYGO SCORECARDS.—The (1) in clause (i), by striking ‘‘October 1, in fiscal year 2022, the authority provided in
budgetary effects of this division and each 2022’’ and inserting ‘‘December 17, 2022’’; and section 2106 of division C of Public Law 116–
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5101
159 (42 U.S.C. 210–1 note) shall apply to such SEC. 204. EXTENSION OF AUTHORITY TO PRO- SEC. 403. EXTENSION OF ADVISORY COMMITTEE
leave by substituting ‘‘2022’’ for ‘‘2020’’ in VIDE ASSISTANCE FOR SPECIALLY ON MINORITY VETERANS.
ADAPTED HOUSING FOR DISABLED Section 544(e) of title 38, United States
subsections (a) and (d)(2).
VETERANS RESIDING TEMPORARILY Code, is amended by striking ‘‘September 30,
TITLE IV—INDIAN HEALTH IN HOUSING OWNED BY A FAMILY
MEMBER.
2022’’ and inserting ‘‘September 30, 2026’’.
SEC. 401. EXTENSION OF MORATORIUM. SEC. 404. EXTENSION OF VETERANS’ ADVISORY
Section 2102A(e) of title 38, United States
Section 424(a) of title IV of division G of COMMITTEE ON EDUCATION.
Code, is amended by striking ‘‘December 31,
Public Law 113–76 is amended by striking 2022’’ and inserting ‘‘December 31, 2024’’. Section 3692(c) of title 38, United States
‘‘October 1, 2019’’ and inserting ‘‘December Code, is amended by striking ‘‘December 31,
SEC. 205. EXTENSION OF SPECIALLY ADAPTED
16, 2022’’. HOUSING ASSISTIVE TECHNOLOGY 2022’’ and inserting ‘‘December 31, 2026’’.
GRANT PROGRAM. SEC. 405. EXTENSION OF AUTHORITY FOR TRANS-
DIVISION E—VETERANS AFFAIRS
Section 2108(g) of title 38, United States FER OF REAL PROPERTY.
EXTENSIONS
Code, is amended by striking ‘‘September 30, Section 8118(a)(5) of title 38, United States
TITLE I—EXTENSIONS OF AUTHORITIES 2022’’ and inserting ‘‘September 30, 2024’’. Code, is amended by striking ‘‘September 30,
RELATING TO HEALTH CARE 2022’’ and inserting ‘‘September 30, 2024’’.
TITLE III—EXTENSIONS OF AUTHORITIES
SEC. 101. EXTENSION OF AUTHORITY FOR COL- RELATING TO HOMELESS VETERANS DIVISION F—FDA USER FEE
LECTION OF COPAYMENTS FOR HOS- REAUTHORIZATION ACT OF 2022
SEC. 301. EXTENSION OF AUTHORIZATION OF AP-
PITAL CARE AND NURSING HOME
PROPRIATIONS FOR HOMELESS VET- SECTION 1. SHORT TITLE.
CARE.
ERANS REINTEGRATION PROGRAMS. This division may be cited as the ‘‘FDA
Section 1710(f)(2)(B) of title 38, United Section 2021(e)(1)(F) of title 38, United User Fee Reauthorization Act of 2022’’.
States Code, is amended by striking ‘‘Sep- States Code, is amended by striking ‘‘2022’’ SEC. 2. TABLE OF CONTENTS.
tember 30, 2022’’ and inserting ‘‘September and inserting ‘‘2024’’.
30, 2024’’. The table of contents for this division is as
SEC. 302. EXTENSION OF AUTHORIZATION OF AP- follows:
SEC. 102. EXTENSION OF REQUIREMENT TO PRO- PROPRIATIONS FOR HOMELESS
VIDE NURSING HOME CARE TO CER- WOMEN VETERANS AND HOMELESS DIVISION F—FDA USER FEE
TAIN VETERANS WITH SERVICE-CON- VETERANS WITH CHILDREN RE- REAUTHORIZATION ACT OF 2022
NECTED DISABILITIES. INTEGRATION GRANT PROGRAM. Sec. 1. Short title.
Section 1710A(d) of title 38, United States Section 2021A(f)(1) of title 38, United States Sec. 2. Table of contents.
Code, is amended by striking ‘‘September 30, Code, is amended by striking ‘‘2022’’ and in- TITLE I—FEES RELATING TO DRUGS
2022’’ and inserting ‘‘September 30, 2024’’. serting ‘‘2024’’.
Sec. 1001. Short title; finding.
SEC. 303. EXTENSION OF AUTHORITY FOR TREAT-
SEC. 103. EXTENSION OF AUTHORITY TO CON-
MENT AND REHABILITATION FOR
Sec. 1002. Definitions.
TINUE DOD-VA HEALTH CARE SHAR- Sec. 1003. Authority to assess and use drug
SERIOUSLY MENTALLY ILL AND
ING INCENTIVE FUND. fees.
HOMELESS VETERANS.
Section 8111(d)(3) of title 38, United States (a) GENERAL TREATMENT.—Section 2031(b) Sec. 1004. Reauthorization; reporting re-
Code, is amended by striking ‘‘September 30, of title 38, United States Code, is amended by quirements.
2023’’ and inserting ‘‘September 30, 2026’’. striking ‘‘September 30, 2022’’ and inserting Sec. 1005. Sunset dates.
SEC. 104. EXTENSION OF AUTHORITY FOR JOINT ‘‘September 30, 2024’’. Sec. 1006. Effective date.
DEPARTMENT OF DEFENSE-DEPART- (b) ADDITIONAL SERVICES AT CERTAIN LOCA- Sec. 1007. Savings clause.
MENT OF VETERANS AFFAIRS MED- TIONS.—Section 2033(d) of such title is TITLE II—FEES RELATING TO DEVICES
ICAL FACILITY DEMONSTRATION amended by striking ‘‘September 30, 2022’’ Sec. 2001. Short title; finding.
FUND.
and inserting ‘‘September 30, 2024’’. Sec. 2002. Definitions.
Section 1704(e) of the National Defense Au- SEC. 304. EXTENSION OF FUNDING FOR FINAN- Sec. 2003. Authority to assess and use device
thorization Act for Fiscal Year 2010 (Public CIAL ASSISTANCE FOR SUPPORTIVE fees.
Law 111–84; 123 Stat. 2573), as most recently SERVICES FOR VERY LOW-INCOME Sec. 2004. Reauthorization; reporting re-
amended by section 715 of the National De- VETERAN FAMILIES IN PERMANENT quirements.
fense Authorization Act for Fiscal Year 2022 HOUSING. Sec. 2005. Conformity assessment pilot pro-
(Public Law 117–81; 135 Stat. 1787), is amend- Section 2044(e)(1)(H) of title 38, United gram.
ed by striking ‘‘September 30, 2023’’ and in- States Code, is amended by striking ‘‘and Sec. 2006. Reauthorization of third-party re-
serting ‘‘September 30, 2024’’. 2022’’ and inserting ‘‘through 2024’’. view program.
SEC. 305. EXTENSION OF FUNDING FOR GRANT Sec. 2007. Sunset dates.
SEC. 105. EXTENSION OF TEMPORARY EXPAN-
PROGRAM FOR HOMELESS VET- Sec. 2008. Effective date.
SION OF PAYMENTS AND ALLOW-
ERANS WITH SPECIAL NEEDS. Sec. 2009. Savings clause.
ANCES FOR BENEFICIARY TRAVEL
IN CONNECTION WITH VETERANS Section 2061(d)(1) of title 38, United States
TITLE III—FEES RELATING TO GENERIC
RECEIVING CARE FROM VET CEN- Code, is amended by striking ‘‘2022’’ and in-
DRUGS
TERS. serting ‘‘2024’’.
SEC. 306. EXTENSION OF AUTHORITY FOR THE Sec. 3001. Short title; finding.
Section 104(a) of the Honoring America’s
ADVISORY COMMITTEE ON HOME- Sec. 3002. Authority to assess and use
Veterans and Caring for Camp Lejeune Fami-
LESS VETERANS. human generic drug fees.
lies Act of 2012 (Public Law 112–154; 126 Stat.
Section 2066(d) of title 38, United States Sec. 3003. Reauthorization; reporting re-
1169), as most recently amended by section 3
Code, is amended by striking ‘‘September 30, quirements.
of the Department of Veterans Affairs Expir- Sec. 3004. Sunset dates.
ing Authorities Act of 2021 (Public Law 117– 2022’’ and inserting ‘‘September 30, 2026’’.
Sec. 3005. Effective date.
42; 135 Stat. 342), is amended by striking TITLE IV—EXTENSIONS OF OTHER
Sec. 3006. Savings clause.
‘‘September 30, 2022’’ and inserting ‘‘Sep- AUTHORITIES
TITLE IV—FEES RELATING TO
tember 30, 2023’’. SEC. 401. EXTENSION OF AUTHORIZATION OF AP-
PROPRIATIONS FOR MONTHLY AS-
BIOSIMILAR BIOLOGICAL PRODUCTS
TITLE II—EXTENSIONS OF AUTHORITIES SISTANCE ALLOWANCE UNDER THE Sec. 4001. Short title; finding.
RELATING TO BENEFITS OFFICE OF NATIONAL VETERANS Sec. 4002. Definitions.
SEC. 201. EXTENSION OF AUTHORITY TO TRANS- SPORTS PROGRAMS AND SPECIAL Sec. 4003. Authority to assess and use bio-
PORT INDIVIDUALS TO AND FROM EVENTS. similar biological product fees.
DEPARTMENT OF VETERANS AF- Section 322(d)(4) of title 38, United States Sec. 4004. Reauthorization; reporting re-
FAIRS FACILITIES. Code, is amended by striking ‘‘2022’’ and in- quirements.
Section 111A(a)(2) of title 38, United States serting ‘‘2026’’. Sec. 4005. Sunset dates.
Code, is amended by striking ‘‘September 30, SEC. 402. EXTENSION AND AUTHORIZATION OF Sec. 4006. Effective date.
2022’’ and inserting ‘‘September 30, 2024’’. APPROPRIATIONS FOR ADAPTIVE Sec. 4007. Savings clause.
SPORTS PROGRAMS FOR DISABLED
SEC. 202. EXTENSION OF AUTHORITY TO MAIN- VETERANS AND MEMBERS OF THE TITLE V—REAUTHORIZATION OF OTHER
TAIN REGIONAL OFFICE IN THE RE- ARMED FORCES. PROVISIONS
PUBLIC OF THE PHILIPPINES.
(a) AUTHORIZATION OF APPROPRIATIONS.— Sec. 5001. Reauthorization of the best phar-
Section 315(b) of title 38, United States Subsection (g)(1)(B) of section 521A of title maceuticals for children pro-
Code, is amended by striking ‘‘September 30, 38, United States Code, is amended by strik- gram.
2022’’ and inserting ‘‘September 30, 2024’’. ing ‘‘and 2022’’ and inserting ‘‘through 2026’’. Sec. 5002. Reauthorization of the humani-
ctelli on DSK11ZRN23PROD with SENATE
SEC. 203. EXTENSION OF AUTHORITY FOR RE- (b) EXTENSION.—Subsection (l) of such sec- tarian device exemption incen-
PORT ON EQUITABLE RELIEF PRO- tion is amended by striking ‘‘2022’’ and in- tive.
VIDED DUE TO ADMINISTRATIVE serting ‘‘2026’’. Sec. 5003. Reauthorization of the pediatric
ERROR. (c) TECHNICAL CORRECTION.—Subsection device consortia program.
Section 503(c) of title 38, United States (g)(1)(A) of such section is amended by strik- Sec. 5004. Reauthorization of provision per-
Code, is amended by striking ‘‘December 31, ing ‘‘. for each of fiscal years 2010 through taining to drugs containing sin-
2022’’ and inserting ‘‘December 31, 2024’’. 2020’’. gle enantiomers.
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S5102 CONGRESSIONAL RECORD — SENATE September 27, 2022
Sec. 5005. Reauthorization of the critical ‘‘(ii) For purposes of this subparagraph, a day of such fiscal year and shall be paid only
path public-private partnership. product shall be considered withdrawn from once for each such product for a fiscal year
Sec. 5006. Reauthorization of orphan drug sale once the applicant has ceased its own in which the fee is payable.’’; and
grants. distribution of the product, whether or not (B) by amending subparagraph (B) to read
Sec. 5007. Reauthorization of certain device the applicant has ordered recall of all pre- as follows:
inspections. viously distributed lots of the product, ex- ‘‘(B) EXCEPTION FOR CERTAIN PRESCRIPTION
Sec. 5008. Reauthorization of reporting re- cept that a routine, temporary interruption DRUG PRODUCTS.—A prescription drug pro-
quirements related to pending in supply shall not render a product with- gram fee shall not be assessed for a prescrip-
generic drug applications and drawn from sale.’’. tion drug product under subparagraph (A) if
priority review applications. (c) SKIN-TEST DIAGNOSTIC PRODUCT.—Sec- such product is—
TITLE I—FEES RELATING TO DRUGS tion 735 of the Federal Food, Drug, and Cos- ‘‘(i) a large volume parenteral product (a
SEC. 1001. SHORT TITLE; FINDING. metic Act (21 U.S.C. 379g) is amended by add- sterile aqueous drug product packaged in a
(a) SHORT TITLE.—This title may be cited ing at the end the following: single-dose container with a volume greater
as the ‘‘Prescription Drug User Fee Amend- ‘‘(12) The term ‘skin-test diagnostic prod- than or equal to 100 mL, not including pow-
ments of 2022’’. uct’— ders for reconstitution or pharmacy bulk
(b) FINDING.—Congress finds that the fees ‘‘(A) means a product— packages) identified on the list compiled
authorized by the amendments made by this ‘‘(i) for prick, scratch, intradermal, or sub- under section 505(j)(7);
title will be dedicated toward expediting the cutaneous administration; ‘‘(ii) pharmaceutically equivalent (as de-
drug development process and the process for ‘‘(ii) expected to produce a limited, local fined in section 314.3 of title 21, Code of Fed-
the review of human drug applications, in- reaction at the site of administration (if eral Regulations (or any successor regula-
cluding postmarket drug safety activities, as positive), rather than a systemic effect; tion)) to another product on the list of prod-
set forth in the goals identified for purposes ‘‘(iii) not intended to be a preventive or ucts compiled under section 505(j)(7) (not in-
of part 2 of subchapter C of chapter VII of therapeutic intervention; and cluding the discontinued section of such
the Federal Food, Drug, and Cosmetic Act ‘‘(iv) intended to detect an immediate- or list); or
(21 U.S.C. 379g et seq.), in the letters from delayed-type skin hypersensitivity reaction ‘‘(iii) a skin-test diagnostic product.’’.
the Secretary of Health and Human Services to aid in the diagnosis of—
‘‘(I) an allergy to an antimicrobial agent; (b) FEE REVENUE AMOUNTS.—
to the Chairman of the Committee on
‘‘(II) an allergy that is not to an anti- (1) IN GENERAL.—Paragraph (1) of section
Health, Education, Labor, and Pensions of
microbial agent, if the diagnostic product 736(b) of the Federal Food, Drug, and Cos-
the Senate and the Chairman of the Com-
mittee on Energy and Commerce of the was authorized for marketing prior to Octo- metic Act (21 U.S.C. 379h(b)) is amended to
House of Representatives, as set forth in the ber 1, 2022; or read as follows:
Congressional Record. ‘‘(III) infection with fungal or ‘‘(1) IN GENERAL.—For each of the fiscal
SEC. 1002. DEFINITIONS. mycobacterial pathogens; and years 2023 through 2027, fees under subsection
‘‘(B) includes positive and negative con- (a) shall, except as provided in subsections
(a) HUMAN DRUG APPLICATION.—Section
735(1) of the Federal Food, Drug, and Cos- trols required to interpret the results of a (c), (d), (f), and (g), be established to gen-
metic Act (21 U.S.C. 379g(1)) is amended, in product described in subparagraph (A).’’. erate a total revenue amount under such
the matter following subparagraph (B), by SEC. 1003. AUTHORITY TO ASSESS AND USE DRUG subsection that is equal to the sum of—
striking ‘‘an allergenic extract product, or’’ FEES. ‘‘(A) the annual base revenue for the fiscal
and inserting ‘‘does not include an applica- (a) TYPES OF FEES.— year (as determined under paragraph (3));
tion with respect to an allergenic extract (1) HUMAN DRUG APPLICATION FEE.—Section ‘‘(B) the dollar amount equal to the infla-
product licensed before October 1, 2022, does 736(a) of the Federal Food, Drug, and Cos- tion adjustment for the fiscal year (as deter-
not include an application with respect to a metic Act (21 U.S.C. 379h(a)) is amended— mined under subsection (c)(1));
standardized allergenic extract product sub- (A) in the matter preceding paragraph (1), ‘‘(C) the dollar amount equal to the stra-
mitted pursuant to a notification to the ap- by striking ‘‘fiscal year 2018’’ and inserting tegic hiring and retention adjustment for the
plicant from the Secretary regarding the ex- ‘‘fiscal year 2023’’; fiscal year (as determined under subsection
istence of a potency test that measures the (B) in paragraph (1)(A), by striking ‘‘(c)(5)’’ (c)(2));
allergenic activity of an allergenic extract each place it appears and inserting ‘‘(c)(6)’’; ‘‘(D) the dollar amount equal to the capac-
product licensed by the applicant before Oc- (C) in paragraph (1)(C), by inserting ‘‘prior ity planning adjustment for the fiscal year
tober 1, 2022, does not include an application to approval’’ after ‘‘or was withdrawn’’; and (as determined under subsection (c)(3));
with respect to’’. (D) in paragraph (1), by adding at the end ‘‘(E) the dollar amount equal to the oper-
(b) PRESCRIPTION DRUG PRODUCT.—Section the following: ating reserve adjustment for the fiscal year,
735(3) of the Federal Food, Drug, and Cos- ‘‘(H) EXCEPTION FOR SKIN-TEST DIAGNOSTIC if applicable (as determined under subsection
metic Act (21 U.S.C. 379g(3)) is amended— PRODUCTS.—A human drug application for a (c)(4));
(1) by redesignating subparagraphs (A), (B), skin-test diagnostic product shall not be sub- ‘‘(F) the dollar amount equal to the addi-
and (C) as clauses (i), (ii), and (iii), respec- ject to a fee under subparagraph (A).’’. tional direct cost adjustment for the fiscal
tively; (2) PRESCRIPTION DRUG PROGRAM FEE.—Sec- year (as determined under subsection (c)(5));
(2) by striking ‘‘(3) The term’’ and insert- tion 736(a)(2) of the Federal Food, Drug, and and
ing ‘‘(3)(A) The term’’; Cosmetic Act (21 U.S.C. 379h(a)(2)) is amend- ‘‘(G) additional dollar amounts for each fis-
(3) by striking ‘‘Such term does not include ed— cal year as follows:
whole blood’’ and inserting the following: (A) in subparagraph (A)— ‘‘(i) $65,773,693 for fiscal year 2023.
‘‘(B) Such term does not include whole (i) by striking ‘‘Except as provided in sub- ‘‘(ii) $25,097,671 for fiscal year 2024.
blood’’; paragraphs (B) and (C)’’ and inserting the ‘‘(iii) $14,154,169 for fiscal year 2025.
(4) by striking ‘‘an allergenic extract prod- following: ‘‘(iv) $4,864,860 for fiscal year 2026.
uct,’’ and inserting ‘‘an allergenic extract ‘‘(i) PAYMENT OF FEES.—Except as provided ‘‘(v) $1,314,620 for fiscal year 2027.’’.
product licensed before October 1, 2022, a in subparagraphs (B) and (C)’’; (2) ANNUAL BASE REVENUE.—Paragraph (3)
standardized allergenic extract product sub- (ii) by striking ‘‘subsection (c)(5)’’ and in- of section 736(b) of the Federal Food, Drug,
mitted pursuant to a notification to the ap- serting ‘‘subsection (c)(6)’’; and and Cosmetic Act (21 U.S.C. 379h(b)) is
plicant from the Secretary regarding the ex- (iii) by adding at the end the following: amended to read as follows:
istence of a potency test that measures the ‘‘(ii) SPECIAL RULE FOR PREVIOUSLY DISCON- ‘‘(3) ANNUAL BASE REVENUE.—For purposes
allergenic activity of an allergenic extract TINUED DRUG PRODUCTS.—If a drug product of paragraph (1), the dollar amount of the an-
product licensed by the applicant before Oc- that is identified in a human drug applica- nual base revenue for a fiscal year shall be—
tober 1, 2022,’’ ; and tion approved as of October 1 of a fiscal year ‘‘(A) for fiscal year 2023, $1,151,522,958; and
(5) by adding at the end the following: is not a prescription drug product as of that ‘‘(B) for fiscal years 2024 through 2027, the
‘‘(C)(i) If a written request to place a prod- date because the drug product is in the dis- dollar amount of the total revenue amount
uct in the discontinued section of either of continued section of a list referenced in sec- established under paragraph (1) for the pre-
the lists referenced in subparagraph (A)(iii) tion 735(3)(A)(iii), and on any subsequent day vious fiscal year, not including any adjust-
is submitted to the Secretary on behalf of an during such fiscal year the drug product is a ments made under subsection (c)(4) or
applicant, and the request identifies the date prescription drug product, then except as (c)(5).’’.
the product is, or will be, withdrawn from provided in subparagraphs (B) and (C), each (c) ADJUSTMENTS; ANNUAL FEE SETTING.—
sale, then for purposes of assessing the pre- person who is named as the applicant in a (1) INFLATION ADJUSTMENT.—Section
scription drug program fee under section human drug application with respect to such 736(c)(1)(B)(ii) of the Federal Food, Drug, and
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736(a)(2), the Secretary shall consider such product, and who, after September 1, 1992, Cosmetic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is
product to have been included in the discon- had pending before the Secretary a human amended by striking ‘‘Washington-Balti-
tinued section on the later of— drug application or supplement, shall pay more, DC–MD–VA–WV’’ and inserting ‘‘Wash-
‘‘(I) the date such request was received; or the annual prescription drug program fee es- ington-Arlington-Alexandria, DC–VA–MD–
‘‘(II) if the product will be withdrawn from tablished for a fiscal year under subsection WV’’.
sale on a future date, such future date when (c)(6) for such prescription drug product. (2) STRATEGIC HIRING AND RETENTION AD-
the product is withdrawn from sale. Such fee shall be due on the last business JUSTMENT.—Section 736(c) of the Federal
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5103
Food, Drug, and Cosmetic Act (21 U.S.C. carryover user fees for the process for the re- tion is requested. Such certification shall be
379h(c)) is amended— view of human drug applications for each fis- supported by—
(A) by redesignating paragraphs (2) cal year in at least the following amounts: ‘‘(A) tax returns submitted to the United
through (6) as paragraphs (3) through (7), re- ‘‘(i) For fiscal year 2023, at least 8 weeks of States Internal Revenue Service; or
spectively; and operating reserves. ‘‘(B) as necessary, other appropriate finan-
(B) by inserting after paragraph (1) the fol- ‘‘(ii) For fiscal year 2024, at least 9 weeks cial information.’’.
lowing: of operating reserves. SEC. 1004. REAUTHORIZATION; REPORTING RE-
‘‘(2) STRATEGIC HIRING AND RETENTION AD- ‘‘(iii) For fiscal year 2025 and subsequent QUIREMENTS.
JUSTMENT.—For each fiscal year, after the fiscal years, at least 10 weeks of operating Section 736B of the Federal Food, Drug,
annual base revenue established in sub- reserves.’’; and and Cosmetic Act (21 U.S.C. 379h–2) is amend-
section (b)(1)(A) is adjusted for inflation in (B) in subparagraph (C), by striking ‘‘para- ed—
accordance with paragraph (1), the Secretary graph (5)’’ and inserting ‘‘paragraph (6)’’. (1) in subsection (a)(1), by striking ‘‘Begin-
shall further increase the fee revenue and (5) ADDITIONAL DIRECT COST ADJUSTMENT.— ning with fiscal year 2018, not’’ and inserting
fees by the following amounts: Paragraph (5), as redesignated, of section ‘‘Not’’;
‘‘(A) For fiscal year 2023, $9,000,000. 736(c) of the Federal Food, Drug, and Cos- (2) by striking ‘‘Prescription Drug User
‘‘(B) For each of fiscal years 2024 through metic Act (21 U.S.C. 379h(c)) is amended to Fee Amendments of 2017’’ each place it ap-
2027, $4,000,000.’’. read as follows: pears and inserting ‘‘Prescription Drug User
(3) CAPACITY PLANNING ADJUSTMENT.—Para- ‘‘(5) ADDITIONAL DIRECT COST ADJUST- Fee Amendments of 2022’’;
graph (3), as redesignated, of section 736(c) of MENT.— (3) in subsection (a)(3)(A), by striking ‘‘Not
the Federal Food, Drug, and Cosmetic Act ‘‘(A) INCREASE.—The Secretary shall, in ad- later than 30 calendar days after the end of
(21 U.S.C. 379h(c)) is amended to read as fol- dition to adjustments under paragraphs (1), the second quarter of fiscal year 2018, and
lows: (2), (3), and (4), further increase the fee rev- not later than 30 calendar days after the end
‘‘(3) CAPACITY PLANNING ADJUSTMENT.— enue and fees— of each quarter of each fiscal year there-
‘‘(A) IN GENERAL.—For each fiscal year, ‘‘(i) for fiscal year 2023, by $44,386,150; and after’’ and inserting ‘‘Not later than 30 cal-
after the annual base revenue established in ‘‘(ii) for each of fiscal years 2024 through endar days after the end of each quarter of
subsection (b)(1)(A) is adjusted in accordance 2027, by the amount set forth in clauses (i) each fiscal year for which fees are collected
with paragraphs (1) and (2), such revenue through (iv) of subparagraph (B), as applica- under this part’’;
shall be adjusted further for such fiscal year, ble, multiplied by the Consumer Price Index (4) in subsection (a)(4), by striking ‘‘Begin-
in accordance with this paragraph, to reflect for urban consumers (Washington-Arlington- ning with fiscal year 2020, the’’ and inserting
changes in the resource capacity needs of the Alexandria, DC–VA–MD–WV; Not Seasonally ‘‘The’’;
Secretary for the process for the review of Adjusted; All Items; Annual Index) for the (5) in subsection (b), by striking ‘‘Begin-
human drug applications. most recent year of available data, divided ning with fiscal year 2018, not’’ and inserting
‘‘(B) METHODOLOGY.—For purposes of this by such Index for 2021. ‘‘Not’’;
paragraph, the Secretary shall employ the ‘‘(B) APPLICABLE AMOUNTS.—The amounts (6) in subsection (c), by striking ‘‘Begin-
capacity planning methodology utilized by referred to in subparagraph (A)(ii) are the ning with fiscal year 2018, for’’ and inserting
the Secretary in setting fees for fiscal year ‘‘For’’; and
following:
2021, as described in the notice titled ‘Pre- (7) in subsection (f)—
‘‘(i) For fiscal year 2024, $60,967,993.
scription Drug User Fee Rates for Fiscal (A) in paragraph (1), in the matter pre-
‘‘(ii) For fiscal year 2025, $35,799,314.
Year 2021’ published in the Federal Register ceding subparagraph (A), by striking ‘‘fiscal
‘‘(iii) For fiscal year 2026, $35,799, 314.
on August 3, 2020 (85 Fed. Reg. 46651). The year 2022’’ and inserting ‘‘fiscal year 2027’’;
‘‘(iv) For fiscal year 2027, $35,799,314.’’.
workload categories used in applying such and
(6) ANNUAL FEE SETTING.—Paragraph (6), as
methodology in forecasting shall include
redesignated, of section 736(c) of the Federal (B) in paragraph (5), by striking ‘‘January
only the activities described in that notice
Food, Drug, and Cosmetic Act (21 U.S.C. 15, 2022’’ and inserting ‘‘January 15, 2027’’.
and, as feasible, additional activities that
379h(c)) is amended by striking ‘‘September SEC. 1005. SUNSET DATES.
are directly related to the direct review of
30, 2017’’ and inserting ‘‘September 30, 2022’’. (a) AUTHORIZATION.—Sections 735 and 736 of
applications and supplements, including ad-
(d) CREDITING AND AVAILABILITY OF FEES.— the Federal Food, Drug, and Cosmetic Act
ditional formal meeting types, the direct re-
Section 736(g)(3) of the Federal Food, Drug, (21 U.S.C. 379g; 379h) shall cease to be effec-
view of postmarketing commitments and re-
quirements, the direct review of risk evalua- and Cosmetic Act (21 U.S.C. 379h(g)(3)) is tive October 1, 2027.
amended by striking ‘‘fiscal years 2018 (b) REPORTING REQUIREMENTS.—Section
tion and mitigation strategies, and the di-
through 2022’’ and inserting ‘‘fiscal years 2023 736B of the Federal Food, Drug, and Cos-
rect review of annual reports for approved
through 2027’’. metic Act (21 U.S.C. 379h–2) shall cease to be
prescription drug products. Subject to the
(e) WRITTEN REQUESTS FOR WAIVERS, RE- effective January 31, 2028.
exceptions in the preceding sentence, the (c) PREVIOUS SUNSET PROVISION.—Effective
Secretary shall not include as workload cat- DUCTIONS, EXEMPTIONS, AND RETURNS; DIS-
PUTES CONCERNING FEES.—Section 736(i) of October 1, 2022, subsections (a) and (b) of sec-
egories in applying such methodology in
the Federal Food, Drug, and Cosmetic Act tion 104 of the FDA Reauthorization Act of
forecasting any non-core review activities,
(21 U.S.C. 379h(i)) is amended to read as fol- 2017 (Public Law 115–52) are repealed.
including those activities that the Secretary
lows: SEC. 1006. EFFECTIVE DATE.
referenced for potential future use in such
‘‘(i) WRITTEN REQUESTS FOR WAIVERS, RE- The amendments made by this title shall
notice but did not utilize in setting fees for
DUCTIONS, EXEMPTIONS, AND RETURNS; DIS-
take effect on October 1, 2022, or the date of
fiscal year 2021.
‘‘(C) LIMITATION.—Under no circumstances PUTES CONCERNING FEES.—To qualify for con-
the enactment of this Act, whichever is
shall an adjustment under this paragraph re- sideration for a waiver or reduction under later, except that fees under part 2 of sub-
sult in fee revenue for a fiscal year that is subsection (d), an exemption under sub- chapter C of chapter VII of the Federal Food,
less than the sum of the amounts under sub- section (k), or the return of any fee paid Drug, and Cosmetic Act (21 U.S.C. 379g et
sections (b)(1)(A) (the annual base revenue under this section, including if the fee is seq.) shall be assessed for all human drug ap-
for the fiscal year), (b)(1)(B) (the dollar claimed to have been paid in error, a person plications received on or after October 1,
amount of the inflation adjustment for the shall— 2022, regardless of the date of the enactment
fiscal year), and (b)(1)(C) (the dollar amount ‘‘(1) not later than 180 days after such fee of this Act.
is due, submit to the Secretary a written re- SEC. 1007. SAVINGS CLAUSE.
of the strategic hiring and retention adjust-
ment for the fiscal year). quest justifying such waiver, reduction, ex- Notwithstanding the amendments made by
‘‘(D) PUBLICATION IN FEDERAL REGISTER.— emption, or return; and this title, part 2 of subchapter C of chapter
The Secretary shall publish in the Federal ‘‘(2) include in the request any legal au- VII of the Federal Food, Drug, and Cosmetic
Register notice under paragraph (6) of the fee thorities under which the request is made.’’. Act (21 U.S.C. 379g et seq.), as in effect on the
revenue and fees resulting from the adjust- (f) ORPHAN DRUGS.—Section 736(k) of the day before the date of the enactment of this
ment and the methodologies under this para- Federal Food, Drug, and Cosmetic Act (21 title, shall continue to be in effect with re-
graph.’’. U.S.C. 379h(k)) is amended— spect to human drug applications and supple-
(4) OPERATING RESERVE ADJUSTMENT.— (1) in paragraph (1)(B), by striking ‘‘during ments (as defined in such part as of such
Paragraph (4), as redesignated, of section the previous year’’ and inserting ‘‘as deter- day) that were accepted by the Food and
736(c) of the Federal Food, Drug, and Cos- mined under paragraph (2)’’; and Drug Administration for filing on or after
metic Act (21 U.S.C. 379h(c)) is amended— (2) by amending paragraph (2) to read as October 1, 2017, but before October 1, 2022,
(A) by amending subparagraph (A) to read follows: with respect to assessing and collecting any
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as follows: ‘‘(2) EVIDENCE OF QUALIFICATION.—An ex- fee required by such part for a fiscal year
‘‘(A) INCREASE.—For fiscal year 2023 and emption under paragraph (1) applies with re- prior to fiscal year 2023.
subsequent fiscal years, the Secretary shall, spect to a drug only if the applicant involved TITLE II—FEES RELATING TO DEVICES
in addition to adjustments under paragraphs submits a certification that the applicant’s SEC. 2001. SHORT TITLE; FINDING.
(1), (2), and (3), further increase the fee rev- gross annual revenues did not exceed (a) SHORT TITLE.—This title may be cited
enue and fees if such an adjustment is nec- $50,000,000 for the last calendar year ending as the ‘‘Medical Device User Fee Amend-
essary to provide for operating reserves of prior to the fiscal year for which the exemp- ments of 2022’’.
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S5104 CONGRESSIONAL RECORD — SENATE September 27, 2022
(b) FINDING.—Congress finds that the fees (C) in subparagraph (F), by striking ‘‘and (ii) in clause (iii), by striking ‘‘75 percent’’
authorized under the amendments made by premarket notification submissions’’ and in- and inserting ‘‘80 percent’’; and
this title will be dedicated toward expediting serting ‘‘premarket notification submis- (iii) in clause (viii), by striking ‘‘3.4 per-
the process for the review of device applica- sions, and de novo classification requests’’; cent’’ and inserting ‘‘4.5 percent’’;
tions and for assuring the safety and effec- (D) in each of subparagraphs (G) and (H), (B) in subparagraph (B)(iii), by striking ‘‘or
tiveness of devices, as set forth in the goals by striking ‘‘or submissions’’ and inserting premarket notification submission’’ and in-
identified for purposes of part 3 of sub- ‘‘submissions, or requests’’; and serting ‘‘premarket notification submission,
chapter C of chapter VII of the Federal Food, (E) in subparagraph (K), by striking ‘‘or or de novo classification request’’; and
Drug, and Cosmetic Act (21 U.S.C. 379i et premarket notification submissions’’ and in- (C) in subparagraph (C), by striking ‘‘or
seq.), in the letters from the Secretary of serting ‘‘premarket notification submis-
periodic reporting concerning a class III de-
Health and Human Services to the Chairman sions, or de novo classification requests’’;
of the Committee on Health, Education, vice’’ and inserting ‘‘periodic reporting con-
and
Labor, and Pensions of the Senate and the cerning a class III device, or de novo classi-
(2) in paragraph (11), by striking ‘‘2016’’ and
Chairman of the Committee on Energy and inserting ‘‘2021’’. fication request’’.
Commerce of the House of Representatives, (b) FEE AMOUNTS.—Section 738(b) of the
as set forth in the Congressional Record. SEC. 2003. AUTHORITY TO ASSESS AND USE DE-
VICE FEES. Federal Food, Drug, and Cosmetic Act (21
SEC. 2002. DEFINITIONS. U.S.C. 379j(b)) is amended—
Section 737 of the Federal Food, Drug, and (a) TYPES OF FEES.—Section 738(a) of the (1) in paragraph (1), by striking ‘‘2018
Cosmetic Act (21 U.S.C. 379i) is amended— Federal Food, Drug, and Cosmetic Act (21
through 2022’’ and inserting ‘‘2023 through
(1) in paragraph (9)— U.S.C. 379j(a)) is amended—
2027’’;
(A) in the matter preceding subparagraph (1) in paragraph (1), by striking ‘‘fiscal
(2) by amending paragraph (2) to read as
(A), by striking ‘‘and premarket notification year 2018’’ and inserting ‘‘fiscal year 2023’’;
and follows:
submissions’’ and inserting ‘‘premarket noti-
fication submissions, and de novo classifica- (2) in paragraph (2)— ‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For
tion requests’’; (A) in subparagraph (A)— purposes of paragraph (1), the base fee
(B) in subparagraph (D), by striking ‘‘and (i) in the matter preceding clause (i), by amounts specified in this paragraph are as
submissions’’ and inserting ‘‘submissions, striking ‘‘October 1, 2017’’ and inserting ‘‘Oc- follows:
and de novo classification requests’’; tober 1, 2022’’;
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 Registration ........................................................................................................................................... $6,250 $6,875 $7,100 $7,575 $8,465’’;
and
(3) by amending paragraph (3) to read as applications identified in the letters de- the amounts determined under this subpara-
follows: scribed in section 2001(b) of the Medical De- graph are as follows:
‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.— vice User Fee Amendments of 2022, as the ‘‘(I) For fiscal year 2026, $6,323,500 if such
For purposes of paragraph (1), the total rev- Secretary determines necessary to achieve goal for fiscal year 2023 is met.
enue amounts specified in this paragraph are an increase in total fee collections for such ‘‘(II) For fiscal year 2027:
as follows: fiscal year equal to the following amounts, ‘‘(aa) $6,323,500 if such goal for fiscal year
‘‘(A) $312,606,000 for fiscal year 2023. as applicable: 2023 is met and such goal for fiscal year 2024
‘‘(B) $335,750,000 for fiscal year 2024. ‘‘(i) For fiscal year 2025, the product of— is not met.
‘‘(C) $350,746,400 for fiscal year 2025. ‘‘(I) the amount determined under subpara- ‘‘(bb) $11,765,400 if such goal for fiscal year
‘‘(D) $366,486,300 for fiscal year 2026. graph (B)(i)(I); and 2024 is met.
‘‘(E) $418,343,000 for fiscal year 2027.’’. ‘‘(II) the applicable inflation adjustment
‘‘(iii) PREMARKET NOTIFICATION AND PRE-
(c) ANNUAL FEE SETTING; ADJUSTMENTS.— under paragraph (2)(B) for such fiscal year.
MARKET APPROVAL AMOUNT.—For purposes of
Section 738(c) of the Federal Food, Drug, and ‘‘(ii) For fiscal year 2026, the product of—
subparagraph (A), with respect to the 510(k)
Cosmetic Act (21 U.S.C. 379j(c)) is amended— ‘‘(I) the sum of the amounts determined
(1) in paragraph (1), by striking ‘‘2017’’ and under subparagraphs (B)(i)(II), (B)(ii)(I), and decision goal, 510(k) Shared Outcome Total
inserting ‘‘2022’’; (B)(iii)(I); and Time to Decision goal, PMA decision goal,
(2) in paragraph (2)— ‘‘(II) the applicable inflation adjustment and PMA Shared Outcome Total Time to De-
(A) in subparagraph (A), by striking ‘‘2018’’ under paragraph (2)(B) for such fiscal year. cision goal, the amounts determined under
and inserting ‘‘2023’’; ‘‘(iii) For fiscal year 2027, the product of— this subparagraph are as follows:
(B) in subparagraph (B)— ‘‘(I) the sum of the amounts determined ‘‘(I) For fiscal year 2026, $1,020,000 if the 4
(i) in the matter preceding clause (i), by under subparagraphs (B)(i)(III), (B)(ii)(II), goals for fiscal year 2023 are met.
striking ‘‘fiscal year 2018’’ and inserting ‘‘fis- and (B)(iii)(II); and ‘‘(II) For fiscal year 2027:
cal year 2023’’; and ‘‘(II) the applicable inflation adjustment ‘‘(aa) $1,020,000 if the 4 goals for fiscal year
(ii) in clause (ii), by striking ‘‘fiscal year under paragraph (2)(B) for such fiscal year. 2023 are met and one or more of the 4 goals
2016’’ and inserting ‘‘fiscal year 2022’’; ‘‘(B) AMOUNTS.— for fiscal year 2024 are not met.
(C) in subparagraph (C), by striking ‘‘Wash- ‘‘(i) PRESUBMISSION AMOUNT.—For purposes ‘‘(bb) $3,906,000 if the 4 goals for fiscal year
ington-Baltimore, DC–MD–VA–WV’’ and in- of subparagraph (A), with respect to the Pre- 2024 are met.
serting ‘‘Washington-Arlington-Alexandria, submission Written Feedback goal, the ‘‘(C) PERFORMANCE CALCULATION.—For pur-
DC–VA–MD–WV’’; and amounts determined under this subpara- poses of this paragraph, performance of the
(D) in subparagraph (D), in the matter pre- graph are as follows: following goals shall be determined as speci-
ceding clause (i), by striking ‘‘fiscal years ‘‘(I) For fiscal year 2025, $15,396,600 if such fied in the letters described in section 2001(b)
2018 through 2022’’ and inserting ‘‘fiscal years goal for fiscal year 2023 is met. of the Medical Device User Fee Amendments
2023 through 2027’’; ‘‘(II) For fiscal year 2026:
of 2022 and based on data available, as fol-
(3) in paragraph (3), by striking ‘‘2018 ‘‘(aa) $15,396,600 if such goal for fiscal year
lows:
through 2022’’ and inserting ‘‘2023 through 2023 is met and such goal for fiscal year 2024
2027’’; is not met. ‘‘(i) The performance of the Presubmission
(4) by redesignating paragraphs (4) and (5) ‘‘(bb) $36,792,200 if such goal for fiscal year Written Feedback goal shall be based on data
as paragraphs (7) and (8), respectively; and 2024 is met. available as of—
(5) by inserting after paragraph (3) the fol- ‘‘(III) For fiscal year 2027: ‘‘(I) for fiscal year 2023, March 31, 2024;
lowing: ‘‘(aa) $15,396,600 if such goal for fiscal year ‘‘(II) for fiscal year 2024, March 31, 2025; and
‘‘(4) PERFORMANCE IMPROVEMENT ADJUST- 2023 is met and such goal for each of fiscal ‘‘(III) for fiscal year 2025, March 31, 2026.
MENT.— years 2024 and 2025 is not met. ‘‘(ii) The performance of the De Novo Deci-
‘‘(A) IN GENERAL.—For each of fiscal years ‘‘(bb) $36,792,200 if such goal for fiscal year sion goal, 510(k) decision goal, 510(k) Shared
ctelli on DSK11ZRN23PROD with SENATE
2025 through 2027, after the adjustments 2024 is met and such goal for fiscal year 2025 Outcome Total Time to Decision goal, PMA
under paragraphs (2) and (3), the base estab- is not met. decision goal, and PMA Shared Outcome
lishment registration fee amounts for such ‘‘(cc) $40,572,600 if such goal for fiscal year Total Time to Decision goal shall be based
fiscal year shall be increased to reflect 2025 is met. on data available as of—
changes in the resource needs of the Sec- ‘‘(ii) DE NOVO CLASSIFICATION REQUEST ‘‘(I) for fiscal year 2023, March 31, 2025; and
retary due to improved review performance AMOUNT.—For purposes of subparagraph (A),
goals for the process for the review of device with respect to the De Novo Decision goal,
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5105
‘‘(II) for fiscal year 2024, March 31, 2026. ‘‘(ii) 1 month of operating reserves main- be accredited, by accreditation bodies meet-
‘‘(D) GOALS DEFINED.—For purposes of this tained pursuant to paragraph (8). ing criteria specified in guidance by the Sec-
paragraph, the terms ‘Presubmission Written ‘‘(C) EXCLUDED AMOUNT.—For the period of retary, to conduct testing to support the as-
Feedback goal’, ‘De Novo Decision goal’, fiscal years 2023 through 2026, a total amount sessment of the conformity of a device to
‘510(k) decision goal’, ‘510(k) Shared Outcome equal to $118,000,000 shall not be considered certain standards recognized under this sec-
Total Time to Decision goal’, ‘PMA decision part of the designated amount under sub- tion; and
goal’, and ‘PMA Shared Outcome Total Time paragraph (B) and shall not be subject to the ‘‘(B) subject to paragraph (2), results from
to Decision goal’ refer to the goals identified decrease under subparagraph (A).’’. tests conducted to support the assessment of
by the same names in the letters described in (d) CONDITIONS.—Section 738(g) of the Fed- conformity of devices as described in sub-
section 2001(b) of the Medical Device User eral Food, Drug, and Cosmetic Act (21 U.S.C. paragraph (A) conducted by testing labora-
Fee Amendments of 2022. 379j(g)) is amended— tories accredited pursuant to this subsection
‘‘(5) HIRING ADJUSTMENT.— (1) in paragraph (1)(A), by striking shall be accepted by the Secretary for pur-
‘‘(A) IN GENERAL.—For each of fiscal years ‘‘$320,825,000’’ and inserting ‘‘$398,566,000’’; poses of demonstrating such conformity un-
2025 through 2027, after the adjustments and less the Secretary finds that certain results
under paragraphs (2), (3), and (4), if applica- (2) in paragraph (2), by inserting ‘‘de novo of such tests should not be so accepted.
ble, if the number of hires to support the classification requests,’’ after ‘‘class III de- ‘‘(2) SECRETARIAL REVIEW OF ACCREDITED
process for the review of device applications vice,’’. LABORATORY RESULTS.—The Secretary may—
falls below the thresholds specified in sub- (e) CREDITING AND AVAILABILITY OF FEES.— ‘‘(A) review the results of tests conducted
paragraph (B) for the applicable fiscal years, Section 738(h)(3) of the Federal Food, Drug, by testing laboratories accredited pursuant
the base establishment registration fee and Cosmetic Act (21 U.S.C. 379j(h)(3)) is to this subsection, including by conducting
amounts shall be decreased as the Secretary amended to read as follows: periodic audits of such results or of the proc-
determines necessary to achieve a reduction ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— esses of accredited bodies or testing labora-
in total fee collections equal to the hiring ‘‘(A) IN GENERAL.—For each of fiscal years tories;
adjustment amount under subparagraph (C). 2023 through 2027, there is authorized to be ‘‘(B) following such review, take additional
‘‘(B) THRESHOLDS.—The thresholds speci- appropriated for fees under this section an measures under this Act, as the Secretary
fied in this subparagraph are as follows: amount equal to the revenue amount deter- determines appropriate, such as—
‘‘(i) For fiscal year 2025, the threshold is mined under subparagraph (B), less the ‘‘(i) suspension or withdrawal of accredita-
123 hires for fiscal year 2023. amount of reductions determined under sub- tion of a testing laboratory or recognition of
‘‘(ii) For fiscal year 2026, the threshold is 38 paragraph (C). an accreditation body under paragraph
hires for fiscal year 2024. ‘‘(B) REVENUE AMOUNT.—For purposes of (1)(A); or
‘‘(iii) For fiscal year 2027, the threshold this paragraph, the revenue amount for each ‘‘(ii) requesting additional information
is— fiscal year is the sum of— with respect to a device; and
‘‘(I) 22 hires for fiscal year 2025 if the base ‘‘(i) the total revenue amount under sub- ‘‘(C) if the Secretary becomes aware of in-
establishment registration fees are not in- section (b)(3) for the fiscal year, as adjusted formation materially bearing on the safety
creased by the amount determined under under paragraphs (2) and (3) of subsection (c); or effectiveness of a device for which an as-
paragraph (4)(A)(i); or and sessment of conformity was supported by
‘‘(II) 75 hires for fiscal year 2025 if such fees ‘‘(ii) the performance improvement adjust- testing conducted by a testing laboratory ac-
are so increased. ment amount for the fiscal year under sub- credited under this subsection, take such ad-
‘‘(C) HIRING ADJUSTMENT AMOUNT.—The hir- section (c)(4), if applicable. ditional measures under this Act, as the Sec-
ing adjustment amount for fiscal year 2025 ‘‘(C) AMOUNT OF REDUCTIONS.—For purposes retary determines appropriate, such as—
and each subsequent fiscal year is the prod- of this paragraph, the amount of reductions ‘‘(i) suspension or withdrawal of accredita-
uct of— for each fiscal year is the sum of— tion of a testing laboratory or recognition of
‘‘(i) the number of hires by which the hir- ‘‘(i) the hiring adjustment amount for the an accreditation body under paragraph
ing goal specified in subparagraph (D) for the fiscal year under subsection (c)(5), if applica- (1)(A); or
fiscal year before the prior fiscal year was ble; and ‘‘(ii) requesting additional information
not met; ‘‘(ii) the operating reserve adjustment with regard to such device.
‘‘(ii) $72,877; and amount for the fiscal year under subsection ‘‘(3) REPORT.—The Secretary shall make
‘‘(iii) the applicable inflation adjustment (c)(6), if applicable.’’. available on the internet website of the Food
under paragraph (2)(B) for the fiscal year for SEC. 2004. REAUTHORIZATION; REPORTING RE- and Drug Administration an annual report
which the hiring goal was not met. QUIREMENTS. on the progress of the program under this
‘‘(D) HIRING GOALS.—The hiring goals for (a) PERFORMANCE REPORTS.—Section subsection.’’.
each of fiscal years 2023 through 2025 are as 738A(a) of the Federal Food, Drug, and Cos- SEC. 2006. REAUTHORIZATION OF THIRD-PARTY
follows: metic Act (21 U.S.C. 379j–1(a)) is amended— REVIEW PROGRAM.
‘‘(i) For fiscal year 2023, 144 hires. (1) by striking ‘‘fiscal year 2018’’ each place Section 523(c) of the Federal Food, Drug,
‘‘(ii) For fiscal year 2024, 42 hires. it appears and inserting ‘‘fiscal year 2023’’; and Cosmetic Act (21 U.S.C. 360m(c)) is
‘‘(iii) For fiscal year 2025: (2) by striking ‘‘Medical Device User Fee amended by striking ‘‘October 1’’ and insert-
‘‘(I) 24 hires if the base establishment reg- Amendments of 2017’’ each place it appears ing ‘‘December 17’’.
istration fees are not increased by the and inserting ‘‘Medical Device User Fee SEC. 2007. SUNSET DATES.
amount determined under paragraph Amendments of 2022’’; (a) AUTHORIZATION.—Sections 737 and 738 of
(4)(A)(i). (3) in paragraph (1)— the Federal Food, Drug, and Cosmetic Act
‘‘(II) 83 hires if the base establishment reg- (A) in subparagraph (A), by redesignating (21 U.S.C. 379i; 379j) shall cease to be effec-
istration fees are increased by the amount the second clause (iv) (relating to analysis) tive October 1, 2027.
determined under paragraph (4)(A)(i). as clause (v); and (b) REPORTING REQUIREMENTS.—Section
‘‘(E) NUMBER OF HIRES.—For purposes of (B) in subparagraph (A)(iv), by striking 738A of the Federal Food, Drug, and Cos-
this paragraph, the number of hires for a fis- ‘‘fiscal year 2020’’ and inserting ‘‘fiscal year metic Act (21 U.S.C. 379j–1) shall cease to be
cal year shall be determined by the Sec- 2023’’; and effective January 31, 2028.
retary as set forth in the letters described in (4) in paragraph (4), by striking ‘‘2018 (c) PREVIOUS SUNSET PROVISIONS.—Effec-
section 2001(b) of the Medical Device User through 2022’’ and inserting ‘‘2023 through tive October 1, 2022, subsections (a) and (b) of
Fee Amendments of 2022. 2027’’. section 210 of the FDA Reauthorization Act
‘‘(6) OPERATING RESERVE ADJUSTMENT.— (b) REAUTHORIZATION.—Section 738A(b) of of 2017 (Public Law 115–52) are repealed.
‘‘(A) IN GENERAL.—For each of fiscal years the Federal Food, Drug, and Cosmetic Act SEC. 2008. EFFECTIVE DATE.
2023 through 2027, after the adjustments (21 U.S.C. 379j–1(b)) is amended— The amendments made by this title shall
under paragraphs (2), (3), (4), and (5), if appli- (1) in paragraph (1), by striking ‘‘2022’’ and take effect on October 1, 2022, or the date of
cable, if the Secretary has operating reserves inserting ‘‘2027’’; and the enactment of this Act, whichever is
of carryover user fees for the process for the (2) in paragraph (5), by striking ‘‘2022’’ and later, except that fees under part 3 of sub-
review of device applications in excess of the inserting ‘‘2027’’. chapter C of chapter VII of the Federal Food,
designated amount in subparagraph (B), the SEC. 2005. CONFORMITY ASSESSMENT PILOT Drug, and Cosmetic Act (21 U.S.C. 379i et
Secretary shall decrease the base establish- PROGRAM. seq.) shall be assessed for all submissions
ment registration fee amounts to provide for Section 514(d) of the Federal Food, Drug, listed in section 738(a)(2)(A) of such Act re-
not more than such designated amount of op- and Cosmetic Act (21 U.S.C. 360d(d)) is ceived on or after October 1, 2022, regardless
ctelli on DSK11ZRN23PROD with SENATE
erating reserves. amended to read as follows: of the date of the enactment of this Act.
‘‘(B) DESIGNATED AMOUNT.—Subject to sub- ‘‘(d) ACCREDITATION SCHEME FOR CON- SEC. 2009. SAVINGS CLAUSE.
paragraph (C), for each fiscal year, the des- FORMITY ASSESSMENT.— Notwithstanding the amendments made by
ignated amount in this subparagraph is ‘‘(1) IN GENERAL.—The Secretary shall es- this title, part 3 of subchapter C of chapter
equal to the sum of— tablish a program under which— VII of the Federal Food, Drug, and Cosmetic
‘‘(i) 13 weeks of operating reserves of carry- ‘‘(A) testing laboratories meeting criteria Act (21 U.S.C. 379i et seq.), as in effect on the
over user fees; and specified in guidance by the Secretary may day before the date of the enactment of this
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S5106 CONGRESSIONAL RECORD — SENATE September 27, 2022
title, shall continue to be in effect with re- (c) ADJUSTMENTS.—Section 744B(c) of the ‘‘(III) for purposes of a fiscal year 2026 ad-
spect to the submissions listed in section Federal Food, Drug, and Cosmetic Act (21 justment, the Secretary determines that
738(a)(2)(A) of such Act (as defined in such U.S.C. 379j–42(c)) is amended— during the period from April 1, 2023, through
part as of such day) that on or after October (1) in paragraph (1)— March 31, 2025—
1, 2017, but before October 1, 2022, were re- (A) in the matter preceding subparagraph ‘‘(aa) the total number of abbreviated new
ceived by the Food and Drug Administration (A)— drug applications submitted was greater
with respect to assessing and collecting any (i) by striking ‘‘2019’’ and inserting ‘‘2024’’; than or equal to 2,300; or
fee required by such part for a fiscal year and ‘‘(bb) thirty-five percent or more of abbre-
prior to fiscal year 2023. (ii) by striking ‘‘to equal the product of the viated new drug applications submitted re-
TITLE III—FEES RELATING TO GENERIC total revenues established in such notice for lated to complex products (as so defined);
DRUGS the prior fiscal year multiplied’’ and insert- and
SEC. 3001. SHORT TITLE; FINDING. ing ‘‘to equal the base revenue amount for ‘‘(IV) for purposes of a fiscal year 2027 ad-
(a) SHORT TITLE.—This title may be cited the fiscal year (as specified in subsection justment, the Secretary determines that
as the ‘‘Generic Drug User Fee Amendments (b)(1)(B)(ii)) multiplied’’; and during the period from April 1, 2024, through
of 2022’’. (B) in subparagraph (C), by striking March 31, 2026—
(b) FINDING.—Congress finds that the fees ‘‘Washington-Baltimore, DC–MD–VA–WV’’ ‘‘(aa) the total number of abbreviated new
authorized by the amendments made by this and inserting ‘‘Washington-Arlington-Alex- drug applications submitted was greater
title will be dedicated to human generic drug andria, DC–VA–MD–WV’’; and than or equal to 2,300; or
activities, as set forth in the goals identified (2) by striking paragraph (2) and inserting ‘‘(bb) thirty-five percent or more of abbre-
for purposes of part 7 of subchapter C of the following: viated new drug applications submitted re-
chapter VII of the Federal Food, Drug, and ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— lated to complex products (as so defined).
Cosmetic Act (21 U.S.C. 379j–41 et seq.), in ‘‘(A) IN GENERAL.—Beginning with fiscal ‘‘(D) PUBLICATION IN FEDERAL REGISTER.—
the letters from the Secretary of Health and year 2024, the Secretary shall, in addition to The Secretary shall publish in the Federal
Human Services to the Chairman of the the adjustment under paragraph (1), further Register notice referred to in subsection (a)
Committee on Health, Education, Labor, and increase the fee revenue and fees under this the fee revenue and fees resulting from the
Pensions of the Senate and the Chairman of section for a fiscal year, in accordance with adjustment and the methodology under this
the Committee on Energy and Commerce of this paragraph, to reflect changes in the re- paragraph.
the House of Representatives, as set forth in source capacity needs of the Secretary for ‘‘(3) OPERATING RESERVE ADJUSTMENT.—
the Congressional Record. human generic drug activities. ‘‘(A) IN GENERAL.—For fiscal year 2024 and
SEC. 3002. AUTHORITY TO ASSESS AND USE ‘‘(B) CAPACITY PLANNING METHODOLOGY.— each subsequent fiscal year, the Secretary
HUMAN GENERIC DRUG FEES. The Secretary shall establish a capacity may, in addition to adjustments under para-
(a) TYPES OF FEES.—Section 744B(a) of the planning methodology for purposes of this graphs (1) and (2), further increase the fee
Federal Food, Drug, and Cosmetic Act (21 paragraph, which shall— revenue and fees under this section for such
U.S.C. 379j–42(a)) is amended— ‘‘(i) be derived from the methodology and fiscal year if such an adjustment is nec-
(1) in the matter preceding paragraph (1), recommendations made in the report titled essary to provide operating reserves of carry-
by striking ‘‘2018’’ and inserting ‘‘2023’’; ‘Independent Evaluation of the GDUFA Re- over user fees for human generic drug activi-
(2) in paragraph (2)(C), by striking ‘‘2018 source Capacity Planning Adjustment Meth- ties for not more than the number of weeks
through 2022’’ and inserting ‘‘2023 through odology: Evaluation and Recommendations’ specified in subparagraph (B) with respect to
2027’’; announced in the Federal Register on August that fiscal year.
(3) in paragraph (3)(B), by striking ‘‘2018 3, 2020 (85 Fed. Reg. 46658); and ‘‘(B) NUMBER OF WEEKS.—The number of
through 2022’’ and inserting ‘‘2023 through ‘‘(ii) incorporate approaches and attributes weeks specified in this subparagraph is—
2027’’; determined appropriate by the Secretary, in- ‘‘(i) 8 weeks for fiscal year 2024;
(4) in paragraph (4)(D), by striking ‘‘2018 cluding approaches and attributes made in ‘‘(ii) 9 weeks for fiscal year 2025; and
through 2022’’ and inserting ‘‘2023 through such report, except that in incorporating ‘‘(iii) 10 weeks for each of fiscal year 2026
2027’’; and such approaches and attributes the workload and 2027.
(5) in paragraph (5)(D), by striking ‘‘2018 categories used in forecasting resources shall ‘‘(C) DECREASE.—If the Secretary has car-
through 2022’’ and inserting ‘‘2023 through only be the workload categories specified in ryover balances for human generic drug ac-
2027’’. section VIII.B.2.e. of the letters described in tivities in excess of 12 weeks of the operating
(b) FEE REVENUE AMOUNTS.—Section section 3001(b) of the Generic Drug User Fee reserves referred to in subparagraph (A), the
744B(b) of the Federal Food, Drug, and Cos- Amendments of 2022. Secretary shall decrease the fee revenue and
metic Act (21 U.S.C. 379j–42(b)) is amended— ‘‘(C) LIMITATIONS.— fees referred to in such subparagraph to pro-
(1) in paragraph (1)— ‘‘(i) IN GENERAL.—Under no circumstances vide for not more than 12 weeks of such oper-
(A) in subparagraph (A)— shall an adjustment under this paragraph re- ating reserves.
(i) in the heading, by striking ‘‘2018’’ and in- sult in fee revenue for a fiscal year that is ‘‘(D) RATIONALE FOR ADJUSTMENT.—If an
serting ‘‘2023’’; less than the sum of the amounts under sub- adjustment under this paragraph is made,
(ii) by striking ‘‘2018’’ and inserting ‘‘2023’’; section (b)(1)(B)(ii) (the base revenue amount the rationale for the amount of the increase
and for the fiscal year) and paragraph (1) (the
or decrease (as applicable) in fee revenue and
(iii) by striking ‘‘$493,600,000’’ and inserting dollar amount of the inflation adjustment
fees shall be contained in the annual Federal
‘‘$582,500,000’’; and for the fiscal year).
Register notice under subsection (a) pub-
(B) by amending subparagraph (B) to read ‘‘(ii) ADDITIONAL LIMITATION.—An adjust-
lishing the fee revenue and fees for the fiscal
as follows: ment under this paragraph shall not exceed 3
year involved.’’.
‘‘(B) FISCAL YEARS 2024 THROUGH 2027.— percent of the sum described in clause (i) for
‘‘(i) IN GENERAL.—For each of the fiscal the fiscal year, except that such limitation (d) ANNUAL FEE SETTING.—Section
years 2024 through 2027, fees under para- shall be 4 percent if— 744B(d)(1) of the Federal Food, Drug, and
graphs (2) through (5) of subsection (a) shall ‘‘(I) for purposes of a fiscal year 2024 ad- Cosmetic Act (21 U.S.C. 379j–42(d)(1)) is
be established to generate a total estimated justment, the Secretary determines that amended—
revenue amount under such subsection that during the period from April 1, 2021, through (1) in the paragraph heading, by striking
is equal to the base revenue amount for the March 31, 2023— ‘‘2018 THROUGH 2022’’ and inserting ‘‘2023
fiscal year under clause (ii), as adjusted pur- ‘‘(aa) the total number of abbreviated new THROUGH 2027’’; and
suant to subsection (c). drug applications submitted was greater (2) by striking ‘‘more than 60 days before
‘‘(ii) BASE REVENUE AMOUNT.—The base rev- than or equal to 2,000; or the first day of each of fiscal years 2018
enue amount for a fiscal year referred to in ‘‘(bb) thirty-five percent or more of abbre- through 2022’’ and inserting ‘‘later than 60
clause (i) is equal to the total revenue viated new drug applications submitted re- days before the first day of each of fiscal
amount established under this paragraph for lated to complex products (as that term is years 2023 through 2027’’.
the previous fiscal year, not including any defined in section XI of the letters described
adjustments made for such previous fiscal in section 3001(b) of the Generic Drug User (e) EFFECT OF FAILURE TO PAY FEES.—The
year under subsection (c)(3).’’; and Fee Amendments of 2022); heading of paragraph (3) of section 744B(g) of
(2) in paragraph (2)— ‘‘(II) for purposes of a fiscal year 2025 ad- the Federal Food, Drug, and Cosmetic Act
(A) in subparagraph (C), by striking ‘‘one- justment, the Secretary determines that (21 U.S.C. 379j–42(g)) is amended by striking
third the amount’’ and inserting ‘‘twenty- during the period from April 1, 2022, through ‘‘AND PRIOR APPROVAL SUPPLEMENT FEE’’.
ctelli on DSK11ZRN23PROD with SENATE
four percent’’; March 31, 2024—
(f) CREDITING AND AVAILABILITY OF FEES.—
(B) in subparagraph (D), by striking ‘‘(aa) the total number of abbreviated new
‘‘Seven percent’’ and inserting ‘‘Six per- drug applications submitted was greater Section 744B(i)(3) of the Federal Food, Drug,
cent’’; and than or equal to 2,300; or and Cosmetic Act (21 U.S.C. 379j–42(i)(3)) is
(C) in subparagraph (E)(i), by striking ‘‘(bb) thirty-five percent or more of abbre- amended by striking ‘‘fiscal years 2018
‘‘Thirty-five percent’’ and inserting ‘‘Thirty- viated new drug applications submitted re- through 2022’’ and inserting ‘‘fiscal years 2023
six percent’’. lated to complex products (as so defined); through 2027’’.
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5107
SEC. 3003. REAUTHORIZATION; REPORTING RE- (b) FINDING.—Congress finds that the fees logical product development program for a
QUIREMENTS. authorized by the amendments made by this product under subparagraph (C), or who has
Section 744C of the Federal Food, Drug, title will be dedicated to expediting the proc- been administratively removed from such
and Cosmetic Act (21 U.S.C. 379j–43) is ess for the review of biosimilar biological program for a product under subparagraph
amended— product applications, including postmarket (E)(v), shall, if the person seeks to resume
(1) in subsection (a)(1), by striking ‘‘Begin- safety activities, as set forth in the goals participation in such program, pay all an-
ning with fiscal year 2018, not’’ and inserting identified for purposes of part 8 of sub- nual biosimilar biological product develop-
‘‘Not’’; chapter C of chapter VII of the Federal Food, ment fees previously assessed for such prod-
(2) by striking ‘‘Generic Drug User Fee Drug, and Cosmetic Act (21 U.S.C. 379j–51 et uct and still owed and a fee (referred to in
Amendments of 2017’’ each place it appears seq.), in the letters from the Secretary of this section as ‘reactivation fee’) by the ear-
and inserting ‘‘Generic Drug User Fee Health and Human Services to the Chairman lier of the following:
Amendments of 2022’’; of the Committee on Health, Education, ‘‘(I) Not later than 7 days after the Sec-
(3) in subsection (a)(2), by striking ‘‘Not Labor, and Pensions of the Senate and the retary grants a request by such person for a
later than 30 calendar days after the end of Chairman of the Committee on Energy and biosimilar biological product development
the second quarter of fiscal year 2018, and Commerce of the House of Representatives, meeting for the product (after the date on
not later than 30 calendar days after the end as set forth in the Congressional Record. which such participation was discontinued or
of each quarter of each fiscal year there- SEC. 4002. DEFINITIONS. the date of administrative removal, as appli-
after’’ and inserting ‘‘Not later than 30 cal- cable).
(a) ADJUSTMENT FACTOR.—Section 744G(1)
endar days after the end of each quarter of ‘‘(II) Upon the date of submission (after the
of the Federal Food, Drug, and Cosmetic Act
each fiscal year for which fees are collected date on which such participation was discon-
(21 U.S.C. 379j–51(1)) is amended to read as
under this part’’; tinued or the date of administrative re-
follows:
(4) in subsection (a)(3), by striking ‘‘Begin- moval, as applicable) by such person of an in-
‘‘(1) The term ‘adjustment factor’ applica-
ning with fiscal year 2020, the’’ and inserting vestigational new drug application describ-
ble to a fiscal year is the Consumer Price
‘‘The’’; ing an investigation that the Secretary de-
Index for urban consumers (Washington-Ar-
(5) in subsection (b), by striking ‘‘Begin- termines is intended to support a biosimilar
lington-Alexandria, DC–VA–MD–WV; Not
ning with fiscal year 2018, not’’ and inserting biological product application for that prod-
Seasonally Adjusted; All items) for Sep- uct.
‘‘Not’’;
tember of the preceding fiscal year divided ‘‘(ii) APPLICATION OF ANNUAL FEE.—A per-
(6) in subsection (c), by striking ‘‘Begin-
by such Index for September 2011.’’. son that pays a reactivation fee for a product
ning with fiscal year 2018, for’’ and inserting
(b) BIOSIMILAR BIOLOGICAL PRODUCT APPLI- shall pay for such product, beginning in the
‘‘For’’; and
CATION.—Section 744G(4)(B)(iii) of the Fed-
(7) in subsection (f)— next fiscal year, the annual biosimilar bio-
eral Food, Drug, and Cosmetic Act (21 U.S.C. logical product development fee under sub-
(A) in paragraph (1), in the matter pre-
379j–51(4)(B)(iii)) is amended— paragraph (B), except that, in the case that
ceding subparagraph (A), by striking ‘‘fiscal
(1) by striking subclause (II) (relating to an such product (including, where applicable,
year 2022’’ and inserting ‘‘fiscal year 2027’’;
allergenic extract product); and ownership of the relevant investigational
and
(2) by redesignating subclauses (III) and new drug application) is transferred to a li-
(B) in paragraph (5), by striking ‘‘January
(IV) as subclauses (II) and (III), respectively. censee, assignee, or successor of such person,
15, 2022’’ and inserting ‘‘January 15, 2027’’.
SEC. 4003. AUTHORITY TO ASSESS AND USE BIO- and written notice of such transfer is pro-
SEC. 3004. SUNSET DATES.
SIMILAR BIOLOGICAL PRODUCT vided to the Secretary, such licensee, as-
(a) AUTHORIZATION.—Sections 744A and FEES.
744B of the Federal Food, Drug, and Cos- signee, or successor shall pay the annual bio-
(a) TYPES OF FEES.— similar biological product development fee.’’.
metic Act (21 U.S.C. 379j–41; 379j–42) shall (1) IN GENERAL.—The matter preceding
cease to be effective October 1, 2027. (5) EFFECT OF FAILURE TO PAY FEES.—Sec-
paragraph (1) in section 744H(a) of the Fed- tion 744H(a)(1)(E) of the Federal Food, Drug,
(b) REPORTING REQUIREMENTS.—Section
eral Food, Drug, and Cosmetic Act (21 U.S.C. and Cosmetic Act (21 U.S.C. 379j–52(a)(1)(E))
744C of the Federal Food, Drug, and Cosmetic
379j–52(a)) is amended by striking ‘‘fiscal is amended by adding at the end the fol-
Act (21 U.S.C. 379j–43) shall cease to be effec-
year 2018’’ and inserting ‘‘fiscal year 2023’’. lowing:
tive January 31, 2028.
(c) PREVIOUS SUNSET PROVISION.—Effective (2) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT ‘‘(v) ADMINISTRATIVE REMOVAL FROM THE
DEVELOPMENT FEE.—Clauses (iv)(I) and (v)(II) BIOSIMILAR BIOLOGICAL PRODUCT DEVELOP-
October 1, 2022, subsections (a) and (b) of sec-
of section 744H(a)(1)(A) of the Federal Food, MENT PROGRAM.—If a person has failed to pay
tion 305 of the FDA Reauthorization Act of
Drug, and Cosmetic Act (21 U.S.C. 379j– an annual biosimilar biological product de-
2017 (Public Law 115–52) are repealed.
52(a)(1)(A)) are each amended by striking ‘‘5 velopment fee for a product as required
SEC. 3005. EFFECTIVE DATE.
days’’ and inserting ‘‘7 days’’. under subparagraph (B) for a period of 2 con-
The amendments made by this title shall
(3) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT secutive fiscal years, the Secretary may ad-
take effect on October 1, 2022, or the date of
DEVELOPMENT FEE.—Section 744H(a)(1)(B) of ministratively remove such person from the
the enactment of this Act, whichever is
the Federal Food, Drug, and Cosmetic Act biosimilar biological product development
later, except that fees under part 7 of sub-
(21 U.S.C. 379j–52(a)(1)(B)) is amended— program for the product. At least 30 days
chapter C of chapter VII of the Federal Food,
(A) in clause (i), by inserting before the pe- prior to administratively removing a person
Drug, and Cosmetic Act (21 U.S.C. 379j–41 et
riod at the end the following: ‘‘, except that, from the biosimilar biological product devel-
seq.) shall be assessed for all abbreviated new
in the case that such product (including, opment program for a product under this
drug applications received on or after Octo-
where applicable, ownership of the relevant clause, the Secretary shall provide written
ber 1, 2022, regardless of the date of the en-
investigational new drug application) is notice to such person of the intended admin-
actment of this Act.
transferred to a licensee, assignee, or suc- istrative removal.’’.
SEC. 3006. SAVINGS CLAUSE.
cessor of such person, and written notice of (6) BIOSIMILAR BIOLOGICAL PRODUCT APPLI-
Notwithstanding the amendments made by such transfer is provided to the Secretary, CATION FEE.—Section 744H(a)(2)(D) of the
this title, part 7 of subchapter C of chapter such licensee, assignee, or successor shall Federal Food, Drug, and Cosmetic Act (21
VII of the Federal Food, Drug, and Cosmetic pay the annual biosimilar biological product U.S.C. 379j–52(a)(2)(D)) is amended by insert-
Act (21 U.S.C. 379j–41 et seq.), as in effect on development fee’’; ing after ‘‘or was withdrawn’’ the following:
the day before the date of the enactment of (B) in clause (iii)— ‘‘prior to approval’’.
this title, shall continue to be in effect with (i) in subclause (I), by striking ‘‘or’’ at the (7) BIOSIMILAR BIOLOGICAL PRODUCT PRO-
respect to abbreviated new drug applications end; GRAM FEE.—Section 744H(a)(3) of the Federal
(as defined in such part as of such day) that (ii) in subclause (II), by striking the period Food, Drug, and Cosmetic Act (21 U.S.C. 379j–
were received by the Food and Drug Admin- at the end and inserting ‘‘; or’’; and 52(a)(3)) is amended—
istration within the meaning of section (iii) by adding at the end the following: (A) in subparagraph (A)—
505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), ‘‘(III) been administratively removed from (i) in clause (i), by striking ‘‘and’’ at the
prior approval supplements that were sub- the biosimilar biological product develop- end;
mitted, and drug master files for Type II ac- ment program for the product under sub- (ii) by redesignating clause (ii) as clause
tive pharmaceutical ingredients that were paragraph (E)(v).’’; and (iii); and
first referenced on or after October 1, 2017, (C) in clause (iv), by striking ‘‘is accepted (iii) by inserting after clause (i) the fol-
but before October 1, 2022, with respect to as- for filing on or after October 1 of such fiscal lowing:
sessing and collecting any fee required by year’’ and inserting ‘‘is subsequently accept- ‘‘(ii) may be dispensed only under prescrip-
such part for a fiscal year prior to fiscal year ed for filing’’. tion pursuant to section 503(b); and’’; and
2023.
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(4) REACTIVATION FEE.—Section (B) by adding at the end the following:
TITLE IV—FEES RELATING TO 744H(a)(1)(D) of the Federal Food, Drug, and ‘‘(E) MOVEMENT TO DISCONTINUED LIST.—
BIOSIMILAR BIOLOGICAL PRODUCTS Cosmetic Act (21 U.S.C. 379j–52(a)(1)(D)) is ‘‘(i) DATE OF INCLUSION.—If a written re-
SEC. 4001. SHORT TITLE; FINDING. amended to read as follows: quest to place a product on the list ref-
(a) SHORT TITLE.—This title may be cited ‘‘(D) REACTIVATION FEE.— erenced in subparagraph (A) of discontinued
as the ‘‘Biosimilar User Fee Amendments of ‘‘(i) IN GENERAL.—A person that has discon- biosimilar biological products is submitted
2022’’. tinued participation in the biosimilar bio- to the Secretary on behalf of an applicant,
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S5108 CONGRESSIONAL RECORD — SENATE September 27, 2022
and the request identifies the date the prod- ‘‘(3) ANNUAL BASE REVENUE.—For purposes ‘‘(A) INCREASE.—For fiscal year 2023 and
uct is, or will be, withdrawn from sale, then of paragraph (1), the dollar amount of the an- subsequent fiscal years, the Secretary shall,
for purposes of assessing the biosimilar bio- nual base revenue for a fiscal year shall be— in addition to adjustments under paragraphs
logical product program fee, the Secretary ‘‘(A) for fiscal year 2023, $43,376,922; and (1), (2), and (3), further increase the fee rev-
shall consider such product to have been in- ‘‘(B) for fiscal years 2024 through 2027, the enue and fees if such an adjustment is nec-
cluded on such list on the later of— dollar amount of the total revenue amount essary to provide for at least 10 weeks of op-
‘‘(I) the date such request was received; or established under paragraph (1) for the pre- erating reserves of carryover user fees for
‘‘(II) if the product will be withdrawn from vious fiscal year, excluding any adjustments the process for the review of biosimilar bio-
sale on a future date, such future date when to such revenue amount under subsection logical product applications.
the product is withdrawn from sale. (c)(4).’’. ‘‘(B) DECREASE.—
‘‘(ii) TREATMENT AS WITHDRAWN FROM (c) ADJUSTMENTS; ANNUAL FEE SETTING.— ‘‘(i) FISCAL YEAR 2023.—For fiscal year 2023,
SALE.—For purposes of clause (i), a product Section 744H(c) of the Federal Food, Drug, if the Secretary has carryover balances for
shall be considered withdrawn from sale once and Cosmetic Act (21 U.S.C. 379j–52(c)) is such process in excess of 33 weeks of such op-
the applicant has ceased its own distribution amended— erating reserves, the Secretary shall de-
of the product, whether or not the applicant (1) in paragraph (1)— crease such fee revenue and fees to provide
has ordered recall of all previously distrib- (A) in subparagraph (A)— for not more than 33 weeks of such operating
uted lots of the product, except that a rou- (i) in the matter preceding clause (i), by reserves.
tine, temporary interruption in supply shall striking ‘‘subsection (b)(2)(B)’’ and inserting ‘‘(ii) FISCAL YEAR 2024.—For fiscal year 2024,
not render a product withdrawn from sale. ‘‘subsection (b)(1)(B)’’; and if the Secretary has carryover balances for
‘‘(iii) SPECIAL RULE FOR PRODUCTS REMOVED (ii) in clause (i), by striking ‘‘subsection such process in excess of 27 weeks of such op-
FROM DISCONTINUED LIST.—If a biosimilar bio- (b)’’ and inserting ‘‘subsection (b)(1)(A)’’; and erating reserves, the Secretary shall de-
logical product that is identified in a bio- (B) in subparagraph (B)(ii), by striking crease such fee revenue and fees to provide
similar biological product application ap- ‘‘Washington-Baltimore, DC–MD–VA–WV’’ for not more than 27 weeks of such operating
proved as of October 1 of a fiscal year ap- and inserting ‘‘Washington-Arlington-Alex- reserves.
pears, as of October 1 of such fiscal year, on andria, DC–VA–MD–WV’’; ‘‘(iii) FISCAL YEAR 2025 AND SUBSEQUENT FIS-
the list referenced in subparagraph (A) of (2) by striking paragraphs (2) through (4) CAL YEARS.—For fiscal year 2025 and subse-
discontinued biosimilar biological products, and inserting the following:
quent fiscal years, if the Secretary has car-
and on any subsequent day during such fiscal ‘‘(2) STRATEGIC HIRING AND RETENTION AD-
ryover balances for such process in excess of
year the biosimilar biological product does JUSTMENT.—For each fiscal year, after the
21 weeks of such operating reserves, the Sec-
not appear on such list, except as provided in annual base revenue under subsection
retary shall decrease such fee revenue and
subparagraph (D), each person who is named (b)(1)(A) is adjusted for inflation in accord-
fees to provide for not more than 21 weeks of
as the applicant in a biosimilar biological ance with paragraph (1), the Secretary shall
such operating reserves.
product application with respect to such further increase the fee revenue and fees by
‘‘(C) FEDERAL REGISTER NOTICE.—If an ad-
product shall pay the annual biosimilar bio- $150,000.
justment under subparagraph (A) or (B) is
logical product program fee established for a ‘‘(3) CAPACITY PLANNING ADJUSTMENT.—
‘‘(A) IN GENERAL.—For each fiscal year, the made, the rationale for the amount of the in-
fiscal year under subsection (c)(5) for such crease or decrease (as applicable) in fee rev-
biosimilar biological product. Notwith- Secretary shall, in addition to the adjust-
ments under paragraphs (1) and (2), further enue and fees shall be contained in the an-
standing subparagraph (B), such fee shall be
adjust the fee revenue and fees under this nual Federal Register notice under para-
due on the last business day of such fiscal
section for a fiscal year to reflect changes in graph (5)(B) establishing fee revenue and fees
year and shall be paid only once for each
the resource capacity needs of the Secretary for the fiscal year involved.’’; and
such product for each fiscal year.’’.
for the process for the review of biosimilar (3) in paragraph (5), in the matter pre-
(8) BIOSIMILAR BIOLOGICAL PRODUCT FEE.—
biological product applications. ceding subparagraph (A), by striking ‘‘2018’’
Section 744H(a) of the Federal Food, Drug,
‘‘(B) METHODOLOGY.—For purposes of this and inserting ‘‘2023’’.
and Cosmetic Act (21 U.S.C. 379j–52(a)) is
amended by striking paragraph (4). paragraph, the Secretary shall employ the (d) CREDITING AND AVAILABILITY OF FEES.—
(b) FEE REVENUE AMOUNTS.—Subsection (b) capacity planning methodology utilized by Subsection (f)(3) of section 744H of the Fed-
of section 744H of the Federal Food, Drug, the Secretary in setting fees for fiscal year eral Food, Drug, and Cosmetic Act (21 U.S.C.
and Cosmetic Act (21 U.S.C. 379j–52) is 2021, as described in the notice titled ‘Bio- 379j–52(f)(3)) is amended by striking ‘‘2018
amended— similar User Fee Rates for Fiscal Year 2021’ through 2022’’ and inserting ‘‘2023 through
(1) by striking paragraph (1); published in the Federal Register on August 2027’’.
(2) by redesignating paragraphs (2) through 4, 2020 (85 Fed. Reg. 47220). The workload cat- (e) WRITTEN REQUESTS FOR WAIVERS AND
(4) as paragraphs (1) through (3), respec- egories used in applying such methodology RETURNS; DISPUTES CONCERNING FEES.—Sec-
tively; in forecasting shall include only the activi- tion 744H(h) of the Federal Food, Drug, and
(3) by amending paragraph (1) (as so redes- ties described in that notice and, as feasible, Cosmetic Act (21 U.S.C. 379j–52(h)) is amend-
ignated) to read as follows: additional activities that are directly re- ed to read as follows:
‘‘(1) IN GENERAL.—For each of the fiscal lated to the direct review of biosimilar bio- ‘‘(h) WRITTEN REQUESTS FOR WAIVERS AND
years 2023 through 2027, fees under subsection logical product applications and supple- RETURNS; DISPUTES CONCERNING FEES.—To
(a) shall, except as provided in subsection ments, including additional formal meeting qualify for consideration for a waiver under
(c), be established to generate a total rev- types, the direct review of postmarketing subsection (d), or for the return of any fee
enue amount equal to the sum of— commitments and requirements, the direct paid under this section, including if the fee is
‘‘(A) the annual base revenue for the fiscal review of risk evaluation and mitigation claimed to have been paid in error, a person
year (as determined under paragraph (3)); strategies, and the direct review of annual shall submit to the Secretary a written re-
‘‘(B) the dollar amount equal to the infla- reports for approved biosimilar biological quest justifying such waiver or return and,
tion adjustment for the fiscal year (as deter- products. Subject to the exceptions in the except as otherwise specified in this section,
mined under subsection (c)(1)); preceding sentence, the Secretary shall not such written request shall be submitted to
‘‘(C) the dollar amount equal to the stra- include as workload categories in applying the Secretary not later than 180 days after
tegic hiring and retention adjustment (as de- such methodology in forecasting any non- such fee is due. A request submitted under
termined under subsection (c)(2)); core review activities, including those ac- this paragraph shall include any legal au-
‘‘(D) the dollar amount equal to the capac- tivities that the Secretary referenced for po- thorities under which the request is made.’’.
ity planning adjustment for the fiscal year tential future use in such notice but did not
(as determined under subsection (c)(3)); utilize in setting fees for fiscal year 2021. SEC. 4004. REAUTHORIZATION; REPORTING RE-
‘‘(E) the dollar amount equal to the oper- ‘‘(C) LIMITATIONS.—Under no cir- QUIREMENTS.
ating reserve adjustment for the fiscal year, cumstances shall an adjustment under this Section 744I of the Federal Food, Drug, and
if applicable (as determined under subsection paragraph result in fee revenue for a fiscal Cosmetic Act (21 U.S.C. 379j–53) is amended—
(c)(4)); year that is less than the sum of the (1) in subsection (a)(1), by striking ‘‘Begin-
‘‘(F) for fiscal year 2023 an additional amounts under subsections (b)(1)(A) (the an- ning with fiscal year 2018, not’’ and inserting
amount of $4,428,886; and nual base revenue for the fiscal year), ‘‘Not’’;
‘‘(G) for fiscal year 2024 an additional (b)(1)(B) (the dollar amount of the inflation (2) by striking ‘‘Biosimilar User Fee
amount of $320,569.’’; adjustment for the fiscal year), and (b)(1)(C) Amendments of 2017’’ each place it appears
(4) in paragraph (2) (as so redesignated)— (the dollar amount of the strategic hiring and inserting ‘‘Biosimilar User Fee Amend-
(A) in the paragraph heading, by striking and retention adjustment). ments of 2022’’;
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‘‘; LIMITATIONS ON FEE AMOUNTS’’; ‘‘(D) PUBLICATION IN FEDERAL REGISTER.— (3) in subsection (a)(2), by striking ‘‘Begin-
(B) by striking subparagraph (B); and The Secretary shall publish in the Federal ning with fiscal year 2018, the’’ and inserting
(C) by redesignating subparagraphs (C) and Register notice under paragraph (5) the fee ‘‘The’’;
(D) as subparagraphs (B) and (C), respec- revenue and fees resulting from the adjust- (4) in subsection (a)(3)(A), by striking ‘‘Not
tively; and ment and the methodologies under this para- later than 30 calendar days after the end of
(5) by amending paragraph (3) (as so redes- graph. the second quarter of fiscal year 2018, and
ignated) to read as follows: ‘‘(4) OPERATING RESERVE ADJUSTMENT.— not later than 30 calendar days after the end
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5109
of each quarter of each fiscal year there- for the period beginning on October 1, 2022, (7) on May 20, 2022, U.S. Forest Service
after’’ and inserting ‘‘Not later than 30 cal- and ending on December 16, 2022’’. Chief Randy Moore ordered a 90-day review
endar days after the end of each quarter of SEC. 5004. REAUTHORIZATION OF PROVISION of prescribed burn policies to reduce the risk
each fiscal year for which fees are collected PERTAINING TO DRUGS CON- of wildfires and ensure the safety of the com-
under this part’’; TAINING SINGLE ENANTIOMERS. munities involved;
(5) in subsection (b), by striking ‘‘Not later Section 505(u)(4) of the Federal Food, Drug, (8) the U.S. Forest Service has assumed re-
than 120 days after the end of fiscal year 2018 and Cosmetic Act (21 U.S.C. 355(u)(4)) is sponsibility for the Hermit’s Peak/Calf Can-
and each subsequent fiscal year for which amended by striking ‘‘October 1’’ and insert- yon Fire;
fees are collected under this part’’ and in- ing ‘‘December 17’’. (9) the fire resulted in the loss of Federal,
serting ‘‘Not later than 120 days after the SEC. 5005. REAUTHORIZATION OF THE CRITICAL State, local, Tribal, and private property;
end of each fiscal year for which fees are col- PATH PUBLIC-PRIVATE PARTNER- and
lected under this part’’; SHIP. (10) the United States should compensate
(6) in subsection (c), by striking ‘‘Begin- Section 566(f) of the Federal Food, Drug, the victims of the Hermit’s Peak/Calf Can-
ning with fiscal year 2018, and for’’ and in- and Cosmetic Act (21 U.S.C. 360bbb–5(f)) is yon Fire.
serting ‘‘For’’; and amended by striking ‘‘$6,000,000 for each of (b) PURPOSES.—The purposes of this Act
(7) in subsection (f)— fiscal years 2018 through 2022’’ and inserting are—
(A) in paragraph (1), in the matter pre- ‘‘$1,265,753 for the period beginning on Octo- (1) to compensate victims of the Hermit’s
ceding subparagraph (A), by striking ‘‘fiscal ber 1, 2022 and ending on December 16, 2022’’. Peak/Calf Canyon Fire, for injuries resulting
year 2022’’ and inserting ‘‘fiscal year 2027’’; SEC. 5006. REAUTHORIZATION OF ORPHAN DRUG from the fire; and
and GRANTS. (2) to provide for the expeditious consider-
(B) in paragraph (3), by striking ‘‘January Section 5(c) of the Orphan Drug Act (21 ation and settlement of claims for those in-
15, 2022’’ and inserting ‘‘January 15, 2027’’. U.S.C. 360ee(c)) is amended by striking juries.
SEC. 4005. SUNSET DATES. ‘‘$30,000,000 for each of fiscal years 2018 SEC. 103. DEFINITIONS.
(a) AUTHORIZATION.—Sections 744G and through 2022’’ and inserting ‘‘$6,328,767 for In this Act:
744H of the Federal Food, Drug, and Cos- the period beginning on October 1, 2022, and (1) ADMINISTRATOR.—The term ‘‘Adminis-
metic Act (21 U.S.C. 379j–51, 379j–52) shall ending on December 16, 2022’’. trator’’ means—
cease to be effective October 1, 2027. SEC. 5007. REAUTHORIZATION OF CERTAIN DE- (A) the Administrator of the Federal Emer-
(b) REPORTING REQUIREMENTS.—Section VICE INSPECTIONS. gency Management Agency; or
744I of the Federal Food, Drug, and Cosmetic Section 704(g)(11) of the Federal Food, (B) if a Manager is appointed under section
Act (21 U.S.C. 379j–53) shall cease to be effec- Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) 104(a)(3), the Manager.
tive January 31, 2028. is amended by striking ‘‘October 1’’ and in- (2) HERMIT’S PEAK/CALF CANYON FIRE.—The
(c) PREVIOUS SUNSET PROVISION.—Effective serting ‘‘December 17’’. term ‘‘Hermit’s Peak/Calf Canyon Fire’’
October 1, 2022, subsections (a) and (b) of sec- SEC. 5008. REAUTHORIZATION OF REPORTING means—
tion 405 of the FDA Reauthorization Act of REQUIREMENTS RELATED TO PEND- (A) the fire resulting from the initiation by
2017 (Public Law 115–52) are repealed. ING GENERIC DRUG APPLICATIONS
AND PRIORITY REVIEW APPLICA-
the Forest Service of a prescribed burn in
SEC. 4006. EFFECTIVE DATE. the Santa Fe National Forest in San Miguel
TIONS.
The amendments made by this title shall Section 807 of the FDA Reauthorization County, New Mexico, on April 6, 2022;
take effect on October 1, 2022, or the date of Act of 2017 (Public Law 115–52) is amended, in (B) the pile burn holdover resulting from
the enactment of this Act, whichever is the matter preceding paragraph (1), by strik- the prescribed burn by the Forest Service,
later, except that fees under part 8 of sub- ing ‘‘October 1’’ and inserting ‘‘December which reemerged on April 19, 2022; and
chapter C of chapter VII of the Federal Food, 16’’. (C) the merger of the two fires described in
Drug, and Cosmetic Act (21 U.S.C. 379j–51 et subparagraphs (A) and (B), reported as the
seq.) shall be assessed for all biosimilar bio- DIVISION G—HERMIT’S PEAK/CALF Hermit’s Peak Fire or the Hermit’s Peak
logical product applications received on or CANYON FIRE ASSISTANCE ACT Fire/Calf Canyon Fire.
after October 1, 2022, regardless of the date of SEC. 101. SHORT TITLE. (3) INDIAN TRIBE.—The term ‘‘Indian Tribe’’
the enactment of this Act. This division may be cited as the ‘‘Her- means the recognized governing body of any
SEC. 4007. SAVINGS CLAUSE. mit’s Peak/Calf Canyon Fire Assistance Indian or Alaska Native Tribe, band, nation,
Notwithstanding the amendments made by Act’’. pueblo, village, community, component
this title, part 8 of subchapter C of chapter SEC. 102. FINDINGS AND PURPOSES. band, or component reservation individually
VII of the Federal Food, Drug, and Cosmetic (a) FINDINGS.—Congress finds that— identified (including parenthetically) in the
Act (21 U.S.C. 379j–51 et seq.), as in effect on (1) on April 6, 2022, the Forest Service initi- list published most recently as of the date of
the day before the date of the enactment of ated the Las Dispensas-Gallinas prescribed enactment of this Act pursuant to section
this title, shall continue to be in effect with burn on Federal land in the Santa Fe Na- 104 of the Federally Recognized Indian Tribe
respect to biosimilar biological product ap- tional Forest in San Miguel County, New List Act of 1994 (25 U.S.C. 5131).
plications and supplements (as defined in Mexico, when erratic winds were prevalent in (4) INJURED PERSON.—The term ‘‘injured
such part as of such day) that were accepted the area that was also suffering from severe person’’ means—
by the Food and Drug Administration for fil- drought after many years of insufficient pre- (A) an individual, regardless of the citizen-
ing on or after October 1, 2017, but before Oc- cipitation; ship or alien status of the individual; or
tober 1, 2022, with respect to assessing and (2) on April 6, 2022, the prescribed burn, (B) an Indian Tribe, corporation, Tribal
collecting any fee required by such part for which became known as the ‘‘Hermit’s Peak corporation, partnership, company, associa-
a fiscal year prior to fiscal year 2023. Fire’’, exceeded the containment capabilities tion, county, township, city, State, school
TITLE V—REAUTHORIZATION OF OTHER of the Forest Service, was declared a wild- district, or other non-Federal entity (includ-
PROVISIONS fire, and spread to other Federal and non- ing a legal representative) that suffered in-
Federal land; jury resulting from the Hermit’s Peak/Calf
SEC. 5001. REAUTHORIZATION OF THE BEST
PHARMACEUTICALS FOR CHILDREN (3) on April 19, 2022, the Calf Canyon Fire, Canyon Fire.
PROGRAM. also in San Miguel County, New Mexico, (5) INJURY.—The term ‘‘injury’’ has the
Section 409I(d)(1) of the Public Health began burning on Federal land and was later same meaning as the term ‘‘injury or loss of
Service Act (42 U.S.C. 284m(d)(1)) is amended identified as the result of a pile burn in Jan- property, or personal injury or death’’ as
by striking ‘‘$25,000,000 for each of fiscal uary 2022 that remained dormant under the used in section 1346(b)(1) of title 28, United
years 2018 through 2022’’ and inserting surface before reemerging; States Code.
‘‘$5,273,973 for the period beginning on Octo- (4) on April 27, 2022, the Hermit’s Peak Fire (6) MANAGER.—The term ‘‘Manager’’ means
ber 1, 2022 and ending on December 16, 2022’’. and the Calf Canyon Fire merged, and both an Independent Claims Manager appointed
SEC. 5002. REAUTHORIZATION OF THE HUMANI- fires were reported as the Hermit’s Peak Fire under section 104(a)(3).
TARIAN DEVICE EXEMPTION INCEN- or the Hermit’s Peak/Calf Canyon Fire, (7) OFFICE.—The term ‘‘Office’’ means the
TIVE. which shall be referred to hereafter as the Office of Hermit’s Peak/Calf Canyon Fire
Section 520(m)(6)(A)(iv) of the Federal Hermit’s Peak/Calf Canyon Fire; Claims established by section 104(a)(2).
Food, Drug, and Cosmetic Act (21 U.S.C. (5) by May 2, 2022, the fire had grown in (8) TRIBAL ENTITY.—The term ‘‘Tribal enti-
360j(m)(6)(A)(iv)) is amended by striking ‘‘Oc- size and caused evacuations in multiple vil- ty’’ includes any Indian Tribe, tribal organi-
tober 1’’ and inserting ‘‘December 17’’. lages and communities in San Miguel County zation, Indian-controlled organization serv-
SEC. 5003. REAUTHORIZATION OF THE PEDI- and Mora County, including in the San ing Indians, Native Hawaiian organization,
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ATRIC DEVICE CONSORTIA PRO- Miguel county jail, the State’s psychiatric or Alaska Native entity, as such terms are
GRAM. hospital, the United World College, and New defined or used in section 166 of the Work-
Section 305(e) of the Food and Drug Admin- Mexico Highlands University; force Innovation and Opportunity Act (29
istration Amendments Act of 2007 (Public (6) on May 4, 2022, the President issued a U.S.C. 3221).
Law 110–85; 42 U.S.C. 282 note) is amended by major disaster declaration for the counties SEC. 104. COMPENSATION FOR VICTIMS OF HER-
striking ‘‘$5,250,000 for each of fiscal years of Colfax, Mora, and San Miguel, New Mex- MIT’S PEAK/CALF CANYON FIRE.
2018 through 2022’’ and inserting ‘‘$1,107,534 ico; (a) IN GENERAL.—
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S5110 CONGRESSIONAL RECORD — SENATE September 27, 2022
(1) COMPENSATION.—Each injured person Act, the Administrator shall determine Canyon Fire for the following types of other-
shall be eligible to receive from the United only— wise uncompensated business loss:
States compensation for injury suffered by (i) whether the claimant is an injured per- (i) Damage to tangible assets or inventory,
the injured person as a result of the Hermit’s son; including natural resources.
Peak/Calf Canyon Fire, subject to the avail- (ii) whether the injury that is the subject (ii) Business interruption losses.
ability of appropriations and subject to the of the claim resulted from the Hermit’s (iii) Overhead costs.
Administrator making the determinations Peak/Calf Canyon Fire; (iv) Employee wages for work not per-
required under subsection (d). (iii) whether the person or persons are oth- formed.
(2) OFFICE OF HERMIT’S PEAK/CALF CANYON erwise eligible to receive any amount deter- (v) Loss of business net income.
FIRE CLAIMS.— mined under clause (iv); and (vi) Any other loss that the Administrator
(A) IN GENERAL.—There is established with- (iv) whether sufficient funds are available determines to be appropriate for inclusion as
in the Federal Emergency Management for payment and, if so, the amount, if any, to business loss.
Agency an Office of Hermit’s Peak/Calf Can- be allowed and paid under this Act. (C) FINANCIAL LOSS.—A claim that is paid
yon Fire Claims. (C) INSURANCE AND OTHER BENEFITS.— for injury under this Act may include dam-
(B) PURPOSE.—The Office shall receive, (i) IN GENERAL.—In determining the ages resulting from the Hermit’s Peak/Calf
process, and pay claims in accordance with amount of, and paying, a claim under this Canyon Fire for the following types of other-
this Act. Act, to prevent recovery by a claimant in ex- wise uncompensated financial loss:
(C) FUNDING.—The Office— cess of actual compensatory damages, the (i) Increased mortgage interest costs.
(i) shall be funded from funds made avail- Administrator shall reduce the amount to be (ii) An insurance deductible.
able to the Administrator for carrying out paid for the claim by an amount that is (iii) A temporary living or relocation ex-
this section; equal to the total of insurance benefits (ex- pense.
(ii) may appoint and fix the compensation cluding life insurance benefits) or other pay- (iv) Lost wages or personal income.
of such temporary personnel as may be nec- ments or settlements of any nature that (v) Emergency staffing expenses.
essary, without regard to the provisions of were paid, or will be paid, with respect to the (vi) Debris removal and other cleanup
title 5, United States Code, governing ap- claim. costs.
pointments in competitive service; and (ii) GOVERNMENT LOANS.—This subpara- (vii) Costs of reasonable efforts, as deter-
(iii) may reimburse other Federal agencies graph shall not apply to the receipt by a mined by the Administrator, to reduce the
for claims processing support and assistance. claimant of any government loan that is re- risk of wildfire, flood, or other natural dis-
(3) OPTION TO APPOINT INDEPENDENT CLAIMS quired to be repaid by the claimant. aster in the counties impacted by the Her-
MANAGER.—The Administrator may appoint (2) PARTIAL PAYMENT.— mit’s Peak/Calf Canyon Fire to risk levels
an Independent Claims Manager to— (A) IN GENERAL.—At the request of a claim- prevailing in those counties before the Her-
(A) head the Office; and ant, the Administrator may make 1 or more mit’s Peak/Calf Canyon Fire, that are in-
(B) assume the duties of the Administrator advance or partial payments, subject to the curred not later than the date that is 3 years
under this Act. determination required under paragraph after the date on which the regulations
(4) DETAIL.—Upon the request of the Ad- (1)(B), before the final settlement of a claim, under subsection (f) are first promulgated.
ministrator, the head of any Federal depart- including final settlement on any portion or
(viii) A premium for flood insurance that is
ment or agency may detail, on a reimburs- aspect of a claim that is determined to be
required to be paid on or before May 31, 2024,
able basis, any of the personnel of that de- severable.
if, as a result of the Hermit’s Peak/Calf Can-
partment or agency to the Federal Emer- (B) JUDICIAL DECISION.—If a claimant re-
yon Fire, a person that was not required to
gency Management Agency to assist the ceives a partial payment on a claim under
purchase flood insurance before the Hermit’s
Agency in carrying out the duties under this this Act, but further payment on the claim
Peak/Calf Canyon Fire is required to pur-
Act. is subsequently denied by the Administrator,
chase flood insurance.
(b) SUBMISSION OF CLAIMS.—Not later than the claimant may—
(ix) A disaster assistance loan received
2 years after the date on which regulations (i) seek judicial review under subsection
from the Small Business Administration.
are first promulgated under subsection (f), (i); and
(ii) keep any partial payment that the (x) Any other loss that the Administrator
an injured person may submit to the Admin-
claimant received, unless the Administrator determines to be appropriate for inclusion as
istrator a written claim for 1 or more inju-
determines that the claimant— financial loss.
ries suffered by the injured person in accord-
ance with such requirements as the Adminis- (I) was not eligible to receive the com- (e) ACCEPTANCE OF AWARD.—The accept-
trator determines to be appropriate. pensation; or ance by a claimant of any payment under
(c) INVESTIGATION OF CLAIMS.— (II) fraudulently procured the compensa- this Act, except an advance or partial pay-
(1) IN GENERAL.—In accordance with sub- tion. ment made under subsection (d)(2), shall—
section (d), the Administrator shall, on be- (3) RIGHTS OF INSURER OR OTHER THIRD (1) be final and conclusive on the claimant,
half of the United States, investigate, con- PARTY.—If an insurer or other third party with respect to all claims arising out of or
sider, ascertain, adjust, determine, grant, pays any amount to a claimant to com- relating to the same subject matter; and
deny, or settle any claim for money damages pensate for an injury described in subsection (2) constitute a complete release of all
asserted under subsection (b). (a), the insurer or other third party shall be claims against the United States (including
(2) APPLICABILITY OF STATE LAW.—Except subrogated to any right that the claimant any agency or employee of the United
as otherwise provided in this Act, the laws of has to receive any payment under this Act or States) under chapter 171 of title 28, United
the State of New Mexico shall apply to the any other law. States Code (commonly known as the ‘‘Fed-
calculation of damages under subsection (4) ALLOWABLE DAMAGES.— eral Tort Claims Act’’), or any other Federal
(d)(4). (A) LOSS OF PROPERTY.—A claim that is or State law, arising out of or relating to the
(3) EXTENT OF DAMAGES.—Any payment paid for loss of property under this Act may same subject matter.
under this Act— include otherwise uncompensated damages (f) REGULATIONS AND PUBLIC INFORMA-
(A) shall be limited to actual compen- resulting from the Hermit’s Peak/Calf Can- TION.—
satory damages measured by injuries suf- yon Fire for— (1) REGULATIONS.—Notwithstanding any
fered; and (i) an uninsured or underinsured property other provision of law, not later than 45 days
(B) shall not include— loss; after the date of enactment of this Act, the
(i) interest before settlement or payment (ii) a decrease in the value of real property; Administrator shall promulgate and publish
of a claim; or (iii) damage to physical infrastructure, in- in the Federal Register interim final regula-
(ii) punitive damages. cluding irrigation infrastructure such as tions for the processing and payment of
(d) PAYMENT OF CLAIMS.— acequia systems; claims under this Act.
(1) DETERMINATION AND PAYMENT OF (iv) a cost resulting from lost subsistence (2) PUBLIC INFORMATION.—
AMOUNT.— from hunting, fishing, firewood gathering, (A) IN GENERAL.—At the time at which the
(A) IN GENERAL.— timbering, grazing, or agricultural activities Administrator promulgates regulations
(i) PAYMENT.—Not later than 180 days after conducted on land damaged by the Hermit’s under paragraph (1), the Administrator shall
the date on which a claim is submitted under Peak/Calf Canyon Fire; publish, online and in print, in newspapers of
this Act, the Administrator shall determine (v) a cost of reforestation or revegetation general circulation in the State of New Mex-
and fix the amount, if any, to be paid for the on Tribal or non-Federal land, to the extent ico, a clear, concise, and easily understand-
claim. that the cost of reforestation or revegetation able explanation, in English and Spanish,
(ii) PRIORITY.—The Administrator, to the is not covered by any other Federal program; of—
ctelli on DSK11ZRN23PROD with SENATE
maximum extent practicable, shall pay sub- and (i) the rights conferred under this Act; and
rogation claims submitted under this Act (vi) any other loss that the Administrator (ii) the procedural and other requirements
only after paying claims submitted by in- determines to be appropriate for inclusion as of the regulations promulgated under para-
jured parties that are not insurance compa- loss of property. graph (1).
nies seeking payment as subrogees. (B) BUSINESS LOSS.—A claim that is paid (B) DISSEMINATION THROUGH OTHER MEDIA.—
(B) PARAMETERS OF DETERMINATION.—In de- for injury under this Act may include dam- The Administrator shall disseminate the ex-
termining and settling a claim under this ages resulting from the Hermit’s Peak/Calf planation published under subparagraph (A)
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September 27, 2022 CONGRESSIONAL RECORD — SENATE S5111
through websites, blogs, social media, bro- nection with a claim submitted under this (2) a brief description of the nature of the
chures, pamphlets, radio, television, and Act, fees in excess of the limitations estab- claim; and
other media that the Administrator deter- lished under section 2678 of title 28, United (3) the status or disposition of the claim,
mines are likely to reach prospective claim- States Code. including the amount of any payment under
ants. (2) VIOLATION.—An attorney or agent who this Act.
(g) CONSULTATION.—In administering this violates paragraph (1) shall be fined not more (o) AUTHORIZATION OF APPROPRIATIONS.—
Act, the Administrator shall consult with than $10,000. There are authorized to be appropriated such
the Secretary of the Interior, the Secretary (k) WAIVER OF REQUIREMENT FOR MATCHING sums as are necessary to carry out this Act.
of Energy, the Secretary of Agriculture, the FUNDS.— ---
Administrator of the Small Business Admin- (1) STATE AND LOCAL PROJECT.— SA 5746. Mr. CORNYN (for himself
istration, other Federal agencies, and State, (A) IN GENERAL.—Notwithstanding any and Mr. CARPER) submitted an amend-
local, and Tribal authorities, as determined other provision of law, a State or local ment intended to be proposed to
to be necessary by the Administrator, to— project that is determined by the Adminis-
(1) ensure the efficient administration of amendment SA 5499 submitted by Mr.
trator to be carried out in response to the REED (for himself and Mr. INHOFE) and
the claims process; and Hermit’s Peak/Calf Canyon Fire under any
(2) provide for local concerns. intended to be proposed to the bill H.R.
Federal program that applies to an area af-
(h) ELECTION OF REMEDY.—
fected by the Hermit’s Peak/Calf Canyon
7900, to authorize appropriations for
(1) IN GENERAL.—An injured person may fiscal year 2023 for military activities
Fire shall not be subject to any requirement
elect to seek compensation from the United of the Department of Defense, for mili-
States for 1 or more injuries resulting from for State or local matching funds to pay the
the Hermit’s Peak/Calf Canyon Fire by— cost of the project under the Federal pro- tary construction, and for defense ac-
(A) submitting a claim under this Act; gram. tivities of the Department of Energy,
(B) filing a claim or bringing a civil action (B) FEDERAL SHARE.—The Federal share of to prescribe military personnel
under chapter 171 of title 28, United States the costs of a project described in subpara- strengths for such fiscal year, and for
Code (commonly known as the ‘‘Federal Tort graph (A) shall be 100 percent. other purposes; which was ordered to
Claims Act’’); or (2) OTHER NEEDS PROGRAM ASSISTANCE.—
Notwithstanding section 408(g)(2) of the Rob-
lie on the table; as follows:
(C) bringing an authorized civil action At the end of subtitle F of title XII, add
under any other provision of law. ert T. Stafford Disaster Relief and Emer-
gency Assistance Act (42 U.S.C. 5174(g)(2)), the following:
(2) EFFECT OF ELECTION.—In accordance
for any emergency or major disaster de- SEC. 1276. STRATEGY TO ENHANCE COOPERA-
with subsection (e), an election by an injured TION WITH CANADA AND MEXICO
person to seek compensation in any manner clared by the President under that Act for
WITH RESPECT TO THE RESILIENCY
described in paragraph (1) shall be final and the Hermit’s Peak/Calf Canyon Fire, the
OF NORTH AMERICAN SUPPLY
conclusive on the claimant with respect to Federal share of assistance provided under CHAINS.
all injuries resulting from the Hermit’s that section shall be 100 percent. (a) IN GENERAL.—Not later than 180 days
Peak/Calf Canyon Fire that are suffered by (3) AGRICULTURAL PROGRAM ASSISTANCE.— after the date of the enactment of this Act,
the claimant upon acceptance of an award. (A) IN GENERAL.—Notwithstanding any the United States Trade Representative, in
(3) ARBITRATION.— other provision of law, a State, local, or indi- consultation with the Secretary of State, the
(A) IN GENERAL.—Not later than 45 days vidual project that is determined by the Sec- Secretary of Commerce, the Commissioner of
after the date of enactment of this Act, the retary of Agriculture to be carried out in re- U.S. Customs and Border Protection, and the
Administrator shall establish by regulation sponse to the Hermit’s Peak/Calf Canyon heads of other relevant agencies, shall sub-
procedures under which a dispute regarding a Fire under any Federal program that applies mit to the appropriate congressional com-
claim submitted under this Act may be set- to an area affected by the Hermit’s Peak/Calf mittees a strategy for how the United States
tled by arbitration. Canyon Fire shall not be subject to any re- will work with the governments of Canada
(B) ARBITRATION AS REMEDY.—On establish- quirement for State, local, or individual and Mexico to improve the resiliency of
ment of arbitration procedures under sub- matching funds to pay the cost of the project North American supply chains, including by
paragraph (A), an injured person that sub- under the Federal program. reducing overdependence on, and concentra-
mits a disputed claim under this Act may (B) FEDERAL SHARE.—The Federal share of tion of critical supply chains in, countries
elect to settle the claim through arbitration. the costs of a project described in subpara- that are foreign adversaries of the United
(C) BINDING EFFECT.—An election by an in- graph (A) shall be 100 percent. States.
jured person to settle a claim through arbi- (l) APPLICABILITY OF DEBT COLLECTION RE- (b) ELEMENTS.—The strategy required by
tration under this paragraph shall— QUIREMENTS.—Section 3711(a) of title 31, subsection (a) shall—
(i) be binding; and United States Code, shall not apply to any (1) include a summary of initiatives car-
(ii) preclude any exercise by the injured payment under this Act, unless— ried out with counterparts in Canada and
person of the right to judicial review of a (1) there is evidence of civil or criminal Mexico to enhance cooperation between the
claim described in subsection (i). fraud, misrepresentation, presentation of a United States, Canada, and Mexico with re-
(4) NO EFFECT ON ENTITLEMENTS.—The false claim; or spect to supply chain resiliency, including
value of compensation that may be provided (2) a claimant was not eligible under sub- through the USMCA (as defined in section 3
under this Act shall not be considered in- section (d)(2) of this Act to any partial pay- of the United States-Mexico-Canada Agree-
come or resources for any purpose under any ment. ment Implementation Act (19 U.S.C. 4502));
Federal, State, or local laws, including laws (m) INDIAN COMPENSATION.—Notwith- (2) identify critical sectors for which co-
relating to taxation, welfare, and public as- standing any other provision of law, in the operation with Canada and Mexico can
sistance programs, and no State or political case of an Indian Tribe, a Tribal entity, or a strengthen the resiliency of supply chains;
subdivision thereof shall decrease any assist- member of an Indian Tribe that submits a and
ance otherwise provided to an injured person claim under this Act— (3) identify challenges to improving the re-
because of the receipt of benefits under this (1) the Bureau of Indian Affairs shall have siliency of supply chains.
Act. no authority over, or any trust obligation re- (c) CONSULTATIONS.—Not later than one
(i) JUDICIAL REVIEW.— garding, any aspect of the submission of, or year after the date of enactment of this Act,
(1) IN GENERAL.—Any claimant aggrieved any payment received for, the claim; the United States Trade Representative shall
by a final decision of the Administrator (2) the Indian Tribe, Tribal entity, or mem- consult with the appropriate congressional
under this Act may, not later than 60 days ber of an Indian Tribe shall be entitled to committees regarding the development and
after the date on which the decision is proceed under this Act in the same manner implementation of the strategy required by
issued, bring a civil action in the United and to the same extent as any other injured subsection (a).
States District Court for the District of New person; and (d) APPROPRIATE CONGRESSIONAL COMMIT-
Mexico, to modify or set aside the decision, (3) except with respect to land damaged by TEES DEFINED.—In this section, the term
in whole or in part. the Hermit’s Peak/Calf Canyon Fire that is ‘‘appropriate congressional committees’’
(2) RECORD.—The court shall hear a civil the subject of the claim, the Bureau of In- means the Committee on Finance of the Sen-
action under paragraph (1) on the record dian Affairs shall have no responsibility to ate and the Committee on Ways and Means
made before the Administrator. restore land damaged by the Hermit’s Peak/ of the House of Representatives.
(3) STANDARD.—The decision of the Admin- Calf Canyon Fire. f
istrator incorporating the findings of the Ad- (n) REPORT.—Not later than 1 year after
ministrator shall be upheld if the decision is the date of promulgation of regulations AUTHORITY FOR COMMITTEES TO
ctelli on DSK11ZRN23PROD with SENATE
supported by substantial evidence on the under subsection (f)(1), and annually there- MEET
record considered as a whole. after, the Administrator shall submit to
Mr. MURPHY. Mr. President, I have
(j) ATTORNEY’S AND AGENT’S FEES.— Congress a report that describes the claims
(1) IN GENERAL.—No attorney or agent, act- submitted under this Act during the year two requests for committees to meet
ing alone or in combination with any other preceding the date of submission of the re- during today’s session of the Senate.
attorney or agent, shall charge, demand, re- port, including, for each claim— They have the approval of the Majority
ceive, or collect, for services rendered in con- (1) the amount claimed; and Minority Leaders.
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