H. R. 6833 

One Hundred Seventeenth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Monday, 

the third day of January, two thousand and twenty-two 

An Act 

Making continuing appropriations for fiscal year 2023, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Continuing Appropriations and 

Ukraine Supplemental Appropriations Act, 2023’’. 

SEC. 2. TABLE OF CONTENTS. 

Sec. 1. Short Title. 

Sec. 2. Table of Contents. 

Sec. 3. References. 

Sec. 4. Payment to Widows and Heirs of Deceased Members of Congress. 

DIVISION A—CONTINUING APPROPRIATIONS ACT, 2023 

DIVISION B—UKRAINE SUPPLEMENTAL APPROPRIATIONS ACT, 2023 

DIVISION C—OTHER MATTERS 

Title I—Extensions, Technical Corrections, and Other Matters 

Title II—Budgetary Effects 

DIVISION D—HEALTH AND HUMAN SERVICES EXTENSIONS 

Title I—Medicare and Medicaid 

Title II—Human Services 

Title III—Public Health 

Title IV—Indian Health 

DIVISION E—VETERANS AFFAIRS EXTENSIONS 

Title I—Extensions of authorities relating to health care 

Title II—Extensions of authorities relating to benefits 

Title III—Extensions of authorities relating to homeless veterans 

Title IV—Extensions of other authorities 

DIVISION F—FDA USER FEE REAUTHORIZATION ACT OF 2022 

DIVISION G—HERMIT’S PEAK/CALF CANYON FIRE ASSISTANCE ACT 

SEC. 3. REFERENCES. 

Except as expressly provided otherwise, any reference to ‘‘this 

Act’’ contained in any division of this Act shall be treated as 

referring only to the provisions of that division. 

SEC. 4. PAYMENT TO WIDOWS AND HEIRS OF DECEASED MEMBERS 

OF CONGRESS. 

There is hereby appropriated for fiscal year 2023, out of any 

money in the Treasury not otherwise appropriated, for payment 

to Dean Swihart, beneficiary of Jacqueline Walorski-Swihart, late 

a Representative from the State of Indiana, $174,000. 
H. R. 6833—2 

DIVISION A—CONTINUING APPROPRIATIONS ACT, 2023 

The following sums are hereby appropriated, out of any money 

in the Treasury not otherwise appropriated, and out of applicable 

corporate or other revenues, receipts, and funds, for the several 

departments, agencies, corporations, and other organizational units 

of Government for fiscal year 2023, and for other purposes, namely: 

SEC. 101. Such amounts as may be necessary, at a rate for 

operations as provided in the applicable appropriations Acts for 

fiscal year 2022 and under the authority and conditions provided 

in such Acts, for continuing projects or activities (including the 

costs of direct loans and loan guarantees) that are not otherwise 

specifically provided for in this Act, that were conducted in fiscal 

year 2022, and for which appropriations, funds, or other authority 

were made available in the following appropriations Acts: 

(1) The Agriculture, Rural Development, Food and Drug 

Administration, and Related Agencies Appropriations Act, 2022 

(division A of Public Law 117–103), except section 783, and 

except that section 785 shall be applied by substituting 

‘‘$125,000,000’’ for ‘‘$250,000,000’’. 

(2) The Commerce, Justice, Science, and Related Agencies 

Appropriations Act, 2022 (division B of Public Law 117–103), 

except section 521(c)(1). 

(3) The Department of Defense Appropriations Act, 2022 

(division C of Public Law 117–103). 

(4) The Energy and Water Development and Related Agencies Appropriations Act, 2022 (division D of Public Law 117– 

103). 

(5) The Financial Services and General Government Appropriations Act, 2022 (division E of Public Law 117–103), except 

the matter under the heading ‘‘Postal Regulatory Commission’’ 

in title V. 

(6) The Department of Homeland Security Appropriations 

Act, 2022 (division F of Public Law 117–103), except sections 

544 and 545, and including title II of division O of Public 

Law 117–103. 

(7) The Department of the Interior, Environment, and 

Related Agencies Appropriations Act, 2022 (division G of Public 

Law 117–103). 

(8) The Departments of Labor, Health and Human Services, 

and Education, and Related Agencies Appropriations Act, 2022 

(division H of Public Law 117–103), and section 162 of division 

A of Public Law 117–43. 

(9) The Legislative Branch Appropriations Act, 2022 (division I of Public Law 117–103), and section 6 in the matter 

preceding division A of Public Law 117–103. 

(10) The Military Construction, Veterans Affairs, and 

Related Agencies Appropriations Act, 2022 (division J of Public 

Law 117–103). 

(11) The Department of State, Foreign Operations, and 

Related Programs Appropriations Act, 2022 (division K of Public 

Law 117–103), except the first proviso of section 7069(e). 

(12) The Transportation, Housing and Urban Development, 

and Related Agencies Appropriations Act, 2022 (division L of 

Public Law 117–103). 
H. R. 6833—3 

SEC. 102. (a) No appropriation or funds made available or 

authority granted pursuant to section 101 for the Department of 

Defense shall be used for: 

(1) the new production of items not funded for production 

in fiscal year 2022 or prior years; 

(2) the increase in production rates above those sustained 

with fiscal year 2022 funds; or 

(3) the initiation, resumption, or continuation of any 

project, activity, operation, or organization (defined as any 

project, subproject, activity, budget activity, program element, 

and subprogram within a program element, and for any investment items defined as a P–1 line item in a budget activity 

within an appropriation account and an R–1 line item that 

includes a program element and subprogram element within 

an appropriation account) for which appropriations, funds, or 

other authority were not available during fiscal year 2022. 

(b) No appropriation or funds made available or authority 

granted pursuant to section 101 for the Department of Defense 

shall be used to initiate multi-year procurements utilizing advance 

procurement funding for economic order quantity procurement 

unless specifically appropriated later. 

SEC. 103. Appropriations made by section 101 shall be available 

to the extent and in the manner that would be provided by the 

pertinent appropriations Act. 

SEC. 104. Except as otherwise provided in section 102, no 

appropriation or funds made available or authority granted pursuant to section 101 shall be used to initiate or resume any project 

or activity for which appropriations, funds, or other authority were 

not available during fiscal year 2022. 

SEC. 105. Appropriations made and authority granted pursuant 

to this Act shall cover all obligations or expenditures incurred 

for any project or activity during the period for which funds or 

authority for such project or activity are available under this Act. 

SEC. 106. Unless otherwise provided for in this Act or in the 

applicable appropriations Act for fiscal year 2023, appropriations 

and funds made available and authority granted pursuant to this 

Act shall be available until whichever of the following first occurs: 

(1) The enactment into law of an appropriation for any 

project or activity provided for in this Act. 

(2) The enactment into law of the applicable appropriations 

Act for fiscal year 2023 without any provision for such project 

or activity. 

(3) December 16, 2022. 

SEC. 107. Expenditures made pursuant to this Act shall be 

charged to the applicable appropriation, fund, or authorization 

whenever a bill in which such applicable appropriation, fund, or 

authorization is contained is enacted into law. 

SEC. 108. Appropriations made and funds made available by 

or authority granted pursuant to this Act may be used without 

regard to the time limitations for submission and approval of apportionments set forth in section 1513 of title 31, United States Code, 

but nothing in this Act may be construed to waive any other 

provision of law governing the apportionment of funds. 

SEC. 109. Notwithstanding any other provision of this Act, 

except section 106, for those programs that would otherwise have 

high initial rates of operation or complete distribution of appropriations at the beginning of fiscal year 2023 because of distributions 
H. R. 6833—4 

of funding to States, foreign countries, grantees, or others, such 

high initial rates of operation or complete distribution shall not 

be made, and no grants shall be awarded for such programs funded 

by this Act that would impinge on final funding prerogatives. 

SEC. 110. This Act shall be implemented so that only the 

most limited funding action of that permitted in the Act shall 

be taken in order to provide for continuation of projects and activities. 

SEC. 111. (a) For entitlements and other mandatory payments 

whose budget authority was provided in appropriations Acts for 

fiscal year 2022, and for activities under the Food and Nutrition 

Act of 2008, activities shall be continued at the rate to maintain 

program levels under current law, under the authority and conditions provided in the applicable appropriations Act for fiscal year 

2022, to be continued through the date specified in section 106(3). 

(b) Notwithstanding section 106, obligations for mandatory payments due on or about the first day of any month that begins 

after October 2022 but not later than 30 days after the date specified 

in section 106(3) may continue to be made, and funds shall be 

available for such payments. 

SEC. 112. Amounts made available under section 101 for civilian 

personnel compensation and benefits in each department and 

agency may be apportioned up to the rate for operations necessary 

to avoid furloughs within such department or agency, consistent 

with the applicable appropriations Act for fiscal year 2022, except 

that such authority provided under this section shall not be used 

until after the department or agency has taken all necessary actions 

to reduce or defer non-personnel-related administrative expenses. 

SEC. 113. Funds appropriated by this Act may be obligated 

and expended notwithstanding section 10 of Public Law 91–672 

(22 U.S.C. 2412), section 15 of the State Department Basic Authorities Act of 1956 (22 U.S.C. 2680), section 313 of the Foreign Relations Authorization Act, Fiscal Years 1994 and 1995 (22 U.S.C. 

6212), and section 504(a)(1) of the National Security Act of 1947 

(50 U.S.C. 3094(a)(1)). 

SEC. 114. Each amount incorporated by reference in this Act 

that was previously designated by the Congress as an emergency 

requirement pursuant to sections 4001(a)(1) and 4001(b) of S. Con. 

Res. 14 (117th Congress), the concurrent resolution on the budget 

for fiscal year 2022, or as being for disaster relief pursuant to 

section 4005(f) of such concurrent resolution, is designated as being 

an emergency requirement pursuant to section 4001(a)(1) of such 

concurrent resolution and section 1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of Representatives on June 8, 

2022, or as being for disaster relief pursuant to section 1(f) of 

such House resolution, respectively. 

SEC. 115. (a) Rescissions or cancellations of discretionary budget 

authority that continue pursuant to section 101 in Treasury Appropriations Fund Symbols (TAFS)— 

(1) to which other appropriations are not provided by this 

Act, but for which there is a current applicable TAFS that 

does receive an appropriation in this Act; or 

(2) which are no-year TAFS and receive other appropriations in this Act, 

may be continued instead by reducing the rate for operations otherwise provided by section 101 for such current applicable TAFS, 
H. R. 6833—5 

as long as doing so does not impinge on the final funding prerogatives of the Congress. 

(b) Rescissions or cancellations described in subsection (a) shall 

continue in an amount equal to the lesser of— 

(1) the amount specified for rescission or cancellation in 

the applicable appropriations Act referenced in section 101 

of this Act; or 

(2) the amount of balances available, as of October 1, 

2022, from the funds specified for rescission or cancellation 

in the applicable appropriations Act referenced in section 101 

of this Act. 

(c) No later than November 21, 2022, the Director of the Office 

of Management and Budget shall provide to the Committees on 

Appropriations of the House of Representatives and the Senate 

a comprehensive list of the rescissions or cancellations that will 

continue pursuant to section 101: Provided, That the information 

in such comprehensive list shall be periodically updated to reflect 

any subsequent changes in the amount of balances available, as 

of October 1, 2022, from the funds specified for rescission or cancellation in the applicable appropriations Act referenced in section 

101, and such updates shall be transmitted to the Committees 

on Appropriations of the House of Representatives and the Senate 

upon request. 

SEC. 116. Amounts made available by section 101 for ‘‘Farm 

Service Agency—Agricultural Credit Insurance Fund Program 

Account’’ may be apportioned up to the rate for operations necessary 

to accommodate approved applications for direct and guaranteed 

farm ownership loans, as authorized by 7 U.S.C. 1922 et seq. 

SEC. 117. Amounts made available by section 101 to the Department of Agriculture for ‘‘Rural Business—Cooperative Service— 

Rural Microentrepreneur Assistance Program’’ may be used for 

the costs of loans, including the cost of modifying such loans, 

as defined in section 502 of the Congressional Budget Act of 1974, 

under the same terms and conditions as authorized by section 

379E of the Consolidated Farm and Rural Development Act (7 

U.S.C. 2008s). 

SEC. 118. Section 260 of the Agricultural Marketing Act of 

1946 (7 U.S.C. 1636i) and section 942 of the Livestock Mandatory 

Reporting Act of 1999 (7 U.S.C. 1635 note; Public Law 106–78) 

shall be applied by substituting the date specified in section 106(3) 

of this Act for ‘‘September 30, 2022’’. 

SEC. 119. Amounts made available by section 101 to the Department of Commerce for ‘‘Economic Development Administration— 

Salaries and Expenses’’ may be apportioned up to the rate for 

operations necessary to maintain agency operations. 

SEC. 120. Amounts made available by section 101 for ‘‘Department of Commerce—National Telecommunications and Information 

Administration—Salaries and Expenses’’ may be apportioned up 

to the rate for operations necessary to ensure continued oversight 

of public safety communications programs. 

SEC. 121. In addition to amounts otherwise provided by section 

101, for ‘‘Department of Justice—Federal Bureau of Investigation— 

Salaries and Expenses’’, there is appropriated $15,300,000, for an 

additional amount for fiscal year 2023, to remain available until 

September 30, 2023, for investigative activities associated with 

Afghan resettlement operations: Provided, That such amount is 

designated by the Congress as being for an emergency requirement 
H. R. 6833—6 

pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), 

the concurrent resolution on the budget for fiscal year 2022, and 

section 1(e) of H. Res. 1151 (117th Congress), as engrossed in 

the House of Representatives on June 8, 2022. 

SEC. 122. (a) Notwithstanding sections 101 and 106, through 

September 30, 2023, the Secretary of Defense may transfer up 

to $3,000,000,000 from unobligated balances from amounts made 

available under the heading ‘‘Department of Defense—Operation 

and Maintenance—Overseas Humanitarian, Disaster, and Civic 

Aid’’ in division C of Public Law 117–43 and division B of Public 

Law 117–70 to any appropriation account under the headings 

‘‘Department of State and Related Agency—Department of State— 

Administration of Foreign Affairs’’, ‘‘Bilateral Economic Assistance—Department of State—Migration and Refugee Assistance’’, 

and ‘‘Bilateral Economic Assistance—Department of State—United 

States Emergency Refugee and Migration Assistance Fund’’ for 

support of Operation Allies Welcome or any successor operation: 

Provided, That upon transfer, such funds shall be merged with 

the appropriation to which such funds are transferred except that 

such funds may be made available for such purposes notwithstanding any requirement or limitation applicable to the appropriation to which transferred, including sections 2(c)(1) and 2(c)(2) 

of the Migration and Refugee Assistance Act of 1962 with respect 

to the United States Emergency Refugee and Migration Assistance 

Fund and in sections 4(a) and 4(b) of the State Department Basic 

Authorities Act of 1956 with respect to funds transferred to the 

Emergencies in the Diplomatic and Consular Service account: Provided further, That section 2215 of title 10, United States Code, 

shall not apply to a transfer of funds under this subsection: Provided 

further, That the exercise of the authority of this subsection shall 

be subject to prior consultation with, and the regular notification 

procedures of, the Committees on Appropriations of the House 

of Representatives and the Senate: Provided further, That any 

funds transferred pursuant to this subsection that were previously 

designated by the Congress as an emergency requirement pursuant 

to the concurrent resolution on the budget are designated by the 

Congress as being for an emergency requirement pursuant to section 

4001(a)(1) of S. Con. Res. 14 (117th Congress), the concurrent 

resolution on the budget for fiscal year 2022, and section 1(e) 

of H. Res. 1151 (117th Congress), as engrossed in the House of 

Representatives on June 8, 2022. 

(b) Not later than November 1, 2022 and prior to any transfer 

of funds pursuant to subsection (a), the Director of the Office 

of Management and Budget shall provide to the Committees on 

Appropriations of the House of Representatives and the Senate 

a written report on Operation Allies Welcome or any successor 

operation: Provided, That such report shall describe the number 

and status of Afghans residing at Department of Defense and 

Department of State-managed facilities and any anticipated future 

arrivals at such facilities; the strategy and plan, including timeline, 

for adjudicating and relocating all Afghans residing at Department 

of Defense or overseas civilian facilities and for the transition 

of operations and responsibilities under Operation Allies Welcome 

or any successor operation from the Department of Defense to 

the Department of State during fiscal year 2023; the activities 

and responsibilities assigned to each Federal agency involved in 

such strategy and plan; and a spend plan, containing an estimate 
H. R. 6833—7 

of the costs, including additional construction and security costs, 

to be incurred by each such agency for carrying out such strategy 

and plan, and the sources of funds: Provided further, That prior 

to the initial obligation of funds transferred to the Department 

of State pursuant to subsection (a), the Secretary of State shall 

submit a report to such Committees detailing the roles and responsibilities of Department of State bureaus and offices in Operation 

Allies Welcome or any successor operation. 

SEC. 123. During the period covered by this Act, section 

714(b)(2)(B) of title 10, United States Code, shall be applied by 

substituting ‘‘three years’’ for ‘‘two years’’. 

SEC. 124. (a) Of the remaining unobligated balances, as of 

September 30, 2022, from amounts provided under the heading 

‘‘Afghanistan Security Forces Fund’’ in title IX of division C of 

Public Law 116–260, $100,000,000 is hereby permanently rescinded, 

and in addition to amounts otherwise provided by section 101, 

an amount of additional new budget authority equivalent to the 

amount rescinded pursuant to this subsection is hereby appropriated on September 30, 2022, for an additional amount for fiscal 

year 2022, to remain available until September 30, 2025, for the 

same purposes and under the same authorities provided under 

such heading in Public Law 116–260, in addition to other funds 

as may be available for such purposes. 

(b)(1) Subject to paragraph (2), this section shall become effective immediately upon enactment of this Act. 

(2) If this Act is enacted after September 30, 2022, this 

section shall be applied as if it were in effect on September 

30, 2022. 

SEC. 125. In addition to amounts otherwise provided by section 

101, for ‘‘Corps of Engineers—Civil—Construction’’, there is appropriated $20,000,000, for an additional amount for fiscal year 2023, 

to remain available until expended, for necessary expenses related 

to water and wastewater infrastructure under section 219 of the 

Water Resources Development Act of 1992 (106 Stat. 4835): Provided, That such amount is designated by the Congress as being 

for an emergency requirement pursuant to section 4001(a)(1) of 

S. Con. Res. 14 (117th Congress), the concurrent resolution on 

the budget for fiscal year 2022, and section 1(e) of H. Res. 1151 

(117th Congress), as engrossed in the House of Representatives 

on June 8, 2022. 

SEC. 126. (a) During the period covered by this Act, title I 

of Public Law 108–361 (the Calfed Bay-Delta Authorization Act) 

(118 Stat. 1681), as amended by section 204 of division D of Public 

Law 117–103, shall be applied by substituting ‘‘2023’’ for ‘‘2022’’ 

each place it appears. 

(b) During the period covered by this Act, section 103(f)(4)(A) 

of title I of Public Law 108–361 (the Calfed Bay-Delta Authorization 

Act) (118 Stat. 1696) shall be applied by substituting ‘‘$25,650,000’’ 

for ‘‘$25,000,000’’. 

SEC. 127. (a) During the period covered by this Act, section 

9106(g)(2) of Public Law 111–11 (Omnibus Public Land Management Act of 2009) shall be applied by substituting ‘‘2023’’ for ‘‘2022’’. 

(b) During the period covered by this Act, section 104(c) of 

the Reclamation States Emergency Drought Relief Act of 1991 

(43 U.S.C. 2214(c)) shall be applied by substituting ‘‘2023’’ for 

‘‘2022’’. 
H. R. 6833—8 

(c) During the period covered by this Act, section 301 of the 

Reclamation States Emergency Drought Relief Act of 1991 (43 

U.S.C. 2241) shall be applied by substituting ‘‘2023’’ for ‘‘2022’’. 

SEC. 128. In addition to amounts otherwise provided by section 

101, amounts are provided for ‘‘Department of the Treasury— 

Alcohol and Tobacco Tax and Trade Bureau—Salaries and 

Expenses’’ at a rate for operations of $14,929,000, for an additional 

amount to administer the Craft Beverage Modernization Act import 

claims program, as required by the Taxpayer Certainty and Disaster 

Tax Relief Act of 2020, and such amounts may be apportioned 

up to the rate for operations necessary to establish and implement 

a new import claims program. 

SEC. 129. Notwithstanding section 101, title II of division E 

of Public Law 117–103 shall be applied by adding the following 

new heading and appropriation language under the heading ‘‘Executive Office of the President and Funds Appropriated to the President’’: 

‘‘OFFICE OF THE NATIONAL CYBER DIRECTOR

‘‘SALARIES AND EXPENSES

‘‘For necessary expenses of the Office of the National Cyber 

Director, as authorized by section 1752 of the William M. (Mac) 

Thornberry National Defense Authorization Act for Fiscal Year 

2021 (Public Law 116–283), $21,000,000, of which not to exceed 

$5,000 shall be available for official reception and representation 

expenses.’’. 

SEC. 130. Notwithstanding section 101, amounts are provided 

for ‘‘The Judiciary—Courts of Appeals, District Courts, and Other 

Judicial Services—Fees of Jurors and Commissioners’’ at a rate 

for operations of $59,565,000. 

SEC. 131. In addition to amounts otherwise provided by section 

101, for ‘‘The Judiciary—Courts of Appeals, District Courts, and 

Other Judicial Services—Court Security’’, there is appropriated 

$112,500,000, for an additional amount for fiscal year 2023, to 

remain available until expended, for security improvements at 

United States courthouses and Federal court facilities: Provided, 

That not later than 90 days after the date of enactment of this 

Act, and every 90 days thereafter until all funds provided by this 

section have been expended, the Director of the Administrative 

Office of the United States Courts shall provide, in an appropriate 

format, quarterly reports on the obligations and expenditures of 

the funds provided under this section to the Committees on Appropriations of the House of Representatives and the Senate: Provided 

further, That such amount is designated by the Congress as being 

for an emergency requirement pursuant to section 4001(a)(1) of 

S. Con. Res. 14 (117th Congress), the concurrent resolution on 

the budget for fiscal year 2022, and section 1(e) of H. Res. 1151 

(117th Congress), as engrossed in the House of Representatives 

on June 8, 2022. 

SEC. 132. Notwithstanding any other provision of this Act, 

except section 106, the District of Columbia may expend local funds 

made available under the heading ‘‘District of Columbia—District 

of Columbia Funds’’ for such programs and activities under the 

District of Columbia Appropriations Act, 2022 (title IV of division 

E of Public Law 117–103) at the rate set forth in the Fiscal Year 
H. R. 6833—9 

2023 Local Budget Act of 2022 (D.C. Act 24–486), as modified 

as of the date of enactment of this Act. 

SEC. 133. In addition to amounts otherwise provided by section 

101, amounts are provided for ‘‘Small Business Administration— 

Salaries and Expenses’’ at a rate for operations of $20,000,000, 

for an additional amount for costs associated with the establishment 

and implementation of a Government-wide service-disabled veteranowned small business certification program within the Small Business Administration, as required by section 36 of the Small Business 

Act (15 U.S.C. 657f) and section 862 of Public Law 116–283: Provided, That such amounts may be apportioned up to the rate for 

operations necessary to establish and implement such certification 

program: Provided further, That such amounts may be obligated 

in the account and budget structure set forth in H.R. 8294, as 

passed by the House of Representatives on July 20, 2022. 

SEC. 134. Amounts made available by section 101 for ‘‘Small 

Business Administration—Business Loans Program Account’’ may 

be apportioned up to the rate for operations necessary to accommodate increased demand for commitments for general business loans 

authorized under paragraphs (1) through (35) of section 7(a) of 

the Small Business Act (15 U.S.C. 636(a)), for guarantees of trust 

certificates authorized by section 5(g) of the Small Business Act 

(15 U.S.C. 634(g)), for commitments to guarantee loans under section 503 of the Small Business Investment Act of 1958 (15 U.S.C. 

697), and for commitments to guarantee loans for debentures under 

section 303(b) of the Small Business Investment Act of 1958 (15 

U.S.C. 683(b)). 

SEC. 135. Amounts made available by section 101 to the Department of Homeland Security under the heading ‘‘Federal Emergency 

Management Agency—Disaster Relief Fund’’ may be apportioned 

up to the rate for operations necessary to carry out response and 

recovery activities under the Robert T. Stafford Disaster Relief 

and Emergency Assistance Act (42 U.S.C. 5121 et seq.). 

SEC. 136. Notwithstanding sections 101, 104, and 106, to carry 

out the Hermit’s Peak/Calf Canyon Fire Assistance Act, there is 

appropriated $2,500,000,000, to remain available until expended, 

to the Department of Homeland Security for ‘‘Federal Emergency 

Management Agency—Hermit’s Peak/Calf Canyon Fire Assistance 

Account’’, which shall be derived by transfer from amounts made 

available under the heading ‘‘Federal Emergency Management 

Agency—Disaster Relief Fund’’ in title VI of division B of the 

Coronavirus Aid, Relief, and Economic Security Act (Public Law 

116–136), of which $1,000,000 shall be transferred to ‘‘Office of 

the Inspector General—Operations and Support’’ for oversight of 

activities authorized by the Hermit’s Peak/Calf Canyon Fire Assistance Act: Provided, That no amounts may be derived from amounts 

made available for major disasters declared pursuant to the Robert 

T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 

5121 et seq.): Provided further, That amounts provided by this 

section shall be subject to the same authorities and conditions 

as if such amounts were provided by title III of the Department 

of Homeland Security Appropriations Act, 2022 (division F of Public 

Law 117–103): Provided further, That not later than 90 days after 

the date of enactment of this Act, and every 90 days thereafter 

until all funds provided by this section have been expended, the 

Administrator of the Federal Emergency Management Agency shall 
H. R. 6833—10 

provide, in an appropriate format, quarterly reports to the Committees on Appropriations of the Senate and the House of Representatives on the obligations and expenditures of the funds made available by this section: Provided further, That amounts transferred 

by this section that were previously designated by the Congress 

as an emergency requirement pursuant to the Balanced Budget 

and Emergency Deficit Control Act of 1985 or a concurrent resolution on the budget are designated as an emergency requirement 

pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), 

the concurrent resolution on the budget for fiscal year 2022, and 

section 1(e) of H. Res. 1151 (117th Congress), as engrossed in 

the House of Representatives on June 8, 2022. 

SEC. 137. Section 708(b)(13) of the Homeland Security Act 

of 2002 (6 U.S.C. 348(b)(13)) shall be applied by substituting the 

date specified in section 106(3) of this Act for ‘‘September 30, 

2022’’. 

SEC. 138. During the period covered by this Act, section 822(a) 

of the Homeland Security Act of 2002 (6 U.S.C. 383(a)) shall be 

applied by substituting ‘‘2023’’ for ‘‘2022’’. 

SEC. 139. (a) Sections 1309(a) and 1319 of the National Flood 

Insurance Act of 1968 (42 U.S.C. 4016(a) and 4026) shall be applied 

by substituting the date specified in section 106(3) of this Act 

for ‘‘September 30, 2022’’. 

(b)(1) Subject to paragraph (2), this section shall become effective immediately upon enactment of this Act. 

(2) If this Act is enacted after September 30, 2022, this 

section shall be applied as if it were in effect on September 

30, 2022. 

SEC. 140. Section 880(g) of the National Defense Authorization 

Act for Fiscal Year 2017 (Public Law 114–328) shall be applied 

by substituting the date specified in section 106(3) of this Act 

for ‘‘September 30, 2022’’. 

SEC. 141. Section 210G(i) of the Homeland Security Act of 

2002 (6 U.S.C. 124n(i)) shall be applied by substituting the date 

specified in section 106(3) of this Act for ‘‘the date that is 4 years 

after the date of enactment of this section’’. 

SEC. 142. Amounts made available by section 101 for ‘‘Department of the Interior—National Park Service—National Recreation 

and Preservation’’ for heritage partnership programs may be used 

to provide financial assistance to any national heritage area, 

national heritage corridor, cultural heritage corridor, national heritage partnership, national heritage route, national heritage 

canalway, and battlefields national historic district established as 

of September 1, 2022, notwithstanding any statutory sunset provision terminating the Secretary’s authority to provide assistance 

to any such area and notwithstanding any limitation on amounts 

authorized to be appropriated with respect to any such area. 

SEC. 143. Amounts made available by section 101 to the Department of the Interior under the heading ‘‘Working Capital Fund’’ 

may be apportioned up to the rate for operations necessary to 

implement enterprise cybersecurity safeguards. 

SEC. 144. (a) In addition to amounts otherwise provided by 

section 101, amounts are provided for ‘‘Department of Health and 

Human Services—Indian Health Service—Indian Health Services’’ 

at a rate for operations of $16,721,000, for an additional amount 

for costs of staffing and operating facilities that were opened, renovated, or expanded in fiscal years 2022 and 2023, and such 
H. R. 6833—11 

amounts may be apportioned up to the rate for operations necessary 

to staff and operate such facilities. 

(b) In addition to amounts otherwise provided by section 101, 

amounts are provided for ‘‘Department of Health and Human Services—Indian Health Service—Indian Health Facilities’’ at a rate 

for operations of $1,201,000, for an additional amount for costs 

of staffing and operating facilities that were opened, renovated, 

or expanded in fiscal years 2022 and 2023, and such amounts 

may be apportioned up to the rate for operations necessary to 

staff and operate such facilities. 

SEC. 145. In addition to amounts otherwise provided by section 

101, for ‘‘Department of Health and Human Services—Substance 

Abuse and Mental Health Services Administration—Mental 

Health’’, there is appropriated $62,000,000, for an additional 

amount for fiscal year 2023, to remain available until September 

30, 2023, for carrying out 988 Suicide Lifeline activities and behavioral health crisis services. 

SEC. 146. In addition to amounts otherwise provided by section 

101, for ‘‘Department of Health and Human Services—Administration for Children and Families—Low Income Home Energy Assistance’’, there is appropriated $1,000,000,000, for an additional 

amount for fiscal year 2023, to remain available until September 

30, 2023, for making payments under subsection (b) of section 

2602 of the Low-Income Home Energy Assistance Act of 1981 (42 

U.S.C. 8621 et seq.): Provided, That of the funds made available 

by this section, $500,000,000 shall be allocated as though the total 

appropriation for such payments for fiscal year 2023 was less than 

$1,975,000,000: Provided further, That such amount is designated 

by the Congress as being for an emergency requirement pursuant 

to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the concurrent resolution on the budget for fiscal year 2022, and section 

1(e) of H. Res. 1151 (117th Congress), as engrossed in the House 

of Representatives on June 8, 2022. 

SEC. 147. In addition to amounts otherwise provided by section 

101, for ‘‘Department of Health and Human Services—Administration for Children and Families—Refugee and Entrant Assistance’’, 

there is appropriated $1,775,000,000, for an additional amount for 

fiscal year 2023, to remain available until September 30, 2025, 

to carry out section 462 of the Homeland Security Act of 2002 

and section 235 of the William Wilberforce Trafficking Victims 

Protection Reauthorization Act of 2008, and for refugee and entrant 

assistance activities authorized by section 414 of the Immigration 

and Nationality Act and section 501 of the Refugee Education 

Assistance Act of 1980: Provided, That such amount is designated 

by the Congress as being for an emergency requirement pursuant 

to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the concurrent resolution on the budget for fiscal year 2022, and section 

1(e) of H. Res. 1151 (117th Congress), as engrossed in the House 

of Representatives on June 8, 2022. 

SEC. 148. Notwithstanding section 101, the first paragraph 

under the heading ‘‘Social Security Administration—Limitation on 

Administrative Expenses’’ in title IV of division H of Public Law 

117–103 shall be applied by substituting ‘‘$13,602,945,000’’ for 

‘‘$13,202,945,000’’. 

SEC. 149. (a) During the period covered by this Act, subsection 

(a)(1)(A) of section 2502 of the Afghanistan Supplemental Appropriations Act, 2022 (division C of Public Law 117–43) shall be 
H. R. 6833—12 

applied by substituting the date specified in section 106(3) for 

‘‘September 30, 2022’’. 

(b) The amount provided by this section is designated as an 

emergency requirement pursuant to section 4001(a)(1) of S. Con. 

Res. 14 (117th Congress), the concurrent resolution on the budget 

for fiscal year 2022, and section 1(e) of H. Res. 1151 (117th Congress), as engrossed in the House of Representatives on June 8, 

2022. 

SEC. 150. Activities authorized by part A of title IV (other 

than under section 403(c) or 418) and section 1108(b) of the Social 

Security Act shall continue through the date specified in section 

106(3), in the manner authorized for fiscal year 2022, and out 

of any money in the Treasury of the United States not otherwise 

appropriated, there are hereby appropriated such sums as may 

be necessary for such purpose. 

SEC. 151. Notwithstanding section 101, section 126 of division 

J of Public Law 117–103 shall be applied during the period covered 

by this Act by substituting ‘‘fiscal year 2017 and fiscal year 2018’’ 

for ‘‘fiscal year 2017’’. 

SEC. 152. Notwithstanding section 101, amounts are provided 

for— 

(1) ‘‘Department of State and Related Agency—Department 

of State—Administration of Foreign Affairs—Diplomatic Programs’’ at a rate for operations of $9,228,789,000; 

(2) ‘‘Bilateral Economic Assistance—Funds Appropriated 

to the President—International Disaster Assistance’’ at a rate 

for operations of $4,555,460,000; 

(3) ‘‘Bilateral Economic Assistance—Funds Appropriated 

to the President—Transition Initiatives’’ at a rate for operations 

of $100,000,000; 

(4) ‘‘Bilateral Economic Assistance—Funds Appropriated 

to the President—Assistance for Europe, Eurasia and Central 

Asia’’ at a rate for operations of $850,000,000; 

(5) ‘‘Bilateral Economic Assistance—Department of State— 

Migration and Refugee Assistance’’ at a rate for operations 

of $3,562,188,000; 

(6) ‘‘International Security Assistance—Department of 

State—International Narcotics Control and Law Enforcement’’ 

at a rate for operations of $1,421,004,000; and 

(7) ‘‘International Security Assistance—Funds Appropriated to the President—Foreign Military Financing Program’’ 

at a rate for operations of $6,190,424,000. 

SEC. 153. During the period covered by this Act, section 579 

of the Multifamily Assisted Housing Reform and Affordability Act 

of 1997 (42 U.S.C. 1437f note) shall be applied by substituting 

‘‘2023’’ for ‘‘2022’’ each place it appears. 

SEC. 154. Amounts made available by section 101 to the Department of Housing and Urban Development for ‘‘Public and Indian 

Housing—Native Hawaiian Housing Loan Guarantee Fund Program 

Account’’ may be apportioned up to the rate for operations necessary 

to accommodate demand for commitments to guarantee loans as 

authorized by section 184A of the Housing and Community Development Act of 1992 (12 U.S.C. 1715z–13b). 

SEC. 155. In addition to amounts otherwise provided by section 

101, for ‘‘Department of Housing and Urban Development—Community Planning and Development—Community Development Fund’’, 

there is appropriated $2,000,000,000, for an additional amount for 
H. R. 6833—13 

fiscal year 2023, to remain available until expended, for the same 

purposes and under the same terms and conditions as funds appropriated under such heading in title VIII of the Disaster Relief 

Supplemental Appropriations Act, 2022 (division B of Public Law 

117–43), except that such amounts shall be for major disasters 

that occurred in 2021 or 2022 and the fourth, twentieth, and twentyfirst provisos under such heading in such Act shall not apply: 

Provided, That amounts made available under this section and 

under such heading in such Act may be used by a grantee to 

assist utilities as part of a disaster-related eligible activity under 

section 105(a) of the Housing and Community Development Act 

of 1974 (42 U.S.C. 5305(a)): Provided further, That such amount 

is designated by the Congress as being for an emergency requirement pursuant to section 4001(a)(1) of S. Con. Res. 14 (117th 

Congress), the concurrent resolution on the budget for fiscal year 

2022, and section 1(e) of H. Res. 1151 (117th Congress), as engrossed 

in the House of Representatives on June 8, 2022. 

SEC. 156. Notwithstanding section 106 of this Act, at any time 

during fiscal year 2023, the Secretary of Housing and Urban 

Development may transfer up to $1,300,000 in unobligated balances 

from amounts made available in prior Acts under the heading 

‘‘Housing Programs—Project-Based Rental Assistance’’ to Treasury 

Appropriation Fund Symbol 86 X 0148 for the liquidation of obligations incurred in fiscal year 2018 in connection with the continued 

provision of interest reduction payments authorized under section 

236 of the National Housing Act (12 U.S.C. 1715z–1). 

SEC. 157. (a) The remaining unobligated balances, as of September 30, 2022, from amounts made available for ‘‘Department 

of Transportation—Office of the Secretary—National Infrastructure 

Investments’’ in title I of division H of the Further Consolidated 

Appropriations Act, 2020 (Public Law 116–94) are hereby permanently rescinded, and in addition to amounts otherwise provided 

by section 101, an amount of additional new budget authority 

equivalent to the amount rescinded pursuant to this subsection 

is hereby appropriated on September 30, 2022, for an additional 

amount for fiscal year 2022, to remain available until September 

30, 2023, and shall be available, without additional competition, 

for completing the funding of awards made pursuant to the fiscal 

year 2020 national infrastructure investments program, in addition 

to other funds as may be available for such purposes. 

(b) The remaining unobligated balances, as of September 30, 

2022, from amounts made available to the Department of Transportation in section 105 of division L of the Consolidated Appropriations 

Act, 2021 (Public Law 116–260) are hereby permanently rescinded, 

and in addition to amounts otherwise provided by section 101, 

an amount of additional new budget authority equivalent to the 

amount rescinded pursuant to this subsection is hereby appropriated on September 30, 2022, for an additional amount for fiscal 

year 2022, to remain available until September 30, 2023, and shall 

be available, without additional competition, for completing the 

funding of awards made pursuant to the fiscal year 2019 national 

infrastructure investments program, in addition to other funds as 

may be available for such purposes. 

(c)(1) Subject to paragraph (2), this section shall become effective immediately upon enactment of this Act. 
H. R. 6833—14 

(2) If this Act is enacted after September 30, 2022, this 

section shall be applied as if it were in effect on September 

30, 2022. 

This division may be cited as the ‘‘Continuing Appropriations 

Act, 2023’’. 

DIVISION B—UKRAINE SUPPLEMENTAL 

APPROPRIATIONS ACT, 2023 

The following sums are appropriated, out of any money in 

the Treasury not otherwise appropriated, for the fiscal year ending 

September 30, 2023, and for other purposes, namely: 

TITLE I 

DEPARTMENT OF DEFENSE 

MILITARY PERSONNEL

MILITARY PERSONNEL, ARMY

For an additional amount for ‘‘Military Personnel, Army’’, 

$110,107,000, to remain available until September 30, 2023, to 

respond to the situation in Ukraine and for related expenses. 

MILITARY PERSONNEL, NAVY

For an additional amount for ‘‘Military Personnel, Navy’’, 

$462,000, to remain available until September 30, 2023, to respond 

to the situation in Ukraine and for related expenses. 

MILITARY PERSONNEL, MARINE CORPS

For an additional amount for ‘‘Military Personnel, Marine 

Corps’’, $600,000, to remain available until September 30, 2023, 

to respond to the situation in Ukraine and for related expenses. 

MILITARY PERSONNEL, AIR FORCE

For an additional amount for ‘‘Military Personnel, Air Force’’, 

$11,582,000, to remain available until September 30, 2023, to 

respond to the situation in Ukraine and for related expenses. 

OPERATION AND MAINTENANCE 

OPERATION AND MAINTENANCE, ARMY

For an additional amount for ‘‘Operation and Maintenance, 

Army’’, $654,696,000, to remain available until September 30, 2023, 

to respond to the situation in Ukraine and for related expenses. 

OPERATION AND MAINTENANCE, NAVY

For an additional amount for ‘‘Operation and Maintenance, Navy’’, $433,035,000, to remain available until September 30, 2023, 

to respond to the situation in Ukraine and for related expenses. 
H. R. 6833—15 

OPERATION AND MAINTENANCE, MARINE CORPS

For an additional amount for ‘‘Operation and Maintenance, 

Marine Corps’’, $34,984,000, to remain available until September 

30, 2023, to respond to the situation in Ukraine and for related 

expenses. 

OPERATION AND MAINTENANCE, AIR FORCE

For an additional amount for ‘‘Operation and Maintenance, 

Air Force’’, $267,084,000, to remain available until September 30, 

2023, to respond to the situation in Ukraine and for related 

expenses. 

OPERATION AND MAINTENANCE, SPACE FORCE

For an additional amount for ‘‘Operation and Maintenance, 

Space Force’’, $1,771,000, to remain available until September 30, 

2023, to respond to the situation in Ukraine and for related 

expenses. 

OPERATION AND MAINTENANCE, DEFENSE-WIDE

(INCLUDING TRANSFER OF FUNDS)

For an additional amount for ‘‘Operation and Maintenance, 

Defense-Wide’’, $4,713,544,000, to remain available until September 

30, 2023, to respond to the situation in Ukraine and for related 

expenses: Provided, That of the total amount provided under this 

heading in this Act, $3,000,000,000, to remain available until September 30, 2024, shall be for the Ukraine Security Assistance 

Initiative: Provided further, That such funds for the Ukraine Security Assistance Initiative shall be available to the Secretary of 

Defense under the same terms and conditions as are provided 

for in section 8139 of the Department of Defense Appropriations 

Act, 2022 (division C of Public Law 117–103): Provided further, 

That of the total amount provided under this heading in this 

Act, up to $1,500,000,000, to remain available until September 

30, 2024, may be transferred to accounts under the headings ‘‘Operation and Maintenance’’ and ‘‘Procurement’’ for replacement of 

defense articles from the stocks of the Department of Defense, 

and for reimbursement for defense services of the Department of 

Defense and military education and training, provided to the 

government of Ukraine or to foreign countries that have provided 

support to Ukraine at the request of the United States: Provided 

further, That funds transferred pursuant to a transfer authority 

provided under this heading in this Act shall be merged with 

and available for the same purposes and for the same time period 

as the appropriations to which the funds are transferred: Provided 

further, That the Secretary of Defense shall notify the congressional 

defense committees of the details of such transfers not less than 

15 days before any such transfer: Provided further, That upon 

a determination that all or part of the funds transferred from 

this appropriation are not necessary for the purposes provided 

herein, such amounts may be transferred back and merged with 

this appropriation: Provided further, That the transfer authority 

provided under this heading in this Act is in addition to any 

other transfer authority provided by law. 
H. R. 6833—16 

PROCUREMENT 

MISSILE PROCUREMENT, ARMY

For an additional amount for ‘‘Missile Procurement, Army’’, 

$450,000,000, to remain available until September 30, 2025, to 

respond to the situation in Ukraine and for related expenses. 

PROCUREMENT OF AMMUNITION, ARMY

For an additional amount for ‘‘Procurement of Ammunition, 

Army’’, $540,000,000, to remain available until September 30, 2025, 

for expansion of public and private plants, including the land necessary therefor, and procurement and installation of equipment, 

appliances, and machine tools in such plants, for the purpose of 

increasing production of critical munitions to replace defense articles provided to the Government of Ukraine or foreign countries 

that have provided support to Ukraine at the request of the United 

States. 

OTHER PROCUREMENT, ARMY

For an additional amount for ‘‘Other Procurement, Army’’, 

$3,890,000, to remain available until September 30, 2025, to 

respond to the situation in Ukraine and for related expenses. 

OTHER PROCUREMENT, NAVY

For an additional amount for ‘‘Other Procurement, Navy’’, 

$2,170,000, to remain available until September 30, 2025, to 

respond to the situation in Ukraine and for related expenses. 

OTHER PROCUREMENT, AIR FORCE

For an additional amount for ‘‘Other Procurement, Air Force’’, 

$437,991,000, to remain available until September 30, 2025, to 

respond to the situation in Ukraine and for other expenses. 

PROCUREMENT, DEFENSE-WIDE

For an additional amount for ‘‘Procurement, Defense-Wide’’, 

$9,770,000, to remain available until September 30, 2025, to 

respond to the situation in Ukraine and for related expenses. 

RESEARCH, DEVELOPMENT, TEST AND EVALUATION 

RESEARCH, DEVELOPMENT, TEST AND EVALUATION, ARMY

For an additional amount for ‘‘Research, Development, Test 

and Evaluation, Army’’, $3,300,000, to remain available until September 30, 2024, to respond to the situation in Ukraine and for 

related expenses. 

RESEARCH, DEVELOPMENT, TEST AND EVALUATION, NAVY

For an additional amount for ‘‘Research, Development, Test 

and Evaluation, Navy’’, $2,077,000, to remain available until September 30, 2024, to respond to the situation in Ukraine and for 

related expenses. 
H. R. 6833—17 

RESEARCH, DEVELOPMENT, TEST AND EVALUATION, AIR FORCE

For an additional amount for ‘‘Research, Development, Test 

and Evaluation, Air Force’’, $99,704,000, to remain available until 

September 30, 2024, to respond to the situation in Ukraine and 

for related expenses. 

RESEARCH, DEVELOPMENT, TEST AND EVALUATION, DEFENSE-WIDE

For an additional amount for ‘‘Research, Development, Test 

and Evaluation, Defense-Wide’’, $31,230,000, to remain available 

until September 30, 2024, to respond to the situation in Ukraine 

and for related expenses. 

OTHER DEPARTMENT OF DEFENSE PROGRAMS 

OFFICE OF THE INSPECTOR GENERAL

For an additional amount for ‘‘Office of the Inspector General’’, 

$2,000,000, to remain available until September 30, 2023, to carry 

out reviews of the activities of the Department of Defense to execute 

funds appropriated in this title, including assistance provided to 

Ukraine: Provided, That the Inspector General of the Department 

of Defense shall provide to the congressional defense committees 

a briefing not later than 90 days after the date of enactment 

of this Act. 

RELATED AGENCIES 

INTELLIGENCE COMMUNITY MANAGEMENT ACCOUNT

For an additional amount for ‘‘Intelligence Community Management Account’’, $500,000, to remain available until September 30, 

2023, to respond to the situation in Ukraine and for related 

expenses. 

GENERAL PROVISIONS—THIS TITLE 

SEC. 1101. Not later than 60 days after the date of enactment 

of this Act, the Secretary of Defense, in coordination with the 

Secretary of State, shall submit a report to the Committees on 

Appropriations, Armed Services, and Foreign Affairs of the House 

of Representatives and the Committees on Appropriations, Armed 

Services, and Foreign Relations of the Senate on measures being 

taken to account for United States defense articles designated for 

Ukraine since the February 24, 2022, Russian invasion of Ukraine, 

particularly measures with regard to such articles that require 

enhanced end-use monitoring; measures to ensure that such articles 

reach their intended recipients and are used for their intended 

purposes; and any other measures to promote accountability for 

the use of such articles: Provided, That such report shall include 

a description of any occurrences of articles not reaching their 

intended recipients or used for their intended purposes and a 

description of any remedies taken: Provided further, That such 

report shall be submitted in unclassified form, but may be accompanied by a classified annex. 

SEC. 1102. Not later than 30 days after the date of enactment 

of this Act, and every 30 days thereafter through fiscal year 2023, 
H. R. 6833—18 

the Secretary of Defense, in coordination with the Secretary of 

State, shall provide a written report to the Committees on Appropriations, Armed Services, and Foreign Affairs of the House of 

Representatives and the Committees on Appropriations, Armed 

Services, and Foreign Relations of the Senate describing United 

States security assistance provided to Ukraine since the February 

24, 2022, Russian invasion of Ukraine, including a comprehensive 

list of the defense articles and services provided to Ukraine and 

the associated authority and funding used to provide such articles 

and services: Provided, That such report shall be submitted in 

unclassified form, but may be accompanied by a classified annex. 

TITLE II 

DEPARTMENT OF ENERGY 

ATOMIC ENERGY DEFENSE ACTIVITIES 

NATIONAL NUCLEAR SECURITY ADMINISTRATION 

DEFENSE NUCLEAR NONPROLIFERATION

For an additional amount for ‘‘Defense Nuclear Nonproliferation’’, $35,000,000, to remain available until expended, to respond 

to the situation in Ukraine and for related expenses. 

TITLE III 

BILATERAL ECONOMIC ASSISTANCE 

FUNDS APPROPRIATED TO THE PRESIDENT

ECONOMIC SUPPORT FUND

For an additional amount for ‘‘Economic Support Fund’’, 

$4,500,000,000, to remain available until September 30, 2024, for 

assistance for Ukraine: Provided, That funds appropriated under 

this heading in this Act may be made available notwithstanding 

any other provision of law that restricts assistance to foreign countries and may be made available as contributions. 

GENERAL PROVISIONS—THIS TITLE 

SEC. 1301. During fiscal year 2023, section 506(a)(1) of the 

Foreign Assistance Act of 1961 (22 U.S.C. 2318(a)(1)) shall be 

applied by substituting ‘‘$3,700,000,000’’ for ‘‘$100,000,000’’. 

SEC. 1302. (a) Funds appropriated by this title shall be made 

available for direct financial support for the Government of Ukraine, 

including for Ukrainian first responders, and may be made available 

as a cash transfer subject to the requirements of subsection (b): 

Provided, That such funds shall be provided on a reimbursable 

basis and matched by sources other than the United States Government, to the maximum extent practicable: Provided further, That 

the Secretary of State or the Administrator of the United States 

Agency for International Development, as appropriate, shall ensure 

third-party monitoring of such funds: Provided further, That at 

least 15 days prior to the initial obligation of such funds, the 

Secretary of State, following consultation with the Administrator 
H. R. 6833—19 

of the United States Agency for International Development, shall 

certify and report to the appropriate congressional committees that 

mechanisms for monitoring and oversight of such funds are in 

place and functioning and that the Government of Ukraine has 

in place substantial safeguards to prevent corruption and ensure 

accountability of such funds: Provided further, That not less than 

45 days after the initial obligation of such funds, the Inspectors 

General of the Department of State and the United States Agency 

for International Development shall submit a report to the appropriate congressional committees detailing and assessing the mechanisms for monitoring and safeguards described in the previous 

proviso. 

(b) Funds made available to the Government of Ukraine as 

a cash transfer under subsection (a) shall be subject to a memorandum of understanding between the Governments of the United 

States and Ukraine that describes how the funds proposed to be 

made available will be used and the appropriate safeguards to 

ensure transparency and accountability: Provided, That such assistance shall be maintained in a separate, auditable account and 

may not be comingled with any other funds. 

(c) The Secretary of State or the Administrator of the United 

States Agency for International Development, as appropriate, shall 

report to the appropriate congressional committees on the uses 

of funds provided for direct financial support to the Government 

of Ukraine pursuant to subsection (a) not later than 45 days after 

the date of enactment of this Act and every 45 days thereafter 

until all such funds have been expended: Provided, That such 

report shall include a detailed description of the use of such funds, 

including categories and amounts, the intended results and the 

results achieved, a summary of other donor contributions, and a 

description of the efforts undertaken by the Secretary and Administrator to increase other donor contributions for direct financial 

support: Provided further, That such report shall also include the 

metrics established to measure such results. 

(d) Funds made available for the purposes of subsection (a) 

shall be subject to the regular notification procedures of the 

Committees on Appropriations of the House of Representatives and 

the Senate. 

TITLE IV 

GENERAL PROVISIONS—THIS ACT 

SEC. 1401. Each amount appropriated or made available by 

this Act is in addition to amounts otherwise appropriated for the 

fiscal year involved. 

SEC. 1402. No part of any appropriation contained in this 

Act shall remain available for obligation beyond the current fiscal 

year unless expressly so provided herein. 

SEC. 1403. Unless otherwise provided for by this Act, the additional amounts appropriated by this Act to appropriations accounts 

shall be available under the authorities and conditions applicable 

to such appropriations accounts for fiscal year 2023. 

SEC. 1404. Each amount provided by this division is designated 

by the Congress as being for an emergency requirement pursuant 

to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the concurrent resolution on the budget for fiscal year 2022, and section 
H. R. 6833—20 

1(e) of H. Res. 1151 (117th Congress), as engrossed in the House 

of Representatives on June 8, 2022. 

This division may be cited as the ‘‘Ukraine Supplemental Appropriations Act, 2023’’. 

DIVISION C—OTHER MATTERS 

TITLE I—EXTENSIONS, TECHNICAL 

CORRECTIONS, AND OTHER MATTERS 

SEC. 101. EXTENSION OF FCC AUCTION AUTHORITY. 

Section 309(j)(11) of the Communications Act of 1934 (47 U.S.C. 

309(j)(11)) is amended by striking ‘‘September 30, 2022’’ and 

inserting ‘‘December 16, 2022’’. 

SEC. 102. EXTENSION OF AUTHORIZATION FOR SPECIAL ASSESSMENT 

FOR DOMESTIC TRAFFICKING VICTIMS’ FUND. 

Section 3014(a) of title 18, United States Code, is amended, 

in the matter preceding paragraph (1), by striking ‘‘September 

30, 2022’’ and inserting ‘‘December 16, 2022’’. 

SEC. 103. UNITED STATES PAROLE COMMISSION EXTENSION. 

(a) SHORT TITLE.—This section may be cited as the ‘‘United 

States Parole Commission Extension Act of 2022’’. 

(b) AMENDMENT OF SENTENCING REFORM ACT OF 1984.—For 

purposes of section 235(b) of the Sentencing Reform Act of 1984 

(18 U.S.C. 3551 note; Public Law 98–473; 98 Stat. 2032), as such 

section relates to chapter 311 of title 18, United States Code, 

and the United States Parole Commission, each reference in such 

section to ‘‘35 years’’ or ‘‘35-year period’’ shall be deemed a reference 

to ‘‘35 years and 46 days’’ or ‘‘35-year and 46-day period’’, respectively. 

SEC. 104. EXTENSION OF COMMODITY FUTURES TRADING COMMISSION 

CUSTOMER PROTECTION FUND EXPENSES ACCOUNT. 

Section 1(b) of Public Law 117–25 (135 Stat. 297) is amended 

by striking ‘‘October 1, 2022’’ each place it appears and inserting 

‘‘December 16, 2022’’. 

TITLE II—BUDGETARY EFFECTS 

SEC. 201. BUDGETARY EFFECTS. 

(a) STATUTORY PAYGO SCORECARDS.—The budgetary effects 

of this division and each succeeding division shall not be entered 

on either PAYGO scorecard maintained pursuant to section 4(d) 

of the Statutory Pay-As-You-Go Act of 2010. 

(b) SENATE PAYGO SCORECARDS.—The budgetary effects of this 

division and each succeeding division shall not be entered on any 

PAYGO scorecard maintained for purposes of section 4106 of H. 

Con. Res. 71 (115th Congress). 

(c) CLASSIFICATION OF BUDGETARY EFFECTS.—Notwithstanding 

Rule 3 of the Budget Scorekeeping Guidelines set forth in the 

joint explanatory statement of the committee of conference accompanying Conference Report 105–217 and section 250(c)(8) of the 

Balanced Budget and Emergency Deficit Control Act of 1985, the 
H. R. 6833—21 

budgetary effects of this division and each succeeding division shall 

not be estimated— 

(1) for purposes of section 251 of such Act; 

(2) for purposes of an allocation to the Committee on Appropriations pursuant to section 302(a) of the Congressional 

Budget Act of 1974; and 

(3) for purposes of paragraph (4)(C) of section 3 of the 

Statutory Pay-As-You-Go Act of 2010 as being included in an 

appropriation Act. 

DIVISION D—HEALTH AND HUMAN 

SERVICES EXTENSIONS 

TITLE I—MEDICARE AND MEDICAID 

SEC. 101. EXTENSION OF INCREASED INPATIENT HOSPITAL PAYMENT 

ADJUSTMENT FOR CERTAIN LOW-VOLUME HOSPITALS. 

(a) IN GENERAL.—Section 1886(d)(12) of the Social Security 

Act (42 U.S.C. 1395ww(d)(12)) is amended— 

(1) in subparagraph (B), in the matter preceding clause 

(i), by striking ‘‘in fiscal year 2023 and subsequent fiscal years’’ 

and inserting ‘‘during the portion of fiscal year 2023 beginning 

on December 17, 2022, and ending on September 30, 2023, 

and in fiscal year 2024 and subsequent fiscal years’’; 

(2) in subparagraph (C)(i)— 

(A) in the matter preceding subclause (I)— 

(i) by inserting ‘‘or portion of a fiscal year’’ after 

‘‘for a fiscal year’’; and 

(ii) by inserting ‘‘and the portion of fiscal year 

2023 beginning on October 1, 2022, and ending on 

December 16, 2022’’ after ‘‘through 2022’’; 

(B) in subclause (III), by inserting ‘‘and the portion 

of fiscal year 2023 beginning on October 1, 2022, and 

ending on December 16, 2022’’ after ‘‘through 2022’’; and 

(C) in subclause (IV), by striking ‘‘fiscal year 2023’’ 

and inserting ‘‘the portion of fiscal year 2023 beginning 

on December 17, 2022, and ending on September 30, 2023, 

and fiscal year 2024’’; and 

(3) in subparagraph (D)— 

(A) in the matter preceding clause (i), by inserting 

‘‘or during the portion of fiscal year 2023 beginning on 

October 1, 2022, and ending on December 16, 2022’’ after 

‘‘through 2022’’; and 

(B) in clause (ii), by inserting ‘‘and the portion of 

fiscal year 2023 beginning on October 1, 2022, and ending 

on December 16, 2022’’ after ‘‘through 2022’’. 

(b) IMPLEMENTATION.—Notwithstanding any other provision of 

law, the Secretary of Health and Human Services may implement 

the provisions of, including the amendments made by, this section 

by program instruction or otherwise. 

SEC. 102. EXTENSION OF THE MEDICARE-DEPENDENT HOSPITAL (MDH) 

PROGRAM. 

(a) IN GENERAL.—Section 1886(d)(5)(G) of the Social Security 

Act (42 U.S.C. 1395ww(d)(5)(G)) is amended— 
H. R. 6833—22 

(1) in clause (i), by striking ‘‘October 1, 2022’’ and inserting 

‘‘December 17, 2022’’; and 

(2) in clause (ii)(II), by striking ‘‘October 1, 2022’’ and 

inserting ‘‘December 17, 2022’’. 

(b) CONFORMING AMENDMENTS.— 

(1) EXTENSION OF TARGET AMOUNT.—Section 1886(b)(3)(D) 

of the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is 

amended— 

(A) in the matter preceding clause (i), by striking 

‘‘October 1, 2022’’ and inserting ‘‘December 17, 2022’’; and 

(B) in clause (iv), by inserting ‘‘and the portion of 

fiscal year 2023 beginning on October 1, 2022, and ending 

on December 16, 2022,’’ after ‘‘through fiscal year 2022’’. 

(2) PERMITTING HOSPITALS TO DECLINE RECLASSIFICATION.— 

Section 13501(e)(2) of the Omnibus Budget Reconciliation Act 

of 1993 (42 U.S.C. 1395ww note) is amended by striking ‘‘or 

fiscal year 2000 through fiscal year 2022,’’ and inserting ‘‘fiscal 

year 2000 through fiscal year 2022, or the portion of fiscal 

year 2023 beginning on October 1, 2022, and ending on 

December 16, 2022’’. 

SEC. 103. EXTENSION OF INCREASED FMAPS FOR THE TERRITORIES. 

Section 1905(ff) of the Social Security Act (42 U.S.C. 1396d(ff)) 

is amended by striking ‘‘December 13’’ each place it appears and 

inserting ‘‘December 16’’ in each such place. 

SEC. 104. REDUCTION OF MEDICARE IMPROVEMENT FUND. 

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 

1395iii(b)(1)) is amended by striking ‘‘$7,500,000,000’’ and inserting 

‘‘$7,308,000,000’’. 

TITLE II—HUMAN SERVICES 

SEC. 201. EXTENSION OF MATERNAL, INFANT, AND EARLY CHILDHOOD 

HOME VISITING PROGRAMS. 

Activities authorized by section 511 of the Social Security Act 

shall continue through December 16, 2022, in the manner authorized for fiscal year 2022, and out of any money in the Treasury 

of the United States not otherwise appropriated, there is hereby 

appropriated for such purpose an amount equal to the pro rata 

portion of the amount appropriated for such activities for fiscal 

year 2022. 

SEC. 202. EXTENSION OF CHILD AND FAMILY SERVICES PROGRAMS. 

Activities authorized by part B of title IV of the Social Security 

Act shall continue through December 16, 2022, in the manner 

authorized for fiscal year 2022, and out of any money in the 

Treasury of the United States not otherwise appropriated, there 

are hereby appropriated such sums as may be necessary for such 

purpose. 
H. R. 6833—23 

TITLE III—PUBLIC HEALTH 

SEC. 301. EXTENSION OF THE PROGRAM TO DEEM CERTAIN HEALTH 

PROFESSIONAL VOLUNTEERS EMPLOYEES OF THE PUBLIC 

HEALTH SERVICE UNDER CERTAIN CIRCUMSTANCES. 

(a) IN GENERAL.—Section 224(q) of the Public Health Service 

Act (42 U.S.C. 233(q)) is amended by striking paragraph (6). 

(b) TECHNICAL CORRECTIONS.—Section 224 of the Public Health 

Service Act (42 U.S.C. 233) is amended— 

(1) in subsection (g)(1)(H)(iv), by striking ‘‘this section.’’ 

and inserting ‘‘this section).’’; 

(2) in subsection (k)(3), by inserting ‘‘governing board members,’’ after ‘‘officers,’’; 

(3) in subsection (p)(7)(A)(i), by moving the margin of subclause (II) 2 ems to the left; and 

(4) in subsection (q)(5)(A), by striking ‘‘and paragraph (6)’’. 

SEC. 302. EXTENSION OF AUTHORIZATION FOR A COMMISSIONED 

OFFICER OF THE PUBLIC HEALTH SERVICE TO ACCUMULATE EXCESS ANNUAL LEAVE. 

For purposes of annual leave accumulated in fiscal year 2022, 

the authority provided in section 2106 of division C of Public Law 

116–159 (42 U.S.C. 210–1 note) shall apply to such leave by substituting ‘‘2022’’ for ‘‘2020’’ in subsections (a) and (d)(2). 

TITLE IV—INDIAN HEALTH 

SEC. 401. EXTENSION OF MORATORIUM. 

Section 424(a) of title IV of division G of Public Law 113– 

76 is amended by striking ‘‘October 1, 2019’’ and inserting 

‘‘December 16, 2022’’. 

DIVISION E—VETERANS AFFAIRS 

EXTENSIONS 

TITLE I—EXTENSIONS OF AUTHORITIES 

RELATING TO HEALTH CARE 

SEC. 101. EXTENSION OF AUTHORITY FOR COLLECTION OF COPAYMENTS FOR HOSPITAL CARE AND NURSING HOME CARE. 

Section 1710(f)(2)(B) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2024’’. 

SEC. 102. EXTENSION OF REQUIREMENT TO PROVIDE NURSING HOME 

CARE TO CERTAIN VETERANS WITH SERVICE-CONNECTED 

DISABILITIES. 

Section 1710A(d) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2024’’. 
H. R. 6833—24 

SEC. 103. EXTENSION OF AUTHORITY TO CONTINUE DOD–VA HEALTH 

CARE SHARING INCENTIVE FUND. 

Section 8111(d)(3) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2023’’ and inserting ‘‘September 30, 

2026’’. 

SEC. 104. EXTENSION OF AUTHORITY FOR JOINT DEPARTMENT OF 

DEFENSE-DEPARTMENT OF VETERANS AFFAIRS MEDICAL 

FACILITY DEMONSTRATION FUND. 

Section 1704(e) of the National Defense Authorization Act for 

Fiscal Year 2010 (Public Law 111–84; 123 Stat. 2573), as most 

recently amended by section 715 of the National Defense Authorization Act for Fiscal Year 2022 (Public Law 117–81; 135 Stat. 1787), 

is amended by striking ‘‘September 30, 2023’’ and inserting ‘‘September 30, 2024’’. 

SEC. 105. EXTENSION OF TEMPORARY EXPANSION OF PAYMENTS AND 

ALLOWANCES FOR BENEFICIARY TRAVEL IN CONNECTION 

WITH VETERANS RECEIVING CARE FROM VET CENTERS. 

Section 104(a) of the Honoring America’s Veterans and Caring 

for Camp Lejeune Families Act of 2012 (Public Law 112–154; 126 

Stat. 1169), as most recently amended by section 3 of the Department of Veterans Affairs Expiring Authorities Act of 2021 (Public 

Law 117–42; 135 Stat. 342), is amended by striking ‘‘September 

30, 2022’’ and inserting ‘‘September 30, 2023’’. 

TITLE II—EXTENSIONS OF 

AUTHORITIES RELATING TO BENEFITS 

SEC. 201. EXTENSION OF AUTHORITY TO TRANSPORT INDIVIDUALS 

TO AND FROM DEPARTMENT OF VETERANS AFFAIRS 

FACILITIES. 

Section 111A(a)(2) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2024’’. 

SEC. 202. EXTENSION OF AUTHORITY TO MAINTAIN REGIONAL OFFICE 

IN THE REPUBLIC OF THE PHILIPPINES. 

Section 315(b) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2024’’. 

SEC. 203. EXTENSION OF AUTHORITY FOR REPORT ON EQUITABLE 

RELIEF PROVIDED DUE TO ADMINISTRATIVE ERROR. 

Section 503(c) of title 38, United States Code, is amended 

by striking ‘‘December 31, 2022’’ and inserting ‘‘December 31, 2024’’. 

SEC. 204. EXTENSION OF AUTHORITY TO PROVIDE ASSISTANCE FOR 

SPECIALLY ADAPTED HOUSING FOR DISABLED VETERANS 

RESIDING TEMPORARILY IN HOUSING OWNED BY A 

FAMILY MEMBER. 

Section 2102A(e) of title 38, United States Code, is amended 

by striking ‘‘December 31, 2022’’ and inserting ‘‘December 31, 2024’’. 
H. R. 6833—25 

SEC. 205. EXTENSION OF SPECIALLY ADAPTED HOUSING ASSISTIVE 

TECHNOLOGY GRANT PROGRAM. 

Section 2108(g) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2024’’. 

TITLE III—EXTENSIONS OF AUTHORITIES RELATING TO HOMELESS VETERANS 

SEC. 301. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 

HOMELESS VETERANS REINTEGRATION PROGRAMS. 

Section 2021(e)(1)(F) of title 38, United States Code, is amended 

by striking ‘‘2022’’ and inserting ‘‘2024’’. 

SEC. 302. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 

HOMELESS WOMEN VETERANS AND HOMELESS VETERANS 

WITH CHILDREN REINTEGRATION GRANT PROGRAM. 

Section 2021A(f)(1) of title 38, United States Code, is amended 

by striking ‘‘2022’’ and inserting ‘‘2024’’. 

SEC. 303. EXTENSION OF AUTHORITY FOR TREATMENT AND 

REHABILITATION FOR SERIOUSLY MENTALLY ILL AND 

HOMELESS VETERANS. 

(a) GENERAL TREATMENT.—Section 2031(b) of title 38, United 

States Code, is amended by striking ‘‘September 30, 2022’’ and 

inserting ‘‘September 30, 2024’’. 

(b) ADDITIONAL SERVICES AT CERTAIN LOCATIONS.—Section 

2033(d) of such title is amended by striking ‘‘September 30, 2022’’ 

and inserting ‘‘September 30, 2024’’. 

SEC. 304. EXTENSION OF FUNDING FOR FINANCIAL ASSISTANCE FOR 

SUPPORTIVE SERVICES FOR VERY LOW-INCOME VETERAN 

FAMILIES IN PERMANENT HOUSING. 

Section 2044(e)(1)(H) of title 38, United States Code, is amended 

by striking ‘‘and 2022’’ and inserting ‘‘through 2024’’. 

SEC. 305. EXTENSION OF FUNDING FOR GRANT PROGRAM FOR HOMELESS VETERANS WITH SPECIAL NEEDS. 

Section 2061(d)(1) of title 38, United States Code, is amended 

by striking ‘‘2022’’ and inserting ‘‘2024’’. 

SEC. 306. EXTENSION OF AUTHORITY FOR THE ADVISORY COMMITTEE 

ON HOMELESS VETERANS. 

Section 2066(d) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2026’’. 
H. R. 6833—26 

TITLE IV—EXTENSIONS OF OTHER 

AUTHORITIES 

SEC. 401. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 

MONTHLY ASSISTANCE ALLOWANCE UNDER THE OFFICE 

OF NATIONAL VETERANS SPORTS PROGRAMS AND SPECIAL EVENTS. 

Section 322(d)(4) of title 38, United States Code, is amended 

by striking ‘‘2022’’ and inserting ‘‘2026’’. 

SEC. 402. EXTENSION AND AUTHORIZATION OF APPROPRIATIONS FOR 

ADAPTIVE SPORTS PROGRAMS FOR DISABLED VETERANS 

AND MEMBERS OF THE ARMED FORCES. 

(a) AUTHORIZATION OF APPROPRIATIONS.—Subsection (g)(1)(B) 

of section 521A of title 38, United States Code, is amended by 

striking ‘‘and 2022’’ and inserting ‘‘through 2026’’. 

(b) EXTENSION.—Subsection (l) of such section is amended by 

striking ‘‘2022’’ and inserting ‘‘2026’’. 

(c) TECHNICAL CORRECTION.—Subsection (g)(1)(A) of such section is amended by striking ‘‘. for each of fiscal years 2010 through 

2020’’. 

SEC. 403. EXTENSION OF ADVISORY COMMITTEE ON MINORITY VETERANS. 

Section 544(e) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2026’’. 

SEC. 404. EXTENSION OF VETERANS’ ADVISORY COMMITTEE ON EDUCATION. 

Section 3692(c) of title 38, United States Code, is amended 

by striking ‘‘December 31, 2022’’ and inserting ‘‘December 31, 2026’’. 

SEC. 405. EXTENSION OF AUTHORITY FOR TRANSFER OF REAL PROPERTY. 

Section 8118(a)(5) of title 38, United States Code, is amended 

by striking ‘‘September 30, 2022’’ and inserting ‘‘September 30, 

2024’’. 

DIVISION F—FDA USER FEE 

REAUTHORIZATION ACT OF 2022 

SEC. 1. SHORT TITLE. 

This division may be cited as the ‘‘FDA User Fee Reauthorization Act of 2022’’. 

SEC. 2. TABLE OF CONTENTS. 

The table of contents for this division is as follows: 

DIVISION F—FDA USER FEE REAUTHORIZATION ACT OF 2022 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 1001. Short title; finding. 

Sec. 1002. Definitions. 
H. R. 6833—27 

Sec. 1003. Authority to assess and use drug fees. 

Sec. 1004. Reauthorization; reporting requirements. 

Sec. 1005. Sunset dates. 

Sec. 1006. Effective date. 

Sec. 1007. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 2001. Short title; finding. 

Sec. 2002. Definitions. 

Sec. 2003. Authority to assess and use device fees. 

Sec. 2004. Reauthorization; reporting requirements. 

Sec. 2005. Conformity assessment pilot program. 

Sec. 2006. Reauthorization of third-party review program. 

Sec. 2007. Sunset dates. 

Sec. 2008. Effective date. 

Sec. 2009. Savings clause. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 3001. Short title; finding. 

Sec. 3002. Authority to assess and use human generic drug fees. 

Sec. 3003. Reauthorization; reporting requirements. 

Sec. 3004. Sunset dates. 

Sec. 3005. Effective date. 

Sec. 3006. Savings clause. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 

Sec. 4001. Short title; finding. 

Sec. 4002. Definitions. 

Sec. 4003. Authority to assess and use biosimilar biological product fees. 

Sec. 4004. Reauthorization; reporting requirements. 

Sec. 4005. Sunset dates. 

Sec. 4006. Effective date. 

Sec. 4007. Savings clause. 

TITLE V—REAUTHORIZATION OF OTHER PROVISIONS 

Sec. 5001. Reauthorization of the best pharmaceuticals for children program. 

Sec. 5002. Reauthorization of the humanitarian device exemption incentive. 

Sec. 5003. Reauthorization of the pediatric device consortia program. 

Sec. 5004. Reauthorization of provision pertaining to drugs containing single 

enantiomers. 

Sec. 5005. Reauthorization of the critical path public-private partnership. 

Sec. 5006. Reauthorization of orphan drug grants. 

Sec. 5007. Reauthorization of certain device inspections. 

Sec. 5008. Reauthorization of reporting requirements related to pending generic 

drug applications and priority review applications. 

TITLE I—FEES RELATING TO DRUGS 

SEC. 1001. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 

Drug User Fee Amendments of 2022’’. 

(b) FINDING.—Congress finds that the fees authorized by the 

amendments made by this title will be dedicated toward expediting 

the drug development process and the process for the review of 

human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379g et seq.), in the letters from the 

Secretary of Health and Human Services to the Chairman of the 

Committee on Health, Education, Labor, and Pensions of the Senate 

and the Chairman of the Committee on Energy and Commerce 

of the House of Representatives, as set forth in the Congressional 

Record. 

SEC. 1002. DEFINITIONS. 

(a) HUMAN DRUG APPLICATION.—Section 735(1) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended, 
H. R. 6833—28 

in the matter following subparagraph (B), by striking ‘‘an allergenic 

extract product, or’’ and inserting ‘‘does not include an application 

with respect to an allergenic extract product licensed before October 

1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification 

to the applicant from the Secretary regarding the existence of 

a potency test that measures the allergenic activity of an allergenic 

extract product licensed by the applicant before October 1, 2022, 

does not include an application with respect to’’. 

(b) PRESCRIPTION DRUG PRODUCT.—Section 735(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is amended— 

(1) by redesignating subparagraphs (A), (B), and (C) as 

clauses (i), (ii), and (iii), respectively; 

(2) by striking ‘‘(3) The term’’ and inserting ‘‘(3)(A) The 

term’’; 

(3) by striking ‘‘Such term does not include whole blood’’ 

and inserting the following: 

‘‘(B) Such term does not include whole blood’’; 

(4) by striking ‘‘an allergenic extract product,’’ and inserting 

‘‘an allergenic extract product licensed before October 1, 2022, 

a standardized allergenic extract product submitted pursuant 

to a notification to the applicant from the Secretary regarding 

the existence of a potency test that measures the allergenic 

activity of an allergenic extract product licensed by the 

applicant before October 1, 2022,’’ ; and 

(5) by adding at the end the following: 

‘‘(C)(i) If a written request to place a product in the 

discontinued section of either of the lists referenced in 

subparagraph (A)(iii) is submitted to the Secretary on 

behalf of an applicant, and the request identifies the date 

the product is, or will be, withdrawn from sale, then for 

purposes of assessing the prescription drug program fee 

under section 736(a)(2), the Secretary shall consider such 

product to have been included in the discontinued section 

on the later of— 

‘‘(I) the date such request was received; or 

‘‘(II) if the product will be withdrawn from sale 

on a future date, such future date when the product 

is withdrawn from sale. 

‘‘(ii) For purposes of this subparagraph, a product shall 

be considered withdrawn from sale once the applicant has 

ceased its own distribution of the product, whether or not 

the applicant has ordered recall of all previously distributed 

lots of the product, except that a routine, temporary 

interruption in supply shall not render a product withdrawn from sale.’’. 

(c) SKIN-TEST DIAGNOSTIC PRODUCT.—Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended 

by adding at the end the following: 

‘‘(12) The term ‘skin-test diagnostic product’— 

‘‘(A) means a product— 

‘‘(i) for prick, scratch, intradermal, or subcutaneous 

administration; 

‘‘(ii) expected to produce a limited, local reaction 

at the site of administration (if positive), rather than 

a systemic effect; 
H. R. 6833—29 

‘‘(iii) not intended to be a preventive or therapeutic 

intervention; and 

‘‘(iv) intended to detect an immediate- or delayedtype skin hypersensitivity reaction to aid in the diagnosis of— 

‘‘(I) an allergy to an antimicrobial agent; 

‘‘(II) an allergy that is not to an antimicrobial 

agent, if the diagnostic product was authorized 

for marketing prior to October 1, 2022; or 

‘‘(III) infection with fungal or mycobacterial 

pathogens; and 

‘‘(B) includes positive and negative controls required 

to interpret the results of a product described in subparagraph (A).’’. 

SEC. 1003. AUTHORITY TO ASSESS AND USE DRUG FEES. 

(a) TYPES OF FEES.— 

(1) HUMAN DRUG APPLICATION FEE.—Section 736(a) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is 

amended— 

(A) in the matter preceding paragraph (1), by striking 

‘‘fiscal year 2018’’ and inserting ‘‘fiscal year 2023’’; 

(B) in paragraph (1)(A), by striking ‘‘(c)(5)’’ each place 

it appears and inserting ‘‘(c)(6)’’; 

(C) in paragraph (1)(C), by inserting ‘‘prior to approval’’ 

after ‘‘or was withdrawn’’; and 

(D) in paragraph (1), by adding at the end the following: 

‘‘(H) EXCEPTION FOR SKIN-TEST DIAGNOSTIC PRODUCTS.—A human drug application for a skin-test diagnostic 

product shall not be subject to a fee under subparagraph 

(A).’’. 

(2) PRESCRIPTION DRUG PROGRAM FEE.—Section 736(a)(2) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379h(a)(2)) is amended— 

(A) in subparagraph (A)— 

(i) by striking ‘‘Except as provided in subparagraphs (B) and (C)’’ and inserting the following: 

‘‘(i) PAYMENT OF FEES.—Except as provided in subparagraphs (B) and (C)’’; 

(ii) by striking ‘‘subsection (c)(5)’’ and inserting 

‘‘subsection (c)(6)’’; and 

(iii) by adding at the end the following: 

‘‘(ii) SPECIAL RULE FOR PREVIOUSLY DISCONTINUED

DRUG PRODUCTS.—If a drug product that is identified 

in a human drug application approved as of October 

1 of a fiscal year is not a prescription drug product 

as of that date because the drug product is in the 

discontinued section of a list referenced in section 

735(3)(A)(iii), and on any subsequent day during such 

fiscal year the drug product is a prescription drug 

product, then except as provided in subparagraphs (B) 

and (C), each person who is named as the applicant 

in a human drug application with respect to such 

product, and who, after September 1, 1992, had 

pending before the Secretary a human drug application 

or supplement, shall pay the annual prescription drug 
H. R. 6833—30 

program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such 

fee shall be due on the last business day of such 

fiscal year and shall be paid only once for each such 

product for a fiscal year in which the fee is payable.’’; 

and 

(B) by amending subparagraph (B) to read as follows: 

‘‘(B) EXCEPTION FOR CERTAIN PRESCRIPTION DRUG PRODUCTS.—A prescription drug program fee shall not be 

assessed for a prescription drug product under subparagraph (A) if such product is— 

‘‘(i) a large volume parenteral product (a sterile 

aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 

mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled 

under section 505(j)(7); 

‘‘(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations 

(or any successor regulation)) to another product on 

the list of products compiled under section 505(j)(7) 

(not including the discontinued section of such list); 

or 

‘‘(iii) a skin-test diagnostic product.’’. 

(b) FEE REVENUE AMOUNTS.— 

(1) IN GENERAL.—Paragraph (1) of section 736(b) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is 

amended to read as follows: 

‘‘(1) IN GENERAL.—For each of the fiscal years 2023 through 

2027, fees under subsection (a) shall, except as provided in 

subsections (c), (d), (f), and (g), be established to generate 

a total revenue amount under such subsection that is equal 

to the sum of— 

‘‘(A) the annual base revenue for the fiscal year (as 

determined under paragraph (3)); 

‘‘(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection 

(c)(1)); 

‘‘(C) the dollar amount equal to the strategic hiring 

and retention adjustment for the fiscal year (as determined 

under subsection (c)(2)); 

‘‘(D) the dollar amount equal to the capacity planning 

adjustment for the fiscal year (as determined under subsection (c)(3)); 

‘‘(E) the dollar amount equal to the operating reserve 

adjustment for the fiscal year, if applicable (as determined 

under subsection (c)(4)); 

‘‘(F) the dollar amount equal to the additional direct 

cost adjustment for the fiscal year (as determined under 

subsection (c)(5)); and 

‘‘(G) additional dollar amounts for each fiscal year as 

follows: 

‘‘(i) $65,773,693 for fiscal year 2023. 

‘‘(ii) $25,097,671 for fiscal year 2024. 

‘‘(iii) $14,154,169 for fiscal year 2025. 

‘‘(iv) $4,864,860 for fiscal year 2026. 

‘‘(v) $1,314,620 for fiscal year 2027.’’. 
H. R. 6833—31 

(2) ANNUAL BASE REVENUE.—Paragraph (3) of section 736(b) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) 

is amended to read as follows: 

‘‘(3) ANNUAL BASE REVENUE.—For purposes of paragraph 

(1), the dollar amount of the annual base revenue for a fiscal 

year shall be— 

‘‘(A) for fiscal year 2023, $1,151,522,958; and 

‘‘(B) for fiscal years 2024 through 2027, the dollar 

amount of the total revenue amount established under 

paragraph (1) for the previous fiscal year, not including 

any adjustments made under subsection (c)(4) or (c)(5).’’. 

(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 

(1) INFLATION ADJUSTMENT.—Section 736(c)(1)(B)(ii) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379h(c)(1)(B)(ii)) is amended by striking ‘‘Washington-Baltimore, DC–MD–VA–WV’’ and inserting ‘‘Washington-ArlingtonAlexandria, DC–VA–MD–WV’’. 

(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—Section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379h(c)) is amended— 

(A) by redesignating paragraphs (2) through (6) as 

paragraphs (3) through (7), respectively; and 

(B) by inserting after paragraph (1) the following: 

‘‘(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—For 

each fiscal year, after the annual base revenue established 

in subsection (b)(1)(A) is adjusted for inflation in accordance 

with paragraph (1), the Secretary shall further increase the 

fee revenue and fees by the following amounts: 

‘‘(A) For fiscal year 2023, $9,000,000. 

‘‘(B) For each of fiscal years 2024 through 2027, 

$4,000,000.’’. 

(3) CAPACITY PLANNING ADJUSTMENT.—Paragraph (3), as 

redesignated, of section 736(c) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as follows: 

‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For each fiscal year, after the 

annual base revenue established in subsection (b)(1)(A) 

is adjusted in accordance with paragraphs (1) and (2), 

such revenue shall be adjusted further for such fiscal year, 

in accordance with this paragraph, to reflect changes in 

the resource capacity needs of the Secretary for the process 

for the review of human drug applications. 

‘‘(B) METHODOLOGY.—For purposes of this paragraph, 

the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal 

year 2021, as described in the notice titled ‘Prescription 

Drug User Fee Rates for Fiscal Year 2021’ published in 

the Federal Register on August 3, 2020 (85 Fed. Reg. 

46651). The workload categories used in applying such 

methodology in forecasting shall include only the activities 

described in that notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting 

types, the direct review of postmarketing commitments 

and requirements, the direct review of risk evaluation and 

mitigation strategies, and the direct review of annual 

reports for approved prescription drug products. Subject 
H. R. 6833—32 

to the exceptions in the preceding sentence, the Secretary 

shall not include as workload categories in applying such 

methodology in forecasting any non-core review activities, 

including those activities that the Secretary referenced for 

potential future use in such notice but did not utilize 

in setting fees for fiscal year 2021. 

‘‘(C) LIMITATION.—Under no circumstances shall an 

adjustment under this paragraph result in fee revenue 

for a fiscal year that is less than the sum of the amounts 

under subsections (b)(1)(A) (the annual base revenue for 

the fiscal year), (b)(1)(B) (the dollar amount of the inflation 

adjustment for the fiscal year), and (b)(1)(C) (the dollar 

amount of the strategic hiring and retention adjustment 

for the fiscal year). 

‘‘(D) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice under 

paragraph (6) of the fee revenue and fees resulting from 

the adjustment and the methodologies under this paragraph.’’. 

(4) OPERATING RESERVE ADJUSTMENT.—Paragraph (4), as 

redesignated, of section 736(c) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379h(c)) is amended— 

(A) by amending subparagraph (A) to read as follows: 

‘‘(A) INCREASE.—For fiscal year 2023 and subsequent 

fiscal years, the Secretary shall, in addition to adjustments 

under paragraphs (1), (2), and (3), further increase the 

fee revenue and fees if such an adjustment is necessary 

to provide for operating reserves of carryover user fees 

for the process for the review of human drug applications 

for each fiscal year in at least the following amounts: 

‘‘(i) For fiscal year 2023, at least 8 weeks of operating reserves. 

‘‘(ii) For fiscal year 2024, at least 9 weeks of operating reserves. 

‘‘(iii) For fiscal year 2025 and subsequent fiscal 

years, at least 10 weeks of operating reserves.’’; and 

(B) in subparagraph (C), by striking ‘‘paragraph (5)’’ 

and inserting ‘‘paragraph (6)’’. 

(5) ADDITIONAL DIRECT COST ADJUSTMENT.—Paragraph (5), 

as redesignated, of section 736(c) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as 

follows: 

‘‘(5) ADDITIONAL DIRECT COST ADJUSTMENT.— 

‘‘(A) INCREASE.—The Secretary shall, in addition to 

adjustments under paragraphs (1), (2), (3), and (4), further 

increase the fee revenue and fees— 

‘‘(i) for fiscal year 2023, by $44,386,150; and 

‘‘(ii) for each of fiscal years 2024 through 2027, 

by the amount set forth in clauses (i) through (iv) 

of subparagraph (B), as applicable, multiplied by the 

Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not 

Seasonally Adjusted; All Items; Annual Index) for the 

most recent year of available data, divided by such 

Index for 2021. 

‘‘(B) APPLICABLE AMOUNTS.—The amounts referred to 

in subparagraph (A)(ii) are the following: 
H. R. 6833—33 

‘‘(i) For fiscal year 2024, $60,967,993. 

‘‘(ii) For fiscal year 2025, $35,799,314. 

‘‘(iii) For fiscal year 2026, $35,799, 314. 

‘‘(iv) For fiscal year 2027, $35,799,314.’’. 

(6) ANNUAL FEE SETTING.—Paragraph (6), as redesignated, 

of section 736(c) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379h(c)) is amended by striking ‘‘September 30, 

2017’’ and inserting ‘‘September 30, 2022’’. 

(d) CREDITING AND AVAILABILITY OF FEES.—Section 736(g)(3) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) 

is amended by striking ‘‘fiscal years 2018 through 2022’’ and 

inserting ‘‘fiscal years 2023 through 2027’’. 

(e) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, EXEMPTIONS, AND RETURNS; DISPUTES CONCERNING FEES.—Section 736(i) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) 

is amended to read as follows: 

‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, EXEMPTIONS, AND RETURNS; DISPUTES CONCERNING FEES.—To qualify for 

consideration for a waiver or reduction under subsection (d), an 

exemption under subsection (k), or the return of any fee paid 

under this section, including if the fee is claimed to have been 

paid in error, a person shall— 

‘‘(1) not later than 180 days after such fee is due, submit 

to the Secretary a written request justifying such waiver, reduction, exemption, or return; and 

‘‘(2) include in the request any legal authorities under 

which the request is made.’’. 

(f) ORPHAN DRUGS.—Section 736(k) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379h(k)) is amended— 

(1) in paragraph (1)(B), by striking ‘‘during the previous 

year’’ and inserting ‘‘as determined under paragraph (2)’’; and 

(2) by amending paragraph (2) to read as follows: 

‘‘(2) EVIDENCE OF QUALIFICATION.—An exemption under 

paragraph (1) applies with respect to a drug only if the 

applicant involved submits a certification that the applicant’s 

gross annual revenues did not exceed $50,000,000 for the last 

calendar year ending prior to the fiscal year for which the 

exemption is requested. Such certification shall be supported 

by— 

‘‘(A) tax returns submitted to the United States 

Internal Revenue Service; or 

‘‘(B) as necessary, other appropriate financial information.’’. 

SEC. 1004. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 736B of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379h–2) is amended— 

(1) in subsection (a)(1), by striking ‘‘Beginning with fiscal 

year 2018, not’’ and inserting ‘‘Not’’; 

(2) by striking ‘‘Prescription Drug User Fee Amendments 

of 2017’’ each place it appears and inserting ‘‘Prescription Drug 

User Fee Amendments of 2022’’; 

(3) in subsection (a)(3)(A), by striking ‘‘Not later than 30 

calendar days after the end of the second quarter of fiscal 

year 2018, and not later than 30 calendar days after the end 

of each quarter of each fiscal year thereafter’’ and inserting 

‘‘Not later than 30 calendar days after the end of each quarter 
H. R. 6833—34 

of each fiscal year for which fees are collected under this 

part’’; 

(4) in subsection (a)(4), by striking ‘‘Beginning with fiscal 

year 2020, the’’ and inserting ‘‘The’’; 

(5) in subsection (b), by striking ‘‘Beginning with fiscal 

year 2018, not’’ and inserting ‘‘Not’’; 

(6) in subsection (c), by striking ‘‘Beginning with fiscal 

year 2018, for’’ and inserting ‘‘For’’; and 

(7) in subsection (f)— 

(A) in paragraph (1), in the matter preceding subparagraph (A), by striking ‘‘fiscal year 2022’’ and inserting 

‘‘fiscal year 2027’’; and 

(B) in paragraph (5), by striking ‘‘January 15, 2022’’ 

and inserting ‘‘January 15, 2027’’. 

SEC. 1005. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 735 and 736 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to 

be effective October 1, 2027. 

(b) REPORTING REQUIREMENTS.—Section 736B of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to 

be effective January 31, 2028. 

(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2022, 

subsections (a) and (b) of section 104 of the FDA Reauthorization 

Act of 2017 (Public Law 115–52) are repealed. 

SEC. 1006. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2022, or the date of the enactment of this Act, whichever is 

later, except that fees under part 2 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g 

et seq.) shall be assessed for all human drug applications received 

on or after October 1, 2022, regardless of the date of the enactment 

of this Act. 

SEC. 1007. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 2 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the day 

before the date of the enactment of this title, shall continue to 

be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted 

by the Food and Drug Administration for filing on or after October 

1, 2017, but before October 1, 2022, with respect to assessing 

and collecting any fee required by such part for a fiscal year 

prior to fiscal year 2023. 

TITLE II—FEES RELATING TO DEVICES 

SEC. 2001. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 

Device User Fee Amendments of 2022’’. 

(b) FINDING.—Congress finds that the fees authorized under 

the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for 

assuring the safety and effectiveness of devices, as set forth in 

the goals identified for purposes of part 3 of subchapter C of 
H. R. 6833—35 

chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

379i et seq.), in the letters from the Secretary of Health and 

Human Services to the Chairman of the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Chairman 

of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 

SEC. 2002. DEFINITIONS. 

Section 737 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379i) is amended— 

(1) in paragraph (9)— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘and premarket notification submissions’’ and 

inserting ‘‘premarket notification submissions, and de novo 

classification requests’’; 

(B) in subparagraph (D), by striking ‘‘and submissions’’ 

and inserting ‘‘submissions, and de novo classification 

requests’’; 

(C) in subparagraph (F), by striking ‘‘and premarket 

notification submissions’’ and inserting ‘‘premarket notification submissions, and de novo classification requests’’; 

(D) in each of subparagraphs (G) and (H), by striking 

‘‘or submissions’’ and inserting ‘‘submissions, or requests’’; 

and 

(E) in subparagraph (K), by striking ‘‘or premarket 

notification submissions’’ and inserting ‘‘premarket notification submissions, or de novo classification requests’’; and 

(2) in paragraph (11), by striking ‘‘2016’’ and inserting 

‘‘2021’’. 

SEC. 2003. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

(a) TYPES OF FEES.—Section 738(a) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j(a)) is amended— 

(1) in paragraph (1), by striking ‘‘fiscal year 2018’’ and 

inserting ‘‘fiscal year 2023’’; and 

(2) in paragraph (2)— 

(A) in subparagraph (A)— 

(i) in the matter preceding clause (i), by striking 

‘‘October 1, 2017’’ and inserting ‘‘October 1, 2022’’; 

(ii) in clause (iii), by striking ‘‘75 percent’’ and 

inserting ‘‘80 percent’’; and 

(iii) in clause (viii), by striking ‘‘3.4 percent’’ and 

inserting ‘‘4.5 percent’’; 

(B) in subparagraph (B)(iii), by striking ‘‘or premarket 

notification submission’’ and inserting ‘‘premarket notification submission, or de novo classification request’’; and 

(C) in subparagraph (C), by striking ‘‘or periodic 

reporting concerning a class III device’’ and inserting ‘‘periodic reporting concerning a class III device, or de novo 

classification request’’. 

(b) FEE AMOUNTS.—Section 738(b) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j(b)) is amended— 

(1) in paragraph (1), by striking ‘‘2018 through 2022’’ and 

inserting ‘‘2023 through 2027’’; 

(2) by amending paragraph (2) to read as follows: 

‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of paragraph (1), the base fee amounts specified in this paragraph 

are as follows: 
H. R. 6833—36 

‘‘Fee Type 

Fiscal 

Year 

2023 

Fiscal 

Year 

2024 

Fiscal 

Year 

2025 

Fiscal 

Year 

2026 

Fiscal 

Year 

2027 

Premarket Application .... $425,000 $435,000 $445,000 $455,000 $470,000 

Establishment Registration ................................ $6,250 $6,875 $7,100 $7,575 $8,465’’; 

and 

(3) by amending paragraph (3) to read as follows: 

‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.—For purposes 

of paragraph (1), the total revenue amounts specified in this 

paragraph are as follows: 

‘‘(A) $312,606,000 for fiscal year 2023. 

‘‘(B) $335,750,000 for fiscal year 2024. 

‘‘(C) $350,746,400 for fiscal year 2025. 

‘‘(D) $366,486,300 for fiscal year 2026. 

‘‘(E) $418,343,000 for fiscal year 2027.’’. 

(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 738(c) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is 

amended— 

(1) in paragraph (1), by striking ‘‘2017’’ and inserting 

‘‘2022’’; 

(2) in paragraph (2)— 

(A) in subparagraph (A), by striking ‘‘2018’’ and 

inserting ‘‘2023’’; 

(B) in subparagraph (B)— 

(i) in the matter preceding clause (i), by striking 

‘‘fiscal year 2018’’ and inserting ‘‘fiscal year 2023’’; 

and 

(ii) in clause (ii), by striking ‘‘fiscal year 2016’’ 

and inserting ‘‘fiscal year 2022’’; 

(C) in subparagraph (C), by striking ‘‘WashingtonBaltimore, DC–MD–VA–WV’’ and inserting ‘‘WashingtonArlington-Alexandria, DC–VA–MD–WV’’; and 

(D) in subparagraph (D), in the matter preceding clause 

(i), by striking ‘‘fiscal years 2018 through 2022’’ and 

inserting ‘‘fiscal years 2023 through 2027’’; 

(3) in paragraph (3), by striking ‘‘2018 through 2022’’ and 

inserting ‘‘2023 through 2027’’; 

(4) by redesignating paragraphs (4) and (5) as paragraphs 

(7) and (8), respectively; and 

(5) by inserting after paragraph (3) the following: 

‘‘(4) PERFORMANCE IMPROVEMENT ADJUSTMENT.— ‘‘(A) IN GENERAL.—For each of fiscal years 2025 

through 2027, after the adjustments under paragraphs (2) 

and (3), the base establishment registration fee amounts 

for such fiscal year shall be increased to reflect changes 

in the resource needs of the Secretary due to improved 

review performance goals for the process for the review 

of device applications identified in the letters described 

in section 2001(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to 

achieve an increase in total fee collections for such fiscal 

year equal to the following amounts, as applicable: 

‘‘(i) For fiscal year 2025, the product of— 

‘‘(I) the amount determined under subparagraph (B)(i)(I); and 
H. R. 6833—37 

‘‘(II) the applicable inflation adjustment under 

paragraph (2)(B) for such fiscal year. 

‘‘(ii) For fiscal year 2026, the product of— 

‘‘(I) the sum of the amounts determined under 

subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); 

and 

‘‘(II) the applicable inflation adjustment under 

paragraph (2)(B) for such fiscal year. 

‘‘(iii) For fiscal year 2027, the product of— 

‘‘(I) the sum of the amounts determined under 

subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); 

and 

‘‘(II) the applicable inflation adjustment under 

paragraph (2)(B) for such fiscal year. 

‘‘(B) AMOUNTS.— 

‘‘(i) PRESUBMISSION AMOUNT.—For purposes of 

subparagraph (A), with respect to the Presubmission 

Written Feedback goal, the amounts determined under 

this subparagraph are as follows: 

‘‘(I) For fiscal year 2025, $15,396,600 if such 

goal for fiscal year 2023 is met. 

‘‘(II) For fiscal year 2026: 

‘‘(aa) $15,396,600 if such goal for fiscal 

year 2023 is met and such goal for fiscal year 

2024 is not met. 

‘‘(bb) $36,792,200 if such goal for fiscal 

year 2024 is met. 

‘‘(III) For fiscal year 2027: 

‘‘(aa) $15,396,600 if such goal for fiscal 

year 2023 is met and such goal for each of 

fiscal years 2024 and 2025 is not met. 

‘‘(bb) $36,792,200 if such goal for fiscal 

year 2024 is met and such goal for fiscal year 

2025 is not met. 

‘‘(cc) $40,572,600 if such goal for fiscal 

year 2025 is met. 

‘‘(ii) DE NOVO CLASSIFICATION REQUEST AMOUNT.— For purposes of subparagraph (A), with respect to the 

De Novo Decision goal, the amounts determined under 

this subparagraph are as follows: ‘‘(I) For fiscal year 2026, $6,323,500 if such 

goal for fiscal year 2023 is met. 

‘‘(II) For fiscal year 2027: ‘‘(aa) $6,323,500 if such goal for fiscal year 

2023 is met and such goal for fiscal year 2024 

is not met. 

‘‘(bb) $11,765,400 if such goal for fiscal 

year 2024 is met. 

‘‘(iii) PREMARKET NOTIFICATION AND PREMARKET

APPROVAL AMOUNT.—For purposes of subparagraph (A), 

with respect to the 510(k) decision goal, 510(k) Shared 

Outcome Total Time to Decision goal, PMA decision 

goal, and PMA Shared Outcome Total Time to Decision 

goal, the amounts determined under this subparagraph 

are as follows: 

‘‘(I) For fiscal year 2026, $1,020,000 if the 

4 goals for fiscal year 2023 are met. 
H. R. 6833—38 

‘‘(II) For fiscal year 2027: 

‘‘(aa) $1,020,000 if the 4 goals for fiscal 

year 2023 are met and one or more of the 

4 goals for fiscal year 2024 are not met. 

‘‘(bb) $3,906,000 if the 4 goals for fiscal 

year 2024 are met. 

‘‘(C) PERFORMANCE CALCULATION.—For purposes of this 

paragraph, performance of the following goals shall be 

determined as specified in the letters described in section 

2001(b) of the Medical Device User Fee Amendments of 

2022 and based on data available, as follows: 

‘‘(i) The performance of the Presubmission Written 

Feedback goal shall be based on data available as 

of— 

‘‘(I) for fiscal year 2023, March 31, 2024; 

‘‘(II) for fiscal year 2024, March 31, 2025; and 

‘‘(III) for fiscal year 2025, March 31, 2026. 

‘‘(ii) The performance of the De Novo Decision goal, 

510(k) decision goal, 510(k) Shared Outcome Total 

Time to Decision goal, PMA decision goal, and PMA 

Shared Outcome Total Time to Decision goal shall 

be based on data available as of— 

‘‘(I) for fiscal year 2023, March 31, 2025; and 

‘‘(II) for fiscal year 2024, March 31, 2026. 

‘‘(D) GOALS DEFINED.—For purposes of this paragraph, 

the terms ‘Presubmission Written Feedback goal’, ‘De Novo 

Decision goal’, ‘510(k) decision goal’, ‘510(k) Shared Outcome Total Time to Decision goal’, ‘PMA decision goal’, 

and ‘PMA Shared Outcome Total Time to Decision goal’ 

refer to the goals identified by the same names in the 

letters described in section 2001(b) of the Medical Device 

User Fee Amendments of 2022. 

‘‘(5) HIRING ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For each of fiscal years 2025 

through 2027, after the adjustments under paragraphs (2), 

(3), and (4), if applicable, if the number of hires to support 

the process for the review of device applications falls below 

the thresholds specified in subparagraph (B) for the 

applicable fiscal years, the base establishment registration 

fee amounts shall be decreased as the Secretary determines 

necessary to achieve a reduction in total fee collections 

equal to the hiring adjustment amount under subparagraph 

(C). 

‘‘(B) THRESHOLDS.—The thresholds specified in this 

subparagraph are as follows: 

‘‘(i) For fiscal year 2025, the threshold is 123 hires 

for fiscal year 2023. 

‘‘(ii) For fiscal year 2026, the threshold is 38 hires 

for fiscal year 2024. 

‘‘(iii) For fiscal year 2027, the threshold is— 

‘‘(I) 22 hires for fiscal year 2025 if the base 

establishment registration fees are not increased 

by the amount determined under paragraph 

(4)(A)(i); or 

‘‘(II) 75 hires for fiscal year 2025 if such fees 

are so increased. 
H. R. 6833—39 

‘‘(C) HIRING ADJUSTMENT AMOUNT.—The hiring adjustment amount for fiscal year 2025 and each subsequent 

fiscal year is the product of— 

‘‘(i) the number of hires by which the hiring goal 

specified in subparagraph (D) for the fiscal year before 

the prior fiscal year was not met; 

‘‘(ii) $72,877; and 

‘‘(iii) the applicable inflation adjustment under 

paragraph (2)(B) for the fiscal year for which the hiring 

goal was not met. 

‘‘(D) HIRING GOALS.—The hiring goals for each of fiscal 

years 2023 through 2025 are as follows: 

‘‘(i) For fiscal year 2023, 144 hires. 

‘‘(ii) For fiscal year 2024, 42 hires. 

‘‘(iii) For fiscal year 2025: 

‘‘(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i). 

‘‘(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i). 

‘‘(E) NUMBER OF HIRES.—For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary as set forth in the letters described 

in section 2001(b) of the Medical Device User Fee Amendments of 2022. 

‘‘(6) OPERATING RESERVE ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For each of fiscal years 2023 

through 2027, after the adjustments under paragraphs (2), 

(3), (4), and (5), if applicable, if the Secretary has operating 

reserves of carryover user fees for the process for the review 

of device applications in excess of the designated amount 

in subparagraph (B), the Secretary shall decrease the base 

establishment registration fee amounts to provide for not 

more than such designated amount of operating reserves. 

‘‘(B) DESIGNATED AMOUNT.—Subject to subparagraph 

(C), for each fiscal year, the designated amount in this 

subparagraph is equal to the sum of— 

‘‘(i) 13 weeks of operating reserves of carryover 

user fees; and 

‘‘(ii) 1 month of operating reserves maintained 

pursuant to paragraph (8). 

‘‘(C) EXCLUDED AMOUNT.—For the period of fiscal years 

2023 through 2026, a total amount equal to $118,000,000 

shall not be considered part of the designated amount 

under subparagraph (B) and shall not be subject to the 

decrease under subparagraph (A).’’. 

(d) CONDITIONS.—Section 738(g) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j(g)) is amended— (1) in paragraph (1)(A), by striking ‘‘$320,825,000’’ and inserting ‘‘$398,566,000’’; and 

(2) in paragraph (2), by inserting ‘‘de novo classification 

requests,’’ after ‘‘class III device,’’. 

(e) CREDITING AND AVAILABILITY OF FEES.—Section 738(h)(3) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) 

is amended to read as follows: 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 
H. R. 6833—40 

‘‘(A) IN GENERAL.—For each of fiscal years 2023 

through 2027, there is authorized to be appropriated for 

fees under this section an amount equal to the revenue 

amount determined under subparagraph (B), less the 

amount of reductions determined under subparagraph (C). 

‘‘(B) REVENUE AMOUNT.—For purposes of this paragraph, the revenue amount for each fiscal year is the 

sum of— 

‘‘(i) the total revenue amount under subsection 

(b)(3) for the fiscal year, as adjusted under paragraphs 

(2) and (3) of subsection (c); and 

‘‘(ii) the performance improvement adjustment 

amount for the fiscal year under subsection (c)(4), if 

applicable. 

‘‘(C) AMOUNT OF REDUCTIONS.—For purposes of this 

paragraph, the amount of reductions for each fiscal year 

is the sum of— 

‘‘(i) the hiring adjustment amount for the fiscal 

year under subsection (c)(5), if applicable; and 

‘‘(ii) the operating reserve adjustment amount for 

the fiscal year under subsection (c)(6), if applicable.’’. 

SEC. 2004. REAUTHORIZATION; REPORTING REQUIREMENTS. 

(a) PERFORMANCE REPORTS.—Section 738A(a) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended— 

(1) by striking ‘‘fiscal year 2018’’ each place it appears 

and inserting ‘‘fiscal year 2023’’; 

(2) by striking ‘‘Medical Device User Fee Amendments of 

2017’’ each place it appears and inserting ‘‘Medical Device 

User Fee Amendments of 2022’’; 

(3) in paragraph (1)— 

(A) in subparagraph (A), by redesignating the second 

clause (iv) (relating to analysis) as clause (v); and 

(B) in subparagraph (A)(iv), by striking ‘‘fiscal year 

2020’’ and inserting ‘‘fiscal year 2023’’; and 

(4) in paragraph (4), by striking ‘‘2018 through 2022’’ and 

inserting ‘‘2023 through 2027’’. 

(b) REAUTHORIZATION.—Section 738A(b) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is amended— 

(1) in paragraph (1), by striking ‘‘2022’’ and inserting 

‘‘2027’’; and 

(2) in paragraph (5), by striking ‘‘2022’’ and inserting 

‘‘2027’’. 

SEC. 2005. CONFORMITY ASSESSMENT PILOT PROGRAM. 

Section 514(d) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360d(d)) is amended to read as follows: 

‘‘(d) ACCREDITATION SCHEME FOR CONFORMITY ASSESSMENT.— ‘‘(1) IN GENERAL.—The Secretary shall establish a program 

under which— 

‘‘(A) testing laboratories meeting criteria specified in 

guidance by the Secretary may be accredited, by accreditation bodies meeting criteria specified in guidance by the 

Secretary, to conduct testing to support the assessment 

of the conformity of a device to certain standards recognized 

under this section; and 

‘‘(B) subject to paragraph (2), results from tests conducted to support the assessment of conformity of devices 
H. R. 6833—41 

as described in subparagraph (A) conducted by testing laboratories accredited pursuant to this subsection shall be 

accepted by the Secretary for purposes of demonstrating 

such conformity unless the Secretary finds that certain 

results of such tests should not be so accepted. 

‘‘(2) SECRETARIAL REVIEW OF ACCREDITED LABORATORY

RESULTS.—The Secretary may— 

‘‘(A) review the results of tests conducted by testing 

laboratories accredited pursuant to this subsection, 

including by conducting periodic audits of such results or 

of the processes of accredited bodies or testing laboratories; 

‘‘(B) following such review, take additional measures 

under this Act, as the Secretary determines appropriate, 

such as— 

‘‘(i) suspension or withdrawal of accreditation of 

a testing laboratory or recognition of an accreditation 

body under paragraph (1)(A); or 

‘‘(ii) requesting additional information with respect 

to a device; and 

‘‘(C) if the Secretary becomes aware of information 

materially bearing on the safety or effectiveness of a device 

for which an assessment of conformity was supported by 

testing conducted by a testing laboratory accredited under 

this subsection, take such additional measures under this 

Act, as the Secretary determines appropriate, such as— 

‘‘(i) suspension or withdrawal of accreditation of 

a testing laboratory or recognition of an accreditation 

body under paragraph (1)(A); or 

‘‘(ii) requesting additional information with regard 

to such device. 

‘‘(3) REPORT.—The Secretary shall make available on the 

internet website of the Food and Drug Administration an 

annual report on the progress of the program under this subsection.’’. 

SEC. 2006. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM. 

Section 523(c) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360m(c)) is amended by striking ‘‘October 1’’ and 

inserting ‘‘December 17’’. 

SEC. 2007. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 737 and 738 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be 

effective October 1, 2027. 

(b) REPORTING REQUIREMENTS.—Section 738A of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1) shall cease to 

be effective January 31, 2028. 

(c) PREVIOUS SUNSET PROVISIONS.—Effective October 1, 2022, 

subsections (a) and (b) of section 210 of the FDA Reauthorization 

Act of 2017 (Public Law 115–52) are repealed. 

SEC. 2008. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2022, or the date of the enactment of this Act, whichever is 

later, except that fees under part 3 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i 

et seq.) shall be assessed for all submissions listed in section 
H. R. 6833—42 

738(a)(2)(A) of such Act received on or after October 1, 2022, regardless of the date of the enactment of this Act. 

SEC. 2009. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 3 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day 

before the date of the enactment of this title, shall continue to 

be in effect with respect to the submissions listed in section 

738(a)(2)(A) of such Act (as defined in such part as of such day) 

that on or after October 1, 2017, but before October 1, 2022, were 

received by the Food and Drug Administration with respect to 

assessing and collecting any fee required by such part for a fiscal 

year prior to fiscal year 2023. 

TITLE III—FEES RELATING TO GENERIC 

DRUGS 

SEC. 3001. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Generic 

Drug User Fee Amendments of 2022’’. 

(b) FINDING.—Congress finds that the fees authorized by the 

amendments made by this title will be dedicated to human generic 

drug activities, as set forth in the goals identified for purposes 

of part 7 of subchapter C of chapter VII of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), in the letters 

from the Secretary of Health and Human Services to the Chairman 

of the Committee on Health, Education, Labor, and Pensions of 

the Senate and the Chairman of the Committee on Energy and 

Commerce of the House of Representatives, as set forth in the 

Congressional Record. 

SEC. 3002. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 

FEES. 

(a) TYPES OF FEES.—Section 744B(a) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–42(a)) is amended— 

(1) in the matter preceding paragraph (1), by striking 

‘‘2018’’ and inserting ‘‘2023’’; 

(2) in paragraph (2)(C), by striking ‘‘2018 through 2022’’ 

and inserting ‘‘2023 through 2027’’; 

(3) in paragraph (3)(B), by striking ‘‘2018 through 2022’’ 

and inserting ‘‘2023 through 2027’’; 

(4) in paragraph (4)(D), by striking ‘‘2018 through 2022’’ 

and inserting ‘‘2023 through 2027’’; and 

(5) in paragraph (5)(D), by striking ‘‘2018 through 2022’’ 

and inserting ‘‘2023 through 2027’’. 

(b) FEE REVENUE AMOUNTS.—Section 744B(b) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(b)) is amended— 

(1) in paragraph (1)— 

(A) in subparagraph (A)— 

(i) in the heading, by striking ‘‘2018’’ and inserting 

‘‘2023’’; 

(ii) by striking ‘‘2018’’ and inserting ‘‘2023’’; and 

(iii) by striking ‘‘$493,600,000’’ and inserting 

‘‘$582,500,000’’; and 

(B) by amending subparagraph (B) to read as follows: 
H. R. 6833—43 

‘‘(B) FISCAL YEARS 2024 THROUGH 2027.— 

‘‘(i) IN GENERAL.—For each of the fiscal years 2024 

through 2027, fees under paragraphs (2) through (5) 

of subsection (a) shall be established to generate a 

total estimated revenue amount under such subsection 

that is equal to the base revenue amount for the fiscal 

year under clause (ii), as adjusted pursuant to subsection (c). 

‘‘(ii) BASE REVENUE AMOUNT.—The base revenue 

amount for a fiscal year referred to in clause (i) is 

equal to the total revenue amount established under 

this paragraph for the previous fiscal year, not 

including any adjustments made for such previous 

fiscal year under subsection (c)(3).’’; and 

(2) in paragraph (2)— 

(A) in subparagraph (C), by striking ‘‘one-third the 

amount’’ and inserting ‘‘twenty-four percent’’; 

(B) in subparagraph (D), by striking ‘‘Seven percent’’ 

and inserting ‘‘Six percent’’; and 

(C) in subparagraph (E)(i), by striking ‘‘Thirty-five percent’’ and inserting ‘‘Thirty-six percent’’. 

(c) ADJUSTMENTS.—Section 744B(c) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended— 

(1) in paragraph (1)— 

(A) in the matter preceding subparagraph (A)— 

(i) by striking ‘‘2019’’ and inserting ‘‘2024’’; and 

(ii) by striking ‘‘to equal the product of the total 

revenues established in such notice for the prior fiscal 

year multiplied’’ and inserting ‘‘to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied’’; and 

(B) in subparagraph (C), by striking ‘‘WashingtonBaltimore, DC–MD–VA–WV’’ and inserting ‘‘WashingtonArlington-Alexandria, DC–VA–MD–WV’’; and 

(2) by striking paragraph (2) and inserting the following: 

‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

‘‘(A) IN GENERAL.—Beginning with fiscal year 2024, 

the Secretary shall, in addition to the adjustment under 

paragraph (1), further increase the fee revenue and fees 

under this section for a fiscal year, in accordance with 

this paragraph, to reflect changes in the resource capacity 

needs of the Secretary for human generic drug activities. 

‘‘(B) CAPACITY PLANNING METHODOLOGY.—The Secretary shall establish a capacity planning methodology for 

purposes of this paragraph, which shall— 

‘‘(i) be derived from the methodology and recommendations made in the report titled ‘Independent 

Evaluation of the GDUFA Resource Capacity Planning 

Adjustment Methodology: Evaluation and Recommendations’ announced in the Federal Register on 

August 3, 2020 (85 Fed. Reg. 46658); and 

‘‘(ii) incorporate approaches and attributes determined appropriate by the Secretary, including 

approaches and attributes made in such report, except 

that in incorporating such approaches and attributes 

the workload categories used in forecasting resources 
H. R. 6833—44 

shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 

3001(b) of the Generic Drug User Fee Amendments 

of 2022. 

‘‘(C) LIMITATIONS.— 

‘‘(i) IN GENERAL.—Under no circumstances shall 

an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of 

the amounts under subsection (b)(1)(B)(ii) (the base 

revenue amount for the fiscal year) and paragraph 

(1) (the dollar amount of the inflation adjustment for 

the fiscal year). 

‘‘(ii) ADDITIONAL LIMITATION.—An adjustment 

under this paragraph shall not exceed 3 percent of 

the sum described in clause (i) for the fiscal year, 

except that such limitation shall be 4 percent if— 

‘‘(I) for purposes of a fiscal year 2024 adjustment, the Secretary determines that during the 

period from April 1, 2021, through March 31, 

2023— 

‘‘(aa) the total number of abbreviated new 

drug applications submitted was greater than 

or equal to 2,000; or 

‘‘(bb) thirty-five percent or more of abbreviated new drug applications submitted 

related to complex products (as that term is 

defined in section XI of the letters described 

in section 3001(b) of the Generic Drug User 

Fee Amendments of 2022); 

‘‘(II) for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the 

period from April 1, 2022, through March 31, 

2024— 

‘‘(aa) the total number of abbreviated new 

drug applications submitted was greater than 

or equal to 2,300; or 

‘‘(bb) thirty-five percent or more of abbreviated new drug applications submitted 

related to complex products (as so defined); 

‘‘(III) for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the 

period from April 1, 2023, through March 31, 

2025— 

‘‘(aa) the total number of abbreviated new 

drug applications submitted was greater than 

or equal to 2,300; or 

‘‘(bb) thirty-five percent or more of abbreviated new drug applications submitted 

related to complex products (as so defined); 

and 

‘‘(IV) for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the 

period from April 1, 2024, through March 31, 

2026— 

‘‘(aa) the total number of abbreviated new 

drug applications submitted was greater than 

or equal to 2,300; or 
H. R. 6833—45 

‘‘(bb) thirty-five percent or more of abbreviated new drug applications submitted 

related to complex products (as so defined). 

‘‘(D) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice referred 

to in subsection (a) the fee revenue and fees resulting 

from the adjustment and the methodology under this paragraph. 

‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the 

fee revenue and fees under this section for such fiscal 

year if such an adjustment is necessary to provide operating 

reserves of carryover user fees for human generic drug 

activities for not more than the number of weeks specified 

in subparagraph (B) with respect to that fiscal year. 

‘‘(B) NUMBER OF WEEKS.—The number of weeks specified in this subparagraph is— 

‘‘(i) 8 weeks for fiscal year 2024; 

‘‘(ii) 9 weeks for fiscal year 2025; and 

‘‘(iii) 10 weeks for each of fiscal year 2026 and 

2027. 

‘‘(C) DECREASE.—If the Secretary has carryover balances for human generic drug activities in excess of 12 

weeks of the operating reserves referred to in subparagraph 

(A), the Secretary shall decrease the fee revenue and fees 

referred to in such subparagraph to provide for not more 

than 12 weeks of such operating reserves. 

‘‘(D) RATIONALE FOR ADJUSTMENT.—If an adjustment 

under this paragraph is made, the rationale for the amount 

of the increase or decrease (as applicable) in fee revenue 

and fees shall be contained in the annual Federal Register 

notice under subsection (a) publishing the fee revenue and 

fees for the fiscal year involved.’’. 

(d) ANNUAL FEE SETTING.—Section 744B(d)(1) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(d)(1)) is 

amended— 

(1) in the paragraph heading, by striking ‘‘2018 THROUGH

2022’’ and inserting ‘‘2023 THROUGH 2027’’; and 

(2) by striking ‘‘more than 60 days before the first day 

of each of fiscal years 2018 through 2022’’ and inserting ‘‘later 

than 60 days before the first day of each of fiscal years 2023 

through 2027’’. 

(e) EFFECT OF FAILURE TO PAY FEES.—The heading of paragraph (3) of section 744B(g) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379j–42(g)) is amended by striking ‘‘AND PRIOR

APPROVAL SUPPLEMENT FEE’’. 

(f) CREDITING AND AVAILABILITY OF FEES.—Section 744B(i)(3) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

42(i)(3)) is amended by striking ‘‘fiscal years 2018 through 2022’’ 

and inserting ‘‘fiscal years 2023 through 2027’’. 

SEC. 3003. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 744C of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379j–43) is amended— 
H. R. 6833—46 

(1) in subsection (a)(1), by striking ‘‘Beginning with fiscal 

year 2018, not’’ and inserting ‘‘Not’’; 

(2) by striking ‘‘Generic Drug User Fee Amendments of 

2017’’ each place it appears and inserting ‘‘Generic Drug User 

Fee Amendments of 2022’’; 

(3) in subsection (a)(2), by striking ‘‘Not later than 30 

calendar days after the end of the second quarter of fiscal 

year 2018, and not later than 30 calendar days after the end 

of each quarter of each fiscal year thereafter’’ and inserting 

‘‘Not later than 30 calendar days after the end of each quarter 

of each fiscal year for which fees are collected under this 

part’’; 

(4) in subsection (a)(3), by striking ‘‘Beginning with fiscal 

year 2020, the’’ and inserting ‘‘The’’; 

(5) in subsection (b), by striking ‘‘Beginning with fiscal 

year 2018, not’’ and inserting ‘‘Not’’; 

(6) in subsection (c), by striking ‘‘Beginning with fiscal 

year 2018, for’’ and inserting ‘‘For’’; and 

(7) in subsection (f)— 

(A) in paragraph (1), in the matter preceding subparagraph (A), by striking ‘‘fiscal year 2022’’ and inserting 

‘‘fiscal year 2027’’; and 

(B) in paragraph (5), by striking ‘‘January 15, 2022’’ 

and inserting ‘‘January 15, 2027’’. 

SEC. 3004. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 744A and 744B of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall 

cease to be effective October 1, 2027. 

(b) REPORTING REQUIREMENTS.—Section 744C of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to 

be effective January 31, 2028. 

(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2022, 

subsections (a) and (b) of section 305 of the FDA Reauthorization 

Act of 2017 (Public Law 115–52) are repealed. 

SEC. 3005. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2022, or the date of the enactment of this Act, whichever is 

later, except that fees under part 7 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

41 et seq.) shall be assessed for all abbreviated new drug applications received on or after October 1, 2022, regardless of the date 

of the enactment of this Act. 

SEC. 3006. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 7 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j–41 et seq.), as in effect on the day 

before the date of the enactment of this title, shall continue to 

be in effect with respect to abbreviated new drug applications 

(as defined in such part as of such day) that were received by 

the Food and Drug Administration within the meaning of section 

505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval 

supplements that were submitted, and drug master files for Type 

II active pharmaceutical ingredients that were first referenced on 

or after October 1, 2017, but before October 1, 2022, with respect 
H. R. 6833—47 

to assessing and collecting any fee required by such part for a 

fiscal year prior to fiscal year 2023. 

TITLE IV—FEES RELATING TO 

BIOSIMILAR BIOLOGICAL PRODUCTS 

SEC. 4001. SHORT TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Biosimilar 

User Fee Amendments of 2022’’. 

(b) FINDING.—Congress finds that the fees authorized by the 

amendments made by this title will be dedicated to expediting 

the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the 

goals identified for purposes of part 8 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

51 et seq.), in the letters from the Secretary of Health and Human 

Services to the Chairman of the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, 

as set forth in the Congressional Record. 

SEC. 4002. DEFINITIONS. 

(a) ADJUSTMENT FACTOR.—Section 744G(1) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read 

as follows: 

‘‘(1) The term ‘adjustment factor’ applicable to a fiscal 

year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally 

Adjusted; All items) for September of the preceding fiscal year 

divided by such Index for September 2011.’’. 

(b) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION.—Section 

744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379j–51(4)(B)(iii)) is amended— 

(1) by striking subclause (II) (relating to an allergenic 

extract product); and 

(2) by redesignating subclauses (III) and (IV) as subclauses 

(II) and (III), respectively. 

SEC. 4003. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL 

PRODUCT FEES. 

(a) TYPES OF FEES.— (1) IN GENERAL.—The matter preceding paragraph (1) in 

section 744H(a) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379j–52(a)) is amended by striking ‘‘fiscal year 2018’’ 

and inserting ‘‘fiscal year 2023’’. 

(2) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT

FEE.—Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

52(a)(1)(A)) are each amended by striking ‘‘5 days’’ and inserting 

‘‘7 days’’. 

(3) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT

FEE.—Section 744H(a)(1)(B) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j–52(a)(1)(B)) is amended— 

(A) in clause (i), by inserting before the period at 

the end the following: ‘‘, except that, in the case that 

such product (including, where applicable, ownership of 
H. R. 6833—48 

the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, 

and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the 

annual biosimilar biological product development fee’’; 

(B) in clause (iii)— 

(i) in subclause (I), by striking ‘‘or’’ at the end; 

(ii) in subclause (II), by striking the period at 

the end and inserting ‘‘; or’’; and 

(iii) by adding at the end the following: 

‘‘(III) been administratively removed from the 

biosimilar biological product development program 

for the product under subparagraph (E)(v).’’; and 

(C) in clause (iv), by striking ‘‘is accepted for filing 

on or after October 1 of such fiscal year’’ and inserting 

‘‘is subsequently accepted for filing’’. 

(4) REACTIVATION FEE.—Section 744H(a)(1)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)(1)(D)) 

is amended to read as follows: 

‘‘(D) REACTIVATION FEE.— 

‘‘(i) IN GENERAL.—A person that has discontinued 

participation in the biosimilar biological product 

development program for a product under subparagraph (C), or who has been administratively removed 

from such program for a product under subparagraph 

(E)(v), shall, if the person seeks to resume participation 

in such program, pay all annual biosimilar biological 

product development fees previously assessed for such 

product and still owed and a fee (referred to in this 

section as ‘reactivation fee’) by the earlier of the following: 

‘‘(I) Not later than 7 days after the Secretary 

grants a request by such person for a biosimilar 

biological product development meeting for the 

product (after the date on which such participation 

was discontinued or the date of administrative 

removal, as applicable). 

‘‘(II) Upon the date of submission (after the 

date on which such participation was discontinued 

or the date of administrative removal, as 

applicable) by such person of an investigational 

new drug application describing an investigation 

that the Secretary determines is intended to support a biosimilar biological product application for 

that product. 

‘‘(ii) APPLICATION OF ANNUAL FEE.—A person that 

pays a reactivation fee for a product shall pay for 

such product, beginning in the next fiscal year, the 

annual biosimilar biological product development fee 

under subparagraph (B), except that, in the case that 

such product (including, where applicable, ownership 

of the relevant investigational new drug application) 

is transferred to a licensee, assignee, or successor of 

such person, and written notice of such transfer is 

provided to the Secretary, such licensee, assignee, or 

successor shall pay the annual biosimilar biological 

product development fee.’’. 
H. R. 6833—49 

(5) EFFECT OF FAILURE TO PAY FEES.—Section 744H(a)(1)(E) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

52(a)(1)(E)) is amended by adding at the end the following: 

‘‘(v) ADMINISTRATIVE REMOVAL FROM THE BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT PROGRAM.—If a person has failed to pay an annual biosimilar biological product development fee for a product 

as required under subparagraph (B) for a period of 

2 consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar 

biological product development program for the 

product. At least 30 days prior to administratively 

removing a person from the biosimilar biological 

product development program for a product under this 

clause, the Secretary shall provide written notice to 

such person of the intended administrative removal.’’. 

(6) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FEE.— 

Section 744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379j–52(a)(2)(D)) is amended by inserting after 

‘‘or was withdrawn’’ the following: ‘‘prior to approval’’. 

(7) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEE.—Section 744H(a)(3) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379j–52(a)(3)) is amended— 

(A) in subparagraph (A)— 

(i) in clause (i), by striking ‘‘and’’ at the end; 

(ii) by redesignating clause (ii) as clause (iii); and 

(iii) by inserting after clause (i) the following: 

‘‘(ii) may be dispensed only under prescription 

pursuant to section 503(b); and’’; and 

(B) by adding at the end the following: 

‘‘(E) MOVEMENT TO DISCONTINUED LIST.— 

‘‘(i) DATE OF INCLUSION.—If a written request to 

place a product on the list referenced in subparagraph 

(A) of discontinued biosimilar biological products is 

submitted to the Secretary on behalf of an applicant, 

and the request identifies the date the product is, 

or will be, withdrawn from sale, then for purposes 

of assessing the biosimilar biological product program 

fee, the Secretary shall consider such product to have 

been included on such list on the later of— 

‘‘(I) the date such request was received; or 

‘‘(II) if the product will be withdrawn from 

sale on a future date, such future date when the 

product is withdrawn from sale. 

‘‘(ii) TREATMENT AS WITHDRAWN FROM SALE.—For 

purposes of clause (i), a product shall be considered 

withdrawn from sale once the applicant has ceased 

its own distribution of the product, whether or not 

the applicant has ordered recall of all previously 

distributed lots of the product, except that a routine, 

temporary interruption in supply shall not render a 

product withdrawn from sale. 

‘‘(iii) SPECIAL RULE FOR PRODUCTS REMOVED FROM

DISCONTINUED LIST.—If a biosimilar biological product 

that is identified in a biosimilar biological product 

application approved as of October 1 of a fiscal year 

appears, as of October 1 of such fiscal year, on the 
H. R. 6833—50 

list referenced in subparagraph (A) of discontinued 

biosimilar biological products, and on any subsequent 

day during such fiscal year the biosimilar biological 

product does not appear on such list, except as provided 

in subparagraph (D), each person who is named as 

the applicant in a biosimilar biological product application with respect to such product shall pay the annual 

biosimilar biological product program fee established 

for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business 

day of such fiscal year and shall be paid only once 

for each such product for each fiscal year.’’. 

(8) BIOSIMILAR BIOLOGICAL PRODUCT FEE.—Section 744H(a) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

52(a)) is amended by striking paragraph (4). 

(b) FEE REVENUE AMOUNTS.—Subsection (b) of section 744H 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

52) is amended— 

(1) by striking paragraph (1); 

(2) by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively; 

(3) by amending paragraph (1) (as so redesignated) to read 

as follows: 

‘‘(1) IN GENERAL.—For each of the fiscal years 2023 through 

2027, fees under subsection (a) shall, except as provided in 

subsection (c), be established to generate a total revenue 

amount equal to the sum of— 

‘‘(A) the annual base revenue for the fiscal year (as 

determined under paragraph (3)); 

‘‘(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection 

(c)(1)); 

‘‘(C) the dollar amount equal to the strategic hiring 

and retention adjustment (as determined under subsection 

(c)(2)); 

‘‘(D) the dollar amount equal to the capacity planning 

adjustment for the fiscal year (as determined under subsection (c)(3)); 

‘‘(E) the dollar amount equal to the operating reserve 

adjustment for the fiscal year, if applicable (as determined 

under subsection (c)(4)); 

‘‘(F) for fiscal year 2023 an additional amount of 

$4,428,886; and 

‘‘(G) for fiscal year 2024 an additional amount of 

$320,569.’’; 

(4) in paragraph (2) (as so redesignated)— 

(A) in the paragraph heading, by striking ‘‘; LIMITA- TIONS ON FEE AMOUNTS’’; 

(B) by striking subparagraph (B); and 

(C) by redesignating subparagraphs (C) and (D) as 

subparagraphs (B) and (C), respectively; and 

(5) by amending paragraph (3) (as so redesignated) to read 

as follows: 

‘‘(3) ANNUAL BASE REVENUE.—For purposes of paragraph 

(1), the dollar amount of the annual base revenue for a fiscal 

year shall be— 
H. R. 6833—51 

‘‘(A) for fiscal year 2023, $43,376,922; and 

‘‘(B) for fiscal years 2024 through 2027, the dollar 

amount of the total revenue amount established under 

paragraph (1) for the previous fiscal year, excluding any 

adjustments to such revenue amount under subsection 

(c)(4).’’. 

(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 744H(c) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(c)) 

is amended— 

(1) in paragraph (1)— 

(A) in subparagraph (A)— 

(i) in the matter preceding clause (i), by striking 

‘‘subsection (b)(2)(B)’’ and inserting ‘‘subsection 

(b)(1)(B)’’; and 

(ii) in clause (i), by striking ‘‘subsection (b)’’ and 

inserting ‘‘subsection (b)(1)(A)’’; and 

(B) in subparagraph (B)(ii), by striking ‘‘WashingtonBaltimore, DC–MD–VA–WV’’ and inserting ‘‘WashingtonArlington-Alexandria, DC–VA–MD–WV’’; 

(2) by striking paragraphs (2) through (4) and inserting 

the following: 

‘‘(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—For 

each fiscal year, after the annual base revenue under subsection 

(b)(1)(A) is adjusted for inflation in accordance with paragraph 

(1), the Secretary shall further increase the fee revenue and 

fees by $150,000. 

‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 

‘‘(A) IN GENERAL.—For each fiscal year, the Secretary 

shall, in addition to the adjustments under paragraphs 

(1) and (2), further adjust the fee revenue and fees under 

this section for a fiscal year to reflect changes in the 

resource capacity needs of the Secretary for the process 

for the review of biosimilar biological product applications. 

‘‘(B) METHODOLOGY.—For purposes of this paragraph, 

the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal 

year 2021, as described in the notice titled ‘Biosimilar 

User Fee Rates for Fiscal Year 2021’ published in the 

Federal Register on August 4, 2020 (85 Fed. Reg. 47220). 

The workload categories used in applying such methodology 

in forecasting shall include only the activities described 

in that notice and, as feasible, additional activities that 

are directly related to the direct review of biosimilar 

biological product applications and supplements, including 

additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct 

review of risk evaluation and mitigation strategies, and 

the direct review of annual reports for approved biosimilar 

biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting 

any non-core review activities, including those activities 

that the Secretary referenced for potential future use in 

such notice but did not utilize in setting fees for fiscal 

year 2021. 

‘‘(C) LIMITATIONS.—Under no circumstances shall an 

adjustment under this paragraph result in fee revenue 
H. R. 6833—52 

for a fiscal year that is less than the sum of the amounts 

under subsections (b)(1)(A) (the annual base revenue for 

the fiscal year), (b)(1)(B) (the dollar amount of the inflation 

adjustment for the fiscal year), and (b)(1)(C) (the dollar 

amount of the strategic hiring and retention adjustment). 

‘‘(D) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice under 

paragraph (5) the fee revenue and fees resulting from the 

adjustment and the methodologies under this paragraph. 

‘‘(4) OPERATING RESERVE ADJUSTMENT.— 

‘‘(A) INCREASE.—For fiscal year 2023 and subsequent 

fiscal years, the Secretary shall, in addition to adjustments 

under paragraphs (1), (2), and (3), further increase the 

fee revenue and fees if such an adjustment is necessary 

to provide for at least 10 weeks of operating reserves of 

carryover user fees for the process for the review of biosimilar biological product applications. 

‘‘(B) DECREASE.— 

‘‘(i) FISCAL YEAR 2023.—For fiscal year 2023, if the 

Secretary has carryover balances for such process in 

excess of 33 weeks of such operating reserves, the 

Secretary shall decrease such fee revenue and fees 

to provide for not more than 33 weeks of such operating 

reserves. 

‘‘(ii) FISCAL YEAR 2024.—For fiscal year 2024, if 

the Secretary has carryover balances for such process 

in excess of 27 weeks of such operating reserves, the 

Secretary shall decrease such fee revenue and fees 

to provide for not more than 27 weeks of such operating 

reserves. 

‘‘(iii) FISCAL YEAR 2025 AND SUBSEQUENT FISCAL

YEARS.—For fiscal year 2025 and subsequent fiscal 

years, if the Secretary has carryover balances for such 

process in excess of 21 weeks of such operating 

reserves, the Secretary shall decrease such fee revenue 

and fees to provide for not more than 21 weeks of 

such operating reserves. 

‘‘(C) FEDERAL REGISTER NOTICE.—If an adjustment 

under subparagraph (A) or (B) is made, the rationale for 

the amount of the increase or decrease (as applicable) 

in fee revenue and fees shall be contained in the annual 

Federal Register notice under paragraph (5)(B) establishing 

fee revenue and fees for the fiscal year involved.’’; and 

(3) in paragraph (5), in the matter preceding subparagraph 

(A), by striking ‘‘2018’’ and inserting ‘‘2023’’. 

(d) CREDITING AND AVAILABILITY OF FEES.—Subsection (f)(3) 

of section 744H of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 379j–52(f)(3)) is amended by striking ‘‘2018 through 2022’’ 

and inserting ‘‘2023 through 2027’’. 

(e) WRITTEN REQUESTS FOR WAIVERS AND RETURNS; DISPUTES

CONCERNING FEES.—Section 744H(h) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 379j–52(h)) is amended to read as 

follows: 

‘‘(h) WRITTEN REQUESTS FOR WAIVERS AND RETURNS; DISPUTES

CONCERNING FEES.—To qualify for consideration for a waiver under 

subsection (d), or for the return of any fee paid under this section, 

including if the fee is claimed to have been paid in error, a person 
H. R. 6833—53 

shall submit to the Secretary a written request justifying such 

waiver or return and, except as otherwise specified in this section, 

such written request shall be submitted to the Secretary not later 

than 180 days after such fee is due. A request submitted under 

this paragraph shall include any legal authorities under which 

the request is made.’’. 

SEC. 4004. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Section 744I of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379j–53) is amended— 

(1) in subsection (a)(1), by striking ‘‘Beginning with fiscal 

year 2018, not’’ and inserting ‘‘Not’’; 

(2) by striking ‘‘Biosimilar User Fee Amendments of 2017’’ 

each place it appears and inserting ‘‘Biosimilar User Fee 

Amendments of 2022’’; 

(3) in subsection (a)(2), by striking ‘‘Beginning with fiscal 

year 2018, the’’ and inserting ‘‘The’’; 

(4) in subsection (a)(3)(A), by striking ‘‘Not later than 30 

calendar days after the end of the second quarter of fiscal 

year 2018, and not later than 30 calendar days after the end 

of each quarter of each fiscal year thereafter’’ and inserting 

‘‘Not later than 30 calendar days after the end of each quarter 

of each fiscal year for which fees are collected under this 

part’’; 

(5) in subsection (b), by striking ‘‘Not later than 120 days 

after the end of fiscal year 2018 and each subsequent fiscal 

year for which fees are collected under this part’’ and inserting 

‘‘Not later than 120 days after the end of each fiscal year 

for which fees are collected under this part’’; 

(6) in subsection (c), by striking ‘‘Beginning with fiscal 

year 2018, and for’’ and inserting ‘‘For’’; and 

(7) in subsection (f)— 

(A) in paragraph (1), in the matter preceding subparagraph (A), by striking ‘‘fiscal year 2022’’ and inserting 

‘‘fiscal year 2027’’; and 

(B) in paragraph (3), by striking ‘‘January 15, 2022’’ 

and inserting ‘‘January 15, 2027’’. 

SEC. 4005. SUNSET DATES. 

(a) AUTHORIZATION.—Sections 744G and 744H of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51, 379j–52) shall 

cease to be effective October 1, 2027. 

(b) REPORTING REQUIREMENTS.—Section 744I of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) shall cease to 

be effective January 31, 2028. 

(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2022, 

subsections (a) and (b) of section 405 of the FDA Reauthorization 

Act of 2017 (Public Law 115–52) are repealed. 

SEC. 4006. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2022, or the date of the enactment of this Act, whichever is 

later, except that fees under part 8 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

51 et seq.) shall be assessed for all biosimilar biological product 

applications received on or after October 1, 2022, regardless of 

the date of the enactment of this Act. 
H. R. 6833—54 

SEC. 4007. SAVINGS CLAUSE. 

Notwithstanding the amendments made by this title, part 8 

of subchapter C of chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379j–51 et seq.), as in effect on the day 

before the date of the enactment of this title, shall continue to 

be in effect with respect to biosimilar biological product applications 

and supplements (as defined in such part as of such day) that 

were accepted by the Food and Drug Administration for filing 

on or after October 1, 2017, but before October 1, 2022, with 

respect to assessing and collecting any fee required by such part 

for a fiscal year prior to fiscal year 2023. 

TITLE V—REAUTHORIZATION OF 

OTHER PROVISIONS 

SEC. 5001. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR 

CHILDREN PROGRAM. 

Section 409I(d)(1) of the Public Health Service Act (42 U.S.C. 

284m(d)(1)) is amended by striking ‘‘$25,000,000 for each of fiscal 

years 2018 through 2022’’ and inserting ‘‘$5,273,973 for the period 

beginning on October 1, 2022 and ending on December 16, 2022’’. 

SEC. 5002. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION INCENTIVE. 

Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking 

‘‘October 1’’ and inserting ‘‘December 17’’. 

SEC. 5003. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA 

PROGRAM. 

Section 305(e) of the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note) is 

amended by striking ‘‘$5,250,000 for each of fiscal years 2018 

through 2022’’ and inserting ‘‘$1,107,534 for the period beginning 

on October 1, 2022, and ending on December 16, 2022’’. 

SEC. 5004. REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS 

CONTAINING SINGLE ENANTIOMERS. 

Section 505(u)(4) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(u)(4)) is amended by striking ‘‘October 1’’ and 

inserting ‘‘December 17’’. 

SEC. 5005. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIP. 

Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5(f)) is amended by striking ‘‘$6,000,000 for 

each of fiscal years 2018 through 2022’’ and inserting ‘‘$1,265,753 

for the period beginning on October 1, 2022 and ending on December 

16, 2022’’. 

SEC. 5006. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 

Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended by striking ‘‘$30,000,000 for each of fiscal years 2018 

through 2022’’ and inserting ‘‘$6,328,767 for the period beginning 

on October 1, 2022, and ending on December 16, 2022’’. 
H. R. 6833—55 

SEC. 5007. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS. 

Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 374(g)(11)) is amended by striking ‘‘October 1’’ and 

inserting ‘‘December 17’’. 

SEC. 5008. REAUTHORIZATION OF REPORTING REQUIREMENTS 

RELATED TO PENDING GENERIC DRUG APPLICATIONS 

AND PRIORITY REVIEW APPLICATIONS. 

Section 807 of the FDA Reauthorization Act of 2017 (Public 

Law 115–52) is amended, in the matter preceding paragraph (1), 

by striking ‘‘October 1’’ and inserting ‘‘December 16’’. 

DIVISION G—HERMIT’S PEAK/CALF 

CANYON FIRE ASSISTANCE ACT 

SEC. 101. SHORT TITLE. 

This division may be cited as the ‘‘Hermit’s Peak/Calf Canyon 

Fire Assistance Act’’. 

SEC. 102. FINDINGS AND PURPOSES. 

(a) FINDINGS.—Congress finds that— 

(1) on April 6, 2022, the Forest Service initiated the Las 

Dispensas-Gallinas prescribed burn on Federal land in the 

Santa Fe National Forest in San Miguel County, New Mexico, 

when erratic winds were prevalent in the area that was also 

suffering from severe drought after many years of insufficient 

precipitation; 

(2) on April 6, 2022, the prescribed burn, which became 

known as the ‘‘Hermit’s Peak Fire’’, exceeded the containment 

capabilities of the Forest Service, was declared a wildfire, and 

spread to other Federal and non-Federal land; 

(3) on April 19, 2022, the Calf Canyon Fire, also in San 

Miguel County, New Mexico, began burning on Federal land 

and was later identified as the result of a pile burn in January 

2022 that remained dormant under the surface before reemerging; 

(4) on April 27, 2022, the Hermit’s Peak Fire and the 

Calf Canyon Fire merged, and both fires were reported as 

the Hermit’s Peak Fire or the Hermit’s Peak/Calf Canyon Fire, 

which shall be referred to hereafter as the Hermit’s Peak/ 

Calf Canyon Fire; 

(5) by May 2, 2022, the fire had grown in size and caused 

evacuations in multiple villages and communities in San Miguel 

County and Mora County, including in the San Miguel county 

jail, the State’s psychiatric hospital, the United World College, 

and New Mexico Highlands University; 

(6) on May 4, 2022, the President issued a major disaster 

declaration for the counties of Colfax, Mora, and San Miguel, 

New Mexico; 

(7) on May 20, 2022, U.S. Forest Service Chief Randy 

Moore ordered a 90-day review of prescribed burn policies to 

reduce the risk of wildfires and ensure the safety of the communities involved; 

(8) the U.S. Forest Service has assumed responsibility for 

the Hermit’s Peak/Calf Canyon Fire; 
H. R. 6833—56 

(9) the fire resulted in the loss of Federal, State, local, 

Tribal, and private property; and 

(10) the United States should compensate the victims of 

the Hermit’s Peak/Calf Canyon Fire. 

(b) PURPOSES.—The purposes of this Act are— 

(1) to compensate victims of the Hermit’s Peak/Calf Canyon 

Fire, for injuries resulting from the fire; and 

(2) to provide for the expeditious consideration and settlement of claims for those injuries. 

SEC. 103. DEFINITIONS. 

In this Act: 

(1) ADMINISTRATOR.—The term ‘‘Administrator’’ means— 

(A) the Administrator of the Federal Emergency 

Management Agency; or 

(B) if a Manager is appointed under section 104(a)(3), 

the Manager. 

(2) HERMIT’S PEAK/CALF CANYON FIRE.—The term ‘‘Hermit’s 

Peak/Calf Canyon Fire’’ means— 

(A) the fire resulting from the initiation by the Forest 

Service of a prescribed burn in the Santa Fe National 

Forest in San Miguel County, New Mexico, on April 6, 

2022; 

(B) the pile burn holdover resulting from the prescribed 

burn by the Forest Service, which reemerged on April 

19, 2022; and 

(C) the merger of the two fires described in subparagraphs (A) and (B), reported as the Hermit’s Peak Fire 

or the Hermit’s Peak Fire/Calf Canyon Fire. 

(3) INDIAN TRIBE.—The term ‘‘Indian Tribe’’ means the 

recognized governing body of any Indian or Alaska Native 

Tribe, band, nation, pueblo, village, community, component 

band, or component reservation individually identified 

(including parenthetically) in the list published most recently 

as of the date of enactment of this Act pursuant to section 

104 of the Federally Recognized Indian Tribe List Act of 1994 

(25 U.S.C. 5131). 

(4) INJURED PERSON.—The term ‘‘injured person’’ means— 

(A) an individual, regardless of the citizenship or alien 

status of the individual; or 

(B) an Indian Tribe, corporation, Tribal corporation, 

partnership, company, association, county, township, city, 

State, school district, or other non-Federal entity (including 

a legal representative) that suffered injury resulting from 

the Hermit’s Peak/Calf Canyon Fire. 

(5) INJURY.—The term ‘‘injury’’ has the same meaning as 

the term ‘‘injury or loss of property, or personal injury or 

death’’ as used in section 1346(b)(1) of title 28, United States 

Code. 

(6) MANAGER.—The term ‘‘Manager’’ means an Independent 

Claims Manager appointed under section 104(a)(3). 

(7) OFFICE.—The term ‘‘Office’’ means the Office of Hermit’s 

Peak/Calf Canyon Fire Claims established by section 104(a)(2). 

(8) TRIBAL ENTITY.—The term ‘‘Tribal entity’’ includes any 

Indian Tribe, tribal organization, Indian-controlled organization 

serving Indians, Native Hawaiian organization, or Alaska 

Native entity, as such terms are defined or used in section 
H. R. 6833—57 

166 of the Workforce Innovation and Opportunity Act (29 U.S.C. 

3221). 

SEC. 104. COMPENSATION FOR VICTIMS OF HERMIT’S PEAK/CALF 

CANYON FIRE. 

(a) IN GENERAL.— 

(1) COMPENSATION.—Each injured person shall be eligible 

to receive from the United States compensation for injury suffered by the injured person as a result of the Hermit’s Peak/ 

Calf Canyon Fire, subject to the availability of appropriations 

and subject to the Administrator making the determinations 

required under subsection (d). 

(2) OFFICE OF HERMIT’S PEAK/CALF CANYON FIRE CLAIMS.— 

(A) IN GENERAL.—There is established within the Federal Emergency Management Agency an Office of Hermit’s 

Peak/Calf Canyon Fire Claims. 

(B) PURPOSE.—The Office shall receive, process, and 

pay claims in accordance with this Act. 

(C) FUNDING.—The Office— 

(i) shall be funded from funds made available to 

the Administrator for carrying out this section; 

(ii) may appoint and fix the compensation of such 

temporary personnel as may be necessary, without 

regard to the provisions of title 5, United States Code, 

governing appointments in competitive service; and 

(iii) may reimburse other Federal agencies for 

claims processing support and assistance. 

(3) OPTION TO APPOINT INDEPENDENT CLAIMS MANAGER.— 

The Administrator may appoint an Independent Claims Manager to— 

(A) head the Office; and 

(B) assume the duties of the Administrator under this 

Act. 

(4) DETAIL.—Upon the request of the Administrator, the 

head of any Federal department or agency may detail, on 

a reimbursable basis, any of the personnel of that department 

or agency to the Federal Emergency Management Agency to 

assist the Agency in carrying out the duties under this Act. 

(b) SUBMISSION OF CLAIMS.—Not later than 2 years after the 

date on which regulations are first promulgated under subsection 

(f), an injured person may submit to the Administrator a written 

claim for 1 or more injuries suffered by the injured person in 

accordance with such requirements as the Administrator determines 

to be appropriate. 

(c) INVESTIGATION OF CLAIMS.— 

(1) IN GENERAL.—In accordance with subsection (d), the 

Administrator shall, on behalf of the United States, investigate, 

consider, ascertain, adjust, determine, grant, deny, or settle 

any claim for money damages asserted under subsection (b). 

(2) APPLICABILITY OF STATE LAW.—Except as otherwise provided in this Act, the laws of the State of New Mexico shall 

apply to the calculation of damages under subsection (d)(4). 

(3) EXTENT OF DAMAGES.—Any payment under this Act— 

(A) shall be limited to actual compensatory damages 

measured by injuries suffered; and 

(B) shall not include— 
H. R. 6833—58 

(i) interest before settlement or payment of a claim; 

or 

(ii) punitive damages. 

(d) PAYMENT OF CLAIMS.— 

(1) DETERMINATION AND PAYMENT OF AMOUNT.— 

(A) IN GENERAL.— 

(i) PAYMENT.—Not later than 180 days after the 

date on which a claim is submitted under this Act, 

the Administrator shall determine and fix the amount, 

if any, to be paid for the claim. 

(ii) PRIORITY.—The Administrator, to the maximum extent practicable, shall pay subrogation claims 

submitted under this Act only after paying claims submitted by injured parties that are not insurance companies seeking payment as subrogees. 

(B) PARAMETERS OF DETERMINATION.—In determining 

and settling a claim under this Act, the Administrator 

shall determine only— 

(i) whether the claimant is an injured person; 

(ii) whether the injury that is the subject of the 

claim resulted from the Hermit’s Peak/Calf Canyon 

Fire; 

(iii) whether the person or persons are otherwise 

eligible to receive any amount determined under clause 

(iv); and 

(iv) whether sufficient funds are available for payment and, if so, the amount, if any, to be allowed 

and paid under this Act. 

(C) INSURANCE AND OTHER BENEFITS.— 

(i) IN GENERAL.—In determining the amount of, 

and paying, a claim under this Act, to prevent recovery 

by a claimant in excess of actual compensatory damages, the Administrator shall reduce the amount to 

be paid for the claim by an amount that is equal 

to the total of insurance benefits (excluding life insurance benefits) or other payments or settlements of 

any nature that were paid, or will be paid, with respect 

to the claim. 

(ii) GOVERNMENT LOANS.—This subparagraph shall 

not apply to the receipt by a claimant of any government loan that is required to be repaid by the claimant. 

(2) PARTIAL PAYMENT.— 

(A) IN GENERAL.—At the request of a claimant, the 

Administrator may make 1 or more advance or partial 

payments, subject to the determination required under 

paragraph (1)(B), before the final settlement of a claim, 

including final settlement on any portion or aspect of a 

claim that is determined to be severable. 

(B) JUDICIAL DECISION.—If a claimant receives a partial 

payment on a claim under this Act, but further payment 

on the claim is subsequently denied by the Administrator, 

the claimant may— 

(i) seek judicial review under subsection (i); and 

(ii) keep any partial payment that the claimant 

received, unless the Administrator determines that the 

claimant— 
H. R. 6833—59 

(I) was not eligible to receive the compensation; or 

(II) fraudulently procured the compensation. 

(3) RIGHTS OF INSURER OR OTHER THIRD PARTY.—If an 

insurer or other third party pays any amount to a claimant 

to compensate for an injury described in subsection (a), the 

insurer or other third party shall be subrogated to any right 

that the claimant has to receive any payment under this Act 

or any other law. 

(4) ALLOWABLE DAMAGES.— 

(A) LOSS OF PROPERTY.—A claim that is paid for loss 

of property under this Act may include otherwise 

uncompensated damages resulting from the Hermit’s Peak/ 

Calf Canyon Fire for— 

(i) an uninsured or underinsured property loss; 

(ii) a decrease in the value of real property; 

(iii) damage to physical infrastructure, including 

irrigation infrastructure such as acequia systems; 

(iv) a cost resulting from lost subsistence from 

hunting, fishing, firewood gathering, timbering, 

grazing, or agricultural activities conducted on land 

damaged by the Hermit’s Peak/Calf Canyon Fire; 

(v) a cost of reforestation or revegetation on Tribal 

or non-Federal land, to the extent that the cost of 

reforestation or revegetation is not covered by any 

other Federal program; and 

(vi) any other loss that the Administrator determines to be appropriate for inclusion as loss of property. 

(B) BUSINESS LOSS.—A claim that is paid for injury 

under this Act may include damages resulting from the 

Hermit’s Peak/Calf Canyon Fire for the following types 

of otherwise uncompensated business loss: 

(i) Damage to tangible assets or inventory, 

including natural resources. 

(ii) Business interruption losses. 

(iii) Overhead costs. 

(iv) Employee wages for work not performed. 

(v) Loss of business net income. 

(vi) Any other loss that the Administrator determines to be appropriate for inclusion as business loss. 

(C) FINANCIAL LOSS.—A claim that is paid for injury 

under this Act may include damages resulting from the 

Hermit’s Peak/Calf Canyon Fire for the following types 

of otherwise uncompensated financial loss: 

(i) Increased mortgage interest costs. 

(ii) An insurance deductible. 

(iii) A temporary living or relocation expense. 

(iv) Lost wages or personal income. 

(v) Emergency staffing expenses. 

(vi) Debris removal and other cleanup costs. 

(vii) Costs of reasonable efforts, as determined by 

the Administrator, to reduce the risk of wildfire, flood, 

or other natural disaster in the counties impacted by 

the Hermit’s Peak/Calf Canyon Fire to risk levels prevailing in those counties before the Hermit’s Peak/ 

Calf Canyon Fire, that are incurred not later than 
H. R. 6833—60 

the date that is 3 years after the date on which the 

regulations under subsection (f) are first promulgated. 

(viii) A premium for flood insurance that is 

required to be paid on or before May 31, 2024, if, 

as a result of the Hermit’s Peak/Calf Canyon Fire, 

a person that was not required to purchase flood insurance before the Hermit’s Peak/Calf Canyon Fire is 

required to purchase flood insurance. 

(ix) A disaster assistance loan received from the 

Small Business Administration. 

(x) Any other loss that the Administrator determines to be appropriate for inclusion as financial loss. 

(e) ACCEPTANCE OF AWARD.—The acceptance by a claimant 

of any payment under this Act, except an advance or partial payment made under subsection (d)(2), shall— 

(1) be final and conclusive on the claimant, with respect 

to all claims arising out of or relating to the same subject 

matter; and 

(2) constitute a complete release of all claims against the 

United States (including any agency or employee of the United 

States) under chapter 171 of title 28, United States Code (commonly known as the ‘‘Federal Tort Claims Act’’), or any other 

Federal or State law, arising out of or relating to the same 

subject matter. 

(f) REGULATIONS AND PUBLIC INFORMATION.— 

(1) REGULATIONS.—Notwithstanding any other provision of 

law, not later than 45 days after the date of enactment of 

this Act, the Administrator shall promulgate and publish in 

the Federal Register interim final regulations for the processing 

and payment of claims under this Act. 

(2) PUBLIC INFORMATION.— 

(A) IN GENERAL.—At the time at which the Administrator promulgates regulations under paragraph (1), the 

Administrator shall publish, online and in print, in newspapers of general circulation in the State of New Mexico, 

a clear, concise, and easily understandable explanation, 

in English and Spanish, of— 

(i) the rights conferred under this Act; and 

(ii) the procedural and other requirements of the 

regulations promulgated under paragraph (1). 

(B) DISSEMINATION THROUGH OTHER MEDIA.—The 

Administrator shall disseminate the explanation published 

under subparagraph (A) through websites, blogs, social 

media, brochures, pamphlets, radio, television, and other 

media that the Administrator determines are likely to reach 

prospective claimants. 

(g) CONSULTATION.—In administering this Act, the Administrator shall consult with the Secretary of the Interior, the Secretary 

of Energy, the Secretary of Agriculture, the Administrator of the 

Small Business Administration, other Federal agencies, and State, 

local, and Tribal authorities, as determined to be necessary by 

the Administrator, to— 

(1) ensure the efficient administration of the claims process; 

and 

(2) provide for local concerns. 

(h) ELECTION OF REMEDY.— 
H. R. 6833—61 

(1) IN GENERAL.—An injured person may elect to seek 

compensation from the United States for 1 or more injuries 

resulting from the Hermit’s Peak/Calf Canyon Fire by— 

(A) submitting a claim under this Act; 

(B) filing a claim or bringing a civil action under 

chapter 171 of title 28, United States Code (commonly 

known as the ‘‘Federal Tort Claims Act’’); or 

(C) bringing an authorized civil action under any other 

provision of law. 

(2) EFFECT OF ELECTION.—In accordance with subsection 

(e), an election by an injured person to seek compensation 

in any manner described in paragraph (1) shall be final and 

conclusive on the claimant with respect to all injuries resulting 

from the Hermit’s Peak/Calf Canyon Fire that are suffered 

by the claimant upon acceptance of an award. 

(3) ARBITRATION.— 

(A) IN GENERAL.—Not later than 45 days after the 

date of enactment of this Act, the Administrator shall 

establish by regulation procedures under which a dispute 

regarding a claim submitted under this Act may be settled 

by arbitration. 

(B) ARBITRATION AS REMEDY.—On establishment of 

arbitration procedures under subparagraph (A), an injured 

person that submits a disputed claim under this Act may 

elect to settle the claim through arbitration. 

(C) BINDING EFFECT.—An election by an injured person 

to settle a claim through arbitration under this paragraph 

shall— 

(i) be binding; and 

(ii) preclude any exercise by the injured person 

of the right to judicial review of a claim described 

in subsection (i). 

(4) NO EFFECT ON ENTITLEMENTS.—The value of compensation that may be provided under this Act shall not be considered 

income or resources for any purpose under any Federal, State, 

or local laws, including laws relating to taxation, welfare, and 

public assistance programs, and no State or political subdivision 

thereof shall decrease any assistance otherwise provided to 

an injured person because of the receipt of benefits under 

this Act. 

(i) JUDICIAL REVIEW.— 

(1) IN GENERAL.—Any claimant aggrieved by a final decision of the Administrator under this Act may, not later than 

60 days after the date on which the decision is issued, bring 

a civil action in the United States District Court for the District 

of New Mexico, to modify or set aside the decision, in whole 

or in part. 

(2) RECORD.—The court shall hear a civil action under 

paragraph (1) on the record made before the Administrator. 

(3) STANDARD.—The decision of the Administrator incorporating the findings of the Administrator shall be upheld 

if the decision is supported by substantial evidence on the 

record considered as a whole. 

(j) ATTORNEY’S AND AGENT’S FEES.— (1) IN GENERAL.—No attorney or agent, acting alone or 

in combination with any other attorney or agent, shall charge, 

demand, receive, or collect, for services rendered in connection 
H. R. 6833—62 

with a claim submitted under this Act, fees in excess of the 

limitations established under section 2678 of title 28, United 

States Code. 

(2) VIOLATION.—An attorney or agent who violates paragraph (1) shall be fined not more than $10,000. 

(k) WAIVER OF REQUIREMENT FOR MATCHING FUNDS.— 

(1) STATE AND LOCAL PROJECT.— 

(A) IN GENERAL.—Notwithstanding any other provision 

of law, a State or local project that is determined by the 

Administrator to be carried out in response to the Hermit’s 

Peak/Calf Canyon Fire under any Federal program that 

applies to an area affected by the Hermit’s Peak/Calf 

Canyon Fire shall not be subject to any requirement for 

State or local matching funds to pay the cost of the project 

under the Federal program. 

(B) FEDERAL SHARE.—The Federal share of the costs 

of a project described in subparagraph (A) shall be 100 

percent. 

(2) OTHER NEEDS PROGRAM ASSISTANCE.—Notwithstanding 

section 408(g)(2) of the Robert T. Stafford Disaster Relief and 

Emergency Assistance Act (42 U.S.C. 5174(g)(2)), for any emergency or major disaster declared by the President under that 

Act for the Hermit’s Peak/Calf Canyon Fire, the Federal share 

of assistance provided under that section shall be 100 percent. 

(3) AGRICULTURAL PROGRAM ASSISTANCE.— 

(A) IN GENERAL.—Notwithstanding any other provision 

of law, a State, local, or individual project that is determined by the Secretary of Agriculture to be carried out 

in response to the Hermit’s Peak/Calf Canyon Fire under 

any Federal program that applies to an area affected by 

the Hermit’s Peak/Calf Canyon Fire shall not be subject 

to any requirement for State, local, or individual matching 

funds to pay the cost of the project under the Federal 

program. 

(B) FEDERAL SHARE.—The Federal share of the costs 

of a project described in subparagraph (A) shall be 100 

percent. 

(l) APPLICABILITY OF DEBT COLLECTION REQUIREMENTS.—Section 3711(a) of title 31, United States Code, shall not apply to 

any payment under this Act, unless— 

(1) there is evidence of civil or criminal fraud, misrepresentation, presentation of a false claim; or 

(2) a claimant was not eligible under subsection (d)(2) 

of this Act to any partial payment. 

(m) INDIAN COMPENSATION.—Notwithstanding any other provision of law, in the case of an Indian Tribe, a Tribal entity, or 

a member of an Indian Tribe that submits a claim under this 

Act— 

(1) the Bureau of Indian Affairs shall have no authority 

over, or any trust obligation regarding, any aspect of the 

submission of, or any payment received for, the claim; 

(2) the Indian Tribe, Tribal entity, or member of an Indian 

Tribe shall be entitled to proceed under this Act in the same 

manner and to the same extent as any other injured person; 

and 

(3) except with respect to land damaged by the Hermit’s 

Peak/Calf Canyon Fire that is the subject of the claim, the 
H. R. 6833—63 

Bureau of Indian Affairs shall have no responsibility to restore 

land damaged by the Hermit’s Peak/Calf Canyon Fire. 

(n) REPORT.—Not later than 1 year after the date of promulgation of regulations under subsection (f)(1), and annually thereafter, 

the Administrator shall submit to Congress a report that describes 

the claims submitted under this Act during the year preceding 

the date of submission of the report, including, for each claim— 

(1) the amount claimed; 

(2) a brief description of the nature of the claim; and 

(3) the status or disposition of the claim, including the 

amount of any payment under this Act. 

(o) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated such sums as are necessary to carry out this 

Act. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.