In the Senate of the United States, 

September 29, 2022. 

Resolved, That the bill from the House of Representatives (H.R. 6833) entitled ‘‘An Act to amend title XXVII of 

the Public Health Service Act, the Internal Revenue Code of 

1986, and the Employee Retirement Income Security Act of 

1974 to establish requirements with respect to cost-sharing 

for certain insulin products, and for other purposes.’’, do pass 

with the following 

AMENDMENT: 

Strike all after the enacting clause and insert the 

following: 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Continuing Appropria3 tions and Ukraine Supplemental Appropriations Act, 

4 2023’’. 

5 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. 
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† HR 6833 EAS 

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 

1 SEC. 3. REFERENCES. 

2 Except as expressly provided otherwise, any reference 

3 to ‘‘this Act’’ contained in any division of this Act shall 

4 be treated as referring only to the provisions of that divi5 sion. 

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

7 MEMBERS OF CONGRESS. 

8 There is hereby appropriated for fiscal year 2023, out 

9 of any money in the Treasury not otherwise appropriated, 

10 for payment to Dean Swihart, beneficiary of Jacqueline 

11 Walorski-Swihart, late a Representative from the State of 

12 Indiana, $174,000. 
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1 DIVISION A—CONTINUING 

2 APPROPRIATIONS ACT, 2023 

3 The following sums are hereby appropriated, out of 

4 any money in the Treasury not otherwise appropriated, 

5 and out of applicable corporate or other revenues, receipts, 

6 and funds, for the several departments, agencies, corpora7 tions, and other organizational units of Government for fis8 cal year 2023, and for other purposes, namely: 

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

10 rate for operations as provided in the applicable appropria11 tions Acts for fiscal year 2022 and under the authority and 

12 conditions provided in such Acts, for continuing projects 

13 or activities (including the costs of direct loans and loan 

14 guarantees) that are not otherwise specifically provided for 

15 in this Act, that were conducted in fiscal year 2022, and 

16 for which appropriations, funds, or other authority were 

17 made available in the following appropriations Acts: 

18 (1) The Agriculture, Rural Development, Food 

19 and Drug Administration, and Related Agencies Ap20 propriations Act, 2022 (division A of Public Law 

21 117–103), except section 783, and except that section 

22 785 shall be applied by substituting ‘‘$125,000,000’’ 

23 for ‘‘$250,000,000’’. 
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† HR 6833 EAS 

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

2 Agencies Appropriations Act, 2022 (division B of 

3 Public Law 117–103), except section 521(c)(1). 

4 (3) The Department of Defense Appropriations 

5 Act, 2022 (division C of Public Law 117–103). 

6 (4) The Energy and Water Development and Re7 lated Agencies Appropriations Act, 2022 (division D 

8 of Public Law 117–103). 

9 (5) The Financial Services and General Govern10 ment Appropriations Act, 2022 (division E of Public 

11 Law 117–103), except the matter under the heading 

12 ‘‘Postal Regulatory Commission’’ in title V. 

13 (6) The Department of Homeland Security Ap14 propriations Act, 2022 (division F of Public Law 

15 117–103), except sections 544 and 545, and including 

16 title II of division O of Public Law 117–103. 

17 (7) The Department of the Interior, Environ18 ment, and Related Agencies Appropriations Act, 2022 

19 (division G of Public Law 117–103). 

20 (8) The Departments of Labor, Health and 

21 Human Services, and Education, and Related Agen22 cies Appropriations Act, 2022 (division H of Public 

23 Law 117–103), and section 162 of division A of Pub24 lic Law 117–43. 
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1 (9) The Legislative Branch Appropriations Act, 

2 2022 (division I of Public Law 117–103), and section 

3 6 in the matter preceding division A of Public Law 

4 117–103. 

5 (10) The Military Construction, Veterans Affairs, 

6 and Related Agencies Appropriations Act, 2022 (divi7 sion J of Public Law 117–103). 

8 (11) The Department of State, Foreign Oper9 ations, and Related Programs Appropriations Act, 

10 2022 (division K of Public Law 117–103), except the 

11 first proviso of section 7069(e). 

12 (12) The Transportation, Housing and Urban 

13 Development, and Related Agencies Appropriations 

14 Act, 2022 (division L of Public Law 117–103). 

15 SEC. 102. (a) No appropriation or funds made avail16 able or authority granted pursuant to section 101 for the 

17 Department of Defense shall be used for: 

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

19 production in fiscal year 2022 or prior years; 

20 (2) the increase in production rates above those 

21 sustained with fiscal year 2022 funds; or 

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

23 any project, activity, operation, or organization (de24 fined as any project, subproject, activity, budget ac25 tivity, program element, and subprogram within a 
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† HR 6833 EAS 

1 program element, and for any investment items de2 fined as a P–1 line item in a budget activity within 

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

4 includes a program element and subprogram element 

5 within an appropriation account) for which appro6 priations, funds, or other authority were not available 

7 during fiscal year 2022. 

8 (b) No appropriation or funds made available or au9 thority granted pursuant to section 101 for the Department 

10 of Defense shall be used to initiate multi-year procurements 

11 utilizing advance procurement funding for economic order 

12 quantity procurement unless specifically appropriated 

13 later. 

14 SEC. 103. Appropriations made by section 101 shall 

15 be available to the extent and in the manner that would 

16 be provided by the pertinent appropriations Act. 

17 SEC. 104. Except as otherwise provided in section 102, 

18 no appropriation or funds made available or authority 

19 granted pursuant to section 101 shall be used to initiate 

20 or resume any project or activity for which appropriations, 

21 funds, or other authority were not available during fiscal 

22 year 2022. 

23 SEC. 105. Appropriations made and authority granted 

24 pursuant to this Act shall cover all obligations or expendi25 tures incurred for any project or activity during the period 
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1 for which funds or authority for such project or activity 

2 are available under this Act. 

3 SEC. 106. Unless otherwise provided for in this Act 

4 or in the applicable appropriations Act for fiscal year 2023, 

5 appropriations and funds made available and authority 

6 granted pursuant to this Act shall be available until which7 ever of the following first occurs: 

8 (1) The enactment into law of an appropriation 

9 for any project or activity provided for in this Act. 

10 (2) The enactment into law of the applicable ap11 propriations Act for fiscal year 2023 without any 

12 provision for such project or activity. 

13 (3) December 16, 2022. 

14 SEC. 107. Expenditures made pursuant to this Act 

15 shall be charged to the applicable appropriation, fund, or 

16 authorization whenever a bill in which such applicable ap17 propriation, fund, or authorization is contained is enacted 

18 into law. 

19 SEC. 108. Appropriations made and funds made avail20 able by or authority granted pursuant to this Act may be 

21 used without regard to the time limitations for submission 

22 and approval of apportionments set forth in section 1513 

23 of title 31, United States Code, but nothing in this Act may 

24 be construed to waive any other provision of law governing 

25 the apportionment of funds. 
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1 SEC. 109. Notwithstanding any other provision of this 

2 Act, except section 106, for those programs that would other3 wise have high initial rates of operation or complete dis4 tribution of appropriations at the beginning of fiscal year 

5 2023 because of distributions of funding to States, foreign 

6 countries, grantees, or others, such high initial rates of oper7 ation or complete distribution shall not be made, and no 

8 grants shall be awarded for such programs funded by this 

9 Act that would impinge on final funding prerogatives. 

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

11 the most limited funding action of that permitted in the 

12 Act shall be taken in order to provide for continuation of 

13 projects and activities. 

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

15 payments whose budget authority was provided in appro16 priations Acts for fiscal year 2022, and for activities under 

17 the Food and Nutrition Act of 2008, activities shall be con18 tinued at the rate to maintain program levels under current 

19 law, under the authority and conditions provided in the 

20 applicable appropriations Act for fiscal year 2022, to be 

21 continued through the date specified in section 106(3). 

22 (b) Notwithstanding section 106, obligations for man23 datory payments due on or about the first day of any month 

24 that begins after October 2022 but not later than 30 days 
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1 after the date specified in section 106(3) may continue to 

2 be made, and funds shall be available for such payments. 

3 SEC. 112. Amounts made available under section 101 

4 for civilian personnel compensation and benefits in each de5 partment and agency may be apportioned up to the rate 

6 for operations necessary to avoid furloughs within such de7 partment or agency, consistent with the applicable appro8 priations Act for fiscal year 2022, except that such author9 ity provided under this section shall not be used until after 

10 the department or agency has taken all necessary actions 

11 to reduce or defer non-personnel-related administrative ex12 penses. 

13 SEC. 113. Funds appropriated by this Act may be obli14 gated and expended notwithstanding section 10 of Public 

15 Law 91–672 (22 U.S.C. 2412), section 15 of the State De16 partment Basic Authorities Act of 1956 (22 U.S.C. 2680), 

17 section 313 of the Foreign Relations Authorization Act, Fis18 cal Years 1994 and 1995 (22 U.S.C. 6212), and section 

19 504(a)(1) of the National Security Act of 1947 (50 U.S.C. 

20 3094(a)(1)). 

21 SEC. 114. Each amount incorporated by reference in 

22 this Act that was previously designated by the Congress as 

23 an emergency requirement pursuant to sections 4001(a)(1) 

24 and 4001(b) of S. Con. Res. 14 (117th Congress), the con25 current resolution on the budget for fiscal year 2022, or as 
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1 being for disaster relief pursuant to section 4005(f) of such 

2 concurrent resolution, is designated as being an emergency 

3 requirement pursuant to section 4001(a)(1) of such concur4 rent resolution and section 1(e) of H. Res. 1151 (117th Con5 gress), as engrossed in the House of Representatives on June 

6 8, 2022, or as being for disaster relief pursuant to section 

7 1(f) of such House resolution, respectively. 

8 SEC. 115. (a) Rescissions or cancellations of discre9 tionary budget authority that continue pursuant to section 

10 101 in Treasury Appropriations Fund Symbols (TAFS)— 

11 (1) to which other appropriations are not pro12 vided by this Act, but for which there is a current ap13 plicable TAFS that does receive an appropriation in 

14 this Act; or 

15 (2) which are no-year TAFS and receive other 

16 appropriations in this Act, 

17 may be continued instead by reducing the rate for oper18 ations otherwise provided by section 101 for such current 

19 applicable TAFS, as long as doing so does not impinge on 

20 the final funding prerogatives of the Congress. 

21 (b) Rescissions or cancellations described in subsection 

22 (a) shall continue in an amount equal to the lesser of— 

23 (1) the amount specified for rescission or can24 cellation in the applicable appropriations Act ref25 erenced in section 101 of this Act; or 
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1 (2) the amount of balances available, as of Octo2 ber 1, 2022, from the funds specified for rescission or 

3 cancellation in the applicable appropriations Act ref4 erenced in section 101 of this Act. 

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

6 the Office of Management and Budget shall provide to the 

7 Committees on Appropriations of the House of Representa8 tives and the Senate a comprehensive list of the rescissions 

9 or cancellations that will continue pursuant to section 101: 

10 Provided, That the information in such comprehensive list 

11 shall be periodically updated to reflect any subsequent 

12 changes in the amount of balances available, as of October 

13 1, 2022, from the funds specified for rescission or cancella14 tion in the applicable appropriations Act referenced in sec15 tion 101, and such updates shall be transmitted to the Com16 mittees on Appropriations of the House of Representatives 

17 and the Senate upon request. 

18 SEC. 116. Amounts made available by section 101 for 

19 ‘‘Farm Service Agency—Agricultural Credit Insurance 

20 Fund Program Account’’ may be apportioned up to the rate 

21 for operations necessary to accommodate approved applica22 tions for direct and guaranteed farm ownership loans, as 

23 authorized by 7 U.S.C. 1922 et seq. 

24 SEC. 117. Amounts made available by section 101 to 

25 the Department of Agriculture for ‘‘Rural Business—Coop-
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1 erative Service—Rural Microentrepreneur Assistance Pro2 gram’’ may be used for the costs of loans, including the cost 

3 of modifying such loans, as defined in section 502 of the 

4 Congressional Budget Act of 1974, under the same terms 

5 and conditions as authorized by section 379E of the Con6 solidated Farm and Rural Development Act (7 U.S.C. 

7 2008s). 

8 SEC. 118. Section 260 of the Agricultural Marketing 

9 Act of 1946 (7 U.S.C. 1636i) and section 942 of the Live10 stock Mandatory Reporting Act of 1999 (7 U.S.C. 1635 

11 note; Public Law 106–78) shall be applied by substituting 

12 the date specified in section 106(3) of this Act for ‘‘Sep13 tember 30, 2022’’. 

14 SEC. 119. Amounts made available by section 101 to 

15 the Department of Commerce for ‘‘Economic Development 

16 Administration—Salaries and Expenses’’ may be appor17 tioned up to the rate for operations necessary to maintain 

18 agency operations. 

19 SEC. 120. Amounts made available by section 101 for 

20 ‘‘Department of Commerce—National Telecommunications 

21 and Information Administration—Salaries and Expenses’’ 

22 may be apportioned up to the rate for operations necessary 

23 to ensure continued oversight of public safety communica24 tions programs. 
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1 SEC. 121. In addition to amounts otherwise provided 

2 by section 101, for ‘‘Department of Justice—Federal Bu3 reau of Investigation—Salaries and Expenses’’, there is ap4 propriated $15,300,000, for an additional amount for fiscal 

5 year 2023, to remain available until September 30, 2023, 

6 for investigative activities associated with Afghan resettle7 ment operations: Provided, That such amount is designated 

8 by the Congress as being for an emergency requirement pur9 suant to section 4001(a)(1) of S. Con. Res. 14 (117th Con10 gress), the concurrent resolution on the budget for fiscal year 

11 2022, and section 1(e) of H. Res. 1151 (117th Congress), 

12 as engrossed in the House of Representatives on June 8, 

13 2022. 

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

15 through September 30, 2023, the Secretary of Defense may 

16 transfer up to $3,000,000,000 from unobligated balances 

17 from amounts made available under the heading ‘‘Depart18 ment of Defense—Operation and Maintenance—Overseas 

19 Humanitarian, Disaster, and Civic Aid’’ in division C of 

20 Public Law 117–43 and division B of Public Law 117– 

21 70 to any appropriation account under the headings ‘‘De22 partment of State and Related Agency—Department of 

23 State—Administration of Foreign Affairs’’, ‘‘Bilateral Eco24 nomic Assistance—Department of State—Migration and 

25 Refugee Assistance’’, and ‘‘Bilateral Economic Assistance— 
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1 Department of State—United States Emergency Refugee 

2 and Migration Assistance Fund’’ for support of Operation 

3 Allies Welcome or any successor operation: Provided, That 

4 upon transfer, such funds shall be merged with the appro5 priation to which such funds are transferred except that 

6 such funds may be made available for such purposes not7 withstanding any requirement or limitation applicable to 

8 the appropriation to which transferred, including sections 

9 2(c)(1) and 2(c)(2) of the Migration and Refugee Assistance 

10 Act of 1962 with respect to the United States Emergency 

11 Refugee and Migration Assistance Fund and in sections 

12 4(a) and 4(b) of the State Department Basic Authorities 

13 Act of 1956 with respect to funds transferred to the Emer14 gencies in the Diplomatic and Consular Service account: 

15 Provided further, That section 2215 of title 10, United 

16 States Code, shall not apply to a transfer of funds under 

17 this subsection: Provided further, That the exercise of the 

18 authority of this subsection shall be subject to prior con19 sultation with, and the regular notification procedures of, 

20 the Committees on Appropriations of the House of Rep21 resentatives and the Senate: Provided further, That any 

22 funds transferred pursuant to this subsection that were pre23 viously designated by the Congress as an emergency require24 ment pursuant to the concurrent resolution on the budget 

25 are designated by the Congress as being for an emergency 
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1 requirement pursuant to section 4001(a)(1) of S. Con. Res. 

2 14 (117th Congress), the concurrent resolution on the budget 

3 for fiscal year 2022, and section 1(e) of H. Res. 1151 (117th 

4 Congress), as engrossed in the House of Representatives on 

5 June 8, 2022. 

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

7 transfer of funds pursuant to subsection (a), the Director 

8 of the Office of Management and Budget shall provide to 

9 the Committees on Appropriations of the House of Rep10 resentatives and the Senate a written report on Operation 

11 Allies Welcome or any successor operation: Provided, That 

12 such report shall describe the number and status of Afghans 

13 residing at Department of Defense and Department of 

14 State-managed facilities and any anticipated future arriv15 als at such facilities; the strategy and plan, including 

16 timeline, for adjudicating and relocating all Afghans resid17 ing at Department of Defense or overseas civilian facilities 

18 and for the transition of operations and responsibilities 

19 under Operation Allies Welcome or any successor operation 

20 from the Department of Defense to the Department of State 

21 during fiscal year 2023; the activities and responsibilities 

22 assigned to each Federal agency involved in such strategy 

23 and plan; and a spend plan, containing an estimate of the 

24 costs, including additional construction and security costs, 

25 to be incurred by each such agency for carrying out such 
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1 strategy and plan, and the sources of funds: Provided fur2 ther, That prior to the initial obligation of funds trans3 ferred to the Department of State pursuant to subsection 

4 (a), the Secretary of State shall submit a report to such 

5 Committees detailing the roles and responsibilities of De6 partment of State bureaus and offices in Operation Allies 

7 Welcome or any successor operation. 

8 SEC. 123. During the period covered by this Act, sec9 tion 714(b)(2)(B) of title 10, United States Code, shall be 

10 applied by substituting ‘‘three years’’ for ‘‘two years’’. 

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

12 as of September 30, 2022, from amounts provided under 

13 the heading ‘‘Afghanistan Security Forces Fund’’ in title 

14 IX of division C of Public Law 116–260, $100,000,000 is 

15 hereby permanently rescinded, and in addition to amounts 

16 otherwise provided by section 101, an amount of additional 

17 new budget authority equivalent to the amount rescinded 

18 pursuant to this subsection is hereby appropriated on Sep19 tember 30, 2022, for an additional amount for fiscal year 

20 2022, to remain available until September 30, 2025, for the 

21 same purposes and under the same authorities provided 

22 under such heading in Public Law 116–260, in addition 

23 to other funds as may be available for such purposes. 

24 (b)(1) Subject to paragraph (2), this section shall be25 come effective immediately upon enactment of this Act. 
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1 (2) If this Act is enacted after September 30, 

2 2022, this section shall be applied as if it were in ef3 fect on September 30, 2022. 

4 SEC. 125. In addition to amounts otherwise provided 

5 by section 101, for ‘‘Corps of Engineers—Civil—Construc6 tion’’, there is appropriated $20,000,000, for an additional 

7 amount for fiscal year 2023, to remain available until ex8 pended, for necessary expenses related to water and waste9 water infrastructure under section 219 of the Water Re10 sources Development Act of 1992 (106 Stat. 4835): Pro11 vided, That such amount is designated by the Congress as 

12 being for an emergency requirement pursuant to section 

13 4001(a)(1) of S. Con. Res. 14 (117th Congress), the concur14 rent resolution on the budget for fiscal year 2022, and sec15 tion 1(e) of H. Res. 1151 (117th Congress), as engrossed 

16 in the House of Representatives on June 8, 2022. 

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

18 title I of Public Law 108–361 (the Calfed Bay-Delta Au19 thorization Act) (118 Stat. 1681), as amended by section 

20 204 of division D of Public Law 117–103, shall be applied 

21 by substituting ‘‘2023’’ for ‘‘2022’’ each place it appears. 

22 (b) During the period covered by this Act, section 

23 103(f)(4)(A) of title I of Public Law 108–361 (the Calfed 

24 Bay-Delta Authorization Act) (118 Stat. 1696) shall be ap25 plied by substituting ‘‘$25,650,000’’ for ‘‘$25,000,000’’. 
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1 SEC. 127. (a) During the period covered by this Act, 

2 section 9106(g)(2) of Public Law 111–11 (Omnibus Public 

3 Land Management Act of 2009) shall be applied by sub4 stituting ‘‘2023’’ for ‘‘2022’’. 

5 (b) During the period covered by this Act, section 

6 104(c) of the Reclamation States Emergency Drought Relief 

7 Act of 1991 (43 U.S.C. 2214(c)) shall be applied by sub8 stituting ‘‘2023’’ for ‘‘2022’’. 

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

10 of the Reclamation States Emergency Drought Relief Act 

11 of 1991 (43 U.S.C. 2241) shall be applied by substituting 

12 ‘‘2023’’ for ‘‘2022’’. 

13 SEC. 128. In addition to amounts otherwise provided 

14 by section 101, amounts are provided for ‘‘Department of 

15 the Treasury—Alcohol and Tobacco Tax and Trade Bu16 reau—Salaries and Expenses’’ at a rate for operations of 

17 $14,929,000, for an additional amount to administer the 

18 Craft Beverage Modernization Act import claims program, 

19 as required by the Taxpayer Certainty and Disaster Tax 

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

21 up to the rate for operations necessary to establish and im22 plement a new import claims program. 

23 SEC. 129. Notwithstanding section 101, title II of divi24 sion E of Public Law 117–103 shall be applied by adding 

25 the following new heading and appropriation language 
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1 under the heading ‘‘Executive Office of the President and 

2 Funds Appropriated to the President’’: 

3 ‘‘OFFICE OF THE NATIONAL CYBER DIRECTOR

4 ‘‘SALARIES AND EXPENSES

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

6 Cyber Director, as authorized by section 1752 of the Wil7 liam M. (Mac) Thornberry National Defense Authorization 

8 Act for Fiscal Year 2021 (Public Law 116–283), 

9 $21,000,000, of which not to exceed $5,000 shall be available 

10 for official reception and representation expenses.’’. 

11 SEC. 130. Notwithstanding section 101, amounts are 

12 provided for ‘‘The Judiciary—Courts of Appeals, District 

13 Courts, and Other Judicial Services—Fees of Jurors and 

14 Commissioners’’ at a rate for operations of $59,565,000. 

15 SEC. 131. In addition to amounts otherwise provided 

16 by section 101, for ‘‘The Judiciary—Courts of Appeals, Dis17 trict Courts, and Other Judicial Services—Court Security’’, 

18 there is appropriated $112,500,000, for an additional 

19 amount for fiscal year 2023, to remain available until ex20 pended, for security improvements at United States court21 houses and Federal court facilities: Provided, That not later 

22 than 90 days after the date of enactment of this Act, and 

23 every 90 days thereafter until all funds provided by this 

24 section have been expended, the Director of the Administra25 tive Office of the United States Courts shall provide, in an 
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1 appropriate format, quarterly reports on the obligations 

2 and expenditures of the funds provided under this section 

3 to the Committees on Appropriations of the House of Rep4 resentatives and the Senate: Provided further, That such 

5 amount is designated by the Congress as being for an emer6 gency requirement pursuant to section 4001(a)(1) of S. Con. 

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

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

9 (117th Congress), as engrossed in the House of Representa10 tives on June 8, 2022. 

11 SEC. 132. Notwithstanding any other provision of this 

12 Act, except section 106, the District of Columbia may ex13 pend local funds made available under the heading ‘‘Dis14 trict of Columbia—District of Columbia Funds’’ for such 

15 programs and activities under the District of Columbia Ap16 propriations Act, 2022 (title IV of division E of Public Law 

17 117–103) at the rate set forth in the Fiscal Year 2023 Local 

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

19 the date of enactment of this Act. 

20 SEC. 133. In addition to amounts otherwise provided 

21 by section 101, amounts are provided for ‘‘Small Business 

22 Administration—Salaries and Expenses’’ at a rate for op23 erations of $20,000,000, for an additional amount for costs 

24 associated with the establishment and implementation of a 

25 Government-wide service-disabled veteran-owned small 
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1 business certification program within the Small Business 

2 Administration, as required by section 36 of the Small 

3 Business Act (15 U.S.C. 657f) and section 862 of Public 

4 Law 116–283: Provided, That such amounts may be appor5 tioned up to the rate for operations necessary to establish 

6 and implement such certification program: Provided fur7 ther, That such amounts may be obligated in the account 

8 and budget structure set forth in H.R. 8294, as passed by 

9 the House of Representatives on July 20, 2022. 

10 SEC. 134. Amounts made available by section 101 for 

11 ‘‘Small Business Administration—Business Loans Pro12 gram Account’’ may be apportioned up to the rate for oper13 ations necessary to accommodate increased demand for 

14 commitments for general business loans authorized under 

15 paragraphs (1) through (35) of section 7(a) of the Small 

16 Business Act (15 U.S.C. 636(a)), for guarantees of trust cer17 tificates authorized by section 5(g) of the Small Business 

18 Act (15 U.S.C. 634(g)), for commitments to guarantee loans 

19 under section 503 of the Small Business Investment Act of 

20 1958 (15 U.S.C. 697), and for commitments to guarantee 

21 loans for debentures under section 303(b) of the Small Busi22 ness Investment Act of 1958 (15 U.S.C. 683(b)). 

23 SEC. 135. Amounts made available by section 101 to 

24 the Department of Homeland Security under the heading 

25 ‘‘Federal Emergency Management Agency—Disaster Relief 
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1 Fund’’ may be apportioned up to the rate for operations 

2 necessary to carry out response and recovery activities 

3 under the Robert T. Stafford Disaster Relief and Emer4 gency Assistance Act (42 U.S.C. 5121 et seq.). 

5 SEC. 136. Notwithstanding sections 101, 104, and 106, 

6 to carry out the Hermit’s Peak/Calf Canyon Fire Assistance 

7 Act, there is appropriated $2,500,000,000, to remain avail8 able until expended, to the Department of Homeland Secu9 rity for ‘‘Federal Emergency Management Agency—Her10 mit’s Peak/Calf Canyon Fire Assistance Account’’, which 

11 shall be derived by transfer from amounts made available 

12 under the heading ‘‘Federal Emergency Management Agen13 cy—Disaster Relief Fund’’ in title VI of division B of the 

14 Coronavirus Aid, Relief, and Economic Security Act (Pub15 lic Law 116–136), of which $1,000,000 shall be transferred 

16 to ‘‘Office of the Inspector General—Operations and Sup17 port’’ for oversight of activities authorized by the Hermit’s 

18 Peak/Calf Canyon Fire Assistance Act: Provided, That no 

19 amounts may be derived from amounts made available for 

20 major disasters declared pursuant to the Robert T. Stafford 

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

22 5121 et seq.): Provided further, That amounts provided by 

23 this section shall be subject to the same authorities and con24 ditions as if such amounts were provided by title III of 

25 the Department of Homeland Security Appropriations Act, 
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1 2022 (division F of Public Law 117–103): Provided further, 

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

3 of this Act, and every 90 days thereafter until all funds 

4 provided by this section have been expended, the Adminis5 trator of the Federal Emergency Management Agency shall 

6 provide, in an appropriate format, quarterly reports to the 

7 Committees on Appropriations of the Senate and the House 

8 of Representatives on the obligations and expenditures of 

9 the funds made available by this section: Provided further, 

10 That amounts transferred by this section that were pre11 viously designated by the Congress as an emergency require12 ment pursuant to the Balanced Budget and Emergency Def13 icit Control Act of 1985 or a concurrent resolution on the 

14 budget are designated as an emergency requirement pursu15 ant to section 4001(a)(1) of S. Con. Res. 14 (117th Con16 gress), the concurrent resolution on the budget for fiscal year 

17 2022, and section 1(e) of H. Res. 1151 (117th Congress), 

18 as engrossed in the House of Representatives on June 8, 

19 2022. 

20 SEC. 137. Section 708(b)(13) of the Homeland Secu21 rity Act of 2002 (6 U.S.C. 348(b)(13)) shall be applied by 

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

23 for ‘‘September 30, 2022’’. 
24 

† HR 6833 EAS 

1 SEC. 138. During the period covered by this Act, sec2 tion 822(a) of the Homeland Security Act of 2002 (6 U.S.C. 

3 383(a)) shall be applied by substituting ‘‘2023’’ for ‘‘2022’’. 

4 SEC. 139. (a) Sections 1309(a) and 1319 of the Na5 tional Flood Insurance Act of 1968 (42 U.S.C. 4016(a) and 

6 4026) shall be applied by substituting the date specified in 

7 section 106(3) of this Act for ‘‘September 30, 2022’’. 

8 (b)(1) Subject to paragraph (2), this section shall be9 come effective immediately upon enactment of this Act. 

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

11 2022, this section shall be applied as if it were in ef12 fect on September 30, 2022. 

13 SEC. 140. Section 880(g) of the National Defense Au14 thorization Act for Fiscal Year 2017 (Public Law 114–328) 

15 shall be applied by substituting the date specified in section 

16 106(3) of this Act for ‘‘September 30, 2022’’. 

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

18 Act of 2002 (6 U.S.C. 124n(i)) shall be applied by sub19 stituting the date specified in section 106(3) of this Act for 

20 ‘‘the date that is 4 years after the date of enactment of this 

21 section’’. 

22 SEC. 142. Amounts made available by section 101 for 

23 ‘‘Department of the Interior—National Park Service—Na24 tional Recreation and Preservation’’ for heritage partner25 ship programs may be used to provide financial assistance 
25 

† HR 6833 EAS 

1 to any national heritage area, national heritage corridor, 

2 cultural heritage corridor, national heritage partnership, 

3 national heritage route, national heritage canalway, and 

4 battlefields national historic district established as of Sep5 tember 1, 2022, notwithstanding any statutory sunset pro6 vision terminating the Secretary’s authority to provide as7 sistance to any such area and notwithstanding any limita8 tion on amounts authorized to be appropriated with respect 

9 to any such area. 

10 SEC. 143. Amounts made available by section 101 to 

11 the Department of the Interior under the heading ‘‘Working 

12 Capital Fund’’ may be apportioned up to the rate for oper13 ations necessary to implement enterprise cybersecurity safe14 guards. 

15 SEC. 144. (a) In addition to amounts otherwise pro16 vided by section 101, amounts are provided for ‘‘Depart17 ment of Health and Human Services—Indian Health Serv18 ice—Indian Health Services’’ at a rate for operations of 

19 $16,721,000, for an additional amount for costs of staffing 

20 and operating facilities that were opened, renovated, or ex21 panded in fiscal years 2022 and 2023, and such amounts 

22 may be apportioned up to the rate for operations necessary 

23 to staff and operate such facilities. 

24 (b) In addition to amounts otherwise provided by sec25 tion 101, amounts are provided for ‘‘Department of Health 
26 

† HR 6833 EAS 

1 and Human Services—Indian Health Service—Indian 

2 Health Facilities’’ at a rate for operations of $1,201,000, 

3 for an additional amount for costs of staffing and operating 

4 facilities that were opened, renovated, or expanded in fiscal 

5 years 2022 and 2023, and such amounts may be appor6 tioned up to the rate for operations necessary to staff and 

7 operate such facilities. 

8 SEC. 145. In addition to amounts otherwise provided 

9 by section 101, for ‘‘Department of Health and Human 

10 Services—Substance Abuse and Mental Health Services Ad11 ministration—Mental Health’’, there is appropriated 

12 $62,000,000, for an additional amount for fiscal year 2023, 

13 to remain available until September 30, 2023, for carrying 

14 out 988 Suicide Lifeline activities and behavioral health 

15 crisis services. 

16 SEC. 146. In addition to amounts otherwise provided 

17 by section 101, for ‘‘Department of Health and Human 

18 Services—Administration for Children and Families—Low 

19 Income Home Energy Assistance’’, there is appropriated 

20 $1,000,000,000, for an additional amount for fiscal year 

21 2023, to remain available until September 30, 2023, for 

22 making payments under subsection (b) of section 2602 of 

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

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

25 available by this section, $500,000,000 shall be allocated as 
27 

† HR 6833 EAS 

1 though the total appropriation for such payments for fiscal 

2 year 2023 was less than $1,975,000,000: Provided further, 

3 That such amount is designated by the Congress as being 

4 for an emergency requirement pursuant to section 

5 4001(a)(1) of S. Con. Res. 14 (117th Congress), the concur6 rent resolution on the budget for fiscal year 2022, and sec7 tion 1(e) of H. Res. 1151 (117th Congress), as engrossed 

8 in the House of Representatives on June 8, 2022. 

9 SEC. 147. In addition to amounts otherwise provided 

10 by section 101, for ‘‘Department of Health and Human 

11 Services—Administration for Children and Families—Ref12 ugee and Entrant Assistance’’, there is appropriated 

13 $1,775,000,000, for an additional amount for fiscal year 

14 2023, to remain available until September 30, 2025, to 

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

16 and section 235 of the William Wilberforce Trafficking Vic17 tims Protection Reauthorization Act of 2008, and for ref18 ugee and entrant assistance activities authorized by section 

19 414 of the Immigration and Nationality Act and section 

20 501 of the Refugee Education Assistance Act of 1980: Pro21 vided, That such amount is designated by the Congress as 

22 being for an emergency requirement pursuant to section 

23 4001(a)(1) of S. Con. Res. 14 (117th Congress), the concur24 rent resolution on the budget for fiscal year 2022, and sec-
28 

† HR 6833 EAS 

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

2 in the House of Representatives on June 8, 2022. 

3 SEC. 148. Notwithstanding section 101, the first para4 graph under the heading ‘‘Social Security Administra5 tion—Limitation on Administrative Expenses’’ in title IV 

6 of division H of Public Law 117–103 shall be applied by 

7 substituting ‘‘$13,602,945,000’’ for ‘‘$13,202,945,000’’. 

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

9 subsection (a)(1)(A) of section 2502 of the Afghanistan Sup10 plemental Appropriations Act, 2022 (division C of Public 

11 Law 117–43) shall be applied by substituting the date speci12 fied in section 106(3) for ‘‘September 30, 2022’’. 

13 (b) The amount provided by this section is designated 

14 as an emergency requirement pursuant to section 

15 4001(a)(1) of S. Con. Res. 14 (117th Congress), the concur16 rent resolution on the budget for fiscal year 2022, and sec17 tion 1(e) of H. Res. 1151 (117th Congress), as engrossed 

18 in the House of Representatives on June 8, 2022. 

19 SEC. 150. Activities authorized by part A of title IV 

20 (other than under section 403(c) or 418) and section 

21 1108(b) of the Social Security Act shall continue through 

22 the date specified in section 106(3), in the manner author23 ized for fiscal year 2022, and out of any money in the 

24 Treasury of the United States not otherwise appropriated, 
29 

† HR 6833 EAS 

1 there are hereby appropriated such sums as may be nec2 essary for such purpose. 

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

4 division J of Public Law 117–103 shall be applied during 

5 the period covered by this Act by substituting ‘‘fiscal year 

6 2017 and fiscal year 2018’’ for ‘‘fiscal year 2017’’. 

7 SEC. 152. Notwithstanding section 101, amounts are 

8 provided for— 

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

10 Department of State—Administration of Foreign Af11 fairs—Diplomatic Programs’’ at a rate for operations 

12 of $9,228,789,000; 

13 (2) ‘‘Bilateral Economic Assistance—Funds Ap14 propriated to the President—International Disaster 

15 Assistance’’ at a rate for operations of $4,555,460,000; 

16 (3) ‘‘Bilateral Economic Assistance—Funds Ap17 propriated to the President—Transition Initiatives’’ 

18 at a rate for operations of $100,000,000; 

19 (4) ‘‘Bilateral Economic Assistance—Funds Ap20 propriated to the President—Assistance for Europe, 

21 Eurasia and Central Asia’’ at a rate for operations 

22 of $850,000,000; 

23 (5) ‘‘Bilateral Economic Assistance—Depart24 ment of State—Migration and Refugee Assistance’’ at 

25 a rate for operations of $3,562,188,000; 
30 

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1 (6) ‘‘International Security Assistance—Depart2 ment of State—International Narcotics Control and 

3 Law Enforcement’’ at a rate for operations of 

4 $1,421,004,000; and 

5 (7) ‘‘International Security Assistance—Funds 

6 Appropriated to the President—Foreign Military Fi7 nancing Program’’ at a rate for operations of 

8 $6,190,424,000. 

9 SEC. 153. During the period covered by this Act, sec10 tion 579 of the Multifamily Assisted Housing Reform and 

11 Affordability Act of 1997 (42 U.S.C. 1437f note) shall be 

12 applied by substituting ‘‘2023’’ for ‘‘2022’’ each place it ap13 pears. 

14 SEC. 154. Amounts made available by section 101 to 

15 the Department of Housing and Urban Development for 

16 ‘‘Public and Indian Housing—Native Hawaiian Housing 

17 Loan Guarantee Fund Program Account’’ may be appor18 tioned up to the rate for operations necessary to accommo19 date demand for commitments to guarantee loans as au20 thorized by section 184A of the Housing and Community 

21 Development Act of 1992 (12 U.S.C. 1715z–13b). 

22 SEC. 155. In addition to amounts otherwise provided 

23 by section 101, for ‘‘Department of Housing and Urban De24 velopment—Community Planning and Development— 

25 Community Development Fund’’, there is appropriated 
31 

† HR 6833 EAS 

1 $2,000,000,000, for an additional amount for fiscal year 

2 2023, to remain available until expended, for the same pur3 poses and under the same terms and conditions as funds 

4 appropriated under such heading in title VIII of the Dis5 aster Relief Supplemental Appropriations Act, 2022 (divi6 sion B of Public Law 117–43), except that such amounts 

7 shall be for major disasters that occurred in 2021 or 2022 

8 and the fourth, twentieth, and twenty-first provisos under 

9 such heading in such Act shall not apply: Provided, That 

10 amounts made available under this section and under such 

11 heading in such Act may be used by a grantee to assist 

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

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

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

15 such amount is designated by the Congress as being for an 

16 emergency requirement pursuant to section 4001(a)(1) of 

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

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

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

20 Representatives on June 8, 2022. 

21 SEC. 156. Notwithstanding section 106 of this Act, at 

22 any time during fiscal year 2023, the Secretary of Housing 

23 and Urban Development may transfer up to $1,300,000 in 

24 unobligated balances from amounts made available in prior 

25 Acts under the heading ‘‘Housing Programs—Project-Based 
32 

† HR 6833 EAS 

1 Rental Assistance’’ to Treasury Appropriation Fund Sym2 bol 86 X 0148 for the liquidation of obligations incurred 

3 in fiscal year 2018 in connection with the continued provi4 sion of interest reduction payments authorized under sec5 tion 236 of the National Housing Act (12 U.S.C. 1715z– 

6 1). 

7 SEC. 157. (a) The remaining unobligated balances, as 

8 of September 30, 2022, from amounts made available for 

9 ‘‘Department of Transportation—Office of the Secretary— 

10 National Infrastructure Investments’’ in title I of division 

11 H of the Further Consolidated Appropriations Act, 2020 

12 (Public Law 116–94) are hereby permanently rescinded, 

13 and in addition to amounts otherwise provided by section 

14 101, an amount of additional new budget authority equiva15 lent to the amount rescinded pursuant to this subsection 

16 is hereby appropriated on September 30, 2022, for an addi17 tional amount for fiscal year 2022, to remain available 

18 until September 30, 2023, and shall be available, without 

19 additional competition, for completing the funding of 

20 awards made pursuant to the fiscal year 2020 national in21 frastructure investments program, in addition to other 

22 funds as may be available for such purposes. 

23 (b) The remaining unobligated balances, as of Sep24 tember 30, 2022, from amounts made available to the De25 partment of Transportation in section 105 of division L 
33 

† HR 6833 EAS 

1 of the Consolidated Appropriations Act, 2021 (Public Law 

2 116–260) are hereby permanently rescinded, and in addi3 tion to amounts otherwise provided by section 101, an 

4 amount of additional new budget authority equivalent to 

5 the amount rescinded pursuant to this subsection is hereby 

6 appropriated on September 30, 2022, for an additional 

7 amount for fiscal year 2022, to remain available until Sep8 tember 30, 2023, and shall be available, without additional 

9 competition, for completing the funding of awards made 

10 pursuant to the fiscal year 2019 national infrastructure in11 vestments program, in addition to other funds as may be 

12 available for such purposes. 

13 (c)(1) Subject to paragraph (2), this section shall be14 come effective immediately upon enactment of this Act. 

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

16 2022, this section shall be applied as if it were in ef17 fect on September 30, 2022. 

18 This division may be cited as the ‘‘Continuing Appro19 priations Act, 2023’’. 
34 

† HR 6833 EAS 

1 DIVISION B—UKRAINE SUPPLEMENTAL 

2 APPROPRIATIONS ACT, 2023 

3 The following sums are appropriated, out of any 

4 money in the Treasury not otherwise appropriated, for the 

5 fiscal year ending September 30, 2023, and for other pur6 poses, namely: 

7 TITLE I 

8 DEPARTMENT OF DEFENSE 

9 MILITARY PERSONNEL

10 MILITARY PERSONNEL, ARMY

11 For an additional amount for ‘‘Military Personnel, 

12 Army’’, $110,107,000, to remain available until September 

13 30, 2023, to respond to the situation in Ukraine and for 

14 related expenses. 

15 MILITARY PERSONNEL, NAVY

16 For an additional amount for ‘‘Military Personnel, 

17 Navy’’, $462,000, to remain available until September 30, 

18 2023, to respond to the situation in Ukraine and for related 

19 expenses. 

20 MILITARY PERSONNEL, MARINE CORPS

21 For an additional amount for ‘‘Military Personnel, 

22 Marine Corps’’, $600,000, to remain available until Sep23 tember 30, 2023, to respond to the situation in Ukraine and 

24 for related expenses. 
35 

† HR 6833 EAS 

1 MILITARY PERSONNEL, AIR FORCE

2 For an additional amount for ‘‘Military Personnel, 

3 Air Force’’, $11,582,000, to remain available until Sep4 tember 30, 2023, to respond to the situation in Ukraine and 

5 for related expenses. 

6 OPERATION AND MAINTENANCE 

7 OPERATION AND MAINTENANCE, ARMY

8 For an additional amount for ‘‘Operation and Mainte9 nance, Army’’, $654,696,000, to remain available until 

10 September 30, 2023, to respond to the situation in Ukraine 

11 and for related expenses. 

12 OPERATION AND MAINTENANCE, NAVY

13 For an additional amount for ‘‘Operation and Mainte14 nance, Navy’’, $433,035,000, to remain available until Sep15 tember 30, 2023, to respond to the situation in Ukraine and 

16 for related expenses. 

17 OPERATION AND MAINTENANCE, MARINE CORPS

18 For an additional amount for ‘‘Operation and Mainte19 nance, Marine Corps’’, $34,984,000, to remain available 

20 until September 30, 2023, to respond to the situation in 

21 Ukraine and for related expenses. 

22 OPERATION AND MAINTENANCE, AIR FORCE

23 For an additional amount for ‘‘Operation and Mainte24 nance, Air Force’’, $267,084,000, to remain available until 
36 

† HR 6833 EAS 

1 September 30, 2023, to respond to the situation in Ukraine 

2 and for related expenses. 

3 OPERATION AND MAINTENANCE, SPACE FORCE

4 For an additional amount for ‘‘Operation and Mainte5 nance, Space Force’’, $1,771,000, to remain available until 

6 September 30, 2023, to respond to the situation in Ukraine 

7 and for related expenses. 

8 OPERATION AND MAINTENANCE, DEFENSE-WIDE

9 (INCLUDING TRANSFER OF FUNDS)

10 For an additional amount for ‘‘Operation and Mainte11 nance, Defense-Wide’’, $4,713,544,000, to remain available 

12 until September 30, 2023, to respond to the situation in 

13 Ukraine and for related expenses: Provided, That of the 

14 total amount provided under this heading in this Act, 

15 $3,000,000,000, to remain available until September 30, 

16 2024, shall be for the Ukraine Security Assistance Initia17 tive: Provided further, That such funds for the Ukraine Se18 curity Assistance Initiative shall be available to the Sec19 retary of Defense under the same terms and conditions as 

20 are provided for in section 8139 of the Department of De21 fense Appropriations Act, 2022 (division C of Public Law 

22 117–103): Provided further, That of the total amount pro23 vided under this heading in this Act, up to $1,500,000,000, 

24 to remain available until September 30, 2024, may be 

25 transferred to accounts under the headings ‘‘Operation and 
37 

† HR 6833 EAS 

1 Maintenance’’ and ‘‘Procurement’’ for replacement of de2 fense articles from the stocks of the Department of Defense, 

3 and for reimbursement for defense services of the Depart4 ment of Defense and military education and training, pro5 vided to the government of Ukraine or to foreign countries 

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

7 United States: Provided further, That funds transferred 

8 pursuant to a transfer authority provided under this head9 ing in this Act shall be merged with and available for the 

10 same purposes and for the same time period as the appro11 priations to which the funds are transferred: Provided fur12 ther, That the Secretary of Defense shall notify the congres13 sional defense committees of the details of such transfers not 

14 less than 15 days before any such transfer: Provided further, 

15 That upon a determination that all or part of the funds 

16 transferred from this appropriation are not necessary for 

17 the purposes provided herein, such amounts may be trans18 ferred back and merged with this appropriation: Provided 

19 further, That the transfer authority provided under this 

20 heading in this Act is in addition to any other transfer 

21 authority provided by law. 

22 PROCUREMENT 

23 MISSILE PROCUREMENT, ARMY

24 For an additional amount for ‘‘Missile Procurement, 

25 Army’’, $450,000,000, to remain available until September 
38 

† HR 6833 EAS 

1 30, 2025, to respond to the situation in Ukraine and for 

2 related expenses. 

3 PROCUREMENT OF AMMUNITION, ARMY

4 For an additional amount for ‘‘Procurement of Am5 munition, Army’’, $540,000,000, to remain available until 

6 September 30, 2025, for expansion of public and private 

7 plants, including the land necessary therefor, and procure8 ment and installation of equipment, appliances, and ma9 chine tools in such plants, for the purpose of increasing pro10 duction of critical munitions to replace defense articles pro11 vided to the Government of Ukraine or foreign countries 

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

13 United States. 

14 OTHER PROCUREMENT, ARMY

15 For an additional amount for ‘‘Other Procurement, 

16 Army’’, $3,890,000, to remain available until September 

17 30, 2025, to respond to the situation in Ukraine and for 

18 related expenses. 

19 OTHER PROCUREMENT, NAVY

20 For an additional amount for ‘‘Other Procurement, 

21 Navy’’, $2,170,000, to remain available until September 30, 

22 2025, to respond to the situation in Ukraine and for related 

23 expenses. 
39 

† HR 6833 EAS 

1 OTHER PROCUREMENT, AIR FORCE

2 For an additional amount for ‘‘Other Procurement, 

3 Air Force’’, $437,991,000, to remain available until Sep4 tember 30, 2025, to respond to the situation in Ukraine and 

5 for other expenses. 

6 PROCUREMENT, DEFENSE-WIDE

7 For an additional amount for ‘‘Procurement, Defense8 Wide’’, $9,770,000, to remain available until September 30, 

9 2025, to respond to the situation in Ukraine and for related 

10 expenses. 

11 RESEARCH, DEVELOPMENT, TEST AND 

12 EVALUATION 

13 RESEARCH, DEVELOPMENT, TEST AND EVALUATION, ARMY

14 For an additional amount for ‘‘Research, Develop15 ment, Test and Evaluation, Army’’, $3,300,000, to remain 

16 available until September 30, 2024, to respond to the situa17 tion in Ukraine and for related expenses. 

18 RESEARCH, DEVELOPMENT, TEST AND EVALUATION, NAVY

19 For an additional amount for ‘‘Research, Develop20 ment, Test and Evaluation, Navy’’, $2,077,000, to remain 

21 available until September 30, 2024, to respond to the situa22 tion in Ukraine and for related expenses. 
40 

† HR 6833 EAS 

1 RESEARCH, DEVELOPMENT, TEST AND EVALUATION, AIR

2 FORCE

3 For an additional amount for ‘‘Research, Develop4 ment, Test and Evaluation, Air Force’’, $99,704,000, to re5 main available until September 30, 2024, to respond to the 

6 situation in Ukraine and for related expenses. 

7 RESEARCH, DEVELOPMENT, TEST AND EVALUATION, 

8 DEFENSE-WIDE

9 For an additional amount for ‘‘Research, Develop10 ment, Test and Evaluation, Defense-Wide’’, $31,230,000, to 

11 remain available until September 30, 2024, to respond to 

12 the situation in Ukraine and for related expenses. 

13 OTHER DEPARTMENT OF DEFENSE PROGRAMS 

14 OFFICE OF THE INSPECTOR GENERAL

15 For an additional amount for ‘‘Office of the Inspector 

16 General’’, $2,000,000, to remain available until September 

17 30, 2023, to carry out reviews of the activities of the Depart18 ment of Defense to execute funds appropriated in this title, 

19 including assistance provided to Ukraine: Provided, That 

20 the Inspector General of the Department of Defense shall 

21 provide to the congressional defense committees a briefing 

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

23 Act. 
41 

† HR 6833 EAS 

1 RELATED AGENCIES 

2 INTELLIGENCE COMMUNITY MANAGEMENT ACCOUNT

3 For an additional amount for ‘‘Intelligence Commu4 nity Management Account’’, $500,000, to remain available 

5 until September 30, 2023, to respond to the situation in 

6 Ukraine and for related expenses. 

7 GENERAL PROVISIONS—THIS TITLE 

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

9 enactment of this Act, the Secretary of Defense, in coordina10 tion with the Secretary of State, shall submit a report to 

11 the Committees on Appropriations, Armed Services, and 

12 Foreign Affairs of the House of Representatives and the 

13 Committees on Appropriations, Armed Services, and For14 eign Relations of the Senate on measures being taken to 

15 account for United States defense articles designated for 

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

17 Ukraine, particularly measures with regard to such articles 

18 that require enhanced end-use monitoring; measures to en19 sure that such articles reach their intended recipients and 

20 are used for their intended purposes; and any other meas21 ures to promote accountability for the use of such articles: 

22 Provided, That such report shall include a description of 

23 any occurrences of articles not reaching their intended re24 cipients or used for their intended purposes and a descrip25 tion of any remedies taken: Provided further, That such re-
42 

† HR 6833 EAS 

1 port shall be submitted in unclassified form, but may be 

2 accompanied by a classified annex. 

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

4 enactment of this Act, and every 30 days thereafter through 

5 fiscal year 2023, the Secretary of Defense, in coordination 

6 with the Secretary of State, shall provide a written report 

7 to the Committees on Appropriations, Armed Services, and 

8 Foreign Affairs of the House of Representatives and the 

9 Committees on Appropriations, Armed Services, and For10 eign Relations of the Senate describing United States secu11 rity assistance provided to Ukraine since the February 24, 

12 2022, Russian invasion of Ukraine, including a comprehen13 sive list of the defense articles and services provided to 

14 Ukraine and the associated authority and funding used to 

15 provide such articles and services: Provided, That such re16 port shall be submitted in unclassified form, but may be 

17 accompanied by a classified annex. 

18 TITLE II 

19 DEPARTMENT OF ENERGY 

20 ATOMIC ENERGY DEFENSE ACTIVITIES 

21 NATIONAL NUCLEAR SECURITY ADMINISTRATION 

22 DEFENSE NUCLEAR NONPROLIFERATION

23 For an additional amount for ‘‘Defense Nuclear Non24 proliferation’’, $35,000,000, to remain available until ex-
43 

† HR 6833 EAS 

1 pended, to respond to the situation in Ukraine and for re2 lated expenses. 

3 TITLE III 

4 BILATERAL ECONOMIC ASSISTANCE 

5 FUNDS APPROPRIATED TO THE PRESIDENT

6 ECONOMIC SUPPORT FUND

7 For an additional amount for ‘‘Economic Support 

8 Fund’’, $4,500,000,000, to remain available until Sep9 tember 30, 2024, for assistance for Ukraine: Provided, That 

10 funds appropriated under this heading in this Act may be 

11 made available notwithstanding any other provision of law 

12 that restricts assistance to foreign countries and may be 

13 made available as contributions. 

14 GENERAL PROVISIONS—THIS TITLE 

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

16 of the Foreign Assistance Act of 1961 (22 U.S.C. 

17 2318(a)(1)) shall be applied by substituting 

18 ‘‘$3,700,000,000’’ for ‘‘$100,000,000’’. 

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

20 be made available for direct financial support for the Gov21 ernment of Ukraine, including for Ukrainian first respond22 ers, and may be made available as a cash transfer subject 

23 to the requirements of subsection (b): Provided, That such 

24 funds shall be provided on a reimbursable basis and 

25 matched by sources other than the United States Govern-
44 

† HR 6833 EAS 

1 ment, to the maximum extent practicable: Provided further, 

2 That the Secretary of State or the Administrator of the 

3 United States Agency for International Development, as 

4 appropriate, shall ensure third-party monitoring of such 

5 funds: Provided further, That at least 15 days prior to the 

6 initial obligation of such funds, the Secretary of State, fol7 lowing consultation with the Administrator of the United 

8 States Agency for International Development, shall certify 

9 and report to the appropriate congressional committees that 

10 mechanisms for monitoring and oversight of such funds are 

11 in place and functioning and that the Government of 

12 Ukraine has in place substantial safeguards to prevent cor13 ruption and ensure accountability of such funds: Provided 

14 further, That not less than 45 days after the initial obliga15 tion of such funds, the Inspectors General of the Department 

16 of State and the United States Agency for International 

17 Development shall submit a report to the appropriate con18 gressional committees detailing and assessing the mecha19 nisms for monitoring and safeguards described in the pre20 vious proviso. 

21 (b) Funds made available to the Government of 

22 Ukraine as a cash transfer under subsection (a) shall be 

23 subject to a memorandum of understanding between the 

24 Governments of the United States and Ukraine that de25 scribes how the funds proposed to be made available will 
45 

† HR 6833 EAS 

1 be used and the appropriate safeguards to ensure trans2 parency and accountability: Provided, That such assistance 

3 shall be maintained in a separate, auditable account and 

4 may not be comingled with any other funds. 

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

6 United States Agency for International Development, as 

7 appropriate, shall report to the appropriate congressional 

8 committees on the uses of funds provided for direct financial 

9 support to the Government of Ukraine pursuant to sub10 section (a) not later than 45 days after the date of enact11 ment of this Act and every 45 days thereafter until all such 

12 funds have been expended: Provided, That such report shall 

13 include a detailed description of the use of such funds, in14 cluding categories and amounts, the intended results and 

15 the results achieved, a summary of other donor contribu16 tions, and a description of the efforts undertaken by the Sec17 retary and Administrator to increase other donor contribu18 tions for direct financial support: Provided further, That 

19 such report shall also include the metrics established to 

20 measure such results. 

21 (d) Funds made available for the purposes of sub22 section (a) shall be subject to the regular notification proce23 dures of the Committees on Appropriations of the House 

24 of Representatives and the Senate. 
46 

† HR 6833 EAS 

1 TITLE IV 

2 GENERAL PROVISIONS—THIS ACT 

3 SEC. 1401. Each amount appropriated or made avail4 able by this Act is in addition to amounts otherwise appro5 priated for the fiscal year involved. 

6 SEC. 1402. No part of any appropriation contained 

7 in this Act shall remain available for obligation beyond the 

8 current fiscal year unless expressly so provided herein. 

9 SEC. 1403. Unless otherwise provided for by this Act, 

10 the additional amounts appropriated by this Act to appro11 priations accounts shall be available under the authorities 

12 and conditions applicable to such appropriations accounts 

13 for fiscal year 2023. 

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

15 designated by the Congress as being for an emergency re16 quirement pursuant to section 4001(a)(1) of S. Con. Res. 

17 14 (117th Congress), the concurrent resolution on the budget 

18 for fiscal year 2022, and section 1(e) of H. Res. 1151 (117th 

19 Congress), as engrossed in the House of Representatives on 

20 June 8, 2022. 

21 This division may be cited as the ‘‘Ukraine Supple22 mental Appropriations Act, 2023’’. 
47 

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1 DIVISION C—OTHER MATTERS 

2 TITLE I—EXTENSIONS, TECH3 NICAL CORRECTIONS, AND 

4 OTHER MATTERS 

5 SEC. 101. EXTENSION OF FCC AUCTION AUTHORITY. 

6 Section 309(j)(11) of the Communications Act of 1934 

7 (47 U.S.C. 309(j)(11)) is amended by striking ‘‘September 

8 30, 2022’’ and inserting ‘‘December 16, 2022’’. 

9 SEC. 102. EXTENSION OF AUTHORIZATION FOR SPECIAL AS10 SESSMENT FOR DOMESTIC TRAFFICKING VIC11 TIMS’ FUND. 

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

13 amended, in the matter preceding paragraph (1), by strik14 ing ‘‘September 30, 2022’’ and inserting ‘‘December 16, 

15 2022’’. 

16 SEC. 103. UNITED STATES PAROLE COMMISSION EXTEN17 SION. 

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

19 ‘‘United States Parole Commission Extension Act of 2022’’. 

20 (b) AMENDMENT OF SENTENCING REFORM ACT OF

21 1984.—For purposes of section 235(b) of the Sentencing Re22 form Act of 1984 (18 U.S.C. 3551 note; Public Law 98– 

23 473; 98 Stat. 2032), as such section relates to chapter 311 

24 of title 18, United States Code, and the United States Pa25 role Commission, each reference in such section to ‘‘35 
48 

† HR 6833 EAS 

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

2 ‘‘35 years and 46 days’’ or ‘‘35-year and 46-day period’’, 

3 respectively. 

4 SEC. 104. EXTENSION OF COMMODITY FUTURES TRADING 

5 COMMISSION CUSTOMER PROTECTION FUND 

6 EXPENSES ACCOUNT. 

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

8 amended by striking ‘‘October 1, 2022’’ each place it ap9 pears and inserting ‘‘December 16, 2022’’. 

10 TITLE II—BUDGETARY EFFECTS 

11 SEC. 201. BUDGETARY EFFECTS. 

12 (a) STATUTORY PAYGO SCORECARDS.—The budg13 etary effects of this division and each succeeding division 

14 shall not be entered on either PAYGO scorecard maintained 

15 pursuant to section 4(d) of the Statutory Pay-As-You-Go 

16 Act of 2010. 

17 (b) SENATE PAYGO SCORECARDS.—The budgetary ef18 fects of this division and each succeeding division shall not 

19 be entered on any PAYGO scorecard maintained for pur20 poses of section 4106 of H. Con. Res. 71 (115th Congress). 

21 (c) CLASSIFICATION OF BUDGETARY EFFECTS.—Not22 withstanding Rule 3 of the Budget Scorekeeping Guidelines 

23 set forth in the joint explanatory statement of the committee 

24 of conference accompanying Conference Report 105–217 

25 and section 250(c)(8) of the Balanced Budget and Emer-
49 

† HR 6833 EAS 

1 gency Deficit Control Act of 1985, the budgetary effects of 

2 this division and each succeeding division shall not be esti3 mated— 

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

5 (2) for purposes of an allocation to the Com6 mittee on Appropriations pursuant to section 302(a) 

7 of the Congressional Budget Act of 1974; and 

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

9 3 of the Statutory Pay-As-You-Go Act of 2010 as 

10 being included in an appropriation Act. 
50 

† HR 6833 EAS 

1 DIVISION D—HEALTH AND 

2 HUMAN SERVICES EXTENSIONS 

3 TITLE I—MEDICARE AND 

4 MEDICAID 

5 SEC. 101. EXTENSION OF INCREASED INPATIENT HOSPITAL 

6 PAYMENT ADJUSTMENT FOR CERTAIN LOW7 VOLUME HOSPITALS. 

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

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

10 (1) in subparagraph (B), in the matter pre11 ceding clause (i), by striking ‘‘in fiscal year 2023 and 

12 subsequent fiscal years’’ and inserting ‘‘during the 

13 portion of fiscal year 2023 beginning on December 17, 

14 2022, and ending on September 30, 2023, and in fis15 cal year 2024 and subsequent fiscal years’’; 

16 (2) in subparagraph (C)(i)— 

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

18 (i) by inserting ‘‘or portion of a fiscal 

19 year’’ after ‘‘for a fiscal year’’; and 

20 (ii) by inserting ‘‘and the portion of 

21 fiscal year 2023 beginning on October 1, 

22 2022, and ending on December 16, 2022’’ 

23 after ‘‘through 2022’’; 

24 (B) in subclause (III), by inserting ‘‘and 

25 the portion of fiscal year 2023 beginning on Oc-
51 

† HR 6833 EAS 

1 tober 1, 2022, and ending on December 16, 

2 2022’’ after ‘‘through 2022’’; and 

3 (C) in subclause (IV), by striking ‘‘fiscal 

4 year 2023’’ and inserting ‘‘the portion of fiscal 

5 year 2023 beginning on December 17, 2022, and 

6 ending on September 30, 2023, and fiscal year 

7 2024’’; and 

8 (3) in subparagraph (D)— 

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

10 inserting ‘‘or during the portion of fiscal year 

11 2023 beginning on October 1, 2022, and ending 

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

13 and 

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

15 portion of fiscal year 2023 beginning on October 

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

17 ‘‘through 2022’’. 

18 (b) IMPLEMENTATION.—Notwithstanding any other 

19 provision of law, the Secretary of Health and Human Serv20 ices may implement the provisions of, including the amend21 ments made by, this section by program instruction or oth22 erwise. 
52 

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1 SEC. 102. EXTENSION OF THE MEDICARE-DEPENDENT HOS2 PITAL (MDH) PROGRAM. 

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

4 Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amended— 

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

6 and inserting ‘‘December 17, 2022’’; and 

7 (2) in clause (ii)(II), by striking ‘‘October 1, 

8 2022’’ and inserting ‘‘December 17, 2022’’. 

9 (b) CONFORMING AMENDMENTS.— 

10 (1) EXTENSION OF TARGET AMOUNT.—Section 

11 1886(b)(3)(D) of the Social Security Act (42 U.S.C. 

12 1395ww(b)(3)(D)) is amended— 

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

14 striking ‘‘October 1, 2022’’ and inserting ‘‘De15 cember 17, 2022’’; and 

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

17 portion of fiscal year 2023 beginning on October 

18 1, 2022, and ending on December 16, 2022,’’ 

19 after ‘‘through fiscal year 2022’’. 

20 (2) PERMITTING HOSPITALS TO DECLINE RE21 CLASSIFICATION.—Section 13501(e)(2) of the Omni22 bus Budget Reconciliation Act of 1993 (42 U.S.C. 

23 1395ww note) is amended by striking ‘‘or fiscal year 

24 2000 through fiscal year 2022,’’ and inserting ‘‘fiscal 

25 year 2000 through fiscal year 2022, or the portion of 
53 

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

2 ending on December 16, 2022’’. 

3 SEC. 103. EXTENSION OF INCREASED FMAPS FOR THE TER4 RITORIES. 

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

6 1396d(ff)) is amended by striking ‘‘December 13’’ each place 

7 it appears and inserting ‘‘December 16’’ in each such place. 

8 SEC. 104. REDUCTION OF MEDICARE IMPROVEMENT FUND. 

9 Section 1898(b)(1) of the Social Security Act (42 

10 U.S.C. 1395iii(b)(1)) is amended by striking 

11 ‘‘$7,500,000,000’’ and inserting ‘‘$7,308,000,000’’. 

12 TITLE II—HUMAN SERVICES 

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

14 CHILDHOOD HOME VISITING PROGRAMS. 

15 Activities authorized by section 511 of the Social Secu16 rity Act shall continue through December 16, 2022, in the 

17 manner authorized for fiscal year 2022, and out of any 

18 money in the Treasury of the United States not otherwise 

19 appropriated, there is hereby appropriated for such purpose 

20 an amount equal to the pro rata portion of the amount ap21 propriated for such activities for fiscal year 2022. 

22 SEC. 202. EXTENSION OF CHILD AND FAMILY SERVICES 

23 PROGRAMS. 

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

25 Security Act shall continue through December 16, 2022, in 
54 

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1 the manner authorized for fiscal year 2022, and out of any 

2 money in the Treasury of the United States not otherwise 

3 appropriated, there are hereby appropriated such sums as 

4 may be necessary for such purpose. 

5 TITLE III—PUBLIC HEALTH 

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

7 HEALTH PROFESSIONAL VOLUNTEERS EM8 PLOYEES OF THE PUBLIC HEALTH SERVICE 

9 UNDER CERTAIN CIRCUMSTANCES. 

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

11 Service Act (42 U.S.C. 233(q)) is amended by striking 

12 paragraph (6). 

13 (b) TECHNICAL CORRECTIONS.—Section 224 of the 

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

15 (1) in subsection (g)(1)(H)(iv), by striking ‘‘this 

16 section.’’ and inserting ‘‘this section).’’; 

17 (2) in subsection (k)(3), by inserting ‘‘governing 

18 board members,’’ after ‘‘officers,’’; 

19 (3) in subsection (p)(7)(A)(i), by moving the 

20 margin of subclause (II) 2 ems to the left; and 

21 (4) in subsection (q)(5)(A), by striking ‘‘and 

22 paragraph (6)’’. 
55 

† HR 6833 EAS 

1 SEC. 302. EXTENSION OF AUTHORIZATION FOR A COMMIS2 SIONED OFFICER OF THE PUBLIC HEALTH 

3 SERVICE TO ACCUMULATE EXCESS ANNUAL 

4 LEAVE. 

5 For purposes of annual leave accumulated in fiscal 

6 year 2022, the authority provided in section 2106 of divi7 sion C of Public Law 116–159 (42 U.S.C. 210–1 note) shall 

8 apply to such leave by substituting ‘‘2022’’ for ‘‘2020’’ in 

9 subsections (a) and (d)(2). 

10 TITLE IV—INDIAN HEALTH 

11 SEC. 401. EXTENSION OF MORATORIUM. 

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

13 113–76 is amended by striking ‘‘October 1, 2019’’ and in14 serting ‘‘December 16, 2022’’. 
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1 DIVISION E—VETERANS AFFAIRS 

2 EXTENSIONS 

3 TITLE I—EXTENSIONS OF AU4 THORITIES RELATING TO 

5 HEALTH CARE 

6 SEC. 101. EXTENSION OF AUTHORITY FOR COLLECTION OF 

7 COPAYMENTS FOR HOSPITAL CARE AND 

8 NURSING HOME CARE. 

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

10 is amended by striking ‘‘September 30, 2022’’ and inserting 

11 ‘‘September 30, 2024’’. 

12 SEC. 102. EXTENSION OF REQUIREMENT TO PROVIDE NURS13 ING HOME CARE TO CERTAIN VETERANS 

14 WITH SERVICE-CONNECTED DISABILITIES. 

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

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

17 ‘‘September 30, 2024’’. 

18 SEC. 103. EXTENSION OF AUTHORITY TO CONTINUE DOD– 

19 VA HEALTH CARE SHARING INCENTIVE FUND. 

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

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

22 ‘‘September 30, 2026’’. 
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1 SEC. 104. EXTENSION OF AUTHORITY FOR JOINT DEPART2 MENT OF DEFENSE-DEPARTMENT OF VET3 ERANS AFFAIRS MEDICAL FACILITY DEM4 ONSTRATION FUND. 

5 Section 1704(e) of the National Defense Authorization 

6 Act for Fiscal Year 2010 (Public Law 111–84; 123 Stat. 

7 2573), as most recently amended by section 715 of the Na8 tional Defense Authorization Act for Fiscal Year 2022 (Pub9 lic Law 117–81; 135 Stat. 1787), is amended by striking 

10 ‘‘September 30, 2023’’ and inserting ‘‘September 30, 2024’’. 

11 SEC. 105. EXTENSION OF TEMPORARY EXPANSION OF PAY12 MENTS AND ALLOWANCES FOR BENEFICIARY 

13 TRAVEL IN CONNECTION WITH VETERANS RE14 CEIVING CARE FROM VET CENTERS. 

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

16 and Caring for Camp Lejeune Families Act of 2012 (Public 

17 Law 112–154; 126 Stat. 1169), as most recently amended 

18 by section 3 of the Department of Veterans Affairs Expiring 

19 Authorities Act of 2021 (Public Law 117–42; 135 Stat. 

20 342), is amended by striking ‘‘September 30, 2022’’ and 

21 inserting ‘‘September 30, 2023’’. 
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1 TITLE II—EXTENSIONS OF AU2 THORITIES RELATING TO 

3 BENEFITS 

4 SEC. 201. EXTENSION OF AUTHORITY TO TRANSPORT INDI5 VIDUALS TO AND FROM DEPARTMENT OF 

6 VETERANS AFFAIRS FACILITIES. 

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

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

9 ‘‘September 30, 2024’’. 

10 SEC. 202. EXTENSION OF AUTHORITY TO MAINTAIN RE11 GIONAL OFFICE IN THE REPUBLIC OF THE 

12 PHILIPPINES. 

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

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

15 ‘‘September 30, 2024’’. 

16 SEC. 203. EXTENSION OF AUTHORITY FOR REPORT ON EQ17 UITABLE RELIEF PROVIDED DUE TO ADMINIS18 TRATIVE ERROR. 

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

20 amended by striking ‘‘December 31, 2022’’ and inserting 

21 ‘‘December 31, 2024’’. 
59 

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1 SEC. 204. EXTENSION OF AUTHORITY TO PROVIDE ASSIST2 ANCE FOR SPECIALLY ADAPTED HOUSING 

3 FOR DISABLED VETERANS RESIDING TEMPO4 RARILY IN HOUSING OWNED BY A FAMILY 

5 MEMBER. 

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

7 amended by striking ‘‘December 31, 2022’’ and inserting 

8 ‘‘December 31, 2024’’. 

9 SEC. 205. EXTENSION OF SPECIALLY ADAPTED HOUSING AS10 SISTIVE TECHNOLOGY GRANT PROGRAM. 

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

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

13 ‘‘September 30, 2024’’. 

14 TITLE III—EXTENSIONS OF AU15 THORITIES RELATING TO 

16 HOMELESS VETERANS 

17 SEC. 301. EXTENSION OF AUTHORIZATION OF APPROPRIA18 TIONS FOR HOMELESS VETERANS RE19 INTEGRATION PROGRAMS. 

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

21 is amended by striking ‘‘2022’’ and inserting ‘‘2024’’. 
60 

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1 SEC. 302. EXTENSION OF AUTHORIZATION OF APPROPRIA2 TIONS FOR HOMELESS WOMEN VETERANS 

3 AND HOMELESS VETERANS WITH CHILDREN 

4 REINTEGRATION GRANT PROGRAM. 

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

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

7 SEC. 303. EXTENSION OF AUTHORITY FOR TREATMENT AND 

8 REHABILITATION FOR SERIOUSLY MENTALLY 

9 ILL AND HOMELESS VETERANS. 

10 (a) GENERAL TREATMENT.—Section 2031(b) of title 

11 38, United States Code, is amended by striking ‘‘September 

12 30, 2022’’ and inserting ‘‘September 30, 2024’’. 

13 (b) ADDITIONAL SERVICES AT CERTAIN LOCATIONS.— 

14 Section 2033(d) of such title is amended by striking ‘‘Sep15 tember 30, 2022’’ and inserting ‘‘September 30, 2024’’. 

16 SEC. 304. EXTENSION OF FUNDING FOR FINANCIAL ASSIST17 ANCE FOR SUPPORTIVE SERVICES FOR VERY 

18 LOW-INCOME VETERAN FAMILIES IN PERMA19 NENT HOUSING. 

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

21 is amended by striking ‘‘and 2022’’ and inserting ‘‘through 

22 2024’’. 
61 

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1 SEC. 305. EXTENSION OF FUNDING FOR GRANT PROGRAM 

2 FOR HOMELESS VETERANS WITH SPECIAL 

3 NEEDS. 

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

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

6 SEC. 306. EXTENSION OF AUTHORITY FOR THE ADVISORY 

7 COMMITTEE ON HOMELESS VETERANS. 

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

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

10 ‘‘September 30, 2026’’. 

11 TITLE IV—EXTENSIONS OF 

12 OTHER AUTHORITIES 

13 SEC. 401. EXTENSION OF AUTHORIZATION OF APPROPRIA14 TIONS FOR MONTHLY ASSISTANCE ALLOW15 ANCE UNDER THE OFFICE OF NATIONAL VET16 ERANS SPORTS PROGRAMS AND SPECIAL 

17 EVENTS. 

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

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

20 SEC. 402. EXTENSION AND AUTHORIZATION OF APPROPRIA21 TIONS FOR ADAPTIVE SPORTS PROGRAMS 

22 FOR DISABLED VETERANS AND MEMBERS OF 

23 THE ARMED FORCES. 

24 (a) AUTHORIZATION OF APPROPRIATIONS.—Sub25 section (g)(1)(B) of section 521A of title 38, United States 
62 

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1 Code, is amended by striking ‘‘and 2022’’ and inserting 

2 ‘‘through 2026’’. 

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

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

5 (c) TECHNICAL CORRECTION.—Subsection (g)(1)(A) of 

6 such section is amended by striking ‘‘. for each of fiscal 

7 years 2010 through 2020’’. 

8 SEC. 403. EXTENSION OF ADVISORY COMMITTEE ON MINOR9 ITY VETERANS. 

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

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

12 ‘‘September 30, 2026’’. 

13 SEC. 404. EXTENSION OF VETERANS’ ADVISORY COMMITTEE 

14 ON EDUCATION. 

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

16 amended by striking ‘‘December 31, 2022’’ and inserting 

17 ‘‘December 31, 2026’’. 

18 SEC. 405. EXTENSION OF AUTHORITY FOR TRANSFER OF 

19 REAL PROPERTY. 

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

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

22 ‘‘September 30, 2024’’. 
63 

† HR 6833 EAS 

1 DIVISION F—FDA USER FEE 

2 REAUTHORIZATION ACT OF 2022 

3 SECTION 1. SHORT TITLE. 

4 This division may be cited as the ‘‘FDA User Fee Re5 authorization Act of 2022’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents for this division is as follows: 

DIVISION F—FDA USER FEE REAUTHORIZATION ACT OF 2022 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 1001. Short title; finding. 

Sec. 1002. Definitions. 

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

Sec. 1004. Reauthorization; reporting requirements. 

Sec. 1005. Sunset dates. 

Sec. 1006. Effective date. 

Sec. 1007. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 2001. Short title; finding. 

Sec. 2002. Definitions. 

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

Sec. 2004. Reauthorization; reporting requirements. 

Sec. 2005. Conformity assessment pilot program. 

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

Sec. 2007. Sunset dates. 

Sec. 2008. Effective date. 

Sec. 2009. Savings clause. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 3001. Short title; finding. 

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

Sec. 3003. Reauthorization; reporting requirements. 

Sec. 3004. Sunset dates. 

Sec. 3005. Effective date. 

Sec. 3006. Savings clause. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 

Sec. 4001. Short title; finding. 

Sec. 4002. Definitions. 

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

Sec. 4004. Reauthorization; reporting requirements. 
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† HR 6833 EAS 

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. 

1 TITLE I—FEES RELATING TO 

2 DRUGS 

3 SEC. 1001. SHORT TITLE; FINDING. 

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

5 ‘‘Prescription Drug User Fee Amendments of 2022’’. 

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

7 by the amendments made by this title will be dedicated to8 ward expediting the drug development process and the proc9 ess for the review of human drug applications, including 

10 postmarket drug safety activities, as set forth in the goals 

11 identified for purposes of part 2 of subchapter C of chapter 

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

13 379g et seq.), in the letters from the Secretary of Health 

14 and Human Services to the Chairman of the Committee on 

15 Health, Education, Labor, and Pensions of the Senate and 

16 the Chairman of the Committee on Energy and Commerce 

17 of the House of Representatives, as set forth in the Congres18 sional Record. 
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† HR 6833 EAS 

1 SEC. 1002. DEFINITIONS. 

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

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

4 379g(1)) is amended, in the matter following subparagraph 

5 (B), by striking ‘‘an allergenic extract product, or’’ and in6 serting ‘‘does not include an application with respect to an 

7 allergenic extract product licensed before October 1, 2022, 

8 does not include an application with respect to a standard9 ized allergenic extract product submitted pursuant to a no10 tification to the applicant from the Secretary regarding the 

11 existence of a potency test that measures the allergenic ac12 tivity of an allergenic extract product licensed by the appli13 cant before October 1, 2022, does not include an application 

14 with respect to’’. 

15 (b) PRESCRIPTION DRUG PRODUCT.—Section 735(3) 

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

17 379g(3)) is amended— 

18 (1) by redesignating subparagraphs (A), (B), 

19 and (C) as clauses (i), (ii), and (iii), respectively; 

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

21 ‘‘(3)(A) The term’’; 

22 (3) by striking ‘‘Such term does not include 

23 whole blood’’ and inserting the following: 

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

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

26 and inserting ‘‘an allergenic extract product licensed 
66 

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1 before October 1, 2022, a standardized allergenic ex2 tract product submitted pursuant to a notification to 

3 the applicant from the Secretary regarding the exist4 ence of a potency test that measures the allergenic ac5 tivity of an allergenic extract product licensed by the 

6 applicant before October 1, 2022,’’ ; and 

7 (5) by adding at the end the following: 

8 ‘‘(C)(i) If a written request to place a prod9 uct in the discontinued section of either of the 

10 lists referenced in subparagraph (A)(iii) is sub11 mitted to the Secretary on behalf of an appli12 cant, and the request identifies the date the prod13 uct is, or will be, withdrawn from sale, then for 

14 purposes of assessing the prescription drug pro15 gram fee under section 736(a)(2), the Secretary 

16 shall consider such product to have been included 

17 in the discontinued section on the later of— 

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

19 or 

20 ‘‘(II) if the product will be withdrawn 

21 from sale on a future date, such future date 

22 when the product is withdrawn from sale. 

23 ‘‘(ii) For purposes of this subparagraph, a 

24 product shall be considered withdrawn from sale 

25 once the applicant has ceased its own distribu-
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† HR 6833 EAS 

1 tion of the product, whether or not the applicant 

2 has ordered recall of all previously distributed 

3 lots of the product, except that a routine, tem4 porary interruption in supply shall not render a 

5 product withdrawn from sale.’’. 

6 (c) SKIN-TEST DIAGNOSTIC PRODUCT.—Section 735 of 

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

8 is amended by adding at the end the following: 

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

10 ‘‘(A) means a product— 

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

12 subcutaneous administration; 

13 ‘‘(ii) expected to produce a limited, 

14 local reaction at the site of administration 

15 (if positive), rather than a systemic effect; 

16 ‘‘(iii) not intended to be a preventive 

17 or therapeutic intervention; and 

18 ‘‘(iv) intended to detect an immediate19 or delayed-type skin hypersensitivity reac20 tion to aid in the diagnosis of— 

21 ‘‘(I) an allergy to an anti22 microbial agent; 

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

24 antimicrobial agent, if the diagnostic 
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1 product was authorized for marketing 

2 prior to October 1, 2022; or 

3 ‘‘(III) infection with fungal or 

4 mycobacterial pathogens; and 

5 ‘‘(B) includes positive and negative controls 

6 required to interpret the results of a product de7 scribed in subparagraph (A).’’. 

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

9 (a) TYPES OF FEES.— 

10 (1) HUMAN DRUG APPLICATION FEE.—Section 

11 736(a) of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 379h(a)) is amended— 

13 (A) in the matter preceding paragraph (1), 

14 by striking ‘‘fiscal year 2018’’ and inserting ‘‘fis15 cal year 2023’’; 

16 (B) in paragraph (1)(A), by striking 

17 ‘‘(c)(5)’’ each place it appears and inserting 

18 ‘‘(c)(6)’’; 

19 (C) in paragraph (1)(C), by inserting 

20 ‘‘prior to approval’’ after ‘‘or was withdrawn’’; 

21 and 

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

23 the following: 

24 ‘‘(H) EXCEPTION FOR SKIN-TEST DIAG25 NOSTIC PRODUCTS.—A human drug application 
69 

† HR 6833 EAS 

1 for a skin-test diagnostic product shall not be 

2 subject to a fee under subparagraph (A).’’. 

3 (2) PRESCRIPTION DRUG PROGRAM FEE.—Sec4 tion 736(a)(2) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 379h(a)(2)) is amended— 

6 (A) in subparagraph (A)— 

7 (i) by striking ‘‘Except as provided in 

8 subparagraphs (B) and (C)’’ and inserting 

9 the following: 

10 ‘‘(i) PAYMENT OF FEES.—Except as 

11 provided in subparagraphs (B) and (C)’’; 

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

13 inserting ‘‘subsection (c)(6)’’; and 

14 (iii) by adding at the end the fol15 lowing: 

16 ‘‘(ii) SPECIAL RULE FOR PREVIOUSLY

17 DISCONTINUED DRUG PRODUCTS.—If a drug 

18 product that is identified in a human drug 

19 application approved as of October 1 of a 

20 fiscal year is not a prescription drug prod21 uct as of that date because the drug product 

22 is in the discontinued section of a list ref23 erenced in section 735(3)(A)(iii), and on 

24 any subsequent day during such fiscal year 

25 the drug product is a prescription drug 
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1 product, then except as provided in sub2 paragraphs (B) and (C), each person who is 

3 named as the applicant in a human drug 

4 application with respect to such product, 

5 and who, after September 1, 1992, had 

6 pending before the Secretary a human drug 

7 application or supplement, shall pay the 

8 annual prescription drug program fee estab9 lished for a fiscal year under subsection 

10 (c)(6) for such prescription drug product. 

11 Such fee shall be due on the last business 

12 day of such fiscal year and shall be paid 

13 only once for each such product for a fiscal 

14 year in which the fee is payable.’’; and 

15 (B) by amending subparagraph (B) to read 

16 as follows: 

17 ‘‘(B) EXCEPTION FOR CERTAIN PRESCRIP18 TION DRUG PRODUCTS.—A prescription drug 

19 program fee shall not be assessed for a prescrip20 tion drug product under subparagraph (A) if 

21 such product is— 

22 ‘‘(i) a large volume parenteral product 

23 (a sterile aqueous drug product packaged in 

24 a single-dose container with a volume great25 er than or equal to 100 mL, not including 
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1 powders for reconstitution or pharmacy 

2 bulk packages) identified on the list com3 piled under section 505(j)(7); 

4 ‘‘(ii) pharmaceutically equivalent (as 

5 defined in section 314.3 of title 21, Code of 

6 Federal Regulations (or any successor regu7 lation)) to another product on the list of 

8 products compiled under section 505(j)(7) 

9 (not including the discontinued section of 

10 such list); or 

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

12 (b) FEE REVENUE AMOUNTS.— 

13 (1) IN GENERAL.—Paragraph (1) of section 

14 736(b) of the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 379h(b)) is amended to read as follows: 

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

17 2023 through 2027, fees under subsection (a) shall, ex18 cept as provided in subsections (c), (d), (f), and (g), 

19 be established to generate a total revenue amount 

20 under such subsection that is equal to the sum of— 

21 ‘‘(A) the annual base revenue for the fiscal 

22 year (as determined under paragraph (3)); 

23 ‘‘(B) the dollar amount equal to the infla24 tion adjustment for the fiscal year (as deter25 mined under subsection (c)(1)); 
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1 ‘‘(C) the dollar amount equal to the stra2 tegic hiring and retention adjustment for the fis3 cal year (as determined under subsection (c)(2)); 

4 ‘‘(D) the dollar amount equal to the capac5 ity planning adjustment for the fiscal year (as 

6 determined under subsection (c)(3)); 

7 ‘‘(E) the dollar amount equal to the oper8 ating reserve adjustment for the fiscal year, if 

9 applicable (as determined under subsection 

10 (c)(4)); 

11 ‘‘(F) the dollar amount equal to the addi12 tional direct cost adjustment for the fiscal year 

13 (as determined under subsection (c)(5)); and 

14 ‘‘(G) additional dollar amounts for each fis15 cal year as follows: 

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

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

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

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

20 ‘‘(v) $1,314,620 for fiscal year 2027.’’. 

21 (2) ANNUAL BASE REVENUE.—Paragraph (3) of 

22 section 736(b) of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 379h(b)) is amended to read as 

24 follows: 
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1 ‘‘(3) ANNUAL BASE REVENUE.—For purposes of 

2 paragraph (1), the dollar amount of the annual base 

3 revenue for a fiscal year shall be— 

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

5 and 

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

7 dollar amount of the total revenue amount estab8 lished under paragraph (1) for the previous fis9 cal year, not including any adjustments made 

10 under subsection (c)(4) or (c)(5).’’. 

11 (c) ADJUSTMENTS; ANNUAL FEE SETTING.— 

12 (1) INFLATION ADJUSTMENT.—Section 

13 736(c)(1)(B)(ii) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 379h(c)(1)(B)(ii)) is amended 

15 by striking ‘‘Washington-Baltimore, DC–MD–VA– 

16 WV’’ and inserting ‘‘Washington-Arlington-Alexan17 dria, DC–VA–MD–WV’’. 

18 (2) STRATEGIC HIRING AND RETENTION ADJUST19 MENT.—Section 736(c) of the Federal Food, Drug, 

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

21 (A) by redesignating paragraphs (2) 

22 through (6) as paragraphs (3) through (7), re23 spectively; and 

24 (B) by inserting after paragraph (1) the fol25 lowing: 
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† HR 6833 EAS 

1 ‘‘(2) STRATEGIC HIRING AND RETENTION AD2 JUSTMENT.—For each fiscal year, after the annual 

3 base revenue established in subsection (b)(1)(A) is ad4 justed for inflation in accordance with paragraph (1), 

5 the Secretary shall further increase the fee revenue 

6 and fees by the following amounts: 

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

8 ‘‘(B) For each of fiscal years 2024 through 

9 2027, $4,000,000.’’. 

10 (3) CAPACITY PLANNING ADJUSTMENT.—Para11 graph (3), as redesignated, of section 736(c) of the 

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

13 379h(c)) is amended to read as follows: 

14 ‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 

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

16 after the annual base revenue established in sub17 section (b)(1)(A) is adjusted in accordance with 

18 paragraphs (1) and (2), such revenue shall be 

19 adjusted further for such fiscal year, in accord20 ance with this paragraph, to reflect changes in 

21 the resource capacity needs of the Secretary for 

22 the process for the review of human drug appli23 cations. 

24 ‘‘(B) METHODOLOGY.—For purposes of this 

25 paragraph, the Secretary shall employ the capac-
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1 ity planning methodology utilized by the Sec2 retary in setting fees for fiscal year 2021, as de3 scribed in the notice titled ‘Prescription Drug 

4 User Fee Rates for Fiscal Year 2021’ published 

5 in the Federal Register on August 3, 2020 (85 

6 Fed. Reg. 46651). The workload categories used 

7 in applying such methodology in forecasting 

8 shall include only the activities described in that 

9 notice and, as feasible, additional activities that 

10 are directly related to the direct review of appli11 cations and supplements, including additional 

12 formal meeting types, the direct review of post13 marketing commitments and requirements, the 

14 direct review of risk evaluation and mitigation 

15 strategies, and the direct review of annual re16 ports for approved prescription drug products. 

17 Subject to the exceptions in the preceding sen18 tence, the Secretary shall not include as work19 load categories in applying such methodology in 

20 forecasting any non-core review activities, in21 cluding those activities that the Secretary ref22 erenced for potential future use in such notice 

23 but did not utilize in setting fees for fiscal year 

24 2021. 
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1 ‘‘(C) LIMITATION.—Under no circumstances 

2 shall an adjustment under this paragraph result 

3 in fee revenue for a fiscal year that is less than 

4 the sum of the amounts under subsections 

5 (b)(1)(A) (the annual base revenue for the fiscal 

6 year), (b)(1)(B) (the dollar amount of the infla7 tion adjustment for the fiscal year), and 

8 (b)(1)(C) (the dollar amount of the strategic hir9 ing and retention adjustment for the fiscal year). 

10 ‘‘(D) PUBLICATION IN FEDERAL REG11 ISTER.—The Secretary shall publish in the Fed12 eral Register notice under paragraph (6) of the 

13 fee revenue and fees resulting from the adjust14 ment and the methodologies under this para15 graph.’’. 

16 (4) OPERATING RESERVE ADJUSTMENT.—Para17 graph (4), as redesignated, of section 736(c) of the 

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

19 379h(c)) is amended— 

20 (A) by amending subparagraph (A) to read 

21 as follows: 

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

23 subsequent fiscal years, the Secretary shall, in 

24 addition to adjustments under paragraphs (1), 

25 (2), and (3), further increase the fee revenue and 
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1 fees if such an adjustment is necessary to provide 

2 for operating reserves of carryover user fees for 

3 the process for the review of human drug appli4 cations for each fiscal year in at least the fol5 lowing amounts: 

6 ‘‘(i) For fiscal year 2023, at least 8 

7 weeks of operating reserves. 

8 ‘‘(ii) For fiscal year 2024, at least 9 

9 weeks of operating reserves. 

10 ‘‘(iii) For fiscal year 2025 and subse11 quent fiscal years, at least 10 weeks of oper12 ating reserves.’’; and 

13 (B) in subparagraph (C), by striking 

14 ‘‘paragraph (5)’’ and inserting ‘‘paragraph (6)’’. 

15 (5) ADDITIONAL DIRECT COST ADJUSTMENT.— 

16 Paragraph (5), as redesignated, of section 736(c) of 

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

18 379h(c)) is amended to read as follows: 

19 ‘‘(5) ADDITIONAL DIRECT COST ADJUSTMENT.— 

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

21 addition to adjustments under paragraphs (1), 

22 (2), (3), and (4), further increase the fee revenue 

23 and fees— 

24 ‘‘(i) for fiscal year 2023, by 

25 $44,386,150; and 
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1 ‘‘(ii) for each of fiscal years 2024 

2 through 2027, by the amount set forth in 

3 clauses (i) through (iv) of subparagraph 

4 (B), as applicable, multiplied by the Con5 sumer Price Index for urban consumers 

6 (Washington-Arlington-Alexandria, DC– 

7 VA–MD–WV; Not Seasonally Adjusted; All 

8 Items; Annual Index) for the most recent 

9 year of available data, divided by such 

10 Index for 2021. 

11 ‘‘(B) APPLICABLE AMOUNTS.—The amounts 

12 referred to in subparagraph (A)(ii) are the fol13 lowing: 

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

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

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

17 314. 

18 ‘‘(iv) For fiscal year 2027, 

19 $35,799,314.’’. 

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

21 redesignated, of section 736(c) of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is 

23 amended by striking ‘‘September 30, 2017’’ and in24 serting ‘‘September 30, 2022’’. 
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1 (d) CREDITING AND AVAILABILITY OF FEES.—Section 

2 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 379h(g)(3)) is amended by striking ‘‘fiscal years 

4 2018 through 2022’’ and inserting ‘‘fiscal years 2023 

5 through 2027’’. 

6 (e) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, 

7 EXEMPTIONS, AND RETURNS; DISPUTES CONCERNING

8 FEES.—Section 736(i) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 379h(i)) is amended to read as follows: 

10 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, 

11 EXEMPTIONS, AND RETURNS; DISPUTES CONCERNING

12 FEES.—To qualify for consideration for a waiver or reduc13 tion under subsection (d), an exemption under subsection 

14 (k), or the return of any fee paid under this section, includ15 ing if the fee is claimed to have been paid in error, a person 

16 shall— 

17 ‘‘(1) not later than 180 days after such fee is 

18 due, submit to the Secretary a written request justi19 fying such waiver, reduction, exemption, or return; 

20 and 

21 ‘‘(2) include in the request any legal authorities 

22 under which the request is made.’’. 

23 (f) ORPHAN DRUGS.—Section 736(k) of the Federal 

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

25 amended— 
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1 (1) in paragraph (1)(B), by striking ‘‘during the 

2 previous year’’ and inserting ‘‘as determined under 

3 paragraph (2)’’; and 

4 (2) by amending paragraph (2) to read as fol5 lows: 

6 ‘‘(2) EVIDENCE OF QUALIFICATION.—An exemp7 tion under paragraph (1) applies with respect to a 

8 drug only if the applicant involved submits a certifi9 cation that the applicant’s gross annual revenues did 

10 not exceed $50,000,000 for the last calendar year end11 ing prior to the fiscal year for which the exemption 

12 is requested. Such certification shall be supported 

13 by— 

14 ‘‘(A) tax returns submitted to the United 

15 States Internal Revenue Service; or 

16 ‘‘(B) as necessary, other appropriate finan17 cial information.’’. 

18 SEC. 1004. REAUTHORIZATION; REPORTING REQUIRE19 MENTS. 

20 Section 736B of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 379h–2) is amended— 

22 (1) in subsection (a)(1), by striking ‘‘Beginning 

23 with fiscal year 2018, not’’ and inserting ‘‘Not’’; 

24 (2) by striking ‘‘Prescription Drug User Fee 

25 Amendments of 2017’’ each place it appears and in-
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† HR 6833 EAS 

1 serting ‘‘Prescription Drug User Fee Amendments of 

2 2022’’; 

3 (3) in subsection (a)(3)(A), by striking ‘‘Not 

4 later than 30 calendar days after the end of the sec5 ond quarter of fiscal year 2018, and not later than 

6 30 calendar days after the end of each quarter of each 

7 fiscal year thereafter’’ and inserting ‘‘Not later than 

8 30 calendar days after the end of each quarter of each 

9 fiscal year for which fees are collected under this 

10 part’’; 

11 (4) in subsection (a)(4), by striking ‘‘Beginning 

12 with fiscal year 2020, the’’ and inserting ‘‘The’’; 

13 (5) in subsection (b), by striking ‘‘Beginning 

14 with fiscal year 2018, not’’ and inserting ‘‘Not’’; 

15 (6) in subsection (c), by striking ‘‘Beginning 

16 with fiscal year 2018, for’’ and inserting ‘‘For’’; and 

17 (7) in subsection (f)— 

18 (A) in paragraph (1), in the matter pre19 ceding subparagraph (A), by striking ‘‘fiscal 

20 year 2022’’ and inserting ‘‘fiscal year 2027’’; 

21 and 

22 (B) in paragraph (5), by striking ‘‘January 

23 15, 2022’’ and inserting ‘‘January 15, 2027’’. 
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1 SEC. 1005. SUNSET DATES. 

2 (a) AUTHORIZATION.—Sections 735 and 736 of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 

4 379h) shall cease to be effective October 1, 2027. 

5 (b) REPORTING REQUIREMENTS.—Section 736B of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h– 

7 2) shall cease to be effective January 31, 2028. 

8 (c) PREVIOUS SUNSET PROVISION.—Effective October 

9 1, 2022, subsections (a) and (b) of section 104 of the FDA 

10 Reauthorization Act of 2017 (Public Law 115–52) are re11 pealed. 

12 SEC. 1006. EFFECTIVE DATE. 

13 The amendments made by this title shall take effect 

14 on October 1, 2022, or the date of the enactment of this 

15 Act, whichever is later, except that fees under part 2 of sub16 chapter C of chapter VII of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for 

18 all human drug applications received on or after October 

19 1, 2022, regardless of the date of the enactment of this Act. 

20 SEC. 1007. SAVINGS CLAUSE. 

21 Notwithstanding the amendments made by this title, 

22 part 2 of subchapter C of chapter VII of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in effect 

24 on the day before the date of the enactment of this title, 

25 shall continue to be in effect with respect to human drug 

26 applications and supplements (as defined in such part as 
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1 of such day) that were accepted by the Food and Drug Ad2 ministration for filing on or after October 1, 2017, but be3 fore October 1, 2022, with respect to assessing and collecting 

4 any fee required by such part for a fiscal year prior to fiscal 

5 year 2023. 

6 TITLE II—FEES RELATING TO 

7 DEVICES 

8 SEC. 2001. SHORT TITLE; FINDING. 

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

10 ‘‘Medical Device User Fee Amendments of 2022’’. 

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

12 under the amendments made by this title will be dedicated 

13 toward expediting the process for the review of device appli14 cations and for assuring the safety and effectiveness of de15 vices, as set forth in the goals identified for purposes of part 

16 3 of subchapter C of chapter VII of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 379i et seq.), in the letters 

18 from the Secretary of Health and Human Services to the 

19 Chairman of the Committee on Health, Education, Labor, 

20 and Pensions of the Senate and the Chairman of the Com21 mittee on Energy and Commerce of the House of Represent22 atives, as set forth in the Congressional Record. 

23 SEC. 2002. DEFINITIONS. 

24 Section 737 of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 379i) is amended— 
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1 (1) in paragraph (9)— 

2 (A) in the matter preceding subparagraph 

3 (A), by striking ‘‘and premarket notification 

4 submissions’’ and inserting ‘‘premarket notifica5 tion submissions, and de novo classification re6 quests’’; 

7 (B) in subparagraph (D), by striking ‘‘and 

8 submissions’’ and inserting ‘‘submissions, and de 

9 novo classification requests’’; 

10 (C) in subparagraph (F), by striking ‘‘and 

11 premarket notification submissions’’ and insert12 ing ‘‘premarket notification submissions, and de 

13 novo classification requests’’; 

14 (D) in each of subparagraphs (G) and (H), 

15 by striking ‘‘or submissions’’ and inserting ‘‘sub16 missions, or requests’’; and 

17 (E) in subparagraph (K), by striking ‘‘or 

18 premarket notification submissions’’ and insert19 ing ‘‘premarket notification submissions, or de 

20 novo classification requests’’; and 

21 (2) in paragraph (11), by striking ‘‘2016’’ and 

22 inserting ‘‘2021’’. 
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1 SEC. 2003. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

2 (a) TYPES OF FEES.—Section 738(a) of the Federal 

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

4 amended— 

5 (1) in paragraph (1), by striking ‘‘fiscal year 

6 2018’’ and inserting ‘‘fiscal year 2023’’; and 

7 (2) in paragraph (2)— 

8 (A) in subparagraph (A)— 

9 (i) in the matter preceding clause (i), 

10 by striking ‘‘October 1, 2017’’ and inserting 

11 ‘‘October 1, 2022’’; 

12 (ii) in clause (iii), by striking ‘‘75 per13 cent’’ and inserting ‘‘80 percent’’; and 

14 (iii) in clause (viii), by striking ‘‘3.4 

15 percent’’ and inserting ‘‘4.5 percent’’; 

16 (B) in subparagraph (B)(iii), by striking 

17 ‘‘or premarket notification submission’’ and in18 serting ‘‘premarket notification submission, or de 

19 novo classification request’’; and 

20 (C) in subparagraph (C), by striking ‘‘or 

21 periodic reporting concerning a class III device’’ 

22 and inserting ‘‘periodic reporting concerning a 

23 class III device, or de novo classification re24 quest’’. 
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1 (b) FEE AMOUNTS.—Section 738(b) of the Federal 

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

3 amended— 

4 (1) in paragraph (1), by striking ‘‘2018 through 

5 2022’’ and inserting ‘‘2023 through 2027’’; 

6 (2) by amending paragraph (2) to read as fol7 lows: 

8 ‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For pur9 poses of paragraph (1), the base fee amounts specified 

10 in this paragraph are as follows: 

‘‘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 

11 (3) by amending paragraph (3) to read as fol12 lows: 

13 ‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.— 

14 For purposes of paragraph (1), the total revenue 

15 amounts specified in this paragraph are as follows: 

16 ‘‘(A) $312,606,000 for fiscal year 2023. 

17 ‘‘(B) $335,750,000 for fiscal year 2024. 

18 ‘‘(C) $350,746,400 for fiscal year 2025. 

19 ‘‘(D) $366,486,300 for fiscal year 2026. 

20 ‘‘(E) $418,343,000 for fiscal year 2027.’’. 

21 (c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 

22 738(c) of the Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 379j(c)) is amended— 
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1 (1) in paragraph (1), by striking ‘‘2017’’ and in2 serting ‘‘2022’’; 

3 (2) in paragraph (2)— 

4 (A) in subparagraph (A), by striking 

5 ‘‘2018’’ and inserting ‘‘2023’’; 

6 (B) in subparagraph (B)— 

7 (i) in the matter preceding clause (i), 

8 by striking ‘‘fiscal year 2018’’ and inserting 

9 ‘‘fiscal year 2023’’; and 

10 (ii) in clause (ii), by striking ‘‘fiscal 

11 year 2016’’ and inserting ‘‘fiscal year 

12 2022’’; 

13 (C) in subparagraph (C), by striking 

14 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ and 

15 inserting ‘‘Washington-Arlington-Alexandria, 

16 DC–VA–MD–WV’’; and 

17 (D) in subparagraph (D), in the matter 

18 preceding clause (i), by striking ‘‘fiscal years 

19 2018 through 2022’’ and inserting ‘‘fiscal years 

20 2023 through 2027’’; 

21 (3) in paragraph (3), by striking ‘‘2018 through 

22 2022’’ and inserting ‘‘2023 through 2027’’; 

23 (4) by redesignating paragraphs (4) and (5) as 

24 paragraphs (7) and (8), respectively; and 
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1 (5) by inserting after paragraph (3) the fol2 lowing: 

3 ‘‘(4) PERFORMANCE IMPROVEMENT ADJUST4 MENT.— 

5 ‘‘(A) IN GENERAL.—For each of fiscal years 

6 2025 through 2027, after the adjustments under 

7 paragraphs (2) and (3), the base establishment 

8 registration fee amounts for such fiscal year shall 

9 be increased to reflect changes in the resource 

10 needs of the Secretary due to improved review 

11 performance goals for the process for the review 

12 of device applications identified in the letters de13 scribed in section 2001(b) of the Medical Device 

14 User Fee Amendments of 2022, as the Secretary 

15 determines necessary to achieve an increase in 

16 total fee collections for such fiscal year equal to 

17 the following amounts, as applicable: 

18 ‘‘(i) For fiscal year 2025, the product 

19 of— 

20 ‘‘(I) the amount determined under 

21 subparagraph (B)(i)(I); and 

22 ‘‘(II) the applicable inflation ad23 justment under paragraph (2)(B) for 

24 such fiscal year. 
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1 ‘‘(ii) For fiscal year 2026, the product 

2 of— 

3 ‘‘(I) the sum of the amounts deter4 mined under subparagraphs (B)(i)(II), 

5 (B)(ii)(I), and (B)(iii)(I); and 

6 ‘‘(II) the applicable inflation ad7 justment under paragraph (2)(B) for 

8 such fiscal year. 

9 ‘‘(iii) For fiscal year 2027, the product 

10 of— 

11 ‘‘(I) the sum of the amounts deter12 mined under subparagraphs 

13 (B)(i)(III), (B)(ii)(II), and 

14 (B)(iii)(II); and 

15 ‘‘(II) the applicable inflation ad16 justment under paragraph (2)(B) for 

17 such fiscal year. 

18 ‘‘(B) AMOUNTS.— 

19 ‘‘(i) PRESUBMISSION AMOUNT.—For 

20 purposes of subparagraph (A), with respect 

21 to the Presubmission Written Feedback goal, 

22 the amounts determined under this sub23 paragraph are as follows: 
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1 ‘‘(I) For fiscal year 2025, 

2 $15,396,600 if such goal for fiscal year 

3 2023 is met. 

4 ‘‘(II) For fiscal year 2026: 

5 ‘‘(aa) $15,396,600 if such 

6 goal for fiscal year 2023 is met 

7 and such goal for fiscal year 2024 

8 is not met. 

9 ‘‘(bb) $36,792,200 if such 

10 goal for fiscal year 2024 is met. 

11 ‘‘(III) For fiscal year 2027: 

12 ‘‘(aa) $15,396,600 if such 

13 goal for fiscal year 2023 is met 

14 and such goal for each of fiscal 

15 years 2024 and 2025 is not met. 

16 ‘‘(bb) $36,792,200 if such 

17 goal for fiscal year 2024 is met 

18 and such goal for fiscal year 2025 

19 is not met. 

20 ‘‘(cc) $40,572,600 if such 

21 goal for fiscal year 2025 is met. 

22 ‘‘(ii) DE NOVO CLASSIFICATION RE23 QUEST AMOUNT.—For purposes of subpara24 graph (A), with respect to the De Novo De-
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1 cision goal, the amounts determined under 

2 this subparagraph are as follows: 

3 ‘‘(I) For fiscal year 2026, 

4 $6,323,500 if such goal for fiscal year 

5 2023 is met. 

6 ‘‘(II) For fiscal year 2027: 

7 ‘‘(aa) $6,323,500 if such goal 

8 for fiscal year 2023 is met and 

9 such goal for fiscal year 2024 is 

10 not met. 

11 ‘‘(bb) $11,765,400 if such 

12 goal for fiscal year 2024 is met. 

13 ‘‘(iii) PREMARKET NOTIFICATION AND

14 PREMARKET APPROVAL AMOUNT.—For pur15 poses of subparagraph (A), with respect to 

16 the 510(k) decision goal, 510(k) Shared 

17 Outcome Total Time to Decision goal, PMA 

18 decision goal, and PMA Shared Outcome 

19 Total Time to Decision goal, the amounts 

20 determined under this subparagraph are as 

21 follows: 

22 ‘‘(I) For fiscal year 2026, 

23 $1,020,000 if the 4 goals for fiscal year 

24 2023 are met. 

25 ‘‘(II) For fiscal year 2027: 
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1 ‘‘(aa) $1,020,000 if the 4 

2 goals for fiscal year 2023 are met 

3 and one or more of the 4 goals for 

4 fiscal year 2024 are not met. 

5 ‘‘(bb) $3,906,000 if the 4 

6 goals for fiscal year 2024 are met. 

7 ‘‘(C) PERFORMANCE CALCULATION.—For 

8 purposes of this paragraph, performance of the 

9 following goals shall be determined as specified 

10 in the letters described in section 2001(b) of the 

11 Medical Device User Fee Amendments of 2022 

12 and based on data available, as follows: 

13 ‘‘(i) The performance of the Pre14 submission Written Feedback goal shall be 

15 based on data available as of— 

16 ‘‘(I) for fiscal year 2023, March 

17 31, 2024; 

18 ‘‘(II) for fiscal year 2024, March 

19 31, 2025; and 

20 ‘‘(III) for fiscal year 2025, March 

21 31, 2026. 

22 ‘‘(ii) The performance of the De Novo 

23 Decision goal, 510(k) decision goal, 510(k) 

24 Shared Outcome Total Time to Decision 

25 goal, PMA decision goal, and PMA Shared 
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1 Outcome Total Time to Decision goal shall 

2 be based on data available as of— 

3 ‘‘(I) for fiscal year 2023, March 

4 31, 2025; and 

5 ‘‘(II) for fiscal year 2024, March 

6 31, 2026. 

7 ‘‘(D) GOALS DEFINED.—For purposes of 

8 this paragraph, the terms ‘Presubmission Writ9 ten Feedback goal’, ‘De Novo Decision goal’, 

10 ‘510(k) decision goal’, ‘510(k) Shared Outcome 

11 Total Time to Decision goal’, ‘PMA decision 

12 goal’, and ‘PMA Shared Outcome Total Time to 

13 Decision goal’ refer to the goals identified by the 

14 same names in the letters described in section 

15 2001(b) of the Medical Device User Fee Amend16 ments of 2022. 

17 ‘‘(5) HIRING ADJUSTMENT.— 

18 ‘‘(A) IN GENERAL.—For each of fiscal years 

19 2025 through 2027, after the adjustments under 

20 paragraphs (2), (3), and (4), if applicable, if the 

21 number of hires to support the process for the re22 view of device applications falls below the thresh23 olds specified in subparagraph (B) for the appli24 cable fiscal years, the base establishment registra25 tion fee amounts shall be decreased as the Sec-
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1 retary determines necessary to achieve a reduc2 tion in total fee collections equal to the hiring 

3 adjustment amount under subparagraph (C). 

4 ‘‘(B) THRESHOLDS.—The thresholds speci5 fied in this subparagraph are as follows: 

6 ‘‘(i) For fiscal year 2025, the threshold 

7 is 123 hires for fiscal year 2023. 

8 ‘‘(ii) For fiscal year 2026, the thresh9 old is 38 hires for fiscal year 2024. 

10 ‘‘(iii) For fiscal year 2027, the thresh11 old is— 

12 ‘‘(I) 22 hires for fiscal year 2025 

13 if the base establishment registration 

14 fees are not increased by the amount 

15 determined under paragraph (4)(A)(i); 

16 or 

17 ‘‘(II) 75 hires for fiscal year 2025 

18 if such fees are so increased. 

19 ‘‘(C) HIRING ADJUSTMENT AMOUNT.—The 

20 hiring adjustment amount for fiscal year 2025 

21 and each subsequent fiscal year is the product 

22 of— 

23 ‘‘(i) the number of hires by which the 

24 hiring goal specified in subparagraph (D) 
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1 for the fiscal year before the prior fiscal 

2 year was not met; 

3 ‘‘(ii) $72,877; and 

4 ‘‘(iii) the applicable inflation adjust5 ment under paragraph (2)(B) for the fiscal 

6 year for which the hiring goal was not met. 

7 ‘‘(D) HIRING GOALS.—The hiring goals for 

8 each of fiscal years 2023 through 2025 are as fol9 lows: 

10 ‘‘(i) For fiscal year 2023, 144 hires. 

11 ‘‘(ii) For fiscal year 2024, 42 hires. 

12 ‘‘(iii) For fiscal year 2025: 

13 ‘‘(I) 24 hires if the base establish14 ment registration fees are not increased 

15 by the amount determined under para16 graph (4)(A)(i). 

17 ‘‘(II) 83 hires if the base establish18 ment registration fees are increased by 

19 the amount determined under para20 graph (4)(A)(i). 

21 ‘‘(E) NUMBER OF HIRES.—For purposes of 

22 this paragraph, the number of hires for a fiscal 

23 year shall be determined by the Secretary as set 

24 forth in the letters described in section 2001(b) 
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1 of the Medical Device User Fee Amendments of 

2 2022. 

3 ‘‘(6) OPERATING RESERVE ADJUSTMENT.— 

4 ‘‘(A) IN GENERAL.—For each of fiscal years 

5 2023 through 2027, after the adjustments under 

6 paragraphs (2), (3), (4), and (5), if applicable, 

7 if the Secretary has operating reserves of carry8 over user fees for the process for the review of de9 vice applications in excess of the designated 

10 amount in subparagraph (B), the Secretary shall 

11 decrease the base establishment registration fee 

12 amounts to provide for not more than such des13 ignated amount of operating reserves. 

14 ‘‘(B) DESIGNATED AMOUNT.—Subject to 

15 subparagraph (C), for each fiscal year, the des16 ignated amount in this subparagraph is equal to 

17 the sum of— 

18 ‘‘(i) 13 weeks of operating reserves of 

19 carryover user fees; and 

20 ‘‘(ii) 1 month of operating reserves 

21 maintained pursuant to paragraph (8). 

22 ‘‘(C) EXCLUDED AMOUNT.—For the period 

23 of fiscal years 2023 through 2026, a total 

24 amount equal to $118,000,000 shall not be con25 sidered part of the designated amount under sub-
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1 paragraph (B) and shall not be subject to the de2 crease under subparagraph (A).’’. 

3 (d) CONDITIONS.—Section 738(g) of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 379j(g)) is amended— 

5 (1) in paragraph (1)(A), by striking 

6 ‘‘$320,825,000’’ and inserting ‘‘$398,566,000’’; and 

7 (2) in paragraph (2), by inserting ‘‘de novo clas8 sification requests,’’ after ‘‘class III device,’’. 

9 (e) CREDITING AND AVAILABILITY OF FEES.—Section 

10 738(h)(3) of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 379j(h)(3)) is amended to read as follows: 

12 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

13 ‘‘(A) IN GENERAL.—For each of fiscal years 

14 2023 through 2027, there is authorized to be ap15 propriated for fees under this section an amount 

16 equal to the revenue amount determined under 

17 subparagraph (B), less the amount of reductions 

18 determined under subparagraph (C). 

19 ‘‘(B) REVENUE AMOUNT.—For purposes of 

20 this paragraph, the revenue amount for each fis21 cal year is the sum of— 

22 ‘‘(i) the total revenue amount under 

23 subsection (b)(3) for the fiscal year, as ad24 justed under paragraphs (2) and (3) of sub25 section (c); and 
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1 ‘‘(ii) the performance improvement ad2 justment amount for the fiscal year under 

3 subsection (c)(4), if applicable. 

4 ‘‘(C) AMOUNT OF REDUCTIONS.—For pur5 poses of this paragraph, the amount of reduc6 tions for each fiscal year is the sum of— 

7 ‘‘(i) the hiring adjustment amount for 

8 the fiscal year under subsection (c)(5), if 

9 applicable; and 

10 ‘‘(ii) the operating reserve adjustment 

11 amount for the fiscal year under subsection 

12 (c)(6), if applicable.’’. 

13 SEC. 2004. REAUTHORIZATION; REPORTING REQUIRE14 MENTS. 

15 (a) PERFORMANCE REPORTS.—Section 738A(a) of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

17 1(a)) is amended— 

18 (1) by striking ‘‘fiscal year 2018’’ each place it 

19 appears and inserting ‘‘fiscal year 2023’’; 

20 (2) by striking ‘‘Medical Device User Fee 

21 Amendments of 2017’’ each place it appears and in22 serting ‘‘Medical Device User Fee Amendments of 

23 2022’’; 

24 (3) in paragraph (1)— 
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1 (A) in subparagraph (A), by redesignating 

2 the second clause (iv) (relating to analysis) as 

3 clause (v); and 

4 (B) in subparagraph (A)(iv), by striking 

5 ‘‘fiscal year 2020’’ and inserting ‘‘fiscal year 

6 2023’’; and 

7 (4) in paragraph (4), by striking ‘‘2018 through 

8 2022’’ and inserting ‘‘2023 through 2027’’. 

9 (b) REAUTHORIZATION.—Section 738A(b) of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) 

11 is amended— 

12 (1) in paragraph (1), by striking ‘‘2022’’ and in13 serting ‘‘2027’’; and 

14 (2) in paragraph (5), by striking ‘‘2022’’ and in15 serting ‘‘2027’’. 

16 SEC. 2005. CONFORMITY ASSESSMENT PILOT PROGRAM. 

17 Section 514(d) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 360d(d)) is amended to read as fol19 lows: 

20 ‘‘(d) ACCREDITATION SCHEME FOR CONFORMITY AS21 SESSMENT.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall establish 

23 a program under which— 

24 ‘‘(A) testing laboratories meeting criteria 

25 specified in guidance by the Secretary may be 
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1 accredited, by accreditation bodies meeting cri2 teria specified in guidance by the Secretary, to 

3 conduct testing to support the assessment of the 

4 conformity of a device to certain standards rec5 ognized under this section; and 

6 ‘‘(B) subject to paragraph (2), results from 

7 tests conducted to support the assessment of con8 formity of devices as described in subparagraph 

9 (A) conducted by testing laboratories accredited 

10 pursuant to this subsection shall be accepted by 

11 the Secretary for purposes of demonstrating such 

12 conformity unless the Secretary finds that cer13 tain results of such tests should not be so accept14 ed. 

15 ‘‘(2) SECRETARIAL REVIEW OF ACCREDITED LAB16 ORATORY RESULTS.—The Secretary may— 

17 ‘‘(A) review the results of tests conducted by 

18 testing laboratories accredited pursuant to this 

19 subsection, including by conducting periodic au20 dits of such results or of the processes of accred21 ited bodies or testing laboratories; 

22 ‘‘(B) following such review, take additional 

23 measures under this Act, as the Secretary deter24 mines appropriate, such as— 
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1 ‘‘(i) suspension or withdrawal of ac2 creditation of a testing laboratory or rec3 ognition of an accreditation body under 

4 paragraph (1)(A); or 

5 ‘‘(ii) requesting additional information 

6 with respect to a device; and 

7 ‘‘(C) if the Secretary becomes aware of in8 formation materially bearing on the safety or ef9 fectiveness of a device for which an assessment of 

10 conformity was supported by testing conducted 

11 by a testing laboratory accredited under this 

12 subsection, take such additional measures under 

13 this Act, as the Secretary determines appro14 priate, such as— 

15 ‘‘(i) suspension or withdrawal of ac16 creditation of a testing laboratory or rec17 ognition of an accreditation body under 

18 paragraph (1)(A); or 

19 ‘‘(ii) requesting additional information 

20 with regard to such device. 

21 ‘‘(3) REPORT.—The Secretary shall make avail22 able on the internet website of the Food and Drug Ad23 ministration an annual report on the progress of the 

24 program under this subsection.’’. 
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1 SEC. 2006. REAUTHORIZATION OF THIRD-PARTY REVIEW 

2 PROGRAM. 

3 Section 523(c) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 360m(c)) is amended by striking ‘‘Oc5 tober 1’’ and inserting ‘‘December 17’’. 

6 SEC. 2007. SUNSET DATES. 

7 (a) AUTHORIZATION.—Sections 737 and 738 of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 

9 379j) shall cease to be effective October 1, 2027. 

10 (b) REPORTING REQUIREMENTS.—Section 738A of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

12 1) shall cease to be effective January 31, 2028. 

13 (c) PREVIOUS SUNSET PROVISIONS.—Effective October 

14 1, 2022, subsections (a) and (b) of section 210 of the FDA 

15 Reauthorization Act of 2017 (Public Law 115–52) are re16 pealed. 

17 SEC. 2008. EFFECTIVE DATE. 

18 The amendments made by this title shall take effect 

19 on October 1, 2022, or the date of the enactment of this 

20 Act, whichever is later, except that fees under part 3 of sub21 chapter C of chapter VII of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for 

23 all submissions listed in section 738(a)(2)(A) of such Act 

24 received on or after October 1, 2022, regardless of the date 

25 of the enactment of this Act. 
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1 SEC. 2009. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

3 part 3 of subchapter C of chapter VII of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect 

5 on the day before the date of the enactment of this title, 

6 shall continue to be in effect with respect to the submissions 

7 listed in section 738(a)(2)(A) of such Act (as defined in such 

8 part as of such day) that on or after October 1, 2017, but 

9 before October 1, 2022, were received by the Food and Drug 

10 Administration with respect to assessing and collecting any 

11 fee required by such part for a fiscal year prior to fiscal 

12 year 2023. 

13 TITLE III—FEES RELATING TO 

14 GENERIC DRUGS 

15 SEC. 3001. SHORT TITLE; FINDING. 

16 (a) SHORT TITLE.—This title may be cited as the ‘‘Ge17 neric Drug User Fee Amendments of 2022’’. 

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

19 by the amendments made by this title will be dedicated to 

20 human generic drug activities, as set forth in the goals iden21 tified for purposes of part 7 of subchapter C of chapter VII 

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

23 379j–41 et seq.), in the letters from the Secretary of Health 

24 and Human Services to the Chairman of the Committee on 

25 Health, Education, Labor, and Pensions of the Senate and 

26 the Chairman of the Committee on Energy and Commerce 
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1 of the House of Representatives, as set forth in the Congres2 sional Record. 

3 SEC. 3002. AUTHORITY TO ASSESS AND USE HUMAN GE4 NERIC DRUG FEES. 

5 (a) TYPES OF FEES.—Section 744B(a) of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)) is 

7 amended— 

8 (1) in the matter preceding paragraph (1), by 

9 striking ‘‘2018’’ and inserting ‘‘2023’’; 

10 (2) in paragraph (2)(C), by striking ‘‘2018 

11 through 2022’’ and inserting ‘‘2023 through 2027’’; 

12 (3) in paragraph (3)(B), by striking ‘‘2018 

13 through 2022’’ and inserting ‘‘2023 through 2027’’; 

14 (4) in paragraph (4)(D), by striking ‘‘2018 

15 through 2022’’ and inserting ‘‘2023 through 2027’’; 

16 and 

17 (5) in paragraph (5)(D), by striking ‘‘2018 

18 through 2022’’ and inserting ‘‘2023 through 2027’’. 

19 (b) FEE REVENUE AMOUNTS.—Section 744B(b) of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

21 42(b)) is amended— 

22 (1) in paragraph (1)— 

23 (A) in subparagraph (A)— 

24 (i) in the heading, by striking ‘‘2018’’ 

25 and inserting ‘‘2023’’; 
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1 (ii) by striking ‘‘2018’’ and inserting 

2 ‘‘2023’’; and 

3 (iii) by striking ‘‘$493,600,000’’ and 

4 inserting ‘‘$582,500,000’’; and 

5 (B) by amending subparagraph (B) to read 

6 as follows: 

7 ‘‘(B) FISCAL YEARS 2024 THROUGH 2027.— 

8 ‘‘(i) IN GENERAL.—For each of the fis9 cal years 2024 through 2027, fees under 

10 paragraphs (2) through (5) of subsection (a) 

11 shall be established to generate a total esti12 mated revenue amount under such sub13 section that is equal to the base revenue 

14 amount for the fiscal year under clause (ii), 

15 as adjusted pursuant to subsection (c). 

16 ‘‘(ii) BASE REVENUE AMOUNT.—The 

17 base revenue amount for a fiscal year re18 ferred to in clause (i) is equal to the total 

19 revenue amount established under this 

20 paragraph for the previous fiscal year, not 

21 including any adjustments made for such 

22 previous fiscal year under subsection 

23 (c)(3).’’; and 

24 (2) in paragraph (2)— 
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1 (A) in subparagraph (C), by striking ‘‘one2 third the amount’’ and inserting ‘‘twenty-four 

3 percent’’; 

4 (B) in subparagraph (D), by striking 

5 ‘‘Seven percent’’ and inserting ‘‘Six percent’’; 

6 and 

7 (C) in subparagraph (E)(i), by striking 

8 ‘‘Thirty-five percent’’ and inserting ‘‘Thirty-six 

9 percent’’. 

10 (c) ADJUSTMENTS.—Section 744B(c) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is 

12 amended— 

13 (1) in paragraph (1)— 

14 (A) in the matter preceding subparagraph 

15 (A)— 

16 (i) by striking ‘‘2019’’ and inserting 

17 ‘‘2024’’; and 

18 (ii) by striking ‘‘to equal the product of 

19 the total revenues established in such notice 

20 for the prior fiscal year multiplied’’ and in21 serting ‘‘to equal the base revenue amount 

22 for the fiscal year (as specified in subsection 

23 (b)(1)(B)(ii)) multiplied’’; and 

24 (B) in subparagraph (C), by striking 

25 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ and 
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1 inserting ‘‘Washington-Arlington-Alexandria, 

2 DC–VA–MD–WV’’; and 

3 (2) by striking paragraph (2) and inserting the 

4 following: 

5 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

6 ‘‘(A) IN GENERAL.—Beginning with fiscal 

7 year 2024, the Secretary shall, in addition to the 

8 adjustment under paragraph (1), further in9 crease the fee revenue and fees under this section 

10 for a fiscal year, in accordance with this para11 graph, to reflect changes in the resource capacity 

12 needs of the Secretary for human generic drug 

13 activities. 

14 ‘‘(B) CAPACITY PLANNING METHODOLOGY.— 

15 The Secretary shall establish a capacity plan16 ning methodology for purposes of this paragraph, 

17 which shall— 

18 ‘‘(i) be derived from the methodology 

19 and recommendations made in the report ti20 tled ‘Independent Evaluation of the 

21 GDUFA Resource Capacity Planning Ad22 justment Methodology: Evaluation and Rec23 ommendations’ announced in the Federal 

24 Register on August 3, 2020 (85 Fed. Reg. 

25 46658); and 
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1 ‘‘(ii) incorporate approaches and at2 tributes determined appropriate by the Sec3 retary, including approaches and attributes 

4 made in such report, except that in incor5 porating such approaches and attributes the 

6 workload categories used in forecasting re7 sources shall only be the workload categories 

8 specified in section VIII.B.2.e. of the letters 

9 described in section 3001(b) of the Generic 

10 Drug User Fee Amendments of 2022. 

11 ‘‘(C) LIMITATIONS.— 

12 ‘‘(i) IN GENERAL.—Under no cir13 cumstances shall an adjustment under this 

14 paragraph result in fee revenue for a fiscal 

15 year that is less than the sum of the 

16 amounts under subsection (b)(1)(B)(ii) (the 

17 base revenue amount for the fiscal year) 

18 and paragraph (1) (the dollar amount of 

19 the inflation adjustment for the fiscal year). 

20 ‘‘(ii) ADDITIONAL LIMITATION.—An 

21 adjustment under this paragraph shall not 

22 exceed 3 percent of the sum described in 

23 clause (i) for the fiscal year, except that 

24 such limitation shall be 4 percent if— 
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1 ‘‘(I) for purposes of a fiscal year 

2 2024 adjustment, the Secretary deter3 mines that during the period from 

4 April 1, 2021, through March 31, 

5 2023— 

6 ‘‘(aa) the total number of ab7 breviated new drug applications 

8 submitted was greater than or 

9 equal to 2,000; or 

10 ‘‘(bb) thirty-five percent or 

11 more of abbreviated new drug ap12 plications submitted related to 

13 complex products (as that term is 

14 defined in section XI of the letters 

15 described in section 3001(b) of the 

16 Generic Drug User Fee Amend17 ments of 2022); 

18 ‘‘(II) for purposes of a fiscal year 

19 2025 adjustment, the Secretary deter20 mines that during the period from 

21 April 1, 2022, through March 31, 

22 2024— 

23 ‘‘(aa) the total number of ab24 breviated new drug applications 
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1 submitted was greater than or 

2 equal to 2,300; or 

3 ‘‘(bb) thirty-five percent or 

4 more of abbreviated new drug ap5 plications submitted related to 

6 complex products (as so defined); 

7 ‘‘(III) for purposes of a fiscal year 

8 2026 adjustment, the Secretary deter9 mines that during the period from 

10 April 1, 2023, through March 31, 

11 2025— 

12 ‘‘(aa) the total number of ab13 breviated new drug applications 

14 submitted was greater than or 

15 equal to 2,300; or 

16 ‘‘(bb) thirty-five percent or 

17 more of abbreviated new drug ap18 plications submitted related to 

19 complex products (as so defined); 

20 and 

21 ‘‘(IV) for purposes of a fiscal year 

22 2027 adjustment, the Secretary deter23 mines that during the period from 

24 April 1, 2024, through March 31, 

25 2026— 
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1 ‘‘(aa) the total number of ab2 breviated new drug applications 

3 submitted was greater than or 

4 equal to 2,300; or 

5 ‘‘(bb) thirty-five percent or 

6 more of abbreviated new drug ap7 plications submitted related to 

8 complex products (as so defined). 

9 ‘‘(D) PUBLICATION IN FEDERAL REG10 ISTER.—The Secretary shall publish in the Fed11 eral Register notice referred to in subsection (a) 

12 the fee revenue and fees resulting from the ad13 justment and the methodology under this para14 graph. 

15 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

16 ‘‘(A) IN GENERAL.—For fiscal year 2024 

17 and each subsequent fiscal year, the Secretary 

18 may, in addition to adjustments under para19 graphs (1) and (2), further increase the fee rev20 enue and fees under this section for such fiscal 

21 year if such an adjustment is necessary to pro22 vide operating reserves of carryover user fees for 

23 human generic drug activities for not more than 

24 the number of weeks specified in subparagraph 

25 (B) with respect to that fiscal year. 
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1 ‘‘(B) NUMBER OF WEEKS.—The number of 

2 weeks specified in this subparagraph is— 

3 ‘‘(i) 8 weeks for fiscal year 2024; 

4 ‘‘(ii) 9 weeks for fiscal year 2025; and 

5 ‘‘(iii) 10 weeks for each of fiscal year 

6 2026 and 2027. 

7 ‘‘(C) DECREASE.—If the Secretary has car8 ryover balances for human generic drug activi9 ties in excess of 12 weeks of the operating re10 serves referred to in subparagraph (A), the Sec11 retary shall decrease the fee revenue and fees re12 ferred to in such subparagraph to provide for not 

13 more than 12 weeks of such operating reserves. 

14 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If an 

15 adjustment under this paragraph is made, the 

16 rationale for the amount of the increase or de17 crease (as applicable) in fee revenue and fees 

18 shall be contained in the annual Federal Reg19 ister notice under subsection (a) publishing the 

20 fee revenue and fees for the fiscal year involved.’’. 

21 (d) ANNUAL FEE SETTING.—Section 744B(d)(1) of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

23 42(d)(1)) is amended— 
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1 (1) in the paragraph heading, by striking ‘‘2018

2 THROUGH 2022’’ and inserting ‘‘2023 THROUGH 2027’’; 

3 and 

4 (2) by striking ‘‘more than 60 days before the 

5 first day of each of fiscal years 2018 through 2022’’ 

6 and inserting ‘‘later than 60 days before the first day 

7 of each of fiscal years 2023 through 2027’’. 

8 (e) EFFECT OF FAILURE TO PAY FEES.—The heading 

9 of paragraph (3) of section 744B(g) of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 379j–42(g)) is amended 

11 by striking ‘‘AND PRIOR APPROVAL SUPPLEMENT FEE’’. 

12 (f) CREDITING AND AVAILABILITY OF FEES.—Section 

13 744B(i)(3) of the Federal Food, Drug, and Cosmetic Act 

14 (21 U.S.C. 379j–42(i)(3)) is amended by striking ‘‘fiscal 

15 years 2018 through 2022’’ and inserting ‘‘fiscal years 2023 

16 through 2027’’. 

17 SEC. 3003. REAUTHORIZATION; REPORTING REQUIRE18 MENTS. 

19 Section 744C of the Federal Food, Drug, and Cosmetic 

20 Act (21 U.S.C. 379j–43) is amended— 

21 (1) in subsection (a)(1), by striking ‘‘Beginning 

22 with fiscal year 2018, not’’ and inserting ‘‘Not’’; 

23 (2) by striking ‘‘Generic Drug User Fee Amend24 ments of 2017’’ each place it appears and inserting 

25 ‘‘Generic Drug User Fee Amendments of 2022’’; 
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1 (3) in subsection (a)(2), by striking ‘‘Not later 

2 than 30 calendar days after the end of the second 

3 quarter of fiscal year 2018, and not later than 30 cal4 endar days after the end of each quarter of each fiscal 

5 year thereafter’’ and inserting ‘‘Not later than 30 cal6 endar days after the end of each quarter of each fiscal 

7 year for which fees are collected under this part’’; 

8 (4) in subsection (a)(3), by striking ‘‘Beginning 

9 with fiscal year 2020, the’’ and inserting ‘‘The’’; 

10 (5) in subsection (b), by striking ‘‘Beginning 

11 with fiscal year 2018, not’’ and inserting ‘‘Not’’; 

12 (6) in subsection (c), by striking ‘‘Beginning 

13 with fiscal year 2018, for’’ and inserting ‘‘For’’; and 

14 (7) in subsection (f)— 

15 (A) in paragraph (1), in the matter pre16 ceding subparagraph (A), by striking ‘‘fiscal 

17 year 2022’’ and inserting ‘‘fiscal year 2027’’; 

18 and 

19 (B) in paragraph (5), by striking ‘‘January 

20 15, 2022’’ and inserting ‘‘January 15, 2027’’. 

21 SEC. 3004. SUNSET DATES. 

22 (a) AUTHORIZATION.—Sections 744A and 744B of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

24 41; 379j–42) shall cease to be effective October 1, 2027. 
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1 (b) REPORTING REQUIREMENTS.—Section 744C of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

3 43) shall cease to be effective January 31, 2028. 

4 (c) PREVIOUS SUNSET PROVISION.—Effective October 

5 1, 2022, subsections (a) and (b) of section 305 of the FDA 

6 Reauthorization Act of 2017 (Public Law 115–52) are re7 pealed. 

8 SEC. 3005. EFFECTIVE DATE. 

9 The amendments made by this title shall take effect 

10 on October 1, 2022, or the date of the enactment of this 

11 Act, whichever is later, except that fees under part 7 of sub12 chapter C of chapter VII of the Federal Food, Drug, and 

13 Cosmetic Act (21 U.S.C. 379j–41 et seq.) shall be assessed 

14 for all abbreviated new drug applications received on or 

15 after October 1, 2022, regardless of the date of the enactment 

16 of this Act. 

17 SEC. 3006. SAVINGS CLAUSE. 

18 Notwithstanding the amendments made by this title, 

19 part 7 of subchapter C of chapter VII of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), as in 

21 effect on the day before the date of the enactment of this 

22 title, shall continue to be in effect with respect to abbre23 viated new drug applications (as defined in such part as 

24 of such day) that were received by the Food and Drug Ad25 ministration within the meaning of section 505(j)(5)(A) of 
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1 such Act (21 U.S.C. 355(j)(5)(A)), prior approval supple2 ments that were submitted, and drug master files for Type 

3 II active pharmaceutical ingredients that were first ref4 erenced on or after October 1, 2017, but before October 1, 

5 2022, with respect to assessing and collecting any fee re6 quired by such part for a fiscal year prior to fiscal year 

7 2023. 

8 TITLE IV—FEES RELATING TO 

9 BIOSIMILAR BIOLOGICAL 

10 PRODUCTS 

11 SEC. 4001. SHORT TITLE; FINDING. 

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

13 ‘‘Biosimilar User Fee Amendments of 2022’’. 

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

15 by the amendments made by this title will be dedicated to 

16 expediting the process for the review of biosimilar biological 

17 product applications, including postmarket safety activi18 ties, as set forth in the goals identified for purposes of part 

19 8 of subchapter C of chapter VII of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 379j–51 et seq.), in the letters 

21 from the Secretary of Health and Human Services to the 

22 Chairman of the Committee on Health, Education, Labor, 

23 and Pensions of the Senate and the Chairman of the Com24 mittee on Energy and Commerce of the House of Represent25 atives, as set forth in the Congressional Record. 
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1 SEC. 4002. DEFINITIONS. 

2 (a) ADJUSTMENT FACTOR.—Section 744G(1) of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

4 51(1)) is amended to read as follows: 

5 ‘‘(1) The term ‘adjustment factor’ applicable to a 

6 fiscal year is the Consumer Price Index for urban 

7 consumers (Washington-Arlington-Alexandria, DC– 

8 VA–MD–WV; Not Seasonally Adjusted; All items) for 

9 September of the preceding fiscal year divided by such 

10 Index for September 2011.’’. 

11 (b) BIOSIMILAR BIOLOGICAL PRODUCT APPLICA12 TION.—Section 744G(4)(B)(iii) of the Federal Food, Drug, 

13 and Cosmetic Act (21 U.S.C. 379j–51(4)(B)(iii)) is amend14 ed— 

15 (1) by striking subclause (II) (relating to an al16 lergenic extract product); and 

17 (2) by redesignating subclauses (III) and (IV) as 

18 subclauses (II) and (III), respectively. 

19 SEC. 4003. AUTHORITY TO ASSESS AND USE BIOSIMILAR BI20 OLOGICAL PRODUCT FEES. 

21 (a) TYPES OF FEES.— 

22 (1) IN GENERAL.—The matter preceding para23 graph (1) in section 744H(a) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)) is 

25 amended by striking ‘‘fiscal year 2018’’ and inserting 

26 ‘‘fiscal year 2023’’. 
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1 (2) INITIAL BIOSIMILAR BIOLOGICAL PRODUCT

2 DEVELOPMENT FEE.—Clauses (iv)(I) and (v)(II) of 

3 section 744H(a)(1)(A) of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 379j–52(a)(1)(A)) are each 

5 amended by striking ‘‘5 days’’ and inserting ‘‘7 

6 days’’. 

7 (3) ANNUAL BIOSIMILAR BIOLOGICAL PRODUCT

8 DEVELOPMENT FEE.—Section 744H(a)(1)(B) of the 

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

10 379j–52(a)(1)(B)) is amended— 

11 (A) in clause (i), by inserting before the pe12 riod at the end the following: ‘‘, except that, in 

13 the case that such product (including, where ap14 plicable, ownership of the relevant investiga15 tional new drug application) is transferred to a 

16 licensee, assignee, or successor of such person, 

17 and written notice of such transfer is provided to 

18 the Secretary, such licensee, assignee, or successor 

19 shall pay the annual biosimilar biological prod20 uct development fee’’; 

21 (B) in clause (iii)— 

22 (i) in subclause (I), by striking ‘‘or’’ at 

23 the end; 

24 (ii) in subclause (II), by striking the 

25 period at the end and inserting ‘‘; or’’; and 
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1 (iii) by adding at the end the fol2 lowing: 

3 ‘‘(III) been administratively re4 moved from the biosimilar biological 

5 product development program for the 

6 product under subparagraph (E)(v).’’; 

7 and 

8 (C) in clause (iv), by striking ‘‘is accepted 

9 for filing on or after October 1 of such fiscal 

10 year’’ and inserting ‘‘is subsequently accepted for 

11 filing’’. 

12 (4) REACTIVATION FEE.—Section 744H(a)(1)(D) 

13 of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 379j–52(a)(1)(D)) is amended to read as fol15 lows: 

16 ‘‘(D) REACTIVATION FEE.— 

17 ‘‘(i) IN GENERAL.—A person that has 

18 discontinued participation in the biosimilar 

19 biological product development program for 

20 a product under subparagraph (C), or who 

21 has been administratively removed from 

22 such program for a product under subpara23 graph (E)(v), shall, if the person seeks to re24 sume participation in such program, pay 

25 all annual biosimilar biological product de-
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1 velopment fees previously assessed for such 

2 product and still owed and a fee (referred to 

3 in this section as ‘reactivation fee’) by the 

4 earlier of the following: 

5 ‘‘(I) Not later than 7 days after 

6 the Secretary grants a request by such 

7 person for a biosimilar biological prod8 uct development meeting for the prod9 uct (after the date on which such par10 ticipation was discontinued or the date 

11 of administrative removal, as applica12 ble). 

13 ‘‘(II) Upon the date of submission 

14 (after the date on which such partici15 pation was discontinued or the date of 

16 administrative removal, as applicable) 

17 by such person of an investigational 

18 new drug application describing an in19 vestigation that the Secretary deter20 mines is intended to support a bio21 similar biological product application 

22 for that product. 

23 ‘‘(ii) APPLICATION OF ANNUAL FEE.— 

24 A person that pays a reactivation fee for a 

25 product shall pay for such product, begin-
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1 ning in the next fiscal year, the annual bio2 similar biological product development fee 

3 under subparagraph (B), except that, in the 

4 case that such product (including, where 

5 applicable, ownership of the relevant inves6 tigational new drug application) is trans7 ferred to a licensee, assignee, or successor of 

8 such person, and written notice of such 

9 transfer is provided to the Secretary, such 

10 licensee, assignee, or successor shall pay the 

11 annual biosimilar biological product devel12 opment fee.’’. 

13 (5) EFFECT OF FAILURE TO PAY FEES.—Section 

14 744H(a)(1)(E) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 379j–52(a)(1)(E)) is amended 

16 by adding at the end the following: 

17 ‘‘(v) ADMINISTRATIVE REMOVAL FROM

18 THE BIOSIMILAR BIOLOGICAL PRODUCT DE19 VELOPMENT PROGRAM.—If a person has 

20 failed to pay an annual biosimilar biologi21 cal product development fee for a product as 

22 required under subparagraph (B) for a pe23 riod of 2 consecutive fiscal years, the Sec24 retary may administratively remove such 

25 person from the biosimilar biological prod-
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1 uct development program for the product. 

2 At least 30 days prior to administratively 

3 removing a person from the biosimilar bio4 logical product development program for a 

5 product under this clause, the Secretary 

6 shall provide written notice to such person 

7 of the intended administrative removal.’’. 

8 (6) BIOSIMILAR BIOLOGICAL PRODUCT APPLICA9 TION FEE.—Section 744H(a)(2)(D) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

11 52(a)(2)(D)) is amended by inserting after ‘‘or was 

12 withdrawn’’ the following: ‘‘prior to approval’’. 

13 (7) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM

14 FEE.—Section 744H(a)(3) of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 379j–52(a)(3)) is 

16 amended— 

17 (A) in subparagraph (A)— 

18 (i) in clause (i), by striking ‘‘and’’ at 

19 the end; 

20 (ii) by redesignating clause (ii) as 

21 clause (iii); and 

22 (iii) by inserting after clause (i) the 

23 following: 
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1 ‘‘(ii) may be dispensed only under pre2 scription pursuant to section 503(b); and’’; 

3 and 

4 (B) by adding at the end the following: 

5 ‘‘(E) MOVEMENT TO DISCONTINUED LIST.— 

6 ‘‘(i) DATE OF INCLUSION.—If a writ7 ten request to place a product on the list 

8 referenced in subparagraph (A) of discon9 tinued biosimilar biological products is sub10 mitted to the Secretary on behalf of an ap11 plicant, and the request identifies the date 

12 the product is, or will be, withdrawn from 

13 sale, then for purposes of assessing the bio14 similar biological product program fee, the 

15 Secretary shall consider such product to 

16 have been included on such list on the later 

17 of— 

18 ‘‘(I) the date such request was re19 ceived; or 

20 ‘‘(II) if the product will be with21 drawn from sale on a future date, such 

22 future date when the product is with23 drawn from sale. 

24 ‘‘(ii) TREATMENT AS WITHDRAWN

25 FROM SALE.—For purposes of clause (i), a 
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1 product shall be considered withdrawn from 

2 sale once the applicant has ceased its own 

3 distribution of the product, whether or not 

4 the applicant has ordered recall of all pre5 viously distributed lots of the product, ex6 cept that a routine, temporary interruption 

7 in supply shall not render a product with8 drawn from sale. 

9 ‘‘(iii) SPECIAL RULE FOR PRODUCTS

10 REMOVED FROM DISCONTINUED LIST.—If a 

11 biosimilar biological product that is identi12 fied in a biosimilar biological product ap13 plication approved as of October 1 of a fis14 cal year appears, as of October 1 of such fis15 cal year, on the list referenced in subpara16 graph (A) of discontinued biosimilar bio17 logical products, and on any subsequent day 

18 during such fiscal year the biosimilar bio19 logical product does not appear on such list, 

20 except as provided in subparagraph (D), 

21 each person who is named as the applicant 

22 in a biosimilar biological product applica23 tion with respect to such product shall pay 

24 the annual biosimilar biological product 

25 program fee established for a fiscal year 
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1 under subsection (c)(5) for such biosimilar 

2 biological product. Notwithstanding sub3 paragraph (B), such fee shall be due on the 

4 last business day of such fiscal year and 

5 shall be paid only once for each such prod6 uct for each fiscal year.’’. 

7 (8) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

8 Section 744H(a) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 379j–52(a)) is amended by 

10 striking paragraph (4). 

11 (b) FEE REVENUE AMOUNTS.—Subsection (b) of sec12 tion 744H of the Federal Food, Drug, and Cosmetic Act 

13 (21 U.S.C. 379j–52) is amended— 

14 (1) by striking paragraph (1); 

15 (2) by redesignating paragraphs (2) through (4) 

16 as paragraphs (1) through (3), respectively; 

17 (3) by amending paragraph (1) (as so redesig18 nated) to read as follows: 

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

20 2023 through 2027, fees under subsection (a) shall, ex21 cept as provided in subsection (c), be established to 

22 generate a total revenue amount equal to the sum 

23 of— 

24 ‘‘(A) the annual base revenue for the fiscal 

25 year (as determined under paragraph (3)); 
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1 ‘‘(B) the dollar amount equal to the infla2 tion adjustment for the fiscal year (as deter3 mined under subsection (c)(1)); 

4 ‘‘(C) the dollar amount equal to the stra5 tegic hiring and retention adjustment (as deter6 mined under subsection (c)(2)); 

7 ‘‘(D) the dollar amount equal to the capac8 ity planning adjustment for the fiscal year (as 

9 determined under subsection (c)(3)); 

10 ‘‘(E) the dollar amount equal to the oper11 ating reserve adjustment for the fiscal year, if 

12 applicable (as determined under subsection 

13 (c)(4)); 

14 ‘‘(F) for fiscal year 2023 an additional 

15 amount of $4,428,886; and 

16 ‘‘(G) for fiscal year 2024 an additional 

17 amount of $320,569.’’; 

18 (4) in paragraph (2) (as so redesignated)— 

19 (A) in the paragraph heading, by striking 

20 ‘‘; LIMITATIONS ON FEE AMOUNTS’’; 

21 (B) by striking subparagraph (B); and 

22 (C) by redesignating subparagraphs (C) 

23 and (D) as subparagraphs (B) and (C), respec24 tively; and 
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1 (5) by amending paragraph (3) (as so redesig2 nated) to read as follows: 

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

4 paragraph (1), the dollar amount of the annual base 

5 revenue for a fiscal year shall be— 

6 ‘‘(A) for fiscal year 2023, $43,376,922; and 

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

8 dollar amount of the total revenue amount estab9 lished under paragraph (1) for the previous fis10 cal year, excluding any adjustments to such rev11 enue amount under subsection (c)(4).’’. 

12 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 

13 744H(c) of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 379j–52(c)) is amended— 

15 (1) in paragraph (1)— 

16 (A) in subparagraph (A)— 

17 (i) in the matter preceding clause (i), 

18 by striking ‘‘subsection (b)(2)(B)’’ and in19 serting ‘‘subsection (b)(1)(B)’’; and 

20 (ii) in clause (i), by striking ‘‘sub21 section (b)’’ and inserting ‘‘subsection 

22 (b)(1)(A)’’; and 

23 (B) in subparagraph (B)(ii), by striking 

24 ‘‘Washington-Baltimore, DC–MD–VA–WV’’ and 
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1 inserting ‘‘Washington-Arlington-Alexandria, 

2 DC–VA–MD–WV’’; 

3 (2) by striking paragraphs (2) through (4) and 

4 inserting the following: 

5 ‘‘(2) STRATEGIC HIRING AND RETENTION AD6 JUSTMENT.—For each fiscal year, after the annual 

7 base revenue under subsection (b)(1)(A) is adjusted 

8 for inflation in accordance with paragraph (1), the 

9 Secretary shall further increase the fee revenue and 

10 fees by $150,000. 

11 ‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 

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

13 the Secretary shall, in addition to the adjust14 ments under paragraphs (1) and (2), further ad15 just the fee revenue and fees under this section 

16 for a fiscal year to reflect changes in the resource 

17 capacity needs of the Secretary for the process 

18 for the review of biosimilar biological product 

19 applications. 

20 ‘‘(B) METHODOLOGY.—For purposes of this 

21 paragraph, the Secretary shall employ the capac22 ity planning methodology utilized by the Sec23 retary in setting fees for fiscal year 2021, as de24 scribed in the notice titled ‘Biosimilar User Fee 

25 Rates for Fiscal Year 2021’ published in the Fed-
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1 eral Register on August 4, 2020 (85 Fed. Reg. 

2 47220). The workload categories used in apply3 ing such methodology in forecasting shall include 

4 only the activities described in that notice and, 

5 as feasible, additional activities that are directly 

6 related to the direct review of biosimilar biologi7 cal product applications and supplements, in8 cluding additional formal meeting types, the di9 rect review of postmarketing commitments and 

10 requirements, the direct review of risk evaluation 

11 and mitigation strategies, and the direct review 

12 of annual reports for approved biosimilar bio13 logical products. Subject to the exceptions in the 

14 preceding sentence, the Secretary shall not in15 clude as workload categories in applying such 

16 methodology in forecasting any non-core review 

17 activities, including those activities that the Sec18 retary referenced for potential future use in such 

19 notice but did not utilize in setting fees for fiscal 

20 year 2021. 

21 ‘‘(C) LIMITATIONS.—Under no cir22 cumstances shall an adjustment under this para23 graph result in fee revenue for a fiscal year that 

24 is less than the sum of the amounts under sub25 sections (b)(1)(A) (the annual base revenue for 
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1 the fiscal year), (b)(1)(B) (the dollar amount of 

2 the inflation adjustment for the fiscal year), and 

3 (b)(1)(C) (the dollar amount of the strategic hir4 ing and retention adjustment). 

5 ‘‘(D) PUBLICATION IN FEDERAL REG6 ISTER.—The Secretary shall publish in the Fed7 eral Register notice under paragraph (5) the fee 

8 revenue and fees resulting from the adjustment 

9 and the methodologies under this paragraph. 

10 ‘‘(4) OPERATING RESERVE ADJUSTMENT.— 

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

12 subsequent fiscal years, the Secretary shall, in 

13 addition to adjustments under paragraphs (1), 

14 (2), and (3), further increase the fee revenue and 

15 fees if such an adjustment is necessary to provide 

16 for at least 10 weeks of operating reserves of car17 ryover user fees for the process for the review of 

18 biosimilar biological product applications. 

19 ‘‘(B) DECREASE.— 

20 ‘‘(i) FISCAL YEAR 2023.—For fiscal 

21 year 2023, if the Secretary has carryover 

22 balances for such process in excess of 33 

23 weeks of such operating reserves, the Sec24 retary shall decrease such fee revenue and 
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1 fees to provide for not more than 33 weeks 

2 of such operating reserves. 

3 ‘‘(ii) FISCAL YEAR 2024.—For fiscal 

4 year 2024, if the Secretary has carryover 

5 balances for such process in excess of 27 

6 weeks of such operating reserves, the Sec7 retary shall decrease such fee revenue and 

8 fees to provide for not more than 27 weeks 

9 of such operating reserves. 

10 ‘‘(iii) FISCAL YEAR 2025 AND SUBSE11 QUENT FISCAL YEARS.—For fiscal year 

12 2025 and subsequent fiscal years, if the Sec13 retary has carryover balances for such proc14 ess in excess of 21 weeks of such operating 

15 reserves, the Secretary shall decrease such 

16 fee revenue and fees to provide for not more 

17 than 21 weeks of such operating reserves. 

18 ‘‘(C) FEDERAL REGISTER NOTICE.—If an 

19 adjustment under subparagraph (A) or (B) is 

20 made, the rationale for the amount of the in21 crease or decrease (as applicable) in fee revenue 

22 and fees shall be contained in the annual Federal 

23 Register notice under paragraph (5)(B) estab24 lishing fee revenue and fees for the fiscal year in25 volved.’’; and 
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1 (3) in paragraph (5), in the matter preceding 

2 subparagraph (A), by striking ‘‘2018’’ and inserting 

3 ‘‘2023’’. 

4 (d) CREDITING AND AVAILABILITY OF FEES.—Sub5 section (f)(3) of section 744H of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 379j–52(f)(3)) is amended by 

7 striking ‘‘2018 through 2022’’ and inserting ‘‘2023 through 

8 2027’’. 

9 (e) WRITTEN REQUESTS FOR WAIVERS AND RETURNS; 

10 DISPUTES CONCERNING FEES.—Section 744H(h) of the 

11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

12 52(h)) is amended to read as follows: 

13 ‘‘(h) WRITTEN REQUESTS FOR WAIVERS AND RE14 TURNS; DISPUTES CONCERNING FEES.—To qualify for con15 sideration for a waiver under subsection (d), or for the re16 turn of any fee paid under this section, including if the 

17 fee is claimed to have been paid in error, a person shall 

18 submit to the Secretary a written request justifying such 

19 waiver or return and, except as otherwise specified in this 

20 section, such written request shall be submitted to the Sec21 retary not later than 180 days after such fee is due. A re22 quest submitted under this paragraph shall include any 

23 legal authorities under which the request is made.’’. 
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1 SEC. 4004. REAUTHORIZATION; REPORTING REQUIRE2 MENTS. 

3 Section 744I of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 379j–53) is amended— 

5 (1) in subsection (a)(1), by striking ‘‘Beginning 

6 with fiscal year 2018, not’’ and inserting ‘‘Not’’; 

7 (2) by striking ‘‘Biosimilar User Fee Amend8 ments of 2017’’ each place it appears and inserting 

9 ‘‘Biosimilar User Fee Amendments of 2022’’; 

10 (3) in subsection (a)(2), by striking ‘‘Beginning 

11 with fiscal year 2018, the’’ and inserting ‘‘The’’; 

12 (4) in subsection (a)(3)(A), by striking ‘‘Not 

13 later than 30 calendar days after the end of the sec14 ond quarter of fiscal year 2018, and not later than 

15 30 calendar days after the end of each quarter of each 

16 fiscal year thereafter’’ and inserting ‘‘Not later than 

17 30 calendar days after the end of each quarter of each 

18 fiscal year for which fees are collected under this 

19 part’’; 

20 (5) in subsection (b), by striking ‘‘Not later than 

21 120 days after the end of fiscal year 2018 and each 

22 subsequent fiscal year for which fees are collected 

23 under this part’’ and inserting ‘‘Not later than 120 

24 days after the end of each fiscal year for which fees 

25 are collected under this part’’; 
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1 (6) in subsection (c), by striking ‘‘Beginning 

2 with fiscal year 2018, and for’’ and inserting ‘‘For’’; 

3 and 

4 (7) in subsection (f)— 

5 (A) in paragraph (1), in the matter pre6 ceding subparagraph (A), by striking ‘‘fiscal 

7 year 2022’’ and inserting ‘‘fiscal year 2027’’; 

8 and 

9 (B) in paragraph (3), by striking ‘‘January 

10 15, 2022’’ and inserting ‘‘January 15, 2027’’. 

11 SEC. 4005. SUNSET DATES. 

12 (a) AUTHORIZATION.—Sections 744G and 744H of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

14 51, 379j–52) shall cease to be effective October 1, 2027. 

15 (b) REPORTING REQUIREMENTS.—Section 744I of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

17 53) shall cease to be effective January 31, 2028. 

18 (c) PREVIOUS SUNSET PROVISION.—Effective October 

19 1, 2022, subsections (a) and (b) of section 405 of the FDA 

20 Reauthorization Act of 2017 (Public Law 115–52) are re21 pealed. 

22 SEC. 4006. EFFECTIVE DATE. 

23 The amendments made by this title shall take effect 

24 on October 1, 2022, or the date of the enactment of this 

25 Act, whichever is later, except that fees under part 8 of sub-
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1 chapter C of chapter VII of the Federal Food, Drug, and 

2 Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be assessed 

3 for all biosimilar biological product applications received 

4 on or after October 1, 2022, regardless of the date of the 

5 enactment of this Act. 

6 SEC. 4007. SAVINGS CLAUSE. 

7 Notwithstanding the amendments made by this title, 

8 part 8 of subchapter C of chapter VII of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), as in 

10 effect on the day before the date of the enactment of this 

11 title, shall continue to be in effect with respect to biosimilar 

12 biological product applications and supplements (as defined 

13 in such part as of such day) that were accepted by the Food 

14 and Drug Administration for filing on or after October 1, 

15 2017, but before October 1, 2022, with respect to assessing 

16 and collecting any fee required by such part for a fiscal 

17 year prior to fiscal year 2023. 

18 TITLE V—REAUTHORIZATION OF 

19 OTHER PROVISIONS 

20 SEC. 5001. REAUTHORIZATION OF THE BEST PHARMA21 CEUTICALS FOR CHILDREN PROGRAM. 

22 Section 409I(d)(1) of the Public Health Service Act 

23 (42 U.S.C. 284m(d)(1)) is amended by striking 

24 ‘‘$25,000,000 for each of fiscal years 2018 through 2022’’ 
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1 and inserting ‘‘$5,273,973 for the period beginning on Octo2 ber 1, 2022 and ending on December 16, 2022’’. 

3 SEC. 5002. REAUTHORIZATION OF THE HUMANITARIAN DE4 VICE EXEMPTION INCENTIVE. 

5 Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended 

7 by striking ‘‘October 1’’ and inserting ‘‘December 17’’. 

8 SEC. 5003. REAUTHORIZATION OF THE PEDIATRIC DEVICE 

9 CONSORTIA PROGRAM. 

10 Section 305(e) of the Food and Drug Administration 

11 Amendments Act of 2007 (Public Law 110–85; 42 U.S.C. 

12 282 note) is amended by striking ‘‘$5,250,000 for each of 

13 fiscal years 2018 through 2022’’ and inserting ‘‘$1,107,534 

14 for the period beginning on October 1, 2022, and ending 

15 on December 16, 2022’’. 

16 SEC. 5004. REAUTHORIZATION OF PROVISION PERTAINING 

17 TO DRUGS CONTAINING SINGLE 

18 ENANTIOMERS. 

19 Section 505(u)(4) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355(u)(4)) is amended by striking 

21 ‘‘October 1’’ and inserting ‘‘December 17’’. 

22 SEC. 5005. REAUTHORIZATION OF THE CRITICAL PATH PUB23 LIC-PRIVATE PARTNERSHIP. 

24 Section 566(f) of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 
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1 ‘‘$6,000,000 for each of fiscal years 2018 through 2022’’ and 

2 inserting ‘‘$1,265,753 for the period beginning on October 

3 1, 2022 and ending on December 16, 2022’’. 

4 SEC. 5006. REAUTHORIZATION OF ORPHAN DRUG GRANTS. 

5 Section 5(c) of the Orphan Drug Act (21 U.S.C. 

6 360ee(c)) is amended by striking ‘‘$30,000,000 for each of 

7 fiscal years 2018 through 2022’’ and inserting ‘‘$6,328,767 

8 for the period beginning on October 1, 2022, and ending 

9 on December 16, 2022’’. 

10 SEC. 5007. REAUTHORIZATION OF CERTAIN DEVICE INSPEC11 TIONS. 

12 Section 704(g)(11) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 374(g)(11)) is amended by striking 

14 ‘‘October 1’’ and inserting ‘‘December 17’’. 

15 SEC. 5008. REAUTHORIZATION OF REPORTING REQUIRE16 MENTS RELATED TO PENDING GENERIC 

17 DRUG APPLICATIONS AND PRIORITY REVIEW 

18 APPLICATIONS. 

19 Section 807 of the FDA Reauthorization Act of 2017 

20 (Public Law 115–52) is amended, in the matter preceding 

21 paragraph (1), by striking ‘‘October 1’’ and inserting ‘‘De22 cember 16’’. 
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1 DIVISION G—HERMIT’S PEAK/ 

2 CALF CANYON FIRE ASSIST3 ANCE ACT 

4 SEC. 101. SHORT TITLE. 

5 This division may be cited as the ‘‘Hermit’s Peak/Calf 

6 Canyon Fire Assistance Act’’. 

7 SEC. 102. FINDINGS AND PURPOSES. 

8 (a) FINDINGS.—Congress finds that— 

9 (1) on April 6, 2022, the Forest Service initiated 

10 the Las Dispensas-Gallinas prescribed burn on Fed11 eral land in the Santa Fe National Forest in San 

12 Miguel County, New Mexico, when erratic winds were 

13 prevalent in the area that was also suffering from se14 vere drought after many years of insufficient precipi15 tation; 

16 (2) on April 6, 2022, the prescribed burn, which 

17 became known as the ‘‘Hermit’s Peak Fire’’, exceeded 

18 the containment capabilities of the Forest Service, 

19 was declared a wildfire, and spread to other Federal 

20 and non-Federal land; 

21 (3) on April 19, 2022, the Calf Canyon Fire, 

22 also in San Miguel County, New Mexico, began burn23 ing on Federal land and was later identified as the 

24 result of a pile burn in January 2022 that remained 

25 dormant under the surface before reemerging; 
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1 (4) on April 27, 2022, the Hermit’s Peak Fire 

2 and the Calf Canyon Fire merged, and both fires were 

3 reported as the Hermit’s Peak Fire or the Hermit’s 

4 Peak/Calf Canyon Fire, which shall be referred to 

5 hereafter as the Hermit’s Peak/Calf Canyon Fire; 

6 (5) by May 2, 2022, the fire had grown in size 

7 and caused evacuations in multiple villages and com8 munities in San Miguel County and Mora County, 

9 including in the San Miguel county jail, the State’s 

10 psychiatric hospital, the United World College, and 

11 New Mexico Highlands University; 

12 (6) on May 4, 2022, the President issued a major 

13 disaster declaration for the counties of Colfax, Mora, 

14 and San Miguel, New Mexico; 

15 (7) on May 20, 2022, U.S. Forest Service Chief 

16 Randy Moore ordered a 90-day review of prescribed 

17 burn policies to reduce the risk of wildfires and en18 sure the safety of the communities involved; 

19 (8) the U.S. Forest Service has assumed respon20 sibility for the Hermit’s Peak/Calf Canyon Fire; 

21 (9) the fire resulted in the loss of Federal, State, 

22 local, Tribal, and private property; and 

23 (10) the United States should compensate the 

24 victims of the Hermit’s Peak/Calf Canyon Fire. 

25 (b) PURPOSES.—The purposes of this Act are— 
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1 (1) to compensate victims of the Hermit’s Peak/ 

2 Calf Canyon Fire, for injuries resulting from the fire; 

3 and 

4 (2) to provide for the expeditious consideration 

5 and settlement of claims for those injuries. 

6 SEC. 103. DEFINITIONS. 

7 In this Act: 

8 (1) ADMINISTRATOR.—The term ‘‘Adminis9 trator’’ means— 

10 (A) the Administrator of the Federal Emer11 gency Management Agency; or 

12 (B) if a Manager is appointed under section 

13 104(a)(3), the Manager. 

14 (2) HERMIT’S PEAK/CALF CANYON FIRE.—The 

15 term ‘‘Hermit’s Peak/Calf Canyon Fire’’ means— 

16 (A) the fire resulting from the initiation by 

17 the Forest Service of a prescribed burn in the 

18 Santa Fe National Forest in San Miguel Coun19 ty, New Mexico, on April 6, 2022; 

20 (B) the pile burn holdover resulting from 

21 the prescribed burn by the Forest Service, which 

22 reemerged on April 19, 2022; and 

23 (C) the merger of the two fires described in 

24 subparagraphs (A) and (B), reported as the Her-
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1 mit’s Peak Fire or the Hermit’s Peak Fire/Calf 

2 Canyon Fire. 

3 (3) INDIAN TRIBE.—The term ‘‘Indian Tribe’’ 

4 means the recognized governing body of any Indian 

5 or Alaska Native Tribe, band, nation, pueblo, village, 

6 community, component band, or component reserva7 tion individually identified (including parentheti8 cally) in the list published most recently as of the 

9 date of enactment of this Act pursuant to section 104 

10 of the Federally Recognized Indian Tribe List Act of 

11 1994 (25 U.S.C. 5131). 

12 (4) INJURED PERSON.—The term ‘‘injured per13 son’’ means— 

14 (A) an individual, regardless of the citizen15 ship or alien status of the individual; or 

16 (B) an Indian Tribe, corporation, Tribal 

17 corporation, partnership, company, association, 

18 county, township, city, State, school district, or 

19 other non-Federal entity (including a legal rep20 resentative) that suffered injury resulting from 

21 the Hermit’s Peak/Calf Canyon Fire. 

22 (5) INJURY.—The term ‘‘injury’’ has the same 

23 meaning as the term ‘‘injury or loss of property, or 

24 personal injury or death’’ as used in section 

25 1346(b)(1) of title 28, United States Code. 
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1 (6) MANAGER.—The term ‘‘Manager’’ means an 

2 Independent Claims Manager appointed under section 

3 104(a)(3). 

4 (7) OFFICE.—The term ‘‘Office’’ means the Office 

5 of Hermit’s Peak/Calf Canyon Fire Claims established 

6 by section 104(a)(2). 

7 (8) TRIBAL ENTITY.—The term ‘‘Tribal entity’’ 

8 includes any Indian Tribe, tribal organization, In9 dian-controlled organization serving Indians, Native 

10 Hawaiian organization, or Alaska Native entity, as 

11 such terms are defined or used in section 166 of the 

12 Workforce Innovation and Opportunity Act (29 

13 U.S.C. 3221). 

14 SEC. 104. COMPENSATION FOR VICTIMS OF HERMIT’S PEAK/ 

15 CALF CANYON FIRE. 

16 (a) IN GENERAL.— 

17 (1) COMPENSATION.—Each injured person shall 

18 be eligible to receive from the United States com19 pensation for injury suffered by the injured person as 

20 a result of the Hermit’s Peak/Calf Canyon Fire, sub21 ject to the availability of appropriations and subject 

22 to the Administrator making the determinations re23 quired under subsection (d). 

24 (2) OFFICE OF HERMIT’S PEAK/CALF CANYON

25 FIRE CLAIMS.— 
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1 (A) IN GENERAL.—There is established 

2 within the Federal Emergency Management 

3 Agency an Office of Hermit’s Peak/Calf Canyon 

4 Fire Claims. 

5 (B) PURPOSE.—The Office shall receive, 

6 process, and pay claims in accordance with this 

7 Act. 

8 (C) FUNDING.—The Office— 

9 (i) shall be funded from funds made 

10 available to the Administrator for carrying 

11 out this section; 

12 (ii) may appoint and fix the com13 pensation of such temporary personnel as 

14 may be necessary, without regard to the 

15 provisions of title 5, United States Code, 

16 governing appointments in competitive 

17 service; and 

18 (iii) may reimburse other Federal 

19 agencies for claims processing support and 

20 assistance. 

21 (3) OPTION TO APPOINT INDEPENDENT CLAIMS

22 MANAGER.—The Administrator may appoint an Inde23 pendent Claims Manager to— 

24 (A) head the Office; and 
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1 (B) assume the duties of the Administrator 

2 under this Act. 

3 (4) DETAIL.—Upon the request of the Adminis4 trator, the head of any Federal department or agency 

5 may detail, on a reimbursable basis, any of the per6 sonnel of that department or agency to the Federal 

7 Emergency Management Agency to assist the Agency 

8 in carrying out the duties under this Act. 

9 (b) SUBMISSION OF CLAIMS.—Not later than 2 years 

10 after the date on which regulations are first promulgated 

11 under subsection (f), an injured person may submit to the 

12 Administrator a written claim for 1 or more injuries suf13 fered by the injured person in accordance with such require14 ments as the Administrator determines to be appropriate. 

15 (c) INVESTIGATION OF CLAIMS.— 

16 (1) IN GENERAL.—In accordance with subsection 

17 (d), the Administrator shall, on behalf of the United 

18 States, investigate, consider, ascertain, adjust, deter19 mine, grant, deny, or settle any claim for money 

20 damages asserted under subsection (b). 

21 (2) APPLICABILITY OF STATE LAW.—Except as 

22 otherwise provided in this Act, the laws of the State 

23 of New Mexico shall apply to the calculation of dam24 ages under subsection (d)(4). 
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1 (3) EXTENT OF DAMAGES.—Any payment under 

2 this Act— 

3 (A) shall be limited to actual compensatory 

4 damages measured by injuries suffered; and 

5 (B) shall not include— 

6 (i) interest before settlement or pay7 ment of a claim; or 

8 (ii) punitive damages. 

9 (d) PAYMENT OF CLAIMS.— 

10 (1) DETERMINATION AND PAYMENT OF

11 AMOUNT.— 

12 (A) IN GENERAL.— 

13 (i) PAYMENT.—Not later than 180 

14 days after the date on which a claim is sub15 mitted under this Act, the Administrator 

16 shall determine and fix the amount, if any, 

17 to be paid for the claim. 

18 (ii) PRIORITY.—The Administrator, to 

19 the maximum extent practicable, shall pay 

20 subrogation claims submitted under this Act 

21 only after paying claims submitted by in22 jured parties that are not insurance compa23 nies seeking payment as subrogees. 
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1 (B) PARAMETERS OF DETERMINATION.—In 

2 determining and settling a claim under this Act, 

3 the Administrator shall determine only— 

4 (i) whether the claimant is an injured 

5 person; 

6 (ii) whether the injury that is the sub7 ject of the claim resulted from the Hermit’s 

8 Peak/Calf Canyon Fire; 

9 (iii) whether the person or persons are 

10 otherwise eligible to receive any amount de11 termined under clause (iv); and 

12 (iv) whether sufficient funds are avail13 able for payment and, if so, the amount, if 

14 any, to be allowed and paid under this Act. 

15 (C) INSURANCE AND OTHER BENEFITS.— 

16 (i) IN GENERAL.—In determining the 

17 amount of, and paying, a claim under this 

18 Act, to prevent recovery by a claimant in 

19 excess of actual compensatory damages, the 

20 Administrator shall reduce the amount to be 

21 paid for the claim by an amount that is 

22 equal to the total of insurance benefits (ex23 cluding life insurance benefits) or other 

24 payments or settlements of any nature that 
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1 were paid, or will be paid, with respect to 

2 the claim. 

3 (ii) GOVERNMENT LOANS.—This sub4 paragraph shall not apply to the receipt by 

5 a claimant of any government loan that is 

6 required to be repaid by the claimant. 

7 (2) PARTIAL PAYMENT.— 

8 (A) IN GENERAL.—At the request of a 

9 claimant, the Administrator may make 1 or 

10 more advance or partial payments, subject to the 

11 determination required under paragraph (1)(B), 

12 before the final settlement of a claim, including 

13 final settlement on any portion or aspect of a 

14 claim that is determined to be severable. 

15 (B) JUDICIAL DECISION.—If a claimant re16 ceives a partial payment on a claim under this 

17 Act, but further payment on the claim is subse18 quently denied by the Administrator, the claim19 ant may— 

20 (i) seek judicial review under sub21 section (i); and 

22 (ii) keep any partial payment that the 

23 claimant received, unless the Administrator 

24 determines that the claimant— 
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1 (I) was not eligible to receive the 

2 compensation; or 

3 (II) fraudulently procured the 

4 compensation. 

5 (3) RIGHTS OF INSURER OR OTHER THIRD

6 PARTY.—If an insurer or other third party pays any 

7 amount to a claimant to compensate for an injury de8 scribed in subsection (a), the insurer or other third 

9 party shall be subrogated to any right that the claim10 ant has to receive any payment under this Act or any 

11 other law. 

12 (4) ALLOWABLE DAMAGES.— 

13 (A) LOSS OF PROPERTY.—A claim that is 

14 paid for loss of property under this Act may in15 clude otherwise uncompensated damages result16 ing from the Hermit’s Peak/Calf Canyon Fire 

17 for— 

18 (i) an uninsured or underinsured 

19 property loss; 

20 (ii) a decrease in the value of real 

21 property; 

22 (iii) damage to physical infrastructure, 

23 including irrigation infrastructure such as 

24 acequia systems; 
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1 (iv) a cost resulting from lost subsist2 ence from hunting, fishing, firewood gath3 ering, timbering, grazing, or agricultural 

4 activities conducted on land damaged by the 

5 Hermit’s Peak/Calf Canyon Fire; 

6 (v) a cost of reforestation or revegeta7 tion on Tribal or non-Federal land, to the 

8 extent that the cost of reforestation or re9 vegetation is not covered by any other Fed10 eral program; and 

11 (vi) any other loss that the Adminis12 trator determines to be appropriate for in13 clusion as loss of property. 

14 (B) BUSINESS LOSS.—A claim that is paid 

15 for injury under this Act may include damages 

16 resulting from the Hermit’s Peak/Calf Canyon 

17 Fire for the following types of otherwise uncom18 pensated business loss: 

19 (i) Damage to tangible assets or inven20 tory, including natural resources. 

21 (ii) Business interruption losses. 

22 (iii) Overhead costs. 

23 (iv) Employee wages for work not per24 formed. 

25 (v) Loss of business net income. 
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1 (vi) Any other loss that the Adminis2 trator determines to be appropriate for in3 clusion as business loss. 

4 (C) FINANCIAL LOSS.—A claim that is paid 

5 for injury under this Act may include damages 

6 resulting from the Hermit’s Peak/Calf Canyon 

7 Fire for the following types of otherwise uncom8 pensated financial loss: 

9 (i) Increased mortgage interest costs. 

10 (ii) An insurance deductible. 

11 (iii) A temporary living or relocation 

12 expense. 

13 (iv) Lost wages or personal income. 

14 (v) Emergency staffing expenses. 

15 (vi) Debris removal and other cleanup 

16 costs. 

17 (vii) Costs of reasonable efforts, as de18 termined by the Administrator, to reduce 

19 the risk of wildfire, flood, or other natural 

20 disaster in the counties impacted by the 

21 Hermit’s Peak/Calf Canyon Fire to risk lev22 els prevailing in those counties before the 

23 Hermit’s Peak/Calf Canyon Fire, that are 

24 incurred not later than the date that is 3 

25 years after the date on which the regula-
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1 tions under subsection (f) are first promul2 gated. 

3 (viii) A premium for flood insurance 

4 that is required to be paid on or before May 

5 31, 2024, if, as a result of the Hermit’s 

6 Peak/Calf Canyon Fire, a person that was 

7 not required to purchase flood insurance be8 fore the Hermit’s Peak/Calf Canyon Fire is 

9 required to purchase flood insurance. 

10 (ix) A disaster assistance loan received 

11 from the Small Business Administration. 

12 (x) Any other loss that the Adminis13 trator determines to be appropriate for in14 clusion as financial loss. 

15 (e) ACCEPTANCE OF AWARD.—The acceptance by a 

16 claimant of any payment under this Act, except an advance 

17 or partial payment made under subsection (d)(2), shall— 

18 (1) be final and conclusive on the claimant, with 

19 respect to all claims arising out of or relating to the 

20 same subject matter; and 

21 (2) constitute a complete release of all claims 

22 against the United States (including any agency or 

23 employee of the United States) under chapter 171 of 

24 title 28, United States Code (commonly known as the 

25 ‘‘Federal Tort Claims Act’’), or any other Federal or 
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1 State law, arising out of or relating to the same sub2 ject matter. 

3 (f) REGULATIONS AND PUBLIC INFORMATION.— 

4 (1) REGULATIONS.—Notwithstanding any other 

5 provision of law, not later than 45 days after the date 

6 of enactment of this Act, the Administrator shall pro7 mulgate and publish in the Federal Register interim 

8 final regulations for the processing and payment of 

9 claims under this Act. 

10 (2) PUBLIC INFORMATION.— 

11 (A) IN GENERAL.—At the time at which the 

12 Administrator promulgates regulations under 

13 paragraph (1), the Administrator shall publish, 

14 online and in print, in newspapers of general 

15 circulation in the State of New Mexico, a clear, 

16 concise, and easily understandable explanation, 

17 in English and Spanish, of— 

18 (i) the rights conferred under this Act; 

19 and 

20 (ii) the procedural and other require21 ments of the regulations promulgated under 

22 paragraph (1). 

23 (B) DISSEMINATION THROUGH OTHER

24 MEDIA.—The Administrator shall disseminate 

25 the explanation published under subparagraph 
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1 (A) through websites, blogs, social media, bro2 chures, pamphlets, radio, television, and other 

3 media that the Administrator determines are 

4 likely to reach prospective claimants. 

5 (g) CONSULTATION.—In administering this Act, the 

6 Administrator shall consult with the Secretary of the Inte7 rior, the Secretary of Energy, the Secretary of Agriculture, 

8 the Administrator of the Small Business Administration, 

9 other Federal agencies, and State, local, and Tribal authori10 ties, as determined to be necessary by the Administrator, 

11 to— 

12 (1) ensure the efficient administration of the 

13 claims process; and 

14 (2) provide for local concerns. 

15 (h) ELECTION OF REMEDY.— 

16 (1) IN GENERAL.—An injured person may elect 

17 to seek compensation from the United States for 1 or 

18 more injuries resulting from the Hermit’s Peak/Calf 

19 Canyon Fire by— 

20 (A) submitting a claim under this Act; 

21 (B) filing a claim or bringing a civil action 

22 under chapter 171 of title 28, United States Code 

23 (commonly known as the ‘‘Federal Tort Claims 

24 Act’’); or 
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1 (C) bringing an authorized civil action 

2 under any other provision of law. 

3 (2) EFFECT OF ELECTION.—In accordance with 

4 subsection (e), an election by an injured person to 

5 seek compensation in any manner described in para6 graph (1) shall be final and conclusive on the claim7 ant with respect to all injuries resulting from the 

8 Hermit’s Peak/Calf Canyon Fire that are suffered by 

9 the claimant upon acceptance of an award. 

10 (3) ARBITRATION.— 

11 (A) IN GENERAL.—Not later than 45 days 

12 after the date of enactment of this Act, the Ad13 ministrator shall establish by regulation proce14 dures under which a dispute regarding a claim 

15 submitted under this Act may be settled by arbi16 tration. 

17 (B) ARBITRATION AS REMEDY.—On estab18 lishment of arbitration procedures under sub19 paragraph (A), an injured person that submits 

20 a disputed claim under this Act may elect to set21 tle the claim through arbitration. 

22 (C) BINDING EFFECT.—An election by an 

23 injured person to settle a claim through arbitra24 tion under this paragraph shall— 

25 (i) be binding; and 
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1 (ii) preclude any exercise by the in2 jured person of the right to judicial review 

3 of a claim described in subsection (i). 

4 (4) NO EFFECT ON ENTITLEMENTS.—The value 

5 of compensation that may be provided under this Act 

6 shall not be considered income or resources for any 

7 purpose under any Federal, State, or local laws, in8 cluding laws relating to taxation, welfare, and public 

9 assistance programs, and no State or political sub10 division thereof shall decrease any assistance other11 wise provided to an injured person because of the re12 ceipt of benefits under this Act. 

13 (i) JUDICIAL REVIEW.— 

14 (1) IN GENERAL.—Any claimant aggrieved by a 

15 final decision of the Administrator under this Act 

16 may, not later than 60 days after the date on which 

17 the decision is issued, bring a civil action in the 

18 United States District Court for the District of New 

19 Mexico, to modify or set aside the decision, in whole 

20 or in part. 

21 (2) RECORD.—The court shall hear a civil action 

22 under paragraph (1) on the record made before the 

23 Administrator. 

24 (3) STANDARD.—The decision of the Adminis25 trator incorporating the findings of the Administrator 
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1 shall be upheld if the decision is supported by sub2 stantial evidence on the record considered as a whole. 

3 (j) ATTORNEY’S AND AGENT’S FEES.— 

4 (1) IN GENERAL.—No attorney or agent, acting 

5 alone or in combination with any other attorney or 

6 agent, shall charge, demand, receive, or collect, for 

7 services rendered in connection with a claim sub8 mitted under this Act, fees in excess of the limitations 

9 established under section 2678 of title 28, United 

10 States Code. 

11 (2) VIOLATION.—An attorney or agent who vio12 lates paragraph (1) shall be fined not more than 

13 $10,000. 

14 (k) WAIVER OF REQUIREMENT FOR MATCHING

15 FUNDS.— 

16 (1) STATE AND LOCAL PROJECT.— 

17 (A) IN GENERAL.—Notwithstanding any 

18 other provision of law, a State or local project 

19 that is determined by the Administrator to be 

20 carried out in response to the Hermit’s Peak/Calf 

21 Canyon Fire under any Federal program that 

22 applies to an area affected by the Hermit’s Peak/ 

23 Calf Canyon Fire shall not be subject to any re24 quirement for State or local matching funds to 
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1 pay the cost of the project under the Federal pro2 gram. 

3 (B) FEDERAL SHARE.—The Federal share 

4 of the costs of a project described in subpara5 graph (A) shall be 100 percent. 

6 (2) OTHER NEEDS PROGRAM ASSISTANCE.—Not7 withstanding section 408(g)(2) of the Robert T. Staf8 ford Disaster Relief and Emergency Assistance Act 

9 (42 U.S.C. 5174(g)(2)), for any emergency or major 

10 disaster declared by the President under that Act for 

11 the Hermit’s Peak/Calf Canyon Fire, the Federal 

12 share of assistance provided under that section shall 

13 be 100 percent. 

14 (3) AGRICULTURAL PROGRAM ASSISTANCE.— 

15 (A) IN GENERAL.—Notwithstanding any 

16 other provision of law, a State, local, or indi17 vidual project that is determined by the Sec18 retary of Agriculture to be carried out in re19 sponse to the Hermit’s Peak/Calf Canyon Fire 

20 under any Federal program that applies to an 

21 area affected by the Hermit’s Peak/Calf Canyon 

22 Fire shall not be subject to any requirement for 

23 State, local, or individual matching funds to pay 

24 the cost of the project under the Federal pro25 gram. 
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1 (B) FEDERAL SHARE.—The Federal share 

2 of the costs of a project described in subpara3 graph (A) shall be 100 percent. 

4 (l) APPLICABILITY OF DEBT COLLECTION REQUIRE5 MENTS.—Section 3711(a) of title 31, United States Code, 

6 shall not apply to any payment under this Act, unless— 

7 (1) there is evidence of civil or criminal fraud, 

8 misrepresentation, presentation of a false claim; or 

9 (2) a claimant was not eligible under subsection 

10 (d)(2) of this Act to any partial payment. 

11 (m) INDIAN COMPENSATION.—Notwithstanding any 

12 other provision of law, in the case of an Indian Tribe, a 

13 Tribal entity, or a member of an Indian Tribe that submits 

14 a claim under this Act— 

15 (1) the Bureau of Indian Affairs shall have no 

16 authority over, or any trust obligation regarding, any 

17 aspect of the submission of, or any payment received 

18 for, the claim; 

19 (2) the Indian Tribe, Tribal entity, or member 

20 of an Indian Tribe shall be entitled to proceed under 

21 this Act in the same manner and to the same extent 

22 as any other injured person; and 

23 (3) except with respect to land damaged by the 

24 Hermit’s Peak/Calf Canyon Fire that is the subject of 

25 the claim, the Bureau of Indian Affairs shall have no 
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1 responsibility to restore land damaged by the Her2 mit’s Peak/Calf Canyon Fire. 

3 (n) REPORT.—Not later than 1 year after the date of 

4 promulgation of regulations under subsection (f)(1), and 

5 annually thereafter, the Administrator shall submit to Con6 gress a report that describes the claims submitted under this 

7 Act during the year preceding the date of submission of the 

8 report, including, for each claim— 

9 (1) the amount claimed; 

10 (2) a brief description of the nature of the claim; 

11 and 

12 (3) the status or disposition of the claim, includ13 ing the amount of any payment under this Act. 

14 (o) AUTHORIZATION OF APPROPRIATIONS.—There are 

15 authorized to be appropriated such sums as are necessary 

16 to carry out this Act. 

Attest: 

Secretary. 
117TH CONGRESS 

2D SESSION H.R. 6833 

AMENDMENT