[Congressional Record Volume 168, Number 156 (Tuesday, September 27, 2022)]
[Senate]
[Pages S5094-S5111]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 5745. Mr. SCHUMER submitted an amendment intended to be proposed 
by him to the bill H.R. 6833, to amend title XXVII of the Public Health 
Service Act, the Internal Revenue Code of 1986, and the Employee 
Retirement Income Security Act of 1974 to establish requirements with 
respect to cost-sharing for certain insulin products, and for other 
purposes; which was ordered to lie on the table; as follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Continuing Appropriations 
     and Ukraine Supplemental Appropriations Act, 2023''.

     SEC. 2. TABLE OF CONTENTS.

Sec. 1. Short Title.
Sec. 2. Table of Contents.
Sec. 3. References.
Sec. 4. Payment to Widows and Heirs of Deceased Members of Congress.

            DIVISION A--CONTINUING APPROPRIATIONS ACT, 2023

       DIVISION B--UKRAINE SUPPLEMENTAL APPROPRIATIONS ACT, 2023

                       DIVISION C--OTHER MATTERS

Title I--Extensions, Technical Corrections, and Other Matters
Title II--Budgetary Effects

            DIVISION D--HEALTH AND HUMAN SERVICES EXTENSIONS

Title I--Medicare and Medicaid
Title II--Human Services
Title III--Public Health
Title IV--Indian Health

                DIVISION E--VETERANS AFFAIRS EXTENSIONS

Title I--Extensions of authorities relating to health care
Title II--Extensions of authorities relating to benefits
Title III--Extensions of authorities relating to homeless veterans
Title IV--Extensions of other authorities

          DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022

       DIVISION G--HERMIT'S PEAK/CALF CANYON FIRE ASSISTANCE ACT

     SEC. 3. REFERENCES.

       Except as expressly provided otherwise, any reference to 
     ``this Act'' contained in any division of this Act shall be 
     treated as referring only to the provisions of that division.

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

       There is hereby appropriated for fiscal year 2023, out of 
     any money in the Treasury not otherwise appropriated, for 
     payment to Dean Swihart, beneficiary of Jacqueline Walorski-
     Swihart, late a Representative from the State of Indiana, 
     $174,000.

            DIVISION A--CONTINUING APPROPRIATIONS ACT, 2023

        The following sums are hereby appropriated, out of any 
     money in the Treasury not otherwise appropriated, and out of 
     applicable corporate or other revenues, receipts, and funds, 
     for the several departments, agencies, corporations, and 
     other organizational units of Government for fiscal year 
     2023, and for other purposes, namely:

[[Page S5095]]

       Sec. 101.  Such amounts as may be necessary, at a rate for 
     operations as provided in the applicable appropriations Acts 
     for fiscal year 2022 and under the authority and conditions 
     provided in such Acts, for continuing projects or activities 
     (including the costs of direct loans and loan guarantees) 
     that are not otherwise specifically provided for in this Act, 
     that were conducted in fiscal year 2022, and for which 
     appropriations, funds, or other authority were made available 
     in the following appropriations Acts:
       (1) The Agriculture, Rural Development, Food and Drug 
     Administration, and Related Agencies Appropriations Act, 2022 
     (division A of Public Law 117-103), except section 783, and 
     except that section 785 shall be applied by substituting 
     ``$125,000,000'' for ``$250,000,000''.
       (2) The Commerce, Justice, Science, and Related Agencies 
     Appropriations Act, 2022 (division B of Public Law 117-103), 
     except section 521(c)(1).
       (3) The Department of Defense Appropriations Act, 2022 
     (division C of Public Law 117-103).
       (4) The Energy and Water Development and Related Agencies 
     Appropriations Act, 2022 (division D of Public Law 117-103).
       (5) The Financial Services and General Government 
     Appropriations Act, 2022 (division E of Public Law 117-103), 
     except the matter under the heading ``Postal Regulatory 
     Commission'' in title V.
       (6) The Department of Homeland Security Appropriations Act, 
     2022 (division F of Public Law 117-103), except sections 544 
     and 545, and including title II of division O of Public Law 
     117-103.
       (7) The Department of the Interior, Environment, and 
     Related Agencies Appropriations Act, 2022 (division G of 
     Public Law 117-103).
       (8) The Departments of Labor, Health and Human Services, 
     and Education, and Related Agencies Appropriations Act, 2022 
     (division H of Public Law 117-103), and section 162 of 
     division A of Public Law 117-43.
       (9) The Legislative Branch Appropriations Act, 2022 
     (division I of Public Law 117-103), and section 6 in the 
     matter preceding division A of Public Law 117-103.
       (10) The Military Construction, Veterans Affairs, and 
     Related Agencies Appropriations Act, 2022 (division J of 
     Public Law 117-103).
       (11) The Department of State, Foreign Operations, and 
     Related Programs Appropriations Act, 2022 (division K of 
     Public Law 117-103), except the first proviso of section 
     7069(e).
       (12) The Transportation, Housing and Urban Development, and 
     Related Agencies Appropriations Act, 2022 (division L of 
     Public Law 117-103).
       Sec. 102. (a) No appropriation or funds made available or 
     authority granted pursuant to section 101 for the Department 
     of Defense shall be used for:
       (1) the new production of items not funded for production 
     in fiscal year 2022 or prior years;
       (2) the increase in production rates above those sustained 
     with fiscal year 2022 funds; or
       (3) the initiation, resumption, or continuation of any 
     project, activity, operation, or organization (defined as any 
     project, subproject, activity, budget activity, program 
     element, and subprogram within a program element, and for any 
     investment items defined as a P-1 line item in a budget 
     activity within an appropriation account and an R-1 line item 
     that includes a program element and subprogram element within 
     an appropriation account) for which appropriations, funds, or 
     other authority were not available during fiscal year 2022.
       (b) No appropriation or funds made available or authority 
     granted pursuant to section 101 for the Department of Defense 
     shall be used to initiate multi-year procurements utilizing 
     advance procurement funding for economic order quantity 
     procurement unless specifically appropriated later.
       Sec. 103.  Appropriations made by section 101 shall be 
     available to the extent and in the manner that would be 
     provided by the pertinent appropriations Act.
       Sec. 104.  Except as otherwise provided in section 102, no 
     appropriation or funds made available or authority granted 
     pursuant to section 101 shall be used to initiate or resume 
     any project or activity for which appropriations, funds, or 
     other authority were not available during fiscal year 2022.
       Sec. 105.  Appropriations made and authority granted 
     pursuant to this Act shall cover all obligations or 
     expenditures incurred for any project or activity during the 
     period for which funds or authority for such project or 
     activity are available under this Act.
       Sec. 106.  Unless otherwise provided for in this Act or in 
     the applicable appropriations Act for fiscal year 2023, 
     appropriations and funds made available and authority granted 
     pursuant to this Act shall be available until whichever of 
     the following first occurs:
       (1) The enactment into law of an appropriation for any 
     project or activity provided for in this Act.
       (2) The enactment into law of the applicable appropriations 
     Act for fiscal year 2023 without any provision for such 
     project or activity.
       (3) December 16, 2022.
       Sec. 107.  Expenditures made pursuant to this Act shall be 
     charged to the applicable appropriation, fund, or 
     authorization whenever a bill in which such applicable 
     appropriation, fund, or authorization is contained is enacted 
     into law.
       Sec. 108.  Appropriations made and funds made available by 
     or authority granted pursuant to this Act may be used without 
     regard to the time limitations for submission and approval of 
     apportionments set forth in section 1513 of title 31, United 
     States Code, but nothing in this Act may be construed to 
     waive any other provision of law governing the apportionment 
     of funds.
       Sec. 109.  Notwithstanding any other provision of this Act, 
     except section 106, for those programs that would otherwise 
     have high initial rates of operation or complete distribution 
     of appropriations at the beginning of fiscal year 2023 
     because of distributions of funding to States, foreign 
     countries, grantees, or others, such high initial rates of 
     operation or complete distribution shall not be made, and no 
     grants shall be awarded for such programs funded by this Act 
     that would impinge on final funding prerogatives.
       Sec. 110.  This Act shall be implemented so that only the 
     most limited funding action of that permitted in the Act 
     shall be taken in order to provide for continuation of 
     projects and activities.
       Sec. 111. (a) For entitlements and other mandatory payments 
     whose budget authority was provided in appropriations Acts 
     for fiscal year 2022, and for activities under the Food and 
     Nutrition Act of 2008, activities shall be continued at the 
     rate to maintain program levels under current law, under the 
     authority and conditions provided in the applicable 
     appropriations Act for fiscal year 2022, to be continued 
     through the date specified in section 106(3).
       (b) Notwithstanding section 106, obligations for mandatory 
     payments due on or about the first day of any month that 
     begins after October 2022 but not later than 30 days after 
     the date specified in section 106(3) may continue to be made, 
     and funds shall be available for such payments.
       Sec. 112.  Amounts made available under section 101 for 
     civilian personnel compensation and benefits in each 
     department and agency may be apportioned up to the rate for 
     operations necessary to avoid furloughs within such 
     department or agency, consistent with the applicable 
     appropriations Act for fiscal year 2022, except that such 
     authority provided under this section shall not be used until 
     after the department or agency has taken all necessary 
     actions to reduce or defer non-personnel-related 
     administrative expenses.
       Sec. 113.  Funds appropriated by this Act may be obligated 
     and expended notwithstanding section 10 of Public Law 91-672 
     (22 U.S.C. 2412), section 15 of the State Department Basic 
     Authorities Act of 1956 (22 U.S.C. 2680), section 313 of the 
     Foreign Relations Authorization Act, Fiscal Years 1994 and 
     1995 (22 U.S.C. 6212), and section 504(a)(1) of the National 
     Security Act of 1947 (50 U.S.C. 3094(a)(1)).
       Sec. 114.  Each amount incorporated by reference in this 
     Act that was previously designated by the Congress as an 
     emergency requirement pursuant to sections 4001(a)(1) and 
     4001(b) of S. Con. Res. 14 (117th Congress), the concurrent 
     resolution on the budget for fiscal year 2022, or as being 
     for disaster relief pursuant to section 4005(f) of such 
     concurrent resolution, is designated as being an emergency 
     requirement pursuant to section 4001(a)(1) of such concurrent 
     resolution and section 1(e) of H. Res. 1151 (117th Congress), 
     as engrossed in the House of Representatives on June 8, 2022, 
     or as being for disaster relief pursuant to section 1(f) of 
     such House resolution, respectively.
       Sec. 115. (a) Rescissions or cancellations of discretionary 
     budget authority that continue pursuant to section 101 in 
     Treasury Appropriations Fund Symbols (TAFS)--
       (1) to which other appropriations are not provided by this 
     Act, but for which there is a current applicable TAFS that 
     does receive an appropriation in this Act; or
       (2) which are no-year TAFS and receive other appropriations 
     in this Act,
     may be continued instead by reducing the rate for operations 
     otherwise provided by section 101 for such current applicable 
     TAFS, as long as doing so does not impinge on the final 
     funding prerogatives of the Congress.
       (b) Rescissions or cancellations described in subsection 
     (a) shall continue in an amount equal to the lesser of--
       (1) the amount specified for rescission or cancellation in 
     the applicable appropriations Act referenced in section 101 
     of this Act; or
       (2) the amount of balances available, as of October 1, 
     2022, from the funds specified for rescission or cancellation 
     in the applicable appropriations Act referenced in section 
     101 of this Act.
       (c) No later than November 21, 2022, the Director of the 
     Office of Management and Budget shall provide to the 
     Committees on Appropriations of the House of Representatives 
     and the Senate a comprehensive list of the rescissions or 
     cancellations that will continue pursuant to section 101:  
     Provided, That the information in such comprehensive list 
     shall be periodically updated to reflect any subsequent 
     changes in the amount of balances available, as of October 1, 
     2022, from the funds specified for rescission or cancellation 
     in the applicable appropriations Act referenced in section 
     101, and such updates shall be transmitted to the Committees 
     on Appropriations of the House of Representatives and the 
     Senate upon request.
       Sec. 116.  Amounts made available by section 101 for ``Farm 
     Service Agency--Agricultural Credit Insurance Fund Program 
     Account'' may be apportioned up to the rate for

[[Page S5096]]

     operations necessary to accommodate approved applications for 
     direct and guaranteed farm ownership loans, as authorized by 
     7 U.S.C. 1922 et seq.
       Sec. 117.  Amounts made available by section 101 to the 
     Department of Agriculture for ``Rural Business--Cooperative 
     Service--Rural Microentrepreneur Assistance Program'' may be 
     used for the costs of loans, including the cost of modifying 
     such loans, as defined in section 502 of the Congressional 
     Budget Act of 1974, under the same terms and conditions as 
     authorized by section 379E of the Consolidated Farm and Rural 
     Development Act (7 U.S.C. 2008s).
       Sec. 118.  Section 260 of the Agricultural Marketing Act of 
     1946 (7 U.S.C. 1636i) and section 942 of the Livestock 
     Mandatory Reporting Act of 1999 (7 U.S.C. 1635 note; Public 
     Law 106-78) shall be applied by substituting the date 
     specified in section 106(3) of this Act for ``September 30, 
     2022''.
       Sec. 119.  Amounts made available by section 101 to the 
     Department of Commerce for ``Economic Development 
     Administration--Salaries and Expenses'' may be apportioned up 
     to the rate for operations necessary to maintain agency 
     operations.
       Sec. 120.  Amounts made available by section 101 for 
     ``Department of Commerce--National Telecommunications and 
     Information Administration--Salaries and Expenses'' may be 
     apportioned up to the rate for operations necessary to ensure 
     continued oversight of public safety communications programs.
       Sec. 121.  In addition to amounts otherwise provided by 
     section 101, for ``Department of Justice--Federal Bureau of 
     Investigation--Salaries and Expenses'', there is appropriated 
     $15,300,000, for an additional amount for fiscal year 2023, 
     to remain available until September 30, 2023, for 
     investigative activities associated with Afghan resettlement 
     operations:  Provided, That such amount is designated by the 
     Congress as being for an emergency requirement pursuant to 
     section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the 
     concurrent resolution on the budget for fiscal year 2022, and 
     section 1(e) of H. Res. 1151 (117th Congress), as engrossed 
     in the House of Representatives on June 8, 2022.
       Sec. 122. (a) Notwithstanding sections 101 and 106, through 
     September 30, 2023, the Secretary of Defense may transfer up 
     to $3,000,000,000 from unobligated balances from amounts made 
     available under the heading ``Department of Defense--
     Operation and Maintenance--Overseas Humanitarian, Disaster, 
     and Civic Aid'' in division C of Public Law 117-43 and 
     division B of Public Law 117-70 to any appropriation account 
     under the headings ``Department of State and Related Agency--
     Department of State--Administration of Foreign Affairs'', 
     ``Bilateral Economic Assistance--Department of State--
     Migration and Refugee Assistance'', and ``Bilateral Economic 
     Assistance--Department of State--United States Emergency 
     Refugee and Migration Assistance Fund'' for support of 
     Operation Allies Welcome or any successor operation:  
     Provided, That upon transfer, such funds shall be merged with 
     the appropriation to which such funds are transferred except 
     that such funds may be made available for such purposes 
     notwithstanding any requirement or limitation applicable to 
     the appropriation to which transferred, including sections 
     2(c)(1) and 2(c)(2) of the Migration and Refugee Assistance 
     Act of 1962 with respect to the United States Emergency 
     Refugee and Migration Assistance Fund and in sections 4(a) 
     and 4(b) of the State Department Basic Authorities Act of 
     1956 with respect to funds transferred to the Emergencies in 
     the Diplomatic and Consular Service account:  Provided 
     further, That section 2215 of title 10, United States Code, 
     shall not apply to a transfer of funds under this subsection: 
      Provided further, That the exercise of the authority of this 
     subsection shall be subject to prior consultation with, and 
     the regular notification procedures of, the Committees on 
     Appropriations of the House of Representatives and the 
     Senate:  Provided further, That any funds transferred 
     pursuant to this subsection that were previously designated 
     by the Congress as an emergency requirement pursuant to the 
     concurrent resolution on the budget are designated by the 
     Congress as being for an emergency requirement pursuant to 
     section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the 
     concurrent resolution on the budget for fiscal year 2022, and 
     section 1(e) of H. Res. 1151 (117th Congress), as engrossed 
     in the House of Representatives on June 8, 2022.
       (b) Not later than November 1, 2022 and prior to any 
     transfer of funds pursuant to subsection (a), the Director of 
     the Office of Management and Budget shall provide to the 
     Committees on Appropriations of the House of Representatives 
     and the Senate a written report on Operation Allies Welcome 
     or any successor operation:  Provided, That such report shall 
     describe the number and status of Afghans residing at 
     Department of Defense and Department of State-managed 
     facilities and any anticipated future arrivals at such 
     facilities; the strategy and plan, including timeline, for 
     adjudicating and relocating all Afghans residing at 
     Department of Defense or overseas civilian facilities and for 
     the transition of operations and responsibilities under 
     Operation Allies Welcome or any successor operation from the 
     Department of Defense to the Department of State during 
     fiscal year 2023; the activities and responsibilities 
     assigned to each Federal agency involved in such strategy and 
     plan; and a spend plan, containing an estimate of the costs, 
     including additional construction and security costs, to be 
     incurred by each such agency for carrying out such strategy 
     and plan, and the sources of funds:  Provided further, That 
     prior to the initial obligation of funds transferred to the 
     Department of State pursuant to subsection (a), the Secretary 
     of State shall submit a report to such Committees detailing 
     the roles and responsibilities of Department of State bureaus 
     and offices in Operation Allies Welcome or any successor 
     operation.
       Sec. 123.  During the period covered by this Act, section 
     714(b)(2)(B) of title 10, United States Code, shall be 
     applied by substituting ``three years'' for ``two years''.
       Sec. 124. (a) Of the remaining unobligated balances, as of 
     September 30, 2022, from amounts provided under the heading 
     ``Afghanistan Security Forces Fund'' in title IX of division 
     C of Public Law 116-260, $100,000,000 is hereby permanently 
     rescinded, and in addition to amounts otherwise provided by 
     section 101, an amount of additional new budget authority 
     equivalent to the amount rescinded pursuant to this 
     subsection is hereby appropriated on September 30, 2022, for 
     an additional amount for fiscal year 2022, to remain 
     available until September 30, 2025, for the same purposes and 
     under the same authorities provided under such heading in 
     Public Law 116-260, in addition to other funds as may be 
     available for such purposes.
       (b)(1) Subject to paragraph (2), this section shall become 
     effective immediately upon enactment of this Act.
       (2) If this Act is enacted after September 30, 2022, this 
     section shall be applied as if it were in effect on September 
     30, 2022.
       Sec. 125.  In addition to amounts otherwise provided by 
     section 101, for ``Corps of Engineers--Civil--Construction'', 
     there is appropriated $20,000,000, for an additional amount 
     for fiscal year 2023, to remain available until expended, for 
     necessary expenses related to water and wastewater 
     infrastructure under section 219 of the Water Resources 
     Development Act of 1992 (106 Stat. 4835):  Provided, That 
     such amount is designated by the Congress as being for an 
     emergency requirement pursuant to section 4001(a)(1) of S. 
     Con. Res. 14 (117th Congress), the concurrent resolution on 
     the budget for fiscal year 2022, and section 1(e) of H. Res. 
     1151 (117th Congress), as engrossed in the House of 
     Representatives on June 8, 2022.
       Sec. 126. (a) During the period covered by this Act, title 
     I of Public Law 108-361 (the Calfed Bay-Delta Authorization 
     Act) (118 Stat. 1681), as amended by section 204 of division 
     D of Public Law 117-103, shall be applied by substituting 
     ``2023'' for ``2022'' each place it appears.
       (b) During the period covered by this Act, section 
     103(f)(4)(A) of title I of Public Law 108-361 (the Calfed 
     Bay-Delta Authorization Act) (118 Stat. 1696) shall be 
     applied by substituting ``$25,650,000'' for ``$25,000,000''.
       Sec. 127. (a) During the period covered by this Act, 
     section 9106(g)(2) of Public Law 111-11 (Omnibus Public Land 
     Management Act of 2009) shall be applied by substituting 
     ``2023'' for ``2022''.
       (b) During the period covered by this Act, section 104(c) 
     of the Reclamation States Emergency Drought Relief Act of 
     1991 (43 U.S.C. 2214(c)) shall be applied by substituting 
     ``2023'' for ``2022''.
       (c) During the period covered by this Act, section 301 of 
     the Reclamation States Emergency Drought Relief Act of 1991 
     (43 U.S.C. 2241) shall be applied by substituting ``2023'' 
     for ``2022''.
       Sec. 128.  In addition to amounts otherwise provided by 
     section 101, amounts are provided for ``Department of the 
     Treasury--Alcohol and Tobacco Tax and Trade Bureau--Salaries 
     and Expenses'' at a rate for operations of $14,929,000, for 
     an additional amount to administer the Craft Beverage 
     Modernization Act import claims program, as required by the 
     Taxpayer Certainty and Disaster Tax Relief Act of 2020, and 
     such amounts may be apportioned up to the rate for operations 
     necessary to establish and implement a new import claims 
     program.
       Sec. 129.  Notwithstanding section 101, title II of 
     division E of Public Law 117-103 shall be applied by adding 
     the following new heading and appropriation language under 
     the heading ``Executive Office of the President and Funds 
     Appropriated to the President'':

                ``Office of the National Cyber Director

                        ``salaries and expenses

       ``For necessary expenses of the Office of the National 
     Cyber Director, as authorized by section 1752 of the William 
     M. (Mac) Thornberry National Defense Authorization Act for 
     Fiscal Year 2021 (Public Law 116-283), $21,000,000, of which 
     not to exceed $5,000 shall be available for official 
     reception and representation expenses.''.
       Sec. 130.  Notwithstanding section 101, amounts are 
     provided for ``The Judiciary--Courts of Appeals, District 
     Courts, and Other Judicial Services--Fees of Jurors and 
     Commissioners'' at a rate for operations of $59,565,000.
       Sec. 131.  In addition to amounts otherwise provided by 
     section 101, for ``The Judiciary--Courts of Appeals, District 
     Courts, and Other Judicial Services--Court Security'', there 
     is appropriated $112,500,000, for an additional amount for 
     fiscal year 2023, to remain available until expended, for 
     security improvements at United States courthouses and 
     Federal court facilities:  Provided, That not later than 90 
     days after the date of enactment of this Act, and every 90 
     days thereafter until all funds provided by this section have 
     been expended, the Director of the Administrative Office of 
     the United States Courts shall provide, in an appropriate 
     format, quarterly reports on the obligations and expenditures 
     of

[[Page S5097]]

     the funds provided under this section to the Committees on 
     Appropriations of the House of Representatives and the 
     Senate:  Provided further, That such amount is designated by 
     the Congress as being for an emergency requirement pursuant 
     to section 4001(a)(1) of S. Con. Res. 14 (117th Congress), 
     the concurrent resolution on the budget for fiscal year 2022, 
     and section 1(e) of H. Res. 1151 (117th Congress), as 
     engrossed in the House of Representatives on June 8, 2022.
       Sec. 132.  Notwithstanding any other provision of this Act, 
     except section 106, the District of Columbia may expend local 
     funds made available under the heading ``District of 
     Columbia--District of Columbia Funds'' for such programs and 
     activities under the District of Columbia Appropriations Act, 
     2022 (title IV of division E of Public Law 117-103) at the 
     rate set forth in the Fiscal Year 2023 Local Budget Act of 
     2022 (D.C. Act 24-486), as modified as of the date of 
     enactment of this Act.
       Sec. 133.  In addition to amounts otherwise provided by 
     section 101, amounts are provided for ``Small Business 
     Administration--Salaries and Expenses'' at a rate for 
     operations of $20,000,000, for an additional amount for costs 
     associated with the establishment and implementation of a 
     Government-wide service-disabled veteran-owned small business 
     certification program within the Small Business 
     Administration, as required by section 36 of the Small 
     Business Act (15 U.S.C. 657f) and section 862 of Public Law 
     116-283:  Provided, That such amounts may be apportioned up 
     to the rate for operations necessary to establish and 
     implement such certification program:  Provided further, That 
     such amounts may be obligated in the account and budget 
     structure set forth in H.R. 8294, as passed by the House of 
     Representatives on July 20, 2022.
       Sec. 134.  Amounts made available by section 101 for 
     ``Small Business Administration--Business Loans Program 
     Account'' may be apportioned up to the rate for operations 
     necessary to accommodate increased demand for commitments for 
     general business loans authorized under paragraphs (1) 
     through (35) of section 7(a) of the Small Business Act (15 
     U.S.C. 636(a)), for guarantees of trust certificates 
     authorized by section 5(g) of the Small Business Act (15 
     U.S.C. 634(g)), for commitments to guarantee loans under 
     section 503 of the Small Business Investment Act of 1958 (15 
     U.S.C. 697), and for commitments to guarantee loans for 
     debentures under section 303(b) of the Small Business 
     Investment Act of 1958 (15 U.S.C. 683(b)).
       Sec. 135.  Amounts made available by section 101 to the 
     Department of Homeland Security under the heading ``Federal 
     Emergency Management Agency--Disaster Relief Fund'' may be 
     apportioned up to the rate for operations necessary to carry 
     out response and recovery activities under the Robert T. 
     Stafford Disaster Relief and Emergency Assistance Act (42 
     U.S.C. 5121 et seq.).
       Sec. 136.  Notwithstanding sections 101, 104, and 106, to 
     carry out the Hermit's Peak/Calf Canyon Fire Assistance Act, 
     there is appropriated $2,500,000,000, to remain available 
     until expended, to the Department of Homeland Security for 
     ``Federal Emergency Management Agency--Hermit's Peak/Calf 
     Canyon Fire Assistance Account'', which shall be derived by 
     transfer from amounts made available under the heading 
     ``Federal Emergency Management Agency--Disaster Relief Fund'' 
     in title VI of division B of the Coronavirus Aid, Relief, and 
     Economic Security Act (Public Law 116-136), of which 
     $1,000,000 shall be transferred to ``Office of the Inspector 
     General--Operations and Support'' for oversight of activities 
     authorized by the Hermit's Peak/Calf Canyon Fire Assistance 
     Act:  Provided, That no amounts may be derived from amounts 
     made available for major disasters declared pursuant to the 
     Robert T. Stafford Disaster Relief and Emergency Assistance 
     Act (42 U.S.C. 5121 et seq.):  Provided further, That amounts 
     provided by this section shall be subject to the same 
     authorities and conditions as if such amounts were provided 
     by title III of the Department of Homeland Security 
     Appropriations Act, 2022 (division F of Public Law 117-103):  
     Provided further, That not later than 90 days after the date 
     of enactment of this Act, and every 90 days thereafter until 
     all funds provided by this section have been expended, the 
     Administrator of the Federal Emergency Management Agency 
     shall provide, in an appropriate format, quarterly reports to 
     the Committees on Appropriations of the Senate and the House 
     of Representatives on the obligations and expenditures of the 
     funds made available by this section:  Provided further, That 
     amounts transferred by this section that were previously 
     designated by the Congress as an emergency requirement 
     pursuant to the Balanced Budget and Emergency Deficit Control 
     Act of 1985 or a concurrent resolution on the budget are 
     designated as an emergency requirement pursuant to section 
     4001(a)(1) of S. Con. Res. 14 (117th Congress), the 
     concurrent resolution on the budget for fiscal year 2022, and 
     section 1(e) of H. Res. 1151 (117th Congress), as engrossed 
     in the House of Representatives on June 8, 2022.
       Sec. 137.  Section 708(b)(13) of the Homeland Security Act 
     of 2002 (6 U.S.C. 348(b)(13)) shall be applied by 
     substituting the date specified in section 106(3) of this Act 
     for ``September 30, 2022''.
       Sec. 138.  During the period covered by this Act, section 
     822(a) of the Homeland Security Act of 2002 (6 U.S.C. 383(a)) 
     shall be applied by substituting ``2023'' for ``2022''.
       Sec. 139. (a) Sections 1309(a) and 1319 of the National 
     Flood Insurance Act of 1968 (42 U.S.C. 4016(a) and 4026) 
     shall be applied by substituting the date specified in 
     section 106(3) of this Act for ``September 30, 2022''.
       (b)(1) Subject to paragraph (2), this section shall become 
     effective immediately upon enactment of this Act.
       (2) If this Act is enacted after September 30, 2022, this 
     section shall be applied as if it were in effect on September 
     30, 2022.
       Sec. 140.  Section 880(g) of the National Defense 
     Authorization Act for Fiscal Year 2017 (Public Law 114-328) 
     shall be applied by substituting the date specified in 
     section 106(3) of this Act for ``September 30, 2022''.
       Sec. 141.  Section 210G(i) of the Homeland Security Act of 
     2002 (6 U.S.C. 124n(i)) shall be applied by substituting the 
     date specified in section 106(3) of this Act for ``the date 
     that is 4 years after the date of enactment of this 
     section''.
       Sec. 142.  Amounts made available by section 101 for 
     ``Department of the Interior--National Park Service--National 
     Recreation and Preservation'' for heritage partnership 
     programs may be used to provide financial assistance to any 
     national heritage area, national heritage corridor, cultural 
     heritage corridor, national heritage partnership, national 
     heritage route, national heritage canalway, and battlefields 
     national historic district established as of September 1, 
     2022, notwithstanding any statutory sunset provision 
     terminating the Secretary's authority to provide assistance 
     to any such area and notwithstanding any limitation on 
     amounts authorized to be appropriated with respect to any 
     such area.
       Sec. 143.  Amounts made available by section 101 to the 
     Department of the Interior under the heading ``Working 
     Capital Fund'' may be apportioned up to the rate for 
     operations necessary to implement enterprise cybersecurity 
     safeguards.
       Sec. 144. (a) In addition to amounts otherwise provided by 
     section 101, amounts are provided for ``Department of Health 
     and Human Services--Indian Health Service--Indian Health 
     Services'' at a rate for operations of $16,721,000, for an 
     additional amount for costs of staffing and operating 
     facilities that were opened, renovated, or expanded in fiscal 
     years 2022 and 2023, and such amounts may be apportioned up 
     to the rate for operations necessary to staff and operate 
     such facilities.
       (b) In addition to amounts otherwise provided by section 
     101, amounts are provided for ``Department of Health and 
     Human Services--Indian Health Service--Indian Health 
     Facilities'' at a rate for operations of $1,201,000, for an 
     additional amount for costs of staffing and operating 
     facilities that were opened, renovated, or expanded in fiscal 
     years 2022 and 2023, and such amounts may be apportioned up 
     to the rate for operations necessary to staff and operate 
     such facilities.
       Sec. 145.  In addition to amounts otherwise provided by 
     section 101, for ``Department of Health and Human Services--
     Substance Abuse and Mental Health Services Administration--
     Mental Health'', there is appropriated $62,000,000, for an 
     additional amount for fiscal year 2023, to remain available 
     until September 30, 2023, for carrying out 988 Suicide 
     Lifeline activities and behavioral health crisis services.
       Sec. 146.  In addition to amounts otherwise provided by 
     section 101, for ``Department of Health and Human Services--
     Administration for Children and Families--Low Income Home 
     Energy Assistance'', there is appropriated $1,000,000,000, 
     for an additional amount for fiscal year 2023, to remain 
     available until September 30, 2023, for making payments under 
     subsection (b) of section 2602 of the Low-Income Home Energy 
     Assistance Act of 1981 (42 U.S.C. 8621 et seq.):  Provided, 
     That of the funds made available by this section, 
     $500,000,000 shall be allocated as though the total 
     appropriation for such payments for fiscal year 2023 was less 
     than $1,975,000,000:  Provided further, That such amount is 
     designated by the Congress as being for an emergency 
     requirement pursuant to section 4001(a)(1) of S. Con. Res. 14 
     (117th Congress), the concurrent resolution on the budget for 
     fiscal year 2022, and section 1(e) of H. Res. 1151 (117th 
     Congress), as engrossed in the House of Representatives on 
     June 8, 2022.
       Sec. 147.  In addition to amounts otherwise provided by 
     section 101, for ``Department of Health and Human Services--
     Administration for Children and Families--Refugee and Entrant 
     Assistance'', there is appropriated $1,775,000,000, for an 
     additional amount for fiscal year 2023, to remain available 
     until September 30, 2025, to carry out section 462 of the 
     Homeland Security Act of 2002 and section 235 of the William 
     Wilberforce Trafficking Victims Protection Reauthorization 
     Act of 2008, and for refugee and entrant assistance 
     activities authorized by section 414 of the Immigration and 
     Nationality Act and section 501 of the Refugee Education 
     Assistance Act of 1980:  Provided, That such amount is 
     designated by the Congress as being for an emergency 
     requirement pursuant to section 4001(a)(1) of S. Con. Res. 14 
     (117th Congress), the concurrent resolution on the budget for 
     fiscal year 2022, and section 1(e) of H. Res. 1151 (117th 
     Congress), as engrossed in the House of Representatives on 
     June 8, 2022.
       Sec. 148.  Notwithstanding section 101, the first paragraph 
     under the heading ``Social Security Administration--
     Limitation on Administrative Expenses'' in title IV of 
     division H of Public Law 117-103 shall be applied by 
     substituting ``$13,602,945,000'' for ``$13,202,945,000''.
       Sec. 149. (a) During the period covered by this Act, 
     subsection (a)(1)(A) of section 2502 of the Afghanistan 
     Supplemental Appropriations Act, 2022 (division C of Public 
     Law 117-

[[Page S5098]]

     43) shall be applied by substituting the date specified in 
     section 106(3) for ``September 30, 2022''.
       (b) The amount provided by this section is designated as an 
     emergency requirement pursuant to section 4001(a)(1) of S. 
     Con. Res. 14 (117th Congress), the concurrent resolution on 
     the budget for fiscal year 2022, and section 1(e) of H. Res. 
     1151 (117th Congress), as engrossed in the House of 
     Representatives on June 8, 2022.
       Sec. 150.  Activities authorized by part A of title IV 
     (other than under section 403(c) or 418) and section 1108(b) 
     of the Social Security Act shall continue through the date 
     specified in section 106(3), in the manner authorized for 
     fiscal year 2022, and out of any money in the Treasury of the 
     United States not otherwise appropriated, there are hereby 
     appropriated such sums as may be necessary for such purpose.
       Sec. 151.  Notwithstanding section 101, section 126 of 
     division J of Public Law 117-103 shall be applied during the 
     period covered by this Act by substituting ``fiscal year 2017 
     and fiscal year 2018'' for ``fiscal year 2017''.
       Sec. 152.  Notwithstanding section 101, amounts are 
     provided for--
       (1) ``Department of State and Related Agency--Department of 
     State--Administration of Foreign Affairs--Diplomatic 
     Programs'' at a rate for operations of $9,228,789,000;
       (2) ``Bilateral Economic Assistance--Funds Appropriated to 
     the President--International Disaster Assistance'' at a rate 
     for operations of $4,555,460,000;
       (3) ``Bilateral Economic Assistance--Funds Appropriated to 
     the President--Transition Initiatives'' at a rate for 
     operations of $100,000,000;
       (4) ``Bilateral Economic Assistance--Funds Appropriated to 
     the President--Assistance for Europe, Eurasia and Central 
     Asia'' at a rate for operations of $850,000,000;
       (5) ``Bilateral Economic Assistance--Department of State--
     Migration and Refugee Assistance'' at a rate for operations 
     of $3,562,188,000;
       (6) ``International Security Assistance--Department of 
     State--International Narcotics Control and Law Enforcement'' 
     at a rate for operations of $1,421,004,000; and
       (7) ``International Security Assistance--Funds Appropriated 
     to the President--Foreign Military Financing Program'' at a 
     rate for operations of $6,190,424,000.
       Sec. 153.  During the period covered by this Act, section 
     579 of the Multifamily Assisted Housing Reform and 
     Affordability Act of 1997 (42 U.S.C. 1437f note) shall be 
     applied by substituting ``2023'' for ``2022'' each place it 
     appears.
       Sec. 154.  Amounts made available by section 101 to the 
     Department of Housing and Urban Development for ``Public and 
     Indian Housing--Native Hawaiian Housing Loan Guarantee Fund 
     Program Account'' may be apportioned up to the rate for 
     operations necessary to accommodate demand for commitments to 
     guarantee loans as authorized by section 184A of the Housing 
     and Community Development Act of 1992 (12 U.S.C. 1715z-13b).
       Sec. 155.  In addition to amounts otherwise provided by 
     section 101, for ``Department of Housing and Urban 
     Development--Community Planning and Development--Community 
     Development Fund'', there is appropriated $2,000,000,000, for 
     an additional amount for fiscal year 2023, to remain 
     available until expended, for the same purposes and under the 
     same terms and conditions as funds appropriated under such 
     heading in title VIII of the Disaster Relief Supplemental 
     Appropriations Act, 2022 (division B of Public Law 117-43), 
     except that such amounts shall be for major disasters that 
     occurred in 2021 or 2022 and the fourth, twentieth, and 
     twenty-first provisos under such heading in such Act shall 
     not apply:  Provided, That amounts made available under this 
     section and under such heading in such Act may be used by a 
     grantee to assist utilities as part of a disaster-related 
     eligible activity under section 105(a) of the Housing and 
     Community Development Act of 1974 (42 U.S.C. 5305(a)):  
     Provided further, That such amount is designated by the 
     Congress as being for an emergency requirement pursuant to 
     section 4001(a)(1) of S. Con. Res. 14 (117th Congress), the 
     concurrent resolution on the budget for fiscal year 2022, and 
     section 1(e) of H. Res. 1151 (117th Congress), as engrossed 
     in the House of Representatives on June 8, 2022.
       Sec. 156.  Notwithstanding section 106 of this Act, at any 
     time during fiscal year 2023, the Secretary of Housing and 
     Urban Development may transfer up to $1,300,000 in 
     unobligated balances from amounts made available in prior 
     Acts under the heading ``Housing Programs--Project-Based 
     Rental Assistance'' to Treasury Appropriation Fund Symbol 86 
     X 0148 for the liquidation of obligations incurred in fiscal 
     year 2018 in connection with the continued provision of 
     interest reduction payments authorized under section 236 of 
     the National Housing Act (12 U.S.C. 1715z-1).
       Sec. 157. (a) The remaining unobligated balances, as of 
     September 30, 2022, from amounts made available for 
     ``Department of Transportation--Office of the Secretary--
     National Infrastructure Investments'' in title I of division 
     H of the Further Consolidated Appropriations Act, 2020 
     (Public Law 116-94) are hereby permanently rescinded, and in 
     addition to amounts otherwise provided by section 101, an 
     amount of additional new budget authority equivalent to the 
     amount rescinded pursuant to this subsection is hereby 
     appropriated on September 30, 2022, for an additional amount 
     for fiscal year 2022, to remain available until September 30, 
     2023, and shall be available, without additional competition, 
     for completing the funding of awards made pursuant to the 
     fiscal year 2020 national infrastructure investments program, 
     in addition to other funds as may be available for such 
     purposes.
       (b) The remaining unobligated balances, as of September 30, 
     2022, from amounts made available to the Department of 
     Transportation in section 105 of division L of the 
     Consolidated Appropriations Act, 2021 (Public Law 116-260) 
     are hereby permanently rescinded, and in addition to amounts 
     otherwise provided by section 101, an amount of additional 
     new budget authority equivalent to the amount rescinded 
     pursuant to this subsection is hereby appropriated on 
     September 30, 2022, for an additional amount for fiscal year 
     2022, to remain available until September 30, 2023, and shall 
     be available, without additional competition, for completing 
     the funding of awards made pursuant to the fiscal year 2019 
     national infrastructure investments program, in addition to 
     other funds as may be available for such purposes.
       (c)(1) Subject to paragraph (2), this section shall become 
     effective immediately upon enactment of this Act.
       (2) If this Act is enacted after September 30, 2022, this 
     section shall be applied as if it were in effect on September 
     30, 2022.
        This division may be cited as the ``Continuing 
     Appropriations Act, 2023''.

       DIVISION B--UKRAINE SUPPLEMENTAL APPROPRIATIONS ACT, 2023

        The following sums are appropriated, out of any money in 
     the Treasury not otherwise appropriated, for the fiscal year 
     ending September 30, 2023, and for other purposes, namely:

                                TITLE I

                         DEPARTMENT OF DEFENSE

                           Military Personnel

                        Military Personnel, Army

       For an additional amount for ``Military Personnel, Army'', 
     $110,107,000, to remain available until September 30, 2023, 
     to respond to the situation in Ukraine and for related 
     expenses.

                        Military Personnel, Navy

       For an additional amount for ``Military Personnel, Navy'', 
     $462,000, to remain available until September 30, 2023, to 
     respond to the situation in Ukraine and for related expenses.

                    Military Personnel, Marine Corps

       For an additional amount for ``Military Personnel, Marine 
     Corps'', $600,000, to remain available until September 30, 
     2023, to respond to the situation in Ukraine and for related 
     expenses.

                     Military Personnel, Air Force

       For an additional amount for ``Military Personnel, Air 
     Force'', $11,582,000, to remain available until September 30, 
     2023, to respond to the situation in Ukraine and for related 
     expenses.

                       OPERATION AND MAINTENANCE

                    Operation and Maintenance, Army

       For an additional amount for ``Operation and Maintenance, 
     Army'', $654,696,000, to remain available until September 30, 
     2023, to respond to the situation in Ukraine and for related 
     expenses.

                    Operation and Maintenance, Navy

       For an additional amount for ``Operation and Maintenance, 
     Navy'', $433,035,000, to remain available until September 30, 
     2023, to respond to the situation in Ukraine and for related 
     expenses.

                Operation and Maintenance, Marine Corps

       For an additional amount for ``Operation and Maintenance, 
     Marine Corps'', $34,984,000, to remain available until 
     September 30, 2023, to respond to the situation in Ukraine 
     and for related expenses.

                  Operation and Maintenance, Air Force

       For an additional amount for ``Operation and Maintenance, 
     Air Force'', $267,084,000, to remain available until 
     September 30, 2023, to respond to the situation in Ukraine 
     and for related expenses.

                 Operation and Maintenance, Space Force

       For an additional amount for ``Operation and Maintenance, 
     Space Force'', $1,771,000, to remain available until 
     September 30, 2023, to respond to the situation in Ukraine 
     and for related expenses.

                Operation and Maintenance, Defense-Wide

                     (including transfer of funds)

       For an additional amount for ``Operation and Maintenance, 
     Defense-Wide'', $4,713,544,000, to remain available until 
     September 30, 2023, to respond to the situation in Ukraine 
     and for related expenses:  Provided, That of the total amount 
     provided under this heading in this Act, $3,000,000,000, to 
     remain available until September 30, 2024, shall be for the 
     Ukraine Security Assistance Initiative:  Provided further, 
     That such funds for the Ukraine Security Assistance 
     Initiative shall be available to the Secretary of Defense 
     under the same terms and conditions as are provided for in 
     section 8139 of the Department of Defense Appropriations Act, 
     2022 (division C of Public Law 117-103):  Provided further, 
     That of the total amount provided under this heading in this 
     Act, up to $1,500,000,000, to remain available until 
     September 30, 2024, may be transferred to accounts under the 
     headings ``Operation and Maintenance'' and ``Procurement'' 
     for replacement of defense articles from the

[[Page S5099]]

     stocks of the Department of Defense, and for reimbursement 
     for defense services of the Department of Defense and 
     military education and training, provided to the government 
     of Ukraine or to foreign countries that have provided support 
     to Ukraine at the request of the United States:  Provided 
     further, That funds transferred pursuant to a transfer 
     authority provided under this heading in this Act shall be 
     merged with and available for the same purposes and for the 
     same time period as the appropriations to which the funds are 
     transferred:  Provided further, That the Secretary of Defense 
     shall notify the congressional defense committees of the 
     details of such transfers not less than 15 days before any 
     such transfer:  Provided further, That upon a determination 
     that all or part of the funds transferred from this 
     appropriation are not necessary for the purposes provided 
     herein, such amounts may be transferred back and merged with 
     this appropriation:  Provided further, That the transfer 
     authority provided under this heading in this Act is in 
     addition to any other transfer authority provided by law.

                              PROCUREMENT

                       Missile Procurement, Army

       For an additional amount for ``Missile Procurement, Army'', 
     $450,000,000, to remain available until September 30, 2025, 
     to respond to the situation in Ukraine and for related 
     expenses.

                    Procurement of Ammunition, Army

       For an additional amount for ``Procurement of Ammunition, 
     Army'', $540,000,000, to remain available until September 30, 
     2025, for expansion of public and private plants, including 
     the land necessary therefor, and procurement and installation 
     of equipment, appliances, and machine tools in such plants, 
     for the purpose of increasing production of critical 
     munitions to replace defense articles provided to the 
     Government of Ukraine or foreign countries that have provided 
     support to Ukraine at the request of the United States.

                        Other Procurement, Army

       For an additional amount for ``Other Procurement, Army'', 
     $3,890,000, to remain available until September 30, 2025, to 
     respond to the situation in Ukraine and for related expenses.

                        Other Procurement, Navy

       For an additional amount for ``Other Procurement, Navy'', 
     $2,170,000, to remain available until September 30, 2025, to 
     respond to the situation in Ukraine and for related expenses.

                      Other Procurement, Air Force

       For an additional amount for ``Other Procurement, Air 
     Force'', $437,991,000, to remain available until September 
     30, 2025, to respond to the situation in Ukraine and for 
     other expenses.

                       Procurement, Defense-Wide

       For an additional amount for ``Procurement, Defense-Wide'', 
     $9,770,000, to remain available until September 30, 2025, to 
     respond to the situation in Ukraine and for related expenses.

               RESEARCH, DEVELOPMENT, TEST AND EVALUATION

            Research, Development, Test and Evaluation, Army

       For an additional amount for ``Research, Development, Test 
     and Evaluation, Army'', $3,300,000, to remain available until 
     September 30, 2024, to respond to the situation in Ukraine 
     and for related expenses.

            Research, Development, Test and Evaluation, Navy

       For an additional amount for ``Research, Development, Test 
     and Evaluation, Navy'', $2,077,000, to remain available until 
     September 30, 2024, to respond to the situation in Ukraine 
     and for related expenses.

         Research, Development, Test and Evaluation, Air Force

       For an additional amount for ``Research, Development, Test 
     and Evaluation, Air Force'', $99,704,000, to remain available 
     until September 30, 2024, to respond to the situation in 
     Ukraine and for related expenses.

        Research, Development, Test and Evaluation, Defense-Wide

       For an additional amount for ``Research, Development, Test 
     and Evaluation, Defense-Wide'', $31,230,000, to remain 
     available until September 30, 2024, to respond to the 
     situation in Ukraine and for related expenses.

                  OTHER DEPARTMENT OF DEFENSE PROGRAMS

                    Office of the Inspector General

       For an additional amount for ``Office of the Inspector 
     General'', $2,000,000, to remain available until September 
     30, 2023, to carry out reviews of the activities of the 
     Department of Defense to execute funds appropriated in this 
     title, including assistance provided to Ukraine:  Provided, 
     That the Inspector General of the Department of Defense shall 
     provide to the congressional defense committees a briefing 
     not later than 90 days after the date of enactment of this 
     Act.

                            RELATED AGENCIES

               Intelligence Community Management Account

       For an additional amount for ``Intelligence Community 
     Management Account'', $500,000, to remain available until 
     September 30, 2023, to respond to the situation in Ukraine 
     and for related expenses.

                     GENERAL PROVISIONS--THIS TITLE

       Sec. 1101.  Not later than 60 days after the date of 
     enactment of this Act, the Secretary of Defense, in 
     coordination with the Secretary of State, shall submit a 
     report to the Committees on Appropriations, Armed Services, 
     and Foreign Affairs of the House of Representatives and the 
     Committees on Appropriations, Armed Services, and Foreign 
     Relations of the Senate on measures being taken to account 
     for United States defense articles designated for Ukraine 
     since the February 24, 2022, Russian invasion of Ukraine, 
     particularly measures with regard to such articles that 
     require enhanced end-use monitoring; measures to ensure that 
     such articles reach their intended recipients and are used 
     for their intended purposes; and any other measures to 
     promote accountability for the use of such articles:  
     Provided, That such report shall include a description of any 
     occurrences of articles not reaching their intended 
     recipients or used for their intended purposes and a 
     description of any remedies taken:  Provided further, That 
     such report shall be submitted in unclassified form, but may 
     be accompanied by a classified annex.
       Sec. 1102.  Not later than 30 days after the date of 
     enactment of this Act, and every 30 days thereafter through 
     fiscal year 2023, the Secretary of Defense, in coordination 
     with the Secretary of State, shall provide a written report 
     to the Committees on Appropriations, Armed Services, and 
     Foreign Affairs of the House of Representatives and the 
     Committees on Appropriations, Armed Services, and Foreign 
     Relations of the Senate describing United States security 
     assistance provided to Ukraine since the February 24, 2022, 
     Russian invasion of Ukraine, including a comprehensive list 
     of the defense articles and services provided to Ukraine and 
     the associated authority and funding used to provide such 
     articles and services:  Provided, That such report shall be 
     submitted in unclassified form, but may be accompanied by a 
     classified annex.

                                TITLE II

                          DEPARTMENT OF ENERGY

                    ATOMIC ENERGY DEFENSE ACTIVITIES

                NATIONAL NUCLEAR SECURITY ADMINISTRATION

                    Defense Nuclear Nonproliferation

       For an additional amount for ``Defense Nuclear 
     Nonproliferation'', $35,000,000, to remain available until 
     expended, to respond to the situation in Ukraine and for 
     related expenses.

                               TITLE III

                     BILATERAL ECONOMIC ASSISTANCE

                  Funds Appropriated to the President

                         economic support fund

       For an additional amount for ``Economic Support Fund'', 
     $4,500,000,000, to remain available until September 30, 2024, 
     for assistance for Ukraine:  Provided, That funds 
     appropriated under this heading in this Act may be made 
     available notwithstanding any other provision of law that 
     restricts assistance to foreign countries and may be made 
     available as contributions.

                     GENERAL PROVISIONS--THIS TITLE

       Sec. 1301.  During fiscal year 2023, section 506(a)(1) of 
     the Foreign Assistance Act of 1961 (22 U.S.C. 2318(a)(1)) 
     shall be applied by substituting ``$3,700,000,000'' for 
     ``$100,000,000''.
       Sec. 1302. (a) Funds appropriated by this title shall be 
     made available for direct financial support for the 
     Government of Ukraine, including for Ukrainian first 
     responders, and may be made available as a cash transfer 
     subject to the requirements of subsection (b):  Provided, 
     That such funds shall be provided on a reimbursable basis and 
     matched by sources other than the United States Government, 
     to the maximum extent practicable:  Provided further, That 
     the Secretary of State or the Administrator of the United 
     States Agency for International Development, as appropriate, 
     shall ensure third-party monitoring of such funds:  Provided 
     further, That at least 15 days prior to the initial 
     obligation of such funds, the Secretary of State, following 
     consultation with the Administrator of the United States 
     Agency for International Development, shall certify and 
     report to the appropriate congressional committees that 
     mechanisms for monitoring and oversight of such funds are in 
     place and functioning and that the Government of Ukraine has 
     in place substantial safeguards to prevent corruption and 
     ensure accountability of such funds:  Provided further, That 
     not less than 45 days after the initial obligation of such 
     funds, the Inspectors General of the Department of State and 
     the United States Agency for International Development shall 
     submit a report to the appropriate congressional committees 
     detailing and assessing the mechanisms for monitoring and 
     safeguards described in the previous proviso.
       (b) Funds made available to the Government of Ukraine as a 
     cash transfer under subsection (a) shall be subject to a 
     memorandum of understanding between the Governments of the 
     United States and Ukraine that describes how the funds 
     proposed to be made available will be used and the 
     appropriate safeguards to ensure transparency and 
     accountability:  Provided, That such assistance shall be 
     maintained in a separate, auditable account and may not be 
     comingled with any other funds.
       (c) The Secretary of State or the Administrator of the 
     United States Agency for International Development, as 
     appropriate, shall report to the appropriate congressional 
     committees on the uses of funds provided for direct financial 
     support to the Government of Ukraine pursuant to subsection 
     (a) not later than 45 days after the date of enactment of 
     this Act and every 45 days thereafter until

[[Page S5100]]

     all such funds have been expended:  Provided, That such 
     report shall include a detailed description of the use of 
     such funds, including categories and amounts, the intended 
     results and the results achieved, a summary of other donor 
     contributions, and a description of the efforts undertaken by 
     the Secretary and Administrator to increase other donor 
     contributions for direct financial support:  Provided 
     further, That such report shall also include the metrics 
     established to measure such results.
       (d) Funds made available for the purposes of subsection (a) 
     shall be subject to the regular notification procedures of 
     the Committees on Appropriations of the House of 
     Representatives and the Senate.

                                TITLE IV

                      GENERAL PROVISIONS--THIS ACT

       Sec. 1401.  Each amount appropriated or made available by 
     this Act is in addition to amounts otherwise appropriated for 
     the fiscal year involved.
       Sec. 1402.  No part of any appropriation contained in this 
     Act shall remain available for obligation beyond the current 
     fiscal year unless expressly so provided herein.
       Sec. 1403.  Unless otherwise provided for by this Act, the 
     additional amounts appropriated by this Act to appropriations 
     accounts shall be available under the authorities and 
     conditions applicable to such appropriations accounts for 
     fiscal year 2023.
       Sec. 1404.  Each amount provided by this division is 
     designated by the Congress as being for an emergency 
     requirement pursuant to section 4001(a)(1) of S. Con. Res. 14 
     (117th Congress), the concurrent resolution on the budget for 
     fiscal year 2022, and section 1(e) of H. Res. 1151 (117th 
     Congress), as engrossed in the House of Representatives on 
     June 8, 2022.
        This division may be cited as the ``Ukraine Supplemental 
     Appropriations Act, 2023''.

                       DIVISION C--OTHER MATTERS

     TITLE I--EXTENSIONS, TECHNICAL CORRECTIONS, AND OTHER MATTERS

     SEC. 101. EXTENSION OF FCC AUCTION AUTHORITY.

       Section 309(j)(11) of the Communications Act of 1934 (47 
     U.S.C. 309(j)(11)) is amended by striking ``September 30, 
     2022'' and inserting ``December 16, 2022''.

     SEC. 102. EXTENSION OF AUTHORIZATION FOR SPECIAL ASSESSMENT 
                   FOR DOMESTIC TRAFFICKING VICTIMS' FUND.

       Section 3014(a) of title 18, United States Code, is 
     amended, in the matter preceding paragraph (1), by striking 
     ``September 30, 2022'' and inserting ``December 16, 2022''.

     SEC. 103. UNITED STATES PAROLE COMMISSION EXTENSION.

       (a) Short Title.--This section may be cited as the ``United 
     States Parole Commission Extension Act of 2022''.
       (b) Amendment of Sentencing Reform Act of 1984.--For 
     purposes of section 235(b) of the Sentencing Reform Act of 
     1984 (18 U.S.C. 3551 note; Public Law 98-473; 98 Stat. 2032), 
     as such section relates to chapter 311 of title 18, United 
     States Code, and the United States Parole Commission, each 
     reference in such section to ``35 years'' or ``35-year 
     period'' shall be deemed a reference to ``35 years and 46 
     days'' or ``35-year and 46-day period'', respectively.

     SEC. 104. EXTENSION OF COMMODITY FUTURES TRADING COMMISSION 
                   CUSTOMER PROTECTION FUND EXPENSES ACCOUNT.

       Section 1(b) of Public Law 117-25 (135 Stat. 297) is 
     amended by striking ``October 1, 2022'' each place it appears 
     and inserting ``December 16, 2022''.

                      TITLE II--BUDGETARY EFFECTS

     SEC. 201. BUDGETARY EFFECTS.

       (a) Statutory PAYGO Scorecards.--The budgetary effects of 
     this division and each succeeding division shall not be 
     entered on either PAYGO scorecard maintained pursuant to 
     section 4(d) of the Statutory Pay-As-You-Go Act of 2010.
       (b) Senate PAYGO Scorecards.--The budgetary effects of this 
     division and each succeeding division shall not be entered on 
     any PAYGO scorecard maintained for purposes of section 4106 
     of H. Con. Res. 71 (115th Congress).
       (c) Classification of Budgetary Effects.--Notwithstanding 
     Rule 3 of the Budget Scorekeeping Guidelines set forth in the 
     joint explanatory statement of the committee of conference 
     accompanying Conference Report 105-217 and section 250(c)(8) 
     of the Balanced Budget and Emergency Deficit Control Act of 
     1985, the budgetary effects of this division and each 
     succeeding division shall not be estimated--
       (1) for purposes of section 251 of such Act;
       (2) for purposes of an allocation to the Committee on 
     Appropriations pursuant to section 302(a) of the 
     Congressional Budget Act of 1974; and
       (3) for purposes of paragraph (4)(C) of section 3 of the 
     Statutory Pay-As-You-Go Act of 2010 as being included in an 
     appropriation Act.

            DIVISION D--HEALTH AND HUMAN SERVICES EXTENSIONS

                     TITLE I--MEDICARE AND MEDICAID

     SEC. 101. EXTENSION OF INCREASED INPATIENT HOSPITAL PAYMENT 
                   ADJUSTMENT FOR CERTAIN LOW-VOLUME HOSPITALS.

       (a) In General.--Section 1886(d)(12) of the Social Security 
     Act (42 U.S.C. 1395ww(d)(12)) is amended--
       (1) in subparagraph (B), in the matter preceding clause 
     (i), by striking ``in fiscal year 2023 and subsequent fiscal 
     years'' and inserting ``during the portion of fiscal year 
     2023 beginning on December 17, 2022, and ending on September 
     30, 2023, and in fiscal year 2024 and subsequent fiscal 
     years'';
       (2) in subparagraph (C)(i)--
       (A) in the matter preceding subclause (I)--
       (i) by inserting ``or portion of a fiscal year'' after 
     ``for a fiscal year''; and
       (ii) by inserting ``and the portion of fiscal year 2023 
     beginning on October 1, 2022, and ending on December 16, 
     2022'' after ``through 2022'';
       (B) in subclause (III), by inserting ``and the portion of 
     fiscal year 2023 beginning on October 1, 2022, and ending on 
     December 16, 2022'' after ``through 2022''; and
       (C) in subclause (IV), by striking ``fiscal year 2023'' and 
     inserting ``the portion of fiscal year 2023 beginning on 
     December 17, 2022, and ending on September 30, 2023, and 
     fiscal year 2024''; and
       (3) in subparagraph (D)--
       (A) in the matter preceding clause (i), by inserting ``or 
     during the portion of fiscal year 2023 beginning on October 
     1, 2022, and ending on December 16, 2022'' after ``through 
     2022''; and
       (B) in clause (ii), by inserting ``and the portion of 
     fiscal year 2023 beginning on October 1, 2022, and ending on 
     December 16, 2022'' after ``through 2022''.
       (b) Implementation.--Notwithstanding any other provision of 
     law, the Secretary of Health and Human Services may implement 
     the provisions of, including the amendments made by, this 
     section by program instruction or otherwise.

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

       (a) In General.--Section 1886(d)(5)(G) of the Social 
     Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amended--
       (1) in clause (i), by striking ``October 1, 2022'' and 
     inserting ``December 17, 2022''; and
       (2) in clause (ii)(II), by striking ``October 1, 2022'' and 
     inserting ``December 17, 2022''.
       (b) Conforming Amendments.--
       (1) Extension of target amount.--Section 1886(b)(3)(D) of 
     the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is 
     amended--
       (A) in the matter preceding clause (i), by striking 
     ``October 1, 2022'' and inserting ``December 17, 2022''; and
       (B) in clause (iv), by inserting ``and the portion of 
     fiscal year 2023 beginning on October 1, 2022, and ending on 
     December 16, 2022,'' after ``through fiscal year 2022''.
       (2) Permitting hospitals to decline reclassification.--
     Section 13501(e)(2) of the Omnibus Budget Reconciliation Act 
     of 1993 (42 U.S.C. 1395ww note) is amended by striking ``or 
     fiscal year 2000 through fiscal year 2022,'' and inserting 
     ``fiscal year 2000 through fiscal year 2022, or the portion 
     of fiscal year 2023 beginning on October 1, 2022, and ending 
     on December 16, 2022''.

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

       Section 1905(ff) of the Social Security Act (42 U.S.C. 
     1396d(ff)) is amended by striking ``December 13'' each place 
     it appears and inserting ``December 16'' in each such place.

     SEC. 104. REDUCTION OF MEDICARE IMPROVEMENT FUND.

       Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
     1395iii(b)(1)) is amended by striking ``$7,500,000,000'' and 
     inserting ``$7,308,000,000''.

                        TITLE II--HUMAN SERVICES

     SEC. 201. EXTENSION OF MATERNAL, INFANT, AND EARLY CHILDHOOD 
                   HOME VISITING PROGRAMS.

       Activities authorized by section 511 of the Social Security 
     Act shall continue through December 16, 2022, in the manner 
     authorized for fiscal year 2022, and out of any money in the 
     Treasury of the United States not otherwise appropriated, 
     there is hereby appropriated for such purpose an amount equal 
     to the pro rata portion of the amount appropriated for such 
     activities for fiscal year 2022.

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

       Activities authorized by part B of title IV of the Social 
     Security Act shall continue through December 16, 2022, in the 
     manner authorized for fiscal year 2022, and out of any money 
     in the Treasury of the United States not otherwise 
     appropriated, there are hereby appropriated such sums as may 
     be necessary for such purpose.

                        TITLE III--PUBLIC HEALTH

     SEC. 301. EXTENSION OF THE PROGRAM TO DEEM CERTAIN HEALTH 
                   PROFESSIONAL VOLUNTEERS EMPLOYEES OF THE PUBLIC 
                   HEALTH SERVICE UNDER CERTAIN CIRCUMSTANCES.

       (a) In General.--Section 224(q) of the Public Health 
     Service Act (42 U.S.C. 233(q)) is amended by striking 
     paragraph (6).
       (b) Technical Corrections.--Section 224 of the Public 
     Health Service Act (42 U.S.C. 233) is amended--
       (1) in subsection (g)(1)(H)(iv), by striking ``this 
     section.'' and inserting ``this section).'';
       (2) in subsection (k)(3), by inserting ``governing board 
     members,'' after ``officers,'';
       (3) in subsection (p)(7)(A)(i), by moving the margin of 
     subclause (II) 2 ems to the left; and
       (4) in subsection (q)(5)(A), by striking ``and paragraph 
     (6)''.

     SEC. 302. EXTENSION OF AUTHORIZATION FOR A COMMISSIONED 
                   OFFICER OF THE PUBLIC HEALTH SERVICE TO 
                   ACCUMULATE EXCESS ANNUAL LEAVE.

       For purposes of annual leave accumulated in fiscal year 
     2022, the authority provided in section 2106 of division C of 
     Public Law 116-

[[Page S5101]]

     159 (42 U.S.C. 210-1 note) shall apply to such leave by 
     substituting ``2022'' for ``2020'' in subsections (a) and 
     (d)(2).

                        TITLE IV--INDIAN HEALTH

     SEC. 401. EXTENSION OF MORATORIUM.

       Section 424(a) of title IV of division G of Public Law 113-
     76 is amended by striking ``October 1, 2019'' and inserting 
     ``December 16, 2022''.

                DIVISION E--VETERANS AFFAIRS EXTENSIONS

       TITLE I--EXTENSIONS OF AUTHORITIES RELATING TO HEALTH CARE

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

       Section 1710(f)(2)(B) of title 38, United States Code, is 
     amended by striking ``September 30, 2022'' and inserting 
     ``September 30, 2024''.

     SEC. 102. EXTENSION OF REQUIREMENT TO PROVIDE NURSING HOME 
                   CARE TO CERTAIN VETERANS WITH SERVICE-CONNECTED 
                   DISABILITIES.

       Section 1710A(d) of title 38, United States Code, is 
     amended by striking ``September 30, 2022'' and inserting 
     ``September 30, 2024''.

     SEC. 103. EXTENSION OF AUTHORITY TO CONTINUE DOD-VA HEALTH 
                   CARE SHARING INCENTIVE FUND.

       Section 8111(d)(3) of title 38, United States Code, is 
     amended by striking ``September 30, 2023'' and inserting 
     ``September 30, 2026''.

     SEC. 104. EXTENSION OF AUTHORITY FOR JOINT DEPARTMENT OF 
                   DEFENSE-DEPARTMENT OF VETERANS AFFAIRS MEDICAL 
                   FACILITY DEMONSTRATION FUND.

       Section 1704(e) of the National Defense Authorization Act 
     for Fiscal Year 2010 (Public Law 111-84; 123 Stat. 2573), as 
     most recently amended by section 715 of the National Defense 
     Authorization Act for Fiscal Year 2022 (Public Law 117-81; 
     135 Stat. 1787), is amended by striking ``September 30, 
     2023'' and inserting ``September 30, 2024''.

     SEC. 105. EXTENSION OF TEMPORARY EXPANSION OF PAYMENTS AND 
                   ALLOWANCES FOR BENEFICIARY TRAVEL IN CONNECTION 
                   WITH VETERANS RECEIVING CARE FROM VET CENTERS.

       Section 104(a) of the Honoring America's Veterans and 
     Caring for Camp Lejeune Families Act of 2012 (Public Law 112-
     154; 126 Stat. 1169), as most recently amended by section 3 
     of the Department of Veterans Affairs Expiring Authorities 
     Act of 2021 (Public Law 117-42; 135 Stat. 342), is amended by 
     striking ``September 30, 2022'' and inserting ``September 30, 
     2023''.

        TITLE II--EXTENSIONS OF AUTHORITIES RELATING TO BENEFITS

     SEC. 201. EXTENSION OF AUTHORITY TO TRANSPORT INDIVIDUALS TO 
                   AND FROM DEPARTMENT OF VETERANS AFFAIRS 
                   FACILITIES.

       Section 111A(a)(2) of title 38, United States Code, is 
     amended by striking ``September 30, 2022'' and inserting 
     ``September 30, 2024''.

     SEC. 202. EXTENSION OF AUTHORITY TO MAINTAIN REGIONAL OFFICE 
                   IN THE REPUBLIC OF THE PHILIPPINES.

       Section 315(b) of title 38, United States Code, is amended 
     by striking ``September 30, 2022'' and inserting ``September 
     30, 2024''.

     SEC. 203. EXTENSION OF AUTHORITY FOR REPORT ON EQUITABLE 
                   RELIEF PROVIDED DUE TO ADMINISTRATIVE ERROR.

       Section 503(c) of title 38, United States Code, is amended 
     by striking ``December 31, 2022'' and inserting ``December 
     31, 2024''.

     SEC. 204. EXTENSION OF AUTHORITY TO PROVIDE ASSISTANCE FOR 
                   SPECIALLY ADAPTED HOUSING FOR DISABLED VETERANS 
                   RESIDING TEMPORARILY IN HOUSING OWNED BY A 
                   FAMILY MEMBER.

       Section 2102A(e) of title 38, United States Code, is 
     amended by striking ``December 31, 2022'' and inserting 
     ``December 31, 2024''.

     SEC. 205. EXTENSION OF SPECIALLY ADAPTED HOUSING ASSISTIVE 
                   TECHNOLOGY GRANT PROGRAM.

       Section 2108(g) of title 38, United States Code, is amended 
     by striking ``September 30, 2022'' and inserting ``September 
     30, 2024''.

   TITLE III--EXTENSIONS OF AUTHORITIES RELATING TO HOMELESS VETERANS

     SEC. 301. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 
                   HOMELESS VETERANS REINTEGRATION PROGRAMS.

       Section 2021(e)(1)(F) of title 38, United States Code, is 
     amended by striking ``2022'' and inserting ``2024''.

     SEC. 302. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 
                   HOMELESS WOMEN VETERANS AND HOMELESS VETERANS 
                   WITH CHILDREN REINTEGRATION GRANT PROGRAM.

       Section 2021A(f)(1) of title 38, United States Code, is 
     amended by striking ``2022'' and inserting ``2024''.

     SEC. 303. EXTENSION OF AUTHORITY FOR TREATMENT AND 
                   REHABILITATION FOR SERIOUSLY MENTALLY ILL AND 
                   HOMELESS VETERANS.

       (a) General Treatment.--Section 2031(b) of title 38, United 
     States Code, is amended by striking ``September 30, 2022'' 
     and inserting ``September 30, 2024''.
       (b) Additional Services at Certain Locations.--Section 
     2033(d) of such title is amended by striking ``September 30, 
     2022'' and inserting ``September 30, 2024''.

     SEC. 304. EXTENSION OF FUNDING FOR FINANCIAL ASSISTANCE FOR 
                   SUPPORTIVE SERVICES FOR VERY LOW-INCOME VETERAN 
                   FAMILIES IN PERMANENT HOUSING.

       Section 2044(e)(1)(H) of title 38, United States Code, is 
     amended by striking ``and 2022'' and inserting ``through 
     2024''.

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

       Section 2061(d)(1) of title 38, United States Code, is 
     amended by striking ``2022'' and inserting ``2024''.

     SEC. 306. EXTENSION OF AUTHORITY FOR THE ADVISORY COMMITTEE 
                   ON HOMELESS VETERANS.

       Section 2066(d) of title 38, United States Code, is amended 
     by striking ``September 30, 2022'' and inserting ``September 
     30, 2026''.

               TITLE IV--EXTENSIONS OF OTHER AUTHORITIES

     SEC. 401. EXTENSION OF AUTHORIZATION OF APPROPRIATIONS FOR 
                   MONTHLY ASSISTANCE ALLOWANCE UNDER THE OFFICE 
                   OF NATIONAL VETERANS SPORTS PROGRAMS AND 
                   SPECIAL EVENTS.

       Section 322(d)(4) of title 38, United States Code, is 
     amended by striking ``2022'' and inserting ``2026''.

     SEC. 402. EXTENSION AND AUTHORIZATION OF APPROPRIATIONS FOR 
                   ADAPTIVE SPORTS PROGRAMS FOR DISABLED VETERANS 
                   AND MEMBERS OF THE ARMED FORCES.

       (a) Authorization of Appropriations.--Subsection (g)(1)(B) 
     of section 521A of title 38, United States Code, is amended 
     by striking ``and 2022'' and inserting ``through 2026''.
       (b) Extension.--Subsection (l) of such section is amended 
     by striking ``2022'' and inserting ``2026''.
       (c) Technical Correction.--Subsection (g)(1)(A) of such 
     section is amended by striking ``. for each of fiscal years 
     2010 through 2020''.

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

       Section 544(e) of title 38, United States Code, is amended 
     by striking ``September 30, 2022'' and inserting ``September 
     30, 2026''.

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

       Section 3692(c) of title 38, United States Code, is amended 
     by striking ``December 31, 2022'' and inserting ``December 
     31, 2026''.

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

       Section 8118(a)(5) of title 38, United States Code, is 
     amended by striking ``September 30, 2022'' and inserting 
     ``September 30, 2024''.

          DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022

     SECTION 1. SHORT TITLE.

       This division may be cited as the ``FDA User Fee 
     Reauthorization Act of 2022''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents for this division is as follows:

          DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022

Sec. 1. Short title.
Sec. 2. Table of contents.

                    TITLE I--FEES RELATING TO DRUGS

Sec. 1001. Short title; finding.
Sec. 1002. Definitions.
Sec. 1003. Authority to assess and use drug fees.
Sec. 1004. Reauthorization; reporting requirements.
Sec. 1005. Sunset dates.
Sec. 1006. Effective date.
Sec. 1007. Savings clause.

                   TITLE II--FEES RELATING TO DEVICES

Sec. 2001. Short title; finding.
Sec. 2002. Definitions.
Sec. 2003. Authority to assess and use device fees.
Sec. 2004. Reauthorization; reporting requirements.
Sec. 2005. Conformity assessment pilot program.
Sec. 2006. Reauthorization of third-party review program.
Sec. 2007. Sunset dates.
Sec. 2008. Effective date.
Sec. 2009. Savings clause.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 3001. Short title; finding.
Sec. 3002. Authority to assess and use human generic drug fees.
Sec. 3003. Reauthorization; reporting requirements.
Sec. 3004. Sunset dates.
Sec. 3005. Effective date.
Sec. 3006. Savings clause.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 4001. Short title; finding.
Sec. 4002. Definitions.
Sec. 4003. Authority to assess and use biosimilar biological product 
              fees.
Sec. 4004. Reauthorization; reporting requirements.
Sec. 4005. Sunset dates.
Sec. 4006. Effective date.
Sec. 4007. Savings clause.

              TITLE V--REAUTHORIZATION OF OTHER PROVISIONS

Sec. 5001. Reauthorization of the best pharmaceuticals for children 
              program.
Sec. 5002. Reauthorization of the humanitarian device exemption 
              incentive.
Sec. 5003. Reauthorization of the pediatric device consortia program.
Sec. 5004. Reauthorization of provision pertaining to drugs containing 
              single enantiomers.

[[Page S5102]]

Sec. 5005. Reauthorization of the critical path public-private 
              partnership.
Sec. 5006. Reauthorization of orphan drug grants.
Sec. 5007. Reauthorization of certain device inspections.
Sec. 5008. Reauthorization of reporting requirements related to pending 
              generic drug applications and priority review 
              applications.

                    TITLE I--FEES RELATING TO DRUGS

     SEC. 1001. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Prescription Drug User Fee Amendments of 2022''.
       (b) Finding.--Congress finds that the fees authorized by 
     the amendments made by this title will be dedicated toward 
     expediting the drug development process and the process for 
     the review of human drug applications, including postmarket 
     drug safety activities, as set forth in the goals identified 
     for purposes of part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et 
     seq.), in the letters from the Secretary of Health and Human 
     Services to the Chairman of the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the Chairman 
     of the Committee on Energy and Commerce of the House of 
     Representatives, as set forth in the Congressional Record.

     SEC. 1002. DEFINITIONS.

       (a) Human Drug Application.--Section 735(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended, 
     in the matter following subparagraph (B), by striking ``an 
     allergenic extract product, or'' and inserting ``does not 
     include an application with respect to an allergenic extract 
     product licensed before October 1, 2022, does not include an 
     application with respect to a standardized allergenic extract 
     product submitted pursuant to a notification to the applicant 
     from the Secretary regarding the existence of a potency test 
     that measures the allergenic activity of an allergenic 
     extract product licensed by the applicant before October 1, 
     2022, does not include an application with respect to''.
       (b) Prescription Drug Product.--Section 735(3) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is 
     amended--
       (1) by redesignating subparagraphs (A), (B), and (C) as 
     clauses (i), (ii), and (iii), respectively;
       (2) by striking ``(3) The term'' and inserting ``(3)(A) The 
     term'';
       (3) by striking ``Such term does not include whole blood'' 
     and inserting the following:
       ``(B) Such term does not include whole blood'';
       (4) by striking ``an allergenic extract product,'' and 
     inserting ``an allergenic extract product licensed before 
     October 1, 2022, a standardized allergenic extract product 
     submitted pursuant to a notification to the applicant from 
     the Secretary regarding the existence of a potency test that 
     measures the allergenic activity of an allergenic extract 
     product licensed by the applicant before October 1, 2022,'' ; 
     and
       (5) by adding at the end the following:
       ``(C)(i) If a written request to place a product in the 
     discontinued section of either of the lists referenced in 
     subparagraph (A)(iii) is submitted to the Secretary on behalf 
     of an applicant, and the request identifies the date the 
     product is, or will be, withdrawn from sale, then for 
     purposes of assessing the prescription drug program fee under 
     section 736(a)(2), the Secretary shall consider such product 
     to have been included in the discontinued section on the 
     later of--
       ``(I) the date such request was received; or
       ``(II) if the product will be withdrawn from sale on a 
     future date, such future date when the product is withdrawn 
     from sale.
       ``(ii) For purposes of this subparagraph, a product shall 
     be considered withdrawn from sale once the applicant has 
     ceased its own distribution of the product, whether or not 
     the applicant has ordered recall of all previously 
     distributed lots of the product, except that a routine, 
     temporary interruption in supply shall not render a product 
     withdrawn from sale.''.
       (c) Skin-Test Diagnostic Product.--Section 735 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is 
     amended by adding at the end the following:
       ``(12) The term `skin-test diagnostic product'--
       ``(A) means a product--
       ``(i) for prick, scratch, intradermal, or subcutaneous 
     administration;
       ``(ii) expected to produce a limited, local reaction at the 
     site of administration (if positive), rather than a systemic 
     effect;
       ``(iii) not intended to be a preventive or therapeutic 
     intervention; and
       ``(iv) intended to detect an immediate- or delayed-type 
     skin hypersensitivity reaction to aid in the diagnosis of--

       ``(I) an allergy to an antimicrobial agent;
       ``(II) an allergy that is not to an antimicrobial agent, if 
     the diagnostic product was authorized for marketing prior to 
     October 1, 2022; or
       ``(III) infection with fungal or mycobacterial pathogens; 
     and

       ``(B) includes positive and negative controls required to 
     interpret the results of a product described in subparagraph 
     (A).''.

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

       (a) Types of Fees.--
       (1) Human drug application fee.--Section 736(a) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is 
     amended--
       (A) in the matter preceding paragraph (1), by striking 
     ``fiscal year 2018'' and inserting ``fiscal year 2023'';
       (B) in paragraph (1)(A), by striking ``(c)(5)'' each place 
     it appears and inserting ``(c)(6)'';
       (C) in paragraph (1)(C), by inserting ``prior to approval'' 
     after ``or was withdrawn''; and
       (D) in paragraph (1), by adding at the end the following:
       ``(H) Exception for skin-test diagnostic products.--A human 
     drug application for a skin-test diagnostic product shall not 
     be subject to a fee under subparagraph (A).''.
       (2) Prescription drug program fee.--Section 736(a)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(a)(2)) is amended--
       (A) in subparagraph (A)--
       (i) by striking ``Except as provided in subparagraphs (B) 
     and (C)'' and inserting the following:
       ``(i) Payment of fees.--Except as provided in subparagraphs 
     (B) and (C)'';
       (ii) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(6)''; and
       (iii) by adding at the end the following:
       ``(ii) Special rule for previously discontinued drug 
     products.--If a drug product that is identified in a human 
     drug application approved as of October 1 of a fiscal year is 
     not a prescription drug product as of that date because the 
     drug product is in the discontinued section of a list 
     referenced in section 735(3)(A)(iii), and on any subsequent 
     day during such fiscal year the drug product is a 
     prescription drug product, then except as provided in 
     subparagraphs (B) and (C), each person who is named as the 
     applicant in a human drug application with respect to such 
     product, and who, after September 1, 1992, had pending before 
     the Secretary a human drug application or supplement, shall 
     pay the annual prescription drug program fee established for 
     a fiscal year under subsection (c)(6) for such prescription 
     drug product. Such fee shall be due on the last business day 
     of such fiscal year and shall be paid only once for each such 
     product for a fiscal year in which the fee is payable.''; and
       (B) by amending subparagraph (B) to read as follows:
       ``(B) Exception for certain prescription drug products.--A 
     prescription drug program fee shall not be assessed for a 
     prescription drug product under subparagraph (A) if such 
     product is--
       ``(i) a large volume parenteral product (a sterile aqueous 
     drug product packaged in a single-dose container with a 
     volume greater than or equal to 100 mL, not including powders 
     for reconstitution or pharmacy bulk packages) identified on 
     the list compiled under section 505(j)(7);
       ``(ii) pharmaceutically equivalent (as defined in section 
     314.3 of title 21, Code of Federal Regulations (or any 
     successor regulation)) to another product on the list of 
     products compiled under section 505(j)(7) (not including the 
     discontinued section of such list); or
       ``(iii) a skin-test diagnostic product.''.
       (b) Fee Revenue Amounts.--
       (1) In general.--Paragraph (1) of section 736(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is 
     amended to read as follows:
       ``(1) In general.--For each of the fiscal years 2023 
     through 2027, fees under subsection (a) shall, except as 
     provided in subsections (c), (d), (f), and (g), be 
     established to generate a total revenue amount under such 
     subsection that is equal to the sum of--
       ``(A) the annual base revenue for the fiscal year (as 
     determined under paragraph (3));
       ``(B) the dollar amount equal to the inflation adjustment 
     for the fiscal year (as determined under subsection (c)(1));
       ``(C) the dollar amount equal to the strategic hiring and 
     retention adjustment for the fiscal year (as determined under 
     subsection (c)(2));
       ``(D) the dollar amount equal to the capacity planning 
     adjustment for the fiscal year (as determined under 
     subsection (c)(3));
       ``(E) the dollar amount equal to the operating reserve 
     adjustment for the fiscal year, if applicable (as determined 
     under subsection (c)(4));
       ``(F) the dollar amount equal to the additional direct cost 
     adjustment for the fiscal year (as determined under 
     subsection (c)(5)); and
       ``(G) additional dollar amounts for each fiscal year as 
     follows:
       ``(i) $65,773,693 for fiscal year 2023.
       ``(ii) $25,097,671 for fiscal year 2024.
       ``(iii) $14,154,169 for fiscal year 2025.
       ``(iv) $4,864,860 for fiscal year 2026.
       ``(v) $1,314,620 for fiscal year 2027.''.
       (2) Annual base revenue.--Paragraph (3) of section 736(b) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(b)) is amended to read as follows:
       ``(3) Annual base revenue.--For purposes of paragraph (1), 
     the dollar amount of the annual base revenue for a fiscal 
     year shall be--
       ``(A) for fiscal year 2023, $1,151,522,958; and
       ``(B) for fiscal years 2024 through 2027, the dollar amount 
     of the total revenue amount established under paragraph (1) 
     for the previous fiscal year, not including any adjustments 
     made under subsection (c)(4) or (c)(5).''.
       (c) Adjustments; Annual Fee Setting.--
       (1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(c)(1)(B)(ii)) is amended by striking ``Washington-
     Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
     Arlington-Alexandria, DC-VA-MD-WV''.
       (2) Strategic hiring and retention adjustment.--Section 
     736(c) of the Federal

[[Page S5103]]

     Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
       (A) by redesignating paragraphs (2) through (6) as 
     paragraphs (3) through (7), respectively; and
       (B) by inserting after paragraph (1) the following:
       ``(2) Strategic hiring and retention adjustment.--For each 
     fiscal year, after the annual base revenue established in 
     subsection (b)(1)(A) is adjusted for inflation in accordance 
     with paragraph (1), the Secretary shall further increase the 
     fee revenue and fees by the following amounts:
       ``(A) For fiscal year 2023, $9,000,000.
       ``(B) For each of fiscal years 2024 through 2027, 
     $4,000,000.''.
       (3) Capacity planning adjustment.--Paragraph (3), as 
     redesignated, of section 736(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as 
     follows:
       ``(3) Capacity planning adjustment.--
       ``(A) In general.--For each fiscal year, after the annual 
     base revenue established in subsection (b)(1)(A) is adjusted 
     in accordance with paragraphs (1) and (2), such revenue shall 
     be adjusted further for such fiscal year, in accordance with 
     this paragraph, to reflect changes in the resource capacity 
     needs of the Secretary for the process for the review of 
     human drug applications.
       ``(B) Methodology.--For purposes of this paragraph, the 
     Secretary shall employ the capacity planning methodology 
     utilized by the Secretary in setting fees for fiscal year 
     2021, as described in the notice titled `Prescription Drug 
     User Fee Rates for Fiscal Year 2021' published in the Federal 
     Register on August 3, 2020 (85 Fed. Reg. 46651). The workload 
     categories used in applying such methodology in forecasting 
     shall include only the activities described in that notice 
     and, as feasible, additional activities that are directly 
     related to the direct review of applications and supplements, 
     including additional formal meeting types, the direct review 
     of postmarketing commitments and requirements, the direct 
     review of risk evaluation and mitigation strategies, and the 
     direct review of annual reports for approved prescription 
     drug products. Subject to the exceptions in the preceding 
     sentence, the Secretary shall not include as workload 
     categories in applying such methodology in forecasting any 
     non-core review activities, including those activities that 
     the Secretary referenced for potential future use in such 
     notice but did not utilize in setting fees for fiscal year 
     2021.
       ``(C) Limitation.--Under no circumstances shall an 
     adjustment under this paragraph result in fee revenue for a 
     fiscal year that is less than the sum of the amounts under 
     subsections (b)(1)(A) (the annual base revenue for the fiscal 
     year), (b)(1)(B) (the dollar amount of the inflation 
     adjustment for the fiscal year), and (b)(1)(C) (the dollar 
     amount of the strategic hiring and retention adjustment for 
     the fiscal year).
       ``(D) Publication in federal register.--The Secretary shall 
     publish in the Federal Register notice under paragraph (6) of 
     the fee revenue and fees resulting from the adjustment and 
     the methodologies under this paragraph.''.
       (4) Operating reserve adjustment.--Paragraph (4), as 
     redesignated, of section 736(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
       (A) by amending subparagraph (A) to read as follows:
       ``(A) Increase.--For fiscal year 2023 and subsequent fiscal 
     years, the Secretary shall, in addition to adjustments under 
     paragraphs (1), (2), and (3), further increase the fee 
     revenue and fees if such an adjustment is necessary to 
     provide for operating reserves of carryover user fees for the 
     process for the review of human drug applications for each 
     fiscal year in at least the following amounts:
       ``(i) For fiscal year 2023, at least 8 weeks of operating 
     reserves.
       ``(ii) For fiscal year 2024, at least 9 weeks of operating 
     reserves.
       ``(iii) For fiscal year 2025 and subsequent fiscal years, 
     at least 10 weeks of operating reserves.''; and
       (B) in subparagraph (C), by striking ``paragraph (5)'' and 
     inserting ``paragraph (6)''.
       (5) Additional direct cost adjustment.--Paragraph (5), as 
     redesignated, of section 736(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as 
     follows:
       ``(5) Additional direct cost adjustment.--
       ``(A) Increase.--The Secretary shall, in addition to 
     adjustments under paragraphs (1), (2), (3), and (4), further 
     increase the fee revenue and fees--
       ``(i) for fiscal year 2023, by $44,386,150; and
       ``(ii) for each of fiscal years 2024 through 2027, by the 
     amount set forth in clauses (i) through (iv) of subparagraph 
     (B), as applicable, multiplied by the Consumer Price Index 
     for urban consumers (Washington-Arlington-Alexandria, DC-VA-
     MD-WV; Not Seasonally Adjusted; All Items; Annual Index) for 
     the most recent year of available data, divided by such Index 
     for 2021.
       ``(B) Applicable amounts.--The amounts referred to in 
     subparagraph (A)(ii) are the following:
       ``(i) For fiscal year 2024, $60,967,993.
       ``(ii) For fiscal year 2025, $35,799,314.
       ``(iii) For fiscal year 2026, $35,799, 314.
       ``(iv) For fiscal year 2027, $35,799,314.''.
       (6) Annual fee setting.--Paragraph (6), as redesignated, of 
     section 736(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379h(c)) is amended by striking ``September 30, 
     2017'' and inserting ``September 30, 2022''.
       (d) Crediting and Availability of Fees.--Section 736(g)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379h(g)(3)) is amended by striking ``fiscal years 2018 
     through 2022'' and inserting ``fiscal years 2023 through 
     2027''.
       (e) Written Requests for Waivers, Reductions, Exemptions, 
     and Returns; Disputes Concerning Fees.--Section 736(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is 
     amended to read as follows:
       ``(i) Written Requests for Waivers, Reductions, Exemptions, 
     and Returns; Disputes Concerning Fees.--To qualify for 
     consideration for a waiver or reduction under subsection (d), 
     an exemption under subsection (k), or the return of any fee 
     paid under this section, including if the fee is claimed to 
     have been paid in error, a person shall--
       ``(1) not later than 180 days after such fee is due, submit 
     to the Secretary a written request justifying such waiver, 
     reduction, exemption, or return; and
       ``(2) include in the request any legal authorities under 
     which the request is made.''.
       (f) Orphan Drugs.--Section 736(k) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended--
       (1) in paragraph (1)(B), by striking ``during the previous 
     year'' and inserting ``as determined under paragraph (2)''; 
     and
       (2) by amending paragraph (2) to read as follows:
       ``(2) Evidence of qualification.--An exemption under 
     paragraph (1) applies with respect to a drug only if the 
     applicant involved submits a certification that the 
     applicant's gross annual revenues did not exceed $50,000,000 
     for the last calendar year ending prior to the fiscal year 
     for which the exemption is requested. Such certification 
     shall be supported by--
       ``(A) tax returns submitted to the United States Internal 
     Revenue Service; or
       ``(B) as necessary, other appropriate financial 
     information.''.

     SEC. 1004. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 736B of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379h-2) is amended--
       (1) in subsection (a)(1), by striking ``Beginning with 
     fiscal year 2018, not'' and inserting ``Not'';
       (2) by striking ``Prescription Drug User Fee Amendments of 
     2017'' each place it appears and inserting ``Prescription 
     Drug User Fee Amendments of 2022'';
       (3) in subsection (a)(3)(A), by striking ``Not later than 
     30 calendar days after the end of the second quarter of 
     fiscal year 2018, and not later than 30 calendar days after 
     the end of each quarter of each fiscal year thereafter'' and 
     inserting ``Not later than 30 calendar days after the end of 
     each quarter of each fiscal year for which fees are collected 
     under this part'';
       (4) in subsection (a)(4), by striking ``Beginning with 
     fiscal year 2020, the'' and inserting ``The'';
       (5) in subsection (b), by striking ``Beginning with fiscal 
     year 2018, not'' and inserting ``Not'';
       (6) in subsection (c), by striking ``Beginning with fiscal 
     year 2018, for'' and inserting ``For''; and
       (7) in subsection (f)--
       (A) in paragraph (1), in the matter preceding subparagraph 
     (A), by striking ``fiscal year 2022'' and inserting ``fiscal 
     year 2027''; and
       (B) in paragraph (5), by striking ``January 15, 2022'' and 
     inserting ``January 15, 2027''.

     SEC. 1005. SUNSET DATES.

       (a) Authorization.--Sections 735 and 736 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall 
     cease to be effective October 1, 2027.
       (b) Reporting Requirements.--Section 736B of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease 
     to be effective January 31, 2028.
       (c) Previous Sunset Provision.--Effective October 1, 2022, 
     subsections (a) and (b) of section 104 of the FDA 
     Reauthorization Act of 2017 (Public Law 115-52) are repealed.

     SEC. 1006. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 2 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for 
     all human drug applications received on or after October 1, 
     2022, regardless of the date of the enactment of this Act.

     SEC. 1007. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 2 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to human drug 
     applications and supplements (as defined in such part as of 
     such day) that were accepted by the Food and Drug 
     Administration for filing on or after October 1, 2017, but 
     before October 1, 2022, with respect to assessing and 
     collecting any fee required by such part for a fiscal year 
     prior to fiscal year 2023.

                   TITLE II--FEES RELATING TO DEVICES

     SEC. 2001. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the ``Medical 
     Device User Fee Amendments of 2022''.

[[Page S5104]]

       (b) Finding.--Congress finds that the fees authorized under 
     the amendments made by this title will be dedicated toward 
     expediting the process for the review of device applications 
     and for assuring the safety and effectiveness of devices, as 
     set forth in the goals identified for purposes of part 3 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.), in the letters from 
     the Secretary of Health and Human Services to the Chairman of 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate and the Chairman of the Committee on Energy and 
     Commerce of the House of Representatives, as set forth in the 
     Congressional Record.

     SEC. 2002. DEFINITIONS.

       Section 737 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379i) is amended--
       (1) in paragraph (9)--
       (A) in the matter preceding subparagraph (A), by striking 
     ``and premarket notification submissions'' and inserting 
     ``premarket notification submissions, and de novo 
     classification requests'';
       (B) in subparagraph (D), by striking ``and submissions'' 
     and inserting ``submissions, and de novo classification 
     requests'';
       (C) in subparagraph (F), by striking ``and premarket 
     notification submissions'' and inserting ``premarket 
     notification submissions, and de novo classification 
     requests'';
       (D) in each of subparagraphs (G) and (H), by striking ``or 
     submissions'' and inserting ``submissions, or requests''; and
       (E) in subparagraph (K), by striking ``or premarket 
     notification submissions'' and inserting ``premarket 
     notification submissions, or de novo classification 
     requests''; and
       (2) in paragraph (11), by striking ``2016'' and inserting 
     ``2021''.

     SEC. 2003. AUTHORITY TO ASSESS AND USE DEVICE FEES.

       (a) Types of Fees.--Section 738(a) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended--
       (1) in paragraph (1), by striking ``fiscal year 2018'' and 
     inserting ``fiscal year 2023''; and
       (2) in paragraph (2)--
       (A) in subparagraph (A)--
       (i) in the matter preceding clause (i), by striking 
     ``October 1, 2017'' and inserting ``October 1, 2022'';
       (ii) in clause (iii), by striking ``75 percent'' and 
     inserting ``80 percent''; and
       (iii) in clause (viii), by striking ``3.4 percent'' and 
     inserting ``4.5 percent'';
       (B) in subparagraph (B)(iii), by striking ``or premarket 
     notification submission'' and inserting ``premarket 
     notification submission, or de novo classification request''; 
     and
       (C) in subparagraph (C), by striking ``or periodic 
     reporting concerning a class III device'' and inserting 
     ``periodic reporting concerning a class III device, or de 
     novo classification request''.
       (b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379j(b)) is amended--
       (1) in paragraph (1), by striking ``2018 through 2022'' and 
     inserting ``2023 through 2027'';
       (2) by amending paragraph (2) to read as follows:
       ``(2) Base fee amounts specified.--For purposes of 
     paragraph (1), the base fee amounts specified in this 
     paragraph are as follows:

----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        ``Fee Type                         Year 2023  Year 2024  Year 2025  Year 2026  Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $425,000   $435,000   $445,000   $455,000   $470,000
Establishment Registration...............................     $6,250     $6,875     $7,100     $7,575  $8,465'';
                                                                                                             and
----------------------------------------------------------------------------------------------------------------

       (3) by amending paragraph (3) to read as follows:
       ``(3) Total revenue amounts specified.--For purposes of 
     paragraph (1), the total revenue amounts specified in this 
     paragraph are as follows:
       ``(A) $312,606,000 for fiscal year 2023.
       ``(B) $335,750,000 for fiscal year 2024.
       ``(C) $350,746,400 for fiscal year 2025.
       ``(D) $366,486,300 for fiscal year 2026.
       ``(E) $418,343,000 for fiscal year 2027.''.
       (c) Annual Fee Setting; Adjustments.--Section 738(c) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is 
     amended--
       (1) in paragraph (1), by striking ``2017'' and inserting 
     ``2022'';
       (2) in paragraph (2)--
       (A) in subparagraph (A), by striking ``2018'' and inserting 
     ``2023'';
       (B) in subparagraph (B)--
       (i) in the matter preceding clause (i), by striking 
     ``fiscal year 2018'' and inserting ``fiscal year 2023''; and
       (ii) in clause (ii), by striking ``fiscal year 2016'' and 
     inserting ``fiscal year 2022'';
       (C) in subparagraph (C), by striking ``Washington-
     Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
     Arlington-Alexandria, DC-VA-MD-WV''; and
       (D) in subparagraph (D), in the matter preceding clause 
     (i), by striking ``fiscal years 2018 through 2022'' and 
     inserting ``fiscal years 2023 through 2027'';
       (3) in paragraph (3), by striking ``2018 through 2022'' and 
     inserting ``2023 through 2027'';
       (4) by redesignating paragraphs (4) and (5) as paragraphs 
     (7) and (8), respectively; and
       (5) by inserting after paragraph (3) the following:
       ``(4) Performance improvement adjustment.--
       ``(A) In general.--For each of fiscal years 2025 through 
     2027, after the adjustments under paragraphs (2) and (3), the 
     base establishment registration fee amounts for such fiscal 
     year shall be increased to reflect changes in the resource 
     needs of the Secretary due to improved review performance 
     goals for the process for the review of device applications 
     identified in the letters described in section 2001(b) of the 
     Medical Device User Fee Amendments of 2022, as the Secretary 
     determines necessary to achieve an increase in total fee 
     collections for such fiscal year equal to the following 
     amounts, as applicable:
       ``(i) For fiscal year 2025, the product of--

       ``(I) the amount determined under subparagraph (B)(i)(I); 
     and
       ``(II) the applicable inflation adjustment under paragraph 
     (2)(B) for such fiscal year.

       ``(ii) For fiscal year 2026, the product of--

       ``(I) the sum of the amounts determined under subparagraphs 
     (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and
       ``(II) the applicable inflation adjustment under paragraph 
     (2)(B) for such fiscal year.

       ``(iii) For fiscal year 2027, the product of--

       ``(I) the sum of the amounts determined under subparagraphs 
     (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and
       ``(II) the applicable inflation adjustment under paragraph 
     (2)(B) for such fiscal year.

       ``(B) Amounts.--
       ``(i) Presubmission amount.--For purposes of subparagraph 
     (A), with respect to the Presubmission Written Feedback goal, 
     the amounts determined under this subparagraph are as 
     follows:

       ``(I) For fiscal year 2025, $15,396,600 if such goal for 
     fiscal year 2023 is met.
       ``(II) For fiscal year 2026:

       ``(aa) $15,396,600 if such goal for fiscal year 2023 is met 
     and such goal for fiscal year 2024 is not met.
       ``(bb) $36,792,200 if such goal for fiscal year 2024 is 
     met.

       ``(III) For fiscal year 2027:

       ``(aa) $15,396,600 if such goal for fiscal year 2023 is met 
     and such goal for each of fiscal years 2024 and 2025 is not 
     met.
       ``(bb) $36,792,200 if such goal for fiscal year 2024 is met 
     and such goal for fiscal year 2025 is not met.
       ``(cc) $40,572,600 if such goal for fiscal year 2025 is 
     met.
       ``(ii) De novo classification request amount.--For purposes 
     of subparagraph (A), with respect to the De Novo Decision 
     goal, the amounts determined under this subparagraph are as 
     follows:

       ``(I) For fiscal year 2026, $6,323,500 if such goal for 
     fiscal year 2023 is met.
       ``(II) For fiscal year 2027:

       ``(aa) $6,323,500 if such goal for fiscal year 2023 is met 
     and such goal for fiscal year 2024 is not met.
       ``(bb) $11,765,400 if such goal for fiscal year 2024 is 
     met.
       ``(iii) Premarket notification and premarket approval 
     amount.--For purposes of subparagraph (A), with respect to 
     the 510(k) decision goal, 510(k) Shared Outcome Total Time to 
     Decision goal, PMA decision goal, and PMA Shared Outcome 
     Total Time to Decision goal, the amounts determined under 
     this subparagraph are as follows:

       ``(I) For fiscal year 2026, $1,020,000 if the 4 goals for 
     fiscal year 2023 are met.
       ``(II) For fiscal year 2027:

       ``(aa) $1,020,000 if the 4 goals for fiscal year 2023 are 
     met and one or more of the 4 goals for fiscal year 2024 are 
     not met.
       ``(bb) $3,906,000 if the 4 goals for fiscal year 2024 are 
     met.
       ``(C) Performance calculation.--For purposes of this 
     paragraph, performance of the following goals shall be 
     determined as specified in the letters described in section 
     2001(b) of the Medical Device User Fee Amendments of 2022 and 
     based on data available, as follows:
       ``(i) The performance of the Presubmission Written Feedback 
     goal shall be based on data available as of--

       ``(I) for fiscal year 2023, March 31, 2024;
       ``(II) for fiscal year 2024, March 31, 2025; and
       ``(III) for fiscal year 2025, March 31, 2026.

       ``(ii) The performance of the De Novo Decision goal, 510(k) 
     decision goal, 510(k) Shared Outcome Total Time to Decision 
     goal, PMA decision goal, and PMA Shared Outcome Total Time to 
     Decision goal shall be based on data available as of--

       ``(I) for fiscal year 2023, March 31, 2025; and

[[Page S5105]]

       ``(II) for fiscal year 2024, March 31, 2026.

       ``(D) Goals defined.--For purposes of this paragraph, the 
     terms `Presubmission Written Feedback goal', `De Novo 
     Decision goal', `510(k) decision goal', `510(k) Shared 
     Outcome Total Time to Decision goal', `PMA decision goal', 
     and `PMA Shared Outcome Total Time to Decision goal' refer to 
     the goals identified by the same names in the letters 
     described in section 2001(b) of the Medical Device User Fee 
     Amendments of 2022.
       ``(5) Hiring adjustment.--
       ``(A) In general.--For each of fiscal years 2025 through 
     2027, after the adjustments under paragraphs (2), (3), and 
     (4), if applicable, if the number of hires to support the 
     process for the review of device applications falls below the 
     thresholds specified in subparagraph (B) for the applicable 
     fiscal years, the base establishment registration fee amounts 
     shall be decreased as the Secretary determines necessary to 
     achieve a reduction in total fee collections equal to the 
     hiring adjustment amount under subparagraph (C).
       ``(B) Thresholds.--The thresholds specified in this 
     subparagraph are as follows:
       ``(i) For fiscal year 2025, the threshold is 123 hires for 
     fiscal year 2023.
       ``(ii) For fiscal year 2026, the threshold is 38 hires for 
     fiscal year 2024.
       ``(iii) For fiscal year 2027, the threshold is--

       ``(I) 22 hires for fiscal year 2025 if the base 
     establishment registration fees are not increased by the 
     amount determined under paragraph (4)(A)(i); or
       ``(II) 75 hires for fiscal year 2025 if such fees are so 
     increased.

       ``(C) Hiring adjustment amount.--The hiring adjustment 
     amount for fiscal year 2025 and each subsequent fiscal year 
     is the product of--
       ``(i) the number of hires by which the hiring goal 
     specified in subparagraph (D) for the fiscal year before the 
     prior fiscal year was not met;
       ``(ii) $72,877; and
       ``(iii) the applicable inflation adjustment under paragraph 
     (2)(B) for the fiscal year for which the hiring goal was not 
     met.
       ``(D) Hiring goals.--The hiring goals for each of fiscal 
     years 2023 through 2025 are as follows:
       ``(i) For fiscal year 2023, 144 hires.
       ``(ii) For fiscal year 2024, 42 hires.
       ``(iii) For fiscal year 2025:

       ``(I) 24 hires if the base establishment registration fees 
     are not increased by the amount determined under paragraph 
     (4)(A)(i).
       ``(II) 83 hires if the base establishment registration fees 
     are increased by the amount determined under paragraph 
     (4)(A)(i).

       ``(E) Number of hires.--For purposes of this paragraph, the 
     number of hires for a fiscal year shall be determined by the 
     Secretary as set forth in the letters described in section 
     2001(b) of the Medical Device User Fee Amendments of 2022.
       ``(6) Operating reserve adjustment.--
       ``(A) In general.--For each of fiscal years 2023 through 
     2027, after the adjustments under paragraphs (2), (3), (4), 
     and (5), if applicable, if the Secretary has operating 
     reserves of carryover user fees for the process for the 
     review of device applications in excess of the designated 
     amount in subparagraph (B), the Secretary shall decrease the 
     base establishment registration fee amounts to provide for 
     not more than such designated amount of operating reserves.
       ``(B) Designated amount.--Subject to subparagraph (C), for 
     each fiscal year, the designated amount in this subparagraph 
     is equal to the sum of--
       ``(i) 13 weeks of operating reserves of carryover user 
     fees; and
       ``(ii) 1 month of operating reserves maintained pursuant to 
     paragraph (8).
       ``(C) Excluded amount.--For the period of fiscal years 2023 
     through 2026, a total amount equal to $118,000,000 shall not 
     be considered part of the designated amount under 
     subparagraph (B) and shall not be subject to the decrease 
     under subparagraph (A).''.
       (d) Conditions.--Section 738(g) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379j(g)) is amended--
       (1) in paragraph (1)(A), by striking ``$320,825,000'' and 
     inserting ``$398,566,000''; and
       (2) in paragraph (2), by inserting ``de novo classification 
     requests,'' after ``class III device,''.
       (e) Crediting and Availability of Fees.--Section 738(h)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379j(h)(3)) is amended to read as follows:
       ``(3) Authorization of appropriations.--
       ``(A) In general.--For each of fiscal years 2023 through 
     2027, there is authorized to be appropriated for fees under 
     this section an amount equal to the revenue amount determined 
     under subparagraph (B), less the amount of reductions 
     determined under subparagraph (C).
       ``(B) Revenue amount.--For purposes of this paragraph, the 
     revenue amount for each fiscal year is the sum of--
       ``(i) the total revenue amount under subsection (b)(3) for 
     the fiscal year, as adjusted under paragraphs (2) and (3) of 
     subsection (c); and
       ``(ii) the performance improvement adjustment amount for 
     the fiscal year under subsection (c)(4), if applicable.
       ``(C) Amount of reductions.--For purposes of this 
     paragraph, the amount of reductions for each fiscal year is 
     the sum of--
       ``(i) the hiring adjustment amount for the fiscal year 
     under subsection (c)(5), if applicable; and
       ``(ii) the operating reserve adjustment amount for the 
     fiscal year under subsection (c)(6), if applicable.''.

     SEC. 2004. REAUTHORIZATION; REPORTING REQUIREMENTS.

       (a) Performance Reports.--Section 738A(a) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is 
     amended--
       (1) by striking ``fiscal year 2018'' each place it appears 
     and inserting ``fiscal year 2023'';
       (2) by striking ``Medical Device User Fee Amendments of 
     2017'' each place it appears and inserting ``Medical Device 
     User Fee Amendments of 2022'';
       (3) in paragraph (1)--
       (A) in subparagraph (A), by redesignating the second clause 
     (iv) (relating to analysis) as clause (v); and
       (B) in subparagraph (A)(iv), by striking ``fiscal year 
     2020'' and inserting ``fiscal year 2023''; and
       (4) in paragraph (4), by striking ``2018 through 2022'' and 
     inserting ``2023 through 2027''.
       (b) Reauthorization.--Section 738A(b) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
       (1) in paragraph (1), by striking ``2022'' and inserting 
     ``2027''; and
       (2) in paragraph (5), by striking ``2022'' and inserting 
     ``2027''.

     SEC. 2005. CONFORMITY ASSESSMENT PILOT PROGRAM.

       Section 514(d) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360d(d)) is amended to read as follows:
       ``(d) Accreditation Scheme for Conformity Assessment.--
       ``(1) In general.--The Secretary shall establish a program 
     under which--
       ``(A) testing laboratories meeting criteria specified in 
     guidance by the Secretary may be accredited, by accreditation 
     bodies meeting criteria specified in guidance by the 
     Secretary, to conduct testing to support the assessment of 
     the conformity of a device to certain standards recognized 
     under this section; and
       ``(B) subject to paragraph (2), results from tests 
     conducted to support the assessment of conformity of devices 
     as described in subparagraph (A) conducted by testing 
     laboratories accredited pursuant to this subsection shall be 
     accepted by the Secretary for purposes of demonstrating such 
     conformity unless the Secretary finds that certain results of 
     such tests should not be so accepted.
       ``(2) Secretarial review of accredited laboratory 
     results.--The Secretary may--
       ``(A) review the results of tests conducted by testing 
     laboratories accredited pursuant to this subsection, 
     including by conducting periodic audits of such results or of 
     the processes of accredited bodies or testing laboratories;
       ``(B) following such review, take additional measures under 
     this Act, as the Secretary determines appropriate, such as--
       ``(i) suspension or withdrawal of accreditation of a 
     testing laboratory or recognition of an accreditation body 
     under paragraph (1)(A); or
       ``(ii) requesting additional information with respect to a 
     device; and
       ``(C) if the Secretary becomes aware of information 
     materially bearing on the safety or effectiveness of a device 
     for which an assessment of conformity was supported by 
     testing conducted by a testing laboratory accredited under 
     this subsection, take such additional measures under this 
     Act, as the Secretary determines appropriate, such as--
       ``(i) suspension or withdrawal of accreditation of a 
     testing laboratory or recognition of an accreditation body 
     under paragraph (1)(A); or
       ``(ii) requesting additional information with regard to 
     such device.
       ``(3) Report.--The Secretary shall make available on the 
     internet website of the Food and Drug Administration an 
     annual report on the progress of the program under this 
     subsection.''.

     SEC. 2006. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.

       Section 523(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360m(c)) is amended by striking ``October 1'' and 
     inserting ``December 17''.

     SEC. 2007. SUNSET DATES.

       (a) Authorization.--Sections 737 and 738 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall 
     cease to be effective October 1, 2027.
       (b) Reporting Requirements.--Section 738A of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1) shall cease 
     to be effective January 31, 2028.
       (c) Previous Sunset Provisions.--Effective October 1, 2022, 
     subsections (a) and (b) of section 210 of the FDA 
     Reauthorization Act of 2017 (Public Law 115-52) are repealed.

     SEC. 2008. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 3 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for 
     all submissions listed in section 738(a)(2)(A) of such Act 
     received on or after October 1, 2022, regardless of the date 
     of the enactment of this Act.

     SEC. 2009. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 3 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the 
     day before the date of the enactment of this

[[Page S5106]]

     title, shall continue to be in effect with respect to the 
     submissions listed in section 738(a)(2)(A) of such Act (as 
     defined in such part as of such day) that on or after October 
     1, 2017, but before October 1, 2022, were received by the 
     Food and Drug Administration with respect to assessing and 
     collecting any fee required by such part for a fiscal year 
     prior to fiscal year 2023.

               TITLE III--FEES RELATING TO GENERIC DRUGS

     SEC. 3001. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the ``Generic 
     Drug User Fee Amendments of 2022''.
       (b) Finding.--Congress finds that the fees authorized by 
     the amendments made by this title will be dedicated to human 
     generic drug activities, as set forth in the goals identified 
     for purposes of part 7 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41 et 
     seq.), in the letters from the Secretary of Health and Human 
     Services to the Chairman of the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the Chairman 
     of the Committee on Energy and Commerce of the House of 
     Representatives, as set forth in the Congressional Record.

     SEC. 3002. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       (a) Types of Fees.--Section 744B(a) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``2018'' and inserting ``2023'';
       (2) in paragraph (2)(C), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027'';
       (3) in paragraph (3)(B), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027'';
       (4) in paragraph (4)(D), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027''; and
       (5) in paragraph (5)(D), by striking ``2018 through 2022'' 
     and inserting ``2023 through 2027''.
       (b) Fee Revenue Amounts.--Section 744B(b) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is 
     amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A)--
       (i) in the heading, by striking ``2018'' and inserting 
     ``2023'';
       (ii) by striking ``2018'' and inserting ``2023''; and
       (iii) by striking ``$493,600,000'' and inserting 
     ``$582,500,000''; and
       (B) by amending subparagraph (B) to read as follows:
       ``(B) Fiscal years 2024 through 2027.--
       ``(i) In general.--For each of the fiscal years 2024 
     through 2027, fees under paragraphs (2) through (5) of 
     subsection (a) shall be established to generate a total 
     estimated revenue amount under such subsection that is equal 
     to the base revenue amount for the fiscal year under clause 
     (ii), as adjusted pursuant to subsection (c).
       ``(ii) Base revenue amount.--The base revenue amount for a 
     fiscal year referred to in clause (i) is equal to the total 
     revenue amount established under this paragraph for the 
     previous fiscal year, not including any adjustments made for 
     such previous fiscal year under subsection (c)(3).''; and
       (2) in paragraph (2)--
       (A) in subparagraph (C), by striking ``one-third the 
     amount'' and inserting ``twenty-four percent'';
       (B) in subparagraph (D), by striking ``Seven percent'' and 
     inserting ``Six percent''; and
       (C) in subparagraph (E)(i), by striking ``Thirty-five 
     percent'' and inserting ``Thirty-six percent''.
       (c) Adjustments.--Section 744B(c) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
       (1) in paragraph (1)--
       (A) in the matter preceding subparagraph (A)--
       (i) by striking ``2019'' and inserting ``2024''; and
       (ii) by striking ``to equal the product of the total 
     revenues established in such notice for the prior fiscal year 
     multiplied'' and inserting ``to equal the base revenue amount 
     for the fiscal year (as specified in subsection 
     (b)(1)(B)(ii)) multiplied''; and
       (B) in subparagraph (C), by striking ``Washington-
     Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
     Arlington-Alexandria, DC-VA-MD-WV''; and
       (2) by striking paragraph (2) and inserting the following:
       ``(2) Capacity planning adjustment.--
       ``(A) In general.--Beginning with fiscal year 2024, the 
     Secretary shall, in addition to the adjustment under 
     paragraph (1), further increase the fee revenue and fees 
     under this section for a fiscal year, in accordance with this 
     paragraph, to reflect changes in the resource capacity needs 
     of the Secretary for human generic drug activities.
       ``(B) Capacity planning methodology.--The Secretary shall 
     establish a capacity planning methodology for purposes of 
     this paragraph, which shall--
       ``(i) be derived from the methodology and recommendations 
     made in the report titled `Independent Evaluation of the 
     GDUFA Resource Capacity Planning Adjustment Methodology: 
     Evaluation and Recommendations' announced in the Federal 
     Register on August 3, 2020 (85 Fed. Reg. 46658); and
       ``(ii) incorporate approaches and attributes determined 
     appropriate by the Secretary, including approaches and 
     attributes made in such report, except that in incorporating 
     such approaches and attributes the workload categories used 
     in forecasting resources shall only be the workload 
     categories specified in section VIII.B.2.e. of the letters 
     described in section 3001(b) of the Generic Drug User Fee 
     Amendments of 2022.
       ``(C) Limitations.--
       ``(i) In general.--Under no circumstances shall an 
     adjustment under this paragraph result in fee revenue for a 
     fiscal year that is less than the sum of the amounts under 
     subsection (b)(1)(B)(ii) (the base revenue amount for the 
     fiscal year) and paragraph (1) (the dollar amount of the 
     inflation adjustment for the fiscal year).
       ``(ii) Additional limitation.--An adjustment under this 
     paragraph shall not exceed 3 percent of the sum described in 
     clause (i) for the fiscal year, except that such limitation 
     shall be 4 percent if--

       ``(I) for purposes of a fiscal year 2024 adjustment, the 
     Secretary determines that during the period from April 1, 
     2021, through March 31, 2023--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,000; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as that 
     term is defined in section XI of the letters described in 
     section 3001(b) of the Generic Drug User Fee Amendments of 
     2022);

       ``(II) for purposes of a fiscal year 2025 adjustment, the 
     Secretary determines that during the period from April 1, 
     2022, through March 31, 2024--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,300; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as so 
     defined);

       ``(III) for purposes of a fiscal year 2026 adjustment, the 
     Secretary determines that during the period from April 1, 
     2023, through March 31, 2025--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,300; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as so 
     defined); and

       ``(IV) for purposes of a fiscal year 2027 adjustment, the 
     Secretary determines that during the period from April 1, 
     2024, through March 31, 2026--

       ``(aa) the total number of abbreviated new drug 
     applications submitted was greater than or equal to 2,300; or
       ``(bb) thirty-five percent or more of abbreviated new drug 
     applications submitted related to complex products (as so 
     defined).
       ``(D) Publication in federal register.--The Secretary shall 
     publish in the Federal Register notice referred to in 
     subsection (a) the fee revenue and fees resulting from the 
     adjustment and the methodology under this paragraph.
       ``(3) Operating reserve adjustment.--
       ``(A) In general.--For fiscal year 2024 and each subsequent 
     fiscal year, the Secretary may, in addition to adjustments 
     under paragraphs (1) and (2), further increase the fee 
     revenue and fees under this section for such fiscal year if 
     such an adjustment is necessary to provide operating reserves 
     of carryover user fees for human generic drug activities for 
     not more than the number of weeks specified in subparagraph 
     (B) with respect to that fiscal year.
       ``(B) Number of weeks.--The number of weeks specified in 
     this subparagraph is--
       ``(i) 8 weeks for fiscal year 2024;
       ``(ii) 9 weeks for fiscal year 2025; and
       ``(iii) 10 weeks for each of fiscal year 2026 and 2027.
       ``(C) Decrease.--If the Secretary has carryover balances 
     for human generic drug activities in excess of 12 weeks of 
     the operating reserves referred to in subparagraph (A), the 
     Secretary shall decrease the fee revenue and fees referred to 
     in such subparagraph to provide for not more than 12 weeks of 
     such operating reserves.
       ``(D) Rationale for adjustment.--If an adjustment under 
     this paragraph is made, the rationale for the amount of the 
     increase or decrease (as applicable) in fee revenue and fees 
     shall be contained in the annual Federal Register notice 
     under subsection (a) publishing the fee revenue and fees for 
     the fiscal year involved.''.
       (d) Annual Fee Setting.--Section 744B(d)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is 
     amended--
       (1) in the paragraph heading, by striking ``2018 through 
     2022'' and inserting ``2023 through 2027''; and
       (2) by striking ``more than 60 days before the first day of 
     each of fiscal years 2018 through 2022'' and inserting 
     ``later than 60 days before the first day of each of fiscal 
     years 2023 through 2027''.
       (e) Effect of Failure to Pay Fees.--The heading of 
     paragraph (3) of section 744B(g) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379j-42(g)) is amended by 
     striking ``and prior approval supplement fee''.
       (f) Crediting and Availability of Fees.--Section 744B(i)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     42(i)(3)) is amended by striking ``fiscal years 2018 through 
     2022'' and inserting ``fiscal years 2023 through 2027''.

[[Page S5107]]

  


     SEC. 3003. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 744C of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-43) is amended--
       (1) in subsection (a)(1), by striking ``Beginning with 
     fiscal year 2018, not'' and inserting ``Not'';
       (2) by striking ``Generic Drug User Fee Amendments of 
     2017'' each place it appears and inserting ``Generic Drug 
     User Fee Amendments of 2022'';
       (3) in subsection (a)(2), by striking ``Not later than 30 
     calendar days after the end of the second quarter of fiscal 
     year 2018, and not later than 30 calendar days after the end 
     of each quarter of each fiscal year thereafter'' and 
     inserting ``Not later than 30 calendar days after the end of 
     each quarter of each fiscal year for which fees are collected 
     under this part'';
       (4) in subsection (a)(3), by striking ``Beginning with 
     fiscal year 2020, the'' and inserting ``The'';
       (5) in subsection (b), by striking ``Beginning with fiscal 
     year 2018, not'' and inserting ``Not'';
       (6) in subsection (c), by striking ``Beginning with fiscal 
     year 2018, for'' and inserting ``For''; and
       (7) in subsection (f)--
       (A) in paragraph (1), in the matter preceding subparagraph 
     (A), by striking ``fiscal year 2022'' and inserting ``fiscal 
     year 2027''; and
       (B) in paragraph (5), by striking ``January 15, 2022'' and 
     inserting ``January 15, 2027''.

     SEC. 3004. SUNSET DATES.

       (a) Authorization.--Sections 744A and 744B of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) 
     shall cease to be effective October 1, 2027.
       (b) Reporting Requirements.--Section 744C of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease 
     to be effective January 31, 2028.
       (c) Previous Sunset Provision.--Effective October 1, 2022, 
     subsections (a) and (b) of section 305 of the FDA 
     Reauthorization Act of 2017 (Public Law 115-52) are repealed.

     SEC. 3005. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 7 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-41 et seq.) shall be assessed 
     for all abbreviated new drug applications received on or 
     after October 1, 2022, regardless of the date of the 
     enactment of this Act.

     SEC. 3006. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 7 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-41 et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to abbreviated new drug 
     applications (as defined in such part as of such day) that 
     were received by the Food and Drug Administration within the 
     meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 
     355(j)(5)(A)), prior approval supplements that were 
     submitted, and drug master files for Type II active 
     pharmaceutical ingredients that were first referenced on or 
     after October 1, 2017, but before October 1, 2022, with 
     respect to assessing and collecting any fee required by such 
     part for a fiscal year prior to fiscal year 2023.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     SEC. 4001. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Biosimilar User Fee Amendments of 2022''.
       (b) Finding.--Congress finds that the fees authorized by 
     the amendments made by this title will be dedicated to 
     expediting the process for the review of biosimilar 
     biological product applications, including postmarket safety 
     activities, as set forth in the goals identified for purposes 
     of part 8 of subchapter C of chapter VII of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 379j-51 et seq.), in the 
     letters from the Secretary of Health and Human Services to 
     the Chairman of the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Chairman of the Committee 
     on Energy and Commerce of the House of Representatives, as 
     set forth in the Congressional Record.

     SEC. 4002. DEFINITIONS.

       (a) Adjustment Factor.--Section 744G(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(1)) is 
     amended to read as follows:
       ``(1) The term `adjustment factor' applicable to a fiscal 
     year is the Consumer Price Index for urban consumers 
     (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally 
     Adjusted; All items) for September of the preceding fiscal 
     year divided by such Index for September 2011.''.
       (b) Biosimilar Biological Product Application.--Section 
     744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-51(4)(B)(iii)) is amended--
       (1) by striking subclause (II) (relating to an allergenic 
     extract product); and
       (2) by redesignating subclauses (III) and (IV) as 
     subclauses (II) and (III), respectively.

     SEC. 4003. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL 
                   PRODUCT FEES.

       (a) Types of Fees.--
       (1) In general.--The matter preceding paragraph (1) in 
     section 744H(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-52(a)) is amended by striking ``fiscal year 
     2018'' and inserting ``fiscal year 2023''.
       (2) Initial biosimilar biological product development 
     fee.--Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     52(a)(1)(A)) are each amended by striking ``5 days'' and 
     inserting ``7 days''.
       (3) Annual biosimilar biological product development fee.--
     Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
       (A) in clause (i), by inserting before the period at the 
     end the following: ``, except that, in the case that such 
     product (including, where applicable, ownership of the 
     relevant investigational new drug application) is transferred 
     to a licensee, assignee, or successor of such person, and 
     written notice of such transfer is provided to the Secretary, 
     such licensee, assignee, or successor shall pay the annual 
     biosimilar biological product development fee'';
       (B) in clause (iii)--
       (i) in subclause (I), by striking ``or'' at the end;
       (ii) in subclause (II), by striking the period at the end 
     and inserting ``; or''; and
       (iii) by adding at the end the following:

       ``(III) been administratively removed from the biosimilar 
     biological product development program for the product under 
     subparagraph (E)(v).''; and

       (C) in clause (iv), by striking ``is accepted for filing on 
     or after October 1 of such fiscal year'' and inserting ``is 
     subsequently accepted for filing''.
       (4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is 
     amended to read as follows:
       ``(D) Reactivation fee.--
       ``(i) In general.--A person that has discontinued 
     participation in the biosimilar biological product 
     development program for a product under subparagraph (C), or 
     who has been administratively removed from such program for a 
     product under subparagraph (E)(v), shall, if the person seeks 
     to resume participation in such program, pay all annual 
     biosimilar biological product development fees previously 
     assessed for such product and still owed and a fee (referred 
     to in this section as `reactivation fee') by the earlier of 
     the following:

       ``(I) Not later than 7 days after the Secretary grants a 
     request by such person for a biosimilar biological product 
     development meeting for the product (after the date on which 
     such participation was discontinued or the date of 
     administrative removal, as applicable).
       ``(II) Upon the date of submission (after the date on which 
     such participation was discontinued or the date of 
     administrative removal, as applicable) by such person of an 
     investigational new drug application describing an 
     investigation that the Secretary determines is intended to 
     support a biosimilar biological product application for that 
     product.

       ``(ii) Application of annual fee.--A person that pays a 
     reactivation fee for a product shall pay for such product, 
     beginning in the next fiscal year, the annual biosimilar 
     biological product development fee under subparagraph (B), 
     except that, in the case that such product (including, where 
     applicable, ownership of the relevant investigational new 
     drug application) is transferred to a licensee, assignee, or 
     successor of such person, and written notice of such transfer 
     is provided to the Secretary, such licensee, assignee, or 
     successor shall pay the annual biosimilar biological product 
     development fee.''.
       (5) Effect of failure to pay fees.--Section 744H(a)(1)(E) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     52(a)(1)(E)) is amended by adding at the end the following:
       ``(v) Administrative removal from the biosimilar biological 
     product development program.--If a person has failed to pay 
     an annual biosimilar biological product development fee for a 
     product as required under subparagraph (B) for a period of 2 
     consecutive fiscal years, the Secretary may administratively 
     remove such person from the biosimilar biological product 
     development program for the product. At least 30 days prior 
     to administratively removing a person from the biosimilar 
     biological product development program for a product under 
     this clause, the Secretary shall provide written notice to 
     such person of the intended administrative removal.''.
       (6) Biosimilar biological product application fee.--Section 
     744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or 
     was withdrawn'' the following: ``prior to approval''.
       (7) Biosimilar biological product program fee.--Section 
     744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379j-52(a)(3)) is amended--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``and'' at the end;
       (ii) by redesignating clause (ii) as clause (iii); and
       (iii) by inserting after clause (i) the following:
       ``(ii) may be dispensed only under prescription pursuant to 
     section 503(b); and''; and
       (B) by adding at the end the following:
       ``(E) Movement to discontinued list.--
       ``(i) Date of inclusion.--If a written request to place a 
     product on the list referenced in subparagraph (A) of 
     discontinued biosimilar biological products is submitted to 
     the Secretary on behalf of an applicant,

[[Page S5108]]

     and the request identifies the date the product is, or will 
     be, withdrawn from sale, then for purposes of assessing the 
     biosimilar biological product program fee, the Secretary 
     shall consider such product to have been included on such 
     list on the later of--

       ``(I) the date such request was received; or
       ``(II) if the product will be withdrawn from sale on a 
     future date, such future date when the product is withdrawn 
     from sale.

       ``(ii) Treatment as withdrawn from sale.--For purposes of 
     clause (i), a product shall be considered withdrawn from sale 
     once the applicant has ceased its own distribution of the 
     product, whether or not the applicant has ordered recall of 
     all previously distributed lots of the product, except that a 
     routine, temporary interruption in supply shall not render a 
     product withdrawn from sale.
       ``(iii) Special rule for products removed from discontinued 
     list.--If a biosimilar biological product that is identified 
     in a biosimilar biological product application approved as of 
     October 1 of a fiscal year appears, as of October 1 of such 
     fiscal year, on the list referenced in subparagraph (A) of 
     discontinued biosimilar biological products, and on any 
     subsequent day during such fiscal year the biosimilar 
     biological product does not appear on such list, except as 
     provided in subparagraph (D), each person who is named as the 
     applicant in a biosimilar biological product application with 
     respect to such product shall pay the annual biosimilar 
     biological product program fee established for a fiscal year 
     under subsection (c)(5) for such biosimilar biological 
     product. Notwithstanding subparagraph (B), such fee shall be 
     due on the last business day of such fiscal year and shall be 
     paid only once for each such product for each fiscal year.''.
       (8) Biosimilar biological product fee.--Section 744H(a) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     52(a)) is amended by striking paragraph (4).
       (b) Fee Revenue Amounts.--Subsection (b) of section 744H of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) 
     is amended--
       (1) by striking paragraph (1);
       (2) by redesignating paragraphs (2) through (4) as 
     paragraphs (1) through (3), respectively;
       (3) by amending paragraph (1) (as so redesignated) to read 
     as follows:
       ``(1) In general.--For each of the fiscal years 2023 
     through 2027, fees under subsection (a) shall, except as 
     provided in subsection (c), be established to generate a 
     total revenue amount equal to the sum of--
       ``(A) the annual base revenue for the fiscal year (as 
     determined under paragraph (3));
       ``(B) the dollar amount equal to the inflation adjustment 
     for the fiscal year (as determined under subsection (c)(1));
       ``(C) the dollar amount equal to the strategic hiring and 
     retention adjustment (as determined under subsection (c)(2));
       ``(D) the dollar amount equal to the capacity planning 
     adjustment for the fiscal year (as determined under 
     subsection (c)(3));
       ``(E) the dollar amount equal to the operating reserve 
     adjustment for the fiscal year, if applicable (as determined 
     under subsection (c)(4));
       ``(F) for fiscal year 2023 an additional amount of 
     $4,428,886; and
       ``(G) for fiscal year 2024 an additional amount of 
     $320,569.'';
       (4) in paragraph (2) (as so redesignated)--
       (A) in the paragraph heading, by striking ``; limitations 
     on fee amounts'';
       (B) by striking subparagraph (B); and
       (C) by redesignating subparagraphs (C) and (D) as 
     subparagraphs (B) and (C), respectively; and
       (5) by amending paragraph (3) (as so redesignated) to read 
     as follows:
       ``(3) Annual base revenue.--For purposes of paragraph (1), 
     the dollar amount of the annual base revenue for a fiscal 
     year shall be--
       ``(A) for fiscal year 2023, $43,376,922; and
       ``(B) for fiscal years 2024 through 2027, the dollar amount 
     of the total revenue amount established under paragraph (1) 
     for the previous fiscal year, excluding any adjustments to 
     such revenue amount under subsection (c)(4).''.
       (c) Adjustments; Annual Fee Setting.--Section 744H(c) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
     52(c)) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A)--
       (i) in the matter preceding clause (i), by striking 
     ``subsection (b)(2)(B)'' and inserting ``subsection 
     (b)(1)(B)''; and
       (ii) in clause (i), by striking ``subsection (b)'' and 
     inserting ``subsection (b)(1)(A)''; and
       (B) in subparagraph (B)(ii), by striking ``Washington-
     Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
     Arlington-Alexandria, DC-VA-MD-WV'';
       (2) by striking paragraphs (2) through (4) and inserting 
     the following:
       ``(2) Strategic hiring and retention adjustment.--For each 
     fiscal year, after the annual base revenue under subsection 
     (b)(1)(A) is adjusted for inflation in accordance with 
     paragraph (1), the Secretary shall further increase the fee 
     revenue and fees by $150,000.
       ``(3) Capacity planning adjustment.--
       ``(A) In general.--For each fiscal year, the Secretary 
     shall, in addition to the adjustments under paragraphs (1) 
     and (2), further adjust the fee revenue and fees under this 
     section for a fiscal year to reflect changes in the resource 
     capacity needs of the Secretary for the process for the 
     review of biosimilar biological product applications.
       ``(B) Methodology.--For purposes of this paragraph, the 
     Secretary shall employ the capacity planning methodology 
     utilized by the Secretary in setting fees for fiscal year 
     2021, as described in the notice titled `Biosimilar User Fee 
     Rates for Fiscal Year 2021' published in the Federal Register 
     on August 4, 2020 (85 Fed. Reg. 47220). The workload 
     categories used in applying such methodology in forecasting 
     shall include only the activities described in that notice 
     and, as feasible, additional activities that are directly 
     related to the direct review of biosimilar biological product 
     applications and supplements, including additional formal 
     meeting types, the direct review of postmarketing commitments 
     and requirements, the direct review of risk evaluation and 
     mitigation strategies, and the direct review of annual 
     reports for approved biosimilar biological products. Subject 
     to the exceptions in the preceding sentence, the Secretary 
     shall not include as workload categories in applying such 
     methodology in forecasting any non-core review activities, 
     including those activities that the Secretary referenced for 
     potential future use in such notice but did not utilize in 
     setting fees for fiscal year 2021.
       ``(C) Limitations.--Under no circumstances shall an 
     adjustment under this paragraph result in fee revenue for a 
     fiscal year that is less than the sum of the amounts under 
     subsections (b)(1)(A) (the annual base revenue for the fiscal 
     year), (b)(1)(B) (the dollar amount of the inflation 
     adjustment for the fiscal year), and (b)(1)(C) (the dollar 
     amount of the strategic hiring and retention adjustment).
       ``(D) Publication in federal register.--The Secretary shall 
     publish in the Federal Register notice under paragraph (5) 
     the fee revenue and fees resulting from the adjustment and 
     the methodologies under this paragraph.
       ``(4) Operating reserve adjustment.--
       ``(A) Increase.--For fiscal year 2023 and subsequent fiscal 
     years, the Secretary shall, in addition to adjustments under 
     paragraphs (1), (2), and (3), further increase the fee 
     revenue and fees if such an adjustment is necessary to 
     provide for at least 10 weeks of operating reserves of 
     carryover user fees for the process for the review of 
     biosimilar biological product applications.
       ``(B) Decrease.--
       ``(i) Fiscal year 2023.--For fiscal year 2023, if the 
     Secretary has carryover balances for such process in excess 
     of 33 weeks of such operating reserves, the Secretary shall 
     decrease such fee revenue and fees to provide for not more 
     than 33 weeks of such operating reserves.
       ``(ii) Fiscal year 2024.--For fiscal year 2024, if the 
     Secretary has carryover balances for such process in excess 
     of 27 weeks of such operating reserves, the Secretary shall 
     decrease such fee revenue and fees to provide for not more 
     than 27 weeks of such operating reserves.
       ``(iii) Fiscal year 2025 and subsequent fiscal years.--For 
     fiscal year 2025 and subsequent fiscal years, if the 
     Secretary has carryover balances for such process in excess 
     of 21 weeks of such operating reserves, the Secretary shall 
     decrease such fee revenue and fees to provide for not more 
     than 21 weeks of such operating reserves.
       ``(C) Federal register notice.--If an adjustment under 
     subparagraph (A) or (B) is made, the rationale for the amount 
     of the increase or decrease (as applicable) in fee revenue 
     and fees shall be contained in the annual Federal Register 
     notice under paragraph (5)(B) establishing fee revenue and 
     fees for the fiscal year involved.''; and
       (3) in paragraph (5), in the matter preceding subparagraph 
     (A), by striking ``2018'' and inserting ``2023''.
       (d) Crediting and Availability of Fees.--Subsection (f)(3) 
     of section 744H of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-52(f)(3)) is amended by striking ``2018 
     through 2022'' and inserting ``2023 through 2027''.
       (e) Written Requests for Waivers and Returns; Disputes 
     Concerning Fees.--Section 744H(h) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379j-52(h)) is amended to read as 
     follows:
       ``(h) Written Requests for Waivers and Returns; Disputes 
     Concerning Fees.--To qualify for consideration for a waiver 
     under subsection (d), or for the return of any fee paid under 
     this section, including if the fee is claimed to have been 
     paid in error, a person shall submit to the Secretary a 
     written request justifying such waiver or return and, except 
     as otherwise specified in this section, such written request 
     shall be submitted to the Secretary not later than 180 days 
     after such fee is due. A request submitted under this 
     paragraph shall include any legal authorities under which the 
     request is made.''.

     SEC. 4004. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 744I of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 379j-53) is amended--
       (1) in subsection (a)(1), by striking ``Beginning with 
     fiscal year 2018, not'' and inserting ``Not'';
       (2) by striking ``Biosimilar User Fee Amendments of 2017'' 
     each place it appears and inserting ``Biosimilar User Fee 
     Amendments of 2022'';
       (3) in subsection (a)(2), by striking ``Beginning with 
     fiscal year 2018, the'' and inserting ``The'';
       (4) in subsection (a)(3)(A), by striking ``Not later than 
     30 calendar days after the end of the second quarter of 
     fiscal year 2018, and not later than 30 calendar days after 
     the end

[[Page S5109]]

     of each quarter of each fiscal year thereafter'' and 
     inserting ``Not later than 30 calendar days after the end of 
     each quarter of each fiscal year for which fees are collected 
     under this part'';
       (5) in subsection (b), by striking ``Not later than 120 
     days after the end of fiscal year 2018 and each subsequent 
     fiscal year for which fees are collected under this part'' 
     and inserting ``Not later than 120 days after the end of each 
     fiscal year for which fees are collected under this part'';
       (6) in subsection (c), by striking ``Beginning with fiscal 
     year 2018, and for'' and inserting ``For''; and
       (7) in subsection (f)--
       (A) in paragraph (1), in the matter preceding subparagraph 
     (A), by striking ``fiscal year 2022'' and inserting ``fiscal 
     year 2027''; and
       (B) in paragraph (3), by striking ``January 15, 2022'' and 
     inserting ``January 15, 2027''.

     SEC. 4005. SUNSET DATES.

       (a) Authorization.--Sections 744G and 744H of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51, 379j-52) 
     shall cease to be effective October 1, 2027.
       (b) Reporting Requirements.--Section 744I of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53) shall cease 
     to be effective January 31, 2028.
       (c) Previous Sunset Provision.--Effective October 1, 2022, 
     subsections (a) and (b) of section 405 of the FDA 
     Reauthorization Act of 2017 (Public Law 115-52) are repealed.

     SEC. 4006. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2022, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 8 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-51 et seq.) shall be assessed 
     for all biosimilar biological product applications received 
     on or after October 1, 2022, regardless of the date of the 
     enactment of this Act.

     SEC. 4007. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, part 8 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379j-51 et seq.), as in effect on the 
     day before the date of the enactment of this title, shall 
     continue to be in effect with respect to biosimilar 
     biological product applications and supplements (as defined 
     in such part as of such day) that were accepted by the Food 
     and Drug Administration for filing on or after October 1, 
     2017, but before October 1, 2022, with respect to assessing 
     and collecting any fee required by such part for a fiscal 
     year prior to fiscal year 2023.

              TITLE V--REAUTHORIZATION OF OTHER PROVISIONS

     SEC. 5001. REAUTHORIZATION OF THE BEST PHARMACEUTICALS FOR 
                   CHILDREN PROGRAM.

       Section 409I(d)(1) of the Public Health Service Act (42 
     U.S.C. 284m(d)(1)) is amended by striking ``$25,000,000 for 
     each of fiscal years 2018 through 2022'' and inserting 
     ``$5,273,973 for the period beginning on October 1, 2022 and 
     ending on December 16, 2022''.

     SEC. 5002. REAUTHORIZATION OF THE HUMANITARIAN DEVICE 
                   EXEMPTION INCENTIVE.

       Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by 
     striking ``October 1'' and inserting ``December 17''.

     SEC. 5003. REAUTHORIZATION OF THE PEDIATRIC DEVICE CONSORTIA 
                   PROGRAM.

       Section 305(e) of the Food and Drug Administration 
     Amendments Act of 2007 (Public Law 110-85; 42 U.S.C. 282 
     note) is amended by striking ``$5,250,000 for each of fiscal 
     years 2018 through 2022'' and inserting ``$1,107,534 for the 
     period beginning on October 1, 2022, and ending on December 
     16, 2022''.

     SEC. 5004. REAUTHORIZATION OF PROVISION PERTAINING TO DRUGS 
                   CONTAINING SINGLE ENANTIOMERS.

       Section 505(u)(4) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(u)(4)) is amended by striking ``October 
     1'' and inserting ``December 17''.

     SEC. 5005. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-
                   PRIVATE PARTNERSHIP.

       Section 566(f) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360bbb-5(f)) is amended by striking ``$6,000,000 
     for each of fiscal years 2018 through 2022'' and inserting 
     ``$1,265,753 for the period beginning on October 1, 2022 and 
     ending on December 16, 2022''.

     SEC. 5006. REAUTHORIZATION OF ORPHAN DRUG GRANTS.

       Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is 
     amended by striking ``$30,000,000 for each of fiscal years 
     2018 through 2022'' and inserting ``$6,328,767 for the period 
     beginning on October 1, 2022, and ending on December 16, 
     2022''.

     SEC. 5007. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.

       Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 374(g)(11)) is amended by striking ``October 
     1'' and inserting ``December 17''.

     SEC. 5008. REAUTHORIZATION OF REPORTING REQUIREMENTS RELATED 
                   TO PENDING GENERIC DRUG APPLICATIONS AND 
                   PRIORITY REVIEW APPLICATIONS.

       Section 807 of the FDA Reauthorization Act of 2017 (Public 
     Law 115-52) is amended, in the matter preceding paragraph 
     (1), by striking ``October 1'' and inserting ``December 16''.

       DIVISION G--HERMIT'S PEAK/CALF CANYON FIRE ASSISTANCE ACT

     SEC. 101. SHORT TITLE.

       This division may be cited as the ``Hermit's Peak/Calf 
     Canyon Fire Assistance Act''.

     SEC. 102. FINDINGS AND PURPOSES.

       (a) Findings.--Congress finds that--
       (1) on April 6, 2022, the Forest Service initiated the Las 
     Dispensas-Gallinas prescribed burn on Federal land in the 
     Santa Fe National Forest in San Miguel County, New Mexico, 
     when erratic winds were prevalent in the area that was also 
     suffering from severe drought after many years of 
     insufficient precipitation;
       (2) on April 6, 2022, the prescribed burn, which became 
     known as the ``Hermit's Peak Fire'', exceeded the containment 
     capabilities of the Forest Service, was declared a wildfire, 
     and spread to other Federal and non-Federal land;
       (3) on April 19, 2022, the Calf Canyon Fire, also in San 
     Miguel County, New Mexico, began burning on Federal land and 
     was later identified as the result of a pile burn in January 
     2022 that remained dormant under the surface before 
     reemerging;
       (4) on April 27, 2022, the Hermit's Peak Fire and the Calf 
     Canyon Fire merged, and both fires were reported as the 
     Hermit's Peak Fire or the Hermit's Peak/Calf Canyon Fire, 
     which shall be referred to hereafter as the Hermit's Peak/
     Calf Canyon Fire;
       (5) by May 2, 2022, the fire had grown in size and caused 
     evacuations in multiple villages and communities in San 
     Miguel County and Mora County, including in the San Miguel 
     county jail, the State's psychiatric hospital, the United 
     World College, and New Mexico Highlands University;
       (6) on May 4, 2022, the President issued a major disaster 
     declaration for the counties of Colfax, Mora, and San Miguel, 
     New Mexico;
       (7) on May 20, 2022, U.S. Forest Service Chief Randy Moore 
     ordered a 90-day review of prescribed burn policies to reduce 
     the risk of wildfires and ensure the safety of the 
     communities involved;
       (8) the U.S. Forest Service has assumed responsibility for 
     the Hermit's Peak/Calf Canyon Fire;
       (9) the fire resulted in the loss of Federal, State, local, 
     Tribal, and private property; and
       (10) the United States should compensate the victims of the 
     Hermit's Peak/Calf Canyon Fire.
       (b) Purposes.--The purposes of this Act are--
       (1) to compensate victims of the Hermit's Peak/Calf Canyon 
     Fire, for injuries resulting from the fire; and
       (2) to provide for the expeditious consideration and 
     settlement of claims for those injuries.

     SEC. 103. DEFINITIONS.

       In this Act:
       (1) Administrator.--The term ``Administrator'' means--
       (A) the Administrator of the Federal Emergency Management 
     Agency; or
       (B) if a Manager is appointed under section 104(a)(3), the 
     Manager.
       (2) Hermit's peak/calf canyon fire.--The term ``Hermit's 
     Peak/Calf Canyon Fire'' means--
       (A) the fire resulting from the initiation by the Forest 
     Service of a prescribed burn in the Santa Fe National Forest 
     in San Miguel County, New Mexico, on April 6, 2022;
       (B) the pile burn holdover resulting from the prescribed 
     burn by the Forest Service, which reemerged on April 19, 
     2022; and
       (C) the merger of the two fires described in subparagraphs 
     (A) and (B), reported as the Hermit's Peak Fire or the 
     Hermit's Peak Fire/Calf Canyon Fire.
       (3) Indian tribe.--The term ``Indian Tribe'' means the 
     recognized governing body of any Indian or Alaska Native 
     Tribe, band, nation, pueblo, village, community, component 
     band, or component reservation individually identified 
     (including parenthetically) in the list published most 
     recently as of the date of enactment of this Act pursuant to 
     section 104 of the Federally Recognized Indian Tribe List Act 
     of 1994 (25 U.S.C. 5131).
       (4) Injured person.--The term ``injured person'' means--
       (A) an individual, regardless of the citizenship or alien 
     status of the individual; or
       (B) an Indian Tribe, corporation, Tribal corporation, 
     partnership, company, association, county, township, city, 
     State, school district, or other non-Federal entity 
     (including a legal representative) that suffered injury 
     resulting from the Hermit's Peak/Calf Canyon Fire.
       (5) Injury.--The term ``injury'' has the same meaning as 
     the term ``injury or loss of property, or personal injury or 
     death'' as used in section 1346(b)(1) of title 28, United 
     States Code.
       (6) Manager.--The term ``Manager'' means an Independent 
     Claims Manager appointed under section 104(a)(3).
       (7) Office.--The term ``Office'' means the Office of 
     Hermit's Peak/Calf Canyon Fire Claims established by section 
     104(a)(2).
       (8) Tribal entity.--The term ``Tribal entity'' includes any 
     Indian Tribe, tribal organization, Indian-controlled 
     organization serving Indians, Native Hawaiian organization, 
     or Alaska Native entity, as such terms are defined or used in 
     section 166 of the Workforce Innovation and Opportunity Act 
     (29 U.S.C. 3221).

     SEC. 104. COMPENSATION FOR VICTIMS OF HERMIT'S PEAK/CALF 
                   CANYON FIRE.

       (a) In General.--

[[Page S5110]]

       (1) Compensation.--Each injured person shall be eligible to 
     receive from the United States compensation for injury 
     suffered by the injured person as a result of the Hermit's 
     Peak/Calf Canyon Fire, subject to the availability of 
     appropriations and subject to the Administrator making the 
     determinations required under subsection (d).
       (2) Office of hermit's peak/calf canyon fire claims.--
       (A) In general.--There is established within the Federal 
     Emergency Management Agency an Office of Hermit's Peak/Calf 
     Canyon Fire Claims.
       (B) Purpose.--The Office shall receive, process, and pay 
     claims in accordance with this Act.
       (C) Funding.--The Office--
       (i) shall be funded from funds made available to the 
     Administrator for carrying out this section;
       (ii) may appoint and fix the compensation of such temporary 
     personnel as may be necessary, without regard to the 
     provisions of title 5, United States Code, governing 
     appointments in competitive service; and
       (iii) may reimburse other Federal agencies for claims 
     processing support and assistance.
       (3) Option to appoint independent claims manager.--The 
     Administrator may appoint an Independent Claims Manager to--
       (A) head the Office; and
       (B) assume the duties of the Administrator under this Act.
       (4) Detail.--Upon the request of the Administrator, the 
     head of any Federal department or agency may detail, on a 
     reimbursable basis, any of the personnel of that department 
     or agency to the Federal Emergency Management Agency to 
     assist the Agency in carrying out the duties under this Act.
       (b) Submission of Claims.--Not later than 2 years after the 
     date on which regulations are first promulgated under 
     subsection (f), an injured person may submit to the 
     Administrator a written claim for 1 or more injuries suffered 
     by the injured person in accordance with such requirements as 
     the Administrator determines to be appropriate.
       (c) Investigation of Claims.--
       (1) In general.--In accordance with subsection (d), the 
     Administrator shall, on behalf of the United States, 
     investigate, consider, ascertain, adjust, determine, grant, 
     deny, or settle any claim for money damages asserted under 
     subsection (b).
       (2) Applicability of state law.--Except as otherwise 
     provided in this Act, the laws of the State of New Mexico 
     shall apply to the calculation of damages under subsection 
     (d)(4).
       (3) Extent of damages.--Any payment under this Act--
       (A) shall be limited to actual compensatory damages 
     measured by injuries suffered; and
       (B) shall not include--
       (i) interest before settlement or payment of a claim; or
       (ii) punitive damages.
       (d) Payment of Claims.--
       (1) Determination and payment of amount.--
       (A) In general.--
       (i) Payment.--Not later than 180 days after the date on 
     which a claim is submitted under this Act, the Administrator 
     shall determine and fix the amount, if any, to be paid for 
     the claim.
       (ii) Priority.--The Administrator, to the maximum extent 
     practicable, shall pay subrogation claims submitted under 
     this Act only after paying claims submitted by injured 
     parties that are not insurance companies seeking payment as 
     subrogees.
       (B) Parameters of determination.--In determining and 
     settling a claim under this Act, the Administrator shall 
     determine only--
       (i) whether the claimant is an injured person;
       (ii) whether the injury that is the subject of the claim 
     resulted from the Hermit's Peak/Calf Canyon Fire;
       (iii) whether the person or persons are otherwise eligible 
     to receive any amount determined under clause (iv); and
       (iv) whether sufficient funds are available for payment 
     and, if so, the amount, if any, to be allowed and paid under 
     this Act.
       (C) Insurance and other benefits.--
       (i) In general.--In determining the amount of, and paying, 
     a claim under this Act, to prevent recovery by a claimant in 
     excess of actual compensatory damages, the Administrator 
     shall reduce the amount to be paid for the claim by an amount 
     that is equal to the total of insurance benefits (excluding 
     life insurance benefits) or other payments or settlements of 
     any nature that were paid, or will be paid, with respect to 
     the claim.
       (ii) Government loans.--This subparagraph shall not apply 
     to the receipt by a claimant of any government loan that is 
     required to be repaid by the claimant.
       (2) Partial payment.--
       (A) In general.--At the request of a claimant, the 
     Administrator may make 1 or more advance or partial payments, 
     subject to the determination required under paragraph (1)(B), 
     before the final settlement of a claim, including final 
     settlement on any portion or aspect of a claim that is 
     determined to be severable.
       (B) Judicial decision.--If a claimant receives a partial 
     payment on a claim under this Act, but further payment on the 
     claim is subsequently denied by the Administrator, the 
     claimant may--
       (i) seek judicial review under subsection (i); and
       (ii) keep any partial payment that the claimant received, 
     unless the Administrator determines that the claimant--

       (I) was not eligible to receive the compensation; or
       (II) fraudulently procured the compensation.

       (3) Rights of insurer or other third party.--If an insurer 
     or other third party pays any amount to a claimant to 
     compensate for an injury described in subsection (a), the 
     insurer or other third party shall be subrogated to any right 
     that the claimant has to receive any payment under this Act 
     or any other law.
       (4) Allowable damages.--
       (A) Loss of property.--A claim that is paid for loss of 
     property under this Act may include otherwise uncompensated 
     damages resulting from the Hermit's Peak/Calf Canyon Fire 
     for--
       (i) an uninsured or underinsured property loss;
       (ii) a decrease in the value of real property;
       (iii) damage to physical infrastructure, including 
     irrigation infrastructure such as acequia systems;
       (iv) a cost resulting from lost subsistence from hunting, 
     fishing, firewood gathering, timbering, grazing, or 
     agricultural activities conducted on land damaged by the 
     Hermit's Peak/Calf Canyon Fire;
       (v) a cost of reforestation or revegetation on Tribal or 
     non-Federal land, to the extent that the cost of 
     reforestation or revegetation is not covered by any other 
     Federal program; and
       (vi) any other loss that the Administrator determines to be 
     appropriate for inclusion as loss of property.
       (B) Business loss.--A claim that is paid for injury under 
     this Act may include damages resulting from the Hermit's 
     Peak/Calf Canyon Fire for the following types of otherwise 
     uncompensated business loss:
       (i) Damage to tangible assets or inventory, including 
     natural resources.
       (ii) Business interruption losses.
       (iii) Overhead costs.
       (iv) Employee wages for work not performed.
       (v) Loss of business net income.
       (vi) Any other loss that the Administrator determines to be 
     appropriate for inclusion as business loss.
       (C) Financial loss.--A claim that is paid for injury under 
     this Act may include damages resulting from the Hermit's 
     Peak/Calf Canyon Fire for the following types of otherwise 
     uncompensated financial loss:
       (i) Increased mortgage interest costs.
       (ii) An insurance deductible.
       (iii) A temporary living or relocation expense.
       (iv) Lost wages or personal income.
       (v) Emergency staffing expenses.
       (vi) Debris removal and other cleanup costs.
       (vii) Costs of reasonable efforts, as determined by the 
     Administrator, to reduce the risk of wildfire, flood, or 
     other natural disaster in the counties impacted by the 
     Hermit's Peak/Calf Canyon Fire to risk levels prevailing in 
     those counties before the Hermit's Peak/Calf Canyon Fire, 
     that are incurred not later than the date that is 3 years 
     after the date on which the regulations under subsection (f) 
     are first promulgated.
       (viii) A premium for flood insurance that is required to be 
     paid on or before May 31, 2024, if, as a result of the 
     Hermit's Peak/Calf Canyon Fire, a person that was not 
     required to purchase flood insurance before the Hermit's 
     Peak/Calf Canyon Fire is required to purchase flood 
     insurance.
       (ix) A disaster assistance loan received from the Small 
     Business Administration.
       (x) Any other loss that the Administrator determines to be 
     appropriate for inclusion as financial loss.
       (e) Acceptance of Award.--The acceptance by a claimant of 
     any payment under this Act, except an advance or partial 
     payment made under subsection (d)(2), shall--
       (1) be final and conclusive on the claimant, with respect 
     to all claims arising out of or relating to the same subject 
     matter; and
       (2) constitute a complete release of all claims against the 
     United States (including any agency or employee of the United 
     States) under chapter 171 of title 28, United States Code 
     (commonly known as the ``Federal Tort Claims Act''), or any 
     other Federal or State law, arising out of or relating to the 
     same subject matter.
       (f) Regulations and Public Information.--
       (1) Regulations.--Notwithstanding any other provision of 
     law, not later than 45 days after the date of enactment of 
     this Act, the Administrator shall promulgate and publish in 
     the Federal Register interim final regulations for the 
     processing and payment of claims under this Act.
       (2) Public information.--
       (A) In general.--At the time at which the Administrator 
     promulgates regulations under paragraph (1), the 
     Administrator shall publish, online and in print, in 
     newspapers of general circulation in the State of New Mexico, 
     a clear, concise, and easily understandable explanation, in 
     English and Spanish, of--
       (i) the rights conferred under this Act; and
       (ii) the procedural and other requirements of the 
     regulations promulgated under paragraph (1).
       (B) Dissemination through other media.--The Administrator 
     shall disseminate the explanation published under 
     subparagraph (A)

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     through websites, blogs, social media, brochures, pamphlets, 
     radio, television, and other media that the Administrator 
     determines are likely to reach prospective claimants.
       (g) Consultation.--In administering this Act, the 
     Administrator shall consult with the Secretary of the 
     Interior, the Secretary of Energy, the Secretary of 
     Agriculture, the Administrator of the Small Business 
     Administration, other Federal agencies, and State, local, and 
     Tribal authorities, as determined to be necessary by the 
     Administrator, to--
       (1) ensure the efficient administration of the claims 
     process; and
       (2) provide for local concerns.
       (h) Election of Remedy.--
       (1) In general.--An injured person may elect to seek 
     compensation from the United States for 1 or more injuries 
     resulting from the Hermit's Peak/Calf Canyon Fire by--
       (A) submitting a claim under this Act;
       (B) filing a claim or bringing a civil action under chapter 
     171 of title 28, United States Code (commonly known as the 
     ``Federal Tort Claims Act''); or
       (C) bringing an authorized civil action under any other 
     provision of law.
       (2) Effect of election.--In accordance with subsection (e), 
     an election by an injured person to seek compensation in any 
     manner described in paragraph (1) shall be final and 
     conclusive on the claimant with respect to all injuries 
     resulting from the Hermit's Peak/Calf Canyon Fire that are 
     suffered by the claimant upon acceptance of an award.
       (3) Arbitration.--
       (A) In general.--Not later than 45 days after the date of 
     enactment of this Act, the Administrator shall establish by 
     regulation procedures under which a dispute regarding a claim 
     submitted under this Act may be settled by arbitration.
       (B) Arbitration as remedy.--On establishment of arbitration 
     procedures under subparagraph (A), an injured person that 
     submits a disputed claim under this Act may elect to settle 
     the claim through arbitration.
       (C) Binding effect.--An election by an injured person to 
     settle a claim through arbitration under this paragraph 
     shall--
       (i) be binding; and
       (ii) preclude any exercise by the injured person of the 
     right to judicial review of a claim described in subsection 
     (i).
       (4) No effect on entitlements.--The value of compensation 
     that may be provided under this Act shall not be considered 
     income or resources for any purpose under any Federal, State, 
     or local laws, including laws relating to taxation, welfare, 
     and public assistance programs, and no State or political 
     subdivision thereof shall decrease any assistance otherwise 
     provided to an injured person because of the receipt of 
     benefits under this Act.
       (i) Judicial Review.--
       (1) In general.--Any claimant aggrieved by a final decision 
     of the Administrator under this Act may, not later than 60 
     days after the date on which the decision is issued, bring a 
     civil action in the United States District Court for the 
     District of New Mexico, to modify or set aside the decision, 
     in whole or in part.
       (2) Record.--The court shall hear a civil action under 
     paragraph (1) on the record made before the Administrator.
       (3) Standard.--The decision of the Administrator 
     incorporating the findings of the Administrator shall be 
     upheld if the decision is supported by substantial evidence 
     on the record considered as a whole.
       (j) Attorney's and Agent's Fees.--
       (1) In general.--No attorney or agent, acting alone or in 
     combination with any other attorney or agent, shall charge, 
     demand, receive, or collect, for services rendered in 
     connection with a claim submitted under this Act, fees in 
     excess of the limitations established under section 2678 of 
     title 28, United States Code.
       (2) Violation.--An attorney or agent who violates paragraph 
     (1) shall be fined not more than $10,000.
       (k) Waiver of Requirement for Matching Funds.--
       (1) State and local project.--
       (A) In general.--Notwithstanding any other provision of 
     law, a State or local project that is determined by the 
     Administrator to be carried out in response to the Hermit's 
     Peak/Calf Canyon Fire under any Federal program that applies 
     to an area affected by the Hermit's Peak/Calf Canyon Fire 
     shall not be subject to any requirement for State or local 
     matching funds to pay the cost of the project under the 
     Federal program.
       (B) Federal share.--The Federal share of the costs of a 
     project described in subparagraph (A) shall be 100 percent.
       (2) Other needs program assistance.--Notwithstanding 
     section 408(g)(2) of the Robert T. Stafford Disaster Relief 
     and Emergency Assistance Act (42 U.S.C. 5174(g)(2)), for any 
     emergency or major disaster declared by the President under 
     that Act for the Hermit's Peak/Calf Canyon Fire, the Federal 
     share of assistance provided under that section shall be 100 
     percent.
       (3) Agricultural program assistance.--
       (A) In general.--Notwithstanding any other provision of 
     law, a State, local, or individual project that is determined 
     by the Secretary of Agriculture to be carried out in response 
     to the Hermit's Peak/Calf Canyon Fire under any Federal 
     program that applies to an area affected by the Hermit's 
     Peak/Calf Canyon Fire shall not be subject to any requirement 
     for State, local, or individual matching funds to pay the 
     cost of the project under the Federal program.
       (B) Federal share.--The Federal share of the costs of a 
     project described in subparagraph (A) shall be 100 percent.
       (l) Applicability of Debt Collection Requirements.--Section 
     3711(a) of title 31, United States Code, shall not apply to 
     any payment under this Act, unless--
       (1) there is evidence of civil or criminal fraud, 
     misrepresentation, presentation of a false claim; or
       (2) a claimant was not eligible under subsection (d)(2) of 
     this Act to any partial payment.
       (m) Indian Compensation.--Notwithstanding any other 
     provision of law, in the case of an Indian Tribe, a Tribal 
     entity, or a member of an Indian Tribe that submits a claim 
     under this Act--
       (1) the Bureau of Indian Affairs shall have no authority 
     over, or any trust obligation regarding, any aspect of the 
     submission of, or any payment received for, the claim;
       (2) the Indian Tribe, Tribal entity, or member of an Indian 
     Tribe shall be entitled to proceed under this Act in the same 
     manner and to the same extent as any other injured person; 
     and
       (3) except with respect to land damaged by the Hermit's 
     Peak/Calf Canyon Fire that is the subject of the claim, the 
     Bureau of Indian Affairs shall have no responsibility to 
     restore land damaged by the Hermit's Peak/Calf Canyon Fire.
       (n) Report.--Not later than 1 year after the date of 
     promulgation of regulations under subsection (f)(1), and 
     annually thereafter, the Administrator shall submit to 
     Congress a report that describes the claims submitted under 
     this Act during the year preceding the date of submission of 
     the report, including, for each claim--
       (1) the amount claimed;
       (2) a brief description of the nature of the claim; and
       (3) the status or disposition of the claim, including the 
     amount of any payment under this Act.
       (o) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as are necessary to carry out 
     this Act.
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