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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6833 Enrolled Bill (ENR)]

        H.R.6833

                    One Hundred Seventeenth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Monday,
          the third day of January, two thousand and twenty-two

                                 An Act

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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
    This Act may be cited as the ``Continuing Appropriations and 
Ukraine Supplemental Appropriations Act, 2023''.
SEC. 2. TABLE OF CONTENTS.
Sec. 1. Short Title.
Sec. 2. Table of Contents.
Sec. 3. References.
Sec. 4. Payment to Widows and Heirs of Deceased Members of Congress.

             DIVISION A--CONTINUING APPROPRIATIONS ACT, 2023

        DIVISION B--UKRAINE SUPPLEMENTAL APPROPRIATIONS ACT, 2023

                        DIVISION C--OTHER MATTERS

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

            DIVISION D--HEALTH AND HUMAN SERVICES EXTENSIONS

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

                 DIVISION E--VETERANS AFFAIRS EXTENSIONS

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

          DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022

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

SEC. 3. REFERENCES.
    Except as expressly provided otherwise, any reference to ``this 
Act'' contained in any division of this Act shall be treated as 
referring only to the provisions of that division.
SEC. 4. PAYMENT TO WIDOWS AND HEIRS OF DECEASED MEMBERS OF CONGRESS.
    There is hereby appropriated for fiscal year 2023, out of any money 
in the Treasury not otherwise appropriated, for payment to Dean 
Swihart, beneficiary of Jacqueline Walorski-Swihart, late a 
Representative from the State of Indiana, $174,000.

            DIVISION A--CONTINUING APPROPRIATIONS ACT, 2023

     The following sums are hereby appropriated, out of any money in 
the Treasury not otherwise appropriated, and out of applicable 
corporate or other revenues, receipts, and funds, for the several 
departments, agencies, corporations, and other organizational units of 
Government for fiscal year 2023, and for other purposes, namely:
    Sec. 101.  Such amounts as may be necessary, at a rate for 
operations as provided in the applicable appropriations Acts for fiscal 
year 2022 and under the authority and conditions provided in such Acts, 
for continuing projects or activities (including the costs of direct 
loans and loan guarantees) that are not otherwise specifically provided 
for in this Act, that were conducted in fiscal year 2022, and for which 
appropriations, funds, or other authority were made available in the 
following appropriations Acts:
        (1) The Agriculture, Rural Development, Food and Drug 
    Administration, and Related Agencies Appropriations Act, 2022 
    (division A of Public Law 117-103), except section 783, and except 
    that section 785 shall be applied by substituting ``$125,000,000'' 
    for ``$250,000,000''.
        (2) The Commerce, Justice, Science, and Related Agencies 
    Appropriations Act, 2022 (division B of Public Law 117-103), except 
    section 521(c)(1).
        (3) The Department of Defense Appropriations Act, 2022 
    (division C of Public Law 117-103).
        (4) The Energy and Water Development and Related Agencies 
    Appropriations Act, 2022 (division D of Public Law 117-103).
        (5) The Financial Services and General Government 
    Appropriations Act, 2022 (division E of Public Law 117-103), except 
    the matter under the heading ``Postal Regulatory Commission'' in 
    title V.
        (6) The Department of Homeland Security Appropriations Act, 
    2022 (division F of Public Law 117-103), except sections 544 and 
    545, and including title II of division O of Public Law 117-103.
        (7) The Department of the Interior, Environment, and Related 
    Agencies Appropriations Act, 2022 (division G of Public Law 117-
    103).
        (8) The Departments of Labor, Health and Human Services, and 
    Education, and Related Agencies Appropriations Act, 2022 (division 
    H of Public Law 117-103), and section 162 of division A of Public 
    Law 117-43.
        (9) The Legislative Branch Appropriations Act, 2022 (division I 
    of Public Law 117-103), and section 6 in the matter preceding 
    division A of Public Law 117-103.
        (10) The Military Construction, Veterans Affairs, and Related 
    Agencies Appropriations Act, 2022 (division J of Public Law 117-
    103).
        (11) The Department of State, Foreign Operations, and Related 
    Programs Appropriations Act, 2022 (division K of Public Law 117-
    103), except the first proviso of section 7069(e).
        (12) The Transportation, Housing and Urban Development, and 
    Related Agencies Appropriations Act, 2022 (division L of Public Law 
    117-103).
    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 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 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 117-43) 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 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 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 116-159 
(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

SEC. 1. SHORT TITLE.
    This division may be cited as the ``FDA User Fee Reauthorization 
Act of 2022''.
SEC. 2. TABLE OF CONTENTS.
    The table of contents for this division is as follows:

          DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022

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

                     TITLE I--FEES RELATING TO DRUGS

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

                   TITLE II--FEES RELATING TO DEVICES

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

                TITLE III--FEES RELATING TO GENERIC DRUGS

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

        TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

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

              TITLE V--REAUTHORIZATION OF OTHER PROVISIONS

Sec. 5001. Reauthorization of the best pharmaceuticals for children 
          program.
Sec. 5002. Reauthorization of the humanitarian device exemption 
          incentive.
Sec. 5003. Reauthorization of the pediatric device consortia program.
Sec. 5004. Reauthorization of provision pertaining to drugs containing 
          single enantiomers.
Sec. 5005. Reauthorization of the critical path public-private 
          partnership.
Sec. 5006. Reauthorization of orphan drug grants.
Sec. 5007. Reauthorization of certain device inspections.
Sec. 5008. Reauthorization of reporting requirements related to pending 
          generic drug applications and priority review applications.

                    TITLE I--FEES RELATING TO DRUGS

SEC. 1001. SHORT TITLE; FINDING.
    (a) Short Title.--This title may be cited as the ``Prescription 
Drug User Fee Amendments of 2022''.
    (b) Finding.--Congress finds that the fees authorized by the 
amendments made by this title will be dedicated toward expediting the 
drug development process and the process for the review of human drug 
applications, including postmarket drug safety activities, as set forth 
in the goals identified for purposes of part 2 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g 
et seq.), in the letters from the Secretary of Health and Human 
Services to the Chairman of the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Chairman of the Committee on Energy 
and Commerce of the House of Representatives, as set forth in the 
Congressional Record.
SEC. 1002. DEFINITIONS.
    (a) Human Drug Application.--Section 735(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended, 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 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''.
    (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
----------------------------------------------------------------------------------------------------------------

    ''; 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
                    ``(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 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''.
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, 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 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.--
        (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) 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
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