Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023
This act provides continuing FY2023 appropriations to federal agencies through December 16, 2022, provides supplemental appropriations for assistance to Ukraine, and establishes a compensation program for victims of the Hermit's Peak/Calf Canyon fire in New Mexico.
The act also extends several expiring programs and authorities. (Unless otherwise specified, the extensions referred to in this summary are effective through December 16, 2022.)
(Sec. 3) This section provides that references to this Act included in any division of this act refer only to the provisions of the division unless the act expressly provides otherwise.
(Sec. 4) This section provides appropriations for a payment to Dean Swihart, the beneficiary of the late Representative Jacqueline Walorski-Swihart. (A gratuity equal to one year's salary has long been given to the heirs or beneficiaries of Members of Congress who die in office.)
DIVISION A--CONTINUING APPROPRIATIONS ACT, 2023
Continuing Appropriations Act, 2023
This division provides continuing FY2023 appropriations to federal agencies through the earlier of December 16, 2022, or the enactment of the applicable appropriations act.
It is known as a continuing resolution (CR) and prevents a government shutdown that would otherwise occur if the FY2023 appropriations bills have not been enacted when FY2023 begins on October 1, 2022.
The CR funds most programs and activities at the FY2022 levels with several exceptions that provide funding flexibility and additional appropriations for various programs.
(Sec. 101) This section provides FY2023 appropriations to federal agencies for continuing projects or activities at the levels and under the conditions included in specified FY2022 appropriations acts.
The section extends several immigration-related programs and specifies several exceptions. It also includes a provision that provides additional funding for the Administration for Children and Families to carry out the Unaccompanied Children Program.
(Sec. 102) This section prohibits the Department of Defense (DOD) from funding new or accelerated production of certain projects and other activities and certain multiyear procurements prior to the enactment of the regular annual appropriations act.
(Sec. 103) This section specifies that funds provided by Section 101 of this division shall be available to the extent and in the manner that would be provided in the pertinent appropriations act.
(Sec. 104) This section prohibits appropriations provided by Section 101 of this division from being used to initiate or resume any project or activity that was not funded during FY2022.
(Sec. 105) This section specifies that appropriations provided by the CR are to be used to conduct FY2023 activities and programs during the period of the CR.
(Sec. 106) This section continues the appropriations provided by this division through the earlier of December 16, 2022, or the enactment of the applicable appropriations act.
(Sec. 107) This section requires expenditures for activities funded in this division to be charged to the full-year appropriations bill and relevant account when the applicable appropriations bill becomes law.
(Sec. 108) This section waives the normal time limitations for submission and approval of apportionments of accounts funded in annual appropriations acts.
(Sec. 109) This section limits disbursements for programs that would otherwise have high initial rates of operation or would complete distribution of funding at the beginning of the fiscal year if those actions would impinge on final congressional funding prerogatives.
(Sec. 110) This section requires this division to be implemented so that only the most limited funding action permitted by this division is taken in order to provide for continuation of projects and activities.
(Sec. 111) This section continues funding for certain appropriated entitlements and mandatory payments with budget authority provided in an FY2022 appropriations act at the rate necessary to maintain program levels under current law. It also provides authority to pay obligations for mandatory payments required to be made through the beginning of January 2023.
(Sec. 112) This section permits funding made available by this division for civilian personnel compensation and benefits in each department and agency to be apportioned at the rate necessary to avoid furloughs. It also requires all necessary actions to reduce or defer non-personnel-related administrative expenses to be taken prior to using this authority.
(Sec. 113) This section permits funds appropriated by this division to be obligated and expended notwithstanding specified statutory provisions restricting appropriations for foreign assistance, the Department of State, international broadcasting, and intelligence activities in the absence of prior authorizations.
(Sec. 114) This section extends designations of disaster relief and emergency requirements to funds provided by this division that previously carried those designations.
(Sec. 115) This section sets forth requirements for the treatment of rescissions when federal agencies implement the funding levels provided by the CR.
(Sec. 116) This section allows the Department of Agriculture's (USDA's) Farm Service Agency to apportion funding for the Agricultural Credit Insurance Fund Program account at the rate necessary to accommodate approved applications for direct and guaranteed farm ownership loans.
(Sec. 117) This section allows USDA's Rural Business-Cooperative Service to use funds provided by this division for loans under the Rural Microentrepreneur Assistance Program.
(Sec. 118) This section extends various authorities under the Livestock Mandatory Reporting Act of 1999, which requires buyers of live cattle, swine, and lamb and sellers of wholesale beef, pork, and lamb to report prices, volumes, and other marketing characteristics to USDA's Agricultural Marketing Service.
(Sec. 119) This section allows the Economic Development Administration to apportion funding for salaries and expenses at the rate necessary to maintain agency operations.
(Sec. 120) This section allows the National Telecommunications and Information Administration to apportion funding for salaries and expenses at the rate necessary to ensure continued oversight of public safety communications programs.
(Sec. 121) This section provides additional appropriations to the Federal Bureau of Investigation for investigative activities associated with Afghan resettlement operations.
(Sec. 122) This section allows DOD to transfer specified Overseas Humanitarian, Disaster, and Civic Aid funds to the Department of State to support Operation Allies Welcome or any successor operation. (Operation Allies Welcome is the coordinated effort across the federal government to support and resettle Afghan evacuees.)
(Sec. 123) This section extends the authority for DOD to provide physical protection and personal security for certain former or retired DOD officials who face serious and credible threats arising from duties performed while employed by DOD.
(Sec. 124) This section extends the availability of funding for the Afghan Security Forces Fund by rescinding specified FY2021 funding, appropriating the same amount for FY2022, and allowing the funds to remain available through FY2025.
(Sec. 125) This section provides additional emergency funding to the U.S. Army Corps of Engineers for specified water and wastewater infrastructure projects.
(Sec. 126) This section extends the authority for the Calfed Bay-Delta Program, which addresses ecosystem restoration and water management issues in California.
(Sec. 127) This section extends various Bureau of Reclamation authorities, including authorities related to (1) grants for improvements to Rio Grande Pueblo irrigation infrastructure, and (2) certain activities to aid eligible states affected by drought.
(Sec. 128) This section provides additional funding for the Department of the Treasury's Alcohol and Tobacco Tax and Trade Bureau to administer the new Craft Beverage Modernization Act import claims program.
(Sec. 129) This section provides additional funding for the Office of the National Cyber Director.
(Sec. 130) This section provides additional funding for fees that are paid to jurors.
(Sec. 131) This section provides additional funding for security improvements at U.S. courthouses and federal court facilities.
(Sec. 132) This section authorizes the District of Columbia to spend local funds at the rates set forth in the Fiscal Year 2023 Local Budget Act of 2022 for programs and activities that were funded in FY2022.
(Sec. 133) This section provides additional appropriations to the Small Business Administration (SBA) for costs associated with the establishment and implementation of a government-wide certification program within SBA for service-disabled veteran-owned small businesses.
(Sec. 134) This section allows the SBA to apportion funding at the rate necessary to meet demand for commitments for several of its lending programs.
(Sec. 135) This section allows the Federal Emergency Management Agency to apportion funding for the Disaster Relief Fund at the rate necessary to carry out response and recovery activities under the Robert T. Stafford Disaster Relief and Emergency Assistance Act.
(Sec. 136) This section transfers specified funds from the Disaster Relief Fund to carry out the Hermit's Peak/Calf Canyon Fire Assistance Act.
(Sec. 137) This section extends the authority for the Department of Homeland Security's joint task forces.
(Sec. 138) This section extends the authorization for the U.S. Secret Service's National Computer Forensic Institute.
(Sec. 139) This section extends the authorization for the National Flood Insurance Program.
(Sec. 140) This section extends the authority for the Department of Homeland Security (DHS) and the General Services Administration to carry out a pilot program to acquire innovative commercial items through an expedited competitive process.
(Sec. 141) This section extends the authority for DHS and the Department of Justice to protect certain facilities and assets from unmanned aircraft.
(Sec. 142) This section permits funding provided for the National Park Service's National Recreation and Preservation account for heritage partnership programs to be used to provide continued 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.
(Sec. 143) This section permits funding for the Department of the Interior's Working Capital Fund to be apportioned at the rate necessary to implement enterprise cybersecurity safeguards.
(Sec. 144) This section provides additional funding to the Indian Health Service for costs related to staffing and operating facilities that were opened, renovated, or expanded in FY2022 and FY2023. It also allows the funds to be apportioned at the rate necessary to staff and operate the facilities.
(Sec. 145) This section provides additional funding for the Substance Abuse and Mental Health Services Administration to carry out 988 Suicide & Crisis Lifeline activities and behavioral health crisis services.
(Sec. 146) This section provides additional funding for the Low Income Home Energy Assistance Program (LIHEAP), which provides grants for states, tribes, and territories to operate home energy assistance programs for low-income households.
(Sec. 147) This section provides additional funding to the Administration for Children and Families for refugee and entrant assistance activities, including providing shelter and services for unaccompanied minors.
(Sec. 148) This section allows a higher spending rate for the Social Security Administration's administrative expenses.
(Sec. 149) This section extends the authority to provide resettlement assistance and other benefits and services to evacuees from Afghanistan.
(Sec. 150) This section extends funding for the Temporary Assistance for Needy Families (TANF) program.
(Sec. 151) This section extends the authority for the Department of Defense to obligate funds for certain military construction projects that first received appropriations in FY2018.
(Sec. 152) This section provides additional funding for various Department of State and U.S. Agency for International Development (USAID) programs and activities, including
(Sec. 153) This section extends the authorization for the Department of Housing and Urban Development's (HUD's) Mark-to-Market Program. (The program authorizes HUD to renew certain expiring project-based rental assistance contracts with private property owners to allow rents to be reduced to market rates and Federal House Administration-insured mortgages to be restructured to a level that can be supported by the lower rents.)
(Sec. 154) This section allows HUD to apportion funding for the Native Hawaiian Housing Loan Guarantee Fund Program at the rate necessary to accommodate demand for commitments to guarantee loans under the program.
(Sec. 155) This section provides additional funding for HUD's Community Development Block Grant Disaster Recovery Program to provide assistance for areas impacted by major disasters that occurred in 2021 and 2022.
(Sec. 156) This section allows HUD to transfer specified funds from the Project-Based Rental Assistance account to the Rental Housing Assistance account to address a funding shortfall related to the Section 236 Interest Reduction Payment (IRP) program. (The Section 236 IRP program provides payments to owners of certain affordable multifamily rental properties to reduce the effective interest rates on Federal House Administration-insured mortgages.)
(Sec. 157) This section extends the availability of specified Department of Transportation funding for National Infrastructure Investments grants through FY2023.
DIVISION B--UKRAINE SUPPLEMENTAL APPROPRIATIONS ACT, 2023
Ukraine Supplemental Appropriations Act, 2023
TITLE I--DEPARTMENT OF DEFENSE
This title provides appropriations to the Department of Defense (DOD) to respond to the situation in Ukraine and for related expenses, including for
Specifically, the title provides appropriations to DOD for
It also provides appropriations for the Intelligence Community Management Account.
(Sec. 1101) This section requires DOD to report to Congress on measures being taken to account for U.S. defense articles designated for Ukraine since the February 24, 2022, Russian invasion of Ukraine.
(Sec. 1102) This section requires DOD, in coordination with the Department of State, to report to Congress on U.S. security assistance provided to Ukraine since the February 24, 2022, Russian invasion of Ukraine.
TITLE II-- DEPARTMENT OF ENERGY
This title provides appropriations to the National Nuclear Security Administration for defense nuclear nonproliferation activities to respond to the situation in Ukraine (e.g., preparing for and responding to potential nuclear and radiological incidents.)
TITLE III--BILATERAL ECONOMIC ASSISTANCE
This title provides appropriations to the Economic Support Fund for assistance to Ukraine. (The fund is managed by the State Department and USAID.)
(Sec. 1301) This section increases the FY2023 funding cap for the Presidential Drawdown Authority, which authorizes the President to immediately transfer defense articles and services from U.S. stocks to a foreign country or international organization to respond to an unforeseen emergency. This authority has recently been used to provide defense items to Ukraine.
(Sec. 1302) This section allows funds provided by this title to be made available for direct financial support for the government of Ukraine, including Ukrainian first responders, and as a cash transfer. It also specifies requirements and restrictions for the funding such as reporting, oversight, and monitoring requirements.
TITLE IV--GENERAL PROVISIONS--THIS ACT
(Sec. 1401) This section specifies that the funds provided by this division are in addition to funds otherwise appropriated for the fiscal year involved.
(Sec. 1402) This section specifies that the funds provided by this division may not remain available beyond the current fiscal year, unless this division provides otherwise.
(Sec. 1403) Unless otherwise specified by this division, the funds provided by this division are subject to the authorities and conditions that apply to the applicable appropriations accounts for FY2023.
(Sec. 1404) This section designates the funding provided by this division as emergency spending, which is exempt from various budget enforcement procedures.
DIVISION C--OTHER MATTERS
TITLE I--EXTENSIONS, TECHNICAL CORRECTIONS, AND OTHER MATTERS
(Sec. 101) This section extends the authority of the Federal Communications Commission to conduct auctions for electromagnetic spectrum licenses.
(Sec. 102) This section extends a special assessment on nonindigent persons or entities convicted of certain offenses involving sexual abuse or human trafficking. The assessment funds programs for human-trafficking survivors.
United States Parole Commission Extension Act of 2022
(Sec. 103) This section extends the U.S. Parole Commission.
(Sec. 104) This section extends the Commodity Futures Trading Commission Customer Protection Fund expenses account.
TITLE II--BUDGETARY EFFECTS
This title exempts the budgetary effects of this division and each succeeding division from (1) the Statutory Pay-As-You-Go Act of 2010 (PAYGO), (2) the Senate PAYGO rule, and (3) certain budget scorekeeping rules.
DIVISION D--HEALTH AND HUMAN SERVICES EXTENSIONS
TITLE I--MEDICARE AND MEDICAID
(Sec. 101) This section extends certain increased payment adjustments for low-volume hospitals under Medicare's inpatient prospective payment system.
(Sec. 102) This section extends the Medicare-Dependent Hospital Program, which provides additional payments to certain small rural hospitals that have a high proportion of Medicare patients.
(Sec. 103) This section extends the increased Medicaid federal matching rate (also known as the Federal Medical Assistance Percentage) for U.S. territories.
(Sec. 104) This section decreases funding for the Medicare Improvement Fund.
TITLE II--HUMAN SERVICES
(Sec. 201) This section extends and provides additional funding for the Maternal, Infant, and Early Childhood Home Visiting Program, which supports pregnant individuals and parents of young children in certain communities through home visits and partnerships with health, social service, and child development professionals.
(Sec. 202) This section extends and provides additional funding for the Stephanie Tubbs Jones Child Welfare Services Program and the MaryLee Allen Promoting Safe and Stable Families Program (i.e., Title IV-B child and family services programs).
TITLE III--PUBLIC HEALTH
(Sec. 301) This section makes permanent the Health Center Volunteer Health Professionals Program, which allows health professionals who volunteer at public or nonprofit health centers to be considered covered Public Health Service employees for purposes of medical malpractice liability coverage under the Federal Tort Claims Act.
(Sec. 302) This section allows commissioned officers of the Public Health Service to retain excess annual leave that would otherwise be lost at the end of FY2022.
TITLE IV--INDIAN HEALTH
This title extends provisions that prohibit the Indian Health Service from disbursing funds to Alaska Native villages or corporations that are located in areas served by Alaska Native regional health entities.
DIVISION E--VETERANS AFFAIRS EXTENSIONS
TITLE I--EXTENSIONS OF AUTHORITIES RELATING TO HEALTH CARE
(Sec. 101) This section extends through FY2024 the authority for the Department of Veterans Affairs (VA) to collect copayments from veterans for hospital care and nursing home care.
(Sec. 102) This section extends through FY2024 the requirement that the VA provide nursing home care to certain veterans with a service-connected disability.
(Sec. 103) This section extends through FY2026 the authority to continue the VA and Department of Defense joint incentives program related to health care resources.
(Sec. 104) This section extends through FY2024 the authority for the Joint Department of Defense-Department of Veterans Affairs Medical Facility Demonstration Fund.
(Sec. 105) This section extends through FY2023 the temporary expansion of payments and allowances for beneficiary travel in connection with veterans receiving care from Vet Centers.
TITLE II--EXTENSIONS OF AUTHORITIES RELATING TO BENEFITS
(Sec. 201) This section extends through FY2024 the authority of the VA to transport individuals to and from VA facilities in connection with vocational rehabilitation, required counseling, or for the purpose of examination, treatment, or care.
(Sec. 202) This section extends through FY2024 the authority of the VA to maintain a regional office in the Philippines.
(Sec. 203) This section extends through December 31, 2024, the requirement for the VA to submit a report containing a statement for each case recommended to the VA for equitable relief due to administrative error.
(Sec. 204) This section extends through December 31, 2024, the authority to provide assistance for specially adapted housing for disabled veterans who are residing temporarily in a residence owned by a family member.
(Sec. 205) This section extends through FY2024 the specially adapted housing assistive technology grant program.
TITLE III--EXTENSIONS OF AUTHORITIES RELATING TO HOMELESS VETERANS
(Sec. 301) This section reauthorizes through FY2024 homeless veterans reintegration programs conducted by the Department of Labor.
(Sec. 302) This section reauthorizes through FY2024 a Labor grant program that provides dedicated services for homeless women veterans and homeless veterans with children to expedite the reintegration of the veterans into the labor force.
(Sec. 303) This section extends through FY2024 the authority of the VA to provide outreach, treatment, and rehabilitation for seriously mentally ill and homeless veterans. Additionally, the section extends the authority of the VA to operate a program to establish centers for the provision of comprehensive services to homeless veterans.
(Sec. 304) This section reauthorizes through FY2024 the Supportive Services for Veterans Families program, which provides financial assistance for supportive services for very low-income veteran families in permanent housing or transitioning from homelessness.
(Sec. 305) This section reauthorizes through FY2024 the VA program to provide grants to entities to encourage the development of programs for homeless veterans with special needs.
(Sec. 306) This section reauthorizes through FY2026 the Advisory Committee on Homeless Veterans.
TITLE IV--EXTENSIONS OF OTHER AUTHORITIES
(Sec. 401) This section reauthorizes through FY2026 the monthly assistance allowances available to certain disabled veterans from the Office of National Veterans Sports Programs and Special Events.
(Sec. 402) This section reauthorizes through FY2026 the VA program to provide grants to entities planning, developing, managing, and implementing programs to provide adaptive sports opportunities for disabled veterans and members of the Armed Forces.
(Sec. 403) This section extends through FY2026 the authority for the VA Advisory Committee on Minority Veterans.
(Sec. 404) This section extends through FY2026 the authority for the Veterans' Advisory Committee on Education.
(Sec. 405) This section extends through FY2024 the authority of the VA to transfer real property to other agencies, states, or public or private entities.
DIVISION F--FDA USER FEE REAUTHORIZATION ACT OF 2022
FDA User Fee Reauthorization Act of 2022
This division extends through FY2027 the authority of the Food and Drug Administration (FDA) to collect user fees for drugs, medical devices, generic drugs, and biosimilar biological products. It also addresses other related issues, such as modifying the formulas for calculating such user fees and reauthorizing various programs. (The FDA collects user fees from various entities, including companies that produce drugs and medical devices. The total amounts generated by each user fee program are set out in statutes. Generally, the FDA negotiates these user fees with the relevant industry every five years.)
TITLE I--FEES RELATING TO DRUGS
Prescription Drug User Fee Amendments of 2022
(Sec. 1002) This section modifies various definitions in the Federal Food, Drug, and Cosmetic Act. Specifically, it modifies the definition of human drug application to include applications for certain allergenic extract products licensed on or after October 1, 2022.
For the purposes of assessing the prescription drug program fee, if a drug manufacturer makes a request for a particular prescription drug to be placed on the list for discontinued drugs, the FDA shall consider the drug discontinued on the date the request is received or when the product will be withdrawn from sale, whichever is later.
This section also establishes a statutory definition for skin-test diagnostic product. Generally, such a product is administered to the skin to detect a local hypersensitivity reaction to aid the diagnosis of an allergy or infection with certain pathogens.
(Sec. 1003) This section modifies the method by which the FDA assesses drug user fees and extends through FY2027 the FDA's authority to assess and collect such fees. For example, this section establishes through FY2027 the annual base revenue and various adjustments. (The base revenue and various adjustments set the total amount of user fees that the FDA must collect through the particular user fee program each fiscal year.)
For the purposes of setting drug user fees, the FDA must make various adjustments including (1) increasing the fees collected each fiscal year for strategic hiring and retention purposes, and (2) adjusting the fees collected for each fiscal year by employing the capacity planning method the FDA used to set such fees for FY2021.
This section also establishes that a human drug application for a skin-test diagnostic product shall not be subject to certain fees.
Furthermore, this section establishes a rule for fees for an approved human prescription drug that was on the discontinued list on the first day of a fiscal year but is no longer on the list later in the same fiscal year. Generally, the relevant manufacturers of such a drug must pay the annual prescription drug program fee for that fiscal year, if the manufacturer has had a human drug application or supplement pending before the FDA after September 1, 1992.
This section also modifies exemptions to the prescription drug program fees for certain drugs. Specifically, this section exempts from such fees (1) certain large volume parenteral products, (2) drugs that are pharmaceutically equivalent to certain FDA-approved drugs, and (3) skin-test diagnostic products.
(Sec. 1005) This section repeals a provision that terminates (1) on October 1, 2022, the FDA's authority to assess and collect user fees relating to human drugs, and (2) reporting requirements related to such authority.
TITLE II--FEES RELATING TO DEVICES
Medical Device User Fee Amendments of 2022
(Sec. 2002) This section amends the statutory definition of process for the review of device applications to include activities related to de novo classification requests. (Medical devices are assigned to one of three classes based on the level of control necessary to assure the device's safety and effectiveness.)
(Sec. 2003) This section modifies the method by which the FDA assesses medical device user fees and extends through FY2027 the FDA's authority to assess and collect such fees. For example, the section establishes the total revenue amounts to be generated from such fees for each fiscal year through FY2027.
For the purpose of calculating such user fees, this section also authorizes increases for various purposes. For example, for FY2025-FY2027, the base establishment registration fee amounts shall be increased by specified amounts to meet improved performance goals for reviewing certain medical device applications. Other adjustments required by this section include decreases in the amount to be collected for such user fees if (1) the FDA's hiring to support the medical device application process is below certain thresholds, or (2) operating reserves for medical device application review operations exceed certain thresholds.
(Sec. 2005) This section permanently reauthorizes and modifies a program under which accredited testing laboratories are involved in assessing whether a medical device complies with certain statutory requirements. Currently, such a laboratory shall assess whether a device conforms to the relevant requirements. Under this section, a laboratory shall conduct tests to support such assessments.
(Sec. 2006) This section reauthorizes through December 17, 2022, a program that allows accredited persons to review reports and make recommendations to the FDA pertaining to the initial classification of medical devices.
(Sec. 2007) This section repeals a provision that terminates (1) on October 1, 2022, the FDA's authority to assess and collect user fees relating to medical devices, and (2) reporting requirements related to such authority.
TITLE III--FEES RELATING TO GENERIC DRUGS  Generic Drug User Fee Amendments of 2022
(Sec. 3002) This section modifies the method by which the FDA assesses generic drug user fees and extends through FY2027 the FDA's authority to assess and collect such fees. For example, this section establishes through FY2027 the annual base revenue amount and various adjustments to set the total amount that the FDA must collect each fiscal year for the particular user fee program.
The FDA must establish a capacity planning methodology to meet the resource capacity needed for the FDA's human generic drug activities and increase the revenue collected under this user fee program accordingly.
The FDA may also increase the user fees assessed for a fiscal year to meet certain operating reserve thresholds for the FDA's human generic drug activities. If the operating reserve increases above certain thresholds, the FDA must reduce the user fees accordingly.
(Sec. 3004) This section repeals a provision that terminates (1) on October 1, 2022, the FDA's authority to assess and collect user fees relating to human generic drugs, and (2) reporting requirements related to such authority.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Biosimilar User Fee Amendments of 2022
(Sec. 4002) This section amends the definition of biosimilar biological product application to include a qualifying application for an allergenic extract product. Currently, applications for allergenic extract products are specifically excluded from the definition.
(Sec. 4003) This section modifies the method by which the FDA assesses biosimilar biological product user fees and extends through FY2027 the FDA's authority to assess and collect such fees. For example, this section establishes through FY2027 the annual base revenue and various adjustments to set the total amount that the FDA must collect each fiscal year through the user fee program.
For the purposes of setting such user fees, the FDA must (1) increase the fees collected each fiscal year for strategic hiring and retention purposes, and (2) adjust the fees collected for each fiscal year by employing the capacity planning method the FDA used to set such fees in FY2021.
The FDA must also increase the user fees assessed for a fiscal year if doing so is necessary to meet certain operating reserve thresholds for the FDA's review of biosimilar biological product applications. If the operating reserve increases above certain thresholds, the FDA must reduce the user fees accordingly.
The section also makes other changes to the biosimilar user fees, including by (1) authorizing the FDA to administratively remove from the biosimilar biological product development program a person who has failed to pay the required fee for two consecutive years, and (2) eliminating the biosimilar biological product fee.
Furthermore, for the purposes of assessing the biosimilar biological product program fee, if a biosimilar product manufacturer makes a request for a particular biosimilar product to be placed on a list for discontinued products, the FDA shall consider the product discontinued on the date the request is received or when the product will be withdrawn from sale, whichever is later.
If an approved biosimilar product was on the discontinued list on the first day of a fiscal year but is no longer on the list later in the fiscal year, the manufacturer of the product must pay the annual biosimilar biological product program fee for that fiscal year.
(Sec. 4005) This section repeals a provision that terminates (1) on October 1, 2022, the FDA's authority to assess and collect user fees relating to biosimilar biological products, and (2) reporting requirements related to such authority.
TITLE V--REAUTHORIZATION OF OTHER PROVISIONS
(Sec. 5001) This section reauthorizes a National Institutes of Health program to (1) develop and publish a priority list of needs in pediatric therapeutics, and (2) award funds to entities with expertise in conducting research regarding such needs.
(Sec. 5002) This section reauthorizes through December 17, 2022, the humanitarian device exemption program, which authorizes the FDA to, for the purposes of an application for approval to market a medical device, waive certain effectiveness requirements for an eligible device designed to treat or diagnose a disease or condition that affects no more than 8,000 individuals in the United States. Specifically, a request for such an exemption must be submitted on or before December 17, 2022.
(Sec. 5003) This section reauthorizes a program that provides grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development.
(Sec. 5004) This section reauthorizes a provision that allows an applicant for market approval for an eligible single-enantiomer drug to make an election that may qualify the drug for a five-year market exclusivity period.
(Sec. 5005) This section reauthorizes the Critical Path Public-Private Partnerships, through which the FDA may enter into collaborative agreements with eligible entities to develop projects designed to achieve certain goals, such as fostering medical product innovation and accelerating medical product development.
(Sec. 5006) This section reauthorizes an FDA program that provides grants to defray the costs of developing drugs, medical devices, and medical foods for rare diseases or conditions.
(Sec. 5007) This section extends through December 17, 2022, a provision requiring the FDA to accredit persons to inspect facilities that manufacture certain classes of medical devices.
(Sec. 5008) This section reauthorizes a provision requiring the FDA to post on its website quarterly reports with information on received generic drug applications and priority review applications.
DIVISION G--HERMIT'S PEAK/CALF CANYON FIRE ASSISTANCE ACT
Hermit's Peak/Calf Canyon Fire Assistance Act
This division provides for monetary compensation to the persons injured by the prescribed fire burn in the Santa Fe National Forest in New Mexico that became a wildfire known as the Hermit's Peak Fire or the Hermit's Peak Fire/Calf Canyon Fire.
Each person injured as a result the Hermit's Peak Fire shall be eligible to receive monetary compensation from the United States, including for personal injury, loss of property, business loss, or financial loss.
An Office of Hermit's Peak Fire Claims is established within the Federal Emergency Management Agency (FEMA) to receive, process, and pay claims from persons injured by the fire.
FEMA or the independent claims manager (which FEMA may appoint) shall, on behalf of the United States, investigate, consider, ascertain, adjust, determine, grant, deny, or settle any claim for money damages asserted by a person injured by the Hermit's Peak Fire.
Any claimant aggrieved by a final decision of FEMA concerning compensation may, not later than 60 days after the date on which the decision is issued, bring a civil action in the U.S. District Court for the District of New Mexico to modify or set aside the decision.
[117th Congress Public Law 180]
[From the U.S. Government Publishing Office]



[[Page 2113]]

                       CONTINUING APPROPRIATIONS 
                        AND UKRAINE SUPPLEMENTAL 
                        APPROPRIATIONS ACT, 2023

[[Page 136 STAT. 2114]]

Public Law 117-180
117th Congress

                                 An Act


 
  Making continuing appropriations for fiscal year 2023, and for other 
           purposes. <<NOTE: Sept. 30, 2022 -  [H.R. 6833]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Continuing 
Appropriations and Ukraine Supplemental Appropriations Act, 2023.>> 
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. <<NOTE: Dean Swihart.>>  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.

[[Page 136 STAT. 2115]]

 DIVISION A <<NOTE: Continuing Appropriations Act, 2023.>> --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) <<NOTE: Applicability.>>  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).

[[Page 136 STAT. 2116]]

    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) <<NOTE: Expiration date.>>  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

[[Page 136 STAT. 2117]]

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) <<NOTE: Extension.>>  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) <<NOTE: Time period. Deadline.>>  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. <<NOTE: Rescissions.>>  (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,

[[Page 136 STAT. 2118]]

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 <<NOTE: Effective date.>>  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 <<NOTE: Deadline. List.>>  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, <<NOTE: Updates. Effective date.>> 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. <<NOTE: Applicability.>> 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

[[Page 136 STAT. 2119]]

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. <<NOTE: Expiration date.>> (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, <<NOTE: Consultation. Notification.>> 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) <<NOTE: Reports.>> 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, <<NOTE: Afghans. Relocation. Strategy. Plan. Timeline. Spend 
plan. Cost estimate.>> 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

[[Page 136 STAT. 2120]]

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. <<NOTE: Applicability.>> 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) <<NOTE: Rescission.>>  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) <<NOTE: Effective date.>>  Subject to paragraph (2), this 
section shall become effective immediately upon enactment of this Act.
            (2) <<NOTE: Applicability.>>  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. <<NOTE: Applicability.>>  (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. <<NOTE: Applicability.>>  (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''.

[[Page 136 STAT. 2121]]

    (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. <<NOTE: Applicability.>> 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: <<NOTE: Reports. Time period.>>   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

[[Page 136 STAT. 2122]]

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, <<NOTE: Apportionment. Certification.>> 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, <<NOTE: Reports. Time period.>> 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

[[Page 136 STAT. 2123]]

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. <<NOTE: Applicability.>> 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. <<NOTE: Applicability.>>  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. <<NOTE: Applicability.>>  (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) <<NOTE: Effective date.>>  Subject to paragraph (2), this 
section shall become effective immediately upon enactment of this Act.
            (2) If <<NOTE: Applicability.>>  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. <<NOTE: Applicability.>>  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. <<NOTE: Applicability. Time period.>>  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

[[Page 136 STAT. 2124]]

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. <<NOTE: Applicability.>>  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. <<NOTE: Applicability.>>  (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

[[Page 136 STAT. 2125]]

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. <<NOTE: Extension.>>  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. <<NOTE: Applicability.>>  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. <<NOTE: Applicability.>>  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

[[Page 136 STAT. 2126]]

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. <<NOTE: Effective date. Rescissions.>>  (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) <<NOTE: Rescission.>>  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) <<NOTE: Effective date.>>  Subject to paragraph (2), this 
section shall become effective immediately upon enactment of this Act.

[[Page 136 STAT. 2127]]

            (2) <<NOTE: Applicability.>>  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 <<NOTE: Ukraine Supplemental Appropriations Act, 2023.>> --
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.

[[Page 136 STAT. 2128]]

                 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, <<NOTE: Notification. Deadline.>>  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, <<NOTE: Determination.>> 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.

[[Page 136 STAT. 2129]]

                               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.

[[Page 136 STAT. 2130]]

          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, <<NOTE: Briefing. Deadline.>> 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. <<NOTE: Reports. Coordination.>>  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. <<NOTE: Reports. Time periods. Coordination.>>  Not later 
than 30 days after the date of enactment of this Act, and every 30 days 
thereafter through fiscal year 2023,

[[Page 136 STAT. 2131]]

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. <<NOTE: Applicability.>>  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. <<NOTE: Requirements.>>  (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, <<NOTE: Reimbursement.>> 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, <<NOTE: Deadline. Consultation. Certification. Reports.>>  That 
at least 15 days prior to the initial obligation of such funds, the 
Secretary of State, following consultation with the Administrator

[[Page 136 STAT. 2132]]

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, <<NOTE: Reports. Assessments.>>  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) <<NOTE: Memorandum.>>  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) <<NOTE: Reports. Time period.>>  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, <<NOTE: Summary.>>  
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) <<NOTE: Notification.>>  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

[[Page 136 STAT. 2133]]

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. <<NOTE: United States Parole Commission Extension Act of 
                        2022.>>  UNITED STATES PAROLE COMMISSION 
                        EXTENSION.

    (a) <<NOTE: 18 USC 1 note.>>  Short Title.--This section may be 
cited as the ``United States Parole Commission Extension Act of 2022''.

    (b) <<NOTE: 18 USC 3551 note.>>  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

[[Page 136 STAT. 2134]]

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) <<NOTE: Time periods.>>  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) <<NOTE: 42 USC 1395ww note.>>  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--

[[Page 136 STAT. 2135]]

            (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) <<NOTE: Time period.>>  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) <<NOTE: Time periods.>>  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.

[[Page 136 STAT. 2136]]

                        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. <<NOTE: Applicability. 42 USC 210-1 note.>>  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 <<NOTE: 128 Stat. 343.>> 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''.

[[Page 136 STAT. 2137]]

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''.

[[Page 136 STAT. 2138]]

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''.

[[Page 136 STAT. 2139]]

                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 <<NOTE: FDA User Fee Reauthorization Act of 2022.>> --FDA 
USER FEE REAUTHORIZATION ACT OF 2022
SEC. 1. <<NOTE: 21 USC 301 note.>>  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.

[[Page 136 STAT. 2140]]

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 <<NOTE: Prescription Drug User Fee Amendments of 2022.>> --FEES 
RELATING TO DRUGS
SEC. 1001. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Prescription Drug User Fee Amendments of 2022''.

    (b) <<NOTE: 21 USC 379g note.>> 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,

[[Page 136 STAT. 2141]]

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) <<NOTE: Assessment. Effective date.>>  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;

[[Page 136 STAT. 2142]]

                          ``(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) <<NOTE: Time period.>>  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. <<NOTE: Effective 
                      date. Time period. Payment fee.>> --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

[[Page 136 STAT. 2143]]

                      program fee established for a fiscal year under 
                      subsection (c)(6) for such prescription drug 
                      product. <<NOTE: Deadline.>>  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) <<NOTE: Time period.>>  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.''.

[[Page 136 STAT. 2144]]

            (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) <<NOTE: Time periods.>>  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

[[Page 136 STAT. 2145]]

                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) <<NOTE: Notice.>>  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:

[[Page 136 STAT. 2146]]

                          ``(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) <<NOTE: Deadline.>>  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) <<NOTE: Applicability. Certification.>>  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

[[Page 136 STAT. 2147]]

        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) <<NOTE: 21 USC 379g note.>>  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) <<NOTE: 21 USC 379h-2 note.>>  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) <<NOTE: Repeal. 21 USC 379g note.>>  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. <<NOTE: Assessment. 21 USC 379g note.>>  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. <<NOTE: Extension. Time period. 21 USC 379g note.>>  
                          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-- <<NOTE: Medical Device User Fee Amendments of 2022.>> FEES 
RELATING TO DEVICES
SEC. 2001. SHORT TITLE; FINDING.

    (a) Short <<NOTE: 21 USC 301 note.>>  Title.--This title may be 
cited as the ``Medical Device User Fee Amendments of 2022''.

    (b) <<NOTE: 21 USC 379i note.>>  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

[[Page 136 STAT. 2148]]

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. <<NOTE: Time periods.>>  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:

[[Page 136 STAT. 2149]]



----------------------------------------------------------------------------------------------------------------
                                                             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) <<NOTE: Determination.>>  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

[[Page 136 STAT. 2150]]

                                    ``(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.

[[Page 136 STAT. 2151]]

                                    ``(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) <<NOTE: Determination.>>  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) <<NOTE: Data.>>  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) <<NOTE: Determination.>>  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.

[[Page 136 STAT. 2152]]

                    ``(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) <<NOTE: Determination.>>  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.--

[[Page 136 STAT. 2153]]

                    ``(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) <<NOTE: Guidelines.>>  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

[[Page 136 STAT. 2154]]

                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) <<NOTE: Public information. Website.>>  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) <<NOTE: 21 USC 379i note.>>  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) <<NOTE: 21 USC 379j-1 note.>>  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) <<NOTE: Repeal. 21 USC 379i note.>>  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. <<NOTE: Assessment. 21 USC 360d note.>>  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

[[Page 136 STAT. 2155]]

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. <<NOTE: Extension. Time period. 21 USC 379i note.>>  
                          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-- <<NOTE: Generic Drug User Fee Amendments of 2022.>> FEES 
RELATING TO GENERIC DRUGS
SEC. 3001. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Generic Drug User Fee Amendments of 2022''.

    (b) <<NOTE: 21 USC 379j-41 note.>>  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. <<NOTE: Time periods.>>  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:

[[Page 136 STAT. 2156]]

                    ``(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

[[Page 136 STAT. 2157]]

                      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) <<NOTE: Determinations.>>  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

[[Page 136 STAT. 2158]]

                                            ``(bb) thirty-five percent 
                                        or more of abbreviated new drug 
                                        applications submitted related 
                                        to complex products (as so 
                                        defined).
                    ``(D) <<NOTE: Notice.>>  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) <<NOTE: Notice. Federal Register, 
                publication.>>  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--

[[Page 136 STAT. 2159]]

            (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) <<NOTE: Deadline.>>  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) <<NOTE: 21 USC 379j-41 note.>>  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) <<NOTE: 21 USC 379j-43 note.>>  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) <<NOTE: Repeal. 21 USC 379j-41 note.>>  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. <<NOTE: Assessment. 21 USC 379j-41 note.>>  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. <<NOTE: Extension. Time period. 21 USC 379j-41 note.>>  
                          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

[[Page 136 STAT. 2160]]

to assessing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2023.

   TITLE IV-- <<NOTE: Biosimilar User Fee Amendments of 2022.>> FEES 
RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 4001. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Biosimilar User Fee Amendments of 2022''.

    (b) <<NOTE: 21 USC 379j-51 note.>>  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) <<NOTE: Notice.>>  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

[[Page 136 STAT. 2161]]

                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) <<NOTE: Deadline.>>  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) <<NOTE: Determination.>>  
                                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) <<NOTE: Notice.>>  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.''.

[[Page 136 STAT. 2162]]

            (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) <<NOTE: Time periods.>>  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. <<NOTE: Notice.>>  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

[[Page 136 STAT. 2163]]

                      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 <<NOTE: Time periods.>>  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--

[[Page 136 STAT. 2164]]

                    ``(A) for fiscal year 2023, $43,376,922; and
                    ``(B) <<NOTE: Time period.>>  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

[[Page 136 STAT. 2165]]

                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) <<NOTE: Notice.>>  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) <<NOTE: Time periods.>>  Operating reserve 
        adjustment.--
                    ``(A) <<NOTE: Review.>>  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.-- <<NOTE: Deadline.>> 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

[[Page 136 STAT. 2166]]

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) <<NOTE: 21 USC 379j-51 note.>>  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) <<NOTE: 21 USC 379j-53 note.>>  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) <<NOTE: Repeal. 21 USC 379j-51 note.>>  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. <<NOTE: Assessment. 21 USC 379j-51 note.>>  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.

[[Page 136 STAT. 2167]]

SEC. 4007. <<NOTE: Extension. Time period. 21 USC 379j-51 note.>>  
                          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-- <<NOTE: Time periods.>> 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''.

[[Page 136 STAT. 2168]]

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-- <<NOTE: Hermit's Peak/Calf Canyon Fire Assistance 
Act. Claims.>> 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;

[[Page 136 STAT. 2169]]

            (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

[[Page 136 STAT. 2170]]

        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) <<NOTE: Establishment.>>  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) <<NOTE: Appointment.>>  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) <<NOTE: Reimbursement.>>  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) <<NOTE: Reimbursement.>>  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) <<NOTE: Deadline. Requirements. Determination.>>  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--

[[Page 136 STAT. 2171]]

                          (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) <<NOTE: Deadline.>>  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) <<NOTE: Determination.>>  seek judicial 
                      review under subsection (i); and
                          (ii) keep any partial payment that the 
                      claimant received, unless the Administrator 
                      determines that the claimant--

[[Page 136 STAT. 2172]]

                                    (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) <<NOTE: Determination. Deadlines.>>  
                      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

[[Page 136 STAT. 2173]]

                      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) <<NOTE: Deadline. Federal Register, publication.>>  
        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) <<NOTE: Web posting. Newspapers. New Mexico.>>  
                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.--

[[Page 136 STAT. 2174]]

            (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) <<NOTE: Deadline. Regulations. Procedures.>>  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) <<NOTE: Deadline.>>  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

[[Page 136 STAT. 2175]]

        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) <<NOTE: Determinations.>>  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

[[Page 136 STAT. 2176]]

        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.

    Approved September 30, 2022.

LEGISLATIVE HISTORY--H.R. 6833:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 168 (2022):
            Mar. 31, considered and passed House.
            Sept. 28, 29, considered and passed Senate, amended.
            Sept. 30, House concurred in Senate amendment.

                                  <all>
Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023
To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes.
Affordable Insulin Now Act
Affordable Insulin Now Act
Rep. Craig, Angie