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.