TABLE OF CONTENTS.

SEC. 2. TABLE OF CONTENTS. The table of contents for this division is as follows: DIVISION FF— HEALTH AND HUMAN SERVICES Sec. 1. Short title. Sec. 2. Table of contents. TITLE I— RESTORING HOPE FOR MENTAL HEALTH AND WELL-BEING Sec. 1001. Short title. Subtitle A— Mental Health and Crisis Care Needs Chapter 1— Crisis Care Services and 9–8–8 Implementation Sec. 1101. Behavioral Health Crisis Coordinating Office.136 STAT. 5628 Sec. 1102. Crisis response continuum of care. Sec. 1103. Suicide Prevention Lifeline Improvement. Chapter 2— Into the Light for Maternal Mental Health and Substance Use Disorders Sec. 1111. Screening and treatment for maternal mental health and substance use disorders. Sec. 1112. Maternal mental health hotline. Sec. 1113. Task force on maternal mental health. Sec. 1114. Residential treatment program for pregnant and postpartum women pilot program reauthorization. Chapter 3— Reaching Improved Mental Health Outcomes for Patients Sec. 1121. Innovation for mental health. Sec. 1122. Crisis care coordination. Sec. 1123. Treatment of serious mental illness. Sec. 1124. Study on the costs of serious mental illness. Chapter 4— Anna Westin Legacy Sec. 1131. Maintaining education and training on eating disorders. Chapter 5— Community Mental Health Services Block Grant Reauthorization Sec. 1141. Reauthorization of block grants for community mental health services. Chapter 6— Peer-Supported Mental Health Services Sec. 1151. Peer-supported mental health services. Subtitle B— Substance Use Disorder Prevention, Treatment, and Recovery Services Chapter 1— Native Behavioral Health Resources Sec. 1201. Behavioral health and substance use disorder resources for Native Americans. Chapter 2— Summer Barrow Prevention, Treatment, and Recovery Sec. 1211. Grants for the benefit of homeless individuals. Sec. 1212. Priority substance use disorder treatment needs of regional and national significance. Sec. 1213. Evidence-based prescription opioid and heroin treatment and interventions demonstration. Sec. 1214. Priority substance use disorder prevention needs of regional and national significance. Sec. 1215. Sober Truth on Preventing (STOP) Underage Drinking Reauthorization. Sec. 1216. Grants for jail diversion programs. Sec. 1217. Formula grants to States. Sec. 1218. Projects for Assistance in Transition From Homelessness. Sec. 1219. Grants for reducing overdose deaths. Sec. 1220. Opioid overdose reversal medication access and education grant programs. Sec. 1221. Emergency department alternatives to opioids. Chapter 3— Excellence in Recovery Housing Sec. 1231. Clarifying the role of SAMHSA in promoting the availability of high-quality recovery housing. Sec. 1232. Developing guidelines for States to promote the availability of high-quality recovery housing. Sec. 1233. Coordination of Federal activities to promote the availability of recovery housing. Sec. 1234. National Academies of Sciences, Engineering, and Medicine study and report. Sec. 1235. Grants for States to promote the availability of recovery housing and services. Sec. 1236. Funding. Sec. 1237. Technical correction. Chapter 4— Substance Use Prevention, Treatment, and Recovery Services Block Grant Sec. 1241. Eliminating stigmatizing language relating to substance use. Sec. 1242. Authorized activities.136 STAT. 5629 Sec. 1243. State plan requirements. Sec. 1244. Updating certain language relating to Tribes. Sec. 1245. Block grants for substance use prevention, treatment, and recovery services. Sec. 1246. Requirement of reports and audits by States. Sec. 1247. Study on assessment for use of State resources. Chapter 5— Timely Treatment for Opioid Use Disorder Sec. 1251. Study on exemptions for treatment of opioid use disorder through opioid treatment programs during the COVID–19 public health emergency. Sec. 1252. Changes to Federal opioid treatment standards. Chapter 6— Additional Provisions Relating to Addiction Treatment Sec. 1261. Prohibition. Sec. 1262. Eliminating additional requirements for dispensing narcotic drugs in schedule III, IV, and V for maintenance or detoxification treatment. Sec. 1263. Requiring prescribers of controlled substances to complete training. Sec. 1264. Increase in number of days before which certain controlled substances must be administered. Chapter 7— Opioid Crisis Response Sec. 1271. Opioid prescription verification. Sec. 1272. Synthetic opioid and emerging drug misuse danger awareness. Sec. 1273. Grant program for State and Tribal response to opioid use disorders. Subtitle C— Access to Mental Health Care and Coverage Chapter 1— Improving Uptake and Patient Access to Integrated Care Services Sec. 1301. Improving uptake and patient access to integrated care services. Chapter 2— Helping Enable Access to Lifesaving Services Sec. 1311. Reauthorization and provision of certain programs to strengthen the health care workforce. Sec. 1312. Reauthorization of minority fellowship program. Chapter 3— Eliminating the Opt-Out for Nonfederal Governmental Health Plans Sec. 1321. Eliminating the opt-out for nonfederal governmental health plans. Chapter 4— Mental Health and Substance Use Disorder Parity Implementation Sec. 1331. Grants to support mental health and substance use disorder parity implementation. Subtitle D— Children and Youth Chapter 1— Supporting Children’s Mental Health Care Access Sec. 1401. Technical assistance for school-based health centers. Sec. 1402. Infant and early childhood mental health promotion, intervention, and treatment. Sec. 1403. Co-occurring chronic conditions and mental health in youth study. Sec. 1404. Best practices for behavioral and mental health intervention teams. Chapter 2— Continuing Systems of Care for Children Sec. 1411. Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances. Sec. 1412. Substance Use Disorder Treatment and Early Intervention Services for Children and Adolescents. Chapter 3— Garrett Lee Smith Memorial Reauthorization Sec. 1421. Suicide prevention technical assistance center. Sec. 1422. Youth suicide early intervention and prevention strategies. Sec. 1423. Mental health and substance use disorder services for students in higher education. Sec. 1424. Mental and behavioral health outreach and education at institutions of higher education. Chapter 4— Media and Mental Health Sec. 1431. Study on the effects of smartphone and social media use on adolescents.136 STAT. 5630 Sec. 1432. Research on the health and development effects of media and related technology on infants, children, and adolescents. Subtitle E— Miscellaneous Provisions Sec. 1501. Limitations on authority. TITLE II— PREPARING FOR AND RESPONDING TO EXISTING VIRUSES, EMERGING NEW THREATS, AND PANDEMICS Sec. 2001. Short title. Subtitle A— Strengthening Federal and State Preparedness Chapter 1— Federal Leadership and Accountability Sec. 2101. Appointment and authority of the Director of the Centers for Disease Control and Prevention. Sec. 2102. Advisory committee to the director of the centers for disease control and prevention. Sec. 2103. Public health and medical preparedness and response coordination. Sec. 2104. Office of Pandemic Preparedness and Response Policy. Chapter 2— State and Local Readiness Sec. 2111. Improving State and local public health security. Sec. 2112. Supporting access to mental health and substance use disorder services during public health emergencies. Sec. 2113. Trauma care reauthorization. Sec. 2114. Assessment of containment and mitigation of infectious diseases. Sec. 2115. Consideration of unique challenges in noncontiguous States and territories. Subtitle B— Improving Public Health Preparedness and Response Capacity Chapter 1— Improving Public Health Emergency Responses Sec. 2201. Addressing factors related to improving health outcomes. Chapter 2— Improving State, Local, and Tribal Public Health Data Sec. 2211. Modernizing State, local, and Tribal biosurveillance capabilities and infectious disease data. Sec. 2212. Genomic sequencing, analytics, and public health surveillance of pathogens. Sec. 2213. Supporting State, local, and Tribal public health data. Sec. 2214. Epidemic forecasting and outbreak analytics. Sec. 2215. Public health data transparency. Sec. 2216. GAO report on public health preparedness, response, and recovery data capabilities. Chapter 3— Revitalizing the Public Health Workforce Sec. 2221. Improving recruitment and retention of the frontline public health workforce. Sec. 2222. Awards to support community health workers and community health. Sec. 2223. Improving public health emergency response capacity. Sec. 2224. Increasing educational opportunities for allied health professions. Sec. 2225. Public Health Service Corps annual and sick leave. Sec. 2226. Leadership exchange pilot for public health and medical preparedness and response positions at the Department of Health and Human Services. Sec. 2227. Continuing educational support for health professionals serving in rural and underserved communities. Chapter 4— Enhancing Public Health Preparedness and Response Sec. 2231. Centers for public health preparedness and response. Sec. 2232. Vaccine distribution plans. Sec. 2233. Coordination and collaboration regarding blood supply. Sec. 2234. Supporting laboratory capacity and international collaboration to address antimicrobial resistance. Sec. 2235. One Health framework. Sec. 2236. Supporting children during public health emergencies. Subtitle C— Accelerating Research and Countermeasure Discovery Chapter 1— Fostering Research and Development and Improving Coordination Sec. 2301. Research centers for pathogens of pandemic concern.136 STAT. 5631 Sec. 2302. Improving medical countermeasure research coordination. Sec. 2303. Accessing specimen samples and diagnostic tests. Sec. 2304. National Academies of Sciences, Engineering, and Medicine study on natural immunity in relation to the COVID–19 pandemic. Chapter 2— Improving Biosafety and Biosecurity Sec. 2311. Improving control and oversight of select biological agents and toxins. Sec. 2312. Strategy for Federal high-containment laboratories. Sec. 2313. National Science Advisory Board for Biosecurity. Sec. 2314. Research to improve biosafety. Sec. 2315. Federally-funded research with enhanced pathogens of pandemic potential. Chapter 3— Preventing Undue Foreign Influence in Biomedical Research Sec. 2321. Foreign talent recruitment programs. Sec. 2322. Securing identifiable, sensitive information and addressing other national security risks related to research. Sec. 2323. Duties of the Director. Sec. 2324. Protecting America’s biomedical research enterprise. Sec. 2325. GAO Study. Sec. 2326. Report on progress to address undue foreign influence. Chapter 4— Advanced Research Projects Agency–Health Sec. 2331. Advanced Research Projects Agency–Health. Subtitle D— Modernizing and Strengthening the Supply Chain for Vital Medical Products Sec. 2401. Warm base manufacturing capacity for medical countermeasures. Sec. 2402. Supply chain considerations for the Strategic National Stockpile. Sec. 2403. Strategic National Stockpile equipment maintenance. Sec. 2404. Improving transparency and predictability of processes of the Strategic National Stockpile. Sec. 2405. Improving supply chain flexibility for the Strategic National Stockpile. Sec. 2406. Reimbursement for certain supplies. Sec. 2407. Action reporting on stockpile depletion. Sec. 2408. Provision of medical countermeasures to Indian programs and facilities. Sec. 2409. Grants for State strategic stockpiles. Sec. 2410. Study on incentives for domestic production of generic medicines. Sec. 2411. Increased manufacturing capacity for certain critical antibiotic drugs. Subtitle E— Enhancing Development and Combating Shortages of Medical Products Chapter 1— Development and Review Sec. 2501. Accelerating countermeasure development and review. Sec. 2502. Third party test evaluation during emergencies. Sec. 2503. Platform technologies. Sec. 2504. Increasing EUA decision transparency. Sec. 2505. Improving FDA guidance and communication. Chapter 2— Mitigating Shortages Sec. 2511. Ensuring registration of foreign drug and device manufacturers. Sec. 2512. Extending expiration dates for certain drugs. Sec. 2513. Combating counterfeit devices. Sec. 2514. Preventing medical device shortages. Sec. 2515. Technical corrections. TITLE III— FOOD AND DRUG ADMINISTRATION Sec. 3001. Short title. Sec. 3002. Definition. Subtitle A— Reauthorizations Sec. 3101. Reauthorization of the critical path public-private partnership. Sec. 3102. Reauthorization of the best pharmaceuticals for children program. Sec. 3103. Reauthorization of the humanitarian device exemption incentive. Sec. 3104. Reauthorization of the pediatric device consortia program. Sec. 3105. Reauthorization of provision pertaining to drugs containing single enantiomers. Sec. 3106. Reauthorization of certain device inspections. Sec. 3107. Reauthorization of orphan drug grants. Sec. 3108. Reauthorization of reporting requirements related to pending generic drug applications and priority review applications.136 STAT. 5632 Sec. 3109. Reauthorization of third-party review program. Subtitle B— Drugs and Biologics Chapter 1— Research, Development, and Competition Improvements Sec. 3201. Prompt reports of marketing status by holders of approved applications for biological products. Sec. 3202. Improving the treatment of rare diseases and conditions. Sec. 3203. Emerging technology program. Sec. 3204. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing. Sec. 3205. Public workshop on cell therapies. Sec. 3206. Clarifications to exclusivity provisions for first interchangeable biosimilar biological products. Sec. 3207. GAO report on nonprofit pharmaceutical organizations. Sec. 3208. Rare disease endpoint advancement pilot program. Sec. 3209. Animal testing alternatives. Sec. 3210. Modernizing accelerated approval. Sec. 3211. Antifungal research and development. Sec. 3212. Advancing qualified infectious disease product innovation. Sec. 3213. Advanced manufacturing technologies designation program. Chapter 2— Transparency, Program Integrity, and Regulatory Improvements Sec. 3221. Safer disposal of opioids. Sec. 3222. Therapeutic equivalence evaluations. Sec. 3223. Public docket on proposed changes to third-party vendors. Sec. 3224. Enhancing access to affordable medicines. Subtitle C— Medical Devices Sec. 3301. Dual submission for certain devices. Sec. 3302. Medical Devices Advisory Committee meetings. Sec. 3303. GAO report on third-party review. Sec. 3304. Certificates to foreign governments. Sec. 3305. Ensuring cybersecurity of medical devices. Sec. 3306. Bans of devices for one or more intended uses. Sec. 3307. Third party data transparency. Sec. 3308. Predetermined change control plans for devices. Sec. 3309. Small business fee waiver. Subtitle D— Infant Formula Sec. 3401. Protecting infants and improving formula supply. Subtitle E— Cosmetics Sec. 3501. Short title. Sec. 3502. Amendments to cosmetic requirements. Sec. 3503. Enforcement and conforming amendments. Sec. 3504. Records inspection. Sec. 3505. Talc-containing cosmetics. Sec. 3506. PFAS in cosmetics. Sec. 3507. Sense of the Congress on animal testing. Sec. 3508. Funding. Subtitle F— Cross-Cutting Provisions Chapter 1— Clinical Trial Diversity and Modernization Sec. 3601. Diversity action plans for clinical studies. Sec. 3602. Guidance on diversity action plans for clinical studies. Sec. 3603. Public workshops to enhance clinical study diversity. Sec. 3604. Annual summary report on progress to increase diversity in clinical studies. Sec. 3605. Public meeting on clinical study flexibilities initiated in response to COVID–19 pandemic. Sec. 3606. Decentralized clinical studies. Sec. 3607. Modernizing clinical trials. Chapter 2— Inspections Sec. 3611. Device inspections. Sec. 3612. Bioresearch monitoring inspections. Sec. 3613. Improving Food and Drug Administration inspections. Sec. 3614. GAO report on inspections of foreign establishments manufacturing drugs.136 STAT. 5633 Sec. 3615. Unannounced foreign facility inspections pilot program. Sec. 3616. Enhancing coordination and transparency on inspections. Sec. 3617. Enhancing transparency of drug facility inspection timelines. Chapter 3— Miscellaneous Sec. 3621. Regulation of certain products as drugs. Sec. 3622. Women’s Health Research Roadmap. Sec. 3623. Strategic workforce plan and report. Sec. 3624. Enhancing Food and Drug Administration hiring authority for scientific, technical, and professional personnel. Sec. 3625. Facilities management. Sec. 3626. User fee program transparency and accountability. Sec. 3627. Improving information technology systems of the Food and Drug Administration. Sec. 3628. Reporting on mailroom and Office of the Executive Secretariat of the Food and Drug Administration. Sec. 3629. Facilitating the use of real world evidence. Sec. 3630. Facilitating exchange of product information prior to approval. Sec. 3631. Streamlining blood donor input. TITLE IV— MEDICARE PROVISIONS Subtitle A— Medicare Extenders Sec. 4101. Extension of increased inpatient hospital payment adjustment for certain low-volume hospitals. Sec. 4102. Extension of the Medicare-Dependent Hospital program. Sec. 4103. Extension of add-on payments for ambulance services. Subtitle B— Other Expiring Medicare Provisions Sec. 4111. Extending incentive payments for participation in eligible alternative payment models. Sec. 4112. Extension of support for physicians and other professionals in adjusting to Medicare payment changes. Sec. 4113. Advancing telehealth Beyond COVID–19. Sec. 4114. Revised phase-in of Medicare clinical laboratory test payment changes. Subtitle C— Medicare Mental Health Provisions Sec. 4121. Coverage of marriage and family therapist services and mental health counselor services under part B of the Medicare program. Sec. 4122. Additional residency positions. Sec. 4123. Improving mobile crisis care in Medicare. Sec. 4124. Ensuring adequate coverage of outpatient mental health services under the Medicare program. Sec. 4125. Improvements to Medicare prospective payment system for psychiatric hospitals and psychiatric units. Sec. 4126. Exception for physician wellness programs. Sec. 4127. Consideration of safe harbor under the anti-kickback statute for certain contingency management interventions. Sec. 4128. Provider outreach and reporting on certain behavioral health integration services. Sec. 4129. Outreach and reporting on opioid use disorder treatment services furnished by opioid treatment programs. Sec. 4130. GAO study and report comparing coverage of mental health and substance use disorder benefits and non-mental health and substance use disorder benefits. Subtitle D— Other Medicare Provisions Sec. 4131. Temporary inclusion of authorized oral antiviral drugs as covered part D drug. Sec. 4132. Restoration of CBO access to certain part D payment data. Sec. 4133. Medicare coverage of certain lymphedema compression treatment items. Sec. 4134. Permanent in-home benefit for IVIG services. Sec. 4135. Access to non-opioid treatments for pain relief. Sec. 4136. Technical amendments to Medicare separate payment for disposable negative pressure wound therapy devices. Sec. 4137. Extension of certain home health rural add-on payments. Sec. 4138. Remedying election revocations relating to administration of COVID–19 vaccines. Sec. 4139. Payment rates for durable medical equipment under the Medicare Program. Sec. 4140. Extending Acute Hospital Care at Home waivers and flexibilities.136 STAT. 5634 Sec. 4141. Extension of pass-through status under the Medicare program for certain devices impacted by COVID–19. Sec. 4142. Increasing transparency for home health payments under the Medicare program. Sec. 4143. Waiver of cap on annual payments for nursing and allied health education payments. Subtitle E— Health Care Tax Provisions Sec. 4151. Extension of safe harbor for absence of deductible for telehealth. Subtitle F— Offsets Sec. 4161. Reduction of Medicare Improvement Fund. Sec. 4162. Extension of adjustment to calculation of hospice cap amount under Medicare. Sec. 4163. Medicare direct spending reductions. TITLE V— MEDICAID AND CHIP PROVISIONS Subtitle A— Territories Sec. 5101. Medicaid adjustments for the territories. Subtitle B— Medicaid and CHIP Coverage Sec. 5111. Funding extension of the Children’s Health Insurance Program and related provisions. Sec. 5112. Continuous eligibility for children under Medicaid and CHIP. Sec. 5113. Modifications to postpartum coverage under Medicaid and CHIP. Sec. 5114. Extension of Money Follows the Person Rebalancing demonstration. Sec. 5115. Extension of Medicaid protections against spousal impoverishment for recipients of home and community-based services. Subtitle C— Medicaid and CHIP Mental Health Sec. 5121. Medicaid and CHIP requirements for health screenings, referrals, and case management services for eligible juveniles in public institutions. Sec. 5122. Removal of limitations on Federal financial participation for inmates who are eligible juveniles pending disposition of charges. Sec. 5123. Requiring accurate, updated, and searchable provider directories. Sec. 5124. Supporting access to a continuum of crisis response services under Medicaid and CHIP. Subtitle D— Transitioning From Medicaid FMAP Increase Requirements Sec. 5131. Transitioning from Medicaid FMAP increase requirements. Subtitle E— Medicaid Improvement Fund Sec. 5141. Medicaid improvement fund. TITLE VI— HUMAN SERVICES Sec. 6101. Jackie Walorski Maternal and Child Home Visiting Reauthorization Act of 2022. Sec. 6102. Extension of Temporary Assistance for Needy Families Program. Sec. 6103. 1-year extension of child and family services programs.