21st Century Cures Act

Pub. L. 114-255

Also known as: Helping Families in Mental Health Crisis Reform Act of 2016, Increasing Choice, Access, and Quality in Health Care for Americans Act

247 sections of the Code credited to this law, found between Public Law 114-254 and Public Law 114-321.

15 U.S.C. § 2229a — Staffing for adequate fire and emergency response
21 U.S.C. § 321 — Definitions; generally
21 U.S.C. § 331 — Prohibited acts
21 U.S.C. § 352 — Misbranded drugs and devices
21 U.S.C. § 353 — Exemptions and consideration for certain drugs, devices, and biological products
21 U.S.C. § 355 — New drugs
21 U.S.C. § 355–1 — Risk evaluation and mitigation strategies
21 U.S.C. § 355a — Pediatric studies of drugs
21 U.S.C. § 355c — Research into pediatric uses for drugs and biological products
21 U.S.C. § 355g — Utilizing real world evidence
21 U.S.C. § 356 — Expedited approval of drugs for serious or life-threatening diseases or conditions
21 U.S.C. § 356c — Discontinuance or interruption in the production of life-saving drugs
21 U.S.C. § 356c–1 — Annual reporting on drug shortages
21 U.S.C. § 356e — Drug shortage list
21 U.S.C. § 356g — Standards for regenerative medicine and regenerative advanced therapies
21 U.S.C. § 357 — Qualification of drug development tools
21 U.S.C. § 360 — Registration of producers of drugs or devices
21 U.S.C. § 360a–2 — Susceptibility test interpretive criteria for microorganisms
21 U.S.C. § 360b — New animal drugs
21 U.S.C. § 360c — Classification of devices intended for human use
21 U.S.C. § 360d — Performance standards
21 U.S.C. § 360e — Premarket approval
21 U.S.C. § 360e–3 — Breakthrough devices
21 U.S.C. § 360g–1 — Agency documentation and review of significant decisions regarding devices
21 U.S.C. § 360h–1 — Program to improve the device recall system
21 U.S.C. § 360i — Records and reports on devices
21 U.S.C. § 360j — General provisions respecting control of devices intended for human use
21 U.S.C. § 360m — Accredited persons
21 U.S.C. § 360n — Priority review to encourage treatments for tropical diseases
21 U.S.C. § 360n–1 — Priority review for qualified infectious disease products
21 U.S.C. § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
21 U.S.C. § 360ff — Priority review to encourage treatments for rare pediatric diseases
21 U.S.C. § 360ff–1 — Targeted drugs for rare diseases
21 U.S.C. § 360bbb–0 — Expanded access policy required for investigational drugs
21 U.S.C. § 360bbb–3 — Authorization for medical products for use in emergencies
21 U.S.C. § 360bbb–3a — Emergency use of medical products
21 U.S.C. § 360bbb–3b — Products held for emergency use
21 U.S.C. § 360bbb–4a — Priority review to encourage treatments for agents that present national security threats
21 U.S.C. § 360bbb–8 — Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
21 U.S.C. § 360bbb–8a — Optimizing global clinical trials
21 U.S.C. § 360bbb–8b — Use of clinical investigation data from outside the United States
21 U.S.C. § 360bbb–8c — Patient participation in medical product discussion
21 U.S.C. § 360ddd — Definitions
21 U.S.C. § 360ddd–1 — Regulation of medical gases
21 U.S.C. § 360ddd–2 — Inapplicability of drug fees to designated medical gases
21 U.S.C. § 379d–1 — Conflicts of interest
21 U.S.C. § 379d–3a — Hiring authority for scientific, technical, and professional personnel
21 U.S.C. § 379i — Definitions
21 U.S.C. § 379j–52 — Authority to assess and use biosimilar biological product fees
21 U.S.C. § 379dd — Establishment and functions of the Foundation
21 U.S.C. § 381 — Imports and exports
21 U.S.C. § 384e — Recognition of foreign government inspections
21 U.S.C. § 399c — Improving the training of State, local, territorial, and tribal food safety officials
21 U.S.C. § 399d — Employee protections
21 U.S.C. § 399g — Food and Drug Administration Intercenter Institutes
21 U.S.C. § 399h — Grants for studying continuous drug manufacturing
26 U.S.C. § 36B — Refundable credit for coverage under a qualified health plan
26 U.S.C. § 106 — Contributions by employer to accident and health plans
26 U.S.C. § 4980I — Excise tax on high cost employer-sponsored health coverage
26 U.S.C. § 6051 — Receipts for employees
26 U.S.C. § 6652 — Failure to file certain information returns, registration statements, etc.
26 U.S.C. § 9831 — General exceptions
29 U.S.C. § 1167 — Definitions and special rules
29 U.S.C. § 1191b — Definitions
38 U.S.C. § 5501A — Beneficiaries’ rights in mental competence determinations
42 U.S.C. § 233 — Civil actions or proceedings against commissioned officers or employees
42 U.S.C. § 237 — Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service
42 U.S.C. § 241 — Research and investigations generally
42 U.S.C. § 247b–13a — Screening and treatment for maternal depression
42 U.S.C. § 247d — Public health emergencies
42 U.S.C. § 247d–5 — Combating antimicrobial resistance
42 U.S.C. § 247d–6b — Strategic National Stockpile and security countermeasure procurements
42 U.S.C. § 247d–7e — Biomedical Advanced Research and Development Authority
42 U.S.C. § 254c–19 — Pediatric mental health care access grants
42 U.S.C. § 262 — Regulation of biological products
42 U.S.C. § 280g–7a — Surveillance of neurological diseases
42 U.S.C. § 280h–6 — Infant and early childhood mental health promotion, intervention, and treatment
42 U.S.C. § 280i–4 — Authorization of appropriations
42 U.S.C. § 282 — Director of National Institutes of Health
42 U.S.C. § 282a — Authorization of appropriations
42 U.S.C. § 283 — Triennial reports of Director of NIH
42 U.S.C. § 283a–1 — Annual reporting to prevent fraud and abuse
42 U.S.C. § 283a–2 — Annual reporting regarding training of graduate students for doctoral degrees
42 U.S.C. § 283d — Children’s Vaccine Initiative
42 U.S.C. § 283o — Next generation of researchers
42 U.S.C. § 283p — Population focused research
42 U.S.C. § 283q — Eureka prize competitions
42 U.S.C. § 284 — Directors of national research institutes
42 U.S.C. § 284h — Pediatric Research Initiative
42 U.S.C. § 284r — Basic research
42 U.S.C. § 284s — Tick-borne diseases
42 U.S.C. § 285g–4 — National Center for Medical Rehabilitation Research
42 U.S.C. § 285q–2 — Advisory council
42 U.S.C. § 285t — Purpose of Institute
42 U.S.C. § 287 — National Center for Advancing Translational Sciences
42 U.S.C. § 287d — Office of Research on Women’s Health
42 U.S.C. § 288–1 — Intramural loan repayment program
42 U.S.C. § 288–2 — Extramural loan repayment program
42 U.S.C. § 289a–2 — Inclusion of women and minorities in clinical research
42 U.S.C. § 289g–5 — Precision medicine initiative
42 U.S.C. § 290aa — Substance Abuse and Mental Health Services Administration
42 U.S.C. § 290aa–0 — National Mental Health and Substance Use Policy Laboratory
42 U.S.C. § 290aa–1 — Advisory councils
42 U.S.C. § 290aa–3 — Peer review
42 U.S.C. § 290aa–4 — Center for behavioral health statistics and quality
42 U.S.C. § 290aa–5 — Grants for the benefit of homeless individuals
42 U.S.C. § 290bb — Center for Substance Abuse Treatment
42 U.S.C. § 290bb–1 — Residential treatment programs for pregnant and postpartum women
42 U.S.C. § 290bb–2 — Priority substance abuse treatment needs of regional and national significance
42 U.S.C. § 290bb–7 — Substance use disorder treatment and early intervention services for children and adolescents
42 U.S.C. § 290bb–21 — Center for Substance Abuse Prevention
42 U.S.C. § 290bb–22 — Priority substance use disorder prevention needs of regional and national significance
42 U.S.C. § 290bb–25 — Grants for services for children of substance abusers
42 U.S.C. § 290bb–25b — Programs to reduce underage drinking
42 U.S.C. § 290bb–31 — Center for Mental Health Services
42 U.S.C. § 290bb–32 — Priority mental health needs of regional and national significance
42 U.S.C. § 290bb–34 — Suicide prevention technical assistance center
42 U.S.C. § 290bb–36 — Youth suicide early intervention and prevention strategies
42 U.S.C. § 290bb–36b — Mental health and substance use disorder services on campus
42 U.S.C. § 290bb–36c — National Suicide Prevention Lifeline program
42 U.S.C. § 290bb–36d — Treatment Referral Routing Service
42 U.S.C. § 290bb–37 — Strengthening community crisis response systems
42 U.S.C. § 290bb–38 — Grants for jail diversion programs
42 U.S.C. § 290bb–41 — Mental health awareness training grants
42 U.S.C. § 290bb–42 — Integration incentive grants and cooperative agreements
42 U.S.C. § 290bb–43 — Adult suicide prevention
42 U.S.C. § 290bb–44 — Assertive community treatment grant program
42 U.S.C. § 290cc–21 — Formula grants to States
42 U.S.C. § 290cc–22 — Purpose of grants
42 U.S.C. § 290cc–27 — Description of intended expenditures of grant
42 U.S.C. § 290cc–28 — Requirement of reports by States
42 U.S.C. § 290cc–30 — Technical assistance
42 U.S.C. § 290cc–34 — Definitions
42 U.S.C. § 290cc–35 — Funding
42 U.S.C. § 290dd — Substance abuse among government and other employees
42 U.S.C. § 290dd–2a — Promoting access to information on evidence-based programs and practices
42 U.S.C. § 290ee–4 — Mental and behavioral health outreach and education on college campuses
42 U.S.C. § 290ff — Comprehensive community mental health services for children with serious emotional disturbances
42 U.S.C. § 290ff–1 — Requirements with respect to carrying out purpose of grants
42 U.S.C. § 290ff–3 — Additional provisions
42 U.S.C. § 290ff–4 — General provisions
42 U.S.C. § 290hh–1 — Grants to address the problems of persons who experience violence related stress
42 U.S.C. § 290ll — Fellowships
42 U.S.C. § 294e–1 — Mental and behavioral health education and training grants
42 U.S.C. § 294k — Training demonstration program
42 U.S.C. § 300u–11 — Prevention and Public Health Fund
42 U.S.C. § 300x — Formula grants to States
42 U.S.C. § 300x–1 — State plan for comprehensive community mental health services for certain individuals
42 U.S.C. § 300x–4 — Additional provisions
42 U.S.C. § 300x–6 — Application for grant
42 U.S.C. § 300x–9 — Funding
42 U.S.C. § 300x–21 — Formula grants to States
42 U.S.C. § 300x–23 — Intravenous substance abuse
42 U.S.C. § 300x–24 — Requirements regarding tuberculosis and human immunodeficiency virus
42 U.S.C. § 300x–25 — Group homes for persons in recovery from substance use disorders
42 U.S.C. § 300x–28 — Additional agreements
42 U.S.C. § 300x–30 — Maintenance of effort regarding State expenditures
42 U.S.C. § 300x–31 — Restrictions on expenditure of grant
42 U.S.C. § 300x–32 — Application for grant; approval of State plan
42 U.S.C. § 300x–34 — Definitions
42 U.S.C. § 300x–35 — Funding
42 U.S.C. § 300x–53 — Additional requirements
42 U.S.C. § 300x–63 — Continuation of certain programs
42 U.S.C. § 300x–67 — Public health emergencies
42 U.S.C. § 300x–68 — Joint applications
42 U.S.C. § 300aa–11 — Petitions for compensation
42 U.S.C. § 300aa–14 — Vaccine Injury Table
42 U.S.C. § 300bb–8 — Definitions
42 U.S.C. § 300gg–26 — Parity in mental health and substance use disorder benefits
42 U.S.C. § 300gg–91 — Definitions
42 U.S.C. § 300hh–10 — Coordination of preparedness for and response to all-hazards public health emergencies
42 U.S.C. § 300jj — Definitions
42 U.S.C. § 300jj–11 — Office of the National Coordinator for Health Information Technology
42 U.S.C. § 300jj–12 — Health Information Technology Advisory Committee
42 U.S.C. § 300jj–13 — Setting priorities for standards adoption
42 U.S.C. § 300jj–14 — Process for adoption of endorsed recommendations; adoption of initial set of standards, implementation specifications, and certification criteria
42 U.S.C. § 300jj–17 — Federal health information technology
42 U.S.C. § 300jj–18 — Transitions
42 U.S.C. § 300jj–19 — Miscellaneous provisions
42 U.S.C. § 300jj–19a — Electronic health record reporting program
42 U.S.C. § 300jj–51 — Health information technology enrollment standards and protocols
42 U.S.C. § 300jj–52 — Information blocking
42 U.S.C. § 1320a–7a — Civil monetary penalties
42 U.S.C. § 1395b–9 — Provisions relating to administration
42 U.S.C. § 1395l — Payment of benefits
42 U.S.C. § 1395m — Special payment rules for particular items and services
42 U.S.C. § 1395u — Provisions relating to the administration of part B
42 U.S.C. § 1395w–3 — Competitive acquisition of certain items and services
42 U.S.C. § 1395w–4 — Payment for physicians’ services
42 U.S.C. § 1395w–21 — Eligibility, election, and enrollment
42 U.S.C. § 1395w–22 — Benefits and beneficiary protections
42 U.S.C. § 1395w–23 — Payments to Medicare+Choice organizations
42 U.S.C. § 1395w–27 — Contracts with Medicare+Choice organizations
42 U.S.C. § 1395w–28 — Definitions; miscellaneous provisions
42 U.S.C. § 1395x — Definitions
42 U.S.C. § 1395y — Exclusions from coverage and medicare as secondary payer
42 U.S.C. § 1395cc — Agreements with providers of services; enrollment processes
42 U.S.C. § 1395kk — Administration of insurance programs
42 U.S.C. § 1395ww — Payments to hospitals for inpatient hospital services
42 U.S.C. § 1395iii — Medicare Improvement Fund
42 U.S.C. § 1395jjj — Shared savings program
42 U.S.C. § 1395lll — Standardized post-acute care (PAC) assessment data for quality, payment, and discharge planning
42 U.S.C. § 1396a — State plans for medical assistance
42 U.S.C. § 1396b — Payment to States
42 U.S.C. § 1396d — Definitions
42 U.S.C. § 1396p — Liens, adjustments and recoveries, and transfers of assets
42 U.S.C. § 1396u–2 — Provisions relating to managed care
42 U.S.C. § 1397gg — Strategic objectives and performance goals; plan administration
42 U.S.C. § 3506a — Scientific engagement
42 U.S.C. § 3751 — Description
42 U.S.C. § 3796dd — Authority to make public safety and community policing grants
42 U.S.C. § 3796ff — Grant authorization
42 U.S.C. § 3796ii — Grant authority
42 U.S.C. § 3796ii–1 — Definitions
42 U.S.C. § 3796ii–8 — Mental health responses in the judicial system
42 U.S.C. § 3797a — Program authorized
42 U.S.C. § 3797q — Mental health and drug treatment alternatives to incarceration programs
42 U.S.C. § 3797s–6 — Definitions
42 U.S.C. § 3797u — Grant authority
42 U.S.C. § 3797u–8 — Technical assistance, training, and evaluation
42 U.S.C. § 3797w — Adult and juvenile offender State and local reentry demonstration projects
42 U.S.C. § 3797aa — Adult and juvenile collaboration programs
42 U.S.C. § 3797aa–1 — National criminal justice and mental health training and technical assistance
42 U.S.C. § 6241 — Drawdown and sale of petroleum products
42 U.S.C. § 10805 — System requirements
42 U.S.C. § 10824 — Reports by Secretary
42 U.S.C. § 17531 — Mentoring grants to nonprofit organizations
42 U.S.C. § 17935 — Restrictions on certain disclosures and sales of health information; accounting of certain protected health information disclosures; access to certain information in electronic format
42 U.S.C. § 18081 — Procedures for determining eligibility for Exchange participation, premium tax credits and reduced cost-sharing, and individual responsibility exemptions
34 U.S.C. § 10152 — Description
34 U.S.C. § 10381 — Authority to make public safety and community policing grants
34 U.S.C. § 10421 — Grant authorization
34 U.S.C. § 10471 — Grant authority
34 U.S.C. § 10472 — Definitions
34 U.S.C. § 10479 — Mental health responses in the judicial system
34 U.S.C. § 10551 — Program authorized
34 U.S.C. § 10581 — Repealed.
34 U.S.C. § 10596 — Definitions
34 U.S.C. § 10611 — Grant authority
34 U.S.C. § 10619 — Technical assistance, training, and evaluation
34 U.S.C. § 10631 — Adult and juvenile offender State and local reentry demonstration projects
34 U.S.C. § 10651 — Adult and juvenile collaboration programs
34 U.S.C. § 10652 — National criminal justice and mental health training and technical assistance
34 U.S.C. § 41311 — Improving Department of Justice data collection on mental illness involved in crime
34 U.S.C. § 60531 — Community-based mentoring and transitional service grants to nonprofit organizations
42 U.S.C. § 290aa–17 — Assisted outpatient treatment grant program for individuals with serious mental illness
42 U.S.C. § 290ee–3a — Grant program for State and Tribal response to opioid use disorders