Public Law 114–255 114th Congress An Act
嚜燕UBLIC LAW 114每255〞DEC. 13, 2016
130 STAT. 1033
Public Law 114每255
114th Congress
An Act
To accelerate the discovery, development, and delivery of 21st century cures, and
for other purposes.
Dec. 13, 2016
[H.R. 34]
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
21st Century
Cures Act.
42 USC 201 note.
(a) SHORT TITLE.〞This Act may be cited as the ＆＆21st Century
Cures Act＊＊.
(b) TABLE OF CONTENTS.〞The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
DIVISION A〞21ST CENTURY CURES
Sec. 1000. Short title.
TITLE I〞INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID
ABUSE
Sec. 1001. Beau Biden Cancer Moonshot and NIH innovation projects.
Sec. 1002. FDA innovation projects.
Sec. 1003. Account for the state response to the opioid abuse crisis.
Sec. 1004. Budgetary treatment.
TITLE II〞DISCOVERY
Subtitle A〞National Institutes of Health Reauthorization
Sec. 2001. National Institutes of Health Reauthorization.
Sec. 2002. EUREKA prize competitions.
Sec.
Sec.
Sec.
Sec.
2011.
2012.
2013.
2014.
Subtitle B〞Advancing Precision Medicine
Precision Medicine Initiative.
Privacy protection for human research subjects.
Protection of identifiable and sensitive information.
Data sharing.
Subtitle C〞Supporting Young Emerging Scientists
Sec. 2021. Investing in the next generation of researchers.
Sec. 2022. Improvement of loan repayment program.
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Sec.
Sec.
Sec.
Sec.
Sec.
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Subtitle D〞National Institutes of Health Planning and Administration
2031. National Institutes of Health strategic plan.
2032. Triennial reports.
2033. Increasing accountability at the National Institutes of Health.
2034. Reducing administrative burden for researchers.
2035. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.
2036. High-risk, high-reward research.
2037. National Center for Advancing Translational Sciences.
2038. Collaboration and coordination to enhance research.
2039. Enhancing the rigor and reproducibility of scientific research.
2040. Improving medical rehabilitation research at the National Institutes of
Health.
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130 STAT. 1034
Sec.
Sec.
Sec.
Sec.
PUBLIC LAW 114每255〞DEC. 13, 2016
2041.
2042.
2043.
2044.
Task force on research specific to pregnant women and lactating women.
Streamlining National Institutes of Health reporting requirements.
Reimbursement for research substances and living organisms.
Sense of Congress on increased inclusion of underrepresented populations in clinical trials.
Subtitle E〞Advancement of the National Institutes of Health Research and Data
Access
Sec. 2051. Technical updates to clinical trials database.
Sec. 2052. Compliance activities reports.
Sec. 2053. Updates to policies to improve data.
Sec. 2054. Consultation.
Subtitle F〞Facilitating Collaborative Research
Sec. 2061. National neurological conditions surveillance system.
Sec. 2062. Tick-borne diseases.
Sec. 2063. Accessing, sharing, and using health data for research purposes.
Subtitle G〞Promoting Pediatric Research
Sec. 2071. National pediatric research network.
Sec. 2072. Global pediatric clinical study network.
TITLE III〞DEVELOPMENT
Sec.
Sec.
Sec.
Sec.
3001.
3002.
3003.
3004.
Subtitle A〞Patient-Focused Drug Development
Patient experience data.
Patient-focused drug development guidance.
Streamlining patient input.
Report on patient experience drug development.
Subtitle B〞Advancing New Drug Therapies
Sec. 3011. Qualification of drug development tools.
Sec. 3012. Targeted drugs for rare diseases.
Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric
diseases.
Sec. 3014. GAO study of priority review voucher programs.
Sec. 3015. Amendments to the Orphan Drug grants.
Sec. 3016. Grants for studying continuous drug manufacturing.
Sec.
Sec.
Sec.
Sec.
3021.
3022.
3023.
3024.
Sec.
Sec.
Sec.
Sec.
3031.
3032.
3033.
3034.
Sec. 3035.
Sec. 3036.
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Sec. 3037.
Sec. 3038.
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Sec.
Sec.
Sec.
Sec.
3041.
3042.
3043.
3044.
Sec.
Sec.
Sec.
Sec.
3051.
3052.
3053.
3054.
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Subtitle C〞Modern Trial Design and Evidence Development
Novel clinical trial designs.
Real world evidence.
Protection of human research subjects.
Informed consent waiver or alteration for clinical investigations.
Subtitle D〞Patient Access to Therapies and Information
Summary level review.
Expanded access policy.
Accelerated approval for regenerative advanced therapies.
Guidance regarding devices used in the recovery, isolation, or delivery
of regenerative advanced therapies.
Report on regenerative advanced therapies.
Standards for regenerative medicine and regenerative advanced therapies.
Health care economic information.
Combination product innovation.
Subtitle E〞Antimicrobial Innovation and Stewardship
Antimicrobial resistance monitoring.
Limited population pathway.
Prescribing authority.
Susceptibility test interpretive criteria for microorganisms; antimicrobial
susceptibility testing devices.
Subtitle F〞Medical Device Innovations
Breakthrough devices.
Humanitarian device exemption.
Recognition of standards.
Certain class I and class II devices.
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PUBLIC LAW 114每255〞DEC. 13, 2016
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
3055.
3056.
3057.
3058.
3059.
3060.
130 STAT. 1035
Classification panels.
Institutional review board flexibility.
CLIA waiver improvements.
Least burdensome device review.
Cleaning instructions and validation data requirement.
Clarifying medical software regulation.
Subtitle G〞Improving Scientific Expertise and Outreach at FDA
Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service.
Sec. 3072. Hiring authority for scientific, technical, and professional personnel.
Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes.
Sec. 3074. Scientific engagement.
Sec. 3075. Drug surveillance.
Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.
Subtitle H〞Medical Countermeasures Innovation
Medical countermeasure guidelines.
Clarifying BARDA contracting authority.
Countermeasure budget plan.
Medical countermeasures innovation.
Streamlining Project BioShield procurement.
Encouraging treatments for agents that present a national security
threat.
Sec. 3087. Paperwork Reduction Act waiver during a public health emergency.
Sec. 3088. Clarifying Food and Drug Administration emergency use authorization.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
3081.
3082.
3083.
3084.
3085.
3086.
Subtitle I〞Vaccine Access, Certainty, and Innovation
Sec. 3091. Predictable review timelines of vaccines by the Advisory Committee on
Immunization Practices.
Sec. 3092. Review of processes and consistency of Advisory Committee on Immunization Practices recommendations.
Sec. 3093. Encouraging vaccine innovation.
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Subtitle J〞Technical Corrections
Sec. 3101. Technical corrections.
Sec. 3102. Completed studies.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
4001.
4002.
4003.
4004.
4005.
4006.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
4007.
4008.
4009.
4010.
4011.
4012.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
5001.
5002.
5003.
5004.
5005.
5006.
5007.
5008.
Sec.
Sec.
Sec.
Sec.
5009.
5010.
5011.
5012.
TITLE IV〞DELIVERY
Assisting doctors and hospitals in improving quality of care for patients.
Transparent reporting on usability, security, and functionality.
Interoperability.
Information blocking.
Leveraging electronic health records to improve patient care.
Empowering patients and improving patient access to their electronic
health information.
GAO study on patient matching.
GAO study on patient access to health information.
Improving Medicare local coverage determinations.
Medicare pharmaceutical and technology ombudsman.
Medicare site-of-service price transparency.
Telehealth services in Medicare.
TITLE V〞SAVINGS
Savings in the Medicare Improvement Fund.
Medicaid reimbursement to States for durable medical equipment.
Penalties for violations of grants, contracts, and other agreements.
Reducing overpayments of infusion drugs.
Increasing oversight of termination of Medicaid providers.
Requiring publication of fee-for-service provider directory.
Fairness in Medicaid supplemental needs trusts.
Eliminating Federal financial participation with respect to expenditures
under Medicaid for agents used for cosmetic purposes or hair growth.
Amendment to the Prevention and Public Health Fund.
Strategic Petroleum Reserve drawdown.
Rescission of portion of ACA territory funding.
Medicare coverage of home infusion therapy.
DIVISION B〞HELPING FAMILIES IN MENTAL HEALTH CRISIS
Sec. 6000. Short title.
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130 STAT. 1036
PUBLIC LAW 114每255〞DEC. 13, 2016
TITLE VI〞STRENGTHENING LEADERSHIP AND ACCOUNTABILITY
Subtitle A〞Leadership
Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
Sec. 6002. Strengthening the leadership of the Substance Abuse and Mental Health
Services Administration.
Sec. 6003. Chief Medical Officer.
Sec. 6004. Improving the quality of behavioral health programs.
Sec. 6005. Strategic plan.
Sec. 6006. Biennial report concerning activities and progress.
Sec. 6007. Authorities of centers for mental health services, substance abuse prevention, and substance abuse treatment.
Sec. 6008. Advisory councils.
Sec. 6009. Peer review.
Subtitle B〞Oversight and Accountability
Sec. 6021. Improving oversight of mental and substance use disorders programs
through the Assistant Secretary for Planning and Evaluation.
Sec. 6022. Reporting for protection and advocacy organizations.
Sec. 6023. GAO study.
Subtitle C〞Interdepartmental Serious Mental Illness Coordinating Committee
Sec. 6031. Interdepartmental Serious Mental Illness Coordinating Committee.
TITLE VII〞ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH
SCIENCE AND TECHNOLOGY
Sec. 7001. Encouraging innovation and evidence-based programs.
Sec. 7002. Promoting access to information on evidence-based programs and practices.
Sec. 7003. Priority mental health needs of regional and national significance.
Sec. 7004. Priority substance use disorder treatment needs of regional and national
significance.
Sec. 7005. Priority substance use disorder prevention needs of regional and national significance.
TITLE VIII〞SUPPORTING STATE PREVENTION ACTIVITIES AND
RESPONSES TO MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS
Sec. 8001. Community mental health services block grant.
Sec. 8002. Substance abuse prevention and treatment block grant.
Sec. 8003. Additional provisions related to the block grants.
Sec. 8004. Study of distribution of funds under the substance abuse prevention and
treatment block grant and the community mental health services block
grant.
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TITLE IX〞PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE
USE DISORDER CARE
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
9001.
9002.
9003.
9004.
9005.
9006.
9007.
9008.
9009.
9010.
9011.
Sec.
Sec.
Sec.
Sec.
Sec.
Sec.
9012.
9013.
9014.
9015.
9016.
9017.
Subtitle A〞Helping Individuals and Families
Grants for treatment and recovery for homeless individuals.
Grants for jail diversion programs.
Promoting integration of primary and behavioral health care.
Projects for assistance in transition from homelessness.
National Suicide Prevention Lifeline Program.
Connecting individuals and families with care.
Strengthening community crisis response systems.
Garrett Lee Smith Memorial Act reauthorization.
Adult suicide prevention.
Mental health awareness training grants.
Sense of Congress on prioritizing American Indians and Alaska Native
youth within suicide prevention programs.
Evidence-based practices for older adults.
National violent death reporting system.
Assisted outpatient treatment.
Assertive community treatment grant program.
Sober truth on preventing underage drinking reauthorization.
Center and program repeals.
Subtitle B〞Strengthening the Health Care Workforce
Sec. 9021. Mental and behavioral health education and training grants.
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PUBLIC LAW 114每255〞DEC. 13, 2016
Sec.
Sec.
Sec.
Sec.
130 STAT. 1037
9022.
9023.
9024.
9025.
Strengthening the mental and substance use disorders workforce.
Clarification on current eligibility for loan repayment programs.
Minority fellowship program.
Liability protections for health professional volunteers at community
health centers.
Sec. 9026. Reports.
Subtitle C〞Mental Health on Campus Improvement
Sec. 9031. Mental health and substance use disorder services on campus.
Sec. 9032. Interagency Working Group on College Mental Health.
Sec. 9033. Improving mental health on college campuses.
TITLE X〞STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER
CARE FOR CHILDREN AND ADOLESCENTS
Sec. 10001. Programs for children with a serious emotional disturbance.
Sec. 10002. Increasing access to pediatric mental health care.
Sec. 10003. Substance use disorder treatment and early intervention services for
children and adolescents.
Sec. 10004. Children＊s recovery from trauma.
Sec. 10005. Screening and treatment for maternal depression.
Sec. 10006. Infant and early childhood mental health promotion, intervention, and
treatment.
TITLE XI〞COMPASSIONATE COMMUNICATION ON HIPAA
Sec. 11001. Sense of Congress.
Sec. 11002. Confidentiality of records.
Sec. 11003. Clarification on permitted uses and disclosures of protected health information.
Sec. 11004. Development and dissemination of model training programs.
TITLE XII〞MEDICAID MENTAL HEALTH COVERAGE
Sec. 12001. Rule of construction related to Medicaid coverage of mental health
services and primary care services furnished on the same day.
Sec. 12002. Study and report related to Medicaid managed care regulation.
Sec. 12003. Guidance on opportunities for innovation.
Sec. 12004. Study and report on Medicaid emergency psychiatric demonstration
project.
Sec. 12005. Providing EPSDT services to children in IMDs.
Sec. 12006. Electronic visit verification system required for personal care services
and home health care services under Medicaid.
TITLE XIII〞MENTAL HEALTH PARITY
Sec. 13001. Enhanced compliance with mental health and substance use disorder
coverage requirements.
Sec. 13002. Action plan for enhanced enforcement of mental health and substance
use disorder coverage.
Sec. 13003. Report on investigations regarding parity in mental health and substance use disorder benefits.
Sec. 13004. GAO study on parity in mental health and substance use disorder benefits.
Sec. 13005. Information and awareness on eating disorders.
Sec. 13006. Education and training on eating disorders.
Sec. 13007. Clarification of existing parity rules.
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TITLE XIV〞MENTAL HEALTH AND SAFE COMMUNITIES
Subtitle A〞Mental Health and Safe Communities
Sec. 14001. Law enforcement grants for crisis intervention teams, mental health
purposes.
Sec. 14002. Assisted outpatient treatment programs.
Sec. 14003. Federal drug and mental health courts.
Sec. 14004. Mental health in the judicial system.
Sec. 14005. Forensic assertive community treatment initiatives.
Sec. 14006. Assistance for individuals transitioning out of systems.
Sec. 14007. Co-occurring substance abuse and mental health challenges in drug
courts.
Sec. 14008. Mental health training for Federal uniformed services.
Sec. 14009. Advancing mental health as part of offender reentry.
Sec. 14010. School mental health crisis intervention teams.
Sec. 14011. Active-shooter training for law enforcement.
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