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Regulations

Federal regulation is one of the basic tools government uses to carry out public policy. Agencies create regulations (also known as "rules") when Congress provides the authority to do so.

Public Participation in Rulemaking

The public plays an extremely important role in the rulemaking process by commenting on proposed rules. Your comments can help shape the decisions the Department makes. Learn more about regulations and how you can make your voice heard by reading the HHS Regulations Toolkit .

Find and comment on rules

HHS Regulations Infographic: 5 Things You Need to Know about HHS Regulations. What Is a Federal Regulation? After Congressional bills become laws, federal agencies are responsible for putting those laws into action through regulations (also known as "rules"). The public plays an extremely important role in the rulemaking process by commenting on proposed rules to help improve them. Why Should I Comment? We value your input. HHS must seek public review and comments before finalizing a regulation. This action is called a "Notice of Proposed Rulemaking" (NPRM).

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HHS Regulations

HHS Regulations by Operating Division

Administration for Children and Families (ACF)

Administration for Community Living (ACL)
Formerly the Administration on Aging, ACF's Administration on Developmental Disabilities, and the Office on Disability

Agency for Healthcare Research and Quality (AHRQ)

Centers for Disease Control and Prevention (CDC)

Centers for Medicare and Medicaid Services (CMS)

Food and Drug Administration (FDA)

Health Resources and Services Administration (HRSA)

Indian Health Service (IHS)

National Institutes of Health (NIH)

Substance Abuse Mental Health Services Administration (SAMHSA)

More on regulations

Learn about HHS’s efforts to review existing regulations and provide feedback.
View HHS Regulations under EO 12866 review at the Office of Management and Budget (OMB).
See all rules and notices at Regulations.gov.

Additional Laws & Regulations

Find laws and regulations on civil and privacy rights, food and drugs, medical and health care, Medicaid and Medicare, research, fraud prevention and detection, tribal matters, and HHS employment.

Civil and Privacy Rights

Understanding Civil Rights (Office for Civil Rights)
Nondiscrimination Laws, Regulations, and Standards (Office for Civil Rights)
How to File a Civil Rights Complaint (Office for Civil Rights)
Health Information Privacy - See the section on this topic
The Privacy Act (Freedom of Information/Privacy Acts Division, ASPA)

Food & Drugs

Laws Enforced by the FDA and Related Statutes (Food and Drug Administration)
Search CFR Title 21 - Food and Drugs: Parts 1 to 1499 (Food and Drug Administration)

Fraud Prevention & Detection

List of Excluded Individuals/Entities Search (Office of Inspector General)
Federal Register Notices (Office of Inspector General)
Regulatory Authorities (Office of Inspector General)
Report Fraud (Office of Inspector General)

Freedom of Information Act & Privacy Act

(FOIA) Freedom of Information Act (FOIA and Privacy Acts Division, ASPA)
Privacy Act (FOIA and Privacy Acts Division, ASPA)
System of Records Notices (SORN) (FOIA and Privacy Acts Division, ASPA)

Medical & Health Care

Legislation & Regulation (Centers for Disease Control and Prevention)
Select Agent Transfer Program: Regulation and Supporting Material (Centers for Disease Control and Prevention)

Medicare/Medicaid

CMS Regulations, Guidance & Legislation (i.e. Medicare, Medicaid, HIPAA) (Centers for Medicare & Medicaid Services)

Research

Human Research Protections – See the section on this topic
Laboratory Animals Welfare (National Institutes of Health)
Animal care and use in CDC laboratory research (Centers for Disease Control and Prevention)

Tribes

Regulations & Records Access (Indian Health Service)

HHS Acquisition Regulation

HHS Employment (No Fear Act)

Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002 (No FEAR Act) (Equal Employment & Opportunity Division)

Content created by Immediate Office of the Secretary
Content last reviewed on March 27, 2015

Top HHS Regulations

Affordable Care Act

The Department uses regulations and guidance to implement parts of the Affordable Care Act that deal with private and public health insurance.

Health Information Privacy (HIPAA)

HIPAA provides protections for personal health information and gives patients a variety of rights. Learn more about health information privacy.

Human Research Protections

If your institution is engaged in human subjects research (not otherwise exempt, and supported by HHS), your institution must have an Office for Human Research Protections-approved assurance of compliance with the HHS regulations for the protection of human subjects.

Health Information Technology

The Health Information Technology for Economic and Clinical Health (HITECH) Act provides HHS with the authority to write regulations and guidance to support development of a nationwide health information technology infrastructure.