Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock (LockA locked padlock) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

  • About HHS
  • Programs & Services
  • Grants & Contracts
  • Laws & Regulations
  • Radical Transparency
  • Big Wins
Breadcrumb
  1. Home
  2. Laws & Regulations
  3. Find Rules by Operating Division
  4. HHS Significant Guidance Documents
  • Affordable Care Act
  • HIPAA Privacy Rule
  • Human Subjects Research Protections
  • HITECH Act
  • Comment on Open Rules
  • Find Rules by Operating Division
  • Additional HHS Laws & Regulations

Significant Guidance Documents Subject To EO 12866 and OMB's Bulletin For Agency Good Guidance Practices

In accordance with Executive Order (EO) 12866 on Regulatory Planning and Review, as amended by Executive Order 13422 (January 18, 2007), and the Bulletin for Agency Good Guidance Practices, adopted by the Office of Management and Budget (OMB), HHS is maintaining this Web page to provide the public with links to any documents that are determined to be "significant guidance documents" subject to the EO and Bulletin.

The OMB Bulletin for Agency Good Guidance Practices establishes policies and procedures for the development, issuance, and use of significant guidance documents by Executive Branch departments. Specifically, the Bulletin defines "significant guidance document;" establishes standard elements for significant guidance documents; describes practices for developing and using significant guidance documents by agencies; as well as requirements for agencies to enable the public to comment on significant guidance documents or request that they be created, reconsidered, modified or rescinded.

If you have comments on significant guidance documents or would like to request that a division issue, reconsider, modify, or rescind significant guidance documents, please e-mail the comment/request to HHSExecSec@hhs.gov.  You may use the same e-mail address to file complaints that a division has not followed the Bulletin’s procedures in developing its guidance documents or is treating guidance as a binding requirement. When submitting a comment or complaint, please identify the particular division and guidance document you are addressing.

Significant Guidance

Food and Drug Administration - https://www.fda.gov/RegulatoryInformation/Guidances/

Centers for Medicare & Medicaid Services - https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance.html

Additional Information

  • Executive Order 12866
  • Executive Order 13422
  • Bulletin for Agency Good Guidance Practices
  • HHSExecSec@hhs.gov
Content created by Immediate Office of the Secretary (IOS)
Content last reviewed July 20, 2017
Back to top

Subscribe to Email Updates

Receive the latest updates from the Secretary and Press Releases.

Subscribe
  • Contact HHS
  • Careers
  • HHS FAQs
  • Nondiscrimination Notice
  • Press Room
  • HHS Archive
  • Accessibility Statement
  • Privacy Policy
  • Budget/Performance
  • Inspector General
  • Web Site Disclaimers
  • EEO/No Fear Act
  • FOIA
  • The White House
  • USA.gov
  • Vulnerability Disclosure Policy
HHS Logo

HHS Headquarters

200 Independence Avenue, S.W.
Washington, D.C. 20201
Toll Free Call Center: 1-877-696-6775​

Follow HHS

Follow Secretary Kennedy