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the public to comment on significant guidance documents or request that they be created, reconsidered, modified or rescinded.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.
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