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HHS Guidance Submissions

On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 55235). The EO requires HHS to establish a single, searchable, indexed database that contains links to all of HHS's guidance documents currently in effect. Guidance documents come in a variety of formats, including interpretive memoranda, policy statements, manuals, bulletins, advisories, and more.

On December 3, 2020, HHS released a Final Rule governing the agency's release and maintenance of guidance documents. See Good Guidance Practices Final Rule. These regulations will help to ensure that the public receives appropriate notice of new guidance and that the Department's guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.

Additional HHS guidance is incorporated throughout the preambles to proposed and final rules. These preambles are available at Department of Health and Human Services Federal Register entries, then performing a keyword search.

As explained in the Good Guidance Practices Final Rule, guidance documents issued by the Food and Drug Administration (“FDA”) will be subject to the requirements of the Final Rule until the Secretary amends FDA’s existing good guidance practices regulation. FDA has obtained two exemptions from the Director of the Office of Management and Budget that exempt the following types of guidance documents from the requirement that they be posted to the guidance repository: (1) Product-Specific Guidances for Generic Drug Development, and (2) Mammography Quality Standards Act (MQSA) Policy Guidance Help System (PGHS). These exemptions will be incorporated into the FDA’s amendments to its good guidance practices regulation. In the meantime, copies of these guidance documents can be found here:

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.

Announcements

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Issue Date
Checklist for 1332 State Relief and Empowerment Waiver Applications Centers for Medicare & Medicaid Services (CMS) Final
Overview of Waiver Concept Templates and Papers Centers for Medicare & Medicaid Services (CMS) Final
Overview of 1332 State Relief and Empowerment Waivers Concepts Centers for Medicare & Medicaid Services (CMS) Final
Overview of 1332 Guidance for State Relief and Empowerment Waivers Centers for Medicare & Medicaid Services (CMS) Final
2018 Letter to States on 1332 Waiver Guidance Centers for Medicare & Medicaid Services (CMS) Final
2017 Letter to States on 1332 Waivers and Reinsurance Programs Centers for Medicare & Medicaid Services (CMS) Final
Data Brief on Section 1332 State-Based Reinsurance Programs Centers for Medicare & Medicaid Services (CMS) Final
Fact Sheet: Take Action Using Section 1332 Waivers - What States Need to Know Centers for Medicare & Medicaid Services (CMS) Final
Fact Sheet: Request for Information on 1332 Waivers Centers for Medicare & Medicaid Services (CMS) Final
Fact Sheet: 1332 State Relief and Empowerment Waiver Concepts Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 38765 documents.

Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

CMS

* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.