HHS Guidance Submissions
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:
- Product-Specific Guidances for Generic Drug Development .
- Mammography Quality Standards Act Policy Guidance Help System
- FDA Guidance Documents Search Page
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.
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| Title | OpDiv/StaffDiv | Guidance Status | Issue Date |
|---|---|---|---|
| Q&A Addressing Drug Costs Reported on PDEs | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Updated Instructions: Requirements for Submitting | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Provider Promotional Activity for SNP | Centers for Medicare & Medicaid Services (CMS) | Final | |
| 2007 Model Evidence of Coverage Draft Issuance | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PDP Sponsor Part D Audit Guide | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Monthly Auto Assignment File Notice | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Helping Providers Understand PFFS | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Assisting Pharmacists in Completing Pharmacy Transactions | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Prescription Drug Benefit Manual: Chapter 9, Revision 1 | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Enhancements to the MA, MA-PD, and PDP Marketing Modules | Centers for Medicare & Medicaid Services (CMS) | Final |
Petition Submissions
To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov
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