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.
Search HHS Guidance Documents
Filter Guidance Documents by ...
| Title | OpDiv/StaffDiv | Guidance Status Sort descending | Issue Date |
|---|---|---|---|
| HPMS Memo: Updates on the new Medicare Part D Coverage Gap Discount Program Direct Payment Process | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Contract Negative Invoice Balance Report Confirmation Instructions | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Manufacturer Negative Confirmation Balance Report Instructions | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Manufacturer Payment Confirmation Procedures | Centers for Medicare & Medicaid Services (CMS) | Final | |
| HPMS MEMO: Updates to the Process for Resolving Coverage Gap Discount Program Negative Invoiced Amounts | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Manufacturer Edit Codes | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Sponsor Edit Codes.pdf | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Slides-December 2016 | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Slides-April 2016 | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Slides-November 2015 | Centers for Medicare & Medicaid Services (CMS) | Final |
Petition Submissions
To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov
CDC
CMS
* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.