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 Sort descending||Guidance Status||Issue Date|
|QCA RA-CAP||Office for Civil Rights (OCR)||Final|
|Sample NPP Layered Format for HC Providers||Office for Civil Rights (OCR)||Final|
|Sentara RA-CAP||Office for Civil Rights (OCR)||Final|
|Transmittal Letters for Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012||Office for Civil Rights (OCR)||Final|
|$2.5 million settlement shows that not understanding HIPAA requirements creates risk||Office for Civil Rights (OCR)||Final|
|Affinity RA CAP||Office for Civil Rights (OCR)||Final|
|Archives - Chronology of Past HHS Actions on the Olmstead decision||Office for Civil Rights (OCR)||Final|
|Breach Notification Rule||Office for Civil Rights (OCR)||Final|
|Case Example Cornell, Index||Office for Civil Rights (OCR)||Final|
|Case Examples Organized by Covered Entity||Office for Civil Rights (OCR)||Final|
To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov
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