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 |
|---|---|---|---|
| PRO Collection Timeline & Submission Deadlines_v2.0_03.30.17_CJRConnect | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PRO Data Collection Patient Selection Flowchart | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PRO Postcard for Patients_Fillable_v1.0_08.09.16 | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PRO The Veterans RAND 12 (VR-12) Read Me_v1.0_06 15 16 | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Problem Solving Template Risk Stratification Affinity Group Session Three 05 30 18 | Centers for Medicare & Medicaid Services (CMS) | Final | |
| Provider and Technical Fact Sheet 04 01 18 | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PY5 CJR HARP Registration Instructions | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PY 5 CJR PRO Data Collection FAQs | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PY 5 CJR PRO Data Collection Overview | Centers for Medicare & Medicaid Services (CMS) | Final | |
| PY 5 CJR PRO Guidance for Managed File Transfer | Centers for Medicare & Medicaid Services (CMS) | Final |
Petition Submissions
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