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Why do we have a Guidance Portal?

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.


HHS Good Guidance Rule

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 PageDISCLAIMER: 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

Guidance Document Rescinded For Non-Compliance With Allina and the Administrative Procedure Act (Dec. 3, 2020)
	OGC Advisory Opinion 20-05
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  Title
                                                            OpDiv/StaffDiv
                                                            Guidance Status
                                                            Issue DateSort descendingCompliance Policy Guide Sec. 390.100 Definition of “Commerce” -21 CFR 1000.3(d) 2
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalNew/Revised/Withdrawn Guidances 2014
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalRecommended Uniform Screening Panel
                                                                                                        Health Resources and Services Administration (HRSA)
                                                                                                        Final340B Program Updates
                                                                                                        Health Resources and Services Administration (HRSA)
                                                                                                        FinalCompliance Policy Guide Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        Final340B Drug Pricing Program Program Integrity
                                                                                                        Health Resources and Services Administration (HRSA)
                                                                                                        FinalCPG Sec. 420.500 Interference with Compendial Tests
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalCPG Sec. 160.800, Year 2000 (Y2K) Computer Compliance
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        Final340B Drug Pricing Program Annual Recertification
                                                                                                        Health Resources and Services Administration (HRSA)
                                                                                                        FinalDairy Products Sec. 527.300 Microbial Contaminants & Alkaline Phosphatase Activity
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        Final

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Petition Submissions

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

Petition Responses

CDC

Petition Response to RB with Exhibit A*CMS

Good Guidance Petition Response No. 21-01** This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties. Return to top



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