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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Guidance Document Rescinded For Non-Compliance With Allina and the Administrative Procedure Act (Dec. 3, 2020)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 descendingCPG Sec. 460.700 Controlled Release Dosage Form Drugs - Rate of Release of Active Ingredients
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        Final590.600 WigsCompliance Policy Guide 7128.05
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalChapter 4 - Human Drugs
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalCompliance Policy Guide Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalGuía para la Industria:  Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata.
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalCPG Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalChapter 48 7348.809A Radioactive Drug Research Committee
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalGuía para la Industria:  Formas de dosificación oral de liberación prolongada: elaboración, evaluación y aplicación de correlaciones in vitro/in vivo
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalFormas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo.
                                                                                                        Food and Drug Administration (FDA)
                                                                                                        FinalCPG Sec. 390.100 Definition of "Commerce" - 21 CFR 1000.3(d)
                                                                                                        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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