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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Guidance Document Rescinded For Non-Compliance With Allina and the Administrative Procedure Act (Dec. 3, 2020)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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  Administration for Children and Families (ACF)Administration for Community Living (ACL)Administration for Strategic Preparedness and Response (ASPR)Agency for Healthcare Research and Quality (AHRQ)Agency for Toxic Substances and Disease Registry (ATSDR)Assistant Secretary for Administration (ASA)Assistant Secretary for Financial Resources (ASFR)Assistant Secretary for Health (ASH)Assistant Secretary for Legislation (ASL)Assistant Secretary for Planning and Evaluation (ASPE)Assistant Secretary for Public Affairs (ASPA)Center for Faith-Based and Neighborhood Partnerships (CFBNP)Centers for Disease Control and Prevention (CDC)Centers for Medicare & Medicaid Services (CMS)Departmental Appeals Board (DAB)Food and Drug Administration (FDA)Health Resources and Services Administration (HRSA)Immediate Office of the Secretary (IOS)Indian Health Service (IHS)National Institutes of Health (NIH)Office for Civil Rights (OCR)Office of Global Affairs (OGA)Office of Inspector General (OIG)Office of Intergovernmental and External Affairs (IEA)Office of Medicare Hearings and Appeals (OMHA)Office of National Security (ONS)Office of the Chief Technology Officer (CTO)Office of the General Counsel (OGC)Office of the National Coordinator (ONC) of Health Information TechnologyOffice of the Secretary (OS)Public Health Service (PHS)Substance Abuse and Mental Health Services (SAMHSA)The Center for Faith and Opportunity Initiatives (the Partnership Center)
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  Title
                                                            OpDiv/StaffDiv
                                                            Guidance Status
                                                            Issue DateCustodial Parents Living in Poverty
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        1/31/2014Major Change in Who is Owed Child Support Arrears
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        3/31/2014Effect of Male Employment on Child Support Collections
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        4/22/2014Why Don't More Poor Custodial Parents Have a Child Support Order?
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        6/28/2016Report on Child Access and Visitation Programs: Participant Outcomes
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        5/24/2007A Caseworker's Guide for Cases with Foreign Reciprocating Countries
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        12/23/2003Documents for Cases with Reciprocating Canadian Jurisdictions
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        7/21/2005A Caseworker's Guide to Processing Cases with Poland
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        2/13/2007A Caseworker's Guide to Processing Cases with Switzerland
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        1/13/2009A Caseworker's Guide to Processing Cases with El Salvador
                                                                                                        Administration for Children and Families (ACF)
                                                                                                        Final
                                                                                                        2/17/2009

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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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