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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Guidance Document Rescinded For Non-Compliance With Allina and the Administrative Procedure Act (Dec. 3, 2020)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 DateTaxes, Reconciling APTC, Failure to Reconcile, and Marketplace Exemptions
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/11/2024Coverage to Care
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/11/2024Making Care Primary (MCP) Model Implementation
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/5/2024Changes to The Electronic Correspondence Referral System (ECRS) Web Includes Updates to Submitting Duplicate and Overlapping Drug Records; Addition of Action Code (DR) to Investigate Deleted Drug Records and Updates to the Electronic Data Interchange (EDI
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/4/2024MM13577 - Ambulatory Surgical Center Payment Update – April 2024
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/4/2024MARx_Plan_Payment_Letter_APR_2024_508_G
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/29/2024CY 2025 Rate Announcement
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/1/2024Guiding an Improved Dementia Experience (GUIDE) Model Implementation
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/1/2024Taxes, Exemptions, Reconciling Advance Payments of the Premium Tax Credit, and Failure to File and Reconcile
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        4/4/2024Medicare Provider Reimbursement Manual Part 2, Provider Cost Reporting Forms and Instructions, Chapter 48, Form CMS-287-22
                                                                                                        Centers for Medicare & Medicaid Services (CMS)
                                                                                                        Final
                                                                                                        3/29/2024

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            4993This Guidance Portal contains 49930 documents.
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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