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HHS Guidance Submissions

On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 55235). The EO requires HHS to establish a single, searchable, indexed database that contains links to all of HHS's guidance documents currently in effect. Guidance documents come in a variety of formats, including interpretive memoranda, policy statements, manuals, bulletins, advisories, and more.

On August 20, 2020, HHS published a Notice of Proposed Rulemaking that proposes to issue regulations governing the agency's release and maintenance of guidance documents. See 85 FR 51396. These regulations should, if finalized, 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 has issued a Request for Information soliciting comments relating to the Department's current compliance with Executive Order 13891, and in particular, seeks specific feedback about potential opportunities to improve and ensure the Department's compliance with, and best practices relating to, the legal obligations governing the appropriate issuance of guidance. Comments are due on October 12, 2020 and should be submitted electronically to GuidanceRFI@hhs.gov.

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.

HHS Guidance

Title Subtitle OpDiv/StaffDiv Guidance Status Issue Date
Advisory Opinion 20-04 on the Public Readiness and Emergency Preparedness Act and the Secretary's Declaration under the Act October 22, 2020, as Modified on October 23, 2020 This Advisory Opinion re-emphasizes the breadth of PREP Act immunity. It covers a broad range of entities when such entities take reasonable steps to follow public-health guidelines and directives in using covered medical products. Office of the General Counsel (OGC) Final
Advisory Opinion 20-03 on the Public Readiness and Emergency Preparedness Act and the Secretary's Declaration under the Act October 22, 2020, as Modified on October 23, 2020 This Advisory Opinion addresses three vaccination-related issues that have arisen under the Public Readiness and Emergency Preparedness (PREP) Act, 42 U.S.C. § 247d-6d. Office of the General Counsel (OGC) Final
Resources to TAGGS TAGGS Administration for Children and Families (ACF) Final
IM ACF COVID-19 IM-ACF-OA-2020-01 Administration for Children and Families (ACF) Final
Guidance & IM Guidance, updates, and IM Administration for Children and Families (ACF) Final
ACF Grant Recipient COVID-19 Guidance COVID-19 Guidance landing page. Administration for Children and Families (ACF) Final
Grant Management Contacts Guidance on who to contact Administration for Children and Families (ACF) Final
Single Audit Requirements Guidance on Single Audit Requirments Administration for Children and Families (ACF) Final
Requesting Payment of Federal Awards Guidance on Award Payments Administration for Children and Families (ACF) Final
Internal Controls Guidance regarding Internal Controls Administration for Children and Families (ACF) Final
This Guidance Portal contains 29551 documents.