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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 30, 2020 and should be submitted electronically to GuidanceRFI@hhs.gov.

HHS Extension Request for EO 13891

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 OpDiv/StaffDiv Guidance Status Issue Date Sort descending
Apply For A Grant Health Resources and Services Administration (HRSA) Final
Chapter 1 - General Food and Drug Administration (FDA) Final
CHAPTER 48 - 7348.809 Bioresearch Monitoring Food and Drug Administration (FDA) Final
Standard Respirator Testing Procedures Centers for Disease Control and Prevention (CDC) Final
340B Drug Pricing Program Duplicate Discount Prohibition Health Resources and Services Administration (HRSA) Final
CPG Sec. 335.300 Hypnotherapy Devices - Self Hypnotic Tape Recordings Food and Drug Administration (FDA) Final
NEPA_Final_Guidance Food and Drug Administration (FDA) Final
2018 Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Annual Report Health Resources and Services Administration (HRSA) Final
Formas 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) Final
SSBG IM 04-2001 Reporting of Funds Transferred from TANF to SSBG Administration for Children and Families (ACF) Final
This Guidance Portal contains 30362 documents.