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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
Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products: Guidance for Industry Food and Drug Administration (FDA) Final
A Caseworker's Guide to Processing Cases with Poland IM-07-02 Administration for Children and Families (ACF) Final
Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes: Guidance for Industry Food and Drug Administration (FDA) Final
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry Food and Drug Administration (FDA) Proposed
Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for Industry Food and Drug Administration (FDA) Final
Cellular Therapy for Cardiac Disease: Guidance for Industry Food and Drug Administration (FDA) Final
Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff Food and Drug Administration (FDA) Final
Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications: Guidance for Industry Food and Drug Administration (FDA) Final
Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors Food and Drug Administration (FDA) Final
Cost Benefit Analysis Illustrated Companion Guide Administration for Children and Families (ACF) Final
This Guidance Portal contains 29551 documents.