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On October 9, 2019, the President issued Executive Order (EO) 13891 entitled Promoting the Rule of Law through Improved Agency Guidance Documents (84 FR 552350). 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. Please note, the contents of this database do not have the force and effect of law and are not meant to bind the public in any way. These documents are intended only to provide clarity to the public regarding existing requirements under the law or HHS policies.

HHS Guidance Submissions

Title Sort descending Subtitle OpDiv/StaffDiv Guidance Status
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