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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 Sort descending Issue Date
How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD: Draft Guidance for Industry Food and Drug Administration (FDA) Proposed
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry Food and Drug Administration (FDA) Proposed
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Draft Guidance for Industry Food and Drug Administration (FDA) Proposed
Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff Food and Drug Administration (FDA) Proposed
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Draft Guidance for Industry and Food and Drug Administration Staff Food and Drug Administration (FDA) Proposed
Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff Food and Drug Administration (FDA) Proposed
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff Food and Drug Administration (FDA) Proposed
Solicitation of Comments on the OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute Solicitation of comments on a Special Advisory Bulletin being developed to address requirements of the patient anti-dumping statute and the obligations of hospitals to screen all patients seeking emergency services and provide stabilizing medical treatment to enrollees of managed care plans if their condition warrants it. Office of Inspector General (OIG) Proposed
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (French Translation) Food and Drug Administration (FDA) Proposed
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 29551 documents.