U.S. flag

An official website of the United States government

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 Subtitle OpDiv/StaffDiv Guidance Status Sort descending
Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Quick Links Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies Food and Drug Administration (FDA) Proposed
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications Food and Drug Administration (FDA) Proposed
CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Level for Arsenic in Apple Juice Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration Food and Drug Administration (FDA) Proposed
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry Food and Drug Administration (FDA) Proposed
Exculpatory Language in Informed Consent Food and Drug Administration (FDA) Proposed