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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort descending
Guidance to tribes on actions required to complete and submit the (1) Final Report for FYs 2020-2024; (2) the new CFSP for FYs 2025- 2029; and (3) the CFS-101, Parts I, II, and III  Administration for Children and Families (ACF) Final
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry  Food and Drug Administration (FDA) Final
OTIP Award Program Glossary  Administration for Children and Families (ACF) Final
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
Administrative Claiming for Nurse Advice Lines and for Skilled Professional Medical Personnel for Certain Behavioral Health Professionals (SMD 24-001)  Centers for Medicare & Medicaid Services (CMS) Final
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
PI-24-04 - Instructions for State Courts on Applying for State Court Improvement Program (CIP) Funds for Fiscal Year (FY) 2025  Administration for Children and Families (ACF) Final
Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements  Food and Drug Administration (FDA) Final
Q2(R2) Validation of Analytical Procedures  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3999 documents.