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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
How-To Guide: Change of Authorizing Official Principal Investigator, or Program Director  Administration for Children and Families (ACF) Final
How-to Guide: Carryover Request  Administration for Children and Families (ACF) Final
OCS Releases the LIHWAP Implementation and Impact Report, Part 1  Administration for Children and Families (ACF) Final
Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry  Food and Drug Administration (FDA) Final
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
2024 Federal Poverty Level Standards  Centers for Medicare & Medicaid Services (CMS) Final
Required Data Elements for Paternity Establishment Affidavits – Expires Jan. 31, 2027  Administration for Children and Families (ACF) Final
CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products  Food and Drug Administration (FDA) Proposed
Human Gene Therapy Products Incorporating Human Genome Editing: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.