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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
Spousal Support Only Cases  Administration for Children and Families (ACF) Final
Clinical Considerations for Therapeutic Cancer Vaccines: Guidance for Industry  Food and Drug Administration (FDA) Final
CVM GFI #215 Target Animal Safety & Effectiveness Protocol Development & Submission  Food and Drug Administration (FDA) Final
Time and Extent Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Final
Applications for Premarket Review of New Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
User Fee Waivers, Reductions, and Refunds for Drug and Biological Products  Food and Drug Administration (FDA) Final
Reproductive and Developmental Toxicities -- Integrating Study Results to Assess Concerns  Food and Drug Administration (FDA) Final
Balancing Incentive Program/Basic Health Program RFI/Access to Lab Test Results Proposed Rules  Centers for Medicare & Medicaid Services (CMS) Final
CVM GFI #205 (VICH GL46) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK)  Food and Drug Administration (FDA) Final
CVM GFI #206 (VICH GL47) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.