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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
MLN Product (Revised) DMEPOS Competitive Bidding Program: Traveling Patients (MLN904484)  Centers for Medicare & Medicaid Services (CMS) Final
"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); : Guidance for Industry  Food and Drug Administration (FDA) Final
"Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications"  Food and Drug Administration (FDA) Final
(Potassium Iodide) KI in Radiation Emergencies-Questions and Answers  Food and Drug Administration (FDA) Final
06.20.2025 PREP Noncompliance Letter to California  Administration for Children and Families (ACF) Final
1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers  Food and Drug Administration (FDA) Final
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day  Food and Drug Administration (FDA) Final
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
1915(i) State Plan HCBS, 5-Year Period for Waivers, Provider Payment Reassignment, Setting Requirements for Community First Choice, and 1915(c) HCBS Waivers - CMS-2249-F/CMS-2296-F  Centers for Medicare & Medicaid Services (CMS) Final
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.