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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
Deadlines for the Submission of Risk Adjustment Data for Risk Adjustment Data Validation Sampling G  Centers for Medicare & Medicaid Services (CMS) Final
Medicare Advantage Prescription Drug System June 2025 Payment INFORMATION G  Centers for Medicare & Medicaid Services (CMS) Final
cib06052025  Centers for Medicare & Medicaid Services (CMS) Final
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Replacing Color Additives in Approved or Marketed Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Updated 2025 SSI and Spousal Impoverishment Standards  Centers for Medicare & Medicaid Services (CMS) Final
Data Reporting Compliance for the Transformed-Medicaid Statistical Information System (T-MSIS)  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 4735 documents.