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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
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs  Food and Drug Administration (FDA) Final
Psychedelic Drugs: Considerations for Clinical Investigations  Food and Drug Administration (FDA) Final
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence  Food and Drug Administration (FDA) Final
Influenza Vaccine Payment Allowances - Annual Update for 2026-2027 Season  Centers for Medicare & Medicaid Services (CMS) Final
Implementation of VMS Application Programming Interfaces (APIs) to Support the Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) Migration to the Centers for Medicare & Medicaid Services (CMS) Amazon Web Services (AWS) Contact Cente  Centers for Medicare & Medicaid Services (CMS) Final
Expansion of the Supplemental Security Income (SSI) Ratio on the Inpatient Provider Specific File (PSF)  Centers for Medicare & Medicaid Services (CMS) Final
Modify the Application Logic to Conditionally Retain the Medicare Carrier System (MCS) Medicare Secondary Payer (MSP) Claim Trailer Based on Specific Common Working File (CWF) Error Codes, Dispositions, and Override Values  Centers for Medicare & Medicaid Services (CMS) Final
Updates to Chapters 4 and Exhibit 16 in Publication (Pub.) 100-08, Including Updates to the Provider Identity Theft Investigations, and Victimized Provider Waiver of Liability Process  Centers for Medicare & Medicaid Services (CMS) Final
Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4017 documents.