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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
Announcement of the MARx Software Release 20260710 INFORMATION G.pdf  Centers for Medicare & Medicaid Services (CMS) Final
Calendar Year 2027 Risk Adjustment Implementation Information G.pdf  Centers for Medicare & Medicaid Services (CMS) Final
Notice of New Interest Rate for Medicare Overpayments and Underpayments -4th Quarter Notification for FY 2026  Centers for Medicare & Medicaid Services (CMS) Final
DHS Terminations of Parole Programs for Cubans, Haitians, Nicaraguans, and Venezuelans: Implications for Medicaid and CHIP Eligibility and Verification Process  Centers for Medicare & Medicaid Services (CMS) Final
Rescission of Guidance on “Fast Track” Federal Review Process for Section 1115 Demonstration Extensions  Centers for Medicare & Medicaid Services (CMS) Final
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products  Food and Drug Administration (FDA) Final
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials  Food and Drug Administration (FDA) Proposed
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug  Food and Drug Administration (FDA) Final
Forms FDA 3542a and FDA 3542: Questions and Answers  Food and Drug Administration (FDA) Proposed
Budget Neutrality and Certification by the Chief Actuary of CMS for Section 1115 Medicaid Demonstration Projects (SMD 26-003)  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 3979 documents.