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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
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
Clarifying Duplication in Modular Modernization, Replacement, and Data Readiness Efforts for Comprehensive Child Welfare Information Systems (CCWIS)  Administration for Children and Families (ACF) Final
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for Industry  Food and Drug Administration (FDA) Final
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products  Food and Drug Administration (FDA) Final
Rescission of Guidance on “Fast Track” Federal Review Process for Section 1115 Demonstration Extensions  Centers for Medicare & Medicaid Services (CMS) Final
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
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
Notice of New Interest Rate for Medicare Overpayments and Underpayments -4th Quarter Notification for FY 2026  Centers for Medicare & Medicaid Services (CMS) Final
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4128 documents.