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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
Health Insurance Portability and Accountability Act (HIPAA) Electronic Data Interchange (EDI) Front End Updates for October 2026  Centers for Medicare & Medicaid Services (CMS) Final
Reporting Face-to-Face Encounter Conducted by a Hospice Physician or Hospice Nurse Practitioner for Recertification via Telecommunications Technology on Hospice Claims, effective January 1, 2027  Centers for Medicare & Medicaid Services (CMS) Final
ECRS Update for Prescription Drug Inquiries (PDIs) to Prevent the Creation of Records with Invalid or Missing Information and to Reduce the Number of Records with Invalid Insurer Names  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
Certain Postapproval Requirements and Resources for ANDAs  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3953 documents.