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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
E11A Pediatric Extrapolation  Food and Drug Administration (FDA) Final
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document  Food and Drug Administration (FDA) Proposed
Medicaid and Children’s Health Insurance Program Requirements for Providing, Prepopulating and Accepting Eligibility Renewal Forms  Centers for Medicare & Medicaid Services (CMS) Final
2026 Updates to the Child and Adult Core Health Care Quality Measurement Sets and Mandatory Reporting Guidance  Centers for Medicare & Medicaid Services (CMS) Final
Ensuring Seamless Coverage Transitions between Medicaid, Separate CHIP, and Other Insurance Affordability Programs and Exercise of Enforcement Discretion to Delay Implementation of Certain Coverage Transition Requirements  Centers for Medicare & Medicaid Services (CMS) Final
Provision of Medicaid and CHIP Services to Incarcerated Youth - FAQs  Centers for Medicare & Medicaid Services (CMS) Final
Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH): Guidance for Industry Technical Specifications Document  Food and Drug Administration (FDA) Final
Advisory Opinion 24-01 on Medicaid Section 1115 Demonstrations Imposing Work Requirements December 11, 2024  Office of the General Counsel (OGC) Final
Advisory Opinion 24-02 on the Scope of States’ Authority to Exclude Providers from Participation under a Medicaid State Plan December 11, 2024  Office of the General Counsel (OGC) Final
This Guidance Portal contains 3320 documents.

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