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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
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
Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products  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
Coverage of Services and Supports to Address Health-Related Social Needs in Medicaid and CHIP  Centers for Medicare & Medicaid Services (CMS) Final
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry  Food and Drug Administration (FDA) Final
Accelerated Approval – Expedited Program for Serious Conditions  Food and Drug Administration (FDA) Proposed
Protecting Medicaid Beneficiaries Against Impermissible Fraud and Abuse Sanctions (SMD 24-005) [RESCINDED ON MAY 1, 2025]  Centers for Medicare & Medicaid Services (CMS) Final
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