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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Considerations for Complying with 21 CFR 211.110  Food and Drug Administration (FDA) Proposed
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document  Food and Drug Administration (FDA) Proposed
E6(R3) Good Clinical Practice: Annex 2  Food and Drug Administration (FDA) Proposed
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices  Food and Drug Administration (FDA) Proposed
M15 General Principles for Model-Informed Drug Development  Food and Drug Administration (FDA) Proposed
Medicaid Continuous Enrollment Condition Changes, Conditions for Receiving the FFCRA Temporary FMAP Increase, Reporting Requirements, and Enforcement Provisions in the Consolidated Appropriations Act, 2023  Centers for Medicare & Medicaid Services (CMS) Final
Ending Coverage in the Optional COVID-19 Group: Preparing States for the End of the Public Health Emergency  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
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