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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Medicare Advantage Prescription Drug System June 2025 Payment INFORMATION G  Centers for Medicare & Medicaid Services (CMS) Final
Deadlines for the Submission of Risk Adjustment Data for Risk Adjustment Data Validation Sampling G  Centers for Medicare & Medicaid Services (CMS) Final
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Replacing Color Additives in Approved or Marketed Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Updated 2025 SSI and Spousal Impoverishment Standards  Centers for Medicare & Medicaid Services (CMS) Final
Data Reporting Compliance for the Transformed-Medicaid Statistical Information System (T-MSIS)  Centers for Medicare & Medicaid Services (CMS) Final
Medicaid Program; Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole Proposed Rule  Centers for Medicare & Medicaid Services (CMS) Final
Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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