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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Reminder PY 2023 Deadline for the Submission of Risk Adjustment Data for Risk Adjustment Data Validation Sampling G  Centers for Medicare & Medicaid Services (CMS) Final
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations  Food and Drug Administration (FDA) Proposed
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
October 2025 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files  Centers for Medicare & Medicaid Services (CMS) Final
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medicare Advantage Prescription Drug System July 2025 Payment INFORMATION G  Centers for Medicare & Medicaid Services (CMS) Final
Reminder PY 2021 Deadline for the Submission of Risk Adjustment Data for Risk Adjustment Data Validation Sampling G  Centers for Medicare & Medicaid Services (CMS) Final
Reminder PY 2022 Deadline for the Submission of Risk Adjustment Data for Risk Adjustment Data Validation Sampling G  Centers for Medicare & Medicaid Services (CMS) Final
NY CY 2026 AIP D SNP HPMS revised release memo G  Centers for Medicare & Medicaid Services (CMS) Final
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3318 documents.

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