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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry  Food and Drug Administration (FDA) Final
Pub 100-17 Medicare Business Partners Systems Security Manual Update  Centers for Medicare & Medicaid Services (CMS) Final
Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Update of a National Uniform Billing Committee (NUBC) Condition Code “63”, “Incarcerated Beneficiaries  Centers for Medicare & Medicaid Services (CMS) Final
Technical Revisions Only to the Claims Processing Manual (CPM), Publication (Pub) 100-04, Chapter 18 and Chapter 32  Centers for Medicare & Medicaid Services (CMS) Final
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Federal Fiscal Year 2026 Updates to the Health Home Core Quality Measure Sets  Centers for Medicare & Medicaid Services (CMS) Final
Revisions to State Operations Manual (SOM) Chapter 6 - Special Procedures for Laboratories  Centers for Medicare & Medicaid Services (CMS) Final
Notice of New Interest Rate for Medicare Overpayments and Underpayments - 4th Quarter Notification for FY 2025  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 3359 documents.

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