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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
Data Standards Catalog  Food and Drug Administration (FDA) Final
Rescission of Guidance on Health-Related Social Needs  Centers for Medicare & Medicaid Services (CMS) Final
Advisory Opinion 25-01 on Application of Dei Executive Orders to the Department's Legal Obligations to Indian Tribes and Their Citizens February 25, 2025  Office of the General Counsel (OGC) Final
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs  Food and Drug Administration (FDA) Final
Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Evaluation of Sex Differences in Clinical Investigations: Guidance for Industry  Food and Drug Administration (FDA) Final
Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology  Food and Drug Administration (FDA) Proposed
2025 Federal Poverty Level Standards  Centers for Medicare & Medicaid Services (CMS) Final
Healthy Adult Opportunity State Guidance  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 3359 documents.

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