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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
CMS Limited Data Sets: Health Outcomes Survey (HOS)  Centers for Medicare & Medicaid Services (CMS) Final
Systems of Records Notices (SORNs)  Centers for Medicare & Medicaid Services (CMS) Final
Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)  Food and Drug Administration (FDA) Final
American Indians/Alaska Natives  Centers for Medicare & Medicaid Services (CMS) Final
Hospital Quality Initiative - Measure Methodology  Centers for Medicare & Medicaid Services (CMS) Final
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Final
Migraine: Developing Drugs for Acute Treatment  Food and Drug Administration (FDA) Final
Regulatory Classification of Pharmaceutical Co-Crystals  Food and Drug Administration (FDA) Final
Use of IV-D Incentive Funds for NCP Work Activities  Administration for Children and Families (ACF) Final
This Guidance Portal contains 5570 documents.