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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Draft OIG Compliance Program for Individual and Small Group Physician Practices  Office of Inspector General (OIG) Proposed
Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees  Office of Inspector General (OIG) Proposed
Office Based Opioid Use Disorder Treatment Billing  Centers for Medicare & Medicaid Services (CMS) Proposed
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommended Methods for Blood Grouping Reagents Evaluation: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2): Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).”   Food and Drug Administration (FDA) Proposed
Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards   Office of Inspector General (OIG) Proposed
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