Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Regulatory Considerations for Microneedling Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Manufacturers, Retailers, Importers and FDA Staff  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for Individual Physicians and Small Group Practices  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft OIG Compliance Program Guidance for Certain Medicare+Choice Organizations  Office of Inspector General (OIG) Proposed
Proposed Rule: Additional Safe Harbor Provisions Under the Anti-Kickback Statute  Office of Inspector General (OIG) Proposed
2021 Rate Review Timeline Bulletin  Centers for Medicare & Medicaid Services (CMS) Proposed
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry  Food and Drug Administration (FDA) Proposed
Proposed Rule: OIG Anti-Kickback Provisions  Office of Inspector General (OIG) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VII Biotechnology Final Consultations  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 46923 documents.

Petition Submissions

To submit a petition to HHS, please send your petition to Good.Guidance@hhs.gov

CMS

* This PDF is not Section 508 compliant. Assistive Technology users should contact good.guidance@hhs.gov if they experience any difficulties.