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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
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)  Food and Drug Administration (FDA) Final
Guidance for Industry: Questions and Answers on FDA’s Fortification Policy  Food and Drug Administration (FDA) Final
Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act  Food and Drug Administration (FDA) Final
Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)  Food and Drug Administration (FDA) Final
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)  Food and Drug Administration (FDA) Final
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)  Food and Drug Administration (FDA) Final
Guidance for Industry: Questions and Answers Regarding the Final Rule on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House)  Food and Drug Administration (FDA) Final
Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation  Food and Drug Administration (FDA) Final
Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation  Food and Drug Administration (FDA) Final
Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme Preparations  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.