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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
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Levels for Lead in Juice  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.