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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Considerations for Complying with 21 CFR 211.110  Food and Drug Administration (FDA) Proposed
CPG Sec. 665.100 Common or Usual Names for Animal Feed Ingredients (Withdrawn 1/6/2025)  Food and Drug Administration (FDA) Final
Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children  Food and Drug Administration (FDA) Final
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway  Food and Drug Administration (FDA) Proposed
Considerations for Including Tissue Biopsies in Clinical Trials  Food and Drug Administration (FDA) Proposed
CVM GFI #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease  Food and Drug Administration (FDA) Proposed
CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk Reviews  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods  Food and Drug Administration (FDA) Proposed
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