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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Proposed Rule: Safe Harbor Anti-Kickback Provisions  Office of Inspector General (OIG) Proposed
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Attachement - Qualification Process for Drug Development Tools: Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive…  Food and Drug Administration (FDA) Proposed
CGO Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli  Food and Drug Administration (FDA) Proposed
CPG Sec 527.300 (Draft) Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity  Food and Drug Administration (FDA) Proposed
CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Best Practices for Convening a GRAS Panel  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)  Food and Drug Administration (FDA) Proposed
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers  Food and Drug Administration (FDA) Proposed
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act)  Food and Drug Administration (FDA) Proposed
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