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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Amendments to OIG Exclusion and CMP Authorities Resulting From Public Law 100-93  Office of Inspector General (OIG) Proposed
Applications Covered by Section 505(b)(2)  Food and Drug Administration (FDA) Proposed
Proposed Rule: Safe Harbor for Federally Qualified Health Centers Under the Anti-Kickback Statute  Office of Inspector General (OIG) Proposed
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs  Food and Drug Administration (FDA) Proposed
Revisions to State Medicaid Fraud Control Units Rules - Proposed   Office of Inspector General (OIG) Proposed
Community-Acquired Bacterial Pneumonia — Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
CVM GFI #197 Documenting Electronic Data Files and Statistical Analysis Programs  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods for Voluntary Sodium Reduction Goals  Food and Drug Administration (FDA) Proposed
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