FDA Announced that OMB Has Approved the Following Collections
- General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
- Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
- Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
FDA Announced the Following Collections Have Been Submitted to OMB for Approval
- Medical Device Tracking
- Animal Drug User Fee Cover Sheet
- Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation
FDA Announced the Following Proposed Information Collections
- Labeling of Natural Rubber Latex Condoms
- CGMP for Blood and Blood Components: Donor Testing and Notification
- Survey of Pharmacists and Patients: Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions
- Exports: Notification and Recordkeeping Requirements
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