3rd PARTY DISCLOSURE: Sterility Test Failure Notices

Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs

OMB: 0910-0667

IC ID: 207965

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3rd PARTY DISCLOSURE: Sterility Test Failure Notices
No Modified
21 CFR 211 21 CFR 210 21 CFR 212

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety


7 0
Private Sector Businesses or other for-profits
   100 %

  Requested Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 21 0 0 -15 0 36
Annual IC Time Burden (Hours) 53 0 0 -37 0 90
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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