ORIGINATOR: complete section 1 REVIEWER: complete section 2 ICR- __ __ -__ __ __
1. Date: 2. Title: ICR (Chapter/subchapter/Section/subsection/Item/subitem number) Year (YYYY) Title (or short description) e.g. ICR 5.3.4.1Y2006 EVIDENCE DEVELOPMENT – IN PLANT PHOTOGRAPHS 3. Name: 4. Organization: 5. Phone: 6. E-mail address: 7. Reason for Change Request (Define in Detail): 8. Recommended Solution1: Priority: Urgent __ High __ Routine __ 9. Attachments: Yes __ or No __ (electronic attachments only) 1If the change affects organizations outside originator’s, additional review and concurrence is required by the Organization(s)
1. Date: 2. Reviewing Official Name(s): 3. Organization: 4. Concur __ Forward ICR to other Reviewing Organizations (if applicable) and IOM@fda.hhs.gov 2. carbon copy (cc) Originator 5. Do Not Concur __ Give reason for nonconcurrence: 6. Suggest a corrective action (describe in detail): Forward electronically to Originator and cc: IOM@fda.hhs.gov and other Reviewing Organizations (Reserved for HQ use only) Concurred Yes __ No __ Signature _______________________________________Date ___/___/___ Comment: Assigned To:________________________________________ Priority - Urgent __ High __ Routine __
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