IOM CHANGE REQUEST/Notice (ICR/N) (PDF , 28kb)
Send to IOM@FDA.HHS.GOV

         Directions                                                                ICR Number

ORIGINATOR: complete section 1    REVIEWER: complete section 2                   ICR- __ __ -__ __ __

SECTION 1

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)

SECTION 2

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 __