CSMS# 17-000780 - FDA Programming Reminder for PG24
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12/15/2017 04:09 PM EST
Partner Government Agencies
As per FDA’s Supplemental Guide, https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16, only one PG24 Remarks record is allowed per PG02; IE only one PG24 is allowed per FDA line and remarks type must be “GEN”. FDA has received many entries with multiple PG24 records. When multiple PG24 Remarks records are received, FDA is only able to process one record. Failure to follow Supplemental Guide instructions will prevent FDA field staff from receiving remarks entered by the filer and could cause delays in review or prevent processing.
For ACE inquiries, contact FDA ACE Support at ACE_Support@fda.hhs.gov or 877-345-1101, from 6:00 AM -10:00 PM Eastern, 7 days a week.
The above message content is also attached so that the trade community will have a version with active hyperlinks.
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Please follow the link in this email message to the CSMS web site to access this information.
As per FDA’s Supplemental Guide, https://www.cbp.gov/document/guidance/fda-supplemental-guide-release-16, only one PG24 Remarks record is allowed per PG02; IE only one PG24 is allowed per FDA line and remarks type must be “GEN”. FDA has received many entries with multiple PG24 records. When multiple PG24 Remarks records are received, FDA is only able to process one record. Failure to follow Supplemental Guide instructions will prevent FDA field staff from receiving remarks entered by the filer and could cause delays in review or prevent processing.
For ACE inquiries, contact FDA ACE Support at ACE_Support@fda.hhs.gov or 877-345-1101, from 6:00 AM -10:00 PM Eastern, 7 days a week.
The above message content is also attached so that the trade community will have a version with active hyperlinks.
Note that supplemental information to this message is available in the form of one or more file downloads.
Please follow the link in this email message to the CSMS web site to access this information.
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