Transmitting Electronic ISCRs and ICSR Attachments on Physical Media
This document provides specifications for transmitting electronic ICSRs and ICSR attachments on physical media.
- ADDRESS FOR ELECTRONIC ICSRs AND ICSR ATTACHMENTS ON PHYSICAL MEDIA
- TYPE OF MEDIA
- Veritas backup exec,
- Win2000 native backup.
- Veritas backup exec
- Win2000 native backup
- MEDIA PREPARATION
Send Physical Media for CDER and CBER to:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266
Attn: (Use one of the attention lines from below)
Attn: AERS ICSR Reports Test
Attn: AERS ICSR Reports Production
Attn: AERS ICSR Reports Attachment Test
Attn: AERS ICSR Reports Attachment Production
Note that the attention line is extremely important because each type of package will be given a different priority for internal delivery depending on the type of report.
See the following table:
Type of media
|
Format |
Size |
---|---|---|
Floppy Disk |
3.5 inch 1.44 MB |
Up to 14.4 MB (10 disks) |
CD ROM |
CD-R Joliet Specification |
Up to 3 GB (1- 5 CDs) |
DVD |
DVD-RAM, DVD-Dual Disk |
Up to 45 GB (1 to 6 DVDs) |
Digital Linear Tape |
35/70 or 40/80 DLT tapes using Do not use compression. |
No limit |
Linear Tape Open |
LTO 2 (200/400 GB) tapes using Uncompressed. |
No limit |
Send all electronic media adequately secured in a standard binder marked clearly on the outside using one of the headings from below:
ELECTRONIC REGULATORY SUBMISSION FOR ARCHIVE - ICSRs
ELECTRONIC REGULATORY SUBMISSION FOR ARCHIVE - ICSR ATTACHMENTS
ELECTRONIC REGULATORY SUBMISSION FOR ARCHIVE - ICSRs AND ICSR ATTACHMENTS
Additionally, indicate whether the submission contains 15-day Alert reports or 15-day Alert report-followups.1 The following information should be included on the media labels:
Sponsor, applicant or company name
Name of the product, chemical or ingredient
Appropriate regulatory ID number (e.g., NDA number)
Submission date (dd-mmm-yyyy)
Media series (e.g., "1 of 1", "1 of 2")
___________________________
1 Current regulations require that postmarketing 15-day Alert reports bear prominent identification as to their contents (i.e., "15-day Alert report," or "15-day Alert report-followup").See ยงยง 310.305(c)(4), 314.80(c)(1)(iv), and 600.80(c)(1)(iv).