About FDA
Food Contact Notification (FCN) Transparency Initiative
Description: In order to inform the public about our safety evaluations of food contact materials, OFAS will pilot a project to proactively release the redacted FDA generated review memos and FDA FORM 3480s from industry-submitted applications. This pilot intends to process and post documents for 20 FCNs, and to determine the best way to do this while meeting requirements of the Freedom of Information Act (FOIA) and Section 508.
Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
---|---|---|---|
A. Develop draft SOPs for proactive release redaction and web posting of FDA memos |
7/10/2012 |
Completed | 7/10/2012 |
B. Build web template for testing |
7/11/2012 |
Completed | 7/11/2012 |
C. Explore potential for exemption from Section 508 requirements |
11/30/2012 |
Completed | 11/27/2012 |
D. Develop SOPs for proactive release redaction and web posting of industry submitted Form 3480 |
1/15/2013 |
Completed | 1/7/2013 |
E. Collect memos from reviewers/consumer safety officiers (CSOs) in Word or WordPerfect |
3/1/2013 |
Completed | 2/15/2013 |
F. Develop SOPs for Division of Food Contact Substance Notification Review (DFCN) reviewers/ CSOs / contractors for proactive release redaction of memos |
4/15/2013 |
Completed | 5/30/2013 |
G. Develop SOPs for DFCN reviewers/CSOs to review redactions (of Form 3480s and memos) |
4/15/2013 |
Completed | 9/18/2013 |
H. Explore possibilities for the most efficient method to create Section 508 compliant redacted documents for the web |
5/1/2013 |
Completed | 7/1/2013 |
I. Develop updated templates for future memos, to expedite future postings that are Section 508 compliant |
5/1/2013 |
Completed | 7/1/2013 |
J. Develop SOPs for collecting memos from newly effective FCNs |
5/15/2013 |
Completed | 6/16/2014 |
K. Finalize SOPs for proactive release redaction and web posting of FDA memos |
6/30/2013 |
Completed | 9/10/2014 |
L. Identify and redact FDA-generated memos for 20 FCNs to Section 508 compliant web documents[2] |
8/15/2013 |
Completed | 8/1/2013 |
M. Develop methodologies for 508 compliance |
3/30/2014 |
Completed | 3/18/2014 |
N. Complete conversion of review memos for 508 Compliancy |
4/30/2014 |
Completed | 4/3/2014 |
O. Upload 508 compliant memos to website |
6/30/2014 |
Completed | 6/30/2014 |
Foot Notes
- The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.
Key Projects Legend
Milestone Status | Definition |
---|---|
Not Yet Started | Work for specific milestone has not yet been started. |
Completed | Milestone and/or overall project is completed. |
On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |