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U.S. Department of Health and Human Services

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.

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone 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

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 [1]

5/15/2013

Delayed

K. Finalize SOPs for proactive release redaction and web posting of FDA memos

6/30/2013

Delayed

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

On Track

Footnotes

  • 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.
  • [1]Task may be deprecated depending on results for most efficient method of creating Section 508 compliant redacted documents.
  • [2]Milestones L-O were modified or added as a result of the need to investigate various methods of getting the memos 508 compliant.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.