Submission of Petitions: Food Additive, Color Additive (Including Labeling), GRAS Affirmation; Master File Information to Support Petition & Electronic Submission Using FDA Forms 3503
ICR 201008-0910-010
OMB: 0910-0016
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0016 can be found here:
Submission of Petitions: Food
Additive, Color Additive (Including Labeling), GRAS Affirmation;
Master File Information to Support Petition & Electronic
Submission Using FDA Forms 3503
Extension without change of a currently approved collection
In accordance
with 5 CFR 1320, OMB notes that this collection has been improperly
submitted. FDA has classified the request as an extension. The
supporting statement correctly notes that the changest made by the
agency constitute a "revision" to the package. Please correct this
error and resubmit the collection for OMB review.
Inventory as of this Action
Requested
Previously Approved
08/31/2010
36 Months From Approved
10/31/2010
12
0
12
49,186
0
49,186
8,200
0
8,200
FDA is revising Form FDA 3503 with
instructions to better enable its use for electronic submission and
to permit its use for multiple types of submissions, which
eliminates the need for for form FDA 3504 which will be
discontinued. The revised form FDA 3503 can be used to submit
information to FDA in electronic format using the Electronic
Submission Gateway portal. Because Form FDA 3503 helps the
respondent organize their submission to focus on the information
needed for FDA safety review , FDA now recommends that this form be
used for food and color additive petitions., whether submitted in
electronic or paper format. In addition the form accomodates GRAS
affirmation petitions and can also be used to organize information
within a Master File submitted in support of Petitions.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.