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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0016
ICR Reference No:
201008-0910-010
Status:
Historical Inactive
Previous ICR Reference No:
200705-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Submission of Petitions: Food Additive, Color Additive (Including Labeling), GRAS Affirmation; Master File Information to Support Petition & Electronic Submission Using FDA Forms 3503
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Improperly submitted and continue
Conclusion Date:
10/18/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/31/2010
Terms of Clearance:
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
Expiration Date
08/31/2010
36 Months From Approved
10/31/2010
Responses
12
0
12
Time Burden (Hours)
49,186
0
49,186
Cost Burden (Dollars)
8,200
0
8,200
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 348
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
75 FR 33624
06/14/2010
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 52954
08/30/2010
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Electronic Submission Using Form FDA 3503
3503
Food Additive( FAP); Color Additive ( CAP); Food Master File ; Color Master File
Submission of Petitions: Generally Recognized as Safe Affirmation
3503
Food Additive ( FAP); Color additive ( CAP); Food Master File; Color Master File
Submission of Petitions: Color Additive Including Labeling
3503
Food Additive ( FAP); Color Additive ( CAP); Food Master File ; Color Master File
Submission of Petitions: Food Additive Inciuding Labeling
3503
Food Additive ( FAP); Color Additive ( CAP); Food Master FIle; Color Master File
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$935,498
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Denver Presley 3018271462
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/31/2010
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