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

ICR Details
0910-0016 201008-0910-010
Historical Inactive 200705-0910-002
HHS/FDA
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   No
Regular
Improperly submitted and continue 10/18/2010
Retrieve Notice of Action (NOA) 08/31/2010
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.

US Code: 21 USC 348 Name of Law: FFDCA
  
None

Not associated with rulemaking

  75 FR 33624 06/14/2010
75 FR 52954 08/30/2010
No

No
No

$935,498
No
No
No
No
No
Uncollected
Denver Presley 3018271462

  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:
 
 
 
 
 
 
 
    (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.
08/31/2010


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