Providing Regulatory Submissions in Electronic Format for Food Additive and Color Additive Petitions

ICR 200311-0910-010

OMB: 0910-0480

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0480 200311-0910-010
Historical Active 200112-0910-001
HHS/FDA
Providing Regulatory Submissions in Electronic Format for Food Additive and Color Additive Petitions
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 11/20/2003
Retrieve Notice of Action (NOA) 11/20/2003
  Inventory as of this Action Requested Previously Approved
11/30/2003 11/30/2003 11/30/2003
3 0 3
17,403 0 17,403
56,000 0 56,000

Providing Regulatory Submissions in Electronic Format, General Considerations and Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format for Food Additive and Color Additive Petitions." These documents are the first in a series of guidance documents intended to provide guidance for industry regarding the preparation of regulatory submissions in elecgtronic format to the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN). OPA is providing these draft guidances as part of its implementation of 21 CFR Part 11, the Government Paperwork Elimination Act and.....

None
None


No

1
IC Title Form No. Form Name
Providing Regulatory Submissions in Electronic Format for Food Additive and Color Additive Petitions FDA-3503, FDA-3504

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 3 3 0 0 0 0
Annual Time Burden (Hours) 17,403 17,403 0 0 0 0
Annual Cost Burden (Dollars) 56,000 56,000 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
11/20/2003


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