Affirmation of Generally Recognized as Safe GRAS Status

ICR 200009-0910-008

OMB: 0910-0132

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5748
Migrated
ICR Details
0910-0132 200009-0910-008
Historical Active 199705-0910-001
HHS/FDA
Affirmation of Generally Recognized as Safe GRAS Status
Extension without change of a currently approved collection   No
Regular
Approved without change 11/20/2000
Retrieve Notice of Action (NOA) 09/20/2000
  Inventory as of this Action Requested Previously Approved
11/30/2003 11/30/2003 11/30/2000
1 0 5
2,614 0 13,070
0 0 0

To implement the GRAS (Generally Recognized as Safe) provisions of section 201(s) of the Food, Drug, and Cosmetic Act, FDA issued procedural regulations to establish a process by which a person may obtain FDA concurrence with a GRAS determination referred to as a GRAS affirmation. GRAS petitions are reviewed by FDA to determine whether the available data establish that the intended use of the substance is GRAS based upon either a safe history of the safe use of the substance, or upon widely available safety data.

None
None


No

1
IC Title Form No. Form Name
Affirmation of Generally Recognized as Safe GRAS Status

  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 1 5 0 -4 0 0
Annual Time Burden (Hours) 2,614 13,070 0 -10,456 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes

$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.
09/20/2000


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