Substances Generally Recognized as Safe: Notification Procedure

ICR 202204-0910-014

OMB: 0910-0342

Federal Form Document

Forms and Documents
IC Document Collections
IC ID
Document
Title
Status
5950 Modified
ICR Details
0910-0342 202204-0910-014
Received in OIRA 201907-0910-015
HHS/FDA CFSAN
Substances Generally Recognized as Safe: Notification Procedure
Extension without change of a currently approved collection   No
Regular 06/09/2022
  Requested Previously Approved
36 Months From Approved 07/31/2022
125 125
21,250 21,250
0 1,159,400

This ICR collects information from food manufacturers who wish to obtain a determination from FDA that a food additive is generally recognized as safe (GRAS) and therefore not subject to premarket approval requirements. Respondents submit information as provided in agency regulations regarding GRAS notification, including a description of the substance, intended use, previous communications with the agency, contact information, etc. FDA has developed Form 3667 to facilitate its review of information being submitted so that a GRAS determination can be made. Food additives that are not GRAS must obtain premarket approval.

US Code: 21 USC 321 Name of Law: FFDCA
   US Code: 21 USC 348 Name of Law: FFDCA
  
None

Not associated with rulemaking

  86 FR 64943 11/19/2021
87 FR 34882 06/08/2022
Yes

1
IC Title Form No. Form Name
GRAS Notice under 21 CFR Parts 170 and 570 Form FDA 3667 GRAS Notification

  Total Request 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 125 125 0 0 0 0
Annual Time Burden (Hours) 21,250 21,250 0 0 0 0
Annual Cost Burden (Dollars) 0 1,159,400 0 0 -1,159,400 0
No
No

$1,383,452
No
    No
    No
No
No
No
No
Rachel Showalter 202 693-2146 [email protected]

  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.
06/09/2022


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