Substances Generally Recognized as Safe: Notification Procedure

ICR 201602-0910-001

OMB: 0910-0342

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Supporting Statement A
2016-02-16
IC Document Collections
IC ID
Document
Title
Status
5950 Modified
ICR Details
0910-0342 201602-0910-001
Historical Active 201211-0910-010
HHS/FDA CFSAN
Substances Generally Recognized as Safe: Notification Procedure
Extension without change of a currently approved collection   No
Regular
Approved without change 03/21/2016
Retrieve Notice of Action (NOA) 02/18/2016
Previous terms continue: In accordance with the terms of 5 CFR 1320, this ICR is approved for a period of three years. OMB notes that the Supporting Statement claims that the new form will be more efficient than the existing form, but it does not calculate a reduction in the burden on the public or a reduction in Agency processing time. Please examine this as the form is in use and consider updating these figures, as appropriate, when resubmitting to OMB.
  Inventory as of this Action Requested Previously Approved
03/31/2019 36 Months From Approved 03/31/2016
60 0 60
9,900 0 9,900
0 0 0

This ICR collects information from food manufactures 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

  80 FR 55857 09/17/2015
81 FR 8206 02/18/2016
No

1
IC Title Form No. Form Name
GRAS Notice for 21 CFR 170.36 and 570.36 FDA 3667 GRAS Notice

  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 60 60 0 0 0 0
Annual Time Burden (Hours) 9,900 9,900 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,204,000
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
02/18/2016


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