Substances Generally Recognized as Safe: Notification Procedure

ICR 201907-0910-015

OMB: 0910-0342

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0910-0342 201907-0910-015
Active 201608-0910-012
HHS/FDA CFSAN
Substances Generally Recognized as Safe: Notification Procedure
Extension without change of a currently approved collection   No
Regular
Approved without change 07/23/2019
Retrieve Notice of Action (NOA) 07/16/2019
We have removed one-time burden previously included and attributed to rulemaking because we believe respondents have realized burden associated with review of the new requirements. At the same time, we have received an increase in submissions since last OMB review. Cumulatively these changes result in an overall reduction to the collection by 475 responses and 38,225 burden hours. We have also uploaded cost information that, although previously included, had not been reflected at omb.report.
  Inventory as of this Action Requested Previously Approved
07/31/2022 36 Months From Approved 09/30/2019
125 0 600
21,250 0 59,475
1,159,400 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

  84 FR 8876 03/19/2019
84 FR 29216 06/21/2019
No

1
IC Title Form No. Form Name
GRAS Notice under 21 CFR Parts 170 and 570 Form FDA 3667 GRAS Notification
ONE TIME Reporting Burden FDA 3667 Generally Recognized as Safe (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 125 600 0 0 -475 0
Annual Time Burden (Hours) 21,250 59,475 0 0 -38,225 0
Annual Cost Burden (Dollars) 1,159,400 0 0 0 1,159,400 0
No
No

$1,284,360
No
    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.
07/16/2019


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