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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0342
ICR Reference No:
201608-0910-012
Status:
Historical Active
Previous ICR Reference No:
201602-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CFSAN
Title:
Substances Generally Recognized as Safe: Notification Procedure
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/27/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/22/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2019
36 Months From Approved
03/31/2019
Responses
600
0
60
Time Burden (Hours)
59,475
0
9,900
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 321
Name of Law: FFDCA
US Code:
21 USC 348
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AH15
Final or interim final rulemaking
81 FR 54960
08/17/2016
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
62 FR 18938
04/17/1997
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 54960
08/17/2016
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
GRAS Notice under 21 CFR Parts 170 and 570
FDA 3667
Generally Recognized as Safe (GRAS) Notice
ONE TIME Reporting Burden
FDA 3667
Generally Recognized as Safe (GRAS) Notice
ICR Summary of Burden
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
600
60
0
540
0
0
Annual Time Burden (Hours)
59,475
9,900
0
49,575
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Information collection finalized through rulemaking.
Annual Cost to Federal Government:
$1,204,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/22/2016
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