Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
201208-0910-009
Status:
Historical Inactive
Previous ICR Reference No:
200905-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
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:
Improperly submitted and continue
Conclusion Date:
11/05/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/30/2012
Terms of Clearance:
In accordance with the terms of 5 CFR 1320, OMB considers this package to have been improperly submitted. The supporting statement describes a request to approve a new form. However, no new form appears to have been uploaded, nor is this accounted for by a change in burden. Please review the collection and make any appropriate corrections before resubmitting this ICR to OMB.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2012
36 Months From Approved
02/28/2013
Responses
30
0
30
Time Burden (Hours)
4,950
0
4,950
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information used in making a GRAS determination, and the notifier would maintain a record of such data and information. FDA asks companies to provide information about whether a product that they wish to market qualifies for GRAS status.
Authorizing Statute(s):
US Code:
21 USC 348
Name of Law: FFDCA
US Code:
21 USC 321
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
77 FR 2552
01/18/2012
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 38638
06/28/2012
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Substances Generally Recognized as Safe: Notification Procedure CFSAN
FDA Form 3667
GENERALLY RECOGNIZED AS SAFE
Substances Generally Recognized as Safe: Notification Procedure CVM
FDA Form 3667
GENERALLY RECOGNIZED AS SAFE
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$1,176,630
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:
JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@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:
08/30/2012
An official website of the United States government
The .gov means it's official.
The site is secure.
