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.
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.