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.
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.