Extension without change of a currently approved collection
No
Regular
09/30/2025
Requested
Previously Approved
36 Months From Approved
09/30/2025
28,485
30,423
540,529
325,404
0
0
This information collection supports
FDA implementation of the National Environmental Policy Act (NEPA).
NEPA requires the preparation of an environmental impact statement
(EIS) for every major Federal action that will significantly affect
the quality of the human environment or, in the alternative, the
assertion of a categorical exclusion. Agency regulations governing
NEPA compliance are found in 21 CFR part 25.
US Code:
42 USC 4321-4347 Name of Law: National Environmental Policy
Act
Based on a review of the
information collection since our last request for OMB approval, we
have made adjustments to our burden estimate. Our estimated burden
for the information collection reflects an overall increase of
215,125 hours and a decrease of 1,938 responses.
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.