Export Notification and
Recordkeeping Requirements
Reinstatement with change of a previously approved collection
No
Regular
07/30/2025
Requested
Previously Approved
36 Months From Approved
2,690
0
55,498
0
0
0
The information collection supports
FDA regulations at 21 CFR 1.101 and pertains to the notifications
and records required for human drug, biological product, device,
animal drug, food, cosmetic, and tobacco product exports under
sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or
(21 U.S.C. 381 and 382) or section 351 of the Public Health Service
Act (42 U.S.C. 262).
Based on a review of Agency
data, our estimated burden for the information collection reflects
an overall increase of 10,419 hours and a corresponding increase of
2,690 responses. In the previous extension request FDA included
burden for the Center for Food Safety and Applied Nutrition (now
known as Human Foods Program (HFP)). However, upon reevaluation of
these burden estimates, we have determined that the burden
associated with HFP is already accounted for under OMB Control
Number 0910-0793.
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.