Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and cle...
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Submit written comments (including recommendations) on the collection of information by August 28, 2025.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
https://www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0482. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Export Notification and Recordkeeping Requirements—21 CFR 1.101
OMB Control Number 0910-0482—Extension
This information collection supports FDA regulations. Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381 and 21 U.S.C. 382) charge the Secretary of Health and Human Services, through FDA, with the responsibility of helping to ensure that exports of unapproved new drugs, biologics, devices, animal drugs, food, cosmetics, and tobacco products that are not to be sold in the United States meet the requirements of the country to which the product is to be exported. The respondents to this information collection are exporters who have notified FDA of their intent to export unapproved products that may not be sold or offered for sale in domestic commerce in the United States as allowed under section 801(e) of the FD&C Act. In general, the notification identifies the product being exported (
e.g.,
name, description, and in some cases, country of destination) and specifies where the notifications were sent. These notifications are sent only for an initial export. Subsequent exports of the same product to the same destination or to certain countries identified in section 802(b) of the FD&C Act would not result in a notification to FDA.
Respondents to the information collection are exporters of products that may not be sold in the United States and are regulated by FDA's Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM); and Center for Tobacco Products (CTP). Respondents to this collection of information maintain records
( printed page 35698)
demonstrating their compliance with the requirements in 21 CFR 1.101.
In the
Federal Register
of May 1, 2025 (90 FR 18691), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Notification requirements for exports; 1.101(d)
CBER
5
92
460
15
6,900
CDER
5
2.4
12
15
180
CDRH
16
3.375
54
15
810
Total
7,890
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2—Estimated Annual Recordkeeping Burden 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping requirements for exports; 101(b), (c), and (e)
CBER
17
3
51
22
1,122
CDER
121
7.9
956
22
21,032
CDRH
16
3
48
22
1,056
CVM
26
3
78
22
1,716
Recordkeeping requirements for exports; 1.101(b)
Office of Global Policy and Strategy
1
65
65
22
1,430
CTP
322
3
966
22
21,252
Total
47,608
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
In table 1, we estimate the number of respondents increased for biologics from 4 to 5. The number of respondents increased for drugs from 3 to 5. However, this increase is offset by respondents for devices as the estimated number of exporters decreased from 22 to 16. The number of responses per respondent increased for biologics from 35 to 92 resulting in an increase in burden for biologics reporting from 2,100 to 6,900. Despite decreases in the number of responses per respondent for drugs and devices, the increase in biologics reporting resulted in an overall total reporting burden increase from 5,985 to 7,890.
In table 2, we separated each center's recordkeeping to ensure consistency with table 1 and to accurately capture each center's burden estimates. The average No. of Records Per Recordkeeper increased from 4.12 to 14.15 which represents a total recordkeeping burden increase from 39,094 to 47,608.
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 514 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.
Dated: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
Use this for formal legal and research references to the published document.
90 FR 35697
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements,” thefederalregister.org (July 29, 2025), https://thefederalregister.org/documents/2025-14229/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-export-no.