Notice2025-14229
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35697-35698]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0338]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export Notification
and Recordkeeping Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#c797958694b3a6a1a187a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="cc9c9e8d9fb8adaaaa8caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>.
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
[[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\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section Number of responses per annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Total Average burden
21 CFR section Number of records per annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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 1 65 65 22 1,430
Strategy.........................
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.
[FR Doc. 2025-14229 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 29, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.