Notice2025-07593
Agency Information Collection Activities; Proposed Collection; 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
May 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports.
Full Text
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<title>Federal Register, Volume 90 Issue 83 (Thursday, May 1, 2025)</title>
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[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18691-18693]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07593]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0338]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Export Notification and Recordkeeping Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with notifications and records required for human drug,
biological product, device, animal drug, food, cosmetic, and tobacco
product exports.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 30, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 30, 2025. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-0338 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Export Notification and
Recordkeeping Requirements.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management
[[Page 18692]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#550507140621343333153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="702022312304111616301614115e1818035e171f06">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Export Notification and Recordkeeping Requirements--21 CFR 1.101
OMB Control Number 0910-0482--Extension
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); Human Foods
Program (HFP); and Center for Tobacco Products (CTP). Respondents to
this collection of information maintain records demonstrating their
compliance with the requirements in 21 CFR 1.101.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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1.101(d) (CBER)................. 5 92 460 15 6,900
1.101(d) (CDER)................. 5 2.4 12 15 180
1.101(d) (CDRH)................. 16 3.375 54 15 810
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Total....................... .............. .............. .............. .............. 7,890
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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1.101(b), (c), and (e) (CBER)... 17 3 51 22 1,122
1.101(b), (c), and (e) (CDER)... 121 7.9 960 22 21,120
1.101(b), (c), and (e) (CDRH)... 16 3 54 22 1,188
1.101(b), (c), and (e) (CVM).... 26 3 78 22 1,716
1.101(b) Office of Global Policy 1 65 65 22 1,430
and Strategy...................
1.101(b) (CTP).................. 322 3 966 22 21,252
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Total....................... .............. .............. .............. .............. 47,828
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\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
[[Page 18693]]
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 47,828.
Based on a review of Agency data the total burden hours have
increased by 13,367. In the previous extension request FDA included
burden for the Center for Food Safety and Applied Nutrition (now known
as HFP). However, upon reevaluation of these burden estimates, HFP
offers a ``Certificate of Exportability'' for conventional foods, food
additives, food contact substances, and infant formula products that
cannot be legally marketed in the United States but meets the
requirements of section 801(e) of the FD&C Act and may be legally
exported (<a href="https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates">https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates</a>). An interested person may apply for
this certificate electronically using the Export Certification
Application and Tracking System (<a href="https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food">https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food</a>). As part of
the application, the interested person attests to compliance with
section 801(e) of the FD&C Act as provided in 21 CFR 1.101(b). This
information collection activity is approved under OMB control number
0910-0793.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07593 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
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