[Federal Register Volume 90, Number 161 (Friday, August 22, 2025)]
[Notices]
[Pages 41077-41078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-16075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0183]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishing and
Maintaining Lists of United States Establishments With Interest in
Exporting Human Food Program-Regulated Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 September 22, 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 0910-0509. Also include the FDA docket
number found in brackets in the heading of this document.
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,
[email protected].
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.
Establishing and Maintaining Lists of U.S. Establishments With Interest
in Exporting HFP-Regulated Products
OMB Control Number 0910-0509--Extension
This information collection supports Agency export programs and
associated guidance. The United States exports a large volume and
variety of foods in international trade. Foreign governments often
require official certification from the responsible authority of the
country of origin about imported foods and establishments involved in
their production, storage, or distribution. Some foreign governments
establish additional requirements with which exporters are required to
comply and ask for additional assurances from the responsible
authority. Importing countries may require, and FDA may provide,
official certification or assurances for food products in different
forms, including certificates that accompany specific products or lists
of establishments and products that comply with certain requirements.
To facilitate exports of food subject to importing country listing
requirements, FDA has historically provided official certification in
the form of country- and product-specific export lists that include
establishments and their products when: (1) the establishment has
expressed interest in exporting their products to these countries; (2)
the establishment and the products are subject to FDA's jurisdiction;
and (3) the establishment can demonstrate that it is in good regulatory
standing for the products it intends to export, and the products are
expected to comply with applicable FDA requirements. As we advised in
the guidance document ``Establishing and Maintaining a List of U.S.
Milk and Milk Product, Seafood, Infant Formula, and Formula for Young
Children Manufacturers/Processors with Interest in Exporting to
China,'' FDA considers ``good regulatory standing'' as meaning that an
establishment is in substantial compliance with applicable FDA
requirements and is not the subject of a pending enforcement action
(e.g., an injunction or seizure) or pending administrative action
(e.g., a warning letter).
FDA has generally published guidance documents for these country
and product-specific lists under the authority of section 701(h) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)),
which authorizes the Secretary of Health and Human Services (the
Secretary) to develop guidance documents with public participation
presenting the views of the Secretary on matters under the jurisdiction
of FDA. The guidance documents generally explain what information
establishments should submit to FDA to be considered for inclusion on
the lists and what criteria FDA intends to use to determine eligibility
for placement on the lists. The guidance documents also explain how FDA
intends to update the lists and communicate any new information to the
governments that requested the lists. Finally, the guidance documents
note that the information is provided voluntarily by establishments
with the understanding that it may be posted on FDA's external website
and that it will be communicated to, and possibly further disseminated
by, the government that requested the list; thus, FDA considers the
information on the lists to be information that is not protected from
disclosure under 5 U.S.C. 552(b)(4). The guidance documents include
``Establishing and Maintaining a List of U.S. Dairy Product
Manufacturers/Processors with Interest in Exporting to Chile''
(November 2018) and ``Establishing and Maintaining a List of U.S. Milk
and Milk Product, Seafood, Infant Formula, and Formula for Young
Children Manufacturers/Processors with Interest in Exporting to China''
(November 2018) available at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements. Additional information
about FDA's Food Export Lists program is available at https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists.
[[Page 41078]]
FDA has also published guidance on export certification that contains
useful information that applies to export lists: ``FDA Export
Certification'' (August 2021) available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certification.
Foreign governments are increasingly relying on certification as a
strategy for ensuring the safety of imported food products, and many
countries have announced new requirements for lists of establishments
and products certified to comply with certain food safety requirements.
FDA is committed to facilitating compliance with new listing
requirements for U.S. establishments that export FDA-regulated food
products by establishing and maintaining country- and product-specific
export lists.
Application for inclusion on all export lists will continue to be
voluntary. However, some foreign governments may require inclusion on
export lists as a precondition for market access or to satisfy other
importing country registration or approval requirements. FDA uses the
Export Listing Module (ELM), an electronic system (Form FDA 3972), to
receive and process applications for inclusion on export lists for HFP-
regulated products. The ELM allows applicants to provide information
about the products intended for export, the establishment that produces
those products, evidence of the establishment's compliance with
applicable requirements for the products intended for export, and any
additional data or information (such as third-party certifications)
that foreign governments may require. We request that this information
be updated every 2 years. Additional information and screenshots of the
ELM are available at https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists. If an establishment is unable to
submit an application via the ELM, it may contact HFP and request
assistance.
We use the information submitted by establishments to determine
eligibility for certification and inclusion on the export lists, which
may be published on our website or the websites of foreign governments.
The purpose of the lists is to help HFP-regulated industries meet the
import requirements of foreign governments. This collection of
information is intended to cover all of HFP's existing export lists, as
well as any additional export lists established by the program.
FDA notes section 801 of the FD&C Act (21 U.S.C. 381) also provides
that FDA may charge a fee of up to $175 if the Agency issues export
certification within 20 days of receipt of a complete request for such
certification.
Description of Respondents: Respondents to this collection of
information include U.S. establishments subject to FDA/HFP jurisdiction
that wish to be included on export lists.
In the Federal Register of May 1, 2025 (90 FR 18688), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. We received two comments, believing one to have been
posted erroneously to docket FDA-2025-N-0183 because it discussed
vaccines. The second comment offered general support for the
information collection and suggested technical enhancements to FDA's
collection mechanisms. Because FDA developed the ELM to facilitate the
export of food and avoid delay, we appreciate this comment. At the same
time, we are only able to make updates to our automated systems as our
limited resources allow. We made no adjustment to our estimate after
review of the public comments.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
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Number of
IC activity recommended by guidance Number of responses per Total annual Average burden per response Total
respondents respondent responses (hours) hours
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New request..................................................... 167 5 835 1 835
New request + third-party certification......................... 85 2 170 22 3,740
Biennial update................................................. 132 4 528 0.5 (30 minutes) 264
Biennial update + third-party certification..................... 58 2 116 22 2,552
Occasional updates.............................................. 60 2 120 0.5 (30 minutes) 60
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Total....................................................... .............. .............. 1,769 ............................ 7,451
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 15, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16075 Filed 8-21-25; 8:45 am]
BILLING CODE 4164-01-P