Notice2022-13074
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of U.S. Establishments With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products
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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
June 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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
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[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36510-36512]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13074]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4042]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishing and
Maintaining Lists of U.S. Establishments With Interest in Exporting
Center for Food Safety and Applied Nutrition-Regulated Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 July 18, 2022.
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 0910-0509. 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,
<a href="/cdn-cgi/l/email-protection#87d7d5c6d4f3e6e1e1c7e1e3e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8">[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.
Establishing and Maintaining Lists of U.S. Establishments With Interest
in Exporting CFSAN-Regulated Products
OMB Control Number 0910-0509--Extension
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
[[Page 36511]]
products it intends to export and the products are expected to comply
with applicable FDA requirements. As we advise 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,'' (November 2018),
available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-establishing-and-maintaining-list-us-milk-and-milk-product-seafood-infant-formula">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-establishing-and-maintaining-list-us-milk-and-milk-product-seafood-infant-formula</a>, 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'' 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.'' Additional
information about FDA's Food Export Lists program is available at
<a href="https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists">https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists</a>. FDA has also published a guidance document on export
certification that contains useful information that applies to export
lists entitled, ``FDA Export Certification,'' (August 2021) available
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certification">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certification</a>.
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. We also understand that complying with multiple country- and
product-specific listing requirements can be burdensome to U.S.
establishments. For this reason, we plan to create a new list of
establishments and products certified for export that would be offered
to importing countries in lieu of country-specific 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
Center for Food Safety and Applied Nutrition (CFSAN)-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 <a href="https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists">https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists</a>. If an establishment is unable to apply via
the ELM, it may contact CFSAN 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 CFSAN-regulated industries meet the
import requirements of foreign governments. This collection of
information is intended to cover all of CFSAN's existing export lists,
as well as any additional export lists established by the center.
FDA notes that 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
an 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/CFSAN
jurisdiction that wish to be included on export lists.
In the Federal Register of January 25, 2022 (87 FR 3814), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received offering general
support for the information collection and offered points FDA might
consider as it develops and maintains such lists. FDA appreciates this
comment and continuously works to provide interested persons with
useful information as its limited resources permit. The comment did not
suggest alternative estimates.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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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
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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, the estimated burden for this information
collection has decreased. The number of respondents has declined
dramatically since we transitioned to using the ELM, which also allows
us to collect more precise data. These changes resulted in overall
decreases of 3,421 responses and 14,837 burden hours.
Dated: June 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13074 Filed 6-16-22; 8:45 am]
BILLING CODE 4164-01-P
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