Notice2022-01376
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Establishments With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products
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Published
January 25, 2022
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 the information collection associated with export lists for products regulated by the Center for Food Safety and Applied Nutrition (CFSAN).
Full Text
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<title>Federal Register, Volume 87 Issue 16 (Tuesday, January 25, 2022)</title>
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[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3814-3817]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01376]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4042]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Establishing and Maintaining Lists of United States
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 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 the information collection
associated with export lists for products regulated by the Center for
Food Safety and Applied Nutrition (CFSAN).
DATES: Submit either electronic or written comments on the collection
of information by March 28, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 28, 2022. 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 March 28, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
[[Page 3815]]
<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-2018-N-4042 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Establishing and Maintaining
Lists of U.S. Establishments with Interest in Exporting Center for Food
Safety and Applied Nutrition-Regulated Products.'' 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 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#2e7e7c6f7d5a4f48486e484a4f0046465d00494158"><span class="__cf_email__" data-cfemail="e6b6b4a7b592878080a6808287c88e8e95c8818990">[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.
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 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,
[[Page 3816]]
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'' 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'' available at <a href="https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements">https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements</a>. 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
guidance on export certification that contains useful information that
applies to export lists: ``FDA Export Certification'' 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
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 submit an application 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 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/CFSAN
jurisdiction that wish to be included on export lists.
FDA estimates 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 Total hours
respondents respondent responses per response
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New request................... 167 5 835 1............... 835
New request + third party 85 2 170 22.............. 3,740
certification.
Biennial update............... 132 4 528 0.5 (30 minutes) 264
Biennial update + third party 58 2 116 22.............. 2,552
certification.
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
[[Page 3817]]
decreases of 3,421 responses and 14,837 burden hours.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01376 Filed 1-24-22; 8:45 am]
BILLING CODE 4164-01-P
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