[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3814-3817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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]]

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 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. FDA has also published 
guidance on export certification that contains useful information that 
applies to export lists: ``FDA Export Certification'' 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. 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 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 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
                               ---------------------------------------------------------------------------------
    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