[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36510-36512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-establishing-and-maintaining-list-us-milk-and-milk-product-seafood-infant-formula, 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 
https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists. 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 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 
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 https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists. 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

[[Page 36512]]

 
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


