[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Notices]
[Pages 27331-27333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12321]


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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 United States Manufacturers/Processors 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) 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: Fax written comments on the collection of information by July 
12, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs,

[[Page 27332]]

OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to 
oira_submission@omb.eop.gov. All comments should be identified with the 
OMB control number 0910-0509. Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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. Manufacturers/Processors 
With Interest in Exporting CFSAN-Regulated Products

OMB Control Number 0910-0509--Revision

    The United States exports a large volume and variety of foods in 
international trade. For certain food products, foreign governments may 
require assurances from the responsible authority of the country of 
origin of an imported food that the processor of the food is in 
compliance with applicable country of origin regulatory requirements. 
Some foreign governments establish additional requirements with which 
exporters are required to comply and ask for additional assurances from 
the responsible authority. When requested, FDA may provide this 
information in the form of lists which are provided to the foreign 
governments.
    For products subject to importing country listing requirements, FDA 
has historically maintained certain export lists of manufacturers/
processors that: (1) Have expressed interest in exporting their 
products to these countries; (2) are subject to FDA's jurisdiction; and 
(3) are 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 lists 
under the authority of section 701(h) of the Federal, Food, Drug, and 
Cosmetic 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 
manufacturers/processors 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 request the 
lists. Finally, the guidance documents note that the information is 
provided voluntarily by manufacturers/processors 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).
    Application for inclusion on each list is voluntary. However, some 
foreign governments may require inclusion on the list for acceptance of 
imported products. FDA recommends that U.S. manufacturers/processors 
that want to be placed on the export lists send FDA the following 
information: (1) Country to which the food manufacturer/processor wants 
to export product; (2) type of food product facility; (3) the Food 
Facility Registration number (the information collected by this module 
is approved under OMB control number 0910-0502), FDA Establishment 
Identifier number or Dun & Bradstreet number for the facility; (4) name 
and address of the firm and the manufacturing plant; (5) name, 
telephone number, and email address of the contact person; (6) 
information on the products intended for export; (7) identities of 
agencies that inspected the plant; (8) date of last inspection, plant 
number, and copy of last inspection notice; and (9) if other than an 
FDA inspection, copy of last inspection report. We request that this 
information be updated every 2 years.
    In addition to the information above, some countries may require 
additional information such as documentation that the firm has been 
certified by a third-party certification body that it meets the 
requirements of the importing country. Other information may need to be 
submitted to be included on the lists depending on the requirements of 
the importing country. We plan to provide exporters with information 
about any such additional information required by a foreign country as 
a condition for entry and collect the other information to accommodate 
the importing countries' requirements.
    We use the information submitted by firms to determine their 
eligibility for placement on the export lists, which may be published 
on our website. The purpose of the lists is to help CFSAN (Center for 
Food Safety and Applied Nutrition)-regulated industries meet the import 
requirements of foreign governments.
    FDA currently maintains export lists for the European Community and 
China covered under OMB control numbers 0910-0320 and 0910-0839, 
respectively. These export lists also serve to assist firms to meet the 
import requirements of foreign governments. OMB control numbers 0910-
0509, 0910-0320, and 0910-0839 are similar in that they allow FDA to 
collect information from firms for the purpose of establishing export 
lists for foreign governments that require these lists before allowing 
the subject goods to be imported. Thus, with this notice, FDA proposes 
to consolidate these collections of information for government 
efficiency and to allow the public to look to one OMB control number 
for all collections of information for CFSAN export lists. This 
collection of information is intended to cover all CFSAN existing 
export lists, as well as any additional export lists required by 
foreign countries.
    In 2016, FDA launched the Dairy Listing Module, an electronic 
registry system (Form FDA 3972) to facilitate applications for 
inclusion on the dairy export lists. FDA has expanded this system to 
accommodate applications for inclusion on export lists for CFSAN-
regulated products, affording all firms the efficiencies of submitting 
information electronically. The expanded system is called the Export 
Listing Module (ELM). The ELM has data fields that allow firms to input 
the information identified above that FDA recommends providing. In 
addition, the ELM contains data fields such as ``Additional 
Information'' and ``Additional Documents'' that allow firms to submit 
any additional data or information (such as third-party certifications) 
that foreign governments may require. Screenshots of the ELM are 
available at https://www.fda.gov/food/food-export-lists/online-applications-export-lists. If a firm is unable to submit an application 
via the ELM, it may contact CFSAN and request assistance.
    In the Federal Register of November 13, 2018 (83 FR 56350), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received a number of comments. One letter 
cited a related public meeting docket (FDA-2016-D-4484) and included 
comments regarding

[[Page 27333]]

topics covered in the subject guidance document. The comments did not 
address the information collection elements solicited in our notice; 
however, we will consider the comments consistent with our good 
guidance practice regulations at 21 CFR 10.115.
    Another comment covered multiple topics suggesting that FDA clarify 
more specifically the utility of the information being collected, and 
that some of the information collection may be duplicative. The comment 
also appears to question both FDA's role in and authority for the 
information collection, however, this comment goes beyond the scope of 
the topics solicited in our 60-day notice, and is therefore not 
discussed in this notice.
    Another comment suggested that the burden estimate associated with 
new requests to be placed on the list was too low. We appreciate 
feedback regarding user experience with reporting information. Although 
we believe that the new module will ultimately reduce the time 
necessary for completing the application process, we have raised the 
estimate to 1 hour in deference to the comment.
    Finally, other comments expressed encouragement for finding 
continued ways to improve the program, and we look forward to receiving 
continued feedback.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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New requests to be placed on the           1,460               1           1,460         \2\ 0.5             730
 lists..........................
Third-party certification.......             370               1             370              21           7,770
Biennial update.................           2,505               1           2,505         \2\ 0.5           1,253
Third-party certification                    555               1             555              21          11,655
 biennial update................
Occasional updates..............             300               1             300         \2\ 0.5             150
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          21,558
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ (30 minutes).

    The information collection reflects an increase in burden by 18,458 
hours due to the consolidation of the information collections covered 
by OMB control numbers 0910-0839 and 0910-0320. Also, our current 
estimate of the number of foreign countries that may require us to 
establish lists in the next 3 years and the type of information they 
may require us to collect to maintain such lists has also resulted in 
an increase. At the same time, we have developed an electronic 
reporting portal that is expected to reduce the overall reporting time 
per submission. The portal will enhance the ability of firms to more 
efficiently request inclusion on export lists.
    We base our estimate on the number of manufacturers/processors that 
have submitted new written requests, biennial updates, and occasional 
updates over the past 10 years. The estimate of the number of burden 
hours it will take a manufacturer/processor to gather the information 
needed to be placed on the list or update its information is based on 
our experience with manufacturers/processors submitting similar 
requests. We believe that the information to be submitted will be 
readily available to manufacturers/processors. This collection is 
incorporating additional information collected to maintain lists of 
eligible exporters of CFSAN-regulated products who wish to export to 
foreign markets, including the European Union, Chile and China under 
OMB control numbers 0910-0320, ``Request for Information from U.S. 
Processors that Export to the European Community'' and 0910-0839, 
``Establishing and Maintaining Lists of U.S. Manufacturers/Processors 
with Interest in Exporting CFSAN-Regulated Products to China.''
    We estimate that 1,460 firms will average 30 minutes (0.5 hour) to 
submit new requests for inclusion on the list, 2,505 firms will average 
30 minutes (0.5 hour) to update their information every 2 years, and 
300 firms will average 30 minutes (0.5 hour) to occasionally update 
their information in this system.
    Some firms will need to provide documentation that they obtained 
third-party certification to certify that they have met the 
requirements of the importing country. Currently, only China has this 
requirement. Based on our experience with this program, 370 firms will 
spend about 21 hours to complete the third-party certification for a 
total of 7,770 burden hours. During the biennial update, we estimate 
that about half of the 1,110 manufacturers/processors for which the 
importing country requires third-party certification will be 
recertified, meaning that 555 manufacturers/processors (1,110 
manufacturers/processors x 0.5) will get recertified each year. We 
estimate that it will take each such manufacturer/processor about 21 
hours to complete the certification process for a total of 11,655 
burden hours (555 manufacturers/processors x 21 hours).
    We calculate, therefore, that the total burden for this collection 
is 21,558 hours.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12321 Filed 6-11-19; 8:45 am]
BILLING CODE 4164-01-P


