[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Pages 56350-56353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24618]


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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 U.S. 
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 or Agency) 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 collection of information that FDA uses 
to establish and maintain lists of U.S. manufacturers and processors 
with an interest in exporting products regulated by the Center for Food 
Safety and Applied Nutrition (CFSAN) to countries that require such 
lists to be maintained. The notice also solicits comments on changes to 
the electronic registry that will allow manufacturers and processors of 
CFSAN-regulated products to electronically request inclusion on the 
export lists.

DATES: Submit either electronic or written comments on the collection 
of information by January 14, 2019.

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 January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 14, 2019. 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:
     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 Manufacturers/Processors With Interest in Exporting CFSAN-
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.
     Confidential Submissions--To submit a comment with 
confidential

[[Page 56351]]

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.gpo.gov/fdsys/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.

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. 3501-3520), 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. 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 requested 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. FDA plans to

[[Page 56352]]

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-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 very 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 of CFSAN's 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/GuidanceRegulation/ImportsExports/Exporting/ucm496929.htm. If a firm is unable to submit 
an application via the ELM, it may contact CFSAN and request 
assistance.
    Description of Respondents: Respondents to this collection of 
information include U.S. manufacturers/processors subject to FDA/CFSAN 
jurisdiction that wish to export to certain foreign countries that 
require inclusion 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 per response           Total hours
                                                respondents     respondent       responses
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New requests to be placed on the lists......           1,460               1           1,460  0.5 (30 minutes)..........................             730
Third-party certification...................             370               1             370  21........................................           7,770
Biennial update.............................           2,505               1           2,505  0.5 (30 minutes)..........................           1,253
Third-party certification biennial update...             555               1             555  21........................................          11,655
Occasional updates..........................             300               1             300  0.5 (30 minutes)..........................             150
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    Total...................................  ..............  ..............  ..............  ..........................................          21,558
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 in order 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 (1110 
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.


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    Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24618 Filed 11-9-18; 8:45 am]
 BILLING CODE 4164-01-P


