[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27485-27487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0192]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Establishing and Maintaining Lists of U.S. Milk 
Product Manufacturers/Processors With Interest in Exporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, we, 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 information collection 
entitled ``Establishing and Maintaining Lists of U.S. Milk Product 
Manufacturers/Processors With Interest in Exporting,'' which 
establishes and maintains lists of U.S. milk product manufacturers and 
processors with interest in exporting to countries that require such 
lists to be maintained. The notice also solicits comments on an 
electronic registry that will allow manufacturers and processors of 
milk products to electronically request inclusion on the export lists.

DATES: Submit either electronic or written comments on the collection 
of information by August 14, 2017.

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 August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 14, 2017. 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 27486]]

     For written/paper comments submitted to the Division of 
Dockets Management, 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-2014-N-0192 for ``Establishing and Maintaining Lists of U.S. Milk 
Product Manufacturers/Processors with Interest in Exporting.'' 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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. Milk Product Manufacturers/
Processors With Interest in Exporting--21 U.S.C. 371--OMB Control 
Number 0910-0509--Extension

    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. 
With regard to U.S. milk products, FDA is the competent U.S. food 
safety authority to provide this information to foreign governments. 
FDA provides the requested information about processors in the form of 
lists, which are provided to the foreign governments and posted online 
at http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/default.htm.
    Currently, FDA provides Chile, China, and the European Union (EU) 
with a list of U.S. milk product 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 (i.e., an injunction or seizure or a pending 
warning letter).
    FDA has published guidance documents for these countries 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 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 list and communicate any new information to the 
government that requested the list. Finally, the guidance documents 
note that the information is provided voluntarily by manufacturers/
processors with the understanding that it will be posted on FDA's 
external Web site and 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 food. 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 milk manufacturer/processor wants 
to export product; (2) type of milk product facility; (3) the Food 
Facility Registration Module number (the information collected by this 
module is approved under OMB control number 0910-0502); (4) name and 
address of the firm and the

[[Page 27487]]

manufacturing plant; (5) name, telephone number, and email address of 
the contact person; (6) list of products divided into three categories: 
Presently shipped, ready to ship, and available for shipment in the 
next 3 years; (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.
    We use the information submitted by firms to determine their 
eligibility for placement on the export lists, which are published on 
our Web site. The purpose of the lists is to help foreign governments 
in their determinations of which U.S. milk product manufacturers and 
processors are eligible to export to their respective countries.
    FDA has recently developed an electronic registry system (Form FDA 
3972) that allows milk product manufacturers and processors to 
electronically send a request to FDA to be included on the export 
lists. Manufacturers and processors that prefer to submit a paper 
request in a format of their own choosing will still have the option to 
do so. Electronic Form FDA 3972 collects the same information as is 
currently collected via the existing paper-based process. Draft 
screenshots of Form FDA 3972 and instructions are available at http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm496929.htm and is entitled ``Dairy Listing Module.''
    Description of Respondents: Respondents to this collection of 
information include U.S. milk product manufacturers/processors subject 
to FDA 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......           2,000               1           2,000  1.........................................           2,000
Biennial update.............................           2,000               1           2,000  0.5 (30 minutes)..........................           1,000
Occasional updates..........................             200               1             200  0.5 (30 minutes)..........................             100
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    Total...................................  ..............  ..............  ..............  ..........................................           3,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its 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 FDA's experience with manufacturers/processors submitting 
similar requests. FDA believes that the information to be submitted 
will be readily available to manufacturers/processors. This collection 
is also incorporating information collected to maintain lists of 
eligible exporters of dairy products who wish to export to the EU from 
OMB control number 0910-0320, ``Request for Information from U.S. 
Processors that Export to the European Community.''
    FDA estimates that 2,000 firms will average 60 minutes (1 hour) to 
submit new requests for inclusion on the list, 2,000 firms will average 
30 minutes (0.5 hour) to update their information every 2 years, and 
200 firms will average 30 minutes (0.5 hour) to occasionally update 
their information in this system. We also believe that submission via 
the electronic registry system will not affect the burden estimates. An 
electronic registry will enhance the ability of firms to more 
efficiently request inclusion on export lists. FDA calculates, 
therefore, that the total burden for this collection is 3,100 hours 
((2,000 x 1) plus (2,000 x 0.5) plus (200 x 0.5)).

    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12356 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P