
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46074-46075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21212]



[[Page 46074]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 
November 2, 2017.

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, 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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. 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 https://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 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 https://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.
    In the Federal Register of June 15, 2017 (82 FR 27485), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received three comments, however, they 
were not responsive to the four collection of information topics 
solicited and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

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                                                      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: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21212 Filed 10-2-17; 8:45 am]
 BILLING CODE 4164-01-P


