[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16511-16512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1106]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Establishing and 
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With 
Interest in Exporting to Chile

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 April 
15, 2013.

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 [email protected]. 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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 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 a List of U.S. Dairy Product 
Manufacturers/Processors With Interest in Exporting to Chile (OMB 
Control Number 0910-0509)--Extension

    As a direct result of discussions that have been adjunct to the 
U.S./Chile Free Trade Agreement, Chile has recognized FDA as the 
competent U.S. food safety authority and has accepted the U.S. 
regulatory system for dairy inspections. Chile has concluded that it 
will not require individual inspections of U.S. firms by Chile as a 
prerequisite for trade, but will accept firms identified by FDA as 
eligible to export to Chile. Therefore, in the Federal Register of June 
22, 2005 (70 FR 36190), FDA announced the availability of a revised 
guidance document entitled ``Establishing and Maintaining a List of 
U.S. Dairy Product Manufacturers/Processors With Interest in Exporting 
to Chile.'' The guidance can be found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ImportsExports/ucm078936.htm. The guidance document explains that FDA 
has established a list that is provided to the government of Chile and 
posted on http://www.fda.gov/Food/InternationalActivities/Exports/ucm120245.htm, which identifies U.S. dairy product manufacturers/
processors that have expressed interest to FDA in exporting dairy 
products to Chile, are subject to FDA jurisdiction, and are not the 
subject of a pending judicial enforcement action (i.e., an injunction 
or seizure) or a pending warning letter. The term ``dairy products,'' 
for purposes of this list, is not intended to cover the raw 
agricultural commodity raw milk. Application for inclusion on the list 
is voluntary. However, Chile has advised that dairy products from firms 
not on

[[Page 16512]]

this list could be delayed or prevented by Chilean authorities from 
entering commerce in Chile. The guidance explains what information 
firms should submit to FDA in order to be considered for inclusion on 
the list and what criteria FDA intends to use to determine eligibility 
for placement on the list. The document also explains how FDA intends 
to update the list and how FDA intends to communicate any new 
information to Chile. Finally, the guidance notes that FDA considers 
the information on this list, which is provided voluntarily with the 
understanding that it will be posted on FDA's Web site and communicated 
to, and possibly further disseminated by, Chile, to be information that 
is not protected from disclosure under 5 U.S.C. 552(b)(4). Under the 
guidance, FDA recommends that U.S. firms that want to be placed on the 
list send the following information to FDA: Name and address of the 
firm and the manufacturing plant; name, telephone number, and email 
address (if available) of the contact person; a list of products 
presently shipped and expected to be shipped in the next 3 years; 
identities of Agencies that inspect the plant and the date of last 
inspection; plant number and copy of last inspection notice; and, if 
other than an FDA inspection, copy of last inspection report. FDA 
requests that this information be updated every 2 years.
    In the Federal Register of November 15, 2012 (77 FR 68128), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information 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 written requests to be                    25               1              25             1.5              38
 placed on the list.............
Biannual update.................              88               1              88             1.0              88
Occasional updates..............              25               1              25             0.5              13
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    Total.......................  ..............  ..............  ..............  ..............             139
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the number of firms that will submit new written 
requests to be placed on the list, biannual updates and occasional 
updates is based on the FDA's experience maintaining the list over the 
past 7 years. The estimate of the number of hours that it will take a 
firm to gather the information needed to be placed on the list or 
update its information is based on FDA's experience with firms 
submitting similar requests. FDA believes that the information to be 
submitted will be readily available to the firms.
    On average, over the last 3 years, the list contained approximately 
176 firms. FDA estimates that, each year, approximately 25 new firms 
will apply to be added to the list. In any given year, some firms 
choose not to resubmit their information. These firms are removed from 
the list quarterly. This occurrence results in the number of firms to 
remain at approximately 176. We estimate that a firm will require 1.5 
hours to read the guidance, gather the information needed, and to 
prepare a communication to FDA that contains the information and 
requests that the firm be placed on the list for a total of 37.5 hours, 
rounded to 38. Under the guidance, every 2 years each producer on the 
list must provide updated information in order to remain on the list. 
FDA estimates that each year approximately half of the firms on the 
list, 88 firms (176 x 0.5 = 88), will resubmit the information to 
remain on the list. We estimate that a firm already on the list will 
require 1.0 hours to biannually update and resubmit the information to 
FDA, including time reviewing the information and corresponding with 
FDA, for a total of 88 hours. In addition, FDA expects that, each year, 
approximately 25 firms will need to submit an occasional update and 
each firm will require 0.5 hours to prepare a communication to FDA 
reporting the change, for a total of 12.5 hours, rounded to 13.

    Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06017 Filed 3-14-13; 8:45 am]
BILLING CODE 4160-01-P