[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68128-68129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27723]



[[Page 68128]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 
provisions of the guidance document entitled ``Establishing and 
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With 
Interest in Exporting to Chile.''

DATES: Submit either electronic or written comments on the collection 
of information by January 14, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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., PI50-400T, 
Rockville, MD 20850, [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 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 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 68129]]



                                 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 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: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27723 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P