[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