Document ID: FDA-2009-N-0246-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2010-01-22T05:00Z

[Federal Register: January 22, 2010 (Volume 75, Number 14)]
[Notices]               
[Page 3738-3739]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22ja10-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0246]

 
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 
February 22, 2010.

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 e-mailed 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: Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.cfsan.fda.gov/
guidance.html. The guidance document explains that FDA has established 
a list that is provided to the government of Chile and posted on http:/
/

[[Page 3739]]

www.cfsan.fda.gov/~comm/expcllst.html, 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: (1) Name and address of the 
firm and the manufacturing plant; (2) name, telephone number, and e-
mail address (if available) of the contact person; (3) a list of 
products presently shipped and expected to be shipped in the next 3 
years; (4) identities of agencies that inspect the plant and the date 
of last inspection; (5) plant number and copy of last inspection 
notice; and (6) 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 June 4, 2009 (74 FR 26867), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two letters in response, each 
containing one or more comments. The comments were outside the scope of 
the comment request in the notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                    No. of        Annual Frequency      Total Annual
  Activity       Respondents        per Response          Responses       Hours per  Response     Total Hours
----------------------------------------------------------------------------------------------------------------
New written                  15                  1                    15                  1.5                 23
 requests to
 be placed
 on the list
----------------------------------------------------------------------------------------------------------------
Biannual                     88                  1                    88                  1.0                 88
 update
----------------------------------------------------------------------------------------------------------------
Occasional                   25                  1                    25                  0.5                 13
 updates
----------------------------------------------------------------------------------------------------------------
Total                                                                                                        124
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital 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 4 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.
    To date, over 175 producers have sought to be included on the list. 
FDA estimates that, each year, approximately 15 new firms will apply to 
be added to the list. 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 22.5 hours, rounded to 
23. 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 (175 x 0.5 = 87.5, rounded to 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: January 15, 2010.
David Dorsey
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1153 Filed 1-21-10; 8:45 am]
BILLING CODE 4160-01-S