[Federal Register Volume 74, Number 106 (Thursday, June 4, 2009)]
[Notices]
[Pages 26867-26869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13041]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

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 written or electronic comments on the collection of 
information by August 3, 2009.

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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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

[[Page 26868]]

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.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:/
/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, a 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:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of        Annual Frequency      Total Annual          Hours per
   Activity        Respondents        per Response          Responses            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, to 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.


[[Page 26869]]


    Dated: May 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13041 Filed 6-3-09; 8:45 am]
BILLING CODE 4160-01-S