[Federal Register Volume 71, Number 146 (Monday, July 31, 2006)]
[Notices]
[Pages 43202-43203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0274]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Establishing and Maintaining a List of United States 
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 associated with 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 September 29, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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 Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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.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 FDA's 
Internet site, 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 revised 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

[[Page 43203]]

new information to Chile. Finally, the revised 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 Internet 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 this 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 e-mail 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:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                       Activity                            Respondents         per Response          Responses           Response         Total Hours
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New written requests to be placed on the list                          15                     1                 15                1.5               22.5
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Biannual update                                                        55                     1                 55                1.0               55.0
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Occasional updates                                                     25                     1                 25                0.5               12.5
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Total                                                   .................  ....................  .................  .................                 90
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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 3 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 110 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. Under the revised 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, 55 firms, 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. 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.

    Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12160 Filed 7-28-06; 8:45 am]
BILLING CODE 4160-01-S