[Federal Register Volume 71, Number 235 (Thursday, December 7, 2006)]
[Notices]
[Pages 70972-70973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20704]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0274]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 January 
8, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 United States 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

[[Page 70973]]

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 
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.
    In the Federal Register of July 31, 2006 (71 FR 43202), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 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                    15                  1                    15                1.5               22.5
 Requests To
 Be Placed On
 The List
Biannual                       55                  1                    55                1.0               55.0
 Update
Occasional                     25                  1                    25                0.5               12.5
 Updates
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. FDA estimates 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. FDA estimates 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: November 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20704 Filed 12-6-06; 8:45 am]
BILLING CODE 4160-01-S