[Federal Register Volume 68, Number 195 (Wednesday, October 8, 2003)]
[Notices]
[Pages 58114-58115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25448]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0295]


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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 7, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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

    Section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 371(h)) authorizes the Secretary of Health and Human Services 
(the Secretary) to develop guidance documents with public participation 
presenting the views of the Secretary on matters under the jurisdiction 
of FDA.

[[Page 58115]]

    In the Federal Register of May 23, 2003 (68 FR 28237), FDA 
announced the availability of a guidance entitled ``Establishing and 
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With 
Interest in Exporting to Chile.'' The guidance provided voluntary 
recommendations on the process for firms that wish to export dairy 
products to Chile. FDA is taking this action in response to discussions 
with Chile that have been adjunct to the negotiations of the United 
States-Chile Free Trade Agreement. As a result of those discussions, 
Chile recognized FDA as the competent food safety authority in the 
United States to identify U.S. dairy product manufacturers and 
processors eligible to export to Chile and concluded that it will not 
conduct individual inspections of U.S. firms identified by FDA as 
eligible to export to Chile.
    Therefore, FDA intends to establish and maintain a list identifying 
U.S. 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 an unresolved warning letter. Under this 
guidance, FDA recommends that U.S. firms that want to be placed on the 
list send information to FDA (i.e., name and address of the firm and 
the manufacturing plant; name, telephone number, and e-mail address (if 
available) of contact person; list of products presently shipped and 
expected to be shipped in the next 3 years; identities of agencies that 
inspect the plant and date of last inspection plant number and copy of 
last inspection notice; and, if other than an FDA inspection, copy of 
last inspection report. The term ``dairy products,'' for purposes of 
this list, is not intended to cover the raw agricultural commodity raw 
milk. The guidance can be found at http://www.cfsan.fda.gov/guidance.html.
    The burden estimates presented in the following paragraphs 
considered the number of U.S. firms that FDA believes produce dairy 
products and that will be interested in exporting to Chile, which is 
estimated to total 75. After the first year, FDA believes that 
approximately eight new firms each year will be interested in exporting 
dairy products to Chile, and thus, being placed on the list. In the 
Federal Register of April 10, 2003 (68 FR 17655), FDA published an 
emergency notice requesting public comment on the information 
collection provisions that had been submitted to OMB for emergency 
processing under the PRA. Four comments were received from trade 
associations and private industry.
    Those comments were answered in the 60-day notice.
    In the Federal Register of July 10, 2003 (68 FR 41157), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         Type of Survey               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Mail questionnaire                         1,000               1           1,000               3           3,000
Phone Survey                               1,000               1           1,000              .5             500
Internet or Cable Survey                   3,000               1           3,000               1           3,000
Total                             ..............  ..............  ..............  ..............           6,500
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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 is based on the actual number 
of U.S. firms that applied to be placed on the list as a result of the 
Federal Register of May 23, 2003 (68 FR 28237), publication of the 
availability of a guidance entitled ``Establishing and Maintaining a 
List of U.S. Dairy Product Manufacturers/Processors With Interest in 
Exporting to Chile.'' The estimate of the number of hours that it will 
take a firm to gather the information needed to be placed on the list 
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. We (FDA) estimate that for the first year a 
firm will require 1.5 hours to read the Federal Register, 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. We 
estimate the recurring burden in subsequent years to be 1.5 hours for a 
new firm to be placed on the list and 0.5 hours for reporting changes 
to FDA for firms already on the list.

    Dated: September 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25448 Filed 10-7-03; 8:45 am]
BILLING CODE 4160-01-S