[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Notices]
[Page 58114-58115]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc03-58]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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