[Federal Register Volume 68, Number 69 (Thursday, April 10, 2003)]
[Notices]
[Pages 17655-17656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8901]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0135]


Agency Emergency Processing Under OMB Review; Guidance: 
Establishing and Maintaining a List of U.S. Dairy Product Manufacturers 
With Interest in Exporting to Chile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). FDA is preparing a guidance 
document intended to notify the public of procedures being implemented 
by the agency to assist U.S. firms that wish to export dairy products 
to Chile. FDA is taking this action in response to trade discussions 
with Chile that have been adjunct to the negotiations of the United 
States-Chile Free Trade Agreement. FDA is requesting this emergency 
processing under the PRA because a normal clearance is likely to impede 
completion of the United States-Chile Free Trade Agreement.

DATES: Fax or electronically mail written comments on the collection of 
information by May 12, 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 
electronically mailed to [email protected] or faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk 
Officer for FDA, FAX 202-395-6974. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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

SUPPLEMENTARY INFORMATION: FDA is preparing a guidance document 
intended to notify the public of procedures being implemented by the 
agency to assist U.S. firms that wish to export dairy products to 
Chile. FDA is taking this action in response to trade

[[Page 17656]]

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 has recognized FDA as the competent food safety 
authority in the United States to identify U.S. dairy product 
manufacturers eligible to export to Chile and has 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, which will be posted on the Internet and given to 
Chile, identifying U.S. firms 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.
    FDA has requested emergency processing of this proposed collection 
of information under section 3507(j) of the PRA (44 U.S.C. 3507(j)) and 
5 CFR 1320.13. This information is needed immediately because it will 
take time to establish a list of U.S. firms that wish to export dairy 
products to Chile. Immediate collection of the information will reduce 
the length of delay before any U.S. firm can actually export their 
dairy products to Chile without submitting to prior individual 
inspections from Chile. The use of normal clearance procedures would 
prolong the time needed to provide guidance on the process for firms to 
seek inclusion on the referenced list. Delay in resolution of this 
agricultural trade issue is likely to impede completion of the United 
States-Chile Free Trade Agreement.
    FDA invites comments on: (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.

Guidance: Establishing and Maintaining a List of U.S. Dairy Product 
Manufacturers With Interest in Exporting to Chile

    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.
    At a later date, FDA will announce the availability of a final 
guidance entitled ``Establishing and Maintaining a List of U.S. Dairy 
Product Manufacturers With Interest in Exporting to Chile.'' The 
guidance will provide voluntary recommendations on the process for 
firms that wish to export dairy products to Chile. 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 and telephone number 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 burden estimates presented below considered the number of U.S. 
firms that FDA believes produce dairy products and which will be 
interested in exporting to Chile, which is estimated to total 50. After 
the first year, FDA believes that approximately five new firms each 
year will be interested in exporting dairy products to Chile, and thus, 
being placed on the list.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                       Annual Frequency of       Total Annual
 No. of Respondents       per Response             Responses          Hours per Response         Total Hours
----------------------------------------------------------------------------------------------------------------
50\2\                           1                    50                       1.5                    75
----------------------------------------------------------------------------------------------------------------
5\3\                            1                     5                       1.5                     7.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ First year burden.
\3\ Recurring burden.

    The estimate of the number of firms that will seek to be on the 
list is based on FDA's current knowledge of the number of U.S. firms 
that produce dairy products and that will be interested 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 estimate that for the first year a firm will require 1.5 
hours to read the Federal Register, gather the information needed, and 
prepare a communication to FDA that contains the information and 
requests that the firm be placed on the list.

    Dated: April 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8901 Filed 4-8-03; 11:52 am]
BILLING CODE 4160-01-S