[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Pages 41157-41160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0295]


Agency Information Collection Activities; Proposed Collection; 
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 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 procedures being 
implemented by FDA to assist U.S. dairy product manufacturers and 
processors that wish to export dairy products to Chile. In the Federal 
Register of May 21, 2003 (68 FR 27821), FDA published a notice 
announcing the Office of Management and Budget's (OMB) approval of this 
collection of information (OMB control number 0910-0509). Since this 
was an emergency approval that expires on

[[Page 41158]]

October 31, 2003, FDA is following the normal PRA clearance procedures 
by issuing this notice.

DATES: Submit written or electronic comments on the collection of 
information by September 8, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. Submit written comments 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from 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: (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 for Industry and FDA: Establishing and Maintaining a List of 
U.S. Dairy Product Manufacturers/Processors 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.
    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.
    Two comments expressed concern that there may be a significant 
delay between the time a firm submits a request to FDA to be listed and 
the time it is actually placed on the list for export to Chile. FDA 
believes that it has addressed this situation in development of its 
guidance. The agency developed procedures for establishing and 
maintaining the list to minimize the time required for placement of an 
eligible firm within a reasonable and predictable time after making a 
request to FDA to be listed.
    One comment expressed concern that it is unnecessary for FDA to 
request, for firms already on other recognized Federal Government 
lists, the identity of the agencies that inspect the plant and the date 
of last inspection; plant number and copy of the last inspection 
notice; and, if other than an FDA inspection, a copy of the last 
inspection. FDA believes that it is necessary to verify the status of 
all firms making application to the agency to be included on the list. 
This process will be greatly facilitated by the information that is 
being requested. By placing a firm on the list, FDA will be attesting 
that the firm is under the regulatory jurisdiction of FDA and is not 
the subject of a pending FDA judicial enforcement action or an 
unresolved warning letter. The lists identified by the comments, ``The 
Interstate Milk Shippers List for Grade `A' Dairy Plants'' and ``The 
List of Dairy Plants Surveyed and Approved for USDA Grading Service,'' 
are product specific and may not include the products the firms intend 
to export to Chile. This would preclude the use of these lists for some 
firms.
    One comment noted that FDA should make use of existing lists and 
inspection programs when determining if a firm should be placed on the 
list. FDA believes that it is necessary, for each initial listing of a 
firm, for the agency to create a complete and unique file corresponding 
to each request for placement on the list. The documentation contained 
in this file

[[Page 41159]]

would include all relevant information necessary to demonstrate 
satisfaction of the minimum conditions for listing of a firm, including 
a copy of the most current inspection report, whether that inspection 
was conducted by FDA or by another regulatory entity, i.e., the U.S. 
Department of Agriculture (USDA) or a State regulatory agency. FDA 
believes that a copy of the inspection report, appended to the request 
for placement on the list, is necessary to meet minimum documentation 
requirements. A firm's presence on any other list would not be 
sufficient to document satisfaction of the listing criteria. FDA's 
request to receive information on the Federal or State agency that 
conducted the most current inspection and, if other than FDA, a copy of 
the most current inspection report, will facilitate the completion of 
the documentation file and the review process and will expedite the 
overall listing procedure.
    One comment encouraged FDA to establish a system for adding plants 
to the list that is simple and rapid, with clear administrative rules 
and to consider allowing application to the list through the Internet. 
FDA will be using the Internet to post and maintain the list. FDA is 
not prepared to allow application to the list through the Internet at 
this time. Once the list is established and in use, FDA will consider 
whether it is feasible to use the Internet to receive applications.
    One comment expressed concern that FDA, by establishing a list of 
U.S. dairy product manufacturers/processors that wish to export dairy 
products to Chile, would do the following actions: (1) Duplicate 
existing procedures already in place at USDA and State Departments of 
Agriculture for obtaining export ``documents'' necessary for market 
access of U.S. dairy products into Chile; (2) cause manufacturers to 
have to obtain such documents from more than one Federal or State 
agency; and (3) otherwise complicate the procedures whereby U.S. dairy 
manufacturers could export their products to Chile. These comments also 
suggested that, in the future, FDA should defer to the USDA on 
``negotiations'' pertaining to export of U.S. dairy products to other 
countries.
    The comments indicate that some clarification of the roles and 
responsibilities of U.S. Government agencies is necessary. While FDA 
participates in many cooperative activities with U.S. States and with 
USDA in the area of food safety, FDA is the principal Federal agency 
within the U.S. Government responsible for the human health aspects of 
dairy product safety. As such, FDA is the appropriate U.S. agency to 
participate in discussions with foreign governments on matters relevant 
to the public (human) health aspects of U.S. dairy products. As stated 
in the April 10, 2003, Federal Register document, Chilean authorities 
have recognized FDA as the competent food safety (public health) 
authority in the United States to identify U.S. dairy product 
manufacturers eligible to export to Chile. In this context, Chilean 
authorities will rely on FDA to list these firms and to notify Chile 
regularly of all U.S. dairy firms that have met the criteria to be 
listed. On the basis of a regularly updated list identifying firms that 
have applied to FDA to be listed, that are under FDA jurisdiction, and 
that are not the subject of a pending judicial FDA enforcement action 
or unresolved FDA warning letter, Chilean authorities will consider 
U.S. dairy products entering Chile to have satisfied public (human) 
health requirements. Contrary to the suggestion in the comment, no 
consignment-specific ``document'' issued by FDA must accompany any 
individual consignment of these dairy products.
    USDA's Animal and Plant Health Inspection Service (APHIS) is 
responsible for dairy product safety with respect to animal health. 
Many countries, including Chile, mandate that each exported consignment 
of U.S. dairy products be accompanied by a certificate issued by APHIS 
attesting to satisfaction of certain animal health requirements. With 
regard to the present situation, Chilean authorities will still require 
the consignment-specific certificate demonstrating satisfaction of 
certain animal health provisions. The establishment of the proposed 
list of U.S. dairy product manufacturers and processors by FDA will not 
affect the requirement for the consignment-specific APHIS certificate.
    Negotiations with Chile which led to the proposal for, and decision 
to move forward with, the list were conducted by a U.S. Government team 
comprised of, among others, both FDA and several USDA agencies, 
including APHIS and Agricultural Marketing Service.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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     No. of        Annual Frequency per
   Respondents           Response          Total Annual Records     Hours per Response          Total Hours
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75\2\                       1                      75                       1.5                   112.5
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8\3\                        1                       8                       1.5                    12
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8\4\                        1                       8                       0.5                     4
                                                                                         -----------------------
Total             ......................  ......................  ......................          129
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ First year burden.
\3\ Recurring burden.
\4\ Recurring burden in reporting changes, including time reviewing collection of information and corresponding
  to FDA.

    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 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

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hours for reporting changes to FDA for firms already on the list.

    Dated: July 2, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-17408 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S