[Federal Register Volume 68, Number 100 (Friday, May 23, 2003)]
[Notices]
[Pages 28237-28238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0180]


Guidance for Industry and FDA; Establishing and Maintaining a 
List of U.S. Dairy Product Manufacturers/Processors With Interest in 
Exporting to Chile; Availability and a Request for Information From 
Such Manufacturers/Processors

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry and FDA; 
Establishing and Maintaining a List of U.S. Dairy Product 
Manufacturers/Processors With Interest in Exporting to Chile.'' This 
guidance explains that FDA intends to establish and maintain a list, 
which will be sent to Chile and posted on FDA's Internet site, 
identifying the names and addresses of U.S. manufacturers 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., injunction or seizure) or an 
unresolved warning letter.

DATES: This guidance is final upon the date of publication. However, 
you may submit written or electronic comments at any time.

ADDRESSES: Submit electronic or written information for inclusion on 
the Chilean dairy list to Esther Z. Lazar, Center for Food Safety and 
Applied Nutrition (HFS-306) (see FOR FURTHER INFORMATION CONTACT). Send 
one self-addressed adhesive label to assist that office in processing 
your request or include a fax number to which the guidance may be sent. 
Submit written comments on the guidance document or the collection of 
information to the Dockets Management Branch (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. Submit electronic comments on the 
guidance document or the collection of information to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. See the 
SUPPLEMENTARY INFORMATION section for electronic access to this 
guidance document.
    Submit written requests for single copies of this guidance to the 
Office of Plant and Dairy Foods and Beverages, Division of Dairy and 
Egg Safety, Center for Food Safety and Applied Nutrition, 5100 Paint 
Branch Pkwy., College Park, MD 20740.

FOR FURTHER INFORMATION CONTACT: Esther Z. Lazar, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1485, or e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As a direct result of trade discussions that have been adjunct to 
the United States-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, FDA intends to establish and 
maintain a list, which will be sent to Chile and posted on FDA's 
Internet site, identifying the names and addresses of U.S. dairy 
product manufacturers/processors that have expressed to FDA their 
interest 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. The term ``dairy products,'' for purposes of this list, is not 
intended to cover the raw agricultural commodity raw milk.

II. Discussion

    The guidance document states that 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

[[Page 28238]]

injunction or seizure) or an unresolved warning letter. Inclusion of 
U.S. dairy product manufacturers/processors on this list is voluntary. 
However, dairy products from firms not on this list could be refused 
entry at the Chilean port of entry. The 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 guidance notes that FDA will 
consider the information on this list, which will be posted on FDA's 
Internet site and communicated to Chile, to be information that is not 
protected from disclosure under 5 U.S.C. 552(b)(4).
    This guidance represents the agency's current thinking on the 
procedures for assisting Chile in determining which U.S. manufacturers 
or processors are eligible to export dairy products to Chile. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.
    This guidance document is being issued as a level 1 guidance 
consistent with FDA's good guidance practices (GGPs) regulation (Sec.  
10.115 (21 CFR 10.115)). Consistent with GGPs, the agency will accept 
comment, but is implementing the guidance document immediately in 
accordance with Sec.  10.115(g)(2), because the agency has determined 
that prior public participation is not feasible or appropriate. The 
guidance document presents a less burdensome policy that is consistent 
with the public health.

III. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this guidance at 
any time. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The guidance and received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

    The Office of Management and Budget (OMB) has approved this 
collection of information under the emergency processing provision of 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(j) and 5 CFR 
1320.13) and has assigned OMB control number 0910-0509. As discussed in 
the Federal Register of April 10, 2003 (68 FR 17655), public reporting 
burden for this collection of information is estimated to be 1.5 hours 
per response, including the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.

V. Electronic Access

    Interested persons also may access the guidance document at http://www.cfsan.fda.gov/guidance.html.

    Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12975 Filed 5-22-03; 8:45 am]
BILLING CODE 4160-01-S