[Federal Register Volume 70, Number 119 (Wednesday, June 22, 2005)]
[Notices]
[Pages 36190-36191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0180]


Guidance for Industry and Food and Drug Administration: 
Establishing and Maintaining a List of U.S. Dairy Product 
Manufacturers/Processors With Interest in Exporting to Chile; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or agency) is announcing 
the availability of a revised guidance 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.'' 
The guidance explains that FDA has established a list that is provided 
to the government of Chile and posted on FDA's Internet site, which 
identifies U.S. dairy product 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 (e.g., injunction or seizure) or a pending warning 
letter. Application for inclusion on the list is voluntary. However, 
Chile has advised that dairy products from firms not on this list could 
be delayed or prevented by Chilean authorities from entering commerce 
in Chile. The revised guidance document describes the recommended 
process for U.S. manufacturers to follow to be included on the list and 
explains FDA's request, on Chile's behalf, that this information be 
updated every 2 years.

DATES: This revised guidance is final upon the date of publication. 
Submit written or electronic comments on the revised guidance document 
at any time.

ADDRESSES: Submit written requests for single copies of the revised 
guidance document to the Office of Plant and Dairy Foods and Beverages, 
Division of Dairy and Egg Safety (HFS-306), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Include a self-addressed adhesive label 
to assist that office in processing your request or include a fax 
number to which the guidance document may be sent.
    Submit written comments on the revised guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revised guidance 
document.

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 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 has established a list, 
which is provided to the government of Chile and posted on FDA's 
Internet site, identifying 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 
a pending 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 revised guidance document states that FDA has established 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 a pending 
warning letter. Inclusion of U.S. dairy product manufacturers/
processors on this list is voluntary. However, Chile has advised that 
dairy products from firms not on this list could be refused entry at 
the Chilean port of entry. The revised 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 revised guidance notes that FDA 
considers the information on this list, which is provided voluntarily 
with the understanding that it will be posted on FDA's Internet site 
and communicated to, and possibly further disseminated by, Chile, to be 
information that is not protected from disclosure under 5 U.S.C. 
552(b)(4).
    This is a revision of the guidance that FDA issued in May 2003 (68 
FR 28237, May 23, 2003). This revised guidance adds to the information 
that FDA intends to post on its Web site and share with Chile, and it 
explains the actions that FDA intends to take to update the list every 
2 years.
    FDA is issuing this revised guidance as a level 1 guidance 
consistent with FDA's good guidance practices regulation Sec.  10.115 
(21 CFR 10.115). Consistent with FDA's good guidance practices 
regulation, the agency will accept comment, but is implementing the 
revised 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. This revised guidance 
represents the agency's current thinking on how FDA intends to comply 
with Chile's request for a list of U.S. manufacturers or processors 
that 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.

[[Page 36191]]

III. Paperwork Reduction Act of 1995

    This revised final guidance contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in this guidance was approved 
under OMB control number 0910-0509. The approval expires on December 
31, 2006. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this revised 
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 revised 
guidance and received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the revised guidance 
document at http://www.cfsan.fda.gov/guidance.html.

    Dated: June 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12234 Filed 6-21-05; 8:45 am]
BILLING CODE 4160-01-S