[Federal Register: May 23, 2003 (Volume 68, Number 100)]
[Notices]
[Page 28237-28238]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my03-103]
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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: elazar@cfsan.fda.gov.
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