[Federal Register: May 18, 2004 (Volume 69, Number 96)]
[Rules and Regulations]
[Page 28060-28061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18my04-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 2002N-0278]
Prior Notice of Imported Food Under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to July
13, 2004, the comment period on the prior notice interim final rule
(IFR) that appeared in the Federal Register of October 10, 2003 (68 FR
58974). The prior notice IFR requires the submission to FDA of prior
notice of food, including animal feed, that is imported or offered for
import into the United States. FDA reopened the comment period for 30
days in the Federal Register of April 14, 2004 (69 FR 19766), to
solicit comments on the ``Joint FDA-CBP Plan for Increasing Integration
and Assessing the Coordination of Prior Notice Timeframes'' and to
ensure that those who comment on this IFR would have had the benefit of
our outreach and education efforts and would have had some experience
with the systems, timeframes, and data elements of the prior notice
system. In response to a request from the Government of Canada, FDA is
extending the comment period for an additional 60 days. Accordingly,
the comment period for the prior notice rulemaking, including the
comment period for the ``Joint FDA-CBP Plan for Increasing Integration
and Assessing the Coordination of Prior Notice Timeframes,'' is
extended to July 13, 2004.
DATES: Submit written or electronic comments no later than July 13,
2004.
ADDRESSES: You may submit comments, identified by Docket 2002N-0278, by
any of the following methods:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
<bullet> E-mail: fdadockets@oc.fda.gov. Include Docket No. 2002N-
0278 in the subject line of your e-mail message.
<bullet> FAX: 301-827-6870.
<bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. or Regulatory Information Number (RIN) for this
rulemaking. All comments received will be posted without change to
http://www.fda.gov/dockets/ecomments, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/dockets/ecomments and/or
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: May D. Nelson, Center for Food Safety
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1722.
SUPPLEMENTARY INFORMATION: FDA issued this rule as an IFR, with an
opportunity for public comment for 75 days. Moreover, to ensure that
those that comment on this IFR would have had the benefit of actual
experience with the systems, timeframes, and data elements, FDA
reopened the comment period for an additional 30 days on April 14, 2004
(to close on May 14, 2004). On April 29, 2004, FDA received a request
from the Government of Canada to extend the comment period for an
additional 60 days (Comment EXT1, 2002N-0278) (69 FR 19763). According
to the Canadian government, the 30-day comment period does not allow
Canada to consult adequately with its stakeholders and formally explore
with FDA effective alternatives in response to FDA's request for
comments. Additionally, Canada states it is concerned that its industry
is not yet fully aware of the prior notice IFR's impact since during
the initial period of implementation feedback to affected industries
from FDA and Customs and Border Protection concerning noncompliance was
minimal. The Government of Canada submitted this request with the
understanding that such an extension would not interfere with the
issuance of the prior notice final rule, which FDA plans to publish in
March 2005. FDA intends to publish a final rule in an expeditious
manner while carefully considering the comments we receive.
Comments
In response to the request from the Government of Canada, we are
extending the comment period an additional 60 days to close on July 13,
2004. Accordingly, we are seeking comments on all aspects of the prior
notice IFR, including the specific questions we posed in the previous
notice to reopen the comment period (see 69 FR 19763 at 19764), and the
``Joint Food and Drug Administration-Customs Border Protection Plan for
Increasing Integration and Assessing the
[[Page 28061]]
Coordination of Prior Notice Timeframes'' (69 FR 19765).
To be timely, interested persons must submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments on
the prior notice IFR by July 13, 2004. Submit a single copy of
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
This regulation was effective on December 12, 2003. We will address
comments received during the entire reopened comment period and the
previous comment period that closed on December 24, 2003, and will
confirm or amend the IFR in a final rule. We, however, will not address
any comments that have been previously considered during this
rulemaking.
Dated: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11247 Filed 5-13-04; 4:27 pm]
BILLING CODE 4160-01-S
Interim Final Rule: Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (68 FR 58975) October 10, 2003
