[Federal Register Volume 69, Number 96 (Tuesday, May 18, 2004)]
[Rules and Regulations]
[Pages 28060-28061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11247]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 2002N-
0278 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     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