[Federal Register Volume 69, Number 72 (Wednesday, April 14, 2004)]
[Rules and Regulations]
[Pages 19766-19767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 20

[Docket No. 2002N-0276]


Registration of Food Facilities Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; reopening of comment period

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 30 
days, on a limited set of issues, the comment period on the 
registration of food facilities interim final rule (IFR) that appeared 
in the Federal Register of October 10, 2003 (68 FR 58894). The IFR 
requires domestic and foreign facilities that manufacture/process, 
pack, or hold food for human or animal consumption in the United States 
to register with FDA by December 12, 2003. FDA is taking this action 
consistent with its statement in the IFR that it would reopen the 
comment period for 30 days in March 2004 to ensure that those 
commenting on the IFR have had the benefit of FDA's outreach and 
educational efforts and have had experience with the systems, 
timeframes, and data elements of the registration program.

DATES: Submit written or electronic comments on the identified set of 
issues for the IFR by May 14, 2004.

ADDRESSES: Submit written comments 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.

FOR FURTHER INFORMATION CONTACT: Melissa S. Scales, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 10, 2003 (68 FR 58894), FDA 
issued an IFR to implement section 305 of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism 
Act). The registration regulation requires facilities that manufacture/
process, pack, or hold food (including animal feed) for consumption in 
the United States to register with FDA by December 12, 2003. In the 
``Request for Comments'' section of the IFR, FDA requested comments on 
specific issues in order to improve the assumptions used in its 
economic analysis. The IFR stated that its comment period would 
coincide with that of the prior notice IFR, given the relatedness of 
the two rules. Therefore, the registration IFR was open for comments 
for 75 days following the publication of the IFR. The IFR also stated 
that ``to ensure that those commenting on this interim final rule have 
had the benefit of FDA's outreach and educational efforts and have had 
experience with the systems, timeframes, and data elements of this 
interim final rule,'' FDA would reopen the comment period for an 
additional 30 days in March 2004.

II. Comments

    Consistent with the intent expressed in the preamble to the IFR, we 
are seeking comments on the following issues in order to improve FDA's 
economic analysis:
    1. The cost to foreign facilities of hiring and retaining a U.S. 
agent.

[[Page 19767]]

Specifically, FDA invites comment, and the submission of data or other 
information, on the following:
    a. The costs to a foreign facility of hiring a U.S. agent;
    b. The number of foreign facilities that have hired a U.S. agent or 
negotiated additional duties from someone with whom they have an 
existing relationship, in response to the IFR, instead of relying on an 
existing relationship with a person who qualifies as a U.S. agent;
    c. The number of foreign facilities that have ceased exporting to 
the United States because they have decided not to hire/retain a U.S. 
agent for registration purposes;
    d. The distribution of costs between submitting registrations and 
other services offered by the U.S. agent; and
    e. The assumptions underlying FDA's estimates of the costs of 
hiring and retaining a U.S. agent.
    2. The effects on domestic small businesses, if any, if some 
foreign facilities cease exporting to the United States due to the U.S. 
agent requirement for registration. Specifically, FDA invites comment, 
and the submission of data or other information, on the following:
    a. The number of domestic small businesses that have been adversely 
affected by trading partners that have ceased exporting to the United 
States due to the U.S. agent requirement for foreign facility 
registration; and
    b. The costs incurred by these domestic small businesses due to the 
loss of these trading partners.
    To be timely, interested persons must submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the above issues as indicated in the DATES section of this 
document. Two copies of any comments are to be submitted by commenting 
entities; individuals may submit one copy. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. 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.
    As noted, the IFR was effective on December 12, 2003. The agency 
will address comments on the identified set of issues that are received 
during this reopened comment period and were received during the 
previous comment period that closed on December 24, 2003, and will 
confirm or amend the IFR in a final rule. The agency, however, will not 
address any comments that have been previously considered during this 
rulemaking.

    Dated: March 24, 2004.
Lester M. Crawford,
Acting Commissioner for Food and Drugs.

    Dated: April 6, 2004.
Robert C. Bonner,
Commissioner, Customs and Border Protection.
[FR Doc. 04-8516 Filed 4-9-04; 4:51 pm]
BILLING CODE 4160-01-S