[Federal Register: April 14, 2004 (Volume 69, Number 72)]
[Rules and Regulations]
[Page 19766-19767]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap04-9]
-----------------------------------------------------------------------
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
-----------------------------------------------------------------------
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
