[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Notices]
[Pages 6623-6624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1866]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1571]
Enrofloxacin for Poultry; Opportunity for Hearing; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
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SUMMARY: The Food and Drug Administration's (FDA's) Center for
Veterinary Medicine (CVM), is revising a notice of opportunity for
hearing (NOOH) that published in the Federal Register on October 31,
2000 (65 FR 64954). After publishing the NOOH, CVM determined that some
estimates of numbers of human campylobacteriosis cases and
fluoroquinolone-resistant Campylobacter cases provided by a risk
assessment used as a reference in the NOOH were incorrect. CVM has
revised the risk assessment and is revising the estimates that were
provided in the NOOH. This notice also extends the deadline for the
sponsor to submit data and analysis upon which a request for a hearing
relies. Other interested persons may submit comments on the NOOH before
the deadline.
DATES: Submit all written data and analysis upon which a request for a
hearing relies and other written comments by February 21, 2001.
ADDRESSES: Data and analysis and other comments are to be identified
with Docket No. 00N-1571 and must be submitted to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
The revised risk assessment entitled ``The Human Health Impact of
Fluoroquinolone Resistant Campylobacter Attributed to the Consumption
of Chicken, Revised: January 5, 2001'' (hereafter referred to as Ref.
2a) is available electronically at http://www.fda.gov/cvm/antimicrobial/antimicrobial.html and in this docket.
FOR FURTHER INFORMATION CONTACT: Linda Tollefson, Center for Veterinary
Medicine (HFV-200), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-2950.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 31, 2000 (65 FR 64954), CVM
published an NOOH proposing withdrawal of the approval of a new animal
drug application (NADA) for the use of the fluoroquinolone enrofloxacin
in poultry. The NOOH included estimates that were taken from Ref. 2 of
the October 31, 2000, NOOH, the risk assessment entitled ``Human Health
Impact of Fluoroquinolone Resistant Campylobacter Attributed to the
Consumption of Chicken, October 18, 2000.'' After publication of the
NOOH, CVM determined that two of the cell references in the risk
assessment were mislabeled and as a result, the model outputs were
incorrect. CVM has revised the risk assessment to correct the cell
references. Because CVM needed to make these corrections to the risk
assessment, it has also incorporated the final FoodNet data for 1999
into the risk assessment and has made other related changes. CVM is
revising the NOOH to reflect the changes in the risk assessment and to
add the revised risk assessment Ref. 2a to the list of references in
the NOOH. CVM does not believe that these revisions in any way alter
the underlying basis of the NOOH.
The following section describes the location and revisions to the
October 31, 2000, NOOH.
II. Revisions
Based on the revisions to the risk assessment, CVM is revising the
estimates in the October 31, 2000, NOOH for the mean estimate of cases
of campylobacteriosis; the mean estimate of the domestically-acquired
[[Page 6624]]
fluoroquinolone-resistant Campylobacter cases in humans attributable to
consumption of chicken; and the mean estimate of the number of people
who were infected with fluoroquinolone-resistant Campylobacter from
consuming or handling chicken and who subsequently received a
fluoroquinolone as therapy for their illness. CVM is also adding the
revised risk assessment to the References section of the NOOH.
Table 1 provides the location and actual revisions of items in the
NOOH.
Table 1.--Revisions to the October 31, 2000, NOOH
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Location Sentence as published Correction
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64955, 2d column, beginning on the The risk assessment determined * * * ``The risk assessment determined * *
9th line from bottom of page a mean estimate of 11,477 persons * a mean estimate of 9,261
(5th and 95th percentiles: 6,412 persons,(5th and 95th percentiles:
and 18,978) * * *'' 5,227 and 15,326) * * *''
64962, 1st column, beginning on the ``Using the data on human ``Using the data on
8th line Campylobacter * * * calculated a humanCampylobacter * * * calculated
mean estimate of 1.7 million cases a mean estimate of 1.4 million
of campylobacteriosis (5th and 95th cases of campylobacteriosis (5th
percentiles: 1.1 million and 2.7 and 95th percentiles: 0.9 million
million) for 1999 (Ref. 2).'' and 2.1 million) for 1999 (Ref.
2a).''
64962, 1st column, 1st full ``For 1999, the mean estimate of * * ``For 1999, the mean estimate of * *
paragraph, beginning on the 7th * is 190,421 (5th and 95th * is 153,580 (5th and 95th
line from the bottom of the percentiles: 103,471 and 318,321) percentiles: 83,990 and 258,047)
paragraph (Ref. 2).'' (Ref. 2a).''
64962, 1st column, 2d full ``For 1999, the estimated * * * ``For 1999, the estimated * * * a
paragraph, beginning on the 7th 11,477 (5th and 95th percentiles: mean estimate of 9,261 persons,
line 6,412 and 18,978) (Ref. 2).'' (5th and 95th percentiles: 5,227
and 15,326) (Ref. 2a).''
64962, 2d column, 1st full ``The risk assessment determined in ``The risk assessment determined in
paragraph, beginning on the 13th 1999 a mean estimate of 11, 477 1999 a mean estimate of 9,261
line from the bottom of the people (5th and 95th percentiles: people (5th and 95th percentiles:
paragraph 6,412 and 18,978) * * *'' 5,227 and 15,326) * * *''
64963, 2d column under IX. Insert the following reference
References, between Refs. 2 and 3 between Refs. 2 and 3: ``2a. The
Human Health Impact of
Fluoroquinolone
ResistantCampylobacter Attributed
to the Consumption of Chicken,
Revised: January 5, 2001.''
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Dated: January 16, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-1866 Filed 1-18-01; 11:03 am]
BILLING CODE 4160-01-F