[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