[Federal Register Volume 68, Number 194 (Tuesday, October 7, 2003)]
[Notices]
[Pages 57911-57912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0324]


Certain Antibiotic New Animal Drug Products and Use Combinations 
Subject to Listings in the New Animal Drug Regulations; Drug Efficacy 
Study Implementation; Notice of Opportunity for Hearing; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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[[Page 57912]]

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
of opportunity for hearing that published in the Federal Register on 
August 8, 2003 (68 FR 47332). FDA is correcting a product name used by 
the current sponsor of NADA 141-137, the FR citation for a Drug 
Efficacy Study Implementation Program finding of effectiveness, and the 
column headings of six tables. These corrections are being made to 
improve the accuracy of the Federal Register. This notice also extends 
the deadline for parties who have requested a hearing to submit data 
and analysis upon which their request for a hearing relies. Other 
interested persons may submit comments on the notice of opportunity for 
hearing (NOOH) before the deadline.

DATES: Submit all written data and analysis upon which a request for a 
hearing relies and other written comments by November 6, 2003.

FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for 
Veterinary Medicine (HFV-1), 7519 Standish Pl., Rockville, MD 20855, 
301-827-2954, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 8, 2003 (68 FR 47332), FDA 
announced the effective conditions of use for some of the drug products 
and use combinations subject to the listings in Sec. Sec.  510.515 and/
or 558.15 (21 CFR 510.515 and/or 558.15), and proposed to withdraw the 
new animal drug applications (NADAs) for those products or use 
combinations lacking substantial evidence of effectiveness following a 
90-day opportunity to supplement the NADAs with labeling conforming to 
the relevant findings of effectiveness. The Center for Veterinary 
Medicine (CVM) also provided an opportunity for hearing for 
applications proposed to be withdrawn. Interested persons were given 
until September 8, 2003, to submit written appearances and requests for 
a hearing; until October 7, 2003, to submit data and analysis upon 
which a request for a hearing relies; and until November 6, 2003, to 
submit supplemental NADAs. After publication of the NOOH, several 
errors were found by CVM and others. CVM is correcting these errors, 
but does not believe that these corrections alter the underlying basis 
of the NOOH.

II. Corrections

    In FR Doc. 03-20241, published August 8, 2003 (68 FR 47332), the 
following corrections are made:
    1. On page 47333, in the third column, under ``A. Bacitracin 
Methylene Disalicylate Single-Ingredient Type A Medicated Articles,'' 
the trade name following NADA 141-137, ``FORTRACIN'', is corrected to 
read ``PENNITRACIN''.
    2. On pages 47335 in tables 2, 3, and 4, and on page 47336 in table 
5, in the table heading ``Oxytetracycline'' is corrected to read 
``Oxytetracycline\1\''with a footnote added to read ``\1\Expressed in 
terms of an equivalent amount of oxytetracycline hydrochloride'' and 
``Neomycin'' is corrected to read ``Neomycin Sulfate''.
    3. On pages 47335 in tables 2, 3, and 4, and on page 47336 in table 
5 in the first column heading ``Oxytetracycline'' is corrected to read 
``Oxytetracycline\1\'' and ``neomycin'' is corrected to read ``neomycin 
sulfate''.
    4. On page 47336, in the first column, under ``C. Combination Drug 
Type B and Type C Medicated Feeds for Poultry Containing 
Nicarbazin,''the combination use following NADA 98-371 ``NICARBAZIN 
(nicarbazin), PENICILLIN G PROCAINE (procaine penicillin), and 3-NITRO 
(roxarsone)'' is corrected to read ``nicarbazin, procaine penicillin, 
and roxarsone''.
    5. On page 47336, in the first column, under ``C. Combination Drug 
Type B and Type C Medicated Feeds for Poultry Containing Nicarbazin,'' 
the combination use following NADA 98-374 ``NICARBAZIN (nicarbazin) and 
PENICILLIN G PROCAINE (procaine penicillin)'' is corrected to read 
``nicarbazin and procaine penicillin''.
    6. On page 47336, in the second column, under ``C. Combination Drug 
Type B and Type C Medicated Feeds for Poultry Containing Nicarbazin,'' 
the combination use following NADA 100-853 ``NICARBAZIN (nicarbazin), 
BACIFERM (BMD), and 3-NITRO (roxarsone)'' is corrected to read 
``nicarbazin, bacitracin methylene disalicylate, and roxarsone''.
    7. On page 47336, in the third column, under ``C. Combination Drug 
Type B and Type C Medicated Feeds for Poultry Containing Nicarbazin,'' 
in the fourth line, ``bacitracin zinc'' is corrected to read 
``bacitracin methylene disalicylate''.
    8. On page 47336, in the third column, in the eighth and ninth 
lines, ``35 FR 12490, August 5, 1970 (bacitracin zinc)'' is corrected 
to read ``35 FR 11531, July 17, 1970, as corrected by 35 FR 15408, 
October 2, 1970 (bacitracin methylene disalicylate)''.
    9. On page 47337 in table 6, and on page 47338 in table 7, in the 
first three column headings ``Type A article in g/ton'' is corrected to 
read ``Drug in g/ton''.

    Dated: October 1, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-25343 Filed 10-6-03; 8:45 am]
BILLING CODE 4160-01-S