[Federal Register: October 7, 2003 (Volume 68, Number 194)]
[Notices]
[Page 57911-57912]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc03-61]
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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: abeaulie@cvm.fda.gov.
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applications proposed to be withdrawn.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