[Federal Register Volume 70, Number 146 (Monday, August 1, 2005)]
[Notices]
[Page 44105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15224]
[[Page 44105]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000N-1571]
Enrofloxacin for Poultry; Final Decision on Withdrawal of New
Animal Drug Application Following Formal Evidentiary Public Hearing;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the final decision setting forth the findings of fact
and conclusions of law on the issues addressed in a formal evidentiary
public hearing to determine whether FDA should withdraw approval of the
new animal drug application (NADA) for use of enrofloxacin in poultry.
Once this final decision becomes effective on September 12, 2005, this
drug may no longer be distributed or administered for this use in the
United States, nor may it be exported except as allowed by law.
Elsewhere in this issue of the Federal Register, a final rule removing
the applicable regulations is published.
ADDRESSES: The transcript of the hearing, evidence submitted, and the
final decision, may be seen in the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm.1061,
Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for
electronic access to these documents.
FOR FURTHER INFORMATION CONTACT: Erik P. Mettler, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
I. Background
On October 31, 2000, FDA's Center for Veterinary Medicine (CVM)
proposed to withdraw the approval of the NADA 140-828 for the use in
chickens and turkeys of enrofloxacin, an antimicrobial drug belonging
to a class of drugs known as fluoroquinolones (65 FR 64954, October 31,
2000). On November 29, 2000, Bayer Corp. (Bayer), the sponsor of
enrofloxacin (sold under the trade name Baytril[reg] 3.23% Concentrate
Antimicrobial Solution), requested a hearing on the proposed
withdrawal. On February 20, 2002, FDA's then Acting Principal Deputy
Commissioner published a notice of hearing granting Bayer's request and
identifying the factual issues that would be the subject of the
evidentiary hearing (67 FR 7700, February 20, 2002). On March 21, 2002,
the Animal Health Institute submitted a notice of participation under
21 CFR 12.45. Oral hearing for the purposes of cross-examination of
witnesses was held at FDA from April 28 through May 7, 2003. On March
16, 2004, an FDA Administrative Law Judge (ALJ) issued an initial
decision under 21 CFR 12.120. The ALJ determined that enrofloxacin had
not been ``shown to be safe under the conditions of use upon the basis
of which the application was approved,'' as required under section
512(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360b(e)(1)(B)) and ordered that the approval of the NADA for
Baytril be withdrawn. Bayer and CVM each filed exceptions to the
initial decision on May 17, 2004.
After reviewing the evidence in the administrative record and the
exceptions to the initial decision, I have issued a final decision
withdrawing the approval of the NADA for use of enrofloxacin in
poultry, for the reasons described more fully in the final decision
that is the subject of this notice. In addition, elsewhere in this
issue of the Federal Register, a final rule removing the applicable
regulations is published.
II. Electronic Access
Persons with access to the Internet may obtain the final decision
at www.fda.gov/oc/antimicrobial/baytril.pdf. The final decision as well
as documents cited in the decision are available for inspection by
means of writing to, or visiting, the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All other documents related to this docket also
are available for inspection, unless considered confidential.
Dated: July 27, 2005.
Lester M. Crawford,
Commissioner of Food and Drugs.
[FR Doc. 05-15224 Filed 7-28-05; 2:31 pm]
BILLING CODE 4160-01-S