[Federal Register Volume 70, Number 146 (Monday, August 1, 2005)]
[Page 44105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15224]

[[Page 44105]]



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; 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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.


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]