[Federal Register Volume 70, Number 146 (Monday, August 1, 2005)]
[Rules and Regulations]
[Pages 44048-44049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556

[Docket No. 2000N-1571]


Animal Drugs, Feeds, and Related Products; Enrofloxacin for 
Poultry; Withdrawal of Approval of New Animal Drug Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations by removing the portions reflecting approval of a new 
animal drug application (NADA) for which FDA has withdrawn approval. 
NADA 140-828, sponsored by Bayer Corp., provides for use of 
enrofloxacin to treat poultry. In a notice published elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of 
the final decision withdrawing approval of this NADA.

DATES: This rule is effective September 12, 2005.

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: 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

[[Page 44049]]

FR 64954, October 31, 2000). On November 29, 2000, Bayer Corp. (Bayer), 
the sponsor of enrofloxacin (sold under the trade name Baytril[supreg] 
3.23% Concentrate Antimicrobial Solution), requested a hearing on the 
proposed withdrawal. On February 20, 2002, the 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.
    In a notice published elsewhere in this issue of the Federal 
Register, FDA is announcing the final decision withdrawing approval of 
the NADA held by Bayer Corp., Agriculture Division, Animal Health, 
Shawnee Mission, KS 66201. NADA 140-828, Baytril[supreg] 3.23% 
Concentrate Antimicrobial Solution provides for use of enrofloxacin to 
treat poultry under Sec.  520.813 (21 CFR 520.813). Relevant 
information concerning tolerances for residues of enrofloxacin in 
edible tissues of poultry is under Sec.  556.228(a) (21 CFR 
556.228(a)).
    Therefore, in accordance with the final decision withdrawing 
approval and section 512(i) of the act (21 U.S.C. 360(b)(i)), FDA is 
amending the regulations to remove Sec. Sec.  520.813 and 556.228(a).
    The agency has determined under 21 CFR 25.33(g) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 520

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
520 and 556 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.813  [Removed]

0
2. Section 520.813 is removed.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.


Sec.  556.228  [Amended]

0
4. Section 556.228 is amended by removing paragraph (a), by 
redesignating paragraph (b) as paragraph (a), and by adding and 
reserving new paragraph (b).

    Dated: July 27, 2005.
Lester M. Crawford,
Commissioner of Food and Drugs.
[FR Doc. 05-15223 Filed 7-28-05; 2:31 pm]
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