[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animal drug application (NADA) for which FDA has withdrawn approval.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.
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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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.813 [Removed]
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2. Section 520.813 is removed.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
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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]
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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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