Document ID: FDA-2009-P-0405-0019
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-09-30T04:00Z

[Federal Register: August 1, 2005 (Volume 70, Number 146)]

[Rules and Regulations]               

[Page 44048-44049]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr01au05-3]                         

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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animal drug application (NADA) for which FDA has withdrawn approval.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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