[Federal Register Volume 61, Number 215 (Tuesday, November 5, 1996)]
[Rules and Regulations]
[Pages 56892-56893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 556


Animal Drugs, Feeds, and Related Products; Enrofloxacin Oral 
Solution

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 to reflect approval of a new animal drug application 
(NADA) filed by Bayer Corp. The NADA provides for the use of drinking 
water medicated with enrofloxacin for the control of mortality 
associated with certain bacteria in chickens and turkeys.

EFFECTIVE DATE:  November 5, 1996.
FOR FURTHER INFORMATION CONTACT:  George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 140-828 
that covers Baytril (enrofloxacin) 3.23% Concentrate 
Antimicrobial Solution. The concentrate is added to drinking water to 
produce a final concentration of 25 to 50 parts per million. The 
medicated drinking water is used in chickens for the control of 
mortality associated with Escherichia coli susceptible to enrofloxacin 
and in turkeys for the control of mortality associated with E. coli and 
Pasteurella multocida (fowl cholera) susceptible to enrofloxacin. The 
NADA is approved as of October 4, 1996, and the regulations are amended 
by adding new Sec. 520.813 to reflect the approval. The regulations are 
also amended to provide for a tolerance for enrofloxacin residues in 
chickens and turkeys in new Sec. 556.228. The drug product is available 
on a prescription basis. The basis of approval is discussed in the 
freedom of information summary.
    In accordance with the freedom of information (FOI) provisions of 
part 20 (21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 
514.11(e)(2)(ii)), a summary of safety and effectiveness data and 
information submitted to support approval of this application (FOI 
summary) may be seen in the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 
20857, between 9 a.m. and 4 p.m., Monday through Friday. The FOI 
summary is also electronically available on the Center for Veterinary 
Medicine's home page on the World Wide Web (http://www.cvm.fda.gov/). 
The summaries are located in the section entitled, ``FDA CVM Documents 
and Databases--Information and Resources Library.''
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning October 4, 1996, because the 
NADA contains reports of new clinical or field investigations and new 
human food safety studies (other than bioequivalence or residue 
studies) essential to the approval of the

[[Page 56893]]

application and conducted or sponsored by the applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 520

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 
556 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 520.813 is added to read as follows:


Sec. 520.813  Enrofloxacin oral solution.

    (a) Specifications. Each milliliter of concentrate solution 
contains 32.3 milligrams of enrofloxacin.
    (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.228 of this chapter.
    (d) Conditions of use. It is used in drinking water as follows:
    (1) Chickens and turkeys--(i) Amount. 25 to 50 parts per million of 
enrofloxacin in drinking water.
    (ii) Indications. Chickens: Control of mortality associated with 
Escherichia coli susceptible to enrofloxacin. Turkeys: Control of 
mortality associated with E. coli and Pasteurella multocida (fowl 
cholera) susceptible to enrofloxacin.
    (iii) Limitations. Do not use in laying hens producing eggs for 
human consumption. Administer medicated water continuously as sole 
source of drinking water for 3 to 7 days. Prepare fresh stock solution 
daily. Effects on the reproductive function of turkeys have not been 
determined. Treated animals must not be slaughtered for food within 2 
days of the last treatment. Individuals with a history of 
hypersensitivity to quinolones should avoid exposure to this product. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

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

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

    Authority: Secs. 402, 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 360b, 371).

    4. New Sec. 556.228 is added to subpart B to read as follows:


Sec. 556.228  Enrofloxacin.

    A tolerance of 0.3 part per million is established for residues of 
enrofloxacin (marker residue) in muscle (target tissue) of chickens and 
turkeys.

    Dated: October 28, 1996.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 96-28291 Filed 11-4-96; 8:45 am]
BILLING CODE 4160-01-F