[Federal Register Volume 60, Number 225 (Wednesday, November 22, 1995)]
[Rules and Regulations]
[Pages 57833-57834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28544]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Sarafloxacin Hydrochloride

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 Abbott Laboratories. The NADA provides for use of 
sarafloxacin hydrochloride solution for injection in day-old broiler 
chickens for control of early mortality associated with Escherichia 
coli organisms susceptable to sarafloxacin.

EFFECTIVE DATE: November 22, 1995.

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: Abbott Laboratories, 1401 Sheridan Rd., 
North Chicago, IL 60064-4000, filed NADA 141-018, which provides for 
use of SaraFlox Injection (sarafloxacin hydrochloride 
solution for injection) to be used in day-old broiler chickens for 
control of early mortality associated with E. coli organisms 
susceptable to sarafloxacin. The NADA is approved as of October 12, 
1995, and the regulations are amended in part 522 (21 CFR part 522) by 
adding new Sec. 522.2095 to reflect the approval. The basis of approval 
is discussed in the freedom of information summary.-
    In accordance with the freedom of information 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 may be seen in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    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 12, 1995, because 
the NADA contains reports of new clinical or field investigations and 
new human food safety studies essential to the approval 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 in 21 CFR Part 522

    Animal drugs.
    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 part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).
    2. New Sec. 522.2095 is added to read as follows:


Sec. 522.2095  Sarafloxacin solution for injection.

    (a) Specifications. Each milliliter contains sarafloxacin 
hydrochloride equivalent to 50 milligrams of sarafloxacin in a 20 
percent propylene glycol solution.
    (b) Sponsor. See No. 000074 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.594 of this chapter.
    (d) Conditions of use. Day-old broiler chickens:
    (1) Amount. 0.1 milligram sarafloxacin per 0.2 milliliter dose.
    (2) Indications for use. For control of early mortality in day-old 
broiler chickens associated with Escherichia coli organisms susceptable 
to sarafloxacin.
    (3) Limitations. A single subcutaneous 0.2 milliliter - injection 
in the neck. Dilute 1 milliliter of SaraFlox with 100 
milliliters of sterile water or physiologic saline to provide 0.1 
milligram sarafloxacin in a 0.2 milliliter dose. Use entire contents of 
diluted solution within 24 hours. No preslaughter drug withdrawal 
period is required when the product is used as directed. Use in a
manner other than that indicated or with dosages in excess of that 
recommended may result in illegal drug residues in edible tissues. Do 
not use in laying hens producing eggs for human consumption. Do not use 
in replacement layers or fowl intended for breeding 

[[Page 57834]]
purposes. The effects of sarafloxacin on the -reproductive function of 
treated fowl have not been determined. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.

    Dated: November 13, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-28544 Filed 11-21-95; 8:45 am]
BILLING CODE 4160-01-F