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[Federal Register Volume 62, Number 44 (Thursday, March 6, 1997)]
[Rules and Regulations]
[Pages 10219-10220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5452]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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 supplemental new animal drug 
application (NADA) filed by Abbott Laboratories. The supplement 
provides for use of sarafloxacin hydrochloride solution for injection 
in 18-day embryonated broiler eggs for control of early chick mortality 
associated with Escherichia coli organisms susceptible to sarafloxacin.

EFFECTIVE DATE: March 6, 1997.

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 a supplement to NADA 141-018 that 
provides for use of sarafloxacin hydrochloride solution for injection 
(SaraFlox Injection) in 18-day embryonated broiler eggs in 
addition to approved use in day-old broiler chickens for control of 
early chick mortality associated with E. coli organisms susceptible to 
sarafloxacin. The supplement is approved as of January 21, 1997, and 
the regulations are amended by revising 21 CFR 522.2095(d) 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 21 CFR 
part 20 and 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning January 21, 1997, 
because this supplement contains substantial evidence of the 
effectiveness of the drug involved, studies of animal safety, or human 
food safety studies (other than bioequivalence or residue studies), 
required for approval and conducted or sponsored by the applicant. 
Marketing exclusivity applies only to use in 18-day embryonated broiler 
eggs.
    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

[[Page 10220]]

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. Section 522.2095 is amended by revising paragraph (d) to read as 
follows:

Sec. 522.2095  Sarafloxacin solution for injection.

* * * * *
    (d) Conditions of use. 18-day embryonated broiler eggs and day-old 
broiler chickens:
     (1) Amount--(i) 18-day embryonated broiler eggs: 0.05 milligram 
sarafloxacin in 0.1 milliliter dose in single in ovo injection.
     (ii) Day-old broiler chickens: 0.1 milligrams sarafloxacin per 0.2 
milliliter dose in single subcutaneous injection in the neck.
     (2) Indications for use. For control of early chick mortality 
associated with Escherichia coli organisms susceptible to sarafloxacin.
     (3) Limitations. Dilute 1 milliliter with 99 milliliters of 
sterile water or physiologic saline for use. 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 eggs intended for human consumption. 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: February 7, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-5452 Filed 3-5-97; 8:45 am]
BILLING CODE 4160-01-F
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