[Federal Register Volume 60, Number 188 (Thursday, September 28, 1995)]
[Rules and Regulations]
[Pages 50097-50098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24159]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Parts 520 and 556


Animal Drugs, Feeds, and Related Products; Sarafloxacin 
Hydrochloride

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 in turkey and broiler chicken drinking water 
for control of mortality associated with Escherichia coli organisms 
susceptible to sarafloxacin.

EFFECTIVE DATE: September 28, 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 141-017, which provides for 
use of sarafloxacin hydrochloride (SaraFlox WSP) water 
soluble powder to make turkey and broiler chicken medicated drinking 
water used for control of mortality associated with E. coli organisms 
susceptible to sarafloxacin.
    The NADA is approved as of August 18, 1995, and the regulations are 
amended by adding new Sec. 520.2095 to reflect the approval. The basis 
of approval is discussed in the freedom of information summary.
    In addition, part 556 (21 CFR part 556) is amended by adding new 
Sec. 556.594 to reflect that a tolerance for residues of sarafloxacin 
in edible turkey and broiler chicken tissues is not required. At zero 
withdrawal, the total residue of sarafloxacin HC1 in the target tissue 
(liver) is less than half the safe concentration (5.25 ppm). The marker 
compound, parent sarafloxacin HC1, represents 20 to 80 percent of the 
total residue in liver of turkeys and 60 to 80 percent of the total 
residue in liver of chickens, depending upon the extraction procedure.
    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)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning August 18, 1995, because no 
active ingredient (including any ester or salt thereof) has been 
previously approved in any other application filed under section 
512(b)(1) of the act.
    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. 520.2095 is added to read as follows:


Sec. 520.2095  Sarafloxacin soluble powder.

    (a) Specifications. Each 145 grams (5.1 ounces) pouch contains 
sarafloxacin hydrochloride equivalent to 14.5 grams of sarafloxacin 
base.
     (b) Sponsor. See No. 000074 in Sec. 510.600(c) of this chapter.
     (c) Related tolerances. See Sec. 556.594 of this chapter.

[[Page 50098]]

     (d) Conditions of use. Used in drinking water as follows: (1) 
Amount. Chickens--20 to 40 parts per million for 5 consecutive days as 
the only source of drinking water. Turkeys--30 to 50 parts per million 
for 5 consecutive days as the only source of drinking water.
     (2) Indications for use. For control of mortality in growing 
turkeys and broiler chickens associated with Escherichia coli organisms 
susceptible to sarafloxacin.
     (3)  Limitations. No preslaughter drug withdrawal period is 
required when the product is used as directed. Use in a manner other 
than that indicated or with a dose in excess of that recommended may 
result in drug residues in edible tissues. Do not use in laying hens 
producing eggs 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.

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. 556.594 is added to subpart B to read as follows:


Sec. 556.594   Sarafloxacin.

    A tolerance for residues of sarafloxacin in edible turkey and 
broiler chickens tissues is not required.

    Dated: September 21, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-24159 Filed 9-27-95; 8:45 am]
BILLING CODE 4160-01-F