[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Page 36291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline

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 Hoffmann-La Roche, Inc. The supplemental 
NADA provides for use of a free-choice, mineral, Type C cattle feed 
containing chlortetracycline (CTC) for grazing beef cattle weighing 
over 700 pounds (lb) for control of active anaplasmosis infections.

EFFECTIVE DATE: July 10, 1996.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0217.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St., 
Nutley, NJ 07110, filed a supplement to NADA 48-761, 
Aureomycin<Register> (chlortetracycline) mineral, Type C cattle feed 
containing 4 grams CTC per lb. The supplement provides for free-choice 
feeding to grazing beef cattle weighing over 700 lb at 0.0125 to 0.05 
lb of Type C feed per 100 lb of body weight per day (0.5 to 2.0 
milligrams (mg) CTC per lb of body weight per day) for control of 
active infections of anaplasmosis caused by Anaplasma marginale 
susceptible to chlortetracycline. The supplement is approved as of July 
10, 1996, and the regulations are amended in 21 CFR 558.128(c)(4) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    With approval of this supplement, cattle may be fed 0.5 to 2.0 mg 
CTC per head per day. To provide for safe use at the upper limit, a 
withdrawal time of 4 days prior to slaughter is provided.
    Use of Type A medicated articles to make free-choice CTC Type C 
medicated feeds requires an approved Form FDA 1900 as in 21 CFR 
510.455.
    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, 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 supplemental approval 
qualifies for 3 years of marketing exclusivity beginning July 10, 1996, 
because the supplemental application contains reports of new clinical 
or field investigations (other than bioequivalence or residue studies) 
or human food safety studies (other than bioequivalence or residue 
studies) essential to the approval and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity applies only to the new 
claim for which the supplement was approved.
    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 558

    Animal drugs, Animal feeds.
    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 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

Sec. 558.128  [Amended]

    2. Section 558.128 Chlortetracycline is amended in paragraph (c)(4) 
by removing the phrase ``daily minimum intake of 0.5 milligram of 
chlortetracycline per pound of body weight to aid in the prevention of 
anaplasmosis'' and adding in its place ``daily intake of 0.5 to 2.0 
milligrams of chlortetracycline per pound of body weight to aid in the 
control of active infection of anaplasmosis caused by Anaplasma 
marginale susceptible to chlortetracycline; discontinue use 4 days 
prior to slaughter''.

    Dated: May 31, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-17315 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F