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[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Rules and Regulations]
[Pages 26826-26827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12291]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520

Oral Dosage Form New Animal Drugs; Chlortetracycline Soluble 
Powder Concentrate

AGENCY: Food and Drug Administration, HHS.

[[Page 26827]] 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 the American Cyanamid Co. The supplemental 
NADA provides for the safe and effective use of chlortetracycline 
bisulfate (CTC bisulfate) soluble powder concentrate in the drinking 
water of chickens and turkeys for control of certain bacterial diseases 
susceptible to CTC, in the drinking water of swine, and as a drench in 
cattle for control and treatment of certain bacterial diseases 
susceptible to CTC. The approved supplemental NADA reflects compliance 
with findings of the National Academy of Sciences/National Research 
Council (NAS/NRC), Drug Efficacy Study Group's (DESI) evaluation of 
related drug products' effectiveness and FDA's conclusions concerning 
that evaluation.

EFFECTIVE DATE: May 19, 1995.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: American Cyanamid Co., Berdan Ave., Wayne, 
NJ 07470, is the sponsor of NADA 55-020 which provides for use of 
Aureomycin CTC (bisulfate) Soluble Powder Concentrate 
(available in 1/4 and 10 pound packets) containing CTC bisulfate 
equivalent to 102.4 grams of CTC hydrochloride (CTC HCl) per pound. The 
drug product is used to medicate the drinking water of chickens, 
turkeys, swine, calves, beef cattle, and nonlactating dairy cattle in 
accordance with Sec. 520.445b(d)(4) (21 CFR 520.445b(d)(4)). The NADA 
was originally approved on June 7, 1963.
    American Cyanamid Co. filed a supplement to NADA 55-020 revising 
the product labeling to conform to that approved for the firm's 
supplemental NADA's 65-071 (Aureomycin (CTC HCl) Soluble 
Powder) and 65-440 (Aureomycin (CTC HCl) Soluble Powder 
Concentrate). Approval of those supplemental NADA's was published in 
the Federal Register of August 3, 1994 (59 FR 39438). The approval 
reflects compliance of the products' labeling with NAS/NRC findings and 
FDA's concurrence with those findings.
    The NAS/NRC evaluation is concerned only with the drugs' 
effectiveness and safety to the treated animal. It does not take into 
account the safety for food use of food derived from drug-treated 
animals. Nothing herein will constitute a bar to further proceedings 
with respect to questions of safety of the drug or its metabolites in 
food products derived from treated animals.
     Supplemental NADA 55-020 is approved as of April 6, 1995, and the 
regulations are amended by revising Sec. 520.445b(d)(4) to reflect the 
approval. The basis for this 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food 
producing animals does not qualify for marketing exclusivity because 
the supplemental application does not contain reports of new clinical 
or field investigations (other than bioequivalence or residue studies) 
and new human food safety studies (other than bioequivalence or residue 
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 520

    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 520 is 
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. Section 520.445b is amended by revising paragraph (d)(4) 
introductory text to read as follows:

 Sec. 520.445b  Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate).

* * * * *
    (d) *  *  *
    (4) The following uses of chlortetracycline hydrochloride or 
chlortetracycline bisulfate in drinking water or drench were reviewed 
by the National Academy of Sciences/National Research Council (NAS/NRC) 
and found effective:
* * * * * *

    Dated: May 4, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 95-12291 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-01-F
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