[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
