[Federal Register Volume 61, Number 196 (Tuesday, October 8, 1996)]
[Rules and Regulations]
[Pages 52690-52691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25811]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride
Soluble Powder
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 abbreviated new
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The
supplemental ANADA provides for an additional container size for the
firm's oxytetracycline hydrochloride (OTC HCl) soluble powder. The drug
product is administered orally in drinking water for either control or
control and treatment of certain diseases of chickens, turkeys, swine,
cattle, and sheep. In addition, the regulations are amended to specify
the withdrawal period for use of medicated drinking water made from the
subject sponsor's drug and to add certain warning statements required
on the labeling.
EFFECTIVE DATE: October 8, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, is the sponsor
of ANADA 200-146, which provides for use of OTC HCl soluble powder in
drinking water for either control or control and treatment of certain
diseases of chickens, turkeys, swine, cattle, and sheep in accordance
with Sec. 520.1660d (21 CFR 520.1660d). The firm has filed a supplement
to the ANADA that provides for the drug product in a 5-pound (lb) pail
in addition to the previously approved 2-lb pail. The supplemental
ANADA is approved as of August 15, 1996, and the regulations are
amended in Sec. 520.1660d to reflect the approval. The basis for
approval is discussed in the freedom of information summary.
Also, the regulations are amended to reflect the appropriate
withdrawal times for the subject drug product. The withdrawal times
were inadvertently omitted in the final rule which announced the
original approval (61 FR 2914, January 30, 1996).
In addition, Sec. 520.1660d(e)(1)(iv)(C) is revised by adding
required warning statements against use of the drug product in the
drinking water of calves to be processed for veal or female dairy
cattle 20 months of age or older.
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.
The agency has determined under 21 CFR 25.24(d)(1)(i) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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 520.1660d is amended by revising paragraph (a)(7), the
sixth sentence in paragraphs (e)(1)(ii)(A)(3), (e)(1)(ii)(B)(3), and
(e)(1)(ii)(C)(3), the third sentence in paragraph (e)(1)(iii)(C), and
by adding four sentences at the end of paragraph (e)(1)(iv)(C) to read
as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
(a) * * *
(7) Each 18.1 grams of powder contains 1 gram of OTC HCl (pails: 2
and 5 lb).
* * * * *
(e) * * *
(1) * * *
(ii) * * *
(A) * * *
(3) * * * Withdraw 5 days prior to slaughter those products
sponsored by Nos. 000069, 017144, 057561, and 059130 in Sec. 510.600(c)
of this chapter. * * *
[[Page 52691]]
(B) * * *
(3) * * * Withdraw 5 days prior to slaughter those products
sponsored by Nos. 000069, 017144, 057561, and 059130 in Sec. 510.600(c)
of this chapter. * * *
(C) * * *
(3) * * * Withdraw 5 days prior to slaughter those products
sponsored by Nos. 000069, 017144, 057561, and 059130 in Sec. 510.600(c)
of this chapter. * * *
(iii) * * *
(C) * * * Administer up to 14 days; do not use for more than 14
consecutive days; withdraw 5 days prior to slaughter those products
sponsored by Nos. 000069 and 059130. * * *
(iv) * * *
(C) * * * A withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in calves to be processed
for veal. A milk discard period has not been established for this
product in lactating dairy cattle. Do not use in female dairy cattle 20
months of age or older.
* * * * *
Dated: September 13, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-25811 Filed 10-7-96; 8:45 am]
BILLING CODE 4160-01-F
