[Federal Register Volume 62, Number 83 (Wednesday, April 30, 1997)]
[Rules and Regulations]
[Page 23356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11079]
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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 an abbreviated new animal drug
application (ANADA) filed by the Pennfield Oil Co. The ANADA provides
for the use of a generic oxytetracycline hydrochloride soluble powder
for the drinking water of cattle, swine, sheep, chickens, and turkeys.
EFFECTIVE DATE: April 30, 1997.
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: Pennfield Oil Co., 14040 Industrial Rd.,
Omaha, NE 68137, filed ANADA 200-026, which provides for use of 102.4-
gram (g) oxytetracycline hydrochloride per 4.78-ounce (135.5-g) packet
for making medicated drinking water for cattle, swine, sheep, chickens,
and turkeys for control and treatment of bacterial infections caused by
oxytetracycline susceptible organisms.
ANADA 200-026 for Pennfield Oil Co.'s oxytetracycline
hydrochloride water soluble powder is approved as a generic copy of
Pfizer's NADA 8-622 Terramycin-343 (oxytetracycline hydrochloride)
soluble powder. The ANADA is approved as of March 13, 1997, and the
regulations are amended in 21 CFR 520.1660d by adding new paragraphs
(a)(8) and (b)(6) to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 adding new paragraphs (a)(8) and
(b)(6) to read as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
(a) * * *
(8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC
HCl.
(b) * * *
(6) No. 053389 for use of OTC HCl concentrations in paragraph
(a)(8) of this section in chickens, turkeys, swine, cattle, and sheep.
* * * * *
Dated: April 2, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-11079 Filed 4-29-97; 8:45 am]
BILLING CODE 4160-01-F