[Federal Register Volume 64, Number 54 (Monday, March 22, 1999)]
[Rules and Regulations]
[Pages 13678-13679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6807]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of two supplemental abbreviated
new animal drug applications (ANADA's) filed by PennField Oil Co. The
ANADA's provide for a zero-day withdrawal period for use of
oxytetracycline hydrochloride (OTC HCl) soluble powder in the drinking
water of turkeys and for an additional package size.
EFFECTIVE DATE: March 22, 1999.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0212.
SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd.,
Omaha, NE 68144, filed two supplements to ANADA 200-026. One supplement
provides for a zero-day withdrawal period for turkeys using PennField
Oil Co.'s Oxytetracycline HCl-343 (oxytetracycline hydrochloride)
treated drinking water. The other supplement provides for use of a
package containing 512 grams of OTC HCl per 23.9 ounces of soluble
powder for making medicated drinking water for cattle, swine, sheep,
chickens, and turkeys. The medicated drinking water is used for the
control and treatment of bacterial infections caused by oxytetracycline
susceptible organisms.
The supplemental ANADA's are approved as of February 5, 1999, and
21 CFR 520.1660d(a)(8) and (d)(1)(ii) are amended 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) 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: 21 U.S.C. 360b.
2. Section 520.1660d is amended in paragraphs (a)(8),
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by adding a
sentence to the end of each paragraph to read as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
(a) * * *
(8) * * * Each 677.5-gram packet (23.9 ounce) contains 512 grams
of OTC HCl.
* * * * *
(d) * * *
(1) * * *
(ii) * * *
(A) * * *
(3) * * * Zero-day withdrawal for those products sponsored by No.
053389.
[[Page 13679]]
(B) * * *
(3) * * * Zero-day withdrawal for those products sponsored by No.
053389.
(C) * * *
(3) * * * Zero-day withdrawal for those products sponsored by No.
053389.
* * * * *
Dated: February 26, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 99-6807 Filed 3-19-99; 8:45 am]
BILLING CODE 4160-01-F
