[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Rules and Regulations]
[Pages 21281-21282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10621]


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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 new 
animal drug application (NADA) filed by Alpharma, Inc. The NADA which 
provides for a revised withdrawal time for use of oxytetracycline 
hydrochloride soluble powder in the drinking water of turkeys and 
swine.

DATES: This rule is effective April 30, 2001.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center 
for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., 
P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 130-435 
that provides for use of Oxytet (oxytetracycline HCl) Soluble for 
making medicated drinking water for the treatment of various bacterial 
diseases of livestock. The NADA provides for a zero-day slaughter 
withdrawal time after the use of the product in drinking water of 
turkeys and swine. The supplemental application is approved as of 
November 29, 2000, and the regulations are amended in 21 CFR 520.1660d 
to reflect the approval. The basis of 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

[[Page 21282]]

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 25.24(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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subject 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.


Sec.  520.1660d  [Amended]

    2. Section 520.1660d Oxytetracycline hydrochloride soluble 
powder is amended in the sixth sentence in paragraphs 
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and 
(d)(1)(ii)(C)(3) by removing ``046573''; in the last sentence 
in paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and 
(d)(1)(ii)(C)(3) by removing ``No. 053389'' and by adding in 
its place ``Nos. 046573 and 053389''; and in the fourth sentence in 
paragraph (d)(1)(iii)(C) by removing ``Nos. 046573 and 057561'' and by 
adding in its place ``No. 057561 and zero days those products sponsored 
by No. 046573.''

    Dated: April 16, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-10621 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S