[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Rules and Regulations]
[Pages 29019-29020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13379]


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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 Pfizer, Inc. The NADA provides for a 
revised withdrawal time for use of oxytetracycline hydrochloride 
soluble powder in drinking water of swine.

DATES: This rule is effective May 29, 2001.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7580.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to NADA 8-622 that provides for use of 
TERRAMYCIN<Register> (oxytetracycline hydrochloride) Soluble Powder for 
making medicated drinking water for the treatment of various bacterial 
diseases of livestock. The supplemental NADA provides for a zero-day 
slaughter withdrawal time after the use of the product in drinking 
water of swine. The application is approved as of April 25, 2001, 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

[[Page 29020]]

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.
    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 paragraph (d)(1)(iii)(C) by removing ``Nos. 000069 and 
059130'' and by adding in its place ``No. 059130 and zero days those 
products sponsored by No. 000069''.

    Dated: May 16, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-13379 Filed 5-25-01; 8:45 am]
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