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Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder

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 [Federal Register: July 5, 2006 (Volume 71, Number 128)]
[Rules and Regulations]
[Page 38072]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jy06-10]

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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 V[eacute]toquinol NA, Inc. The ANADA 
provides for use of oxytetracycline soluble powder to prepare medicated 
drinking water for the treatment of various bacterial diseases of 
livestock.

DATES: This rule is effective July 5, 2006.

FOR FURTHER INFORMATION CONTACT:  Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: V[eacute]toquinol NA, Inc., 2000 chemin 
Georges, Lavaltrie (PQ), Canada J5T 3S5, filed a supplement to ANADA 
200-305 that provides for use of Oxytetracycline HCl Soluble Powder to 
prepare medicated drinking water for the treatment of various bacterial 
diseases of livestock. V[eacute]toquinol NA, Inc.'s Oxytetracycline HCl 
Soluble Powder is approved as a generic copy of Alpharma, Inc.'s OXY-
TET (oxytetracycline hydrochloride) Soluble approved under NADA 130-
435. The ANADA is approved as of June 2, 2006, 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 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 Division of Dockets Management 
(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 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.

Sec.  520.1660d  [Amended]

? 2. Amend Sec.  520.1660d as follows:
? a. Revise the section heading;
? b. In paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), 
and (d)(1)(iii)(C), remove ``and 061133'' and add in its place 
``059320, and 061133''; and
? c. Add paragraphs (a)(10) and (b)(8).
    The revisions read as follows:

Sec.  520.1660d  Oxytetracycline powder.

    (a) * * *
    (10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
9.87 and 19.74 oz; pails: 5 lb).
    (b) * * *
    (8) No. 059320 for use of OTC concentration in paragraph (a)(10) of 
this section in chickens, turkeys, and swine as in paragraph (d) of 
this section.
* * * * *

    Dated: June 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-10445 Filed 7-3-06; 8:45 am]
BILLING CODE 4160-01-S

 
 

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