[Federal Register Volume 70, Number 135 (Friday, July 15, 2005)]
[Rules and Regulations]
[Pages 40880-40881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Lincomycin and Spectinomycin 
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 Cross Vetpharm Group Ltd. The ANADA 
provides for the oral use of lincomycin and spectinomycin soluble 
powder to create a solution administered in the drinking water of 
chickens as an aid in the control of airsacculitis.

DATES: This rule is effective July 15, 2005.

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: [email protected].

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-380 that provides for use 
of SPECLINX-50 (spectinomycin dihydrochloride pentahydrate and 
lincomycin hydrochloride monohydrate) Water Soluble Powder to create a 
solution administered in the drinking water of chickens. This solution 
acts as an aid in the control of airsacculitis caused by either 
Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-
spectinomycin and complicated chronic respiratory disease (air sac 
infection) caused by Escherichia coli and M. gallisepticum susceptible 
to lincomycin-spectinomycin. Cross Vetpharm Group Ltd.'s SPECLINX-50, 
Water Soluble Powder is approved as a generic copy of Pharmacia & 
Upjohn Co.'s L-S 50 Water Soluble Powder, approved under NADA 046-109. 
The ANADA is approved as of June 7, 2005, and the regulations are 
amended in 21 CFR 520.1265 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

[[Page 40881]]

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.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.1265  [Amended]

0
2. Section 520.1265 is amended in paragraph (b)(2) by removing ``No. 
059130'' and by adding in its place ``Nos. 059130 and 061623''.

    Dated: July 1, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-13975 Filed 7-14-05; 8:45 am]
BILLING CODE 4160-01-S