[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Rules and Regulations]
[Pages 51995-51996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Lincomycin

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 use of lincomycin injectable solution in swine for the 
treatment of infectious arthritis and mycoplasma pneumonia.

DATES: This rule is effective September 1, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-368 that provides for use 
of LINCOMED 100 (lincomycin hydrochloride) and LINCOMED 300 (lincomycin 
hydrochloride) in swine for the treatment of infectious arthritis and 
mycoplasma pneumonia. Cross Vetpharm Group Ltd.'s LINCOMED 100 and 
LINCOMED 300 are approved as generic copies of LINCOMIX 100 Injectable 
and LINCOMIX 300 Injectable, sponsored by Pharmacia & Upjohn Co., a 
Division of Pfizer, Inc., under NADA 034 025. The ANADA is approved as 
of July 27, 2006, and the regulations are amended in Sec.  522.1260 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

[[Page 51996]]

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 522

    Animal drugs.

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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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


0
2. In Sec.  522.1260, add paragraphs (a)(4) and (b)(4) to read as 
follows:


Sec.  522.1260  Lincomycin.

    (a) * * *
    (4) 100 or 300 mg lincomycin.
    (b) * * *
    (4) No. 061623 for use of concentrations in paragraph (a)(4) of 
this section as in paragraph (e)(2) of this section.
* * * * *

    Dated: August 10, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-14509 Filed 8-31-06; 8:45 am]
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