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Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride Soluble Powder

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 [Federal Register: January 11, 2005 (Volume 70, Number 7)]
[Rules and Regulations]
[Page 1818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja05-6]

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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 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 Cross Vetpharm Group Ltd. The ANADA 
provides for oral use of lincomycin soluble powder to make medicated 
drinking water for administration to swine for the treatment of swine 
dysentery or to broiler chickens for the control of necrotic enteritis.

DATES: This rule is effective January 11, 2005.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
lonnie.luther@fda.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-377 for LINCOMED 
(lincomycin hydrochloride) Soluble Powder. The application provides for 
oral use of lincomycin soluble powder to make medicated drinking water 
for administration to swine for the treatment of swine dysentery or to 
broiler chickens for the control of necrotic enteritis. Cross Vetpharm 
Group Ltd.'s LINCOMED Soluble Powder is approved as a generic copy of 
Pharmacia & Upjohn Co.'s LINCOMIX Soluble Powder, approved under NADA 
111-636. ANADA 200-377 is approved as of December 6, 2004, and the 
regulations are amended in 21 CFR 520.1263c 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.
    FDA 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 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.

? 2. Section 520.1263c is amended by revising paragraph (b) to read as 
follows:

Sec.  520.1263c  Lincomycin hydrochloride soluble powder.

* * * * *
    (b) Sponsors. See Nos. 000009, 046573, 054925, 059130, and 061623 
in Sec.  510.600(c) of this chapter for use as in paragraph (d) of this 
section.
* * * * *

    Dated: December 29, 2004 .
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-524 Filed 1-10-05; 8:45 am]
BILLING CODE 4160-01-S

 
 

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