[Federal Register Volume 62, Number 237 (Wednesday, December 10, 1997)]
[Rules and Regulations]
[Page 65020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32217]



[[Page 65020]]

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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 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 I. D. Russell Co. Laboratories. The ANADA 
provides for use of lincomycin hydrochloride soluble powder to make 
medicated drinking water for swine for the treatment of dysentery 
(bloody scours) and broiler chickens for the control of necrotic 
enteritis.

EFFECTIVE DATE: December 10, 1997.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: I. D. Russell Co. Laboratories, 1301 Iowa 
Ave., Longmont, CO 80501, filed ANADA 200-189 that provides for use of 
lincomycin hydrochloride soluble powder to make medicated drinking 
water for swine for the treatment of dysentery (bloody scours) and 
broiler chickens for the control of necrotic enteritis caused by 
Clostridium perfringens susceptible to lincomycin.
    Approval of I. D. Russell Co. Laboratories' ANADA 200-189 
lincomycin hydrochloride soluble powder is as a generic copy of 
Pharmacia & Upjohn's NADA 111-636 Lincomix<SUP>TM</SUP> soluble powder. 
The ANADA is approved as of November 7, 1997, and the regulations are 
amended in 21 CFR 520.1263c(b) 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 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
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.

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. 520.1263c  [Amended]

    2. Section 520.1263c Lincomycin hydrochloride soluble powder is 
amended in paragraph (b) by removing ``No. 000009'' and adding in its 
place ``Nos. 000009 and 017144''.

    Dated: December 1, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-32217 Filed 12-9-97; 8:45 am]
BILLING CODE 4160-01-F