[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Rules and Regulations]
[Page 13508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6671]


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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 Med-Pharmex, Inc. The ANADA provides for 
use of 40- and 80-gram packets and 32-ounce containers 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: March 19, 1999.
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: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, has filed ANADA 200-241 that provides for use of 
lincomycin hydrochloride soluble powder to make medicated drinking 
water for swine for the treatment of dysentery (bloody scours) and for 
broiler chickens for the control of necrotic enteritis caused by 
Clostridium perfringens susceptible to lincomycin. The ANADA provides 
for use of 40- and 80-gram packets and 32-ounce containers of product.
    The ANADA is approved as a generic copy of Pharmacia & Upjohn's 
NADA 111-636, Lincomix Soluble Powder. ANADA 200-241 is 
approved as of February 4, 1999, and the regulations are amended in 21 
CFR 520.1263c to reflect the approval. The basis for 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, 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.

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 adding a sentence to the end of 
paragraph (a) and by revising paragraph (b) to read as follows:


Sec. 520.1263c  Lincomycin hydrochloride soluble powder.

    (a) Specifications. * * * The 40-gram measuring device contains 
lincomycin hydrochloride equivalent to 16 grams of lincomycin (the 
measuring device is packaged with a 32-ounce jar).
    (b) Sponsors. Approval for use of 40- and 80-gram packet to Nos. 
000009 and 017144 in Sec. 510.600(c) of this chapter. Approval for use 
of 40- and 80-gram packet and 32-ounce jar to No. 051259 in 
Sec. 510.600(c) of this chapter.
 * * * * *

    Dated: February 26, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-6671 Filed 3-18-99; 8:45 am]
BILLING CODE 4160-01-F