[Federal Register Volume 67, Number 69 (Wednesday, April 10, 2002)]
[Rules and Regulations]
[Page 17284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8570]


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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 a supplemental new animal drug 
application (NADA) filed by Pharmacia and Upjohn Co. The supplemental 
NADA provides for the use of lincomycin hydrochloride soluble powder in 
the drinking water of swine weighing greater than 250 pounds for the 
treatment of swine dysentery.

DATES: This rule is effective April 10, 2002.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia and Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed a supplement to NADA 111-636 that 
provides for use of LINCOMIX (lincomycin hydrochloride) Soluble Powder 
for making medicated drinking water for the management of various 
bacterial diseases of swine and chickens. The supplemental NADA 
provides for replacement of the limitation ``Not for use in swine 
weighing more than 250 pounds'' with ``The safety of lincomycin has not 
been demonstrated for pregnant swine or swine intended for breeding.'' 
The supplemental application is approved as of December 31, 2001, and 
the regulations are amended in 21 CFR 520.1263c to reflect the 
approval. Section 520.1263c is also being revised to reflect current 
editorial format.
    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 supplemental 
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.
    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.

    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 paragraphs (a), (b), 
and (d) to read as follows:


Sec. 520.1263c  Lincomycin hydrochloride soluble powder.

    (a) Specifications. Each gram of soluble powder contains lincomycin 
hydrochloride equivalent to 0.4 grams of lincomycin.
    (b) Sponsors. See Nos. 000009, 046573, and 051259 in Sec.  
510.600(c) of this chapter for use as in paragraph (d) of this section.
* * * * *
    (d) Conditions of use--(1) Swine--(i) Amount. 250 milligrams per 
gallon of drinking water to provide 3.8 milligrams per pound of body 
weight per day.
    (ii) Indications for use. For the treatment of swine dysentery 
(bloody scours).
    (iii) Limitations. Discard medicated drinking water if not used 
within 2 days. Prepare fresh stock solution daily. Do not use for more 
than 10 days. If clinical signs of disease have not improved within 6 
days, discontinue treatment and reevaluate diagnosis. The safety of 
lincomycin has not been demonstrated in pregnant swine or swine 
intended for breeding.
    (2) Chickens--(i) Amount. 64 milligrams per gallon of drinking 
water.
    (ii) Indications for use. For the control of necrotic enteritis 
caused by Clostridium perfringens susceptible to lincomycin in broiler 
chickens.
    (iii) Limitations. Discard medicated drinking water if not used 
within 2 days. Prepare fresh stock solution daily. Administer for 7 
consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, 
or ruminants access to water containing lincomycin. Not for use in 
layer and breeder chickens.

    Dated: March 25, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-8570 Filed 4-9-02; 8:45 am]
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