[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]
BILLING CODE 4160-01-S