[Federal Register Volume 60, Number 51 (Thursday, March 16, 1995)]
[Rules and Regulations]
[Pages 14216-14217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6531]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 The Upjohn Co. The NADA provides for the 
use of lincomycin hydrochloride soluble powder to make medicated swine 
and broiler chicken drinking water. The supplement provides for use of 
a packet containing the equivalent of 32 grams (g) of lincomycin in 
addition to the currently approved packet containing the equivalent of 
16 g of lincomycin.

EFFECTIVE DATE: March 16, 1995.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2701.

SUPPLEMENTARY INFORMATION: The Upjohn Co., Kalamazoo, MI 49001, filed a 
supplement to NADA 111-636 for Lincomix (lincomycin hydrochloride) 
soluble powder. The supplemental NADA provides for the use of an 80-g 
packet containing the equivalent of 32 g of lincomycin in addition to 
the approved 40-g packet containing the equivalent of 16 g of 
lincomycin. Both packets are used to make a swine drinking water 
containing 250 milligrams (mg) of lincomycin per gallon used for the 
treatment of swine dysentery and broiler chicken drinking water 
containing 64 mg of lincomycin per gallon for the control of necrotic 
enteritis.
    This supplemental NADA is approved as of February 9, 1995, and the 
regulations in Sec. 520.1263c(a) (21 CFR 520.126c(a)) are amended to 
reflect the approval.
    This is a manufacturing supplement to an approved NADA. The 
approval does not require a summary of safety, effectiveness data, or 
information. Therefore, a freedom of information summary as provided in 
part 20 (21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 
514.11(e)(2)(ii)) is not required.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals does not qualify for marketing exclusivity because 
the supplemental application does not contain new clinical or field 
investigations (other than bioequivalence or residue studies) and new 
human food safety studies (other than bioequivalence or residue 
studies) essential to the approval and conducted or sponsored by the 
applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(iii) 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 
[[Page 14217]] 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

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

Sec. 520.1263c  Lincomycin hydrochloride soluble powder.

    (a) Specifications. Each 40-gram packet (1.41 ounce) contains 
lincomycin hydrochloride equivalent to 16 grams of lincomycin. Each 80-
gram packet (2.82 ounces) contains lincomycin hydrochloride equivalent 
to 32 grams of lincomycin.
* * * * *

    Dated: March 8, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 95-6531 Filed 3-15-95; 8:45 am]
BILLING CODE 4160-01-F