[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
