[Federal Register Volume 62, Number 237 (Wednesday, December 10, 1997)]
[Rules and Regulations]
[Page 65020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32217]
[[Page 65020]]
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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 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 I. D. Russell Co. Laboratories. The ANADA
provides for use 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: December 10, 1997.
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: I. D. Russell Co. Laboratories, 1301 Iowa
Ave., Longmont, CO 80501, filed ANADA 200-189 that provides for use 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 caused by
Clostridium perfringens susceptible to lincomycin.
Approval of I. D. Russell Co. Laboratories' ANADA 200-189
lincomycin hydrochloride soluble powder is as a generic copy of
Pharmacia & Upjohn's NADA 111-636 LincomixTM soluble powder.
The ANADA is approved as of November 7, 1997, and the regulations are
amended in 21 CFR 520.1263c(b) to reflect the approval. The basis of
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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
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.
Sec. 520.1263c [Amended]
2. Section 520.1263c Lincomycin hydrochloride soluble powder is
amended in paragraph (b) by removing ``No. 000009'' and adding in its
place ``Nos. 000009 and 017144''.
Dated: December 1, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-32217 Filed 12-9-97; 8:45 am]
BILLING CODE 4160-01-F
