[Federal Register Volume 64, Number 227 (Friday, November 26, 1999)]
[Rules and Regulations]
[Page 66382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30701]
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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 Alpharma Inc. 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 for
broiler chickens for the control of necrotic enteritis.
EFFECTIVE DATE: November 26, 1999.
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: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed ANADA 200-233 that provides for use of
Linco Soluble (lincomycin hydrochloride soluble powder) to make
medicated drinking water for swine for the treatment of dysentery
(bloody scours) and for broiler chickens for the control of necrotic
enteritis caused by Clostridium perfringens susceptible to lincomycin.
The ANADA is approved as a generic copy of Pharmacia & Upjohn's
NADA 111-636 Lincomix Soluble Powder. ANADA 200-233 is
approved as of September 22, 1999, and 21 CFR 520.1263c(b) is amended
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, 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.
Sec. 520.1263c [Amended]
2. Section 520.1263c Lincomycin hydrochloride soluble powder is
amended in paragraph (b) by adding at the end the sentence ``Approval
for use of 40-gram packet to No. 046573 in Sec. 510.600(c) of this
chapter''.
Dated: November 10, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-30701 Filed 11-24-99; 8:45 am]
BILLING CODE 4160-01-F
