[Federal Register Volume 68, Number 17 (Monday, January 27, 2003)]
[Rules and Regulations]
[Pages 3816-3817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1685]


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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 an abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for oral use of lincomycin soluble powder to make medicated 
drinking water for administration to swine for the treatment of swine 
dysentery or to broiler chickens for the control of necrotic enteritis.

DATES: This rule is effective January 27, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64506-0457, filed ANADA 200-303 for 
Lincomycin Hyrochloride Soluble Powder. The application provides for 
oral use of lincomycin soluble powder to make medicated drinking water 
for administration to swine for the treatment of swine dysentery or to 
broiler chickens for the control of necrotic enteritis. Phoenix 
Scientific's Lincomycin Hyrochloride Soluble Powder is approved as a 
generic copy of Pharmacia & Upjohn's LINCOMIX Soluble Powder, approved 
under NADA 111-636. ANADA 200-303 is approved as of October 1, 2002, 
and the regulations are amended in 21 CFR 520.1263c 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

[[Page 3817]]

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.
    FDA 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 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 removing ``and 051259'' and by adding in 
its place ``051259, and 059130''.

    Dated: January 7, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-1685 Filed 1-24-03; 8:45 am]
BILLING CODE 4160-01-S