[Federal Register Volume 69, Number 55 (Monday, March 22, 2004)]
[Rules and Regulations]
[Pages 13220-13221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6249]


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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 and 
Spectinomycin Soluble Powder

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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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 and spectinomycin soluble powder to 
make medicated drinking water for administration to chickens up to 7 
days of age as an aid in the control of several bacterial respiratory 
diseases.

DATES: This rule is effective March 22, 2004.

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

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, St. Joseph, MO 64503, filed ANADA 200-345 for Lincomycin-
Spectinomycin (lincomycin hydrochloride monohydrate/spectinomycin 
dihydrochloride pentahydrate) Water Soluble Powder. The application 
provides for oral use of lincomycin and spectinomycin soluble powder to 
make medicated drinking water for administration to chickens up to 7 
days of age as an aid in the control of airsacculitis caused by either 
Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to 
lincomycin-spectinomycin and complicated chronic respiratory disease 
(air sac infection) caused by Escherichia coli and M. gallisepticum 
susceptible to lincomycin-spectinomycin. Phoenix Scientific's 
Lincomycin-Spectinomycin Water Soluble Powder is approved as a generic 
copy of Pharmacia & Upjohn's L-S 50 (lincomycin hydrochloride 
monohydrate/ spectinomycin sulfate tetrahydrate) Water Soluble Powder, 
approved under NADA 46 109. ANADA 200 345 is approved as of February 5, 
2004, and the regulations are amended in part 520 (21 CFR part 520) by 
removing Sec.  520.1263b and by adding Sec.  520.1265 to reflect the 
approval and a current format. 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 21 CFR 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 Division of Dockets Management 
(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.

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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

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.1263b  [Removed and Reserved]

0
2. Section 520.1263b is removed and reserved.
0
3. Section 520.1265 is added to read as follows:


Sec.  520.1265  Lincomycin and spectinomycin soluble powder.

    (a) Specifications. The following salts of lincomycin and 
spectinomycin are present in a soluble powder in the ratio of 1 to 2 on 
the basis of equivalency of lincomycin base to equivalency of 
spectinomycin base:
    (1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate 
tetrahydrate.
    (2) Lincomycin hydrochloride monohydrate and spectinomycin 
dihydrochloride pentahydrate.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.

[[Page 13221]]

    (1) No. 000009 for use of product described in paragraph (a)(1) of 
this section.
    (2) No. 059130 for use of product described in paragraph (a)(2) of 
this section.
    (c) Tolerances. See Sec. Sec.  556.360 and 556.600 of this chapter.
    (d) Conditions of use in chickens--(1) Amount. 2 grams of 
antibiotic activity per gallon of drinking water; administer as the 
sole source of water for the first 5 to 7 days of life.
    (2) Indications for use. As an aid in the control of airsacculitis 
caused by either Mycoplasma synoviae or M. gallisepticum susceptible to 
lincomycin-spectinomycin and complicated chronic respiratory disease 
(air sac infection) caused by Escherichia coli and M. gallisepticum 
susceptible to lincomycin-spectinomycin.

    Dated: March 11, 2004.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 04-6249 Filed 3-19-04; 8:45 am]
BILLING CODE 4160-01-S