[Federal Register Volume 69, Number 167 (Monday, August 30, 2004)]
[Rules and Regulations]
[Pages 52815-52816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Spectinomycin Dihydrochloride 
Oral Solution

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 Cross Vetpharm Group Ltd. The ANADA 
provides for the oral use of spectinomycin dihydrochloride pentahydrate 
oral solution in pigs under 4 weeks of age for the treatment and 
control of infectious bacterial enteritis.

DATES:  This rule is effective August 30, 2004.

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: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-364 that provides for 
oral use of SPECMED (spectinomycin dihydrochloride pentahydrate) Scour-
Chek in pigs under 4 weeks of age for the treatment and control of 
infectious bacterial enteritis (white scours) associated with 
Escherichia coli. Cross Vetpharm Group Ltd.'s SPECMED Scour-Chek is 
approved as a generic copy of Phoenix Scientific, Inc.'s SPECTAM Scour 
Halt, approved under NADA 033-157. The ANADA is approved as of July 29, 
2004, and the regulations are amended by removing 21 CFR 520.2122 and 
by adding 21 CFR 520.2123c 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 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.
    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 Subject in 21 CFR Part 520

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.2122   [Removed]

0
2. Section 520.2122 is removed.

0
3. Section 520.2123c is added to read as follows:


Sec.  520.2123c   Spectinomycin dihydrochloride pentahydrate solution.

    (a) Specifications. Each milliliter of solution contains 50 
milligrams (mg) spectinomycin activity.
    (b) Sponsors. See Nos. 000856, 059130, and 061623 in Sec.  
510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Amount. Administer 5 mg per 
pound (lb) of body weight orally twice daily for 3 to 5 days.

[[Page 52816]]

    (2) Indications for use. For the treatment and control of 
infectious bacterial enteritis (white scours) associated with E. coli 
in pigs under 4 weeks of age.
    (3) Limitations. Do not administer to pigs over 15 lb of body 
weight or over 4 weeks of age. Do not administer within 21 days of 
slaughter.

    Dated: August 17, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-19655 Filed 8-27-04; 8:45 am]
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