[Federal Register Volume 70, Number 236 (Friday, December 9, 2005)]
[Rules and Regulations]
[Pages 73136-73137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfadimethoxine 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 Cross Vetpharm Group Ltd. The ANADA 
provides for the oral use of sulfadimethoxine soluble powder to create 
a solution administered as a drench to cattle or in the drinking water 
of chickens, turkeys, or cattle for the treatment of coccidiosis or 
various bacterial diseases.

DATES: This rule is effective December 9, 2005.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed

[[Page 73137]]

ANADA 200-376 that provides for use of SULFAMED-G (sulfadimethoxine) 
Soluble Powder to create a solution administered as a drench to cattle 
or in the drinking water of chickens, turkeys, or cattle for the 
treatment of coccidiosis or various bacterial diseases. Cross Vetpharm 
Group Ltd.'s SULFAMED-G Soluble Powder is approved as a generic copy of 
Pfizer, Inc.'s ALBON (sulfadimethoxine) Soluble Powder, approved under 
NADA 46-285. The ANADA is approved as of November 14, 2005, and the 
regulations are amended in 21 CFR 520.2220a 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.
    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 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.

0
2. Section 520.2220a is amended by revising paragraphs (a)(2) and (b); 
and by adding two sentences at the end of paragraph (d)(3)(iii) to read 
as follows:


Sec.  520.2220a  Sulfadimethoxine oral solution and soluble powder.

    (a) * * *
    (2) For soluble powder, each 107 grams contain the equivalent of 
94.6 grams of sulfadimethoxine (as the sodium salt); see Nos. 000069, 
051259, 057561, 059130, and 061623 in Sec.  510.600(c) of this chapter.
    (b) Special considerations. Federal law prohibits the extralabel 
use of this product in lactating dairy cattle.
* * * * *
    (d) * * *
    (3) * * *
    (iii) * * * A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.

    Dated: November 30, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-23813 Filed 12-8-05; 8:45 am]
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