Oral Dosage Form New Animal Drugs; Sulfachlorpyridazine Powder, 35579 [E8-14291]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 122 (Tuesday, June 24, 2008)]
[Rules and Regulations]
[Page 35579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14291]



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Federal Register / Vol. 73, No. 122 / Tuesday, June 24, 2008 / Rules 
and Regulations

[[Page 35579]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfachlorpyridazine 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 a supplemental new animal drug 
application (NADA) filed by Fort Dodge Animal Health, A Division of 
Wyeth Holdings Corp. The supplemental NADA provides for a revised food 
safety warning statement for oral use of sulfachlorpyridazine in the 
milk or milk replacer of ruminating calves.

DATES: This rule is effective June 24, 2008.

FOR FURTHER INFORMATION CONTACT:  Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, A Division of 
Wyeth Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501, filed a 
supplement to NADA 33-373 for VETISULID (sulfachlorpyridazine sodium) 
Powder, approved for oral use in calves and swine for the treatment of 
diarrhea caused or complicated by Escherichia coli (colibacillosis). 
The supplemental NADA provides for a revised food safety warning 
statement for oral use of sulfachlorpyridazine in the milk or milk 
replacer of ruminating calves. The supplemental application is approved 
as of May 19, 2008, and the regulations are amended in 21 CFR 520.2200b 
to reflect the approval and a current format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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.

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. Revise Sec.  520.2200b to read as follows:


Sec.  520.2200b  Sulfachlorpyridazine powder.

    (a) Specifications. Sodium sulfachlorpyridazine powder.
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.630 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Calves--(i) Amount. Administer 30 to 45 milligrams per pound 
(mg/lb) body weight per day in milk or milk replacer for 1 to 5 days in 
2 divided doses twice daily.
    (ii) Indications for use. For the treatment of diarrhea caused or 
complicated by E. coli (colibacillosis).
    (iii) Limitations. Treated, ruminating calves must not be 
slaughtered for food during treatment or for 7 days after the last 
treatment. A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
    (2) Swine--(i) Amount. Administer 20 to 35 mg/lb body weight per 
day for 1 to 5 days in 2 divided doses twice daily:
    (A) In drinking water; or
    (B) For individual treatment, in an oral suspension containing 
approximately 42 mg sulfachlorpyridazine per milliliter in divided 
doses twice daily.
    (ii) Indications for use. For the treatment of diarrhea caused or 
complicated by E. coli (colibacillosis).
    (iii) Limitations. Treated swine must not be slaughtered for food 
during treatment or for 4 days after the last treatment.

    Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-14291 Filed 6-23-08; 8:45 am]
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