[Federal Register Volume 73, Number 122 (Tuesday, June 24, 2008)]
[Rules and Regulations]
[Page 35579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14291]
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Rules and Regulations
Federal Register
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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:
[email protected].
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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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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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