Document ID: FDA-2008-N-0039-0015
Agency: fda
Document Type: Rule
Title: Intramammary Dosage Forms; Cephapirin Benzathine
Posted Date: 2008-03-07T05:00Z

[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Rules and Regulations]               
[Page 12262]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr08-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526

 
Intramammary Dosage Forms; Cephapirin Benzathine

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, Division of 
Wyeth. The supplemental NADA provides for a revision to the labeling of 
cephapirin benzathine intramammary infusion administered to dairy cows 
entering their dry period for the treatment of mastitis.

DATES: This rule is effective March 7, 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, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
108-114 that revises labeling of CEFA-DRI (cephapirin benzathine) 
Intramammary Infusion administered to dairy cows entering their dry 
period for the treatment of mastitis. The application is approved as of 
February 7, 2008, and the regulations are amended in 21 CFR 526.363 to 
reflect the approval, an editorial change, 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.
    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 Subjects in 21 CFR Part 526

    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 526 is 
amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORMS

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1. The authority citation for 21 CFR part 526 continues to read as 
follows:

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

Sec.  526.363  [Amended]

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2. In Sec.  526.363, at the end of paragraph (d)(2), add ``, including 
penicillin-resistant strains''; and in the second sentence of paragraph 
(d)(3), remove ``use'' and add in its place ``used''.

    Dated: February 27, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-4473 Filed 3-6-08; 8:45 am]

BILLING CODE 4160-01-S