[Federal Register Volume 68, Number 147 (Thursday, July 31, 2003)]
[Rules and Regulations]
[Page 44878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526


Intramammary Dosage Forms; Change of Sponsor

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 a change of sponsor for three approved new 
animal drug applications (NADAs) from Pfizer, Inc., to Schering-Plough 
Animal Health Corp.

DATES: This rule is effective July 31, 2003.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following three approved NADAs to Schering-
Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083:

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          NADA No.                            Trade Name
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55-069                       ORBENIN DC (cloxacillin benzathine)
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55-070                       DARICLOX (cloxacillin sodium)
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55-100                       AMOXI-MAST (amoxicillin trihydrate)
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    Accordingly, the agency is amending the regulations in 21 CFR 
526.88, 526.464b, and 526.464c to reflect the transfer of ownership.
    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.  526.88  [Amended]

0
2. Section 526.88 Amoxicillin trihydrate for intramammary infusion is 
amended in paragraph (b) by removing ``000069'' and by adding in its 
place ``000061''.


Sec.  526.464b  [Amended]

0
3. Section 526.464b Cloxacillin benzathine for intramammary infusion, 
sterile is amended in paragraph (d) by removing ``000069'' and by 
adding in its place ``000061''.


Sec.  526.464c  [Amended]

0
4. Section 526.464c Cloxacillin sodium for intramammary infusion, 
sterile is amended in paragraph (b) by removing ``000069'' and by 
adding in its place ``000061''.

    Dated: July 18, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-19445 Filed 7-30-03; 8:45 am]
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