Animal drugs, feeds, and related products: Sponsor name and address changes Schering-Plough Animal Health Corp.,
[Federal Register: July 31, 2003 (Volume 68, Number 147)]
[Rules and Regulations]
[Page 44878]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy03-8]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Intramammary Dosage Forms; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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: dnewkirk@cvm.fda.gov. 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:
NADA No.
Trade Name
55-069
ORBENIN DC (cloxacillin benzathine)
55-070
DARICLOX (cloxacillin sodium)
55-100
AMOXI-MAST (amoxicillin trihydrate)
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.
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 526 is amended as follows:
PART 526--INTRAMAMMARY DOSAGE FORMS
0 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]
BILLING CODE 4160-01-S
