Animal drugs, feeds, and related products: Sponsor name and address changes Wellmark International,
[Federal Register: March 8, 2005 (Volume 70, Number 44)]
[Rules and Regulations]
[Page 11120-11121]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr05-5]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
New Animal Drugs; Change of Sponsor's Address
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's address for Wellmark International.
DATES: This rule is effective March 8, 2005.
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: david.newkirk@fda.gov.
SUPPLEMENTARY INFORMATION: Wellmark International, 1100 East Woodfield Rd., suite 500, Schaumburg, IL 60173 has informed FDA of a change of address to 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect the change.
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 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
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 510 is amended as follows:
PART 510--NEW ANIMAL DRUGS
0 1. The authority citation for 21 CFR part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 0 2. Section 510.600 is amended in the table in paragraph (c)(1) by revising the entry for ``Wellmark International''; and in the table in paragraph (c)(2) by revising the entry for ``011536'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
Firm name and address
Drug labeler code
* * * * *
Wellmark International, 1501 East Woodfield 011536 Rd., suite 200 West, Schaumburg, IL 60173
* * * * *
(2) * * *
Drug labeler code
Firm name and address
* * * * *
011536
Wellmark International, 1501 East Woodfield Rd., suite 200 West, Schaumburg, IL 60173
* * * * *
[[Page 11121]]
Dated: February 16, 2005. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 05-4480 Filed 3-7-05; 8:45 am]
BILLING CODE 4160-01-S