68 FR 111 pgs. 34533-34534 - Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor
Type: RULEVolume: 68Number: 111Pages: 34533 - 34534
FR document: [FR Doc. 03-14547 Filed 6-9-03; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; 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 two approved new animal drug applications (NADAs) from Anthony Products Co. to Cross Vetpharm Group Ltd.
DATES:
This rule is effective June 10, 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:
Anthony Products Co., 5600 Peck Rd., Arcadia, CA 91006, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs to Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:
| NADA Number | Trade Name |
|---|---|
| 065-505 | MICROCILLIN Injectable Suspension |
| 065-506 | COMBICILLIN Injectable Suspension |
Accordingly, the agency is amending the regulations in 21 CFR 522.1696a and 522.1696b 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 522
Animal drugs.
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 522 is amended as follows:
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 522.1696a [Amended]
2. Section 522.1696a Penicillin G benzathine and penicillin G procaine sterile suspension is amended in paragraph (b)(1) by removing "000864, 010515, and 049185" and by adding in its place "010515, 049185, and 061623"; and in paragraph (b)(3) by removing "000864, 010515, and 059130" and by adding in its place "010515, 059130, and 061623".
§ 522.1696b [Amended]
3. Section 522.1696b Penicillin G procaine aqueous suspension is amended in paragraph (b)(2) by removing "000864 and 055529" and by adding in its place "055529 and 061623"; in paragraph (d)(2)(i)(A) by removing "000864, 010515, 053501, and 059130" and by adding in its place "010515, 053501, 059130, and 061623"; and in paragraph (d)(2)(iii)(A) by removing "000864, 010515, 053501, and 059130" and by adding in its place "010515, 053501, and 059130".
Dated: May 19, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-14547 Filed 6-9-03; 8:45 am]
BILLING CODE 4160-01-S