[Federal Register Volume 68, Number 111 (Tuesday, June 10, 2003)]
[Rules and Regulations]
[Pages 34533-34534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14547]


-----------------------------------------------------------------------

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

[[Page 34534]]

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: 
[email protected].

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.

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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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


Sec.  522.1696a   [Amended]

0
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''.


Sec.  522.1696b  [Amended]

0
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