[Federal Register Volume 68, Number 188 (Monday, September 29, 2003)]
[Rules and Regulations]
[Pages 55823-55824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 522


New Animal Drugs; 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 two new animal drug 
applications (NADAs) and three abbreviated new animal drug applications 
(ANADAs) from Delmarva Pharmaceuticals, Inc., to Virbac AH, Inc.

DATES: This rule is effective September 29, 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: Delmarva Laboratories, Inc., 1500 Huguenot 
Rd., suite 106, Midlothian, VA 23113, has informed FDA that it has 
transferred ownership of, and all rights and interest in, the following 
two approved NADAs and three approved ANADAs to Virbac AH, Inc., 3200 
Meacham Blvd., Ft. Worth, TX 76137:

------------------------------------------------------------------------
                            21 CFR
    Application No.         Section                Trade Name
------------------------------------------------------------------------
NADA 065-492                 520.88f   ROBAMOX V (amoxicillin
                                        trihydrate) Tablets
------------------------------------------------------------------------
NADA 065-495                 520.88b   ROBAMOX V (amoxicillin
                                        trihydrate)
------------------------------------------------------------------------
ANADA 200-071                522.900   EUTHASOL Solution
------------------------------------------------------------------------
ANADA 200-291                520.447   CLINSOL (clindamycin
                                        hydrochloride) Liquid
------------------------------------------------------------------------
ANADA 200-316                520.446   CLINTABS (clindamycin
                                        hydrochloride) Tablets
------------------------------------------------------------------------


[[Page 55824]]

Accordingly, the agency is amending the regulations in Sec. Sec.  
520.88b, 520.88f, 520.446, 520.447, and 522.900 to reflect the transfer 
of ownership.
    Following these changes of sponsorship, Delmarva Laboratories, 
Inc., is no longer the sponsor of an approved application. Accordingly, 
21 CFR 510.600(c) is being amended to remove the entries for Delmarva 
Laboratories, Inc.
    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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520 and 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 parts 510, 
520, and 522 are 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.


Sec.  510.600  [Amended]

0
2. Section 510.600 Names, addresses, and drug labeler codes of sponsors 
of approved applications is amended in the table in paragraph (c)(1) by 
removing the entry for ``Delmarva Laboratories, Inc.'' and in the table 
in paragraph (c)(2) by removing the entry for ``059079''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.88b  [Amended]

0
4. Section 520.88b Amoxicillin trihydrate for oral suspension is 
amended in paragraph (c) by removing ``059079'' and by adding in its 
place ``051311''.


Sec.  520.88f  [Amended]

0
5. Section 520.88f Amoxicillin trihydrate tablets is amended in 
paragraph (b) by removing ``059079'' and by adding in its place 
``051311''.


Sec.  520.446  [Amended]

0
6. Section 520.446 Clindamycin capsules and tablets is amended in 
paragraph (b)(3) by removing ``059079'' and by adding in its place 
``051311''.


Sec.  520.447  [Amended]

0
7. Section 520.447 Clindamycin liquid is amended in paragraph (b)(2) by 
removing ``059079'' and by adding in its place ``051311''.

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

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

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


Sec.  522.900  [Amended]

0
9. Section 522.900 Euthanasia solution is amended in paragraph (b)(1) 
by removing ``059079'' and by adding in its place ``051311''.

    Dated: September 15, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-24492 Filed 9-26-03; 8:45 am]
BILLING CODE 4160-01-S