Animal drugs, feeds, and related products: Sponsor name and address changes— Cross Vetpharm Group, Ltd.,

[Federal Register: October 20, 2003 (Volume 68, Number 202)]

[Rules and Regulations]

[Page 59880-59881]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr20oc03-4]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, and 529

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 12 approved new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from Anthony Products Co. to Cross Vetpharm Group, Ltd.

DATES: This rule is effective October 20, 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 12 approved NADAs and one approved ANADA to Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.

Application No. 21 CFR Section

Trade Name

NADA 046-780

522.1720

PHEN-BUTA-VET (phenylbutazone) Injection

NADA 096-671

522.1720

PHEN-BUTA-VET (phenylbutazone) Injection

NADA 096-672

520.1720a

PHEN-BUTA-VET (phenylbutazone) Tablets

NADA 098-288

522.1883

PREDNIS-A-VET (prednisolone sodium phosphate) Injection

NADA 099-604

522.540

DEX-A-VET (dexamethasone sodium phosphate) Injection

NADA 099-605

522.540

DEX-A-VET (dexamethasone sodium phosphate) Injection

NADA 099-606

522.540

DEXAMETH-A-VET (dexamethasone) Injection

NADA 099-607

522.540

DEXAMETH-A-VET (dexamethasone) Injection

NADA 118-550

522.1010

FUROS-A-VET (furosemide) Injection

NADA 119-141

522.1962

TRANQUAZINE (promazine hydrochloride) Injection

NADA 138-405

522.2063

Pyrilamine Maleate Injection

NADA 140-583

522.480

ACTH Gel

ANADA 200-115

529.1044a

GENTAMEX 100 (gentamicin sulfate)

Accordingly, the agency is amending the regulations in 21 CFR 520.1720a, 522.480, 522.540, 522.1010, 522.1720, 522.1883, 522.1962, 522.2063, and 529.1044a to reflect the transfer of ownership. Sections 522.1883 and 522.1962 are also being revised to reflect a current format.

Following these changes of sponsorship, Anthony Products Co. is no longer the sponsor of an approved application. Accordingly, Sec. 510.600(c) is being amended to remove the entries for Anthony Products Co.

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, 522, and 529

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, 522, and 529 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.

[[Page 59881]]

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 ``Anthony Products Co.'' and in the table in paragraph (c)(2) by removing the entry for ``000864''.

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. 520.1720a [Amended]

0 4. Section 520.1720a Phenylbutazone tablets and boluses is amended in paragraph (b)(3) by removing ``000864''.

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

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

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

Sec. 522.480 [Amended]

0 6. Section 522.480 Repository corticotropin injection is amended in paragraph (b)(2) by removing ``000864'' and by adding in its place ``061623''.

Sec. 522.540 [Amended]

0 7. Section 522.540 Dexamethasone injection is amended in paragraphs (b)(2)(i) and (c)(2) by removing ``000864'' and by adding in its place ``061623''.

Sec. 522.1010 [Amended]

0 8. Section 522.1010 Furosemide is amended in paragraph (b)(2) by removing ``000864'' and by adding in its place ``061623''.

Sec. 522.1720 [Amended]

0 9. Section 522.1720 Phenylbutazone injection is amended in paragraph (b)(1) by removing ``and 059130'' and by adding in its place ``059130, and 061623''; in paragraph (b)(2) by removing ``Nos. 000010 and 000864'' and by adding in its place ``No. 000010''; and by removing paragraph (b)(4).

0 10. Section 522.1883 is revised to read as follows:

Sec. 522.1883 Prednisolone sodium phosphate.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg of prednisolone).

(b) Sponsor. See No. 061623 in Sec. 510.600(c) of this chapter.

(c) Conditions of use in dogs--(1) Amount. Administer intravenously in a dosage of 2 1/2 to 5 mg per pound of body weight, initially for shock and shock-like states, followed by equal maintenance doses at 1-, 3-, 6-, or 10-hour intervals as determined by the condition of the animal.

(2) Indications for use. Administer when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

0 11. Section 522.1962 is amended: 0 a. By removing ``injection'' from the heading; 0 b. By removing footnote 1; 0 c. In paragraph (b) by removing ``000864'' and by adding in its place ``061623''; 0 d. By removing paragraphs (c)(3) and (c)(4); 0 e. By revising paragraphs (a) and (c)(2); and 0 f. By adding a heading to (c)(1). 0 The amendments read as follows:

Sec. 522.1962 Promazine hydrochloride.

(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride. * * * * *

(c) * * *

(1) Amounts and indications for use. (i) * * * * * * * *

(2) Limitations. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Sec. 522.2063 [Amended]

0 12. Section 522.2063 Pyrilamine maleate injection is amended in paragraph (b) by removing ``000864'' and by adding in its place ``061623''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0 13. The authority citation for 21 CFR part 529 continues to read as follows:

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

Sec. 529.1044a [Amended]

0 14. Section 529.1044a Gentamicin sulfate intrauterine solution is amended in paragraph (b) by removing ``000864, 057561, and 059130'' and by adding in its place ``057561, 059130, and 061623''.

Dated: October 2, 2003. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

[FR Doc. 03-26336 Filed 10-17-03; 8:45 am]

BILLING CODE 4160-01-S