Rules and Regulations. Final rule

626 words·~3 min read·/register/2003/09/29/03-24492·

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BILLING CODE 4160-01-S 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. 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: *dnewkirk@cvm.fda.gov* . 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: Application No. 21 CFR 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 Accordingly, the agency is amending the regulations in §§ 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. 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 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. § 510.600 [Amended] 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 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. § 520.88b [Amended] 4. Section 520.88b *Amoxicillin trihydrate for oral suspension* is amended in paragraph

(c)by removing “059079” and by adding in its place “051311”. § 520.88f [Amended] 5. Section 520.88f *Amoxicillin trihydrate tablets* is amended in paragraph

(b)by removing “059079” and by adding in its place “051311”. § 520.446 [Amended] 6. Section 520.446 *Clindamycin capsules and tablets* is amended in paragraph (b)(3) by removing “059079” and by adding in its place “051311”. § 520.447 [Amended] 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 8. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.900 [Amended] 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]

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