-
Start Preamble
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 four new animal drug applications (NADAs) from PM Resources, Inc., to Virbac AH, Inc.
DATES:
This rule is effective July 9, 2004.
Start Further InfoFOR 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: davidnewkirk@fda.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
PM Resources, Inc., 13001 St. Charles Rock Rd., Bridgeton, MO 63044, has informed FDA that it has transferred ownership of, and all rights and interest in, the following four approved NADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:
Application No. 21 CFR Section Trade Name NADA 007-076 520.2325a SULFA-NOX (sulfaquinoxaline) Liquid NADA 008-244 520.2325a SULFA-NOX (sulfaquinoxaline) Concentrate NADA 043-215 524.900 PURINA Grub-Kill (famphur) NADA 092-150 520.2045 PURINA Horse & Colt Wormer (pyrantel tartrate) Accordingly, the agency is amending the regulations in 21 CFR 520.2045, 520.2325a, and 524.900 to reflect the transfer of ownership.
Following these changes of sponsorship, PM Resources, Inc., is no longer the sponsor of an approved application. Accordingly, § 510.600(c) is being amended to remove the entries for PM Resources, 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.
Start List of SubjectsList of Subjects
21 CFR Part 510
- Administrative practice and procedure
- Animal drugs
- Labeling
- Reporting and recordkeeping requirements
21 CFR Parts 520 and 524
- 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 524 are amended as follows:
End Amendment Part Start PartPART 510—NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “PM Resources, Inc.” and in the table in paragraph (c)(2) by removing the entry for “060594”.
End Amendment Part Start PartPART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for 21 CFR part 520 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]4. Section 520.2045 is amended in paragraph (b)(2) by removing “060594” and by adding in its place “051311”.
End Amendment PartStart Amendment Part[Amended]5. Section 520.2325a is amended in paragraph (a)(2) by removing “060594” and by adding in its place “051311”.
End Amendment Part Start PartPART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part6. The authority citation for 21 CFR part 524 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]7. Section 524.900 is amended in paragraph (c) by removing “060594” and by adding in its place “051311”.
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: June 18, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 04-15568 Filed 7-8-04; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Effective Date:
- 7/9/2004
- Published:
- 07/09/2004
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 04-15568
- Dates:
- This rule is effective July 9, 2004.
- Pages:
- 41427-41427 (1 pages)
- PDF File:
- 04-15568.pdf
- CFR: (4)
- 21 CFR 510.600
- 21 CFR 520.2045
- 21 CFR 524.900
- 21 CFR 520.2325a