Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of four new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
This rule is effective September 24, 2010.Start Further Info
FOR FURTHER INFORMATION CONTACT:
John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079; email: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611; International Nutrition, Inc., 7706 “I” Plaza, Omaha, NE 68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001 have requested that FDA withdraw approval of the four NADAs listed in the following paragraph because they are no longer manufactured or marketed:
In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 65-137, 121-337, 132-923, and 138-342, and all supplements and amendments thereto, is withdrawn, effective September 24, 2010. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals of approval.
Following these changes of sponsorship, Feed Service Co., Inc., and John J. Ferrante are no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for these firms.
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 Subjects
List of Subjects
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 510.600, in the table in paragraph (c)(1), remove the entries for “Feed Service Co., Inc.” and “John J. Ferrante”; and in the table in paragraph (c)(2), remove the entries for “030841” and “058034”.End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part Start Amendment Part
4. In § 520.390b, revise paragraph (b) to read as follows:End Amendment Part
(b) Sponsors. See Nos. 000069 and 050057 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
5. The authority citation forEnd Amendment Part Start Amendment Part
6. In § 558.325, revise paragraphs (a) and (c)(3)(ii); and in the table in paragraphs (d)(2)(ii) and (d)(2)(iii), in the “Sponsor” column, remove “043733” to read as follows:End Amendment Part
(a) Approvals. Type A articles and Type B feeds approved for sponsors in § 510.600(c) of this chapter for specific uses as in paragraph (d) of this section as follows:
(1) No. 000009 for 20 and 50 grams per pound.
(2) No. 051311 for 2.5 and 8 grams per pound.
(c) * * *
(3) * * *
(ii) No. 051311:“CAUTION: Not to be fed to swine that weigh more than 250 lb.”
7. In paragraph (b)(3) of § 558.485, remove “043733”.End Amendment Part
8. In paragraph (b)(5) of § 558.630, remove “030841”.End Amendment Part Start Signature
Dated: September 1, 2010.
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22808 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S