2010-22808. Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol; Lincomycin; Pyrantel Tartrate; and Tylosin Phosphate and Sulfamethazine
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Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
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.
DATES:
This rule is effective September 24, 2010.
Start Further InfoFOR 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: john.bartkowiak@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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gave notice that approval of NADA 65-137, 121-337, 132-923, and 138-342, and all supplements and amendments thereto, is withdrawn, effective September 24, 2010.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 SubjectsList of Subjects
21 CFR Part 510
- Administrative practice and procedure
- Animal drugs
- Labeling
- Reporting and recordkeeping requirements
21 CFR Part 520
- Animal drugs
21 CFR Part 558
- Animal drugs
- Animal feeds
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 558 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. 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 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 Part Start Amendment Part4. In § 520.390b, revise paragraph (b) to read as follows:
End Amendment PartStart PartChloramphenicol capsules.(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 FEEDS
End Part Start Amendment Part5. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment Part Start Amendment Part6. 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 PartStart Printed Page 55677Lincomycin.(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.”
Start Amendment Part[Amended]7. In paragraph (b)(3) of § 558.485, remove “043733”.
End Amendment PartStart Amendment Part[Amended]8. In paragraph (b)(5) of § 558.630, remove “030841”.
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22808 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S
Document Information
- Comments Received:
- 0 Comments
- Effective Date:
- 9/24/2010
- Published:
- 09/14/2010
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2010-22808
- Dates:
- This rule is effective September 24, 2010.
- Pages:
- 55676-55677 (2 pages)
- Docket Numbers:
- Docket No. FDA-2010-N-0002
- Topics:
- Administrative practice and procedure, Animal drugs, Animal feeds, Labeling, Reporting and recordkeeping requirements
- PDF File:
- 2010-22808.pdf
- CFR: (5)
- 21 CFR 510.600
- 21 CFR 558.325
- 21 CFR 558.485
- 21 CFR 558.630
- 21 CFR 520.390b