-
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 the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
DATES:
This rule is effective October 15, 2012.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6843, email: david.alterman@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
The sponsors of the NADA and ANADAs listed in table 1 have requested that FDA withdraw approval because the products are no longer manufactured or marketed:
Start Printed Page 60302Table 1—NADA and ANADAs for Which Withdrawal of Approval Has Been Requested
NADA/ANADA No. Trade name (drug) Applicant Citation in 21 CFR 100-556 Vigorena Feeds Hy-Ty Premix (tylosin phosphate) Springfield Milling Corp., Vigorena Feeds, Springfield, MN 56087 558.625 200-435 RESPIRAM (doxapram hydrochloride) Injection Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., suite 317, Miami, FL 33157 522.775 200-446 BUTORPHINE (butorphanol tartrate) Injection Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., suite 317, Miami, FL 33157 522.246 200-459 VETAZINE (triamcinolone) Cream Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., suite 317, Miami, FL 33157 524.2483 Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 100-556 and ANADAs 200-435, 200-446, and 200-459, and all supplements and amendments thereto, is withdrawn, effective October 15, 2012. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval.
Following these withdrawals of approval, Modern Veterinary Therapeutics, LLC, and Springfield Milling Corp. will no longer be 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 Parts 522 and 524
- Animal drugs
21 CFR Parts 558
- Animal drugs
- Animal feeds
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 522, 524, and 558 are amended as follows:
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 “Modern Veterinary Therapeutics, LLC” and “Springfield Milling Corp.”; and in the table in paragraph (c)(2), remove the entries for “015914” and “035955”.
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part3. The authority citation for 21 CFR part 522 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]4. In § 522.246, in paragraph (b)(2), remove “Nos. 015914 and 059130” and in its place add “No. 059130”.
End Amendment PartStart Amendment Part[Amended]5. In § 522.775, in paragraph (b), remove “Nos. 000010 and 015914” and in its place add “No. 000010”.
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. In § 524.2483, in paragraph (b), remove “015914,”.
End Amendment Part Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part8. The authority citation for 21 CFR part 558 continues to read as follows:
End Amendment PartStart Amendment Part[Amended]9. In § 558.625, remove and reserve paragraph (b)(40).
End Amendment Part Start SignatureEnd Signature End Supplemental InformationDated: September 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24331 Filed 10-2-12; 8:45 am]
BILLING CODE P
Document Information
- Comments Received:
- 0 Comments
- Effective Date:
- 10/15/2012
- Published:
- 10/03/2012
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2012-24331
- Dates:
- This rule is effective October 15, 2012.
- Pages:
- 60301-60302 (2 pages)
- Docket Numbers:
- Docket No. FDA-2012-N-0002
- Topics:
- Administrative practice and procedure, Animal drugs, Animal feeds, Labeling, Reporting and recordkeeping requirements
- PDF File:
- 2012-24331.pdf
- Supporting Documents:
- » Freedom of Information Summary ANADA 200-543 Cefpodoxime Proxetil
- » Freedom of Information Summary ANADA 200-491, Loxicom (meloxicam)
- » Freedom of Information Summary ANADA 200-485, Meloxicam Injection (meloxicam)
- » Freedom of Information Summary NADA 200-496 96% Solution Growing chickens, turkeys and laying hens
- » Freedom of Information Summary NADA 200-534 Melengestrol acetate plus monensin USP plus tylosin phosphate
- » Freedom of Information Summary NADA 141-068 BAYTRIL 100 Injectable Solution
- » Freedom of Information Summary NADA 141-346 OroCAM
- » Freedom of Information Summary NADA 141-344 VERAFLOX Suspension for Cats
- » Freedom of Information Summary ANADA 200-466 SPARMECTIN Plus Clorsulon
- » Freedom of Information Summary NADA 141-342 ALFAXAN
- CFR: (5)
- 21 CFR 510.600
- 21 CFR 522.246
- 21 CFR 522.775
- 21 CFR 524.2483
- 21 CFR 558.625