[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Rules and Regulations]
[Pages 60301-60302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24331]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, 524, and 558
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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.
FOR 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: [email protected].
SUPPLEMENTARY 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:
Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been
Requested
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Trade name Citation in 21
NADA/ANADA No. (drug) Applicant CFR
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100-556.......... Vigorena Feeds Springfield Milling 558.625
Hy-Ty Premix Corp., Vigorena
(tylosin Feeds, Springfield,
phosphate). MN 56087.
200-435.......... RESPIRAM Modern Veterinary 522.775
(doxapram Therapeutics, LLC,
hydrochloride) 18001 Old Cutler
Injection. Rd., suite 317,
Miami, FL 33157.
200-446.......... BUTORPHINE Modern Veterinary 522.246
(butorphanol Therapeutics, LLC,
tartrate) 18001 Old Cutler
Injection. Rd., suite 317,
Miami, FL 33157.
200-459.......... VETAZINE Modern Veterinary 524.2483
(triamcinolone Therapeutics, LLC,
) Cream. 18001 Old Cutler
Rd., suite 317,
Miami, FL 33157.
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[[Page 60302]]
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and all supplements and amendments thereto, is withdrawn, effective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.
List 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:
PART 510--NEW ANIMAL DRUGS
0
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.
Sec. 510.600 [Amended]
0
2. In Sec. 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''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.246 [Amended]
0
4. In Sec. 522.246, in paragraph (b)(2), remove ``Nos. 015914 and
059130'' and in its place add ``No. 059130''.
Sec. 522.775 [Amended]
0
5. In Sec. 522.775, in paragraph (b), remove ``Nos. 000010 and
015914'' and in its place add ``No. 000010''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.2483 [Amended]
0
7. In Sec. 524.2483, in paragraph (b), remove ``015914,''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
8. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.625 [Amended]
0
9. In Sec. 558.625, remove and reserve paragraph (b)(40).
Dated: September 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-24331 Filed 10-2-12; 8:45 am]
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