[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Rules and Regulations]
[Pages 55413-55414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22196]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2012-N-0902]
New Animal Drugs; Chorionic Gonadotropin; Naloxone; Oxymorphone;
Oxytocin
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 of approval of four new
animal drug applications (NADAs) at the sponsor's request because the
products are no longer manufactured or marketed.
DATES: This rule is effective September 20, 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 four approved NADAs
listed in table 1 of this document have requested that FDA withdraw
approval because the products are no longer manufactured or marketed:
Table 1--Withdrawal of Approval Requests
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Citation in 21
NADA No. Trade name (drug) Applicant CFR
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030-525......................... NUMORPHAN (oxymorphone Endo Pharmaceuticals Inc., 100 522.1642
hydrochloride) Injection. Painters Dr., Chadds Ford, PA
19317.
035-825......................... NARCAN (naloxone Endo Pharmaceuticals Inc., 100 522.1462
hydrochloride) Injection. Painters Dr., Chadds Ford, PA
19317.
046-822......................... VETOCIN (oxytocin) United Vaccines, A Harlan 522.1680
Injection. Sprague Dawley, Inc., Co.,
P.O. Box 4220, Madison, WI
53711.
103-090......................... CHORTROPIN (chorionic United Vaccines, A Harlan 522.1081
gonadotropin) Injection. Sprague Dawley, Inc., Co.,
P.O. Box 4220, Madison, WI
53711.
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Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 030-525, 035-825, 046-822, and 103-090, and all
supplements and amendments thereto, is withdrawn, effective September
20, 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, Endo Pharmaceuticals Inc.
and United Vaccines, A Harlan Sprague Dawley, Inc., Co., 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.
[[Page 55414]]
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 Part 522
Animal drugs.
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 and
522 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 ``Endo Pharmaceuticals Inc.'' and ``United Vaccines, A
Harlan Sprague Dawley, Inc., Co.''; and in the table in paragraph
(c)(2), remove the entries for ``058639'' and ``060951''.
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. 522.1081 [Amended]
0
4. In Sec. 522.1081, remove and reserve paragraph (b)(2).
Sec. 522.1462 [Removed]
0
5. Remove Sec. 522.1462.
Sec. 522.1642 [Removed]
0
6. Remove Sec. 522.1642.
Sec. 522.1680 [Amended]
0
7. In Sec. 522.1680, in paragraph (b), remove ``058639,''.
Dated: September 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-22196 Filed 9-7-12; 8:45 am]
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