[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Rules and Regulations]
[Pages 17776-17778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7560]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2011-N-0160]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin;
Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone;
Pyrantel; Tylosin; Tylosin and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of 13
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 April 11, 2011.
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, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: The sponsors of the 13 approved NADAs listed
in table 1 have requested that FDA withdraw approval because the
products are no longer manufactured or marketed.
[[Page 17777]]
Table 1--Voluntary Requests for Withdrawal of Approval of 13 NADAs
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NADA No. product 21 CFR section affected (sponsor's
Sponsor (established name of drug) drug labeler code)
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Roche Vitamins, Inc., 45 Waterview Blvd., NADA 093-029, UNITOP Cream 524.520 (063238).
Parsippany, NJ 07054-1298. (cuprimyxin).
Quali-Tech Products, Inc., 318 Lake NADA 097-981, TYLAN 40 Sulfa- 558.630 (016968).
Hazeltine Dr., Chaska, MN 55318. G Premix (tylosin phosphate/
sulfamethazine).
Abraxis Pharmaceutical Products, Division NADA 100-840, Chorionic 522.1081 (063323).
of Abraxis Bioscience, 6133 River Rd., Gonadotropin for Injection
suite 500, Rosemont, IL 60018. (chorionic gonadotropin).
Furst-McNess Co., Freeport, IL 61032..... NADA 100-991, McNess Custom 558.625 (010439).
Premix L200 (tylosin
phosphate).
Fort Dodge Animal Health, Division of NADA 101-079 TRAMISOL-10% Not codified (000856).
Wyeth Holdings, a wholly owned Pig Wormer (levamisole).
subsidiary of Pfizer, Inc., 235 East 42d
St., New York, NY 10017.
Waterloo Mills Co., 2050 Mitchell Ave., NADA 101-905, Mill Co- 558.625 (017139).
Waterloo, IA 50704. Medicator TY-10 (tylosin
phosphate).
Waterloo Mills Co., 2050 Mitchell Ave., NADA 101-906, Mill Co- 558.630 (017139).
Waterloo, IA 50704. Medicator TS-40 Premix
(tylosin phosphate/
sulfamethazine).
Pegasus Laboratories, Inc., 8809 Ely Rd., NADA 102-824,Phenylbutazone 520.1720a (055246).
Pensacola, FL 32514. Tablets (phenylbutazone).
Wendt Laboratories, Inc., 100 Nancy Dr., NADA 108-487, DEC Tabs 520.622a (015579).
Belle Plaine, MN 56011. (diethylcarbamazine
citrate).
Wendt Laboratories, Inc., 100 Nancy Dr., NADA 108-863, DEC Chewable 520.622c (015579).
Belle Plaine, MN 56011. Tabs (diethylcarbamazine
citrate).
Furst-McNess Co., Freeport, IL 61032..... NADA 140-820, TYLAN 40 Sulfa- 558.630 (010439).
G Premix (tylosin phosphate/
sulfamethazine).
Furst-McNess Co., Freeport, IL 61032..... NADA 140-825, BANMINTH 558.485 (010439).
Intermediate Premix
(pyrantel tartrate).
Hess & Clark, Inc., 944 Nandino Blvd., NADA 140-910, NFZ Wound 524.1580c (050749).
Lexington, KY 40511. Powder (nitrofurazone).
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In a notice published elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADAs 93-029, 97-981, 100-
840, 100-991, 101-079, 101-905, 101-906, 102-824, 108-487, 108-863,
140-820, 140-825, and 140-910, and all supplements and amendments
thereto, is withdrawn, effective April 11, 2011. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect these withdrawals of approval and a current format.
Following these changes of sponsorship, Abraxis Pharmaceutical
Products, Furst-McNess Co., Roche Vitamins, Inc., Waterloo Mills Co.,
and Wendt Laboratories, Inc., are no longer the sponsors 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 520, 522, and 524
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, 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 ``Abraxis Pharmaceutical Products'', ``Furst-McNess Co.'',
``Roche Vitamins, Inc.'', ``Waterloo Mills Co.'', and ``Wendt
Laboratories, Inc.''; and in the table in paragraph (c)(2), remove the
entries for ``010439'', ``015579'', ``017139'', ``063238'', and
``063323''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.622a, remove and reserve paragraph (a)(1); in paragraph
(a)(5), remove ``000081' and in its place add ``No. 000061''; and
revise paragraph (b)(2) to read as follows:
Sec. 520.622a Diethylcarbamazine citrate tablets.
* * * * *
(b) * * *
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
5. In Sec. 520.622c, remove and reserve paragraph (b)(1); remove
reserved paragraph (b)(7); and revise paragraph (c)(3) to read as
follows:
Sec. 520.622c Diethylcarbamazine citrate chewable tablets.
* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.1720a [Amended]
0
6. In Sec. 520.1720a, remove and reserve paragraph (b)(4).
[[Page 17778]]
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1081 [Amended]
0
8. In paragraph (b)(2) of Sec. 522.1081, remove ``Nos. 058639 and
063323'' and in its place add ``No. 058639''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.520 [Removed]
0
10. Remove Sec. 524.520.
Sec. 524.1580c [Amended]
0
11. In paragraph (b) of Sec. 524.1580c, remove ``Nos. 000010, 000069,
and 050749'' and in its place add ``Nos. 000010 and 000069''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
12. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.485 [Amended]
0
13. In Sec. 558.485, in paragraph (b)(3), remove ``010439''.
Sec. 558.625 [Amended]
0
14. In Sec. 558.625, remove and reserve paragraphs (b)(42) and
(b)(45).
Sec. 558.630 [Amended]
0
15. In Sec. 558.630, remove and reserve paragraph (b)(4); and in
paragraph (b)(5), remove ``010439,'' and ``016968,''.
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7560 Filed 3-30-11; 8:45 am]
BILLING CODE 4160-01-P