Document ID: FDA-2011-N-0160-0001
Agency: fda
Document Type: Rule
Title: 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
Posted Date: 2011-03-31T04:00Z

[Federal Register: March 31, 2011 (Volume 76, Number 62)]
[Rules and Regulations]               
[Page 17776-17778]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr11-5]                         

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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: john.bartkowiak@fda.hhs.gov.

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
----------------------------------------------------------------------------------------------------------------
                                                 NADA No. product          21 CFR section  affected (sponsor's
                 Sponsor                    (established name of drug)             drug  labeler code)
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------

    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