Document ID: FDA-2012-N-1167-0003
Agency: fda
Document Type: Rule
Title: New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Alfaprostol; Bicyclohexylammonium Competitive Exclusion Culture; Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel; Tylosin; Tylosin and Sulfamethazine
Posted Date: 2013-03-07T05:00Z

[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14667-14669]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04999]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 529, and 558

[Docket No. FDA-2012-N-1167]

New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium 
Fumagillin; N-Butyl Chloride; Competitive Exclusion Culture; 
Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; 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 to reflect the withdrawal approval of 19 new animal 
drug applications (NADAs) and one abbreviated new animal drug 
application (ANADA). The applications are being withdrawn for lack of 
compliance with the reporting requirements in an FDA regulation.

DATES: This rule is effective March 18, 2013.

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; david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA gave notice that approval of the 19 
NADAs and one ANADA listed in table 1, and all supplements and 
amendments thereto, is withdrawn, effective March 18, 2013, for lack of 
compliance with reporting requirements in 21 CFR 514.80. As provided in 
the regulatory text of this document, the animal drug regulations are 
amended to reflect withdrawal of approval of the following applications 
and a current format. Withdrawal of approval of some applications did 
not require amending the regulations.

                            Table 1--NADAs and ANADA for Which Approval Is Withdrawn
----------------------------------------------------------------------------------------------------------------
        Application No.            Trade name (drug)                 Applicant                Citation in 21 CFR
----------------------------------------------------------------------------------------------------------------
NADA 009-252..................  FUMIDIL B               Mid-Continent Agrimarketing, Inc.,   520.182
                                 (bicyclohexylammonium   8833 Quivira Rd., Overland Park,
                                 fumagillin).            KS 66214
NADA 034-601..................  SYNCHRO-MATE            G. D. Searle LLC, Pharmacia Corp.,   529.1003
                                 (flurogestone           4901 Searle Pkwy., Skokie, IL
                                 acetate).               60077

[[Page 14668]]

 
NADA 039-284..................  Swisher Super Broiler   Swisher Feed Division, William       558.58
                                 300-108 (amprolium,     Davies Co., Inc., P.O. Box 578,
                                 ethopabate,             Danville, IL 61832
                                 bacitracin zinc, and
                                 roxarsone).
NADA 040-920..................  Chick Grower Developer  Honeggers and Co., Inc., 201 W.      Not codified
                                 Fortified (amprolium).  Locust St., Fairbury, IL 61739
NADA 094-223..................  Canine Worm Caps (n-    K. C. Pharmacal, Inc., 8345 Melrose  520.260
                                 butyl chloride).        Dr., Lenexa, KS 66214
NADA 098-429..................  Medic-Meal-T Premix     J. C. Feed Mills, 1050 Sheffield,    558.625
                                 (tylosin phosphate).    P.O. Box 224, Waterloo, IA 50704
NADA 098-639..................  TYLAN Sulfa-G (tylosin  Bioproducts, Inc., 320 Springside    558.630
                                 phosphate and           Dr., suite 300, Fairlawn, OH 44333-
                                 sulfamethazine).        2435
NADA 106-507..................  TYLAN 10 (tylosin       Custom Feed Blenders Corp., 540      558.625
                                 phosphate).             Hawkeye Ave., Fort Dodge, IA 50501
NADA 110-044..................  PRO-TONE Plus Pak GF T- Peavey Co., 730 Second Ave. South,   558.625
                                 1 (tylosin phosphate).  Minneapolis, MN 55402
NADA 117-688..................  Dichlorophene and       Texas Vitamin Co., P.O. Box 18417,   520.580
                                 Toluene Capsules.       10695 Aledo St., Dallas, TX 57218
NADA 120-614..................  TYLAN Sulfa-G (tylosin  Webel Feeds, Inc., R.R. 3,           558.630
                                 phosphate and           Pittsfield, IL 62363
                                 sulfamethazine).
NADA 120-671..................  Pet-Worm-Caps           K. C. Pharmacal, Inc., 8345 Melrose  520.580
                                 (dichlorophene and      Dr., Lenexa, KS 66214
                                 toluene).
NADA 121-147..................  Nutra-Mix TYLAN         Ag-Mark, Inc., P.O. Box 127,         558.625
                                 (tylosin phosphate).    Teachey, NC 28464
NADA 122-522..................  TYLAN Sulfa-G (tylosin  Custom Feed Blenders Corp., 540      558.630
                                 phosphate and           Hawkeye Ave., Fort Dodge, IA 50501
                                 sulfamethazine).
NADA 124-391..................  Nutra-Mix TYLAN-Sulfa   Ag-Mark, Inc., P.O. Box 127,         558.630
                                 Premixes (tylosin       Teachey, NC 28464
                                 phosphate and
                                 sulfamethazine).
NADA 127-195..................  TYLAN 10 (tylosin       I.M.S. Inc., 13619 Industrial Rd.,   558.625
                                 phosphate).             Omaha, NE 68137
NADA 129-415..................  Custom Ban Wormer 9.6   Custom Feed Blenders Corp., 540      558.485
                                 Banminth (pyrantel      Hawkeye Ave., Fort Dodge, IA 50501
                                 tartrate).
NADA 130-092..................  ALFAVET (alfaprostol).  Vetem, S.p.A., Viale E. Bezzi 24,    522.46
                                                         20146 Milano, Italy
NADA 141-101..................  PREEMPT (competitive    Bioscience Division, of Milk         529.469
                                 exclusion culture).     Specialties Co., 1902 Tennyson
                                                         Lane, Madison, WI 53704
ANADA 200-187.................  Isoflurane, USP.......  Marsam Pharmaceuticals, LLC, Bldg.   529.1186
                                                         31, 24 Olney Ave., Cherry Hill, NJ
                                                         08034
----------------------------------------------------------------------------------------------------------------

    Following these withdrawals of approval, Ag-Mark, Inc.; 
Bioproducts, Inc.; Bioscience Division of Milk Specialties Co.; Custom 
Feed Blenders Corp.; G. D. Searle LLC; I.M.S. Inc.; J. C. Feed Mills; 
K. C. Pharmacal, Inc.; Marsam Pharmaceuticals, LLC; Mid-Continent 
Agrimarketing, Inc.; Peavey Co.; Texas Vitamin Co.; Vetem, S.p.A.; and 
Webel Feeds, Inc., are no longer the sponsor of an approved 
application. Accordingly, 21 CFR 510.600(c) is being amended to remove 
the entries for these firms. In addition, the entries for Wyeth 
Laboratories, Division American Home Products Corp. are being removed 
because that firm is not the sponsor of an approved NADA.
    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 529

    Animal drugs.

21 CFR Part 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, 
520, 522, 529, 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 ``Ag-Mark, Inc.'', ``Bioproducts, Inc.'', ``Bioscience 
Division of Milk Specialties Co.'', ``Custom Feed Blenders Corp.'', 
``G. D. Searle LLC'', ``I.M.S. Inc.'', ``J. C. Feed Mills'', ``K. C. 
Pharmacal, Inc.'', ``Marsam Pharmaceuticals, LLC'', ``Mid-Continent 
Agrimarketing, Inc.'', ``Peavey Co.'', ``Texas Vitamin Co.'', ``Vetem, 
S.p.A.'', ``Webel Feeds, Inc.'', and ``Wyeth Laboratories, Division 
American Home Products Corp.''; and in the table in paragraph (c)(2), 
remove the entries for ``000008'', ``000014'', ``000209'', ``000842'', 
``024174'', ``028459'', ``032761'', ``035098'', ``038782'', ``039741'', 
``046987'', ``050639'', ``051359'', ``055882'', and ``059620''.

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.

[[Page 14669]]

Sec.  520.182  [Removed]

0
4. Remove Sec.  520.182.

0
5. In Sec.  520.260, revise the section heading and add paragraphs 
(b)(1) through (3) to read as follows:

Sec.  520.260  n-Butyl chloride.

* * * * *
    (b) * * *
    (1) Specifications. Each capsule contains 221, 272, 442, 816, 884, 
1,768 milligrams, or 4.42 grams of n-butyl chloride.
    (2) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (i) No. 000069 for use of 221-milligram capsules.
    (ii) No. 021091 for use of 272- or 816-milligram capsules.
    (iii) No. 023851 for use of 221-, 442-, 884-, or 1,768-milligram, 
or 4.42-gram capsules.
    (3) Conditions of use in dogs--(i) Amount. Administered capsules 
orally. Capsules containing 221 milligrams of n-butyl chloride are 
administered to dogs weighing under 5 pounds at a dosage of 1 capsule 
per 1\1/4\ pounds of body weight. Capsules containing 442 milligrams of 
n-butyl chloride are administered to dogs weighing under 5 pounds at a 
dosage of 1 capsule per 2\1/2\ pounds body weight. Capsules containing 
884 milligrams of n-butyl chloride are administered to dogs as follows: 
Weighing under 5 pounds, 1 capsule; weighing 5 to 10 pounds, 2 
capsules; weighing 10 to 20 pounds, 3 capsules; weighing 20 to 40 
pounds, 4 capsules; over 40 pounds, 5 capsules. Capsules containing 
1,768 milligrams of n-butyl chloride are administered at a dosage level 
of 1 capsule per dog weighing 5 to 10 pounds. Capsules containing 4.42 
grams of n-butyl chloride are administered at a dosage level of 1 
capsule per dog weighing 40 pounds or over.
    (ii) Indications for use. For the removal of ascarids (Toxocara 
canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, 
Ancylostoma braziliense, and Uncinaria stenocephala).
    (iii) Limitations. Dogs should not be fed for 18 to 24 hours before 
being given the drug. Administration of the drug should be followed in 
\1/2\ to 1 hour with a mild cathartic. Normal feeding may be resumed 4 
to 8 hours after treatment. Animals subject to reinfection may be 
retreated in 2 weeks. A veterinarian should be consulted before using 
in severely debilitated dogs.

0
6. In Sec.  520.580, revise the section heading and paragraphs (a), 
(b), and (d)(1) and (2) to read as follows:

Sec.  520.580  Dichlorophene and toluene.

    (a) Specifications. Each capsule contains 50 milligrams (mg) of 
dichlorophene and 60 mg of toluene, or multiples thereof.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) Nos. 017135, 023851, 051311, and 058670 for use only as a 
single dose.
    (2) Nos. 000010 and 000061 for use in a single dose or divided-
dosage regimen.
* * * * *
    (d) * * *
    (1) Amount. Administer as follows:
    (i) Single dose: Administer 100 mg of dicholorophene and 120 mg of 
toluene per pound of body weight.
    (ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of 
toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for 
6 days.
    (2) Indications for use. For the removal of ascarids (Toxocara 
canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and 
Uncinaria stenocephala); and as an aid in removing tapeworms (Taenia 
pisiformis, Dipylidium caninum, and Echinococcus granulosus) from dogs 
and cats.
* * * * *

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.  522.46  [Removed]

0
8. Remove Sec.  522.46.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.

Sec.  529.469  [Removed]

0
10. Remove Sec.  529.469.

Sec.  529.1003  [Removed]

0
11. Remove Sec.  529.1003.

Sec.  529.1186  [Amended]

0
12. In paragraph (b) of Sec.  529.1186, remove ``000209,''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
13. 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
14. In Sec.  558.485, in paragraph (b)(6), remove ``Nos. 034936 and 
046987'' and add in its place ``No. 034936''.

Sec.  558.625  [Amended]

0
15. In Sec.  558.625, remove and reserve paragraphs (b)(35), (b)(63), 
(b)(66), and (b)(77).

0
16. In Sec.  558.630, add paragraph (b)(5) to read as follows:

Sec.  558.630  Tylosin and sulfamethazine.

* * * * *
    (b) * * *
    (5) Nos. 000986, 012286, 034936, and 046573: 5, 10, 20, or 40 grams 
per pound each for use as in paragraph (e)(2)(ii) of this section.
* * * * *

    Dated: February 27, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-04999 Filed 3-6-13; 8:45 am]
BILLING CODE 4160-01-P