Document ID: FDA-2011-N-0003-0073
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Chloramphenicol, Diethylcarbamazine Citrate, Hygromycin B, Methoxyflurane, Neomycin Sulfate, Penicillin G, Phenylbutazone,etc.
Posted Date: 2012-02-01T05:00Z

[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Rules and Regulations]
[Pages 4895-4897]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2103]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Chloramphenicol, Diethylcarbamazine Citrate, 
Hygromycin B, Methoxyflurane, Neomycin Sulfate, Penicillin G, 
Phenylbutazone, Pyrantel Tartrate, Tylosin Phosphate, and 
Sulfamethazine

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 20 new animal 
drug applications (NADAs).

DATES: Withdrawal of approval is effective February 13, 2012.

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, email: john.bartkowiak@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The sponsors of the 20 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--Voluntary Requests for Withdrawal of Approval (WOA) of 20 NADAs
------------------------------------------------------------------------
       Application No.         Trade name  (drug)         Applicant
------------------------------------------------------------------------
NADA 014-485................  METOPHANE Inhalation  Medical
                               (methoxyflurane).     Developments,
                                                     International,
                                                     Ltd., P.O. Box 21,
                                                     Sandown Village,
                                                     3171 VIC Australia.
NADA 032-322................  LIQUISONE F with      Evsco
                               Cerumene              Pharmaceuticals, an
                               (hexamethyltetracos   Affiliate of IGI,
                               ane, prednisolone,    Inc., Box 209,
                               tetracaine,           Harding Hwy.,
                               neomycin sulfate).    Buena, NJ 08310.
NADA 044-655................  NEOMYCANE Ophthalmic  Evsco
                               Ointment (neomycin    Pharmaceuticals, an
                               sulfate).             Affiliate of IGI,
                                                     Inc., Box 209,
                                                     Harding Hwy.,
                                                     Buena, NJ 08310.
NADA 045-288................  OPTISONE (neomycin    Evsco
                               sulfate,              Pharmaceuticals, an
                               prednisolone          Affiliate of IGI,
                               acetate).             Inc., Box 209,
                                                     Harding Hwy.,
                                                     Buena, NJ 08310.
NADA 049-890................  NORCO T-2 Pre-Pak     Norco Mills of
                               (tylosin phosphate).  Norfolk, Inc., P.O.
                                                     Box 56, Norfolk, NE
                                                     68701.
NADA 055-034................  CHLORASOL             Evsco
                               (chloramphenicol).    Pharmaceuticals, an
                                                     Affiliate of IGI,
                                                     Inc., Box 209,
                                                     Harding Hwy.,
                                                     Buena, NJ 08310.
NADA 055-052................  Chlora-Tabs 100       Evsco
                               (chloramphenicol).    Pharmaceuticals, an
                                                     Affiliate of IGI,
                                                     Inc., Box 209,
                                                     Harding Hwy.,
                                                     Buena, NJ 08310.
NADA 065-158................  CHLORICOL             Evsco
                               (chloramphenicol).    Pharmaceuticals, an
                                                     Affiliate of IGI,
                                                     Inc., Box 209,
                                                     Harding Hwy.,
                                                     Buena, NJ 08310.
NADA 065-259................  CHLORASONE            Evsco
                               Ophthalmic Ointment   Pharmaceuticals, an
                               (chloramphenicol,     Affiliate of IGI,
                               prednisolone          Inc., Box 209,
                               acetate).             Harding Hwy.,
                                                     Buena, NJ 08310.

[[Page 4896]]

 
NADA 065-488................  BENZA-PEN             Walco International,
                               (penicillin G         Inc., 15 West
                               benzathine,           Putnam,
                               penicillin G          Porterville, CA
                               procaine).            93257.
NADA 095-953................  MOORMABOOST TY 4000   ADM Alliance
                               Medicated (tylosin    Nutrition, Inc.,
                               phosphate).           1000 North 30th
                                                     St., Quincy, IL
                                                     62305-3115.
NADA 100-689................  DIFIL Syrup           Evsco
                               (diethylcarbamazine   Pharmaceuticals, an
                               citrate).             Affiliate of IGI,
                                                     Inc., Box 209,
                                                     Harding Hwy.,
                                                     Buena, NJ 08310.
NADA 100-690................  DIFIL Tablets         Evsco
                               (diethylcarbamazine   Pharmaceuticals, an
                               citrate).             Affiliate of IGI,
                                                     Inc., Box 209,
                                                     Harding Hwy.,
                                                     Buena, NJ 08310.
NADA 107-957................  TYLAN 20 Sulfa-G      ADM Alliance
                               (tylosin phosphate    Nutrition, Inc.,
                               and sulfamethazine).  1000 North 30th
                                                     St., Quincy, IL
                                                     62305-3115.
NADA 111-069................  TYLAN 40 Sulfa-G      ADM Alliance
                               (tylosin phosphate    Nutrition, Inc.,
                               and sulfamethazine).  1000 North 30th
                                                     St., Quincy, IL
                                                     62305-3115.
NADA 131-956................  TYLAN Sulfa-G         ADM Alliance
                               (tylosin phosphate    Nutrition, Inc.,
                               and sulfamethazine).  1000 North 30th
                                                     St., Quincy, IL
                                                     62305-3115.
NADA 131-957................  TYLAN 40 (tylosin     ADM Alliance
                               phosphate).           Nutrition, Inc.,
                                                     1000 North 30th
                                                     St., Quincy, IL
                                                     62305-3115.
NADA 133-490................  Ban-D-Wormer II       ADM Alliance
                               BANMINTH (pyrantel    Nutrition, Inc.,
                               tartrate).            1000 North 30th
                                                     St., Quincy, IL
                                                     62305-3115.
NADA 140-842................  HYGROMIX 2.4 Premix   ADM Alliance
                               (hygromycin B).       Nutrition, Inc.,
                                                     1000 North 30th
                                                     St., Quincy, IL
                                                     62305-3115.
NADA 140-958................  EQUIPHEN Paste        Luitpold
                               (phenylbutazone)      Pharmaceuticals,
                               520.1720c.            Inc., Animal Health
                                                     Division, Shirley,
                                                     NY 11967.
------------------------------------------------------------------------

    In a notice published elsewhere in this issue of the Federal 
Register, FDA gave notice that approval of NADAs 014-485, 032-322, 044-
655, 045-288, 049-890, 055-034, 055-052, 065-158, 065-259, 065-488, 
095-953, 100-689, 100-690, 107-957, 111-069, 131-956, 131-957, 133-490, 
140-842, and 140-958, and all supplements and amendments thereto, is 
withdrawn, effective February 13, 2012. 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 withdrawals of approval, Evsco Pharmaceuticals, an 
Affiliate of IGI, Inc.; Medical Developments International, Ltd.; and 
Norco Mills of Norfolk, 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.
    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 520, 522, 524, 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, 524, 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 ``Evsco Pharmaceuticals, An Affiliate of IGI, Inc.'', 
``Medical Developments International, Ltd.'', and ``Norco Mills of 
Norfolk, Inc.''; and in the table in paragraph (c)(2), remove the 
entries for ``017030'', ``025245'', and ``027190''.

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. Revise Sec.  520.390a to read as follows:

Sec.  520.390a  Chloramphenicol tablets.

    (a) Specifications. Each tablet contains 50, 100, 250, or 500 
milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.
    (b) Sponsors. See Sec.  510.600(c) of this chapter:
    (1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this 
section:
    (i) No. 000010 for 100-, 250-, and 500-mg; and 1- and 2.5-g 
tablets;
    (ii) No. 000856 for 100-, 250-, and 500-mg tablets;
    (iii) No. 000069 for 250-mg tablets.
    (2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this 
section:
    (i) No. 061623 for 50-, 100-, 250-, and 500-mg; and 1-g tablets;
    (ii) [Reserved]
    (c) Conditions of use in dogs--(1) Amount. Administer 25 mg per 
pound of body weight by mouth every 6 hours.
    (2) Indications for use--(i) For the treatment of bacterial 
pulmonary infections, bacterial infections of the urinary tract, 
bacterial enteritis, and bacterial infections associated with canine 
distemper caused by susceptible organisms.
    (ii) For the treatment of bacterial gastroenteritis associated with 
bacterial diarrhea, bacterial pulmonary infections, and bacterial 
infections of the urinary tract caused by susceptible organisms.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Federal law prohibits the 
extralabel use of this drug in food-producing animals.

Sec.  520.622a  [Amended]

0
5. In Sec.  520.622a, remove and reserve paragraph (a)(4).

[[Page 4897]]

Sec.  520.622b  [Amended]

0
6. In Sec.  520.622b, remove and reserve paragraph (b).

Sec.  520.1720c  [Amended]

0
7. In Sec.  520.1720c, in paragraph (b)(1), remove ``Nos. 000061 and 
010797'' and in its place add ``No. 000061''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
9. In Sec.  522.1696a, revise paragraphs (b)(1), (b)(3), (d)(1)(iii), 
and (d)(2)(iii) to read as follows:

Sec.  522.1696a  Penicillin G benzathine and penicillin G procaine 
suspension.

* * * * *
    (b) * * *
    (1) Nos. 000856, 055529, and 061623 for use as in paragraph (d)(1) 
of this section.
* * * * *
    (3) No. 000856 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(B), 
and (d)(2)(iii) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Not for use in beef cattle within 30 days of 
slaughter. Do not use in horses intended for human consumption. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) * * *
    (iii) Limitations. Not for use within 30 days of slaughter. For 
Nos. 055529, 059130, and 061623: A withdrawal period has not been 
established for this product in pre-ruminating calves. Do not use in 
calves to be processed for veal.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
10. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
11. Revise Sec.  524.390 to read as follows:

Sec.  524.390  Chloramphenicol ophthalmic ointment.

    (a) Specifications. Each gram contains 10 milligrams 
chloramphenicol.
    (b) Sponsors. See Nos. 000856 and 025463 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply every 3 
hours around the clock for 48 hours, after which night instillations 
may be omitted.
    (2) Indications for use. For treatment of bacterial conjunctivitis 
caused by pathogens susceptible to chloramphenicol.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    Sec. Sec.  524.390a, 524.390b, and 524.390d [Removed]

0
12. Remove Sec. Sec.  524.390a, 524.390b, and 524.390d.
    Sec. Sec.  524.1484a, 524.1484j, and 524.1484k [Removed]

0
13. Remove 524.1484a, 524.1484j, and 524.1484k.
    Sec. Sec.  524.1880 [Removed]

0
14. Remove 524.1880.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  529.1455  [Removed]

0
16. Remove 529.1455.

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

0
17. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.274  [Amended]

0
18. In Sec.  558.274, remove and reserve paragraph (a)(7); and in the 
table in paragraphs (c)(1)(i) and (c)(1)(ii), in the ``Sponsor'' 
column, remove ``012286''.

Sec.  558.485  [Amended]

0
19. In paragraph (b)(3) of Sec.  558.485, remove ``012286''.

Sec.  558.625  [Amended]

0
20. In Sec.  558.625, remove and reserve paragraphs (b)(10), (b)(12), 
and (b)(67).

Sec.  558.630  [Amended]

0
21. In Sec.  558.630, remove and reserve paragraph (b)(2) and in 
paragraph (b)(5), remove ``012286''.

    Dated: January 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-2103 Filed 1-31-12; 8:45 am]
BILLING CODE 4160-01-P