New Animal Drugs; Change of Sponsor; Chloramphenicol Capsules, 75398 [05-24270]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 243 (Tuesday, December 20, 2005)]
[Rules and Regulations]
[Page 75398]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24270]



[[Page 75398]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


New Animal Drugs; Change of Sponsor; Chloramphenicol Capsules

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 a change of sponsor for a new animal drug 
application (NADA) for chloramphenicol capsules from Nylos Trading Co., 
Inc., to Pharmaceutical Ventures, Ltd.

DATES: This rule is effective December 20, 2005.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
david.newkirk@fda.gov.

SUPPLEMENTARY INFORMATION: Nylos Trading Co., Inc., P.O. Box 2, Route 
202, Pomona, NY 10970, has informed FDA that it has transferred 
ownership of, and all rights and interest in, NADA 65-150 for 
Chloramphenicol Capsules to Pharmaceutical Ventures, Ltd., P.O. Box 
D1400, Pomona, NY 10970. Accordingly, the regulations are amended in 
Sec.  520.390b (21 CFR 520.390b) to reflect this change of sponsorship 
and a current format. In addition, FDA is taking this opportunity to 
revise Sec.  520.390b to reflect the prohibition of extralabel use of 
chloramphenicol in food-producing animals under 21 CFR 530.41.
    Following these changes of sponsorship, Nylos Trading Co., Inc., is 
no longer the sponsor of an approved application. Accordingly, 21 CFR 
510.600(c) is being amended to remove the entries for Nylos Trading 
Co., Inc.
    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

    Animal drugs.

0
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 and 
520 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.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
removing the entry for ``Nylos Trading Co., Inc.'' and by 
alphabetically adding a new entry for ``Pharmaceutical Ventures, 
Ltd.''; and in the table in paragraph (c)(2) by removing the entry for 
``027454'' and by numerically adding a new entry for ``050057'' to read 
as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Pharmaceutical Ventures, Ltd., P.O. Box       050057
 D1400, Pomona, NY 10970
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
050057                       Pharmaceutical Ventures, Ltd., P.O. Box
                              D1400, Pomona, NY 10970
                                * * * * *
------------------------------------------------------------------------

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.  520.390b to read as follows:


Sec.  520.390b  Chloramphenicol capsules.

    (a) Specifications. Each capsule contains 50, 100, 250, or 500 
milligrams (mg) chloramphenicol.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) Nos. 000069, 000185, and 050057 for capsules containing 50, 
100, 250, or 500 mg chloramphenicol.
    (2) No. 058034 for capsules containing 100 or 250 mg 
chloramphenicol.
    (c) Special considerations. Federal law prohibits the extralabel 
use of this product in food-producing animals.
    (d) Conditions of use in dogs--(1) Amount. 25 mg per pound of body 
weight every 6 hours.
    (2) Indications for use. For treatment of bacterial pulmonary 
infections, bacterial infections of the urinary tract, bacterial 
enteritis, and bacterial infections associated with canine distemper 
caused by susceptible organisms.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 8, 2005.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 05-24270 Filed 12-19-05; 8:45 am]
BILLING CODE 4160-01-S