

[Federal Register: January 24, 2008 (Volume 73, Number 16)]
[Rules and Regulations]               
[Page 4077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja08-17]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

 
Oral Dosage Form New Animal Drugs; Clindamycin

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 approval of an abbreviated new animal drug 
application (ANADA) filed by Novopharm Ltd. The ANADA provides for the 
veterinary prescription use of clindamycin hydrochloride oral capsules 
in dogs for the treatment of various infections due to susceptible 
bacterial pathogens.

DATES: This rule is effective January 24, 2008.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
john.harshman@fda.hhs.gov.


SUPPLEMENTARY INFORMATION: Novopharm Ltd., 30 Novopharm Ct., Toronto, 
Ontario, Canada M1B 2K9, filed ANADA 200-383 that provides for the 
veterinary prescription use of CLINDAROBE (clindamycin hydrochloride) 
Capsules in dogs for the treatment of various infections due to 
susceptible bacterial pathogens. Novopharm Ltd.'s CLINDAROBE Capsules 
is approved as a generic copy of Pharmacia & Upjohn Co.'s ANTIROBE 
Capsules, approved under NADA 120-161. The ANADA is approved as of 
December 19, 2007, and 21 CFR 520.446 is amended to reflect the 
approval.
    In addition, Novopharm Ltd. has not been previously listed in the 
animal drug regulations as a sponsor of an approved application. At 
this time, 21 CFR 510.600(c) is being amended to add entries for the 
firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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 
alphabetically adding a new entry for ``Novopharm Ltd.'' and in the 
table in paragraph (c)(2) by numerically adding a new entry for 
``043806'' 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
------------------------------------------------------------------------
                                * * * * *
Novopharm Ltd., 30 Novopharm Ct., Toronto,    043806
 Ontario, Canada M1B 2K9
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
043806                       Novopharm Ltd., 30 Novopharm Ct., Toronto,
                              Ontario, Canada M1B 2K9
                                * * * * *
------------------------------------------------------------------------

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.  520.446, add paragraphs (a)(3) and (b)(3) to read as 
follows:


Sec.  520.446  Clindamycin capsules and tablets.

    (a) * * *
    (3) Each capsule contains the equivalent of 25, 75, or 150 mg 
clindamycin as the hydrochloride salt.
    (b) * * *
    (3) No. 043806 for use of tablets described in paragraph (a)(3) of 
this section.
* * * * *

    Dated: January 14, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-1199 Filed 1-23-08; 8:45 am]

BILLING CODE 4160-01-S
