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Oral Dosage Form New Animal Drugs; Clindamycin Liquid; Change of Sponsor's Address

 [Federal Register: December 26, 2002 (Volume 67, Number 248)]
[Rules and Regulations]
[Page 78684]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de02-5]

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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 Liquid; Change of 
Sponsor's Address

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 Delmarva Laboratories, Inc., and a change 
of this sponsor's address. The ANADA provides for oral use of 
clindamycin hydrochloride liquid in dogs and cats for the treatment of 
various bacterial infections.

DATES:  This rule is effective December 26, 2002.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
lluther@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Delmarva Laboratories, Inc., 2200 Wadebridge 
Rd., P.O. Box 525, Midlothian, VA 23113, filed ANADA 200-291 for 
CLINSOL (clindamycin hydrochloride) Liquid. The application provides 
for oral use of clindamycin hydrochloride liquid in dogs and cats for 
the treatment of various bacterial infections. Delmarva Laboratories' 
CLINSOL Liquid is approved as a generic copy of Pharmacia & Upjohn's 
ANTIROBE Aquadrops Liquid, approved under NADA 135-940. ANADA 200-291 
is approved as of August 26, 2002, and the regulations are amended in 
21 CFR 520.447 to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, Delmarva Laboratories, Inc., has informed FDA of a 
change of address to 1500 Huguenot Rd., suite 106, Midlothian, VA 
23113. Accordingly, the agency is amending the regulations in 21 CFR 
510.600 to reflect the change of sponsor address.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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 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.

    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

    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.

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
revising the entry for ``Delmarva Laboratories, Inc.'' and in the table 
in paragraph (c)(2) by revising the entry for ``059079'' 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
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                                * * * * *
Delmarva Laboratories, Inc., 1500 Huguenot   059079
 Rd., suite 106, Midlothian, VA 23113
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
059079                        Delmarva Laboratories, Inc., 1500 Huguenot
                               Rd., suite 106, Midlothian, VA 23113
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

Sec.  520.447  [Amended]

    4. Section 520.447 Clindamycin liquid is amended in paragraph 
(b)(2) by removing ``No.'' and by adding in its place ``Nos. 059079 
and''.

    Dated: December 17, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-32440 Filed 12-24-02; 8:45 am]
BILLING CODE 4160-01-S

 
 

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