[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Rules and Regulations]
[Pages 39543-39544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Clindamycin Liquid

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 approval of a supplemental abbreviated new 
animal drug application (ANADA) filed by Virbac AH, Inc. The 
supplemental ANADA provides for an expanded dose range and revised 
wording of indications for the oral use of clindamycin hydrochloride 
liquid in dogs and cats for the treatment of certain bacterial 
diseases.

DATES: This rule is effective July 13, 2006.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz @fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, filed a supplement to ANADA 200-291 for CLINSOL 
(clindamycin hydrochloride) Liquid. The supplement provides for an 
expanded dose range and revised wording of indications for the oral use 
of clindamycin hydrochloride liquid in dogs and cats for the treatment 
of certain bacterial diseases. The supplemental ANADA is approved as of 
June 12, 2006, and the regulations are amended in Sec.  520.447 (21 CFR 
520.447) to reflect the approval and a current format.
    In addition, FDA has found that a 2003 change of sponsorship for 
CLINSOL Liquid (68 FR 55823, September 29, 2003) is not reflected in 
the Code of Federal Regulations. Accordingly, Sec.  520.447 is being 
revised to reflect the correct sponsor drug labeler code. This action 
is being taken to improve the accuracy of the regulations.
    Approval of this supplemental ANADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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 in 21 CFR Part 520

    Animal drugs.

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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 part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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2. In Sec.  520.447, revise the section heading and paragraphs (b), 
(d)(1)(i), (d)(1)(ii), (d)(2)(i), and (d)(2)(ii) to read as follows:


Sec.  520.447  Clindamycin solution.

* * * * *
    (b) Sponsors. See Nos. 000009, 051311, and 059130 in Sec.  
510.600(c) of this chapter.
* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg 
per pound (/lb) body weight every 12 hours for a maximum of 28 days. 
Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum 
of 28 days.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of coagulase-positive 
staphylococci (Staphylococcus aureus or S. intermedius), deep wounds 
and abscesses due to susceptible strains of Bacteroides fragilis, 
Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium 
perfringens; dental infections due to susceptible strains of S. aureus, 
B. fragilis, P. melaninogenicus, F.

[[Page 39544]]

necrophorum, and C. perfringens; and osteomyelitis due to susceptible 
strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, 
and C. perfringens.
    (2) * * *
    (i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours for a 
maximum of 14 days.
    (ii) Indications for use. For the treatment of skin infections 
(wounds and abscesses) due to susceptible strains of Staphylococcus 
aureus, S. intermedius, Streptococcus spp.; deep wounds and abscesses 
due to susceptible strains of Clostridium perfringens and Bacteroides 
fragilis; and dental infections due to susceptible strains of S. 
aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. 
fragilis.

    Dated: June 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10971 Filed 7-12-06; 8:45 am]
BILLING CODE 4160-01-S