[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Rules and Regulations]
[Pages 8348-8349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4077]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Animal Drugs, Feeds, and Related Products; Doxycycline Hyclate

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 a new animal drug application 
(NADA) filed by Heska Corp. The NADA provides for use of doxycycline 
hyclate solution for treatment and control of periodontal disease in 
dogs by application subgingivally to the periodontal pocket(s) of 
affected teeth.

EFFECTIVE DATE: February 19, 1998.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20857, 301-594-1612.

SUPPLEMENTARY INFORMATION: Heska Corp., 1825 Sharp Point Dr., Fort 
Collins, CO 80525, filed NADA 141-082, which provides for use of 
doxycycline hyclate solution for treatment and control of periodontal 
disease in dogs by application subgingivally to the periodontal 
pocket(s) of affected teeth. The NADA is approved as of November 19, 
1997, and the regulations are amended by adding new 21 CFR 522.778 to 
reflect the approval. The basis for approval is discussed in the 
freedom of information summary.

    Also, the regulations are amended in Sec. 510.600(c) to add the new 
sponsor to the list of sponsors of approved applications.
    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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning November 19, 1997, because 
no active ingredient, including any ester or salt of the active 
ingredient, has been previously approved in any other application filed 
under section 512(b)(1) of the act.
    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.

List of Subjects in

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 522

    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 
522 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 paragraph (c)(1) by alphabetically 
adding a new entry for ``Heska Corp.'' and in paragraph (c)(2) by 
numerically

[[Page 8349]]

adding a new entry for ``063604'' to read as follows:

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

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


                                                                        
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       Firm name and address                  Drug labeler code         
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  *                    *                    *                    *      
                   *                    *                    *          
Heska Corp., 1825 Sharp Point Dr.,   063604                             
 Fort Collins, CO 80525                                                 
  *                    *                    *                    *      
                   *                    *                    *          
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    (2) * *  *


                                                                        
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address       
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
063604                               Heska Corp., 1825 Sharp Point Dr., 
                                      Fort Collins, CO 80525.           
  *                    *                    *                    *      
                   *                    *                    *          
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PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

    4. Section 522.778 is added to read as follows:

Sec. 522.778  Doxycycline hyclate.

    (a) Specifications. Doxycycline hyclate solution contains 8.5 
percent doxycycline activity. A syringe of N-methyl-2-pyrrolidone and 
poly (DL-lactide) mixed with a syringe of doxycycline produces 0.5 
milliliter of solution.
    (b) Sponsor. See 063604 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. Apply subgingivally to 
periodontal pocket(s) of affected teeth.
    (ii) Indications for use. For treatment and control of periodontal 
disease.
    (iii) Limitations. Do not use in dogs less than 1-year old. Use of 
tetracyclines during tooth development has been associated with 
permanent discoloration of teeth. Do not use in pregnant bitches. Use 
in breeding dogs has not been evaluated. Federal law restricts this 
drug to use by or on the order of a licensed veterinarian.

    Dated: January 21, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-4077 Filed 2-18-98; 8:45 am]
BILLING CODE 4160-01-F