[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) * * *
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Drug labeler code Firm name and address
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* * * *
* * *
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