[Federal Register Volume 66, Number 16 (Wednesday, January 24, 2001)]
[Rules and Regulations]
[Pages 7577-7578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin 
Suspension

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 Blue Ridge Pharmaceuticals, Inc. The NADA provides for 
veterinary prescription use of ivermectin otic suspension for the 
treatment of adult ear mite infestations in cats and kittens.

DATES: This rule is effective January 24, 2001.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION: Blue Ridge Pharmaceuticals, Inc., 4249-105 
Piedmont Pkwy., Greensboro, NC 27410, filed NADA 141-174 that provides 
for veterinary prescription use of ACAREXX (0.01% ivermectin) 
Otic Suspension for the treatment of adult ear mite (Otodectes cynotis) 
infestations in cats and kittens 4 weeks of age and older. 
Effectiveness against eggs and immature stages has not been proven. The 
NADA provides for use of one 0.5-milliliter tube per ear. The NADA is 
approved as of December 5, 2000, and the regulations are amended by 
adding 21 CFR 524.1195 to reflect the approval. The basis for approval 
is discussed in the freedom of information summary.
    In addition, Blue Ridge Pharmaceuticals, Inc., has not been

[[Page 7578]]

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 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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for nonfood-
producing animals qualifies for 3 years of marketing exclusivity 
beginning December 5, 2000, because the application contains 
substantial evidence of effectiveness of the drug involved or any 
studies of animal safety required for approval of the application and 
conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.33(d)(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 524

    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 
524 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 
alphabetically adding an entry for ``Blue Ridge Pharmaceuticals, Inc.'' 
and in the table in paragraph (c)(2) by numerically adding an entry for 
``065274'' 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
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
Blue Ridge Pharmaceuticals, Inc.,    065274
 4249-105 Piedmont Pkwy.,
Greensboro, NC 27410
  *                    *                    *                    *
                   *                    *                    *
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    (2) * * *

 
------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
065274                               Blue Ridge Pharmaceuticals, Inc.,
                                      4249-105 Piedmont Pkwy.,
                                     Greensboro, NC 27410
  *                    *                    *                    *
                   *                    *                    *
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PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

    2. Section 524.1195 is added to read as follows:


Sec. 524.1195  Ivermectin otic suspension.

    (a) Specifications. Each tube contains 0.5 milliliter (mL) of a 
0.01 percent suspension of ivermectin.
    (b) Sponsor. See No. 065274 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer the contents of one 
0.5-mL tube topically into each external ear canal.
    (2) Indications for use. For the treatment of adult ear mite 
(Otodectes cynotis) infestations in cats and kittens 4 weeks of age and 
older. Effectiveness against eggs and immature stages has not been 
proven.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: January 8, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-1869 Filed 1-23-01; 8:45 am]
BILLING CODE 4160-01-F