[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Pages 20731-20732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9576]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Hemoglobin Glutamer-200 (bovine)

AGENCY: Food and Drug Administration, HHS.

[[Page 20732]]


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 supplemental new animal drug 
application (NADA) filed by Biopure Corp. The supplemental NADA 
provides for flexible dosing for use of hemoglobin glutamer-200 
(bovine) to treat anemia in dogs.

DATES: This rule is effective April 18, 2000.

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: Biopure Corp., 11 Hurley St., Cambridge, MA 
02141, is the sponsor of NADA 141-067 that provides for the veterinary 
prescription use of Oxyglobin (hemoglobin glutamer-200 
(bovine)) for the treatment of anemia in dogs. The drug increases 
systemic oxygen content (plasma hemoglobin concentration) and improves 
the clinical signs associated with anemia, regardless of the cause of 
anemia (hemolysis, blood loss, or ineffective erythropoiesis). The 
supplemental NADA provides for use of 10 to 30 milliliters per kilogram 
of body weight (mL/kg) administered at 10 mL/kg/hour. The supplemental 
NADA is approved as of January 11, 2000, and 21 CFR 522.1125(d) is 
amended to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for nonfood-
producing animals qualifies for 3 years of marketing exclusivity 
beginning January 11, 2000, because the approval contains substantial 
evidence of effectiveness of the drug involved, or any studies of 
animal safety, required for approval of the supplement and conducted or 
sponsored by the applicant. The 3 years of marketing exclusivity 
applies only to use of the dosing range of 10 to 30 mL/kg.
    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 in 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 part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec. 522.1125  [Amended]

    2. Section 522.1125 Hemoglobin glutamer-200 (bovine) is amended in 
paragraph (d)(1) by removing ``30'' and adding in its place ``10 to 
30'' and in paragraph (d)(2) by removing the phrase ``for at least 24 
hours''.

    Dated: March 17, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-9576 Filed 4-17-00; 8:45 am]
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