[Federal Register Volume 64, Number 23 (Thursday, February 4, 1999)]
[Rules and Regulations]
[Pages 5595-5596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2686]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Florfenicol Solution
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 Schering-Plough Animal Health Corp. The
supplemental NADA provides for subcutaneous use of florfenicol
injectable solution for control of respiratory disease in cattle at
high risk of developing bovine respiratory disease (BRD).
EFFECTIVE DATE: February 4, 1999.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7570.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095
Morris Ave., P.O. Box 1982, Union, NJ
[[Page 5596]]
07083-1982, is sponsor of NADA 141-063 that provides for veterinary
prescription use of Nuflor Injectable Solution (florfenicol)
for treatment of cattle for BRD. The firm filed a supplemental NADA
that provides for veterinary prescription use of Nuflor
Injectable Solution (florfenicol) by a single subcutaneous injection
for control of respiratory disease in cattle at high risk of developing
BRD associated with Pasteurella haemolytica, P. multocida, and
Haemophilus somnus. The supplemental NADA is approved as of December
17, 1998, and the regulations are amended by revising 21 CFR
522.955(d)(1) 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 supplement
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 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental approval for
food-producing animals qualifies for 3 years of marketing exclusivity
beginning December 17, 1998, because the supplemental application
contains substantial evidence of the effectiveness of the drug
involved, any studies of animal safety or, in the case of food-
producing animals, human food safety studies (other than bioequivalence
or residue studies) required for approval and conducted or sponsored by
the applicant. Three years marketing exclusivity is limited to
subcutaneous use of the drug for control of respiratory disease in
cattle at high risk of developing BRD associated with P. haemolytica,
P. multocida, and H. somnus.
The agency has determined under 21 CFR 25.33(d)(5) 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 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.
2. Section 522.955 is amended by revising paragraph (d)(1)(i), by
redesignating paragraph (d)(1)(ii) as paragraph (d)(1)(i)(B), and by
adding paragraphs (d)(1)(ii)(A) and (d)(1)(ii)(B) to read as follows:
Sec. 522.955 Florfenicol solution.
* * * * *
(d) * * *
(1) * * *
(i) Treatment of disease--(A) Amount. 20 milligrams per kilogram of
body weight (3 milliliters per 100 pounds) as an intramuscular
injection. A second dose should be given 48 hours later. Alternatively,
40 milligrams per kilogram of body weight (6 milliliters per 100
pounds) as a single subcutaneous injection may be used.
(B) Indications for use. * * *
(ii) Control of disease--(A) Amount. 40 milligrams per kilogram of
body weight (6 milliliters per 100 pounds) as a single subcutaneous
injection.
(B) Indications for use. For control of respiratory disease in
cattle at high risk of developing bovine respiratory disease (BRD)
associated with Pasteurella haemolytica, P. multocida, and Haemophilus
somnus.
* * * * *
Dated: January 13, 1999.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 99-2686 Filed 2-3-99; 8:45 am]
BILLING CODE 4160-01-F
