[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Rules and Regulations]
[Page 21041-21042]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap08-5]
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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;
Florfenicol
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 Schering-Plough Animal Health Corp. The NADA provides
for use of florfenicol injectable solution for the treatment of bovine
respiratory disease.
DATES: This rule is effective April 18, 2008.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, filed NADA 141-265 for veterinary
prescription use of NUFLOR GOLD (florfenicol) Injectable Solution by
subcutaneous injection in beef and non-lactating dairy cattle for the
treatment of bovine respiratory disease. The NADA is approved as of
March 21, 2008, and the regulations are amended in 21 CFR 522.955 to
reflect the approval.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 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 Division of Dockets Management
(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 qualifies for
3 years of marketing exclusivity beginning on the date of approval.
The agency 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.
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.
0
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
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Revise Sec. 522.955 to read as follows:
Sec. 522.955 Florfenicol.
(a) Specifications. Each milliliter (mL) of solution contains:
(1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin.
(2) 300 mg florfenicol in the inactive vehicle n-methyl-2-
pyrrolidone.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter for
use of product described in paragraph (a)(1) as in paragraph (d)(1)(i)
and for use of product described in paragraph (a)(2) as in paragraph
(d)(1)(ii).
(c) Related tolerance. See Sec. 556.283 of this chapter.
(d) Conditions of use--(1) Cattle--(i) 300 mg/mL florfenicol in 2-
pyrrolidone and triacetin (inactive vehicles).
(A) Amount. 40 mg/kilogram (kg) body weight as a single
subcutaneous injection.
[[Page 21042]]
(B) Indications for use. For treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Histophilus somni in beef and non-lactating dairy
cattle.
(C) Limitations. Do not slaughter within 44 days of last treatment.
Do not use in female dairy cattle 20 months of age or older. Use may
cause milk residues. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(ii) 300 mg/mL florfenicol in n-methyl-2-pyrrolidone (inactive
vehicle).
(A)(1) Amount. 20 mg/kg of body weight as an intramuscular
injection. A second dose should be administered 48 hours later.
Alternatively, 40 mg/kg of body weight as a single subcutaneous
injection may be used.
(2) Indications for use. For treatment of BRD associated with
Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus
somnus. For treatment of bovine interdigital phlegmon (foot rot, acute
interdigital necrobacillosis, infectious pododermatitis) associated
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
(B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous
injection.
(2) Indications for use. For control of respiratory disease in
cattle at high risk of developing BRD associated with Mannheimia
(Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.
(C) Limitations. Do not slaughter within 28 days of last
intramuscular treatment or within 38 days of subcutaneous treatment. Do
not use in female dairy cattle 20 months of age or older. Use may cause
milk residues. A withdrawal period has not been established in
preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
(2) [Reserved]
Dated: April 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8346 Filed 4-17-08; 8:45 am]
BILLING CODE 4160-01-S