[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Rules and Regulations]
[Pages 53164-53165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24882]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2009-N-0665]
Implantation or Injectable Dosage Form New Animal Drugs;
Tulathromycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect
[[Page 53165]]
approval of a supplemental new animal drug application (NADA) filed by
Pfizer, Inc. The supplemental NADA provides for veterinary prescription
use of tulathromycin injectable solution for the control of swine
respiratory disease (SRD) in groups of pigs where SRD has been
diagnosed.
DATES: This rule is effective October 16, 2009.
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:
[email protected].
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY
10017, filed a supplement to NADA 141-244 for DRAXXIN (tulathromycin)
Injectable Solution. The supplemental NADA provides for the use of
tulathromycin injectable solution for control of SRD associated with
Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma
hyopneumoniae in groups of pigs where SRD has been diagnosed. The
application is approved as of September 8, 2009, and the regulations
are amended in Sec. 522.2630 (21 CFR 522.2630) to reflect the
approval.
In addition, FDA has noticed that the approved indications for use
of this product in cattle (73 FR 58872, October 8, 2008) were
inaccurately codified. At this time, Sec. 522.2630 is being amended to
correctly describe these indications for use. This action is being
taken to improve the accuracy of the regulations.
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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
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.
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. In Sec. 522.2630, revise paragraphs (d)(1)(ii) and (d)(2)(ii) to
read as follows:
Sec. 522.2630 Tulathromycin.
* * * * *
(d) * * *
(1) * * *
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, Histophilus somni, and Mycoplasma bovis. For the control of
respiratory disease in cattle at high risk of developing BRD associated
with M. haemolytica, P. multocida, H. somni, and M. bovis. For the
treatment of infectious bovine keratoconjunctivitis associated with
Moraxella bovis. For the treatment of bovine foot rot (interdigital
necrobacillosis) associated with Fusobacterium necrophorum and
Porphyromonas levii.
* * * * *
(2) * * *
(ii) Indications for use. For the treatment of swine respiratory
disease (SRD) associated with Actinobacillus pleuropneumoniae, P.
multocida, Bordetella bronchiseptica, Haemophilus parasuis, and
Mycoplasma hyopneumoniae; and for the control of SRD associated with A.
pleuropneumoniae, P. multocida, and M. hyopneumoniae in groups of pigs
where SRD has been diagnosed.
* * * * *
Dated: September 30, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-24882 Filed 10-15-09; 8:45 am]
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