Justia Regulation Tracker

---

[Federal Register: March 19, 2009 (Volume 74, Number 52)]
[Rules and Regulations]               
[Page 11643-11644]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr09-3]                         

=======================================================================
-----------------------------------------------------------------------

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; Tylosin

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 Elanco Animal Health. The supplemental NADA 
provides for changing scientific nomenclature for a bovine pathogen on 
labeling for tylosin injectable solution.

DATES: This rule is effective March 19, 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: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 12-965 for TYLAN (tylosin) Injection, an injectable 
solution used for the treatment of animal diseases associated with 
several bacterial pathogens. The supplemental NADA provides for 
changing a bovine pathogen name on product labeling. The supplemental 
NADA is approved as of February 24, 2009, and the regulations in 21 CFR 
522.2640 and 522.2640a are amended to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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.

[[Page 11644]]

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.

Sec.  522.2640  [Removed]

0
2. Remove Sec.  522.2640.

Sec.  522.2640a  [Redesignated as Sec.  522.2640]

0
3. Redesignate Sec.  522.2640a as Sec.  522.2640.

Sec.  522.2640  [Amended]

0
4. In the newly redesignated Sec.  522.2640, remove ``injection'' from 
the section heading; remove and reserve paragraph (c); and in paragraph 
(e)(1)(ii), remove ``Corynebacterium pyogenes'' both times it appears 
and in its place add ``Arcanobacterium pyogenes''.

    Dated: March 13, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-6009 Filed 3-18-09; 8:45 am]

BILLING CODE 4160-01-S