Document ID: FDA-2009-N-0665-0045
Agency: fda
Document Type: Rule
Title: New Animal Drugs for Use in Animal Feeds: Semduramicin; Virginiamycin
Posted Date: 2009-08-18T04:00Z

[Federal Register: August 18, 2009 (Volume 74, Number 158)]
[Rules and Regulations]
[Page 41631-41632]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au09-10]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

New Animal Drugs for Use in Animal Feeds; Semduramicin;
Virginiamycin

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 an original new animal drug
application (NADA) filed by Phibro Animal Health. The NADA provides for
use of single-ingredient Type A medicated articles containing
semduramyicin (as semduramicin sodium biomass) and virginiamycin to
manufacture 2-way combination drug Type C medicated feeds for use in
broiler chickens.

DATES: This rule is effective August 18, 2009.

FOR FURTHER INFORMATION CONTACT:  Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d
floor, Ridgefield Park, NJ 07660, filed NADA 141-289 that provides for
the use of AVIAX II (semduramicin sodium biomass) and STAFAC
(virginiamycin) Type A medicated articles to manufacture 2-way
combination drug Type C medicated feeds for broiler chickens. The NADA
is approved as of July 13, 2009, and the regulations are amended in 21
CFR 558.555 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.
    The agency has determined under 21 CFR 25.33 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 558

    Animal drugs, Animal feeds.

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 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.555, add paragraphs (e)(2) through (e)(4) to read as
follows:

Sec.  558.555  Semduramicin.

* * * * *
    (e) * * *

------------------------------------------------------------------------
 Semduramicin   Combination
 in grams per  in grams per    Indications     Limitations     Sponsor
     ton            ton          for use
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
(2) 22.7       Virginiamyci  Broiler         Feed                 066104
                n 5           chickens: As    continuously
                              in paragraph    as sole
                              (e)(1) of       ration.
                              this section;   Withdraw 1
                              for increased   day before
                              rate of         slaughter. Do
                              weight gain     not feed to
                              and improved    laying hens.
                              feed            Virginiamycin
                              efficiency.     provided by
                                              No. 066104 in
                                              Sec.
                                              510.600(c) of
                                              this chapter.
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[[Page 41632]]

(3) 22.7       Virginiamyci  Broiler         Feed                 066104
                n 5 to 15     chickens: As    continuously
                              in paragraph    as sole
                              (e)(1) of       ration.
                              this section;   Withdraw 1
                              for increased   day before
                              rate of         slaughter. Do
                              weight gain.    not feed to
                                              laying hens.
                                              Virginiamycin
                                              provided by
                                              No. 066104 in
                                              Sec.
                                              510.600(c) of
                                              this chapter.
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(4) 22.7       Virginiamyci  Broiler         Feed                 066104
                n 20          chickens: As    continuously
                              in paragraph    as sole
                              (e)(1) of       ration.
                              this section;   Withdraw 1
                              for             day before
                              prevention of   slaughter. Do
                              necrotic        not feed to
                              enteritis       laying hens.
                              caused by C.    Virginiamycin
                              perfringens     provided by
                              susceptible     No. 066104 in
                              to              Sec.
                              virginiamycin   510.600(c) of
                              .               this chapter.
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    Dated: August 12, 2009.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E9-19738 Filed 8-17-09; 8:45 am]

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