[Federal Register Volume 73, Number 3 (Friday, January 4, 2008)]
[Rules and Regulations]
[Pages 811-813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feed; Semduramicin

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 Phibro Animal Health. The NADA provides for use of a 
Type A medicated article containing semduramicin (as semduramicin 
sodium biomass) to manufacture Type C medicated broiler chicken feed 
for the prevention of coccidiosis.

DATES: This rule is effective January 4, 2008.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary

[[Page 812]]

Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7571, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d 
floor, Ridgefield Park, NJ 07660, filed NADA 141-281 that provides for 
the use of AVIAX II (semduramicin) Type A medicated article containing 
semduramicin (as semduramicin sodium biomass) to manufacture Type C 
medicated broiler chicken feed for the prevention of coccidiosis caused 
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mitis. The NADA is approved as of December 3, 2007, and the 
regulations are amended in 21 CFR 558.4 and 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.
    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.
    FDA has determined under 21 CFR 25.33(a)(3) 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 paragraph (d) of Sec.  558.4, in the ``Category I'' table, revise 
the entry for ``Semduramicin'' and alphabetically add an entry for 
``Semduramicin (as semduramicin sodium biomass)'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                               Category I
------------------------------------------------------------------------
                         Assay limits                      Assay limits
         Drug          percent\1\ Type   Type B maximum  percent\1\ Type
                              A              (200x)           B/C\2\
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
Semduramicin (as       90-110           2.27 g/lb        80-110
 semduramicin sodium)                    (0.50%)
Semduramicin (as       90-110           2.27 g/lb        80-120
 semduramicin sodium                     (0.50%)
 biomass)
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------
\1\Percent of labeled amount.
\2\Values given represent ranges for either Type B or Type C medicated
  feeds. For those drugs that have two range limits, the first set is
  for a Type B medicated feed and the second set is for a Type C
  medicated feed. These values (ranges) have been assigned in order to
  provide for the possibility of dilution of a Type B medicated feed
  with lower assay limits to make a Type C medicated feed.

* * * * *

0
3. In Sec.  558.555, revise paragraphs (a) and (b); and add paragraph 
(e) to read as follows:


Sec.  558.555  Semduramicin.

    (a) Specifications. Type A medicated article containing:
    (1) 22.7 grams (g) per pound (lb) (50 g/kilogram (kg)) semduramicin 
(as semduramicin sodium).
    (2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium 
biomass).
    (b) Approvals. See No. 066104 in Sec.  510.600(c) of this chapter 
for use of product described in paragraph (a)(1) as in paragraph (d) of 
this section; for use of product described in paragraph (a)(2) as in 
paragraph (e) of this section.
* * * * *
    (e) Conditions of use in chickens. It is used in chicken feed as 
follows:

------------------------------------------------------------------------
 Semduramicin    Combination
 in grams per    in grams per   Indications    Limitations     Sponsor
      ton            ton          for use
------------------------------------------------------------------------
(1) 22.7 (25    .............  Broiler       Do not feed to       066104
 ppm)                           chickens:     laying hens.
                                For the
                                prevention
                                of
                                coccidiosis
                                caused by
                                Eimeria
                                tenella, E.
                                acervulina,
                                E. maxima,
                                E.
                                brunetti,
                                E.
                                necatrix,
                                and E.
                                mitis.
------------------------------------------------------------------------
(2) [Reserved]  .............  ............  ..............  ...........
------------------------------------------------------------------------



[[Page 813]]

    Dated: December 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-25605 Filed 1-3-08; 8:45 am]
BILLING CODE 4160-01-S