[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\
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* * * * * * *
------------------------------------------------------------------------
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)
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* * * * * * *
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\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
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(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] ............. ............ .............. ...........
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[[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]
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