[Federal Register: September 28, 2006 (Volume 71, Number 188)]
[Rules and Regulations]
[Page 56866-56867]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se06-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Neomycin
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 abbreviated new animal drug
application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA
provides for use of neomycin sulfate soluble powder in livestock for
the treatment and control of bacterial enteritis.
DATES: This rule is effective September 28, 2006.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Sparhawk Laboratories, Inc., 12340 Santa Fe
Trail Dr., Lenexa, KS 66215, filed ANADA 200-378 for the use of
Neomycin Soluble Powder in cattle, swine, sheep, goats, and turkeys for
the treatment and control of bacterial enteritis. Sparhawk
Laboratories, Inc.'s Neomycin Soluble Powder is approved as a generic
copy of NEOMIX 325 (neomycin sulfate) Soluble Powder, sponsored by
Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 11-315.
The ANADA is approved as of August 31, 2006, and the regulations in 21
CFR 520.1484 and 520.1485 are amended to reflect the approval and a
current format. The basis of approval is discussed in the freedom of
information summary.
In addition, a label statement warning against the use of these
products in calves to be processed for veal was not codified at the
time supplemental NADAs or ANADAs for oral neomycin products were
approved. At this time, FDA is amending the animal drug regulations to
reflect required food safety warning statements.
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.
FDA 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.
List of Subjects in 21 CFR Part 520
Animal drugs.
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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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. Revise Sec. 520.1484 to read as follows:
[[Page 56867]]
Sec. 520.1484 Neomycin.
(a) Specifications--(1) Each ounce of powder contains 20.3 grams
(g) neomycin sulfate (equivalent to 14.2 g neomycin base).
(2) Each milliliter of solution contains 200 milligrams (mg)
neomycin sulfate (equivalent to 140 mg neomycin base).
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for
use as in paragraph (e) of this section.
(1) Nos. 000069 and 054925 for use of product described in
paragraph (a)(1) as in paragraph (e)(1) of this section.
(2) Nos. 000009, 046573, 058005, and 061623 for use of product
described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of
this section.
(3) Nos. 000009, 054925, and 059130 for use of product described in
paragraph (a)(2) as in paragraph (e)(1) of this section.
(c) Related tolerances. See Sec. 556.430 of this chapter.
(d) Special labeling considerations. Labeling shall bear the
following warning statements: ``A withdrawal period has not been
established for use in preruminating calves. Do not use in calves to be
processed for veal. Use of more than one product containing neomycin or
failure to follow withdrawal times may result in illegal drug
residues.''
(e) Conditions of use--(1) Cattle, swine, sheep, and goats--(i)
Amount. 10 mg per pound (/lb) of body weight per day (22 mg per
kilogram (/kg)) in divided doses for a maximum of 14 days.
(ii) Indications for use. For the treatment and control of
colibacillosis (bacterial enteritis) caused by Escherichia coli
susceptible to neomycin sulfate.
(iii) Limitations. Add powder to drinking water or milk; not for
use in liquid supplements. Administer solution undiluted or in drinking
water. Prepare a fresh solution in drinking water daily. If symptoms
persist after using this preparation for 2 or 3 days, consult a
veterinarian. Treatment should continue 24 to 48 hours beyond remission
of disease symptoms, but not to exceed a total of 14 consecutive days.
Discontinue treatment prior to slaughter as follows: Cattle, 1 day;
sheep, 2 days; swine and goats, 3 days.
(2) Turkeys--(i) Amount. 10 mg/lb of body weight per day (22 mg/kg)
for 5 days.
(ii) Indications for use. For the control of mortality associated
with E. coli susceptible to neomycin sulfate in growing turkeys.
(iii) Limitations. Add to drinking water; not for use in liquid
supplements. Prepare a fresh solution daily. If symptoms persist after
using this preparation for 2 or 3 days, consult a veterinarian.
Treatment should continue 24 to 48 hours beyond remission of disease
symptoms, but not to exceed a total of 5 consecutive days.
Sec. 520.1485 [Removed]
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3. Remove Sec. 520.1485.
Dated: September 12, 2006.
Stephen F. Sundlof
Director, Center for Veterinary Medicine.
[FR Doc. E6-15889 Filed 9-27-06; 8:45 am]
BILLING CODE 4160-01-S