[Federal Register Volume 64, Number 112 (Friday, June 11, 1999)]
[Rules and Regulations]
[Pages 31497-31498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14924]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 556
Oral Dosage Form New Animal Drugs; Neomycin Sulfate
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 supplemental new animal drug
application (NADA) filed by Pharmacia & Upjohn Co. The supplemental
NADA provides for use of neomycin sulfate in turkey drinking water for
the control of mortality associated with Escherichia coli organisms
susceptible to neomycin sulfate in growing turkeys. The regulations are
also amended to provide for a tolerance for neomycin residues in edible
turkey tissues and an acceptable daily intake (ADI).
EFFECTIVE DATE: June 11, 1999.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7570.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed supplemental NADA 11-315 that provides
for use of Neomix 325 and Neomix AG 325 (neomycin
sulfate) soluble powder in turkey drinking water for the control of
mortality associated with E. coli organisms susceptible to neomycin
sulfate in growing turkeys. The supplemental NADA is approved as of May
5, 1999, and 21 CFR 520.1484 is amended to reflect the approval. The
basis of approval is discussed in the freedom of information summary.
In addition, a tolerance for residues of neomycin in edible
tissues of turkeys has not been previously established. Section 556.430
is amended editorially to reflect current format, to provide tolerances
for neomycin residues in edible turkey tissue, and to provide an ADI
for neomycin.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this supplemental
application may be seen in the Dockets Management Branch (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)(iii) of the Federal, Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
for use in turkey drinking water qualifies for 3 years of marketing
exclusivity beginning May 5, 1999, because the supplemental application
contains substantial evidence of the effectiveness of the drug
involved, any studies of animal safety or, in the case of food-
producing animals, human food safety studies (other than bioequivalence
or residue studies) required for this approval and conducted or
sponsored by the applicant. The 3 years marketing exclusivity is
limited to use of the drug for the control of mortality associated with
E. coli organisms susceptible to neomycin sulfate in growing turkeys.
FDA has carefully considered the potential environmental effects
of this action and has concluded that the action will not have a
significant impact on the human environment. Therefore, an
environmental impact statement is not required. FDA's finding of no
significant impact and the evidence supporting that finding, contained
in an environmental assessment, may be seen in the Dockets Management
Branch (address above) between 9 a.m. and 4 p.m., Monday through
Friday.
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
21 CFR Part 520
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 parts 520 and
556 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 520.1484 is revised to read as follows:
Sec. 520.1484 Neomycin sulfate soluble powder.
(a) Specifications. Neomycin sulfate soluble powder contains 20.3
grams of neomycin sulfate (equivalent to 14.2 grams of neomycin base)
per ounce.
(b) Sponsors. See 000069, 046573, 050604, and 051259 in
Sec. 510.600(c) of this chapter for use as in paragraph (d)(1) of this
section. See 000009 for use as in paragraphs (d)(1) and (d)(2) of this
section.
(c) Related tolerances. See Sec. 556.430 of this chapter.
(d) Conditions of use-(1) Cattle (excluding veal calves), swine,
sheep, and goats.
(i) Amount. 10 milligrams of neomycin sulfate per pound of body
weight per day (22 milligrams per kilogram) 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 in cattle (excluding veal calves),
swine, sheep, and goats.
(iii) Limitations. Add to drinking water or milk; 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 14 consecutive days. Discontinue
treatment prior to slaughter as follows: Cattle (not for use in veal
calves), 1 day; sheep, 2 days; swine and goats, 3 days.
(2) Turkeys-(i) Amount. 10 milligrams of neomycin sulfate per
pound of body weight per day (22 milligrams per kilogram) for 5 days.
(ii) Indications for use. For the control of mortality associated
with E. coli organisms 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.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
3. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
[[Page 31498]]
4. Section 556.430 is revised to read as follows:
Sec. 556.430 Neomycin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
neomycin is 6 micrograms per kilogram of body weight per day.
(b) Tolerances. Tolerances are established for residues of parent
neomycin in uncooked edible tissues as follows:
(1) Cattle, swine, sheep, and goats. 7.2 parts per million (ppm)
in kidney (target tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in
muscle.
(2) Turkeys. 7.2 ppm in skin with adhearing fat, 3.6 ppm in liver,
and 1.2 ppm in muscle.
(3) Milk. A tolerance is established for residues of parent
neomycin of 0.15 ppm.
Dated: May 28, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-14924 Filed 6-10-99; 8:45 am]
BILLING CODE 4160-01-F
