[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