[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Rules and Regulations]
[Pages 31398-31399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15724]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 520 and 556
Animal Drugs, Feeds, and Related Products; Neomycin Sulfate
Soluble Powder
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 The Upjohn Co. and two supplemental
abbreviated new animal drug applications (ANADA's), one filed by
Pfizer, Inc., and the other filed by Rhone Merieux, Inc. The
applications provide for use of neomycin sulfate soluble powder in
drinking water or in milk for cattle (excluding veal calves), swine,
sheep, and goats for the treatment and control of colibacillosis. The
supplements provide for revised preslaughter withdrawal times following
use of the drug and revised tolerances for neomycin residues in edible
tissues of treated animals.
EFFECTIVE DATE: June 20, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: The Upjohn Co., Agricultural Division,
Kalamazoo, MI 49001-0199, filed supplemental NADA 11-315; Pfizer, Inc.,
235 East 42d St., New York, NY 10017, filed supplemental ANADA 200-046;
Rhone Merieux, Inc., 7101 College Blvd., Overland Park, KS 66210, filed
supplemental ANADA 200-050. The supplements provide for revised
withdrawal times for use of neomycin sulfate soluble powder in drinking
water or in milk for cattle (excluding veal calves), swine, sheep, and
goats for the treatment and control of colibacillosis (bacterial
scours) caused by Escherichia coli susceptible to neomycin sulfate. The
supplements are approved as of April 3, 1996, and Sec. 520.1484(c)(3)
(21 CFR 520.1484(c)(3)) is amended to reflect the approvals. The basis
for approval is discussed in the freedom of information summary as
indicated below. Also, the firms sponsored studies which provided data
to support revised tolerances for residues of neomycin in the edible
tissues of cattle, swine, sheep, and goats. Based on evaluation of the
data as provided in the General Principles for Evaluating the Safety of
Compounds Used in Food-Producing Animals Guidelines, tolerances of 1.2
parts per million (ppm) in muscle, 3.6 ppm in liver, and 7.2 ppm in
kidney and fat, and withdrawal times of 1 day for cattle, 2 days for
sheep, and 3 days for swine and goats, are established. The revised
withdrawal times are provided in Sec. 520.1484(c)(3). The revised
tolerances for neomycin residues are established in amended 21 CFR
556.430.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, 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)), these approvals do not
qualify for marketing exclusivity because the applications do not
contain reports of new clinical or field investigations (other than
bioequivalence or residue studies) or new human food safety studies
(other than bioequivalence or residue studies) essential to the
approvals and conducted or sponsored by the applicants.
The agency has determined under 21 CFR 25.24(d)(1)(i) 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.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 520.1484 is amended in paragraph (c)(3) by revising the
last sentence to read as follows:
[[Page 31399]]
Sec. 520.1484 Neomycin sulfate soluble powder.
* * * * *
(c) * * *
(3) * * * Discontinue treatment prior to slaughter as follows:
For sponsor 059130--cattle and goats, 30 days; swine and sheep, 20
days; for sponsors 000009, 000069, 050604--cattle (not for use in veal
calves), 1 day; sheep, 2 days; swine and goats, 3 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: Secs. 402, 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 360b, 371).
4. Section 556.430 is revised to read as follows:
Sec. 556.430 Neomycin.
A tolerance of 7.2 parts per million (ppm) is established for
residues of parent neomycin (marker residue) in uncooked edible kidney
(target tissue), 7.2 ppm in fat, 3.6 ppm in liver, 1.2 ppm in muscle of
cattle, swine, sheep, and goats. A tolerance of 0.15 ppm is established
for neomycin in milk.
Dated: May 31, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-15724 Filed 6-19-96; 8:45 am]
BILLING CODE 4160-01-F
