[Federal Register Volume 64, Number 242 (Friday, December 17, 1999)]
[Rules and Regulations]
[Pages 70576-70578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32426]
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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 Feeds; 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 Type A medicated articles to
make Type B and C medicated feeds for cattle, swine, sheep, and goats,
and medicated milk replacers for calves, piglets, lambs, and goat kids.
EFFECTIVE DATE: December 17, 1999.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0212.
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., 7000 Portage Rd.,
Kalamazoo, MI 49001-0199, filed supplemental NADA 140-976 that provides
for use of neomycin sulfate Type A medicated articles to make Type B
and C medicated feeds for cattle, swine, sheep, and goats, and
medicated milk replacers for calves, piglets, lambs, and goat kids, for
treatment and control of colibacillosis (bacterial enteritis) caused by
Escherichia coli susceptible to neomycin. The products were the subject
of a National Academy of Sciences/National Research Council (NAS/NRC)
Drug Efficacy Study Group review of the product's effectiveness (DESI
11-315V). The results of the NAS/NRC review and FDA's conclusions based
on that review were published in the Federal Register of January 19,
1971 (36 FR 837). The sponsor filed a supplemental NADA that reflects
compliance with the results of the NAS/NRC review and FDA's conclusions
based on that review. The supplement is approved as of November 3,
1999, and 21 CFR 558.364 is added to reflect the approval. The basis
for approval is discussed in the freedom of information summary.
Also, 21 CFR 558.4 is amended in the ``Category II'' table in
paragraph (d) to add an entry for neomycin sulfate.
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 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.
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.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the 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
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
2. Section 558.4 is amended in the ``Category II'' table in
paragraph (d) by adding an entry alphabetically for neomycin sulfate to
read as follows:
Sec. 558.4 Medicated feed applications.
* * * * *
(d) * * *
Category II
------------------------------------------------------------------------
Assay limits
Drug Assay limits Type B maximum percent\1\ type
percent\1\ type A (100x) B/C\2\
------------------------------------------------------------------------
* * * *
* * *
Neomycin sulfate 80-120 100 g/lb (22.0%) 70-125
* * * *
* * *
------------------------------------------------------------------------
\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 limit, 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.
* * * * *
3. Section 558.364 is added to subpart B to read as follows:
Sec. 558.364 Neomycin sulfate.
(a) Approvals. Type A medicated article: 325 grams per pound to
000009 in Sec. 510.600(c) of this chapter.
(b) Related tolerances. See Sec. 556.430 of this chapter.
(c) [Reserved]
(d) Conditions of use. Neomycin sulfate is used as follows:
[[Page 70577]]
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Neomycin Sulfate Combination Indications for Use Limitations Sponsor
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(1) 400 to 1,600 Cattle, swine, sheep, To provide 10 000009
grams per ton (g/t) and goats. For milligrams (mg) of
of dry type C feed. treatment and neomycin sulfate per
control of pound of body weight
colibacillosis per day for a
(bacterial maximum of 14 days.
enteritis) caused by The concentration of
Escherichia coli neomycin sulfate
susceptible to required in
neomycin. medicated feed must
be adjusted to
compensate for
variation in age and
weight of animal,
the nature and
severity of disease
signs, and
environmental
temperature and
humidity, each of
which affects feed
consumption. If
symptoms persist
after using for 2 or
3 days, consult a
veterinarian.
Treatment should
continue 24 to 48
hours beyond
remission of disease
symptoms.
Discontinue
treatment prior to
slaughter as
follows: Cattle 1
day, swine 3 days,
sheep 2 days, and
goats 3 days. A
withdrawal period
has not been
established for use
in preruminating
calves. Do not use
in calves to be
processed for veal.
A milk discard time
has not been
established for use
in lactating dairy
cattle or lactating
dairy goats. Do not
use in female dairy
cattle 20 months of
age or older or
female dairy goats
12 months of age or
older. For use in
dry feeds only. Not
for use in liquid
feed supplements.
[[Page 70578]]
(2) 400 to 2,000 g/t Do. To provide 10 mg of 000009
of type C milk neomycin sulfate per
replacer. pound of body weight
per day for a
maximum of 14 days.
Amount consumed will
vary depending on
animal's consumption
and weight. If
symptoms persist
after using for 2 or
3 days, consult a
veterinarian.
Treatment should
continue 24 to 48
hours beyond
remission of disease
symptoms.
Discontinue
treatment prior to
slaughter as
follows: Cattle 1
day, swine 3 days,
sheep 2 days, and
goats 3 days. A
withdrawal period
has not been
established for use
in preruminating
calves. Do not use
in calves to be
processed for veal.
A milk discard time
has not been
established for use
in lactating dairy
cattle or lactating
dairy goats. Do not
use in female dairy
cattle 20 months of
age or older or
female dairy goats
12 months of age or
older. For use in
milk replacers only.
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Dated: December 1, 1999.
Andrew J. Beaulieu,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 99-32426 Filed 12-16-99; 8:45 am]
BILLING CODE 4160-01-F
