[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
----------------------------------------------------------------------------------------------------------------
(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