[Federal Register Volume 60, Number 107 (Monday, June 5, 1995)]
[Rules and Regulations]
[Pages 29483-29484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13635]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Nicarbazin and
Bacitracin Methylene Disalicylate
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to codify a previously approved new animal drug
application (NADA) held by Merck Research Laboratories, Division of
Merck & Co., Inc. The NADA provides for use of nicarbazin and
bacitracin methylene disalicylate in Type C broiler feeds for
prevention of certain forms of coccidiosis and for increased rate of
weight gain and improved feed efficiency.
EFFECTIVE DATE: June 5, 1995.
FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1623.
SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, is sponsor of NADA
98-378 which provides for the use of approved nicarbazin and bacitracin
methylene disalicylate Type A medicated articles to make Type C
medicated broiler feeds containing 113.5 grams per ton (g/t) nicarbazin
with 30 g/t bacitracin methylene disalicylate. The NADA was approved by
letter of March 15, 1955, for prevention of certain forms of
coccidiosis and for increased rate of weight gain and improved feed
efficiency. This document amends the regulations in 21 CFR 558.76(d)
and in the table in 21 CFR 558.366(c) to reflect the approval.
Also, the table in Sec. 558.366(c) contains two entries in the
first column for ``113.5 (0.0125 pct).'' The second entry in the first
column is unnecessary, and is being removed at this time. In addition,
the entry for ``113.5 (0.0125)'' contains an outdated footnote to the
approval for use of 113.5 g/t nicarbazin. Because the National Academy
of Sciences/National Research Council (NAS/NRC) status was changed by
enactment of the Generic Animal Drug and Patent Term Restoration Act of
1988, the footnote is hereby removed.
NADA 98-378 provides for use of nicarbazin and bacitracin methylene
disalicylate Type A medicated articles to make Type C medicated feeds.
Nicarbazin is a Category II drug which, as provided in 21 CFR 558.4,
requires an approved Form FDA 1900 for making Type C medicated feeds.
Therefore, use of nicarbazin Type A medicated articles in making Type C
medicated feeds as in this NADA requires an approved Form FDA 1900.
Because this NADA was approved prior to July 1, 1975, the freedom
of information (FOI) summary specified in 21 CFR part 20 and 21 CFR
514.11(e)(2)(ii) is not required.
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 in 21 CFR Part 558
Animal drugs, Animal feeds.
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 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: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
2. Section 558.76 is amended by adding paragraph (d)(3)(v) to read
as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(3) * * *
(v) Nicarbazin as in Sec. 558.366.
* * * * *
3. Section 558.366 is amended in the table in paragraph (c) by
removing footnote ``1'' for the entry ``113.5 (0.0125 pct),'' by
removing the second entry ``113.5 (0.0125 pct),'' and by adding a new
item before the entry for ``Lincomycin 2 (0.00044 pct),'' to read as
follows:
Sec. 558.366 Nicarbazin.
* * * * *
(c) * * *
----------------------------------------------------------------------------------------------------------------
Nicarbazin in grams per Combination in grams
ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Bacitracin methylene Broiler chickens; aid in ......do................ 000006
disalicylate 30 preventing outbreaks of
cecal (Eimeria tenella)
and intestinal (E.
acervulina, E. maxima,
E. necatrix, and E.
brunetti) coccidiosis;
for increased rate of
weight gain and improved
feed efficiency.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
[[Page 29484]] Dated: May 24, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13635 Filed 6-2-95; 8:45 am]
BILLING CODE 4160-01-F
