[Federal Register Volume 61, Number 16 (Wednesday, January 24, 1996)]
[Rules and Regulations]
[Pages 1831-1832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-941]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Planalquimica Industrial Ltda. The ANADA
provides for use of nicarbazin and bacitracin methylene disalicylate in
Type C broiler feed for the prevention of certain forms of coccidiosis
and for
[[Page 1832]]
increased rate of weight gain and improved feed efficiency.
EFFECTIVE DATE: January 24, 1996.
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: Planalquimica Industrial Ltda., Rua das
Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao
Paulo, Brazil, has filed ANADA 200-164, which provides for the use of
single ingredient nicarbazin and bacitracin methylene disalicylate Type
A articles to make combination drug Type C broiler feed containing
113.5 grams per ton (g/t) nicarbazin with 30 g/t bacitracin methylene
disalicylate. The feed is used as an aid in preventing outbreaks of
cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E.
necatrix, and E. brunetti) coccidiosis and for increased rate of weight
gain and improved feed efficiency in broiler chickens.
The ANADA is approved as a generic copy of Merck Research
Laboratories' NADA 98-378, which was approved on March 15, 1995, and
announced in the Federal Register of June 5, 1995 (60 FR 29483). ANADA
200-164 is approved as of January 24, 1996, and the regulations are
amended in Sec. 558.366 (21 CFR 558.366) to reflect the approval. The
basis for approval is discussed in the freedom of information summary.
Additionally, Sec. 558.366(a) is revised to clarify that the listed
sponsors are only approved for those uses of the 25 percent nicarbazin
Type A medicated article in the table accompanied by their drug labeler
code in the ``Sponsor'' column. Consistent with this, the code for
Planalquimica is being added to the ``Sponsor'' column because it was
inadvertently omitted when the firm's approval for use of nicarbazin
alone in chicken feed was announced in the Federal Register of June 28,
1995 (60 FR 33342).
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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
ANADA 200-164 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 ANADA requires an approved
Form FDA 1900.
The agency has determined under 21 CFR 25.24(d)(1)(ii) 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 558.366 is amended by revising paragraph (a), and in
the table in paragraph (c) under the ``Sponsor'' column in the entry
for ``113.5 (0.0125 pct)'' by numerically adding ``060728'', and in the
same column in the item ``Bacitracin methylene disalicylate 30'' by
numerically adding ``060728'' to read as follows:
Sec. 558.366 Nicarbazin.
(a) Type A medicated articles: 25 percent to 000006, 000986, and
060728 in Sec. 510.600(c) of this chapter for use as indicated in the
table in paragraph (c) of this section.
* * * * *
Dated: December 28, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-941 Filed 1-23-96; 8:45 am]
BILLING CODE 4160-01-F
