[Federal Register Volume 64, Number 176 (Monday, September 13, 1999)]
[Rules and Regulations]
[Pages 49383-49385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23665]
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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; Nicarbazin and
Bambermycins
AGENCY: Food and Drug Administration, HHS.
[[Page 49384]]
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 new animal drug application
(NADA) filed by Hoechst Roussel Vet. The NADA provides for combining
approved single ingredient nicarbazin and bambermycins Type A medicated
articles to make Type C medicated broiler chicken feeds to be used as
an aid in preventing outbreaks of cecal and intestinal forms of
coccidiosis, and for increased rate of weight gain and improved feed
efficiency.
EFFECTIVE DATE: September 13, 1999
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1600.
SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, 30 Independence Blvd.,
P.O. Box 4915, Warren, NJ 07059, filed NADA 140-339 that provides for
combining approved single ingredient Nicarb (nicarbazin) and
Flavomycin (bambermycins) Type A medicated articles to make
Type C medicated broiler chicken feeds containing 113.5 grams per ton
(g/t) nicarbazin and 1 to 2 g/t bambermycins. The Type C medicated
broiler chicken feeds are 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 NADA
is approved as of August 6, 1999, and the regulations are amended in
Sec. 558.95 (21 CFR 558.95) by adding paragraph (d)(5)(iv), and in 21
CFR 558.366 in the table in paragraph (c) by adding an entry, to
reflect the approval. Also, the introductory text of Sec. 558.95(d)(5)
is revised to better reflect the combination approvals.
In accordance with the freedom of information provisions of 21 CFR
parts 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.
This approval is for use of single ingredient Type A medicated
articles to make combination drug Type C medicated feeds. One
ingredient, nicarbazin, is a Category II drug as defined in 21 CFR
558.3(b)(1)(ii). As provided in 21 CFR 558.4(b), an approved form FDA
1900 is required to make Type C medicated feed from a Category II drug.
Under section 512(m) of the act (21 U.S.C. 360b(m)), as amended by the
Animal Drug Availability Act of 1996 (Public Law 104-250), medicated
feed applications have been replaced by a requirement for feed mill
licenses. Therefore, use of Type A medicated articles to make Type C
medicated feeds as provided in NADA 140-339 is limited to manufacture
in a licensed feed mill.
The agency has determined under 21 CFR 25.33(a)(2) 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
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 558.95 is amended by revising the introductory text of
paragraph (d)(5) and by adding paragraph (d)(5)(iv) to read as follows:
Sec. 558.95 Bambermycins.
* * * * *
(d) * * *
(5) Bambermycins may be used in chickens as in paragraph (d)(1) of
this section in combination with:
* * * * *
(iv) Nicarbazin as in Sec. 558.366.
3. Section 558.366 is amended in the table in paragraph (c) under
the entry for ``113.5 (0.0125 pct)'' by alphabetically adding an item
for ``Bambermycins 1 to 2'' and revising the item for ``Lincomycin 2''
to read as follows:
Sec. 558.366 Nicarbazin.
* * * * *
(c) * * *
----------------------------------------------------------------------------------------------------------------
Nicarbazin in grams Combination in grams
per ton per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
113.5 (0.0125 pct) * * * * * * * * *
* * * * * *
*
Bambermycins 1 to 2 Broiler chickens; aid Feed continuously as 012799
in preventing sole ration from
outbreaks of cecal time chicks are
(Eimeria tenella) placed on litter
and intestinal (E. until past the time
acervulina, E. when coccidiosis is
maxima, E. necatrix, ordinarily a hazard;
and E. brunetti) do not use as a
coccidiosis, for treatment for
increased rate of coccidiosis; do not
weight gain and use in flushing
improved feed mashes; do not feed
efficiency. to laying hens;
withdraw 4 days
before slaughter.
Nicarbazin as
provided by 063271.
[[Page 49385]]
Lincomycin 2 (0.00044 Broiler chickens; aid Feed continuously as 060728 063271
pct) in preventing sole ration from
outbreaks of secal time chicks are
(Eimeria tenella) placed on litter
and intestinal (E. until past the time
acervulina, E. when coccidiosis is
maxima, E. necatrix, ordinarily a hazard;
and E. brunetti) do not use as a
coccidiosis; for treatment for
increased rate of coccidiosis; do not
weight gain. use in flushing
mashes; do not feed
to laying hens;
withdraw 4 days
before slaughter.
* * * * * *
*
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Dated: August 30, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-23665 Filed 9-10-99; 8:45 am]
BILLING CODE 4160-01-F
