[Federal Register Volume 61, Number 64 (Tuesday, April 2, 1996)]
[Rules and Regulations]
[Page 14483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7977]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Nicarbazin, Roxarsone,
and Lincomycin; Nicarbazin and Lincomycin; Nicarbazin and Roxarsone
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of three abbreviated new animal
drug applications (ANADA's) filed by Planalquimica Industrial Ltda. The
ANADA's provide for use of single ingredient nicarbazin, roxarsone, and
lincomycin Type A medicated articles to make combination drug Type C
medicated broiler feeds containing nicarbazin, roxarsone, and
lincomycin; nicarbazin and lincomycin; or nicarbazin and roxarsone.
EFFECTIVE DATE: April 2, 1996.
FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center For
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1607.
SUPPLEMENTARY INFORMATION: Planalquimica Industrial Ltda., Rua das
Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao
Paulo, Brazil, filed the following ANADA's:
ANADA 200-170: Nicarbazin with roxarsone and lincomycin, for Type C
medicated feeds, as an aid in preventing outbreaks of cecal (Eimeria
tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E.
brunetti) coccidiosis; for increased rate of weight gain, in broiler
chickens;
ANADA 200-171: Nicarbazin and lincomycin, for Type C medicated
feeds, as an aid in preventing outbreaks of cecal (E. tenella) and
intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti)
coccidiosis; for increased rate of weight gain, in broiler chickens;
ANADA 200-172: Nicarbazin and roxarsone, for Type C medicated
feeds, as an aid in preventing outbreaks of cecal (E. tenella) and
intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti)
coccidiosis; for increased rate of weight gain, in broiler chickens.
The ANADA's provide for use of previously approved single
ingredient Type A medicated articles to make combination drug Type C
medicated feeds. Planalquimica's ANADA 200-170 is approved as a generic
copy of Merck Research Laboratories' NADA 107-997, ANADA 200-171 as a
generic copy of Merck's NADA 108-116, and ANADA 200-172 as a generic
copy of Merck's 108-115. The ANADA's are approved as of April 2, 1996,
and the regulations are amended in 21 CFR 558.366(c) to reflect the
approvals. The basis for approval is discussed in the freedom of
information summary.
These approvals are for use of Type A medicated articles to make
Type C medicated feeds. Nicarbazin and roxarsone are Catagory II drugs
which, as provided in 21 CFR 558.4, require an approved Form FDA 1900
for making a Type C medicated feed. Therefore, use of nicarbazin to
make combination drug Type C medicated feeds as provided in ANADA 200-
170, 200-171, and 200-172 require an approved Form FDA 1900.
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 these applications may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
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).
Sec. 558.366 [Amended]
2. Section 558.366 Nicarbazin is amended in the table in paragraph
(c) under the ``Sponsor'' column for the entries ``Lincomycin 2
(0.00044 pct),'' ``Roxarsone 22.7 (0.0025),'' and ``Roxarsone 22.7
(0.0025) plus lincomycin 2 (0.0004)'' by removing ``000006'' and adding
in its place ``000006, 060728''.
Dated: March 19, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-7977 Filed 4-1-96; 8:45 am]
BILLING CODE 4160-01-F
