[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]



-----------------------------------------------------------------------


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 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