[Federal Register Volume 60, Number 124 (Wednesday, June 28, 1995)]
[Rules and Regulations]
[Pages 33342-33343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15768]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


Animal Drugs, Feeds, and Related Products; Nicarbazin Type A 
Medicated Article

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 the use of a nicarbazin-containing Type A medicated 
article in making Type C medicated chicken feeds for the prevention of 
coccidiosis.

EFFECTIVE DATE: June 28, 1995.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Planalquimica Industrial Ltda., Rua das 
Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao 
Paulo, Brazil, has filed ANADA 200-027, which provides for the use of a 
nicarbazin-containing Type A medicated article in making Type C 
medicated chicken feeds as an aid in preventing outbreaks of cecal and 
intestinal coccidiosis.
    Planalquimica's ANADA 200-027 for a 113.5-gram-per-pound nicarbazin 
Type A medicated article (Nicarmix) is approved as a generic copy of 
Merck Research Laboratories' NADA 9-476 for Nicarb. The ANADA 
is approved as of June 28, 1995, and the regulations are amended in 21 
CFR 510.600(c) and 558.366(a) to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    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.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 510 continues to read as 
follows:

     Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
353, 360b, 371, 379e).

    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Planalquimica Industrial 
Ltda.'' and in the table in paragraph (c)(2) by numerically adding a 
new entry for ``060728'' to read as follows:


Sec. 510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

                                                                        
[[Page 33343]]
                                                                        
------------------------------------------------------------------------
        Firm name and address                  Drug labeler code        
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Planalquimica Industrial Ltda., Rua                                     
 das Magnolias nr. 2405, Jardim das                                     
 Bandeiras, CEP 13053-120, Campinas,                                    
 Sao Paulo, Brazil..................                              060728
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

   (2) * * *

                                                                        
------------------------------------------------------------------------
   Drug labeler code                  Firm name and address             
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
 060728................  Planalquimica Industrial Ltda., Rua das        
                          Magnolias nr. 2405, Jardim das Bandeiras, CEP 
                          13053-120, Campinas, Sao Paulo, Brazil        
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. 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]

    4. Section 558.366 Nicarbazin is amended in paragraph (a) by 
removing the phrase ``000006 and 000986'' and adding in its place 
``000006, 000986, and 060728''.

    Dated: June 21, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-15768 Filed 6-27-95; 8:45 am]
BILLING CODE 4160-01-F