[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Rules and Regulations]
[Pages 25163-25164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529


Certain Other Dosage Form New Animal Drugs; Competitive Exclusion 
Culture

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 a new animal drug application 
(NADA) filed by BioScience Division of Milk Specialties Co. The NADA 
provides for use of a competitive exclusion culture (lyophilized 
bacterial cultures) for early establishment of intestinal microflora in 
chickens to reduce Salmonella colonization.

EFFECTIVE DATE: May 7, 1998.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1659.

SUPPLEMENTARY INFORMATION: BioScience Division of Milk Specialties Co., 
Illinois and Water Sts., P.O. Box 278, Dundee, IL 60118, is sponsor of 
NADA 141-101 that provides for the use of PreemptTM, a 
competitive exclusion culture (lyophilized bacterial cultures), for the 
early establishment of intestinal microflora in chickens to reduce 
Salmonella colonization. The NADA is approved as of March 13, 1998, and 
the regulations are amended by adding 21 CFR 529.469 to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.

    In addition, BioScience Division of Milk Specialties Co. has not 
been previously listed in the animal drug regulations as sponsor of an 
approved application. At this time, 21 CFR 510.600(c)(1) and (c)(2) are 
amended to add entries for the firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval for food-
producing animals qualifies for 5 years of marketing exclusivity 
beginning March 13, 1998, because no active ingredient (including any 
salt or ester of the active ingredient) has been approved in any other 
application.
    The agency has determined under 21 CFR 25.33(c) 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

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,

[[Page 25164]]

Reporting and recordkeeping requirements.

21 CFR Part 529

    Animal drugs.
    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 
529 are amended as follows:

PART 510--NEW ANIMAL DRUGS

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

    Authority: 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 an entry for ``BioScience Division of Milk 
Specialties Co.''and in paragraph (c)(2) by numerically adding an entry 
for ``032761'' to read as follows:

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

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

                                                                                                                
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                Firm name and address                                      Drug labeler code                    
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
BioScience Division of Milk Specialties Co., Illinois                                                           
 and Water Sts., P.O. Box 278, Dundee, IL 60118                                                          032761 
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    (2) * * *

                                                                                                                
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                    Drug labeler code                                      Firm name and address                
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
032761...................................................  BioScience Division of Milk Specialties Co., Illinois
                                                            and Water Sts., P.O. Box 278, Dundee, IL 60118.     
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

    2. Section 529.469 is added to read as follows:

Sec. 529.469  Competitive exclusion culture.

    (a) Specifications. Each packet of lyophilized culture contains 
either 2,000 or 5,000 doses in frozen pellets to be reconstituted for 
use.
    (1) For 2,000-dose packet, add contents of one 2,000-dose packet of 
reconstitution powder to 490 milliliters of deionized water. Mix. Add 
contents of one 2,000-dose packet of lyophilized culture. Mix 
thoroughly.
    (2) For 5,000-dose packet, add contents of one 5,000-dose packet of 
reconstitution powder to 1,250 milliliters of deionized water. Mix. Add 
contents of one 5,000-dose packet of lyophilized culture. Mix 
thoroughly. Allow to stand for 45 minutes before use. Use within 5 
hours of reconstitution.
    (b) Sponsor. See No. 032761 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use. Chickens--(1) Amount. Apply 25 milliliters 
of reconstituted culture as a topical spray on each tray of 100 chicks 
(0.25 milliliter per chick).
    (2) Indications for use. For early establishment of intestinal 
microflora in chickens to reduce Salmonella colonization.
    (3) Limitations. Administer as soon as possible after hatch, 
preferably at less than 1 day of age. Expose chicks to light for at 
least 5 minutes after spray treatment to encourage preening for oral 
uptake of the organisms. Provide access to feed and water as soon as 
possible after treatment. Do not administer antibiotics to treated 
chickens.

    Dated: April 22, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-12056 Filed 5-6-98; 8:45 am]
BILLING CODE 4160-01-F