[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
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* * * * * *
*
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
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* * * * * *
*
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
