[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Rules and Regulations]
[Pages 13122-13123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6909]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 522 and 556
Implantation or Injectable Dosage Form New Animal Drugs;
Colistimethate Sterile Powder
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 Alpharma Inc. The NADA provides for subcutaneous use of
colistimethate sodium powder, reconstituted in aqueous solution, in the
neck of 1- to 3-day-old chickens.
EFFECTIVE DATE: March 18, 1998.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed NADA 141-069 that provides for use of
First GuardTM Sterile Powder (colistimethate sodium),
reconstituted in sterile saline or sterile water for injection, for
subcutaneous injection in the neck of 1- to 3-day-old chickens for
control of early mortality associated with Escherichia coli organisms
susceptible to colistin. The drug is restricted to use by or on the
order of a licensed veterinarian. The NADA is approved as of January
13, 1998, and the regulations are amended by adding new Sec. 522.468 to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
In addition, the regulations are amended by adding new Sec. 556.167
to reflect that a tolerance for residues of colistimethate in edible
chicken tissues is not required. The drug is a therapeutic product
administered to 1- to 3-day-old chickens at the equivalent of 0.2
milligrams of colistin activity per chicken. At 28 days post-treatment,
the earliest possible time broiler chickens would be considered
marketable, total residues were calculated to be at least 36 times
below the safe concentration level.
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 January 13, 1998, because no active ingredient of the drug
(including any ester or salt thereof) has been previously approved in
any other application filed under section 512(b)(1) of the act.
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
[[Page 13123]]
in the Dockets Management Branch (address above) between 9 a.m. and 4
p.m., Monday through Friday.
List of Subjects
21 CFR Part 522
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 522 and
556 are amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 522.468 is added to read as follows:
Sec. 522.468 Colistimethate sodium powder for injection.
(a) Specifications. Each vial contains colistimethate sodium
equivalent to 10 grams colistin activity and mannitol to be
reconstituted with 62.5 milliliters sterile saline or sterile water for
injection. The resulting solution contains colistimethate sodium
equivalent to 133 milligrams per milliliter colistin activity.
(b) Sponsor. See 046573 in Sec. 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use. (1) 1- to 3-day-old chickens.
(i) Dosage. 0.2 milligram colistin activity per chicken.
(ii) Indications for use. Control of early mortality associated
with Escherichia coli organisms susceptible to colistin.
(iii) Limitations. For subcutaneous injection in the neck of 1- to
3-day-old chickens. Not for use in laying hens producing eggs for human
consumption. Do not use in turkeys. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
(2) [Reserved]
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
3. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
4. Section 556.167 is added to read as follows:
Sec. 556.167 Colistimethate.
A tolerance for residues of colistimethate in the edible tissues of
chickens is not required.
Dated: February 22, 1998.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 98-6909 Filed 3-17-98; 8:45 am]
BILLING CODE 4160-01-F