[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Rules and Regulations]
[Page 31028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15567]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 522 and 556


Animal Drugs, Feeds, and Related Products; Spectinomycin 
Injection

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 an abbreviated new animal drug 
application (ANADA) filed by The Upjohn Co. The ANADA provides for 
subcutaneous use of a generic spectinomycin sterile solution in turkey 
poults and newly-hatched chicks as an aid in the control of bacterial 
respiratory infections, airsacculitis, and mortality. The regulations 
are also amended to add a tolerance for spectinomycin residues in 
turkey tissues.
EFFECTIVE DATE: June 19, 1996.
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: The Upjohn Co., Agricultural Division, 
Kalamazoo, MI 49001-0199, is the sponsor of ANADA 200-127 which 
provides for the use of a generic spectinomycin dihydrochloride 
pentahydrate sterile solution (500 milliliter (mL) vial; 100 milligrams 
of spectinomycin activity per mL). The generic drug product is 
administered subcutaneously to 1- to 3-day-old turkey poults as an aid 
in the control of chronic respiratory disease (CRD) and airsacculitis 
and 1- to 3-day-old chicks as an aid in the control of mortality and to 
lessen the severity of respiratory infections, caused by certain 
microbial species sensitive to spectinomycin.
    Approval of ANADA 200-127 for The Upjohn Co.'s spectinomycin 
dihydrochloride pentahydrate sterile solution is as a generic copy of 
Rhone Merieux's (formerly Sanofi Animal Health) NADA 040-040 for 
Spectam Injectable. The ANADA is approved as of May 9, 1996, 
and the regulations are amended in 21 CFR 522.2120 to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    Spectinomycin was originally approved based on the negligible 
tolerance concept. A negligible tolerance has been applied to animal 
drug residues when the supporting toxicological data are of subchronic 
(90-day) duration. The ``negligible tolerance'' concept is based on two 
precepts: (1) The residue present is at a level of insignificance and 
(2) the safety of the residue is supported by limited toxicological 
data. The upper level for a drug residue to qualify for ``negligible 
tolerance'' is considered customarily to be 0.1 part per million (ppm) 
residue in tissue. Therefore, the tolerance for spectinomycin residues 
in edible tissues is the same for all species in which the drug is 
approved. Accordingly, 21 CFR 556.600 is amended to apply the tolerance 
of 0.1 ppm to edible turkey tissues.
    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, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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 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 to read 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).
    2. Section 522.2120 is amended by revising paragraph (b) and by 
amending paragraph (d)(4) by removing ``M. mileagridis'' and adding in 
its place ``M. meleagridis'' to read as follows:

Sec. 522.2120  Spectinomycin injection.

* * * * *
    (b) Sponsor. In Sec. 510.600 of this chapter, see Nos. 000033 and 
050604 for conditions of use as in paragraph (d) of this section, and 
see No. 000009 for conditions of use as in paragraph (d)(2) and (d)(4) 
of this section.
* * * * *

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: Secs. 402, 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 360b, 371).
    4. Section 556.600 is revised to read as follows:

+Sec. 556.600  Spectinomycin.

    A tolerance of 0.1 part per million is established for negligible 
residues of spectinomycin in the uncooked edible tissues of chickens 
and turkeys.

    Dated: June 10, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-15567 Filed 6-18-96; 8:45 am]
BILLING CODE 4160-01-F