[Federal Register Volume 63, Number 84 (Friday, May 1, 1998)]
[Rules and Regulations]
[Pages 24106-24107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11686]


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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; 
Spectinomycin Solution

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 Pharmacia & Upjohn Co. The NADA provides for veterinary 
prescription use of spectinomycin solution as a subcutaneous injection 
in cattle for treatment of bovine respiratory disease.

EFFECTIVE DATE: May 1, 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: Pharmacia & Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed NADA 141-077 that provides for 
veterinary prescription use of Adspec<SUP>TM</SUP> (spectinomycin) 
sterile solution for cattle, by subcutaneous injection in the neck, for 
treatment of bovine respiratory disease (pneumonia) associated with 
Pasteurella haemolytica, P. multocida, and Haemophilus somnus. The NADA 
is approved as of January 28, 1998, and the regulations are amended by 
adding Sec. 522.2121 (21 CFR 522.2121) to reflect the approval.
    A tolerance for residues of spectinomycin in edible tissues of 
cattle has not been previously established. The regulations are amended 
in 21 CFR 556.600 to provide a tolerance for spectinomycin residues in 
cattle kidney (target tissue) and in cattle muscle.
    FDA is also amending the regulations to provide for the acceptable 
daily intake (ADI) for total residues of spectinomycin. The ADI is the 
amount of total drug residue that can be consumed by humans every day. 
Previously, FDA had provided for safe concentrations, which represent 
the ADI corrected for consumption. The safe concentrations were 
confusing because few individuals understood the relationship between 
safe concentration, a value representing total residues, and tolerance, 
the part of the drug residue in a given tissue that is detected by an 
analytical method. To eliminate this confusion, FDA is codifying the 
ADI.
    Also, the heading of Sec. 522.2120 Spectinomycin injection (21 CFR 
522.2120) is revised to ``Sec. 522.2120 Spectinomycin dihydrochloride 
injection'' to clarify the difference between Sec. 522.2120 and 
Sec. 522.2121 Spectinomycin sulfate solution.
    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.

[[Page 24107]]

    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning January 28, 1998, because the application contains 
substantial evidence of the effectiveness of the drug involved, studies 
of animal safety or, in the case of food-producing animals, human food 
safety studies (other than bioequivalence or residue studies) required 
for approval and conducted or sponsored by the applicant.
    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 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.

Sec. 522.2120  [Amended]

    2. Section 522.2120 Spectinomycin injection is amended by revising 
the heading to read ``Spectinomycin dihydrochloride injection.''
    3. Section 522.2121 is added to read as follows:


Sec. 522.2121  Spectinomycin sulfate solution.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains spectinomycin sulfate tetrahydrate equivalent to 100 
milligrams of spectinomycin.
    (b) Sponsor. See 000009 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.600 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) Dose. 10 to 15 milligrams 
per kilogram of body weight, at 24-hour intervals for 3 to 5 
consecutive days.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (pneumonia) associated with Pasteurella haemolytica, P. 
multocida, and Haemophilus somnus.
    (iii) Limitations. For subcutaneous injection in the neck. Do not 
inject more than 50 milliliters at each site. Do not slaughter within 
11 days of last treatment. Do not use in female dairy cattle 20 months 
of age or older. Use in this class of cattle may cause residues in 
milk. A withdrawal period has not been established for this product in 
pre-ruminating calves. Do not use in calves to be processed for veal. 
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

    4. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.
    5. Section 556.600 is revised to read as follows:


Sec. 556.600  Spectinomycin.

    (a) Acceptible daily intake (ADI). The ADI for total residues of 
spectinomycin is 25 micrograms per kilogram of body weight per day.
    (b) Chickens and turkeys. A tolerance of 0.1 part per million (ppm) 
for negligible residues of spectinomycin in uncooked edible tissues of 
chickens and turkeys is established.
    (c) Cattle. A tolerance of 4 ppm for parent spectinomycin (marker 
residue) in kidney (target tissue) is established. A tolerance of 0.4 
ppm for parent spectinomycin in cattle muscle is established.

    Dated: April 22, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-11686 Filed 4-30-98; 8:45 am]
BILLING CODE 4160-01-F