[Federal Register Volume 72, Number 108 (Wednesday, June 6, 2007)]
[Rules and Regulations]
[Pages 31177-31178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Spectinomycin Sulfate

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 supplemental new animal drug 
application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, 
Inc. The supplemental NADA provides for revising nomenclature for two 
bovine respiratory pathogens on labeling for spectinomycin sulfate 
injectable solution.

DATES: This rule is effective June 6, 2007.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Div. of Pfizer, 
Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 
141-077 for ADSPEC (spectinomycin sulfate) Sterile Solution used for 
the treatment of bovine respiratory disease associated with several 
bacterial pathogens. The supplemental NADA provides for revising 
nomenclature for two bacterial pathogens on product labeling. The 
supplemental NADA is approved as of May 10, 2007, and the regulations 
in 21 CFR 522.2121 are amended to reflect the approval and a current 
format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33(a)(1) 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

[[Page 31178]]

List of Subjects in 21 CFR Part 522

    Animal drugs.

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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 part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. Revise Sec.  522.2121 to read as follows:


Sec.  522.2121  Spectinomycin sulfate.

    (a) Specifications. Each milliliter of solution contains 
spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) 
spectinomycin.
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.600 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. 10 to 15 mg per 
kilogram of body weight at 24-hour intervals for 3 to 5 consecutive 
days.
    (2) Indications for use. For the treatment of bovine respiratory 
disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni.
    (3) Limitations. 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 preruminating 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.

    Dated: May 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-10801 Filed 6-5-07; 8:45 am]
BILLING CODE 4160-01-S