Document ID: FDA-2008-N-0039-0007
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Spectinomycin
Posted Date: 2008-02-05T05:00Z

[Federal Register: February 5, 2008 (Volume 73, Number 24)]
[Rules and Regulations]               
[Page 6607]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe08-14]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 
Oral Dosage Form New Animal Drugs; Spectinomycin

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 correct an error in the indications for use for 
spectinomycin oral solution in swine. FDA is also amending the 
regulations for other oral dosage forms of spectinomycin to reflect a 
current format. These actions are being taken to improve the accuracy 
and readability of the animal drug regulations.

DATES: This rule is effective February 5, 2008.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug 
regulations do not reflect the approved indications for use for 
spectinomycin oral solution in swine. At this time, FDA is amending the 
animal drug regulations in Sec.  520.2123c (21 CFR 520.2123c) to 
correct this error. FDA is also amending the regulations in Sec.  
520.2123a for spectinomycin tablets and in Sec.  520.2123b for 
spectinomycin powder to reflect a current format. These actions are 
being taken to improve the accuracy and readability of the animal drug 
regulations.
    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.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Revise Sec.  520.2123 to read as follows:

Sec.  520.2123  Spectinomycin oral dosage forms.

0
3. Revise Sec.  520.2123a to read as follows:

Sec.  520.2123a  Spectinomycin tablets.

    (a) Specifications. Each tablet contains spectinomycin 
dihydrochloride pentahydrate equivalent to 100 milligrams (mg) 
spectinomycin.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer orally to 
provide 10 mg per pound (lb) of body weight twice daily. Dosage may be 
continued for 4 consecutive days.
    (2) Indications for use. For the treatment of infectious diarrhea 
and gastroenteritis caused by organisms susceptible to spectinomycin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
4. Revise Sec.  520.2123b to read as follows:

Sec.  520.2123b  Spectinomycin powder.

    (a) Specifications. Each gram (g) of powder contains spectinomycin 
dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin.
    (b) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.600 of this chapter.
    (d) Conditions of use in chickens. It is administered in the 
drinking water of growing chickens as follows:
    (1) Indications for use and amounts--(i) For increased rate of 
weight gain and improved feed efficiency in broiler chickens, 
administer 0.5 g per gallon of water as the only source of drinking 
water for the first 3 days of life and for 1 day following each 
vaccination.
    (ii) As an aid in controlling infectious synovitis due to 
Mycoplasma synoviae in broiler chickens, administer 1 g per gallon of 
water as the only source of drinking water for the first 3 to 5 days of 
life.
    (iii) As an aid in the prevention or control of losses due to CRD 
associated with M. gallisepticum (PPLO) in growing chickens, administer 
2 g per gallon of water as the only source of drinking water for the 
first 3 days of life and for 1 day following each vaccination.
    (2) Limitations. Do not administer to laying chickens. Do not 
administer within 5 days of slaughter.

0
5. Revise Sec.  520.2123c to read as follows:

Sec.  520.2123c  Spectinomycin solution.

    (a) Specifications. Each milliliter of solution contains 
spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams 
(mg) spectinomycin.
    (b) Sponsors. See Nos. 000856, 059130, and 061623 in Sec.  
510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.600 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer 5 mg per 
pound (lb) of body weight orally twice daily for 3 to 5 days.
    (2) Indications for use. For the treatment and control of porcine 
enteric colibacillosis (scours) caused by E. coli susceptible to 
spectinomycin in pigs under 4 weeks of age.
    (3) Limitations. Do not administer to pigs over 15 lb body weight 
or over 4 weeks of age. Do not administer within 21 days of slaughter.

    Dated: January 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-2065 Filed 2-4-08; 8:45 am]

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