[Federal Register Volume 69, Number 110 (Tuesday, June 8, 2004)]
[Rules and Regulations]
[Pages 31878-31879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12839]


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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; 
Oxytetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations for oxytetracycline injectable solutions. The 
regulations for oxytetracycline injectable solutions are also being 
revised to conform to a current format. These changes are being made to 
improve the organization and readability of the regulations.

DATES: This rule is effective June 8, 2004.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 19, 
2003 (68 FR 54804), Sec.  522.1660a (21 CFR 522.1660a) was added to 
reflect the approval of a 300-milligram (mg)/milliliter (mL) 
oxytetracycline injectable solution under NADA 141-143. At this time, 
we are redesignating and amending Sec. Sec.  522.1660 (21 CFR 522.1660) 
and 522.1660a as Sec. Sec.  522.1660a and 522.1660b, respectively. 
These sections are also being revised to conform to a current format. 
These changes are being made to improve the organization and 
readability of the 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 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:

[[Page 31879]]

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

0
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. Sections 522.1660 and 522.1660a are redesignated as Sec. Sec.  
522.1660a and 522.1660b, respectively, and new Sec.  522.1660 is added 
to read as follows:


Sec.  522.1660  Oxytetracycline injectable solutions.

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3. Newly redesignated Sec.  522.1660a is amended by revising paragraphs 
(b) and (c), by redesignating paragraph (d) as paragraph (e), by 
revising newly redesignated paragraph (e), and by adding new paragraph 
(d) to read as follows:


Sec.  522.1660a  Oxytetracycline injection, 200 milligrams/milliliter.

    (a) * * *
    (b) Sponsors. See Nos. 000010, 000069, 011722, 053389, 055529, 
057561, 059130, and 061623 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.500 of this chapter.
    (d) Special considerations. When labeled for the treatment of 
anaplasmosis or anthrax, labeling shall also bear the following: 
``Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.''
    (e) Conditions of use--(1) Beef cattle, dairy cattle, and calves 
including prerumenative (veal) calves--(i) Amounts and indications for 
use--(A) 3 to 5 mg per pound of body weight (mg/lb BW) per day (/day) 
intramuscularly, subcutaneously, or intravenously for treatment of 
pneumonia and shipping fever complex associated with Pasteurella spp. 
and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium 
necrophorum, bacterial enteritis (scours) caused by Escherichia coli, 
wooden tongue caused by Actinobacillus lignieresii, leptospirosis 
caused by Leptospira pomona, wound infections and acute metritis caused 
by Staphylococcus spp. and Streptococcus spp., and anthrax caused by 
Bacillus anthracis.
    (B) 5 mg/lb BW/day intramuscularly or intravenously for treatment 
of anaplasmosis caused by Anaplasma marginale, severe foot-rot, and 
advanced cases of other indicated diseases.
    (C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage 
where retreatment of calves and yearlings for bacterial pneumonia is 
impractical, for treatment of infectious bovine keratoconjunctivitis 
(pinkeye) caused by Moraxella bovis, or where retreatment for 
anaplasmosis is impractical.
    (D) 9 to 13.6 mg/lb BW intramuscularly or subcutaneously as single 
dosage where retreatment of calves and yearlings for bacterial 
pneumonia is impractical or for treatment of infectious bovine 
keratoconjunctivitis (pink eye) caused by Moraxella bovis.
    (E) 13.6 mg/lb BW intramuscularly or subcutaneously as a single 
dosage for control of respiratory disease in cattle at high risk of 
developing BRD associated with Mannheimia (Pasteurella) haemolytica.
    (ii) Limitations. Exceeding the highest recommended level of drug 
per pound of bodyweight per day, administering more than the 
recommended number of treatments, and/or exceeding 10 mL 
intramuscularly or subcutaneously per injection site may result in 
antibiotic residues beyond the withdrawal time. Rapid intravenous 
administration in cattle may result in animal collapse. Oxytetracycline 
should be administered intravenously slowly over a period of at least 5 
minutes. Discontinue treatment at least 28 days prior to slaughter. Not 
for use in lactating dairy animals.
    (2) Swine--(i) Amounts and indications for use--(A) Sows: 3 mg/lb 
BW intramuscularly once, approximately 8 hours before farrowing or 
immediately after completion of farrowing, as an aid in control of 
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs 
caused by E. coli.
    (B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial 
enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira 
pomona.
    (C) 9 mg/lb BW as a single dosage where retreatment for pneumonia 
is impractical.
    (ii) Limitations. Administer intramuscularly. Do not inject more 
than 5 mL per site in adult swine. Discontinue treatment at least 28 
days prior to slaughter.

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4. Newly redesignated Sec.  522.1660b is amended in paragraph 
(e)(1)(ii) by removing ``milliliter'' and by adding in its place 
``mL'', by removing paragraph (e)(2)(ii), by redesignating paragraph 
(e)(2)(iii) as new paragraph (e)(2)(ii) and removing ``milliliter'' and 
by adding in its place ``mL'', and by revising paragraph (e)(2)(i) to 
read as follows:


Sec.  522.1660b  Oxytetracycline injection, 300 milligrams/milliliter.

* * * * *
    (e) * * *
    (2) Swine--(i) Amounts and indications for use--(A) Sows: 3 mg/lb 
BW intramuscularly once, approximately 8 hours before farrowing or 
immediately after completion of farrowing, as an aid in control of 
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs 
caused by E. coli.
    (B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial 
enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused 
by Pasteurella multocida, and leptospirosis caused by Leptospira 
pomona.
    (C) 9 mg/lb BW as a single dosage where retreatment for pneumonia 
is impractical.
* * * * *

    Dated: May 20, 2004.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-12839 Filed 6-7-04; 8:45 am]
BILLING CODE 4160-01-S