[Federal Register Volume 66, Number 3 (Thursday, January 4, 2001)]
[Rules and Regulations]
[Pages 711-712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-72]


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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; Change 
of Sponsor

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 a change of sponsor for two approved new 
animal drug applications (NADA's) from Pfizer, Inc., to Phoenix 
Scientific, Inc.

DATES: This rule is effective January 4, 2001.

FOR FURTHER INFORMATION CONTACT: Norman J. Turner, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0214.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, has informed FDA that it has transferred to Phoenix 
Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, St. 
Joseph, MO 64506-0457, ownership of, and all rights and interests in 
NADA 065-110 for Pro-Pen G (penicillin G procaine) in Aqueous 
Suspension and NADA 065-498 for Pen BP-48 (penicillin G benzathine/
procaine). Accordingly, the agency is amending the regulations in 21 
CFR 522.1696a and 522.1696b to reflect the transfer of ownership. The 
agency is also taking the opportunity to restructure the regulation to 
reflect current format.
    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.
    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

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

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

    2. Section 522.1696a is revised to read as follows:


Sec. 522.1696a  Penicillin G benzathine and penicillin G procaine 
sterile suspension.

    (a) Specifications. Each milliliter of aqueous suspension contains 
penicillin G benzathine and penicillin G procaine, each equivalent to 
150,000 units of penicillin G.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
the conditions of use in paragraph (d) of this section as follows:
    (1) Nos. 000008, 000856, 000864, 010515, and 049185 for use as in 
paragraph (d)(1) of this section.
    (2) Nos. 000856 and 049185 for use as in paragraphs (d)(2)(i), 
(d)(2)(ii)(A), and (d)(2)(iii) of this section.
    (3) Nos. 000864, 010515, and 059130 for use as in paragraphs 
(d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of this section.
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use--(1) Horses, dogs, and beef cattle--(i) 
Amount--(A) Beef cattle. 2 milliliters per 150 pounds of body weight 
intramuscularly or subcutaneously. Repeat dosage in 48 hours.
    (B) Horses. 2 milliliters per 150 pounds of body weight 
intramuscularly. Repeat dosage in 48 hours.
    (C) Dogs. 1 milliliter per 10 to 25 pounds of body weight 
intramuscularly or subcutaneously. Repeat dosage in 48 hours.
    (ii) Conditions of use. Treatment of bacterial infections 
susceptible to penicillin G.
    (iii) Limitations. In beef cattle, treatment should be limited to 
two doses. Not for use in beef cattle within 30 days of slaughter. Do 
not use in horses intended for food purposes. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.
    (2) Beef cattle--(i) Amount. 2 milliliters per 150 pounds of body 
weight subcutaneously. Repeat dosage in 48 hours.
    (ii) Conditions of use. (A) Treatment of bacterial pneumonia 
(Streptococcus spp., Corynebacterium pyogenes,

[[Page 712]]

Staphylococcus aureus); upper respiratory infections such as rhinitis 
or pharyngitis (Cpyogenes); blackleg (Clostridium chauvoei).
    (B) As in paragraph (d)(2)(ii)(A) of this section; and prophylaxis 
of bovine shipping fever in 300- to 500-pound beef calves.
    (iii) Limitations. Limit treatment to two doses. Not for use within 
30 days of slaughter.
    3. Section 522.1696b is revised to read as follows.


Sec. 522.1696b  Penicillin G procaine aqueous suspension.

    (a) Specifications. Each milliliter contains penicillin G procaine 
equivalent to 300,000 units of penicillin G.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter as follows:
    (1) Nos. 010515, 053501, and 059130 for use as in paragraph (d) of 
this section.
    (2) Nos. 000864 and 055529 for use as in paragraph (d)(2) of this 
section.
    (c) Related tolerances. See Sec. 556.510 of this chapter.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 10,000 units 
per pound body weight daily by intramuscular injection at 24-hour 
intervals. Continue treatment at least 48 hours after symptoms 
disappear.
    (ii) Indications for use. Treatment of infections caused by 
penicillin-sensitive organisms.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle, sheep, swine, and horses--(i) Amount. 3,000 units per 
pound body weight (1 milliliter per 100 pounds body weight) daily by 
intramuscular injection.
    (A) For Nos. 000864, 010515, 053501, and 059130: Continue treatment 
at least 48 hours after symptoms disappear.
    (B) For No. 055529: Continue treatment at least 1 day after 
symptoms disappear (usually 2 or 3 days).
    (ii) Indications for use. Treatment of cattle and sheep for 
bacterial pneumonia (shipping fever) caused by Pasteurella multocida; 
swine for erysipelas caused by Erysipelothrix insidiosa; and horses for 
strangles caused by Streptococcus equi.
    (iii) Limitations. Not for use in horses intended for food.
    (A) For Nos. 000864, 010515, 053501, and 059130: Do not exceed 7 
days of treatment in nonlactating dairy and beef cattle, sheep, and 
swine, or 5 days in lactating cattle. Milk that has been taken during 
treatment and for 48 hours after the last treatment must not be used 
for food. Discontinue treatment for the following number of days before 
slaughter: Nonruminating cattle (calves)--7, all other cattle--4, 
sheep--8, and swine--6.
    (B) For No. 055529: Treatment should not exceed 4 consecutive days. 
Milk that has been taken during treatment and for 72 hours after the 
last treatment must not be used for food. Discontinue treatment for the 
following number of days before slaughter: Cattle--10, sheep--9, and 
swine--7.

    Dated: December 12, 2000.
Melanie R. Berson,
Acting Deputy Director, Office of New Animal Drug Evaluation, Center 
for Veterinatiy Medicine.
[FR Doc. 01-72 Filed 1-3-01; 8:45 am]
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