Intramammary Dosage Form New Animal Drugs; Pirlimycin, 811 [E7-25606]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 3 (Friday, January 4, 2008)]
[Rules and Regulations]
[Page 811]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25606]



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Federal Register / Vol. 73, No. 3 / Friday, January 4, 2008 / Rules 
and Regulations

[[Page 811]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526


Intramammary Dosage Form New Animal Drugs; Pirlimycin

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 and Upjohn Co., a Division of 
Pfizer, Inc. The supplemental NADA extends the dosage regimen for 
pirlimycin hydrochloride intramammary infusion in lactating dairy 
cattle to daily treatment for up to 8 days.

DATES: This rule is effective January 4, 2008.

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: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement 
to NADA 141-036 that provides for veterinary prescription use of PIRSUE 
(pirlimycin hydrochloride) Sterile Solution in lactating dairy cattle 
for the treatment of mastitis. The supplement extends the dosage 
regimen to daily treatment for up to 8 days. The supplemental NADA is 
approved as of December 12, 2007, and the regulations are amended in 21 
CFR 526.1810 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    FDA has determined under 21 CFR 25.33(d)(5) 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.

List of Subjects in 21 CFR Part 526

    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 526 is 
amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 526 continues to read as 
follows:

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

0
2. In Sec.  526.1810, revise the section heading and paragraphs (a), 
(b), and (d) to read as follows:


Sec.  526.1810  Pirlimycin.

    (a) Specifications. Each 10-milliliter syringe contains 50 
milligrams (mg) pirlimycin (as pirlimycin hydrochloride).
    (b) Sponsor. See No. 000009 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in cattle--(1) Amount. Infuse 50 mg into each 
infected quarter. Repeat treatment after 24 hours. Daily treatment may 
be repeated at 24-hour intervals for up to 8 consecutive days.
    (2) Indications for use. For the treatment of clinical and 
subclinical mastitis in lactating dairy cattle associated with 
Staphylococcus species such as Staphylococcus aureus and Streptococcus 
species such as Streptococcus agalactiae, Streptococcus dysgalactiae, 
and Streptococcus uberis.
    (3) Limitations. Milk taken from animals during treatment and for 
36 hours following the last treatment must not be used for food 
regardless of treatment duration. Following infusion twice at a 24-hour 
interval, treated animals must not be slaughtered for 9 days. Following 
any extended duration of therapy (infusion longer than twice at a 24-
hour interval, up to 8 consecutive days), animals must not be 
slaughtered for 21 days. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

    Dated: December 20, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-25606 Filed 1-3-07; 8:45 am]
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