[Federal Register: January 4, 2008 (Volume 73, Number 3)]
[Rules and Regulations]
[Page 811]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja08-1]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
[[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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-S