Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine, 51365 [E7-17696]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 173 / Friday, September 7, 2007 / Rules and Regulations
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
I
2. Add § 522.870 to read as follows:
§ 522.870
Etodolac.
(a) Specifications. Each milliliter
contains 100 milligrams (mg) etodolac.
(b) Sponsor. See No. 000856 in
§ 510.600 of this chapter.
(c) Conditions of use in dogs—(1)
Amount. Administer 4.5 to 6.8 mg/
pound (10 to 15 mg/kilogram) body
weight as a single, dorsoscapular
subcutaneous injection. If needed, the
daily dose of etodolac tablets as in
§ 520.870 of this chapter may be given
24 hours after the injection.
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: August 28, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–17645 Filed 9–6–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs;
Dexmedetomidine
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with RULES
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 Orion
Corp. The supplemental NADA
provides for veterinary prescription use
of dexmedetomidine hydrochloride
injectable solution as a sedative and
analgesic in cats.
DATES: This rule is effective September
7, 2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
VerDate Aug<31>2005
17:45 Sep 06, 2007
Jkt 211001
Orion
Corp., Orionintie 1, 02200 Espoo,
Finland, filed a supplement to NADA
141–267 for DEXDOMITOR
(dexmedetomidine hydrochloride). The
supplemental NADA provides for
veterinary prescription use of
dexmedetomidine hydrochloride
injectable solution as a sedative and
analgesic in cats. The supplemental
application is approved as of August 15,
2007, and the regulations in 21 CFR
522.558 are amended 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),
summaries of the safety and
effectiveness data and information
submitted to support approval of these
applications 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.
The agency has determined under 21
CFR 25.33(d)(1) 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.
Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(iii)),
this approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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.
SUPPLEMENTARY INFORMATION:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
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:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. In § 522.558, revise paragraph (c) to
read as follows:
I
§ 522.558
Dexmedetomidine.
*
*
PO 00000
*
Frm 00013
*
Fmt 4700
*
Sfmt 4700
51365
(c) Conditions of use—(1) Dogs—(i)
Indications for use and amount. (A) For
use as a sedative and analgesic to
facilitate clinical examinations, clinical
procedures, minor surgical procedures,
and minor dental procedures,
administer 375 micrograms (µg) per
square meter (/m2) of body surface area
by intravenous injection or 500 µg/m2 of
body surface area by intramuscular
injection.
(B) For use as a preanesthetic to
general anesthesia, administer 125
µg/m2 of body surface area or 375 µg/m2
of body surface area by intramuscular
injection.
(ii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
(2) Cats—(i) Amount. 40 µg/killogram
by intramuscular injection.
(ii) Indications for use. For use as a
sedative and analgesic to facilitate
clinical examinations, clinical
procedures, minor surgical procedures,
and minor dental procedures.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
Dated: August 28, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–17696 Filed 9–6–07; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 60
[EPA–HQ–OAR–2002–0071; FRL–8448–9]
RIN 2060–A009
Update of Continuous Instrumental
Test Methods: Technical Amendments
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
SUMMARY: EPA is taking direct final
action on ‘‘Update of Continuous
Instrumental Test Methods: Technical
Amendments’’ to correct errors in a
recent final rule that amended five
instrumental test methods and was
published on May 15, 2006. As
published, the amendments contained
inadvertent errors and provisions that
need to be clarified. We are correcting
errors and clarifying portions of the
amendments to reflect the intent of the
rule and to make them more
understandable by affected parties.
DATES: This rule is effective on
November 6, 2007 without further
E:\FR\FM\07SER1.SGM
07SER1
]]>Agencies
[Federal Register Volume 72, Number 173 (Friday, September 7, 2007)]
[Rules and Regulations]
[Page 51365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17696]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Dexmedetomidine
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 Orion Corp. The supplemental NADA provides
for veterinary prescription use of dexmedetomidine hydrochloride
injectable solution as a sedative and analgesic in cats.
DATES: This rule is effective September 7, 2007.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Orion Corp., Orionintie 1, 02200 Espoo,
Finland, filed a supplement to NADA 141-267 for DEXDOMITOR
(dexmedetomidine hydrochloride). The supplemental NADA provides for
veterinary prescription use of dexmedetomidine hydrochloride injectable
solution as a sedative and analgesic in cats. The supplemental
application is approved as of August 15, 2007, and the regulations in
21 CFR 522.558 are amended 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), summaries of the safety and
effectiveness data and information submitted to support approval of
these applications 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.
The agency has determined under 21 CFR 25.33(d)(1) 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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
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.
0
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
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.558, revise paragraph (c) to read as follows:
Sec. 522.558 Dexmedetomidine.
* * * * *
(c) Conditions of use--(1) Dogs--(i) Indications for use and
amount. (A) For use as a sedative and analgesic to facilitate clinical
examinations, clinical procedures, minor surgical procedures, and minor
dental procedures, administer 375 micrograms ([mu]g) per square meter
([sol]m\2\) of body surface area by intravenous injection or 500
[mu]g[sol]m\2\ of body surface area by intramuscular injection.
(B) For use as a preanesthetic to general anesthesia, administer
125 [mu]g[sol]m\2\ of body surface area or 375 [mu]g[sol]m\2\ of body
surface area by intramuscular injection.
(ii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Cats--(i) Amount. 40 [mu]g/killogram by intramuscular
injection.
(ii) Indications for use. For use as a sedative and analgesic to
facilitate clinical examinations, clinical procedures, minor surgical
procedures, and minor dental procedures.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: August 28, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-17696 Filed 9-6-07; 8:45 am]
BILLING CODE 4160-01-S
