Implantation or Injectable Dosage Form New Animal Drugs; Furosemide, 39547-39548 [E6-10974]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 134 / Thursday, July 13, 2006 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Mepivacaine
AGENCY:
Food and Drug Administration,
HHS.
Final rule, technical
amendment.
ACTION:
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 522
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 & Upjohn Co. The
supplemental NADA provides for
revised food safety labeling for
mepivacaine injectable solution used in
horses for local anesthesia.
DATES: This rule is effective July 13,
2006.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7543, email: melanie.berson@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 100 703 for
CARBOCAINE-V (mepivacaine
hydrochloride) Sterile Aqueous
Solution. The supplemental NADA
provides for revised food safety labeling
for mepivacaine injectable solution used
in horses for local anesthesia. The
application is approved as of June 2,
2006, and the regulations are amended
in § 522.1372 (21 CFR 522.1372) to
reflect the approval.
In addition, FDA has found that the
April 1, 2005, edition of parts 500 to 599
of title 21 of the Code of Federal
Regulations (CFR) does not accurately
reflect the approved conditions of use
for mepivacaine solution used in horses.
These conditions of use were
inadvertently deleted as a publication
error. At this time, the regulations are
being amended in § 522.1372 to correct
this error and to format portions of this
section to reflect a current format. This
action is being taken to improve the
accuracy of the regulations.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under
§ 25.33(d)(1) that this action is of a type
that does not individually or
wwhite on PROD1PC61 with RULES
SUMMARY:
VerDate Aug<31>2005
17:17 Jul 12, 2006
Jkt 208001
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. Revise § 522.1372 to read as
follows:
I
§ 522.1372
Mepivacaine.
(a) Specifications. Each milliliter (mL)
of solution contains 20 milligrams
mepivacaine hydrochloride.
(b) Sponsor. See No. 000009 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. For nerve block, 3 to 5 mL; for
epidural anesthesia, 5 to 20 mL; for
intra-articular anesthesia, 10 to 15 mL;
for infiltration, as required; for
anesthesia of the laryngeal mucosa prior
to ventriculectomy, by topical spray, 25
to 40 mL, by infiltration, 20 to 50 mL.
(2) Indications for use. For use as a
local anesthetic for infiltration, nerve
block, intra-articular and epidural
anesthesia, and topical and/or
infiltration anesthesia of the laryngeal
mucosa prior to ventriculectomy.
(3) Limitations. Not for use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
Dated: June 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–10970 Filed 7–12–06; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
39547
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Furosemide
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
Intervet Inc. The supplemental NADA
provides for the revision of a food safety
warning on labeling of furosemide
injectable solution for use in horses.
DATES: This rule is effective July 13,
2006.
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.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed a supplement
to NADA 34–478 for SALIX
(furosemide) Injection 5%. The
supplemental NADA provides for the
revision of a food safety warning on
labeling of furosemide injectable
solution for use in horses. The
supplemental application is approved as
of June 20, 2006, and the regulations are
amended in 21 CFR 522.1010 to reflect
the approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(a)(1) that these actions are of
a type that do 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 522
Animal drugs.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
E:\FR\FM\13JYR1.SGM
13JYR1
39548
Federal Register / Vol. 71, No. 134 / Thursday, July 13, 2006 / Rules and Regulations
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:
I
Authority: 21 U.S.C. 360b.
2. In § 522.1010, revise paragraph
(b)(3); and add paragraphs (b)(4) and
(d)(2)(iii) to read as follows:
I
§ 522.1010
Furosemide.
*
*
*
*
*
(b) * * *
(3) No. 059130 as described in
paragraph (a)(2) for use as in paragraphs
(d)(1), (d)(2)(i), and (d)(3) of this section.
(4) No. 057926 as described in
paragraph (a)(2) for use as in paragraphs
(d)(1), (d)(2)(iii), and (d)(3) of this
section.
*
*
*
*
*
(d) * * *
(2) * * *
(iii) Amount. 250 to 500 mg/animal
once or twice daily, intramuscularly or
intravenously.
(A) Indications for use. For the
treatment of edema (pulmonary
congestion, ascites) associated with
cardiac insufficiency, and acute
noninflammatory tissue edema.
(B) Limitations. Do not use in horses
intended for human consumption.
*
*
*
*
*
Dated: June 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–10974 Filed 7–12–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9270]
RIN 1545–AW72
Reporting of Gross Proceeds
Payments to Attorneys
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
wwhite on PROD1PC61 with RULES
AGENCY:
SUMMARY: This document contains final
regulations relating to the reporting of
payments of gross proceeds to attorneys.
The regulations reflect changes to the
law made by the Taxpayer Relief Act of
VerDate Aug<31>2005
17:17 Jul 12, 2006
Jkt 208001
1997 (1997 Act). The final regulations
will affect attorneys who receive
payments of gross proceeds on behalf of
their clients and will affect certain
payors (for example, defendants in
lawsuits and their insurance companies
and agents) that, in the course of their
trades or businesses, make payments to
these attorneys.
DATES: Effective Dates: These
regulations are effective July 13, 2006.
Applicability Dates: For dates of
applicability, see § 1.6045–5(h).
FOR FURTHER INFORMATION CONTACT:
Nancy Rose, (202) 622–4940 (not a tollfree number).
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act
The collection of information
contained in these final regulations has
been reviewed and approved by the
Office of Management and Budget in
accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)) under control number 1545–
1644.
Comments on the collection of
information should be sent to the Office
of Management and Budget, Attn: Desk
Officer for the Department of the
Treasury, Office of Information and
Regulatory Affairs, Washington, DC
20503, with copies to the Internal
Revenue Service, Attn: IRS Reports
Clearance Officer,
SE:W:CAR:MP:T:T:SP, Washington, DC
20224. Comments on the collection of
information should be received by
September 11, 2006. Comments are
specifically requested concerning:
Whether the collection of information
is necessary for the proper performance
of the functions of the Internal Revenue
Service, including whether the
information will have practical utility;
The accuracy of the estimated burden
associated with the collection of
information;
How the quality, utility, and clarity of
the information to be collected may be
enhanced;
How the burden of complying with
the collection of information may be
minimized, including through the
application of automated collection
techniques or other forms of information
technology; and
Estimates of capital or start-up costs
and costs of operation, maintenance,
and purchase of services to provide
information.
The collections of information in the
final regulations are in §§ 1.6041–3(p)
and 1.6045–5(a). Section 1021(a) of the
1997 Act added section 6045(f) to the
Internal Revenue Code (Code) and
requires the IRS to implement
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
information reporting of certain
payments made to attorneys. Section
1021(b) of the 1997 Act provides that
the exception to information reporting
in the regulations under section 6041 for
payments to corporations does not
apply to payments to attorneys and
requires the IRS to implement
information reporting for payments to
attorneys. This information will be used
to verify compliance with sections
6045(f) and 6041 and to determine that
the amount of these payments has been
reported correctly. The collections of
information are mandatory. The likely
respondents (payors) are businesses and
other for profit institutions.
Payors provide the information by
completing Form 1099-MISC,
‘‘Miscellaneous Income,’’ for each
attorney who has received one or more
payments aggregating $600 of more from
the payor during the calendar year. The
burden for this requirement is reflected
in the burden estimate for Form 1099MISC. The estimated burden of
information collection for the 2005
Form 1099-MISC is 16 minutes per
return.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless the collection of information
displays a valid control number
assigned by the Office of Management
and Budget.
Books or records relating to a
collection of information must be
retained as long as their contents may
become material in the administration
of any internal revenue law. Generally,
tax returns and return information are
confidential, as required by 26 U.S.C.
6103.
Background
This document contains amendments
to the 26 CFR part 1 under sections 6041
and 6045 of the (Code). These
amendments to the Income Tax
Regulations revise existing §§ 1.6041–1
and 1.6041–3 and add new § 1.6045–5.
This document finalizes proposed
regulations relating to information
reporting under section 6045(f) of the
Code for gross proceeds paid to
attorneys. The proposed regulations
were contained in a notice of proposed
rulemaking (REG–126024–01) published
in the Federal Register on May 17, 2002
(67 FR 35064).
Section 6045(f) was added to the Code
by the 1997 Act (Pub. L. 105–34, section
1021 (111 Stat. 788)). Section 6045(f)
generally requires information reporting
for payments of gross proceeds made in
the course of a trade or business to
attorneys in connection with legal
services (whether or not the services are
E:\FR\FM\13JYR1.SGM
13JYR1
]]>Agencies
[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Rules and Regulations]
[Pages 39547-39548]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10974]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Furosemide
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 Intervet Inc. The supplemental NADA
provides for the revision of a food safety warning on labeling of
furosemide injectable solution for use in horses.
DATES: This rule is effective July 13, 2006.
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: Intervet Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed a supplement to NADA 34-478 for SALIX
(furosemide) Injection 5%. The supplemental NADA provides for the
revision of a food safety warning on labeling of furosemide injectable
solution for use in horses. The supplemental application is approved as
of June 20, 2006, and the regulations are amended in 21 CFR 522.1010 to
reflect the approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under 21 CFR 25.33(a)(1) that these
actions are of a type that do 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 522
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner
[[Page 39548]]
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. 522.1010, revise paragraph (b)(3); and add paragraphs
(b)(4) and (d)(2)(iii) to read as follows:
Sec. 522.1010 Furosemide.
* * * * *
(b) * * *
(3) No. 059130 as described in paragraph (a)(2) for use as in
paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.
(4) No. 057926 as described in paragraph (a)(2) for use as in
paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section.
* * * * *
(d) * * *
(2) * * *
(iii) Amount. 250 to 500 mg/animal once or twice daily,
intramuscularly or intravenously.
(A) Indications for use. For the treatment of edema (pulmonary
congestion, ascites) associated with cardiac insufficiency, and acute
noninflammatory tissue edema.
(B) Limitations. Do not use in horses intended for human
consumption.
* * * * *
Dated: June 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-10974 Filed 7-12-06; 8:45 am]
BILLING CODE 4160-01-S
