Implantation or Injectable Dosage Form New Animal Drugs; Propofol, 38699-38700 [2010-16301]
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Federal Register / Vol. 75, No. 128 / Tuesday, July 6, 2010 / Rules and Regulations
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Final Regulatory Flexibility Analysis
Pursuant to requirements set forth in
the Regulatory Flexibility Act (RFA)(5
U.S.C. 601–612), the Agricultural
Marketing Service (AMS) has
considered the economic impact of this
action on small entities. Accordingly,
AMS has prepared this final regulatory
flexibility analysis.
The purpose of the RFA is to fit
regulatory actions to the scale of
business subject to such actions in order
that small businesses will not be unduly
or disproportionately burdened.
Marketing orders issued pursuant to the
Act, and rules issued thereunder, are
unique in that they are brought about
through group action of essentially
small entities acting on their own
behalf.
Based on Committee data, there are
nine producers (eight of whom are also
handlers) in the regulated area and nine
handlers (eight of whom are also
producers) subject to regulation under
the order. Small agricultural producers
are defined by the Small Business
Administration (13 CFR 121.201) as
those having annual receipts of less than
$750,000, and small agricultural service
firms are defined as those having annual
receipts of less than $7,000,000.
Also based on Committee data,
825,617 hundredweight of Colorado
Area No. 3 potatoes were produced for
the fresh market during the 2007 season.
Based on National Agricultural
Statistics Service (NASS) data, the
average producer price for Colorado
summer potatoes for 2007 was $7.75 per
hundredweight. The average annual
producer revenue for the nine Colorado
Area No. 3 potato producers is therefore
calculated to be approximately
$710,948. Using Committee data
regarding each individual handler’s
total shipments during the 2007–2008
fiscal period and a Committee estimated
average f.o.b. price for 2007 of $9.95 per
hundredweight ($7.75 per
hundredweight plus estimated packing
and handling costs of $2.20 per
hundredweight), all of the Colorado
Area No. 3 potato handlers ship under
$7,000,000 worth of potatoes. Thus, the
majority of handlers and producers of
Colorado Area No. 3 potatoes may be
classified as small entities.
This rule continues in effect the
action that provided for the handling of
all varieties of potatoes with a minimum
diameter of 3⁄4 inch, if they otherwise
meet the requirements of U.S. No. 1
grade. This change enables handlers to
respond to consumer demand for small
potatoes. Authority for regulating grade
and size is provided in § 948.22 of the
order. Section 948.387(a) of the order’s
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administrative rules and regulations
prescribes the actual size requirements.
This action is expected to have a
beneficial impact on handlers and
producers due to the increased volume
of potatoes. There should be no extra
cost to producers or handlers because
current harvesting and handling
methods can accommodate the sorting
of these smaller potatoes. The size
relaxation will result in a greater
quantity of potatoes meeting the
minimum requirements of the handling
regulation. This should translate into an
increased market for small potatoes and
greater returns for handlers and
producers.
By providing Colorado Area No. 3
handlers the flexibility to pack smaller
potatoes, the Committee believes the
industry will remain competitive in the
marketplace. The small potato market is
a premium market and this action is
expected to further increase sales of
Colorado potatoes to benefit the
Colorado potato industry. The benefits
of this rule are not expected to be
disproportionately greater or lesser for
small entities than for large entities.
This rule will not impose any
additional reporting or recordkeeping
requirements on either small or large
potato handlers. As with all Federal
marketing order programs, reports and
forms are periodically reviewed to
reduce information requirements and
duplication by industry and public
sector agencies. In addition, USDA has
not identified any relevant Federal rules
that duplicate, overlap or conflict with
this rule.
Further, the Committee’s meetings
were widely publicized throughout the
Colorado potato industry and all
interested persons were invited to
participate in Committee deliberations.
Like all Committee meetings, the June 4
and November 17, 2009, meetings were
public meetings and all entities, both
large and small, were able to express
views on this issue.
Comments on the interim rule were
required to be received on or before June
4, 2010. No comments were received.
Therefore, for reasons given in the
interim rule, we are adopting the
interim rule as a final rule, without
change.
To view the interim rule, go to:
https://www.regulations.gov/search/
Regs/home.html#documentDetail?R
=0900006480acfc3d.
This action also affirms information
contained in the interim rule concerning
Executive Orders 12866 and 12988, the
Paperwork Reduction Act (44 U.S.C.
Chapter 35), and the E-Gov Act (44
U.S.C. 101).
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38699
After consideration of all relevant
material presented, it is found that
finalizing the interim rule, without
change, as published in the Federal
Register (75 FR 17034, April 5, 2010)
will tend to effectuate the declared
policy of the Act.
List of Subjects in 7 CFR Part 948
Marketing agreements, Potatoes,
Reporting and recordkeeping
requirements.
PART 948—IRISH POTATOES GROWN
IN COLORADO—[AMENDED]
Accordingly, the interim rule that
amended 7 CFR part 948 and that was
published at 75 FR 17034 on April 5,
2010, is adopted as a final rule, without
change.
■
Dated: June 29, 2010.
Robert C. Keeney,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2010–16337 Filed 7–2–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2010–N–0002]
Implantation or Injectable Dosage
Form New Animal Drugs; Propofol
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 new animal drug
application (NADA) filed by Fort Dodge
Animal Health, Division of Wyeth. The
NADA provides for veterinary
prescription use of propofol as an
anesthetic in dogs and cats.
DATES: This rule is effective July 6,
2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337,
email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, a wholly owned subsidiary of
Pfizer, Inc., 235 East 42d St., New York,
NY 10017 filed NADA 141–303 that
provides for veterinary prescription use
of PROPOCLEAR (propofol) in dogs and
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Federal Register / Vol. 75, No. 128 / Tuesday, July 6, 2010 / Rules and Regulations
cats for induction and maintenance of
anesthesia and for induction of
anesthesia followed by maintenance
with an inhalant anesthetic. The
application is approved as of May 21,
2010, and the regulations are amended
in 21 CFR 522.2005 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.
The agency has determined under 21
CFR 25.33 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)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), 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.
(2) No. 000074 for use as in
paragraphs (c)(1), (c)(2)(i), and (c)(3) of
this section.
(3) No. 000856 for use as in
paragraphs (c)(1), (c)(2)(ii), and (c)(3) of
this section.
(c) Conditions of use in dogs and
cats—(1) Amount. Administer by
intravenous injection according to label
directions. The use of preanesthetic
medication reduces propofol dose
requirements.
(2) Indications for use—(i) As a single
injection to provide general anesthesia
for short procedures; for induction and
maintenance of general anesthesia using
incremental doses to effect; for
induction of general anesthesia where
maintenance is provided by inhalant
anesthetics.
(ii) For the induction and
maintenance of anesthesia and for
induction of anesthesia followed by
maintenance with an inhalant
anesthetic.
*
*
*
*
*
Dated: June 29, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–16301 Filed 7–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1, 53, 54, 301 and 602
List of Subjects in 21 CFR Part 522
[TD 9492]
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:
RIN 1545–BG18
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
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Authority: 21 U.S.C. 360b.
2. In § 522.2005, revise paragraphs (b)
and (c) to read as follows:
■
§ 522.2005
Propofol.
*
*
*
*
*
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter.
(1) No. 059130 for use as in
paragraphs (c)(1), (c)(2)(i), and (c)(3) of
this section.
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Excise Taxes on Prohibited Tax Shelter
Transactions and Related Disclosure
Requirements; Disclosure
Requirements With Respect to
Prohibited Tax Shelter Transactions;
Requirement of Return and Time for
Filing
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
SUMMARY: This document contains final
regulations that provide guidance under
section 4965 of the Internal Revenue
Code (Code), relating to entity-level and
manager-level excise taxes with respect
to prohibited tax shelter transactions to
which tax-exempt entities are parties;
sections 6033(a)(2) and 6011(g), relating
to certain disclosure obligations with
respect to such transactions; and
sections 6011 and 6071, relating to the
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requirement of a return and time for
filing with respect to section 4965 taxes.
This action is necessary to implement
section 516 of the Tax Increase
Prevention Reconciliation Act of 2005.
These final regulations affect a broad
array of tax-exempt entities, including
charities, state and local government
entities, Indian tribal governments and
employee benefit plans, as well as entity
managers of these entities.
DATES: Effective Date: These regulations
are effective July 6, 2010.
Applicability Date: For dates of
applicability, see §§ 1.6033–5(f),
53.4965–9(b) and (c), 53.6071–1(h),
54.6011–1(d), 301.6011(g)–1(j) and
301.6033–5(b).
FOR FURTHER INFORMATION CONTACT: For
questions concerning these regulations,
contact Benjamin Akins at (202) 622–
1124 or Michael Blumenfeld at (202)
622–6070. For questions specifically
relating to qualified pension plans,
individual retirement accounts, and
similar tax-favored savings
arrangements, contact Cathy Pastor at
(202) 622–6090 (not toll-free numbers).
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–
2079. The collection of information in
these final regulations is in
§ 301.6011(g)–1. The collection of
information in § 301.6011(g)–1 flows
from section 6011(g), which requires a
taxable party to a prohibited tax shelter
transaction to disclose to any taxexempt entity that is a party to the
transaction that the transaction is a
prohibited tax shelter transaction. The
likely recordkeepers are taxable entities
or individuals that participate in
prohibited tax shelter transactions. The
estimated number of recordkeepers is
between 1,250 and 6,500. The
information that is required to be
collected for purposes of § 301.6011(g)–
1 is a subset of information that is
required to be collected in order to
complete and file Form 8886,
‘‘Reportable Transaction Disclosure
Statement.’’ The estimated paperwork
burden for taxpayers filling out Form
8886 is approved under OMB number
1545–1800.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid control
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06JYR1
]]>Agencies
[Federal Register Volume 75, Number 128 (Tuesday, July 6, 2010)]
[Rules and Regulations]
[Pages 38699-38700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16301]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2010-N-0002]
Implantation or Injectable Dosage Form New Animal Drugs; Propofol
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 new animal drug application
(NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA
provides for veterinary prescription use of propofol as an anesthetic
in dogs and cats.
DATES: This rule is effective July 6, 2010.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, email:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York,
NY 10017 filed NADA 141-303 that provides for veterinary prescription
use of PROPOCLEAR (propofol) in dogs and
[[Page 38700]]
cats for induction and maintenance of anesthesia and for induction of
anesthesia followed by maintenance with an inhalant anesthetic. The
application is approved as of May 21, 2010, and the regulations are
amended in 21 CFR 522.2005 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.
The agency has determined under 21 CFR 25.33 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)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), 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. 522.2005, revise paragraphs (b) and (c) to read as follows:
Sec. 522.2005 Propofol.
* * * * *
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter.
(1) No. 059130 for use as in paragraphs (c)(1), (c)(2)(i), and
(c)(3) of this section.
(2) No. 000074 for use as in paragraphs (c)(1), (c)(2)(i), and
(c)(3) of this section.
(3) No. 000856 for use as in paragraphs (c)(1), (c)(2)(ii), and
(c)(3) of this section.
(c) Conditions of use in dogs and cats--(1) Amount. Administer by
intravenous injection according to label directions. The use of
preanesthetic medication reduces propofol dose requirements.
(2) Indications for use--(i) As a single injection to provide
general anesthesia for short procedures; for induction and maintenance
of general anesthesia using incremental doses to effect; for induction
of general anesthesia where maintenance is provided by inhalant
anesthetics.
(ii) For the induction and maintenance of anesthesia and for
induction of anesthesia followed by maintenance with an inhalant
anesthetic.
* * * * *
Dated: June 29, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-16301 Filed 7-2-10; 8:45 am]
BILLING CODE 4160-01-S
