Intramammary Dosage Forms; Change of Sponsor, 18990 [E9-9527]
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18990
Federal Register / Vol. 74, No. 79 / Monday, April 27, 2009 / Rules and Regulations
particular, Sections 3, 5, 5c(a) and 8a(5)
of the Act, the Commission hereby
amends Part 38 of Title 17 of the Code
of Federal Regulations as follows:
(v) A contract market shall disclose to the
Commission which members of its board are
public directors, and the basis for those
determinations.
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 526 is amended as follows:
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PART 38—DESIGNATED CONTRACT
MARKETS
Issued in Washington, DC, on April 21,
2009 by the Commission.
David A. Stawick,
Secretary to the Commission.
[FR Doc. E9–9508 Filed 4–24–09; 8:45 am]
PART 526—INTRAMAMMARY DOSAGE
FORMS
1. The authority citation for part 38
continues to read as follows:
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Authority: 7 U.S.C. 2, 5, 6, 6c, 7, 7a–2, and
12a, as amended by Appendix E of Public
Law 106–554, 114 Stat. 2763A–365.
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1. The authority citation for 21 CFR
part 526 continues to read as follows:
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Authority: 21 U.S.C. 360b.
§ 526.1696a
BILLING CODE P
[Amended]
2. In paragraph (c) of § 526.1696a,
remove ‘‘050604’’ and add in its place
‘‘061623’’.
■
2. The stay is lifted on paragraph (b)
of Core Principle 15 in Appendix B to
17 CFR Part 38.
■ 3. In Appendix B to Part 38 revise
paragraphs (b)(2)(ii) through (b)(2)(v) of
Core Principle 15 to read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 526
Dated: April 17, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–9527 Filed 4–24–09; 8:45 am]
Appendix B to Part 38—Guidance on,
and Acceptable Practices in,
Compliance With Core Principles
[Docket No. FDA–2009–N–0665]
BILLING CODE 4160–01–S
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Food and Drug Administration
Intramammary Dosage Forms; Change
of Sponsor
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
*
dwashington3 on PROD1PC60 with RULES
Core Principle 15 of section 5(d) of the Act:
CONFLICTS OF INTEREST
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(b) * * *
(2) * * *
(ii) In addition, a director shall be
considered to have a ‘‘material relationship’’
with the contract market if any of the
following circumstances exist:
(A) The director is an officer or employee
of the contract market or an officer or
employee of its affiliate. In this context,
‘‘affiliate’’ includes parents or subsidiaries of
the contract market or entities that share a
common parent with the contract market;
(B) The director is a member of the contract
market, or an officer or director of a member.
‘‘Member’’ is defined according to Section
1a(24) of the Commodity Exchange Act and
Commission Regulation 1.3(q);
(C) The director, or a firm with which the
director is an officer, director, or partner,
receives more than $100,000 in combined
annual payments from the contract market, or
any affiliate of the contract market (as
defined in Subsection (2)(ii)(A)), for legal,
accounting, or consulting services.
Compensation for services as a director of the
contract market or as a director of an affiliate
of the contract market does not count toward
the $100,000 payment limit, nor does
deferred compensation for services prior to
becoming a director, so long as such
compensation is in no way contingent,
conditioned, or revocable;
(D) Any of the relationships above apply to
a member of the director’s ‘‘immediate
family,’’ i.e., spouse, parents, children and
siblings.
(iii) All of the disqualifying circumstances
described in Subsection (2)(ii) shall be
subject to a one-year look back.
(iv) A contract market’s public directors
may also serve as directors of the contract
market’s affiliate (as defined in Subsection
(2)(ii)(A)) if they otherwise meet the
definition of public director in this Section
(2).
VerDate Nov<24>2008
14:31 Apr 24, 2009
Jkt 217001
Coast Guard
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for an approved new
animal drug application (NADA) from
Merial Ltd. to Cross Vetpharm Group
Ltd.
SUMMARY:
DATES:
This rule is effective April 27,
2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307,
e-mail: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640, has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
065–383 for Formula A–34 (procaine
penicillin G) mastitis infusion tube to
Cross Vetpharm Group Ltd., Broomhill
Rd., Tallaght, Dublin 24, Ireland.
Accordingly, the agency is amending
the regulations in 21 CFR 526.1696a to
reflect the transfer of ownership.
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.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
■
PO 00000
Frm 00014
Fmt 4700
DEPARTMENT OF HOMELAND
SECURITY
Sfmt 4700
33 CFR Part 165
[Docket No. USCG–2009–0119]
RIN 1625–AA00
Safety Zone; Red Bull Air Races; San
Diego Bay, San Diego, CA
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing a temporary safety zone on
the navigable waters of the San Diego
Bay in support of the Red Bull Air
Races. The safety zone is necessary to
provide for the safety of the crew,
spectators, participants and other
vessels and users of the waterway.
Persons and vessels will be prohibited
from entering into, transiting through, or
anchoring within this safety zone unless
authorized to do so by the Captain of the
Port or his designated representative.
DATES: This rule is effective from 10
a.m. on May 7, 2009 through 6 p.m. on
May 10, 2009.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2009–
0119 and are available Online by going
to https://www.regulations.gov, selecting
the Advanced Docket Search option on
the right side of the screen, inserting
USCG–2009–0119 in the Docket ID box,
pressing Enter, and then clicking on the
item in the Docket ID column. They are
also available for inspection or copying
at two locations: the Docket
Management Facility (M–30), U.S.
Department of Transportation, West
E:\FR\FM\27APR1.SGM
27APR1
]]>Agencies
[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Rules and Regulations]
[Page 18990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9527]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 526
[Docket No. FDA-2009-N-0665]
Intramammary Dosage Forms; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for an approved new
animal drug application (NADA) from Merial Ltd. to Cross Vetpharm Group
Ltd.
DATES: This rule is effective April 27, 2009.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, has informed FDA that it has transferred
ownership of, and all rights and interest in, NADA 065-383 for Formula
A-34 (procaine penicillin G) mastitis infusion tube to Cross Vetpharm
Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland.
Accordingly, the agency is amending the regulations in 21 CFR
526.1696a to reflect the transfer of ownership.
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
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 FORMS
0
1. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 526.1696a [Amended]
0
2. In paragraph (c) of Sec. 526.1696a, remove ``050604'' and add in
its place ``061623''.
Dated: April 17, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-9527 Filed 4-24-09; 8:45 am]
BILLING CODE 4160-01-S
