New Animal Drugs; Change of Sponsor's Name, 72920-72921 [E7-24974]
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Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations
about reporting in this survey, either by
sending them a report form or by
written inquiry, must respond pursuant
to § 806.4. This may be accomplished
by:
(1) Filing the properly completed BE–
12 report—Form BE–12(LF), Form BE–
12(SF), Form BE–12 Mini, or Form BE–
12 Bank, by May 31, 2008, as required;
(2) Completing and returning the
Form BE–12 Claim for Not Filing by
May 31, 2008; or
(3) Certifying in writing, by May 31,
2008, to the fact that the person is not
a U.S. affiliate of a foreign person and
not subject to the reporting
requirements of the BE–12 survey.
(b) Who must report. A BE–12 report
is required for each U.S. affiliate, that is,
for each U.S. business enterprise in
which a foreign person (foreign parent)
owned or controlled, directly or
indirectly, 10 percent or more of the
voting securities in an incorporated U.S.
business enterprise, or an equivalent
interest in an unincorporated U.S.
business enterprise, at the end of the
business enterprise’s fiscal year that
ended in calendar year 2007. A BE–12
report is required even if the foreign
person’s ownership interest in the U.S.
business enterprise was established or
acquired during the 2007 reporting year.
Beneficial, not record, ownership is the
basis of the reporting criteria.
(c) Forms to be filed. (1)—Form BE–
12(LF) (Long Form) must be completed
by a U.S. affiliate that was majorityowned by one or more foreign parents
(for purposes of this survey, a ‘‘majorityowned’’ U.S. affiliate is one in which
the combined direct and indirect
ownership interest of all foreign parents
of the U.S. affiliate exceeds 50 percent),
if:
(i) It is not a bank and is not owned
directly or indirectly by a U.S. bank
holding company or financial holding
company, and
(ii) On a fully consolidated basis, or,
in the case of real estate investment, on
an aggregated basis, any one of the
following three items for the U.S.
affiliate (not just the foreign parent’s
share), was greater than $175 million
(positive or negative) at the end of, or
for, its fiscal year that ended in calendar
year 2007:
(A) Total assets (do not net out
liabilities);
(B) Sales or gross operating revenues,
excluding sales taxes; or
(C) Net income after provision for U.S.
income taxes.
(2) Form BE–12(SF) (Short Form)
must be completed by a U.S. affiliate if:
(i) It is not a bank and is not owned
directly or indirectly by a U.S. bank
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18:48 Dec 21, 2007
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holding company or financial holding
company, and
(ii) On a fully consolidated basis, or,
in the case of real estate investment, on
an aggregated basis, any one of the three
items listed in paragraph (c)(1)(ii) of this
section for a majority-owned U.S.
affiliate (not just the foreign parent’s
share), was greater than $40 million
(positive or negative) but none of these
items was greater than $175 million
(positive or negative) at the end of, or
for, its fiscal year that ended in calendar
year 2007.
(iii) On a fully consolidated basis, or,
in the case of real estate investment, on
an aggregated basis, any one of the three
items listed in paragraph (c)(1)(ii) of this
section for a minority-owned U.S.
affiliate (not just the foreign parent’s
share), was greater than $40 million
(positive or negative) at the end of, or
for, its fiscal year that ended in calendar
year 2007. (A ‘‘minority-owned’’ U.S.
affiliate is one in which the combined
direct and indirect ownership interest of
all foreign parents of the U.S. affiliate is
50 percent or less.)
(3) Form BE–12 Mini must be
completed by a U.S. affiliate if:
(i) It is not a bank, and is not owned
directly or indirectly by a U.S. bank
holding company or financial holding
company, and
(ii) On a fully consolidated basis, or,
in the case of real estate investment, on
an aggregated basis, none of the three
items listed in paragraph (c)(1)(ii) of this
section for a U.S. affiliate (not just the
foreign parent’s share), was greater than
$40 million (positive or negative) at the
end of, or for, its fiscal year that ended
in calendar year 2007.
(4) Form BE–12 Bank must be
completed by a U.S. affiliate if:
(i) The U.S. affiliate is a bank. For
purposes of the BE–12 survey, a ‘‘bank’’
is a business entity engaged in deposit
banking or closely related functions,
including commercial banks, Edge Act
corporations engaged in international or
foreign banking, U.S. branches and
agencies of foreign banks whether or not
they accept domestic deposits, savings
and loans, savings banks, bank holding
companies and financial holding
companies under the Gramm-LeachBliley Act, including all subsidiaries or
units of a bank holding company or
financial holding company, and
(ii) On a fully consolidated basis any
one of the three items listed in
paragraph (c)(1)(ii) of this section for a
U.S. affiliate (not just the foreign
parent’s share), was greater than $15
million (positive or negative) at the end
of, or for, its fiscal year that ended in
calendar year 2007.
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(5) Form BE–12 Claim for Not Filing
will be provided for response by
persons that are not subject to the
reporting requirements of the BE–12
survey but have been contacted by BEA
concerning their reporting status.
(d) Aggregation of real estate
investments. All real estate investments
of a foreign person must be aggregated
for the purpose of applying the
reporting criteria. A single report form
must be filed to report the aggregate
holdings, unless written permission has
been received from BEA to do
otherwise. Those holdings not
aggregated must be reported separately
on the same type of report that would
have been required if the real estate
holdings were aggregated.
(e) Due date. A fully completed and
certified Form BE–12(LF), BE–12(SF),
BE–12 Mini, BE–12 Bank, or Form BE–
12 Claim for Not Filing is due to be filed
with BEA not later than May 31, 2008.
§ 806.18 OMB control numbers assigned
to the Paperwork Reduction Act.
(a) Purpose. This section complies
with the requirements of section 3507 (f)
of the Paperwork Reduction Act (PRA)
which requires agencies to display a
current control number assigned by the
Director of OMB for each agency
information collection requirement.
(b) Display.
15 CFR section where identified and described
Current
OMB control
No.
806.1 through 806.17 ...............
0608–0020
0024
0032
0004
0035
0030
0009
0023
0034
0042
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[FR Doc. E7–24972 Filed 12–21–07; 8:45 am]
BILLING CODE 3510–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Name
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
E:\FR\FM\26DER1.SGM
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Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Rules and Regulations
animal drug regulations to reflect a
change of sponsor’s name from Altana,
Inc., to Nycomed US, Inc.
DATES: This rule is effective December
26, 2007.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Altana,
Inc., 60 Baylis Rd., Melville, NY 11747,
has informed FDA that it has changed
its name to Nycomed US, Inc.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to
reflect these changes.
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 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
I 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 510 is amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600 in the table in
paragraph (c)(1), remove the entry for
‘‘Altana, Inc.’’ and alphabetically add a
new entry for ‘‘Nycomed US, Inc.’’; and
in the table in paragraph (c)(2), revise
the entry for ‘‘025463’’ to read as
follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
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*
025463
*
Firm name and address
*
*
*
*
Nycomed US, Inc., 60
Baylis Rd., Melville, NY
11747
*
*
*
*
Dated: December 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–24974 Filed 12–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1312
[Docket No. DEA–276F]
RIN 1117–AB00
Reexportation of Controlled
Substances
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
SUMMARY: The Controlled Substances
Export Reform Act of 2005 amended the
Controlled Substances Import and
Export Act to provide authority for the
Drug Enforcement Administration
(DEA) to authorize the export of
controlled substances from the United
States to another country for subsequent
export from that country to a second
country, if certain conditions and
safeguards are satisfied. DEA is
amending its regulations to implement
the new legislation.
DATES: Effective Date: This rule is
effective January 25, 2008.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Telephone (202) 307–7297.
SUPPLEMENTARY INFORMATION:
Background
Firm name and address
*
*
*
Nycomed US, Inc., 60
Baylis Rd., Melville, NY
11747.
*
*
*
Drug labeler
code
*
025463
*
*
The Controlled Substances Export
Reform Act of 2005 (Pub. L. 109–57)
was enacted on August 2, 2005. The Act
amends the Controlled Substances
Import and Export Act (CSIEA) to
provide authority for the Attorney
General (and DEA, by delegation) 1 to
authorize the export of controlled
*
(2) * * *
VerDate Aug<31>2005
Drug labeler
code
1 28
18:48 Dec 21, 2007
Jkt 214001
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CFR 0.100(b).
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72921
substances in schedules I and II, and
narcotic controlled substances in
schedules III and IV, from the United
States to another country for subsequent
export from that country to a second
country, if certain conditions and
safeguards are satisfied.
Previously under the CSIEA (prior to
the 2005 legislation), there were no
circumstances in which it was
permissible to export a controlled
substance in schedules I and II, or a
narcotic controlled substance in
schedules III and IV, for the purpose of
reexport to another country. Such
controlled substances could lawfully be
exported only to the immediate country
where they would be consumed.
The Controlled Substances Export
Reform Act requires the following:
Notwithstanding [21 U.S.C. 953]
subsections (a)(4) and (c)(3), the Attorney
General may authorize any controlled
substance that is in schedule I or II, or is a
narcotic drug in schedule III or IV, to be
exported from the United States to a country
for subsequent export from that country to
another country, if each of the following
conditions is met:
(1) Both the country to which the
controlled substance is exported from the
United States (referred to in this subsection
as the ‘first country’) and the country to
which the controlled substance is exported
from the first country (referred to in this
subsection as the ‘second country’) are
parties to the Single Convention on Narcotic
Drugs, 1961, and the Convention on
Psychotropic Substances, 1971.
(2) The first country and the second
country have each instituted and maintain, in
conformity with such Conventions, a system
of controls of imports of controlled
substances which the Attorney General
deems adequate.
(3) With respect to the first country, the
controlled substance is consigned to a holder
of such permits or licenses as may be
required under the laws of such country, and
a permit or license to import the controlled
substance has been issued by the country.
(4) With respect to the second country,
substantial evidence is furnished to the
Attorney General by the person who will
export the controlled substance from the
United States that—
(A) The controlled substance is to be
consigned to a holder of such permits or
licenses as may be required under the laws
of such country, and a permit or license to
import the controlled substance is to be
issued by the country; and
(B) The controlled substance is to be
applied exclusively to medical, scientific, or
other legitimate uses within the country.
(5) The controlled substance will not be
exported from the second country.
(6) Within 30 days after the controlled
substance is exported from the first country
to the second country, the person who
exported the controlled substance from the
United States delivers to the Attorney
General documentation certifying that such
export from the first country has occurred.
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]]>Agencies
[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Rules and Regulations]
[Pages 72920-72921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24974]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Name
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
[[Page 72921]]
animal drug regulations to reflect a change of sponsor's name from
Altana, Inc., to Nycomed US, Inc.
DATES: This rule is effective December 26, 2007.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Altana, Inc., 60 Baylis Rd., Melville, NY
11747, has informed FDA that it has changed its name to Nycomed US,
Inc. Accordingly, the agency is amending the regulations in 21 CFR
510.600(c) to reflect these changes.
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 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600 in the table in paragraph (c)(1), remove the entry
for ``Altana, Inc.'' and alphabetically add a new entry for ``Nycomed
US, Inc.''; and in the table in paragraph (c)(2), revise the entry for
``025463'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Nycomed US, Inc., 60 Baylis Rd., Melville, 025463
NY 11747.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
025463 Nycomed US, Inc., 60 Baylis Rd., Melville,
NY 11747
* * * * *
------------------------------------------------------------------------
Dated: December 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24974 Filed 12-21-07; 8:45 am]
BILLING CODE 4160-01-S
