New Animal Drugs; Change of Sponsor's Name and Address, 20522-20523 [2010-9045]
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20522
Federal Register / Vol. 75, No. 75 / Tuesday, April 20, 2010 / Rules and Regulations
CFR parts 730–774) are amended as
follows:
Items Controlled section, to read as
follows:
PART 772—[AMENDED]
1C111 Propellants and Constituent
Chemicals for Propellants, Other Than
Those Specified in 1C011, as Follows
(see List of Items Controlled)
1. The authority citation for 15 CFR
part 772 continues to read as follows:
■
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025,
3 CFR, 2001 Comp., p. 783; Notice of August
13, 2009, 74 FR 41325 (August 14, 2009).
2. Section 772.1 is amended by
revising the definition of ‘‘production
facilities’’, as set forth below:
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Production Facilities. (MTCR Context
only). (Cat 7 and 9)—Means ‘‘production
equipment’’ and specially designed
‘‘software’’ therefor integrated into
installations for ‘‘development’’ or for
one or more phases of ‘‘production’’.
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PART 774—[AMENDED]
3. The authority citation for 15 CFR
part 774 continues to read as follows:
■
4. In Supplement No. 1 to part 774,
under Category 1, Export Control
Classification Number (ECCN) 1C011 is
amended by revising the first two
entries in the table under the ‘‘Reason
for Control’’ heading in the License
Requirements section, to read as
follows:
■
Supplement No. 1 to Part 774—The
Commerce Control List
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1C011 Metals and Compounds, as Follows
(see List of Items Controlled)
License Requirements
Reason for Control: * * *
erowe on DSK5CLS3C1PROD with RULES
Control(s)
NS applies to entire entry ..
MT applies to 1C011.a and
.b (for boron).
Country chart
NS Column 1
MT Column 1
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5. In Supplement No. 1 to part 774,
under Category 1, ECCN 1C111 is
amended by revising paragraph a.2 of
the ‘‘items’’ paragraph in the List of
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VerDate Nov<24>2008
13:39 Apr 19, 2010
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7. In Supplement No. 1 to part 774,
under Category 9, ECCN 9A101 is
amended by revising the heading, to
read as follows:
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a.2. Metal fuels, other than that controlled
by the U.S. Munitions List, in particle sizes
of less than 60 × 10¥6 m (60 micrometers),
whether spherical, atomized, spheroidal,
flaked or ground, as follows:
a.2.a. Consisting of 97% by weight or more
of any of the following:
a.2.a.1. Zirconium;
a.2.a.2. Beryllium;
a.2.a.3. Magnesium; or
a.2.a.4. Alloys of the metals specified by
a.2.a.1 to a.2.a.3 above.
Technical Note: The natural content of
hafnium in the zirconium (typically 2% to
7%) is counted with the zirconium.
a.2.b. Boron alloys with a purity of 85% by
weight or more.
*
Authority: 50 U.S.C. app. 2401 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u);
42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C.
1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001
Comp., p. 783; Notice of August 13, 2009, 74
FR 41325 (August 14, 2009).
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Items:
§ 772.1 Definitions of terms as used in the
Export Administration Regulations (EAR).
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List of Items Controlled
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c.2.a. Cylinders having a diameter of 120
mm or greater and a length of 50 mm or
greater;
c.2.b. Tubes having an inner diameter of 65
mm or greater and a wall thickness of 25 mm
or greater and a length of 50 mm or greater;
or
c.2.c. Blocks having a size of 120 mm × 120
mm × 50 mm or greater.
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9A101 Turbojet and Turbofan
Engines, Other Than Those Controlled
by 9A001, as Follows (See List of Items
Controlled)
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Dated: April 9, 2010.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2010–8919 Filed 4–19–10; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
6. In Supplement No. 1 to part 774,
under Category 1, ECCN 1C117 is
amended:
■ a. By revising the heading; and
■ b. By revising the ‘‘items’’ paragraph in
the List of Items Controlled section, to
read as follows:
Food and Drug Administration
1C117 Materials for the Fabrication of
Missile Components for Rockets or
Missiles Capable of Achieving a
‘‘Range’’ Equal to or Greater Than 300
km, as Follows (See List of Items
Controlled)
HHS.
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List of Items Controlled
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Items:
a. Tungsten and alloys in particulate form
with a tungsten content of 97% by weight or
more and a particle size of 50 × 10¥6 m (50
μm) or less;
b. Molybdenum and alloys in particulate
form with a molybdenum content of 97% by
weight or more and a particle size of 50 ×
10¥6 m (50 μm) or less;
c. Tungsten materials in the solid form
having all of the following:
c.1. Any of the following material
compositions:
c.1.a. Tungsten and alloys containing 97%
by weight or more of tungsten;
c.1.b. Copper infiltrated tungsten
containing 80% by weight or more of
tungsten; or
c.1.c. Silver infiltrated tungsten containing
80% by weight or more of tungsten; and
c.2. Able to be machined to any of the
following products:
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21 CFR Part 510
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of
Sponsor’s Name and Address
AGENCY:
ACTION:
Food and Drug Administration,
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Minrad,
Inc. to Piramal Critical Care, Inc. The
sponsor’s mailing address will also be
changed.
DATES: This rule is effective April 20,
2010.
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, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Minrad,
Inc., 836 Main St., 2d floor, Buffalo, NY
14202 has informed FDA that it has
changed its name and address to
Piramal Critical Care, Inc., 3950
Schelden Circle, Bethlehem, PA 18017.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to
reflect this change.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
E:\FR\FM\20APR1.SGM
20APR1
20523
Federal Register / Vol. 75, No. 75 / Tuesday, April 20, 2010 / Rules and Regulations
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects in 21 CFR Part 510
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of
Sponsor’s Name and Address
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:
■
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
‘‘Minrad, Inc.’’ and alphabetically add a
new entry for ‘‘Piramal Critical Care,
Inc.’’; and in the table in paragraph
(c)(2), revise the entry for ‘‘060307’’ to
read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
Drug labeler
code
*
*
*
*
Piramal Critical Care, Inc.,
3950 Schelden Circle,
Bethlehem, PA 18017
*
*
*
*
060307
*
*
(2) * * *
Drug labeler
code
*
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*
Firm name and address
*
*
*
Piramal Critical Care, Inc.,
3950 Schelden Circle,
Bethlehem, PA 18017
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Dated: April 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–9045 Filed 4–19–10; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Parnell
Laboratories (Aust) Pty. Ltd. to Parnell
Technologies Pty. Ltd. In addition, the
sponsor’s mailing address will be
changed.
DATES:
13:39 Apr 19, 2010
Jkt 220001
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
Final rule.
This rule is effective April 20,
2010.
Drug labeler
code
*
*
*
*
Parnell Technologies Pty.
Ltd., unit 4, 476 Gardeners Rd., Alexandria,
New South Wales 2015,
Australia
*
*
*
*
068504
*
*
(2) * * *
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, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Parnell
Laboratories (Aust) Pty. Ltd., Century
Estate, unit 6, 476 Gardeners Rd.,
Alexandria, New South Wales 2015,
Australia, has informed FDA that it has
changed its name and address to Parnell
Technologies Pty. Ltd., unit 4, 476
Gardeners Rd., Alexandria, New South
Wales 2015, Australia. Accordingly, the
agency is amending the regulations in
21 CFR 510.600(c) to reflect this change.
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
*
060307
Food and Drug Administration
2. In § 510.600, in the table in
paragraph (c)(1), revise the entry for
‘‘Parnell Laboratories (Aust) Pty. Ltd.’’;
and in the table in paragraph (c)(2),
revise the entry for ‘‘068504’’ to read as
follows:
■
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
■ 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:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
Drug labeler
code
*
Firm name and address
*
068504
*
*
*
*
Parnell Technologies Pty.
Ltd., unit 4, 476 Gardeners Rd., Alexandria,
New South Wales 2015,
Australia
*
*
*
*
Dated: April 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–9057 Filed 4–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2009–0370]
RIN 1625–AA11
Regulated Navigation Areas; Port of
Portland Terminal 4, Willamette River,
Portland, OR
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing two Regulated Navigation
Areas (RNA) at the Port of Portland
Terminal 4 on the Willamette River in
E:\FR\FM\20APR1.SGM
20APR1
]]>Agencies
[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Rules and Regulations]
[Pages 20522-20523]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9045]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor's Name and Address
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's name from Minrad,
Inc. to Piramal Critical Care, Inc. The sponsor's mailing address will
also be changed.
DATES: This rule is effective April 20, 2010.
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: Minrad, Inc., 836 Main St., 2d floor,
Buffalo, NY 14202 has informed FDA that it has changed its name and
address to Piramal Critical Care, Inc., 3950 Schelden Circle,
Bethlehem, PA 18017. Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c) to reflect this change.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because
[[Page 20523]]
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 ``Minrad, Inc.'' and alphabetically add a new entry for ``Piramal
Critical Care, Inc.''; and in the table in paragraph (c)(2), revise the
entry for ``060307'' 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
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Piramal Critical Care, Inc., 3950 Schelden 060307
Circle, Bethlehem, PA 18017
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
060307..................... Piramal Critical Care, Inc., 3950 Schelden
Circle, Bethlehem, PA 18017
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Dated: April 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-9045 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S
