New Animal Drugs; Change of Sponsor's Name and Address, 20523 [2010-9057]
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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
*
erowe on DSK5CLS3C1PROD with RULES
*
Firm name and address
*
*
*
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
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]
[Page 20523]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9057]
-----------------------------------------------------------------------
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 Parnell
Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In
addition, the sponsor's mailing address will 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: 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
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), 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:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Parnell Technologies Pty. Ltd., unit 4, 476 068504
Gardeners Rd., Alexandria, New South Wales
2015, Australia
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
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
