New Animal Drugs; Change of Sponsor's Name, 68972 [2010-28307]
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68972
Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations
and Surveillance Facility, Virginia
Capes (FACSFAC VACAPES), NAS
Oceana, Virginia Beach, VA’’ and
inserting the words ‘‘Using agency. U.S.
Navy, Fleet Area Control and
Surveillance Facility, Virginia Capes
(FACSFAC VACAPES), Virginia Beach,
VA.’’
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Issued in Washington, DC, on November 4,
2010.
Edith V. Parish,
Manager, Airspace, Regulations and ATC
Procedures Group.
[FR Doc. 2010–28388 Filed 11–9–10; 8:45 am]
BILLING CODE 4910–13–P
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
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from North
American Nutrition Companies, Inc., to
Provimi North America, Inc.
DATES: This rule is effective November
10, 2010.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8300,
E-mail: steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: North
American Nutrition Companies, Inc.,
6531 State Rte. 503, Lewisburg, OH
45338, has informed FDA that it has
changed its name to Provimi North
America, Inc. Accordingly, the Agency
is amending the regulations in 21 CFR
510.600 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.
erowe on DSK5CLS3C1PROD with RULES
SUMMARY:
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:
■
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
‘‘North American Nutrition Companies,
Inc.’’; and alphabetically add a new
entry for ‘‘Provimi North America, Inc.’’;
and in the table in paragraph (c)(2),
revise the entry for ‘‘017790’’ to read as
follows:
■
Jkt 223001
21 CFR Part 878
Medical Devices; General and Plastic
Surgery Devices; Classification of
Tissue Adhesive With Adjunct Wound
Closure Device Intended for Topical
Approximation of Skin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is classifying the
tissue adhesive with adjunct wound
closure device intended for topical
approximation into class II (special
controls). The special control that will
§ 510.600 Names, addresses, and drug
apply to the device is the guidance
labeler codes of sponsors of approved
document entitled ‘‘Guidance for
applications.
Industry and FDA Staff; Class II Special
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Controls Guidance Document: Tissue
(c) * * *
Adhesive With Adjunct Wound Closure
(1) * * *
Device Intended for the Topical
Approximation of Skin.’’ The agency is
Drug labeler
classifying the device into class II
Firm name and address
code
(special controls) in order to provide
reasonable assurance of safety and
effectiveness of the device. Elsewhere in
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this issue of the Federal Register, FDA
Provimi North America, Inc.,
is announcing the availability of a
6531 State Rte. 503,
Lewisburg, OH 45338 .......
017790 guidance document that will serve as
the special control for this device type.
DATES: This final rule is effective
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December 10, 2010. The classification
was effective April 30, 2010.
(2) * * *
FOR FURTHER INFORMATION CONTACT:
Drug labeler code
Firm name and address George J. Mattamal, Center for Devices
and Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 4617,
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10903 New Hampshire Ave., Silver
017790 ................... Provimi North America,
Spring, MD 20993–0002, 301–796–6396.
Inc., 6531 State Rte.
SUPPLEMENTARY INFORMATION:
503, Lewisburg, OH
45338.
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Dated: October 28, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–28307 Filed 11–9–10; 8:45 am]
BILLING CODE 4160–01–P
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
14:24 Nov 09, 2010
Food and Drug Administration
[Docket No. FDA–2010–N–0512]
PART 510—NEW ANIMAL DRUGS
List of Subjects in 21 CFR Part 510
VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
SUMMARY:
I. What is the background of this
rulemaking?
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 301 et seq.)
as amended by the Medical Device
Amendments of 1976 (the 1976
amendments) (Pub. L. 94–295), the Safe
Medical Devices Act of 1990 (Pub. L.
101–629), and the Food and Drug
Administration Modernization Act (Pub.
L. 107–250) established a
comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the FD&C Act (21
U.S.C. 306c) established three categories
(classes) of devices, depending on the
regulatory controls needed to provide
reasonable assurance of their safety and
E:\FR\FM\10NOR1.SGM
10NOR1
]]>Agencies
[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Rules and Regulations]
[Page 68972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28307]
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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
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 North
American Nutrition Companies, Inc., to Provimi North America, Inc.
DATES: This rule is effective November 10, 2010.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8300, E-mail:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: North American Nutrition Companies, Inc.,
6531 State Rte. 503, Lewisburg, OH 45338, has informed FDA that it has
changed its name to Provimi North America, Inc. Accordingly, the Agency
is amending the regulations in 21 CFR 510.600 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), remove the entry
for ``North American Nutrition Companies, Inc.''; and alphabetically
add a new entry for ``Provimi North America, Inc.''; and in the table
in paragraph (c)(2), revise the entry for ``017790'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Provimi North America, Inc., 6531 State Rte. 503, 017790
Lewisburg, OH 45338....................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
017790.................................... Provimi North America, Inc.,
6531 State Rte. 503,
Lewisburg, OH 45338.
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Dated: October 28, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-28307 Filed 11-9-10; 8:45 am]
BILLING CODE 4160-01-P
