New Animal Drugs; Change of Sponsor's Name and Address, 66047 [E9-29627]
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66047
Federal Register / Vol. 74, No. 238 / Monday, December 14, 2009 / Rules and Regulations
MGB, inspect the tightening torque load of
the 6 nuts on the flexible coupling-to-flange
attachment bolts in accordance with
paragraph 2.B.2.b. of the EASB, except you
are not required to contact the manufacturer.
(3) For MGB input flexible coupling flange
assemblies that have more than 75 hours TIS
since new or since a complete overhaul of the
MGB, within the next 50 hours TIS, inspect
the tightening torque load of the 6 nuts on
the flexible coupling-to-flange attachment
bolts, in accordance with paragraph 2.B.2.b.
of the EASB, except you are not required to
contact the manufacturer.
(4) Prior to installing a MGB that contains
an input flexible coupling flange assembly
that has been modified per MOD 0752416
and MOD 0752419, you must comply with
the provisions of this AD.
material at NARA, call (202) 741–6030, or go
to: https://www.archives.gov/federal-register/
cfr/ibr-locations.html.
the Center for Veterinary Medicine, 21
CFR part 510 is amended as follows:
Issued in Fort Worth, Texas, on November
18, 2009.
Gary B. Roach,
Acting Manager, Rotorcraft Directorate,
Aircraft Certification Service.
[FR Doc. E9–29424 Filed 12–11–09; 8:45 am]
PART 510—NEW ANIMAL DRUGS
Differences Between This AD and the MCAI
AD
(f) The MCAI AD uses the term ‘‘flight
hours’’ instead of ‘‘hours time-in-service’’, as
we have used in this AD. Also, the MCAI AD
allows ‘‘use of later approved revisions’’ of
the service information to comply with the
MCAI AD. Our AD requires compliance in
accordance with Eurocopter Emergency Alert
Service Bulletin No. 05.95, dated March 3,
2008. Additionally, this AD requires
‘‘inspections’’ by a qualified mechanic
instead of ‘‘checks’’, which we allow a pilot
to do. Finally, this AD does not require you
to contact Eurocopter Technical Support,
which is required by the MCAI AD.
21 CFR Part 510
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
[Docket No. FDA–2009–N–0665]
*
Other Information
(g) Alternative Methods of Compliance
(AMOCs): The Manager, Safety Management
Group, Attn: DOT/FAA Southwest Region,
Ed Cuevas, Aerospace Engineer, Rotorcraft
Directorate, 2601 Meacham Blvd., Fort
Worth, Texas 76137; telephone (817) 222–
5355, fax (817) 222–5961, has the authority
to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
(h) European Aviation Safety Agency
MCAI Airworthiness Directive No. 2009–
0049–E, dated March 3, 2008 (Corrected:
March 7, 2008), contains related information.
srobinson on DSKHWCL6B1PROD with RULES
Joint Aircraft System/Component Code
(i) JASC Code 6310: Engine/Transmission
Coupling.
Material Incorporated by Reference
(j) You must use the specified portions of
Eurocopter Emergency Alert Service Bulletin
No. 05.95, dated March 3, 2008, to do the
actions required.
(1) The Director of the Federal Register
approved the incorporation by reference of
this service information under 5 U.S.C.
552(a) and 1 CFR part 51.
(2) For service information identified in
this AD, contact American Eurocopter
Corporation, 2701 Forum Drive, Grand
Prairie, TX 75053–4005, telephone (800)
232–0323, fax (972) 641–3710, or at https://
www.eurocopter.com.
(3) You may review copies at the FAA,
Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Fort Worth,
Texas 76137; or at the National Archives and
Records Administration (NARA). For
information on the availability of this
VerDate Nov<24>2008
18:27 Dec 11, 2009
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
New Animal Drugs; Change of
Sponsor’s Name and Address
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
Schering-Plough Animal Health Corp. to
Intervet, Inc., and to change the
sponsor’s mailing address.
DATES: This rule is effective December
14, 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, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit, NJ 07901, has informed
FDA of a change of name and mailing
address to Intervet, Inc., 56 Livingston
Ave., Roseland, NJ 07068. 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.
■ Therefore, under the Federal Food,
Drug and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
PO 00000
Frm 00019
Fmt 4700
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Schering-Plough Animal Health Corp.’’
and alphabetically add a new entry for
‘‘Intervet, Inc.’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘000061’’ to read as follows:
*
*
(c) * * *
(1) * * *
*
*
Sfmt 4700
Firm name and address
Drug labeler
code
*
HHS.
ACTION:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
■
BILLING CODE 4910–13–P
AGENCY:
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
*
*
*
Intervet, Inc., 56 Livingston
Ave., Roseland, NJ
07068
*
*
*
*
000061
*
*
(2) * * *
Drug labeler
code
*
Firm name and address
*
000061
*
*
*
*
Intervet, Inc., 56 Livingston
Ave., Roseland, NJ
07068
*
*
*
*
Dated: December 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–29627 Filed 12–11–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Insulin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\14DER1.SGM
Final rule.
14DER1
]]>Agencies
[Federal Register Volume 74, Number 238 (Monday, December 14, 2009)]
[Rules and Regulations]
[Page 66047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29627]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2009-N-0665]
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 Schering-
Plough Animal Health Corp. to Intervet, Inc., and to change the
sponsor's mailing address.
DATES: This rule is effective December 14, 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: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, has informed FDA of a change of name and
mailing address to Intervet, Inc., 56 Livingston Ave., Roseland, NJ
07068. 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 ``Schering-Plough Animal Health Corp.'' and alphabetically add a
new entry for ``Intervet, Inc.''; and in the table in paragraph (c)(2),
revise the entry for ``000061'' 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
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Intervet, Inc., 56 Livingston Ave., 000061
Roseland, NJ 07068
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
000061 Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Dated: December 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29627 Filed 12-11-09; 8:45 am]
BILLING CODE 4160-01-S
