New Animal Drugs; Change of Sponsor's Address, 70996-70997 [05-23296]
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70996
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations
must demonstrate to the Designated
School Official (DSO) at the academic
institution where the F–1 student
currently is enrolled that such
employment is necessary to avoid
severe economic hardship resulting
from Hurricane Katrina. See 8 CFR
214.2(f)(9)(i). The DSO should sign,
date, and include the following notation
in the student employment box on page
3 of Form I–20: ‘‘Approved for more
than 20 hours per week of on-campus
employment until February 1, 2006,
pursuant to Hurricane Katrina Special
Student Relief.’’ By making this
notation, the DSO certifies that the F–
1 student is covered by this Notice.
2. Off-Campus Employment
An F–1 student covered by this
Notice, who seeks to pursue off-campus
employment pursuant to this Notice,
must file a complete Form I–765,
Application for Employment
Authorization, including required
supporting documentation, with the
USCIS Texas Service Center at:
U.S. Citizenship and Immigration
Services, Texas Service Center, P.O. Box
853062, Mesquite, TX 75815–3062.
The front of the envelope, on the
bottom right-hand side, should include
the following notation: ‘‘HURRICANE
KATRINA SPECIAL STUDENT
RELIEF.’’ Failure to include this
notation may result in significant
processing delays.
An application package is complete if
it contains: (1) A properly completed
Form I–765, Application for
Employment Authorization, with the
required fee or, if the F–1 student
believes he or she is eligible for a waiver
of this fee, a written affidavit or
unsworn declaration, which requests
waiver of the fee under 8 CFR 103.7(c)
and explains the reasons why the
student is unable to pay the prescribed
fee, and (2) Form I–20 with a
recommendation for off-campus
employment from the DSO at the
academic institution where the F–1
student is currently enrolled. See 8 CFR
214.2(f)(9)(ii)(D). The DSO should sign,
date, and include the following notation
in the student employment box on page
3 of Form I–20: ‘‘Approved for more
than 20 hours per week of off-campus
employment until February 1, 2006,
pursuant to Hurricane Katrina Special
Student Relief.’’ By making this
notation, the DSO certifies that the F–
1 student is covered by this Notice.
If U.S. Citizenship and Immigration
Services (USCIS) approves the F–1
student’s Form I–765, Application for
Employment Authorization, USCIS will
send the student a Form I–766,
Employment Authorization Document,
VerDate Aug<31>2005
12:24 Nov 23, 2005
Jkt 208001
to evidence his or her employment
authorization. The Form I–766 will
contain an expiration date that will not
extend beyond February 1, 2006. If
USCIS denies the F–1 student’s Form I–
765, Application for Employment
Authorization, USCIS will notify the
student of the decision, and the
reason(s) for the denial.
Is there a cut-off date for the filing of
a Form I–765, Application for
Employment Authorization, pursuant to
this Notice?
No. DHS has not established a cut-off
date for the filing of a Form I–765,
Application for Employment
Authorization, pursuant to this Notice.
Any benefits granted by means of this
Notice, however, will expire no later
than February 1, 2006. While USCIS
will exercise its best efforts to process
such applications in as prompt a
manner as possible, F–1 students
applying for employment authorization
pursuant to this Notice should bear in
mind this expiration date when
submitting their Forms I–765,
Applications for Employment
Authorization.
Will F–2 dependents (spouse or minor
children) of F–1 students covered by
this Notice be eligible to apply for
employment authorization?
No. Pursuant to 8 CFR 214.2(f)(15)(i),
an F–2 dependent (spouse or minor
children) of an F–1 student, may not
accept employment.
Will F–1 students covered by this
Notice be required to apply for
reinstatement after February 1, 2006?
No. F–1 students, who are granted
employment authorization pursuant to
this Notice, will be deemed to be
engaged in a ‘‘full course of study’’ for
the duration of their employment
authorization, provided such
undergraduate level F–1 students
remain registered for a minimum of 6
semester/quarter hours of instruction
per academic term, and such graduate
level F–1 students remain registered for
a minimum of 3 semester/quarter hours
of instruction per academic term. See 8
CFR 214.2(f)(5)(v). Such F–1 students,
therefore, would not be required to
apply for reinstatement under 8 CFR
214.2(f)(16) if they are otherwise
maintaining F–1 status.
How long will this Notice remain in
effect?
This Notice grants temporary relief to
a specific group of F–1 students for the
estimated length of the current
academic term. As such, this Notice will
remain in effect until February 1, 2006.
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During this period, DHS will continue
to monitor the adverse impact of
Hurricane Katrina in the affected areas
to determine if modification or
rescission of these special provisions is
warranted. Should these special
provisions be modified or rescinded
prior to February 1, 2006, DHS will
announce such changes in the Federal
Register.
Paperwork Reduction Act
The information collection
requirements contained in this rule have
been cleared by the Office of
Management and Budget (OMB) under
the provisions of the Paperwork
Reduction Act. Clearance numbers for
these collections are contained in 8 CFR
299.5, Display Control Numbers, and are
noted herein. Form I–765, Application
for Employment Authorization, OMB
Control Number 1615–0040.
Dated: November 17, 2005.
Michael Chertoff,
Secretary.
[FR Doc. 05–23309 Filed 11–23–05; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s 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 address for
Schering-Plough Animal Health Corp.
DATES: This rule is effective November
25, 2005.
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.gov.
SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, has
informed FDA of a change of address to
556 Morris Ave., Summit, NJ 07901.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to
reflect the 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.’’
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70997
Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations
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
New Animal Drugs; Change of
Sponsor’s Name
AGENCY:
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:
I
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. Section 510.600 is amended in the
table in paragraph (c)(1) by revising the
entry for ‘‘Schering-Plough Animal
Health Corp.’’; and in the table in
paragraph (c)(2) by revising the entry for
‘‘000061’’ to read as follows.
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Schering-Plough Animal
Health Corp., 556 Morris
Ave., Summit, NJ 07901.
*
*
*
Drug labeler
code
*
000061
*
*
*
(2) * * *
Drug labeler
code
*
000061
*
*
*
Food and Drug Administration
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Firm name and address
*
*
*
Schering-Plough Animal
Health Corp., 556 Morris
Ave., Summit, NJ 07901
*
*
*
Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–23296 Filed 11–23–05; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
ACTION:
Final rule.
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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:
21 CFR Part 522
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
12:24 Nov 23, 2005
Jkt 208001
2. Section 510.600 is amended in the
table in paragraph (c)(1) by removing
the entries for ‘‘Phoenix Pharmaceutical,
Inc.’’ and ‘‘Phoenix Scientific, Inc.’’, and
by alphabetically adding a new entry for
‘‘IVX Animal Health, Inc.’’; and in the
table in paragraph (c)(2) by removing
the entry for ‘‘057319’’ and by revising
the entry for ‘‘059130’’ to read as
follows:
I
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Phoenix
Scientific, Inc., to IVX Animal Health,
Inc. In order to improve the accuracy of
the regulations, erroneous entries for
Phoenix Pharmaceutical, Inc., are also
being removed at this time.
DATES: This rule is effective November
25, 2005.
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.gov.
SUPPLEMENTARY INFORMATION: Phoenix
Scientific, Inc., 3915 South 48th Street
Ter., St. Joseph, MO 64503, has
informed FDA that it has changed its
name to IVX Animal Health, Inc.
Accordingly, the agency is amending
the regulations in § 510.600 (21 CFR
510.600) to reflect the change.
In addition, FDA has noticed that
Phoenix Pharmaceutical, Inc., is no
longer a sponsor of an approved new
animal drug application. At this time,
§ 510.600 is amended to remove entries
for this sponsor. This action is being
taken to improve the accuracy of the
regulations.
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.
SUMMARY:
I
VerDate Aug<31>2005
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
IVX Animal Health, Inc.,
3915 South 48th Street
Ter., St. Joseph, MO
64503.
*
*
*
Drug labeler
code
*
059130
*
*
*
(2) * * *
Drug labeler
code
*
059130
*
*
*
Firm name and address
*
*
*
IVX Animal Health, Inc.,
3915 South 48th Street
Ter., St. Joseph, MO
64503
*
*
*
Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 05–23297 Filed 11–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Implantation or Injectable Dosage
Form New Animal Drugs; Boldenone
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Fort
Dodge Animal Health. The
supplemental NADA provides for
E:\FR\FM\25NOR1.SGM
25NOR1
]]>Agencies
[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Rules and Regulations]
[Pages 70996-70997]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23296]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's 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 address for Schering-
Plough Animal Health Corp.
DATES: This rule is effective November 25, 2005.
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.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, has informed FDA of a change of address
to 556 Morris Ave., Summit, NJ 07901. Accordingly, the agency is
amending the regulations in 21 CFR 510.600(c) to reflect the 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.''
[[Page 70997]]
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. Section 510.600 is amended in the table in paragraph (c)(1) by
revising the entry for ``Schering-Plough Animal Health Corp.''; and in
the table in paragraph (c)(2) by revising 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
------------------------------------------------------------------------
* * * * *
Schering-Plough Animal Health Corp., 556 000061
Morris Ave., Summit, NJ 07901.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
000061 Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901
* * * * *
------------------------------------------------------------------------
Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 05-23296 Filed 11-23-05; 8:45 am]
BILLING CODE 4160-01-S
