Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications; Correction, 20918 [05-8049]
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Federal Register / Vol. 70, No. 77 / Friday, April 22, 2005 / Notices
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer in
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: April 15, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–8051 Filed 4–21–05; 8:45 am]
BILLING CODE 4184–01–M
process for voluntarily acknowledging
paternity under which the State must
provide that the mother and putative
father must be given notice, orally and
in writing, of the benefits and legal
responsibilities and consequences of
acknowledging paternity. The
information is to be used by hospitals,
birth record agencies, and other entities
participating in the voluntary paternity
establishment program.
Respondents: State and Tribal IV–D
birth record agencies.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Required Elements for
Voluntary Establishment of Paternity
Affidavits.
OMB No.: 0970–0171.
Description: Section 466(a)(5)(C) of
the Social Security Act requires States
to pass laws ensuring a simple civil
ANNUAL BURDEN ESTIMATES
None ...........................................................................................................
Estimated Total Annual Burden
Hours: 143,099
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
grjohnson@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Attn: Desk Officer for
ACF, E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: April 15, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–8052 Filed 4–21–05; 8:45 am]
BILLING CODE 4184–01–M
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
Variable ............
.166
143,099
Number of
respondents
Instrument
862,043
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. On page 10656, in the table, the
entry for ANDA 76–214 is removed.
Food and Drug Administration
Dated: April 14, 2005.
Steven Galson, Acting Director.
Center for Drug Evaluation and Research.
[FR Doc. 05–8049 Filed 4–21–05; 8:45 am]
[Docket No. 2005N–0058]
Hospira, Inc. et al.; Withdrawal of
Approval of 76 New Drug Applications
and 60 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of March 4, 2005 (70 FR
10651). The document announced the
withdrawal of approval of 76 new drug
applications (NDAs) and 60 abbreviated
new drug applications (ANDAs). The
document inadvertently withdrew
approval of ANDA 76–214 for Sotalol
Hydrochloride Tablets, 80 milligrams
(mg), 120 mg, and 160 mg, held by
TorPharm, c/o Apotex Corp., 616
Heathrow Dr., Lincolnshire, IL 60069.
FDA confirms that approval of ANDA
76–214 is still in effect.
EFFECTIVE DATE: April 4, 2005.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUMMARY:
In FR Doc.
05–4158, appearing on page 10651 in
the Federal Register of Friday, March 4,
2005, the following correction is made:
15:27 Apr 21, 2005
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice; correction.
SUPPLEMENTARY INFORMATION:
VerDate jul<14>2003
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The Eighth Annual FDA–Orange
County Regulatory Affairs Educational
Conference; ‘‘Reality of Regulatory
Affairs’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA) is announcing its eighth annual
educational conference cosponsored
with the Orange County Regulatory
Affairs Discussion Group (OCRA). The
conference is intended to provide the
drug, device, and biologics industries
with an opportunity to interact with
FDA reviewers and compliance officers
from the centers and district offices, as
well as other industry experts. The main
focus of this interactive conference will
be product approval, compliance, and
risk management in the three medical
product areas. Industry speakers,
interactive question and answer and
workshop sessions will also be included
to assure open exchange and dialogue
on the relevant regulatory issues.
E:\FR\FM\22APN1.SGM
22APN1
Agencies
[Federal Register Volume 70, Number 77 (Friday, April 22, 2005)]
[Notices]
[Page 20918]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8049]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0058]
Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug
Applications and 60 Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of March 4, 2005 (70 FR 10651).
The document announced the withdrawal of approval of 76 new drug
applications (NDAs) and 60 abbreviated new drug applications (ANDAs).
The document inadvertently withdrew approval of ANDA 76-214 for Sotalol
Hydrochloride Tablets, 80 milligrams (mg), 120 mg, and 160 mg, held by
TorPharm, c/o Apotex Corp., 616 Heathrow Dr., Lincolnshire, IL 60069.
FDA confirms that approval of ANDA 76-214 is still in effect.
EFFECTIVE DATE: April 4, 2005.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: In FR Doc. 05-4158, appearing on page 10651
in the Federal Register of Friday, March 4, 2005, the following
correction is made:
1. On page 10656, in the table, the entry for ANDA 76-214 is
removed.
Dated: April 14, 2005.
Steven Galson, Acting Director.
Center for Drug Evaluation and Research.
[FR Doc. 05-8049 Filed 4-21-05; 8:45 am]
BILLING CODE 4160-01-S