Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications; Correction, 20918 [05-8049]

Download as PDF 20918 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 Jkt 205001 PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice; correction. SUPPLEMENTARY INFORMATION: VerDate jul<14>2003 BILLING CODE 4160–01–S Frm 00064 Fmt 4703 Sfmt 4703 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]


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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
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