The Eighth Annual FDA-Orange County Regulatory Affairs Educational Conference; “Reality of Regulatory Affairs”, 20918-20919 [05-8050]

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 20919 Federal Register / Vol. 70, No. 77 / Friday, April 22, 2005 / Notices Date and Time: The conference will be held on June 15 and 16, 2005, from 7:30 a.m. to 5 p.m. Location: The conference will be held at the Irvine Marriot Hotel, 18000 Von Karman Ave., Irvine, CA 92612. Contact: Linda Hartley, Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949–608–4413, FAX: 949–608–4417, or OCRA, Attention to detail (ATD), 5319 University Dr., suite 641, Irvine, CA 92612, 949–387–9046, FAX: 949–387–9047, Web site: www.ocra-dg.org. Registration and Meeting Information: See OCRA Web site at www.ocra-dg.org. Contact ATD at 949–387–9046. Before May 6, 2005, registrations fees are as follows: $495.00 for members, $550.00 for nonmembers, and $325.00 for FDA/government/full time students with proper identification. After May 6, 2005: $545.00 for members, $595.00 for nonmembers, and $325.00 for FDA/government/full time students with the proper identification. The registration fee will cover actual expenses including refreshments, lunch, materials and speaker expenses. If you need special accommodations due to a disability, please contact Linda Hartley (see Contact) at least 10 days in advance. Dated: April 15, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8050 Filed 4–21–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Disadvantaged Assistance Tracking and Outcome Report (OMB No. 0915–0233)— Extension The Health Careers Opportunity Program (HCOP) and the Centers of Excellence (COE) Program (authorized under sections 740 and 739 respectively of the Public Health Service (PHS) Act, 42 U.S.C. 293d and 293c) provide opportunities for under-represented minorities and disadvantaged individuals to enter and graduate from health professions schools. The Disadvantaged Assistance Tracking and Outcome Report (DATOR) is used to track program participants throughout the health professions pipeline into the health care workforce. The DATOR, to be completed annually by HCOP AND COE grantees, includes basic data on student participants (name, social security number, gender, race/ethnicity; targeted health professions, their status in the educational pipeline from preprofessional through professional training; financial assistance received through the grants funded under sections 739 and 740 of the PHS Act in the form of stipends, fellowships or per diem; and their employment or practice setting following their entry into the health care work force). The proposed reporting instrument does not add significantly to the grantees reporting burden. This reporting instrument complements the grantees internal automated reporting mechanisms of using name and social security number in tracking students. The reporting burden includes the total time, effort, and financial resources expended to maintain, retain and provide the information including: (1) Reviewing instructions; (2) downloading and utilizing technology for the purposes of collecting, validating, and processing the data; and (3) transmitting electronically, or otherwise disclosing the information. Estimates of annualized burden are as follows: Type of report Number of respondents Responses per respondent Hours per response Total burden hours DATOR ............................................................................................................ 150 1 5.5 825 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities: Submission for OMB Review; Comment Request Proposed Project: The National Health Service Corps (NHSC) Loan Repayment Program (LRP) (OMB No. 0915–0127)— Revision Dated: April 18, 2005. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. 05–8105 Filed 4–21–05; 8:45 am] Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The NHSC LRP was established to assure an adequate supply of trained primary care health professionals to provide services in the neediest Health Professional Shortage Areas (HPSAs) of the United States. Under this program, the Department of Health and Human Services agrees to repay the educational loans of the primary care health professionals. In return, the health professionals agree to serve for a specified period of time in a federally- BILLING CODE 4165–15–P VerDate jul<14>2003 15:27 Apr 21, 2005 Jkt 205001 Health Resources and Services Administration PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: E:\FR\FM\22APN1.SGM 22APN1

Agencies

[Federal Register Volume 70, Number 77 (Friday, April 22, 2005)]
[Notices]
[Pages 20918-20919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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.

[[Page 20919]]

    Date and Time: The conference will be held on June 15 and 16, 2005, 
from 7:30 a.m. to 5 p.m.
    Location: The conference will be held at the Irvine Marriot Hotel, 
18000 Von Karman Ave., Irvine, CA 92612.
    Contact: Linda Hartley, Food and Drug Administration, 19701 
Fairchild, Irvine, CA 92612, 949-608-4413, FAX: 949-608-4417, or OCRA, 
Attention to detail (ATD), 5319 University Dr., suite 641, Irvine, CA 
92612, 949-387-9046, FAX: 949-387-9047, Web site: www.ocra-dg.org.
    Registration and Meeting Information: See OCRA Web site at 
www.ocra-dg.org. Contact ATD at 949-387-9046.
    Before May 6, 2005, registrations fees are as follows: $495.00 for 
members, $550.00 for nonmembers, and $325.00 for FDA/government/full 
time students with proper identification.
    After May 6, 2005: $545.00 for members, $595.00 for nonmembers, and 
$325.00 for FDA/government/full time students with the proper 
identification.
    The registration fee will cover actual expenses including 
refreshments, lunch, materials and speaker expenses.
    If you need special accommodations due to a disability, please 
contact Linda Hartley (see Contact) at least 10 days in advance.

    Dated: April 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8050 Filed 4-21-05; 8:45 am]
BILLING CODE 4160-01-S

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