Memorandum of Understanding Between the United States Food and Drug Administration and the National Cancer Institute, 54285-54290 [06-7630]

Download as PDF 54285 Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. blood exposures in the operating room setting, post exposure management and treatment of blood and body fluid exposures, and safety culture and practices. Data from the National Surveillance System for Health Care Workers (NaSH) indicate that surgeons are at high risk for sharps injuries and/ or blood and body fluid exposures. However, they have the lowest rates of exposure reporting. The results of the proposed survey will be used to determine the nature and frequency of blood exposures in the operating room setting and to make recommendations about mechanisms for improving safety culture and practices in this setting. The questionnaire will be sent to a 5% sample of the 99,042 U.S. surgeons in the American Medical Association’s physician masterfile. The survey sample will be stratified by sub-specialty and geographic region. Assuming a 20% response rate, the total number of respondents would be 990. The survey will take a maximum of 10 minutes to complete. Therefore, the maximum total burden hours may reach 165. There is no cost to the respondents other than their time. Proposed Project Survey of Surgeons on Occupational Exposure to Blood and Body Fluids— New—National Center for Infectious Diseases (NCID), Division of Healthcare Quality Promotion (DHQP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Division of Healthcare Quality Promotion (DHQP), CDC, defines as its primary mission the protection of patients and healthcare personnel through the promotion of safety, quality, and value in the healthcare delivery system. One priority is preventing transmission of blood borne pathogens to healthcare personnel during delivery of medical care. The purpose of this project is to conduct a survey of surgeons regarding the occurrence, reporting, and management of occupational exposures to blood and body fluid in the operating room (OR) setting. Respondents will also be asked about safety perceptions and practices during surgery. The survey is intended to assess the knowledge, attitudes, and behaviors of surgeons regarding sharps injuries and ESTIMATED ANNUALIZED BURDEN HOURS Respondent Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (hours) Surgeons .......................................................................................................... 990 1 10/60 165 Dated: September 7, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6–15235 Filed 9–13–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FDA 225–06–8402 Memorandum of Understanding Between the United States Food and Drug Administration and the National Cancer Institute AGENCY: Food and Drug Administration, rwilkins on PROD1PC63 with NOTICES HHS. VerDate Aug<31>2005 20:23 Sep 13, 2006 Jkt 208001 ACTION: Notice. SUMMARY: The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the National Cancer Institute (NCI) and the Food and Drug Administration (FDA) (collectively ‘‘the Parties’’, or individually as a ‘‘Party’’) to develop and implement the Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD), which will enable clinical investigators, NCI, FDA, and industry entities sponsoring clinical trials of investigational drugs (‘‘Sponsors of Drugs and Biologics’’ or ‘‘Sponsors’’) to manage clinical investigator information electronically in a fully secure manner. DATES: The agreement became effective August 10, 2006. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 For FDA: Randy Levin, Center for Drug Evaluation and Research (HF– 18), Food and Drug Administration, 5600 Fishers Lane, rm. 14B–45, Rockville, MD 20857, 301–827– 7784, FAX: 301–827–1540. For NCI: Peter Covitz, National Cancer Institute, 6116 Executive Blvd., rm. 705, Rockville, MD 20892, 301– 402–0326. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. Dated: September 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S E:\FR\FM\14SEN1.SGM 14SEN1 VerDate Aug<31>2005 Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices 20:23 Sep 13, 2006 Jkt 208001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4725 E:\FR\FM\14SEN1.SGM 14SEN1 EN14SE06.006</GPH> rwilkins on PROD1PC63 with NOTICES 54286 VerDate Aug<31>2005 20:23 Sep 13, 2006 Jkt 208001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4725 E:\FR\FM\14SEN1.SGM 14SEN1 54287 EN14SE06.007</GPH> rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices 20:23 Sep 13, 2006 Jkt 208001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4725 E:\FR\FM\14SEN1.SGM 14SEN1 EN14SE06.008</GPH> rwilkins on PROD1PC63 with NOTICES 54288 VerDate Aug<31>2005 20:23 Sep 13, 2006 Jkt 208001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4725 E:\FR\FM\14SEN1.SGM 14SEN1 54289 EN14SE06.009</GPH> rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices 54290 Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Notices BILLING CODE 4160–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Program Exclusions: August 2006 AGENCY: Office of Inspector General, HHS. rwilkins on PROD1PC63 with NOTICES ACTION: Notice of program exclusions. During the month of August 2006, the HHS Office of Inspector General imposed exclusions in the cases set forth below. When an exclusion is imposed, no program payment is made to anyone for any items or services (other than an emergency item or service not provided in a hospital emergency room) furnished, ordered or prescribed by an excluded party under the Medicare, Medicaid, and all Federal Health Care programs. In addition, no program payment is made to any business or facility, e.g., a hospital, that VerDate Aug<31>2005 20:23 Sep 13, 2006 Jkt 208001 Subject, name, address Effective date PROGRAM-RELATED CONVICTIONS ABERGEL-NAHON, SUZANNE MIAMI, FL ADAM, SALAH ......................... MIDLOTHIAN, VA ADAMSHICK, WILLIAM ........... FORKED RIVER, NJ BALLOU, ROBERT .................. ROOSEVELT, UT BENJAMIN, BARBARA ............ EDINA, MN BRECKENRIDGE, SHELIA ...... PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 9/20/2006 9/20/2006 9/20/2006 9/20/2006 9/20/2006 9/20/2006 Subject, name, address WESTERVILLE, OH BROWN, TAWANA .................. ROOSEVELT, NY BUSSELMAN, SHERRIE ......... LINCOLN, NE COCHRAN, KORENA .............. KELLOGG, ID COLLEY, PHILLIP .................... LINCOLN, NE CONDRA, BERNICE ................ MAIN, CA DENNY, BRIAN ........................ MINNEAPOLIS, MN DULEY, DANIEL ....................... HAMMOND, IN FANG, YI .................................. ARCADIA, CA FARRELL, SHELDON .............. FRESNO, CA FRIEDMAN, VICTOR ............... LONGVIEW, WA GRITTEN, LYNETTE ................ BAYSHORE, NY HALICKI, JANET ...................... BOARDMAN, OH HART, ROSE ............................ SHERMAN OAKS, CA HILSENDEGER, DANIEL ......... E:\FR\FM\14SEN1.SGM 14SEN1 Effective date 9/20/2006 2/8/2006 9/20/2006 2/8/2006 9/20/2006 4/12/2005 9/20/2006 9/20/2006 9/20/2006 9/20/2006 9/20/2006 9/20/2006 9/20/2006 9/20/2006 EN14SE06.010</GPH> submits bills for payment for items or services provided by an excluded party. Program beneficiaries remain free to decide for themselves whether they will continue to use the services of an excluded party even though no program payments will be made for items and services provided by that excluded party. The exclusions have national effect and also apply to all Executive Branch procurement and nonprocurement programs and activities. [FR Doc. 06–7630 Filed 9–13–06; 8:45 am]

Agencies

[Federal Register Volume 71, Number 178 (Thursday, September 14, 2006)]
[Notices]
[Pages 54285-54290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

FDA 225-06-8402


Memorandum of Understanding Between the United States Food and 
Drug Administration and the National Cancer Institute

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The purpose of this Memorandum of Understanding (MOU) is to 
set forth an agreement between the National Cancer Institute (NCI) and 
the Food and Drug Administration (FDA) (collectively ``the Parties'', 
or individually as a ``Party'') to develop and implement the Federal 
Investigator Registry of Biomedical Information Research Data 
(FIREBIRD), which will enable clinical investigators, NCI, FDA, and 
industry entities sponsoring clinical trials of investigational drugs 
(``Sponsors of Drugs and Biologics'' or ``Sponsors'') to manage 
clinical investigator information electronically in a fully secure 
manner.

DATES: The agreement became effective August 10, 2006.

FOR FURTHER INFORMATION CONTACT:
    For FDA: Randy Levin, Center for Drug Evaluation and Research (HF-
18), Food and Drug Administration, 5600 Fishers Lane, rm. 14B-45, 
Rockville, MD 20857, 301-827-7784, FAX: 301-827-1540.
    For NCI: Peter Covitz, National Cancer Institute, 6116 Executive 
Blvd., rm. 705, Rockville, MD 20892, 301-402-0326.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: September 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 06-7630 Filed 9-13-06; 8:45 am]
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