[Federal Register Volume 74, Number 8 (Tuesday, January 13, 2009)]
[Notices]
[Pages 1697-1698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-484]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Follow-up of Kidney 
Cancer Patients From the Central European Multicenter Case-Control 
Study (CEERCC) (NCI)

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute (NCI), the 
National Institutes of Health (NIH), has submitted to the Office of 
Management and Budget (OMB) a request to review and approve the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on November 
3, 2008 (Volume 73, No. 213, p. 65387) and allowed 60 days for public 
comment. There was one public comment received which questioned why 
U.S. tax dollars are being spent on a study located in Europe. The 
investigator responded directly to the comment on 12/19/08 stating that 
this study costs less money to conduct in central Europe than in the 
U.S. since previous data has already been collected. Additionally, 
since this region has the highest rates of kidney cancer in the world a 
study in this area would provide a wealth of data in terms of the 
causes of kidney cancer. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Institutes of 
Health may not conduct or sponsor, and the respondent is not required 
to respond to, an information collection that has been extended, 
revised, or implemented on or after October 1, 1995, unless it displays 
a currently valid OMB control number.
    Proposed Collection: Title: Follow-up of Kidney Cancer Patients 
from the Central European Multicenter Case-Control Study (NCI). Type of 
Information Collection Request: New. Need and Use of Information 
Collection: The purpose of this questionnaire is to obtain information 
on the 5-year survival status of kidney cancer patients that were 
previously enrolled in a Central European Case-Control Study of Kidney 
Cancer that was conducted from 2001 to 2004. The aim is to assess 
survival, the prevalence of recurrent disease and progression, and to 
investigate patient, tumor and genetic determinants of survival among 
cases. The questionnaire will collect information on patient related 
factors, tumor related factors that were not collected during the 
initial study, and the type of treatment(s) received since the patients 
were last contacted for the case-control study. This questionnaire 
adheres to The Public Health Service Act, section 412 (42 U.S.C. 285a-
1) and section 413 (42 U.S.C. 285a-2), which authorizes the Division of 
Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) 
to establish and support programs for the detection, diagnosis, 
prevention and treatment of cancer; and to collect, identify, analyze 
and disseminate information on cancer research, diagnosis, prevention 
and treatment. Frequency of Response: Once. Affected Public: 
Individuals. Type of Respondents: Individuals that participated in the 
Central European Renal Cancer Case-Control Study between 2001-2004 and 
physician abstractors. The estimated total annual burden hours 
requested is 296. The annualized cost to respondents is estimated at 
$5174. The data will be collected within a two-year period. There are 
no additional capital costs, operating costs, and/or maintenance costs 
to report.

                                        Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                          Average
                                                                                          time per      Annual
                     Type of respondents                       Number of    Frequency     response      burden
                                                              respondents  of response   (Minutes/      hours
                                                                                           Hour)
----------------------------------------------------------------------------------------------------------------
Patients....................................................          200            1        40/60       133.33
Families (NOK)..............................................          240            1        40/60       160.00
Physicians..................................................           10            1        15/60         2.50
                                                             ---------------------------------------------------
    Totals..................................................          450  ...........  ...........       295.83
----------------------------------------------------------------------------------------------------------------

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on one or more of the 
following points: (1) Whether the proposed collection of information is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility; (2) The 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) Ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) Ways to minimize 
the burden of the collection of information on those who are to 
respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.

[[Page 1698]]

    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the Attention: NIH Desk Officer, Office of Management and 
Budget, at [email protected] or by fax to 202-395-6974. To 
request more information on the proposed project or to obtain a copy of 
the data collection plans and instruments, contact Lee E. Moore, PhD, 
MPH, Investigator, Occupational and Environmental Epidemiology Branch, 
Division of Cancer Epidemiology and Genetics, National Cancer 
Institute, NIH, DHHS, Executive Plaza South, Room 8102, 6120 Executive 
Blvd., EPS-MSC 7242, Bethesda, MD 20892-7270 or call non-toll-free 
number 301-496-6427 or e-mail your request, including your address to: 
[email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: January 2, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E9-484 Filed 1-12-09; 8:45 am]
BILLING CODE 4140-01-P