[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Notices]
[Pages 52351-52352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21098]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Resource for the
Collection and Evaluation of Human Tissues and Cells From Donors With
an Epidemiology Profile (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 June 16,
2010 (75 FR 34146) and allowed 60-days for public comment. One public
comment was received on 7/16/2010 from a business informing us that
they are able to provide a time-saving ``batch processing service'' to
locate and verify ``the most current addresses and phone numbers'' of
survey respondents. A response was sent on 7/26/2010 to the business
which indicated the existence of similar devices and/or procedures in
the current design of the project. 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: Resource for the Collection and
Evaluation of Human Tissues and Cells from Donors with an Epidemiology
Profile (NCI). Type of Information Collection Request: New: Need and
Use of Information Collection: Under the auspices of three NCI IRB-
approved protocols and instruments, the Laboratory of Human
Carcinogenesis conducts case-control studies to investigate the
relations between biomarkers, the environment, and human cancer. Human
subjects recruited from the general population are needed as controls
(Population Controls) for bio-specimens and personal histories (social,
occupational and health) that serve as references for the significance
of the frequency and prevalence of bio-markers found in cancer patients
and thought to be important in the development, progression, and/or
response to treatment of the malignant growths in cancer patients. The
questionnaires will be used to obtain the personal histories to compare
to the life styles and exposures and the biospecimens will serve as
controls for the assay results obtained from cancer patients. The
collection of information and specimens from the cancer cases received
NIH Clinical Exemption (Request 2009-09-002) on October 28,
2009. Frequency of Response: Once. Affected Public: Adult and senior
members of the licensed driver population in Baltimore, Maryland and
eleven near-by counties, including the Eastern Shore. Type of
Respondents: Responders will be English speaking, male and female,
Caucasian, African-American and Asian. The total annual reporting
burden is estimated to be 692 (see table below). There are no Capital
Costs, Operating Costs, and/or Maintenance Costs to report.
[[Page 52352]]
Table 1--Estimates of Annual Burden Hours
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Average time
Type of respondents Survey Number of Frequency of per response Annual burden
instrument respondents response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Adults (40-79 years old)...... Telephone 1700 1 10/60 (0.17) 283
Screener
(Attachment 16).
Main 225 1 60/60 (1) 225
Questionnaire
(Attachment 6).
Prostate 125 1 30/60 (0.5) 63
Supplemental
Questionnaire
(Attachment 7).
Liver Supplement 225 1 30/60 (0.5) 113
(Attachment 8).
Refusal 225 1 2/60 (0.03) 8
Questionnaire
Form
(Attachment 21).
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Totals.................... ................ 2500 .............. .............. 692
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Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.
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 OIRA_submission@omb.eop.gov 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 Glenwood E. Trivers
or Elise Bowman, Center for Cancer Research, NCI, NIH, 37 Convent Drive
Room 3060-C or 3060-A, Building 37, Bethesda, Maryland 30893-4258 or
call non-toll-free number 301-496-2094 or 301-496-2090 or e-mail your
request, including your address to triversg@mail.nih.gov or
bowmane@mail.nih.gov.
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: August 18, 2010.
Vivian Horovitch-Kelley
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-21098 Filed 8-24-10; 8:45 am]
BILLING CODE 4140-01-P