[Federal Register Volume 75, Number 115 (Wednesday, June 16, 2010)]
[Notices]
[Page 34146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request Resource for the Collection 
and Evaluation of Human Tissues and Cells From Donors With an 
Epidemiology Profile (NCI)

SUMMARY: In compliance with the requirement of Section 3506(c) (2)(A) 
of the Paperwork Reduction Act of 1995, for opportunity for public 
comment on proposed data collection projects, the National Cancer 
Institute (NCI), the National Institutes of Health (NIH) will publish 
periodic summaries of proposed projects to be submitted to the Office 
of Management and Budget (OMB) for review and approval.
    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 nearby 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.

                                    Table 1--Estimates of Annual Burden Hours
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                                                                                Average time per
     Type of respondents            Survey         Number of     Frequency of       response       Annual burden
                                  instrument      respondents      response      (minutes/hour)        hours
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Adults (40-79 years old).....  Telephone                  1700               1             10/60             283
                                Screener                                                  (0.17)
                                (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                       225               1       30/60 (0.5)             113
                                Supplement
                                (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.

FOR FURTHER INFORMATION CONTACT: 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 [email protected] or [email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: June 9, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-14546 Filed 6-15-10; 8:45 am]
BILLING CODE 4140-01-P