[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Notices]
[Pages 52351-52352]
From the Federal Register Online via the Government Publishing 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
----------------------------------------------------------------------------------------------------------------
                                                                                   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).
                                                 ---------------------------------------------------------------
    Totals....................  ................            2500  ..............  ..............             692
----------------------------------------------------------------------------------------------------------------

    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 [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 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 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