[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