2010-21098. 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.

Table 1—Estimates of Annual Burden Hours

Type of respondents	Survey instrument	Number of respondents	Frequency of response	Average time per response (minutes/hour)	Annual burden hours
Adults (40-79 years old)	Telephone Screener (Attachment 16)	1700	1	10/60 (0.17)	283
	Main Questionnaire (Attachment 6)	225	1	60/60 (1)	225
	Prostate Supplemental Questionnaire (Attachment 7)	125	1	30/60 (0.5)	63
	Liver Supplement (Attachment 8)	225	1	30/60 (0.5)	113
	Refusal Questionnaire Form (Attachment 21)	225	1	2/60 (0.03)	8
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 [e-mail] 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 [e-mail] or [e-mail].

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.