2014-14275. Proposed Collection; 60-Day Comment Request; Cancer Epidemiology Descriptive Cohort Database (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), 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.

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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.

To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Seminara, Daniela, Senior Scientist and Cohort and Consortia Coordination Team Lead, Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276-6748 or Email your request, including your address to: [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

DATES:

Comment 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.

Proposed Collection: Cancer Epidemiology Descriptive Cohort Database, 0925—New, National Cancer Institute (NCI), National Institutes of Health (NIH).

Need and Use of Information Collection: The NCI Epidemiology and Genomics Research Program (EGRP) support large-scale collaborations across numerous cancer epidemiology cohorts. The collaborative approach to date has been lacking in easily accessible, centralized, and searchable information. To address the need for better collaborative research and increased transparency, EGRP will develop a Cancer Epidemiology Descriptive Cohort Database (CEDCD) accessible through a public Web site. The information collected from the current survey will be used to populate the CEDCD. This public Web site will allow investigators to know what data and specimens exist among other cohorts. Respondents will be cohort Principal Investigators (PIs). The data collection forms will be sent to participating cohort PIs for initial completion and then annually to update any information that has changed so that the CEDCD Web site will remain current. No cohort participant-level data is being collected from any of the cohorts.

The information to be collected will be aggregate descriptive information and protocols. Though the CEDCD has a biospecimen component (similar to the Specimen Resource Locator), the CEDCD is not a biospecimen locator database. It is a database focusing exclusively on descriptive data pertaining to large, prospective epidemiology cohorts.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 425.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total annual burden hour
Individual:
Principal Investigator	Written Agreement Form	100	1	15/60	25
	Biospecimen Spreadsheet	100	1	1	100
Initial Submission	Descriptive Db Collection Form	100	1	1	100
Individual:
Principal Investigator	Biospecimen Spreadsheet *	200	1	30/60	100
Annual Update	Descriptive Db Collection Form *	200	1	30/60	100
* All forms will be prepopulated with the information that was entered initially.

Dated: June 12, 2014.

Karla Bailey,

NCI Project Clearance Liaison, National Institutes of Health.