Cover Memo 5-23-2103

Date: May 23, 2013

TO: Office of Management and Budget (OMB)

Through: Keith Tucker, Reports Clearance Officer, HHS

Seleda Perryman, Program Clearance Officer, NIH

Vivian Horovitch-Kelley, PRA OMB Clearance Liaison, NCI

FROM: Jim Vaught, Chief

Biorepositories and Biospecimen Research Branch

Cancer Diagnosis Program

Division of Cancer Treatment and Diagnosis

National Cancer Institute (NCI)/NIH

SUBJECT: Financial Sustainability of Human Tissue Biobanking

This is a request for OMB to approve the new submission titled, “Financial Sustainability of Human Tissue Biobanking” for 1 year. The supporting statements and various attachments accompany this memorandum.

The purpose of this web-based survey is to collect information regarding the challenges that human tissue biobanks encounter in achieving financially sustainable operations. The information will be used to assist the National Cancer Institute (NCI) in strategizing program plans to provide increased and tailored support for national and international biobanks.

The survey will collect a combination of structured, quantitative, and free-text descriptive data that characterize the type and maturity of respondent biobanks, their sources of funding, and their usage of funding in conducting operations. The survey will also collect information describing the difficulties in maintaining funding sources and establishing new ones. Finally, the survey will elicit descriptions of techniques used to overcome the difficulties.

The intent of the survey is to answer the following research question “What is the financial burden (to the host institution) of the startup, maintenance and long-term sustainability of a human biospecimen resource used for biomedical research, given the host institution’s geographic and socioeconomic environment and organizational structure?”

A combination of domestic and international biobanks will be asked to participate in the survey, totaling approximately 548 respondents. The annualized burden for the survey by all participants is estimated to be 822 hours.