Tissue bank activities, tissue types handled, and inspections

Form Approved

OMB No. 0990-

Exp. Date XX/XX/20XX

THE NATIONAL TISSUE RECOVERY

THROUGH UTILIZATION SURVEY

SECTION 1 – Activities, Tissue Types, and Inspections

The Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), through a contract with the American Association of Tissue Banks, is conducting the 2016 National Tissue Recovery through Utilization Survey (NTRUS).

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Your responses will remain anonymous in the final dataset. While results of this survey will be released in aggregate form and data may be made available in the form of a de-identified dataset, no specific institutional identifiable information will be included.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0990-xxxx. The time required to complete this information collection is estimated to average 10 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer

Tissue Banking Activities & Tissue Types Handled
Which activity(ies) does your tissue bank perform?	□authorization □informed consent □donor screening □recovery □ acquisition (BT) □processing □storage □distribution □donor testing
What type(s) of human tissue does your tissue bank handle?	□musculoskeletal □cardiac □vascular □skin □autologous □cellular tissue □ birth tissue □osteoarticular graft □surgical bone □dura mater
Indicate inspections of your tissue bank that took place during the calendar year of this survey (choose all that apply and complete columns for rows with a box checked)
Inspection Authority	Total number of facilities inspected (including satellite facilities)	Total number of citations of noncompliance (e.g., FDA 483s, nonconformity, etc)
□American Association of Tissue Banks
□United States Food and Drug Administration
□Australia TGA
□Korean FDA
□Other national authority (specify)
State Agencies
□Florida
□New York
□California
□Maryland
□Georgia
□Other states (Specify)
Identify any other authority that inspected your organization
□CLIA
□ISO
□CAP
□AOPO
□EBAA
□Another tissue bank (or a party on behalf of another tissue bank)
□Other (List)