State Program Satisfaction Survey for Remote Assessments (ORA)

OMB Control No: 0910-0360 Expiration Date: 10/31/2023

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not 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 0910-0360. The time required to complete this information collection is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

This federally sponsored study is conducted on behalf of the U.S. Food and Drug Administration.

OHAFO/IO/Audit Staff State Program Satisfaction Survey for Remote Assessments

1. How would you rate your frustration level in participating in your most recent remote assessment?

Scale: 1 = unbearably frustrating, 2 = pretty frustrating, 3 = somewhat frustrating, 4 = little frustrating, 5 = no frustration

2. How would you rate the overall success of the remote assessment for determining Implementation? 

Note: Implementation for this purpose means the assessment activities employed (questions used or needed to clarify) to determine if required written documents are fit for use and meet individual elements.

Scale: 1 = not successful, 2 = partially successful, 3 = neither successful or unsuccessful, 4 = mostly successful, 5 = fully successful

3. How would you rate the overall success of the remote assessment for determining Conformance? (Applicable to MFRPS assessments only)

Scale: 1 = not successful, 2 = partially successful, 3 = neither successful or unsuccessful, 4 = mostly successful, 5 = fully successful

4. How would you rate the success or failure of the remote computer technology including connectivity during the remote assessment.

Scale: 1 = not successful, 2 = partially successful, 3 = neither successful or unsuccessful, 4 = mostly successful, 5 = fully successful

5. Thinking of your most recent remote assessment, what surprised you, what went well, and what would you suggest we improve in the remote assessment process?

a) I was surprised that ____________________________________.

b) _________________ went really well during the assessment

c)  We should do _______________________ to improve the remote assessment process.