OMB approval memo

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE

OF CUSTOMER SATISFACTION SURVEYS (0910-0360)

The generic clearance will only be used for customer satisfaction and website usability surveys where FDA seeks to gather information that is planned for internal use only, and can provide a justification for qualitative or anecdotal collections that may nonetheless produce useful information for program and service improvement.

TITLE OF INFORMATION COLLECTION: Feedback on Patient-Generated Health Data (PGHD) Workshop

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

We will be holding a virtual (webcast only) public meeting on Patient-Generated Health Data on 5/4/21 and wish to evaluate the quality of the meeting so that we can properly plan future public engagement efforts around this topic. Our intent is to gauge the level of satisfaction with the current meeting, as well as elicit feedback and recommendations on how to improve future meetings to meet the needs of all attendees. We will not solicit other types of feedback from respondents.

2. Intended use of information:

We intend to use this information within the Center for Devices and Radiological Health to improve our future public meetings.

3. Description of respondents:

Only attendees of the PGHD virtual (webcast only) public meeting will be asked to provide feedback. We expect members of the medical device industry, patient organizations, research organizations, health care professionals, and payors to join us for the virtual (webcast only) meeting.

4. Date(s) to be Conducted:

May 4, 2021 – June 4, 2021

5. How the Information is being collected:

At the virtual (webcast only) public meeting, we will request that attendees take our feedback survey via an online survey software (e.g., Qualtrics, SurveyMonkey). Additionally, we will send an email to attendees after the virtual (webcast only) meeting requesting their feedback. Attendees may respond to the survey online.

6. Confidentiality of Respondents:

Using the statement below, we will inform respondents that their participation is completely voluntary and that their responses will be kept private.

“Your participation / nonparticipation is completely voluntary and your responses will not have an effect on your eligibility for receipt of any FDA services. All respondent identification and information will be anonymous unless otherwise indicated. In instances where respondent identity is needed (e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.”

7. Amount and justification for any proposed incentive

No incentive proposed.

8. Questions of a Sensitive Nature (Data will be kept private to the extent allowed by the law)

We will not be collecting data that is of a sensitive nature.

9. Description of Statistical Methods

This survey collects qualitative information. We will use standard descriptive statistics (e.g., measures of distribution and central tendency, dispersion, etc.) when appropriate. For non-numerical feedback, we will cluster ideas by topic.

BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or participation time in minutes (/60) = annual burden hours):

Type/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)
Public Meeting Attendee	300	10	50

REQUESTED APPROVAL DATE: April 27, 2021

NAME OF PRA ANALYST & PROGRAM CONTACT:

Ila S. Mizrachi

Paperwork Reduction Act Staff

ila.mizrachi@fda.hhs.gov

301-796-7726

Abigail Corbin

Abigail.Corbin@fda.hhs.gov

301-796-9142

Christina Webber

Christina.Webber@fda.hhs.gov

301-796-3351

FDA CENTER: Center for Devices and Radiological Health

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