Assessments of Patient and Patient Advocate Experience with the FDA For Patients Website, Patient Listening Sessions, and Patient Affairs Staff Inquiry System

Appendix III: PAS Inquiry System

Questionnaire Webform

PRA Statement

OMB Control No. 0910-0697

Expiration Date: 12/31/2020        

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 for this information collection is 0910-0697 and the expiration date is 12/31/2020. The time required to complete this information collection is estimated to average 3 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestion for reducing burden to [email protected].

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

Questionnaire (3 min)

1. Name: Enter information in free text

2. Name of group (if applicable): Enter information in free text

3. Patient type: Choice of (i) Individual patient, caregiver, or advocate or (ii) Patient group

4. Ask a question or request a meeting: Choice of (i) Ask a question or (ii) Request a meeting

5. Product type: Choice of (i) Medical device, (ii) Drug, (iii) Biologic, (iv) None/unknown

6. Select a program, if known: TBD

7. Name of disease or condition: Enter information in free text

8. Tell us about your question or meeting request (e.g., purpose, agenda, attendees, timeline, etc.): Enter information in free text

9. How we may contact you (E-mail, phone, address): Choice of (i) E-mail, (ii) Phone, or (iii) Address

10. E-mail address, Phone, or Address: Enter information in free text