Change Request Memo

UNITED STATES FOOD & DRUG ADMINISTRATION

Creative Concept Testing Designed to Prevent Youth ENDS, Cigarette and Other Tobacco Product Use

OMB Control Number 0910-0796

Change Request

July 9, 2020

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to update the research delivery mode. Due to the coronavirus (COVID-19) pandemic, Tobacco 21 regulations and the resulting impact to contractor capacity for on-site research operations, FDA seeks OMB concurrence of a non-substantive change to expand our options for data collection and respondent incentives.

We plan to modify our research protocol to reflect the inclusion of young adults, virtual/online focus groups and the use of individual interviews. The original approval outlined in-person focus groups for youth aged 12-17. The change would allow for the provision of conducting research online and in-person during study data collection among an extended age group. This change in protocol will allow for flexibility to conduct research online and in-person, age group expansion for comparison purposes and additional incentive options for online and young adult participation. There is no change to the burden hours.

Overview of the Change Request

• The age of respondents will be extended to 25. After much thought, we realized that accounting for Tobacco 21 regulations requires talking to older young adults as a comparison. Expanding the young adult age group from 18-21 to 18-25 will allow us to compare 18-21 year-olds to both youth participants as well as older young adults.

• Minimum participant numbers for groups will be reduced to accommodate differences in our ability to recruit for online research.

• For online research, youth participants will receive a $25 token of appreciation for participating; the parent/guardian of the youth will not receive a token of appreciation. There is no change to the youth participant or parent/guardian of the youth incentive amount for in-person research.

• Young adult participants aged 18-25 will receive an incentive of $50 for online participation and $75 for in-person participation as a token of appreciation.

Tracked and clean versions of the OMB Approval Memo, Parental Permission Form (Appendix A), Youth Assent Form (Appendix B) and Young Adult Consent Form (Appendix B1) are provided as attachments in the below tables.

Change Documentation

Instrument File	Document Type	Change
	OMB Approval Memo	Revised text to include young adults (aged 18-25), individual interviews and virtual focus groups. Updated text for inclusion of socio-cultural determinates of tobacco use discussion. Revised number of focus groups. Updated Section 6. Confidentiality of respondents. Updated Section 7. Amount and justification for any proposed incentive Online/in-person research Young adult participants Updated burden table “Type of Activity” to include young adults and interviews.
	Appendix A – Parental Permission Form	Revised/expanded text to reflect in-person and virtual research. Updated text for inclusion of individual interviews. Revised number of focus groups. Added $25 youth incentive amount for online research participation.
	Appendix B - Youth Assent Form	Revised/expanded text to reflect in-person and virtual research. Updated text for inclusion of individual interviews. Revised number of focus groups. Added $25 youth incentive amount for online research participation.
	Appendix B1 – Young Adult Consent Form	New form Modified from Youth Assent Form to address expanded age group (young adults aged 18-25) Modified incentive amounts to reflect $50 for online participation and $75 for in-person participation.

Clean Documents

Instrument File	Document Type
	OMB Approval Memo
	Appendix A – Parental Permission Form
	Appendix B - Youth Assent Form
	Appendix B1 – Young Adult Consent Form