Change Request Memo

CENTER FOR TOBACCO PRODUCTS

Change Request for OMB Control No. 0910-0915

The Real Cost Campaign Outcomes Evaluation Study: Cohort 3 (Outcomes Study)

February 2024

The Food and Drug Administration (FDA or we) is seeking OMB approval of this nonmaterial/non-substantive change request to update baseline study documents for use in follow-up waves of data collection.

Overview of Changes to Documents

Document	Tracked Change Documents	Description of Major Changes
Supporting Statement Part A		Clarified when non-substantive edits will be made to survey items and updated study personnel. Corrected error on how long records with PII are kept. Additional procedures for contacting longitudinal participants. Revisions to the burden table (decrease in total burden).
Supporting Statement Part B		Updated study personnel; minor edits to “Test of procedures/methods” section.
Assent/ Consent Documents: Attachments 4, 5a, 5b, 6		Revised to collect email address from parent/guardian and teen participants.
Survey: Attachment 9		Minor revisions of tobacco use items to align with other research and to improve the validity of these items. Added additional instruction text throughout the survey. Added new risk perception measures (Section E) to align with current and upcoming The Real Cost ads. Removed risk perception measures (Section E) no longer needed.
Attachments 3 (Postcards); 10 (Text Messages); 11a (Initial Lead Letter); 14 (Incentive Thank you Letter); 15 (E-mail reminder); 23 (Invitation Emails)		Addition of text based on survey status of participants, including language for Follow-up 1-3 contacts. Revisions to procedures to contact participants that are 14+.
Eligibility letters/emails: Attachments 19 and 20		Revisions to adapt the documents for the Follow-up 2 replenishment sample.
Attachments 21 (study Q&A) and 22 (website mockup)		Added sample-specific language to accommodate longitudinal and replenishment samples.
Attachment 24 (Panel Maintenance for Follow-up)		New attachment for updating participant contact information for Follow-ups 1-3.
Attachment 25 (Reminder Letters for Follow-up 1-3)		New attachment for sending reminder letters for participants in Follow-up 1-3.