OMB Generic IC Submission Template

United States Food and Drug Administration

Center for Tobacco Products

Generic Clearance: The Real Cost Monthly Implementation Assessment

OMB Control Number 0910-NEW

Gen IC Request for Approval

Title of Gen IC: The Real Cost Monthly Implementation Assessment [Month, Wave X]

1. Statement of Need

Provided in Supporting Statement Part A. The variety of study items from month to month is not significant. Include 1-2 sentences to describe individual (Gen IC) submission.

2. Intended Use of the Information
   
   Provided in Supporting Statement Part A. Include 1-2 sentences to describe individual (Gen IC) submission.

3. Description of Respondents

Provided in Supporting Statement Part A and Supporting Statement Part B. Include 1-2 sentences to describe individual (Gen IC) submission.

4. How the Information is Collected

Provided for in Supporting Statement Part A. Include 1-2 sentences to describe how the information will be collected (e.g., self-administered survey, individual in-depth interviews, focus group) and who (e.g,. contractor) will facilitate.

5. Confidentiality of Respondents
   
   Provided for in Supporting Statement Part A.

6. Amount and Justification for Proposed Incentive

Provided in Supporting Statement Part A. Provide details about incentives for the data collection in the individual (Gen IC) submission.

7. Questions of a Sensitive Nature

Provided in Supporting Statement Part A.

8. Description of Statistical Methods

Provided in Supporting Statement Part B.

9. Burden

Category of Respondent/Activity	Number of Respondents	Participation Time	Total Burden (hours)
Parent Screener		0.05 (3 minutes)
Parent Permission		0.05 (3 minutes)
Invitation Emails (Ages 18-20)		0.02 (1 minute)
Assent (Ages 12-17)		0.05 (3 minutes)
Consent (Ages 18-20)		0.05 (3 minutes)
Online Survey		0.42 (25 minutes)
Mixed Methods		1.5 (90 minutes)
Reminder Emails		0.20 (12 minutes)
Total

10. Date(s) to be Conducted

Insert date(s)

11. Requested Approval Date

Insert date accounting for 10 day approval as noted in the SSA.

12. FDA Contacts

Program Office Contact	FDA PRA Contact
Insert name, email Enter program office Center for Tobacco Products	Insert name, email Paperwork Reduction Act Staff Office of Enterprise Management Services Office of Operations

Please note, the following instruments are not being submitted as part of this GenIC request as no changes have been made since OMB approval:

• Attachment 1. Parent Screener

• Attachment 1. Parent Screener_Spanish Language

• Attachment 3. Screener and Survey Invitation Email

• Attachment 3. Screener and Survey Invitation Email_Spanish Language

• Attachment 4. Parent Guardian Permission

• Attachment 4. Parent Guardian Permission_Spanish Language

• Attachment 5. Youth Assent

• Attachment 5. Youth Assent_Spanish Language

• Attachment 6. Young Adult Consent

• Attachment 6. Young Adult Consent_Spanish Language

• Attachment 7. Parent Reminder Emails

• Attachment 7. Parent Reminder Emails__Spanish Language

• Attachment 8. Participant Reminder Emails 18+

• Attachment 8. Participant Reminder Emails 18+_Spanish Language

4