GEN IC REQUEST TEMPLATE
Generic
Clearance for the Collection of qualitative Data on
Tobacco
Products and communications (CTP)
OMB Control Number 0910-0796
BEFORE SUBMISSION
Ensure that your Gen IC meets the requirements of the umbrella generic. This generic facilitates FDA’s ability to assess the need for communications on specific topics and to assist in the development and modification of communication messages.
All documents submitted with this gen IC should indicate FDA sponsorship and display the current OMB approval expiration date and PRA Statement as provided for in the APRA document “Displaying PRA Information on Instruments”.
HOW TO USE THIS TEMPLATE
This template utilizes fill-in enabled text form fields. Simply click on the shaded text and enter your narrative.
U.S.
Food and Drug Administration
Generic Clearance for the
Collection of qualitative Data on
Tobacco Products and
Communications (CTP)
OMB
Control Number 0910-0796
Gen IC Request for Approval
Title of Gen IC: Provide the name of the collection of information that is the subject of the request.
Statement of Need
Provide a brief description of the purpose of this collection.
Intended
Use of the Information
Indicate how the
information will be used and if this is part of a larger study or
effort.
Description of Respondents
Describe participants/respondents.
How the Information is Collected
Provide details about how the information will be collected (e.g., individual in-depth interviews, focus group, intercept interviews, self-admnistered survey, omnibus survey) and who (e.g., contractor) will facilitate.
Confidentiality of Respondents
Describe any assurance of confidentiality provided to respondents.
[You may provide this statement on your survey instrument]: “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-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.”
Amount and Justification for Proposed Incentive
What is the amount, if any, of the incentive offered? Provide a detailed justification as to why this group of respondents for this information collection will receive a stipend, reimbursement of expenses, token of appreciation.
Questions of a Sensitive Nature
Describe and provide justification.
Description of Statistical Methods
Describe sample size and method of selection.
Burden
Replace the content of the example table below with the
estimated burden for this gen IC.
Participation time may be
in the format of hours or minutes (use a decimal) and indicated in
the heading.
Burden Hour Computation:
Number of Respondents multiplied by participation time = total burden
hours. Data in all fields of the table must be entered,
including totals where indicated.
Be sure
not to double count respondents. In the example below the Number of
Respondents is 3,450 because this total includes screened
respondents. Round up to whole numbers for the total burden hours; do
not use decimals. Delete this italicized instruction prior
to submission.
Respondent Type/Category |
Activity (if this column is not needed, please delete) |
Number of Respondents |
Participation Time (choose hours or minutes) |
Total Burden (hours) |
Parents/guardians of youth aged 13–17 |
Parental Consent |
3,450 |
2 |
115 |
Youth aged 13-17 |
Screening |
3,450 |
4 |
230 |
Youth aged 13–17 |
Assent |
152 |
2 |
5 |
Youth aged 13-17 |
Focus Group |
152 |
95 |
241 |
Young Adults aged 18-20 |
Screening |
1,710 |
4 |
114 |
Young Adults aged 18-20 |
Consent |
100 |
2 |
3 |
Young Adults aged 18-20 |
Focus Group |
100 |
95 |
158 |
Totals |
|
3,450 |
--- |
866 |
Date(s) to be Conducted
Insert date(s) and locations, if applicable.
Requested Approval Date
Insert date if shorter than 10 day turn-around time as noted in the SSA and include reason for expedited review. Otherwise use the month and year, only, allowing for a 15 day review time at APRA.
FDA Contacts
Program Office Contact |
FDA PRA Contact |
Insert name,
email Center for Tobacco Products |
Insert name, email [to
be completed by APRA] Office of Operations |
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Title | OMBMemoMERCPtP |
Subject | MERC OMB MEP |
Author | StClair, Christopher |
File Modified | 0000-00-00 |
File Created | 2024-07-22 |