Generic Clearance: Quantitative Data on Tobacco Products and Communications
OMB Control Number 0910-0810
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 Control Number and expiration date.
Delete all italicized instructions.
HOW TO USE THIS TEMPLATE
This template utilizes fill-in enabled text form fields. Simply click on the shaded text and enter your narrative.
Center for Tobacco Products
OMB Control Number 0910-0810
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
[ ] Experimental Study |
[ ] Survey |
[ ] Other (Describe): |
Provide details about how the information will be collected (e.g., web-based, telephone, social media) and who (e.g., contractor) will conduct.
Confidentiality of Respondents
Describe any assurance of
confidentiality provided to respondents and the basis for the
assurance.
[For
example, methods of assuring confidentiality may include not linking
Personally Identifiable Information (PII; e.g., names and contact
information) with respondents’ data from the information
collection, and storing the data in a password-protected folder
accessible only to staff working on the project.]
Cite and describe
Privacy Impact Assessment (PIA), # XXXXX.
[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) 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.
Round up to whole numbers for the total burden
hours.
Type of Information Collection/Category of Respondent/Activity |
Number of Respondents |
Participation Time (choose hours or minutes) |
Total Burden (hours) |
Youth aged 13–17
|
200 |
.25 hour (15 minutes) |
50 |
Youth aged 13–17
|
120 |
1 hour |
120 |
Totals |
200 |
|
170 |
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. Otherwise use the
month and year, only, allowing for a 30 day review time at APRA.
FDA Contacts
Program Office Contact |
FDA PRA Contact |
Insert name,
email Center for Tobacco Products |
Insert name,
email Office of Operations |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | OMBMemoMERCPtP |
| Subject | MERC OMB MEP |
| Author | Hillabrant |
| File Modified | 0000-00-00 |
| File Created | 2024-12-30 |