GEN IC REQUEST TEMPLATE
Generic Clearance: Request for Data to Support Social and Behavioral Research
OMB Control Number 0910-0847
BEFORE SUBMISSION
Ensure that your gen IC meets the requirements of the umbrella generic. This generic facilitates FDA’s ability to better understand patients, consumers, and health care providers perceptions and behaviors regarding various issues and patient reported outcomes associated with the safety and administration of drug products overseen by the agency.
All documents submitted with this gen IC should indicate FDA sponsorship and display the current OMB approval expiration date.
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: Request for Data
to Support Social and Behavioral Research
OMB Control Number
0910-0847
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., focus group, interviews, 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 (see highlight).
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.
Be sure not to double count respondents. In the example
below the Number of Respondents is 200 because focus group
respondents have been counted as part of the focus group screener
respondents. (The focus group respondents are part of the screener
group.) Round up to whole numbers for the total burden hours; do not
use decimals. Delete this italicized instruction prior to
submission.
|
Number of Respondents |
Participation Time (choose hours or minutes) |
Total Burden (hours) |
Focus group screener respondents |
200 |
1 hour |
200 |
Focus group respondents |
120 |
1 hour |
120 |
Totals |
200 |
2 hours |
320 |
Date(s) to be Conducted
Insert date(s) and locations, if applicable.
Requested Approval Date
Insert date.
FDA Contacts
Program Office Contact |
FDA PRA Contact |
Insert name,
email Center for Drug Evaluation and Research |
Insert name,
email 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 | 2023-11-05 |