Pre-Test Study Screener

Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN)

Gen IC Memo Quantitative Testing for the Development of FDA Communications

Pre-Test Study Screener

OMB: 0910-0865

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Request for Approval under the “Generic Clearance for Quantitative Testing for the Development of FDA Communications”
(OMB Control Number: 0910-NEW)

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TITLE OF INFORMATION COLLECTION:
[Provide the name of the collection that is the subject of the request. (e.g. Experimental Study Testing FDA Web Materials on xxxx)]



  1. STATEMENT OF NEED
    [Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.]

  2. TYPE OF COLLECTION

[Check one box.]


[ ] Experiment [ ] Survey


3. PARTICIPANT UNIVERSE AND SAMPLING PLAN

[Describe participants, including justification for their selection, and the sampling frame and sampling method to be used.]


4. INCENTIVE


Is an incentive (e.g., money or reimbursement of expenses, token of (appreciation) provided to participants?) [ ] Yes [ ] No


[If yes, describe the incentive and provide a justification for the amount.]


5. DATA ANALYSIS PLAN

[Describe how the data will be analyzed and reported and discuss how the data will be used.]


6. BURDEN HOURS


Activity: Provide the type of activity (e.g., screener, pre-test, survey)

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey).


BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or participation time in minutes (/60) = annual burden hours):



Activity (by category of respondent, if applicable)

No. of Respondents

Participation Time (minutes)

Burden (hours)









Totals






7. CERTIFICATION:


In submitting this request, I certify the following to be true:

  1. The collections are voluntary;

  2. The collections are low-burden for participants and are low-cost for both the participants and the Federal Government;

  3. The collections are noncontroversial and not of a sensitive nature;

  4. Personally identifiable information (PII) is collected only to the extent necessary1 and is not retained; and

  5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.2


REQUESTED APPROVAL DATE: [insert]



8. NAME OF PRA ANALYST & PROGRAM CONTACT: [insert]



FDA CENTER: [insert]





Please make sure that all instruments, instructions, and scripts are submitted with the request.


1 For example, collections that collect PII in order to provide remuneration for participants of cognitive interviews will be submitted under this request. All privacy act requirements will be met.

2 As defined in OMB and agency Information Quality Guidelines, “influential” means that “an agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important public policies or important private sector decisions.”

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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleDOCUMENTATION FOR THE GENERIC CLEARANCE
Author558022
File Modified0000-00-00
File Created2021-01-15

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