0497 Focus Group Justification Template

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE

OF FOCUS GROUPS (0910-0497)

Focus groups do not yield meaningful quantitative findings. They can provide public input, but they do not yield data about public opinion that can be generalized. As such, they cannot be used to drive the development of policies, programs, and services. Policy makers and educators can use focus groups findings to test and refine their ideas, but should then conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies.

TITLE OF INFORMATION COLLECTION: [insert]

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

[insert]

2. Intended use of information:

[insert]

3. Description of respondents:

[insert]

4. Date(s) to be conducted and location(s):

[insert]

5. How the Information is being collected:

[insert]

6. Number of focus groups:

[insert]

7. Amount and justification for any proposed incentive:

[insert]

8. Questions of a Sensitive Nature:

[insert]

9. Description of Statistical Methods ( I.E. Sample Size & Method of Selection):

[insert]

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

Type/Category of Respondent	No. of Respondents	Participation Time (minutes)	Burden (hours)

REQUESTED APPROVAL DATE: [insert]

NAME OF PRA ANALYST & PROGRAM CONTACT: [insert]

FDA CENTER: [insert]

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