This generic clearance for FDA focus groups is approved for 3 years under the following conditions: 1) FDA shall submit memos for individual focus groups (e.g., statement of need, intended use of information, description of respondents, information collection procedures, justification for incentive, estimated burden, participant screener, and moderator guide). 2) OMB will respond with clearance or questions within 10 working days 3) OMB and FDA will jointly evaluate the generic clearance upon resubmission in 3 years. Upon resubmission, FDA will provide a summary of each collection approved under the generic clearance (e.g., use of information).
Inventory as of this Action
Requested
Previously Approved
02/28/2011
02/28/2011
02/28/2011
5,148
0
2,574
8,504
0
4,252
0
0
0
Information gathered from conducting focus groups provides FDA with a more in-depthy understanding of consumers attitudes, beliefs, motivations, and feelings than do quantitiative studies. The information will be used to develop programmatic proposals that are aligned with the respondents' input and supplements other forms of public involvement.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
add 4252 back into 0497 83-c.doc
FDA FOCUS GROUP- 'Sodium Reduction Education"