Focus Groups as Used by the Food and Drug Administration

ICR 200711-0910-006

OMB: 0910-0497

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2007-10-12
Supporting Statement A
2007-11-20
ICR Details
0910-0497 200711-0910-006
Historical Active 200603-0910-001
HHS/FDA
Focus Groups as Used by the Food and Drug Administration
Extension without change of a currently approved collection   No
Regular
Approved without change 02/05/2008
Retrieve Notice of Action (NOA) 11/20/2007
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 36 Months From Approved 02/29/2008
2,574 0 2,574
4,252 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.

US Code: 21 USC 355 Name of Law: FFDCA
  
None

Not associated with rulemaking

  72 FR 14279 03/27/2007
72 FR 58309 10/15/2007
No

1
IC Title Form No. Form Name
Focus Groups as Used by the Food and Drug Administration

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 2,574 2,574 0 0 0 0
Annual Time Burden (Hours) 4,252 4,252 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$160,000
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto 3018274659

  No

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.
11/20/2007


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