Focus Groups as Used by the Food and Drug Administration

ICR 201404-0910-001

OMB: 0910-0497

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2014-04-01
Supporting Statement B
2011-02-02
Supplementary Document
2011-02-10
Supplementary Document
2011-02-02
Supporting Statement A
2011-03-08
ICR Details
0910-0497 201404-0910-001
Historical Active 201103-0910-003
HHS/FDA Generic
Focus Groups as Used by the Food and Drug Administration
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/02/2014
Retrieve Notice of Action (NOA) 04/16/2014
  Inventory as of this Action Requested Previously Approved
06/30/2014 06/30/2014 06/30/2014
1,915 0 1,440
2,575 0 2,520
0 0 0

The Food and Drug Administration (FDA) is requesting approval for collecting information through the use of focus groups for studies involving all products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency. This information may also be used to help develop communication messages and campaigns. Focus groups play an important role in gathering information because they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic.

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

Not associated with rulemaking

  75 FR 74061 11/30/2010
76 FR 6802 02/08/2011
No

  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 1,915 1,440 0 0 475 0
Annual Time Burden (Hours) 2,575 2,520 0 0 55 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to add 55 burden hours and 475 annual responses. No other changes are occurring.

$200,000
Yes Part B of Supporting Statement
No
No
No
No
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.
04/16/2014


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