View Information Collection Request (ICR) Package
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Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View Generic ICR - OIRA Conclusion
OMB Control No:
0910-0497
ICR Reference No:
200803-0910-002
Status:
Historical Active
Previous ICR Reference No:
200711-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Focus Groups as Used by the Food and Drug Administration
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/28/2008
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/20/2008
Terms of Clearance:
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
Expiration Date
02/28/2011
02/28/2011
02/28/2011
Responses
5,148
0
2,574
Time Burden (Hours)
8,504
0
4,252
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 355
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
72 FR 14279
03/27/2007
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 58309
10/15/2007
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
18
IC Title
Form No.
Form Name
"Make Your Calories Count Focus Group Study"
Barriers to Label Use Focus Group Study
Establishing a Baseline for Consumer Knowledge about Medical Product Benefits and Risks
FDA FOCUS GROUP- 'Sodium Reduction Education"
FDA Focus Group , Identification of Barriers and Opportunities for Clinical Research
Factors related to Listeriosis Prevention in Pregnant Women: a Focus Group Study
Focus Group Research with Physicians Regarding Drug Risk/Benefit Analysis in Variations of Display Pages of Print Direct-to-Consumer Prescription Drug Advertisements
Focus Group- Restaurant Menu Labeling
Food Recalls, Food Safety, and Microwave Safety Focus Group Study
Gluten-Free Labeling of Food Products
Health Care Practitioners' Responses to Medical Device Labeling
Investigation of Consumer and Physician Beliefs about Direct-to-Consumer (DTC) Advertising
Nutrition Facts Label Design Focus Groups
Nutrition Facts Label Focus Groups
Nutrition Symbols Focus Group Study
Risk Communication Strategies for Medical Countermeasure Distribution
Risk Managers' Focus Group: Adverse Event Reporting Practices for Tissue and Cell Products
Warning Labels and Consumer Understanding
ICR Summary of Burden
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
5,148
2,574
0
0
2,574
0
Annual Time Burden (Hours)
8,504
4,252
0
0
4,252
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$160,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jonnalynn Capezzuto 3018274659
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
03/19/2008
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