Focus Groups as Used by the Food and Drug Administration

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
add 4252 back into 0497 83-c.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2008-03-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
196121	FDA FOCUS GROUP- 'Sodium Reduction Education"	Other-Draft Moderator`s Guide	New
195584	Health Care Practitioners' Responses to Medical Device Labeling	Instruction	New
195269	Investigation of Consumer and Physician Beliefs about Direct-to-Consumer (DTC) Advertising	Instruction	New
195005	Focus Group- Restaurant Menu Labeling	Other-Moderator's Guide	New
193902	"Make Your Calories Count Focus Group Study"	Other-Focus Goup Study- Participant Screener	New
192571	Warning Labels and Consumer Understanding	Other-screener	New
192041	Establishing a Baseline for Consumer Knowledge about Medical Product Benefits and Risks	Other-focus group screener	New
191527	Risk Communication Strategies for Medical Countermeasure Distribution	Other-moderator's guide	New
190826	Risk Managers' Focus Group: Adverse Event Reporting Practices for Tissue and Cell Products	Other-focus group script	New
190479	FDA Focus Group , Identification of Barriers and Opportunities for Clinical Research	Other-Seven Questions	New
189701	Factors related to Listeriosis Prevention in Pregnant Women: a Focus Group Study	Other-fogus group moderator's guide	New
188661	Food Recalls, Food Safety, and Microwave Safety Focus Group Study	Other-participant screener	New
188005	Gluten-Free Labeling of Food Products	Other-Screener Questions	New
186204	Focus Group Research with Physicians Regarding Drug Risk/Benefit Analysis in Variations of Display Pages of Print Direct-to-Consumer Prescription Drug Advertisements	Other-Focus Group Moderator Guide and Screener	New
185273	Barriers to Label Use Focus Group Study	Other-Focus Group Appendix 1	New
185237	Nutrition Symbols Focus Group Study	Other-Focus Group Screener-Appendix 1	New
184496	Nutrition Facts Label Design Focus Groups	Other-Focus Group Screener	New
184358	Nutrition Facts Label Focus Groups	Other-Focus Group Moderator's Guide	New

ICR Details

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
	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).

table that charts list comparision

	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

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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.

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Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 18

table that charts list of burden

IC Title	Form No.	Form Name
Risk Communication Strategies for Medical Countermeasure Distribution
Nutrition Symbols Focus Group Study
FDA Focus Group , Identification of Barriers and Opportunities for Clinical Research
Nutrition Facts Label Focus Groups
Risk Managers' Focus Group: Adverse Event Reporting Practices for Tissue and Cell Products
Establishing a Baseline for Consumer Knowledge about Medical Product Benefits and Risks
Warning Labels and Consumer Understanding
"Make Your Calories Count Focus Group Study"
Health Care Practitioners' Responses to Medical Device Labeling
FDA FOCUS GROUP- 'Sodium Reduction Education"
Investigation of Consumer and Physician Beliefs about Direct-to-Consumer (DTC) Advertising
Food Recalls, Food Safety, and Microwave Safety Focus Group Study
Nutrition Facts Label Design Focus Groups
Gluten-Free Labeling of Food Products
Factors related to Listeriosis Prevention in Pregnant Women: a Focus Group Study
Focus Group- Restaurant Menu Labeling
Barriers to Label Use 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

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ICR Summary of Burden

table that charts list 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:

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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

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Common Form ICR:  No

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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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