FOCUS GROUPS ABOUT DRUG PRODUCTS

Forms and Documents

Document	Type	Status	Availability
FDA CDER Abbreviated SS.doc	Supplementary Document	Uploaded 2010-11-03	Available
Supporting Statement B - FOCUS GROUPS ABOUT DRUG PRODUCTS - 2011 01 07.doc	Supporting Statement B	Uploaded 2011-01-10	Available
Supporting Statement A - FOCUS GROUPS ABOUT DRUG PRODUCTS - 2011-01-06.doc	Supporting Statement A	Uploaded 2011-01-10	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
209154	Focus Groups to Investigate Specific Terminology in Prescription Drug Promotion	Other-Informed Consent	New
199900	Conducting Focus Groups & In Depth Interviews to Understand Perceptions Of/Attitudes toward FDA CDER Drug Safety Communications	Other-Moderator Guide - FDA CDER TASK II	New
199093	Concept Testing for Online Pharmacy Communications Campaign	Other-FDA Informed Consent Form Concept Testing	New
198180	Testing Messages to Improve Consumer Knowledge about Prescription Drug Risks and Benefits	Other-Consumer FGs Risk vs Benefit Draft Screener	New
197582	Investigating Online Drug Buying Knowledge and Attitudes"	Other-Moderator's guide	New
197452	Examination of Online Direct-to-Consumer Prescription Drug Promotion	Other-consent form	New
196370	Investigation of Issues Related to Direct-to-Consumer (DTC) Advertising	Other-HIV - Moderator Guide	New

ICR Details

OMB Control No: 0910-0677	ICR Reference No: 201008-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: FOCUS GROUPS ABOUT DRUG PRODUCTS
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/11/2011
	Date Received in OIRA: 08/09/2010
Terms of Clearance: This generic clearance for FDA/CDER focus groups is approved for 3-years under the following conditions: (1) For individual focus groups, FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, number of focus groups, justification for any proposed incentive, and estimated burden); (b) the participant screener, and (c) moderator guide. (2) OMB will respond with clearance or questions within 10 working days. (3) OMB and FDA will jointly evaluate the generic clearance in 18-months; FDA will provide a summary of each collection approved under the generic clearance (e.g., use of information) and an overview of the studies likely to be submitted in the next 18-months.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved
Responses	1,440	0	0
Time Burden (Hours)	2,520	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) is requesting approval for collecting information through the use of focus groups for studies involving drug products that are 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.

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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:
	75 FR 13548	03/22/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 39541	07/09/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Concept Testing for Online Pharmacy Communications Campaign
Investigation of Issues Related to Direct-to-Consumer (DTC) Advertising
Conducting Focus Groups & In Depth Interviews to Understand Perceptions Of/Attitudes toward FDA CDER Drug Safety Communications
Testing Messages to Improve Consumer Knowledge about Prescription Drug Risks and Benefits
Focus Groups to Investigate Specific Terminology in Prescription Drug Promotion
Investigating Online Drug Buying Knowledge and Attitudes"
Examination of Online Direct-to-Consumer Prescription Drug Promotion

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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	1,440	0	0	1,440	0	0
Annual Time Burden (Hours)	2,520	0	0	2,520	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information for the Center for Drug Evaluation and Research.

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Annual Cost to Federal Government: $200,000

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 08/09/2010

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