Request for Generic Clearance of FDA, Testing Communications On Drugs

Forms and Documents

Document Name	Status
Abbreviated SS.doc Supplementary Document	2011-09-27
PART B SUPPORTING STATEMENT DSDPC Generic Clearance.doc Supporting Statement B	2011-08-31
PART A SUPPORTING STATEMENT FOR DSDPC Generic Clearance FINAL 6-7-11.doc Supporting Statement A	2011-06-07

IC Document Collections

IC ID	Document Title	Status
213206	Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements Other-Appendix A	New
210814	Cognitive Interviews for Risk and Benefit Perception Scale Development Study Other-Guide & Questionnaire	New
205722	Stimuli Development and Pretests for an Attentional Effects Study Other-Survey	New
203522	Consumer and provider understanding of safety issues around online purchase of imported drugs -- Modification to Restore Respondents Other-Provider (groups 2&3) interview guide	New
201833	Testing Communications about FDA-regulated Products: Qualitative Feedback on FDA-generated Sunscreen Videos Other-Sunscreen Communication Testing Survey	New
201601	Consumer and Provider Understanding of Safety Issues around Online Purchase of Imported Drugs Other-Interview Guide for Consumers	New

ICR Details

OMB Control No: 0910-0695	ICR Reference No: 201106-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Request for Generic Clearance of FDA, Testing Communications On Drugs
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: 10/12/2011
	Date Received in OIRA: 06/08/2011
Terms of Clearance: This generic clearance for FDA/CDER is approved for 3 years under the following conditions: (1) For individual "tests," 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, justification for any proposed incentive, etc.); (b) participant screeners, and (c) instruments/moderator guides. (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	10/31/2014	36 Months From Approved
Responses	19,822	0	0
Time Burden (Hours)	4,757	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of the information collection is to provide tools to assess the need for communications on specific topics and to assist in the development and modification of communication messages to promote public health and compliance with regulations. FDA is requesting approval for collecting information through a variety of research methods for developing and testing communications involving drug products that are regulated by FDA.

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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:
	76 FR 6800	02/08/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 32217	06/03/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Cognitive Interviews for Risk and Benefit Perception Scale Development Study
Consumer and Provider Understanding of Safety Issues around Online Purchase of Imported Drugs
Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements
Testing Communications about FDA-regulated Products: Qualitative Feedback on FDA-generated Sunscreen Videos
Stimuli Development and Pretests for an Attentional Effects Study
Consumer and provider understanding of safety issues around online purchase of imported drugs -- Modification to Restore Respondents

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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	19,822	0	0	19,822	0	0
Annual Time Burden (Hours)	4,757	0	0	4,757	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 generic IC.

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Annual Cost to Federal Government: $2,209,708

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: 06/08/2011

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