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OMB Control No: 0910-0695	ICR Reference No: 201701-0910-014
Status: Historical Active	Previous ICR Reference No: 201607-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: IMPROVE Study Phase 2
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: 01/23/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/19/2017
Terms of Clearance: Prior terms remain in effect. 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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	12/31/2017	12/31/2017
Responses	20,500	0	20,500
Time Burden (Hours)	9,500	0	9,500
Cost Burden (Dollars)	0	0	0

Abstract: Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews. FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.

Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FD&C Act

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:
	79 FR 19096	04/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 58786	09/30/2014
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	20,500	20,500
Annual Time Burden (Hours)	9,500	9,500
Annual Cost Burden (Dollars)	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: The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-I) to add 9,500 burden hours and 20,500 annual responses. This generic clearance was originally thought to include projects originating in only the Center for Drug Evaluation and Research but because various programs within FDA deal with drug products we experienced more use of this generic approval then anticipated and, therefore, require an increase in hours until the expiration date in 2017.

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

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

View Generic ICR - OIRA Conclusion