IMPROVE Study Phase 2

Data to Support Drug Product Communications as Used by the FDA

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:

Documents and Forms

Document Name Document Type
FDA IMPROVE SURVEY.pdf Other-IMPROVE Survey Instrument
FDA IMPROVE Screener.pdf Other-IMPROVE Survey Screener
FDA IMPROVE PHASE 2 SS.pdf IMPROVE Study Phase 2 Supporting Statement IC Document
FDA IMPROVE Screener Revised 12-19 tracked changes.pdf Revised Screener IC Document
FDA IMPROVE Screener Revised 12-19 clean.pdf Revised Screener clean version IC Document
OMB Amendment Screener Memo 12-19.pdf Non Sub Request Memo re. Screener Revisions IC Document

Information Collection (IC) Details

IC Title:	IMPROVE Study Phase 2	Agency IC Tracking Number:	CDER

IC Status: Unchanged

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-IMPROVE Survey Instrument			FDA IMPROVE SURVEY.pdf		Yes	Yes	Fillable Fileable
Other-IMPROVE Survey Screener			FDA IMPROVE Screener.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 850	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Previously Approved
Annual Number of Responses for this IC	850	850
Annual IC Time Burden (Hours)	170	170
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
IMPROVE Study Phase 2 Supporting Statement	FDA IMPROVE PHASE 2 SS.pdf	10/30/2016
Revised Screener	FDA IMPROVE Screener Revised 12-19 tracked changes.pdf	01/19/2017
Revised Screener clean version	FDA IMPROVE Screener Revised 12-19 clean.pdf	01/19/2017
Non Sub Request Memo re. Screener Revisions	OMB Amendment Screener Memo 12-19.pdf	01/19/2017

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.