Focus Groups on Perceptions of Prescription Drug Promotion and Approval Review Process (Formative Research)

Focus Groups as Used by the Food and Drug Administration

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0497 can be found here:

Documents and Forms

Document Name Document Type
Attachment A - Recruitment Advertisements.docx Other-Advertisements
Attachment B - Consumer and HCP Screeners.docx Other-Consumer and Healthcare Profes
Attachment C - Consumer Reminder Script and Email.docx Other-Consumer Reminder Script and E
Attachment D - HCP Reminder Script and Email.docx Other-Healthcare Professionals Remin
Attachment E - Consumer Informed Consent.docx Other-Consumer Informed Consent
Attachment F - HCP Informed Consent.docx Other-Healthcare Professionals Infor
Attachment G - Consumer Moderator's Guide.docx Other-Consumer Moderator's Guide
Attachment H - HCP Moderator's Guide.docx Other-Healthcare Provider Moderator'
0497 OMB Justification Memo 2019.docx OMB Justification Memo IC Document
0497 Nonsub Change Request November 2019.doc 0497 Nonsub Change Request IC Document

Information Collection (IC) Details

IC Title:	Focus Groups on Perceptions of Prescription Drug Promotion and Approval Review Process (Formative Research)	Agency IC Tracking Number:

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Consumer Moderator's Guide	Attachment G - Consumer Moderator's Guide.docx	Yes	No	Printable Only
Other-Healthcare Provider Moderator's Guide	Attachment H - HCP Moderator's Guide.docx	Yes	No	Printable Only
Other-Advertisements	Attachment A - Recruitment Advertisements.docx	Yes	No	Printable Only
Other-Consumer and Healthcare Professionals Screeners	Attachment B - Consumer and HCP Screeners.docx	Yes	No	Printable Only
Other-Consumer Reminder Script and Email	Attachment C - Consumer Reminder Script and Email.docx	Yes	No	Printable Only
Other-Healthcare Professionals Reminder Script and Email	Attachment D - HCP Reminder Script and Email.docx	Yes	No	Printable Only
Other-Consumer Informed Consent	Attachment E - Consumer Informed Consent.docx	Yes	No	Paper Only
Other-Healthcare Professionals Informed Consent	Attachment F - HCP Informed Consent.docx	Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 200	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	200	0	200
Annual IC Time Burden (Hours)	0	-185	185
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
OMB Justification Memo	0497 OMB Justification Memo 2019.docx	08/16/2019
0497 Nonsub Change Request	0497 Nonsub Change Request November 2019.doc	11/18/2019

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