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⚠️ Notice: This information collection may be referencing outdated material.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 Moderators Guide.docx Other-Consumer Moderator's Guide
Attachment H - HCP Moderator's Guide.docx Other-Healthcare Professionals Moder
0497 OMB Justification Memo 2019.docx OMB Justification Memo 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:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
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
Other-Consumer Moderator's Guide	Attachment G - Consumer Moderators Guide.docx	Yes	No	Printable Only
Other-Healthcare Professionals Moderator's Guide	Attachment H - HCP Moderator's Guide.docx	Yes	No	Printable 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 %

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

Documents for IC

Title	Document	Date Uploaded
OMB Justification Memo	0497 OMB Justification Memo 2019.docx	08/16/2019

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