Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups and INterviews with Healthcare Professionals

Data to Support Drug Product Communications

⚠️ Notice: This information collection may be referencing outdated material.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
Focus Group and IDI Screener.docx Other-Survey Instrument
Consent Form focus groups.docx Other-Consent form - focus groups
Consent Form individual interviews.docx Other-Consent form - individual grou
Screening Invitation Email.docx Other-Invitation Email
Appointment Confirmation Email.docx Other-Appointment confirmation email
FDA Biosimilar Interview Guide.docx Other-Interview guide
FDA Biosimilar Moderator Focus Group Guide.docx Other-Moderator guide
0695 OMB approval memo for Biosimilar Drug Products.doc OMB approval memo IC Document

Information Collection (IC) Details

IC Title:	Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups and INterviews with Healthcare Professionals	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-Survey Instrument	Focus Group and IDI Screener.docx	Yes	No	Paper Only
Other-Consent form - focus groups	Consent Form focus groups.docx	Yes	No	Paper Only
Other-Consent form - individual groups	Consent Form individual interviews.docx	Yes	No	Paper Only
Other-Invitation Email	Screening Invitation Email.docx	Yes	No	Paper Only
Other-Appointment confirmation email	Appointment Confirmation Email.docx	Yes	No	Paper Only
Other-Interview guide	FDA Biosimilar Interview Guide.docx	No		Paper Only
Other-Moderator guide	FDA Biosimilar Moderator Focus Group Guide.docx	No		Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 316	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	316	316
Annual IC Time Burden (Hours)	263	263
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB approval memo	0695 OMB approval memo for Biosimilar Drug Products.doc	04/16/2018

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