Information Collection

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

IC 231073 under ICR 201712-0910-001 · OMB 0910-0695.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.