Information Collection

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020

IC 241197 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⚠️ Notice: This information collection may be referencing outdated material.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
Advance Email.docx	Other-Advance Email
Invitation.docx	Other-Invitation
Consent Form.docx	Other-Consent Form
Moderator Guide.docx	Other-Moderator Guide
Confirmation Script.docx	Other-Confirmation Script
Recruitment Screener - Web.docx	Other-Screener - Web
Recruitment Screener - Phone.docx	Other-Screener - Telephone
Biosimilar Basics Infographic.pdf	Other-Infographic
FDA Facts About Biosimilars Article.pdf	Other-FDA Facts Article
0695 OMB Approval Memo Biosimilars Drugs 2020.docx OMB Approval Memo	IC Document

IC Title:

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient Focus Groups 2020

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-Advance Email	Advance Email.docx	Yes	No	Printable Only
Other-Invitation	Invitation.docx	Yes	No	Printable Only
Other-Consent Form	Consent Form.docx	Yes	Yes	Fillable Fileable
Other-Moderator Guide	Moderator Guide.docx	Yes	No	Printable Only
Other-Confirmation Script	Confirmation Script.docx	Yes	No	Printable Only
Other-Screener - Web	Recruitment Screener - Web.docx	Yes	Yes	Fillable Fileable
Other-Screener - Telephone	Recruitment Screener - Phone.docx	No		Paper Only
Other-Infographic	Biosimilar Basics Infographic.pdf	Yes	No	Printable Only
Other-FDA Facts Article	FDA Facts About Biosimilars Article.pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 144

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	144	144
Annual IC Time Burden (Hours)	292	292
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 Biosimilars Drugs 2020.docx	04/07/2020

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