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

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⚠️ Notice: This information collection may be referencing outdated material.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
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

Information Collection (IC) Details

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:

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 %

	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

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.