Information Collection

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups with Patients

IC 236377 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⚠️ Notice: This information collection may be referencing outdated material.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
Split Web and Phone Screener.docx	Other-Split Web and Phone Screener
Consent Form.docx	Other-Consent Form
Screener Invitation Email.docx	Other-Invitation Email
Confirmation Email.docx	Other-Confirmation Email
Moderator Guide.docx	Other-Moderator Guide
InterVu Respondent Invitation Template.docx	Other-InterVu Respondent Invitation
0695 OMB Approval Memo for Addressing Biosimilar Drug Product 2019.docx OMB approval memo	IC Document

IC Title:

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups with Patients

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-Split Web and Phone Screener	Split Web and Phone Screener.docx	Yes	Yes	Fillable Fileable
Other-Consent Form	Consent Form.docx	Yes	Yes	Fillable Fileable
Other-Invitation Email	Screener Invitation Email.docx	Yes	No	Printable Only
Other-Confirmation Email	Confirmation Email.docx	Yes	No	Printable Only
Other-Moderator Guide	Moderator Guide.docx	Yes	No	Printable Only
Other-InterVu Respondent Invitation Template	InterVu Respondent Invitation Template.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: 1,000

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	1,000	1,000
Annual IC Time Burden (Hours)	192	192
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 Addressing Biosimilar Drug Product 2019.docx	06/17/2019

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