Information Collection

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)

IC 247939 under ICR 202206-0910-015 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Advance Email.docx	Other-Advance Email
Consent Form.docx	Other-Consent Form
Consent Form.docx	Other-Consent Form
Interview Invitation.docx	Other-Invitation
Interview Invitation.docx	Other-Invitation
Confirmation Script.docx	Other-Confirmation Script
Confirmation Script.docx	Other-Confirmation Script
Interview Guide.docx	Other-Interview Guide
Interview Guide.docx	Other-Interview Guide
Recruitment Screener - Web.docx	Other-Recruitment Screener - Web
Recruitment Screener - Web.docx	Other-Recruitment Screener - Web
Recruitment Screener - Phone.docx	Other-Recruitment Screener - Telepho
Recruitment Screener - Phone.docx	Other-Recruitment Screener - Telepho
Patient Infographic.pdf	Other-Patience Infographic
Patient Infographic.pdf	Other-Patience Infographic
FDA Bio Diabetes Fact Sheet.pdf	Other-Diabetes Fact Sheet
FDA Bio Diabetes Fact Sheet.pdf	Other-Diabetes Fact Sheet
FDA Bio Patient General Factsheet.pdf	Other-Patient Fact Sheet
FDA Bio Patient General Factsheet.pdf	Other-Patient Fact Sheet
0695 OMB Approval Memo - Biosimilar Drug Products 2021.docx OMB Approval Memo	IC Document
0695 OMB Approval Memo - Biosimilar Drug Products 2021.docx OMB Approval Memo	IC Document

IC Title:

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)

Agency IC Tracking Number:

CDER

IC Status: Unchanged

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-Consent Form	Consent Form.docx	Yes	No	Printable Only
Other-Invitation	Interview Invitation.docx	Yes	No	Printable Only
Other-Confirmation Script	Confirmation Script.docx	Yes	No	Printable Only
Other-Interview Guide	Interview Guide.docx	Yes	No	Printable Only
Other-Recruitment Screener - Web	Recruitment Screener - Web.docx	Yes	No	Printable Only
Other-Recruitment Screener - Telephone	Recruitment Screener - Phone.docx	Yes	No	Printable Only
Other-Patience Infographic	Patient Infographic.pdf	Yes	No	Printable Only
Other-Diabetes Fact Sheet	FDA Bio Diabetes Fact Sheet.pdf	Yes	No	Printable Only
Other-Patient Fact Sheet	FDA Bio Patient General Factsheet.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: 30

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	30	30
Annual IC Time Burden (Hours)	65	65
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 - Biosimilar Drug Products 2021.docx	06/16/2021

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