Phase 2 - Main Study Completes (HCPs)

Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials

Documents and Forms

Document Name Document Type
Appendix A - Informed Consent.docx Other-Informed Consent
Appendix A - Informed Consent.docx Other-Informed Consent
Appendix B - Study 1 and 2 Questionnaires.docx Other-Questionnaires
Appendix B - Study 1 and 2 Questionnaires.docx Other-Questionnaires

Information Collection (IC) Details

IC Title:	Phase 2 - Main Study Completes (HCPs)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Informed Consent			Appendix A - Informed Consent.docx		Yes	Yes	Fillable Fileable
Other-Questionnaires			Appendix B - Study 1 and 2 Questionnaires.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 396	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	396	396
Annual IC Time Burden (Hours)	131	131
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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