Information Collection

Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies

IC 236674 under ICR 201911-0910-015 · OMB 0910-0497.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0497 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Appendix A - List of Potential Stakeholders.docx	Other-List of Stakeholders
Appendix B - Invitation Letter.docx	Other-Invitation Letter
Appendix B2 - User Guide.docx	Other-User Guide
Appendix B3 - ISPE-ISPOR Joint Task Force Paper.pdf	Other-Task Force Paper
Appendix B4 - Design Visualization Paper.pdf	Other-Visualization Paper
Appendix C - Consent Form.docx	Other-Informed Consent
Appendix D - Notification of Eligibility.docx	Other-Notification of Eligibility
Appendix E - Follow-up email for Acknowledgement Permission.docx	Other-Follow up Email
Appendix F - Moderator Guide.pptx	Other-Moderator Guide
Appendix F1 - Background Rationale.pptx	Other-Background Rationale
Structured Reporting Evaluation Protocol 2019.docx	Other-Protocol
Appendix B1 - Structured Reporting Template.docx	Other-null
0497 OMB Approval Memo for Evaluating a Structured Reporting Template 2019.docx OMB Approval Memo	IC Document

IC Title:

Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies

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-List of Stakeholders	Appendix A - List of Potential Stakeholders.docx	Yes	No	Printable Only
Other-Invitation Letter	Appendix B - Invitation Letter.docx	Yes	No	Printable Only
Other-User Guide	Appendix B2 - User Guide.docx	Yes	No	Printable Only
Other-Task Force Paper	Appendix B3 - ISPE-ISPOR Joint Task Force Paper.pdf	Yes	No	Printable Only
Other-Visualization Paper	Appendix B4 - Design Visualization Paper.pdf	Yes	No	Printable Only
Other-Informed Consent	Appendix C - Consent Form.docx	Yes	No	Paper Only
Other-Notification of Eligibility	Appendix D - Notification of Eligibility.docx	Yes	No	Printable Only
Other-Follow up Email	Appendix E - Follow-up email for Acknowledgement Permission.docx	Yes	No	Printable Only
Other-Moderator Guide	Appendix F - Moderator Guide.pptx	Yes	No	Printable Only
Other-Background Rationale	Appendix F1 - Background Rationale.pptx	Yes	No	Printable Only
Other-Protocol	Structured Reporting Evaluation Protocol 2019.docx	Yes	No	Printable Only
Other-null	Appendix B1 - Structured Reporting Template.docx	Yes	No	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 34

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	34	34
Annual IC Time Burden (Hours)	68	68
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Approval Memo	0497 OMB Approval Memo for Evaluating a Structured Reporting Template 2019.docx	06/26/2019

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