Information Collection

(CDER) Focus Groups Examining Consumer Reporting of Adverse Events

IC 267658 under ICR 202310-0910-007 · OMB 0910-0497.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Attachment A. Screener.docx	Other-Screener
Attachment B. Recruitment Flyer.docx	Other-Recruitment Flyer
Attachment C. Confirmation Letter.docx	Other-Confirmation Letter
Attachment D. Reminder Letter.docx	Other-Reminder Letter
Attachment E. Informed Consent.docx	Other- Informed Consent
Attachment F. Moderator Guide.docx	Other- Moderator Guide
0497 OMB Memo_Examining Consumer Reporting of AE 2024.docx Gen IC Memo	IC Document
IRB Letter.pdf IRB Letter	IC Document

IC Title:

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-Screener	Attachment A. Screener.docx	Yes	Yes	Fillable Fileable
Other-Recruitment Flyer	Attachment B. Recruitment Flyer.docx	No		Printable Only
Other-Confirmation Letter	Attachment C. Confirmation Letter.docx	Yes	No	Printable Only
Other-Reminder Letter	Attachment D. Reminder Letter.docx	Yes	No	Printable Only
Other- Informed Consent	Attachment E. Informed Consent.docx	Yes	No	Fillable Fileable
Other- Moderator Guide	Attachment F. Moderator Guide.docx	No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 150

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	150	150
Annual IC Time Burden (Hours)	114	114
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Gen IC Memo	0497 OMB Memo_Examining Consumer Reporting of AE 2024.docx	05/14/2024
IRB Letter	IRB Letter.pdf	05/14/2024

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