Information Collection

12. Attachment M - Diagnostic Safety Event Report

IC 268500 under ICR 202406-0935-001 · OMB unassigned.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 12 12. Attachment M - Diagnostic Safety Event Report	Form and Instruction
12 Site Data Submission Form Attachment M - Diagnostic Safety Event Report.2024_5_24.docx	Form and Instruction
12 Site Data Submission Form Attachment M - Diagnostic Safety Event Report.2024_5_24.docx	Form and Instruction

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	12	Site Data Submission Form	Attachment M - Diagnostic Safety Event Report.2024_5_24.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: 73

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 90 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	219	219
Annual IC Time Burden (Hours)	73	73
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.