Information Collection

Disclosing illegitimate products: notifications to trading partners

IC 218217 under ICR 202407-0910-009 · OMB 0910-0806.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0806 DSCSA Implementation GFI 2021 - ID of Suspect Product and Notification.pdf	Other-Agency Guidance
0806 DSCSA Implementation GFI 2021 - ID of Suspect Product and Notification.pdf	Other-Agency Guidance

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

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
Other-Agency Guidance					Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 500

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	310,000	155,000	155,000
Annual IC Time Burden (Hours)	1,860,000	620,000	1,240,000
Annual IC Cost Burden (Dollars)	0	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.

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