Disclosing illegitimate products: notifications to trading partners

Pharmaceutical Distribution Supply Chain

Documents and Forms

Document Name Document Type
0806 DSCSA Implementation GFI 2021 - ID of Suspect Product and Notification.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Disclosing illegitimate products: notifications to trading partners	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0806 DSCSA Implementation GFI 2021 - ID of Suspect Product and Notification.pdf		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 %

	Requested	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

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.