Reporting: Notifications to FDA; including requests for waiver, exception, or exemption

Pharmaceutical Distribution Supply Chain

Documents and Forms

Document Name Document Type
21 USC 360eee-1 Drug Supply Chain Security.pdf Other-21 USC 360eee-1
FDA-form-3911_instructions_04-05-2024.pdf www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products Instruction
3911 Drug Notification FDA 3911 Drug Notification 0910-0806.pdf www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products Form

Information Collection (IC) Details

IC Title:	Reporting: Notifications to FDA; including requests for waiver, exception, or exemption	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-21 USC 360eee-1			21 USC 360eee-1 Drug Supply Chain Security.pdf		Yes	Yes	Fillable Fileable
Form	3911	Drug Notification	FDA 3911 Drug Notification 0910-0806.pdf	https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products	Yes	Yes	Fillable Fileable
Instruction			FDA-form-3911_instructions_04-05-2024.pdf	https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products	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	14,700	600	14,100
Annual IC Time Burden (Hours)	121,400	8,600	112,800
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.