Information Collection

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

IC 218211 under ICR 202407-0910-009 · OMB 0910-0806.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3911 Drug Notification Reporting: Notifications to FDA; including requests for waiver, exception, or exemption	Form
21 USC 360eee-1 Drug Supply Chain Security.pdf	Other-21 USC 360eee-1
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
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
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

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.	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-21 USC 360eee-1			Yes	Yes	Fillable Fileable
Form	3911	https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products	Yes	Yes	Fillable Fileable
Instruction		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 %

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	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

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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