OMB.report

Federal forms, ICRs, and supporting documents

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
Document Name
Document Type
Other-21 USC 360eee-1
Instruction
Form
Information Collection (IC) Details

View Information Collection (IC)

Reporting: Notifications to FDA; including requests for waiver, exception, or exemption CDER
 
No Modified
 
Mandatory
 

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

Health Consumer Health and Safety

 

500 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 14,700 0 0 600 14,100 0
Annual IC Time Burden (Hours) 121,400 0 0 8,600 112,800 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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