Reporting; Notify FDA of Plan Activation and Deactivation

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

OMB: 0910-0675

IC ID: 195093

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Reporting; Notify FDA of Plan Activation and Deactivation
 
No Modified
 
Voluntary
 
21 CFR 211; 211.180  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance GFI Planning for High Absenteeism 0675.pdf https://www.fda.gov/downloads/Drugs/.../Guidances/UCM196497.pdf No   Printable Only

Health Consumer Health and Safety

 

2 0
   
Private Sector Businesses or other for-profits
 
   99 %

  Approved 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 2 0 0 0 0 2
Annual IC Time Burden (Hours) 32 0 0 0 0 32
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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