Record Keeping - Develop Initial Plan

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

OMB: 0910-0675

IC ID: 195094

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

View Information Collection (IC)

Record Keeping - Develop Initial Plan
 
No New
 
Voluntary
 
21 CFR 7.40 21 CFR 211 21 CFR 314.81(b)(1) 21 CFR 600.14

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance Guidance for Industry - High Absenteeism.doc Yes Yes Paper Only

Health Consumer Health and Safety

 

70 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 70 0 70 0 0 0
Annual IC Time Burden (Hours) 35,000 0 35,000 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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