Maintain Documentation of Influenze Pandemic Conditions and Resultant High Absenteeism

Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

OMB: 0910-0701

IC ID: 198614

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

View Information Collection (IC)

Maintain Documentation of Influenze Pandemic Conditions and Resultant High Absenteeism CDER
 
No Modified
 
Voluntary
 
21 CFR 379aa  (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-Guidance GUIDANCE 0701 12-24-14.pdf Yes No Paper Only

Health Public Health Monitoring

 

500 0
   
Private Sector Businesses or other for-profits
 
   80 %

  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 500 0 0 0 0 500
Annual IC Time Burden (Hours) 4,000 0 0 0 0 4,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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