In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

OMB: 0910-0409

IC ID: 6072

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In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring CDER
 
No Modified
 
Mandatory
 
21 CFR 315.4, 315.5, and 315.6

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring

 

2 0
   
Private Sector Businesses or other for-profits
 
   75 %

  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) 4,000 0 0 0 0 4,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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