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Federal forms, ICRs, and supporting documents

Information Collection

Sponsor Reporting to FDA on DMC Recommendations

IC 6304 under ICR 202108-0910-007 · OMB 0910-0581.

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Information Collection (IC) Details

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Sponsor Reporting to FDA on DMC Recommendations CBER
 
No Unchanged
 
Voluntary
 
21 CFR 312.50 21 CFR 312.56 21 CFR 812.46 21 CFR 812.40

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

Health Health Care Services

 

37 0
   
Private Sector Businesses or other for-profits
 
   25 %

  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 37 0 0 0 0 37
Annual IC Time Burden (Hours) 19 0 0 0 0 19
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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