Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Certification to Delay Results New 5150 2575 0 Form and Instruction 3 Certification to Delay Submission of Results Information (Reference Document and Screenshorts of Data Entry forms)
Certification to Delay Results Removed 0 0 0 Form and Instruction 3 Certification Form
Expanded Access Records - Initial New 213 426 0 Form and Instruction 5 Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Expanded Access Records - Updates New 426 107 0 Form and Instruction 5 Expanded Access Record Data Element Definitions (reference document and data entry forms (screenshots))
Extension Requests and Appeals New 250 500 0 Form and Instruction 4 Request for the Extension of the Results Information Submission Deadline (Reference document and Screenshots of Data Entry Forms)
Extension Request Removed 0 0 0 Form and Instruction 4 Extension Request
Initial Registration Removed 0 0 0 Form and Instruction 1 ClinicalTrials.gov Registration Data Entry Screen Shots
Initial Registration Data Entry Form Modified 7400 59200 0 Form and Instruction 1 Registration Data Entry Forms screenshot
Initial Registration of Non-regulated Submissions related to NIH policy New 657 5256 0 Form and Instruction 1 Registration Data Entry Forms screenshot
Initial Registration of voluntary and Non-regulated Submissions New 11244 89952 0 Form and Instruction 1 Registration Data Entry Forms screenshot
Initial Results Information Submission New 7400 296000 0 Form and Instruction 2 Results Information Submission Data Entry Forms (screenshots)
Initial Results Information of Non-regulated Submissions New 2000 80000 0 Form and Instruction 2 Results Information Submission Data Entry Forms (screenshots)
Initial Results Information of Non-regulated Submissions related to NIH policy New 657 26280 0 Form and Instruction 2 Results Information Submission Data Entry Forms (screenshots)
Initial Results Submission Removed 0 0 0 Form and Instruction 2 ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Registraion Triggered by Voluntary Submission New 88 704 0 Form and Instruction 1 Registration Data Entry Forms screenshot
Registration Updates Removed 0 0 0 Form and Instruction 1 Registration Data Entry
Result Submission Updates Removed 0 0 0 Form and Instruction 2 ClinicalTrials.gov Results Reporting Data Entry Screen Shots
Results Triggered by Voluntary Submission New 30 1350 0 Form and Instruction 2 Results Information Submission Data Entry Forms (screenshots)
Update Results Information of Non-regulated Submissions New 4000 40000 0 Form and Instruction 2 Results Information Submission Data Entry Forms (screenshots)
Update Results Information of Non-regulated Submissions related to NIH policy New 1314 13140 0 Form and Instruction 2 Results Information Submission Data Entry Forms (screenshots)
Updated Registration of Non-regulated Submissions related to NIH policy New 5256 10512 0 Form and Instruction 1 Registration Data Entry Forms screenshot
Updated Registration of Voluntary Non-regulated Submissions New 89952 179904 0 Form and Instruction 1 Registration Data Entry Forms screenshot
Updates New 59200 118400 0 Form and Instruction 1 Registration Data Entry Forms screenshot
Updates New 14800 148000 0 Form and Instruction 2 Results Information Submission Data Entry Forms (screenshots)
Total burden requested under this ICR: 210037 1072306 0  
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