Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Disclosures to sponsors Modified 8 4 225 Other-PHS Guideline
Document Absence of Infectious Agent in Xeno Product if its Presence Elsewhere in Source Animal Does not Preclude Using It, 3.5.2 Removed 0 0 0 Other-PHS Guideline
Document Complete Necropsy Results on Source Animals (50 year record retention), 3.6.4 Removed 0 0 0 Other-PHS Guideline
Document Each Xenotransplant Procedures, 4.3.1 Removed 0 0 0 Other-PHS Guideline
Document Full Necropsy Investigations Including Evaluation for Infectious Etiologies, 3.4.3.2 Removed 0 0 0 Other-PHS Guideline
Document Location and Nature of Archived PHS Specimens in Health Care Records for Xeno Product Recipient and Source Animal, 5.2 Removed 0 0 0 Other-PHS Guideline
Document Results of Monitoring Program Used to Detect Introduction of Infectious Agents Which May not be Apparent Clinically, 3.4.2 Removed 0 0 0 Other-PHS Guideline
Include Increased Infectious Risk in Inormed Consent if Source Animal Quarantine Period of 3 Weeks is Shortened, 3.5.1 Removed 0 0 0 Other-PHS Guideline
Justify Shortening a Source Animal's Quarantine Period of 3 Weeks Prior to Xenotransplantation Product Procurement, 3.5.1 Removed 0 0 0 Other-PHS Guideline
Keep a Log of Health Care Workers, 4.2.3 and 4.3.2 Removed 0 0 0 Other-PHS Guideline
Link Xeno Product Recipients to Individual Source Animal Records and Archived Biologic Speciments, 3.7 Removed 0 0 0 Other-PHS Guideline
Maintain Summary of Individual Source Animal Record to Permanent Medical Record of the Xeno Product Recipient, 3.5.4 Removed 0 0 0 Other-PHS Guideline
Notification to FDA when source facility or sponsor ceases operations Modified 1 1 37 Other-PHS Guideline
Record Base line sera of Xeno HealthCare Workers and Speciifc Nosocomial Exposure, 4.2.3.2 Removed 0 0 0 Other-PHS Guideline
Record base-line sera of Xeno Health Care Workers and Specific Nonsocomial Exposure, 4.2.3.2 Removed 0 0 0 Other-PHS Guideline
Source Animal Facility to Notify Clinical Center when Infectious Agency is Identified in Source Animal or Herd After Xeno Product Procurement, 3.5.5 Removed 0 0 0 Other-PHS Guideline
Sponsor to Maintain Cross-Referenced System that Links all Relevant Records, 4.3 Removed 0 0 0 Other-PHS Guideline
Sponsor to make Linked Records Described in Section 3.2.7 Available for Review, 3.5.4 Removed 0 0 0 Other-PHS Guideline
Standard Operating Procedures of Source Animal Facility Should be Available to Review Bodies, 3.4 Removed 0 0 0 Other-PHS Guideline
Xenotransplantation Recordkeeping Modified 207 55 3660 Other-PHS Guideline
Total burden requested under this ICR: 216 60 3922  
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