ICR Documents

Document Date Uploaded
06/12/2019

Document Date Uploaded
06/12/2019

Title Document Document Type Date Uploaded
AFM Patient Summary Form track changes Supplementary Document 01/31/2019
Authorizing Legislation Supplementary Document 06/12/2019
60 Day FRN Supplementary Document 06/12/2019
Surveillance Summaries Supplementary Document 06/12/2019
Non-research Determination Supplementary Document 06/12/2019
Case Definition for AFM Supplementary Document 06/12/2019
PIA AFM Supplementary Document 06/12/2019
PIA Supplementary Document 06/12/2019
AFM form with track changes 12.19 Supplementary Document 12/09/2019
Non-Substantive Change Request Memo July2022 Supplementary Document 07/29/2022
Non-substantive Change Summary Report Justification for No Material/Nonsubstantive Change 01/31/2019
Justification for change Justification for No Material/Nonsubstantive Change 12/09/2019

Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received