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W81XWH-18-R-0025
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGES
SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
The Table of Contents has changed from:
Exhibit/Attachment Table of Contents
| DOCUMENT TYPE |
| DESCRIPTION |
| PAGES |
| DATE |
| Exhibit A |
| Exhibit A, CDRL A001 - Clinical Development Plan |
| 3 |
| Exhibit B |
| Exhibit B, CDRL A002 - Regulatory Development Plan |
| 3 |
| Exhibit C |
| Exhibit C, CDRL A003 - FDA Interactions |
| 3 |
| Exhibit D |
| Exhibit D, CDRL A004 - Quality Assurance |
| 3 |
| Exhibit E |
| Exhibit E, CDRL A005 - Clinical Study Protocol |
| 3 |
| Exhibit F |
| Exhibit F, CDRL A006 - Manufacturing Development Plan |
| 3 |
| Exhibit G |
| Exhibit G, CDRL A007 - Biostatistics Deliverables |
| 3 |
| Attachment 1 |
| Non-Disclosure / Non-Use Agreement |
| 2 |
| Attachment 2 |
| Organizational Conflict of Interest (OCI) Certification |
| 4 |
| Attachment 3 |
| Proposed Level of Effort Template |
| 2 |
| Attachment 4 |
| Key Personnel Template |
| 1 |
| Attachment 5 |
| Cost Proposal Spreadsheet (.xls) |
| 12 |
| Attachment 6 |
| Questions & Answers |
| 3 |
to:
Exhibit/Attachment Table of Contents
| DOCUMENT TYPE |
| DESCRIPTION |
| PAGES |
| DATE |
| Exhibit A |
| Exhibit A, CDRL A001 - Clinical Development Plan |
| 3 |
| Exhibit B |
| Exhibit B, CDRL A002 - Regulatory Development Plan |
| 3 |
| Exhibit C |
| Exhibit C, CDRL A003 - FDA Interactions |
| 3 |
| Exhibit D |
| Exhibit D, CDRL A004 - Quality Assurance |
| 3 |
| Exhibit E |
| Exhibit E, CDRL A005 - Clinical Study Protocol |
| 3 |
| Exhibit F |
| Exhibit F, CDRL A006 - Manufacturing Development Plan |
| 3 |
| Exhibit G |
| Exhibit G, CDRL A007 - Biostatistics Deliverables |
| 3 |
| Attachment 1 |
| Non-Disclosure / Non-Use Agreement |
| 2 |
| Attachment 2 |
| Organizational Conflict of Interest (OCI) Certification |
| 4 |
| Attachment 3 |
| Proposed Level of Effort Template |
| 2 |
| Attachment 4 |
| Key Personnel Template |
| 1 |
| Attachment 5 |
| Cost Proposal Spreadsheet (.xls) |
| 12 |
| Attachment 6 |
| Questions & Answers |
| 3 |
| 27-JUL-2018 |
(End of Summary of Changes) image1.wmf