W81XWH18R00250002_Amendment.docx

DOCX document 31 KB Posted

Attached to
Pharmaceutical Interventions for Noise-Induced Hearing Loss--Acute Exposure Treatment (PINIHL-AET)
Solicitation number
W81XWH-18-R-0025
Issued by

About this file

W81XWH18R00250002_Amendment (SF30)

View the file

Other files

File Type Posted
W81XWH18R00250003_Amendment.docx DOCX document
W81XWH18R00250003_RFP.docx DOCX document
W81XWH18R00250002Attch6QuestionsAnswers.pdf PDF
W81XWH18R00250002_RFP.docx DOCX document
W81XWH18R00250001Attch5CostProposal.xls XLS spreadsheet
W81XWH18R00250001_Amendment.docx DOCX document
W81XWH18R00250001_RFP.docx DOCX document
W81XWH18R00250001Attch6QuestionsAnswers.pdf PDF
W81XWH18R0025Attch2ConflictInterest.docx DOCX document
W81XWH18R0025ExhibitD.pdf PDF
W81XWH18R0025ExhibitC.pdf PDF
W81XWH18R0025_RFP.docx DOCX document
W81XWH18R0025ExhibitE.pdf PDF
W81XWH18R0025Attch4KeyPersonnel.docx DOCX document
W81XWH18R0025ExhibitF.pdf PDF
W81XWH18R0025Attch5CostProposal.xls XLS spreadsheet
W81XWH18R0025ExhibitG.pdf PDF
W81XWH18R0025Attch3LevelEffort.docx DOCX document
W81XWH18R0025Attch1NonDisclosureAgreement.rtf RTF text file
W81XWH18R0025ExhibitB.pdf PDF
W81XWH18R0025ExhibitA.pdf PDF
Show all 21

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

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

File details come from the government source that posted it.