W81XWH18R00250002Attch6QuestionsAnswers.pdf

W81XWH‐18‐R‐0025 Questions Last updated: 7/27/2018

Number Reference Question Answer Resulting Amendments

1 Solicitation Does the Presolicitation posted as solicitation number W81XWH18R0025 on FBO contain requirements similar to a existing contract or will this be a new requirement?

This will be a new requirement. None.

2 Solicitation

Please could you let me know which is the main submission document and where to find guidelines etc as this is not evident from this website.

Moreover, is the funding available for preclinical and FiH trials or solely Phase II onwards?

The Solicitation document (i.e. Request for Proposal [RFP]) is the document named “W81XWH18R0025_RFP.docx”. However, as of 26 July 2018 the solicitation has been amended. The current solicitation document is named "W81XWH18R00250001_RFP.docx". It contains all of the proposal submission details.

No, funding is not available for preclinical or First in Human (FiH) trials.

The funding available is for Phase 2 and beyond. If a company is prepared to start beyond Phase 2 (at Phase 3 for example) the Government encourages them to submit a proposal in response to this solicitation as well.

None.

3 Solicitation I am not sure I fully understand the solicitation: does this include preclinical work or is funding intended only for clinical development?

No, this does not include preclinical work. Funding is intended only for Phase 2 clinical development and beyond. If a company is prepared to start beyond Phase 2 (at Phase 3 for example) the Government encourages them to submit a proposal in response to this solicitation as well.

None.

4 Solicitation What is the maximum size allowed of a proposal submission by email attachment? 25MB?

According to Microsoft, the maximum size allowed for email attachments is 20MB; however, the Government's recommended maximum size for email attachments is 10MB. The maximum size limit applies to one large attachment or the sum total size of several attachments included in a single email. The Government's recommendation for Offeror's submitting attachments that are larger than 10MB is to use the U. S.

Army Aviation and Missile Research Development and Engineering Center (AMRDEC) Safe Access File Exchange (SAFE). AMRDEC SAFE provides an alternative way to send files other than email and supports file sizes up to 2GB. AMRDEC SAFE can be accessed via the following URL: https://safe.amrdec.army.mil/safe/Welcome.aspx

SF33, Section L, subsection L.2.1: New paragraph 5 "File Size" added to clarify file size limits and provide an alternative way to send files, other than email.

Solicitation (SF33), Page 14, Section F, Deliverables, under section 2.0 Deliverable/Delivery Schedule, Table 1

Table 1 contains a List of Deliverables with Initial dates that conflict with section 4.0 Contract Data Requirements List due. Please clarify if Exhibits B, C, E & G are to be provided in the proposal submission.

Unless otherwise indicated, Offeror will submit Exhibits B, C, E & G after POP start date.

Section 4.0, Table 2 is just a list of all of the CDRLs that will be required for this effort and their relationship to the contract line item numbers (CLINs) and deliverables. Exhibits B, C, E, and G are not to be provided with proposal submission; they are to be provided in accordance with the schedule outlined in Table 1. Only Exhibits A, D, and F need to be provided with proposal submission. The Offeror is required to complete and submit all of the CDRL forms (DD Form 1423-

1) for Exhibits A thru G by filling in blocks 17 and 18 of the DD 1423-1;

ensuring that the information from Block 18 is also transferred to the Cost Proposal Spreadsheet.

SF33, Section L, subsection L.3.4.4 & Section M, subsection M.4.1.3:

Changed "attachments" to "forms" to clarify that the Offeror has to submit the completed CDRL forms (DD Form 1423-1) for Exhibits A thru G.

Solicitation (SF33), Page 8, Under Statement of Objectives, 3.0 Scope of Effort, 3.2

Please clarify the type of Interim Analysis required and the rationale (Futility? Non-inferiority?).

The interim analysis is typically left to the discretion of the investigator conducting the clinical trial. At a minimum, the interim analysis should examine safety, efficacy, and futility of the drug to determine if the study needs to have an altered design or should be halted.

SF33, Section C, SOO, paragraph 3.2 & Section F, subsection 3.0, Deliverable 15: Added the following clarifying language: "At a minimum, the interim analysis should examine safety, efficacy, and futility of the drug to determine if the study needs to have an altered design or should be halted."

Solicitation (SF33), pages 34-35, Section H: PROHIBITION OF

HUMAN RESEARCH,

PROHIBITION HUMAN

SUBJECTS, and PROHIBITION

HUMAN CADAVERS

Is the Offeror required to submit to the USAMRMC’s Office of Research Protection (ORP)? Is the ORP submission/approval required prior to IRB approval or post-IRB approval?

To be clear this is a post-award requirement. The Contractor (i.e.

awardee) is required to submit to USAMRMC's Office of Research Protection (ORP) prior to initiation of human subjects research.

Institutional Review Board (IRB) approval must be completed prior to submission to the ORP.

None.

Solicitation (SF33), page 11, Section C, CONTRACTOR

MANPOWER REPORTING

Is it expected that all sub-contractors will log into the DoD secure data collection site (ECMRA) to enter their labor hours or is it acceptable for the Offeror to enter the sub-contractors time?

It is expected that the Prime contractor (i.e. successful Offeror) will enter all applicable hours for itself and any subcontractors. None.

Solicitation (SF33), pages 14 & 21, Section F, DELIVERABLES, Deliverable 1

Please clarify if the Kick-Off Meeting would be held at Fort Detrick with all necessary teleconference, IT needs and space (or nearby location), or if we could schedule the meeting at or near the Offeror’s site? Within thirty (30) days of proposal submission, start of POP, notice of award or after award of contract?

The Contractor and the Government will reach agreement regarding the Kick-Off meeting location after contract award. The meeting may be held at Fort Detrick or the Contractor’s site. The Contractor shall propose travel costs for the Kick-Off meeting in the event that the meeting is held at Fort Detrick (see the Cost Proposal Spreadsheet ODC tabs for details). The Government would also like to address the in-person Annual Product Review (Deliverable 7) as it relates to the Kick- Off meeting question and travel. The Contractor and the Government will reach agreement regarding the location for each Annual Product Review after contract award. The review may be held at Fort Detrick or the Contractor's site. The Contractor shall propose travel costs for each Annual Product Review in the event that all are held at Fort Detrick (see the Cost Proposal Spreadsheet ODC tabs for details).

SF33, Section F, DELIVERABLES, Table 1 & subsection 3.0, Deliverables 1 & 7: Kick-Off Meeting Material (Deliverable 1) language in the table and description (subsection 3.0) revised to clarify meeting location, scheduling and agenda/minutes submission. Annual Product Review (Deliverable 7) language in the table and description (subsection 3.0) revised to clarify meeting location, scheduling, and agenda/materials/minutes submission. Cost Proposal Spreadsheet (Solicitation Attachment 5), ODC tabs (Base and Options 1, 2, & 3):

Travel section revised to include placeholders for Offerors to propose travel costs for the Kick-Off Meeting and Annual Product Reviews;

additional travel may also be proposed by the Offeror.

10 Solicitation When can we expect a written response to our questions? Close of Business Friday, July 20, 2018?

A written response to vendor questions can be expected within approximately one week of submission. The questions and answers are posted to FedBizOpps (FBO) as an amendment to the solicitation. Due to the amount of time needed to respond to all questions and amend the solicitation documents, the proposal due date has been extended from 10 August 2018 at 3:00PM ET to 17 August 2018 at 3:00PM ET.

SF33, Section A, GENERAL INFORMATION: Proposal due date extended to 17 August 2018 at 3:00PM ET. SF33, Section J:

"Questions & Answers" (Attachment 6) added to the solicitation and posted to FBO with solicitation amendment 0001. SF33, Section L.3.5, subsections L.3.5.1, L.3.5.2, & L.3.5.3 the date that the Contracting Officer anticipates initiating exchanges changed to 17 August 2018.

Cost Proposal Spreadsheet (Solicitation Attachment 5), Contractor Manpower Reporting (CMR) tab: CMR requirement Fiscal Years (FYs) changed from FY18 thru FY23 to FY19 thru FY24 in anticipation of contract award in October 2018 (after the 30 September 2018 cutoff for

FY18 CMR).

11 Solicitation (SF33), page 104, Section L, Paragraph L.2.1

Paragraph states in one paragraph that “The overall proposal shall consist of five (5) separate and distinct volumes.” However, the paragraph then lists only four (4) proposal volumes (Administrative, Technical, Past Performance, and Cost). Please clarify whether four or five volumes are required, and if a fifth one is required then please provide the details and instructions for that fifth volume.

This was an error; only four (4) volumes are required: Administrative, Technical, Past Performance, and Cost.

SF33, Section L, subsection L.2.1, paragraph 7: Correction made to the number of separate and distinct volumes; only four (4) volumes.

Solicitation (SF33), pages 102 & 103, Section L, Paragraphs L1 & L.2.1

Paragraph states that “The offeror’s proposal shall be submitted in hard copy, with accompanying digital copies… The RFP shall provide the Government address…for the proposal submitted.” However, Paragraph L.2.1 states that “The Offeror shall provide their proposal in electronic format…” and “contents of the disks shall be clearly labeled on the disc and on the jewel case.” Our interpretation of these Section L requirements is that we will satisfy them if we provide our proposal 1) in hard copy, 3-ring binders, and 2) on appropriately labeled compact disks, and that there is no Section L requirement for offerors to email their proposals to the Government. However, Section A of the RFP states “Proposals shall only be electronically submitted to the primary POC via email.” This seems to contradict the Section L requirements.

Please clarify whether Offerors are also (or only, as stated in Section A?) required to submit their proposals via email. Also, please provide the Government’s address to which the hard copy and compact disk versions of Offerors’ proposals are to be delivered.

These were errors. Due to the difficulties in receipt of mail through normal postal services no hard copy proposals or compact discs will be accepted; only electronic proposal submissions will be accepted. The Section L language has been revised to remove any references to hard copy or compact disc proposal submissions.

SF33, Section L, subsection L1, paragraph 5 & L.2.1 paragraphs 1, 2, 4, & 7: References to "foldout pages", "copies", "hard copy", "digital", "compact disc", and "3-ring binder" as they relate to proposal submission have been removed. Additionally, subsection "L1" changed to "L.1".

Solicitation (SF33), pages 103, & 111-112, Section L, Paragraphs L.2.1 & L.3.4.2

Paragraph states that "The Offeror’s proposal shall include a completed version of the Cost Proposal Spreadsheet (.xls)". Also, under the Section L, Paragraph L.2.1 it states that " the Cost/Price proposal, … shall be in Excel (.xls) format." However, the Cost Proposal Volume contents, as presented under Section L, Paragraph L.3.4. include sections such as "Cover Page", "Spend Plan" and "Completed Contract Data Requirements List Forms" which according to our interpretation should be submitted as a searchable PDF file. Could you please clarify whether we should provide the Excel spreadsheet separately as an .xls file while providing full documentation of the spreadsheet's content using screenshots in the PDF Cost Proposal Volume, or should we use a different approach.

The submission requirements for the Cost Proposal Volume have been clarified. The Cost Proposal Spreadsheet shall be submitted separately as an Excel (.xls) file. The Offeror should complete the "Cover Page" tab of the Cost Proposal Spreadsheet (.xls). Additionally, the Offeror should provide a cover page in searchable Adobe (.pdf) format compatible with Adobe Acrobat XI Pro to accompany any remaining Cost Proposal Volume documents. Full documentation of the Cost Proposal Spreadsheet's contents as a searchable PDF is not required.

SF33, Section L, subsection L.2.1, paragraph 1: changed the exception for the "Cost/Price proposal" to an exception for the "Cost Proposal Spreadsheet". SF33, Section L, subsection L.2.1, table 1: Added "(.xls)" to the title description of the "Completed Cost Proposal Spreadsheet"; and clarified that the cover page should be in .pdf and .xls formats. SF33, Section L, subsection L.3.4.1: Included additional instructions clarifying the submission of cover pages for the Cost Proposal Volume.

Solicitation (SF33), page 108, Section L, subsections L.3.2.3.4 and L.3.2.3.5

Drug: Because our identified drug is already an FDA-approved generic drug, do we still need to include both a Commercial Transition Plan and Manufacturing Development Plan with our proposal?

Yes, you still need to include both a Commercial Transition Plan (CTP) and Manufacturing Development Plan (MDP) with your proposal. The CTP and MDP shall be submitted for the proposed PINIHL indication.

None.

15 Solicitation Potential Research Subjects: Are you aware of available clinical models in which testing of the drug with intentional noise exposure can be conducted ethically?

The Government is not aware of any available clinical models for testing drugs with intentional noise exposure. None.

16 Solicitation (SF33), Section M, pages 127-137

Preference: Will you be considering such criteria as the drug development duration and cost when weighing the acceptability of a given proposal for funding? And what is the make-up of your Source Selection Team in terms of their expertise?

Each Offeror's proposal will be evaluated in strict accordance with the criteria outlined in Section M of the Solicitation. The Government cannot share information regarding the make-up of the Source Selection Team (SST); however, the personnel appointed to the SST are highly knowledgeable in the project's subject matters (audiology, materiel acquisition, and FDA regulations), as well as the policy and procedures for properly and efficiently conducting the source selection.

None.