Phase I Questions and Government Responses.pdf

Solicitation No. 75N95021R00008 Interested Offeror Questions and Government Responses

INTERESTED OFFEROR QUESTIONS AND GOVERNMENT RESPONSES

Interested Offeror

Question No.

Solicitation No.

75N95021R00008

Page No.

Solicitation No.

75N95021R00008 Section No./Name

Text of Solicitation No. 75N95021R00008 Interested Offeror Questions and Government Responses

1 50 Past Performance Information

Offerors shall submit the following information as part of their Technical proposal. Past performance information is limited to 10 pages. Each Offeror with similar prior experience must submit detailed information about two prior contracts completed during the past five years for work that is similar in nature to one or more areas in the Statement of Work. These two contracts should also be listed in the Submissions Overview in Phase I. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments, and commercial concerns. Contracts listed should be those of the Offeror and not of predessor companies, key personnel, or proposed subcontractors. Contracts listed may be prime contracts or major subcontracts. For the purposes of this solicitation, a "major subcontract" is defined as a subcontract with a dollar value exceeding $200,000.00.

INTERESTED OFFEROR QUESTION:

This section seems to add to the instructions for Phase I. Can you confirm that the Phase I overview must include information about past performance by offerors?

GOVERNMENT RESPONSE:

The Submissions Overview in Phase I is a snapshot of the submissions the Offeror has worked on during the last five years. It does not include the substantive past performance information required in Phase II. The Past Performance Information in Phase II requires detailed information about two prior contracts completed during the past five years for work that is similar in nature to one or more areas in the Statement of Work.

The Submissions Overview is a list of submissions the Offeror has worked on during the last five years, and the Past Performance Information requires information on two contracts completed during the past five years. It is therefore expected that the past performance information will be for two contracts that involved submissions that were listed in the Submissions Overview.

2 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

Scenario: The Government plans to submit a pre- IND meeting request in six months. Based on this timeline, please present an outline for the "Kick off" meeting with the Government, including the agenda. The presentation must include a discussion on the scope, strategy, roles and responsibilities, and the timeline for compilation of the pre-IND meeting package through pre-IND submission

INTERESTED OFFEROR QUESTION:

Should past performance of offeror be included in the PPT in Phase 1 or only in the Phase 1 overview?

GOVERNMENT RESPONSE:

There is no past performance aspect of the scenario for the PowerPoint presentation.

The PowerPoint presentation is based on the scenario provided in the solicitation. The Submissions Overview is a snapshot of the submissions the Offeror has worked on during the last five years. It does not include the substantive past performance information required in Phase II.

3 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

Scenario: The Government plans to submit a pre- IND meeting request in six months. Based on this timeline, please present an outline for the "Kick off" meeting with the Government, including the agenda. The presentation must include a discussion on the scope, strategy, roles and responsibilities, and the timeline for compilation of the pre-IND meeting package through pre-IND submission.

INTERESTED OFFEROR QUESTION:

Should presentation assume that the pre- IND meeting is related to Task Order - Preparation of an Investigational New Drug (IND) application with Food and Drug Administration (FDA) for a treatment for Jansen’s Metaphyseal Chondrodysplasia?

No, the pre-IND meeting is not related to any specific modality or therapeutic.

Offerors may choose the modality and therapeutic upon which to base the kick-off meeting.

4 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

PowerPoint Presentation. A PowerPoint presentation with accompanying audio that is based on the below scenario. The presentation must be no longer than 10 minutes in length and no larger than 1.0GB in file size. Presentation content after 10:00 minutes will not be viewed.

Presentations in excess of 1.0GB will not be accepted. Scenario: The Government plans to submit a pre-IND meeting request in six months.

Based on this timeline, please present an outline for the "Kick off" meeting with the Government, including the agenda. The presentation must include a discussion on the scope, strategy, roles and responsibilities, and the timeline for compilation of the pre-IND meeting package through pre-IND submission.

2. Submissions Overview. A list of recent submissions (within the past five years) worked on that includes the below information. This list should be provided as an Excel spreadsheet with each of the below discussed in a separate column in the order listed below. ● Disease (indicate orphan) ● Modality (small molecule, biologic (specify type of biologic), medical devices) ● Type of Client (Government, Academic, Non-Profit, Industry) ● Regulatory Body (specify Center and Office) ● Submission Application Type (e.g.

INTERACT, pre-IND, IND, BLA, NDA, pre-submission, IDE, 510(k), PMA) ● Publishing Format (e.g. eCTD, paper) ● Year of Submission ● Level of Regulatory Support (e.g. drafting, sponsor regulatory representative, eCTD submission) ● Contract Dollar Value

INTERESTED OFFEROR QUESTION:

Can the government confirm that Phase 1 has three parts: The overview, which is the spread sheet, the one page narrative and the

PPT?

Yes, the Government confirms Phase I has three parts: the PowerPoint presentation with audio, the Submissions Overview (Excel spreadsheet), and Submissions Narrative (one-page narrative).

3. Submissions Narrative. A one-page descriptive overview of the recent experience listed in the Submissions Overview.

5 P2 P2

Cover Letter and Combined Synopsis/Solicitation

“Offeror questions regarding Phase II must be submitted to the Contracting Officer and Contract Specialist listed above before 12:00:00PM on September 29, 2021.”

Questions for Phase II must be submitted before 12:00:00PM Eastern time on August 30, 2021.

INTERESTED OFFEROR QUESTION:

Kindly clarify if questions with respect to Phase II are due 12:00:00PM on September 29, 2021 (Cover Letter) or 12:00:00PM Eastern time on August 30, 2021 (Synopsis and Solicitation).

GOVERNMENT RESPONSE:

Questions for Phase II are due before 12:00:00PM Eastern Time on September 29, 2021. The incorrect date listed on page 2 of the synopsis will be corrected in Amendment 1.

6 6-7 11-12

Technical Reporting Requirements and Deliveries

INTERESTED OFFEROR QUESTION:

It appears that monthly, quarterly, or annual reports are not required under the IDIQ.

Kindly confirm that there are no additional contract level reporting requirements.

GOVERNMENT RESPONSE:

There are no requirements for monthly, quarterly, or annual reports under the IDIQ contract. Reporting requirements will be specified at the task order level.

7 INTERESTED OFFEROR QUESTION:

Will a task order to fulfill NIH training (e.g., IT Security) and non-task order, contract reporting requirements be awarded to each successful IDIQ offeror (e.g., Non-Disclosure Agreement, Invention Reporting?)

GOVERNMENT RESPONSE:

No, there will not be a separate task order.

The requirements for Contractor Non- Disclosure Agreements and Annual and Final Invention reporting will be included on each task order issued under one or more technical areas of the IDIQ Statement of Work.

8 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

PowerPoint Presentation. A PowerPoint presentation with accompanying audio that is based on the below scenario. The presentation must be no longer than 10 minutes in length and no larger than 1.0GB in file size. Presentation content after 10:00 minutes will not be viewed.

Presentations in excess of 1.0GB will not be accepted.

INTERESTED OFFEROR QUESTION:

Is Audio recording mandatory with the PowerPoint ?

GOVERNMENT RESPONSE:

Yes, audio is required with the PowerPoint presentation. The intent of audio is to get a better understanding of the proposed strategy and to mimic a real kick-off meeting. PowerPoint includes an audio feature that can be utilized without the video. Additional instructions about using audio in PowerPoint are available at https://support.microsoft.com/en-us/office/record-a-slide-show-with-narration-and-slide-timings-0b9502c6-5f6c- 40ae-b1e7-e47d8741161c.

9 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

Scenario: The Government plans to submit a pre- IND meeting request in six months. Based on this timeline, please present an outline for the "Kick off" meeting with the Government, including the agenda. The presentation must include a discussion on the scope, strategy, roles and responsibilities, INTERESTED OFFEROR QUESTION:

For Phase I PowerPoint Presentation, the scenario mentioned under RFP document does not indicate the type of product or therapeutic area. Would it be acceptable if the offeror assumes a therapeutic indication https://support.microsoft.com/en-us/office/record-a-slide-show-with-narration-and-slide-timings-0b9502c6-5f6c-40ae-b1e7-e47d8741161c https://support.microsoft.com/en-us/office/record-a-slide-show-with-narration-and-slide-timings-0b9502c6-5f6c-40ae-b1e7-e47d8741161c https://support.microsoft.com/en-us/office/record-a-slide-show-with-narration-and-slide-timings-0b9502c6-5f6c-40ae-b1e7-e47d8741161c https://support.microsoft.com/en-us/office/record-a-slide-show-with-narration-and-slide-timings-0b9502c6-5f6c-40ae-b1e7-e47d8741161c and the timeline for compilation of the pre-IND meeting package through pre-IND submission.

in the PowerPoint presentation proposal?

For example: The pre-IND meeting request is being planned to initiate a phase-I clinical trial for a new drug candidate in oncology therapeutic area.

GOVERNMENT RESPONSE:

Yes, Offerors may choose the modality and therapeutic upon which to base the kick-off meeting.

10 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

Scenario: The Government plans to submit a pre- IND meeting request in six months. Based on this timeline, please present an outline for the "Kick off" meeting with the Government, including the agenda. The presentation must include a discussion on the scope, strategy, roles and responsibilities, and the timeline for compilation of the pre-IND meeting package through pre-IND submission.

INTERESTED OFFEROR QUESTION:

Can you please clarify the scope of the pre- IND meeting request in the Scenario for the Phase 1 power point presentation? Should the applicant prepare the presentation for a specific type of investigational agent and indication, or provide a more general presentation covering a range of options?

GOVERNMENT RESPONSE:

Offerors should choose the modality and therapeutic upon which to base the kick-off meeting.

11 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

Submissions Overview. A list of recent submissions (within the past five years) worked on that includes the below information. This list should be provided as an Excel spreadsheet with each of the below discussed in a separate column in the order listed below.

INTERESTED OFFEROR QUESTION:

Is the offeror allowed to use multiple Tabs in the Excel Sheet to separate the type of Submissions Application (eg Pre-IND on 1 Tab, IND on another Tab, BLAs on another Tab…etc)

GOVERNMENT RESPONSE:

No, Offerors are to provide all submissions on one spreadsheet. The disease, modality, type of client, etc. is to be noted in separate columns in the order provided in the solicitation. The information provided in each column should be extremely brief – only a few words – to indicate the specific piece of information requested (the disease, modality, type of client, etc.).

12 52 Phase I Instructions:

PowerPoint Presentation and Submissions Overview

Submissions Narrative. A one-page descriptive overview of the recent experience listed in the Submissions Overview.

INTERESTED OFFEROR QUESTION:

The instructions for Phase I, RFP Page 52 - Submission Narrative - Does NCATS want a write-up on only 1 submission or multiple submission that can fit in a page.

GOVERNMENT RESPONSE:

The Submissions Narrative should be a high-level overview of the submissions listed in the Submissions Overview. The Submissions Overview is a snapshot of recent submissions and the Submissions Narrative is a brief discussion of these recent submissions.

13 INTERESTED OFFEROR QUESTION:

What is required to be submitted as the Phase I submission?

GOVERNMENT RESPONSE:

The requirements for the Phase I submission are outlined in Article L.2.b. on page 52.

End of Interested Offeror Questions and Government Responses