questions and responses.pdf

No. Solicitation Document, Section # Page # RFP Language Question Government Response

1. RFP 152

12. Subcontractors If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:

RFP No. 75N92026R00008

a. Willingness to perform as a subcontractor for specific duties (list duties).

b. What priority the work will be given and how it will relate to other work.

c. The amount of time and facilities available to this project.

d. Information on their cognizant field audit offices.

e. How rights to publications and patents are to be handled.

f. A complete cost proposal in the same format as the offeror's cost proposal.

Is it the government’s intent to require subcontractors to create an entire business proposal or is the LOI with a cost proposal (Attachment J, Attachment Number

15) sufficient?

The LOI, together with the cost proposal for each subcontractor, is sufficient.

2. RFP 143 Small Business Subcontracting Plan

Please advise if the Small Business subcontracting Plan shall be submitted as an attachment to the business volume or as a submission into SBCX.

The Small Business Subcontracting Plan is only required to be submitted in SBCX.

3. RFP 95 Attachment 4 Please provide Attachment 4 – Section K - Representations, Certifications, and Other Statements of Offerors

See attached "Attachment 4 – Section K - Representations, Certifications, and Other Statements of Offerors"

4.

Attachment 15 – Breakdown of Proposed Estimated Costs

All Tabs Att 15

Please confirm the required submission format for the Breakdown of Proposed Estimated Cost (plus Fee) and Labor Hours Excel workbook.

Specifically, should the entire Excel workbook also be embedded or incorporated into the PDF business proposal submission package?

If so, please clarify whether the PDF submission must include:

- all worksheets contained within the workbook, including contractor-developed supporting/detail worksheets used to build up the proposed costs; or

- only the primary summary worksheet(s) and any specifically required tabs.

If only a subset of worksheets is required in the PDF submission, please identify which worksheets the Government expects to be included.

The Breakdown of Proposed Estimated Cost (plus Fee) and Labor Hours is only required in Excel format. You don't need to include a PDF in the business proposal.

5. RFP p. 5 Proposal submission through NIH eCPS.

Please clarify whether Human Subjects attachments, FWA documentation, and IRB materials count toward any technical proposal page limitations.

The Human Subjects attachments, FWA documentation and IRB materials do not count toward technical proposal page limitations.

6. RFP 153 Section M Evaluation Factors.

Please clarify whether the Government prefers the Technical Proposal to be organized in alignment with Section L proposal instructions, Section M evaluation factors, SOW task areas, or another preferred structure, as these sections do not appear to fully align.

Specifically, the proposal organization and content requirements outlined in Section L do not directly map to the evaluation criteria identified in Section M, creating potential challenges in ensuring all required information is presented clearly and comprehensively within the current 30-page Technical Proposal limitation.

To ensure offerors are able to provide the Government with the most complete, compliant, and valuable technical information responsive to both the proposal instructions and evaluation criteria, would the Government consider increasing the Technical Proposal page limitation from 30 pages to 50 pages?

There is no preferred structure. Offerors can organize the technical proposal as they see fit to ensure that all areas are covered and address the crieria in Section M.

The page limit will remain the same and is not increased.

RPP No. 75N92026R00008 - Questions and Responses

7. Att 15 Tab 2 Summary of Proposal Cost

Is there a preferred methodology for allocating costs of deliverables shared across both Task Areas 1 and 2 in the per-task-area cost workbooks required by Attachment 6?

For deliverables that are shared across both task areas, please allocate the costs to Task Area 1.

8. RFP 18-19

The Offeror must document in its proposal the approved or active FWA from OHRP, related to the designated Institutional Review Board (IRB) reviewing and overseeing the research.

Please clarify where the Government intends the FWA documentation, IRB certifications, and Human Subjects protections information to be included within the proposal volumes and whether these materials are evaluated under a specific Section M factor or are considered compliance-only documentation.

The FWA documentation, IRB certifications and Human Subjects protections information are compliance-only documentation and can be submitted as attachments.

9 RFP 19

When possible, the Offeror must also certify the IRB's review and approval of the research.

Given that the final protocol will likely evolve post-award, does the Government expect offerors to provide a currently approved IRB protocol at proposal submission, or is a draft/planned IRB approach acceptable?

A draft/planned IRB approach is acceptable for proposal purposes.

10 RFP 20

The Contractor shall maintain the following information… regarding human subjects education/training.

Please clarify whether documentation of Human Subjects Protection Training and GCP training is required at proposal submission or post-award only.

Human Subjects training and GCP training will be required post award.

11 RFP 8 For NIH-defined Phase III Clinical Trials…

Please clarify whether the Phase III Clinical Trial language is informational only or whether offerors are expected to include subgroup analysis plans in the proposal submission.

This contract is for a longitudinal observational study and will not include clinical trials. The Phase III language is informational only.

12 SOW, Task 1.17 5 Maintain the study website that is at the ALA.

Does the study website maintenance include a private (login required) admin or participant website and if so, what is the purpose of the private website?

No, task 1.17 describes a publicly facing website that includes information about the study including: a description of the study (for the public and participants), a description of available data (for outside researchers), a description of biospecimens and procedures for requesting them (for oustide researchers), and links to study policies (for outside researchers and study investigators/contractors). The above requirements will not require a login. It is permissable that a section of the website require a login for information available to study investigators and contractors only.

13 SOW, Task 1.19 5

The Contractor shall perform all following Section 508 compliance requirements for any Information and Communication Technology (ICT) products, including but not limited to:

a. Study website

b. Digital reports, PDFs, Word documents, PowerPoints

c. Data dashboards and repositories

d. Participant-facing tools and digital forms

e. Electronic communications to participants

f. Training materials

g. Any software or web-based application

Are the Participant-facing tools and digital forms part of the study website and, if so, are they built on the same technology framework?

No participant study data will be input through the website. Participant data will be collected through REDCap or a similar tool. No fillable digital forms will be on the website, only downloadable forms.

14 SOW, Task 1.17 5

Maintain the study website that is at the ALA. The website shall be updated and be 508-compliant within 6 months of contract award. Maintain and update the website throughout the contract period...

What languages, platforms, and databases are currently being used for the website?

These details are not available at this time.

15 SOW, Task 1.17 5

Maintain the study website that is at the ALA. The website shall be updated and be 508-compliant within 6 months of contract award. Maintain and update the website throughout the contract period.

Does updating the website mean content updates only or does it include adding additional functionality?

It is expected that most updates will be content updates.

16 SOW, Task 1.17 5

Maintain the study website that is at the ALA. The website shall be updated and be 508-compliant within 6 months of contract award. Maintain and update the website throughout the contract period.

Is the government open to redesigning/rearranging the way content is displayed on pages?

Yes.

17 SOW, Task 1.6 3

Task 1.6: Schedule, plan, and organize annual meetings and ad hoc meetings as directed of an Observational Study Monitoring Board (OSMB), consisting of between 4 and 7 members.

Meetings will be virtual unless otherwise specified by the COR. Provide compensation to OSMB members…

For pricing purposes, what is the compensation amount per OSMB member, per meeting?

For cost proposal purposes, assume $200 per OSMB member per meeting.

18 SOW, Task 1.6 3

Task 1.6: Schedule, plan, and organize annual meetings and ad hoc meetings as directed of an Observational Study Monitoring Board (OSMB), consisting of between 4 and 7 members.

Meetings will be virtual unless otherwise specified by the COR. Provide compensation to OSMB members…

For pricing purposes, how many ad hoc meetings per year should the contractor assume and how long should we assume each meeting will last (2 hours?)?

For cost proposal purposes, assume that there will be only one 2-hour meeting per year.

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