Solicitation Questions and Responses_RFP No 75N95024R00013.pdf

RFP_ 75N95024R00013

The NIH National NeuroHIV Tissue Consortium – New Clinical Site

Solicitation Questions and Government Responses

No. RFP Section Reference

Questions Responses

1 Packaging and Delivery of Proposal, page 57

Could you tell us if a notice of intent to submit is required

The notice of intent to submit is not required or mandatory; however, we highly encourage potential offerors to provide this information if they intend to submit a proposal. The notice of intent helps NIMH gauge the level of interest and participation in the solicitation

Could you tell us how much is the budget for each site?

Specific budget details cannot be disclosed to offerors at this time. The RFP is structured to provide a fair and competitive process for all potential offerors, and disclosing budget information could potentially compromise the integrity of that process. Offerors should carefully review the RFP documents, including the Statement of Work (SOW), evaluation criteria, and any applicable regulations, to ensure that your proposal adequately addresses the requirements and demonstrate your organization’s capabilities.

Offerors are responsible for proposing Level of Effort (LOE) and costs that encompass all aspects of their solution. Please refer to section C, titled ‘Level of Effort’; on page 68 of the RFP for detailed information regarding the level of effort.

3 Will costs for acquiring data from participants be on a per participant basis or will there be a specific sum allotted to a site?

Offerors are responsible for proposing Level of Effort (LOE) and costs that encompass all aspects of their solution. It is expected that the proposed costs will cover all relevant expenses related to the project. Offerors must provide detailed cost breakdown to ensure clarity and accuracy in their cost proposals.

Please refer to section C, titled ‘Level of Effort’; on page 68 of the RFP for detailed information regarding the level of effort.

4 What exact variables will need to be collected from each participant? Can variables not listed in the announcement be also acquired?

Variables listed in the SOW are important to collect.

Please refer to the SOW.

5 Has a final protocol for NNTC been developed?

In collaboration with the NNTC Data Coordinating Center (DCC) the protocol is to be developed if the contract is awarded to the site

6 Will a common IRB be used for all NNTC sites? If so which group will be used?

A single IRB is not a current requirement

7 Will costs be included for uploading of data to the Data Coordinating Center and making sure compliant with new NIH policies?

Offerors are responsible for proposing costs that encompass all aspects of their solution. It is expected that the proposed costs will cover all relevant expenses related to the project. Offerors must provide detailed cost breakdown to ensure clarity and accuracy in their cost proposals.

8 Will costs include space to store samples and materials?

Offerors are responsible for proposing costs that encompass all aspects of their solution. It is expected that the proposed costs will cover all relevant expenses related to the project. Offerors must provide detailed cost breakdown to ensure clarity and accuracy in their cost proposals.

9 Is there a limit regarding the percent effort the contractor and staff can have for this contract? Can effort change for each of the years?

Offerors may propose the effort believed necessary, with justification. Please refer to section C, titled ‘Level of Effort’; on page 68 of the RFP for detailed information regarding the level of effort.

10 Can NIH biosketches be submitted in place of resumes?

Yes – NIH Biosketches are acceptable. If biosketches will be submitted, please use NIH instructions for non-fellowships.

(https://grants.nih.gov/grants/forms/biosketch.htm)

11 How will data requests be met? Will the DCC handle all requests both internally and externally? How will the site request data from other sites?

The clarification of all details pertaining to data handling and requests will be undertaken by the Data Coordinating Center (DCC) upon the site's integration into the consortium.

12 How many participants are expected to be recruited by a site? How many participants should be budgeted per year?

The expectation is to recruit adequate number of participants to fulfill the estimated commitments for Task 1 and 2.

13 Will there be possibility that if a site is efficient in recruitment that it will be able to recruit additional participants?

These details will be discussed during the contract negotiations if the site is selected as a vendor

14 Should a site focus on individuals who are more likely to expire during the time of funding?

The focus of the study is to both understand the heterogeneity of CNS comorbidities in people with HIV as well as to serve as a resource for autopsy specimens. The focus of recruitment can be to fulfill both these obligations

15 How will sites denote medications used be a participant? Will there be a drop-down menu or will all data be entered manually?

The clarification of all details pertaining to data handling and submissions will be undertaken by the Data Coordinating Center (DCC) upon the site's integration into the consortium.

16 Will phantoms need to be performed for MRI acquisition? Will this cost be included in the budget?

In collaboration with the NNTC DCC the neuroimaging protocol is to be developed if the contract is awarded to the site

17 Will IV contrast need to be administered to participants?

In collaboration with the NNTC DCC the neuroimaging protocol is to be developed if the contract is awarded to the site

18 How will staff be trained on the various tests? Will there be a need to video a “pseudo participant”?

The clarification of all details pertaining to training will be undertaken by the Data Coordinating Center (DCC) upon the site's integration into the consortium.

19 What is the role of the pathologist at each site? Will this individual perform basic staining protocol? What happens if additional requirements are developed?

In collaboration with the NNTC DCC the neuropathology protocol is to be developed if the contract is awarded to the site

20 When would a new site come online? With the estimated award date set for August/September 2024, the new clinical site is expected to become operational shortly thereafter.

The specifics will be determined after award.

21 Are there certain requirements for the recruitment of individuals to NNTC? Should a site focus on certain age groups or gender or other demographic characteristics?

The focus of the study is to both understand the heterogeneity of CNS comorbidities in people with HIV as well as to serve as a resource for autopsy specimens. The focus of recruitment can be to fulfill both these obligations

22 Is there any consideration of recruiting persons without HIV as an appropriate control?

The focus of the study is to both understand the heterogeneity of CNS comorbidities in people with HIV as well as to serve as a resource for autopsy specimens. Adequate number of appropriate controls would be value added to achieve the goals of the study

23 Does the spinal cord need to be obtained? Does CSF have to be obtained at death?

In collaboration with the NNTC DCC the in-life and autopsy protocols are to be developed if the contract is awarded to the site

24 How many scientific advisors/ consultants are needed? Should they be from a different institution? Is a letter of support needed from them?

Has NNTC already developed a scientific advisory board?

If justified each clinical site can have one or two advisors or consultants. Standard rules pertaining to NIH defined conflict of interests apply when selecting consultants. NNTC DCC will provide details related to NNTC SAB if the contract is awarded to the site.

25 Is there a minimum number of autopsies that a site must perform?

The focus of the study is to both understand the heterogeneity of CNS comorbidities in people with HIV as well as to serve as a resource for autopsy specimens. The consideration of conducting an adequate number of autopsies to serve as a valuable resource is important.

26 Could you please explain If there is a need to have materials supplied by small local businesses?

Offerors are encouraged to explore strategies for supporting small businesses to comply with the small business subcontracting requirements specified in the RFP.

27 Could you further explain what is needed for a Certificate of Independent Price Determination?

The RFP requires offerors to complete the certificate of current cost or pricing data (attachment 14) and submit as a portion of the Business Proposal. Refer to FAR 15.406-2 “Certificate of Current Cost or Pricing Data”.

28 Will NIH work with the institution to identify a HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

This acquisition is being competed as full and open without any set-aside designation. Additionally, NIH does not facilitate the identification of small businesses for subcontracting opportunities. Please refer to section No. 7, titled ‘Small Business Subcontracting Plan’; on page 103 of the RFP for information regarding Small Business Subcontracting Plan.

29 Could you please clarify whether if successful our performance would require we operate in a NIST-800-171 environment? And if so, which aspects of the project are anticipated to require this security structure?

Contractors that operate an IT system on behalf of the National Institute of Mental Health (NIMH) or store NIMH Information on an IT system are required to conform with NIST 800-171r3 and NIST 800-53r5 security controls. NIMH’s Information Security Systems Officer may be able to assist with the templates needed for the System Security Plan or other deliverables.