RURAL_Expansion_Responses_to_Questions_0001.pdf

Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study – Expansion Cohort

RFP No. 75N98026R00074 – Responses to Offeror Questions

QUESTION #1. Period of Performance – Parent IDIQ and Task Areas A, B, and C Attachment #3 (Statement of Work) and Attachment #6 (Business/Technical Proposal Instructions) appear to contain inconsistent information regarding the periods of performance.

Attachment #6, Business Proposal Instructions, items 2 and 3, state that the acquisition/parent IDIQ contract will have a total duration of 4.25 years (51 months). Attachment #3 (SOW) identifies Task Areas A and B as running from June 1, 2027 through August 31, 2031 (51 months) and Task Area C (Study Closeout/Transfer) as running from June 1, 2031 through August 31, 2031 (3 months). Additionally, Attachment #6, Technical Proposal Instructions, page 2, refers to “closeout activities (5 months).”

Please confirm the correct start date, end date, and duration for the parent IDIQ and for Task Areas A, B, and C, including whether Task Area C is intended to be 3 months or 5 months, and whether the Task Area C closeout period is included within the stated 51-month parent IDIQ period or occurs in addition to that period. Please also confirm which periods offerors should use when preparing the Technical and Business Proposals.

NHLBI Response: Expected start and end dates are listed in the table below. On page 2 of attachment #6, the “closeout activities” is referring to the Exam Task Area only (Task Area B) and not the IDIQ contract. The timeline for Task Area B (Baseline Exam) consists of a planning phase (16 months), implementation phase (30 months), and exam closeout activities (5 months), such as final QC and database locks for analysis data, for a total period of performance of 51 months for Task Area B. Task Area C is listed separately on page 2 with a 3-month period of performance and is expected to occur within the total 51-month contract period.

Task Area

Task Area Description Start Date End date Duration

A Core Operations (Base plus options)

June 1, 2027 August 31, 2031 51 months

B Cohort Examination June 1, 2027 August 31, 2031 51 months

- Planning, MEU acquisition

June 1, 2027 Approx: September 30, 2028

(16 months)

- Cohort Exam Approx: October 1, 2028

March 31, 2031 (30 Months)

- Exam Closeout Approx: April 1, August 31, 2031 (5 Months)

C Study Closeout/Transfer June 1, 2031 August 31, 2031 3 Months

QUESTION #2. Missing Study Objective Attachment #3 (Statement of Work), page 2, lists the Study Objectives, but appears to omit item

(3) from the numbered sequence. Please confirm whether text is missing from the SOW or whether this is simply a numbering error.

NHLBI Response: This is to provide confirmation that this was a numbering error. There is no missing text.

QUESTION #3. CT Imaging – Scope of Reading/Interpretation Attachment #3 (Statement of Work) includes acquisition of CT imaging for coronary artery calcification (CAC), inspiratory and expiratory lung imaging, and abdominal and thigh slices.

The SOW specifically identifies measurement of CAC. Please confirm that interpretation/reading of the lung CT images for lung phenotypes and analysis of the abdominal and thigh slices for fat/body composition are not included within the scope of work for this contract.

NHLBI Response: NHLBI confirms that measurement of CAC should be included in the proposal. The proposal should also include plans for the acquisition of inspiratory and expiratory lung imaging and the acquisition of imaging for abdominal and thigh slices.

Interpretation of lung image phenotyping or abdominal/thigh slices is not included in the Statement of Work; and therefore, not expected to be included in the proposal. These additional images are intended to be available in the repository for future scientific work funded outside of this acquisition.

QUESTION #4. English- and Spanish-Speaking Staff and Materials The SOW and RFP documents reference the need for English- and Spanish-speaking MEU staff and questionnaires/materials. Please confirm that offerors may use these terms and describe these language capabilities in the technical proposal response.

NHLBI Response: NHLBI confirms that given the heterogenous nature of the Southern Plains region, a need for multilingual capabilities is likely. Offerors may describe staffing and exam materials referencing plans for incorporating English and Spanish language elements.

QUESTION #5. Letters of Support / Commitment Are Letters of Support (LOS) permitted as part of the proposal response? If Letters of Support are not permitted, may offerors instead include brief Letters of Commitment or Availability?

Please clarify which types of letters are permitted and from whom they are required or appropriate, including proposed subcontractors/cores, consultants, proposed personnel not currently employed by the offeror, and organizations providing access to essential facilities or resources.

NHLBI Response: As noted in the solicitation (page 114), Commitment Letters are required from those that are not members of the Offeror’s staff that will provide expertise and effort as part of a subcontract or as a consultant. Letters of Support should be limited to those providing a tangible benefit to the project. For example, dedicated facilities, protection of time, or other factors demonstrating institutional commitment to the project.

QUESTION #6. Letter Regarding Potential Future Collaboration May an offeror include a letter from an external research study or organization expressing willingness to pursue a potential future scientific collaboration if the contract is awarded when that organization is not a proposed subcontractor, consultant, or committed participant in the current Statement of Work?

NHLBI Response: Proposals should provide commitment letters only for collaborations that are relevant to the goals and scope of the contract and are firm commitments, i.e., collaborations that are “we will” rather than “we may”. Hypothetical scientific collaborations do not need to be described in detail in the proposal and do not warrant commitment letters. The commitment letter should state explicitly and succinctly the precise nature of the collaboration, and should be directly applicable to the evaluation of the proposal. An example would be a collaborator offering in-kind support that changes the budget estimates needed for the work.

QUESTION #7. County Selection – Task Area A vs. Task Area B Attachment #3 (Statement of Work), pages 4–5, indicates that identification of high- and low-risk counties in the Southern Plains, in consultation with the NHLBI Program Office, is part of Task Area A. However, page 3 also appears to include selection of counties under Task Area B.

Please clarify whether county identification/selection falls under Task Area A, Task Area B, or both, and how the associated effort and costs should be allocated between the two Task Areas.

NHLBI Response: NHLBI provides the following clarification for the contradictory text.

On page 3 of Attachment #3, the SOW, Task Area A includes the identification of the Counties for cohort recruitment and that Task Area B includes developing sampling plans within the selected counties. Page 5 of the SOW suggests that both County identification and sampling are components of Task Area A. However, page 23 of the SOW details that both County identification and sampling fall under Task Area B.

A revised Statement of Work (SOW) with redline strikeouts and revisions in yellow highlight has been prepared to correct the contradictory text. The revised SOW, Attachment #1, is included as an attachment to this RFP Amendment. The corrections clarify that the identification of Counties and the proposed sampling plan should be addressed under Task Area B as described on page 23 of the SOW.

QUESTION #8. SBCX Subcontracting Plan Invitation When will the SBCX Subcontracting Plan Invitation for RFP 75N98026R00074 be issued and assigned to the account and our Authorized Organization Representative? We would like to ensure that the invitation is assigned to the Institution’s AOR) is notified and has sufficient time to complete and submit the required Small Business Subcontracting Plan.

NHLBI Response: The link to the Small Business Subcontracting Plan invitation in the SBCX system is provided below.

https://osdbu.hhs.gov/subcontracting/d4d140f4-9d6f-4daf-a211-9e6eee9d1fa0

QUESTION #9. Southern Plains Region The solicitation is for the Southern Plains region. Could you please define what is meant by

Southern Plains?

NHLBI Response: There are multiple ways to define the Southern Plains region of the United States. For the purposes of this solicitation, NHLBI will define the Southern Plains broadly, encompassing the state of Texas and Oklahoma, as well as southern Kansas, eastern New Mexico, and the southeastern corner of Colorado as noted in the graphic below with the Southern Plains region outlined in green.

QUESTION #10. Is there any incumbent/recompete or this is a brand-new project? If yes, could you please provide us with their award number or even if the customer bought similar services in the past.

NHLBI Response: There is no incumbent contractor as this acquisition is a new requirement.

https://osdbu.hhs.gov/subcontracting/d4d140f4-9d6f-4daf-a211-9e6eee9d1fa0