Attachment #6

TECHNICAL PROPOSAL INSTRUCTIONS

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

1. Provide the necessary information required to allow reviewers to judge the capability of the Offeror to complete the entire Statement of Work (Task Area A, Task Area B, and Task Area C). Include in the proposal a description of major activities and accomplishments in projects of comparable scope to the proposed acquisition.

2. The Program schedule is estimated as follows:

Task Area A – Core Study Operations

This Task Area is planned for 51 months in duration (4 years and 3 months) and will include approximately one (1), 12-month severable base period and four (4) sequential option periods-- three

(3) consisting of 12-month option periods required for completion and one (1), 3-month option period required for completion. Each option will involve support for participant follow-up, support for clinical events investigation and review, clinical events classification, community engagement activities, core study operations, data analysis, and manuscript writing.

Task Area A will include Task Order 001, which will be awarded concurrently with the base IDIQ contract.

For planning purposes, approximately 400 participants are anticipated to be recruited by the end of year 2, 1,200 participants recruited by the end of year 3, and 2,000 participants by the end of year 4.

For planning purposes, continuous funding for community engagement is expected, including full-time support for locally-based community engagement coordinators.

The NHLBI considers community engagement to be an essential function. For information purposes only, the NHLBI estimates that between 6%-10% of the total Contract costs will need to go to State PI / community engagement funding to achieve successful completion of the research objectives. Actual levels of costs associated with community engagement will be determined during negotiations.

The Technical proposal should describe the specific area(s) of the Southern Plains that will be targeted for participant recruitment and a rationale for the selected area.

Note that when new exam procedures, assays or genotyping in an ancillary study reveals potentially clinically actionable conditions, the costs associated with participant notifications must come from the ancillary study and not the contract.

Note that when ancillary study investigators request specimens, they must provide funding necessary for pulling, shipping, and analyzing samples. An exception is pulling and shipping samples for the NHLBI Trans-Omics for Precision Medicine program, which may be incorporated into costs for Task A.

Task Area B – RURAL Expansion Cohort Participant Clinical Examination: Plan and Complete Baseline Examination and Perform Exam Close-Out

This Task Area will be issued as five (5) non-severable task orders consisting of four (4) task orders, each with a 12-month period of performance and one (1), 3-month task order funded on an annual basis, for a total potential duration of 51 months. Task Area B will include planning and preparation activities for the baseline examination (16 months), implementation (30 months), and closeout activities (5 months).

The Offeror shall describe a procurement process for one or more Mobile Examination Unit(s) (MEU) and the minimum requirements a potential vendor must incorporate into the MEU design.

The Offeror shall demonstrate not only the ability to perform the components of the core exam, but also a capacity for “scalability” to capably manage a wide, and uncertain array of exam components that may arise from the separate and independent funding of a to-be-determined number of ancillary studies.

The Offeror shall provide technical justification if more than one subcontractor is proposed for the same scientific function.

Task Area C – Study Closeout or Transfer

If the Government decides to fund this Task Area, a single non-severable task order will be issued for an estimated 3-month period of performance to transition study operations to a successor contractor or to conduct study closeout.

3. Estimated Level of Effort The Government considers the types of personnel and estimated levels of effort identified below to be required for successful completion of the research objectives. Effort is shown as a percentage of FTE (full-time equivalent) labor. The personnel and levels of effort listed below are for information purposes only and are not considered restrictive or exhaustive for proposal purposes. Actual levels of effort will be determined during negotiations. The levels were formulated by NHLBI staff based on prior operations of the RURAL study.

Labor Category Task Area A

Task Area B

Task Area C

Project Director (Prime Award) 10% 10% 15% Deputy PD (Prime Award) 10% 10% 15% Administrative (Prime Award) 350% 40% 100% State PI by Subcontract 25% -- 10% Engagement Support Personnel by Subcontract 200% -- 100% Core PI by Subcontract 10% 10% 10% Co-Investigator by Subcontract 5% 5% 5% Core Support Personnel by Subcontract 200% 150% 100%

MEU Personnel -- 400% --

Note: Offerors shall ensure that the Principal Investigator and all other personnel proposed will not be committed on Federal grants and contracts for more than a total of 100% of their time. If the situation arises where it is determined that a proposed individual is committed for more than 100% of their time, the Government will require action on the part of the offeror to adjust the time commitment.

4. Travel Include cost estimates for the following travel:

a. Steering Committee Meeting – One 2-day meeting per year in Bethesda, MD, for 4 Coordinating Center representatives and 2 representatives from each subcontract in years 1-4. Plan for 2-night stay.

b. Planning Meetings – One 2-day meeting in the base year in Bethesda, MD, for 3 Coordinating Center representatives and 2 representatives from each subcontract for Task Area B Plan for 2-night stay.

c. Central Training – One 4-day training for 10 persons in Task Area B.

d. Site Visits to MEU Counties:

i. Task Area B: Quarterly 5-day visits for Recruitment Director. Annual 3-day visit for each subcontract PI responsible for baseline exam components.

ii. Task Area A: Bi-monthly 3-day visits to counties during non-recruitment years, and monthly 3-day visits when the MEU scheduled to be in county for State PIs. Annual 3-day visit for community engagement for the Prime award Project Director.

BUSINESS PROPOSAL INSTRUCTIONS

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

1. Provide the necessary information required to allow reviewers to judge the capability of the Offeror to complete the entire Statement of Work (Task Area A, Task Area B, and Task Area C).

2. This acquisition will be a single source, multiple year (4.25 years or 51 months in duration) Indefinite- Delivery/Indefinite-Quantity Contract (IDIQ) with three (3) Tasks Areas to be awarded as Cost- Reimbursement and/or Firm-Fixed-Price task orders, as deemed necessary by the Government for the RURAL Expansion Study Coordinating Center.

3. The period of performance of the parent IDIQ contract will be for a total of four (4) years and three (3) months. No new task orders will be awarded, and no funds will be obligated on existing task orders after the ordering period ends in year 5 of the parent contract.

4. The Cost estimate will be evaluated on the first two (2) Request for Task Order Proposal (RFTOP) requirements under Task Areas A and B.

5. Cost estimates for Task Area C are for programmatic planning purposes only and will not be evaluated.

Offerors may be requested to answer questions regarding how the estimates are derived.

6. A separate cost proposal must be submitted for Task Areas A and B, and a cost estimate shall be submitted for Task Area C. The Task Areas are described within Attachment 1 of the RFP. The cost proposal shall be submitted using the Excel workbook found in Section J of the RFP. See below for further information.

a. The Offeror shall propose costs for Task Area A based on one (1), 12-month severable base period and four (4) sequential option periods-- three (3) consisting of 12-month option periods required for completion and one (1), 3-month option period required for completion. The Offeror shall provide supporting cost documentation for proposed costs under Task Area A.

b. The Offeror shall propose costs for Task Area B based on five (5) non-severable task orders consisting of four (4) task orders, each with a 12-month period of performance and one (1), 3-month task order funded on an annual basis, for a total potential period of performance of 51 months. The Offeror shall provide supporting cost documentation for proposed costs under Task Area B.

c. The Offeror shall provide estimated costs in the Cost Proposal Template for Task Area C based on a single, non-severable task order issued for an estimated 3-month period of performance.

Supporting cost documentation is not required for Task Area C.