Amendment_P00003_Questions-Answers_0003.pdf

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Attached to
Research and Development Support Services (Clinica Federal contract opportunity
Solicitation number
75N98026R00062
Issued by
Department of Health and Human Services National Institutes of Health Office of Logisitics and Acquisition Operations

About this file

This document is a Questions and Answers amendment (P00003) for federal contract opportunity 75N98026R00062, addressing clarifications regarding pricing templates, labor category allocations, and scope of work execution.

The Q&A clarifies that offerors must allocate proposed hours by Institute Category (IC) using estimated annual hours provided in a Government Clarification Sheet, with the understanding that work may span multiple task areas and labor categories must be consistent between technical and pricing proposals. The Government will not remove the IC column from the pricing template and will assess performance risk for allocations that lack adequate explanation, are inconsistent with technical approach, or appear insufficient for Statement of Work (SOW) performance. Offerors should not include contingency hours for unidentified future ICs and must base staffing and pricing on three participating ICs (NINDS, NIBIB, and NIEHS) with estimated annual hours identified in the Government Clarification Sheet, though other ICs may access the contract post-award subject to Government direction, scope, and funding availability. The Government will not change the contract type from a single-award time-and-materials arrangement. For option periods and extensions, offerors should assume similar advisory, analytical, and project-based support may be required, though specific projects, priorities, staffing mix, and timing may vary based on Government direction and program needs. The estimated annual level of effort does not represent guaranteed hours, fixed positions, or distribution of work. Offerors should propose flexible, realistic approaches for Tasks 1-3 without assuming additional labor hours or Other Direct Costs beyond the estimated annual level of effort unless otherwise amended. The Government anticipates quarterly customer service board meetings and does not require specific platforms for dashboards or tools at proposal time, though all deliverables must comply with Federal, Section 508, information security, and privacy requirements. Task 3 efforts may be phased or concurrent and should focus on organizational modernization, change management, workflow analysis, and process improvement while maintaining contractor support roles separate from inherently governmental functions. Evaluation will assess the realism, appropriateness, and sufficiency of proposed staffing approaches, labor mixes, technical approaches, management strategies, and quality controls within the established level of effort to determine best value.

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75N98026R00062 Amendment P00003 Questions/Answers

Question: The revised Pricing template includes an IC column under which hours are to be assigned. Although the information provided in the Government Clarification attachment does provide a LOE table by IC, it does not define the work by the illustrative contractor role according to the three tasks described in the RFP and SOW. We are unable to properly allocate hours by each IC. Can the Government remove the IC column?

Response: No. The IC column will remain in the pricing template. Offerors shall allocate proposed hours by IC using the estimated annual hours provided in the Government Clarification Sheet.

The Government recognizes that work may span multiple task areas and that offerors may propose different staffing models. Offerors should use their proposed technical approach and labor mix to allocate hours by IC in a reasonable and supportable manner. The labor-category-to-task-area mapping in the technical proposal should be consistent with the pricing template and should explain how the proposed staffing approach supports the

SOW.

The Government is not prescribing a fixed allocation of hours by illustrative contractor role or by task area. Offerors should propose the allocation they believe provides the best-value solution within the estimated annual level of effort. Proposed allocations that are not adequately explained, are inconsistent with the technical approach, or do not appear sufficient to perform the SOW may be assessed as presenting performance risk in accordance with the solicitation’s evaluation criteria.

Question: Although we appreciate the information included in the Government Clarification attachment, we note that there is still some ambiguity around the specific contract needs. The Government Clarification document notes that there are "at least three (3) Institutes" which require subject matter expertise. The SOW still alludes to more Institutes that could need services. Should proposers account for support services for more than three ICs?

Response: Offerors should not include contingency hours for unidentified future ICs. For proposal preparation and pricing purposes, offerors should base their proposed staffing approach and price on the participating ICs and estimated annual hours identified in the Government Clarification Sheet.

At award, anticipated support includes NINDS, NIBIB, and NIEHS. Other ICs with similar needs may access the contract post-award, as directed by the Government and subject to scope, funding availability, and program needs. Offerors should not price additional unidentified support for other ICs beyond the stated estimated annual level of effort unless otherwise amended by the Government.

The possibility of future access by other ICs does not change the current pricing baseline.

Any additional work requiring changes to scope, hours, funding, labor mix, or other contract terms would be addressed through appropriate contract procedures.

Question: Page 2 of Government Clarification attachment references that the work is for "base-year projects." Will same level of effort and subject matter expertise be expected in Option years 1 and 2 and the 6 month extension? Without additional information about the expectations for the option years, it is difficult for bidders to know how to forecast staffing needs in the option year periods. Additionally, it may give an advantage to those contractors from the related/ predecessor contracts who have been performing similar work as noted in Q&A. The predecessor contractors would likely have actual hours to reference for their basis of estimate. Would the government reconsider the contract type for this effort? For example, a single award BPA would be better suited to the scalable and flexible arrangement and work scope described in the Amendment 2 and also allow for a more equitable price evaluation if only rates and labor categories were considered within pricing.

Response: The Government is not asking offerors to forecast unknown future projects beyond the annual hours and assumptions provided. Offerors should propose pricing for the base period, option periods, and any evaluated extension in accordance with the solicitation and pricing template. For proposal preparation and pricing purposes, offerors should use the Government-provided estimated annual hours and IC-level planning assumptions as the common pricing baseline for the base and option periods, unless otherwise amended by the Government.

Offerors should assume the same general type of advisory, analytical, project-based support may be required during the option periods, although the specific projects, priorities, staffing mix, and timing may vary based on Government direction, program needs, and funding availability. The estimated annual level of effort is provided for pricing and evaluation purposes and does not represent guaranteed hours, staffing levels, fixed positions, labor mix, or distribution of work.

Offerors should propose an approach that can flex across the base and option periods while remaining within the proposed annual level of effort and pricing structure. The Government does not intend to change the contract type. The anticipated award remains a single-award time-and-materials contract. The Government will evaluate proposals in accordance with the solicitation’s evaluation criteria, including technical approach, staffing approach, past performance, and price, to determine best value.

Government_Clarification_Amendment_P00002_0002 & Att 4

Question: Given the project-based and advisory nature of the requirement, can the Government clarify whether additional labor categories or Other Direct Costs (ODCs), if required to support emerging priorities or specialized subject matter expertise, may be proposed now and/or through established contract modification procedures during contract performance? In particular, please clarify the intended scale, depth and concurrency of Task 3 efforts.

Response: Offerors should propose the labor categories and labor mix they believe provide the best-value solution for performing the SOW within the estimated annual level of effort identified in the Government Clarification Sheet. The Government is not prescribing a fixed labor-category structure beyond the solicitation requirements. Offerors may propose full-time, part-time, or fractional personnel, including specialized SMEs, provided the proposed approach is consistent with the SOW, Attachment 4 pricing template, and Government Clarification Sheet.

The estimated annual hours are intended to encompass the total proposed level of effort for contract performance, including program/project coordination, contract management, quality assurance, reporting, operational oversight, advisory support, analytical support, and direct SME support necessary to perform the requirement. Offerors should not assume additional unidentified labor hours beyond the estimated annual level of effort unless otherwise amended by the Government.

ODCs, if proposed, must be clearly identified, justified, and consistent with the solicitation instructions and pricing template. Offerors should not assume reimbursement for ODCs unless they are proposed, accepted by the Government, and included in the resulting contract. Any post-award changes to labor categories, ODCs, or other contract terms would be handled in accordance with applicable contract modification procedures.

Task 3 is expected to involve flexible, project-based advisory and analytical support for organizational assessment, change management, workflow analysis, research administration structure, process improvement, stakeholder engagement, communication planning, and implementation-support activities. Task 3 efforts may be phased or may occur concurrently based on Government priorities, but all such support must remain within the estimated annual level of effort unless otherwise modified by the Government.

The Government is interested in offerors’ proposed approach to sequencing, prioritizing, and staffing Task 3 efforts in a realistic, efficient, and best-value manner.

Government_Clarification_Amendment_P00002_0002 & Att 4

Question: Can the Government clarify the anticipated governance and participation structure for the activities identified (e.g. cross-IC co-ordination) ? Will these activities primarily focus on participating ICs such as NINDS, NIBIB, NIEHS, or whether enterprise-wide analyses spanning additional NIH ICs may be required within the existing labor-hour structure? On that note, what is the anticipated relationship between National Plan implementation support activities and translational portfolio-management activities described under Task 2?

Response: The Government does not anticipate having a formal governance structure; The Government anticipates a quarterly customer service board meeting with the vendor.

Offerors should propose a management approach capable of supporting Government-led governance, prioritization, stakeholder coordination, and decision-making.

At award, anticipated support includes NINDS, NIBIB, and NIEHS, as reflected in the Government Clarification Sheet. Other ICs with similar needs may access the contract post-award, subject to scope, funding availability, and Government direction. Offerors should not price additional unidentified work for other ICs beyond the estimated annual level of effort unless otherwise amended by the Government.

National Plan implementation support and translational portfolio-management support may be related but are not identical. National Plan support may include advisory and analytical support related to external committee outputs, stakeholder engagement, implementation tracking, briefing materials, and translation of priorities into programmatic considerations. Translational research support may include planning, milestone tracking, portfolio analysis, scientific/programmatic summaries, and analytical support for research initiatives.

Offerors should propose an approach that can support related but distinct advisory and analytical needs without duplication of effort. The Contractor’s role is to provide support, analysis, recommendations, coordination, documentation, and subject matter input to assist Government-led decision-making; the Contractor will not make Government decisions or perform inherently governmental functions. More specifically, the Government is seeking to leverage the work vendor across Institutes. For example, a change management approach developed in NIBIB may be used in NINDS. The expectation is that in working across multiple Institutes, the Government gains a cost savings so that it is not paying twice or three times for the development of the same approach.

Government_Clarification_Amendment_P00002_0002

Question: Can the Government clarify whether dashboards, trackers etc are anticipated to be developed within existing NIH-approved platforms and environments or whether contractors may propose independent Section 508-compliant tooling approaches? If they need to be developing within NIH existing platforms, what are those platforms or technical requirements?

Response: Offerors may propose approaches for dashboards, trackers, milestone tools, and portfolio-monitoring tools that are appropriate to the SOW and the advisory/analytical nature of the requirement. The Government does not require offerors to propose a specific platform at this time.

During performance, the Government may direct the Contractor to use NIH-approved systems, Government-furnished tools, or other approved platforms, depending on the nature of the work, data sensitivity, access requirements, and Government needs. Offerors should identify any assumptions regarding tools, systems, software, data storage, accessibility, and Government-furnished information in their proposals.

Any electronic deliverables, dashboards, trackers, or tools must comply with applicable Federal, NIH/HHS, information security, privacy, confidentiality, and Section 508 requirements, as applicable. Offerors should not assume use of non-Government systems for storing or processing Government information unless such use is proposed, approved, and consistent with applicable contract requirements.

Government_Clarification_Amendment_P00002_0002 & RFP

Question: Can the Government clarify whether organizational modernization and consolidation activities described under Task 3 are anticipated to occur as a limited number of phased initiatives or whether multiple concurrent modernization and shared-services assessments may occur simultaneously across participating ICs during the same period of performance?

Response: Task 3 is intended to provide flexible, project-based advisory and analytical support for organizational modernization, consolidation, change management, workflow analysis, process improvement, stakeholder engagement, communication planning, and implementation-support activities. Task 3 is not intended to require the Contractor to assume responsibility for Government operations, independently direct NIH programs, operate laboratories, manage grants as a Government official, or perform inherently governmental functions.

Task 3 efforts may be phased or may occur concurrently, depending on Government priorities and project needs. Offerors should propose a realistic approach for sequencing, prioritizing, staffing, and managing Task 3 efforts within the estimated annual level of effort.

The Government is interested in the offeror’s proposed solution, including how the offeror will flex varied expertise across projects and ICs while maintaining quality, timeliness, and role separation.

At award, Task 3 support is anticipated to focus on the participating ICs identified in the Government Clarification Sheet. For NIBIB specifically, the Government anticipates flexible advisory and analytical support for organizational assessment and change management across scientific and administrative operations, including areas such as the Office of Administration and Management, Research Administration, and Extramural Scientific Programs. NIBIB support may require varied expertise and may be performed by multiple professionals or SMEs on a part-time or fractional basis, while remaining within the estimated NIBIB annual level of effort. For planning and pricing purposes, NIBIB support should remain within the estimated 2,860 annual hours identified in the Government Clarification Sheet unless otherwise amended by the Government.

Other ICs may access the contract post-award if requirements arise and are within scope, subject to funding availability and Government direction. Offerors should not assume additional unidentified work beyond the stated estimated annual hours unless otherwise amended by the Government.

Government_Clarification_Amendment_P00002_0002 & RFP

Question: Given this flexibility and the absence of binding workload or staffing constructs, can the Government clarify how it will evaluate the realism, appropriateness, and comparability of proposed staffing approaches and labor mixes across offerors?

Specifically, how will the Government assess performance risk and ensure a fair and consistent evaluation where proposed solutions may vary significantly in structure, labor mix, and level of effort assumptions relative to the provided illustrative estimates?

Response: The Government will evaluate proposed solutions, staffing approaches and labor mixes in accordance with the solicitation’s evaluation criteria. The Government is seeking the best-value solution and recognizes that offerors may propose different staffing models, labor categories, SME mixes, and technical approaches. The proposal should assume that the level of effort specified in the Clarification Statment when proposing support and staffing solutions.

Offerors should clearly explain the rationale for their proposed labor mix, including how the proposed personnel, hours, expertise, management approach, quality controls, and risk mitigation will meet the SOW requirements within the estimated annual level of effort.

Using the level of effort and the technical evaluation factors, the Government will assess whether the proposed staffing approach is realistic, appropriate, efficient, and sufficient for the advisory and analytical nature of the requirement.

The estimated annual hours are intended to encompass the offeror’s total proposed level of effort for performing the requirement, including program leadership, contract management, implementation coordination, quality assurance, executive reporting, operational oversight, and direct advisory/analytical support. Offerors should not assume separate or additional Government-funded labor outside the estimated annual hours unless otherwise amended by the Government.

The Government may assess performance risk where a proposed approach appears unrealistic, understaffed, overstaffed, poorly aligned to the SOW, inconsistent with the pricing proposal, or unsupported by the offeror’s technical approach. The Government will evaluate the proposed solution as a whole, including technical approach, staffing approach, labor mix, management approach, quality controls, risk mitigation, past performance, and price, to determine best value.

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