Government_Clarification_Amendment_P00002_0002.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 is a Government Clarification document providing illustrative examples of project-based support services for three National Institutes of Health (NIH) Institutes and Centers.

The requirement establishes flexible, project-based advisory and analytical support across the National Institute of Environmental Health Sciences (NIEHS), National Institute of Biomedical Imaging and Bioengineering (NIBIB), and National Institute of Neurological Disorders and Stroke (NINDS). Services are intended to support scientific and management operations, scientific programs and external committees, and change-management initiatives. The contractor will not assume responsibility for full government program operations, laboratory operations, grants management functions, or inherently governmental decision-making. Illustrative support areas include organizational assessment, program transition or winddown support, research administration structure advising, translational research program support, National Plan to End Parkinson's support, scientific/programmatic analysis, change-management support, reporting and dashboards, and advisory support on subject matter expertise.

The estimated total annual level of effort is 12,700 hours (6.61 FTE equivalents), distributed as follows: NINDS requires 8,200 hours (4.27 FTE) supporting up to six individuals in mixed full-time, part-time, or fractional roles; NIBIB requires 2,860 hours (1.49 FTE) with flexible, limited support; and NIEHS requires 1,640 hours (0.85 FTE) with part-time or fractional support. Offerors should price flexible staffing models using full-time, part-time, or fractional personnel without assuming guaranteed dedicated full-time positions. Actual staffing, project assignments, and level of effort may vary based on government direction, program priorities, funding availability, and evolving institute needs. The document clarifies this is a new requirement with no incumbent contractor.

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Government Clarification: Illustrative Examples of Potential Project-Based Support

The Government clarifies that this requirement is intended to provide flexible, project-based support. These services are intended to be advisory and analytical in three main areas: scientific and management operations, scientific programs and external committees and change-management support across participating Institutes and Centers within the estimated annual level of effort provided below. This requirement is not intended to establish a large staff-augmentation model or require the Contractor to assume responsibility for full Government program operations, laboratory operations, grants management functions, or inherently governmental decision-making.

The following examples are provided for proposal preparation and pricing purposes only. They are illustrative and are not intended to represent a guaranteed list of tasks, deliverables, frequency, or level of effort. Actual work will be directed by the Government during performance and may vary based on program priorities, funding availability, and evolving IC needs.

Example Support Area Illustrative Contractor Role

Organizational assessment Assist with assessing current workflows, documenting pain points, identifying options for improved coordination, and preparing recommendations for Government consideration.

Program transition or wind-down support

Provide analytical, coordination, and documentation support related to transition planning, closeout considerations, stakeholder communications, and decision-support materials.

Research administration structure

Advise with respect to structuring or coordinating research administration support functions, including roles, workflows, governance documentation, and process improvement opportunities.

Translational research program support

Support planning, milestone tracking, meeting coordination, briefing materials, and analytical summaries for translational research projects or initiatives.

National Plan to End Parkinson’s support

Assist with stakeholder information synthesis, briefing materials, implementation tracking, and programmatic documentation.

Scientific/programmatic analysis

Develop literature or portfolio summaries, analyze program information, identify gaps or trends, and prepare briefing papers or technical summaries.

Change-management support

Develop draft change-management strategies, communication plans, stakeholder engagement materials, and implementation tracking tools.

Reporting and dashboards Develop or maintain status reports, action-item trackers, milestone trackers, dashboards, and risk logs.

Example Support Area Illustrative Contractor Role

Advisory support Provide expert input on subject matter and make recommendations to support Government-led planning and decision-making.

The Contractor is not expected to perform inherently governmental functions, make Government decisions, independently direct NIH programs, operate laboratories, manage grants as a government official, or assume responsibility for full program operations unless expressly stated in the SOW or directed within the scope of the contract.

The Government requires a vendor to provide subject matter expertise to project-based work across at least three (3) Institutes. None of the base-year projects are expected to need full-time support; rather each of the projects is anticipated to be combined to full-time equivalents as described below. The Contractor’s role is to provide support, analysis, recommendations, coordination, documentation, and subject matter input to assist Government-led decision-making. The Government clarifies that there is no incumbent as this is a new requirement. Some prior work had been accomplished under different contracts. Related contracts are provided in responses to the questions; the Institutes are seeking a consolidated approach in which the vendor can work across different organizations, with the idea to gain efficiencies and not duplicate work. More specifically for the proposal:

• National Institute of Environmental Health Science (NIEHS) requires support for the development of a management strategic plan which will require coordination among and support to internal Institute staff groups.

• National Institute of Biomedical Imaging and Bioengineering (NIBIB) requires assistance in development of flexible organizational structures and change management support of scientific and administrative operations. The Office of Administration and Management, Research Administration and Extramural Scientific Programs are assessing how best to optimally organize to strengthen and build strategic partnerships with NIH and across the scientific research community. NIBIB anticipates for the first year this would be up to 3 projects of organizational assessment and change management across all of NIBIB and more specifically, Office of Administration and Office of Extramural Science and Research Administration.

• National Institute of Neurological Disorders and Stroke (NINDS) requires support for operational change management and support to change in operations. It also requires expertise in advising leadership on external scientific groups related to Parkinsons and other mission-related groups, such as ALS and Alzheimer’s Disease. It primarily requires expertise in its external research communities which it funds. It is not seeking logistical or administrative support of FACA committees. NINDS requires advising and analyzing outputs of external committees and working with NINDS staff to translate those priorities to the external research community to ensure strong stakeholder engagement.

For pricing purposes, offerors should assume support will be provided through a flexible labor mix using full-time, part-time, or fractional personnel, as appropriate, within the estimated annual hours by IC. Offerors should not assume continuous full-time support for every SME area. Offerors should price a staffing model capable of flexing across projects, ICs, and task areas while remaining within the estimated annual level of effort.

For planning purposes, the Government estimates annual level of effort as shown below.

Approximate FTE equivalents are calculated using 1,920 productive hours per FTE per year. These FTE equivalents are provided for pricing and evaluation purposes only and do not represent guaranteed staffing levels, fixed positions, or required numbers of personnel.

IC

Estimated Annual Hours

Approximate FTE Equivalent* Planning Assumption

NINDS 8,200 4.27

Support may involve up to ~six individuals or SMEs in a mix of full-time, part-time, or fractional roles, depending on project needs, while remaining within the estimated annual hours. Offerors should not assume six dedicated full-time positions.

NIBIB 2,860 1.49

Support is expected to be limited and flexible and may involve more than one individual or SME on a part-time or fractional basis, while remaining within the estimated annual hours.

NIEHS 1,640 0.85

Support is expected to be limited, up to approximately one FTE equivalent annually, and may involve part-time or fractional support.

Total 12,700 6.61 Estimated total annual level of effort.

*Approximate FTE equivalents are calculated using 1,920 productive hours per FTE per year.

Offerors may propose full-time, part-time, or fractional staffing models, provided the proposed labor mix and level of effort align with the estimated annual hours and support the requirements of the SOW. Offerors should not assume a guaranteed number of dedicated full-time positions.

Actual staffing mix, project assignments, and level of effort may vary based on Government direction, program priorities, funding availability, and evolving IC needs.

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