Att14AdditionalTechProposalInstruc.pdf

Attachment 14 – Additional Technical Proposal Instructions

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ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

NCI GENOMIC CHARACTERIZATION CENTERS

These Additional Technical Proposal Instructions reflect the requirements of the Request for Proposal (RFP) and provide specific instructions and formatting for the Technical Proposal. Offerors are advised to give careful consideration to the base contract Statement of Work (SOW), sample Task Order SOWs, Technical Evaluation Criteria, and the RFP as a whole in the development of their Technical Proposals.

Offerors shall submit one proposal to the Base IDIQ contract SOW. Offerors shall submit proposals to one OR more Sample Task Order Statements of Work. Separate proposals shall be prepared for the different Sample Task Order Pool SOWs, as follows:

Pool 1. High-throughput DNA Sequencing Pool 2. High-throughput RNA Sequencing Pool 3. Epigenome Characterization with Sequencing-based or Array-based Assays Pool 4. Single-Cell/Spatial Characterization

For general background and current research projects of CCG, please visit https://www.cancer.gov/ccg/.

The Offeror must adhere to a 50-page limit for Base IDIQ SOW and a 25-page limit per characterization pool task order SOW proposed. Pages in excess of this limitation will be removed from the proposal and will not be provided to the reviewers to be read or evaluated. Pages shall be of standard size (8.5 x 11) with a font size of 10 to 12 points. Proposal pages shall be numbered “Page 1 of 50, Page 2 of 50” etc. The page limit excludes the cover sheet, resumes, and all appendices or attachments.

SECTION 1: COVER PAGES AND TABLE OF CONTENTS

It is strongly recommended that Offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal shall be presented in the order specified below.

A. PROPOSAL TITLE PAGE. Include the RFP title and number, name of the organization, UEI SAM number, proposal part, and identify if the proposal is an original or a copy;

B. PROJECT OBJECTIVES;

https://www.cancer.gov/ccg/

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C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS;

D. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043);

E. TABLE OF CONTENTS. Include a Table of Contents with indicated pages of proposal sections that at a minimum use the underlined Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion.

SECTION 2: TECHNICAL DISCUSSIONS

A detailed work plan shall be submitted indicating how each aspect of the SOW is to be accomplished. Offerors’ responses shall include detailed discussions of the project and technical approach, organizational experience, team and key personnel (key positions), and facilities and equipment. Proposals that merely restate the requirements of the Government’s SOW will not be eligible for award. Offerors shall submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the objectives of the SOW. Proposals including multiple characterization platforms will be viewed favorably, but not required.

A. Project and Technical Approach

Offerors shall provide a narrative on how production capacity to meet CCG turnaround-time requirements will be supported by sufficient staff and instrument time. Offerors shall indicate if the turnaround time applies to any number of cases or to a specific volume of cases or volume range. Offerors shall indicate what priority CCG cases will be given in their processing queue. Offerors shall indicate if their production capacity is scalable to handle a sudden spike in cases. Offerors shall indicate the maximum number of cases their production capacity can support over the period of performance.

Offerors shall indicate their historical failure rate for the protocols they are proposing. Offerors shall provide a breakdown of the percentage of failures attributed to biological reasons, technical reasons, equipment reasons, and other reasons, if applicable.

Offerors are not required to address all the platforms in the characterization pool Task Order SOW. However, the ability to perform multiple platforms listed in a characterization pool Task Order SOW will be considered favorably.

If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter(s) of commitment from the subcontractor(s), plus documentation of the subcontractor’s expertise, qualifications, prior performance, as well as, a narrative describing how the Offeror will manage the subcontractor(s).

Offerors shall provide current SOPs that they utilize, or intend to utilize, to perform work under this SOW as part of their Technical Proposal.

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Program Management Plan (PMP)

The Offeror shall demonstrate its understanding of the tasks outlined in the Task Order SOW, including thoroughness in planned execution in a detailed Draft PMP which addresses the allocation of resources and operation timeline. The section of the technical proposal addressing the Offeror's technical approach shall address all the general requirements and detailed functions outlined in the SOW.

The Offeror shall describe its experience in providing relevant genome characterization services. The description shall include examples of the previous and present contracting organizations with identical or similar projects as the ones outlined in the SOW.

Also, include the depth of additional staff and resources to support varying workloads or to provide backup for members of the project staff. If pertinent, the offerors shall describe the organization’s experience in the appropriate use of subcontractors to supplement areas of expertise. Offerors should include:

• Project Management approach in terms of staffing, organization, responsibilities, leadership, and lines of authority.

• Startup plan to achieve required operation capacity

• Management of operation capacity for the task proposed.

• Management controls for tracking the schedule.

• Management controls by which budget and costs are controlled.

• Project risks and identifying risk mitigation strategies.

In addition, the narrative shall provide key aspects of deliverables that ensure the attainment of programmatic goals, describe any special expertise the Offeror brings to this contract, and include descriptions of staffing, resources, and experience in operating genome characterization pipelines.

Transition Plan

The Offeror shall include a Draft Transition-In Plan comprised of the following:

The Offeror shall include a start-up plan of how the Contractor shall commence operations, including specifically the scale-up of staffing (including key personnel) and operational resources as well as obtaining required certifications and the incorporation of data, SOPs, materials and other transition information. The offeror shall include in the plan a timeline to obtain documents for IRB approval or waivers to perform relevant work if that is needed locally.

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B. Organizational Experience

The Offeror shall demonstrate its organizational experience in large-scale cancer genome characterization relevant to this RFP.

The Offeror shall include a list of all relevant projects, with descriptions, sizes, and dollar amounts of the contracts or grants awarded, and other pertinent information. Offerors shall demonstrate experience in the technologies, procedures, and management of high-throughput programs required to execute this project.

C. Team and Key Personnel

Identify in a list or table showing name, highest degree, organizational affiliation (employer), role on the project, and percentage of effort to be committed to the project for all personnel including any subcontract or consultant personnel.

For each named person, include a 2-page Curricula Vitae (CV) which provides selected references for publications relevant to the tasks of the RFP, and includes experience with projects of similar scope, size, and complexity.

The following are key positions required for the contract:

1. Project Director: This individual shall have a doctorate-level degree in biomedical and molecular biology. This individual shall have primary responsibility to interact with NCI investigators and to assure compliance with NIH and CCG policies on genome characterization studies. In addition, s/he shall participate in scientific and policy discussions as requested by the COR or designee.

2. Project Manager: This individual shall serve as the overall project manager. This individual shall provide evidence of experience in managing similar high-throughput characterization projects. The project manager director shall be the primary contact for day-to-day non-technical issues of the characterization pipeline including sample receipt, processing status, resource allocation, and reports. This individual shall be the primary non-technical project contact with the Contracting Officer Representative (COR).

3. Laboratory Operations Manager: This individual shall oversee molecular characterization activities. This individual shall provide evidence of postgraduate experience in high-throughput laboratories. This individual shall be the primary technical contact with the COR.

4. Informatics Project Manager: This individual shall direct the management and processing of all relevant data at the characterization center. This individual is also key for coordination between the COR and NCI’s data repository for the timely submission of produced data. An individual with a BS degree in computer science or information technology and extensive

Additional Technical Proposal Instructions Page 5 of 5 experience with high throughput methods for data processing, quality analysis, and compliance with data standards is preferred.

D. Facilities and Equipment

1. Facilities Information in this section is used to assess the adequacy of the organizational resources available to perform the proposed work. Identify the facilities to be used (laboratory, computer, office, and other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity, and extent of availability to the project. Describe only those resources that are pertinent to the proposed project. Provide any information describing other resources available to the project and the extent to which they would be available to the project (e.g. Increases in capacity, monitoring, backup power resources, etc.). Address how the environment will contribute to the probability of success of the proposed work. Also note any unique features or resources that would contribute to the probable success of the work proposed. If facilities and resources outside of the Offeror’s facilities/resources will be used to carry out the project, describe those facilities in a separate section of the document.

2. Equipment During performance of the SOW, the Contractor is responsible for providing the required equipment needed to perform the work. Briefly describe major items of equipment available for the project, together with their location and pertinent capabilities, if appropriate. Only include equipment that will be necessary to conduct the project being proposed.

3. Information Technology Systems and Support Workflow Informatics Describe the Laboratory Information Management System (LIMS) and how it will be used to store and track pipeline information.

4. Informatics and Data Submission Describe the systems and approach for data handling and submission of finalized data as deliverables in the framework of the requirements provided in this SOW.