A5_Additional_Technical_and_Business_Proposal_Instructions_AMENDMENT_1_0001.pdf

Amendment 1 - Attachment 5 - Additional Technical and Business Proposal Instructions

Offerors Questions should be submitted by: October 24, 2024.

Note: Offerors questions and the Governments responses will be published via Amendment to the RFP on or about November 1, 2024.

Additional Technical and Business Proposal Instructions

TITLE: "NIH NeuroBioBank Brain and Tissue Repository"

OFFERORS QUESTIONS ABOUT THE SOLICITATION/INSTRUCTIONS

Questions should be sent via E-mail to: rieka.plugge@nih and robin.knightly@nih.gov and will be answered in writing. Typically questions and answers are posted as a solicitation amendment, at the discretion of the Contracting Officer. Please review the Statement of Work (SOW) and Solicitation document/Request for Proposal (RFP) carefully before asking for any clarifications.

I. TECHNICAL PROPOSAL INSTRUCTIONS, CONTENT AND FORMAT

It is strongly recommended that Offerors use the order and format specified in the Statement of Work outlining the different General Task Areas as the layout for the Technical Proposal. This standardization will allow a more informative and thorough evaluation of your proposal.

These additional Technical Proposal instructions reflect the requirements of the RFP and provide specific instructions and formatting for the Technical Proposal.

While Section L of the RFP provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of this RFP. In addition to Section L., 'Authorized Official and Submission of Proposal' instructions, the proposal must use 12-point sized font and must not exceed 200 pages. This page count limitation does not include/apply to appendix materials, such as the manual of standard operating procedures.

Offerors should also follow the instructions in Section L of the solicitation, and include the information requested in the format presented here.

Offerors are advised to give careful consideration to the Statement of Work, all reference materials, and attachments, the Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

mailto:robin.knightly@nih.gov

Attachment 5 - Additional Technical and Business Proposal Instructions

IMPORTANT NOTES/TERMS REGARDING TECHNICAL PROPOSAL AND THE CONTRACT

1. Contractor(s) will be permitted to use contract acquired specimens and tissues for research related to funded NIH research grants but will be required to apply through the tissue request process on the NBB portal so that (1) all biospecimens can be tracked and (2) to maintain fair and equitable access for all researchers. Such R&D shall be conducted outside the scope of this contract.

2. All existing specimens donated to this contract project will become Government

Property.

3. The Government reserves the right to be selective in accepting donated specimens into the contract; while donations are encouraged, only high-quality, well-characterized specimens of desired disease focus will be accepted.

FORMAT OF THE TECHNICAL PROPOSAL Include proposal information in the following order and sequence:

1. TECHNICAL PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, UEI number, and indicate whether the proposal is an original or a copy.

2. RFP Form - GOVERNMENT NOTICE FOR HANDLING PROPOSALS

3. RFP Form - PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

4. TABLE OF CONTENTS (SECTIONS I-VI, below)

SECTION I-TECHNICAL - PROPOSAL OVERVIEW

Provide a brief description of the proposed project, including:

1. A summary of the objectives of this Project and the Offeror' s understanding of the problem.

2. A summary describing the Offeror's proposed scope of activities, and a general overview of the proposed organization, history and experience doing similar projects.

3. Identification of the Offeror and proposed key personnel with degrees and titles.

4. Identification of the proposed subcontractor(s) and any key subcontractor personnel with degrees and titles (as applicable).

5. A brief summary of the relative roles to be performed by the Offeror and any proposed subcontractor(s).

6. A brief description of the facilities and other resources to be made available by the

Offeror and any proposed subcontractors.

The Technical Proposal should address all elements in the general Statement of Work, as described in RFP Section L, including: Objectives, Approach, Methods, and Schedule.

The format presented herein suggests you follow the Statement of Work elements and describe precisely how you will provide the services. See Attachment 3 for a detailed and complete description. The schema in statement of work should be used to organize the layout of the Technical Plan/Approach.

A. ACQUISITION VOLUME AND CHARACTERISTICS OF THE DONOR SPECIMENS

1. Provide a projected collection size (per year, and cumulative after 5 years) and the characterization of future donor acquisitions at your proposed site.

Note: Offerors must propose a realistic new specimen acquisition schedule, supported by either historical data or other convincing information. Failure to do so could eliminate an Offeror from the competitive range for award consideration. Also, the Government will evaluate the actual specimen accrual periodically and this information will be a factor in determining whether to exercise options to extend performance under these contracts.

Note: The estimated volume/rate of new donor acquisitions per year.

2. Discuss your approach and methodology to each item in Section III. A of the Statement of Work (i.e. Acquisition Volume and Characteristics of Donor Specimens).

INCLUDE A TABLE (SIMILAR TO THE ONE BELOW) TO SUMMARIZE PROJECTED DONOR

ACCRUALS, INCLUDING AGE, RACE/ETHNICITY, AND DIAGNOSIS:

Period Estimate #

DONORS

Diseases and disorders that can be collected

Type of Associated Clinical Data (e.g. NoK interviews, hospital records etc.)

Geograp hic Catchme nt Area (population size)

05/01/25 – 04/30/26

05/01/26 – 04/30/26 05/01/27 – 04/30/28

SECTION II - TECHNICAL - PLAN/APPROACH (GENERAL TASK AREAS 1-3)

05/01/28 – 04/30/29 05/01/29 – 04/30/30

3. Discuss your established mechanisms for recruiting and registering potential donors and experience with outreach efforts towards and/or collaborations with advocacy organizations.

4. Discussion the potential inclusion of existing, high-quality, well-characterized specimens to be donated for use under this contract.

5. Discuss the estimated disease diversity in acquired donor specimen (with a variety of neurodevelopmental disorders, neurological disorders, and neuropsychiatric disorders) and the capability to acquire healthy controls.

6. Discuss your capability to isolate nucleic acids (DNA, RNA) and the capacity for production, storage, and distribution of nucleic acid libraries.

7. Discuss your capability to provide associated clinical data with donor specimens.

8. Discuss your capability to provide donors from different geographic catchment areas.

9. Discuss your capability and capacity to prepare both fixed and frozen specimens from the tissues and justification if doing only one of these routinely.

10. Discuss your capability of acquiring other tissues, pre-mortem tissues (e.g. blood), and prenatal material.

GENERAL

The Technical Proposal should address all elements of the general Statement of Work, as described in RFP Section L, including: Objectives, Approach, Methods, and Schedule.

The format presented herein suggests you follow the Statement of Work elements and describe precisely how you will provide the services. See Attachment 3 for a detailed and complete description. The schema in SOW should be used to organize the layout of the Technical Proposal.

Document your technical approach and current SOPs for shipping of samples to investigators for research purposes to fulfill the objectives of tissue sharing under this Project.

SECTION II - TECHNICAL - PLAN/APPROACH (GENERAL TASK AREAS 4-11)

GENERAL TASK AREAS 8, 9, 10, AND 11 ARE OPTIONAL

ADDITIONAL CONTRACT REQUIREMENTS

a. STANDARD OPERATING PROCEDURES (SOPs)

Describe and document your current SOPs for all aspects of this Project. Provide the Table of Contents of your SOP Manual. The SOP manual should be provided as an appendix to the technical proposal.

b. QUALITY ASSURANCE SYSTEMS/PROGRAMS

Describe and document your proposed Quality Management Program (QMP) to measure and evaluate the SOPs, as outlined in the Statement of Work.

c. STANDARDS ACROSS SITES

Discuss the capability and feasibility of your site adopting common protocols and measures with other NBTR sites, to minimize variability in tissue quality.

d. CURRENT REGULATIONS AND SAFETY STANDARDS

Discuss the regulatory aspects and safety issues involved in this Project.

e. DATA MANAGEMENT SYSTEMS AND DATABASES

NIH Neurobiobank Portal

Describe procedures and technical approach to interfacing with this site.

Note: The Government will require contractors to submit biospecimen inventory files to the Neurobiobank (3rd party IT infrastructure) at quarterly intervals or as determined by the Contracting Officer Representative (COR). These files must be in a file format specified by the COR, and adhere to data specifications as determined by the COR. The exact format of the submitted files is expected to be in Comma Separated Value (CSV) or XML format. The data specifications will be based on a controlled vocabulary (Data Dictionary) that the submitted files must adhere to.

The specifications may include logic checks on the data that the submitted file must satisfy.

The submissions must be incremental in nature and only include data records for changes in the inventory since the last acceptable submission. The Government reserves the right to reject a submission if it does not meet submission standards, and require the resubmission of the data after deficiencies have been addressed by the submitting site.

The Government may, at its sole discretion, accept a submission file that does not meet some or all of the data file submission specifications. However, acceptance of a submission in this manner will not constitute a waiver for future submissions.

f. Laboratory Information Management System (LIMS)

Describe your procedures and technical approach to providing and utilizing a comprehensive Laboratory Information Management System (LIMS) for curating, tracking, managing inventory, photographing, digitally recording information about tissue quality and integrity of samples, entering clinical data and uploading all data to the Portal using standardized data dictionaries.

g. Adoption of Common Protocols

Discuss the adoption of common protocols when feasible for providing high quality information regarding clinical characterization and diagnoses (for example seehttp://www.commondataelements.ninds.nih.gov/#page=Default)

h. STORAGE FACILITIES, EQUIPMENT AND SECURITY

Describe and document the facilities at your site that are sufficient for providing the services proposed, outlined in this Statement of Work, including security, backup, environment, monitoring, etc.

Provide a description of the current facility (include a detailed floor plan which shows location of the equipment and resources) and a list and description of equipment proposed for the project and its availability (i.e., percentage of time equipment will dedicated to the project, percentage of storage space currently available for the project, etc.). Include age and useful life expectancy of the major pieces of equipment, and plans for replacement, as applicable.

i. TRANSITION/RELOCATION OF GOVERNMENT PROPERTY TO A THIRD-PARTY

Include a plan for this activity as described in the statement of work.

http://www.commondataelements.ninds.nih.gov/#page%3DDefault)

SECTION III - TECHNICAL APPROACH - PROPOSED PERSONNEL AND PROJECT

MANAGEMENT TEAM

The Technical Proposal should include all information relevant to document individual training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements. Clearly identify who is considered to be Key Personnel. Limit CVs to 35 pages, provide selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity.

A. Principal Investigator (PI):

Indicate the experience and qualifications of the PI to plan, manage, and direct the activities to be carried out under this contract; adequate level of effort dedicated to these activities. The experience described should be specific to the conduct of the work proposed.

B. Scientific and Other Technical Personnel:

1. Document the training and availability of all personnel experienced in and dedicated to performance of this contract. Document the training and availability of all personnel with specific areas of expertise key to this effort; justify the proposed level of effort.

2. Discuss the capability of proposed personnel to identify and utilize advances in new state-of- the-art procedures in biospecimen and biorepository research for implementation into this contract (e.g., including but not limited to those from the NCI Office of Biospecimen and Biorepository Research Biospecimen Research Network). Discuss the knowledge and expertise to guide decisions for improving future biospecimen storage and handling, as well as determining scientific utility of the long-term storage of current specimens and the introduction of bias due to processing and storage conditions.

II. BUSINESS PROPOSAL INSTRUCTIONS, CONTENT AND FORMAT

In addition to the format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented in this section of the RFP is intended to provide uniform assumptions and business clarifications.

Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the Technical Evaluation Criteria, and, the RFP as a whole, in the development of your proposal. The information requested in these instructions should be used as a guide for the development and formatting of your Business Proposal. Offerors should consider and include the information requested here, as well as any other information which will benefit the proposal.

The business proposal must contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rate, fee, and profit (as applicable). SEPARATE SUBCONTRACT BUDGETS SHOULD BE PROVIDED, AND

INCORPORATED INTO THE PRIME'S TOTAL BUDGET (AS APPLICABLE).

In addition to Section L., 'Authorized Official and Submission of Proposal' instructions, the proposal must use 12-point sized font and must not exceed 200 pages. This page count limitation does not include/apply to appendix materials..

Carefully read and follow the Packaging and Delivery of Proposal (eCPS) instructions (Attachment 1 of the RFP). While there are no page limitations, unnecessarily elaborate proposals are not solicited.

A. GOVERNMENT-FURNISHED INFORMATION/COST ASSUMPTIONS

1. INSTRUCTION 1 - Estimated Level of Effort

This will be a level of effort type contract, where one of the required deliverables will be hours/effort. The final required effort in any contract will be subject to negotiations.

The Government's Estimate of Effort (and labor mix) below is provided to assist Offerors in preparation of proposals. This estimate is not prescriptive and Offerors can propose the effort believed necessary, with explanation.

Important Not : The Offeror's proposed level of effort may be higher or lower than the estimate below, based upon your type of organization and the source of tissue.

Estimated Level of Effort (not prescriptive)

Position/Labor Category Annual Hours/Percent Effort

PrincipaI Investigator(s), Program Director(s), Associate Director(s), Neuropathologist(s)

2498 hrs./120% FTE

Senior Scientists, Clinicians, Clinical and Donor Coordinators, Laboratory Technicians, IT Database Administrators

20,382 hrs./980% FTE

Consultants, External scientific Advisors

2080 hrs./100% FTE

Total 24,960 hrs./1,200%

Notes:

• This effort does not include any potential subcontractor effort;

• 1 FTE = 100% effort= 2,080 hours

2. INSTRUCTION 2 - Standard Assumptions to be used in developing cost proposals

a. Equipment

(1) The Government will consider the funding of equipment for this contract, in accordance with NIH property regulations, to accommodate an expanded repository collection (e.g., more storage space is necessary due to additional specimens acquired), or to replace equipment that fails unexpectedly or equipment projected to outlive its useful life during the contract.

(2) However, the Government will not consider fonding any equipment needed for contract startup; the Contractor must have a satisfactory facility and infrastructure in place at time of award to perform this contract.

Further, while new equipment can be proposed to accommodate collection expansion and repair/replacement of outdated equipment during the contract, be advised that sources that can provide all their own resources throughout this project might have competitive advantage in the Government's best value source selection process to award a contract (where proposed cost is a selection factor).

If equipment costs (e.g. freezers) are proposed where the equipment will be shared between projects, provide a simple prorated cost allocation basis upon approximate percent of capacity. The Government will only cover those costs specific to this contract.

(3) Important note: Offerors must include all anticipated equipment costs throughout the potential five-year period (if all options years are exercised) of performance in their budget.

(4) Note: Approved equipment purchased with contract funds is considered Government property. The disposition of Government property at the end of the contract is in accordance with Federal regulations.

b. Travel Costs

Assume one (1) trip per year to meet with the COR, in the Washington DC area (2 individuals, 1 night)

c. Special Shipping and Packaging Costs

Assume 3,000-5000 biospecimens shipped to 40 researchers per year.

3. INSTRUCTION 3 - Separation of Costs - Multiple Projects Conducted in Same Facility

All costs for continued operation of an existing repository where these resources are not donated to this contract effort (e.g., including equipment, labor, materials/supplies, etc.) shall not be included in the budgets below. If existing resources are shared between different Projects (i.e., this Project and other research efforts) the costs must be accounted for separately. Provide a simple prorated cost allocation basis. This contract will support/fund only effort directly attributable and beneficial to this contract and it s objectives.

SECTION I - BUSINESS PROPOSAL: REQUIRED BUDGETS

The separate budgets described below should be presented in Excel format, by individual cost categories, using either the NIH electronic spreadsheet (below), or a spreadsheet of your own, but in the same general format as the NIH spreadsheet.

A. REQUIRED BUDGETS

There are four (4) required, separate, yearly budgets for the base period and all options to extend services and options for additional quantities plus a one-time budget for option to transfer Government Property.

The budgets below will be presented by the individual cost elements (direct and indirect costs) for support of the infrastructure, the acquisition effort, in-processing effort, cataloging, quality assurance, data management, outreach effort, and tissue sharing, etc.) as follows:

Present the budgets below by the individual cost elements (direct and indirect costs) for support of the infrastructure, the acquisition effort, in-processing effort, cataloging, quality assurance, data management, outreach effort, and tissue sharing, etc.) as follows:

Budget#l

Provide annual budget (including any current specimens at contract start-up), with annual increases based upon an Offeror-proposed new specimen (donor) accrual rate (five (5) - year budget based upon the Offeror's estimated rate of new acquisitions); as applicable, include costs to accommodate any current specimens/resources donated to this Project at contract start-up.

Budget#2 (See RFP Sections B, F&L for Option Quantity Budget Chart)

Provide a budget for the option below (i.e., complete the chart, as directed)

i. Note: Rates presented below should show a loaded labor rate (all direct and indirect costs), and show how the rate was calculated (by providing a few examples).

ii. Note: Percentage (%) effort is to be based upon 2,080 hours (equals 1 FTE) per 12-month contract period.

iii. Budget #3 will allow for the flexibility of increasing deliverable hours, as needed.

Each Offeror should compute an average labor rate based upon the Budget #1 respective labor mix proposed.

iv. This budget (#3) requests pricing to potentially add additional hours (and associated funding) during each contract period. This pricing will become part of any contract award, and will allow the addition of hours and associated costs within the scope of the contract which will provide flexibility to increase the required hours if necessary.

Options for additional quantity are exercised (unilaterally) at the discretion of the Government.

Budget#3 (Included in Option Quantities Budget Chart, see Section B, F & L)

Provide a detailed budget to transfer the repository to a third party. This includes all specimens collected during the potential five-year period of performance including those donated to the contract effort after award. Include direct labor, and any other direct costs (e.g.materials and supplies, equipment, transportation costs) applicable. Also include applicable fringe, G&A, F&A, and any profit/fee proposed.

Budget # 4 Total estimated cost(summary budget toinclude all relevant costs to conduct tbe requirements)

Provide a summary budget that includes:

• Budget#1 - Cost per performance year tocollect required amount specimensper year for a total of five (5) years (If all option years are exercised)

• Budget #2 -Cost performance year for maximum option quantity at 80% effort/hours for each of the potential five (5) performance years. Note: in this summary budget, include all applicable fringe and indirect costs for 80% effort/hours

• Budget #3 - Cost to transfer repository. Note, for proposal purposes the total cost is to be included in the performance year 5 only (final year of contract if all options are exercised).

• Total estimated cost for entire contract year (see below chart for layout)

• Note: These budgetsare to include all relevantcosts (direct and indirect) to conduct the required work inaccordance with your technical proposal and your institution's accounting system and operating costs.

• The following charts shall be included inthe business proposal response in addition to the Excel Spreadsheetsfor use for budgets submissions as described elsewhere within this Proposal Instructions document.

Base Contract Estimated Cost ($)

Year 1 - Base Year - Total Estimated Cost $

Option Quantity - 80% Additional Effort (Maximum) Option Year 1 - Total Estimated Cost

Option - Transfer of Government Property- (at end of Year 1 - Base Year) - Total Estimated

Total Cost

(FY2025)

of Option Quantities Year 1 $

Option Year 1 (Contract Year 2) Estimated Cost ($)

Option Year 1 – Contract Year 2 - Total Estimated Cost

Option Quantity - 80% Additional Effort end of Option Year 1 – Contract Year 2) - Total Estimated Cost

(FY2026)

Option Year 2 (Contract Year 3) Estimated Cost ($)

Option Year 2 – Contract Year 3 - Total Estimated Cost

Option Quantity - 80% Additional Effort end of Option Year 2 – Contract Year 3) -

(FY2027)

Option Year 3 (Contract Year 4) Estimated Cost ($)

Option Year 3 – Contract Year 4 - Total Estimated Cost

Option Quantity - 80% Additional Effort end of Option Year 3 – Contract Year 4) -

(FY2028)

Option Year 4 (Contract Year 5) Estimated Cost ($)

Option Year 4 – Contract Year 5 - Total Estimated Cost

Option Quantity - 80% Additional Effort end of Option Year 4 – Contract Year 5) -

(FY2029)