NIH-NINDS-CSS-75N95025Q00109.pdf

COMBINED SYNOPSIS / SOLICITATION COMPETITIVE

NIH-NINDS-CSS-75N95025Q00109

TITLE: Biological Therapeutics Product Development Subject Matter Expert Consulting Services to Support the Development of Therapeutic Biotechnology Products (Biologics)

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

The Government reserves the right to make one award, multiple awards, or no awards as a result of this solicitation.

The solicitation number is NIH-NINDS-CSS-75N95025Q00109 and the solicitation is issued as a Request for Quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items and is expected to exceed the simplified acquisition threshold.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-02, dated December 16, 2024.

The associated NAICS code is 541690 (Other Scientific and Technical Consulting Services) and the small business size standard is $16.5 million.

This acquisition is a total small business set-aside.

The Government intends to award a Labor-Hour Purchase Order with Options to Extend the Term of the Contract and Options for Increased Quantity.

Introductory Statement

Solicitation Number and Authority

Applicable Federal Acquisition Circular

NAICS Code and Small Business Standard

Anticipated Contract Type

Statement of Need and Purpose: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and apply that knowledge to enhance health, lengthen life, reduce illness and disability, and conduct, support, and make medical discoveries that improve people’s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is an institute within the NIH that conducts research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and use that knowledge to reduce the burden of neurological disease.

The NINDS has a need for biological therapeutics development subject matter expert (SME) consultants to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs. The support included in this contract will cover all aspects of drug discovery and development through the Phase 1 clinical trial, including but not limited to chemistry, manufacturing, and controls (CMC), assay development, pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, regulatory operations, medical writing, biostatistics, and quality assurance/quality control (QA/QC), and first-in-human trial planning and design. The NINDS is seeking vendors who can supply a broad array of Biologics subject matter experts, including all modalities and cell and gene therapies.

Project Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government that are needed to support NIH biologics programs, including NIH BPN-Biologics, URGenT, HEAL PTDP, and NINDS Intramural labs.

The Contractor shall provide this support on an ad hoc basis or while serving on NIH Biologics Lead Development Teams (LDTs) or URGENT Multi-Disciplinary Project Teams (MPTs) which include both SME consultants and NIH staff. These teams will map out a product development and clinical evaluation research strategy, including milestones, and oversee manufacturing and nonclinical study services by CROs.

SME consultants will be expected to provide feedback and guidance on project milestones, development strategy, study design, and data interpretation through in-person meetings, conference calls, and email. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual biologics projects and programs.

Consultants may be involved in multiple projects.

SMEs will be required on a part-time basis; hours will vary depending on the needs of the projects they are assigned to. The required level-of-effort will be 20-405 hours per SME per year, and NIH anticipates it could require 1 to 10 SMEs depending on the expertise available at the offerors.

Please refer to Attachment #1 - Statement of Work (SOW) for complete details and specifications.

Period of Performance: The anticipated period of performance is a one-year base period from the effective date of award and two (2) subsequent one-year option periods as follows:

Description of Requirement

Period and Place of Performance

Base Period: April 1, 2025 – March 30, 2026 Option Period One: April 1, 2026 – March 30, 2027 Option Period Two: April 1, 2027 – March 30, 2028

Place of Performance: The primary place of performance shall be the Quoter’s site. Conference calls and email shall be the primary mode of communication; however, the Quoter may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as-needed basis.

The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (SEP 2023), applies to this acquisition. The following instructions are included as an addendum.

As described in Attachment #5 – Evaluation Criteria, technical evaluation of quotes submitted in response to this solicitation shall take place in two phases.

During Phase One, quotes shall be evaluated against the criteria for Technical Factor 1:

Personnel Qualifications and for conformance to the solicitation instructions. Therefore, Quoter shall initially submit only the required information outlined under Phase One Response Requirements.

Phase One Response Requirements:

Responses to this solicitation must include clear and convincing evidence of the Quoter’s capability of fulfilling the requirement as it relates to the following evaluation factors:

• Technical Factor 1: Personnel Qualifications;

• Price; and

• Past Performance.

Responses will be evaluated in accordance with the evaluation criteria identified in this solicitation as well as the SOW requirements.

Technical Requirements:

Phase One responses must include clear and convincing evidence of the Quoter’s capability of fulfilling the requirement as it relates to Technical Factor 1: Personnel Qualifications.

These responses shall include resumes of proposed key personnel, consultants, and any subcontractors, as well as a letter of commitment from proposed key personnel. These responses should also clearly identify whether proposed personnel will be or are an employee of the Quoter. Please note that all proposed key personnel must be employed by the

Applicability of FAR clause 52.212-1

Phase One Instructions

Quoter no later than the start of the contract’s period of performance.

Please note, however, that while resumes of all proposed key personnel are required, they are NOT, by themselves, sufficient. Quoter MUST also submit a separate narrative demonstrating how proposed Key Personnel satisfy the Personnel Qualifications evaluation criteria. Please carefully examine the evaluation criteria prior to writing this narrative.

Business Requirements:

Quoters are required to complete Attachment #4 – Price Template. Quoters are only to fill out the highlighted cells (including the proposed labor rate and number of consultants for each SME area); all other cells will then auto-populate. Quoters shall submit the completed pricing template in Excel (do not convert to PDF) as a separate attachment.

Quoters shall not combine or embed the pricing template with other materials.

Quoters will note that the Government anticipates annual funding for an estimated 20 labor hours and has included an annual not to exceed amount of 3980 optional hours (for a total annual ceiling of 4000 hours across all consultants engaged in projects). It should also be noted that the Government will reimburse the successful Quoter for up to $1,500 in travel- related expenses, per-consultant, that are necessary for performance of this requirement. These funds shall be provided only after it is determined there is a need for travel. Furthermore, all travel requests require advance approval by the Government.

In recognition of these facts, Quoter should include the following statement in its response:

“It is anticipated that the Government will fund an estimated amount of 20 hours and that a maximum of up to 3980 additional hours may be funded and exercised in any increment during each contract period. It is also understood that a not‐to‐exceed travel amount of $1,500 per-consultant may be funded and exercised during each contract period and may only be used with advance approval.” Any billable travel expenses must follow the Federal Travel Regulation.

If the Quoter proposes the involvement of any additional staff besides the Key Personnel, it must clearly articulate their role and why it believes additional personnel are necessary to fulfill the requirement. The Quoter must also specify how this time will be charged (e.g. direct hourly rate or included within overhead). Finally, the Quoter is required to document its rationale for any proposed Other Direct Costs (ODCs) besides travel as well as the total amount. If any of these conditions are applicable, the Quoter shall complete the appropriate cells in the Price Template, adding rows if needed, and include a Price Narrative in its response.

Salary Rate Limitation:

Quoters are advised that no NIH funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A)costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Quoter pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Quoter.

This does not preclude Quoters from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The Executive Schedule, Level II* annual salary rate limitation also applies to individuals proposed under subcontracts as well as consultants.

LINK TO EXECUTIVE SCHEDULE RATES OF PAY:

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ (For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

*Note to Quoters: Quoters must adhere to the current Fiscal Year Executive Level II Salary Rate when preparing its response. All costs associated with any resultant contract award shall fully comply with the current Fiscal Year Executive Level II Salary rates.

Quoters are instructed to certify that their quoted labor rates comply with the Department of Health and Human Services Acquisition Regulation (HHSAR) Clause 352.231-70 Salary Rate Limitation through completing Attachment #3 – Representations and Certifications.

Past Performance:

Quoter shall identify 1-2 awards with the Federal Government and/or commercial customers that demonstrate recent and relevant past performance. Relevant is defined as work similar in complexity and magnitude to the work described in the SOW.

Quoter shall include the following information in their past performance examples:

• Project title

• Description of the project

• Contract number

• Contract amount

• Government Agency/Organization

• Point of contact name, address, and phone number

• Contract and, if applicable, task order number

• Current status, e.g., completed and/or if in progress, start and estimated completion dates

• SOW paragraphs that the reference applies to

• Key personnel (please highlight those individuals who worked on the relevant project(s) and are also being proposed for this effort.)

• A brief narrative of why you deem the reference to be relevant to this effort

Response:

Quoter responses shall be no more than ten (10) single-sided pages in length. This page limit includes the following:

(i) Cover Page, if applicable

(ii) Executive Summary, if applicable

(iii) Table of Contents, if applicable

(iv) Key Personnel Narrative

(v) Price Narrative, if applicable https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/

(vi) Past Performance Examples

This page limit does NOT include:

(i) Key Personnel Resume(s)

(ii) Letter(s) of Commitment

(iii) Completed Representations and Certifications

(iv) Completed Price Template

Additional Required Information:

In addition to the previously discussed requirements, Quoters must include the following in their response:

1) Company’s Full Name and Address

2) Dun & Bradstreet (DUNS) Number, Commercial And Government Entity (CAGE) Code, and Taxpayer Identification Number (TIN)

3) Name, Telephone Number, and Email Address of Person Authorized to Provide Quote

Please note that, to be considered for award, Quoters must also be actively registered in the System for Award Management (SAM), accessible at www.sam.gov, at the time of quote submission.

QUOTES DUE: To be considered for Phase One evaluation, Quoter must submit all required materials by 1:00 PM Eastern Time on January 27, 2025 and reference solicitation number NIH-NINDS-CSS-75N95025Q00109. Responses must be submitted electronically to Shayna Simpson, Contract Specialist, at shayna.simpson@nih.gov and Kelly Dempsey, Contracting Officer, at kelly.dempsey@nih.gov. Fax responses will NOT be accepted.

All timely and responsive quotes that fully comply with the solicitation instructions and are submitted by responsible Quoters will be evaluated by the Technical Evaluation Panel (TEP).

Only the highest-rated Quoters will be given the opportunity to submit materials pertaining to Phase Two. Depending on the quality of the quotes received, these Quoters may also be required to give an oral presentation to the Contracting Officer, Contract Specialist, and members of the requiring office. The Government reserves the right to determine whether oral presentations are necessary. If it determines that they are, presenting Quoters must follow the format described in the following section.

All Quoters that have advanced to Phase Two will be given the opportunity to clarify, discuss, or revise aspects of their Phase One response (including Technical Factor 1, Price, and Past Performance). Additionally, they will be evaluated by using the criteria for the following factors:

• Technical Factor 2: Understanding the Project and Technical Approach, and

• Technical Factor 3: Communication and Oral Presentation Skills.

Please note that during Phase Two of the evaluation process, the Government may revise any Quoter’s score for Technical Factor 1 and/or its evaluation of the Quoter’s price and past performance if merited by that Quoter’s oral presentation and Phase Two response.

Please also note that, if required, all presentations will take place via virtual conferences.

The Contract Specialist will provide eligible Quoters with the information necessary to

Phase Two Instructions http://www.sam.gov/ mailto:shayna.simpson@nih.gov join the conferences, including, if applicable, the virtual meeting link, password, and/or call-in number.

Oral Presentation Requirements:

It is strongly recommended that the Key Personnel who would perform the work described in the SOW conduct or participate in the Quoter’s presentation. Quoters shall discuss their Phase One responses and present their proposed technical approach and understanding of the requirement during the oral presentation, which will include, at a minimum:

• Background discussion of the work contemplated under this project

• Personnel qualifications and specific areas of expertise relevant to the SOW

• Proposed technical approach for fulfilling the requirements described in the SOW, including how the key personnel would characterize their role and responsibilities

• Anticipated problems and constraints likely to be encountered in performing the work and potential plans and solutions for resolving them

• If applicable, examples of how the Quoter has effectively trained other project staff or clients in their discipline.

Phase Two Written Response Requirements:

Responses to this solicitation must include clear and convincing evidence of a Quoter’s capability of fulfilling the requirement as it relates to all evaluation factors:

• Technical Factor 1: Personnel Qualifications;

• Technical Factor 2: Understanding the Project and Technical Approach;

• Technical Factor 3: Communication and Oral Presentation Skills;

• Price; and

• Past Performance.

Responses will be evaluated in accordance with the evaluation criteria identified in this solicitation as well as the SOW requirements.

Quoter’s response shall be no more than fifteen (15) single-sided pages in length. This page limit includes the following:

(i) Cover Page, if applicable

(ii) Executive Summary, if applicable

(iii) Table of Contents, if applicable

(iv) Key Personnel Narrative (no more than two pages)

(v) Technical Approach Narrative (no more than two pages)

(vi) Price Narrative, if applicable

(vii) Past Performance Examples

This page limit does NOT include:

(i) Key Personnel Resume(s)

(ii) Letter(s) of Commitment

(iii) Representations and Certifications

(iv) Completed Price Template

(v) Electronic Copy of Oral Presentation materials, if applicable

Applicability of FAR provision 52.212-2

The provision at FAR 52.212-2, Evaluation – Commercial Items (NOV 2021), applies to this acquisition. Attachment #5 – Evaluation Criteria is provided as an addendum.

The provision at FAR 52.212-3, Offeror Representations and Certifications – Commercial Items (MAY 2024), applies to this acquisition.

The provision and representations and certifications is included in full text at Attachment #3 – Representations and Certifications. Quoter must submit a completed and signed version of this form with its response.

The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (NOV 2023), Alternate I (JAN 2017) applies to this acquisition and is incorporated by reference.

The clause at 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (NOV 2024) applies to this acquisition.

FAR 52.212-5 is included in full text at Attachment #2 - Additional Terms and Conditions.

The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

Any questions regarding this solicitation must be submitted electronically to the Contract Specialist, Shayna Simpson, at shayna.simpson@nih.gov and Kelly Dempsey, Contracting Officer, at kelly.dempsey@nih.gov, by 10:00 AM Eastern Time on January 13, 2025. Fax responses will NOT be accepted.

Attachment #1 – Statement of Work (SOW) Attachment #2 – Additional Terms and Conditions Attachment #3 – Representations and Certifications Attachment #4 – Price Template Attachment #5 – Evaluation Criteria Attachment #6 – Invoice Submission Instructions Attachment #7 – Information/Physical Access Security Requirements

Applicability of FAR provision 52.212-3

Applicability of FAR clause 52.212-4

Applicability of FAR clause 52.212-5

Applicability of Defense Priorities and Allocations System (DPAS)

Questions Regarding Solicitation

RFQ Attachments mailto:shayna.simpson@nih.gov