Inactive Total Small Business Set-Aside (FAR 19.5)

AMENDMENT 2 HAS BEEN POSTED TO CORRECT AN ERROR IN THE FORMULA IN ATTACHMENT 4. AMENDMENT 1 HAS BEEN POSTED TO CORRECT AN ERROR IN THE FORMULA IN ATTACHMENT 4. COMBINED SYNOPSIS / SOLICITATION COMPETI... AMENDMENT 2 HAS BEEN POSTED TO CORRECT AN ERROR IN THE FORMULA IN ATTACHMENT 4. AMENDMENT 1 HAS BEEN POSTED TO CORRECT AN ERROR IN THE FORMULA IN ATTACHMENT 4. COMBINED SYNOPSIS / SOLICITATION COMPETITIVE Solicitation Number: 75N95024Q00081 TITLE: Biological Therapeutics Product Development Subject Matter Expert Consulting Services to Support the Development of Cell and Gene Therapy Products Introductory Statement 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. Solicitation Number and Authority The solicitation number is 75N95024Q00081 and the solicitation is issued as a Request for Quotations (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. Applicable Federal Acquisition Circular The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-06, dated December 4, 2023. NAICS Code and Small Business Standard The associated NAICS code is 541690 (All Scientific and Technical Consulting Services) and the small business size standard is $19 million. This acquisition is a total small business set-aside. Anticipated Contract Type The Government intends to award a level of effort type Contract with Options to Extend the Term of the Contract and Options for Increased Quantity-Separately Price Line Item. Description of Requirement Statement of Need and Purpose: 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 areas of cell and gene therapies, including chemistry, manufacturing, and controls, pharmacokinetics/pharmacodynamics, toxicology, medical writing, bioassay development, regulatory affairs, quality assurance/quality control, and biostatistics. Background Information: 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. NIH Drug Development Programs Involving Biologics This requirement supports the NIH Biologics development projects under the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs. The NIH Blueprint Neurotherapeutics (BPN) network (https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-neurotherapeutics-bpn- network) is a consortium comprised of the NIH Office of the Director and 14 NIH Institutes and Centers (ICs) that support neuroscience research. BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program, originally focused on small molecules, was launched for projects requiring medicinal chemistry optimization, pharmacokinetics (PK), pharmacodynamics (PD), drug manufacturing and formulation, investigational new drug (IND)-enabling toxicological studies support through Phase I clinical testing and it is now being expanded to include the development of biological therapeutics for neurological diseases (BPN-Biologics). (https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics). The URGenT program (https://www.ninds.nih.gov/Current-Research/Research-Funded- NINDS/Translational-Research/urgent-network) has been established by the NINDS to support the development and clinical evaluation of therapeutics to address ultra-rare genetically based neurological disorders. The network will provide neuroscience researchers with funding and access to a full range of industry-style biologics development services and expertise and in the future may expand to include other NIH institutes. The program is intended to rapidly advance patient-customized therapeutics through manufacturing, preclinical toxicology testing, and evaluation in Phase 1 clinical studies. The HEAL-PTDP program (https://heal.nih.gov/) is a multi-IC initiative that has been established by the NIH to support preclinical optimization and development of safe, effective, and non- addictive biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads to Phase I clinical trials and readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) or other Phase II clinical studies. Applicants must have a promising biologic hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND- enabling studies, development of a PD/ target engagement biomarker, assembly and filing of an IND application and Phase I clinical testing. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress. Please refer to Attachment #1 - Statement of Work (SOW) for complete details and specifications. Period and Place of Performance Period of Performance: The anticipated period of performance is a one-year base period from the effective date of award and one (1) subsequent one-year option periods as follows: Base Period: 12 Month Period of Performance – Qty 20 hours Option Line 00001 – Qty NTE 380 hours Option Line 00002 – Travel NTE $2,400.00 Option Period One: 12 Month Period of Performance – Qty 20 hours Option Line 00001 – Qty NTE 380 hours Option Line 00002 – Travel NTE $2,400.00 Place of Performance: The primary place of performance shall be the Contractor site. Conference calls and email will be the primary mode of communication; however, the Contractor may be required to work at Government facilities or the facilities of selected principal investigators on an as needed basis. Applicability of FAR clause 52.212-1 The provision at FAR 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services 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. Phase One Instructions 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: Quoter and Personnel Qualifications Non-Technical Factor 2: Price Evaluation; and Non-Technical Factor 3: 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: Quoter and 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 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. Quoters 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 in the highlighted cells (including the proposed labor rate and the number of consultants being proposed); all other cells will then auto-populate. Quoters must submit the completed pricing template in Excel (do not convert to PDF) as a separate attachment and 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 per-consultant and has included an annual not to exceed amount of 380 optional hours (for a total annual ceiling of 400 hours per-consultant). It should also be noted that the Government will reimburse the successful Quoter(s) for up to $2,400.00 in annual 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. Additionally, 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 per-consultant and that a maximum of up to 380 additional hours per-consultant may be funded and exercised in any increment during each contract period. It is also understood that a not?to?exceed travel amount of $2,400.00 per-consultant may be funded and exercised during each contract period and may only be used with advance approval. Additionally, any billable travel expenses will comply with the Federal Travel Regulation (FTR).” 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 add rows for the additional costs to the Price Template 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 #8 – 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: Cover Page, if applicable Executive Summary, if applicable Table of Contents, if applicable Key Personnel Narrative (no more than two pages) Price Narrative, if applicable Past Performance Examples This page limit does NOT include: Key Personnel Resume(s) Letter(s) of Commitment Representations and Certifications Completed Price Template Additional Required Information: In addition to the previously discussed requirements, Quoters must include the following in their response: Company’s Full Name and Address Unique Entity ID (UEI), Commercial And Government Entity (CAGE) Code, and Taxpayer Identification Number (TIN) 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 4:00 PM Eastern Time on January 18, 2024, and reference solicitation number 75N95023Q00081. Responses must be submitted electronically to Michele Pastorek, Contracts Specialist, at michele.pastorek@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 members of the contracting and program office. The Government reserves the right to determine whether oral presentations are necessary. If it determines they are, presenting Quoters must follow the format described in the following section. Phase Two Instructions During Phase Two, respondents whose quotes received the highest ratings for Phase One will be given an opportunity to conduct oral presentations. These presentations will be conducted virtually in accordance with the Government’s instructions outlined in the “Instructions to Quoters” section of this solicitation. The TEP will primarily use these presentations to evaluate Quoter’s proposed technical approach as well as the quality of its oral communication/presentation skills in accordance with Technical Factor 2: Understanding the Project and Technical Approach and Technical Factor 3: Communication and Oral Presentation Skills. Additionally, they will be evaluated by using the criteria for the following factors: Technical Factor 1: Personnel Qualifications 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 Contracting Officer will provide eligible Quoters with the information necessary to 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: Cover Page, if applicable Executive Summary, if applicable Table of Contents, if applicable Key Personnel Narrative (no more than two pages) Technical Approach Narrative (no more than two pages) Price Narrative, if applicable Past Performance Examples This page limit does NOT include: Key Personnel Resume(s) Letter(s) of Commitment Representations and Certifications Completed Price Template Electronic Copy of Oral Presentation materials, if applicable Applicability of FAR provision 52.212-2 The provision at FAR 52.212-2, Evaluation – Commercial Products and Commercial Services (NOV 2021), applies to this acquisition. Attachment #5 – Evaluation Criteria is provided as an addendum. Applicability of FAR provision 52.212-3 The provision at FAR 52.212-3, Offeror Representations and Certifications – Commercial Products and Commercial Services (Nov 2023), applies to this acquisition. The provision is included in full text at Attachment #8 – Representations and Certifications. Quoter must submit a completed and signed version of this form with its response. Applicability of FAR clause 52.212-4 The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Nov 2023), Alternate I (NOV 2021) applies to this acquisition and is incorporated by reference. Applicability of FAR clause 52.212-5 The clause at 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (Dec 2023) applies to this acquisition. FAR 52.212-5 is included in full text at Attachment #3 - Additional Terms and Conditions. Applicability of Defense Priorities and Allocations System (DPAS) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Questions Regarding Solicitation Any questions regarding this solicitation must be submitted electronically to the Contracts Specialist, Michele Pastorek, at michele.pastorek@nih.gov by 4:00 PM Eastern Time on January 9, 2024. Fax responses will NOT be accepted. RFQ Attachments Attachment #1 – Statement of Work (SOW) Attachment #2 – FAR 52.212-4 Addendum Attachment #3 – FAR 52.212-5 (Dec 2023) Attachment #4 – Price Template Attachment #5 – Evaluation Criteria Attachment #6 – Invoicing Instructions With IPP Attachment #7 – Information/Physical Access Security Requirements Attachment #8 – Representations and Certifications