Inactive Total Small Business Set-Aside (FAR 19.5)

2/21/2020: Amendment #A00001 is posted to 1) provide answers to the questions received from interested vendors and 2) make changes to the solicitation. Please see the amendment attachment for more inf... 2/21/2020: Amendment #A00001 is posted to 1) provide answers to the questions received from interested vendors and 2) make changes to the solicitation. Please see the amendment attachment for more information. 2/13/2020: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is NIH-NINDS-CSS-20-001344 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 Federal Acquisition Regulation (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 not expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-04, dated 15 January 2020. The associated NAICS code 541990 (All Other Professional, Scientific and Technical Services) with the small business size standard $15 million. This requirement is a 100% small business set-aside. Statement of Need and Purpose: The purpose of this requirement is to procure pharmacology consulting services in support of NIH Blueprint Neurotherapeutics Network drug discovery and development programs and the associated BPN External Oversight Committee. The NIH is seeking to procure a highly experienced executive-level, drug discovery and development subject matter expert with experience in the area of Pharmacology to provide feedback to the NIH program leadership and technical guidance on drug discovery and development projects within the BPN portfolio. The Contractor will serve as a member of the BPN External Oversight Committee, which provides strategic guidance on BPN projects and on occasion other NIH drug discovery and development programs. Background Information: The NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the NIH Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug discovery and development services and expertise. The BPN program is intended for projects requiring medicinal chemistry optimization and CRO support through phase I clinical testing. Each project is directed by a Lead Development Team composed of the principal investigator, industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by contract research providers. Bioactivity and efficacy studies are funded through an award to the principal investigator; other research services are provided without cost to the PI through NIH contracts. The BPN External Oversight Committee (EOC) was instituted in late 2011 and will continue through, at least 2027. The NIH National Institute of Neurological Disorders and Stroke (NINDS) oversees the EOC. The EOC typically convenes monthly via web-enabled virtual meetings and teleconference calls. Additionally, the EOC meets once per year at NIH for a day long face to face meeting and on an ad hoc basis to evaluate BPN project specific issues. These additional meetings of the EOC are scheduled around EOC member availability and full participation in such scheduled events is expected. 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 as needed to perform the Statement of Work below: The Contractor shall provide this support while serving on NIH BPN Executive Oversight Committee (EOC). Executive Oversight Committee (EOC) meet both monthly for approximately one hour and on an ad-hoc basis for milestone/introductory calls of BPN projects via teleconference. EOC members are also requested to attend one on site visit to the NIH campus yearly for EOC meetings. Please refer to RFQ 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. Place of Performance: The primary place of performance shall be Contractor site. Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as needed basis. Contract Type Contemplated: A Labor-Hour Purchase Order with Options to Extend the Term of the Contract and Options for Increased Quantity Separately Priced Line Item is contemplated. RFQ Attachments: Attachment #1 - Statement of Work (SOW) Attachment #2 - Reps and Certs Attachment #3 - Terms and Conditions Attachment #4 - Invoice and Payment Instructions Attachment #5 – Information and/or Physical Access Security Requirements The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. Evaluation Criteria: All quotations from responsible quoters will be evaluated by a Technical Evaluation Panel according to the technical evaluation factors outlined below. The NIH may elect to discuss or obtain additional information and/or request revisions from only one quoter or any number of quoters in accordance with Part 13 Procedures. Quoters may be invited to give an Oral Presentation to present information to clarify or augment written information submitted. The Government reserves the right to evaluate quotations and award a contract/order without discussions with quoters. Additionally, the Government reserves the right to make no award at all. The Government will award a purchase order resulting from this solicitation on the basis of best value, technical factors, price and past performance considered. Technical factors together shall be considered significantly more important than price and past performance. The Government may consider best value tradeoffs in final award determination. The technical evaluation factors will be evaluated using adjective ratings and no numeric point system will be used. Price will be considered in the evaluation and selection, but price will not be point scored. It is the NIH's intent to evaluate each written quote under the below Technical Evaluation Factors in descending order of importance. Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. A. Technical Evaluation Criteria Technical Evaluation Factors Factor 1: Personnel Qualifications The qualifications of proposed personnel will be evaluated for capability in performing the work contemplated within the Statement of Work including documented experience with drug discovery and development in the area of Pharmacology, educational background, and training. Availability of proposed personnel and their designated responsibility on the project will be evaluated. This includes the experience, executive-level competence and time commitment of the proposed key personnel. Resumes of proposed key personnel, consultants, and any subcontractors will be evaluated for appropriateness of credentials, training, qualifications, experience, and competence to carry out the project. Basic credentials for proposed personnel will be evaluated in the following areas, which are required to carry out the requirements delineated in the SOW: Key Personnel must have extensive experience in managing or being a senior leader in drug discovery and development projects in the biopharmaceutical industry or academia. Key Personnel must have demonstrated ability to work in a cross-functional team environment and manage competing priorities. Leadership experience in executing and managing drug discovery and development tasks, particularly for nervous system conditions, shall be evaluated. Executive level experience across the entire drug discovery and development process from discovery to clinical trials will be considered favorably. Experience providing expert insight pertaining to small molecules drug discovery as it pertains to clinical pharmacology Key Personnel’s experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels. Key Personnel’s in-depth knowledge and understanding of global regulatory regulations and guidelines. Extent and depth of Key Personnel’s skills related to managing on an executive level clinical pharmacology related drug development projects; designing, implementing, conducting, and overseeing clinical trials for neurological disorders with emphasis on proof-of-concept and first-in-human studies; identifying and preparing for trial design and recruitment challenges, knowledge of global regulatory regulations and guidelines, advising scientific boards regarding clinical pharmacology, and working with multi-disciplinary drug development teams. PhD in a Pharmacology and Drug Development-related discipline. Minimum of 10 years of executive-level experience providing Pharmacology guidance related to biopharmaceutical endeavors to government agencies, academic institutions, and/or start-up companies at the executive level. Experience must include responsibility for operations and budgets. Minimum of 8 years of experience directing collaborative research efforts that involves multiple institutions/teams. Factor 2: Understanding the Project and Technical Approach Quoters’ technical approach will be evaluated for soundness, practicality, and feasibility to accomplish the requirements of the Statement of Work. Also, NIH will evaluate your technical response on how well it shows your comprehensive understanding of the project’s goals, objectives, and tasks as called for in the Statement of Work (SOW). This includes an evaluation of the thoroughness of your background discussion of the work contemplated under this project. We will evaluate your understanding of the tasks to be performed, their interrelation and complexity. We will evaluate your discussion of anticipated problems and constraints likely to be encountered in performing the work, and your plans, solutions, and approaches to resolving them. Offerors technical approach will be evaluated for soundness, practicality, and feasibility to accomplish the tasks and requirements of the Statement of Work. More specifically, we will evaluate for efficacy: (a) ability to accomplish and meet all SOW requirements. B. Cost/Price Evaluation Offeror(s) Business Proposal will be evaluated for cost/price reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. The Offerors are expected to establish a reasonable price relationship between all cost/price elements. An evaluation of the Offerors’ price proposals will be made to determine if they reflect a clear understanding of the requirements and are consistent with the Technical Proposal. Cost/Price Risk: Risk refers to any aspect of the Offerors’ proposals that could have significant negative cost consequences for the Government. Proposals will be assessed to identify potential risks. C. Past Performance The Offeror shall identify up to two (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 of the work described in this Statement of Work. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable. Include the following information: Project title Description of the project Contract number Contract amount Government Agency/Organization Contracting Officer’s 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 Dollar value and type of contract Name of company being referenced 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 The Government may also consider information obtained through other sources. Past performance information will be utilized to determine the quality of the contractor’s past performance as it relates to the probability of success of the required effort. The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer (Attachment #2). The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition, Alternate I (JAN 2017). Addendum to FAR clause 52.212-4 Contract Terms and Conditions—Commercial Items applies to this acquisition (Attachment #3). Additional contract requirement(s) or terms and conditions applicable to this acquisition (Attachment #3). The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. Additional instructions include the following: Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical response and 2) a separate price quotation. The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to thirty (30) single-sided pages. The price quotation must include an hourly rate as well as extended pricing for the full level of effort of each contract period. Options for increased quantity must also be detailed. A summary of the whole contract price should all options be exercised must also be included. Since this requirement anticipates funding an estimated amount of thirty (30) hours of support annually, and includes a not to exceed estimated amount of up to an additional sixty (60) optional hours annually (for a total ceiling of 270 hours annually) – pricing must be provided in sufficient detail and should include the following information : Base Period: Hourly rate ? $__/hour Hourly rate x 30 hours = $_____ Option Item: Hourly rate x 60 hours = $______ Option Item: Travel NTE ? $1,500 Estimated Total (90 hours and travel) ? $____ Option Period 1: Hourly rate ? $__/hour Hourly rate x 30 hours = $_____ Option Item: Hourly rate x 60 hours = $______ Option Item: Travel NTE ? $1,500 Estimated Total (90 hours and travel) ? $____ Option Period 2: Hourly rate ? $__/hour Hourly rate x 30 hours = $_____ Option Item: Hourly rate x 60 hours = $______ Option Item: Travel NTE ? $1,500 Estimated Total (90 hours and travel) ? $____ Estimated Total (Base Period and Option Periods 1 & 2): $_____ Offerors should include the following statement within their price quotations: “It is anticipated that the Government will fund an estimated amount of thirty (30) hours and that up to an estimated amount of sixty (60) additional hours may be funded and exercised during each contract period. It is also understand that a not?to?exceed travel amount of up to $1,500 may be funded and exercised during each contract period and may only be used with advanced approval.” In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. DATE QUESTIONS DUE: Any questions regarding this solicitation must be submitted electronically to the listed point of contact by 3:00 PM Eastern Standard Time on Tuesday, February 18, 2020. Fax responses will NOT be accepted. DATE OFFERS DUE: All responses must be received by 3:00 PM Eastern Standard Time on Monday, February 24, 2020, and reference number NIH-NINDS-CSS-20-001344. Responses may be submitted electronically to Rieka Plugge, Contract Specialist, at rieka.plugge@nih.gov. Fax responses will not be accepted. The name and telephone number of the individual to contact for information regarding the solicitation: Rieka Plugge, (301) 827-7515.