Inactive Total Small Business Set-Aside (FAR 19.5)

SOLICITATION No. 75N95022Q00417 TITLE: Tracking Optical Coherence Tomography (OCT) System (or Brand Name Equal) This is a combined synopsis/solicitation for commercial items prepared in accordance wit... SOLICITATION No. 75N95022Q00417 TITLE: Tracking Optical Coherence Tomography (OCT) System (or Brand Name Equal) 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; quotations are being requested and a separate written solicitation will not be issued. The solicitation number is 75N95022Q00417 and is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-07, dated August 10, 2022. This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13— Simplified Acquisition Procedures and FAR Part 12—Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold. A fixed-price type of purchase order is contemplated for this requirement. The associated North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument manufacturing with associated small business size standard of 1,000 employees. This requirement is a small business set-aside. STATEMENT OF NEED AND PURPOSE: NINDS requires an optimized imaging platform for the posterior segment of the eyes. NINDS requires a system that is brand name or equal to the Heidelberg Engineering Spectralis Tracking OCT System with OCT2 Module. NINDS requires a modular design specific to supporting diagnostic workflow in the clinic. This system will replace an outdated generation of equipment and software, thus improving imaging capabilities, enhance clinical decision-making, and preserving patient data in the Translational Neuroradiology Section and Neuroimmunology Clinic. BACKGROUND INFORMATION: The Translational Neuroradiology Section (TNS) in partnership with the Neuroimmunology Clinic (NIC) as part of the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) conducts research into causes, treatment, and prevention of neurological disorders. TNS and NIC investigate detection, diagnosis, and monitoring of neurologic diseases, such as multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML). Having the most up- to-date, advanced optical coherence tomography (OCT) machine is critical to screening research subjects’ eyes with the highest accuracy. It’s critical to implement a machine capable of spectral domain technology for best analysis of macular thickness and volume, factors that are affected by neurologic or clinical changes. PROJECT REQUIREMENT: NINDS requires the following brand name or equal Optical coherence tomography (OCT) system. Item Description Quantity 731004 HEYEX 2 Data Migration Kit 1 0226-OCT2-ADV Spectralis Tracking OCT System - OCT w/OCT2 - Advanced 1 0266-016 Service Agreement - Spectralis OCT 3 Shipping and handling will also be required of the vendor. Refer to Attachment 5 Purchase Description for the brand name or equal salient characteristics and delivery instructions . APPLICABLE PROVISIONS AND CLAUSES: The provision at FAR clause 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2020) is applicable to this solicitation. Offerors MUST include a completed copy of this provision with their offer, OR provide a copy of the valid certifications from the System of Award Management (SAM) applications at www.sam.gov, which may be indicated on the Offeror’s cover sheet. See attachment. The provision at FAR Clause 52.212-1, Instructions to Offerors-Commercial Items (JUN 2020) is applicable to this solicitation. The provision at FAR Clause 52.212-2, Evaluation-Commercial Items (OCT 2014) applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Selection of an offeror for contract award will be based on an evaluation of proposals against five factors. The factors are: Technical, Contract Management and Customer Support, and Delivery, Installation and Set-up, Past Performance, and Price. Although technical factors are of paramount consideration in the award of the contract, price and past performance are also important to the overall contract award decision. All evaluation factors other than price, when combined, are significantly more important than price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the SOLICITATION. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the SOLICITATION. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed below. The evaluation factors are used when reviewing the proposals. Technical Capability and Functionality NIDA shall evaluate the offeror’s technical approach for overall capability and functionality in relation to the General Requirement, Salient Characteristics, Quantity and Deliverables as described in the Purchase Description. 2. Contract Management and Customer Support NIDA shall evaluate the offeror’s ability to provide a high level of customer service, particularly in the area of initial responsiveness and resolution of device and service problems. 3. Speed of Delivery, Installation and Set-up NIDA shall evaluate the offeror’s technical approach for completeness, feasibility, soundness and practicality of the proposed approach and work plan for accomplishing the requirements of the statement of work. 4. Past Performance Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. Furthermore, the Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information. PRICE EVALUATION Offerors price quote will be evaluated for 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. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable. Offerors may respond with a proposal indicating their ability to provide the technical specifications stated in this solicitation. Responses will be evaluated based on the contractor’s ability to meet the Government’s requirements. The provision at FAR Clause 52.212-3, Offeror Representations and Certifications—Commercial Items (JUN 2020), applies to this acquisition. Offerors should include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, OR provide a copy of the valid certifications from the System of Award Management (SAM) applications at www.sam.gov, which may be indicated on the Offeror’s cover sheet. Addendum to FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items (OCT 2018), applies to this acquisition. The additional contract terms and conditions are as follows: 52.204-7 System for Award Management (OCT 2018) 52.204-13 System for Award Management Maintenance. (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (JUL 2016) 52.204-18 Commercial and Government Entity Code Maintenance (JUL 2016) 52.217-9 Option to Extend the Term of the Contract (MAR 2000) 52.242-15 Stop-Work Order (AUG 1989) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (AUG 2020), applies to this acquisition. See attachment. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the Government requirements stated in this solicitation. Cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform an analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; train-in considerations; warranty considerations; maintenance and service coverage availability; serial, product or catalog number(s); product description; delivery terms, and prompt payment discount terms. The Contractor shall submit its quote electronically. In addition, the Unique Entity Identifier (UEI), 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: Questions and requests for clarification must be submitted electronically to the Contracting Officer, Josh Lazarus, at josh.lazarus@nih.gov and the Contract Specialist, Shaun Rostad, at shaun.rostad@nih.gov on or before 11:00 AM EST, September 2, 2022. Fax responses will NOT be accepted. DATE QUOTATIONS DUE: All responses must be received on September 7, 2022 by 11:00 AM EST and must be submitted electronically to the Contracting Officer, Josh Lazarus, at josh.lazarus@nih.gov and the Contract Specialist, Shaun Rostad, at shaun.rostad@nih.gov, citing the RFQ number and the name of firm in the subject line. Late responses may not be accepted. Attachments: Attachment 1 – FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (AUG 2020) Attachment 2 – FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items (OCT 2018) Attachment 3 - FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (AUG 2020) Attachment 4 - Invoice and Payment Instructions Attachment 5 – Purchase Description

Inactive

DESCRIPTION: The National Institute on Drug Abuse (NIDA), the National Institute of Neurological Disorders and Stroke (NINDS) and National Institutes of Health (NIH) are seeking Capability Statements ... DESCRIPTION: The National Institute on Drug Abuse (NIDA), the National Institute of Neurological Disorders and Stroke (NINDS) and National Institutes of Health (NIH) are seeking Capability Statements from Small and Other than Small Business organizations with the demonstrated capability of providing equipment to support NINDS with acquiring Heidelberg Engineering Spectralis Tracking OCT System with OCT2 Module which will serve as an optimized imaging platform for the posterior segment of the eyes. This is a Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; (2) the availability of capable Small Businesses; HUBZone Small Businesses; Service-Disabled, Veteran-Owned Small Businesses; 8(a) Small Businesses; Veteran-Owned Small Businesses; Woman-Owned Small Businesses; or Small Disadvantaged Businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The established NAICS code is 334516, Analytical Laboratory Instrument Manufacturing. The U.S. Small Business Administration establishes a size standard for 334516 as 1,000 employees or less. BACKGROUND INFORMATION AND OBJECTIVE: The Translational Neuroradiology Section (TNS) in partnership with the Neuroimmunology Clinic (NIC) as part of the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) conducts research into causes, treatment and prevention of neurological disorders. TNS and NIC investigate detection, diagnosis, and monitoring of neurologic diseases, such as multiple sclerosis (MS) and progressive multifocal leukoencephalopathy (PML). Having the most up-to-date, advanced optical coherence tomography (OCT) machine is critical to screening research subjects’ eyes with the highest accuracy. It’s critical to implement a machine capable of spectral domain technology for best analysis of macular thickness and volume, factors that are affected by neurologic or clinical changes. GENERIC NAME OF PRODUCT: Optical coherence tomography (OCT) PURCHASE DESCRIPTION (or brand name equal): CT Spectralis Heidelberg Engineering, Inc. Spectralis Tracking OCT System – OCT w/ OCT2 – Advanced Product code: 0226-OCT2-ADV SALIENT CHARACTERISTICS: OCT angiography with spectral domain capabilities. OCT2 Module (Spectral-Domain OCT): providing enhance imaging from vitreous to choroid, with fast scanning speed of 85,000 Hz. Infrared Reflectance and TruTrack Active Eye Tracking for laser scanned, real-time eye tracking. Panning Camera for widefield imaging. Confocal Fundus Imaging for scanning laser ophthalmoscopy for fundus and anterior segment imagining. Accessibility to backup: quick recovery service. Updated software including: Ability to connect diagnostic information with Hood Glaucoma Report Provides the ability to tailor information on patient anatomy for comprehensive assessment from rim to macula Quality check page displaying immediate OCTA scan Customizable settings to reduce processing times based on investigators’ needs. Quantity and Warranty: One OCT machine Lens Touch screen INSTRUCTIONS: Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The established NAICS code is 334516. Respondents must provide, as part of their response: (a) product, catalog, model, and/or part number(s)? (b) product description? (c) best estimated delivery date after receipt of order? (d) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in this announcement. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required. Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Shaun Rostad at Shaun.Rostad@nih.gov, NO LATER THAN 3:00 p.m. EST on July 20, 2022. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements. THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).