Microvolume Plate Reader for Analytical Chemistry

(i) 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.

(ii) The solicitation number is 75N95019Q00126 and the solicitation is issued as a Request for Quotation (RFQ) on a Full and Open competitive basis. 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-Test Program for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items. This acquisition is NOT expected to exceed the simplified acquisition threshold of $250,000.00. A Fixed-Price type of contract is contemplated for any resulting contract entered into as a result of this solicitation.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Regulation (FAR) Federal Acquisition Circular (FAC) Number/Effective Date: 2019-01 / 01-22-2019.

(iv) The North American Industry Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument Manufacturing with size standard 1000 employees. This requirement is restricted on a total Small Business set aside basis.

(v) This requirement is for the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). NCATS has a requirement for quantity one (1) Micro Volume Plate Reader on a BRAND-NAME-OR-EQUAL basis to the Big Lunatic microvolume plate reader platform manufactured by Unchained Labs. The Division of Pre-Clinical Innovation (DPI) at NCATS plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Specifically, the analytical chemistry group at the DPI has a requirement for a microvolume plate reader to determine the protein concentration as a critical step prior to HPLC-MS analysis.

At the analytical chemistry group, there has been an increasing number of project requests analyzing intact protein, peptide (digested from protein extraction), and antibody drug conjugation. In order to address these increasing demands from the data required from these products, the analytical chemistry group requires a microvolume plate reader, which is a powerful QC tool offering high-speed and automation friendly quantification of Protein, DNA and RNA.

(vi) The purpose of this requirement is to obtain quantity one (1) Micro Volume Plate Reader on a BRAND-NAME-OR-EQUAL basis to the Big Lunatic microvolume plate reader platform, part number (PN): 700-2000; 10 Lunatic plates, 0.03-40 OD, PN-701-2002; 30 Lunatic Plate Frame Strips, 0.03-40 OD, 16 sample per chip, PN-701-2005; and half-day installation and training, PN-704-2000, manufactured by Unchained Labs, located at 6870 Koll Ctr Pkwy, Pleasanton, CA 94566.

Products offered must include those salient physical, functional, or other characteristics that are deemed essential in meeting the government's needs. Specifically, the following features are deemed essential that this requirement shall achieve:

Big Lunatic instrument
1. Compact and completely enclosed benchtop instrument
2. No manual sample loading or cleaning steps required on the instrument
3. High speed measurement of a Lunatic Plate (about 5 minutes for 96 samples)
4. Automation and robotics friendly design and optional API interface
5. GLP options for IQOQ and CFR 21 part 11 validation

Lunatic Plate and High Lunatic Plate
1. Microfluidic disposable combining multiple features for robust and convenient sample read-out
2. Up to 96 samples on a plate, multiple barcoded plates per run possible
3. Re-use of the Lunatic Plate on the positions not used in previous measurements
4. Only 2 μl sample loading, with automatic sample uptake by capillary channels
5. Compatible for sample loading using liquid handling robots
6. On-chip sample conservation for up to 2 hours. No spilling, evaporation or cross-contamination
7. On-chip sample retention after analysis
8. Path lengths built into the microfluidic structure
9. Linear measurement range from 0.03 up to 200 OD (10mm path converted)
10. Compatible with various biological samples (DNA, RNA and proteins) and many chemical substances (DMSO, ...)

Lunatic Client and Analysis software
1. Simple experiment design wizard with access to advanced functionalities like replicates handling and standard curves
2. Analytical software including two quantification methods: Standard UV/Vis apps and advanced Unmix apps
3. Customizable data import and export templates to MS Excel and pdf a.o.
4. Wide selection of Unmix applications for different sample sources and common extraction kits and methods for accurate bio-molecule (DNA, RNA or protein) quantification in a wide variety of biological samples, covering most common isolation techniques or kits used • Specific target molecule quantification without need for a dye or assay
5. Quantification of individual carry-over chemicals, process inhibitors and sample source constituents
6. Works across a wide linear range, without need for dilution series
7. Selection of standard single point background correction or unique full spectral turbidity analysis background correction possible

Offerors must: 1) clearly indicate if the line item or items being offered in their quote is a brand-name item to the brand name item described in this solicitation, or if the item or items being offered is an "or-equal" item; 2) include Shipping and handling cost in the quotation or specify if it is included in the price; 3) indicate if items being quoted are warrantied in accordance with their standard commercial warranty practices, and the length of time of such warranty; 4) indicate an estimated delivery time in full after receipt of an order.
(vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date is days after receipt of order (ARO) must be specified and will be determined prior to any award. Delivery will be FOB destination. The place of delivery and acceptance will be 9800 Medical Center Drive, Rockville, MD 20850.

(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:
• FAR 52.204-7, System for Award Management (Oct 2018)
• FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul 2016)
• FAR 52.211-6, Brand Name or Equal (Aug 1999)
• FAR 52.212-1, Instructions to Offerors-Commercial Items (Oct 2018)
• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Oct 2018)
• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:
https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:
• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)
• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul 2016)
• FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Oct 2018).

The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (OCT 2018) is applicable to this solicitation:
52.222-3 Convict Labor (June 2003)
52.222-19 Child Labor-Cooperation With Authorities and Remedies (Jan 2018)
52.222-21 Prohibition of Segregated Facilities (Apr 2015)
52.222-26 Equal Opportunity (Sep 2016)
52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014)
52.222-50 Combating Trafficking in Persons (Jan 2019)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)
52.225-13 Restriction on Certain Foreign Purchases (Jun 2008)
52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Oct 2018)

The following provisions and clauses apply to this acquisition and are incorporated as an attachment:
• NIH Invoice and Payment Provisions (2/2014)

(ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. The following is an addendum to 52.212-2. Responses received to this RFQ will be evaluated on the basis of Lowest Price Technically Acceptable (LPTA). Offeror's submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must indicate fixed unit pricing and total cost, including shipping cost and estimated time of delivery after receipt of order, and warranty and training considerations. Responses will be evaluated based on contractor's ability to meet the government's SALIENT CHARACTERISTICS stated in this notice and on ability to deliver required supplies. Responses to this solicitation must include clear and convincing evidence of the Offeror's capability of fulfilling the requirement as it relates to the essential government requirements stated in this solicitation. Under the lowest-price technically acceptable (LPTA) process, Offerors' will be determined to be "technically acceptable" or "technically unacceptable" based on an evaluation of responses against the following factor to determine if, as submitted, the proposal is technically acceptable.

(1) Technical Capability: Offerors shall clearly indicate possessing the technical capability to achieve the essential salient characteristic features of this requirement. The Offeror must indicate in its quotation the ability to provide all of the requirements. The Offeror must indicate in its quotation the ability to meet the delivery requirements. Offerors submitting a response with documented technical specifications and evidence of possessing the technical knowledge, qualifications and capability and management structure needed in successfully achieving this requirement will be determined to be technically acceptable.

Respondents that believe that they are manufacturers or authorized resellers of any BRAND-NAME product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.

(x) 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.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

(xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is incorporated in full text.

(xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

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

(xv) Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations.

Respondents proposing on an equal product of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.

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.

(xvi) All responses must be received no later than the date specified in this announcement. Late responses will not be accepted. All responses must reference the subject solicitation number. Responses must be submitted electronically to hunter.tjugum@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, contact Hunter Tjugum by email at hunter.tjugum@nih.gov or by phone at 301-827-5304.

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