Cryopreserved No-Spin HepaRG (Brand Name)/Authorized Distributors Only

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1 (b) Soliciting from a single source, only one responsible source and no other supplies or services will satisfy agency requirements in conjunction with FAR Part 12, Acquisition of Commercial Items. This requirement is for an item that requires a specific brand name, product, or feature of a product, peculiar to one manufacturer, to be awarded using Simplified Acquisition Procedures (FAR 13}. This action limits competition to (1) brand name only for the acquisition of up to 400 vials of cryopreserved No-Spin HepaRGTM cells containing 8 million cells per vial and (2) only authorized distributors who can provide the brand-name item (cryopreserved No-Spin HepaRG cells containing 8 million cells per vial) specific to the Government's needs. The combined synopsis/solicitation for commercial items is prepared in accordance with the format in FAR Subpart 12.6 in conjunction with FAR Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested from authorized distributors and a written solicitation will not be issued. All items within the Request for Quote (RFQ) must be fully completed and returned by the due date and time indicated above. The FAR as supplemented by the Health and Human Services Acquisition Regulation (HHSAR) will be used to evaluate the quote and award this requirement. The Biomolecular Screening Branch (BSB) at the National Institute of Environmental Health Sciences (NIEHS) located in Research Triangle Park, North Carolina, requires up to 400 vials of cryopreserved No-Spin HepaRG cells containing 8 million cells per vial for a large toxicology screening project which is being performed in collaboration with the Environmental Protection Agency (EPA). More specifically, the request is for No-Spin HepaRG manufactured by Biopredic International. The cryopreserved No-Spin HepaRG cells must simply require only thawing prior to use. The No-Spin HepaRG version is required due to its qualified simplicity of use that would need to be optimized if any other cell is used. As such, the intent here is not to use any other substitute that requires using alternate protocols. (1) This solicitation document, 75N96019Q00002, is issued as a combined synopsis and solicitation for the Contractor to deliver up to 400 Vials of Cryopreserved No-Spin HepaRG (8m Cells/Vial) in support of the BSB/DNTP. (2) This solicitation document and incorporated provisions and clauses are those in effect through FAR; HHSAR; FAR Federal Acquisition Circular (FAC) 2005-101 October 26, 2018. (3) Notice of Set-Aside, Associated NAICS Code, and Size Standard: This action limits competition to (1) brand name only for the acquisition of up to 400 vials of cryopreserved No-Spin HepaRGTM cells containing 8 million cells per vial and (2) only authorized distributors who can provide the brand-name item (cryopreserved No-Spin HepaRG cells containing 8 million cells per vial) specific to the Government's needs. The North American Industry Classification Service (NAICS) code is 325414 -- Biological Product (except Diagnostic) Manufacturing with a size standard of 1,250 employees. (4) List of Contract Line Item Number(s) and items, quantities and units of measure, (including option(s): See RFQ Section B or: Item# Description Qty Unit Unit Price Amount 0001 - No-Spin HepaRG 400 Each $______ $______ 0002 - Dry Ice & Shipping 1 Lot $______ $______ NET AMT $______ $______ (5) Description of Requirements for the Items to be Acquired: Deliver up to 400 vials of cryopreserved No-Spin HepaRG cells containing 8 million cells per vial in strict compliance with all specifications, terms, conditions, clauses, and all other provisions herein. See Statement of Work (SOW) for specific details. 6) Date(s) and place(s) of performance and acceptance and FOB point: - Anticipated delivery period of 3 to 4 weeks after receipt of order. - NIEHS DNTP BSB Bldg. 105 (111 T. W. Alexander Drive, Durham, NC) - FOB Destination (7) The Provision at FAR 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition. See document titled RFQ, 75N96019Q00002, Cryopreserved No-Spin HepaRG. See RFQ Section L or: a. Volume I - Technical Submission: The Quoter must provide sufficient and specific technical information that demonstrates 1. Your product indisputably complies with the cryopreserved No-Spin HepaRG specifications in the SOW; 2. You can deliver the cryopreserved No-Spin HepaRG as specified in the SOW; 3. You can deliver the quantity needed; and 4. You are an authorized distributor of the cryopreserved No-Spin HepaRG b. Volume II - Price Submission: The price volume shall be organized using the following general outline 1. Cover Letter: This statement page shall also include the following information: - Company Name/Address: ____________________ - DUNS #:____________________ - Cage Code: __________________________ - Federal Tax ID: ____________________ - Point of Contact (POC): ____________________ - POC Title/Phone/Fax/E-mail: ____________________ 2. Representation, Certifications, and Other Statements of Quoter: In accordance with provisions FAR 52.212-3, Offeror Representations and Certifications--Commercial Items, IF YOU INTEND TO SUBMIT A QUOTE, YOU MUST: (1) Go to the Online Representations and Certifications Application (ORCA) and complete the Representations and Certifications. Offerors must access ORCA through the System for Award Management (SAM) at http:// www.sam.gov; and (2). Complete, and INCLUDE as part of your price quote. 3. Price: Submit your quote using the price schedule provided. (8) Applicability of the provision at FAR 52.212-2, Evaluation -- Commercial Items. See document titled RFQ, 75N96019Q00002, Cryopreserved No-Spin HepaRG. See RFQ Section M or: The major evaluation factors for this solicitation include Factor I - Technical Acceptability and Factor II - Price. Technical Acceptability and Price are important to the overall award decision. The Government intends to make an award to the Quoter whose submission is lowest priced and technically acceptable. 1. Factor I - Technical Acceptability: This evaluation provides an assessment that the Quoter's product fully complies with the technical requirements of the SOW. The technical submission will be rated utilizing the ratings defined in the evaluation matrix below: Rating Definition Acceptable - Submission clearly meets the minimum requirements of the RFQ & SOW Unacceptable - Submission does not meet the minimum requirements of the RFQ & SOW 2. Factor II - Price: Price will not be assigned an adjectival rating. The Government will evaluate each line item and total price to determine if the Quoters prices are fair and reasonable (normally, price reasonableness is established through adequate price competition) utilizing price analysis techniques in accordance with the guidelines in FAR Part 13.106. 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. (9) FAR 52.212-3, applies to this acquisition: Representation, Certifications, and Other Statements of Offerors - In accordance with provisions FAR 52.212-3, Offeror Representations and Certifications--Commercial Items, IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST: (1) Go to the Online Representations and Certifications Application (ORCA) and complete the Representations and Certifications. Offerors must access ORCA through the System for Award Management (SAM) at http:// www.sam.gov; and (2). Complete, and INCLUDE as part of your price quote. (10) FAR 52.212-4 Contract Terms and Conditions Commercial Items, applies to this acquisition. See document titled RFQ, 75N96019Q00002, Cryopreserved No-Spin HepaRG. (11) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items. See document titled RFQ, 75N96019Q00002, Cryopreserved No-Spin HepaRG. (12) The Date, Time and Place Quotes are Due: The Quoter shall submit dated quote to the following e-mail address: The CO at uche.washington@nih.gov at or before Friday February 15, 2019 at 10:00 AM. ET. (13) The Point of Contact (POC) for this acquisition is the CO, Ms. Uch Washington at (984) 287-3064/ uche.washington@nih.gov.