D 75N95023Q00508_CSS.pdf

COMBINED SYNOPSIS / SOLICITATION

75N95023Q00508

TITLE: Human Spheroid-Qualified Hepatocytes

(i) THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS

SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING

FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the

National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing full and open competition for Human Spheroid- Qualified Hepatocytes from Life Technologies Corporation, 5781 Van Allen Way, Carlsbad, CA 92008. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1).

The rationale for the brand-name justification: Human Spheroid-Qualified Hepatocytes from

Life Technologies were used to optimize viral infection for this project. Since the assay was optimized using these Hepatocytes from Life Technologies and these Hepatocytes were previously used for this project, the Hepatocytes required in this acquisition must also come from Life Technologies to ensure consistent data and the continuity of science. Introducing cells from another vendor may introduce variables and skew the data. Therefore, the required Hepatocytes must come from Life Technologies and this solicitation is restricted to Life Technologies and its authorized resellers.

(ii) 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; quotations are being requested and a written solicitation will not be issued.

(iii) The solicitation number is 75N95023Q00508 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 - Simplified Acquisition Procedures and Commercial Services and FAR Part 12 - Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold.

(iv) The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2023-04 effective June 2, 2023.

(v) The associated NAICS code is 325414 and the Small Business size standard is 1,250 employees.

DESCRIPTION

(vi) The National Center for Advancing Translational Sciences (NCATS), within the National

Institutes of Health (NIH), requires 50 vials of cryopreserved, primary human liver cells (non-fetal) to support the Antiviral Program for Pandemics (APP) program. NCATS works to identify direct acting antivirals towards viruses and for development of microphysiological systems (MPS) for second-line drug screening. The specific items included in this requirement are:

Human Spheroid-Qualified Hepatocytes Catalog Number: HMCPSQ

QTY: 50

Unit size: 1 vial

The Hepatocytes must have the following salient characteristics:

a. tested for spheroid formation,

b. phase I enzyme induction,

c. proper morphology,

d. viability > 70%,

e. attachment efficiency,

f. monolayer formation and integrity,

g. minimum of 4 million viable cells per vial, sufficient for up to twenty-seven 96-well plates of hepatic spheroids.

(vii) Delivery shall be made to Rockville, MD 20850, FOB destination. The exact address will be included on the purchase order.

EVALUATION AND AWARD

(viii) The anticipated award date is August 1, 2023. The Government anticipates award of a firm, fixed-price purchase order with an anticipated delivery date of 30 days after receipt of order.

(ix) The Government will evaluate quotations in accordance with FAR 13.206-2 and award a purchase order to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered, using comparative evaluations. The following factors will be used to evaluate quotes:

1. Technical Capability: The ability to provide the necessary brand-name items.

2. Price: The total quoted price.

3. Past Performance. Past performance providing similar supplies. The Government may use any source of available past performance information (see FAR 13.106-2(b)(3)).

MANDATORY QUALIFICATION CRITERIA

(x) The contractor must have an active registration in the System for Award Management (SAM).

(xi) The contractor must be authorized to provide the required Human Spheroid-Qualified

Hepatocytes from Life Technologies.

SUBMISSION INSTRUCTIONS

(xii) All responses to this RFQ must be received by 9:00am Eastern Time on July 27, 2023 and must reference the solicitation number cited above. Responses must be submitted via email to Kimberly Espinosa at kimberly.espinosa@nih.gov.

(xiii) This is an RFQ. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this RFQ must be completed by the quoter.

(xiv) Responses to this RFQ must include clear and convincing evidence of the quoter’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. Responses may exceed capability or performance characteristics of the solicitation's requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation's requirements if it provides a benefit to the Government.

(xv) Respondents that believe that they are manufacturers or authorized resellers 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.

(xvi) Responses must include the Unique Entity Identifier (UEI) (which recently replaced the DUNS number), the Taxpayer Identification Number (TIN), the certification of business size, the completed representation in FAR Provision 52.225-2, and the completed representations in FAR Provision 52.212-3. If the quoter’s representations in the System for Award Management (SAM) are accurate, only Paragraph B of 52.212-3 should be completed.

(xvii) Responses must also include a quotation in U.S. dollars that includes:

mailto:kimberly.espinosa@nih.gov

1. The total price,

2. Individual prices for each item,

3. Prompt payment discount terms,

4. Product or catalog number(s),

5. Product description, and

6. Any other information or factors that may be considered in the award decision. Such factors may include: special features required for effective program performance; trade-in considerations; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

(xviii) For information about this RFQ, contact Kimberly Espinosa, Contracting Officer, at 301-827-

3546 or kimberly.espinosa@nih.gov.

(xix) All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xx) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb

1998). 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 www.acquisition.gov.

The following provisions apply to this acquisition and are incorporated by reference:

1. FAR Provision 52.204-7, System for Award Management (Oct 2018)

2. FAR Provision 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

3. FAR Provision 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (Dec 2022)

(xxi) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). 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 www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:

1. FAR Clause 52.204-13, System for Award Management Maintenance (Oct 2018)

2. FAR Clause 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

3. FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services (Dec 2022)

4. HHSAR Clause 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

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

ATTACHMENTS

(xxiii) The following terms, provisions, and clauses are incorporated and attached in full text:

1. The provision at FAR 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services (Mar 2023) (Tailored)

2. FAR Provision 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (Dec 2022)

3. FAR Provision 52.225-2, Buy American Certificate (Oct 2022)

4. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders–Commercial Products and Commercial Services (Jun 2023)

5. Invoice and Payment Provisions with IPP (March 2023)