Mixed Gender Human Liver Microsomes for NCATS Tox21 program

NON-COMPETITIVE
COMBINED SYNOPSIS / SOLICITATION

Title: Mixed Gender Human Liver Microsomes for NCATS Tox21 program

(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 75N95019Q00306 and the solicitation is issued as an 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 and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

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), NIDA Office of Acquisitions - NCATS Section, on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Xenotech, LLC, 1101 W Cambridge Circle Drive, Kansas City, KS 66102-1311 for a reagent named "Mixed Gender Human Liver Microsomes".

This acquisition is conducted as non-competitive for a commercial item or service and is conducted under the authority of the FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items and 13.501 Special documentation requirements and the authority of 41 U.S.C. 1901 and the FAR Subpart 13.106-1(b) Soliciting from a single source.

Pursuant to FAR Subpart 13.501 (a) (1) (iv) the rationale for the brand name justification is that a reagent from Xenotech, LLC was previously optimized and tested for viability. Variables cannot be changed at this point without jeopardizing the continuity of science. In addition, changing variables would cause unnecessary expense for the government.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-02, dated May 6, 2019.

(iv) The associated NAICS code is 325413 and the small business size standard is 1250 employees. No set-aside restriction is applicable.

(v) The mission of the Tox21 group of NCATS at the National Institutes of Health (NIH) is to develop better toxicity assessment methods to quickly and efficiently test chemicals for their potential disrupt processes in the human body that may lead to negative health effects.

Genotoxicity potential is a critical component within comprehensive toxicological profiles. Since P53 is often upregulated in cells subjected to physiological stresses and particularly to DNA damage, P53 activation can be used as an indicator of genotoxicity. Thus, identifying compounds which activate p53 is directly related to the Tox21 mission.
At present, NCATS has completed the Tox21 10k screenings for p53-bla project in the absence of metabolism. This purchase-needed metabolic project is to identify the compounds that require metabolism to activate/inactivate p53. The assay using human liver microsomes will be one of the powerful methods for identifying these kind of compounds. The p53-bla with human liver microsomes assay has been optimized and validated in 1,536 well plate formats.

(vi) Microsomes are subcellular fractions, which are derived from the endoplasmic reticulum of liver containing a rich variety of metabolic enzymes for assessing the in vitro metabolism of drug candidates. They are effective tools for the in vitro evaluation of metabolism, drug-drug interactions, hepatotoxicity, and transporter activity.

Human liver microsomes are required by Tox21 groups to complete this project. "Mixed Gender Human Liver Microsomes" from the vendor will be prepared from fresh human liver tissue which ensures a higher retention of enzyme levels. This product has large pool of 50 donors with mixed gender that provides representation of population average of drug metabolism activity. Every donor used in the pool has a quality tested enzyme profile.

Quantity: 300 vials (1mL each) of "Mixed Gender Human Liver Microsomes"

(vii) Delivery shall be to:

The National Center for Advancing Translational Sciences (NCATS)
9800 Medical Center Drive
Rockville, MD 20850

Delivery shall be 4 weeks ARO.

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition.

(ix) Offers will be evaluated for technical criteria, price, and past performance. Technical criteria consist of matching the line items identified above. Technical and past performance, when combined, are significantly more important than price.

OR The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition.

(a) 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. The following factors shall be used to evaluate offers:

(i) technical evaluation criteria and/or technical capability of the item offered to meet the Government requirement
(ii) price
(iii) past performance [see FAR 13.106-2(b)(3)]

Technical and past performance, when combined, are significantly more important than cost or price.

(b) 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).

(c) 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.

(x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with offers.

(xi) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addendum applies:

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 clause may be accessed electronically at these addresses:

For FAR clauses: https://www.acquisition.gov/browsefar

For HHSAR clauses: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(end of clause)

The following FAR provisions or clauses are incorporated by reference:

52.204-7, System for Award Management (Oct 2018)
52.204-13, System for Award Management Maintenance (Oct 2018)
52.204-16, Commercial and Entity Code Reporting (Jul 2016)
52.204-18, Commercial and Entity Code Maintenance (Jul 2016)

52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions (2/2014).

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

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).
52.219-28 Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2))
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 (Mar 2015)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)
52.225-1 (i), Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
(ii) Alternate I (May 2014) of 52.225-3.
52.225-13 Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury)
52.232-33 Payment by Electronic Funds Transfer-- System for Award Management (Jul. 2013)

(xiii) 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) This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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 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.

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.

A determination by the Government whether to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered to determine whether to proceed on a non-competitive basis as indicated above, or to conduct a competitive procurement.

All responses must be received by August 19th, 2019 at 11:00am, Eastern Standard Time and reference solicitation number 75N95019Q00306. Responses must be submitted electronically to Jessica Adams at jessica.adams@nih.gov.

Fax responses will not be accepted.

(xvi) The name and email address of the individual to contact for information regarding the solicitation: Jessica Adams at jessica.adams@nih.gov.

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