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(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 75N95023Q00127 and the solicitation is issued as a 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), Office of Acquisition (OA), on behalf of The National Center for Advancing Translational Sciences (NCATS), Therapeutic Development Branch (TBD), intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Poochin Scientific LLC, 5350 Partners CT Ste C, Frederick, MD 21703-8349 for services involving tandem mass tag labeling quantitative proteome profiling of Alagille Syndrome (ALGS) patient-derived iPSC-generated hepatoblasts and to detect the effects of amyloid firbrils on mid-brain organoid .

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 sole source justification is that Poochon Scientific LLC uses a proprietary method of pairing the samples through the profiling platforms PROMIC and PROMICPATH. PROMICPATH is a proprietary pathway analysis tool that is only offered through Poochon Scientific.A switch in vendor would result in compromised data quality and yield data that is not directly comparable to previously generated proteome profiles as the analysis platforms would be different. The potential loss of data previously collected and not being able to compare previous data to current results highlights the need to maintain services through Poochon Scientific. No other vendor has access to the proprietary analysis software needed.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-06 dated May 26, 2022.

(iv) The associated NAICS code 541990, All Other Professional, Scientific and Technical Services and the size standard in millions of dollars is $16.5.

(v) This requirement is for a maintenance service contract for NovoCyte Quanteon equipment.

(vi) The agreement will include depot hardware and software maintenance/support.

Background: The Therapeutic Development Branch (TDB) is currently developing therapeutics for the treatment of ALGS. ALGS is caused by mutations in the JAG1 or NOTCH2 genes that leads to bile ducts paucity, or the lack of proper bile duct formation. One of the potential mechanism that could explain this clinical symptom is the failure of hepatoblasts, the bipotent precursor cell of the liver, to properly differentiate into cholangiocytes. Tandem Mass Tag Labeling Quantitative Proteome Profiling will enable us to quickly establish differences in protein levels across 9000 protein between patient-derived hepatoblasts and healthy controls establishing putative biomarkers that could be used for the evaluation of in vitro and in vivo therapeutic efficacy. Additionally, this service would also identify cellular pathways that are dysregulated which would inform our downstream approach for assay development for the identification of potential therapeutics.

TDB is also involved in developing therapeutics for still unaddressed neurological degenerative diseases, such as Parkinson's disease. The aim of this project is to establish how treatment with amyloid fibrils affects the function and health of midbrain organoids, which are iPSC derived 3D tissues that recapitulate many of the functions of the human midbrain in vitro. Amyloid fibrils have been detected in a variety of neurological diseases, but whether they are causative or are just a biomarker of neurodegeneration is unclear. We aim to investigate this through the use of proteome profiling to clarify this because it would allow us to detect changes across up to 9000 protein between treated and untreated samples and allow us to see by what mechanism amyloids may disrupt midbrain function.

Purpose: The purpose of this requirement is to procure services to assist TBD with sample processing and data analysis. The samples for the first described project will be prepared by NCATS and include cell lysates extracted from patient and control iPSC-derived hepatoblasts. The samples for the second described project will be prepared by NCATS and include iPSC-derived midbrain organoids pre-treated with amyloid fibrils and untreated controls. The final report will provide the raw LC-MS/MS data, normalization, differential expression analysis and pathway analysis. This extensive data will be used to inform biomarker discovery and for further assay development. The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in the Statement of Work (SOW).

Project Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work.

Specific Requirements:

For the ALGS project the following is required:

1) Preparation of protein lysates from each cell pellet sample

2) TMT-18plex labeling of lysates

3) Fractionation of labeled peptides by basic reversed phase UHPL

4) Nanospray LC/MS/MS analysis using a Thermo Scientific™ Orbitrap Exploris™ 240 Mass Spectrometer and Thermo Scientific™ UltiMate™ 3000 RSLCnano System

5) MS Raw data files for each sample are searched against the human protein sequence database or other species protein sequence database using the Proteome Discoverer 3.0 software

6) Evaluation of the proteome profile for each sample using Poochon’s PROMICPATH

7) Common pathway analysis using Poochon’s PROMICPATH for entire sample set

8) Custom pathway analysis using Poochon’s PROMICPATH for entire sample

9) Provide documentations of experimental procedures, protein identification results for each sample, TMT-tag based quantification results for each sample and pathway analysis report for the sample set

For the amyloid fibril midbrain project the following is required:

1) Preparation of protein lysates from each cell pellet sample

2) TMT-18plex labeling of lysates

3) Fractionation of labeled peptides by basic reversed phase UHPL

4) Nanospray LC/MS/MS analysis using a Thermo Scientific™ Orbitrap Exploris™ 240 Mass Spectrometer and Thermo Scientific™ UltiMate™ 3000 RSLCnano System

5) MS Raw data files for each sample are searched against the human protein sequence database or other species protein sequence database using the Proteome Discoverer 3.0 software

6) Evaluation of the proteome profile for each sample using Poochon’s PROMICPATH

7) Common pathway analysis using Poochon’s PROMICPATH for entire sample set

8) Custom pathway analysis using Poochon’s PROMICPATH for entire sample

9) Provide documentations of experimental procedures, protein identification results for each sample, TMT-tag based quantification results for each sample and pathway analysis report for the sample set.

Government Responsibilities:

Genration of ALGS hepatoblast and amyloid fibril treated midbrain organoid samples and control samples will be the responsibility of TDB.

Deliverables:

For the ALGS project a final report will be generated that will contain raw LC-MS/MS data, normalization, differential expression analysis and pathway analysis for the 21 ALGS samples submitted. This report will be delivered to NCATS 3 weeks after sample submission.

For the amyloid fibril treated midbrain organoid project a final report will be generated that will contain raw LC-MS/MS data, normalization, differential expression analysis and pathway analysis for the 18 midbrain samples submitted. This report will be delivered to NCATS 3 weeks after sample submission.

(vii) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated period of performance is:

Base Period – 03/27/2023 – 04/27/2023

(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 (Aug 2020)


• FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021)


• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021)


• FAR 52.225-2, Buy American Certificate (Feb 2021)


• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)


• FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)


• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Jan 2022)


• NIH Invoice and Payment Provisions (Feb 2021)

(ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].”

(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

(xii) 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.

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

(xiv) 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.

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

The Unique Entity ID (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.

All offers must be received by 2:00p.m., Eastern Daylight/Standard Time, on Friday March 10, 2023, and reference solicitation number 75N95023Q00127. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov.

Fax responses will not be accepted.

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