75N95023Q00503

Post Date/ Solicitation Issue Date

July 13, 2023 12:00 pm

Closing Response Date

July 20, 2023 9:00 am

Proposed Award Date

July 31, 2023 12:00 pm

Project Title

Anprolene Sterilizer AN75i

Contracting Office

National Center for Advancing Translational Sciences (NCATS)

Small Business Size Standard

200 Employees

FPDS Classification Code

6640

Delivery of Goods

60 Days ARO

Single-Sole Source Determination

There is a need to establish in vitro predictive assays for drug discovery and development. The NCATS 3D Tissue Bioprinting Laboratory is assembling a portfolio of 3D tissue models in microplate format that can be used for drug testing. The 3D Tissue Bioprinting laboratory develops its own custom labware using additive manufacturing/3D printing technologies already available at NCATS. However, one of the limitations is that this custom manufactured labware needs to be sterile and cannot be sterilized by autoclaving. The Anprolene Sterilizer AN75i is the only FDA-cleared room temperature Ethylene Oxide (EtO) sterilizer on the market to achieve hospital-level sterility assurance and enable the used to custom-made labware for sterile lab work with bio fabricated tissues. The instrument should also include the EO-Flexible Chamber Technology that uses a microdose of EO to minimize EO usage, as well as a process to remove more than 99% of the ethylene oxide emitted from the sterilizers (Emission Abator AN5100).

Background/Description of Requirement

Description of Requirement:

The National Center for Advancing Translational Sciences (NCATS) requires an Anprolene Sterilizer AN75i with 99% EtO Emission Abator AN5100.

 

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting, and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a part of the NIH, with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

 

There is a need to establish in vitro predictive assays for drug discovery and development. The NCATS 3D Tissue Bioprinting Laboratory is assembling a portfolio of 3D tissue models in microplate format that can be used for drug testing. The 3D Tissue Bioprinting laboratory develops its own custom labware using additive manufacturing/3D printing technologies already available at NCATS. However, one of the limitations is that this custom manufactured labware needs to be sterile and cannot be sterilized by autoclaving. The Anprolene Sterilizer AN75i is the only FDA-cleared room temperature Ethylene Oxide (EtO) sterilizer on the market to achieve hospital-level sterility assurance and enable the used to custom-made labware for sterile lab work with biofabrciated tissues.

 

General 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 below:

Specific Requirements:

The Anprolene Sterilizer AN75i is the only FDA-cleared room temperature Ethylene Oxide (EtO) sterilizer on the market to achieve hospital-level sterility assurance. The instrument includes a the unique EO-Flexible Chamber Technology that uses a micro dose of EO, as well as a process to remove more than 99% of the ethylene oxide emitted from the sterilizers (Emission Abator AN5100).

See Attachment 1 – Statement of Work.

QUOTER TERMS AND CONDITIONS: (To be completed by the Offeror):

1. Period of Performance OR Delivery Date After Receipt of Order:
2. Shipping Point (F.O.B. OR Destination):
3. Payment Discount Terms:
4. Open Market; GSA FSS Contract Number; Other Government Agency (OGA) Contract Number, Government-wide Agency (GWAC) Contract Number; or National Institute of Health (NIH) Blanket Purchase Agreement (BPA) Number:
5. DUNS No:
6. Name of Company:
7. Street Address, City, State, Zip code:
8. Name of Person Authorized to Provide Quote:
9. Telephone Number and Email Address of Person Authorized to Provide Quote:

 

CONTRACT TYPE:

A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is 07/31/2023

 

ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

 

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 this/these address(es): www.acquisition.gov

(End of provision)

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 this/these address(es): www.acquisition.gov

 

(End of clause)

The FAR provisions and clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/

1.              The provisions of FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (NOV 2021) is applicable to this solicitation.

2.              The provisions of FAR Clause 52.212.2 Evaluation—Commercial Items (NOV 2021) is applicable to this solicitation. 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 service offered to meet the Government requirement;

b.     Price; and

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

3.              The provisions of FAR Clause 52.212-3, Offeror Representations and Certifications—Commercial Items (NOV 2021), is applicable to this solicitation.

4.              The provisions of FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items (NOV 2021) with Addenda: Stop Work Order, FAR Clause 52.242-15 (AUG 1989) is applicable to this solicitation.

5.              The provisions of FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (JUNE 2023) is applicable to this solicitation.  See attachment.  

 

In addition, the following FAR provisions and clauses are applicable to this solicitation and 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 Government Entity Code Reporting (AUG 2020),

52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020).

The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 pursuant to FAR 4.2103 Procedures and submit a completed copy as a separate document with their quotation. 

1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
4. NIH Invoice and Payment Provisions (Rev. 2/10/2021)

Deliver Date: The anticipated date of delivery is 60 days after receipt of order. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.  A firm fixed price type order is anticipated to be awarded as a result of this RFQ.

SUMMARY STATEMENT:

Responses to this notice must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service.  The response shall include: the 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.