Osmotech

This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and solicitation for commercial Items," as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-1977154 and the solicitation is issued as a Request for Quotes (RFQ).

This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) FAC 2019-04 and effective 08/07/2019.

The North American Industry Classification System (NAICS) code for this procurement is 334516, Analytical Laboratory Instrument Manufacturing, the small business size standard of 1000 employees.

This requirement is NOT set-aside for small business.

Background and laboratory needs:
The Vaccine Production Program (VPP) is the development arm of the Vaccine Research Center. The mission of the VRC is to create and develop potentially lifesaving vaccines for HIV, Ebola, Zika, and other known pathogens and get these potentially lifesaving products into the clinic. To manufacture and release these products for clinical use, analytical assays are developed at the VPP and transferred to the VCMP (Vaccine Clinical Materials Program), the cGMP manufacturing arm of the VRC located in Frederick Maryland. To ensure that the assay results generated at the VPP during product development align with those generated at the VCMP (agreement between values is CRITICAL to release of vaccine for use in lifesaving clinical trials), the same methodologies and equipment manufacturers must be employed at both sites. Currently the VCMP uses a method for measurement of osmolality of drug product based on Vapor Dew Point. This method has known reproducibility issues and the variability is inconsistent between clinical products. The VPP uses the freezing point depression method, which possesses increases reproducibility, reliability, and ease of use.

Brand-Name requested and justification:
The lab is requesting an OsmoTECH Single-Sample Micro-Osmometer manufactured by Advanced Instruments. The instrumentation needed is a Freezing point depression Osmometer compatable with GMP use that is manufactured as those in use in multiple groups within the VPP. This offers the least risk of discrepancy between osmolarilty values generated at the two sites, and therefore maximizes the success of clinical manufacture at the VCMP.

In order to be used for GMP manufacturing and testing, the software for the instrument must comply Federal regulation CFR Part 11. Use of an alternate product will increase the risk of delay in release of clinical drug product, or even rejection of drug product lots and will manifest delays within the clinical trials group of the VRC and delay testing of potentially lifesaving vaccines.

*The quote/email should include:
-Cost of equipment
-Cost of Installation and Training
-Cost of Installation Qualificaiton & Operational Qualification

*Include shipping/freight if applicable
*Please include your DUNS number

Place of Delivery: NIH, 9 West Watkins Road, Gaithersburg, MD 20878
FOB: Destination

Submission shall be received not later than 5:00 p.m. EST, 08/26/2019.

The government intends to award a firm fixed price purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein. The award will be based on the following; price, capability to meet the requirements, delivery and the best value to the government.

The following FAR provisions apply to this acquisition:

FAR 52.212-1 Instructions to Offerors Commercial Items (Oct 2018)

FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (Oct 2018)

Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) is updated in your SAM record)

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements - Representation (Jan 2017)

The following FAR contract clauses apply to this acquisition:

FAR 52-212-4 Contract Terms and Conditions Commercial Items (Oct 2018)

FAR 52-212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (May 2019)
*The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting.
FAR 52.203-19 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Jan 2017)

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

FAR 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov).

Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax.

Offers may be mailed, e-mailed or faxed to Ms. Skye Duffner, (E-Mail/ skye.duffner@nih.gov 406-802-6092). Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) (Oct 2018)

All responsible sources may submit an offer that will be considered by this Agency.
Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Ms. Skye Duffner at skye.duffner@nih.gov.

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