MODIFICATION
B -- Test the efficacy and potency of two compounds in reducing induced fibrosis in validated 3D bioprinted liver tissue models - Statement of Work, April 25, 2018
- Notice Date
- 4/25/2018
- Notice Type
- Modification/Amendment
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800153
- Point of Contact
- Stuart G. Kern, Phone: 3014023334
- E-Mail Address
-
stuart.kern@nih.gov
(stuart.kern@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sole Source Justification Statement of Work dated 4/25/2018 COMBINED SYNOPSIS / SOLICITATION NON-COMPETITIVE Title: 3D Fibrosis Modulation with ExVive Liver Tissue (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 NIHDA201800153 and the solicitation is issued as a request for proposals (RFP). 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; FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. Th 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) Combined Office of Acquisition, 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 Organovo, 6275 Nancy Ridge Drive, San Diego, CA 92121, for 3D Fibrosis Modulation with ExVive Liver Tissue. 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, FAR 13.501 Special documentation requirements, and the authority of 41 U.S.C. sections 1901 and 3304(a)(1). Pursuant to FAR Subpart 13.501(a)(1)(iv) the rationale for the brand name justification is that the ExVivre-brand process is proprietary to Organovo and is protected by patent rights and/or secret processes. This acquisition is being used specifically as part of NCATS efforts to evaluate alternative cell-based assay models of disease that are more predictive of efficacy and toxicity to help prioritize compounds for in vivo testing, reduced use of animal testing, and possible reduced time to clinic and cost of drug development. (iii)The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97, dated 1/24/2018. (iv)The associated NAICS code is 541715 and the small business size standard is 1000 employees. This requirement has no set-aside restrictions. (v)Background: Alternative cell-based assay models of disease that are more predictive of efficacy and toxicity of compounds in clinic are being developed to help prioritize compounds for in vivo testing, reduce use of animal testing, and possibly reduce time to clinic and cost of drug development. Manufactured 3D tissue models that mimic a human tissue in cell composition and architecture, and produced with human primary or iPSC-derived cells are now available for some tissues, including liver. 3D liver tissue models of fibrosis have been described in recent worldwide publications and provide a unique opportunity to test compounds for their ability to reduced induced fibrosis in a tissue model that it is possibly more predictive of activity in clinic. (vi)Contractor shall test two compounds in accordance with the Statement of Work dated April 25, 2018 published with this announcement. (vii)The contractor will be required to deliver the results in a fully detailed report within 60 days of receipt of compounds from NCATS. (viii)The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix)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 will be used to evaluate offers: (i) technical: the extent to which the offeror demonstrates an understanding of the work and whether the technical approach satisfies the requirements described in the SOW; (ii) past performance; and (iii) cost/price. 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)The Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xi)The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (xii)FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. A copy identifying the applicable provisions is attached to this solicitation. (xiii)No 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. (xiv)The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) 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. 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. All responses must be received by Wednesday, May 2, at 3 p.m. Eastern time, and reference number NIHDA201800153. Responses must be submitted electronically to Stuart Kern, stuart.kern@nih.gov. Fax responses will not be accepted. (xvi)The name and telephone number of the individual to contact for information regarding the solicitation is Stuart Kern, stuart.kern@nih.gov, tel. 301-402-3334.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/NIHDA201800153/listing.html)
- Place of Performance
- Address: National Center for Advancing Translational Sciences, 9800 Medical Center Drive, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN04900301-W 20180427/180425230708-5f105fd01cb7d358a2b7b7a6ea98e8ac (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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