Generation of induced pluripotent stem cell lines (iPSCs) for the National Institute on Aging

COMBINED SYNOPSIS / SOLICITATION

Title: Generation of induced pluripotent stem cell lines (iPSCs) for the National Institute on Aging

(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 HHS-NIH-NIDA(AG)-19-048 and the solicitation is issued as an Request for Proposal.

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 expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-101, dated October 26, 2018.

(iv) The associated NAICS code 541990 and the small business size standard $15.0 million. This requirement is full and open with no set-aside restrictions.

(v) The Contractor shall provide reprogrammed cells for the purpose of characterizing cell lines with morphological and genetic data to create a cell repository as an open resource for the scientific community.

(vi) The Contractor shall provide the following:

The Contractor shall provide cell recovery and mycoplasma testing for the PBMCs.
The Contractor shall provide human pathogen testing for the PBMCs.
The Contractor shall provide cell reprogramming and clone isolation.
The Contractor shall provide anywhere from 200 to 600 iPSCs, at the rate of 20 to 50 per month.
The Contractor shall provide two clones per sample.
The Contractor shall provide a test to determine pluripotency of each clone.
The Contractor shall provide a test to determine that there is a normal complement of human chromosomes for each clone

TYPE OF CONTRACT

An ID/IQ contract with a three year ordering period is contemplated. Minimum and Maximum Order amounts will be determined at the time of award.

GOVERNMENT RESPONSIBILITIES
The Government will provide appropriate paperwork indicating patient consent. The Government will provide PBMCs containing at least 1 million cells/vial.

DELIVERY OR DELIVERABLES
Two colonies of iPSCs per PBMC vial will be cryopreserved at 1x10^6 cells per vial and delivered to the Government.

REPORTING REQUIREMENTS
The Contractor shall provide a report on the cell recovery, passage and initial testing of the PMBCs. The Contractor shall provide a report on the reprogramming and putative iPSC clone isolation, including gene expression, pluripotency, and karyotype for each clone.

(vii) Time spent on generation of clones is expected to be 14 weeks from receipt of PBMCs. Various QC measures should be no more than 9 weeks from clone generation. Multiple clones can be generated and analyzed in parallel.

(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 shall be used to evaluate offers: See Attached Technical Evaluation Criteria.

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 to 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.

(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) 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.

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 4:00 PM Eastern on April 12, 2019 and reference number HHS-NIH-NIDA(AG)-19-048. Responses may be submitted electronically to Jon Gottschalk, jon.gottschalk@nih.gov. Questions can be submitted until 4:00 PM April 4, 2019 and will be answered promptly on FedBizOpps.

Fax responses will not be accepted.

(xvi) The name and telephone number of the individual to contact for information regarding the solicitation. Jon Gottschalk, (301) 443-9456.

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