N02CP62596-76_JA--REDACTED--FBO_POSTING_PUBLIC_FACING.pdf

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS, NIH

b. Sponsoring organization. National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB)

c. Technical Point of Contact information.

Name:

Address: Metabolic Epidemiology Branch

Division of Cancer Epidemiology and Genetics

Phone:

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of this procurement is to use metabolomics to replicate previously observed associations between serum metabolite levels and future breast cancer risk.

b. Project background.

Breast cancer is the most commonly diagnosed cancer in the United States, with an estimated 232,000 new cases diagnosed in 2015, and metabolic factors are believed to play a role in the etiology of his malignancy. We recently had LC-MS and GC-MS metabolomics analyses performed on serum samples from 621 breast cancer cases and 1:1 matched controls from a prospective cohort study, and detected numerous associations between baseline serum metabolites and future breast cancer risk. We now seek to replicate these findings in an additional U.S. prospective cohort study, the Cancer Prevention Study II (CPSII).

Samples are to be run at the lab of Metabolon Inc. using liquid- and gas-chromatography mass spectrometry. Metabolon Inc. is considered one of the leaders in the field of metabolomics, and has superb reliability and technical properties. Importantly, Metabolon Inc. was the lab used in our prior breast cancer metabolomics study. Because most metabolites do not overlap with metabolomics platforms of other providers, it is necessary to use Metabolon Inc. again to exactly replicate prior observations.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

Justification and Approval for Sole Source Acquisition Under the Test Program for Commercial Items

a. Project title. Acquisition of Laboratory Testing of Blood metabolite profiles and risk of developing breast cancer in the Cancer Prevention Study II

Project description. The purpose of this procurement is to use metabolomics to identify serum metabolites prospectively associated with breast cancer risk. The NCI will send 1,496 serum samples from a breast cancer study in the CPSII cohort (680 cases, 680 controls, 136 QC). Analysis will be done using the Contractor's LC-MS and GC-MS technologies.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. N02CP62596-76

c. Total estimated dollar value and performance/delivery period.

No. of samples Price per sample Total 1,496

The period of performance will be for the twelve (12) months from the time of award.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(_1_) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996, as set forth in FAR Statute: 13.106-1(b)(2) and FAR 13.501(a)(1).

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Metabolon, Inc.

617 Davis Dr. Suite 400 Durham, NC 27713 US

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Metabolon Inc. was the lab used in the MEB’s prior breast cancer metabolomics study referenced above and following, and has exceptionally high technical reliability and technical properties.

To ensure scientific integrity, samples for its replication study need to be run at the lab of Metabolon Inc. in order to exactly replicate prior observations, since metabolites measured by Metabolon Inc. do not extensively overlap with those of other metabolomics platforms from other labs. The MEB's study is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of on-going studies.

A change would be disruptive to the ability to analyze its cumulative results. For scientific comparability, it is imperative the analyses be performed by the proposed source.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR

5.202 applies. A pre-solicitation notice was posted on FedBizOpps on June 6, 2016 with a response date of June 16, 2016; 1:30PM EDT. No responses were received in response to the pre-solicitation notice.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The NCI Contracting Officer will consider the independent government estimate in determining price reasonableness. Based on the aforementioned, there is no reason to believe that the price will not be fair and reasonable to the government. A final determination will be conducted prior to the award of the contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

the Technical Point of Contact has conducted extensive research into the extent of overlap in metabolites measured by different metabolomics platforms. For example, has collected metabolite lists from seven of the most widely-used metabolomics platforms and cross-tabulated metabolite identities through linkage to the Human Metabolome Database. No platform had more than % overlap with the Metabolon Inc. platform, which is insufficient for a replication study. In addition, to confirm the MEB’s estimate of low overlap, it sent samples in common to Metabolon Inc. and the Broad Institute (one of the most widely used metabolomics platforms). Of the ~1,000 metabolites measured by Metabolon Inc., only 111 overlapped with the metabolite list of the Broad Institute.

Given the lack of metabolite overlap between metabolomics platforms, it is scientifically necessary to use Metabolon Inc. for the MEB’s replication study. Otherwise, it would only be able to evaluate replication of associations for a small minority of our prior findings (and, as it turns out, none of its most important findings).

9. Any other facts supporting the use of other than full and open competition.

N/A

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. In the event that additional service is required, the NCI program office and the Contracting Officer will conduct market research to determine if the current state of technology has advanced and to determine if there are other sources available that can provide the supplies required.

An award will only be made, if during negotiations, it is shown that the anticipated cost to the Government is fair and reasonable.