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

“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: NCI/DCEG/HREB

c. Project Officer information:

Katherine McGlynn, Ph.D.

9609 Medical Center Drive Rm 7E104, MSC 9774 Bethesda, MD 20892 Phone: (240) 276-7297

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

a. Acquisition purpose and objectives:

The purpose of this acquisition is for the Contractor to perform an examination of serum samples collected by the NCI’s Hormonal and Reproductive Epidemiology Branch (HREB).

b. Project background:

The Hormonal and Reproductive Epidemiology Branch (HREB) conducts research to identify groups at a high risk of cancer, clarify the natural history of various cancers, understand the interactive effects of genetic and environmental factors on cancer risk, and elucidate biologic mechanisms of carcinogenesis. The Branch also focuses on high-quality, high-impact research on hormonally-related cancers and cancers of the reproductive system: breast, endometrium, ovary, cervix, prostate and testis. In addition, the HREB seeks to understand the epidemiology of a number of other malignancies, some of which are hormonally influenced.

These include cancers of the liver and bladder, and esophageal adenocarcinomas. The branch’s research is predicated on rigorous epidemiologic approaches, with integration of state-of-the-art methods for defining exposures of interest.

HREB forms collaborative partnerships within the NIH/NCI intramural research program, and with scientists at academic and medical institutions around the world, which enables the branch to carry out their research.

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

a. Project title: Serum Hormone Studies in the Hormonal and Reproductive Epidemiology Branch.

b. Project description: See Statement of Work

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 - HHSN261201400658P 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): __IDIQ_______ Other (specify): ___________ Completion Form Term form

Acquisition identification number: N02CP52590-57

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

Estimated amount is a minimum of $110,400 and a maximum of $649,000 for a period of 5 years, starting September 1, 2015 through August 31, 2020.

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)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302- __.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

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).

Universite LavalCHUQ Research Center 2705, Boulevard Laurier, Room T3-48 Quebec, QC, V1V 4G2 Canada Attn: Dr. Chantal Guillemette

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

The nature of the acquisition is to meet HREB’s research mission in identifying groups at a high risk of cancer, clarifying the natural history of various cancers, understanding hormonal and reproductive cancers, and other malignancies with possible hormonal etiologies.

Université Laval is the only known laboratory that can quantitate using gold standard technologies to determine levels of testosterone, estradiol, dehydroepiandrosterone, sulfate, and estrone sulfate in a small serum sample. Their experience has been demonstrated in several peer-reviewed publications. HREB only has a very little of serum available to conduct the proposed experiments, and based on previous studies conducted by the NCI, Universite’ Laval is the only known lab capable of conducting the experiments and determining the above hormone levels in a small amount of serum (200 µL).

In addition, HREB wants to compare the new results from the proposed experiments with the results from the previous study that was also conducted at the Universite’ Laval laboratory. If HREB utilizes the same vendor, this will eliminate lab-to-lab variability, provide additional confidence in comparing hormone values across datasets, and be in the best interest of the Government, in terms of time and funding.

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 July 01, 2015 with a response date of July 17, 2015; 11:00 am EST. 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.

NCI OA’s Contract Specialist will consider the independent government estimate and previous purchase order prices as a determining factor for reasonableness.

Based on the aforementioned, there is no reason to believe that price will not be fair and reasonable to the Government.

A final determination will be conducted prior to the award of this 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:

Market research was not conducted because NCI only has a very small volume of serum available to use for the proposed experiment. As the key factor in the identification of an appropriate laboratory is the volume of serum required, volume requirements are the first barrier. No other laboratory is able to conduct the proposed experiment in such a small volume of serum. Also, the Hormonal and Reproductive Epidemiology Branch (HREB) needs to compare results obtained from last years' study with the new results. As stated above, a pre-solicitation notice was posted and no responses were received.

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 this requirement.

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:

NCI anticipates the needs to be met successfully in this contract. In the event that additional supplies are required, the NCI program office and the Contracting Officer will conduct market research to determine if there are other sources available that can provide the services required. This market research will include a FedBizOpps announcement.