N02RC72521-76--FBO_posting_PUBLC_FACING--REDACTED_J_A.pdf

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 / Center for Cancer Research / Laboratory of Tumor Immunology and Biology (LTIB)

c. NCI Technical Point of Contact information

Name.

Mailing address.

E-mail address.

Telephone number.

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

a. Acquisition purpose and objectives. As part of our ongoing research efforts, the LSRFortessa flow cytometer is needed to replace the LSRII cytometer, which has reached the end of its lifespan. This instrument will allow us to continue to perform immunologic monitoring of patients on our clinical trials.

b. Project background. The Laboratory of Tumor Immunology and Biology (LTIB) functions as a multidisciplinary and interdisciplinary translational research programmatic effort with the goal of developing novel immunotherapies for cancer. The LTIB strategic plan focuses on the development of novel immunotherapeutics for human carcinomas, not only as monotherapies, but more importantly, in combination with other immune-mediating modalities, and other conventional or experimental therapies, as part of an immuno-oncology programmatic effort. Within this effort are several research groups, a clinical trials group, one tenured investigator, one independent tenure-track investigator, and multiple collaborations with intramural and extramural scientific and clinical investigators, as well as with investigators in the private sector.

The program takes advantage of the uniqueness of the NCI intramural program in that it spans high-risk basic discovery research in immunology and tumor biology, through preclinical translational research, to paradigm-shifting clinical trials. Focus is placed on the design and development of novel 'off-the-shelf' recombinant (rec.) vaccines and immunomodulators that can be used in clinical studies at numerous institutions, and do not involve costly and labor-intensive ex vivo manipulations that can be carried out in only one or two centers. This is accomplished via Cooperative Research and Development Agreements (CRADAs) with partners in the private sector that provide agents for preclinical studies in appropriate animal models that we have developed and in human in vitro systems. The immunotherapeutics that LTIB has developed have also enabled collaborations with other clinical investigators at extramural Cancer Centers.

A critical component of the LTIB is the immune analyses of cancer patients receiving immunotherapies. Scientists at the LTIB have developed an expanded flow cytometry assay to identify 123 distinct immune cell subsets in peripheral blood, that include 9 classic subsets and 114 refined subsets relating to the maturation/function of the classic subsets. Each flow cytometry panel measures up 11 immune markers simultaneously and has been performed to date with the LSRII flow cytometer from BD Biosciences. This flow cytometer has five (5) LASERs (red, blue, violet, yellow-green and ultraviolet).

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

a. Project title. Procurement of a BD LSRFortessa Flow cytometer (special order system)

b. Project description. Please refer to the Statement of Need document.

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. N02RC72521-76

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

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).

FAR Statute: 13.106-1 (b)(2)

(b) Soliciting from a single source.

(2) For purchases exceeding the simplified acquisition threshold. The requirements at 13.501(a) apply to sole-source (including brand-name) acquisitions of commercial items conducted pursuant to subpart 13.5.

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).

Becton, Dickinson & Co DBA BD Biosciences One Becton Drive Franklin Lakes, NJ 07417

b. BD Biosciences is the only known manufacturer of a flow cytometer that specifically has five (5) LASERs (red, blue, violet, yellow-green and ultraviolet) that meets all of the stated technical and scientific requirements required by the LTIB. The proposed equipment would ensure the scientific integrity and continuity of LTIB’s on-going experiments and ensure that the system is properly optimized for its assays developed for BD Sciences equipment. It is expected that the scientific results that will be generated with the proposed equipment will be completely compatible with those already generated with the current BD Biosciences machine, therefore allowing for comparison of results. In addition, purchasing from the same Vendor will allow the LTIB to utilize all the reagents and supplies that are currently available in its laboratory without the need for changing them and re-optimizing its experimental systems which is very costly.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FBO 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 Mar. 24 2017 with a response date of Apr. 3, 2017; 8:00AM EDT.

Only one (1) vendor submitted a capability statement in response to the pre-solicitation posting, Beckman Coulter. The NCI Technical Point of Contact for this requirement was provided the vendor’s capability statement for evaluation, and subsequently found the vendor not capable of performing the technical requirements presented in the FBO notice. There were several deficiencies in the vendor’s capability statement, with the most significant deficiency being that the vendor did not demonstrate that its proposed product can meet all of the specific technical requirements of the equipment reflected in the FBO notice.

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

The LTIB has been employing an LSRII flow cytometer from BD Biosciences with successful results. The LSRII has five (5) LASERs (red, blue, violet, yellow-green and ultraviolet) allowing the LTIB to measure up to 11 immune markers simultaneously within the same sample. The expanded flow cytometry panels the LTIB has employed in the last 3 years in analyzing clinical trial specimens requires all five (5) of these LASERs. There are currently only two (2) machines available that have the needed red, blue, violet, yellow-green and ultraviolet LASERs that are required for our flow cytometry panels: the LSRFortessa and the Yeti from Propel Labs. The Yeti is not yet widely used, is extremely new to the market, and is in beta testing. As the current and projected use of a flow cytometer with the capabilities of the LSRII has greatly increased, the purchase of a new LSRFortessa cytometer with its next generation specifications will allow the LTIB to fulfill the current and projected needs. The proposed LSRFortessa cytometer is the equivalent of the older LSRII cytometer that has been discontinued by the vendor and is not available anymore. As its current and past experiments, have been executed in a BD Biosciences flow cytometer machine, purchasing an instrument from the same vendor to assure the continuity of its experiments and to assure that the system is properly optimized for our assays is essential. It is expected that the results that will be generated with the LSRFortessa will be totally compatible with those already generated with the current LSRII machine, therefore allowing for comparison of results. In addition, purchasing from the same vendor will allow the LTIB to utilize all the reagents and supplies that are currently available in its laboratory without the need for changing them and re-optimizing its experimental systems.

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. Only one (1) vendor submitted a capability statement in response to the pre-solicitation posting, Beckman Coulter. The NCI Technical Point of Contact for this requirement was provided the vendor’s capability statement for evaluation, and subsequently found the vendor not capable of performing the technical requirements presented in the FBO notice. There were several deficiencies in the vendor’s capability statement, with the most significant deficiency being that the vendor did not demonstrate that its proposed product can meet all of the specific technical requirements of the equipment reflected in the FBO notice.

11. Statement of the actions, if any, the agency may take to remove overcome any barriers to competition before any subsequent acquisition for the required supplies or services. NCI anticipates the needs to be met successfully with this fulfillment of this requirement. In the event that additional service is required, the NCI Program Office and the and Contracting Officer will conduct market research to determine if the current state of technology has advanced and to determine if there are others sources available that can provide the services required.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

10/2016 muirca Typewritten Text Catherine Muir req 4419203--Justif_approval doc_v4 - FINAL--fully exec - Copy