1811091_LSJ.pdf

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Justification for Other than Full and Open Competition Sole Source

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. National Institute of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID)

b. Sponsoring organization. Vaccine Research Center (VRC), NIAID Vaccine Immune T-Cell and Antibody Laboratory (NVITAL)

c. Project Officer Information:

Project Officer Name.

Mailing address.

E-mail address.

Telephone number.

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

a. Acquisition purpose and objectives.

The requirement is to maintain the Molecular Devices Equipment for NIAID Vaccine Immune T-Cell and Antibody Laboratory (NVITAL) and Vaccine Production Program Laboratory (VPPL). This maintenance is crucial to the scientific research being conducted by the laboratories located in this facility.

b. Project background.

Initially, the Immunology Core (IMC) at the Vaccine Research Center (VRC) was responsible for the method development, assay qualification, and end-point immunogenicity testing of all samples from VRC clinical trials following Good Clinical Laboratory Practices (GCLP). The rational for use of qualified methods following GCLP practices was to assure all data generated would be useful to support product licensure. In addition, well characterized and reproducible assays permits the VRC to rapidly assess immunogenicity of products in Phase I testing, decide if the immunogenicity is sub-optimal, and make vector changes leading to critical product development improvements.

To meet the demands of increased samples associated with expanded scope of work of the VRC and Phase II trials, there was a need to expand the capabilities of the IMC and expand the scope of the laboratory to cover other NIAID sponsored products. Since there was no existing domestic or international

Attachment 5 Page 2 immunology laboratory that possessed the ability to perform the high-throughput immunology assays necessary for pivotal Phase II and Phase III vaccine trials, the NIAID Vaccine Immune T-Cell and Antibody Laboratory (NVITAL) was established in 2005. It is a 15,000 sq. ft. state-of-the-art, fully GCLP-compliant laboratory that supports NIAID vaccine efforts and can perform (1) end point immune analysis, inclusive of inter-study comparisons; (2) Production, monitoring, and distribution of key standard reagents to other collaborator laboratories; (3) Repository of immunological data for distribution to statistical centers, collaborators; (4) Implementation and development of new high-throughput immunological methodologies (5) Assay technology transfer from both intra- and extramural NIAID labs and collaborators; and (6) Clinical trial sample processing and cryopreservation. With that be said sample preparation/analysis are critical elements for this research and maintenance must be acquired to ensure research continues.

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

a. Project title. Service Plan for Molecular Devices Equipment

b. Project description.

Support service the Molecular Devices equipment being utilized by the NVITAL.

Requirement type.

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

Type of action.

X New requirement Follow-on to Other (specify): ______________________

Proposed contract/order type. :

X 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

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Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. N/A

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

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

X This acquisition is conducted under the authority of 41 USC 253(c) (1) and FAR Part 6.302-1

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).

Molecular Devices, LLC, 1311 Orleans Drive, Sunnyvale, CA 94089

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

Molecular Devices, LLC, is the sole manufacturer of this equipment and they do not have any authorized third party service providers.

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 Notice of Intent (NOI) will be publicized. All responses to the NOI will be considered.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable based on comparison to similar equipment.

Commercial pricing. Compared acquisition against similar laboratory maintenance services found on GSA/Federal Supply Schedules (FSS). These prices ranged from 48K to 80K per year. Based on data, this acquisition is fair and reasonable. Please note FSS are predetermined to be fair and reasonable.

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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.

Several market research techniques were used to identify other possible sources, including review of acquisitions on similar items, queries of internet information sources, contact of knowledgeable individuals in the government and in industry, and review of catalogs and product literature. The results of this research indicated there is only one manufacturer/source for this product.

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

NIAID currently has several Molecular Devices LLC equipment items. Molecular Devices is the manufacturer and they do not have any authorized third party service providers. With that being said, the only way to obtain parts is by obtaining service agreement directly with Molecular Devices. This is the only avenue to obtain maintenance/service.

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

No other sources have expressed an interest 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.

It is the policy of NIAID to promote the use of competitive procedures whenever and wherever possible. In an effort to remove or overcome barriers to competition in the future, the market will be scanned frequently for new companies and products that could satisfy the Government’s requirement. The staff meets regularly with products manufacturers and vendors and attends manufacturer and industry training to keep current on technology. Vendor and trade magazines are scanned for new, open technologies that can satisfy future infrastructure requirements. The agency will continually re-evaluate the products currently being used and will research for the manufacturers and products that will be in the Government’s best interest as best value for future replacement products at the agency’s site and at sites the agency supports. The current situation requires a brand name justification to satisfy requirements. Since there is a continual re-evaluation to products currently being used by the agency for the present requirement, if/when alternatives become available, they will be evaluated for use.