C_J&A_open_market_Brand_Name-_Redacted.docx

Attachment C

HHS Template and Instructions for a Justification for Other than Full and Open Competition

Justification for Other than Full and Open Competition

“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

b. Sponsoring organization. NIH, NIAID,

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

a. Acquisition purpose and objectives.

The purpose of this acquisition will support The National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Center of Human Immunology (CHI). The Facilities are located on the NIH Main Campus in Bethesda, Maryland. The Chromium reagents and kits are needed for the cell expression measurements that enable discovery of gene expression dynamics and molecular profiling of individual cell types.

b. Project background.

Our mission here at the Center of Human Immunology (CHI) is to achieve a more integrated and predictive understanding of human immunity and immune-microbiome behavior and function in health and disease. One of the specific aims of our research is large-scale human studies on immune and microbiome monitoring coupled with intensive computational analysis and modeling.

In 2016, CHI acquired a 10X Genomics Chromium Controller, single-cell isolation and preparation system, to conduct a human vaccine clinical trial. The Chromium Controller system is named in the Federal Drug Administration’s (FDA) approval of protocol for single cell genome and exome analysis of many vaccine trails currently being conducted.

These vaccine studies are conducted in the System of Human Immunology Vaccines Section (SHIVS). The Cellular and Molecular Characterizations of the Immune Responses in Healthy subjects as a Baseline, and After Immunization. Human Trails currently being conducted:

· Characterization of Innate Immune Responses to AS03 Adjuvanted H5N1 Vaccine Compared to Non-Adjuvanted H5N1 Vaccine.

· H1N1 and Seasonal Influenza Vaccines

· Phase I Study of the Safety of Herpes Simplex Virus-2 (HSV-2) 529 Vaccine in Adults Aged 18 to 50 Years with and without HSV Infection.

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

a. Project title. Purchase of Chromium Library, Chips, Gel Bead and Multiplex kits.

b. Project description. Reference in the attached Bill of Materials (BOM)

· 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. AMBIS # 1978736 Federal Business Opportunities (FBO) RFQ-NIAID-1978736

c. Total estimated dollar value and performance/delivery period. Dollar Value: $291,437.94. Estimated Delivery Date: 30 days ARO

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.) 41 USC 1901(e)(_2_) as set forth in Federal Acquisition Regulation (FAR) 13.501- _(a)_.

This acquisition will be a brand name Justification. To ensure that new variables are not introduced that would risk the loss of The Federal Drug Administration’s (FDA) approval.

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).

This Acquisition will be limited to Brand Name only and competed on FBO as an Request for Quotes (RFQ). The name of the purposed contract will be announced at award.

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

The requested products are used during the production of vaccines undergoing clinical studies. These libraries, chips, gels and bead kits are listed in the FDA’s approved production protocols by brand and used for various vaccines currently produced for human use. 10X Gemonics brand of kits is required to maintain CHI’s FDA approval for human use.

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 FedBizOpps RFQ notices will be publicized under FAR 5.201 with the publicizing and response time requirements of FAR Part 5.203(a)(2) referring the combine synopsis and solicitation procedures. Quotes will be obtained from FedBisOpps.gov, which is the Governments Point of Entry System. Market research indicates that two small business vendors are able to meet this requirement. Previous awards were made to 10X Genomics and Government Scientific Source. This Brand Name justification will be published with the solicitation.

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

The prices will be evaluated for fair and reasonable pricing in accordance with the FAR after quotes are received.

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. During Market Research, these kits were not found to be offered on any priority sources. These sources included: agency inventories, government excess, and the Federal Prison Industries Inc.(UNICORE).

The General Services Administration (GSA) contract offered the requested products on schedule 66 under Sin 615 1. However, after contacting the listed vendors, only one offeror was found to distribute the products. The pricing offered was not competitive with open market pricing. Considering the absence of competition, this mechanism would not provide competitive pricing and deemed not in the best interest of the government.

While researching the open market I found that 10X genomics was the manufacturer and their manufacturing plant is located in San Francisco California. 10X Genomics is a small business. A review of previous awards for these kits revealed that two vendors are found in the market place. Government Scientific Source and 10X Genomics both small businesses.

9. Any other facts supporting the use of other than full and open competition. Since this RFQ will only be limiting the brand of the products to be purchased, competition in the market place will reveal the best price and delivery time.

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

None