A03.10_JA_ERDC_16-0227_Global_Biologics.pdf

ERDC-16-0227

FOR OFFICIAL USE ONLY

Justification and Approval For Other Than

Full and Open Competition

1. Contracting Activity: The ERDC Contracting Office (ECO) is located at the U.S. Army ERDC, 3909 Halls Ferry Road, Vicksburg, MS 39180-6199.

2. Description of Action: Execute a new sole-source, firm fixed price contract with Global Biologics utilizing Fiscal Year (FY) 16 Research, Development, Test and Evaluation, Army (RDT&E), 21 2040 funds, for genetic library construction services.

3. Description of Supplies/Services: ERDC’s Environmental Laboratory (EL), Environmental Processes Branch (EP-P) has a requirement for a means to monitor biological effects of chemicals and other stressors on microbes, insects, birds, and mammals. EP-P’s projects include assessments of toxicity of environmental contaminants and how the genes are expressed or altered under these conditions. The requirement is to perform genetic library construction services using a modified robotic (touchless) sample preparation from ribonucleic acid (RNA) or deoxyribonucleic acid (DNA) samples and genetic HiSeq sequencing using the libraries generated at ERDC. The total estimated value is $480,000.00 including options.

4. Authority Cited: FAR 13.5(a) Simplified Procedures for Certain Commercial Items.

5. Reason for Authority Cited: The proposed procurement meets the criteria for exclusion from full and open competition under the authority cited above based on the pending patent process provided by Global Biologics. No other known sources are able to provide the touchless total preparation (TTP) system required by ERDC.

a) Background: Under contracts W912HZ-15-P-0001 and W912HZ-15-P-0118, Global Biologics provided genetic library construction services using robotic methods protected under a pending patent. The data resulting from downstream analysis of the genetic library prepared by Global Biologics was of very high quality and had reduced variability compared to samples prepared by traditional methods.

b) Justification: Using other genomic library preparation and sequencing services will result in downstream variation of data because of manual techniques used during library preparation. These variations in data can cause invalid results in downstream processing which could lead to under or over reporting of genomic effects due to chemical stressors. The use of the Global Biologics pending patent processes will virtually eliminate downstream variation and will provide valid data that can be used to accurately determine genomic effects from chemical stressors.

c) Impact of not awarding to Global Biologics: Procurement of any other manufacturer’s products and services would likely result in the substantial duplication of cost to the Government that is not expected to be recovered through competition. The purchase of these services will enable the EP-P Branch to continue providing research and technical

FOR OFFICIAL USE ONLY

expertise at ERDC. It is neither cost effective nor efficient to duplicate the cost already invested in the initial work conducted.

6. Efforts to Obtain Competition: Based on information in paragraph 5, above, and the proprietary nature of the TTP system, competition for this action is not feasible.

7. Actions to Increase Competition: ERDC is a research and development organization that continues to stay abreast of changing, technological developments, new products, equipment, materials, and supplies which may become available and can in the future be used to satisfy similar requirements. Interested vendors also have the opportunity to submit capability statements in response to the notice posted on FedBizOpps.

8. Market Research: The Federal Supply Schedule catalog, the Thomas Register, and trade magazines were consulted for companies that could provide service contracts that could meet the needs stated above. The Thomas Register identified a subsidiary of a large company that provides sequencing, Caliper which is a part of Perkin Elmer. Many universities are able to perform sequencing services but Global Biologics is the only vendor using a robotic prototype (pending patent) for genetic library construction.

9. Interested Sources: A notice of intent to award a sole source contract was posted at the Government point of entry, FedBizOpps on 7 July 2016. No capabilities or qualifications were submitted by interested organizations.

10. Other Facts:

a) Procurement History: Contract W912HZ-15-P-0001 with Global Biologics was approved for solicitation from a single source utilizing the authority in FAR 13.106- 1(b)(1) under ERDC Control Number 14-371 in the amount of $24,525.00 to procure genetic library construction services for a small number of samples. Contract W912HZ- 15-P-0118 with Global Biologics was approved for solicitation from a single source utilizing the authority in FAR 13.5(a) under ERDC Control Number 15-0186 in the amount of $127,020.00 to procure genetic library construction services for 600 samples.

The current requirement is for the same type of services but for a potential increased amount of samples.

b) Acquisition data availability: As provided in paragraph 8, above, Global Biologics is the only source that can provide these services that can meet the full extent of the requirement which include the TTP system that uses methodology protected under a pending patent which reduces downstream variability during genetic library constructions.

c) Unusual and compelling urgency: N/A

d) Subcontracting Opportunities: Global Biologics is a small business under NAICS code 541712 – Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology), with a size standard of 1,000 employees.

FOR OFFICIAL USE ONLY

In accordance with FAR 19.702(b) (1), a subcontracting plan is not required from small business concerns.

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11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief:

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief:

13. Fair and Reasonable Price Determination:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. Cost analysis will be performed to determine that costs are fair and reasonable. Certified cost or pricing data will not be required since this action is beneath the $750,000 threshold.

14. Procuring Contracting Officer Certification:

I certify that this justification is accurate to the best of my knowledge and belief.

Lynn Escalon Signature:

Research Biologist Date:

Lynn Escalon Signature:

Research Biologist Date:

Chelsea Whitten Signature:

Contracting Officer Date:

Chelsea Whitten Signature:

Contracting Officer Date:

ESCALON.BARBARA.

LYNN.1265437571

Digitally signed by

ESCALON.BARBARA.LYNN.1265437571

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=ESCALON.BARBARA.LYNN.1265437571 Date: 2016.07.21 20:38:54 -05'00'

ESCALON.BARBARA

.LYNN.1265437571

Digitally signed by

ESCALON.BARBARA.LYNN.1265437571

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=ESCALON.BARBARA.LYNN.1265437571 Date: 2016.07.21 20:39:21 -05'00'

WHITTEN.CHELSE

A.M.1139493768

Digitally signed by

WHITTEN.CHELSEA.M.1139493768

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=WHITTEN.CHELSEA.M.1139493768 Date: 2016.07.25 13:16:30 -05'00'

WHITTEN.CHELSEA.

M.1139493768

Digitally signed by

WHITTEN.CHELSEA.M.1139493768

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=WHITTEN.CHELSEA.M.1139493768 Date: 2016.07.25 13:16:58 -05'00'

FOR OFFICIAL USE ONLY

15. Approval:

Based on the foregoing justification, I hereby approve the procurement of genetic library construction services on an other than full and open competition basis pursuant to the authority of FAR 13.5(a), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Chelsea Whitten Signature:

Contracting Officer Date:

WHITTEN.CHELSEA.

M.1139493768

Digitally signed by

WHITTEN.CHELSEA.M.1139493768

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=WHITTEN.CHELSEA.M.1139493768 Date: 2016.07.25 13:17:23 -05'00'