Justification Promega FINAL REDACTED.pdf

Control No: JA-20-07-00136

Contractor: Promega Corporation

Program/Equipment: Forensic Reagents and Consumables

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment

The sole source procurement of customized forensic reagents and consumables for the identification of fallen U.S.

service members.

Authority 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Blanket Purchase Agreement (BPA) Ceiling Amount: $11,500,000.00

Prepared by: Christopher L. Cook DSN: 343-2640

Contract Specialist Date: 08/03/2020 christopher.l.cook68.civ@mail.mil

Contracting Officer: Courtney A. Piar DSN: 343-9166

Contracting Officer Date: 08/03/2020 courtney.a.piar.civ@mail.mil

Technical: Timothy P. McMahon, PhD DSN: 366-8910

Director DoD DNA Operations Date: 08/03/2020 timothy.p.mcmahon10.civ@mail.mil

Requirements: Michael A. Fasano DSN: 366-8807

Chief DNA Laboratory Services Date: 08/03/2020 michael.a.fasano4.civ@mail.mil

Reviews

I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Shairose A Lalani

DNA Program Manager

DSN: 366-8918

Signature:

Legal Counsel:

Dmitri G. Goubarkov

Acquisition Attorney

DSN: 343-0283

Signature:

mailto:christopher.l.cook68.civ@mail.mil mailto:courtney.a.piar.civ@mail.mil mailto:timothy.p.mcmahon10.civ@mail.mil mailto:michael.a.fasano4.civ@mail.mil

FAR Part 6 Justification and Approval for Other than

Full and Open Competition

1. Contracting Activity

The Contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820

Chandler Street, Fort Detrick, MD 21702-5014 in support of the Armed Forces Medical Examiner System’s – DoD

DNA Operations (AFMES-DNA Ops).

2. Description of Action

The requiring activity for this action is the Defense Health Agency (DHA), Armed Forces Medical Examiner System

(AFMES) requests a firm fixed price 5-year Blanket Purchase Agreement (BPA) for the purchase of customized

Reagents and Consumables manufactured by Promega Corporation. The Government projects award for September

2020 and will be obligated by issuance of delivery order(s) using Defense Health Program, Operations Maintenance

Army funds.).

This action is a replacement of the current BPA, W81XWH-15-A-0020.

3. Description of Supplies/Services

The required reagents and supplies (listed below) are used to support AFMES-DNA Ops mission of assisting AFMES and the Defense POW/MIA Accounting Agency (DPAA) with human remains DNA testing for the identification of

U.S. Service members as mandated under title 10 USC, chapter 75, 1471 and 10 USC, Chapter 76, 1501-1513;

NDAA 2010, Section 541 (d)(2) and DODI 5154.30. AFMES-DNAOPS requires reagents and supplies that provide optimal performance for the extraction, quantification and amplification of DNA from human remains. To minimize the potential for contamination by extraneous DNA, Promega reagents and consumables are made using Good

Laboratory Practice and Good Manufacturing Practice (GLP/GMP) process as well as following and being compliant with the International Organization for Standardization’s (ISO) ISO 18385 with minimizing the risk of human DNA contamination.

During proof of concept and development of the methods for the automated and manual extraction, quantification, amplification and analysis methods validated at AFMES-DNA Ops, the Promega reagents and consumables listed in this BPA were proven by the government to be: reproducible; robust; reliable from lot to lot; and free from human nuclear and mitochondrial DNA contamination. Vendors that produce contamination free, reproducible and reliable reagents are essential for processing forensic casework samples and meeting AFMES-DNA Ops mission requirements. Development, optimization and validation of the automated and manual extraction, quantification, amplification and analysis methodologies used to identify missing individuals were performed using the Promega reagents and consumables according to the ISO-17025 and Federal Bureau of Investigation - Quality Assurance

Standards for Forensic DNA Testing (FBI-QAS) standards. The Promega reagents and consumables have been validated and in use in a variety of forensically validated methods for the past 17 years and the AFMES-DNA Ops requires sustained ability to purchase these plates for ongoing mission requirements.

These reagents and supplies have been designed, previously optimized, and validated specifically for forensic laboratories; including equipment-specific for the various procedures of DNA identification. The reagents have been tested and are compatible for use with: Life Technologies Genetic analyzers Model 3500xl, Model 3730, and DNA thermocyclers Model 9700 and ProFlex; Promega Maxwell 16 Robotic platform; Beckman Coulter Biomek® FX robotic platform laboratory automation workstation; and Hamilton Robotics® STAR Line automated liquid handling workstations. The manufactures of the instruments above with regards to DNA Forensic testing provided a list of reagents that were developmentally validated for use on their instruments. Based on the compatibility of these reagents, AFMES DNA Operations following the Federal Bureau Investigations – Quality Assurance Standards (FBI-

QAS) and ISO-17025 DNA Forensic accreditation standards validated all the reagents and supplies listed below for use with these instruments. The FBI-QAS and ISO-17025 accreditation standard require a forensic laboratory to validate the platform, which consists of the reagents and instruments used to generate a DNA results. Competitor’s reagents although compatible with these instruments have not been validated by AFMES DoD DNA ops, and a new platform validation would take 9-12 months to perform at a significant cost to the government (see below)

Reagents Required under this BPA

DNA IQ™ System

The DNA IQ™ DNA purification system lyses DNA containing cells in the presence of Dithiothreitol and Proteinase

K; purifies DNA using a paramagnetic bead resin to remove DNA Polymerase-Chain-Reaction (PCR) inhibitors and contaminants; and delivers a consistent amount of purified DNA from a variety of forensic DNA sample types (i.e.

stains and liquid samples, buccal swabs, and blood stains on FTA® or other blood cards).

Tissue and Hair Extraction Kit

The Tissue and Hair Extraction Kit has been optimized to extract samples having higher protein content (i.e. hair and tissue) by using an extraction buffer that uses Proteinase K to lyse samples. The crude DNA extract from these samples is purified using the DNA IQ™ System.

Round Bottom Plate, 96 well format

Promega 1.2 mL round bottom plates were developmentally validated for use with the DNA IQ™ System in conjunction with the MagnaBot® 96 Magnetic Separation Device on automated DNA extraction platforms.

9948 Male Control DNA

A highly purified concentrated (~10 ng/µL) male positive control DNA with a known published mtDNA and short tandem repeat (STR) profiles that can be used during Polymerase-Chain-Reaction quality control and is compatible with analysis on the Applied Biosystems® 3130xl 3500xL Genetic Analyzers

DTT (DL-Dithiothreitol), Molecular Grade

DTT is a strong reducing agent that is included in both the DNA IQ™ and the Tissue and Hair extraction kits is an essential DNA extraction buffer component.

Lysis Buffer

A buffer solution developed solely for use with the Promega DNA IQ™ Systems.

DNA IQ™ Casework Pro Kit for Maxwell® 16

A kit designed for optimal DNA extraction from forensic casework samples on the Promega Maxwell® 16 Forensic automated extraction Instrument. This kit uses the same reagents as the DNA IQ™ System, but in a prefilled cartridge format.

CC5 Internal Lane Standard 500, 300µL

Defined Internal Lane Standard (ILS) fragments used with the PowerPlex 16, PowerPlex 16HS and PowerPlex

Fusion kits that are analyzed on the Applied Biosystems 3130xl and 3500 XL Genetic Analyzers. ILS fragments increase in size by 20-25 base pairs from 70 bp -500 bp

Plexor® HY System The Plexor® qPCR and qRT-PCR Systems are multiplex-capable real-time amplification systems using novel base pair chemistry. The Plexor® Systems work by measuring a reduction in fluorescent signal during amplification.

Plexor® Calibration Kit, set A

A calibration kit required for the proper use of the Promega Plexor® HY System on the Applied Biosystems 7500 real-time PCR system.

2800M Control DNA, custom kit

An alternate positive control DNA for the Promega brand PowerPlex® Systems. This control DNA allows for the use of only one control DNA for both autosomal and Y-STR analyses types of analyses.

The PowerPlex® fusion System (200rxn, 800rxn, and custom kit size)

A 24-locus multiplex for forensic human identification applications that allows for the co-amplification of the following loci CSF1PO, FGA, TH01, TPOX, vWA, D3S1358, D5S818, D7S820, D8S1179, D13S317, D16S539, D18S51 and D21S11, D10S1248, D22S1045, D2S441, D1S1656 and D12S391, Amelogenin, DYS391,Penta D, Penta E, D2S1338 and D19S433. This extended panel of STR markers is intended to satisfy both U.S and European

Forensic recommendations.

9947A Female Control DNA

A female positive control DNA validated for use with the Promega brand PowerPlex® STR analysis System.

PowerPlex® 5-Dye Matrix Standards This Matrix Standard is required for the Promega brand PowerPlex® and Fusion Systems to be properly analyzed on the Life Technologies 3130xl and 3500xl Genetic Analyzer.

Period of Performance: 25 September 2020 to 24 September 2025.

Total Value: $11,500,000.00

4. Authority Cited

10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited

The suggested source for this requirement is Promega Corporation, 2800 Woods Hollow Road, Madison, WI 53711-

5300. Promega Corporation is the sole manufacturer and reseller for the customized reagents and consumables. The

AFMES-DNA Ops is a forensic DNA testing laboratory that is accredited by the American Society of Laboratory

Directors to the International Organization Standards (ISO)-17025, American Society of Laboratory Directors/Lab-

International supplemental, and the Federal Bureau of Investigations (FBI) Quality Assurances Standards (QAS). All accredited laboratories are required to follow the FBI-QAS reagent, instrument, software validation requirements, prior to utilizing any reagents, instrumentation, and/or software for testing casework samples. Furthermore, forensic accreditation standards say that manufactures must demonstrate that the reagents and consumables sold are free of human contamination thorough the use of GLP/GMP process as well as being International Standard Organization -

18385 Forensic DNA grade accredited. Promega reagents and consumables are made using GLP/GMP process as well as following and being ISO 18385 compliant with minimizing the risk of human DNA contamination.

In accordance with the FBI-QAS and ISO-17025 accreditation requirements, the Promega reagents and supplies have been compared against other commercial equivalents; were deemed optimal for use with forensic samples typically processed at AFMES-DoD-DNA Ops in support of AFMES missions; and were then validated for use following accreditation standards. The Promega reagents listed herein have been validated for use with: Life Technologies

Genetic analyzers Model 3500xl, Model 3730, and DNA thermocyclers Model 9700 and ProFlex; Promega Maxwell

16 Robotic platform; Beckman Coulter Biomek® FX robotic platform laboratory automation workstation; and

Hamilton Robotics® STAR Line automated liquid handling workstations. Although, there are other commercially available kits or supplies, the use of these kits or supplies would require extensive validations prior to implementation. The FBI-QAS and ISO-17025 accreditation standards are very specific in that if a new kit, reagent or supply is introduced into a currently validated method, the laboratory must perform a performance check or re-validation depending on the nature of the change. In the case of having to introduce a different extraction, quantification and/or amplification kit never previously validated for AFMES-DNA Ops , the laboratory will have to perform a full validation. Failure to utilize the forensically validated Promega reagents and supplies will lead to work stoppage or mission delays and cause the government a significant amount of time and money to validate other commercial kits as well as retrofit or buy new instrumentation compatible with other commercially available kits.

Due to the time and effort put into the initial validation of the Promega reagents and consumables, it is not time or cost effective to switch to alternative reagents. Although there are comparable products in the market, Promega is the sole manufacturer of the PowerPlex Fusion (developed 2015), PowerPlex HY (developed 2007), and DNA IQ systems (developed 2004), reagents and consumables listed above. These reagents and consumables were specifically developed by Promega for DNA forensic testing and validated by AFMES-DoD-DNA Ops to work in conjunction with current validated instrumentation and accredited standard operating procedures. Instrumentation associated with the Promega reagents include the Life Technologies Genetic analyzers Model 3500xl, Model 3730, and DNA thermocyclers Model 9700 and ProFlex; Promega Maxwell 16 Robotic platform; Beckman Coulter Biomek® FX robotic platform laboratory automation workstation; and Hamilton Robotics® STAR Line automated liquid handling workstations.. Switching the reagents and consumables would require significant re-validations, the need to purchase new robotic platforms that are compatible with these alternative products, the need to pay for custom computer programing of AFMES-DNAOPS’s Laboratory Information System Analysis module, an in house developed LIMS system that currently is maintained by Future Technology Inc.

A cost analysis was conducted to determine the cost of validating and testing new reagents for AFMES-DNA Ops.

Validation of New Short Tandem Repeat amplification kits and DNA Extraction Systems would require 9-12

Months. This would require the time of three (3) DNA Analysts and the purchasing of new instrumentation prior to the validation, which could include alternate automated platforms, custom programing, additional thermal cyclers and other ancillary instruments. The validation will require initial product testing and comparisons, data analysis, and optimization to develop the final procedure. Once a final procedure has been developed the formal FBI-QAS validation will be initiated that requires sensitivity, reproducibility, mixture, precision, contamination and casework sample studies, data analysis, validation write-up, senior scientific staff review, Standard Operating Procedures

(SOP) generation, and Laboratory Information Management Systems (LIMS) system programing. Quality Control

(QC) technicians would require of 3-4 months training prior to actually doing the validation. The total time for training and validation period would be 12-15 months. After the validation, all certified scientist would need to be trained in the new chemistry in accordance with accreditation. There are currently over 98 scientists who are proficiency tested for extraction (DNA IQ), amplification (PowerPlex Fusion), and quantitation (Plexor HY).

Cost Estimate-Complete Validation/Testing of New Product to Replace Promega Products

Note: This is an example for a single STR kit with a 3500 XL instrument and consumables as well as a single extraction kit. The price would be greater since AFMES DoD DNA Ops would need to validate the 3730xl and the 3500xl as well for the STR kits

Timeframe: 9 - 12 months

Personnel

3 Forensic Analysts $ 160,000.00

Alternative STR Kit and Equipment Validation Supplies:

Analysis instrument is Life Technologies 3500xl with Promega Fusion STR kit

Reagents and consumables needed to validate different commercial kit.

a. 52 bottles of POP4 $ 21,116.16

b. 52 bottles of 10 X Running Buffer $ 4,642.56

c. 6- 36cm 16 capillary arrays $ 6,444.00

d. One spectral dye set $ 250.00

e. 100 optical plates $ 3,400.00

f. 100 plate septa $ 1,555.00

g. 100 buffer septa $ 860.00

h. Other Commercial STR kit (i.e. GlobalFiler-1000 rxn) $ 20,000.00

i. Other commercial Robotic Platforms $250,000.000

Alternative DNA Extraction Magnetic Bead Technology

a. 3 Magnetic bead systems (i.e. Life Tech PrepFiler) $ 1800.00

b. Compatible Robotic Platform $ 500,000.00

c. Loss of use of current robotic platforms $ 500,000.00

d. Custom programing for new robotic platform $ 120,000.00

e. 2 New small extraction robots (i.e Automate) $80,000.00

Re-Validation Total Cost (reagents, instruments, consumables) $ 1,670,067.72

Performance Check of remaining twelve 3500 XL instruments $25,000.00

This will be two forensic scientist working for 2 months running, analyzing and writing up the results and there will be limited reagent usage as performance checks only require two runs. Total cost for performance checks would be about 25,000.

Training of all staff. $600,912.00

Training of entire Staff and migration to new products would take an average of 3 months per

Scientist that dedicate approximately 160 hrs. of full time work toward this training. This would cost the government approximately $600,912.00 in salary alone to train 90 scientists according to accreditation standards. Training is completed while still performing normal work requirements to meet AFMES mission requirements.

Total cost of to bring new systems and training to Government: $2,295,979.72

Not having the capability to purchase Promega reagents would lead to mission stoppage at the Armed Forces Medical

Examiner System (AFMES), which will prevent the identification of deceased and missing service members from current day operations and previous conflicts. Currently, if a fallen service member cannot be identified by fingerprint and/or dental, DNA results are required to be provided to the AFMES in under 24 hours. This timeline serves two purposes, one is to bring closure to the families of our fallen heroes and the second to get recovery teams out of harm’s way faster, thus prevention potential deaths. Concurrently, for the past accounting mission under the

NDAA 2010 the past accounting community of which AFMES-DNA Ops is a part of, was congressionally mandated to build the capability and capacity to support 200 identifications. Without the use of the Promega reagents, AFMES-

DNA Ops will not be able to support the Defense POW/MIA Accounting Agency (DPAA) with making 200 or more identification per year. For the last 4 years, DNA has been the sole source or supported over 96% of all new identification for the DPAA.

AFMES-DNA Ops is an American Society of Crime Laboratory Directors-Laboratory Accreditation Board (ASCLD-

LAB), ISO/IEC 17025:2005 accredited forensic lab, which means the FBI's Quality Assurance Document is followed. Based on accreditation adherence (Volume III of the Quality Manual and the FBI's Quality Assurance

Surveillance (QAS) document), all reagents and equipment must be developmentally validated by the manufacturer and internally validated by the laboratory as well as pass a stringent quality control before being released for casework. Developmental validation is costly and AFMES-DNA Ops does not possess the resources to carry out a developmental validation in order to change instrumentation or reagents.

Further, AFMES' mission requires consistency and standardization of testing to accomplish its overall mission and to maintain credibility, therefore, accuracy is critical to AFMES' mission. Commercial kits are used by forensic laboratories to make human identification possible through the use of DNA profiling. Commercial kits make use of standardized combinations of short tandem repeat loci (sequences of genetic material, also known as STR) in specific types of polymerase chain reactions (also known as PCR technology), which results in human identifications made with an extremely high degree of certainty. By using commercial kits with PCR technology, DNA profiles can be generated from exceedingly small, very old, badly preserved, or partially decomposed samples. Vital to the DNA identification mission is the need for reproducible and accurate test results with no lot-to-lot variability as determined through extensive internal validation studies. The sequencing, typing, amplification, quantitation, and other stages of the DNA identification process are performed using reagents compatible with the specific analysis laboratory equipment/instruments.

6. Efforts to Obtain Competition

Not applicable. No effort will be made to solicit other products since Promega Corporation is the only manufacturer and only responsible source capable of providing the supplies and reagents for this requirement.

a. Effective competition: No Effective competition is anticipated. There is only one source capable of performing the required service.

b. Subcontracting competition: Not Applicable: There is only one source capable of performing the required service.

7. Actions to Increase Competition

The Government will continue to survey the market place to identify ISO 18385 accredited and compliant companies that are providing next generation DNA forensic extraction, quantification, and amplification reagents that meet

GLP/GMP processing standards. New proof of concept projects utilizing next generation reagents will allow for competition among companies capable of meeting the Government’s requirements. .

The previous Blanket Purchase Agreement (W81XWH-15-A-0020), was not competed under authority 10 U.S.C.

2304(c) (1), FAR 6.302-1. The Government will continue to survey the market place to see if there are any other companies that are capable of providing the required customized reagents and consumables required for future

AFMES-DNAOPS research.

8. Market Research

Prior to the decision to implement a product into the laboratory at AFMES-DNA Ops, extensive studies are performed to determine which product possesses the desired properties. The AFMES-DNA Ops is a forensic DNA testing laboratory that is accredited by the American Society of Laboratory Directors to the International

Organization Standards (ISO)-17025, American Society of Laboratory Directors/Lab-International supplemental, and the Federal Bureau of Investigations (FBI) Quality Assurances Standards (QAS). All accredited laboratories are required to follow the FBI-QAS reagent, instrument, software validation requirements, prior to utilizing any reagents, instrumentation, and/or software for testing casework samples. In accordance with these requirements, the Promega reagents and supplies have been compared against other commercial equivalents; were deemed optimal for use with samples typically processed at AFMES-DNA Ops in support of AFMES missions; and were then validated for use following accreditation standards. The Promega reagents listed in this source requirement have been validated for use with: Life Technologies Genetic analyzers Model 3500xl, Model 3730, and DNA thermocyclers Model 9700;

Promega Maxwell 16 Robotic platform; Beckman Coulter Biomek® FX and the Hamilton Robotics® STAR Line automated liquid handling workstations. Although, there are other commercially available kits or supplies, the use of these kits or supplies would require extensive validations prior to implementation. The accreditation standards are very specific in that if a new kit, reagent or supply is introduced into a currently validated method, the laboratory must perform a performance check or re-validation. Failure to utilize the forensically validated Promega reagents and supplies will lead to work stoppage or mission delays and cause the government a significant amount of time and money to validate other commercial kits as well as retrofit or buy new instrumentation compatible with other commercially available kits. There are two other companies in the market place that manufacture forensic STR kits, Life Technologies and Qiagen. The customer contacted both companies back in March 2015 to see if they are able to provide the required reagents and consumables for all the required Systems used by AFMES-DNA Ops. Both companies responded that they cannot supply the required reagents and consumables for the DNA IQ System or the

PowerPlex Fusion System that is used by AFMES-DNA Ops.

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-

1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information was posted to

Federal Business Opportunities (FBO) on 28 April 2020 for fifteen (15) days and the results were only one response received (Promega Corporation).

9. Interested Sources

To date, no other sources have written to express interest in the acquisition

10. Other Facts

a. Procurement History:

(1) Contract Numbers and dates of the last several contracts for these same requirements: Current contract is a

BPA W81XWH-15-A-0020 awarded for 5 yrs. The customer contacted Life Technologies and QIAGEN back in March 2015 to see if they are able to provide all of the reagents and consumables forensically validated by AFMES-DNA Ops and required under this BPA. Both companies responded that they could not supply the required reagents and consumables required under this BPA. Life Technologies and QIAGEN companies were again contacted in Aug 2020 and asked if they could provide the reagents and consumables required under this BPA and both companies responded that they could not supply the required reagents and consumables. A sole source Indefinite Delivery Requirements Contract number W81XWH-12-D-0016 was awarded on 01 Apr 2012 for 3-years, which expired on 31 March 2015 to Promega Corporation under

USAMRAA Log No. 12-013. Prior to that, in December 2006, Contract number W81XWH-07-D-0003 was awarded for a 5-year sole source requirements contract to Promega under USAMRAA Log No. 07-012, 21.No other sources were available during this time and the nature of the mission has not changed.

(2) Competitive status of these actions. Sole Source Procurement

(3) Authority previously used for less than full and open competition. The statutory authority permitting Other

Than Full and Open Competition is 10 United States Code 2304(c)(1) as implemented in Federal

Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. The previous justification was the same as this request. The justification was accepted and the products were purchase from Promega.

(5) If any prior award was accomplished by full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Not Applicable. All previous awards were awarded as sole source.

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys. Not Applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes.

Promega Corporation is the sole manufacturer and distributor of the requested kits. There has been no change in AFMES-DNA Ops mission.

b. Class J&A: This Class J&A will cover all future actions for these items/services (as appropriate). Each action will be supported by a memorandum for record stating the action is within the scope of the class J&A in each contract file.

c. Discuss any other facts that should be addressed to support this action: N/A

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.

Typed Name: Timothy P. McMahon Date:

Title: Director DoD DNA Operations Signature:

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.

Typed Name: Michael A. Fasano Date:

Title: Chief DNA Laboratory Services Signature:

13. Fair and Reasonable Cost Determination

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: ☐ cost analysis ☒ price analysis ☐ should cost ☐ IGCE

☐ audit: ☐ other:

As a part of this basis, certified cost or pricing data:

☐ will be required.

☒ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☒ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI

215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Typed Name: Courtney A. Piar Date: 08/03/2020

Title: Contracting Officer Signature:

14. Contracting Officer Certification

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

Typed Name: Courtney A. Piar Date: 08/03/2020

Title: Contracting Officer Signature:

Approval Based on the foregoing justification, I hereby approve the procurement of Customized Reagents and Consumables on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C.

1901 as implemented by FAR 6.302-1, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: Erin K. Cross Date:

Title: Command Advocate for Competition Signature: