REDACTED JA - Arbovirus_Epidemiological_Studies_in_Southern_Thailand.pdf

Control Number: JA-21-05-00330 CUI

(Source Selection information - See FAR 2.101 and 3.104-4) Page 1 Mar 2021

Justification Review Document for Other than Full and Open Competition - FAR Part 6

Program/Equipment: Arbovirus Epidemiological Studies in Southern Thailand

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; (a)(iii)(B) Unacceptable Delays

Amount: $2,592,653.61

Prepared by:

Typed Name: LTC Anthony R. Jones DSN: N/A

Title: Director, Virology Laboratory Date: 29 July 2021

Email: anthony.jones.mil@afrims.org

Contracting Officer:

Typed Name: Laura A. Tomitz DSN: 285-2051

Date Reviewed: 6 Aug 2021 Email: laura.a.tomitz.civ@mail.mil

Technical Representative:

Typed Name: LTC Anthony R. Jones

Title: Director, Virology Laboratory

DSN: N/A

Date Reviewed: 29 July 2021

Requirements Representative:

Typed Name: LTC Anthony R. Jones

Title: Director, Virology Laboratory

DSN: N/A

Date Reviewed: 29 July 2021 mailto:anthony.jones.mil@afrims.org mailto:laura.a.tomitz.civ@mail.mil

Arbovirus Epidemiological Studies in Southern Thailand with the Songklanagarind Hospital

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Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Typed Name: Dmitri Goubarkov DSN: (312) 343-0283

Signature:

GOUBARKOV.DMITRI.GE

NNADIEVI.1399740513

Digitally signed by

GOUBARKOV.DMITRI.GENNADIEVI.13

99740513 Date: 2021.08.12 09:11:44 -04'00'

Date:

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Justification and Approval for Other than Full and Open Competition – FAR Part 6

1. Contracting Activity: The Contracting Activity responsible for this action is the United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Maryland on behalf of the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand.

2. Description of Action: AFRIMS, Walter Reed Army Institute of Research (WRAIR) requests a firm-fixed-price contract with The Songklanagarind Hospital (Prince of Songkla University[PSU] Hospital), Bangkok, Thailand. The Government projects award in September 2021 using fiscal year 2021/2022 2-Year Research, Development, Test and Evaluation funds. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B). This action is a new contract.

3. Description of Supplies/Services: This requirement is for research services associated with scientific/technical, clinical, epidemiological, laboratory, database management, and quality assurance support required by biomedical, clinical and surveillance studies and projects being conducted in Southern Thailand. The contractor shall lead the clinical execution of a Chikungunya (an arbovirus) epidemiology in the province of Songkla, a site with evidence of previous Chikungunya outbreak. In the execution of this study, the contractor will screen, enroll and consent approximately 5,000 subjects in accordance with an AFIRMS, WRAIR and local Institutional Review Board (IRB)-approved study protocols for newly WRAIR Human Subjects Protection Branch (HSPB)-approved WRAIR #2869 (CHIKVSOUTH). The contractor will execute active surveillance of all subjects, and collect bio- samples and clinical and, demographic data for the duration of the approved study. Supported studies and projects include surveillance and epidemiology of arboviruses and respiratory viruses in Southern Thailand, clinical trials of vaccines or therapeutic, clinical validation of diagnostic devices.

AFRIMS mission is, in part, to provide data on circulating viral pathogens in South East (SE) Asia and to support the development of vaccines/therapeutics (a US Army medical development priority) against these pathogens. The lack of clear, predictable Chikungunya epidemiology data in SE Asia deters commercial Chikungunya vaccine developers from investing in costly efficacy trials. Songkla, Thailand, represents the first opportunity to demonstrate clear and predictable Chikungunya data, capable of sustaining future Chikungunya vaccine efficacy trials, and thereby, accelerating the development of a badly needed vaccine.

Base Period: 01 September 2021 to 31 August 2022 Value: $466,993.33 Option Period 1: 01 September 2022 to 31 August 2023 Value: $468,955.33 Option Period 2: 01 September 2023 to 31 August 2024 Value: $470,966.38 Option Period 3: 01 September 2024 to 31 August 2025 Value: $473,027.71 Option Period 4: 01 September 2025 to 31 August 2026 Value: $475,140.33

FAR 52.217-8 Option: 01 September 2026 to 28 February 2026 Value: $237,570.28 Total: $2,592,653.61

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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: PSU Hospital is the only hospital capable of conducting

WRAIR #2869 (CHIKVSOUTH) study as it is a spin-off of PSU / AFIRMS IRB-approved protocols through the ongoing WRAIR#1934 study, which is a separate and distinct study.

The new study, WRAIR #2869, does not duplicate the effort of WRAIR #1934 under contract W81XWH-19-P-0153, but furthers the scientific advancement and analysis of the data collected under WRAIR #1934 into the new WRAIR #2869 study parameters. The newly HSPB-approved WRAIR #2869 will document Chikungunya disease burden, incidence, transmission, and persistence in southern Thailand and further the data collection, analysis, and scientific studies/parameters separately from the prior study, WRAIR #1934.

WRAIR #2869 is a new, separate and independent study to be executed under this new contract and will close the Chikungunya epidemiology gaps left by WRAIR #1934 study protocol. WRAIR #2869 can only take place in Songkla. Further, it requires a very large enrollment of subjects (approximately 5,000 subjects) under the medical auspices and patient regulatory oversight of the PSU Hospital. Additionally, this new study (WRAIR #2869) reflects the partnership of AFIRMS/WRAIR and the Thai government for the continued biomedical, clinical and surveillance study support.

The IRB approval process for these studies can take over a year from start to finish. IRB-approved study, WRAIR #1934, was awarded a contract in 2019. This study, which focused on the circulation of various arboviruses (Chikungunya, Dengue and Zika viruses) in humans in Songkla, produced additional scientific questions. The IRB approved the next focus which required an expansion of the scientific endeavor into WRAIR #2869. A new contractor, other than PSU, would require a complete restart of the study protocols through the IRB process, to include a retraining of the medical research team that would negate all the prior data compilation, and years of study and assessment. As this contract for WRAIR #2869 builds on the data and lessons of WRAIR #1934, there are three years of data plus the IRB approval process that would be required to begin again. This duplication of effort would, at a minimum cost $958,993, or the total cost of the prior award and, at least, the first year of this contemplated award.

6. Efforts to Obtain Competition. A Request for Information (RFI) was posted to

SAM.GOV on 23 March 2021 to announce the Government’s requirement for these services. Two capability statements were received from this announcement: Othello International Co., and PSU Hospital. The Contracting Officer’s Representative (COR) reviewed the capability statements for each, and found PSU to be capable of supporting this requirement. The COR found Othello’s capabilities statements

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unacceptable, as their submission did not address their ability to conduct surveillance studies of hospitalized patients, methods of epidemiology of arboviruses, experience executing studies in Southern Thailand, or ability obtaining regulatory approval in Thailand IRBs. To date, no other sources have written to express an interest in the requirement.

a. Effective Competition: PSU Hospital, given its location, size, experience conducting research and its experience in partnership with AFRIMS and the Thai government, is the only one capable of meeting the study execution, full enrollment, active surveillance and data/sample collection requirement in a way that meets United States and local regulatory requirements as noted in the approve study.

b. Subcontracting Competition: Subcontracting efforts are unlikely as these services reflect IRB-approved protocols to the named entity, PSU. Should any , subcontracting opportunities arise, the COR, the Contracting Officer, and the contractor will assess at that point.

7. Actions to Increase Competition: There are no planned actions to increase competition for this requirement. PSU Hospital is the only source with the capabilities and access to the surveillance study data and populations necessary to conduct the current study, and they are the only contractor that is within the region of the disease endemicity. They are also the only contractor that is IRB-approved for the noted protocols.

8. Market Research: A Request for Information (RFI) was posted to SAM.GOV on 23 March

2021 to announce the Government’s requirement for these services and to find additional potential contractors. The Market Research from the Requiring Activity, completed 25 June 2021, indicated that due to the IRB-approved and international approvals received for PSU, only PSU could provide these protocol services.

9. Interested Sources: In accordance with FAR 5.201, a notice was published on 26 April

2021 on SAM.GOV announcing the Government’s intent to award a sole source contract to PSU Hospital on a non-competitive basis for 15 calendar days. To date, no other sources have written to express an interest.

10. Other Facts:

a. Procurement History:

(1) Contract: W81XWH-19-P-0153, base of 12 months through September 2024. Total value $492,000, covering WRAIR #1934, “Laboratory Analysis of Febrile and Vector- Borne Illnesses and Respiratory Pathogen Surveillance in Southern Thailand”.

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WRAIR #1934 is a limited scope, limited parameters surveillance study that does not include or duplicate the study parameters of WRAIR # 2869. WRAIR #1934 only detects and reports on the circulation of various arboviruses (Chikungunya, Dengue and Zika viruses) in humans in Songkla. WRAIR#1934 is limited in scope and lacks the ability to provide accurate Chikungunya incidence. WRAIR#1934 documents Chikungunya circulation in Songkla and not its incidence and other important

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epidemiological features. However, WRAIR#1934 has generated unique data that documents the Chikungunya circulation in Songkla that has no parallel in Thailand.

The study has been unique in that it provided the clinical research team with the experience and capabilities necessary to execute more complex studies, such as the study parameters of WRAIR #2869 which will assess and document Chikungunya disease burden, incidence, transmission, and persistence in southern Thailand.

(2) The competitive status of these actions. This was an “other than full and open competition” contract.

(3) Authority previously cited if less than full and open competition was used. The Statutory authority permitting other than full and open competition was 10 U.S.C.

2304(c)(1). The FAR citation was 6.302-1(a) only one responsible source and no other supplies or services would 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. Actions to increase competition are not possible since the proposed Vendor, PSU Hospital, is the only one capable of meeting the requirement. No steps can be taken to increase competition as a result of PSU Hospital is the only source with access to the surveillance study data.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

Not applicable

(6) An explanation of any unusual patterns that 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 procurement and whether there have been any significant changes.

There have been no significant changes

b. Other facts. Not applicable.

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.

JONES.ANTHONY.R.

1060176619

JONES.ANTHONY.R.1060176619

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=JONES.ANTHONY.R.1060176619 Date: 29 July 2021

Date: 2021.07.29 07:51:32 -04'00'

Typed Name: LTC Anthony R. Jones Title: Director, Virology Laboratory

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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.

LTC Anthony R. Jones Title: Director, Virology Laboratory

Signature: JONES.ANTHONY.

R.1060176619

Digitally signed by JONES.ANTHONY.R.1060176619 Date: 29 July 2021 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=JONES.ANTHONY.R.1060176619 Date: 2021.07.29 07:52:15 -04'00'

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TOMITZ.LAURA.A.1016349271

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 X price analysis ☒ IGE ☐ audit: N/A ☐ other: N/A

As a part of this basis, certified cost or pricing data is not required because the services being acquired are considered commercial.

Signature: DDigaittaelly: signed by TOMITZ.LAURA.A.1016349271

Date: 2021.08.05 16:28:40 -04'00'

Typed Name: Laura A. Tomitz Title: Contracting Officer

14. Contracting Officer Certification:

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

TOMITZ.LAURA.A.1016349271DaTtOeM: ITZ.LAURA.A.1016349271 Date: 2021.08.05 16:28:58 -04'00'

Typed Name: Laura A. Tomitz Title: Contracting Officer

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Approval

Based on the foregoing justification, I hereby approve the procurement of Arbovirus Epidemiological Studies in Southern Thailand to PSU Hospital for a total of $2,592,653.61 on an other than full and open competition basis pursuant to the authority of 10 U.S.C.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", subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

SHERMAN.C Digitally signed by

SHERMAN.CHRIST

OPHER.E.12306887 Date:

.E.12306887

Date: 2021.08.25 15:49:05 -04'00'

Typed Name: Christopher E. Sherman Title: Command Advocate for Competition

HRISTOPHER