A02. J&A_Final_Redacted.pdf

Control Number: JA-22-09-1243 CUI

(Source Selection information - See FAR 2.101 and 3.104-

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

Program/Equipment: The Uniformed Services University (USU) Infectious Disease Clinical Research Program (IDCRP) for the Development of Clinical Practice Guidelines to Support Care of Military-Relevant Infectious Diseases, requires the simultaneous execution of multiple interrelated observational and epidemiological protocols (located both within the Continental United States (CONUS) and Outside the Continental United States (OCONUS)).

Specifically the execution of each individual protocol requires clinical, epidemiological scientific/technical, laboratory, administrative, database management, quality assurance and logistical services.

Authority: 10 USC 2304(c)(1) as implemented in Federal Acquisition Regulation (FAR) 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

Amount: $4,018,159.00.

Prepared by:

Typed Name: Brandon Roebuck Phone: 301-619-7731

Title: Contract Specialist Date: 9 September 2022

E-mail: brandon.m.roebuck.civ@mail.mil

Contracting Officer:

Typed Name: Erin J. Maddox Phone: 410-417-0028

Date Reviewed: 9 September 2022 E-Mail: erin.j.maddox.civ@mail.mil

Technical Representative:

Typed Name: CDR Mark P. Simons Phone: 240-694-2961

Title: Interim Director, IDCRP Date Reviewed: 9 September 2022

Requirements Representative:

Typed Name: CDR Mark P. Simons Phone: 240-694-2961

Title: Interim Director, IDRCP Date Reviewed: 9 September 2022

Controlled by: USAMRAA Controlled by: FCMR-ACO-AB CUI Category: PROCURE Limited Dissemination Control: FED ONLY POC: Erin J. Maddox, (410) 417-0028

CUI

(Source Selection Information - See FAR 2.101 and 3.104-

Reviews

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

Legal Counsel:

Typed Nam

Signature:

(Source Selection Information - See FAR 2.101 and 3.104-4)

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 U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD, 21702.

2. Description of Action: USU requests the award of a Cost plus Fixed Fee (CPFF) contract for the simultaneous execution of multiple interrelated observational and epidemiological protocols (located both CONUS and OCONUS). Funding is 2022 National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research (DCR) funds.

3. Description of Supplies/Services: The award will be for the simultaneous execution of multiple interrelated observational and epidemiological protocols (located both CONUS and OCONUS).

The overall objectives for the protocols include:

a. To conduct multiple, simultaneous observational and epidemiological studies to address important issues integral to informing new and emerging clinical practice guidelines (CPGs) and clinical recommendations (CR), as well as, modifying or updating existing standards for several different infectious disease therapies.

b. To resolve high priority gaps for military operational infectious diseases and provide solutions (primarily knowledge products with evaluation and validation of some materiel solutions) to the DoD requirements-driven research management process.

c. Results of the protocols are capable of being leveraged to rapidly implement clinical studies that yield operationally oriented, clinically relevant, and timely knowledge for infectious disease threats to military forces.

Ten protocols will be executed under this award:

- IDCRP-000 NHS. A Retrospective and Prospective Observational Study of the Natural History of HIV Infection in Active-Duty U.S. Military Personnel and Department of Defense Beneficiaries, RV168.

- IDCRP-078 ALLHANDS. Evaluation of HIV-associated Neurocognitive Disorders (HAND) Among Military HIV-infected Subjects.

- IDCRP-091. A Cohort Study of Clinical Outcomes among Military HIV+ Beneficiaries and Stratified HIV- Controls (VCS).

- IDCRP-024: DoD-VA Trauma Infectious Disease Outcomes Study (TIDOS).

- IDCRP-079. Clinical Illness and Immunologic responses in Natural and Experimental Campylobacter jejuni Infection.

- IDCRP Concept (C0176). Leptospirosis risk associated with jungle warfare/operations training.

- IDCRP Concept (C0187). Skin & Soft-Tissue Infections (SSTI) Research Specimen and Data Repository and Analysis Project.

- IDCRP Concept (C0186): Epidemiology and Prevention of Acute Respiratory Infections at the US Naval Academy [Acute Respiratory Infections at the Academy (“ARIA”)].

- IDCRP Concept (CO190): Acute Respiratory Infection (ARI) Research Specimen and Data Repository Analysis and Analysis Project.

- IDCRP-037 (TravMil). Deployment and Travel Related Infectious Disease Risk Assessment, Outcomes, and Prevention Strategies among Department of Defense Beneficiaries.

All studies meet national and international regulatory requirements and have already obtained USU and local Institutional Review Board (IRB) approval.

Specifically the execution of each individual protocol requires clinical (examples: subject enrollment, clinical site preparation and biospecimen / data collection, etc.), scientific/technical (regulatory/human use), laboratory, epidemiological, administrative, database management, quality assurance and logistical services.

The award is considered non-severable. Benefit to the Government is only received when the protocols are completed and the contractor provides the final reports.

All of these interrelated observational and epidemiological protocols were previously executed under USU cooperative agreement (CA) HU00012120067 with the Henry M. Jackson Foundation.

Period of Performance: 25 September 2022 – 24 September 2023 Total Value: $4,018,159.00.

4. Authority Cited: 10 USC 2304(c)(1) as implemented in Federal Acquisition Regulation (FAR) 6.302- 1(a)(2)(iii)(B), services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in unacceptable delays in fulfilling the agency’s requirements.

5. Reason for Authority Cited: The required simultaneous execution of multiple observational and epidemiological protocols for USU is solely available from the source that held the previous CA with USU. The Henry M. Jackson Foundation is the only source that can provide the required services and award to any other source would result in unacceptable delays.

The observational and epidemiological protocols are already IRB approved (USU and local) and ongoing. The Personally Identifiable Information, medical records / history and data collected under each protocol is required to be kept confidential and secure. Due to the privacy nature of the subject level data, only individuals approved on the research protocol by the USUHS IRB are able to collect and access this study data.

To stop and restart the protocols with any other contractor requires the stoppage of the protocols to facilitate reinitiating the IRB approval process. This process could take up to 12 months – resulting in a potential 12 month data gap that the research would not be able to recover from. The continuity and validity of the data collected requires a constant observation and collection and analyzation of data from the protocol population. The results of all the protocols are severely (if not totally) degraded in their actual utility if the data is not continuous, because it is next to impossible to draw conclusions from the results of the protocol with any gap in data collection and observation. Without constant observation and collection of data from the protocol populations, it is impossible to be certain if the results are due to unknown events that occurred during the gap in observation and the collection of data and therefore the Government does not derive benefit from them.

Currently, the protocol populations are in place and research is ongoing. A potential 12 month hard stop to the research carries a high probability that that same population may not be in place in 12 months and would result in a loss of existing enrolled subjects in the follow-up phases of the respective studies. And as patient recruitment would be halted during this period, the Government would be unable to partially mitigate this issue as they would be unable to try and proactively recruit (during the stop) so that they could replace subjects lost due to the delay and at least be able to restart at full capacity, once the protocols were reapproved. In addition, there is up to 12 months where ongoing patient recruitment (for future phases of research) is stopped, which significantly impairs the ability of future phases of research to be conducted successfully.

The unacceptable delays caused by awarding this requirement to any source except the Henry M Jackson Foundation would injure the Government in multiple ways. First, any delay in the continuous and constant observation and collection of data from the protocol populations severely impacts the continuity and validity of past, current and future data and can require the studies to be restated from the beginning. Even if the Government could reacquire the funding, collaborating organizations and protocol populations to start these protocols from the beginning (which is far from certain), these delays and the requirements to restart research protocols would delay the results of these protocols and their potential benefits to the Department of Defense out for a period that far exceeds the period of the actual delay (measured in years). Furthermore these delays injure the reputation of USU and the required relationships between USU and the collaborating institutions that fund and provide access to protocol populations that USU requires to conduct the research. Timely delivery of milestones and deliverables to funding sponsors within cycle timelines is a critical aspect for IDCRP program execution and future research development and resourcing support by funding sponsors. Injury to these relationships not only impacts these protocols specifically, but can impact any current or future research protocols that USU and the partner organizations may collaborate on.

6. Efforts to Obtain Competition: Extensive market research to identify potential sources was completed by USU and USAMRAA to identify potential sources in the marketplace that could meet the Government’s requirement.

Please reference Section 8 of the subject J&A, for further discussion of market research.

A sources sought notice (SSN) was posted to the Government Point of Entry (GPE, SAM.gov) on 21 August 2022 for a period of 4 days. No responses to the sources sought notice were received.

The requirement was synopsized to the GPE (SAM.gov) via a notice of intent (NOI) on 25 August 2022 for a period of 15 days. No responses to the sources sought notice were received.

a. Effective competition. Market research has determined that restricting competition to the Henry M. Jackson Foundation, is the sole way to meet the Government’s requirement.

b. Subcontracting competition. Historical knowledge of the subject protocols suggests that a limited scope of subcontracting opportunities exist for this requirement. A minor amount of other direct costs are projected in the Independent Government Cost Estimate. Specific capabilities required under certain research protocols (e.g. specific laboratory or data analysis tools or capabilities, specimen collection and remote subject follow up services, database and/or technical service support) are projected. In these instances the prime contractor does not possess a specialized capability.

7. Actions to Increase Competition: The Government examined all possible strategies to increase competition before for the subject requirement. A SSN and NPI were posted to the GPE for 4 days and 15 days, respectively. No responses to the SSN or NOI were received.

8. Market Research: USU and USAMRAA conducted extensive market research to identify potential sources that could meet the Government’s requirement. Market research consisted of querying online search engines, attendance of scientific conferences, examination of historical contracts and discussions with key collaborators and trusted Government and academic contacts.

Market research through the totality of the above listed methods, suggest that various sources exist in the marketplace that can execute multiple research protocols. However, this is only relevant if the Government was soliciting to execute these protocols from the beginning. The subject requirement is not for the execution of multiple protocols at the starting stage but rather for the execution of 10 ongoing and interrelated observational and epidemiological protocols. Therefore, award of the subject requirement to any source except for the Henry M.

Jackson Foundation will result in unacceptable delays to the Government.

9. Interested Sources: To date, no other sources have written to express interest in the acquisition.

A SSN and NPI were posted to the GPE for 4 days and 15 days, respectively. No responses to the SSN or NOI were received.

10. Other Facts:

a. Procurement history.

USU Awarded CA to the Henry M. Jackson Foundation. Award Number: HU00012120067

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.

9 Sept 2022 Date:

Typed Name: CDR Mark P. Simons Title: Interim Director, Infectious Diseases Clinical Research Program

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.

9 Sept 2022

Typed Name: CDR Mark P. Simons Title: Interim Director, Infectious Diseases Clinical Research Program

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on adequate price competition and price analysis.

As a part of this basis, certified cost or pricing data will not be required and the following exception applies (FAR 15.403): A commercial item is being acquired.

Typed Name: Erin J. Maddox Title: Contracting Officer

14. Contracting Officer Certification:

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

Typed Name: Erin J. Maddox Title: Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement on an other than full and open competition basis pursuant to the authority of 10 USC 2304(c)(1) as implemented in FAR 6.302-1(a)(2) 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 prope

Sign

Typed Name Title: Command Advocate for Competition