JA for Sole Source-75N95020D00014_Redacted.pdf

Justification and Approval for Sole Source

“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.

Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse, Office of Acquisition

b. Sponsoring organization.

National Institute on Aging Center for Alzheimer’s and Related Dementias (CARD)

c. Project Officer information.

Project Officer name:

Mailing address:

Biomedical Research Center 251 Bayview Boulevard Baltimore, MD 21224-6825 E-mail address:

Telephone number:

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

a. Acquisition purpose and objectives. The purpose of this action is to modify an indefinite delivery, indefinite quantity (IDIQ) contract to increase the maximum dollar amount of services the Government will acquire under this contract by $3,089,437.25 from $15,506,205.00 to $18,595,642.25 during the five (5) year ordering period from 08/24/2020 to 08/23/2025; there are no other changes. This contract was awarded under Solicitation No. 75N95020R00030. The IDIQ contract number is 75N95020D00014. This contract was awarded to provide the National Institute on Aging (NIA) with Neurodegenerative Disease Scientific Data Science and Technology Consulting Services.

b. Project background. This contract provides scientific data support in relation to neurodegenerative disease research. It includes providing general analytics support, guidance, and training, the development of analytics tools/pipelines and the application of these tools/pipelines, and the management of analytic ecosystems and analytics projects. To date $13,052,180 has been ordered and obligated as follows:

• Task Order: 75N95020F00001

Title: Neurodegenerative Disease Scientific Data Consulting Services Period of Performance: 08/24/2020 to 08/23/2021 Obligated Amount:

• Task Order: 75N95021F00001 Title: Scientific data consultant services Period of Performance: 01/11/2021 to 01/10/2022

• Task Order: 75N95021F00002

Title: Scientific data consultant services Period of Performance: 02/01/2021 to 01/31/2022

• Task Order: 75N95021F00003

Title: Neurodegenerative Disease Scientific Data Consulting Services Period of Performance: 08/24/2021 to 08/23/2022

• Task Order: 75N95022F00001

Period of Performance: 08/24/2022 to 08/23/2023

• Task Order: 75N95023F00001

Period of Performance: 08/24/2023 to 08/23/2024

• Task Order: 75N95023F00002

Title: Scientific data and technology consulting support services to support Clinical Research Informatics Strategic Planning Initiative (CRISPI) Period of Performance: 09/18/2023 to 09/17/2024 Obligated Amount:

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

a. Project title. Scientific data consulting services related to neurodegenerative diseases.

b. Project description.

This requirement is for scientific data support in relation to neurodegenerative disease research. It includes providing general analytics support, guidance, and training, the development of analytics tools/pipelines and the application of these tools/pipelines, and the management of analytic ecosystems and analytics projects.

• 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): Modification to IDIQ contract to increase the maximum dollar amount of services the Government will acquire under this contract.

• 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.

Proposed bilateral modification to IDIQ contract to increase the contract ceiling:

Modification No. P00005 to Contract No. 75N95020D00014

c. Total estimated dollar value and performance/delivery period.

Contract Ceiling: Maximum ceiling amount is increased by $3,089,437.25 from $15,506,205.00 to $18,595,642.25.

Ordering Period: 08/24/2020 - 08/23/2025 (Unchanged)

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.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

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.

DATACONSULT-IO LLC

1275 25TH STREET NORTHWEST, SUITE 805

WASHINGTON DC 20037-1196

b. Nature of the acquisition and proposed unique qualifications of the contractor.

The estimated cost impact should the ceiling not be increased is $4,130,000, as described below.

The DATACONSULT-IO LLC has been core to the functioning of CARD. The resources and relationships they have built underlie almost every project at CARD.

From laboratory assistance with bioinformatics pipelines to generate data, to innovative data harmonization tools to building and leading international collaborations, this team is fundamental to CARD's further existence. An outline of high-profile projects that would be impacted by a potential work stoppage or contractor switch includes but is not limited to:

- Modifiable risk factors for ADRD across diverse biobanks. This project would cease to exist as it leverages team dynamics, code and program defining efforts coordinated internationally by the contractor. It is likely another contractor would be unable to cultivate these same relationships as the current service provider and the project would be delayed indefinitely if able to be restarted at all. Estimates of just coding time would be full time 6 months from 5 or more junior to mid-level scientists, having a significant budgetary and time impact at a minimum of in labor costs.

- Genetic modifiers of APOE4. This project, with its complicated federated data structure and strict GDPR data brokerage aspects (contractor is a certified GDPR broker which is rare in the US) in addition to high throughput biostatistics coding would likely be delayed indefinitely if able to be restarted at all. Estimates of just coding time would be full time 6 months or more from 3 or more junior to mid-level scientists having an additional significant budgetary impact of minimum labor costs in addition to time delays on an already multi-year collaboration.

- Knowledge transfer platforms for therapeutic targets and CRISPR screens.

This project is a complex mix of statistical inferences and platform development for knowledge synthesis and knowledge transfer. These are specialized skill sets and difficult to hire for. Across all related projects such as CRISPRBrain, OmicSynth and CARD.AI estimates of just coding time would be full time 18 months or more from 6 or more junior to senior level scientists having a significant budgetary impact and time impact of minimum in labor costs, as well as not having a maintenance and upkeep team for the platforms.

- Brain Atlas Single Nucleus and Long Read Sequencing. At the moment, without this contractor, these projects would fail due to data processing backlogs. While not hugely specialized work, the delays caused by a lack of data reduction and post-processing as well as cloud-based data management, NIH would accrue excess storage costs in the hundreds of thousands of dollars per month without the current contractor if work was to stop for a prolonged time measurable on the order of months or a quarter. The minimum estimate for compute and excess storage is $150,000 in labor costs and in compute and storage backlog costs per quarter based on previous benchmarking. Much of this contractor's work is using its institutional knowledge to optimize computational and storage workflows from NIH's Biowulf to the cloud that are rapidly changing as CARD's mission develops.

Market Research included: Publishing a synopsis of proposed contract action to negotiate and award an increase to this IDIQ contract ceiling at Sam.gov on June 5, 2024. No responses were received to the Sam.gov notice.

9. Any other facts supporting the use of other than full and open competition.

The estimated cost impact should the ceiling not be increased is , as described below.

The DATACONSULT-IO LLC has been core to the functioning of CARD. The resources and relationships they have built underlie almost every project at CARD. From laboratory assistance with bioinformatics pipelines to generate data, to innovative data harmonization tools to building and leading international collaborations, this team is fundamental to CARD's further existence. An outline of high-profile projects that would be impacted by a potential work stoppage or contractor switch includes but is not limited to:

- Modifiable risk factors for ADRD across diverse biobanks. This project would cease to exist as it leverages team dynamics, code and program defining efforts coordinated internationally by the contractor. It is likely another contractor would be unable to cultivate these same relationships as the current service provider and the project would be delayed indefinitely if able to be restarted at all. Estimates of just coding time would be full time 6 months from 5 or more junior to mid-level scientists, having a significant budgetary and time impact at a minimum of in labor costs.

- Genetic modifiers of APOE4. This project, with its complicated federated data structure and strict GDPR data brokerage aspects (contractor is a certified GDPR broker which is rare in the US) in addition to high throughput biostatistics coding would likely be delayed indefinitely if able to be restarted at all. Estimates of just coding time would be full time 6 months or more from 3 or more junior to mid-level scientists having an additional significant budgetary impact of minimum labor costs in addition to time delays on an already multi-year collaboration.

- Knowledge transfer platforms for therapeutic targets and CRISPR screens. This project is a complex mix of statistical inferences and platform development for knowledge synthesis and knowledge transfer. These are specialized skill sets and difficult to hire for. Across all related projects such as CRISPRBrain, OmicSynth and CARD.AI estimates of just coding time would be full time 18 months or more from 6 or more junior to senior level scientists having a significant budgetary impact and time impact of minimum in labor costs, as well as not having a maintenance and upkeep team for the platforms.

- Brain Atlas Single Nucleus and Long Read Sequencing. At the moment, without this contractor, these projects would fail due to data processing backlogs. While not hugely specialized work, the delays caused by a lack of data reduction and post-processing as well as cloud-based data management, NIH would accrue excess storage costs in the hundreds of thousands of dollars per month without the current contractor if work was to stop for a prolonged time measurable on the order of months or a quarter.

The minimum estimate for compute and excess storage is in labor costs and in compute and storage backlog costs per quarter based on previous benchmarking. Much of this contractor's work is using its institutional knowledge to

Official Name & Title Signature Date

Head of the Sponsoring Program Office

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official

Contracting

Officer

Name & Title Signature Date

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official

Chief of the Contracting Office

Head of the Contracting Activity

Name & Title

15. Competition Advocate signature.

Official

Competition Advocate

Name & Title

Signature Date

Signature Date