NIDA_JA_P00002_STSS_12-14-2021_NCATS_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.

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

b. Sponsoring organization.

Department of Health and Human Services National Institutes of Health National Center for Advancing Translational Sciences

c. Project Officer information.

Sam Michael CIO and Chief, Information Technology Resources Branch (ITRB) National Center for Advancing Translational Sciences 9800 Medical Center Drive Rockville, MD 20850

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

a. Acquisition purpose and objectives.

The National Center for Advancing Translational Sciences (NCATS) plans to modify the NCATS Scientific and Technology Support Services (STSS) contract with Axle Informatics, LLC, Contract number 75N95021D00001.

STSS was awarded on 2/26/2021 with an ordering period of 3/1/2021 to 2/28/2023 (2 years) and a contract ceiling/maximum of $49.9 million.

STSS is an indefinite delivery, indefinite quantity (IDIQ) contract under FAR 16.504, competitively awarded as a women-owned small business (WOSB) set aside under FAR subpart 6.2.

Due to substantial growth of NCATS programmatic needs as well as being tasked with extensive support for various COVID-19 emergency response initiatives, none of which were anticipated at the time this contract was planned, the contract ceiling will be exhausted well before the ordering period end date. An increase to the contract maximum is critical to avoid a lapse in services and preserve the continuity and integrity of the ongoing programs.

The rapid growth of critical services since just February 2021 were not reasonably foreseeable at the time the initial contract was awarded, and this modification is necessary to ensure continuity of services, pending an award of a competitive follow-on contract. Upon recognizing the accelerated ceiling utilization, NCATS escalated its acquisition planning, but is projecting a problematic gap in critical services. The tasks performed under this contact are running approximately $1.1 million in contractor support per week. Even under the most accelerated procurement timeline and upon examining other contract alternatives, a ceiling increase is needed to avoid unacceptable delays in fulfilling the agency�s requirements.

In accordance with FAR 6.302-1, there is only one (1) responsible source, and no other supplies or services will satisfy agency requirements.

Additionally, any delay in the award of this contract modification will delay the development of drugs and other treatments, and otherwise cause serious injury to public health

This modification seeks to raise the maximum dollar amount of services the Government may acquire under this IDIQ contract by $50.0 million from $49.9 million to $99.9 million. This modification will make funding available for the minimal amount of time needed to permit the follow-on competitive award to be awarded.

b. Project background

NCATS engages in extensive intramural and extramural collaboration as it works to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

NCATS is at the forefront of automated biomedical experimentation, replacing hours of time-consuming basic laboratory work with systems and robots capable of conducting experiments with a fraction of the resources. This technology can both cut costs and increase productivity, which acts as a multiplier effect on research efficiency and raw output.

As described in the NCATS STSS Statement of Work (attached), requirements include essential support for the laboratories, automation efforts, equipment, cheminformatics, bioinformatics, computational chemistry and biology, scientific systems programming and research data management, scientific cloud computing services and engineering support, and scientific research support.

For instance, high throughput screening systems are used as part of the drug discovery process to support the intramural research program and entail SOW task areas supporting laboratory management, laboratory automation, cheminformatics and computational chemistry, scientific systems programming, and scientific research support.

Another example includes tasks on cloud-based data analytics platforms to support extramural clinical informatics initiatives. The Contractor is required in accordance with the contract SOW task areas to support cloud computing services and engineering, bio- and cheminformatics, and research data management.

As such, these systems act as the foundation for key collaborative initiatives and are critical to NCATS� mission, providing access to tools to drive scientific innovation for thousands of Government and non- Government users around the country.

Additionally, NCATS has been tasked with extensive support for various COVID-19 emergency response initiatives, none of which were anticipated at the time this contract was planned, but its usage was critical to NCATS ability to rapidly respond to the pandemic.

The additional ceiling is needed to continue working on, supporting existing and essential tasks, specifically:

Creation and support for the National COVID Cohort Collaborative (N3C), a collaboration between NCATS and the National Center for Data to Health (CD2H);

Creation and support for the COVID Digital Pathology Repository, a collaboration among NCATS, NCI, and NIH;

Support for the RECOVER initiative;

Creation and support for the NCATS OpenData Portal;

Support for the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership;

Support for the NIH Serosurvey;

Support for the Antiviral Program for Pandemics, to include automation, compound management (including the generation, curation and storage of a large anti-viral screening library), scientific service desk support, high performance computing (HPC), and other tasks.

All these programs are novel and have been initiated since the original award of the STSS contract, causing the contract to greatly outpace the spending levels anticipated due to a substantial increase in work. The work to date has been critical to the overall success of NIH responding to COVID-19 pandemic.

c. Contractual background.

Contract number 75N95021D00001 was awarded on 2/28/2021 with an ordering period of 3/1/2021 � 2/28/2023 (2 years). The contract was competitively awarded as a WOSB set-aside. Acquisition planning determined that NCATS requirements could be met with a 2-year ordering period subject to a $49.9 million ordering limit. As noted, unforeseen requirements related to the COVID-19 emergency response will cause NCATS to exhaust that limit prematurely.

In accordance with FAR Part 10 Market Research, and during acquisition planning for the STSS parent award made in February 2021, NCATS considered existing NIH mechanisms to determine if could fulfil its programmatic needs. At that time the NIH-wide Scientific, Technical, and Other Professional Support Services (STOPS) contract was in its final year of its ordering period and there was insufficient remaining ceiling to accommodate additional orders. The STOPS re-competition was ongoing, but there was uncertainty beyond its expiration in July 2021.

NCATS had identified minimum programmatic needs through February 2023. Additionally, NCATS through its market research found two or more WOSB potentially capable of performing this statement of work, and in coordination with SBA set this action aside for WOSB under FAR subpart

6.2. NCATS advance planning ultimately proved opportune as the follow-on to STOPS was protested and not resolved until the 4th quarter of fiscal year 2021. It was during this time February 2021 (when STSS was awarded) to September 2021 that usage of STSS rapidly increased as NCATS was tasked with extensive support for various COVID-19 emergency response initiatives.

The Government anticipates recompeting this requirement this fiscal year.

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

a. Project title. NCATS Scientific and Technology Support Services (STSS)

b. Project description.

To modify contract number 75N95021D00001 to increase the maximum value for services the Government may acquire.

Requirement type.

Research & development (R&D) X R&D support services

Support services (non-R&D) Supplies/equipment

X Information technology (IT) Construction

Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on

X Other (specify): Modification

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

X Indefinite Delivery/Indefinite Quantity Other (specify): ___________ Completion Form Term form

Acquisition identification number

Modification number P00002 to Contract number 75N95021D00001

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

The programmatic costs of these services to date between 2017 and 2021 is $126.7 million. The maximum dollar amount of services the Government will acquire by this modification to the current contract will be increased by $50.0 million from $49.9 million (maximum) to $99.9 million (maximum). See Independent Government Cost Estimate (IGCE), Attachment #1.

The ordering period/period of performance is unchanged. This modification increases the contract maximum and it does not extend the ordering period on the competitively issued award. All work remains within scope of the contract Statement of Work.

4. Identification of the statutory authority permitting other than full and open competition.

X 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 41 U.S.C.

1901.

This acquisition is conducted under the authority of 41 U.S.C.

1903.

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(s).

Axle Informatics, LLC 6116 Executive Blvd Rockville, MD 20852

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This modification will permit continued use of NCATS� essential scientific and technology support contract. Currently, the incumbent is uniquely qualified to continue performing this contract to provide the services below for this requirement and is the only organization with the necessary resources and infrastructure in place to immediately provide the support services. Delays resulting from an awardee needing time to build up efficient operations would pose an unacceptable level of risk to NCATS mission. For example, transition would need to address numerous factors, including:

NCATS maintains a complex, tightly integrated research platform that includes scientific instrumentation, data acquisition, data analytics, intra- and inter-agency collaboration abilities, and technical support. The incumbent contractor provides unified, comprehensive management of support efforts as directed by the contractor�s program manager.

The incumbent has been the prime contractor providing these services since 2017 (contracts HHSN271201700049C;

75N95020C00010) and is intimately familiar with this requirement.

Multiple projects are currently underway that involve central project management by the contractor and draw across the contractor's organization for functional expertise in execution. For instance, NCATS was tasked by HHS to implement high-throughput screening (HTS) in a biosafety level 3 (BSL3) laboratory managed by NIAID in NIH Building 33 on the NIH main campus. This project includes acquisition of new instrumentation, major shifts of instrumentation among the NCATS laboratories at 9800 Medical Center Drive and the new facility on the NIH campus, return of instrumentation for factory refurbishment, and automating and integrating the environments with the NCATS remote control, data acquisition, and laboratory management environment. The Contractor continues to provide integrated project support and execution, including months of working at the technical level to enable this environment to work across the technical and security requirements of both NCATS and NIAID.

This effort requires integrated project execution across the Contractor�s organization. It is impossible to transfer the support to a successor contractor within the available time frame because a discontinuity of service would directly threaten the ongoing science and public health.

As NCATS plans to recompete the full requirement this fiscal year, in the immediate timeframe the current contractor is the only contractor that can fill NCATS� broad range of needs and/or do so without posing a threat to the science and public health to these critical NCATS programs. The appropriated funds for the STSS program will be wasted and the science will be destroyed if this contract does not continue. If NCATS hits the ceiling, the ongoing scientific research on rare diseases and COVID-19 stop. Ending this research has a direct impact on the public and some patients who are diagnosed with a rare disease or COVID-19 may experience a worsening health prognosis and some patients will die.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov Contract Opportunities notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Considerable market research was conducted in which current programmatic knowledge of the marketplace showed no significant changes since award of the IDIQ. Additionally, efforts were made to ensure that offers were solicited from as many potential sources as practicable. A noncompetitive presolicitation notice of intent was published on Sam.gov Contract Opportunities on 11/12/2021 for 17 days, closing on 11/29/2021. See Presolicitation Notice of Intent, Attachment #2.

No vendors submitted a response to this notice.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

NIDA expects the same fixed pricing of year two of the parent award for this modification to increase the contract ceiling. That pricing was previously evaluated and determined to be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Extensive market research which included publishing a formal small business sources sought in sam.gov was conducted in 2020 prior to the issuance of solicitation number 75N95021R00003, which resulted in the current IDIQ contract that was awarded in February 2021. Based on the programmatic knowledge of the current marketplace which NCATS and NIDA have closely monitored there have been no significant changes in the marketplace since award of the IDIQ.

The Government subsequently published a presolicitation notice of intent to award this modification action on Sam.gov Contract Opportunities on 11/12/2021.

See Presolicitation Notice of Intent, Attachment #2. No responses were received.

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

As described above, the Government is modifying the existing award to raise the ceiling to ensure continuity of services until the STSS program is recompeted.

Currently, transition to another contractor for the remaining term of the contract would be impossible and would cause discontinuity of science. The failure of the integrated scientific and technical systems supported by the contractor are critical to the mission of NCATS and would halt the rare disease and COVID-19 research programs. Such an interruption poses a direct threat to public health.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

The Government received no responses to the presolicitation notice published on sam.gov, and no other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

This modification is an interim action to ensure continuity of services; however, NCATS and NIDA intend to fully compete the successor contract. NIDA does not expect any additional barriers to competition at this time beyond the action requested in this J&A. This J&A is critical for continuity of services and to avoid a lapse.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government�s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date Project Officer Sam Michael

Chief, ITRB

CIO, NCATS

Project Officer�s

Immediate Supervisor

Anton M. Simeonov Scientific Director

NCATS

Head of the Sponsoring

Program Office

Keith Lamirande Associate Director for Administration and Executive Officer

NCATS

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 Name & Title Signature Date Contracting

Officer Rieka Plugge Contracting Officer NCATS Section NIDA Office of Acquisition

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

Official Name & Title Signature Date

Chief of the Contracting

Office

Christopher J. Belt Director NIDA Office of Acquisition

Head of the Contracting

Activity

Diane J. Frasier Head of the Contracting Activity, NIH Director, Office of Acquisition and Logistics Management

15. Competition Advocate Signature.

Competition Advocate

Dr. Sheryl K. Brining, Ph.D.

Director, Office of Research Information Systems

(ORIS)

Office of Extramural Research, OD, NIH

Attachments:

1. IGCE, 11/30/2021

2. Presolicitation Notice of Intent, Non-Competitive, 11/12/2021

3. NCATS STSS Statement of Work

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11/12/21, 4:47 PM SAM.gov https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 1/9

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Workspace / Contract Opportunities / NCATS Scientific and Technology Support Services (STSS) -Notice of Intent

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NCACC TAA S Scientififf c and TeTT chnology Supportrr Servrr ices (STSS) -Notice of Intent

This is the currently published version of this notice.

Click here to edit a dra of the Contract Opportunity.

Edit Authenticated Public Action nks

ACTIVE Contract Opportunity

Notice ID 75N95022R00010

Related Notice

Department/Ind. Agency

HEALTLL H AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier

NATAA IONAL INSTITUTES OF HEALTLL H

O ice

NATAA IONAL INSTITUTES OF HEALTLL H NIDA

GGeenneerraarrr ll IInnffoofff rrmmaattiioonn https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 2/9

Contract Opportunity Type: Presolicitation (Original) Original Published Date: Nov 12, 2021 04:46 pm EST Original Response Date: Nov 29, 2021 09:00 am EST

Inactive Policy: 15 days a er response date Original Inactive Date: Dec 14, 2021 Initiative:

None Allow Vendors to Add/remove from Interested Vendors List: Yes Allow Vendors to View Interested Vendors List: Yes

Classification

Original Set Aside:

Product Service Code: R499 - SUPPORT- PROFESSIONAL: OTHER NAICS Code:

541519 - Other Computer Related Services Place of Performance:

Rockville, MD 20850

USA

Description

PRESOLICITATION NOTICE OF INTENT

NON-COMPETITIVE

INTRODUCTION

Pursuant to FAR Subpart 5.2�Synopses of Proposed Contract Actions, this is a Pre-Solicitation Notice Of A Proposed Contract Action.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO

AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR

https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 3/9

AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR

FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), O ice of Acquisition, on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a modification to the following single award indefinite delivery, indefinite quantity (IDIQ) contract that was awarded under Solicitation number 75N95021R00003:

Contract Number: 75N95021D00001, NCATS Scientific and Technology Support Servces (STSS), with Axle Informatics, LLC

This modification will increase the IDIQ maximum value for services the Government will acquire by $75.0 million from $49.9 million to $124.9 million for the two-year ordering period from March 1, 2021 to February 28, 2023.

REGULATORY AND STATUTORY AUTHORITY

The resulting contract will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in e ect through the current Federal Acquisition Circular (FAC).

This acquisition is conducted as non-competitive under the statutory authority of 41 U.S.C. 3304(a)(1) and the authority of FAR 6.302-1 - Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

DESCRIPTION

Background: The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. NCATS is at the forefront of automated biomedical experimentation, replacing hours of time-consuming basic laboratory work with systems and robots capable of conducting experiments with a fraction of the resources. This technology can both cut costs and increase productivity, which acts as a multiplier e ect on research e iciency and raw output.

Though automated systems reduce the need for human labor, the systems and labs are not entirely self-su icient. This contract will support the workforce responsible for the day-to-day operation of robotics and https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 4/9 systems, as well as the infrastructure necessary to achieve top quality results.

NCATS engages in extensive intramural and extramural collaboration as it works to transform the translational science process in order to get more treatments to more patients more rapidly. NCATS relies on contractors for day-to-day support of the scientific and business systems that enable it to engage in that collaboration.

Requirements include support for scientific instrumentation, laboratory automation, robotics, data acquisition, analytics, and visualization, information technology infrastructure, end user customer support, and other areas. These systems are o en components of more extensive scientific collaborative platforms, such as high throughput screening systems as part of the drug discovery process to support the intramural research program, or cloud-based data analytics platforms to support extramural clinical informatics initiatives. As such, these systems act as the foundation for key collaborative initiatives and are absolutely critical to NCATS� mission, providing access to tools to drive scientific innovation for thousands of users around the country.

The purpose of this requirement is to provide the NCATS Information Technology Resources Branch (ITRB) with day-to-day support services for the following:

� Laboratory Management and Support

� Laboratory automation and equipment support

� Automation research services

� Scientific Program and Project Management

� Cheminformatics, Bioinformatics, Computational Chemistry and Biology

� Scientific Systems Programming and Research Data Management

� Scientific Cloud computing services and Engineering support

� Scientific research support

� End user support

REASON FOR THE NON-COMPETITIVE ACTION

https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 5/9

The contract was originally competed and awarded based on full and open competition as a women-owned small business set aside. The contract was awarded on March 1, 2021 with the intent to fulfill NCATS� STSS needs for a two-year ordering period. In order to continue the services unde the contract for the full two years, it is necessary to increase the maximum value of services that can be ordered under the contract.

Since award of the contract, NCATS� requirements for the STSS has surpassed original estimates. ITRB has seen a significant expansion of its scientific and technology portfolio, contributing to the National Institutes of Health (NIH) response to the current COVID-19 pandemic and a new program in antiviral discovery and development to combat future pandemics. An increase in task order requirements under the IDIQ Contract is expected.

The provision of scientific and technical support services to this infrastructure is recurring and long-term in duration. However, in addition, NCATS has been tasked with extensive support for various COVID-19 emergency response initiatives, which has increased the support requirements provided under this contract. Due to the increased support requirements, the contract is anticipated to reach its ordering ceiling by early 2022, well in advance of its planned two-year ordering period.

The Government anticipates recompeting this requirement in FY2022, with award prior to the expiration date; however, it is necessary to increase the maximum dollar amount of services the Government will acquire in order to ensure that these mission-critical services are continued throughout the recompetition period.

Increasing the ordering limit ceiling constitutes a contract action without providing for full and open competition (see FAR 5.001 and Subpart 6.3) and requires justification and approval in accordance with FAR Subpart 6.3.

Axle has unique qualifications to provide the services for this requirement and is the only organization that can complete the specific work at this time. The Contractor has the necessary resources and infrastructure currently in place to meet the NCATS requirements and adhere to NIH and federal policies, laws and regulations.

Modifying the incumbentt IDIQ contract to increase the maximum value is the only e icient and e ective way to ensure continuation of these https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 6/9 the only e icient and e ective way to ensure continuation of these services. Conducting a new acqusition for these services would require a minimum lead time of 12 months. Modifying the current IDIQ contract to increase the contract ceiling is the only e ective way to support this goal without duplication of time and e ort.

PERIOD OF PERFORMANCE

The IDIQ contract proposed for modification has an ordering period of March 1, 2031 to February 28, 2023 (2 years) (unchanged).

CONTRACT TYPE

Any additional task orders awarded to the incumbent contractor will be in accordance with the contract terms and conditions (either fixed price or time-and-materials).

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541519, Other Computer Related Services, with a small business size standard of $30.0 million.

INTENDED SOURCE

Axle Informatics, LLC

6116 Executive Boulevard, Suite 400

North Bethesda, MD 20852-4931

CLOSING STATEMENT

This notice of intent to increase the maximum value of the existing IDIQ contract is NOT a request for competitive proposals; however, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed work based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The Government will consider any such information solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct a competitive acquisition. The determination whether to proceed with the proposed IDIQ contract modification is solely within the discretion of the https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 7/9 p p Q y Government.

Responses to this notice must contain su icient information to establish the interested parties� bona-fide capability of fulfilling the requirements described herein. The statement must also include the contractor�s Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), and its certification of business size. All o erors must have an active registration in the System for Award Management (SAM), which can be accessed at www.sam.gov.

All responses must be reference notice number 75N95022R00010.

Responses must be submitted by email to Stuart Kern, Contract Specialist, stuart.kern@nih.gov.

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Contact Infoff rmation

Contrar cting Offff ice Address c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

USA

Primary Point of Contact

Stuart Kern t t k @ ih https://sam.gov/opp/8dd0f2b9354f47d4bc654babe6481ae8/review 8/9

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Interested VeVV ndorsr List stuart.kern@nih.gov

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Nov 12, 2021 04:46 pm EST Presolicitation (Original)

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Attachment no. 2 STSS Statement of Work

11/5/2020

SCIENTIFIC AND TECHNOLOGY SUPPORT SERVICES (STSS)

STATEMENT OF WORK (SOW)

Contents

1 GENERAL INFORMATION

1.1 Title of Project

1.2 Statement of Need and Purpose

1.3 Background Information and Objective

2 SCOPE OF WORK

2.1 Specific Requirements

2.1.1 Contract Management

2.1.2 Contract-Level Program Management

2.1.3 Laboratory Management and Support

2.1.4 Laboratory Automation and Equipment Support

2.1.5 Automation Research Services

2.1.5.1 Strategic Planning, Capability and Performance Management

2.1.5.2 Strategic Systems and Project Analysis

2.1.5.3 Logistical Operations Support

2.1.6 Scientific Program and Project Management

2.1.6.1 Program Management

2.1.6.2 Project Management

2.1.7 Cheminformatics, Bioinformatics, Computational Chemistry and Biology

2.1.8 Scientific Systems Programming and Research Data Management

2.1.8.1 Platform, Applications and Pipeline Development

2.1.8.2 Resource and Data Management

2.1.8.3 Evaluation, Inventory and Testing

2.1.9 Scientific Cloud Computing Services and Engineering Support

2.1.9.1 Cloud Brokering Services

2.1.9.2 IaaS Services

Attachment no. 2 STSS Statement of Work

11/5/2020

2.1.9.3 PaaS Services

2.1.9.4 Cloud Engineering Support

2.1.9.5 Cloud based High Performance Computing

2.1.10 Scientific Research Support

2.1.10.1 Scientific writing/editing support

2.1.10.2 Graphics, Digital and Media Arts Design

2.1.10.3 SBIR and other Grants Management Support

2.1.10.4 Outreach activities and support

2.1.11 End User Support

2.1.11.1 Scientific Instrumentation Desktop Support

2.1.11.2 Desktop Support

2.1.11.3 Training Support

2.1.11.4 Asset Administration and Support

2.1.11.5 Conference and Video Teleconferencing Support

2.2 EXPERIENCE & FUNCTIONAL RESPONSIBILITY

2.3 GOVERNMENT RESPONSIBILITIES

2.4 OTHER CONSIDERATIONS

2.4.1 Travel

2.4.2 Transition In / Transition Out

2.4.2.1 Transition-In Services

2.4.2.2 Transition-Out Services

1 GENERAL INFORMATION

1.1 Title of Project

Scientific and Technical Support Services (STSS)

1.2 Statement of Need and Purpose

The purpose of this requirement is to provide the Information Technology Resources Branch (ITRB), National Center for Advancing Translational Sciences (NCATS), with day-to-day support services for the following:

Laboratory Management and Support Laboratory automation and equipment support Automation research services Scientific Program and Project Management Cheminformatics, Bioinformatics, Computational Chemistry and Biology Scientific Systems Programming and Research Data Management Scientific Cloud computing services and Engineering support Scientific research support End user support

1.3 Background Information and Objective

The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

NCATS is at the forefront of automated biomedical experimentation, replacing hours of time-consuming basic laboratory work with systems and robots capable of conducting experiments with a fraction of the resources. This technology can both cut costs and increase productivity, which acts as a multiplier effect on research efficiency and raw output.

Though automated systems reduce the need for human labor, the systems and labs are not entirely self-sufficient. This contract will support the workforce responsible for the day-to-day operation of robotics and systems, as well as the infrastructure necessary to achieve top quality results.

2 SCOPE OF WORK

2.1 Specific Requirements

The contractor shall provide all services and qualified personnel, not otherwise provided by the Government, necessary to perform the following tasks:

2.1.1 Contract Management

The contractor shall prepare a management plan describing the technical approach, organizational resources, and management controls to be employed to meet the cost, performance, and schedule requirements throughout contract execution. The proposed management plan shall be submitted with the written technical proposal. At the time of award, the Government may recommend changes to the management plan which will be made final within fifteen days of contract award.

The contractor shall document the efforts performed in the completion of each task in a detailed twice monthly report and presentation. The report shall include the following items and any additional information that NCATS deems necessary:

Individual project status to include objectives met, work completed, and work outstanding.

Weekly resource challenges.

Issues and obstacles impeding progress and recommended solutions.

Status of deliverables/milestones.

Status and plan for activities relating to Very Important Persons (VIPs) and critical service tickets.

Resource planning/status.

Topics or issues identified by the COR.

2.1.2 Contract-Level Program Management

The contractor shall provide the technical and functional activities at the contract level needed for program management. This shall include productivity and management methods such as project management, task level quality assurance, work breakdown structures, onsite and offsite staff supervision, documentation quality reviews, responsive hiring, and maintenance of staff technical skills. The contractor shall also provide the centralized administrative, clerical, documentation, and other related functions appropriate to this level.

2.1.3 Laboratory Management and Support

NCATS requires contractor support with scientific laboratory research activities and laboratory management support across all NCATS laboratories. The contractor will be assisting in studies across various scientific disciplines, perform a variety of complex procedures and calibrate laboratory equipment, provide laboratory management support and training, and ensure compliance with safety procedures.

Examples of work performed within this task include, but are not limited to, the following:

Ensure smooth running of laboratory operations by developing, communicating, and implementing laboratory SOPs. Provide expert advice, guidance, and assistance pertaining to laboratory operations and facility management.

Assist with management of laboratory resources and ensure compliance with laboratory procedures. Develop recommendations to laboratory operations, management, and special requirements.

Provide expert advice on safety issues and communicate safety practices and procedures to the laboratory staff.

Collect and organize data; perform data analysis and interpretation; prepare technical reports, summaries, and protocols; interpret and evaluate results of experiment.

Review and research the proper handling and methods of utilization for different biological and chemical materials in regular use in the lab.

Prepare various media, stock supplies, and other reagents for use in the laboratory.

Assist in the analysis and interpretation of data and prepare summaries of laboratory findings to be used in reports and scientific papers.

Provide training to students and other laboratory personnel in the performance of specialized procedures and techniques.

Perform quality control of the laboratory to include upkeep and routine maintenance; order and maintain laboratory supplies, including chemicals, biological materials, liquid nitrogen, etc.

Perform a wide variety of complex procedures and techniques including but not limited to cell culture, clinical/diagnostic microbiology, DNA isolation, DNA purification, gene cloning.

Calibrate and operate a variety of laboratory instruments used to perform tests, analyses, and other laboratory procedures.

2.1.4 Laboratory Automation and Equipment Support

NCATS requires contractor support with scientific laboratory automation and equipment configuration, management, maintenance, and support across all NCATS laboratories.

Examples of work performed within this task include the following:

Operate and perform maintenance and validation procedures on low volume liquid dispensation systems, such as Beckman Coulter BioRAPTRs, the CyBi well array-based liquid aspirator/dispenser systems used in compound library titration and compression, the Kalypsys pintool, and other off-line liquid handling systems.

Work with staff on the creation and replenishment of compound library plates using automated liquid handlers.

Work with the Agilent BioCel to create daughter and assay plates.

Work with assays performed on various Kalypsys automation systems.

Create �Cherry Pick� plates on the Beckman Biomech FX.

Assess, maintain, perform repairs and validation on numerous pieces of existing equipment throughout the facility.

Perform placement, setup, and validation of new equipment.

Maintain and acquire tools and supplies for repair tasks.

Work with vendors to recommend replacement parts for equipment; maintain stock.

Work with vendors to make recommendations to NCATS on new laboratory equipment.

Train laboratory staff on the use and care of equipment.

Perform basic troubleshooting and correction of minor online screening system failures, including responding to errors that occur during off hours.

Provide compound management support, including cleaning and loading of plates on Kalypsys carousal and other systems, and organization of compound library.

Ensure proper care in the use and maintenance of laboratory equipment and supplies.

Place service calls for scientific equipment in the laboratory.

Collaborate with other laboratory managers on other laboratories.

Perform troubleshooting and correction of laboratory, building and screening system component; diagnose problems down to the component level; respond to errors.

Design various components and fixtures to be used within the laboratory or automated screening platform setting.

Assist in the maintenance, operation, and all support duties for the Sartorius CompacT SelecT automated tissue culture system.

Assist in the maintenance, operation, and experimental design for the BD FACSAria cell sorter.

Assist with the creation of novel tools and printing techniques for the Organovo tissue printer to help facilitate the development of multiple cell type 3D structures.

Prepare oral presentations for internal and external groups.

Develop LabView software to be used in either an offline laboratory setting or on one of the high throughput screening platforms present at the center.

Manage a full compound library including responsibilities associated with acquisition, tracking, upkeep, and disposal.

Monitor and manage automated robotic systems including coordinating use, maintaining, and calibrating hardware, and preparing screening libraries.

Collect data; analyze and interpret data; prepare reports and analyses.

Evaluate and interpret data and make modifications as needed.

2.1.5 Automation Research Services

To address the many scientific and operational opportunities for translational science, NCATS develops, demonstrates, and disseminates tools and resources, and provides relevant expertise to the broader scientific community. One approach is through the continuous expansion of the Center�s Research Services Core (RSC) that features automation and compound management to enable efficiencies in all its translational research activities.

NCATS� automation engineers are not only responsible for the maintenance, operation and continuous improvement of the center�s laboratory, but also for continuous innovation in laboratory systems automation. For continuous improvement in laboratory instrumentation, automation and processes for high-throughput screening, assay development and optimization, these staff members evaluate and implement novel technologies and methods, and develop custom solutions for hardware, software and autonomy. To this end, NCATS has undertaken many innovative initiatives, including:

Automated tissue culture systems.

3-D Bio-printing systems.

Innovative expansion of compound libraries.

Autonomous ground and Ariel based dispensing and delivery systems.

Virtual, augmented, and mixed reality-based system level training and data visualization.

Deep Learning Systems and building neural nets for image and other analysis.

Activities under this task include support for NCATS� innovation in new and ongoing initiatives for advancing translational science in three areas:

2.1.5.1 Strategic Planning, Capability and Performance Management

Tasks in support of Strategic Planning, Capability and Performance Management and include, but are not limited to, the following:

Researching, developing, demonstrating, integrating, and testing innovative technology in support of NCATS� effort to facilitate improvements in laboratory automation.

Evaluating and validating system performance capabilities and effectiveness, assessing risk, and determining operational feasibility and benefits of NCATS� systems or technology prototypes, to include recommending assessments of system performance and identifying deficiencies.

Providing IT support and performing studies, analyses, and experimentation in both laboratory and non-laboratory environments. When supporting Research, Development, Test, and Evaluation (RDT&E) tasks, the contractor shall address, at minimum, any life cycle phase(s) and include science and technology efforts.

Evaluating unproven technology applications, identifying potential risks, and documenting and submit results in support of evaluation findings.

Provide weekly, monthly, quarterly, annual, and ad-hoc reports on performance measures.

Providing drawing support services.

Participating in technical reviews and meetings in support of planning, capability, and performance management activities.

2.1.5.2 Strategic Systems and Project Analysis

Support under this includes, but is not limited to, providing support to:

Prepare, review, and update program documentation and status in support of milestone decisions, leadership, and external reviews.

Prepare white papers, graphs, tables, diagrams, and briefings to present analysis conclusions and recommendations.

Developing methods for tracking program performance and refining project analysis processes, methods, and tools.

Maintaining program plans and coordinating with the program managers to ensure programs fulfill requirements upon delivery.

2.1.5.3 Logistical Operations Support

Support under this includes, but is not limited to, providing support to:

Logistics planning and management expertise for obtaining and managing facility and space requirements, as well as the supply and the planning and executing movements of instruments and materials and any transportation required.

Preparing onsite and offsite research facilities as needed for the conduct of new innovative research methods.

This support includes utilizing existing and help procuring new government proprietary systems/protocols for automation purposes.

The contractor�s Logistics Support shall adhere to and be provided in accordance with Federal government policies.

2.1.6 Scientific Program and Project Management

Activities under this task have been grouped in program management and project management categories.

2.1.6.1 Program Management

Program management shall be performed by a team that comprises Key Personnel functioning as Program Managers and Project Managers. The Program Managers will be responsible for the overall supports of the various NCATS programs like CTSA, GARD, ORDR, DPI to include support in oversight of scientific, technical, and financial aspects. The Project Managers will be responsible for the daily operations of various projects in the programs to include management of contractor personnel, recruiting for contract staff, and quality control.

Examples of work performed within this task include:

Provide quick turn-around response to any situation deemed to be urgent by the NCATS Contracting Officer�s Representative (COR) or Contracting Officer (CO).

Manage a large volume of concurrent work orders and ensure prompt and timely response to all NCATS requirements and requests.

Manage and coordinate contractor�s on-site and off-site personnel.

Provide competitive employee benefits package and implement employee retention strategies. The Contractor shall provide its own immigration support by sponsoring various types of visas for non-US citizens that include H-1B, O-1, F-1, J-2, TN, and others.

Maintain ongoing communication with COR and CO.

Monitor staff availability, project funding, and expenses.

Ensure accuracy and timeliness of contract deliverables.

Prepare and provide technical and financial status reports.

Meet with COR or CO within 24 hours of a request to address specific.

2.1.6.2 Project Management

The Contractor shall provide project management support for scientific and technical projects and initiatives currently underway at NCATS. Activities under this task range from project management activities for building platforms, applications and pipelines, infrastructure upgrades to managing complex research projects.

Examples of work performed within this task include:

Sustain management procedures to ensure the most appropriate resource/priority balancing for individual projects. Assist with budget planning, monitor expenditures, and define recruitment needs.

Develop project timelines, report of status, and develop resource plans. Work with teams to achieve resolution and/or design mitigation strategies.

Record meeting minutes, track action items, and disseminate project information.

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