RFI Instructions with SOW.pdf

Source Sought no. FDA-RFI-25- 130585

Request for Information (RFI) Instructions

1. Background:

This Sources Sought Request for Information (RFI) is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers. The purpose of this RFI is to identify potential small businesses who are interested and capable to meet FDA’s requirements of renewing brand name or equal Scientific Laboratory Information Management System (SLIMS) User and Server licenses to continue use of the Genomics Information Management System (GIMS) in support of FDA’s Whole Genome Sequencing Program (WGS) used for genomic data collection and analysis.

FDA welcomes responses from all interested small businesses to submit a response to this RFI. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's

Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

2. General Instructions:

A complete response to the RFI should include answers to all of the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g.: The response must go beyond the statement that, "XYZ company can provide Material characterization and Analysis Services.").

The RFI responses should be submitted via email to Min Jie Zeng at minjie.zeng@fda.hhs.gov by 4PM ET on August 27, 2025. E-Mail is the only acceptable method of delivery for this notice of sources sought.

FDA-RFI-21- 1240122

3. Questions:

1) On the FACE PAGE of your response, please provide the following:

a. Organization name

b. DUNS number

c. Organization's website

d. Contact Name

e. Contact Telephone

f. Contact E-mail address

g. Size designation and type (i.e. Small Business, etc)

h. Number of employees in your organization

i. Your organization's current and gross revenue

2) Elaborate previous experience on performing similar types of tasks specified in Section IV, V, and VI of Attachment 1 – Statement of Work (draft). The elaboration on each experience shall include:

a. Evidence of performing the similar types of tasks.

b. Brief introduction of the project’s objective and scope.

c. Brief description of the methodology and equipment used to perform the similar types of tasks.

3) Do any gaps exist in the Draft Statement of Works? If so, what are they? What changes, additions, updates, and clarifications would you suggest?

4. Attachments:

Attachment 1 - Statement of Work (draft)

A achment 1 - Statement of Work

Genomics Informa on Management System (GIMS) License Renewal and Support

I. Background

The U.S. Food and Drug AdministraƟon (FDA) impacts the lives of every American every day. The FDA’s informaƟon technology investments are closely aligned with the mission and goals of the FDA to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our naƟon’s food supply, cosmeƟcs, and products that emit radiaƟon. The FDA Human Foods Program (HFP)‘s priority acƟviƟes include: oversight of products, compliance on food labeling, pre-market approval of specific products, and other consumer protecƟon related acƟviƟes associated with food and nutriƟonal products.

The ScienƟfic Laboratory InformaƟon Management System (SLIMS) is a laboratory management soŌware that helps streamline and organize lab operaƟons. It offers a range of features, including sample tracking, experiment management, and automated result reporƟng. With its intuiƟve interface and flexible opƟons, SLIMS can be tailored to meet the specific needs of our laboratory, regardless of its size or complexity. In addiƟon to improving efficiency and accuracy, the soŌware can also be quickly and easily deployed, saving Ɵme and effort during the setup process.

The current HFP Genomics InformaƟon Management System (GIMS) uses SLIMS soŌware and a laboratory informaƟon management system to facilitate organizaƟon, communicaƟon, and analysis reporƟng within HFP’s Whole Genome Sequencing Program.

II. Objec ves

The purpose of this requirement is to renew brand name or equal ScienƟfic Laboratory InformaƟon Management System (SLIMS) User and Server licenses to conƟnue use of the Genomics InformaƟon Management System (GIMS) in support of FDA’s Whole Genome Sequencing Program (WGS) used for genomic data collecƟon and analysis.

III. Scope

The SLIMS soŌware is up for renewal to maintain usability and funcƟonality of the GIMS ApplicaƟon. The informaƟon below details the salient characterisƟcs, deliverables, and period of performance as it pertains to the required licenses.

IV. Salient Characteris cs

Requirements The Contractor will provide Usernames SLIMS license keys, Extra Server license keys, and Engineering IntegraƟonal Support to FDA Human Foods Program (HFP).

Func onality/Capability The SLIMS licenses must include:

• LIMS, ELN, ELS applicaƟons

• ConfiguraƟon for onsite use, for cloud use, and for large-enƟty level use

• Microbial Regulatory Environments

• Workflow and Centralized Data Management

• Sample and Compliance Tracking (ISO/GAMP5)

• Audit Trails

• eSignature (21 CFR Part 11)

• Sequencing, RoboƟcs, and Quality Assurance/Control IntegraƟon

• Scalable

• Named User, Concurrent, and Server licensing

• Helpdesk and/or training documentaƟon

• SSO/MFA

• Meet FDA IT Security Requirements

• Engineering IntegraƟon Support

• API access

• Large Data Handling/IngesƟon of Large Data Files

V. Compa bility Requirement SLIMS licenses must be compaƟble and easily integrated into our current GIMS architecture and must be able to support onsite analysis and cloud computaƟon.

VI. Specific Tasks Task 1 The Contractor will provide license keys for 15 Named User SLIMS licenses. As these are renewals, the SLIMS licenses are installed on the SLIMS Cloud-based server(s) and used via the browser-based access.

Task 2 The Contractor will provide license keys for 3 Extra Servers. A local GIMS Server Unix Administrator will install licenses in the FDA FAWSEA AWS environment accordingly once provided the license keys.

Task 3 The Contractor will provide Engineering IntegraƟonal Support. This support ensures the renewed licenses properly interface with exisƟng FDA systems, parƟcularly coordinaƟng between cloud-based servers and the FAWSEA AWS environment where addiƟonal server licenses will be deployed. The integraƟon involves working with the local GIMS Server Unix Administrator to install and configure licenses without disrupƟng ongoing genomic data processing, while maintaining criƟcal data workflows between laboratory instruments, the laboratory informaƟon management system, and analysis systems used for food safety genomics. This support guarantees operaƟonal conƟnuity by preserving uninterrupted access for users while maintaining all exisƟng genomic data, experimental workflows, and analyƟcal capabiliƟes criƟcal to FDA's food safety mission.

VII. Place of Performance The task will be performed at FDA, Harvey Wiley Building 5001 Campus Drive, College Park, Maryland, 20740.

VIII. Period of Performance 09/30/2025 - 09/29/2026