FDA-SSN-1238254.pdf

Artificial Intelligence Technical Expert Sources Sought Notice

FDA-SSN-1238254

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the National Center for Toxicological Research (NCTR), Division of Bioinformatics and Biostatistics (DBB) in order to determine if there are existing small business sources and other than small business sources capable of providing Artificial Intelligence Technical Expert services with four (4) option years.

The associated North American Industry Classification System (NAICS) code is 541690 – Other Scientific and Technical Consulting Services; Small Business Size standards – $16.5 MIL

Background:

The FDA, NCTR, Division of Bioinformatics and Biostatistics (DBB) requires a Technical Expert in Artificial Intelligence; an experienced individual with written and oral presentation skills, and a thorough understanding of bioinformatics with specific knowledge in Artificial Intelligence (AI) in the area of reproducibility, interpretability and transparency. One of the essential roles of the Division of Bioinformatics and Biostatistics (DBB) at the National Center for Toxicological Research (NCTR) is to deal with the rapid growth of biomedical data present in the public domain and generated within the Food and Drug Administration (FDA), and to develop state-of-art bioinformatics and biostatistics methodologies to translate these burgeoning data to knowledge to be used in the FDA. One area of this research is artificial intelligence (AI). Specifically, the goal is to evaluate, develop and employ the AI methodologies with a specific emphasis on its reproducibility, transparency and interpretability. This will aid in the efforts in the FDA to (1) develop the policy in regulation for the products that contain AI and

(2) improve the agency’s operation by incorporating AI methods in regulatory science.

Objective:

It is critical for the Division of Bioinformatics and Biostatics to develop and coordinate informatics capabilities within NCTR, across FDA Centers, and in the larger community. It is important for these capabilities to be communicated in an effective manner with the research community and the FDA. This requires an experienced individual with written and oral presentation skills, a thorough understanding of bioinformatics with specific knowledge in AI in the area of reproducibility, interpretability and transparency.

Scope of Work:

FDA seeks a contractor with demonstrated expertise in working with Artificial Intelligence (AI). The contractor will support the FDA/Division of Bioinformatics and Biostatics to develop and coordinate informatics capabilities within NCTR and FDA Centers. The contractor shall have a thorough understanding of bioinformatics with specific knowledge in Artificial Intelligence in the area of reproducibility, interpretability and transparency. The contractor shall work in close coordination with the DBB at NCTR in Jefferson, Arkansas, and shall assist in the formulation of innovative ideas/approaches to address the current needs in AI development, to advise bioinformatics staff in the appropriate methods of writing papers and protocols, and to provide support in the generation of manuscripts and other documentation. This shall require periodic visits to the NCTR Campus and communication with the DBB staff via other electronic means, including video conferencing. Specifically, the contractor shall communicate via e-mail, phone calls and video conferences to make recommendations as appropriate, and to schedule visits to the NCTR campus, with theTechnical Point of Contact (TPOC).

Minimum Performance Requirements:

1. The contractor shall conduct Manuscript Review/Protocol Development at the contractor’s facility and shall not exceed four hours per week. The contractor shall review draft manuscripts related to AI; conduct independent AI data analysis, as needed, to verify results in manuscript;

provide recommendations for revisions to manuscript to prepare for publication (shall follow the standard practices in the scientific community for conducting manuscript writing); and assist in the development of research protocols to further the research.

The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.

2. The contractor shall visit NCTR one time per year with each visit being for a period of at least 5 business days. The purpose of the visit is to train DBB junior scientists and to assist the DBB in the writing of manuscripts and research protocols related to AI. Visits shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of AI. The contractor shall perform needed literature assessment, etc., therefore, shall furnish equipment needed to access these resources (i.e. personal laptop). NCTR shall provide access to guest Wi-Fi and projection equipment if needed for presentations.

If unable to visit NCTR due to travel restrictions related to the COVID-19 pandemic contractor shall perform above requirements via virtual platform (video conference).

3. Contractor shall participate in one or two video and/or teleconference meetings per month (meetings approximately 1 hour each).

Minimum Position Requirements & Qualifications:

Education and experience:

1. Shall have in-depth knowledge of current issues in the field of Artificial Intelligence (AI).

2. Shall have presented at one or more international conferences about Artificial Intelligence (AI).

3. Shall have extensive experience with reproducibility, transparency and interpretability in developing and applying Artificial Intelligence (AI).

4. Shall have extensive experience in instructing research professionals.

5. Shall have extensive experience in technical writing and editing.

6. Shall have experience in supervising graduate students and postdoctoral fellows.

7. Shall have verifiable records of publications in cited scientific journals and publications.

8. Shall have a minimum 15-20 years’ experience in the field of (AI).

Deliverables and Milestones:

Deliverables Task Due Date

Manuscript Review/Protocol Development

Review draft manuscripts related to AI;

conduct independent AI data analysis, as necessary, to verify results in manuscript;

provide recommendations for revisions to prepare manuscript for publication (shall follow the standard practice in the scientific community for conducting manuscript writing) and assist in the development of research protocols to further the research.

Annually – not to exceed 4 hours per week

(The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.)

Visit NCTR one time per year (at least 5 business days)

Visit shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of artificial intelligence. Assist the DBB in the writing of manuscripts and research protocols related to artificial intelligence.

*If unable to visit NCTR due to travel restrictions related to the COVID-19 pandemic contractor shall perform above requirements via virtual platform (video conference).

Annually

Attend meetings Participate in monthly video and/or teleconference meetings

Once or twice per month (approximately 1 hour each)

Reports

Provide invoice with a summary of work completed

Quarterly or Semi-annually

Period of Performance: Base + 4 Option Years

Base Period: August 3, 2021 – August 2, 2022 Option Period 1: August 3, 2022 – August 2, 2023 Option Period 2: August 3, 2023 – August 2, 2024 Option Period 3: August 3, 2024 – August 2, 2025 Option Period 4: August 3, 2025 – August 2, 2026

Place of Performance:

At the contractor’s location. However, the contractor shall be required to travel to NCTR one time per year to meet with junior staff and the Project Officer to review materials and conduct training:

US FDA - NCTR

3900 NCTR Rd.

Jefferson, AR. 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing Artificial Intelligence Technical Expert services. All interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the performance requirements identified above. Respondents shall limit their capability statements to no more than ten

(10) pages, excluding cover page and table of contents.

3. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience information for services of the same or substantially similar to Artificial Intelligence Technical Expert services. For each past performance reference include the date of service, description of service provided, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

5. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

6. Though this is not a request for quote, informational pricing for the service would be helpful.

* Pricing shall not exceed four hours per week.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before March 5, 2021 by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and Reference: FDA-SSN-1238254.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern.

mailto:jennifer.johnson3@fda.hhs.gov mailto:jennifer.johnson3@fda.hhs.gov