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Real-World Application for Innovation and Development

ID: FDA-SSN-75F40125Q00029 • Type: Sources Sought

Description

The U.S. Food and Drug Administration (FDA) is issuing this source sought notice as a means of conducting market research, pursuant to FAR Part 10 Market Research, to identify viable industry parties capable of supporting FDA's Real-World Application for Innovation and Development (RAPID), enhancement of the current AWS platform, development of new applications prototypes and Proof of Concepts.

The mission of CDER's Office of Computational Science (OCS) is to modernize the Center's regulatory review process and enable reviewers to spend less time dealing with complex data and more time applying their expertise to information through the use of integrated tools, services, and training. OCS' efforts to accomplish this mission involve developing technology and analytics to support regulatory review work. RAPID was developed as a means to implement a cloud-based and on-premises environment to develop and continuously improve the applications and databases needed to meet the innovation and analytical needs of FDA users.

The RAPID platform is capable of supporting a variety of cloud and other operations including, supporting individual regulatory research, ingest, evaluate, and validate new analytic tools and methodologies, support new methods of multi data base curation, characterization and integration for transdisciplinary analysis of complex and big data, and a range of artificial intelligence tools and use cases for FDA needs.

RAPID is a sandbox that promotes the development of innovative analytic tools, supports data science research, and the evaluation of cutting-edge technologies. The RAPID System in its current form uses Artificial Intelligence (AI) and cloud-based compute facilities to develop innovative analytical solutions that support regulatory decision making and scientific analysis. Refer to the National Academies of Sciences Convergence , https://www.nae.edu/113283.aspx, report to get an understanding of what transdisciplinary FDA scientific need must include.

Background
The U.S. Food and Drug Administration (FDA) is conducting market research to identify viable industry parties capable of supporting the Real-World Application for Innovation and Development (RAPID) program.

The mission of the Center for Drug Evaluation and Research (CDER) Office of Computational Science (OCS) is to modernize the regulatory review process, enabling reviewers to focus on applying their expertise through integrated tools and services.

RAPID aims to develop a cloud-based and on-premises environment for continuous improvement of applications and databases to meet FDA's innovation and analytical needs.

Work Details
The contractor will be responsible for various tasks including:
1. Project Management: Oversee project execution ensuring timely delivery of results.
2. BPA Program Management: Manage the Blanket Purchase Agreement effectively.
3. Task Order Management: Organize work to deliver required results.
4. Personnel Management: Coordinate onboarding/offboarding activities and ensure personnel meet requirements.
5. Meetings: Support routine project management meetings, prepare agendas, minutes, and track action items.
6. Reporting: Provide weekly and monthly status reports detailing progress on tasks.
7. Transition: Facilitate transition from incumbent contractors upon award.
8. Research, Prototyping and Deployment: Develop prototypes and proof-of-concepts to enhance FDA's capabilities in data management and analytics.

Period of Performance
The period of performance will be defined in individual task orders under the Blanket Purchase Agreement (BPA), with ongoing support expected over multiple years as advancements in AI and cloud technologies are integrated.

Place of Performance
The contract work will primarily take place within the FDA facilities located in the Washington D.C. Metro area.
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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Response Deadline
Feb. 11, 2025, 12:00 p.m. EST Past Due
Posted
Jan. 21, 2025, 2:06 p.m. EST
Set Aside
Small Business (SBA)
NAICS
541512 - Computer Systems Design Services
PSC
DB01 - IT And Telecom - High Performance Computing (Hpc) Support Services (Labor)
Place of Performance
Silver Spring, MD 20903 United States
Source
SAM
Current SBA Size Standard
$34 Million
Pricing
Multiple Types Common
Est. Level of Competition
Low
Odds of Award
29%
Signs of Shaping
66% of obligations for similar contracts within the Food and Drug Administration were awarded full & open.
On 1/21/25 Food and Drug Administration issued Sources Sought FDA-SSN-75F40125Q00029 for Real-World Application for Innovation and Development due 2/11/25. The opportunity was issued with a Small Business (SBA) set aside with NAICS 541512 (SBA Size Standard $34 Million) and PSC DB01.
Primary Contact
Name
Noah Padilla   Profile
Email
noah.padilla@fda.hhs.gov
Phone
None

Documents

Posted documents for Sources Sought FDA-SSN-75F40125Q00029

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Additional Details

Source Agency Hierarchy
HEALTH AND HUMAN SERVICES, DEPARTMENT OF > FOOD AND DRUG ADMINISTRATION > FDA OFFICE OF ACQ GRANT SVCS
FPDS Organization Code
7524-00223
Source Organization Code
100188033
Last Updated
Jan. 21, 2025
Last Updated By
noah.padilla@fda.hhs.gov
Archive Date
Feb. 26, 2025