Definitive Contract 75F40124C00120
- Not listed
- This federal contract award was issued by the Food and Drug Administration (FDA) to The Mitre Corporation, a non-profit organization that operates federally funded research and development centers (FFRDCs). The $1,189,907 cost-plus-fixed-fee contract is for the FDA's Office of the Commissioner to engage Mitre in providing strategic support services for a patient engagement project in the FDA's medical products centers. The goal is to generate an action plan and implementation roadmap to...
- The U.S. Food and Drug Administration (FDA) awarded a $1,845,473.00 cost-plus-fixed-fee delivery order contract to The Mitre Corporation, a non-profit organization that operates federally funded research and development centers (FFRDCs). This contract is for the "TITLE 21 MODERNIZATION AND AUTOMATION FOR THE FOOD AND DRUG ADMINISTRATION OFFICE OF TALENT SOLUTIONS" project, which aims to modernize and automate systems for the FDA. The contract has an ultimate completion date of...
- The Food and Drug Administration awarded a $6.04M firm fixed-price definitive contract to Massachusetts Institute of Technology on September 18, 2024, with completion expected by June 28, 2026. This award supports the development of a Broad Agency Announcement addressing continuous manufacturing growth within cell lines, funded through the President's initiative focused on advanced manufacturing. The work will be performed in Cambridge, Massachusetts, and no set-aside designation was applied...
- The Food and Drug Administration (FDA) awarded a delivery order valued at $1,009,892 to The Medical Device Innovation Consortium (MDIC) on January 28, 2026, to provide support for medical device innovation and regulatory science initiatives. This firm fixed-price delivery order, which is not set aside for small business, will be performed in Rosslyn, Virginia and is scheduled for completion by February 22, 2028. MDIC is a non-profit organization specializing in advancing regulatory science for...
- The Food and Drug Administration awarded a $400,000 firm fixed-price contract to the Regents of the University of Michigan on September 26, 2022, to advance regulatory science methodologies in drug development. Specifically, the contract supports the FDA's Broad Agency Announcement seeking research and development proposals across multiple areas of interest, with this award focused on advancing the science of in vitro studies, animal models, pharmacokinetic studies, and real-world evidence...
- This federal contract award, valued at $811,126.00, was issued by the U.S. Food and Drug Administration (FDA) to Digital Medicine Society Inc., a non-profit organization based in Boston, Massachusetts. The contract was awarded under a Broad Agency Announcement (BAA) solicitation for research and development to support the FDA's regulatory science and innovation mission. The contract is a Definitive Contract with a Firm Fixed Price pricing type, and has an ultimate completion date of December 31,...
- The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a cost-plus-fixed-fee delivery order contract to The MITRE Corporation, a nonprofit organization, to provide support for the FDA Center for Drug Evaluation and Research (CDER) Strategic Portfolio Return on Investment (ROI) Framework. The $1,999,202 contract requires MITRE to work with a subcontractor, Grant Thornton LLP's Public Sector Division, to develop a framework for analyzing the ROI of CDER's...
- The Food and Drug Administration (FDA) awarded a $4,567,087.00 cost-plus-fixed-fee delivery order contract to The Mitre Corporation, a non-profit organization, to support the FDA's Chief Data Office for real-world evidence and data agile analytics of specialized data sets. This contract, which has no set-aside designation, is part of the FDA's response to the Coronavirus (COVID-19) pandemic. The Mitre Corporation, a long-standing partner to federal agencies, will leverage its expertise in...
- This federal contract award, valued at $393,043.00, was issued by the U.S. Food and Drug Administration (FDA) to Medstar Health Research Institute Inc., doing business as Medstar Research Institute, a non-profit healthcare organization. The contract is a Definitive Contract with a Cost Plus Fixed Fee pricing type and supports "STRENGTHENING SOCIAL AND BEHAVIORAL SCIENCE AT FDA BY ENHANCING AUDIENCE UNDERSTANDING." No set-aside designation was used for this contract. The original...
- The U.S. Food and Drug Administration (FDA) awarded a $2,769,517.62 definitive contract to the Medical Device Innovation Consortium (MDIC), a non-profit organization focused on advancing medical device regulatory science. The contract, which runs through May 31, 2024, is to expand the Case for Quality Voluntary Improvement Program to aid underperforming medical device manufacturing sites. This contract is not set-aside. MDIC has received multiple other delivery orders and contracts from the...
The Food and Drug Administration (FDA) awarded a $332.9K definitive contract to The Milken Institute on September 10, 2024, to define the value and return on investment of patient engagement in medical technology product development. The contract, issued under BAA-FY24C1IP3, carries a firm fixed price structure with no set-aside designation and is scheduled for completion by March 31, 2026. The work will be performed at The Milken Institute's Silver Spring, Maryland location, leveraging the organization's specialized expertise in healthcare research and policy analysis to support FDA's regulatory mission. As a non-profit research organization with demonstrated federal contracting experience, The Milken Institute brings established capabilities in complex analytical projects and stakeholder engagement. This engagement aligns with the FDA's broader efforts to enhance product development processes through meaningful patient input, an increasingly important consideration in the agency's regulatory framework. The contract represents a direct award recognizing the institute's unique qualifications in conducting sophisticated research on healthcare innovation and community-focused analytical work for civilian federal agencies.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00002 | Other Administrative Action | $0 | 9/16/25 | |
| P00001 | Other Administrative Action | $0 | 9/8/25 | |
| Not listed | Not listed | $332.9k | 9/10/24 |