Definitive Contract 75F40126C00069
- Not listed
- The Food and Drug Administration awarded a $1.52 million definitive contract to National Institute For Pharmaceutical Technology & Education Inc. (NIPTE) on September 1, 2026, under Executive Order 14398 FY26 BAA (BAA FY26C1BP4), with firm fixed pricing and a completion date of August 31, 2028. Place of performance is Minneapolis, MN. The award carries no set-aside. NIPTE is a non-profit collaboration of academia, industry, and other stakeholders focused on advancing pharmaceutical...
- The Food and Drug Administration awarded a $3 million cost-plus-no-fee definitive contract to National Institute For Pharmaceutical Technology & Education Inc. (doing business as Nipte) for continuous drug substance manufacturing from biomass-derived building blocks on September 22, 2022. The contract ceiling is $3 million, with an ultimate completion date of September 28, 2027. This award reflects a 12-month extension requested by the vendor. The originating Broad Agency Announcement sought...
- This is a $4,999,953.00 firm fixed price definitive contract awarded by the Food and Drug Administration (FDA) to the National Institute for Pharmaceutical Technology & Education Inc. (Nipte), a non-profit organization. The contract was awarded under the FDA's Broad Agency Announcement mechanism to support research and development on a "model-based systems engineering approach to end-to-end pharmaceutical manufacturing of liquid" products. This contract is not associated with a...
- The Food and Drug Administration awarded a $499,000 firm fixed-price purchase order to the National Institute For Pharmaceutical Technology & Education Inc. (Nipte) on September 13, 2013, for a Generic Drug User Fee Act (GDUFA) study evaluating drug product formulation. The contract, which was completed by September 15, 2015, was performed in Rosemont, Illinois. No set-aside designation was applied to this award. Nipte, a non-profit collaboration of academic, industry, and other...
- The U.S. Food and Drug Administration (FDA) awarded a $901,888.19 definitive contract to the National Academy of Sciences (NAS), a non-profit organization, to produce a consensus report that identifies innovative technologies to advance pharmaceutical manufacturing. The contract, which is not set aside, was awarded on July 19, 2019 with a completion date of March 31, 2022. The report will assist the FDA's Center for Drug Evaluation and Research (CDER) in fostering the adoption of innovative...
- 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 U.S. Food and Drug Administration (FDA) awarded a $4,400,000.00 Cost Plus Fixed Fee contract to Continuus Pharmaceuticals, Inc. to support the "ADVANCEMENT OF INTEGRATED CONTINUOUS MANUFACTURING (ICM) UNIT OPERATIONS." This definitive contract does not have a set-aside designation and is scheduled to be completed by September 29, 2019. The contract is part of the FDA's efforts to advance integrated continuous manufacturing unit operations, which is a major program focus area for...
- The U.S. Food and Drug Administration (FDA) awarded a $1,155,442.55 Cost Plus Fixed Fee contract to Cubrc, Inc. to conduct research and development on the "Immunogenicity Risk of Peptide Drug Generics and Their Impurities: In Silico and In Vitro Assessment and Validation Methods." The contract, which has a period of performance ending September 27, 2022, was issued under the FDA's Broad Agency Announcement (BAA) solicitation for advanced research and development to support regulatory...
- The Food and Drug Administration awarded a $325,000 definitive contract to Institute For Clinical Pharmacodynamics, Inc. on August 1, 2026, for development of susceptibility guidance for daptomycin and enterococcus species using pharmacometric approaches under the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science. Place of performance is Schenectady, NY. The contract runs through July 31, 2027, under firm fixed price terms with no set-aside. The...
- The Food and Drug Administration awarded a definitive contract to Institute Of Quantitative Systems Pharmacology for basic and applied research on critical quality attributes and specifications for generic nanotechnology products, with a ceiling value of $1,774,200.08 and award date of September 25, 2019. The project tests the hypothesis that unavoidable variabilities in nanoparticle properties and intended target sites (solid tumors) cause uncertainties in formula performance. Place of...
The Food and Drug Administration awarded a $634,642 definitive contract to National Institute For Pharmaceutical Technology & Education Inc. (doing business as Nipte) for an advanced CMC index and intelligence platform for drug quality control, shortage prediction, and strategic reshoring on September 30, 2026, under a no-set-aside BAA mechanism. The award derives from the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science, which seeks extramural research proposals to advance regulatory science across FDA-regulated domains. The solicitation, posted November 21, 2025 with amendments through January 16, 2026, operates under FAR 6.102(d)(2) and 35.016 and prioritizes modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness. The opportunity is classified under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services). Place of performance is Minneapolis, MN 55414. The contract is firm fixed price with an ultimate completion date of September 29, 2027.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FDABAA-26-00123 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Special Notice 1/1 | 11/21/25, 8:57 AM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | Not listed | $634.6k | 9/15/26 |