Definitive Contract 75F40124C00080
- Not listed
- This is a firm fixed-price contract awarded by the Food and Drug Administration (FDA) to Institute For Clinical Pharmacodynamics, Inc., a minority-owned, for-profit organization based in Schenectady, New York. The contract, valued at $263,016.10, is for the development of modernized susceptibility guidance for the antibiotics ampicillin and vancomycin for Enterococcus species using pharmacometric approaches. The contract has a period of performance ending on March 29, 2025. This contract is...
- This $291,618 definitive contract was awarded by the Food and Drug Administration (FDA) to the Institute For Clinical Pharmacodynamics, Inc. (ICPI), a for-profit, minority-owned organization. The contract is in support of the FDA's Combatting Antibiotic Resistant Bacteria (CARB) program and will have a period of performance through September 29, 2023. Under this contract, ICPI will provide pharmacometric analysis and modeling services to the FDA to support updating clinical breakpoints for the...
- This $291,142 firm fixed price prime contract was awarded by the Food and Drug Administration (FDA), a civilian agency, to the Institute For Clinical Pharmacodynamics, Inc. to conduct research on updating susceptibility guidance for the oral antibiotics sulfamethoxazole-trimethoprim. The contract supports the agency's efforts to develop modernized susceptibility guidance using pharmacometric approaches. No set-aside designation was used for this award. The Institute For Clinical...
- This is a $1,904,355.00 definitive cost-no-fee contract awarded by the Food and Drug Administration (FDA), a civilian government agency, to the Institute Of Quantitative Systems Pharmacology, a non-profit organization. The contract is for basic and applied research with two key objectives: (1) to test the hypothesis that variabilities in nanoparticle (NP) properties and tumor targets cause uncertainties in "FORMULA", and (2) to develop computational models to predict the...
- 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...
- Landrau Scientific Innovations LLC was awarded a $567,980 firm fixed price definitive contract by the Department of Health and Human Services Food and Drug Administration to support the agency's Broad Agency Announcement PMQWP#237. This BAA seeks advanced research and development proposals to evaluate critical process parameters for the preparation of amphotericin B that influence toxicity, advancing the FDA's regulatory science and innovation goals. The prime contractor will conduct work at its...
- This definitive, firm fixed-price contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to CFD Research Corporation, a for-profit organization, to develop a multiscale computational framework for assessing the bioequivalence of orally inhaled drugs. The $499,761 contract does not have a set-aside designation. The original solicitation was a Broad Agency Announcement (BAA) seeking research and development to advance FDA's mission of protecting...
- This federal contract award, with ID 75F40122C00192, was issued by the Food and Drug Administration (FDA) to the National Institute for Pharmaceutical Technology & Education Inc. (Nipte), a non-profit organization. The $3,000,000.00 cost-no-fee contract is for continuous drug substance manufacturing from biomass-derived building blocks, in support of the FDA's effort to advance regulatory science. This contract was awarded under the FDA's Broad Agency Announcement mechanism, which solicits...
- 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...
- This is a $315,945.00 firm fixed price delivery order contract awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to Southern Research Institute for "IN VITRO ASSESSMENTS FOR ANTIMICROBIAL ACTIVITY". The contract is a task order under NIAID's larger "In Vitro Antimicrobial Assessments 2011-2018" indefinite delivery/indefinite quantity (IDIQ) contract vehicle. The contract does not have a set-aside...
This is a firm-fixed-price definitive contract awarded by the Food and Drug Administration (FDA), a civilian federal agency, to the Institute for Clinical Pharmacodynamics, Inc., a minority-owned for-profit organization based in Schenectady, New York. The $248,553.46 contract is for the development of modernized susceptibility guidance for the antibiotic nitrofurantoin using a dynamic urinary tract in vitro infection model and pharmacometric approaches. This award is part of the FDA's Broad Agency Announcement (BAA) program, which funds extramural research and development to support the agency's regulatory science and innovation objectives. The contract has no set-aside designation. The research under this contract aligns with the FDA's efforts to combat antibiotic-resistant bacteria and improve clinical treatment guidelines.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Award Notice | FDABAA-24-00123_Award | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Special Notice 2/2 | 10/18/24, 12:29 PM | |
FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FDABAA-24-00123 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Pre-Solicitation 1/2 | 10/2/23, 3:21 PM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00002 | Other Administrative Action | $0 | 8/25/25 | |
| P00001 | Other Administrative Action | $0 | 3/11/25 | |
| Not listed | Not listed | $248.6k | 8/19/24 |