Definitive Contract 75F40118C10184
- Not listed
- This is a $787,013 cost-reimbursement contract awarded by the Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a non-profit organization, for the "Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers." The contract, which does not have a set-aside designation, was awarded on September 8, 2016 and has a completion date of June 29, 2019. C-Path's work under this contract involves collaborating with industry, academia, and patient...
- This is a definitive, firm fixed-price federal contract awarded by the Food and Drug Administration (FDA) to the non-profit organization The Critical Path Institute (C-Path), doing business as C-Path. The contract, which is not set aside for specific business types, has a ceiling value of $3,376,000.00 and a completion date of August 21, 2028. The contract is for the development of drug development tools for autosomal dominant tubulointerstitial kidney disease (ADTKD). C-Path, the prime...
- This is a definitive contract awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a nonprofit organization, to provide services in support of the agency's Model-Informed Drug Development (MIDD) program for the evaluation and development of neurological drug products. The $1,128,848.00 firm fixed-price contract has an anticipated completion date of August 31, 2023. C-Path has previously supported the FDA's...
- This federal contract award is for $4,418,256.96 to The Critical Path Institute (C-Path), a non-profit organization, by the Food and Drug Administration (FDA). The contract was awarded under the FDA's Broad Agency Announcement (BAA) EETWP #63 to develop "A STANDARDIZED FRAMEWORK TO SUPPORT FDA QUALIFICATION OF COMPLEX IN VITRO MODELS FOR USE IN REGULATORY SUBMISSIONS." The BAA solicits research and development proposals to advance regulatory science in various areas of interest for...
- This federal contract award, valued at $977,245.04, was issued by the National Cancer Institute, a civilian agency, to Pathrx, Inc., a small disadvantaged business. The award is for research and development in the biomedical (basic research) domain, with a period of performance ending on September 21, 2017. The contract type is a Definitive Contract with a Cost Plus Fixed Fee pricing structure, and there was no set-aside designation used. The place of performance is East Watertown, MA 02472.
- 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...
- Toxicologic Pathology Associates Inc. was awarded a $20.7 million definitive contract by the Department of Health and Human Services' Food and Drug Administration to provide onsite pathology services from July 2015 through July 2020. The contract has a small business set aside designation. As part of its mission to protect public health, the FDA utilizes pathology expertise to evaluate samples for issues impacting medical products and the safety of the food supply. This award draws on the...
- The U.S. Food and Drug Administration (FDA) awarded a $1,845,195.00 firm fixed price delivery order contract to Biopharma Services USA Inc., a foreign-owned small disadvantaged business, to conduct a randomized, open-label, two-treatment, four-period, single-dose, fully replicate, crossover bioequivalence (BE) study of tacrolimus capsules 5 mg. This task order was issued under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract with the ID HHSF223201610004I. The contract has a May 31,...
- The Food and Drug Administration (FDA) awarded a $724.5K definitive firm fixed-price contract to PPD Development LP on September 11, 2024, for development of a patient-reported outcome (PRO) burden measure focused on Cardiovascular-Kidney-Metabolic (CKM) syndrome. The contract, designated FDABAA-24-00123 with reference number FY24C1EP6, runs through November 15, 2026, and will be performed in Cape Fear, North Carolina. This contract represents a targeted effort to establish standardized...
- The U.S. Food and Drug Administration (FDA) awarded a $19,731,473.00 definitive contract to Zata Pharmaceuticals, Inc. for the development and maintenance of FDA-ARGOS 2 universal closed systems for pathogen reduction in donated whole blood units. This contract, awarded on September 27, 2021, has a completion date of September 26, 2025 and does not have a set-aside designation. The contract was issued under the FDA's Broad Agency Announcement for Advanced Regulatory Science, which solicits...
This is a definitive contract awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a non-profit organization. The contract, which does not have a set-aside designation, is for $1,594,872.00 and is for the development of novel kidney transplant drug development tools to enhance regulatory decision making and enable innovation in medical product development. The contract was awarded on September 19, 2018, with a completion date of December 30, 2022. C-Path has previously provided services to the FDA, including developing frameworks, models, and assessments to support the agency's regulatory science and biomarker qualification initiatives. This contract appears to be a continuation of C-Path's work in supporting the FDA's mission to protect and promote the health of the nation through advancing scientific knowledge, as outlined in the original solicitation.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
Broad Agency Announcement | FDABAA-18-00123 | Department of Health and Human Services Food and Drug Administration | Solicitation 1/1 | 2/13/18, 2:17 PM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00006 | Other Administrative Action | $0 | 8/25/22 | |
| P00005 | Other Administrative Action | $0 | 1/24/22 | |
| P00004 | Supplemental Agreement for work within scope | $0 | 11/9/21 | |
| P00003 | Change Order | $0 | 8/16/21 | |
| P00002 | Other Administrative Action | $0 | 11/1/19 |