Definitive Contract 75F40120C00138
- Not listed
- This is a firm fixed price purchase order awarded by the Department of Health and Human Services' Food and Drug Administration to Husson University, doing business as Nescom, to develop and validate an in vitro cell permeation model and use in vitro to in vivo extrapolation (IVIVE) methods to predict drug transfer into human milk. The award, with a potential value of $264,880, supports tasks such as developing and validating a human mammary epithelial permeability assay, assessing xenobiotic...
- This is a $301,019.50 firm fixed-price contract awarded by the Food and Drug Administration (FDA) to The Research Foundation for the State University of New York (SUNY) for a project titled "Predicting the Transfer of Breast Cancer Resistant Protein (BCRP) Substrates into Human Milk Using In Vitro to In Vivo Extrapolation (IVIVE)". The contract has a period of performance through March 27, 2024 and does not have a set-aside designation. The Research Foundation for SUNY is a...
- 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 $3,526,785.00 definitive, firm fixed-price contract awarded by the Food and Drug Administration (FDA) to the Regents of the University of Michigan, doing business as the University of Michigan, for Prediction of In Vivo Performance Analysis Services. The contract has no set-aside designation. The University of Michigan is providing a range of research and development services under this contract, including developing high-performance computational models to simulate small intestine...
- The Department of Health and Human Services Food and Drug Administration awarded a $247,100 time and materials purchase order contract to Texas A&M Agrilife Research of College Station, Texas. The contract is for a systematic review of contaminant composition in human milk and infant formula to be performed from September 2023 through December 2024. As indicated in the attached notice of intent, the FDA is sole sourcing this requirement to Texas A&M Agrilife Research based on its...
- This is a $1,283,378.00 delivery order contract awarded by the Food and Drug Administration (FDA), a civilian federal agency, to the National Academy of Sciences (NAS), a non-profit organization. The contract is for a consensus study titled "Challenges in Supply, Market Competition and Regulation of Infant Formula in the United States." The contract has a period of performance through September 29, 2025 and is a labor-hour type contract. NAS is an experienced federal contractor,...
- The Department of Health and Human Services Food and Drug Administration (FDA) awarded a $1,050,000.00 definitive contract to The Research Foundation For The State University Of New York (SUNY) to conduct a study on the systemic approach to predicting the excretion of antidepressants into breast milk. This contract does not have a set-aside designation. The original solicitation was a Broad Agency Announcement (BAA) issued by the FDA seeking advanced research and development proposals to support...
- This is a $52,895 firm fixed-price purchase order awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to Metabolon, Inc., a small disadvantaged business. The contract is for global untargeted metabolomics analysis of 149 breast milk samples. The purpose is to support NIAID's research on finding biomarkers to identify infants prone to developing food allergy. This is a sole-source award under the statutory authority of...
- This is a $460,000 firm fixed price definitive contract awarded by the Food and Drug Administration (FDA) to the University of Maryland, Baltimore (UMB) on September 12, 2024. The contract is for characterizing albumin-bound nanoparticle drugs using nuclear magnetic resonance (NMR) and has a completion date of September 29, 2026. The contract was awarded under the FDA's Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. No set-aside was...
- <p>The National Institutes of Health Office of Logistics and Acquisition Operations awarded a $1,497,220 delivery order contract to the National Academy of Sciences to develop a framework addressing legal, ethical, regulatory, and policy issues for research specific to pregnant and lactating persons. The contract, which runs from September 22, 2022 through May 31, 2024, will utilize a cost no fee pricing structure and be performed in Washington, D.C.</p>
This is a $584,639 firm-fixed-price definitive contract awarded by the Food and Drug Administration (FDA) to Husson University, doing business as Nescom, for a research project titled "PREDICTING THE TRANSFER OF BREAST CANCER RESISTANT PROTEIN (BCRP) SUBSTRATES INTO HUMAN MILK USING IN VITRO TO IN VIVO EXTRAPOLATION (IVIVE)." The contract, which has a completion date of September 27, 2023, does not have a set-aside designation. Nescom, a private non-profit educational institution, is the prime contractor with no major subcontractors identified. The research project aims to develop in vitro cell permeation models and utilize IVIVE methods to facilitate physiologically-based pharmacokinetic (PBPK) modeling for predicting the transfer of drugs and substances into human milk.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00002 | Other Administrative Action | $0 | 6/2/21 | |
| P00001 | Other Administrative Action | $0 | 3/24/21 | |
| Not listed | Not listed | $283.6k | 9/28/20 |