Delivery Order 75F40123D00028-75F40123F19001
- Not listed
- This is a 2-year, firm-fixed-price (FFP) task order awarded to Core Human Factors, Inc. by the Food and Drug Administration (FDA) to procure comparative use human factors (CUHF) studies. The studies will assess the impact of differences between the user interfaces of a generic drug-device combination product and its reference listed drug. The $711,830.00 task order is not set aside and is part of a larger $10,000,000 Indefinite Delivery Contract (IDC) that Core Human Factors, Inc. holds with the...
- The Food and Drug Administration (FDA) awarded a $1,046,568.62 firm-fixed price delivery order to Integrated Behavioral Health, Inc., a for-profit subchapter S corporation, to study the prevalence, experiences, knowledge, and perceptions of falsified and unapproved pharmaceuticals among individuals being assessed for or entering substance use disorder treatment. This delivery order is part of a larger $10 million indefinite delivery contract the FDA has with Integrated Behavioral Health to...
- This is a firm fixed price delivery order issued by the Food and Drug Administration (FDA), a civilian agency within the U.S. Department of Health and Human Services (HHS), to Spaulding Clinical Research, LLC, a self-certified small disadvantaged business. The $6,561,386.54 contract is for a range of clinical and laboratory applied regulatory science services that support the FDA's regulatory science programs and decision-making across product lifecycles. Services include conducting clinical...
- This is a delivery order contract awarded by the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to Ihrc, Incorporated, a self-certified small disadvantaged, woman-owned business. The contract is for a Subject Matter Expert to support the development and evaluation of microbiological methods for cosmetics. It is a firm fixed price contract with a potential value of $798,872.66 and a completion date of August 16, 2023. The contract was issued under the FDA's...
- This is a $9,671,431.00 firm fixed-price definitive contract awarded by the Food and Drug Administration (FDA), a civilian agency, to Safe Health Systems, Inc., a self-certified small disadvantaged business. The contract is to stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes. The contract has a period of performance through March 27, 2026 and does not utilize a set-aside. No additional details about larger contract...
- This is a new task order awarded under an existing Indefinite Delivery Indefinite Quantity (IDIQ) contract (HHSF223201610004I) with the Department of Health and Human Services Food and Drug Administration (FDA). The task order, valued at $2,470,791.00, is for a Pharmacokinetic (PK) study of opioid drug products following oral ingestion of chewed products. The study falls under the FDA's In Vivo Study of Generic Drug Products in Human Subjects program. The contract is a Firm Fixed Price...
- This is a Firm Fixed Price delivery order awarded by the Food and Drug Administration (FDA) to Integrated Behavioral Health, Inc., a for-profit subchapter S corporation. The $1,024,971 contract is for data resources and surveillance reports to support post-marketing monitoring of non-medical use of pharmaceuticals and illicit drug use. The contract has a six-month performance period with a completion date of September 29, 2026. This delivery order is part of a larger $10 million FDA indefinite...
- This is a Firm Fixed Price delivery order awarded by the Department of Health and Human Services Food and Drug Administration (HHS/FDA) to Inflexxion, Inc., a for-profit organization. The contract, with a potential value of $754,500.62, is for a DATA ENHANCEMENT PROJECT under the FDA Prescription Drug Abuse Summary Reports Master IDIQ contract vehicle. The project aims to provide DATA RESOURCE FOR POST-MARKETING PRESCRIPTION AND OVER-THE-COUNTER DRUG ABUSE SURVEILLANCE DATA. The contract does...
- This is a Firm Fixed Price delivery order awarded by the Food and Drug Administration (FDA), a civilian agency, to Eastern Research Group Inc., a for-profit Subchapter S corporation, for a study on "PATIENT EXPERIENCE DATA IN REGULATORY DECISION MAKING." The contract award, valued at $520,205.00, is associated with the FDA's Center for Drug Evaluation and Research (CDER) Priority Analysis indefinite delivery, indefinite quantity (IDIQ) contract vehicle. There is no set-aside...
- The U.S. Department of Health and Human Services Food and Drug Administration awarded a $6.9 million delivery order to Aeio LLC under the agency's FDA Human Resource Support Services 2017-2022 master indefinite-delivery, indefinite-quantity contract. The purpose of this task order is to provide human capital and human resources management support services to help ensure mutual understanding of objectives, roles, responsibilities, and timeframes related to efforts sponsored by the Center for Drug...
- 75F40123D00028Indefinite Delivery Contract
- 75F40123D00028-75F40123F19001Delivery Order
This firm-fixed-price delivery order was awarded by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services, to Core Human Factors, Inc., a for-profit S-corporation. The $404,063 contract is to conduct a comparative use human factors study that evaluates whether certain user interface differences between pen-injector combination products affect user error rates among diabetic patients. This study is part of a larger $10,000,000 Indefinite Delivery Contract (IDC) awarded to Core Human Factors, Inc. in September 2023, which serves as a vehicle for the FDA to procure comparative use human factors studies on drug-device combination products. The contract does not have a set-aside designation and was awarded non-competitively. These studies contribute to the FDA's efforts to ensure the usability and safety of combination products through applied human factors research, providing valuable insights that can guide regulatory reviews and product improvements in the medical device industry.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00003 | Other Administrative Action | $0 | 12/5/24 | |
| P00002 | Exercise an Option | $209.1k | 8/20/24 | |
| P00001 | Other Administrative Action | $0 | 10/16/23 | |
| Not listed | Not listed | $195.0k | 9/28/23 |