2-year, firm fixed price (FFP) type task order to procure comparative use human factors studies to assess the impact of differences between the user interfaces of a generic drug-device combination…
Ended Awarded Last action
- Contract number
- 75F40124F19002
- Awardee
-
Core Human Factors, Inc. UEI QMHTLLE1E5B3
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $501,830
Award facts
- Contract value 70% obligated
-
- $501,830.00 Current, with exercised options
- $711,830.00 Potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- NAICS code
- 541720 Research and Development in the Social Sciences and Humanities
- PSC
- B599 Special Studies/Analysis- Other
- Set-aside
- No set-aside
- Competition
- Full and Open Competition Negotiated Proposal / Quote
- Pricing
- Firm Fixed Price
- Place of performance
- Bala Cynwyd, PA 19004, USA
- Legislative mandates
-
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Exercise an Option | $307,090 | |
| Original award | $194,740 |
About this award
The Food and Drug Administration (FDA) awarded a $711,830 firm fixed price delivery order to Core Human Factors, Inc. on September 18, 2024, under a 2-year task order for comparative use human factors (CUHF) studies. The work involves assessing the impact of user interface differences between generic drug-device combination products and their reference listed drugs. This delivery order is part of Core Human Factors, Inc.'s single-award Indefinite Delivery Contract (IDC) with the FDA valued at $10 million and active through September 2028. The work will be performed in Bala Cynwyd, Pennsylvania, with an ultimate completion date of September 29, 2026, and no set-aside designation was used for this award.
Core Human Factors, Inc., an S-corporation specializing in human factors research for the pharmaceutical and medical device industries, conducts detailed usability and user interaction studies to support FDA regulatory review processes. The CUHF studies evaluate potential safety risks and user error rates associated with medical product design, providing critical insights into how interface differences might affect patient outcomes. The company's specialized expertise in assessing complex drug-device combinations, including pen-injector systems and generic alternatives, makes it well-positioned to deliver the comparative analysis required by the FDA to ensure medical product safety and usability compliance.
Description
2-year, firm fixed price (FFP) type task order to procure comparative use human factors studies to assess the impact of differences between the user interfaces of a generic drug-device combination product and its reference listed drug (cuhf) to suppo
Quick answers
Who was awarded contract 75F40124F19002?
75F40124F19002 was awarded to Core Human Factors, Inc. by Food and Drug Administration (Department of Health and Human Services) on September 18, 2024.
How much is contract 75F40124F19002 worth?
The government has obligated $501,830 on 75F40124F19002. Its potential value, with all options, is $711,830.
Is contract 75F40124F19002 an order under another contract?
Yes. 75F40124F19002 is a delivery order under 75F40123D00028, an indefinite delivery contract.
Was contract 75F40124F19002 competed?
The extent of competition for 75F40124F19002 was full and open competition.
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