Comparative use human factors study to assess whether certain user interface differences between pen-injector combination products affect user error rates among diabetic patients
Ended Awarded Last action
- Contract number
- 75F40123F19001
- Awardee
-
Core Human Factors, Inc. UEI QMHTLLE1E5B3
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $404,063
Award facts
- Contract value 100% obligated
- $404,063.00 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- Contracting staff
- 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
- Silver Spring, MD 20993, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Exercise an Option | $209,100 | |
| Other Administrative Action | $0 | |
| Original award | $194,963 |
About this award
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.
Quick answers
Who was awarded contract 75F40123F19001?
75F40123F19001 was awarded to Core Human Factors, Inc. by Food and Drug Administration (Department of Health and Human Services) on September 28, 2023.
How much is contract 75F40123F19001 worth?
The government has obligated $404,063 on 75F40123F19001.
Is contract 75F40123F19001 an order under another contract?
Yes. 75F40123F19001 is a delivery order under 75F40123D00028, an indefinite delivery contract.
Was contract 75F40123F19001 competed?
The extent of competition for 75F40123F19001 was full and open competition.
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