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)
Active Indefinite Delivery Contract Awarded
- Contract number
- 75F40123D00028
- Awardee
-
Core Human Factors, Inc. UEI QMHTLLE1E5B3
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Task orders
- 2 $905,893 obligated
Award facts
- Combined order value
-
- $905,893 Current, with exercised options
- $1,115,893 Potential, with all options
- Last date to order 62% complete
- IDV ceiling 9% used
- $10,000,000.00
- Maximum order
- $10,000,000.00
- Award type
- Single award
- Who can order
- Only the awarding agency
- 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 · 2 offers Negotiated Proposal / Quote
- Pricing
- Firm Fixed Price
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
Award details come from SAM.gov/FPDS.
About this IDV
The Department of Health and Human Services Food and Drug Administration awarded a single award indefinite delivery contract to Core Human Factors, Inc. with a potential value of $10,000,000. The contract aims to procure comparative use human factors studies to assess the impact of differences between the user interfaces of generic drug-device combination products and their reference listed drugs.
A firm fixed price delivery order for $1,035,113 was issued against this contract. Core Human Factors, Inc. will conduct a comparative use human factors study in Silver Spring, Maryland over a two year period to assess whether certain user interface differences between pen-injector combination products affect user error rates among diabetic patients. The study seeks to evaluate whether such differences could impact safe and effective use of these combination products.
The contract and delivery order were awarded non-competitively using no set-aside and will further the FDA's mandate to ensure the usability and safety of combination products through applied human factors research. Insights from these studies can guide regulatory reviews and product improvements. The prime contractor will perform the work in Silver Spring, Maryland through September 2025.
Task orders
Quick answers
Who was awarded contract 75F40123D00028?
75F40123D00028 was awarded to Core Human Factors, Inc. by Food and Drug Administration (Department of Health and Human Services) on September 19, 2023.
How much is contract 75F40123D00028 worth?
Orders under 75F40123D00028 have obligated $905,893. Their combined potential value, with all options, is $1,115,893. 75F40123D00028's own ceiling is $10,000,000. A single order can be worth up to $10,000,000.
How many orders have been placed under contract 75F40123D00028?
2 orders have been placed under 75F40123D00028, the latest on September 18, 2024.
Who can order from contract 75F40123D00028?
75F40123D00028 is a single award indefinite delivery contract. Only the awarding agency can place orders on it.
Was contract 75F40123D00028 competed?
The extent of competition for 75F40123D00028 was full and open competition. The government received 2 offers.
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