The objectives of the proposed study are to examine the effects of postnatal management approaches (non-pharmacological, including ESC versus opioid replacement pharmacotherapy) and the timing and…
Ended Definitive Contract Awarded Last action
- Contract number
- 75F40123C00211
- Awardee
-
The Trustees Of Columbia University In The City Of New York UEI QHF5ZZ114M72 Part of The Trustees Of Columbia University In The City Of New York
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $520,616
Award facts
- Opportunity
-
- FY22 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Solicitation · FDABAA2200123 · Posted Nov 10, 2021
- Contract value 100% obligated
- $520,616.02 Current and potential, with all options
- Completion date 100% complete
-
- Current, with exercised options
- Potential, with all options
- Contracting staff
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Basic Research
- 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 |
|---|---|---|
| Close Out | -$340,379 | |
| Other Administrative Action | $0 | |
| Terminate for Convenience | $0 | |
| Other Administrative Action | $0 | |
| Exercise an Option | $423,419 | |
| Original award | $437,576 |
About this award
The Food and Drug Administration awarded a $520,616 definitive contract with firm fixed pricing to The Trustees of Columbia University in the City of New York (Health Sciences Division) on September 25, 2023, to examine the effects of postnatal management approaches for infants exposed to gestational opioids. The research will compare non-pharmacological interventions, including environmental soothing care, against opioid replacement pharmacotherapy, analyzing their impact on in-hospital outcomes relative to timing and duration of prenatal opioid exposure. The work will be performed in Silver Spring, Maryland, in support of the FDA's regulatory science initiatives. This non-set-aside contract was awarded through a Broad Agency Announcement posted in November 2021, which sought research and development proposals to develop new tools, standards, and approaches supporting safety, efficacy, and quality evaluations of FDA-regulated products.
The contract is currently undergoing modification to de-obligate funds and cancel unfunded items, with an ultimate completion date of September 29, 2025. Columbia University, a prominent academic research institution with extensive experience supporting federal agencies including the National Institutes of Health, Centers for Disease Control and Prevention, and National Heart, Lung, and Blood Institute, brings substantial biomedical research capabilities to this critical investigation of opioid-exposed infants. The research addresses an important public health concern related to neonatal opioid exposure and will contribute to evidence-based clinical management protocols for this vulnerable population.
Description
The objectives of the proposed study are to examine the effects of postnatal management approaches (non-pharmacological, including ESC versus opioid replacement pharmacotherapy) and the timing and duration of gestational opioid exposure on in-hospita
Subawards
| Subcontractor | Amount | Awarded |
|---|---|---|
| Kaiser Foundation Hospitals | $192,826 |
Quick answers
Who was awarded contract 75F40123C00211?
75F40123C00211 was awarded to The Trustees Of Columbia University In The City Of New York by Food and Drug Administration (Department of Health and Human Services) on September 25, 2023.
How much is contract 75F40123C00211 worth?
The government has obligated $520,616 on 75F40123C00211.
Was contract 75F40123C00211 competed?
The extent of competition for 75F40123C00211 was full and open competition. The government received 1 offer.
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