Cder neurodevelopmental and mental health outcomes in preterm infants: effects of EXP

Ended Definitive Contract Awarded Last action

Contract number
75F40124C00081
Awardee
Awarding agency
Obligated
$237,268

Award facts

Opportunity
Contract value 100% obligated
$237,268.00 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Competed under SAP · 1 offer Simplified Acquisition
Pricing
Firm Fixed Price
Place of performance
New York, NY 10032, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Close Out P00003 · EOI::columbiau/PPP::EOI - FY26 UDO initiative -$813,042
Terminate for Convenience P00002 · EOI:: implementing the president's department of government efficiency cost efficiency initiative :: EOI $0
Other Administrative Action P00001 $0
Original award $1,050,310

About this award

The Food and Drug Administration awarded a $237,268 definitive contract to The Trustees of Columbia University in the City of New York on September 16, 2024, for a neurodevelopmental and mental health outcomes study in preterm infants exposed to opioid analgesic, anesthetic, and sedative agents.

The originating solicitation was a Broad Agency Announcement posted October 2, 2023, soliciting advanced research and development proposals to support FDA regulatory science across modernizing product development and evaluation, strengthening post-market surveillance and labeling, and enhancing public health preparedness and response. The contract covers a retrospective cohort study examining neurodevelopmental and mental health outcomes in preterm infants, using electronic health record data from Columbia University's Medical Center, Boston Children's Hospital, and Kaiser Permanente Northern California. The work includes data extraction, analysis of drug-exposure profiles, and stakeholder consensus activities to inform future study design and drug safety evaluation.

Place of performance is New York, NY. The ultimate completion date is March 7, 2025. Performance is firm fixed-price with no set-aside. Boston Children's Hospital and Kaiser Foundation Research Institute (Kaiser Permanente Northern California) are subcontractors contributing retrospective cohort data and supporting data analysis and outcomes evaluation across their respective patient populations.

Subawards

Subcontractor Amount Awarded
The Children's Hospital Corporation CDER NEURODEVELOPMENTAL AND MENTAL HEALTH OUTCOMES IN PRETERM INFANTS: EFFECTS OF EXP The Children’s Hospital Corporation d/b/a Boston Children’s Hospital… $225,162
Kaiser Foundation Hospitals CDER NEURODEVELOPMENTAL AND MENTAL HEALTH OUTCOMES IN PRETERM INFANTS: EFFECTS OF EXP Kaiser Foundation Research Institute, a Division of Kaiser Foundation… $70,097

Quick answers

Who was awarded contract 75F40124C00081?

75F40124C00081 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 16, 2024.

How much is contract 75F40124C00081 worth?

The government has obligated $237,268 on 75F40124C00081.

Was contract 75F40124C00081 competed?

The extent of competition for 75F40124C00081 was competed under sap. The government received 1 offer.

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