Pharmacokinetic and safety of antiretroviral and related drugs lactating women and breastfed infants study

Ended Awarded Last action

Contract number
75N94020F00002
Awardee
Awarding agency
Obligated
$685,624

Award facts

Contract value 100% obligated
$685,624.00 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Set-aside
No set-aside
Competition
Full and Open Competition Negotiated Proposal / Quote
Pricing
Cost No Fee
Place of performance
Durham, NC 27705, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Supplemental Agreement for work within scope P00005 · Nichd: r & d: pharmacokinetic and safety of antiretroviral and related drugs lactating women and breastfed infants study: non-severable $0
Other Administrative Action P00004 $0
Supplemental Agreement for work within scope P00003 $300,001
Other Administrative Action P00002 $0
Other Administrative Action P00001 $0
Original award $385,623

About this award

Duke University's Office of Research Administration was awarded a $685,624 delivery order contract by the National Institute of Child Health and Human Development (NICHD) on September 28, 2020, to support the Pharmacokinetic and Safety of Antiretroviral and Related Drugs in Lactating Women and Breastfed Infants Study. The non-severable contract, which carries no set-aside designation, is structured as a cost-no-fee arrangement with an ultimate completion date of June 30, 2026, and will be performed at Duke's Durham, North Carolina location. This research initiative addresses critical public health needs by investigating how antiretroviral medications used to treat HIV are transmitted through breast milk and their safety implications for nursing mothers and infants, contributing to evidence-based guidance for treatment protocols in resource-limited settings where breastfeeding is prevalent.

As a leading research institution with substantial federal contracting experience across biomedical research, clinical trials, and scientific innovation, Duke University is well-positioned to execute this specialized pharmacokinetic research. The NICHD funding reflects the institute's focus on maternal and child health outcomes, with this study providing essential data to optimize antiretroviral therapy safety and efficacy for vulnerable populations including lactating women and breastfed infants. The delivery order mechanism allows the government to leverage Duke's existing research infrastructure and expertise in drug safety evaluation as part of broader federal objectives to advance pediatric and maternal health research.

Quick answers

Who was awarded contract 75N94020F00002?

75N94020F00002 was awarded to Duke University by National Institute of Child Health and Human Development (National Institutes of Health) on September 28, 2020.

How much is contract 75N94020F00002 worth?

The government has obligated $685,624 on 75N94020F00002.

Is contract 75N94020F00002 an order under another contract?

Yes. 75N94020F00002 is a delivery order under 75N94018D00003, an indefinite delivery contract.

Was contract 75N94020F00002 competed?

The extent of competition for 75N94020F00002 was full and open competition.

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