Broad agency announcement (BAA) contract -- developing novel clinical outcome assessments for pediatric asthma to facilitate innovative patient-focused drug development and aid regulatory decision…

Ended Definitive Contract Awarded Last action

Contract number
75F40119C10135
Awardee
Awarding agency
Obligated
$2,739,757

Award facts

Opportunity
  • FDABAA1900123 Solicitation number
Contract value 100% obligated
$2,739,756.59 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 · 12 offers Negotiated Proposal / Quote
Pricing
Cost No Fee
Place of performance
Tucson, AZ 85718, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Close Out P00009 · The purpose of this modification is to DE-obligate funds and close out the contract. -$18,014
Other Administrative Action P00008 · COR change $0
Supplemental Agreement for work within scope P00007 $0
Other Administrative Action P00006 $1,998,446
Other Administrative Action P00005 -$1,998,446
Other Administrative Action P00004 $0
Other Administrative Action P00003 $0
Supplemental Agreement for work within scope P00002 $0
Supplemental Agreement for work within scope P00001 $0
Original award $2,757,771

About this award

Written by GovTribe AI ·

The Food and Drug Administration (FDA) awarded a definitive, cost-no-fee contract valued at $2.74 million to The Critical Path Institute (C-Path), a non-profit research organization based in Tucson, Arizona, under a Broad Agency Announcement (BAA) solicitation. The contract, awarded on September 30, 2019, supported the development of novel clinical outcome assessments for pediatric asthma to facilitate innovative, patient-focused drug development and aid regulatory decision-making. C-Path, which operates as a public-private partnership entity specializing in creating standardized frameworks and clinical assessment tools for drug development, was well-positioned to execute this work through its established collaborative relationships with the FDA and academic institutions. The contract was performed in Tucson, Arizona, with an ultimate completion date of September 29, 2025. No small business set-aside was utilized for this award.

This contract represents part of the FDA's broader initiative to advance patient-centric drug development methodologies by establishing validated measurement approaches for pediatric populations. The current modification to the contract de-obligates remaining funds and closes out the award, concluding C-Path's work on this pediatric asthma assessment initiative. C-Path's experience in generating quantitative evidence, conducting psychometric analyses, and producing qualification packages for clinical outcome assessment tools made it instrumental in advancing the FDA's regulatory science capabilities and supporting more efficient medical product development pathways for pediatric asthma treatments.

Description

As the agency reported it.

Broad agency announcement (BAA) contract -- developing novel clinical outcome assessments for pediatric asthma to facilitate innovative patient-focused drug development and aid regulatory decision making

Quick answers

Who was awarded contract 75F40119C10135?

75F40119C10135 was awarded to The Critical Path Institute by Food and Drug Administration (Department of Health and Human Services) on September 30, 2019.

How much is contract 75F40119C10135 worth?

The government has obligated $2,739,757 on 75F40119C10135.

Was contract 75F40119C10135 competed?

The extent of competition for 75F40119C10135 was full and open competition. The government received 12 offers.

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