Contract research organization (CRO) support for blueprint medtech (bpmt) regulatory affairs support and related services. Ordering period: 9/22/2022 - 9/21/2027. N02DA-22-1235.

Active Indefinite Delivery Contract Awarded Last action

Contract number
75N95022D00020
Awardee
Awarding agency
Task orders
4 $461,124 obligated

Award facts

Opportunity
Combined order value
$461,124 Current and potential, with all options
Last date to order 82% complete
IDV ceiling 2% used
$24,000,000.00
Award type
Single award
Who can order
Only the awarding agency
Set-aside
No set-aside
Competition
Full and Open Competition · 6 offers Negotiated Proposal / Quote
Pricing
Cost Plus Fixed Fee
Legislative mandates

Award details come from SAM.gov/FPDS.

About this IDV

The National Institute on Drug Abuse awarded a single-award indefinite-delivery contract to PPD Development LP on September 22, 2022, with a ceiling of $24 million for contract research organization support focused on Blueprint MedTech regulatory affairs and related services. The contract runs from September 22, 2022, through September 21, 2027.

Place of performance is Cape Fear, North Carolina. The IDIQ was solicited as a pre-solicitation opportunity posted November 24, 2021, with a due date of December 13, 2021.

Task orders issued under this IDIQ include regulatory consulting assistance for medical device developers, research and development for clinical studies, FDA pre-submission assessments, and package preparation. Recent delivery orders include a $370,621 cost-plus-fixed-fee order awarded April 9, 2024, for regulatory consulting assistance and clinical study research and development through April 8, 2029; a $63,603.26 cost-plus-fixed-fee order awarded September 15, 2023, for regulatory consulting and clinical study support with performance ending December 31, 2024; a $21,566 cost-plus-fixed-fee order awarded September 22, 2022, for FDA pre-submission preparation; and a $5,334 cost-plus-fixed-fee order awarded December 20, 2024, for pre-submission support preparation with completion by December 19, 2025. All task orders are priced on a cost-plus-fixed-fee basis with no set-asides applied.

Task orders

Transactions

Action Obligated Date
Other Administrative Action P00003 $0
Other Administrative Action P00002 $0
Supplemental Agreement for work within scope P00001 $0
Original award $0

Quick answers

Who was awarded contract 75N95022D00020?

75N95022D00020 was awarded to PPD Development LP by National Institute on Drug Abuse (National Institutes of Health) on September 22, 2022.

How much is contract 75N95022D00020 worth?

Orders under 75N95022D00020 have obligated $461,124. 75N95022D00020's own ceiling is $24,000,000.

How many orders have been placed under contract 75N95022D00020?

4 orders have been placed under 75N95022D00020, the latest on December 20, 2024.

Who can order from contract 75N95022D00020?

75N95022D00020 is a single award indefinite delivery contract. Only the awarding agency can place orders on it.

Was contract 75N95022D00020 competed?

The extent of competition for 75N95022D00020 was full and open competition. The government received 6 offers.

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