Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, September 16 at 2:00 PM EDT

Register Free →

CDISC Membership

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

Show more

The Food and Drug Administration is renewing its annual membership in CDISC, the foundational data standard critical to its clinical and non-clinical regulatory reviews. This membership ensures the FDA remains at the forefront of global regulatory innovation by actively participating in the development and refinement of industry-wide data standards. Without CDISC, the agency would be unable to modernize its review processes effectively, compromising efficiency, consistency, and interoperability in evaluating medical products. The cost of renewal is minimal relative to the strategic value it delivers, enabling the FDA to maintain leadership in shaping global regulatory data practices. The opportunity is forecasted for posting on May 25, 2026, under NAICS code 813920, and is managed by the FDA's Center for Drug Evaluation and Research. The primary point of contact for program inquiries is cderacquisitions@fda.hhs.gov, while the contracting officer position is currently pending assignment. There is no set-aside classification specified, and the place of performance is not defined, indicating that this is a non-location-specific organizational membership rather than a service contract with physical deliverables. The continued investment in CDISC membership supports the FDA’s mission to uphold the highest standards of data integrity and regulatory science worldwide.

General Info

FDA renews CDISC membership to maintain and advance clinical data standards globally.

Agency

Food and Drug Administration → Food And Drug AdministrationView Agency

NAICS

813920 - Professional OrganizationsView NAICS

Place of Performance

USA

Set-Aside

NONE

Documents

(0)

No documents available

AI Contract Breakdown

Uniform Contract Format

No contract breakdown available.

Cannot generate Contract Breakdown because no documents were found from this contract's source.

Timeline

Posted

forecast

Ready to pursue this opportunity?

Start your free trial to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

Show more
AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Organization / Agency
Food and Drug Administration → Food And Drug Administration
View Agency Profile
Office AddressN/A
Contacts
Cder Acquisition Liaison
To Be Determined To Be DeterminedContracting Officer

Full Description

Show more
The CDISC standard serves as the foundational data standard for FDA's daily operations in conducting clinical and non-clinical reviews. Our continued participation in CDISC discussions and standard development ensures that FDA maintains its position as the leading global regulatory health authority in establishing critical data standards. Without proper data standards like CDISC, FDA cannot effectively modernize the regulatory review process. The annual membership renewal cost ( per year) represents a minimal investment that enables FDA to exercise leadership in the global regulatory review arena.

Similar Contracts

Same NAICS industry code

More opportunities from Food and Drug Administration → Food And Drug Administration

Same awarding agency

NAICS: 334516
New
Federal
CARR PowerFuge Pilot Separation System
Solicitation # 75F40126Q00172
The Food and Drug Administration, under the Department of Health and Human Services, is pursuing a sole source procurement for one CARR® PowerFuge® Pilot Separation System (C1015PLT) with all required accessories under FAR 13.106-1(b)(1), citing the system’s unique technical specifications and compatibility with existing validated CFPS workflows as justification for excluding competition. The system must be a pilot-scale continuous-feed centrifuge with an imperforate solid bowl design, capable of operating at or above 20,000 × g, featuring integrated cooling and a removable autoclavable titanium bowl, as detailed in the Statement of Work dated March 3, 2026. The procurement is structured as a firm-fixed-price purchase order with delivery required within 90 days of contract award, and no set-aside provisions apply. The solicitation number is 75F40126Q00172, posted on June 15, 2026, with a response deadline of June 22, 2026, at 3:00 PM Eastern Time. Interested parties are invited to submit a capability statement demonstrating their ability to meet all SOW requirements via email to the primary point of contact, Jennifer Mun, but such submissions are solely for the government's evaluation of whether to proceed with competition—responses do not constitute offers and will not be evaluated for award. The government does not assume any costs incurred by respondents in preparing submissions. The contracting office is located in Rockville, Maryland, and the related NAICS code is 334516. No contract value, pricing, inspection criteria, packaging requirements, or administrative details have been disclosed beyond the intent to sole source to CARR Biosystems.
Analytical Laboratory Instrument Manufacturing

POSTED

about 15 hours ago

DEADLINE

in 5 days
View Details

Ready to Pursue This Opportunity?

Get AI-powered intelligence on this solicitation and the ones like it

Every page of the solicitation package shredded into a compliance breakdown

AI-powered matching based on your capabilities and past performance

Competitor and incumbent history on the requirement

Automated alerts on amendments, Q&A deadlines, and award

Miguel
Hillary
Keith Deutsch
Christine

Join 650+ contractors already using CLEATUS