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This Government Contract opportunity from Department Of Health And Human Services was posted on August 25, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Technical Documentation and Hemolysis Safety Reporting

Closed
Federal

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This subcontract with the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services focuses on the preparation and submission of technical documentation regarding hemolysis safety. The primary objective is to develop a comprehensive safety history and risk profile, supported by necessary documentation as outlined in SOW Section 4.7.2, to facilitate a formal FDA regulatory review. The opportunity was posted on August 25, 2026, with a response deadline of September 3, 2026. Classified under NAICS code 541690, the contract requires specialized technical reporting to ensure compliance with regulatory safety standards for hemolysis-related data.

General Info

FDA subcontract for preparing hemolysis safety technical documentation to support regulatory review.

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of 75F40126Q00391.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

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Pulsed Field Ablation System (PFA)

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Preparation and submission of hemolysis-related safety history, risk profile, and supporting documentation in accordance with SOW Section 4.7.2 for FDA regulatory review.

More opportunities from Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

Same awarding agency

NAICS: 541611
Federal
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
Solicitation # 75F40126R00009
Solicitation 75F40126R00009 is a request for proposals for a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract to provide Contractor-Hosted Fully Integrated Records Facility (FIRF) services for the FDA. This acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns under NAICS code 541611. The contract features a five-year ordering period from December 1, 2026, through November 30, 2031, with an additional six-month option to extend services. The IDIQ has a maximum ceiling of 50 million dollars and a guaranteed minimum of 10,000 dollars. Task orders may be issued as Time-and-Materials, Labor-Hour, Firm-Fixed Price, or a combination thereof. The scope of work involves providing personnel, materials, and facilities for offsite document control services, with a strategic goal of transitioning to a near 100 percent electronic environment for premarket and postmarket submissions. Key responsibilities include program management, document processing, data and stakeholder support, and records management. Award will be made on a Lowest Price-Technically Acceptable (LPTA) basis, with technical factors and past performance evaluated as acceptable or unacceptable. Proposals are due by 2:00 PM Eastern Time on October 29, 2026, and must be submitted in three separate volumes, strictly adhering to formatting and file type restrictions to avoid being deemed non-responsive.
Administrative Management and General Management Consulting Services

POSTED

7 days ago

DEADLINE

in 3 days
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