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Specialized Regulatory & Legal Support

Active

Federal

Response Deadline12/04/2026, 05:00:00 PM UTC

Contract Overview

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

AI Contract Overview

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The Specialized Regulatory and Legal Support subcontract provides essential legal and regulatory guidance for prime contractors working on diagnostic device projects for the National Institutes of Health and the National Institute of Biomedical Imaging and Bioengineering. The scope of work includes drafting and managing Non-Disclosure Agreements and Material Transfer Agreements, as well as offering expert guidance on FDA regulatory filings. The primary deliverables for this engagement are executed NDAs, MTAs, and completed regulatory filing documentation. To qualify for this role, providers must possess legal bar certification and demonstrated expertise in FDA diagnostic industry guidance. This opportunity is managed under the Department of Health and Human Services and the National Institutes of Health Olao, falling under NAICS code 541110. Interested parties must submit their responses by the deadline of December 4, 2026.

General Info

Legal and regulatory support for NIH diagnostic projects; requires bar certification; deadline 12/4/2026.

Agency

Department Of Health And Human Services → National Institutes Of Health Olao

NAICS

541110 - Offices of Lawyers

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of 75N98027R00015.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

R--National Institute of Biomedical Imaging and Bioengineering (NIBIB) Innovation

AI Contract Breakdown

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Timeline

PostedNov 3

subcontract

Response DeadlineDec 4

Submission deadline

Response Deadline

12/04/2026, 05:00:00 PM UTCin about 1 month

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

Office AddressN/A

ContactsNo contact information available

Full Description

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Provides legal and regulatory guidance for prime contractors on NIH/NIBIB diagnostic device projects. Drafts and manages Non-Disclosure Agreements (NDAs) and Material Transfer Agreements (MTAs) and provides guidance on FDA regulatory filings. Requires legal bar certification and expertise in FDA diagnostic industry guidance. Delivers executed NDAs, MTAs, and regulatory filing documentation.

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