SOAR Recompete - NIA 210501
Past New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Points of contact
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The National Institutes of Health's National Institute on Aging (NIA) is forecasting a new requirement under the SOAR Recompete (NIA 210501) for human subjects safety oversight, regulatory compliance, and risk management for ongoing NIA-supported clinical trials, with an estimated solicitation release on June 1, 2026 and an estimated award on July 1, 2026. The contract supports NIA's statutory mandate under 42 U.S.C. 285e and the agency's obligations under 45 CFR Part 46 (HHS Common Rule), 21 CFR Parts 50 and 56 (FDA regulations), and 42 CFR Part 11 (ClinicalTrials.gov registration and results reporting). The source states that discontinuing the contract would disrupt NIA's oversight of federally funded clinical trials and compromise its ability to meet these obligations.
The forecast uses no set-aside and is classified under NAICS 541690 (Other Scientific and Technical Consulting Services), with an estimated award value range of $250,000 to $700,000. Points of contact are Patricia Da Silva, Contract Specialist, at patricia.dasilva@nih.gov or +1 301-827-1980, and Melissa Stryker at melissa.stryker@nih.gov, both with the National Institutes of Health.
Forecast text
This contract is essential to the execution of the National Institute on Aging's (NIA) statutory mandate, as codified in 42 U.S.C. 285e, which authorizes the Institute to "conduct and support biomedical, social, and behavioral research and training with respect to the aging process and the diseases and other special problems and needs of the aged." To fulfill this congressional directive, NIA must ensure that all human subjects research it supports complies with applicable federal statutes and regulations that safeguard participant safety, uphold scientific integrity, and ensure robust regulatory oversight. In direct support of this mandate, the contract provides critical technical expertise in human subjects safety oversight, regulatory compliance and risk management for ongoing NIA-supported clinical trials. Specifically, the contract enables the NIA to fulfill federal obligations governing human subject protection under 45 CFR Part 46 (HHS Common Rule) and 21 CFR Parts 50 and 56 (FDA regulations). These enforceable federal regulatory frameworks and standards are collectively designed to protect the safety, rights, and welfare of human research subjects and integrity of the federally supported research enterprise. If the services under this contract are not continued, the National Institute on Aging (NIA) would face immediate and significant disruption in meeting its statutory, regulatory, and operational responsibilities related to the oversight of federally funded clinical trials, and potential loss of federal investment. Discontinuation of this contract would compromise NIA's ability to fulfill its legal obligations under 45 CFR Part 46 (HHS regulations), 21 CFR Parts 50 and 56 (FDA regulations), and 42 CFR Part 11 (ClinicalTrials.gov registration and results reporting).
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