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Notice to Extend the Expiration Date of PA-24-245 PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

The purpose of this notice is to extend the expiration date of PA-24-245 PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) by one receipt date. PA-24-245 will now expire on September 6, 2025.

Due to the extension, the following dates will be added:

Standard application due date : September 5, 2025
Scientific Merit Review: November 2025
Advisory Council: January 2026

The following sections of the NOFO have been changed:

Part 1. Overview Information, Key Dates

Currently reads:

Application Due DatesReview and Award CyclesNewRenewal / Resubmission / Revision (as allowed)AIDS – New/Renewal/Resubmission/Revision, as allowedScientific Merit ReviewAdvisory Council ReviewEarliest

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Implementation Update: Promoting Maximal Transparency Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Institutional Biosafety Committees (IBCs) serve as a critical linchpin in ensuring the safe and responsible conduct of research. Since the issuance of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) in 1976, IBCs have expanded in number to the thousands and have voluntarily expanded their roles to encompass new research approaches as they arise.

IBCs continue to serve as a pillar of biosafety oversight and are essential in building trust on behalf of the biomedical research enterprise. Under the NIH Guidelines, this expectation is a mandate and as such, NIH is reinforcing its commitment to working with IBCs to ensure transparency in biosafety oversight by updating its implementation expectations to protect the safety of all

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Protecting Human Genomic Data when Developing Generative Artificial Intelligence Tools and Applications

Artificial intelligence (AI) tools and applications are proving to be transformative for driving new biomedical research advances. While development and use of generative AI is becoming increasingly prevalent, NIH urges the research community to remain vigilant of potential risks of inadvertent data disclosure when sharing AI tools and applications. Specifically, NIH reminds researchers that:

The Genomic Data Sharing (GDS) Policy and the subsequent Data Use Certification (DUC) Agreement prohibit users from distributing controlled-access data (including genomic or associated data) or their Data Derivatives to any entity or individual not identified in their Data Access Request without appropriate written approvals from the NIH. Sharing, retaining, or training generative AI models using controlled-access human genomic data may risk disclosing controlled-access data and, thus, violates the Non-Transferability provision of

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Rescission of the Final Scientific Integrity Policy of the National Institutes of Health

The purpose of this Notice is to rescind the Final Scientific Integrity Policy of the National Institutes of Health (NIH), issued under NOT-OD-24-178, to ensure alignment with the Administration’s priorities. The NIH remains committed to upholding the principles of scientific integrity and has multiple interlocking policies that support and promote scientific integrity across the agency, including policies on research misconduct, authorship, human and animal subject protections, and data management and sharing, which will continue. This Notice only applies to the Final Scientific Integrity Policy of the NIH and not to any policies cited therein. Additionally, the NIH will adhere to the HHS Scientific Integrity Policy to advance scientific integrity goals. 

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