Temporary Exemption of H5 Avian Influenza Viruses from Select Agents Regulations

Effective June 6, 2024, and for a period of 3 years, H5 avian influenza virus is temporarily exempt from the requirements of the regulations listed in 9 C.F.R. Part 121, as announced in Select Agents and Toxins Exemption: H5 Avian Influenza Virus. 

This decision will allow more laboratories to conduct research and develop solutions to address the disease while still protecting animal health and animal products. For the duration of the exemption, USDA’s Animal and Plant Health Inspection Service will issue permits for importation and interstate transportation of all H5 avian influenza viruses.

NIH Sets Expectations for Upholding the NIH-Lacks Family Agreement

NIH-supported investigators and institutions who generate HeLa cell whole genome sequence data (DNA or RNA), take note: You must include provisions in your Data Management and Sharing Plan for data to be submitted to the NIH database of Genotypes and Phenotypes (dbGaP) as a part of the HeLa Cell Genome Sequencing Studies. 

Investigators and institutions seeking access to HeLa cell data in dbGaP must submit a data access request to NIH and be approved to access those data.

NIH expects investigators who generate HeLa cell data or access such data to acknowledge Mrs. Henrietta Lacks and her family in any publications, presentations, or other public reporting of research. 

Refer to the May 24, 2024 Guide notice for complete details.

Answer Request for Information on All of Us Research Program Data

Through Request for Information (RFI) on Future Data Linkages Within the Center for Linkage and Acquisition of Data for the All of Us Research Program, NIH seeks feedback on potential data linkages that could add value to the All of Us Research Program’s data resource. For example, what new research might be enabled with the addition of economic factors and indicators (e.g., Distressed Communities Index) to the All of Us Researcher Workbench?

Find further instruction in the RFI linked above. Submit your response no later than June 28, 2024, by emailing AOUCLADRFI@od.nih.gov.

NIAID will support integrated multi-project research programs applying emerging and improved technologies to develop innovative gene- or cell-based HIV cure approaches. You can apply through the notice of funding opportunity (NOFO) Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01, Clinical Trial Not Allowed).

We expect applicants to leverage recent insights into virus-host interactions, genotype and phenotype of HIV latent cells, and reservoir cell survival and proliferation in order to achieve sustained viral remission in the absence of antiretroviral treatment or elimination of HIV infection from the body.

Each P01 award will include a minimum of three synergistic individual research projects. Research goals and objectives could include:

• Strategies to apply advanced novel genome engineering technologies to target HIV provirus DNA or RNA—to excise, inactivate, or silence the expression of the integrated viral genome or modulate gene expression and protein function.
• Cell- or tissue-targeting methods to enable in vivo delivery of gene therapies.
• Developing allogeneic or universal “off the shelf” cell and gene therapeutics.
• Approaches to modulate immune responses that impact therapeutic efficacy and dosing, including methods to reduce immunogenicity of delivery vectors or transgenes, avoidance of pre-existing immunity, or minimize elicitation of anti-drug antibodies.
• Ex vivo or in vivo gene modification to render cells resistant to infection or enhance the immune system's ability to suppress viral expression or to eliminate HIV-infected cells. 
• Novel methods to enhance transplantation and engraftment, or minimize rejection, of modified cells as part of an HIV-targeted transplantation strategy.
• Test-of-concept studies in appropriate animal models, including nonhuman primates. 

Refer to the NOFO for examples of the study types listed above.

Your P01 application must also include a private sector partnership to facilitate development of strategies appropriate for future clinical studies and ultimately commercialization, e.g., biotechnology, pharmaceutical, bioengineering, stem cell, and chemical companies.

Include an administrative core in your application to provide management, coordination, and supervision of both the scientific and fiscal aspects of the overall program. You may include scientific cores to provide resources or facilities that are essential for the activities of two or more research projects.

You must provide a Milestone Plan and identify significant research outcomes, with timelines, to reflect planning and management of the overall program. NIAID staff will negotiate the milestones prior to award and may renegotiate them during the project period.

Prior Consultation

This is a complicated NOFO. We strongly encourage potential applicants to arrange a prior consultation with Dr. Betty Poon, our scientific/research contact for this initiative, at poonb@mail.nih.gov or 240-669-5024. 

In the prior consultation, we can advise whether your proposed program meets the goals of this NOFO and discuss matters related to responsiveness. 

Application Details

Request a project period that reflects the scope of your proposed project. The maximum project period you may request is 5 years.

Similarly, request a budget that reflects the actual needs of your proposed project. Your budget request is not expected to exceed $2.2 million in annual direct costs.

The deadline to apply is July 30, 2024, at 5 p.m. local time of the applicant organization. 

Again, direct questions about this initiative to Dr. Betty Poon, whose contact details are listed above. For concerns related to peer review, reach out to Dr. Bruce Sundstrom at sundstromj@niaid.nih.gov or 240-669-5045.

NIAID issued Notice of Special Interest (NOSI): Development of Organotypic Culture Models for Transplantation Immunology Research to invite applications to develop and validate tissue-, stem-, or progenitor-cell-derived “3D” organotypic culture models (OCM) for transplantation immunology research.

There are several advantages of OCM compared to traditional 2D cell cultures, including improved modeling of tissue architecture, cell-cell interactions, and other microenvironmental aspects of tissues and organ systems. Recent developments in OCM have extended the potential use of these models to investigate complex immunological systems in vitro. 

Research Objectives

This NOSI aims to leverage recent OCM advances to further develop these tools for transplantation immunology research. Additionally, this NOSI will support applications that focus on development of allogenic or xenogenic OCM to study immunologic features of transplant-related diseases or conditions, including:

• Cellular rejection, antibody-mediated rejection, or mixed cellular and antibody-mediated rejection.
• Sensitization, i.e., immunogenicity of pre-existing allo-reactive or xeno-reactive antibodies.
• Tolerance or accommodation, i.e., resistance of an organ to immune-mediated damage.
• Zoonotic infection in the context of immunosuppression and exposure to a xenograft.
• Graft-versus-host disease.
• Transplant related ischemia reperfusion injury.

This initiative will support validation studies that compare data obtained from the OCM to clinical or experimental in vivo data (new or preexisting) and establish analogous OCM endpoints (i.e., for graft injury, dysfunction, rejection, tolerance). We encourage you to use cutting-edge technologies and interdisciplinary collaborations that apply progress made in other fields to OCM. Applications in transplantation immunology are encouraged.

Applications proposing any of the following research will not be supported under this NOSI:

• 2D in vitro culture systems.
• Transplant organoids in vivo as a replacement or regenerative therapy. 

Application and Submission Information

This notice applies to due dates on or after February 5, 2024, and subsequent receipt dates through November 16, 2026. 

Submit applications for this initiative using one of the following notices of funding opportunity (NOFOs) or any subsequent reissues. Note that budget and project period requirements will vary depending on the NOFO that you choose. 

• NIH Research Project Grant (Parent R01, Clinical Trial Not Allowed) 
• NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Not Allowed)

Follow all instructions in the SF 424 (R&R) Application Guide and the NOFO through which you apply. Remember, you must include “NOT-AI-23-064” in the Agency Routing Identifier field (box 4B) of the SF 424 R&R form to be considered for funding under this initiative. 

Contact Information

Direct any inquiries to Dr. Shilpa Kulkarni, NIAID’s scientific/research contact at shilpa.kulkarni@nih.gov or 240-747-7365.