Key Dates

Related Announcements

PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-22-178 - PHS 2022-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
PA-22-176 - PHS 2022-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
PAR-22-060 - Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed)
PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-21-219 - Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional)
PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to announce that the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS), encourage applications to advance research activities relevant to the five strategic priorities identified in the recently released NIH Strategic Plan for Tickborne Disease Research:

1. Improve fundamental knowledge of Tickborne Diseases (TBDs) to understand the host, vector, and pathogen factors that drive TBD pathogenesis and transmission. Elucidate the host immune mechanisms in response to and exploited by TBD pathogens.
2. Advance research to improve the diagnosis of TBDs using both host- and pathogen-targeted approaches, including research for rapid diagnostics and multiplex platform approaches that detect multiple tickborne pathogens.
3. Accelerate research to improve TBD prevention by supporting science to design, develop, and evaluate vaccines, vector control strategies, and other prevention approaches.
4. Promote research to improve treatment for all forms of TBDs, including studies to develop effective therapies to treat symptoms that persist after TBD treatment, therapies for non-infectious TBDs, and new antimicrobials.
5. Support tools and resources to advance research in understanding, preventing, diagnosing, and treating TBDs, including repositories, genomic resources, animal models, and preclinical services to aid the development and assessment of diagnostic, vaccine, and therapeutic candidates.

NIAID: NIAID will support research on the biology of tickborne pathogens, their vectors, animal reservoirs, and human hosts, and the interactions among these elements as they help to understand the underlying causes for human disease. NIAID is interested in applications of the basic science behind tickborne infections, including pathogenesis and host response in all organ systems, and in applications seeking to develop new approaches to prevent, diagnose, and treat those infections.

NIAID will also support research on non-infectious TBDs, particularly on alpha-gal syndrome. The focus of research on this syndrome is to understand its pathogenesis and to develop improved diagnostics and therapeutic approaches.

NIAMS: NIAMS is interested in supporting research studies on human immunity and its role in the initiation and propagation of Lyme arthritis. Use of systems biology approaches to identify critical cellular and molecular pathways involved in pathogenesis is encouraged. Other interests include studies of the joint tissue remodeling pathways and the cross-talk of a wide range of hematopoietic and other cell types in Lyme arthritis. Please note, NIAMS only accepts mechanistic studies that meet NIH's definition of a clinical trial to PA-20-183

NIMH: As the lead federal agency for research on mental disorders, NIMH is interested in the following areas:

• Basic mechanistic neuroscience studies of persistent effects of Lyme disease on brain signaling, circuits, and proximal effects on functional processes such as cognition that are impaired in mental illnesses.
• Research to illuminate the mechanisms by which tick-borne diseases lead to specific psychiatric complications.
• Research to understand the neurobiological basis of the impact of tick-borne diseases on specific domains of functions relevant to mental health, as informed by the Research Domain Criteria (RDoC) approach.
• Research to decrease the burden of acute and chronic psychiatric complications of Lyme disease and other tick-borne diseases.

Please note, NIMH only accepts mechanistic studies that meet NIH's definition of a clinical trial to PA-20-183.

NINDS: NINDS is interested in research on the neurological consequences of TBDs. Potential areas of interest include: basic disease mechanistic studies of the long term effects of TBDs on the nervous system; the development of animal and cell culture models to study the nervous system pathogenesis of TBDs; the development of new approaches to diagnose and treat TBD-associated neurological complications; and clinical cohort studies that seek to characterize the post-acute neurological sequelae of TBDs in human patients. Please note for PA-20-183, NINDS only accepts human mechanistic trials/studies that meets NIH’s definition of a clinical trial. Applications that include clinical trials designed to answer specific questions about the safety, tolerability, and/or efficacy of an intervention will not be accepted.

NINDS, as part of NIH, also strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency (https://grants.nih.gov/policy/reproducibility/guidance.htm) and provides additional guidance to the scientific community (https://www.ninds.nih.gov/Funding/grant_policy). For example, the biological rationale for the proposed experiments must be based on rigorous and robust supporting data, which means that data should be collected via methods that minimize the risk of bias and be reported in a transparent manner. If previously published or preliminary studies do not meet these standards, applicants should address how the current study design addresses the deficiencies in rigor and transparency. Proposed experiments should likewise be designed in a manner that minimizes the risk of bias and ensures validity of experimental results.

Application and Submission Information

This notice applies to due date on or after February 5, 2023 and subsequent receipt dates through January 7, 2026.

Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.

In addition, applicants using NIH Parent announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-AI-23-013 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Samuel Perdue, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3341
E-mail: sperdue@nih.gov

Su-Yau Mao, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: maos2@mail.nih.gov

Sarah H. Lisanby, M.D..
National Institute of Mental Health (NIMH)
Telephone: 301-451-3029
Email: lisanbysh@mail.nih.gov

William Daley, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: william.daley@nih.gov