The purpose of this Notice 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), the National Institute of Neurological Disorders and Stroke (NINDS), and the National Center for Complementary and Integrative Health (NCCIH) encourage new 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 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 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 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-19-055.

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-19-055.

NINDS : NINDS is interested in supporting research on the basic biology and mechanisms of the neurological consequences of tick-borne diseases. This includes developing animal and cell models that will facilitate studying the nervous system pathogenesis of these diseases and developing new approaches to diagnose and treat neurological complications. Please note, NINDS only accepts mechanistic studies that meet NIH's definition of a clinical trial to PA-19-055.

NCCIH: NCCIH will support research on the mechanisms by which complementary and integrative health approaches may improve tick-borne disease (TBD) treatment and/or post-TBD symptom care. Complementary and integrative approaches may include mind/brain-focused practices (i.e., meditation, hypnosis), body-based approaches (i.e., acupuncture, massage, spinal manipulation), meditative exercise (i.e., yoga, tai chi, qi gong), or natural products (i.e., botanicals, dietary supplements, probiotics), in isolation or in combination with conventional medical treatments. NCCIH will not accept a clinical trial that measures the efficacy or effectiveness of any intervention through this NOSI. NCCIH only accepts mechanistic studies that meet NIH's definition of a clinical trial to PA-19-055.

Application and Submission Information

This notice applies to due dates on or after January 5, 2020 and subsequent receipt dates through January 8, 2023.

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.

• PA-19-055 NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PAR-19-134 Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed)

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-20-005” (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.