June 13, 2023
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National Institute of Allergy and Infectious Diseases (NIAID)
This notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the update to NIAID’s Strategic Plan for Tuberculosis Research.
NOTE: Review of this entire RFI notice is encouraged to ensure a comprehensive response is prepared and to have a full understanding of how your response will be utilized.
Background
NIH is updating its Strategic Plan for Tuberculosis Research. The strategic plan aligns with the global goal of ending the TB pandemic, and supports the objectives delineated in the U.S. Government Global TB Strategy as well as the National Action Plan for Combating Multidrug-Resistant Tuberculosis.
The strategic plan is structured around five strategic priorities that capitalize on recent advances in the field and are critical to the development and evaluation of the knowledge and tools needed to end TB globally.
Strategic Priorities
Strategic priority: Improve fundamental knowledge of TB
- Improve the understanding of infection and disease spectrum caused by Mycobacterium tuberculosis (Mtb)
- Evaluate the dynamics and pathophysiology of TB disease in humans
- Characterize immune responses and role of other host factors in Mtb infections
- Determine factors that drive TB transmission
- Understand the role of asymptomatic or subclinical TB in disease and transmission
- Improve fundamental knowledge of the above in pediatric populations
Strategic priority: Advance research to improve diagnosis of TB
- Discover and validate novel TB biomarkers or biosignatures
- Improve and develop accurate and rapid diagnostics, including point of care or near to point of care diagnostics
- Improve diagnostics for extra-pulmonary TB
- Improve TB diagnostics for pediatric populations and people living with HIV (PLWH)
Strategic priority: Accelerate research to improve TB prevention
- Support design and development of vaccine candidates
- Identify correlates of immune protection
- Utilize TB Preventative Treatment (TPT) programs and modeling tools to predict transmission and apply preventative tools effectively
- Discover, develop, and improve interventions to reduce TB transmission
Strategic priority: Support research to advance strategies to treat TB
- Discover, develop, and evaluate new and improved therapeutic interventions and combination regimens for pulmonary and extrapulmonary disease
- Evaluate shorter treatment schedules for drug resistant and drug sensitive TB
- Develop and advance new anti-TB drug candidates appropriate for use in HIV-associated TB and pediatric populations
- Develop strategies to detect, minimize and prevent post TB lung disease and emergence of drug resistance
Strategic priority: Develop tools and resources to advance TB research
- Optimize and/or develop animal models that reflect human disease and are predictive of clinical outcomes
- Develop, standardize, and share tools to facilitate product testing as well as resource and data / sample sharing
- Leverage and expand the current clinical capacity of NIAID resources to test new therapeutic candidates, treatment regimens, diagnostics, and vaccine candidates in healthy and high-risk populations including pediatric populations, PLWH, and pregnant women
- Promote cross-disciplinary research and support early investigators to expand the cadre of innovative TB researchers
- Develop quantitative tools to assess treatment response and low bacillary burden in humans
- Develop improved tools for tracking TB cases and outbreaks
- Optimize coordination across U.S. government agencies, global stakeholders, and research funders
Information Requested
This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed framework.
NIH seeks comments on any or all of, but not limited to, the following topics in Tuberculosis research:
- Significant research advances since 2018
- Significant research gaps and or barriers not identified in the strategic priorities above
- Impact of COVID-19 pandemic on Tuberculosis research
- Emerging scientific advances or techniques that may accelerate research related to the strategic priorities identified above
- Resources necessary to advance research in Tuberculosis related to the strategic priorities above
How to Submit a Response
All comments must be submitted electronically on the submission website.
Responses must be received by 11:59:59 PM (ET) on Aug 22, 2023.
Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIAID with this information, NIAID will not share your name or contact information outside of NIAID unless required by law. Responses will be reviewed by NIAID staff, and individual feedback will not be provided to any responder.
Other than your name and contact information, please do not include any personally identifiable information or information that you do not wish to make public. Proprietary, classified, confidential, trade secret, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information, the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.
This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the Government shall arise as a result of a response to this request for information or from the Government’s use of such information.
NIH encourages organizations (e.g., patient advocacy groups, professional organizations) to submit a single response reflective of the views of the organization or membership as a whole.
We look forward to your input and hope that you will share this RFI document with your colleagues.
and Human Services (HHS)
