Notice Number: NOT-AI-18-043
Key Dates
Release Date: June 27, 2018
Response Date: July 16, 2018
None
Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Purpose
This notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the framework for an NIAID Tuberculosis Strategic Plan.
NOTE: It is important to read this entire RFI notice to ensure an adequate response is prepared and to have a full understanding of how your response will be utilized.
Background
In response to the U.S. Government’s alignment with the concerted global effort led by the World Health Organization (WHO) to end the tuberculosis (TB) epidemic, NIAID is developing a strategic framework to advance tuberculosis research and development for the next five years and beyond.
The NIAID strategic framework is also aligned with NIAID’s ongoing efforts to intensify TB research and innovation in support of the U.S. Government Global Tuberculosis Strategy and the National Action Plan for Combating Multidrug-Resistant Tuberculosis, which share and complement the WHO commitment to reduce TB deaths by 95% and reduce TB incidence by 90% by 2035 through advancing TB research and innovation.
The NIAID TB strategic framework aims to progress five areas of research opportunity vital to advancing understanding, prevention, and treatment of TB, and highlights research gaps critical to achieving the aspirational goal of ending TB.
Areas of Research Opportunity
Fundamental Research
- Understand the factors that determine the course of Mycobacterium tuberculosis (Mtb) infection and progression to, and manifestation of disease, including:
- Bacterial and host factors
- Host-pathogen interactions
- Understand factors that determine Mtb transmission
- Understand the epidemiology of TB (e.g., drug-resistant TB, impact of co-infections)
Detection/Diagnosis
- Discover novel biomarkers or biosignatures for TB diagnosis and prediction of treatment outcomes
- Improve/develop accurate and rapid diagnostics (including point-of-care, non-sputum based, speciation, and drug-sensitivity) for all forms of TB, in all age groups
Prevention/Vaccines
- Support discovery, design, development, and evaluation of novel vaccine candidates, antigen/adjuvant combinations, and delivery approaches to:
- Prevent activation of latent Mtb infection
- Prevent new Mtb infections
- Enhance the breadth/durability of protective immune responses
- Identify correlates of immune protection
- Discover, develop, and/or improve interventions that interfere with TB transmission
Treatment/Therapeutics
- Discover, develop, and evaluate new and improved therapeutic interventions and regimens, including therapeutic vaccines and host-directed therapies
- Develop improved regimens to shorten treatment duration (e.g., chemopreventative regimens for drug-resistant and drug-sensitive TB)
- Better understand/characterize existing TB drugs (e.g., in situ pharmacokinetics/dynamics)
- Identify strategies to rapidly assess and prevent permanent disability due to drug adverse events
Resources
- Characterize and optimize existing animal models and develop novel animal models (along with supporting reagents) that represent the human disease state and better predict human responses to support product development
- Develop and standardize assays and reagents to assess vaccine efficacy
- Develop tools to assess bacillary burden in humans
- Improve/develop resources to promote sharing of animal/clinical samples and data sets
- Leverage and expand existing clinical and preclinical capacity to test promising vaccine candidates
Information Requested
This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding the above proposed framework.
The NIAID seeks comments on any or all of, but not limited to, the following topics in TB research:
- Significant research gaps and/or barriers not identified in the framework above
- Resources required or lacking that may be critical to advancing the areas of research opportunity
- Emerging scientific advances or techniques in basic, diagnostic, therapeutic, or vaccine research that may accelerate NIAID research priorities detailed in the framework above
How to Submit a Response
All comments must be submitted electronically on the submission website.
Responses (no longer than 500 words in MS Word or pdf format) must be received by 11:59:59 pm (ET) on July 16, 2018. You will see an electronic confirmation acknowledging receipt of your response.
Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH 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, the NIH, or individual NIH Institutes and Centers 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 U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.
We look forward to your input and hope that you will share this RFI document with your colleagues.
Inquiries
Please direct all inquiries to:
Email: [email protected]
Or
Elizabeth Walsh, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7932
Email: [email protected]
and Human Services (HHS)
