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National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Minority Health and Health Disparities (NIMHD)

National Cancer Institute (NCI)

Purpose

This notice is a time-sensitive Request for Information (RFI) inviting comments and suggestions on the update of the Strategic Plan for Trans-NIH Research to Cure Hepatitis B published in 2019.

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

NIH is updating its Strategic Plan for Trans-NIH Research to Cure Hepatitis B. The strategic plan aligns with NIH's ongoing efforts to intensify innovative hepatitis B research, and with the HHS-wide Viral Hepatitis National Strategic Plan.

The strategic plan is structured around three strategic priorities vital to developing a cure for hepatitis B. A cure is defined as the sustained loss, after completion of a finite course of treatment, of both a) detectable hepatitis B virus (HBV) DNA and b) hepatitis B surface antigen (HBsAg), with or without the presence of antibodies against HBsAg.

Strategic Priorities

Strategic Priority 1: Improve Understanding of Hepatitis B Biology

• Identify viral factors that determine persistence of HBV infection and promote the accompanying liver damage
• Elucidate immune and other host factors that account for persistence of HBV infection and the accompanying liver injury
• Characterize clinical pathology to examine biological, environmental, social, behavioral, or cultural factors that affect disease progression and control in various subpopulations and age groups

Strategic Priority 2: Develop Tools and Resources

• Standardize and promote the sharing of reagents, procedures, and assays
• Improve cell culture and cell-free systems to support basic and translational research
• Improve and create new animal models for evaluating hepatitis B virology, liver pathogenesis, and novel therapeutic strategies
• Discover and develop biomarkers that are accurate, practical, and reflect disease progression and response to therapy
• Develop diagnostics and tools for monitoring disease and evaluating therapeutics using cutting edge technology, such as artificial intelligence and machine learning
• Improve availability and data science tools for hepatitis B biological and clinical data

Strategic Priority 3: Create Hepatitis B Cure and Prevention Strategies

• Expand clinical research capacity with a particular focus on populations at high risk of hepatitis B infection
• Create cure strategies that suppress viral replication and/or stimulate the immune response
• Evaluate curative approaches in diverse subpopulations, especially people at high risk for hepatitis B infection
• Develop effective strategies to screen, treat and/or vaccinate high-risk and underserved populations and ensure follow-up to care and adherence to treatment

Information Requested

This RFI seeks input from stakeholders throughout the scientific research community and the general public regarding possible updates to the Strategic Plan for Trans-NIH Research to Cure Hepatitis B.

NIH seeks comments on any or all of, but not limited to, the following topics in hepatitis B cure research:

• Recent significant research advances in hepatitis B as well as in other areas that could have implications for the development of a hepatitis B cure
• Impact of COVID-19 pandemic on hepatitis B research, and possible solutions
• Emerging research questions and/or barriers
• Resources necessary to advance basic, translational, and clinical research to cure hepatitis B

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 January 31, 2022.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 protected]