June 12, 2023
NOT-OD-23-164: Notice to Extend the Response Date of NOT-OD-23-140: Request for Information on Catalyzing the Development and Use of Novel Alternative Methods to Advance Biomedical Research
Office of The Director, National Institutes of Health (OD)
The National Institutes of Health (NIH) seeks public input on challenges and opportunities for the further development and use of novel alternative methods (NAMs) in biomedical research. NIH investment in these methods have proven beneficial tools across basic and clinical research studies, being developed and applied to interrogate cancer, diabetes, cardiovascular disease, Alzheimer's disease, infectious disease, rare diseases, and more. Each NAM approach has unique strengths and limitations that vary depending on the specific research question being addressed.
To identify areas in which the development and use of NAMs provide the most value to biomedical research, NIH sought the assistance of the Advisory Committee to the Director (ACD), an advisory group that provides advice on matters pertinent to NIH mission responsibilities in the conduct and support of biomedical research, medical science, and biomedical communications. The purpose of this request is to inform the NIH and the development of the ACD’s recommendations on high-priority areas for future investment.
Biomedical researchers rely on a combination of innovative methods, models, and technologies to answer complex questions about human health and disease. The use of any given approach is based on its ability to answer the research question under study. While animal models remain an invaluable resource for researchers' addressing the complexity of human biology, rapid advances in technology are catalyzing the development and use of complementary, nonanimal based approaches. These “novel alternative methods” (NAMs) include in chemico strategies (e.g., experiments on biological molecules like DNA and proteins in test tubes); in vitro methods (e.g., exploring the nature of cells and tissues by culturing them in sterile chambers); and in silico computational models that simulate how these biological systems work and predict outcomes to refine hypotheses (e.g., to define how potential drugs interact with their biological targets and to refine clinical intervention and procedures that increase patient safety and treatment efficacy). The development of these NAMs holds tremendous promise for increasing the tools available to achieve the NIH mission and potentially reduce and refine the future use of animals in some areas of research in the future.
To identify areas in which the development and use of NAMs provide the most value to biomedical research, in January 2023 , the NIH Director charged an Advisory Committee to the Director (ACD) Working Group with articulating high-priority areas for NIH investment (see ACD Working Group on Catalyzing the Development and Use of Novel Alternative Methods to Advance Biomedical Research - NIH Advisory Committee to the Director). In pursuit of its charge, the ACD Working Group has been assessing the value and limitation of NAMs and needs for the development of new and/or more effective NAMs. The ACD Working Group has also been meeting with experts across research sectors to understand both public and private sector investment and identify gaps/areas of opportunity to maximize the value of NAMs to advance biomedical research. Collectively, these activities are being summarized in the ACD Working Group’s initial landscape assessment on the challenges and opportunities in the development and use of NAMs that will be used to inform its final recommendations regarding high-priority areas for NIH investment.
Request for Information
To support the activities of the ACD Working Group, NIH is requesting information from the interested individuals and communities on challenges and opportunities for the development and use of NAMs in biomedical research. Input sought includes, but is not limited to, feedback on the following:
How to submit a response
All comments must be submitted electronically at https://osp.od.nih.gov/request-for-information-rfi-catalyzing-the-development-and-use-of-novel-alternative-methods-to-advance-biomedical-research . It is not necessary to address each question/item.
Responses must be received by 11:59:59 pm (ET) on September 5, 2023.
Responses to this RFI are voluntary and may be submitted anonymously. You may also voluntarily include your name and contact information with your response. Other than your name and contact information, please do not include in the response any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. After OSP has finished reviewing the responses, the responses may be posted to the OSP website without redaction.
NIH Office of Science Policy