| NCI Multi-Cancer Dectection (MCD) Trial Team |
Research Initiative |
CMS, FDA |
NCI |
Scientific development for the evaluation of Multi-Cancer Detection (MCD) assays for the purpose of cancer screening. This group is also known internally as the Tiger Team |
| NCI Scientific Steering Committees (SSCs) |
Committee, Work group, Advisory group, or Task Force |
FDA |
NCI |
Scientific Steering Committees (SSCs) are composed of leading cancer experts and advocates from outside the Institute as well as NCI senior investigators who meet regularly to: (1) increase the transparency and openness of the trial design and prioritization process; (2) enhance patient advocate and community oncologist involvement in clinical trial design and prioritization; (3) convene Clinical Trial Planning Meetings to identify critical questions, unmet needs, and prioritize key strategies. |
| NCI-FDA Joint Fellowship Program (IOTF) |
Training Initiative |
FDA |
NCI |
The objective of the NCI-FDA Joint Fellowship Training Program is to train a cadre of scientists in research and research-related regulatory review, policies, and regulations so that they develop a skill set bridging the two disparate processes. Fellows learn to build awareness of regulatory requirements into the early stages of the medical product development process and develop strategies to improve planning throughout research and regulatory review. There are four different programs tracks within the program. For example, the Clinical Investigator Program track trains physicians in aspects of clinical trials methodology and analysis, epidemiology, clinical aspects of medical product development, and regulation to facilitate the movement of drugs, biologics, and devices from the basic bench science to commercialization. This allows the FDA to gain an academic oncologist with disease-specific expertise who is actively involved and understands critical nuances of the field, NCI gains a clinical investigator and leader who understands regulatory considerations in drug development, and the oncologic community gains a regulator/academic who will provide a leadership voice to help design trials with regulatory endpoints in mind. |
| NCI/FDA Memorandum of Understanding for Proteomics |
Research Initiative |
FDA |
NCI |
This Memorandum of Understanding (MOU), signed in 2007, renewed in 2012, 2017, and 2022 establishes an official relationship in clinical proteomic regulatory science between NCI's Office of Cancer Clinical Proteomics Research and the FDA. Active areas of research collaboration include sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development. |
| Necrotizing Enterocolitis (NEC) in Preterm Infants Working Group of the National Advisory Council of Child Health and Human Development (NACHHD) |
Committee, Work group, Advisory group, or Task Force |
CDC, FDA |
NIAID, NICHD |
A subgroup of NICHD’s National Advisory Child Health and Human Development Council, in response to a U.S. Department of Health and Human Services (HHS) request to evaluate the current state of the science on enteral nutrition and NEC in preterm infants. |
| NEHEP Partnership Summit |
Committee, Work group, Advisory group, or Task Force |
OASH |
NEI |
NEHEP was joined by the Office of Disease Prevention and Health Promotion in a partnership summit in 2023 to connect NEI and NEHEP’s work to the Healthy People 2030 vision objectives. The next NEHEP Partnership Summit is planned for October 2025. |
| NEI-FDA-ONC Joint Partnership on Promoting Adoption of Ocular Imaging Standards |
Research Initiative |
FDA, ONC |
NEI |
This virtual NEI, FDA, and ONC hosted workshop focused on delineating the state of the science and improving interoperability among ocular imaging modalities and devices to improve biomedical research and patient care. This meeting consisted of a day of discussion identifying the gaps in knowledge, barriers to progress, and potential strategies for overcoming them in the context of addressing the goal of Promoting the Adoption of Ocular Imaging Standards. This was an open workshop to the general public, attended by researchers from academia, industry, non-profits, other government agencies, patients and care partners. The white paper from this workshop, Accelerating Care: A Roadmap to Interoperable Ophthalmic Imaging Standards in the United States, was published in January 2024. As a follow up to the workshop, NEI published the Standardized Ocular Imaging Expectations for Clinical and Nonclinical Research Funded by NEI notice in May 2024. This notice strongly encourages applicants to use common formats for files and metadata standards when incorporating ocular imaging in their research proposals. This applies to both clinical and nonclinical research applications submitted in response to NOFOs where NEI is the issuing or participating organization. Investigators are strongly encouraged to adopt common formats for files and metadata standards in their research involving ocular imaging. For instance, the Digital Imaging and Communications in Medicine (DICOM) standard, widely used for medical imaging devices, defines formats and accompanying data. Applicants may propose alternative standards provided they meet the necessary requirements for data interoperability, accessibility, and sharing. The widespread adoption of standardized imaging formats will significantly advance the field by: Enabling streamlined digital workflows.Facilitating interoperability of large datasets.Creating extensive training sets for artificial intelligence-based research.By promoting these standards, we aim to foster an environment where data can be seamlessly integrated and analyzed across different studies, enhancing the overall impact of vision research.This partnership successfully concluded in 2024 after each agency fulfilled the commitments outlined in the white paper references above. While this specific collaboration has ended, our work in this space is far from over. These efforts have laid the foundation for increased interoperability, improved data sharing, and expanded opportunities for AI-driven research in vision science. Moving forward, we remain committed to fostering adoption of imaging standards and supporting the research community in leveraging these advancements to enhance patient care and scientific discovery. One such follow-on activity is the following whitepaper: Ocular Imaging Challenges, Current State, and a Path to Interoperability: A HIMSS-SIIM Enterprise Imaging Community Whitepaper |
| New diagnostic methods for identification of Trypanosoma cruzi |
Research Initiative |
CDC |
CC |
Collaborate with experts from other institutes outside NIH to develop new diagnostic methods for identification of Trypanosoma cruzi, a parasitic protozoan that is the causative agent of Chagas disease (American trypanosomiasis). Outside collaborators include: Sue Montgommery, CDC, United States and Adrienne Showler,, George washington University, United States. |
| Newborn Screening Coding and Terminology Guide |
Resource Development |
AHRQ, CDC, FDA, HRSA, IOS |
NHGRI, NHLBI, NICHD, NLM |
This ongoing collaboration develops, supplements, and promotes a free online resource that provides guidance for the efficient electronic exchange of standardized newborn screening data. Related efforts include examining the screening process for diseases including severe combined immunodeficiency (SCID), lysosomal storage disorders (LSDs), and critical congenital heart disease (CCHD). Additionally, they involve developing standard codes for ordering and reporting the results of newborn screening for SCID, CCHD, and other conditions added to the Recommended Uniform Screening Panel of the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. https://lhncbc.nlm.nih.gov/newbornscreeningcodes/ |
| Newborn Screening Federal Partners Committee |
Committee, Work group, Advisory group, or Task Force |
AHRQ, CDC, FDA, HRSA |
NHGRI, NICHD, NLM |
The federal members of the Advisory Committee on Heritable Disorders in Newborns and Children meet monthly to share information about newborn screening activities. |