| National Toxicology Program Executive Committee |
Committee, Work group, Advisory group, or Task Force |
ATSDR, CDC, FDA |
NCI, NIEHS |
An internal government group comprised of heads (or designees) of HHS (NCEH/ATSDR, FDA, NCI, NIEHS, NIOSH) and non-HHS (CPSC, DoD, EPA, OSHA) agencies |
| National Toxicology Program Steering Committee |
Committee, Work group, Advisory group, or Task Force |
ATSDR, CDC, FDA |
NIEHS |
An internal government group comprised of the principal agencies of the National Toxicology Program |
| National Vaccine Advisory Committee (NVAC) |
Committee, Work group, Advisory group, or Task Force |
OASH |
NIAID |
The National Vaccine Advisory Committee (NVAC) recommends ways to achieve optimal prevention of human infectious diseases through vaccine development and provides direction to prevent adverse reactions to vaccines. This advice is presented to the Assistant Secretary for Health who serves as the Director of National Vaccine Program on matters related to program responsibilities. |
| Natural History Studies and Registries in the Development of Rare Disease Treatments Workshop |
Meeting/ Workshop |
FDA |
NCATS |
NCATS worked with the FDA and the Reagan-Udall Foundation for the FDA to host a hybrid public workshop on May 13, 2024, to bring together rare disease patient advocates, academic researchers, regulated industry, and other key communities to discuss considerations for the use of natural history studies and registry data in rare disease drug development programs. This workshop addresses the role and design of registries and natural history studies to inform the development of rare disease treatments, including aspects of clinical trial design; collecting registry and natural history data that are fit for regulatory purposes; and the use of registries and natural history studies to inform regulatory decision-making. |
| Naval Research Laboratories XRAY Crystallography |
Committee, Work group, Advisory group, or Task Force |
FDA |
NIDA |
The Crystallographic Studies Group at the Naval Research Laboratories provides definitive, three-dimensional structural parameters of compound samples submitted by NIDA grantees, contractors and researchers in drug abuse. Data derived from X-ray crystallographic analysis is used to confirm complex structures in drug development. Researchers use this data for publications, grant applications and patent submissions. |
| NBS Implementation Plans Joint Capabilities Plans-Clinical Research Capacity |
Committee, Work group, Advisory group, or Task Force |
ASPR, FDA |
NIAID |
Several JCP WG to inform implementation |
| NCATS Toolkit for Patient-focused Therapy Development |
Resource Development |
FDA |
NCATS |
NCATS is dedicated to engaging the patient community throughout the translational science process. The NCATS Toolkit for Patient-Focused Therapy Development (Toolkit) was created to provide a collection of online resources that can help patient groups advance through the process of therapy development and provide them with the tools they need to advance medical research. Launched in September 2017, the Toolkit includes resources that have been developed primarily for the rare diseases community to facilitate therapeutics research and development. |
| NCI Cancer Data Standards Repository and Registry (caDSR) |
Committee, Work group, Advisory group, or Task Force |
ASPE, FDA |
CIT, NCATS, NCI, NEI, NHLBI, NIAMS, NIBIB, NIDCD, NIMH, NINDS, NLM |
Also Collaboration Type: Resource DevelopmentThe National Cancer Institute (NCI) is collaborating with other NIH institutes to develop and harmonize data standards across NCI and others NIH institutes for basic, translational and clinical research, clinical care, epidemiology, public health, administration, and public information. NCI caDSR provides services to meet NCI needs, and works with other NIH institutes to reuse/share existing content. |
| NCI Cervical Cancer "Last Mile" Initiative |
Research Initiative |
CDC, FDA, HRSA |
NCI |
The National Cancer Institute (NCI) Cervical Cancer ‘Last Mile’ Initiative is a public-private partnership bringing together federal agencies, industry partners, and professional societies to contribute evidence about the accuracy and clinical effectiveness of self-collection-based HPV testing for cervical cancer screening. The initiative is supporting the "Self-collection for HPV testing to Improve Cervical Cancer Prevention" ("SHIP") Trial, a nationwide multicenter clinical trial focused on an independent non-competetive evaluation of multiple self-collection devices and HPV assays for developing key scientific evidence to facilitate approvals of home-based HPV self-collection. |
| NCI Clinical Trials and Translational Research Advisory Committee (CTAC) |
Committee, Work group, Advisory group, or Task Force |
CMS, FDA |
NCI |
The Clinical Trials and Translational Research Advisory Committee makes recommendations on the National Cancer Institute-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trial process. The Committee will provide advice on matters related to the conduct, oversight, and implementation of clinical trials and translational research across the Institute. |