May 9, 2025
Office of The Director, National Institutes of Health (OD)
This notice clarifies which applications will be reviewed under the simplified review framework for August and October 2025 Councils. NIH has announced and reiterated that all grant applications using specific activity codes (comprising most research project grant applications) with due dates on or after January 25, 2025, will be reviewed under the simplified review framework. However, certain NOFOs using these specific activity codes inadvertently list earlier review criteria in Section V Application Review Information. NIH will review all such applications using the simplified review framework.
Following a Request for Information, NIH announced a simplified review framework in NOT-OD-24-010 and NOT-OD-24-085. The impacted activity codes are R01, R03, R15, R16, R21, R33, R34, R36, R61, RC1, RC2, RC4, RF1, RL1, RL2, U01, U34, U3R, UA5, UC1, UC2, UC4, UF1, UG3, UH2, UH3, UH5, (including the following phased awards: R21/R33, UH2/UH3, UG3/UH3, R61/R33). NIH publicized these changes in several webinars and Notices.
NIH widely publicized the effective date of the Simplified Review Framework as application due dates on or after January 25, 2025. As explained in multiple notices, the Simplified Review Framework requires no actions of applicants; there are no changes to forms or application instructions associated with the simplified review framework. Both the simplified review framework and earlier framework use the review criteria required by regulation of Significance, Innovation, Approach, Investigator(s), and Environment.
However, using two different review frameworks in the same meeting would increase reviewer burden, possibly lead to confusion, and may diminish the overall quality of review. Resource and time constraints make running separate review meetings for scientifically-similar applications impractical. Therefore, consistent with NIHs prior notices, NIH will apply the simplified review framework to the review of all applications submitted to the NOFOs below.
PA-23-317 | Competing Revisions to Existing NIH Single Project Research Grants and Cooperative Agreements (Clinical Trial Optional) |
PAR-22-131 | Imaging, Biomarkers and Digital Pathomics for the Early Detection of Premetastatic Cancer and Precancerous Lesions Associated with Lethal Phenotypes (R01 Clinical Trial Optional) |
PAR-22-149 | NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required) |
PAR-22-181 | Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional) |
PAR-22-198 | Precision Approaches in Radiation Synthetic Combinations (PAIRS, R01 Clinical Trial Optional) |
PAR-22-199 | Precision Approaches in Radiation Synthetic Combinations (PAIRS, R21 Clinical Trial Optional) |
PAR-22-202 | Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) |
PAR-22-210 | Research to Action: Assessing and Addressing Community Exposures to Environmental Contaminants (R01 Clinical Trial Optional) |
PAR-22-230 | NINR Areas of Emphasis for Research to Optimize Health and Advance Health for All (R01 Clinical Trial Optional) |
PAR-22-231 | NINR Areas of Emphasis for Research to Optimize Health and Advance Health for All (R21 Clinical Trial Optional) |
PAR-22-233 | Time-Sensitive Opportunities for Health Research (R61/R33 Clinical Trial Not Allowed) |
PAR-22-242 | Bioengineering Research Grants (BRG) (R01 Clinical Trial Not Allowed) |
PAR-22-243 | Bioengineering Research Grants (BRG) (R01 Clinical Trial Optional) |
PAR-23-060 | Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes (R34 Clinical Trial Optional) |
PAR-23-061 | Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional) |
PAR-23-062 | Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional) |
PAR-23-084 | Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) |
PAR-23-111 | NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional) |
PAR-23-148 | Pulmonary Outcomes and Sequelae after Treatment-TB (POST-TB) (R01 Clinical Trial Optional) |
PAR-23-157 | Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional) |
PAR-23-158 | Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Basic Experimental Studies with Humans (BESH) Required) |
PAR-23-206 | NIAID Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed) |
PAR-23-255 | Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R21 Clinical Trials Not Allowed) |
PAR-23-296 | Opportunities for HIV Cure Strategies at the Time of ART Initiation (R21 Clinical Trial Not Allowed) |
PAR-23-297 | Opportunities for HIV Cure Strategies at the Time of ART Initiation (R01 Clinical Trial Not Allowed) |
PAR-24-051 | NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required) |
PAR-24-059 | Understanding the Impact of Healthcare System and Clinician Factors on Disparities in Maternal Morbidity and Mortality (R01 - Clinical Trial Optional) |
PAR-24-064 | Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional) |
PAR-24-075 | Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) |
PAR-24-076 | Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required) |
PAR-24-100 | NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) |
PAS-22-074 | Stimulating Urology Interdisciplinary Team Opportunity Research (SUITOR) (R01 Clinical Trial Optional) |
RFA-AG-25-027 | Facilitating T1 Translational Aging Research: Preclinical and Early Phase Human Studies (UG3/UH3 Clinical Trial Optional) |
RFA-AG-25-031 | Small Research Grant Program for the Next Generation of Researchers in Low- and Middle-Income Countries (LMICs) for Aging and Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Research (R03 Clinical Trial Not Allowed) |
RFA-AG-25-032 | Consortium for Neuroscience AD/ADRD in Low- and Middle-Income Countries (U01 Clinical Trial Not Allowed) |
RFA-DA-24-031 | Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional) |
RFA-DA-24-032 | Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Basic Experimental Studies with Humans Required) |
RFA-DA-24-033 | Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Clinical Trial Optional) |
RFA-DA-24-034 | Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Basic Experimental Studies with Humans Required) |
RFA-DA-25-023 | Integrated Functional Mapping and Molecular Profiling of Cell Ensembles Encoding the Effects of Addictive Substances in Rodents (R01 Clinical Trial Not Allowed) |
RFA-DA-25-062 | HEAL Initiative: JCOIN Phase II Innovation Hubs (R01 Clinical Trial Optional) |
RFA-EB-21-001 | Technology Development to Reduce Health Disparities (R01 Clinical Trial Optional) |
RFA-EB-23-005 | Research on Bioethical Issues Related to Bionic and Robotic Device Development and Translation (R21 Clinical Trial Optional) |
RFA-MH-25-100 | BRAIN Initiative: Scaled reagent resources for brain cell type-specific access across vertebrate species (U01 Clinical Trial Not Allowed) |
RFA-MH-25-120 | Lethal Means Safety Suicide Prevention Research in Healthcare and Community Settings (R34 Clinical Trial Required) |
RFA-MH-26-100 | BRAIN Initiative: Brain Behavior Quantification and Synchronization (R61/R33 Clinical Trial Optional) |
RFA-NS-24-019 | HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) |
RFA-NS-25-010 | Safety and Efficacy of Amyloid-Beta Directed Antibody Therapy in Mild Cognitive Impairment and Dementia with Evidence of Lewy Body Dementia and Amyloid-Beta Pathology (U01 - Clinical Trial Required) |
RFA-RM-24-011 | Pilot projects to enhance utility and usage of data sets from the Molecular Transducers of Physical Activity Consortium (MoTrPAC) (R03 Clinical Trials Not allowed) |
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