Notice to Applicants That the Simplified Review Framework Will be Applied to All Relevant Applications for August/October 2025 Councils
Notice Number:
NOT-OD-25-116

Key Dates

Release Date:

May 9, 2025

Related Announcements

  • November 21, 2024 - Reminder that Multiple Changes Affecting Extramural Applications and Review are Coming for Application Due Dates on or After January 25, 2025. See Notice NOT-OD-25-035.
  • April 4, 2024 - Simplified Review Framework for NIH Research Project Grant Applications - Update and Implementation Plans. See Notice NOT-OD-24-085
  • April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
  • March 20, 2024 - Registration Open for Webinar on NIH Simplified Review Framework for NIH Research Project Grants (RPGs): Implementation and Impact on Funding Opportunities. See Notice NOT-OD-24-081
  • October 19, 2023 - Online Briefing on NIH’s Simplified Peer Review Framework for NIH Research Project Grant (RPG) Applications: for Applicants and Reviewers. See NOT-OD-24-012.
  • December 8, 2022 - Request for Information (RFI) on Proposed Simplified Review Framework for NIH Research Project Grant Applications. See Notice NOT-OD-23-034.

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

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 NIH’s 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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