Dear Colleagues:

The following summaries of NIH Guide Notices may be of interest to faculty and researchers. Please review and forward to faculty, researchers and others, as appropriate.

Questions regarding these notices should be directed to your assigned Contract and Grant Officer, unless otherwise noted below.

  • Publication of the Revised NIH Grants Policy Statement (Rev. October 2018) for FY 2019
    (NOT-OD-19-021) National Institutes of Health

This notice announces the publication of the revised NIH Grants Policy Statement (NIHGPS, rev. October 2018).  This revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018. This revision supersedes, in its entirety, the NIH Grants Policy Statement (October 2017) as a standard term and condition of award.  Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2018. The NIHGPS provides both up-to-date policy guidance that serves as NIH standard terms and conditions of awards for grants and cooperative agreements, and extensive guidance to those who are interested in pursuing NIH grants.  While this revision does not introduce any new material for the first time, it incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated October 2017. The document is available in the following electronic formats: HTML and PDF http://grants.nih.gov/grants/policy/nihgps/index.htm). Significant changes are outlined at https://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2018.pdf

  • NICHD Policy on Monitoring and Oversight of Clinical Trials
    (NOT-HD-18-020)
    Eunice Kennedy Shriver National Institute of Child Health and Human Development

This outlines NICHD’s policies and procedures related to the monitoring and oversight of clinical trials.  As part of the NIH’s efforts to enhance stewardship of clinical trials (https://grants.nih.gov/policy/clinical-trials.htm), the NICHD is enhancing its monitoring and oversight of clinical trials in several ways.  See the full notice for additional details. 

·Request for Information (RFI) on the Proposed Funding Priorities for Neuroscience Research, Input on Cross-Cutting Opportunities (NIH Neuroscience Blueprint)
(NOT-NS-19-002)

The National Institutes of Health Blueprint for Neuroscience Research (Blueprint) is a collaboration among 14 participating NIH Institutes, Centers and Offices to support cross-cutting funding programs to advance research on the nervous system. This Request for Information (RFI) seeks input from the scientific community on future Blueprint activities. Responses to this RFI should suggest how best to have the broadest possible impact for the neuroscience community, ideally, in a value-added fashion over the current activities of the participating Institutes, Centers and Offices.  Additional information may be found in the full notice.

  • Request for Information (RFI) on Proposed Provisions for a Draft DataManagement and Sharing Policy for NIH Funded or Supported Research
    (NOT-OD-19-014) National Institutes of Health

The purpose of this Notice is to solicit public input on proposed key provisions that could serve as a foundation for a future NIH policy for data management and sharing.

  • New NIH Peer Review Videos for Applicants
    (NOT-OD-19-017) Center for Scientific Review

This notice announces two new important videos released by the NIH Center for Scientific Review (CSR). The first video is entitled,  “What Happens to your NIH Grant Application” and provides researchers and administrators insights into how NIH applications are reviewed so they can better navigate the NIH peer review process.  The second video is entitled, “Top 10 Peer Review Q&As for NIH applicants” and provides answers to questions most commonly asked during the application preparation process. See the full notice for links to the specific videos.

  • Notice Regarding 2018 Bayh-Dole Act Final Rule – Rights to Federally Funded Inventions and Licensing of Government Owned Inventions
    (NOT-OD-18-233) National Institutes of Health

Effective October 1, 2018, NIH will implement the new final regulations of the Bayh-Dole Act. The new rules impose updated timelines for invention reporting as well as new requirements for invention filing. Questions regarding the notice should be directed to Kevin Kennan, , Director, Intellectual Property Administration & Industry Sponsored Research.

  • Notice of Change to the Eligibility of Foreign Components in PA-18-060, ” Neuroscience Research on Drug Abuse (R01)”
    (NOT-DA-18-042)
    National Institute on Drug Abuse

This notice includes updated information on the eligibility of Non-domestic Entities.  See the full notice and the NIH Grants Policy Statement, dated October 2018 for additional information.

  • Clarification: Fixed Amount Award Definition and Implementation for Clinical Trials
    (NOT-OD-18-222) National Institutes of Health

The purpose of this notice is to provide the extramural community with clarification of the definition of fixed amount subawards, specifically regarding their use in clinical trials and other types of human subject studies. See full notice for more information.

  • Notice of Increases to the Simplified Acquisition and Micro-purchase Thresholds by the Office of Management and Budget
    (NOT-OD-18-219) National Institutes of Health

The purpose of this notice is to notify the research community that the Office of Management and Budget (OMB) has raised the threshold for micro-purchases under Federal financial assistance awards to $10,000, and the threshold for simplified acquisitions to $250,000 for all recipients. The notice also announces OMB’s implementation of an approval process for certain institutions that wish to request micro-purchase thresholds higher than $10,000.  More details of these updates may be found in the full notice.   

  • Notice of the Publication of an NIH Proposal to Amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to Streamline Oversight of Human Gene Transfer Protocols
    (NOT-OD-18-218) National Institutes of Health

The National Institutes of Health recently released a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline oversight for human gene transfer clinical research protocols (i.e., gene therapy research) and reduce duplicative reporting requirements already captured within the existing regulatory framework. Specifically, NIH proposes removing the NIH protocol submission, review and reporting requirements under Appendix M of the NIH Guidelines.  Furthermore, the NIH proposes to modify the roles and responsibilities of the Recombinant DNA Advisory Committee (RAC).  See the full notice for more information.

  • Notice of Changes to NICHD Acceptance of Diversity and Re-Entry Supplement Applications
    (NOT-HD-18-006)
    Eunice Kennedy Shriver National Institute of Child Health and Human Development

This Notice provides a  new schedule for application submission for NICHD.   Specifically, NICHD will transition to accept and review applications three times per fiscal year.  See full notice for a more detailed schedule.  

Sandra M. Stevens

Associate Director, Sponsored Projects

 

Sponsored Projects Administration

Office of Research

University of California, Irvine

141 Innovation, Suite 250
Irvine, CA 92617-3213

PH:  (949) 824-4928

Fax: (949) 824-2094

E-mail:     

http://www.research.uci.edu/

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