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Presentation Title Michelle Presented G. Bulls, By: Director Name Office of Policy for Extramural Research Administration, OER, NIH Title Office Federal Demonstration Partnership, May 2015

NIH is currently funded under the Continuing Appropriations Act, 2015 (Public Law 113-235) signed by President Obama on December 16, 2014. NIH Fiscal Policy for Grant Awards FY 2015 NOT-OD-15-050 NIH awarding ICs have developed and posted their fiscal policies consistent with overall NIH goals and available FY 2015 funds. 2

NRSA awards - o Stipends increased for undergraduate, graduate students and postdoctorals o No changes in tuition, fees, and training related expenses o See NOT-OD-15-048 for details 3

Salary Cap - o Limited to Executive Level II currently set at $181,500, increasing to $183,300 effective January 11, 2015. See NOT-OD-15-049 New Investigators - o Support on R01 equivalent awards will continue at rates comparable to established investigators. o Additional information at NOT-OD-09-013 and http://grants.nih.gov/grants/new_investigators/index.htm 4

NIH has revised its definition of clinical trial. The revision was designed for the following; o To make the distinction between clinical trials and clinical research studies clearer, and o To enhance the precision of the information NIH collects, tracks, and reports on clinical trials The revised definition will apply to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates. See NOT-OD-15-015 for details 5

Reminder that the NIH Genomic Data Sharing Policy becomes effective with NIH grant applications submitted for January 25, 2015, due dates and thereafter. The new GDS Policy promotes sharing of large scale genomic data generated by NIH research. o Includes human, non-human, and model organism data Please see NOT-OD-15-027 for reminder 6

NIH and AHRQ encourages applicants to use the newly published biosketch format for all grant and cooperative agreement applications submitted for due dates on or after January 25, 2015, and will require use of the new format for applications submitted for due dates on or after May 25, 2015. The revised forms and instructions are now available and adjustments have been made to improve their usability. The following are some of the features of the new format; Extends the page limit for the biosketch from four to five pages Investigators can outline the central findings of prior work and the influence of those findings on the investigator s field work Investigators involved in Team Science are provided the opportunity to describe their specific role(s) in the work See NOT-OD-15-032 for additional information 7

NIH s standard due dates for SBIR and STTR programs are changing in response to small business community feedback, congressional mandates, and recommendations from the NIH Scientific Management Review Board to decrease delays between submission and award funding. The next standard due date is April 5, 2015, and there will not be an August 5, 2015 due date. From then on, SBIR/STTR due dates will fall on September 5, January 5, and April 5. The current SBIR and STTR Grant Omnibus funding opportunity announcements are being extended one cycle during the transition, to allow submissions on the April 5, 2015 due date and May 7, 2015 AIDS/AIDS-related due date. Please see NOT-OD-15-038 for additional information 8

As of October 17, 2014, NIH requires grantees to submit ALL type 5 progress reports using the RPPR module in era Commons. Annual progress reports submitted in any format other than the RPPR will not be processed by the NIH and will require resubmission through the RPPR. More at NOT-OD-15-014 9

Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (the Policy) issued on September 24, 2014. o Applies to all New and Renewal awards issued on applications submitted on or after January 25, 2015, and to all non-competing continuation awards issued on or after January 25, 2015. o Institutions have one year (until September 24, 2015) to establish the necessary infrastructure to come into full compliance with the Policy. See NOT-OD-15-017 for more information. 10

October 1, 2014 September 30, 2015 o Competing Awards New funding will continue to be awarded to P subaccounts o Type 3 Awards Will continue to be awarded to the same type of account as the parent award o Type 5 Awards Will continue to be awarded to the same type of account as the previous budget period 11

October 1, 2015 September 30, 2016 o Competing Awards NIH will continue to award all new funding to subaccounts o Type 3 Awards Beginning October 1, 2015, all type 3 funding will be awarded to subaccounts regardless of parent award account type o Type 5 Awards Beginning October 1, 2015, NIH will use an administrative process to transition all non-competing awards to P subaccounts September 30, 2016 All awards transitioned to subaccounts. 12

Beginning October 1, 2015 No change in grantee progress report submission NIH will award type 4s to transition funding to subaccounts Grantees will submit Subaccount Transitional Federal Financial Reports (FFRs) o Subaccount Transitional FFRs may include unliquidated obligations See NOT-OD-14-103 for detailed transition steps 13

As a result of the publication of HHS interim final rule, the NIH Grants Policy Statement has been updated in order to reflect NIH s adoption of the regulations and was issued on 3/31/2015. http://grants.nih.gov/grants/policy/nihgps/nihgps.pdf In addition to removing all of the references to the previous OMB Circulars and HHS regulations located at 45 CFR parts 74 and 92. The following are some of the NIH GPS Chapters that have been revised in order to comply with 45 CFR part 75; NIH GPS Chapter 1.1 Definitions and Terms NIH GPS Chapter 2.3 Application Information and Processes NIH GPS Chapter 5 Notice of Award (NoA) NIH GPS Chapter 6 Payment NIH GPS Chapter 7 Cost Considerations NIH GPS Chapter 8 Administrative Requirements 14

NOT-OD-14-084 NIH Updating Grant Closeout Policies and Procedures to Align with New HHS Requirements NOT-OD-14-103 Revised Timeline for Administrative Changes to NIH Domestic Awards to Transition to Payment Management System Subaccounts NOT-OD-14-112 Notice of Annual Reporting Requirements and Revised Financial Closeout Requirements for NIH Administrative Supplements Awarded to Recover Losses Due to Hurricane Sandy under the Disaster Relief Appropriations Act NOT-OD-14-113 Revised Policy: Descriptions on the Use of Individual Development Plans (IDPs) for Graduate Students and Postdoctoral Researchers Required in Annual Progress Reports beginning October 1, 2014 15

Questions? 16