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NSF- NIH Update New Directions & Requirements

NSF- NIH Update New Directions & Requirements. Bob Webster rwebster@uamail.albany.edu 437-4550 December 2010. NIH Update – Fall 2010. Information Obtained from meetings of: Council on Government Relations Federal Demonstration Partnership

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NSF- NIH Update New Directions & Requirements

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  1. NSF- NIH UpdateNew Directions & Requirements Bob Webster rwebster@uamail.albany.edu 437-4550 December 2010

  2. NIH Update – Fall 2010 Information Obtained from meetings of: Council on Government Relations Federal Demonstration Partnership National Council of University Research Administrators by Joe Ellis, Director and Staff from Office of Policy for Extramural Research Administration

  3. NIH Budget and Recovery Act News

  4. NIH Budget FY 2010 & 2011 • President’s 2011 Budget Request: $32.2 billion • Increase of 3.2% from FY 2010 • Increase will support Innovative high throughput technologies, including DNA sequencing, imaging, and computational biology • NIH currently operating under a Continuing Resolution (CR) through 12/18/2010 • As of 12/8 House passed a CR at 2010 levels whereas the Senate has drafted an omnibus appropriations bill More at: http://officeofbudget.od.nih.gov/br.html

  5. Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion $16.4 B

  6. ARRA Reminders • Reminders for spending and no-cost extensions for ARRA awards: • Spending should be timely and expeditious and in accordance with expected pace of research • Standard NIH Terms of Award apply in addition to ARRA specific terms. • Grantee has authority to extend project period end dates up to 12 months. • Additional (prior approval) extensions will only be considered in limited circumstances • Cannot role over funds from ARRA awards to non-ARRA awards http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-067.html

  7. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-004.html Transparency Act (aka FFATA) • Extension of ARRA Reporting Requirements • Additional requirements for Subcontractors • All subawardees required to have DUNS - New • While not required for subrecipients, they are encouraged to register with Central Contract Registry (RF/UA Position)

  8. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-005.htmlhttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-005.html Transparency Act • Executive Compensation Reporting for subawards • Awards of $25,000 or more, and in previous fiscal year, entity received • 80% or more in annual gross revenue from Federal grants, subawards, contracts, and subcontracts subject to the Act, and • $25,000,000 or more annual gross revenue from Federal grants, subawards, contracts, and subcontracts, and • Public access to the information is not already available

  9. Possible Merger of Institutes • NIH Director Francis Collins favors creation of a new institute focusing on addictions • Recommended by NIH’s Scientific Management Review Board • NIDA & NIAAA and selected programs from NCI, NHLB I • Task force to issue recommendations by summer • Proposal for a new center focused on translational medicine and therapeutics.

  10. New Scientific and Grants Management Policies

  11. NIH Grants Policy Statement Revision - FY2011 • Effective October 1, 2010, revision superseded the December 2003 version • incorporates all policy changes since 12/03, public policy changes, clarification of existing policies • Includes new chapters recommended by users (Career Awards, Multiple PD/PI), terminology changes as well as document enhancements. • Improves organization of existing chapters • http://grants.nih.gov/grants/policy/nihgps_2010/index.htm http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-003.html

  12. Revised Policy for JIT Submissions • Applicants are responsible for promptly notifying NIH of any substantive changes to previously submitted Just-in-Time information up the time of award, including: • Current other support, certifications, hESCs, other information requested by awarding IC NIH Guide: NOT-OD-10-120

  13. Mandating eSNAP • All SNAP progress reports must now be submitted electronically through the eRA Commons eSNAP module  • IRB/IACUC dates not routinely required in progress report • Reports due 45 days instead of 60 days before anniversary • PHS 2590 Instructions updated: http://grants.nih.gov/grants/funding/2590/2590.htm • Revised eSNAP User Guide posted at http://era.nih.gov/docs/eSNAP_UG_v2.25.0.0_041210.pdf. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-093.html

  14. Post-Submission of Application Materials, Prior to Peer Review • The only grant application materials accepted after submission of the application and before the initial peer review will be if they result from unforeseen administrative issues. • Must have concurrence of Authorized Organization Representative (Research Administrator) • See Guide Notice for details on acceptable and unacceptable material, exceptions, and page limits http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-091.html

  15. Genomic Array Costs • Facilities and Administrative (F&A) costs awards with Genomic Arrays (GA) costs • First $50,000 treated as supplies each year • Amount in excess of $50,000 treated as consortium costs, F&A rate applied to first $25,000 of excess each year • FAQs are being developed http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-097.html

  16. Resubmission Timeline • NIH will not accept a Resubmission that is submitted later than 37 months after the date of receipt (“receipt date”) of the initial New, Renewal, or Revision application. NIH Guide NOT-OD-10-140

  17. More at: http://stemcells.nih.gov Human Embryonic Stem Cell Research • The receipt, processing, review, and awarding of NIH applications and proposals, involving human embryonic stem cells will continue and NIH Human Embryonic Stem Cell Registry will resume accepting submissions. • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-136.html

  18. Highlights of New and Existing Grant Requirements

  19. Financial Conflict of Interest (FCOI) Regulations (10/1/95) • FCOI regulations require that grantee institutions: • maintain an appropriate written, enforced policy on conflict of interest that complies with the regulations. • establish adequate enforcement mechanisms and provide for sanctions, where appropriate.

  20. Proposed Revision to FCOI Regulations • Notice of Proposed Rule Making (NPRM) • Comment period closed 8/19/10 • Currently evaluating comments received • Next Step – publication of new final rule within 1 year

  21. Major proposed changes to the regulations I • Significant Financial Interest (SFI) • Minimum threshold of $5,000 generally applies to payments and/or equity interests • Includes any equity interest in non-publicly traded entities • Exclusions include income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies or institutions of higher education • Investigator Disclosure • All SFIs related to investigators’ institutional responsibilities • Institutions responsible for determining whether SFIs relate to PHS-funded research and are financial conflicts of interest (FCOI)

  22. Major proposed changes to the regulations II • Institutional Management • Institutions must have a management plan, which may include reducing or eliminating the FCOI • Reporting to PHS Awarding Component (NIH) • Current requirements, along with: • Value of the financial interest • Nature of FCOI, e.g. equity, consulting fees, travel reimbursements, honoraria, and description of how FCOI relate to PHS-funded research • Key elements of the institution’s management plan

  23. Major proposed changes to the regulations III • Public Notice • Before spending funds for PHS-supported research, an institution shall post on a publicly accessible website information on certain SFIs that the institution has determined are related to the PHS-funded research and are FCOI. • Investigator Training • FCOI training required for investigators before engaging in PHS funded research, and every two years thereafter

  24. Closeout Final Reports • Failure to submit timely reports may affect future funding to the organization. • Documents are due within 90 days of project period end date. • Final Financial Status Report (must be submitted electronically) – SFFM responsibility • Final Inventions Statement & Certification – OSP responsibility • Final Progress Report –PI responsibility

  25. Non-Competing Continuation Progress Reports • Failure to submit timely progress reports may affect future funding to the organization • eSNAP progress reports are due 45 days prior to the anniversary date • All grantees have access to a searchable list to determine which progress reports are due at: http://era.nih.gov/userreports/pr_due.cfm

  26. Funding Opportunity Announcements • New FOA templates implemented: • Shorter FOAs • Use of consistent language • All applications intended for due dates of September 25, 2010, and beyond must be submitted in response to an FOA. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-134.html

  27. Update on Electronic Submission & eRA Commons

  28. Elimination of Error Correction Window Beginning January 25, 2011, NIH will eliminate the error correction window from the application submission process. A few key messages: The elimination of the error correction window will not affect the two-business-day application viewing window. Applicants will still be able to view and reject their application and submit a changed/corrected application prior to the submission deadline. Applicants are encouraged to submit early – early submission is the best way to ensure eSubmission success. More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-123.html

  29. Reminder: Tips for eSubmission Success • Carefully follow the specific guidelines found in the Application Guide and the Funding Opportunity Announcement (FOA). Be aware that the instructions in the FOA trump those found in the application guide. • Check your application for common errors before you submit! If errors are found in the submission process, you must submit a changed/corrected application. • Correct any errors before the submission deadline. • Remember: YOU are responsible for verifying that your application is viewable in the eRA Commons. If you can’t view your application, NIH can’t review it! • Submit Early (UAlbany has 5 day submission rule)!

  30. “My NCBI” Tool Replaces eRA Commons for Bibliography Management • eRA Commons linked to the National Center for Biotechnology Information’s personal online tool, “My NCBI.” • My NCBI’s has a bibliography feature called My Bibliography. • PD/PIs must establish a My NCBI account; account must be linked to their eRA Commons account • References saved in My NCBI automatically appear in Commons for future use (i.e. in a future progress report). • Resources: • Overview & Benefits: http://era.nih.gov/ncbi/ncbi_overview.cfm • eRA Virtual School web-based demos: http://era.nih.gov/virtualschool/external/class_bib.htm More at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-103.html

  31. xTrain Enhancements and 2011 Mandate • Effective January 1, 2011, NIH will require the electronic submission of appointment forms and termination notices for research training, fellowship, education and career development awards using xTrain. • Paper forms will not be accepted. • Training materials on the xTrain webpage: http://era.nih.gov/services_for_applicants/other/xTrain.cfm More at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-072.html

  32. FY 2011 Budget Request: NSF-wide Priorities • USGCRP: NSF contributions increase by 16 percent, to $370 million • NSF portfolios: • Science, Engineering, and Education for Sustainability (SEES): $766 million • Cyberlearning Transforming Education (CTE): $41 million • Total NSF Budget Request: $7.4M

  33. FY 2011 NSF Budget Request Administration Priority Programs: Increase FY 2011 over FY Total 2010 Graduate Research Fellowship Program $158 M $22.3 M Faculty Early Career Development $209 M $12.8 M Climate Change Education Program $10 M - Advanced Technological Education $64 M -

  34. America Competes Act Passage • Final passage during the current lame duck session is looking less likely: • As of Nov 24, the bill had yet to be filed in the Senate • Uncertainty of the final FY11 budget discussed under the NIH update

  35. Interdisciplinary Research (IDR) • Important research ideas often transcend the scope of a single discipline or program. • NSF gives high priority to promoting interdisciplinary research and supports it through a number of specific solicitations. • NSF encourages submission of unsolicited interdisciplinary proposals for ideas that are in novel or emerging areas extending beyond any particular current NSF program.

  36. NSF Policy Updates

  37. The America COMPETES Act NSF Implementation Activities

  38. SEC 7008: Postdoctoral Research Fellows • Mentoring - All grant applications that include funding to support postdoctoral researchers shall include a description of the mentoring activities that will be provided for such individuals. Mentoring activities may include career counseling, training in preparing grant applications, guidance on ways to improve teaching skills, and training in research ethics. • Reports - Annual reports and the final report for research grants that include funding to support postdoctoral researchers shall include a description of the mentoring activities provided to such researchers. • The mentoring plan must not exceed one page.

  39. SEC 7009: Responsible Conduct ofResearch • Effective January 4, 2010, a proposing institution's AOR (Research Administrator) must certify that the institution has a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. • Starting January 1, 2011, this requirement applies to all UA NSF grants regardless of start date.

  40. SEC 7009: Responsible Conduct ofResearch • Training plans are not required to be included in submitted proposals, but they are subject to review upon request. • NSF has modified its standard award conditions to clearly stipulate that institutions are responsible for verifying that the RCR requirement has been met.

  41. SEC 7009: Responsible Conduct ofResearch – UAlbany Solutions • CITI Web-Based Training • https://www.citiprogram.org/ • Graduate Courses: • BIO 515a - Responsible Conduct of and Skills in Research • BMS 670/EHS 675 - Responsible Conduct of Scientific Research • Certificate from an approved RCR course taken at another institution.

  42. CITI RCR Program • Choose your discipline-specific course: • Biomedical Research • Social and Behavioral Research • Physical Science • Humanities • Review of the required materials and completion of the quizzes will take about 30-35 minutes per topic. You do not have to complete the course all in one session.  A minimum aggregate score of 80% is required to pass the RCR course.

  43. NSF RCR Resources • RCR Page on the NSF Policy Website • http://www.nsf.gov/bfa/dias/policy/rcr.jsp • Federal Register Notices • FAQs • International Research Integrity

  44. SEC 7010: Reporting of ResearchResults • All final project reports and citations of published research documents resulting from research funded by the Foundation must be made available to the public in a timely manner and in electronic form through the Foundation's Website: Research.gov

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