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NIH Update November 10, 2009

NIH Update November 10, 2009. Joe Ellis David Curren Office of Policy for Extramural Research Administration. New NIH Director.

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NIH Update November 10, 2009

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  1. NIH Update November 10, 2009 Joe Ellis David Curren Office of Policy for Extramural Research Administration

  2. New NIH Director • Francis S. Collins, M.D., Ph.D., was officially sworn in on Monday, August 17, 2009 as the 16th director of the National Institutes of Health (NIH). Dr. Collins was nominated by President Barack Obama on July 8, and was unanimously confirmed by the U.S. Senate on August 7. (Formerly served as Director of the National Human Genome Research Institute (NHGRI),NIH from 1993-2008.)

  3. NIH Budget and Recovery Act News

  4. President’s FY 2010 NIH Budget Request • Proposes NIH receive $30.8 billion • Increase of 1.4% from FY 2009 • Supports 9,849 new and competing RPGs • Proposes temporarily suspending NIH Director’s Bridge Award program (R56) (because of ARRA). • Includes the following strategic priorities: Cancer Research; Autism Research; Nanotechnology-related Environment, Health and Safety Research; NIH Common Fund; Bioethics; Oversight More at: http://officeofbudget.od.nih.gov/br.html

  5. Breakdown of FY 2010 President’s Budget Request for NIH – $30.8 Billion $16.4 B

  6. American Recovery and Reinvestment Act (ARRA) • Stimulate and accelerate biomedical research with existing mechanisms • Expand science with new programs

  7. NIH Recovery Web site www.nih.gov/recovery ARRA Grant Funding Opps and Info at Grants.nih.gov/Recovery

  8. Special ARRA Terms and Administrative Requirements • In addition to the standard NIH terms of award, all NIH ARRA awards include special ARRA terms • http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf (updated July 8, 2009). • ARRA requires recipients to account for, track, monitor, report on, provide for audit of, and closeout ARRA funding separately from non-ARRA awards • Unique business processes established • Guide Notice NOT-OD-09-080 describing ARRA features; updated in Notice NOT-OD-09-120 • Special Quarterly Reporting Requirements More at:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-120.html

  9. ARRA also carries enhanced accountability and transparency. Grantees must fulfill detailed quarterly budget reporting requirements, consistent with section 1512(c) of the ARRA by October 10, 2009. Reports will summarize total amount of ARRA funds received that quarter and how those funds were expended. Compliance with October, 2009 deadline was high with NIH receiving over 99% of expected reports submitted! OMB posted Guidance Memo M-09-21 on June 22, 2009 http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-21.pdf OMB clarified this document through Q&As: http://www.whitehouse.gov/omb/recovery_faqs/ Reporting and Accountability

  10. Recipient Reporting • Reports entered at www.FederalReporting.gov and are now publicly available at www.recovery.gov • Includes web based form, MS Excel template and XML schema options for report submission • OMB Data Model v.3.0 • OMB released the Recipient Reporting Data Model v3.0 for ARRA, Quarter Ending September 30, 2009. • Includes a Data Dictionary describing the data elements specifically required for recipient reporting • Additional NIH guidance (based on the OMB Data Model): http://grants.nih.gov/recovery/Data_Dictionary.xls.

  11. Recipient Reporting • NIH FAQs address ARRA recipient reporting NIH-specific concerns: http://grants.nih.gov/recovery/faqs_recovery.html • ARRA Quarterly Report Sample Templates: http://grants.nih.gov/recovery/sample_quarterly_reports.html • ARRA Data Reports (includes most data needed for quarterly reports) : http://report.nih.gov/recovery/index.aspx More at http://grants.nih.gov/recovery

  12. Agency Review • HHS developed standards for a limited data quality review to identify “Material Omissions” and “Significant Errors” (per OMB Guidance) • Material Omissions = Report Not Submitted • Significant Errors: • Award amount differs from agency records • Award date differs from agency records • Expenditure amount >award amount • Unreasonably high job estimates

  13. Accessing ARRA $$$ in the Payment Management System (PMS) Unique “P” accounts for ARRA funds require a new process to access those funds. Cash pooling is not permitted. When a grantee requests ARRA funds, the grantee must separately account for those funds by subaccount/grant document. If a grantee has more than one “P” account, the grantee MUST request funds by subaccount (grant document). Existing PMS users can access the “P” accounts using already established login & password. More at:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-080.html

  14. New “P” Accounts and the SF272 • When a grantee processes its quarterly 272 Federal Cash Transaction Reports, if the grantee received ARRA funds the previous quarter, the grantee will see two different reports. One report for their “G” account and one report for their “P” account. • Each 272 must be submitted or a hold will be placed on their Division of Payment Management (DPM) account.

  15. Unique Document Number Schema • All HHS agencies required to adopt a unique Document Number Schema for ARRA awards. • For NIH, core schema traditionally used will remain intact; except the last character will be “Z” for initial awards. • Example: Grant Number= 1 R01 AI123456-01; ARRA Doc # = RAI123456Z • Transfers (T-7s): Transfer “competitive segment” for ARRA grants will be denoted with “Y”, “X” or “W” when applicable.

  16. Administrative Supplements & Competing Revisions • Need to accommodate the “separation” and accountability required by ARRA while maintaining a programmatic connection to the parent grant • ARRA T-3 budget/projects periods reflect that of the T-3 only and not the parent • ARRA T-3s issued in FY2009 may be for a single budget/project period up to 24 months. • ARRA T-3s issued in FY2010 will be no more than a 12-month budget/project period • Specific information on ARRA additional funding must be included in annual progress report of the parent grant. • No-cost Extensions of ARRA-funded T-3s • ARRA T-3s are awarded under NIH Terms of Award and therefore are eligible for a one-time no-cost extension • This is separate from the parent record More at:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-080.html

  17. Administrative Supplements & Competing Revisions (cont.) • No “co-mingling” of ARRA T-3 and parent grant $$$ allowed (assuming parent grant funded with regular appropriation $$$) • Separate institution accounts and PMS drawdowns • No rebudgeting between parent and ARRA T-3 • No carryover of ARRA T-3 balances into the parent • If an ARRA award includes a commitment for an ARRA-funded future year in FY2010, grantees will be able to carryover from the FY2009 budget period into FY2010. • No carryover allowed between ARRA funding budget periods and budget periods funded by non-ARRA fund • Separate Financial & Closeout Reports Required More at:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-080.html

  18. Unique Business Processes:Modified Carryover Authorities • -04 Yr funds CANNOT be carried forward into -05; -04 year financially closed • -05 Yr funds CAN be carried forward into -06 • -06 Yr funds CANNOT be carried forward into -07 • -04 Yr funds CANNOT be carried forward into -07

  19. ARRA Grant Compliance (Same as non-ARRA) • The applicant organization certifies in the grant application that it is obligated to comply with the terms and conditions of any resulting grant award • Acceptance of a grant award is signified by drawdown of funds which then obligates the grantee to comply with all standard and special terms and conditions of award (e.g., based on statute, regulation, policy, program requirement) • Failure to comply may cause NIH to take one or more enforcement actions, depending on the severity and duration of the non-compliance. • Enforcement actions may include special conditions, closer monitoring, withholding of support, recovery of funds, suspension, or termination

  20. NIH Allocation of ARRA FundsDollars In Billions Comparative Effectiveness Research Extramural Scientific Equipment Extramural Repair, Improvements, & Const. Intramural Repair, Improvements, & Constr. $8.2 Extramural Scientific Research (All ICs, OD, Common Fund) $1.0 $0.3 $0.5 AHRQ – $0.4 ARRA appropriated $10 billion directly to NIH Oversight, Risk ManagementFinancial & Employment Reporting

  21. Reports, data and analyses website (RePORT) released in 2008 and expanded in 2009 with addition of RCDC data (Research, Condition and Disease Categorization process) Replaces the former Award Information and Data web page and provides: Quick access to “Frequently Requested Reports”, FAQs; Efficient search tools for locating data and reports Links to funding estimates for certain research areas, conditions, and diseases. Includes ARRA-specific data queries More at:http://report.nih.gov New Tools to Search NIH FundingRePORT

  22. New Tools to Search NIH FundingRePORTER • Broader Research Portfolio Online Reporting Tool Expenditures and Result (RePORTER) • Replaces CRISP. Combines NIH project databases and funding records, PubMed abstracts, full-text articles from PubMed Central, and information from the U.S. Patent and Trademark Office with a robust search engine, allowing users to locate descriptions and funding details on NIH-funded projects along with research results. More at:http://projectreporter.nih.gov/reporter.cfm

  23. NIH Remains Committed to Identifying and Attracting New Biomedical Researchers. Assistance to New and Early Stage Investigators NIH Director’s New Innovator Award Pathway to Independence Awards I/C Specific Policies Available at: http://grants.nih.gov/grants/new_investigators NIH Priority:Continued Focuson New Investigators

  24. ESI Definition: A new or first time investigator who is within 10 years of completing his/her terminal research degree or medical residency (or equivalent). Appropriate consideration of ESI career stage applied during review and award selection. Identification of ESIs occurs in the Personal Profile of the eRA Commons. Investigators who enter degree and residency completion dates will be notified of their ESI status by email. Process to request an extension of the ESI period. More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-134.html NIH Priority: Assistance to Early Stage Investigators

  25. Stimulates highly innovative research and supports promising new investigators. Awards provide up to $1.5 million in direct costs for (up to) a 5 year project period. FY 2010 FOA released 8/26/2009: RFA-RM-09-011. New FAQs on eligibility, application requirements, and program features now available. More at:http://nihroadmap.nih.gov/newinnovator NIH Director’sNew Innovator Award (DP2)

  26. New Scientific and Grants Management Policies

  27. Enhancing Peer ReviewInitiative

  28. Phase-out of A2 resubmission applications New and early stage investigator policies Continuous submission process expanded Enhanced peer review criteria published New 1-9 scoring system Scoring of individual review criteria Templates for structured reviewer critiques Score order review Clustered review of new and ESI investigator R01 applications Priorities and Goals Implemented Thus Far More at: http://enhancing-peer-review.nih.gov

  29. Coming Soon: Restructured Applications and Instructions • Implementation of goal: Align the structure and content of applications with review criteria, and shorten the length of applications • Three sections of application instructions to be revised: • Research Plan • Biographical Sketch • Resourcesand Facilities • Shorter Page Limits • NIH Guide Notices NOT-OD-09-149 and NOT-OD-10-001 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-002.html More at: http://enhancing-peer-review.nih.gov

  30. Research Plan Changes • New Research Strategy section to replace 3 sections of the current Plan (Background and Significance, Preliminary Studies/ Progress Report, Research Design and Methods). • Research Strategy will have 3 subsections: • Significance • Innovation • Approach • Preliminary studies for new applications • Progress report for renewal/revision applications More at: http://enhancing-peer-review.nih.gov

  31. Biographical Sketch Changes • Personal Statement:Tell us why your experience and qualifications make you particularly well-suited for your role in the project • Publications: Encouraged to include no more than 15, and to make selections based on recency, importance to the field, and/or relevance to the application • Page limit remains at 4 More at: http://enhancing-peer-review.nih.gov

  32. Facilities and Resource Changes • Provide a description of how the scientific environment will contribute to the probability of success of the project • For ESIs, describe the institutional investment in the success of the investigator • In Select Agent Section of Research Plan describe the biocontainment resources available at all performance sites More at: http://enhancing-peer-review.nih.gov

  33. Shorter Page Limits

  34. Restructured Application Forms/Instructions must be used for due dates on/after January 25, 2010 • New FOAs are being posted without electronic application packages • By December, new application packages will be posted, along with new Parent Announcements, and updated active FOAs • You must return to the FOA to download the new forms and instructions for 1/25/10 due dates • Resubmissions must use new application forms and instructions (and shorter page limits) More at: http://enhancing-peer-review.nih.gov

  35. Establish criteria for NIH review of Human Embryonic Stem Cells (hESCs) to be included in new Registry as eligible for use in NIH funding Centralize processes and procedures for NIH reviews of hESCs New web-based Form 2890, separate from the grant application, will be used for organizations to submit information about hESCs for potential inclusion in the Registry Applicants will cite hESCs from the Registry in grant applications More at: http://stemcells.nih.gov NIH Guidelines on Human Stem Cell Research – 7/7/09

  36. NIH hESC Registry • Until hESCs are listed on new NIH Registry: • New and competing applications should not identify specific hESCs but should include a statement that one from the Registry will be used • New awards will include a restriction that no hESC research may be conducted until hESCs are listed on the Registry and the grantee identifies the line to be used • Ongoing awards will include an informational term that nonew use of hESCs may be initiated unless the grantee notifies NIH and identifies hESC(s) from the Registry to be used More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-123.html

  37. New Assurance & Reporting for Graduate Training Awards • Applies only to doctoral degree granting institutions receiving: D43, TU2, T15, T32, T37, T90, U2R, U90, and U54/TL1 • Assurance that institution will disclose to doctoral applicants: • % of students admitted who attained a doctoral degree • Average time until receipt of doctoral degree • Report same info to NIH on Table 12A of Institutional Research Training Data Tables More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-141.html

  38. Revised Progress Report • Use required as of 10/01/2009 • eSNAP changes released 10/09/2009 • Policy changes: • All Personnel Report (PD/PIs & all others with > 1 person month effort, regardless of compensation) • Assurance for Institutions with Awards for Grad Student Training for Doctoral Degrees • Describe any change to innovative potential • Biosketch • Question regarding hESC change More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-139.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-150.html

  39. eRA Commons ID Required for Postdocs on Progress Reports • All Personnel Report implemented as part of Progress Report (effective 10/01/2009) • Report those in a postdoctoral role for one person month or more • Provide Commons ID for postdocs Note for Commons Account Administrators:help your postdocs establish eRA Commons accounts using the new Commons Postdoctoral role More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-140.html

  40. Extensions of Continuous Submission and Review • Applies only to R01, R21 and R34, submitted for standard due dates. • Eligibility criteria: • Appointed members of chartered study sections or NIH Advisory Groups • Applicants with substantial peer review service (6 times in an 18 month period) • NIH commitment to review no later than 120 days after receipt More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-155.html

  41. New Policies on “K” Career Development Awards • New policy on part-time institutional appointment – may request reduction to less than full-time but at least ¾ time) for up to 12 continuous months; must maintain 75% effort. • Option available only after K award is issued. • Only for legitimate circumstances (e.g., accommodating parental leave, child care, medical condition, disability) • K awardees may also request permission to reduce professional effort to less than 75% (but >50%) for up to 12 continuous months. • A temporary career development experience at another institution for 3 months or less allowable without approval. • A leave of absence may be taken without award support, but may not exceed 12 months. More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-036.html

  42. Omnibus Appropriations Act of 2009 makes the Public Access Policy permanent New postings on Public Access website: Communication and training materials for grantee institutions New National Library of Medicine tool to Identify PubMed Central IDs NIH Policy Notice: Effective 8-21-2009, NIH Manuscript Submission IDs (NIHMSID) may be used to indicate compliance with the Public Access Policy in applications and progress reports for up to three months after a paper is published. After that period, a Pub Med Central ID (PMCID) must be provided to demonstrate compliance. See NIH Guide Notice OD-09-136. More at: http://publicaccess.nih.gov NIH Public Access Policy

  43. Registration of Clinical Trials “The FDA Amendments Act (P.L. 110-85) mandates registration and results reporting at ClinicalTrials.gov by sponsors of applicable clinical trials.” • Expansion of ClinicalTrials.gov registry. • Includes Phase II-IV clinical trials of drugs and devices subject to FDA regulation. • Increased number of data elements to be submitted. • Not limited to trials for serious or life threatening diseases. • Competing applications and progress reports for NIH-funded trials must include a certification of submission. • NIH encourages registration in ClinicalTrials.gov of ALL clinical research trials funded by NIH, whether required under the law or not. More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html

  44. Mandatory Registration All “applicable clinical trials” of drugs and biologics and devices are to be registered in the ClinicalTrials.gov database by responsible party NIH will verify registration before funds are released. Civil penalties to be levied for noncompliance if trials are not properly registered. Results Reporting P. L. 110-85 mandates the establishment of a clinical trials results database. Effective September 27, 2008, the NIH launched an expanded ClinicalTrials.gov database that can accept “basic results” information. Adverse Events Reporting Responsible Parties who submit results information-or update a record that contains results information-on or after 9/27/2009 must have to submit adverse event information in order for their submission to be accepted by the system. Mandatory Registration of Clinical Trials; Reporting of Results & Adverse Events More at: http://prsinfo.clinicaltrials.gov/fdaaa.html

  45. NIH’s Role on Registration & Reporting of Results in ClinicalTrials.gov Responsible Parties are solely responsible for the content, quality and timeliness of registration and results reporting in accord with FDAAA.  Responsible Parties are required to affiliate their applicable clinical trials with their Institution’s organization account or their own individual account, as appropriate.  They will no longer be registered in an NIH IC organization account.  NIH ICs cannot in any way substitute for the Responsible Party in fulfilling its statutory duties. More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-147.html

  46. NIH Salary Cap • Continuing Resolution (P.L. 111-88), effective through 12/18/09, extends FY09 appropriations rules. • Therefore the cap effective January 1, 2009, annual rate of $196,700 (equal to Executive Level I), remains effective. • The rate may change when NIH receives it FY2010 Appropriation. • Grantees should request institutional base salary so NIH can adjust based on future limits. More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-069.html

  47. Federal Funding Accountability and Transparency Act (FFATA) “Public Law 109-282 requires information on every grant, including 1) the amount, 2) descriptive purpose of the grant, and 3) name and location of recipient of primary performance location.” • Prepare for potential increased attention and scrutiny when data is made publicly available. • NIH has tailored processes to meet its requirements. • FFATA has required form changes in the 424 (R&R) and PHS 398 to capture performance site information. – will be implemented for submissions beginning 1/25/2010. • Requires reporting on all subawards over $25,000 (implementation TBD) More at: www.USASpending.gov

  48. Focused on NIH grant policies that apply to grants awarded to foreign institutions, international organizations, and domestic grants with foreign components. Addresses elements of the grant process (from submission to post-award management) specific to foreign applicants/grantees. Includes information on: Foreign-specific programs and foreign research opportunities. Foreign collaborations and partnerships. More at: http://grants.nih.gov/grants/foreign New NIH Web Site to Assist Foreign Grantees

  49. Highlights of New and Existing Grant Requirements

  50. Financial Conflict of Interest (FCOI) Activities NIH continues to enhance and promote compliance with the FCOI Regulation (42 CFR Part 50, Subpart F): • NIH system-wide review of FCOI policies, procedures, and guidance • eRA Commons FCOI module/reporting tool for grantees. Mandatory use began 7/1/09 • Updated FAQs and a Web-based tutorial • Articles in NIH Extramural Nexus • NIH Web based reporting and tracking tool for NIH staff • Pilot Compliance Program on FCOI • NIH Targeted Site Reviews • FCOI mailbox (FCOICompliance@mail.nih.gov) • NIH Guide Notices • Developed an Advanced Notice of Proposed Rule Making (ANPRM) to gather public comment on possible revisions to the FCOI regulation. • Analyzing comments received from the ANPRM Web Postings and Resources at: grants.nih.gov/grants/policy/coi/index.htm

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