Fogarty International Center NIH Grants Update Kasima Brown Grants Management Specialist

1. Fogarty International Center NIH Grants Update Kasima Brown Grants Management Specialist 11th Annual Fogarty International Center Administrator’s Meeting October 26, 2012

2. Topics to Cover • NIH Policy Updates • FIC Training Grant Progress Reports • Compliance and Prior Approvals • Other Important Reminders

3. NIH POLICY UPDATES

4. Updated NIH Grants Policy Statement Now Available • Effective October 1, 2012: http://grants.nih.gov/grants/policy/nihgps_2012/index.htm • NOT-12-157: Includes document summarizing the significant changes that are being implemented: http://grants.nih.gov/grants/policy/nihgps_2012/Significant_Changes_NIHGPS_2012.doc

5. Continuing Resolution through March 27,2013 • NOT-OD-13-002 • Continue at FY 2012 Level: • Salary cap remains at $179,700. • No inflationary increases. • Non-competing awards (Type 5s) may be awarded at up to 90% of the level committed for FY 2013.

6. Electronic Application Submission for Foreign Grantees • Electronic submission of grant applications is required for all competing grant applications to NIH. • Different ways to submit an electronic application: • Downloadable forms (most common) • Institutionally developed system-to-system data stream (usually used only by institutions with lots of NIH grant funding) • Services of a commercial service provider • See the NIH OER webpages for additional information: • Foreign grants-Electronic submission Info Page • Electronic submission for foreign institutions Webinar

7. Electronic Application Submission for Foreign Grantees Continued • Organizations must register in multiple systems to apply. • All registrations must be COMPLETE by the application due date in order to apply: • Start a MINIMUM of 8 weeks before the application due date. • Organizations must be registered in all of the following: NCAGE, DUNS, SAM, Grants.gov, eRA Commons • PIs must work with their institutions to register in eRA Commons

8. The CCR to SAM.GOV Transition • The grantee institution must register to create a new SAM.gov account and migrate any previously existing “legacy” accounts (CCR) by linking your email address. • When registering, can use the same log-in and password for the SAM.gov account • User Guide (PDF) • Awards CANNOT be issued unless the registration is active and will not expire within 30 days of the budget start date. • IMPORTANT: Make sure your entity record is PUBLIC. This is how your GMS will be able to verify your active registration. • “Information Opt-Out: I authorize my entity's information to be displayed in SAM's Public Search: Yes”

9. Implementation of the Research Performance Progress Report (RPPR) • OMB mandated format standardizes interim progress reports submitted to agencies: Includes standard fed-wide questions and NIH-specific data elements • http://grants.nih.gov/grants/rppr/ • Includes the NIH RPPR Instruction Guide • RPPR Training for Grantees (Oct. 17, 2012) (archived) • “How does the RPPR differ from eSNAP Progress Reports?” • SNAP RPPRs currently available. • NIH expects to require use of the RPPR for SNAP activity codes in the Spring of 2013, and to pilot the RPPR for non-SNAP awards during calendar year 2013. Any requirement to submit RPPRs will be announced in the NIH Guide.

10. The Research Performance Progress Report (RPPR) • See the RPPR webpage and Instruction Guide for additional information. • SNAP awards will still not require budget. • Able to link to search PubMed to indicate Public Access Policy compliance status. • Streamlines ClinicalTrials.gov reporting. • Effort for all participants must be rounded to nearest whole person month. • Content varies depending on activity code.

11. Which RPPR do I use? Activity Codes R01-like SNAPs D71, DP1, DP5, G08, G11, G13, P40, R00, R01, R03, R18, R21, R33, R34, R36, R37, R56, RC1, RC2, RL1, S10, S21, S22, SC1, SC2, SC3, UB1, UC2, UH1, UH2, UH3, UP5, P01, P20, P30, P40, P41, P50, PL1, R24, S11, U01, U10, U19, U24, U34, U54 Individual K SNAPs K01, K02, K05, K06, K07, K08, K18, K22, K23, K24, K25, K26, K99, KL1 Education SNAPs D43, K30, R13, R25, RL5, T14, T36, U13, U2R Fellowships F05, F30, F31, F32, F33, F34, F37 SBIR/STTR SNAPs R41, R42, R43, R44, U43, U44

12. Changes in Policies and Procedures for FY13 DIRECT Foreign Awards • NOT-OD-12-139 • Payment for all foreign awards issued after October 1, 2012 will transition to be paid through the Payment Management System (PMS). • Only affects DIRECT Foreign Awards (Foreign Institutions as primary grantee). • There will be no change to the due dates or to the submission or review of progress reports for foreign awards for Fiscal Year 2013. 

13. Changes in Policies and Procedures for FY13 DIRECT Foreign Awards Continued • The FY13 non-competing awards will be issued as a Type 4. • The FY12 award project end date will change: • FY12 FFR will be considered a FINAL FFR. • The Document Number for the FY13 award will change. • MUST REGISTER FOR PMS ACCOUNT AS SOON AS POSSIBLE AFTER THE FY13 AWARD IS ISSUED (the NOA is received). • Link to registration forms available through the NOT-OD-12-139 to get started but do NOT submit prior to the FY13 award issuance.

14. Changes in Policies and Procedures for FY13 DIRECT Foreign Awards Continued • Regardless of the carryover authority noted in the NoA:  Carryover of an unobligated balance from an award issued prior to October 1, 2012 to an award issued after that date must be done with NIH assistance. • For all initial SNAP awards issued to foreign institutions after October 1, 2012, foreign grantees are not required to report expenditure data annually via the FFR. FFR expenditure data is required only at the end of a competitive segment for SNAP awards. • For initial awards issued after October 1, 2012 when preparing the FFR expenditure data, grantees must use the currency rate in effect at the time the funds are drawn down from PMS.

15. PROGRESS REPORTS

16. FIC Training Grant Progress Reports • Refer to the FIC webpage for guidance on D43 research training grant progress reporting http://www.fic.nih.gov/Grants/Pages/progress-reports.aspx • All personnel report: Do not need to include trainees, post-docs, or other persons with less than 1 month effort. • FIC requires Other Support be submitted for all key personnel. • The D43 Training Grant is not a NRSA program. • NRSA can be used as a guideline for items such as stipend levels.

17. FIC Training Grant Progress Reports Continued • Things to include in the Progress Report Summary: • Description of training program activities. • Brief description of how training has met the mission of any co-funders. • Description of your program’s instruction in the responsible conduct of research. • Administrative challenges. • Long term program accomplishments. • Future plans. • Progress of supplement(s).

18. FIC Training Grant Progress Reports Continued • Include detailed budget and detailed budget justification (Explanation of categories: “Other”) • Unobligated balances: Report ANY current unobligated balance (even if less than 25% of the current year Total Costs): • Report the actual/estimated amount. • Explain the reason for the unobligated balance.

19. FIC Training Grant Progress Reports Continued • Tables 12A and 12B: • Enter data into CareerTrac and the data will automatically populate and can be exported for the progress report. • Eliminates the need for double-entry! • CareerTrac: https://careertrac.niehs.nih.gov/

20. FIC Training Grant Progress Reports Continued • Research subjects • Human Subjects: • HS education documentation is required for all personnel working with human subjects. • Federalwide Assurance (FWA) no. for each US or foreign institution. • IRB approval confirmation for the domestic and foreign site(s). • Animal subjects: • Animal Welfare Assurance (AWA) no. required for each US or foreign institution. • IACUC approval confirmation.

21. COMPLIANCE AND PRIOR APPROVALS

22. Consortia • The prime recipient is responsible for performance of the project, reporting requirements, etc. • Requirements of prime generally apply to sub-awardee and administrative and cost principles flow down to consortium participants. • The grantee is responsible for obtaining NIH approval for any actions to be undertaken by consortium participants that require such prior approval. • Domestic grantees with foreign consortium sites are responsible for ensuring foreign institutional compliance.

23. Consortia- Projects Involving Human Subjects • The prime grantee is responsible for ensuring all sites engaged in research involving human subjects have: • An appropriate OHRP-approved assurance (FWA#) • IRB approval • Documentation of completed required human subjects protection education.

24. Consortia- Projects Involving Animal Subjects • The prime grantee is responsible for ensuring all sites engaged in research involving animal subjects have: • An appropriate OLAW-approved assurance (AWA#) • IACUC approval • Domestic grantees with foreign consortia: The foreign site(s) must have: • An appropriate OLAW-approved assurance (AWA#) • IACUC approval • This certifies that the activity, as conducted at the foreign site, is acceptable to the grantee. The grantee IACUC may accept, as its own, the approval of a foreign entity’s IACUC; however, the grantee IACUC remains responsible for the review. • Direct foreign grantees: Need OLAW-approved AWA# and are encouraged to use the Guide for the Case and Use of Lab Animals (8th edition, 1/1/12)

25. Prior Approval Requests • Must be submitted in writing to the Grants Management Specialist from the authorized institutional business official no later than 30 days prior to the proposed change. • Requests are acceptable via email, but there must be proof that an authorized official concurs with the request.

26. Prior Approval Requests Continued • Common actions requiring prior approval: • Change in scope- ALWAYS requires prior approval • Changes in the status of PI/key personnel • Additional subawards • Deviations from terms and conditions • Large equipment purchases not previously approved • Need for additional funds • A&R costs not previously approved • Significant rebudgeting • New foreign component • Additional No-Cost Extensions

27. Changes in Scope ALWAYS Require Prior Approval from the GMS/GMO • A change in scope is a change in the direction, aims, objectives, purposes or type of research training, identified in the approved project. • The grantee must make the initial determination of the significance of a change and should consult with the GMS/GMO as necessary. • Potential indicators of a change in scope include, but are not limited to: • Change in specific aims approved at time of award. • Changes in animal model(s), or in the use of animals or human subjects. • Transfer of the performance of substantive programmatic work to a third party through a consortium agreement, contract, or any other means. • If the third party is a foreign component, NIH prior approval is ALWAYS required. • Change in any key personnel named on the NOA or their level of effort. • Significant rebudgeting in a single direct cost category deviating from the categorical commitment level established for the budget period by 25% or more of the Total Costs awarded. • Purchase of a unit of equipment exceeding $25,000.

28. No-Cost Extensions (NCEs) • First NCE: Use of the eRA Commons required from 90 days prior to the project period end date: After link is closed, becomes a prior approval action. • Additional NCEs: Prior approval request must include: • The proposed revised ending date and detailed justification for the extension. • The amount of unobligated balance available for the grant. • An explanation of the work to be done during the extension. • An itemized budget for the remaining funds. • Updated IRB/IACUC approvals, if applicable. • The existence of a balance is NOT sufficient justification for a NCE. • The proposed use of funding during a NCE MUST be within the originally approved scope of the project.

29. OTHER IMPORTANT REMINDERS

30. Other Important Reminders • ARRA ENDS 9/30/2013! • Travel: US carriers must be used to the maximum extent possible and should not be influenced by cost, convenience, or personal travel. • There are only a few exceptions. (See the GPS and the Fly America Act.) • Also follow your institution’s travel policy. • If your institution does not have a policy, use Federal Travel Regulations issued by the U.S. General Services Administration (http://www.gsa.gov/portal/content/104790)

31. Existing NIH Policy Reminders:Institutional vs. NIH Policy • Institutional policy can be more restrictive than NIH policy. If this is the case, then institutional policy can supersede NIH policy. • Institutional policies must be consistently applied regardless of the source of funding. • Grant funds may not be applied if the institutional policy is less restrictive than NIH policy. • If your institutional policy allows for something that is not allowable under NIH policy, then you cannot charge costs associated with those activities to the grant.

32. Allowable Costs • The NIH Grants Policy Statement is an excellent resource for determining the allowability of a certain cost: • Part II.7: Terms and Conditions of NIH Grants Awards- Cost Considerations • 7.2: The Cost Principles • 7.9: Allowability of Costs/Activities 7.9.1: Examples of Selected Items of Cost

33. Common Unallowable Items • Major Alterations and Renovations > $500,000 for foreign grants and domestic grants with foreign subcomponents. • Consular fees, custom surtaxes, value added taxes and other related charges are unallowable under foreign grants and domestic grants with foreign subcomponents. • Full F&A costs for foreign institutions. • Honoraria for speakers. • Budget items that are not allowable, allocable, and reasonable costs. • This list is not all-inclusive or exhaustive.

34. Public Access Policy • http://publicaccess.nih.gov/index.htm • The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. • Requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central upon acceptance for publication. • Requires these papers are accessible no later than 12 months after publication. • PD/PI’s MyNCBI Account must be established and linked to eRA Commons accounts. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-103.html • Non-competing awards will not be issued until publications are verified as compliant.

35. Revised Regulation on Financial Conflict of Interest (FCOI) • OER Financial Conflict of Interest webpage • Includes Updates and FAQs to Revised Regulations • NIH FCOI Reporting Requirements Webinar 8/14/2012 (archived) • Minimum threshold of $5000 for payments and equities • FCOI must relate to investigator’s professional responsibilities at the institution and the federally funded research; must contain a management plan • An institution’s FCOI policy must be accessible via a public website • More rigorous reporting to include annual FCOI reports • Submission through FCOI module in eRA Commons • FCOI Investigator training prior to start of research

36. Reference Links • Fogarty International Center webpage: http://www.fic.nih.gov/Pages/Default.aspx • FIC Progress Report Guide webpage: http://www.fic.nih.gov/Grants/Pages/progress-reports.aspx • FIC Foreign Grant Information Guide webpage: http://www.fic.nih.gov/Grants/Pages/Foreign.aspx • NIH Office of Extramural Research Webpage: http://grants.nih.gov/grants/oer.htm • Updated NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/nihgps_2012/index.htm • Summary of Significant Changes to NIH GPS: http://grants.nih.gov/grants/policy/nihgps_2012/Significant_Changes_NIHGPS_2012.doc • Continuing Resolution NOT-OD-13-002: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-002.html • NIH OER Foreign Grants Information Webpage: http://grants.nih.gov/grants/foreign/index.htm • Foreign Grant Application Electronic Submission: http://grants.nih.gov/grants/foreign/electronic_submission.htm • Foreign Grant Electronic Submission Webinar: http://grants.nih.gov/grants/webinar_docs/webinar_slides_20120927.pdf

37. Reference Links Continued • Special Council Review for PDs/PIs with more than $1 million in Direct Annual NIH Support NOT-OD-12-140: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html • RPPR Reference Page: http://grants.nih.gov/grants/rppr/ • RPPR Instruction Guide (PDF): http://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf • Changes in Policies and Procedures for Direct Foreign Awards NOT-12-139: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-139.html • OER Financial Conflict of Interest Topic Webpage: http://grants.nih.gov/grants/policy/coi/index.htm • DHHS Office for Human Research Protections (OHRP): http://www.hhs.gov/ohrp/ • OER Research Involving Human Subjects Topic Webpage: http://grants.nih.gov/grants/policy/hs/index.htm • Office of Laboratory Animal Welfare (OLAW) Webpage: http://grants.nih.gov/grants/olaw/olaw.htm • NIH Regional Seminars on Program Funding and Grants Administration: http://grants.nih.gov/grants/seminars.htm#upcoming

38. NIH OER ListServs • NIH Guide for Grants and Contracts: • Official publication for NIH Grant Policies, Guidelines & Funding Opportunities • http://grants.nih.gov/grants/guide/listserv.htm • NIH Regional Seminars on Program Funding and Grants Administration: • http://grants.nih.gov/grants/seminars.htm#listserv • Office for Human Research Protections (OHRP): • http://www.hhs.gov/ohrp/ • Office of Laboratory Animal Welfare (OLAW): • http://grants.nih.gov/grants/olaw/references/list.htm • eSubmission: • Separate listservs available for scientists and administrators • http://era.nih.gov/ElectronicReceipt/listserv.htm

39. Helpful Contacts • General Application Questions: • Email: GrantsInfo@nih.gov • Phone: 301-435-0714 • Grants.gov Customer Support: • Email: support@grants.gov • Web: http://grants.gov/ • Phone: 800-518-4726 • eRA Commons Helpdesk: • Web Ticket: http://ithelpdesk.nih.gov/era/ • Phone: 301-402-7469 or 800-504-9552 • Division of Grants Policy: • Email: GrantsPolicy@mail.nih.gov • Division of Grants Compliance and Oversight • Email: GrantsCompliance@mail.nih.gov

40. Fogarty International Center Grants Office Update Thank you! Any questions? Kasima Brown Kasima.Brown@nih.gov (301) 496-5710