National Institutes of Health Basics

1. National Institutes of Health Basics An Overview of the NIH Grants Process & Unique Vocabulary

2. NIH As A Grant-Making Organization • NIH is an agency within the Public Health Service (PHS), which is under the umbrella of the Department of Health & Human Services (HHS) • NIH’s mission is to improve human health by increasing scientific knowledge related to disease & health. • NIH is made up of 27 Institutes and Centers (IC’s), each with its own mission and functions, separate appropriations and statutory authorities. • They are loosely organized under the Office of the NIH Director, with broad authority to set their own policies and make their own grant funding decisions.

3. NIH’s Extramural Research Program • The NIH conducts its own Intramural Research Program utilizing staff scientists on its Bethesda campus. • The NIH Extramural Research Grants Program funds research nationally at universities and research centers through grants, cooperative agreements and contracts.

4. NIH Office of Extramural Research • The OER website is the best place to start when looking for information about NIH grants: http://grants1.nih.gov/grants/oer.htm • You can find there: • NIH Guide for Grants & • Contracts containing • Notices, PA’s/RFA’s/RFP’s • Application Forms • Supplemental Guidelines • Policies • Peer Review Information

5. Understanding the NIH Grants Process • NIH receives over 28,000 competing grant applications per year. • The Center for Scientific Review (CSR) receives almost 10,000 applications per grant cycle. • NIH funded about 17,000 applications in FY01. • The success rate for competing R01 applications hovers around 30%. CSR’s mailroom on deadline day.

6. So What Happens To That Grant Application After it Leaves RSP?The NIH Grant Peer Review Process Revealed • Applications received at NIH are sorted by Referral Officers at CSR to determine which Integrated Review Group (IRG) would be most appropriate for assessment of scientific merit. IRGs are clusters of study sections that review similar science. • Once the IRG is identified, the application is then assigned to one of the constituent study sections within the IRG. • In addition to the IRG assignment, Referral Officers also identify which Institute(s)/Center(s) (I/C) of the NIH would be most suitable to fund the application, should it be considered sufficiently meritorious. • Once the I/C is identified, a unique application number is assigned to each application. The Referral Office seriously considers written requests from applicants for both study section and Institute assignments (just include a cover letter with the application). A brief description of the peer review process can be found on the NIH website at: http://www.csr.nih.gov/review/peerrev.htm

7. The NIH Peer Review Process • After an application is assigned to a Study Section, the Scientific Review Administrator (SRA) assigns it to 2 or 3 members to read. • Those applications believed to rank in the lower half of the group of applications are “streamlined” or “triaged”i.e., they are returned to the applicant “without review.” The applicant may revise the application and re-submit it for a later deadline. • The Study Section reviews and ranks applications, assigning a “priority score” to each proposal. • Priority scores and percentile rankings are transmitted to the funding institutes, where Program Officials make funding recommendations to the Institute’s National Advisory Council. The Advisory Council conducts a second level of review and makes final funding decisions. It generally takes at least 10 months for a grant to be funded after it is submitted to NIH. A proposal submitted on February 1 will not be funded before December.

8. NIH Contracts, Cooperative Agreements and Grants…What’s the Difference? • NIH Grants are considered financial assistance to support activities in the public interest. NIH assumes that the grantee (UW-Madison) would have conducted the activity/research regardless of whether or not NIH funded it. Generally, the grantee controls all scientific aspects of the project under grant funding. • NIH utilizes the Cooperative Agreement when it wishes to retain control over the scientific and programmatic aspects of the project. While cooperative agreements are considered a financial assistance mechanism, the rules governing the use of funds and conduct of the activity are more restrictive than those governing standard research grants. (They normally are not under FDP or Expanded Authorities.) • The Contract mechanism is used when NIH wishes to purchase a product or service. Contracts are not financial assistance. The contract is a procurement mechanism by which the government purchases goods or services that it needs. • The remainder of this presentation is concerned primarily with grants. However, please be aware that NIH contract opportunities require complex applications, and the PI should give RSP as much lead time as possible. NIH issues a Request for Proposals (RFP) inviting proposals for contract opportunities. The RFP number will look something like: N02CP31013-38. Contract proposals must follow the instructions in the RFP and generally are NOT submitted on the standard NIH grant application forms. Contract proposals require both a technical plan and a business plan. The business plan includes Representations and Certifications which must be signed by RSP.

9. “R01’s and K08’s and T32’s, Oh My!” So What Do All Those Letters Mean? • NIH uses a variety of funding mechanisms, including: grants, cooperative agreements & contracts. • Grants & Cooperative Agreements are classified by “Activity Codes” that indicate the kind of activity that will be conducted under the project: • The R-series indicates Research Project Grants, e.g., R01, R03, R21. • The P-series indicates Program Project Grants, e.g., P01, P30, P50. • The T-series indicates institutional NRSA training grants. • The K-series indicates career development awards. • The F-series indicates individual NRSA fellowships. The IMPAC Manual contains complete explanations of all activity codes and other arcane NIH classification codes. It may be found at: http://grants1.nih.gov/grants/funding/funding.htm

10. A Rose is A Rose By Any Other Name…But What Does That NIH Grant Number Mean? • The NIH application number or grant number conveys a wealth of information about the grant. • The first digit indicates the Type of Application i.e., new(1), non-competing continuation (5), competing renewal (2), supplemental (3), or transfer(7). • The second set of three characters indicates the Activity Code, i.e, R01 is a Research Project Grant. • The two-letter code tells you the funding institute, i.e., AR is the National Institute of Arthritis & Musculoskeletal & Skin Diseases (NIAMS). • The six-digit code is the NIH serial number. • The two digits following the dash indicate the year of funding. • Suffixes after the year may indicate that the application is amended/revised (A) or is a supplement (S) to an existing grant. 2 R01 CA 597631-05A1 The above grant is a competing renewal of a Research Project Grant funded by the NCI. This is the 5th year of funding, and the application is the first amendment/revision of a previously unfunded competing renewal application.

11. NIH Grant Vocabulary • Competitive Segment: The initial project period recommended for support (up to 5 years) or each extension of a project period resulting from a competing continuation award that establishes a new competitive segment for the project. • Budget Period: The intervals of time, usually 12 months each, into which a project period is divided for budgetary and funding purposes. • Project Period:The total time for which NIH approves support of a project. The total project period is comprised of the initial competitive segment, any subsequent competitive segment resulting from competing continuation awards, and non-competing extensions. • New Application: A grant application for a new project that has not previously been submitted to NIH for funding consideration. • Revised Application: An application which was previously not funded by NIH and which the PI has revised to address the concerns of peer reviewers. NIH will only accept up to 2 revisions of the same application. • Competing Continuation/Renewal: An application that requests funding of an additional several years for a project that was previously funded for a period of several years by NIH. The renewal application must compete with all other new, revised and competing continuation applications, i.e., it receives no special consideration for funding. • Non-competing Continuation: An application that must be submitted each year within the competitive segment in order to receive the next budget year of funding. This application includes the PI’s annual progress report on the science of the project. This application does not compete with others for funding, since the funding was already committed by NIH at the beginning of the competitive segment.

12. So Many Application Kits, So Little Time… Which NIH Application Should the PI Use? • PHS-398 • New, Revised and Competing Renewals of Research Project Grants (R-series), Career Development Awards (K-series) and Institutional NRSA Training Grants (T-series). • PHS-2590 • Non-competing continuations of all the above grant series. • PHS-416-1 • New and Revised Individual NRSA Fellowships (F-series) • PHS-416-9 • Non-competing continuations of F-series grants.

13. PHS-398 SUBMISSION REQUIREMENTS • Cover Letter (optional) • Original, single sided application w/ PI and RSP signatures • 5 exact single sided copies (made after signature of original), DO NOT STAPLE • 5 collated sets of appendix materials

14. PHS-398 APPLICATION KIT REMINDERS • Text Size: Helvetica or Arial 11 Point /15 Characters Per Inch / 6 Lines Per Vertical Inch • Watch page limitations on Research Plan • IRB, IACUC & Biosafety approval letters should be attached, if available

15. Revised PHS 398 Forms (Rev. 05/01) • Four (4) page Biographical Sketch • Biosketch the same for modular and non-modular submission • NO Other Support, until requested • NO Personnel Report, until requested • Checklist includes space to calculate F&A for each project year • Provisions for SBIR/STTR applications

16. Biosketch Reminder for the PHS-398 • Biosketch format is identical for modular and non-modular submissions • Four (4) page limit • NOTE: “Positions, Education and Honors” and “Publications” sections each may not exceed two of the four page limit • Include section on Research Support (Ongoing & Completed in the Last 3 Years)

17. NIH Budget Preparation for the “Traditional” Format: DIRECT COSTS • Personnel (Salary & Fringe) • Consultant Costs • Supplies • Equipment* • > $5,000 = equipment • < $5,000 = supplies • Travel • Patient Care Costs • Other Expenses *Equipment is defined at UW-Madison as an article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost of $5,000 or more per unit.

18. Budget Terminology:FRINGE BENEFITS • Retirement • FICA • Health & Dental • Tuition Reimbursement • Post Retirement Benefits • Other

19. NIH Budget Preparation:Fringe Benefit Rates (FY06-07) • Regular Faculty and Academic Staff  35.00% • Regular Classified 50.00% • Research Associates and Grad Interns 24.00% • Research Assistants, Project Assistants, Teaching Assistants, Pre-Doc Fellows and/or Trainees  27.00% • Post-Doc Fellows and/or Trainees 12.50% • Limited Term Employes (LTE's) 20.00% • Ad Hoc Program Specialists, Undergraduate Assistants and Undergraduate Interns 6.00% • Student Hourly Employee 2.00% The rates for Research, Project, and Teaching  Assistants, and Pre and Post-doctoral Fellows and/or Trainees represent the University’s contribution to health insurance only.  All other rates include the University’s contribution to retirement, health and life insurance, social security, unemployment and worker's compensation insurance, and income continuation insurance as appropriate.

20. Budget Terminology:Facilities & Administration Costs • Definition Costs that are incurred by a grantee organization for common or joint objectives which cannot be identified specifically with a particular project or program. • F&A Rates may be found on RSP’s website at: http://www.rsp.wisc.edu/rates.html

21. Variations on a Theme…NIH Modular Grants • NIH modular grant process applies to: • Research Project Grant: Unsolicited New, Revised,Competing Continuation, Competing Supplements (R01, R03, R15, R21, R41, & R43) • For applications up to $250,000 direct cost annually or IF SPECIFIED in program announcement or request for applications

22. What is MODULAR about it? • Costs requested in “Modules” of $25,000 • e.g., $125,000, $225,000 • Level funding for life of competitive period: • “A typical modular grant application will request the same number of modules in each year.” • NOTE: This is not a requirement, but any variation in modules must be justified. • No detailed categorical budget information • Narrative information for Personnel, and (if applicable) consortium/contractual

23. Why the MODULAR GRANT? • Simplify/Improve NIH granting process • Simplify/Improve NIH oversight process • Saves Administrative Effort • -Eliminate pre-award cost analysis • -Focus on Science, not cost detail • Eliminates post-award categorical budget oversight • Oversight based on total cost • Emphasize Program over administration

24. Advantages to the PI • Competes on basis of Science, not budget detail • Minimizes post-award categorical cost management • Must manage project, but not tied to budget • Automatic carry-forward • Requirement for prior approval from NIH for “Significant Rebudgeting” is eliminated

25. Disadvantages to the PI • Extra step preparing proposal budget • Detailed budget still needed by most Division • Requires careful post-award management of funds (responsibility falls to institution to monitor) • Carry-over (greater than 25%) rules still apply

26. Preparing the “Modular” NIH Grant Proposal • Integrated into PHS 398 (Rev. 04/2006) & SF424 R&R • No submission of detailed budget • Provide only narrative NIH Modular Grant budget justification: • Bottom line direct cost totals for each year & grand total • Budget justification listing key personnel by position, role, and level of effort (no salaries) • Itemize subcontracts to nearest $1,000

27. More Variations on a Theme…“Just-in-Time” Instructions for the PHS-398 • Just-in-Time concept applies to the R- and K-series. These instructions are now incorporated into the PHS-398 instructions. • Just-in-Time instructions are still occasionally seen in a PA or RFA. Be aware that the special instructions found in the relevant PA or RFA take precedence over the standard instructions in the PHS-398 kit. • Just-in-Time applies to IRB and IACUC approvals and Other Support.

28. Using the NIH PHS-2590 Application: The Complete, Traditional Format • Some grants, such as Program Project Grants (P-series) and Institutional Training Grants (T-series) must use the complete, traditional instructions for the PHS-2590. • For these grants, PI’s must complete all the relevant forms for their non-competing continuation applications, according to the PHS-2590 instructions.

29. The PHS-2590 & the Streamlined Non-competing Award Process (SNAP) • Most NIH awards under Expanded Authorities and/or Federal Demonstration Partnership (FDP) are under SNAP. These may include: R01, R03, R13, R15, R18, R21, R24, R25, R29, R37, R42, R44, and K awards. • The Streamlined Non-competing Award Process (SNAP) instructions do not require submission of a detailed budget. • Check the PI’s NIH Notice of Grant Award (NGA) to be certain the grant is under SNAP.

30. It’s A SNAP! • PI’s may submit SNAP applications electronically through the NIH Commons. • There are only three parts to a paper SNAP application: 1) Face Page; 2) Progress Report Summary; and 3) Personnel Report. • A Checklist Page is required only if there has been a change in the performance site that affects the F&A rate for the grant and/or if program income is anticipated. (It is not necessary to complete a Checklist Page just because the UW-Madison F& A rate changes. The exact instructions are found on page 2 of the PHS 2590 kit.)

31. SNAP Instructions for the PHS-2590 • Face Page: No Dollar Amounts Required: On the face page, NIH asks that items 8a and 8b remain blank. This is because the NIH already has committed to a specific funding level that will be granted in the continuation years of a grant. For this reason, as well, NIH does not want a detailed budget with SNAP applications. • Progress Report: The Three Questions: NIH requires a Progress Report Summary (Form Page 5) with SNAP applications. In addition to the scientific progress report, three specific questions must be answered: • Has there been a change in the other support of key personnel since the last reporting period? • Will there be, in the next budget period, a significant change in the level of effort for key personnel from what was approved for this project? (>25% reduction) • Is it anticipated that an estimated unobligated balance (including prior year carryover) will be greater than 25 percent of the current year's total budget? • If the answer to any of these questions is "yes," an explanation must be given. • If there has been a change in the other support of any key personnel, updated Other Support pages must be submitted. When a previously active grant has terminated and/or a previously pending grant is now active, then a report is necessary. • Change in level of effort for key personnel is described as a reduction by 25 percent in time devoted to a project, regardless of whether or not the individual receives salary on the grant. (Note that according to the NIH Grants Policy Manual, change in level of effort only applies to persons named in the NGA, almost always only the PI.) • Significant Rebudgeting Not Applicable: Effective with the revised NIH Policy Statement issued March 1, 2001, the question regarding significant rebudgeting is no longer applicable and does not need to be answered. • Personnel Report Form: The final page required for a SNAP application is the Personnel Report Form. All Key Personnel for the current budget period who participated in the project during the current budget period should be listed.

32. The PHS-416-1 and PHS-416-9 • The PHS-416-1 is used for new and revised individual National Research Service Award (NRSA) fellowships (F31, F32, F33.) • The PHS-416-9 is used for non-competing continuation applications (progress reports) for currently funded fellowships. • In addition to the instructions in the PHS-416, applicants should use the relevant supplemental instructions found at: http://grants1.nih.gov/training/nrsa.htm#fellowships • Certain specialized NRSA programs have supplemental guidelines, as do certain Institutes within NIH. • For example, applicants for the standard Postdoctoral Individual NRSA Fellowship should refer to the general postdoctoral program announcement at: http://grants1.nih.gov/grants/guide/pa-files/PA-06-373.html

33. Mysteries of A-21: Cost Accounting Standards • Cost Accounting Standards (CAS) Policy • EFFECTIVE SEPTEMBER 1, 1994 • FOLLOWING COSTS UNALLOWABLE AS Direct Costs, except in justified extraordinary circumstances: • Clerical/Administrative Salaries • Postage • Office Supplies • Local Telephone Service/Equipment • Dues/Memberships • General Purpose Equipment • UW-Madison relies upon the College/School Dean’s offices to review budgets for CAS Exceptions.

34. COMPLIANCE ISSUES • INSTITUTIONAL REVIEW BOARD proof of approval required by NIH in a “Just-in-Time” manner prior to issuance of award. • INSTITUTIONAL ANIMAL CARE & USE COMMITTEE proof of approval required by NIH in a “Just-in-Time” manner prior to issuance of award. • OFFICE OF BIOLOGICAL SAFETY Authorized Organizational Official signature (RSP) on application certifies that the project will not be conducted without this approval in place.

35. NIH Grants Policy Statement: The Ultimate Answer Source • When in doubt, refer to the NIH Grants Policy Statement, revised 12/03. • It contains answers to questions about prior approval requirements, expanded authorities, NIH-specific FDP terms and conditions, allowability of costs, and rules for flowdown of terms to subcontractors/consortium participants. • It may be found at:http://grants1.nih.gov/grants/policy/nihgps_2003/