Office of Sponsored Programs All rights reserved GTRC Working with the NIH

Office of Sponsored Programs All rights reserved GTRC 2 Today’s Topics Introduction to the NIH –History –Mission & Organization –Funding Facts Fundamentals of NIH Grants –Types of Grants –Roles & Responsibilities (handout) Decoding the NIH Funding sources Applications & Scientific Review Current Issues Budgets –Program & Grants Staff Actions –The Notice of Award (and after)

Office of Sponsored Programs All rights reserved GTRC Introduction to NIH

Office of Sponsored Programs All rights reserved GTRC 4 Administration for Children and Families (ACF) Administration for Children and Families (ACF) Food and Drug Administration (FDA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Health Resources and Services Administration (HRSA) Secretary of Health and Human Services Administration on Aging (AoA) Administration on Aging (AoA) Center for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Services (CMS) Indian Health Services (IHS) Indian Health Services (IHS) National Institutes of Health (NIH) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Centers for Disease Control and Prevention (CDC) Substance Abuse and Mental Health Services Administration (SAMHSA) Substance Abuse and Mental Health Services Administration (SAMHSA) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Healthcare Research and Quality (AHRQ) Agency for Healthcare Research and Quality (AHRQ) U. S. Dept. of Health and Human Services

Office of Sponsored Programs All rights reserved GTRC 5 NIH Founded in 1887 One agency of 11 within U.S. Department of Health and Human Services (HHS) Comprises 27 Institutes and Centers (IC)

Office of Sponsored Programs All rights reserved GTRC 6 NIH Mission NIH is the steward of medical and behavioral research for the Nation Our mission: to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability … … from the rarest genetic disorder to the common cold

Office of Sponsored Programs All rights reserved GTRC 7 NIH Organizational Structure National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Institute of Biomedical Imaging and Bioengineering NIH Clinical Center Center for Information Technology Center for Scientific Review National Center on Minority Health and Health Disparities Office of the Director No funding authority

Office of Sponsored Programs All rights reserved GTRC 8 Fulfilling the Mission Support research by non-Federal scientists across U.S. and abroad Help train research investigators Conduct research in our own labs Foster communication of medical and health sciences information

Office of Sponsored Programs All rights reserved GTRC 9 What Stays at NIH? What Goes Elsewhere? 84% Outside NIH > 325,000 Scientists > 3,000 Organizations Worldwide 16% Inside NIH $2.9 B Intramural Research (10%) $1.2 B Staff & Buildings (4%) $0.6 B Other (2%) Total FY 2008 Budget: $29.46 Billion

Office of Sponsored Programs All rights reserved GTRC 10 Success Rates

Office of Sponsored Programs All rights reserved GTRC Fundamentals of NIH Grants

Office of Sponsored Programs All rights reserved GTRC 12 Principal Investigator Authorized Organizational Reps Research Administrator Grantee Institution Team Grants are awarded to institutions as represented by AORs. PD/PIs manage and perform the science Research Administrators support business aspects of the grant Successful grants require close coordination between all members of the grantee team.

Office of Sponsored Programs All rights reserved GTRC 13 The Grantee Institution Actual recipient of award Legally responsible for proper conduct and execution of grant Provides fiscal management Provides oversight on allocation decisions Assures compliance with Federal, NIH, and organization-wide requirements

Office of Sponsored Programs All rights reserved GTRC 14 Georgia Tech Source of Awards

Office of Sponsored Programs All rights reserved GTRC Decoding the NIH

Office of Sponsored Programs All rights reserved GTRC 16 Sample Application Number 1 R01 GM A1/S1 Application Type Activity Code Institute/Center Serial Number Year of Support Suffixes

Office of Sponsored Programs All rights reserved GTRC 17 Award Mechanisms Research Grants Traditional – R01 Exploratory/Development Grants – R03/R21/R33/R34 Program Project – P01 Research Center Grants – P50 Small Business – R41, R42, R43, R44 Cooperative Agreements (U) Specialized Grant mechanism Substantial NIH staff involvement in program and science Typically initiated by NIH Research Training and Career Awards Training Grants – T Institutional Pre-doctoral and Postdoctoral Fellowships – F Individual Pre-doctoral – F31 Postdoctoral – F32 Career Development Award – K

Office of Sponsored Programs All rights reserved GTRC 18 Mandatory Use of Cayuse424

Office of Sponsored Programs All rights reserved GTRC 19 Cayuse424

Office of Sponsored Programs All rights reserved GTRC NIH Scientific Review

Office of Sponsored Programs All rights reserved GTRC 21 NIH Organizational Structure National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Institute of Biomedical Imaging and Bioengineering NIH Clinical Center Center for Information Technology Center for Scientific Review National Center on Minority Health and Health Disparities Office of the Director No funding authority

Office of Sponsored Programs All rights reserved GTRC The Division of Receipt and Referral (DRR) within the CSR

Office of Sponsored Programs All rights reserved GTRC 23 Peer Review

Office of Sponsored Programs All rights reserved GTRC 24 Initial Level of Review Standing study section typically has members 3 face-to-face meetings each year Review applications at each meeting

Office of Sponsored Programs All rights reserved GTRC 25 Impact Score The NIH grant application scoring system uses a 9- point scale This scale is used by all eligible (without conflict of interest)

Office of Sponsored Programs All rights reserved GTRC 26 Peer Review Priority Scores recorded Summary Statements prepared –Overall Resume and Summary of Review Discussion –Essentially Unedited Critiques –Priority Score and Percentile Ranking –Budget Recommendations –Administrative Notes Viewable 4-6 weeks after review meeting –Only available to the PI through the eRA Commons

Office of Sponsored Programs All rights reserved GTRC Summary Statement Understanding the Percentile –A percentile is the approximate percentage of applications that received a better overall impact/priority score from the study section during the past year. – Only a subset of all applications receive percentiles. The types of applications that are percentiled vary across different NIH Institutes and Centers. 27

Office of Sponsored Programs All rights reserved GTRC Video

Office of Sponsored Programs All rights reserved GTRC 29 Second Level of Review - Advisory Council or Board NIH program staff members examine applications, their overall impact scores, percentile rankings (if applicable) and their summary statements and consider these against the IC's needs. Program staff provide a grant-funding plan to the Advisory Board/Council. The Advisory Board/Council also considers the IC’s goals and needs and advises the IC director. The IC director makes final funding decisions based on staff and Advisory Council/Board advice. 8 th Month

Office of Sponsored Programs All rights reserved GTRC 30 Second Level of Review - Advisory Council or Board Beginning in September 2012, Council members will receive a list of competing applications that will be considered for funding from PD/PIs that meet the threshold for Special Council Review. These are investigators who currently receive $1 million or more in direct costs of NIH funding to support Research Project Grants. Council members will be asked to recommend consideration of funding for applications that afford a unique opportunity to advance research which is both highly promising and distinct from the other funded projects from the PD/PI. This does not represent a cap to NIH funding. 8 th Month

Office of Sponsored Programs All rights reserved GTRC 31 Timeline: New Applications Receipt Date February 5 June 5 October 5 Scientific Review July October March Council Review October January May Award Date December April July Review & Award Cycle I Cycle II Cycle III

Office of Sponsored Programs All rights reserved GTRC 32 Do I Contact NIH Before Applying? Mandatory: Application with budget >$500,000 direct costs for any single year R13 Conference Grants Optional: When RFA’s request a Letter of Intent Recommended: When you think about applying for any grant

Office of Sponsored Programs All rights reserved GTRC Award Negotiation & Issuance

Office of Sponsored Programs All rights reserved GTRC Award Negotiation & Issuance There are still many steps after a funding decision is made before a grant is awarded. Grants management staff work closely with grantee and NIH program staff to complete this final process.

Office of Sponsored Programs All rights reserved GTRC 35 Just-In-Time Information Information not required to review the application but which is necessary to implement the grant. Certification of Education on Human Subjects Institutional Review Board (IRB) approval –Required within 1 year and before any human subjects research begins. Institutional Animal Care and Use Committee (IACUC) Approval –Required within 3 years and before animal research begins. Information on “Other Support” received by Key Personnel

Office of Sponsored Programs All rights reserved GTRC 36 Grants Management: Special Issues For Example: Is there a “foreign component” to the grant? –Includes grants to foreign organizations and grants with activities or consortium partners in foreign countries. –Require State Department Clearance prior to award. Are there bars to the award? –Human subjects and animal subjects concerns –Are there research integrity issues?

Office of Sponsored Programs All rights reserved GTRC Award Process Notice of Award (NoA) –The NoA is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual Accepting the Award –The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees. 37

Office of Sponsored Programs All rights reserved GTRC 38 After the Award… Administrative and Fiscal Monitoring Requirements –Annual Progress Report (SNAP) –Annual Financial Status Reports (FSR) –Invention Reporting –Yearly Audits (as applicable) –Final Closeout Reports

Office of Sponsored Programs All rights reserved GTRC Budget

Office of Sponsored Programs All rights reserved GTRC 40 Budgetary Issues Correctly apply modular and categorical budgets –Modular budgets reduce burden by eliminating the need for specific budget numbers –Available for grants at or below $250,000 per year –Grantees awarded grants in “modules” of $25,000 Budget Justification Adjustments may be applied to individual grant awards based on IC financial policies –Caps on certain types of costs specific to that funding opportunity –Limits on overall grant funding due to NIH budget constraints.

Office of Sponsored Programs All rights reserved GTRC 41 Modular Budget

Office of Sponsored Programs All rights reserved GTRC 42 Modular Budget Sections A&B: Personnel Determine the amount of time (effort) that you will spend on this project. –Calendar, Academic, or Summer Months Determine the number, qualifications and amount of time needed for other personnel –Technicians –Postdoctoral Fellows –Graduate Students –Undergraduate Students

Office of Sponsored Programs All rights reserved GTRC 43 There are no magic numbers regarding the qualifications and/or number of individuals needed for each aim. Be realistic about what each individual can accomplish, and the time necessary to complete the work. Remember the current NIH Salary cap is $191,300 Modular Budget Sections A&B: Personnel

Office of Sponsored Programs All rights reserved GTRC 44 Modular Budget Section C: Do you need new equipment? If you need additional equipment, this is the time to consider it. Equipment should be project specific – be sure to include a written justification. Most equipment is requested during the first year of the grant. If you use a modular budget format, you may ask for extra module(s) to cover equipment.

Office of Sponsored Programs All rights reserved GTRC 45 Modular Budget Section D: Travel funds This amount is usually small: –$1, ,000 per meeting per individual per year Generally supports one meeting per year for 2-3 individuals

Office of Sponsored Programs All rights reserved GTRC 46 Modular Budget Section E: Participant/Trainee Support Costs Unless stated in the FOA, this section should be left blank for NIH applications –Include tuition remission under Section F: Other Direct Costs

Office of Sponsored Programs All rights reserved GTRC 47 Modular Budget Section F: Other Direct Costs Estimate the materials and supplies needed for the personnel involved It may be reasonable to estimate a supply budget of ~$12,000–15,000/year for each FTE This number will vary depending on the nature of the research proposed. –Animal intensive studies and studies involving human subjects tend to be more costly. –In silico studies tend to be less costly for supplies. Consider stage of career of personnel involved

Office of Sponsored Programs All rights reserved GTRC 48 Modular Budget Section F: Other Direct Costs This category also includes funds needed for things such as: –Publication costs –Equipment maintenance –Consortium/subcontracts –Tuition remission. Estimate these expenses realistically.

Office of Sponsored Programs All rights reserved GTRC 49 Example Modular Budget Cal Req.FringeFunds MonSalaryBenefitsReq. A. Senior/Key Person PI215,3334,29319,626 B. Other Personnel Postdoc Assoc1238,97610,91349,889 Grad Student1220,7725,45426,226 C. Equipment – Microscope19,000 D. Travel - (2 meetings) 4,000 E. Participant/Traineeusually left blank F. Other Direct Costs Materials/Supplies25,533 Publication Costs 1,500 Subaward/Consortium/Contractual costs none Tuition Remission 7,000 G. Total Direct Costs179,000

Office of Sponsored Programs All rights reserved GTRC 50 Calculate the direct costs for the first year. –(for example, Year 1 budget = $179,000) Calculate the direct costs for subsequent years taking into account salary increases and changes in funds requested for equipment. –Year 2 = $164,800 –Year 3 = $169,744 –Year 4 = $174,836 –Year 5 = $180,081 Example Modular Budget

Office of Sponsored Programs All rights reserved GTRC 51 Do I need to submit a modular budget? Calculate the total direct costs for all years –Total direct costs for 5 years = $868,461 Divide total by the number of years requested –Average direct costs = $173,692/yr Investigator-initiated R01s up to $250,000/yr must use modular format

Office of Sponsored Programs All rights reserved GTRC 52 Convert Your Average Direct Costs to the Modular Format Round up to the next module (number divisible by $25,000) –In the example, $173,692/yr rounds up to $175,000/yr No yearly increases for inflation First year may include additional modules for one-time expenses like equipment –In the example, add one additional module to year 1 = $200,000

Office of Sponsored Programs All rights reserved GTRC 53 Reminder for Budget All budget requests to NIH for R01 applications use: – the modular format when requesting direct costs of $250,000 or less each year – the non-modular format when requesting direct costs greater than $250,000 in any year Consortium F&A costs are not factored into the modular direct cost limit

Office of Sponsored Programs All rights reserved GTRC 54 R01 Budget with Consortium Costs Prepare an itemized budget for the parent award Prepare an itemized budget for consortium/subcontract costs, including: Personnel – salary and benefits Travel – professional or investigator meeting Other Direct Costs –Materials and Supplies Total Direct Costs = $38,300

Office of Sponsored Programs All rights reserved GTRC 55 Total Consortium Costs Consortium Direct Costs = $38,300 Consortium F&A – consortium institution (at 50%) = $19,150 Consortium Total Costs = $57,450 Remember you may round to the nearest $1,000

Office of Sponsored Programs All rights reserved GTRC 56 Should you request a modular budget? Example Modular Budget

Office of Sponsored Programs All rights reserved GTRC 57 R01 Grant with Consortium Budget Submit as a modular budget when requesting Direct Costs at or below $250,000 per year… … excluding Consortium F&A costs.

Office of Sponsored Programs All rights reserved GTRC 58 Modular Grant with Consortium Budget In our example, Year 1 – Itemized Total DC= $256,124 minus Consortium F&A= $ 19,150 Year 1 – Itemized DC excluding F&A= $236,974 Year 2 – Itemized DC excluding F&A= $224,513 Year 3 – Itemized DC excluding F&A= $231,249 Year 4 – Itemized DC excluding F&A= $238,186 Year 5 – Itemized DC excluding F&A= $245,332 Avg Direct Cost per yr (excluding F&A) = $235,251 Round up to the next module = $250,000

Office of Sponsored Programs All rights reserved GTRC 59 Record Modular Budget with Consortium: PHS 398 Modular Budget, Period 1 A. Direct CostsFunds Requested ($) *Direct Cost less Consortium F&A $250,000 Consortium F&A $ 19,150 *Total Direct Costs $269,150 The total direct costs requested are allowed to exceed the modular maximum ($250,000) by the amount of F&A associated with the subcontract.

Office of Sponsored Programs All rights reserved GTRC 60 eRA Will Check to Ensure… Once NIH retrieves the application from Grants.gov, eRA systems check the application against NIH business rules. –Detailed check against the instructions in the application guide –Validates against the instructions in the FOA –For a detailed list of NIH validations: Remember, the SF424 (R&R) forms are used by many agencies, so unfortunately NIH cannot build our specific rules into the forms.

Office of Sponsored Programs All rights reserved GTRC 61 If You Receive Errors & Warnings from NIH… Errors must be addressed for the application to move on to NIH Receipt & Referral. –An application must be error-free in order for eRA systems to generate an image of the application for viewing. Warnings may be fixed at the applicant’s discretion but do not require action for the application to move on. If the PI corrects any Warnings or Errors, they should contact the AOR/SO. The AOR/SO must submit the entire ‘Changed/Corrected’ application again through Grants.gov. –Use changed/corrected check box on SF424(R&R) form NOTE: Reviewers/NIH Staff do not see notifications provided to applicants about errors/warnings.

Office of Sponsored Programs All rights reserved GTRC 62 Submitting Changed/Corrected Application: Cover Letter If submitting a changed/corrected application during the 2-business day error correction window after the receipt date, the cover letter must explain changes. –If your original submission included a cover letter then you must include all previous cover letter text in the revised cover letter attachment.

Office of Sponsored Programs All rights reserved GTRC 63 Check Status in Commons – PD/PI Select Recent/Pending eSubmissions link Or provide Grants.gov tracking number from notification

Office of Sponsored Programs All rights reserved GTRC 64 View Errors/Warnings Check Status Select to show errors/warnings

Office of Sponsored Programs All rights reserved GTRC 65 Check Assembled Application The AOR/SO has a 2-business day (excluding federal holidays) viewing window to reject an application that has system formatting errors. If the application is not rejected within the 2 business days it will automatically proceed to Receipt & Referral.

Office of Sponsored Programs All rights reserved GTRC Current Issues Sequestration: NOT-OD PRRP vs eSNAP PubMed Central GRA Salary Cap 66

Office of Sponsored Programs All rights reserved GTRC NIH Operation Plan in the Event of a Sequestration The NIH continues to operate under a Continuing Resolution as described in NOT-OD , and therefore all non- competing continuation awards are currently being funded at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level) NOT-OD

Office of Sponsored Programs All rights reserved GTRC NIH Operation Plan in the Event of a Sequestration Should a sequestration occur, NIH likely will reduce the final FY 2013 funding levels of non-competing continuation grants and expects to make fewer competing awards to allow the agency to meet the available budget allocation. 68

Office of Sponsored Programs All rights reserved GTRC NIH Research Performance Progress Report The RPPR will have separate screens for each of the following reporting components: Cover Page –Accomplishments –Products –Participants –Impact –Changes –Special [agency specific] Reporting Requirements –Budget [applicable only for non-SNAP awards] 69

Office of Sponsored Programs All rights reserved GTRC NIH Research Performance Progress Report Specific location to report on competitive revisions/administrative supplements associated with the award. Public Access compliance status will be displayed Other support will only be required if there has been a change 70

Office of Sponsored Programs All rights reserved GTRC NIH Research Performance Progress Report instruction_guide.pdf 71

Office of Sponsored Programs All rights reserved GTRC 72 Deposit PubMed Central

Office of Sponsored Programs All rights reserved GTRC 73 Including PMCIDs in Citations After May 25, 2008, “NIH applications, proposals, and progress reports must include the PubMed Central reference number when citing a paper that falls under the policy and is authored or co- authored by the investigator, or arose from the investigator’s NIH award. This policy includes applications submitted to the NIH for the May 25, 2008 due date and subsequent due dates.”

Office of Sponsored Programs All rights reserved GTRC 74 Publisher Deposit Some publishers automatically deposit the published article in PMC Some publishers deposit the final peer- reviewed manuscript in PMC –PIs must approve the submission in the NIH Manuscript Submission System [NIHMS]).

Office of Sponsored Programs All rights reserved GTRC 75 Library Services Offered Answer questions related to the NIH Public Access Policy and how to comply. Offer NIH Public Access Policy informational sessions to departments, research groups, and individual faculty. Deposit manuscripts in PubMed Central and SMARTech on behalf of authors. Provide hands-on PubMed Central submission training. Suggest tools that help researchers retain rights to deposit in repositories like PubMed Central. Contact us at:

Office of Sponsored Programs All rights reserved GTRC 76 Closeout Final Report Submit Closeout document electronically through the eRA Commons Documents are due within 90 days of project period end date –Final Financial Status Report (Required electronically) –Final Invention Statement & Certification –Final Progress Report Failure to submit timely reports may affect future funding to the organization

Office of Sponsored Programs All rights reserved GTRC 77 Definition of Early Stage Investigator A Program Director/Principal Investigator who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).