1 NIH Transforming medicine through discovery

 NIH is the Nation’s leading medical research agency  NIH Bethesda campus is world’s largest research organization

NIH Bootcamp Birthplace of the NIH: 1887 Marine Hospital -- Staten Island, NY

NIH Campus

NIH Campus Today

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 No funding authority NIH Clinical Center Center for Information Technology Center for Scientific Review National Center on Minority Health and Health Disparities Office of the Director

7 NIH INTRAMURAL RESEARCH NIH is an institution Supports: Over 6,000 scientists 10% of NIH budget Primary location: Bethesda, MD A few labs throughout U.S. NIH EXTRAMURAL RESEARCH Supports: Over 3,000 institutions worldwide Over 150,000 PIs & Key Personnel Awards issued to over 100 countries Clinical, Basic, & Translational Research Approximately 83% of the NIH budget *All figures are estimates. NIH supports institutions

AANational Institute on Alcohol Abuse and Alcoholism (NIAAA)National Institute on Alcohol Abuse and Alcoholism (NIAAA) AGNational Institute on Aging (NIA)National Institute on Aging (NIA) AINational Institute of Allergy and Infectious Diseases (NIAID)National Institute of Allergy and Infectious Diseases (NIAID) ARNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ATNational Center for Complementary and Alternative Medicine (NCCAM)National Center for Complementary and Alternative Medicine (NCCAM) CANational Cancer Institute (NCI)National Cancer Institute (NCI) DANational Institute on Drug Abuse (NIDA)National Institute on Drug Abuse (NIDA) DCNational Institute on Deafness and Other Communication Disorders (NIDCD)National Institute on Deafness and Other Communication Disorders (NIDCD) DENational Institute of Dental & Craniofacial Research (NIDCR)National Institute of Dental & Craniofacial Research (NIDCR) DKNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) EBNational Institute of Biomedical Imaging and Bioengineering (NIBIB)National Institute of Biomedical Imaging and Bioengineering (NIBIB) ESNational Institute of Environmental Health Sciences (NIEHS)National Institute of Environmental Health Sciences (NIEHS) EYNational Eye Institute (NEI)National Eye Institute (NEI)

EYNational Eye Institute (NEI)National Eye Institute (NEI) GMNational Institute of General Medical Sciences (NIGMS)National Institute of General Medical Sciences (NIGMS) HDNational Institute of Child Health and Human Development (NICHD)National Institute of Child Health and Human Development (NICHD) HGNational Human Genome Research Institute (NHGRI)National Human Genome Research Institute (NHGRI) HLNational Heart, Lung and Blood Institute (NHLBI)National Heart, Lung and Blood Institute (NHLBI) LMNational Library of Medicine (NLM)National Library of Medicine (NLM) MDNational Center on Minority Health and Health Disparities (NCMHD)National Center on Minority Health and Health Disparities (NCMHD) MHNational Institute of Mental Health (NIMH)National Institute of Mental Health (NIMH) NRNational Institute of Nursing Research (NINR)National Institute of Nursing Research (NINR) NSNational Institute of Neurological Disorders and Stroke (NINDS)National Institute of Neurological Disorders and Stroke (NINDS) RRNational Center for Research Resources (NCRR)National Center for Research Resources (NCRR)

Fiscal Year 2007  Approx. 80,000 grant applications received (all mechanisms)  47,243 research grants awarded ($20.35 billion)  79% of NIH extramural awards go to institutions of higher education

11 NIH uses “Activity Codes” to identify specific categories of research:

GRANT Assistance Government is Patron or Partner Purpose: to support and stimulate research Benefit a public purpose Investigator initiated CONTRACT Acquisition Government is Purchaser Purpose: to acquire goods or services The direct benefit and use of the government Government initiated COOPERATIVE AGREEMENT – means substantial NIH Involvement

 Substantial Federal scientific or programmatic involvement  NIH involved in scientific and/or programmatic guidance, coordination or participation in project activities  Colorado State Research Center for Excellence (RCE) – pass through to MSU

1 R01 AI A1 S1 The application number identifies: type of application (1) activity code (R01) organization or institute (AI) serial number (183723) suffix year (-01) AND, other information identifying a supplement (S1), or an amendment (A1).

1 R01 AI A1 S1 Traditional – R01 “Research Project” Floating due dates: Cycle I :February 5 Cycle II:June 5 Cycle III:October 5 Check institute and request for proposal for variations

1 R03 AI A1 S1 Smaller Grants – R03 Ro3 “Small Research Grants” – limited time and amount, flexibility for PI initiating studies, preliminary short-term projects. Non- renewable. Only one resubmission is allowed

1 R18 AI A1 S1  Research Demonstration and dissemination Projects (R18): Develop, test, and evaluate health service activities, and to foster the application of existing knowledge for the control of categorical diseases.

1 R21 AI A1 S1 Exploratory/Developmental Grants – R21/R33: R21 “Exploratory/Developmental Grants” to encourage new research activities in categorical program areas. R33 – Phase II of the R21

 Training Grants – T  Institutional  Predoctoral and Postdoctoral  Fellowships – F  Individual ▪ Predoctoral – F31 ▪ Postdoctoral – F32  Career Development Awards – K  Center Grants – P20 **Montana INBRE**  Groups of investigators, long-term, multi-disciplinary

 Continued, limited funding for new and established PIs who have submitted a competing renewal, who just miss the nominal funding payline.  Additional funded time for PIs to strengthen a resubmission.  Selectees will receive one-year of funding up to $500,000 DC + applicable F&A (increased from $333,000)  Cannot apply, cannot self-nominate! Criteria:  Must have < $400,000 in other support (total costs) from all sources to fund research (increased from $200,000)

Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training Grant (T32) Postdoctoral Institutional Training Grant (T32) Postdoctoral Individual NRSA (F32) Small Grant (R03) Research Project Grant (R01) Independent Scientist Award (K02) Independent Scientist Award (K02) Senior Scientist Award (K05 ) Senior Scientist Award (K05 ) Approx. Stage of Research Training and Development Mechanism of Support GRADUATE/MEDICALSTUDENT POSTDOCTORAL EARLY MIDDLE SENIOR CAREER Predoctoral Institutional Training Grant (T32) Predoctoral Institutional Training Grant (T32) NIH Pathway to Independence (PI) Award (K99/R00) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25) Midcareer Investigator Award in Patient-Oriented Research (K24) Patient-Oriented Research (K24) Exploratory/Develop ment Grant (R21) Training and Career Timetable

 “Credential” mandatory for all PD/PIs  Do not attach “Current & Pending Support” unless requested in FOA. This will be requested later during the just-in-time process.  Modular or detailed budget?  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 R&R Forms Page available at: grants.nih.gov/grants/funding/424/index.htm

 Item 8, Type of Application-  New is an application submitted for the first time  Resubmission is a revised or amended application  Renewal is equivalent to a Competing Continuation  Continuation is equivalent to a Progress Report. For the purposes of NIH and other PHS agencies, the box for Continuation will not be used and should not be checked.  Revision is somewhat equivalent to a Competing Supplement

 An individual's base salary is NOT constrained by the legislative provision for a limitation of salary. An institution may pay an individual's salary amount in excess of the salary cap with non-federal funds. Effective January 1, 2009, salary and wages on NIH grants limited to an annual rate of $196,700 (equal to Executive Level I).

 Chartered Study Section member must be the PD/PI. Multi-PI applications are eligible if one or more PD/PI is an appointed Study Section member.  Limited to R01, R21 and R34 (including AIDS-related) applications submitted for standard due dates.  Not available for temporary or ad hoc reviewers, or reviewers for other Federal agencies. Appointed members of chartered Study Sections may submit applications as they are developed and NIH will review within 120 days of receipt.

 PIs should create the proposal as a single document using any word processing software. Separate only at the end before uploading  Do not include headers or footers  Do include section headings as part of the text; i.e., Specific Aims, Background & Significance  R&R Budget form - Senior/Key Person effort must be greater than zero

 Do not scan paper documents. Instead, produce documents with word-processing software and then convert electronically to PDF.  Use meaningful titles for file names  Only use standard characters in file names: A-Z, 0-9, Hyphen (-), Underscore ( _ ).  Disable write-protection features.  A zero-byte attachment is an invalid PDF. More at: era.nih.gov/electronicreceipt/pdf_guidelines.htm

 After submission, the eRA system will:  Assemble the grant image  Generate a Table of Contents  Include headers (PI name) & footers (page numbers) on all pages  Perform agency validations  Any errors must be fixed and the application resubmitted before it can be accepted for review.

29 Application Image Be sure to review the entire application carefully……. Your application is not considered received by NIH until you see the application image in the eRA Commons & the 2-day viewing window has elapsed.

Information not required to review the application but which is necessary to implement the grant.  Don’t submit unless requested via from the NIH  Request for updated information on “Other Support” for PI and Key Personnel  FM should add up the calendar months <= more than 12?  FM should verify the IACUC or IRB approval dates with the appropriate MSU administrators:  IACUC dates: Diane Harn X6803  IRB dates:Cheryl Johnson X4706

 Log In to eRA Commons  Click on Status Tab ▪ Click on “Just in Time” Hot Link ▪ Enter PI’s last name  Review documents – you’re certifying they’re accurate on behalf of MSU  Hit Submit – PI receives an that you submitted the JIT information

33 1. Application ID is the link to the application details. 2. Right side of hit list are links to other Commons applications. 1 2

National Advisory Council  Assesses Quality of SRG Review  Makes Recommendation to  Institute Staff on Funding  Evaluates Program Priorities and Relevance  Advises on Policy Scientific Review Group (SRG)  Independent outside reviewers  Evaluate scientific merit & significance  Recommend length and level of funding 1 st Level 2 nd Level

 Scientist peers with appropriate expertise -- recruited by the SRO  Standing study section typically has members  4-year terms  3 face-to-face meetings each year  Review applications at each meeting

 National Advisory Council or Board assesses quality of 1 st level review  Concurs with or modifies IRG action  Reads summary statements only  Can also designate application as “High” or “Low” program priority  The Institute Director makes actual funding decision 8 th Month

Receipt Date February 5 June 5 October 5 Scientific Review July October March Council Review October January May Award Date December April July

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

LEGALLY BINDING DOCUMENT  Award Data & Fiscal Information  Grant Payment Information  OIG* Hotline Information  Terms and Conditions * Office of the Inspector General

The grantee indicates acceptance of the terms and conditions of the award by drawing down funds against the grant from the Payment Management System. MSU’s current negotiation of $7.9 Million COBRE years 6-10…don’t just set up the accounts/grants. (Blue Handout)

 Carry over of unspent funds may or MAY NOT be allowed  Spending suspended pending IACUC approval? Highlight these terms and follow-up on them.  Also, communicate with the investigator regarding the limitations.  Spending suspended based on select agent use?  Non-competitive renewal or competitive renewal?  Final year of award……Financial Status Report due? Put in blue sheet to trigger report.

 NIH looks at PI effort in Person/Months  Can get tricky – use the link below Person/Months FAQ & calculator:

 FM should pull the grant file and an ITD  Review the proposal for effort committed  For example - the PI’s effort in the grant proposal was 5 person months (42%) and he has put 1.2 person months (10%) in his eSNAP progress report. Is this an issue?  Yes, because the effort reduction or fluctuation is greater than 25%  5.0 – 1.2 = 3.8 person months and 3.8 mo / 5 mo. = 76% change  Contact the PI; usually a misunderstanding or typo  If not, Prior Approval should be documented.

 Pull an ITD and review the % that will be carried forward if any  Is it greater than 25% of the current year’s total funding?  Remember, payroll hits on the 11 th of the following month – ok to calculate that into expenditures.  Also good time to check individual budget categories – should an OPAS be processed?

 Change in Scope:  Grantee makes initial determination of significance of a change, consulting the grants management specialist as needed.  The following items may indicate a change in scope: ▪ Change in aims: Change to a different animal model ▪ Significant rebudgeting (deviation between categories of more than 25% of total awarded costs) ▪ Change in use of animals or humans ▪ Significant change in key personnel ▪ Shift in research emphasis: Shift of research emphasis to a different disease area ▪ Application of new technology ▪ Reduce his/her time by more than 25% of approved effort at time of award Refer to NIH Grants Policy Statement for further information.

 All requests for prior approval must be:  Submitted in writing or via – include complete grant number, PI name and contact information, grantee name  Submitted to the awarding IC’s Grants Management Specialist no later than 30 days before the proposed change  Signed by the PI and administrative official  Only responses to prior approval requests signed by the GMO are valid

 Transfer approval is not automatic and requires approval from both NIH and the original grantee organization.  Contact NIH GMO before moving to initiate the transfer process.  Grants to individuals may not be transferred but individual fellowships may transfer to a new sponsoring institution. Prior, written approval is required for transferring legal and administrative authority for a grant to a different organization.

 Documents are due within 90 days of project period end date  Final Financial Status Report (now required electronically)  Final Inventions Statement & Certification  Final Progress Report  Failure to submit timely reports may affect future funding to the organization! More at: Grantees are strongly encouraged to submit closeout documents electronically through the eRA Commons!

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 TTO files invention statements in our grant files – review file for invention  Double check with TTO to see if there have been any inventions or patents filed  If there have been, fill in the invention report with information on NIH screen from the TTO report  If not, “negative” report still needs to be submitted

 Green Handout  Print an MSU Inception to Date report for the grant  Any “Invalid” expenses? If so, get them corrected off the grant  Calculate the IDC base – see handout  Review MSU Authorized Amount – should equal line “o. Total Federal funds authorized for this funding period” on the online FSR  Double check amounts with Financial Officer if something looks off.

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***ON CURRENT “THIS PERIOD” ONLY******

 Click on “Save”  Print “Draft” via the “View FSR” in the FSR screen to review again with the Financial Officer  If there is a residual that is unobligated, LOC will be effected!  Once FM has confirmed the numbers are correct, then go back into the FSR and hit “Submit”  Make a hard copy for the grant file and for the LOC Financial Officer [Peggy :0)]

 NIH Searchable Database of RFAs, PAs, and Guide Notices  NIH Grants Policy Statement (Rev. 12/03)  NIH Extramural Nexus – Bimonthly newsletter for the extramural community  Electronic Submission of Grant Applications Homepage  CRISP database - Search to analyze an Institute’s portfolio of funded projects, research areas, and more  Grant Application Basics

 Grants Administration individuals at all NIH ICs:   NIH Chief Grants Management Officers:   Grants Policy Interpretation & Consultation:   Phone:  Compliance Issues:   Phone:

 General Application Questions: (e-Submission guidelines, resources & referrals, application review & award process, etc.)   Phone:  Customer Support for Grants.gov: (navigating forms, aspects of submitting through the system, resources available, etc.)   Webpage:  Phone:  eRA Commons Help Desk: (Commons registration help, application verification, Commons functionality questions, etc.)  Webpage:  Phone: (Toll Free: ) Enter your own help ticket!