Susan Toy National Human Genome Research Institute Victoria Bishton Joel Snyderman Office of Policy for Extramural Research Administration Administrator’s Boot Camp – Getting Started with NIH 1

INTRODUCTIONS 2

Objectives for administrator’s boot camp  Identify key roles of individuals at applicant/recipient institutions and NIH involved in the application process  Understand how the electronic Funding Opportunity Announcement (FOA) is used as the source document for the application process.  Highlight benefits of Application Submission System & Interface for Submission Tracking (ASSIST)  Respond to a Just-in-Time (JIT) request  Analyze the Notice of Award (NoA)

National Institutes of Health Department of Health and Human Services (HHS) – NIH is one of 11 HHS Operating Divisions – HHS flows down regulatory requirements, policies NIH implements 4

NIH Institutes and Centers (ICs) 27 Institutes and Centers – Each with a specific research agenda Focusing on different diseases and body systems 24 ICs fund extramural research 5

NIH Mission Statement NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. 6

Pursuing the Mission Nation’s medical research agency World’s largest funder of biomedical and behavioral research Congressional budget appropriation of $30.4 billion in Fiscal Year

6% of the NIH budget supports NIH costs Leadership Research Management and Support Facilities Maintenance and Improvements 8

11% of the NIH budget supports NIH intramural research 9

83% of the NIH budget flows to extramural research In FY2015 NIH – Awarded 34,000 grants – Supported more than 300,000 research personnel at over 2,500 organizations Universities Medical Schools Hospitals Other Research Facilities Small Businesses 10

National Institutes of Health Center for Scientific Review Performs the Research How does a grant get funded? Institution Investigator Great Research Idea! Submits Application Assigns to IC & IRG / Study Section Study Section Reviews for Scientific Merit Institute Evaluates for Relevance Advisory Councils & Board Recommends Action Institute Director Makes Funding Decision Allocates Funds 11

WHO’S WHO? ROLES AND RESPONSIBILITIES 12

Who’s Who in Applications NIHApplicant Organization Program Official/Program Director (PO/PD) Program Director/Principal Investigator (PD/PI) Scientific Review Officer (SRO)eBIZ Point of Contact/Principal Signing Official Grants Management Officer (GMO)Authorized Organization Representative (AOR)/Signing Official (SO) Administrative Official (AO) 13

Program Official/Program Director (PO/PD) Responsible for the programmatic, scientific, and/or technical aspects of a grant – Provides scientific guidance to investigators pre- and post-award – Develops initiatives – Provides post-award oversight 14

Scientific Review Officer (SRO) Legal responsibility for managing: – Peer review meeting – Procedures for evaluating applications – Determinations and management of conflicts of interest 15

NIH Peer Review Process for Administrators October AM – 12:30 PM 16

Grants Management Officer (GMO) Responsible for the business management aspects of grants and cooperative agreements Authorized to obligate NIH funds and permit changes to approved grant Each NIH IC that awards grants has one or more GMOs 17

The NIH Extramural Team 18

Program Director/Principal Investigator (PD/PI) Designated by the applicant organization to direct the program or project supported by the award – Scientific knowledge – Appropriate level of authority – Logistical capabilities 19

E-Business Point of Contact (E-Biz POC) Grants.gov Principal Signing Official - NIH Completes all institutional registrations – Is authorized to register the organization in Grants.gov and eRA Commons – May appoint AORs/SOs Who? – Corporation - President, CEO – Institute - Executive Director – University - President, Dean, or Chancellor 20

Authorized Organizational Representative (AOR) – Grants.gov Signing Official (SO) - NIH Submits grant application and required certifications and/or assurances Assumes obligations imposed by Federal laws, regulations, requirements and conditions Legal authority Authority to officially respond on behalf of the applicant institution Create and modify institutional profile (IPF) and eRA user roles Office of Sponsored Research or equivalent 21

Administrative Official (AO) An NIH eRA Commons Role – Individual in research administration or an academic department – Reviews grant applications for accuracy before SO submits – Does not have authority to submit applications – Does not have authority to submit documents for official actions 22

Interactions NIH PO – Applicant PD/PI NIH SRO – Applicant PD/PI NIH GMO – Applicant AOR, SO, AO eBIZ POC/Principal SO registers organization in Grants.gov/eRA Commons More information on eRA Commons roleseRA Commons roles 23

PD/PI – AOR/SO? NIH does not allow PD/PI to have AOR/SO role except: Small business PD/PIs applying for SBIR/STTR grants – PD/PI may hold all roles – Must register for each separate role 24

How many people? Large organizations – 1 eBIZ POC/Principal Signing Official Multiple AOR/SOs Multiple AOs Small organizations – 1 eBiz POC/Principal Signing Official – That individual may also have AOR/SO role – Must register for each separate role 25

ON THE SAME PAGE – SOME DEFINITIONS 26

Grant Financial assistance mechanism for an approved project or activity Used when substantial programmatic involvement is not anticipated 27

Cooperative Agreement Support mechanism Substantial Federal scientific or programmatic involvement 28

Grant or Cooperative Agreement? NIH uses grant to refer to both grants and cooperative agreements The scientific goal of the project determines which type of award is appropriate The registration and application process is the same 29

electronic Research Administration(eRA) The NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical and behavioral investigators worldwide. 30

eRA Commons Secure access point for applicants and recipients to: – Register organization and individuals – Update registrations – Access status of applications and awards – Submit reports – Access ASSIST 31

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Grants.gov Single access point for all grant programs offered by 26 Federal agencies Access to information on all Federal grant opportunities 33

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APPLYING TO NIH – HOW TO BEGIN? 35

Funding Opportunity Announcement (FOA) – The Document that Does it All A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. 36

FOAs – Why? NIH applications must be submitted in response to a Funding Opportunity Announcement. 37

Why does the FOA matter? Submission date – award budget – eligible organizations – application forms – information contacts – page limits – number of awards – high priority research areas – deviations from standard instructions – required registrations – letter of intent – program description – reports – publications – workshops – proposal sections – budget format – application structure – review criteria – excluded costs – allowable costs – etc. 38

Finding and Understanding Funding Opportunity Announcements (FOAs) – for investigators October 15 1:45 – 3:00 PM 39

Types of FOAs Program Announcement (PA) PAR Request for Application (RFA) 40

FOAs – Who? IC Program Officials/Directors initiate FOAs IC Grants Management Officers review for compliance with NIH and IC grant policies NIH Office of Extramural Research provides expertise on – Human Subjects – Animal Research – Current NIH Initiatives – NIH Grant Policies 41

FOAsFOAs – Where? 42

FOA – Parent AnnouncementsParent Announcements 43

FOAs – Grants.gov 44

Anatomy of the FOA Each FOA contains the following sections: Part 1. Overview Information Part 2. Full Text of Announcement – Section I. Funding Opportunity Description – Section II. Award Information – Section III. Eligibility Information – Section IV. Application and Submission Information – Section V. Application Review Information – Section VI. Award Administration Information – Section VII. Agency Contacts – Section VIII. Other Information 45

Part 1. Overview Information Check this section for information about funding agencies and ICs. 46

Additional Overview Information Type of Grant Check these notices. They are included to provide information you may need to complete the application correctly. 47

NIH Guide Notices Guide Notices Announce: – New policies and procedures – Changes to FOAs – General information items 48

NIH Guide, cont. NIH Guide Notices are published daily – Current Weekly Table of Contents (TOC) – Subscribe to the NIH Guide LISTSERV 49

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More Overview Information 51

Application can’t be submitted prior to this date. This section contains important dates for application availability and due dates. 52

NIH Standard Due Dates 53

Review and Expiration Dates 54

Application Instructions 55 This section emphasizes the importance of following the instructions found in the application guide, the FOA, and any relevant NIH Guide notices.

Application Guide Use the Application Guide link in the FOA. It will always take you to the correct version of the guide. PDF Documents Read them online because they contain links to required information and NIH contacts 56

Application Guides The General and Supplemental Guides are used in the preparation of an R01 application 57

Submission Options - ASSIST 58

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60 Us Access using eRA Commons credentials

ASSIST Key features – Online data entry – Multiple user access – Pre-submission verification of application against agency business rules – Pre-submission preview of assembled application image in agency format – Tracking application status within single system – Required for multi-project application submissions Considerations – All ASSIST users working on an application must have eRA Commons accounts 61

Preparing, Submitting and Tracking your Multi-Project Grant Application Using ASSIST October 16 2:00 – 3:15 PM 62

Submission Options – Downloadable Forms 63

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Application Package – Grants.gov 65

66 Best practice: Provide to receive Grants.gov updates

Grants.gov – application download 67

Grant Application Package 68

Interacting Electronically with NIH: Application Preparation and Submission October 15 1:45 – 3:00 PM 69

Table of Contents 70

Specifies the activity code/type of grant 71

IC Contacts 72

Types will vary, check this section to determine what may be submitted. Allowable number of years of funding support. May list specific amounts. 73

Budget Basics for Administrators October 15 1:45 – 3:00 PM Budget Building Blocks for Investigators October 15 3:15 – 4:30 PM 74

Not every FOA is open to all organizations. Check this section to make sure your organization is eligible. 75

Eligible Institutions 76

Required Registrations 77

REGISTRATIONS 78

Required Registrations - Institutional – Data Universal Numbering System (DUNS) – Taxpayer Identification Number (TIN) – System for Award Management – eRA Commons – Grants.gov 79

Additional Registrations Foreign Applicants – NATO Commercial Organization and Government Entity (NCAGE) Code – Foreign organizations only – Business Identification Number Cross Reference System (BINCS) – Foreign organizations only 80

Additional Registrations SBIR/STTR Applicants: Small Business Association (SBA) Company Registry - only required for applicants to NIH Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) programs 81

Required Registrations - Individuals SO/AOR PD/PI Multi-project Component Leads Fellowship Sponsor Diversity Supplement Candidate 82

Registration – When? Right now! The sooner the better! Don’t wait until it’s almost time to submit the application! Registration is a long process. Allow a minimum of 8 weeks to complete all requirements. 83

Registration – How often? For the organization – Just once for all registrations EXCEPT SAM requires an annual update For individuals – Just once, unless the individual needs different roles A separate registration is required for each role – After registration individuals are responsible for updating their personal profiles in eRA Commons 84

Registrations – Domestic Organization DUNS eRA Commons SAM Grants.gov 85

Registrations – Small Business DUNS eRA Commons SAM Grants.gov SBA Registry 86

Registrations – Foreign Organization NCAGE CODE DUNS eRA Commons SAM Grants.gov BINCS 87

88 BACK TO THE FOA

Eligible Individuals 89

Additional Eligibility 90

Section IV. Application and Submission Information 91

Instructions for application submission 92

Additional requirements This FOA does not include any instructions that differ from those In the application guide, but always check to determine whether to follow the application guide or the FOA. The FOA instructions always take precedence over application guide instructions. 93

Foreign Institutions Any instructions for foreign institutions included in the FOA that differ from those in the application guide must be followed. 94

Submission Dates and Times Links back to the information found in the beginning of the FOA. Emphasizes the importance of knowing The submission date! 95

Required Notifications 96

Other Submission Requirements and Information Includes reminders to register, to follow application instructions, and the importance of the PD/PI eRA Commons ID – can’t apply without one. 97

More requirements Over 500K applications won’t be accepted without this notification process. Only information specified in the guide notice will be accepted after the application due date. 98

Tips for Avoiding Errors 99

Section V. Application Review Information Review criteria is based on the type of grant and the specific needs of a program. 100

Review Criteria, cont. 101

Additional Review Criteria 102

NIH Peer Review Process for Investigators October AM – 11:15 AM 103

Just-in-Time 104

JIT What? When? Where?

CURRENT Other support

FAQs for usage of person months:

OTHER SUPPORT

certifications Institutional Review Board (IRB) Approval Human Subjects Protections Education Institutional Animal Care and Use Committee (IACUC) Approval

Certifications Cont. Human Embryonic Stem Cells(hESC) Genome Data Sharing (GDS) Small Business Innovation Research (SBIR) Funding Agreement Small Business Technology Transfer (STTR) Funding Agreement

Budget

resources Commons User Guide: Supplemental Grant Application Instructions: ementalInstructions.pdf ementalInstructions.pdf GDS Institutional Certification: html SBIR/STTR Funding Agreement Certification:

Resources Cont. NIH Grants Policy Statement: L5/section_2/2.5_completing_the_pre- award_process.htm L5/section_2/2.5_completing_the_pre- award_process.htm NIH Guide Notice NOT-OD :

Terms of Award 114

Post-Award 115 The RPPR is now required for all progress reports.

Common Compliance Pitfalls and Strategies for Success: Case Studies 2 dates! October 15 3:15 – 4:30 PM October 16 8:30 – 9:45 AM 116

All About Costs Post-Award Primer October 16 10:00 AM – 11:15 AM 117

Agency Contacts Application Submission Contacts – Provides links to helpdesks for eRA Commons Grants.gov Grants. Info Call eRA Help Desk if you experience any submission problems. 118

Questions? 119