# Presentation: 727879

** **
**Facts about Grants Funding**
**Pre & Post Award**** **
**Ruth Bishop, CPA**
**Teresa Marquette**
** ****Leanne Robey, CPA**
**NIH SBIR Conference**
**June  2004**

**Grants Management **

## Overview

- Roles and Responsibilities
- Eligibility and Budgets
- Funding Considerations – Pre-award
- Post Award
- Compliance
- NIH eRA Commons

## Grants Management Officer (GMO)

**Responsible for the business management of the grant, including:****	**
**Review**
**Negotiation**
**Award Administration**
**Interpretation of policies and provisions**
**GMO is the only person authorized to obligate monies and permit changes to approved projects on behalf of the NIH**

## Program Official

**	**
**	****	****A****dvice and Guidance**
**	****	****W****hat’s Hot: New initiatives**
**	****	****A****nswer your scientific questions **
**	****	****R****eview Issues: Dos and Don’ts**
**	****	****D****iscuss funding alternatives**** **

## Grants Management Specialist (GMS)

**Evaluates grant applications for administrative content and compliance with statutes, regulations and guidelines**
**Responsible for business management and other non-programmatic aspects of the grant**
**Negotiates grant awards **
**Serves as the focal point for receiving and responding to correspondence related to business and policy matters**

## Grantee Institution

**The award is made to the *****institution*****, not an *****individual***
**The Institution:**
**Is legally responsible for the proper conduct and execution of the project**
**Provides fiscal management of the project**
**Provides oversight on allocation decisions**
**Ensures compliance with Federal laws and regulations, and NIH policies and procedures**

## Authorized Institute Official (IO)

**Designated representative of the grantee organization in matters related to the award and administration of NIH grants**
**In signing a grant application, this individual certifies that the institution will:**
- Comply with all applicable assurances and certifications
- Be held accountable for the funds awarded and for the performance of the grant-supported project or activities
- Ensure that the organization complies with applicable Federal laws and regulations

## Principal Investigator (PI)

**Responsible for the scientific and/or technical aspects of the grant **
**Day-to-day management of the project**
**Responsible for the scientific conduct of the project and to provide the required progress reports**

## Eligibility – SBIR/STTR 

**See NIH Omnibus Solicitation**
- http://grants1.nih.gov/grants/funding/sbir.htm#sol
**NIH Guide Announcement -** _[http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-053.html](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-053.html)_
- SBA highlighted the requirement that owners of the SBIR participant be "individuals" who are citizens of, or permanent resident aliens in, the United States.

##         Verifying Eligibility 

**Business Structure: Inc., Corp., LTD, JV, LLC, SA, PLC **
**Review the Project Development Plan in Phase II applications or company description for affiliations.**
**Biosketch information - Are there any former or concurrent employment with larger entities? (Email address?)**

##       Verifying Eligibility

**A listing of the majority or all shareholders, including the venture capital investment companies,**
**The percentage of company stock each investor or company holds, and**
**Identify foreign investors/shareholders**

**Application Considerations **

## Application Preparation Considerations

**Use updated PHS 398 application**
**Include DUNS as well as EIN**
**Adhere to type size and format specifications**
**Review the RFA or PA, if applicable**
**Modular format? (SBIR/STTR **_**<**_** $100,000)**
**Just-in-Time (JIT) considerations **

## Cost Considerations

**Cost Principles and Organizations**
**The Four “Tests”**

## Cost Principles

**Establishes standards for allowability of costs **
**Provides detailed guidance on the cost accounting treatment of costs as direct or F&A (indirect) costs**
**Sets forth allowability principles for selected items of cost**
**For-profit Commercial Organizations (FAR) 48 CFR Subpart 31.2**

## The Four “Tests”

**Reasonableness**
**Allocability**
**Allowability**
**Consistency**

## Reasonableness

**A cost may be considered reasonable if the nature of the goods or services acquired or applied and the associated dollar amount reflect the action that a prudent person would have taken under the circumstances prevailing at the time the decision to incur the cost was made**

## Reasonableness

**The cost principles address the following considerations:**
**Whether the cost is generally necessary to operations or the grant’s performance**
**Whether the recipient complies with their own established policies**
**Whether individuals expending Federal funds acted with due prudence**

## Allocability

**A cost is allocable to a specific grant, function, department, etc., known as a cost objective, if the goods or services involved are chargeable or assignable to that cost objective in accordance with the relative benefits received or other equitable relationship****  **

## Allocability

**A cost is ****allocable**** to a grant if:**
**The cost is incurred solely in order to advance work under the grant**
**It benefits both the grant and other work of the company (including other grant-supported projects)**
**It is necessary to the overall operation of the company and is deemed to be assignable, at least in part, to the grant**

## Allowability

**Applicable cost principles establish standards**
**Applicability of a particular set of cost principles depends on the type of organization making the expenditure**
**In order to be allowable, costs must also conform with NIH specific limitations and exclusions as contained in the terms and conditions of the award**

## Consistency

**Grantees must be consistent in assigning costs to cost objectives**
**Although costs may be charged either as direct or indirect, depending on their identifiable benefit to a particular program, they must be treated consistently for all work of the organization under similar circumstances, regardless of the source of funding**

## Types of Costs

**Indirect Costs/Facilities and Administrative (F&A) Costs**: Not Easily Identified With A Specific Project
- Fringe Benefits, Overhead, G&A
**Direct Costs**: Easily Identified With A Specific Project
- Direct Salaries & Wages
- Materials & Supplies
- Consultants & Subcontracts

## Modular Budget Format for SBIRs/STTRs

**Modular Budget Format for SBIRs/STTRs**

**Phase I applications requesting up to $100,000 total costs (direct + indirect + fee) **
**Budget requests are NOT made in increments of $25,000 as they are for other NIH mechanisms**
** ****Use PHS 398 Modular Budget Form page**

**Notes:**
Checklist should reflect the basis for calculating the indirect costs.

##         Example: Modular

**	****F&A (40% TDC) ****	****  +**_**26,702**_** **
**	****Total Costs****	****             93,458**
**	****7% fee (.07*93,458)   **_**+   6,542**_
**	****Total Award****	****         $100,000**
**	****Modular Award (< $100,000)**

-         **Example: Modular**
**	****	****Budget & Fee Calculation**

## Non-Modular Budget Format

**Use when requesting more than $100,000 total costs (all Phase II and any Phase I >$100K)**
**Submit PHS 398 *****form page 4***** (detailed budget for initial budget period) and *****form page 5***** for entire proposed period of support**
**STTR – include research institution budget form page (Always required in Modular, too)**

## Budget Preparation

**Consortia - third party**
**The ****grantee’s signature**** on the application ****certifies****, ****as**** the direct and primary ****recipient ****of grant funds, that it is ****aware of and is accountable to NIH**** for the ****performance**** of the project, the appropriate ****expenditure ****of grant funds ****by all parties****, and all other obligations as ****specified**** in the ****NIH Grants Policy Statement****.**

## SBIR & STTR Fee/Profit

**Fee ****must**** be requested in application**
**May not exceed 7% of total costs for NIH grants**
**Fee must be justified in the application**
**Based on profit margin consistent with   all projects of similar scope, regardless of source of funding.   **

## Indirect Costs (IDC)  or Facilities & Admin Costs

**Must request these costs in the application!**
**Fill in checklist in PHS 398 and explain base and rate for requested amount**

##  Indirect Cost/F&A Rates

**What Are Indirect/F&A Rates????**
** ****Indirect Cost Pool-How Deep?**
** ****Indirect Cost Base-How Large?**
** ****Indirect Cost Rate-How High?**** **

## Indirect Cost/F&A Rates

**Provide A Uniform Method for**
**Funding Indirect/F&A Costs**
**Charging  Indirect/F&A Costs**
**Provide An Equitable Allocation Of Indirect Costs Across All Projects**
**Ratio Between Indirect Costs (Pool) And An Equitable Base**

## Fringe Benefits

***Allowances And Services Provided To Employees***
**Pd Abs (Vacation, Holiday & Sick Leave)**
**Payroll Taxes**
**Pension Plan**
**Group Ins (Health, Life & Disability)**

## Overhead Costs

***Indirect Costs Relating To The Performance Of A Project***
**Overhead Labor (e.g.; supervision, general meetings)**
**Fringes On Overhead Labor**
**Facility Costs & Depreciation**
**General Lab Supplies**

## G&A Costs

***Indirect Costs Associated With The Overall Management Of The Company***
**Executive & Administrative Labor**
**Fringe Benefits On G&A Labor**
**Professional Fees (CPA)**
**Office Supplies**

## Types of Rates

**Three Types Of Rates**
**Provisional Rates**
**Based On Projections For Current FY**
**Used For Funding & Charging**
**Final Rates****	**
**Based On Actual Costs**
**Charges Adjusted To Reflect Final Rates**
**Ceiling Rates**
**Final Rates Cannot Exceed**

## Indirect Cost Rate Systems

**One Tier System: One Pool**
** ****Fringe Benefits, Overhead & G&A**
**Two Tier System:  Two Pools - Typically**
**Fringe Benefits**
**Overhead and G&A**

## Indirect Cost Rate Systems

**Three Tier System: Three Pools**
**Fringe Benefits**
**Overhead**
**G&A**

## Phase IIndirect Costs (IDC)/F&A 

**Phase I SBIR/STTR**
**If available, use the negotiated rate**
**If a negotiated rate is not available, applicant should propose an estimated rate not to exceed 40% of total direct costs**
**Grantees may only claim actual IDC and these claims are subject to audit **
**NIH will not negotiate Phase I SBIR/STTR F&A rates           **

## Phase IIIndirect Costs (IDC)/F&A

**Phase II SBIR/STTR **
**If available, the negotiated rate will be used**
**No negotiated rate? If the requested rate exceeds 25%, then a rate ****must**** be negotiated.  **
**If the proposed estimated rate does not exceed 25% of total direct costs, then an award can be made without negotiation**
**Grantees may only claim actual costs and these claims are subject to an audit**

## 3. FACILITIES AND ADMINSTRATIVE COSTS (F&A)/ INDIRECT COSTS. See specific instructions.
DHHS Agreement dated: No Facilities And Administrative Costs Requested.
DHHS Agreement being negotiated with Regional Office.
No DHHS Agreement, but rate established with Date
CALCULATION* (The entire grant application, including the Checklist, will be reproduced and provided to peer reviewers as confidential information.)
a. Initial budget period: Amount of base $ x Rate applied = F&A costs $
b. 02 year Amount of base $ x Rate applied = F&A costs $
c. 03 year Amount of base $ x Rate applied = F&A costs $
d. 04 year Amount of base $ x Rate applied = F&A costs $
e. 05 year Amount of base $ x Rate applied = F&A costs $
TOTAL F&A Costs $
*Check appropriate box(es):
Salary and wages base Modified total direct cost base Other base (Explain)
Off-site, other special rate, or more than one rate involved (Explain)
Explanation (Attach separate sheet, if necessary.):
0.00%
0.00%
0.00%
Enter Rate above as a decimal (e.g., 0.25 for 25%, 0.495 for 49.5%)

- DHHS Agreement dated: No Facilities And Administrative Costs Requested.
- DHHS Agreement being negotiated with Regional Office.
- No DHHS Agreement, but rate established with Date
- CALCULATION* *(The entire grant application, including the Checklist, will be reproduced and provided to peer reviewers as confidential information.)*
- a. Initial budget period: Amount of base $ x Rate applied = F&A costs $
- b. 02 year Amount of base $ x Rate applied = F&A costs $
- c. 03 year Amount of base $ x Rate applied = F&A costs $
- d. 04 year Amount of base $ x Rate applied = F&A costs $
- e. 05 year Amount of base $ x Rate applied = F&A costs $
- TOTAL F&A Costs $
- *Check appropriate box(es):
- Salary and wages base Modified total direct cost base Other base *(Explain)*
- Off-site, other special rate, or more than one rate involved *(Explain)*
- Explanation *(Attach separate sheet, if necessary.):*
- 0.00%
- 0.00%
- 0.00%
**Enter Rate above as a decimal (e.g., 0.25 for 25%, 0.495 for 49.5%)**

## Indirect Cost/F&A Rate Negotiation

**NIH Office responsible for Negotiating Indirect Cost Rates With For-profit organizations receiving awards (Grants & Contracts) from the Department of Health and Human Services is the Indirect Cost Branch, Division of Financial Advisory Services, OAMP, OD, NIH**

## Negotiation Process

**Contact the Indirect Cost Branch – Ruth Bishop:**
**When: Notification Grant/Contract Is Going To Be Awarded**
**How: Via **
**E-Mail: rb17i@nih.gov**
**Fax: 301/402-7180**

## Negotiation Process

**Indirect Cost Proposal Submitted **
**Indirect Cost Branch Reviews Proposal**
**Indirect Cost Branch Follows-up With Questions To Company**

## Rates are Negotiated

**POOL: We Want POOL SHALLOW; Company Wants POOL DEEP**
**BASE: We Want BASE LARGE; Company Wants BASE SMALL**
**RATE: We Want RATE LOW; Company Wants RATE HIGH**

## Negotiation Process

**NEGOTIATES RATES WITH COMPANY**
**Typically By Phone**
**Rate Agreement Is Issued Or Rate Memo Is Sent**

## Finally

**We are done!**
**Now that was not so bad, was it?**
**Guess what?**
**We’ll do it all again next year!**

## Additional Information

*Indirect Costs/F&A Rates:*
- _[http://ocm.od.nih.gov/dfas/faqindirectcosts.htm](http://ocm.od.nih.gov/dfas/faqindirectcosts.htm)_
**Ruth Bishop**
**Division of Financial Advisory Services**
- Office of Acquisition Management and Policy, OD, NIH

**Additional Information**

## Pre-award – Funding

**Considerations**

## Just-in-Time (JIT)

**Information that is not submitted with the application, but when the application has a possibility of being funded based on the priority score .  This will be requested:****	**
**Other support**
**Institutional base salaries for non-modular budgets**
**PI and institution documentation of eligibility (see Verification Statement in NIH Solicitation)**
**Human subject assurance/IRB & IACUC  review dates**

## Assurances/Certifications

**Human subjects (See OHRP on NIH.gov website)**
**Vertebrate animals (See OLAW on NIH.gov website)**
**Debarment and suspension**
**Drug-free workplace**
**Lobbying **
**Research misconduct**
**Financial conflict of interest **

## Assurances/Certifications

**PHS metric program**
**Smoke free workplace**
**Government use of information under the privacy act**
**Information available to the PI**
**Information available to the general public**
**Freedom of Information Act (FOIA) **

## Funding Decisions

**The paylist is determined by:**
**IRG recommendations (Peer Reviewers)**
**Scientific merit (score) **
**Council recommendations**
**Program Official recommendations**
**Scientific priorities**

## Determining Award Levels

**Initial review group**** recommendations (summary statement administrative notes)**
**Advisory Council actions**
**Cost analysis**** (GMS review of application)**
**Overlap**
**Policy considerations (e.g., eligibility)**
**Programmatic adjustments**** **

## Budget Cost Elements –Personnel

**Proposed hours for any employee should not exceed direct work year (2,080 hours/ year)**
**Are proposed salaries supported by source documents? (Employment Contract, agreement)**
**Is any part of the proposed labor also charged as indirect? (PI/CEO/President)**
**Is the role of all staff (professional and non-professional) concisely defined?**

## Budget Cost Elements - Consultants

**Consultants must not be employees of the SBC**
**Consultants should only be used when their expertise is essential to the project**
**Documentation provided in the application should include:  name of the consultant; the nature of the services rendered and their relevance to the grant; the period of service; the basis for calculating the amount requested**

## Budget Cost Elements - Equipment

**Equipment may be classified as either “project specific” or “general purpose”**
***Project specific equipment***** is defined as equipment which directly facilitates the purpose of and is an integral part of the activities of a grant**
***General purpose equipment***** includes items such as office equipment and furnishings.  Typically, these items are part of the F&A costs**

## Budget Cost Elements - Supplies

**Are supplies consistently treated as direct costs on other projects, regardless of source of funding?**
**Are the proposed supplies reasonable for the scope of the work?**

## Budget Cost Elements - Travel

**Costs incurred for project related travel**
**Budget costs in accordance with the grantee’s established travel cost reimbursement policy**
**For-profits--Government rates should be used as a basis for charging travel costs to the grant  (www.policyworks.gov)**

## Budget Cost Elements - Subcontracts

**Subcontract costs should be proposed in accordance with their governing cost principles**
**OMB Circulars (A21, A122, A87, FAR)****  **
**F&A for subcontracts are proposed as direct costs on the grantee budget**

## 
 Award Actions  

** ****Award Actions**

## Notice of Grant Award (NGA)

**A legally binding contract**
**Official notice that an award has been made**
**Includes**
**Funding level**
**Periods of support **
**Terms and conditions (footnotes)**
**NIH contact information**
**Program Official for Scientific issues**
**Grants Management Specialist for administrative issues**

## Standard Terms and Conditions

**Carry over **
**The authority to expend funds from the previous budget period **
**Streamlined Non-competing Award Process (SNAP) (Phase II)**
**Eliminates need for annual submission of budget with progress report and annual submission of Financial Status Report (FSR) **

## Other Terms and Conditions

**Restrictive terms - may specify required action on the part of the grantee to remove restriction   (F&A rate negotiation, human subjects)**
** **
**Close-out reporting requirements**
**Included in the Final year NGA**
**Financial, invention and final progress report**

## Expanded Authorities

**All NIH awards are now under EA, which means:**
**90 day pre-award cost authority at grantee’s own risk**
**No-cost extension of project period for up to 12 months (notify GMS before project end date!) **

## Post Award 

## Prior NIH Approval Required

**Change of PI and other Key personnel**
**Change of Grantee Organization**
**Change of Scope **

## Change in Scope

**Change  in direction**
**Change in type of training or **
**Change other area that constitutes a significant change from the aims, objectives, or purposes of the originally approved project**

## Actions Likely to be Considered a Change in Scope

**Change in the specific aims from those approved in the competing application**
**Substitution of one animal model for another**
**Any change from the approved use of animals or human subjects**
**Shifting the research emphasis from one disease area to another**

## Change in Scope

**Transferring the performance of substantive programmatic work to a third party through a consortium agreement, by contract, or any other means (not in original application)**
**Change in key personnel **
**Significant rebudgeting (>25% of total award)**

## Changes - Prior Approval Required!

**Notify the NIH immediately if any of these apply or will apply to your business:**
**Successor-in-interest**
**Name change**
**Merger**

##   Change – Prior Approval Required!

**   ****The following changes involving the PI or other key personnel should also be promptly reported:**
**Withdrawal from the project entirely**
**An absence of three months or more**
**Reduced time devoted to the project by 25% or more**

## Submitting prior approval requests to NIH

**Requests for project changes that require Grants Management Office approval must be submitted in writing and signed by the PI and the Institution Official (IO)**
**An e-mail request is acceptable  **
** ****initiated by the PI and sent through the IO**
**    ****to the agency GMO and Program Official    **

## No-cost Extensions

**Grantee may extend (without additional funds) the final budget period of the project up to 12 months  (one-time only). ****If**** ****registered in Commons grantees can enter a first NCE through the Commons (up to 90 days before the end date of the award).**
**Notify NIH of extensions at least ****10 days prior**** to the project period end date**
**Explain the reason for the extension and the length of the extension**
**No revised NGA for first on-time extension**

## No-cost Extensions

**Requests submitted after the project period has expired or extensions *****beyond the initial 12***** month extension requires NIH prior approval**
**2****nd**** NCE (or late) Request should include:**
**Length of the request**
**An estimate of funds remaining**
**A brief progress report and the goals to be attained during the extended period**
**If the request was submitted late, state the reason for the late request**
**If approved, a revised NGA will be issued**

## Federal Cash Transaction Report (PSC 272)

**Grantees must report expenditures (Cash Disbursements) quarterly using the PSC 272 to the Division of Payment Management  (DPM)**
**Reports are due within 45 days of:  3/31, 6/30, 9/30 and 12/31   **
**Delays in submission of the quarterly reports will result in the withholding of grant payments.**** ****Please contact your DPM account representative with any questions.**
**http://dpmlink.dpm.psc.gov/Contact.aspx**

## Federal Cash Transaction Report (FCTR) form PSC 272

**Awarding agencies (GMS) use these quarterly reports from PMS**
**To monitor patterns of cash expenditures, including accelerated or delayed draw downs, and **
**To assess  performance or to identify financial management problems**

##  Close-out and Compliance

## Close Out Requirements

**Due ****within 90 days**** of the end of the project period to the awarding Institute:**
**Final Progress Report (no form)**
**Final Invention Statement - Form HHS 568**
**Final Financial Status Report – SF 269A or SF 269**
**Refer to the terms and conditions on the final Notice of Grant Award (Section IV)**

## Financial Status Report (FSR)

**FSR**** – grantee’s report of expenditures documenting the financial status of the award **
**Phase I SBIR/STTR - FSR is due no later than 90 days after the budget/project period end date**
**For Phase II SBIR/STTR awards, the FSR is due 90 days after the project period end date and must reflect the cumulative support awarded for the project period.**

## Financial Status Report (SF 269 or 269A)

**The FSR may be accessed through the following URL: **_[http://grants.nih.gov/grants/forms.htm](http://grants.nih.gov/grants/forms.htm)_
**Submit the FSR to the following office:**
**Office of Financial Management**
**Grants Accounting Branch **
**National Institutes of Health**
**31 Center Drive, Room B1B05A, MSC 2050**
**Bethesda, MD  20892-2050**
**Phone:  301-402-5297**

## Final Progress Report

**No standard format.  The report may be typed on plain white paper and should include, at a minimum:**
**Summarization of progress in the ****context of the specific aims, timeline and milestones; **
**List of results (positive or negative)**
**List of publications resulting from the grant**
**Send directly to the Grants Management Office (Refer to Section IV of the NGA)**** **

- Principal Investigators!

## Final Invention Statement (Form HHS 568)

**The Final Invention Statement may be accessed through the following URL:  **
- _[http://grants.nih.gov/grants/forms.htm](http://grants.nih.gov/grants/forms.htm)_
**The Final Invention Statement should be sent to the Grants Management Office (Refer to Section IV of the NGA)**

- Principal Investigators!

## Non-Federal Audit Requirements

**For fiscal years beginning 1/1/04*********, if the grantee expends a total of ****$500,000 ****or more under one or more HHS awards and**
** ****At least one of those awards is an HHS grant ****(as a direct grantee and/or under a consortium agreement) **
**Choice in Type of Audit:**
** ****(1) a financial-related audit (in accordance with the Government Auditing Standards) or**
**(2) an audit that meets the requirements of OMB Circular A-133 **
*******Prior to 1/1/04 expenditures of 300,000 or more required audit.**

## Non-Federal Audit Requirements

- 45 CFR 74.26(d) essentially incorporates the deadlines of OMB Circular A-133 - Audits shall be completed and submitted within:
- 30 days after receipt of the auditor’s   report
- 			***or***
- 9 months after the end of the organization’s fiscal year

**Whichever is earlier**

## Non-Federal Audit Requirements

- Submit Audit reports of for-profit organizations  to:** **
**National External Audit Review Center**
**     ****HHS Office of Audit Services**
**     ****Lucas Place Room 514**
**     ****323 West 8****th**** Street**
**     ****Kansas City, MO 64105**
- There are frequently asked questions (FAQs) related to non-federal audit requirements for commercial (for-profit) organizations on the following web site:
- 	_[http://](http://ocm.od.nih.gov/dfas/faqforprofitaudits.htm)__[ocm.od.nih.gov/dfas/faqforprofitaudits.htm](http://ocm.od.nih.gov/dfas/faqforprofitaudits.htm)_

## Non-Federal Audit Requirements

- 	If you do not expend $500,000 or more under one or more HHS grants, you are not required to have a non-federal audit.  However, your grant-related records must be available to NIH or other designated officials for review or audit.

## Additional Information

*Non-Federal Audit Requirements:*
- _[http://ocm.od.nih.gov/dfas/faqforprofitaudits.htm](http://ocm.od.nih.gov/dfas/faqforprofitaudits.htm)_
**Leanne Robey**
**(301) 496-4494  e-mail: **_[robeyl@mail.nih.gov](mailto:robeyl@mail.nih.gov)_
**Division of Financial Advisory Services**
- Office of Acquisition Management and Policy, OD, NIH

**Additional Information**

## Compliance Basics

**Keep your policies current with Federal requirements**
**Develop a continuing training program**
**Perform risk assessments and implement appropriate internal controls**
**COMMUNICATE!! COMMUNICATE!!**
**	**

## Why is Compliance Important?

**It strengthens the relationship of trust that exists between sponsor and recipient**
**It suggests a presence of the stewardship necessary to properly safeguard the Federal investment in biomedical research**
**Comments on Compliance Program Guidance for Recipients of NIH Research Grants**
**Federal Guide Notice 9/23/03**** ****http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22626.htm**

## Who is Accountable for Compliance?

**The**** ****Institution**** ****is accountable for the finances and the administration of the grant**
**The ****PI**** is accountable for the research**
**The ****PI**** makes allocation decisions**
**The ****Institution**** ****exercises oversight on allocation decisions**

## Types of Issues

**Misuse of funds**
**Unallowable costs**
**Allocation of costs**
**Accelerated expenditures**
**Large unobligated balances**
**Cost transfers**
**Conflict of interest **

## Common Contributors to Compliance Problems

**Inadequate resources**
**Lack of understanding of roles and responsibilities of institutional staff**
**Outdated or nonexistent policies and procedures**
**Inadequate staff training and education**
**Inadequate systems**
**Perception that internal control systems are not necessary**

## Ways Non-Compliance is Discovered

**News media**
**Whistleblowers or anonymous complaints**
**GMS/PO oversight**
**OMA/NIH reviews**
**Office of Inspector General oversight**
**GAO audits**
**DOJ investigations**
**Institutional internal audits (A-133)**
**100 recent allegations:  OIG 24%; NIH 32%; ORI 4%; Anonymous 11%; University 6%; Outside 23%**

##        NIH Enforcement Actions

**Special terms and conditions of awards**
**Loss of carryover authority**
**Cost disallowances**
**Suspension/termination of award**
**Improved grantee systems and policies**

## Financial Conflict of Interest

***Expectation:******  *****Institutions must establish written policies and procedures to address financial conflict of interest for their investigators.  These standards are designed to ensure that investigators maintain research objectivity in the design, conduct, analysis and reporting of research funded under grants**

## Financial Conflict of Interest

**	****	****Identified a conflict of interest?  You must:**
**Notify Chief GMO to a****ssure that the conflicting interest is being managed, reduced, or eliminated**
**Provide additional information, if requested**
**FCOI must be addressed in consortium, consultant and contractual agreements**
**See NIH Guide: http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-OO-040.html**

## What’s New in ’04?

**Electronic Non-competing Grant Progress Report Notification & Financial Reports**
** ****https://commons.era.nih.gov/commons-demo/**
**New PHS 398 application**** (coming soon)**
**DUNS required on face page**
**Just-in-Time for IACUC Review Date**** **
**Audit Threshold increased to $500,000**
**Revised NIH Grants Policy Statement**

## NIH eRA Commons

**Open to All Institutions**
**Authorized Organizational Official should register the institution**
**Is your Institution already registered?   **_[http://era.nih.gov/userreports/ipf_com_org_list.cfm](http://era.nih.gov/userreports/ipf_com_org_list.cfm)_
**To register:**
**Go to Commons home page & click registration link**
**Enter small amount of information**
**Print out page and fax to NIH**
**	****Approx 2-3 days to process registration**
**	****Help desk can help with any problems**

## Commons Functionality

**FSR**** submission**
**IAR**** (internet assisted review)**
**Demo facility – any one can use!**
**JIT submission**** ****(all data in single submission)**
**Profiles **** (Institution and Professional Profiles)**
**View status of application, priority score (PI only), NGA and other grant related documents**
**See  **_[http://era.nih.gov/commons](http://era.nih.gov/commons)__ _
**eRA help desk:  (866) 504-9552 (7:30-5:30 EST M-F)**

## NIH Grants Information Sources

**Provides terms of award and agency contacts**
**Frequently Asked Questions  **
_**http://www.grants.nih.gov/grants/funding/giofaq.htm**_
**Grants Information**
_**grantsinfo@nih.gov**_** *****(contact email address)***
**NIH Grants Policy Information  **
- _[ ](http://grants.nih.gov/grants/policy/nihgps_2001/)__**http://grants1.nih.gov/grants/policy/policy.htm**_

**NIH Grants ****Information Sources**

## QUESTIONS??

***Want to Know More?***
***Subscribe to the NIH Guide:****** ***
_**http://grants1.nih.gov/grants/guide/listserv.htm**__** **_
**Thank You!**
**Teresa Marquette **
**National Institute of Nursing Research **

**QUESTIONS??**