# Presentation: 673698

## Grants Management 

** **
**Facts about Grants Funding**
**Pre & Post Award**** **
**Kathleen Shino**
**Acting NIH SBIR/STTR Coordinator**
**Grants Management Officer, NIDDK**
**NIH SBIR/STTR Conference**
**July 2005**

**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**** **

## 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](http://grants1.nih.gov/grants/funding/sbir.htm#sol)_
**First the definition 13 CFR 121.105: **
-  **a small business is a business entity organized for profit, with a place of business located in the United States, and which operates primarily within the United States or which makes a significant contribution to the U.S. economy through payment of taxes or use of American products, materials or labor.**
-  has, including its affiliates, 500 or fewer employees

##  Eligibility – SBIR/STTR

**Second  - Ownership   -  13 CFR 121.702**
**(1) A for-profit business concern, as defined in Sec.  121.105, that is at least 51% owned and controlled by one or more individuals who are citizens of the United States, or permanent resident aliens in the United States; or,**
**(2)  (SBIR only) A for-profit business concern, as defined in Sec.  121.105, that is at least 51% owned and controlled by another for-profit business concern, as defined in Sec.  121.105, that is itself at least 51% owned and controlled by individuals who are citizens of, or permanent resident aliens in, the United States.**

## 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 Commercialization 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**

##         Verifying Eligibility

**The **_**research space**_** occupied by the grantee is generally not shared with another organization and is under the control of the  grantee.**
**All research on the SBIR/STTR grant will be **_**performed in its entirety**_** in the United States****. **

**Application Considerations **

## Cost Considerations

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

## 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

## Budget Format

**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**

## 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.**   **

## 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**
**Typically By Telephone**
**Rate Agreement Is Issued Or Rate Memo Is Sent To Grant Specialist**

## 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

“It’s free money, but it’s not easy”
	--anonymous grantee

**“****It’s free money, but it’s not easy”**
- 	--anonymous grantee

## 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 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)**

## Compliance Basics

**Do the right thing...**
**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**** ****Company**** ****is accountable for the finances and the administration of the grant**
**The ****PI**** is accountable for the research**
**The ****PI**** makes allocation decisions**
**The ****Company**** ****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**

##        NIH Enforcement Actions

**Special terms and conditions of awards**
**Loss of carryover authority**
**Cost disallowances**
**Suspension/termination of award**
**Opportunity for improved grantee systems and policies to assure compliance**

## Financial Conflict of Interest

***Expectation:******  *****Companies 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 assure 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 FY2006?

**	****	****It’s electric!  Research Administration**
**New Electronic SF424 R&R   **** **
**December 1, 2005 receipt date for SBIR/STTR competing applications**
**	**
**   ****Program Outcomes Data System (PODS)  Electronic final progress report    **

## 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!**
**Kathleen J.  Shino, M.B.A.**
**Acting NIH SBIR/STTR Program Coordinator**
**Voice: 301 435-2689  Fax: 301 480-0146**
**Email:  shinok@mail.nih.gov**

**QUESTIONS??**