# Presentation: 207443

## SMALL BUSINESS INNOVATION RESEARCH PROGRAMS 

**DEPARTMENT OF HEALTH & HUMAN SERVICES**
**                                                                                                                   **
** ****  **** **

**SMALL BUSINESS INNOVATION RESEARCH PROGRAMS **
**Lisa Moeller**
**Grants Management Specialist, NIBIB**
**5th Annual NIH SBIR/STTR Conference**
**June 2-3, 2003 *National Institutes of Health* Bethesda, MD ****  **

## OVERVIEW

**Application Process**
**Roles and Responsibilities**
**Compliance**
**Award Process**
**Post Award Administration**
**What’s New in 2003?**

**OVERVIEW**

## Eligibility

**Small, For-Profit Organization**
**Number of employees not exceeding 500 including affiliates**
**Independently owned and operated by U.S. citizens or lawfully admitted permanent resident aliens**
**Unlimited access and control of space**
**Lease Agreement**
**Resources and Environment**
**All research activities must be conducted within the US**

## Eligibility 

**Principal Investigator (PI)**
**Primary Employment (SBIR only)**
**51% in Small Business**
**DOCUMENTATION REQUIRED**
**If PI is less than full time and employed by another organization**
**From all employers of the PI**

**Notes:**
PI of STTR can be from either the SBC or the RI.

## Award Mechanisms

**GRANT **
- Assistance mechanism
- Benefits a public purpose
- Government is a partner/patron
- Investigator initiated research
- Purpose is to support and stimulate research

**CONTRACT**
- Acquisition instrument
- Benefit the government directly
- Government is a purchaser
- Government initiated
- Purpose is to acquire goods or services

## NIH SBIR/STTR Application Procedures

** ****Phase I ****Up to $100,000 Total Costs**
** ****Omit Detailed Budget Form Page 3 **
** ****Include Narrative Justification:**
-  **Personnel**
** ****Fixed Fee**
** ****Consultant Costs**
** ****Contractual Costs**

##         Example: Budget & Fee 

**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: Budget & Fee
- Calculation

## Types of Costs

**DIRECT COSTS****: *****Easily Identified With A Specific Project:******	***
**Direct Salaries & Wages**
**Materials & Supplies**
**Consultants & Subcontracts**
***FACILITIES AND ADMINISTRATIVE  COSTS (INDIRECT COSTS)******: Not Easily Identified With A Specific Project***** **
**Fringe Benefits**
**Overhead    and     G&A**

## Facilities and Administrative Cost (F&A) Calculations

**   ****PHASE I**** - If you do not have a negotiated F&A rate; F&A costs funded and charged cannot exceed 40% of total direct costs (no exclusions) – will not be negotiated**
**   ****PHASE II -**** If proposed F&A costs are 25% or less of total direct costs (no exclusions), you do not need to provide supporting documentation – will not be negotiated.**

**Notes:**
F&A must be requested in the application – cannot request after the fact.

## Phase II   F&A Costs Negotiation 

***If requested F&A rate is more than 25% in the application (checklist page), contact the NIH Indirect Cost Branch:***
**Who?  Ruth Bishop (301) 496-2444**
**When?  Notification from NIH Institute That Phase II Is Going To Be Awarded**
**How: Via E-Mail: **_[rb17i@nih.gov](mailto:rb17i@nih.gov)_
** **_[http://](http://ocm.od.nih.gov/dfas/rates.htm)__[ocm.od.nih.gov/dfas/rates.htm](http://ocm.od.nih.gov/dfas/rates.htm)_

## Roles and Responsibilities 

**Program Director**** **
**	****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 **

##  Roles and Responsibilities

-  **Grants Management Officer**
**Monitors administrative and fiscal aspects of the project**
**Assures compliance with federal regulations,  policies and procedures**
**The GMO is the only NIH official authorized to obligate NIH to the expenditure of funds or to change the funding, duration, or other terms and conditions of award**

- 

## Roles and Responsibilities

**Grantee**
**Award made to the organization, not PI**
**Legally responsible**
**Assures compliance with federal regulations, policies and procedures **
**Monitors proper conduct of the project**
**Fiscal management of the project**

## Compliance

**Notes:**
Mutual benefit to have in place good financial management systems and policies and procedures that are consistently followed.  

We’re here to work with you on a proactive basis to help you achieve and maintain outstanding financial and administrative management of sponsored projects.

## Audits

**OMB CIRCULAR A-133 or Project specific audit (Yellow Book)**
- Single Audit Circular applies to all Federal grantees
- Focuses on major programs
**Test grantee’s compliance and internal controls**
**These are NOT government audits!**

## Audits Required When

**Expenditures exceed $300,000  a year in Federal awards **
**If less than $300,000 expended per year**
**Records must be available for review  **
**GRANTEES – hire experienced federal audit team**
**Identify programs/projects to be audited  **
**Prepare financial statements  **
**Ensure audits are conducted according to Federal requirements and reports are submitted on time. **
**Follow-up on audit findings **

**Notes:**
Cost of audit should be included in F&A rate.

## Financial Management Systems

**    **
**General ledger to track direct and F&A costs**
**Project ledger to track direct project costs by category**
**Time and effort system to track personnel costs by project -- financial evaluation samples available on NIH SBIR website:  **_**http://grants.nih.gov/grants/funding/sbir.htm**_

**Accounting System**

## Financial Management Systems

**Financial Capability**
**Annual Financial Statements**
**Balance Sheets, Income Statements, Audits**
**Budgetary Controls****	**
**Track expenditures against budget and/or funded amounts**
**Internal Controls**
**One person should not have control over all aspects of the accounting system**

## Administrative Systems

**Must comply with OMB circular A-110**
**Personnel system**
**Property management system**
**Procurement system**
**Travel system**
**Federal Acquisition Regulations**
**(FAR) 31.2**

## Where’$ the money?

**Where’$ the money?**

**Award negotiation phase (2 to 3 months)**
**Third Party Issues**
**Contracts, Consortia, Consultants**
**Office for Human Research Protections (OHRP) Issues**
**IRB (Human Subjects)**
**Human Subjects Protection Training Certification**
**Continuing education program on the protection of human participants in research is now available online at **_** http://cme.cancer.gov/c01/**__** **__** **_
**Office of Laboratory Animal Welfare (OLAW) Issues**
**Vertebrate animal involvement**

## Filing Federal Wide Assurances Protection for Human Subjects

**All organizations needing Assurances are encouraged to file an FWA with OHRP.**
**The requirement to file an Assurance includes the grantee organization and any collaborating institutions that become "engaged" in the research. **
**HHS or other Federal support is not required to file an Assurance. **
**	**_**http://ohrp.osophs.dhhs.gov/irbasur.htm**_

## Award Negotiation

**Letters ****from consultants and contractors**
**Other Support**** ****information for key personnel**
**Detailed future years**** information**
**Peer Review concerns**** in Summary Statement**
**Non-Modular applications**
**Allowable, Allocable and Reasonable Costs**
**Complete Budgets and Justifications**

**Notes:**
Information that we need to determine the allowable and allocable costs, or to verify requested costs must be provided prior to award.

Other support information, IRB and IACUC are just-in-time items, and that really means it just takes longer to process the award since we have to wait for it.

If we have questions about significant variation in future years, or there are administrative or other concerns in the summary statement, they must be explained and resolved prior to award.

## Award Negotiation

**Assurances**
**Research using humans or animals**
**Inter-institutional Agreements**
**Negotiate with OHRP or OLAW**
**Scientific Misconduct Assurance**
**Negotiate with Office of Research Integrity**

**Notes:**
Even if the animal or human subjects research is not conducted at the grantee organization, the grantee is responsible for the oversight of all aspects of the project. Therefore, the grantee must have an assurance and a current IRB or IACUC review date to allow the research to proceed.

The organization is required to provide an annual assurance of compliance with the Office of Research Integrity – that’s around April 1—and may delay your award if it’s late or missing.

## Conflict of Interest -          The Regulations

**For Grants: **_**42 CFR Part 50 Subpart F**_
**“****Responsibility of Applicants for Promoting Objectivity in Research”**
**For Contracts**: _**45 CFR Part 94**_
**“****Responsible Prospective Contractors”**
**Involves: PHS $, Research and Investigators**
****These regulations ***_***do not apply***_*** to Phase I SBIR & STTR***

## Conflict of Interest  

**Regulations promote Objectivity in Research by requiring the establishment of **_***Institutional***_*** ***_***Standards***_** to ensure there is no reasonable expectation that design, conduct or reporting of PHS funded research is biased by a conflicting financial interest of an Investigator.**
- _[http://grants.nih.gov/grants/policy/coi/index.htm](http://grants.nih.gov/grants/policy/coi/index.htm)_
**DRAFT Interim Guidance:**
**	**_**http://ohrp.osophs.dhhs.gov/nhrpac/mtg12-00/finguid.htm**_

## Notice of Grant Award (NGA)	

**Legally Binding Document**
**Sent to the Business Office—they should send you a copy**
**Establishes funding level**
**Establishes period of support**
**Sets forth terms and conditions of award**
**Institute contact information**
**Program Director**
**Grants Management Specialist**
***	******Please ***_***READ IT CAREFULLY***_*** before starting project!***

**Notes:**
Terms and Conditions, Example: in terms for final year gives information about conditions to apply (20% cap)   Tells about any restrictions, explains funding, and may have

## Where’$ the Check?

-  Payments for grants awarded by NIH are made through the Division of Payment Management
-  Requests for downloadable forms and inquiries regarding payments should be directed to:
-          Division of Payment Management
-            P.O. Box 6021
-            Rockville, MD 20852
-            (301) 443-1660
**Call only after you receive your Notice of Grant Award!**

## Post Award Administration

**All requests for project changes that require NIH staff approval must be submitted in writing and be signed by the Principal Investigator AND business official **
-  **NOTIFY NIH IMMEDIATELY IF:**
**Change in name of business, merger, successor-in-interest**
**If PI or other key personnel will:**
**Withdraw from the project entirely**
**Be absent three months or more**
**Reduce time devoted to the project by 25% or more**

## 
Whenever you are contemplating rebudgeting or other postaward changes and you are uncertain about the need for prior approval, consult, in advance, with:

Your Business Office  
Written federal policies and regulations (on-line)
NIH awarding component GMO 
	(Grants Management Specialist named on your NGA)

**Whenever you are contemplating rebudgeting or other postaward changes and you are uncertain about the need for prior approval, consult, *****in advance*****, with:**
**Your Business Office  **
**Written federal policies and regulations (on-line)**
**NIH awarding component GMO **
*	****(Grants Management Specialist named on your NGA)***

**A Rule of Thumb**

## Annual Report Requirements

**It’s a**** SNAP! (Streamlined Non-competing Application Process) ****for continuation funding**
**You MUST Answer the SNAP questions!**
**Estimated unobligated balance of >25%  of total costs? **
**Changes in Other Support?**
**Significant changes in Time and Effort?**
**Progress report based on achievement of the originally stated aims, results (+/-), and list of publications resulting from the project. **
**	**_**http://grants1.nih.gov/grants/funding/2590/2590.htm**_

**Notes:**
All you need to send in is the PHS 2590 to apply for funds each year of the  project period.  Follow the instructions in the application:
Answer the  three  questions at the beginning of Form Page 5

## Final Report Requirements

**Final Reports**
**Due within 90 days of the project end date**
**Financial Status Report (SF 269)**
- 	_**http://grants1.nih.gov/grants/forms.htm**_
**Final Progress Report (no form)**
**Final Invention Report (HHS 568)**
- 	_**http://g**__**rants.nih.gov/grants/forms.htm#inventionstatement**_
**Federal Cash Transaction Report (PSC 272)**

- PI

## Didactic content to inform investigators & grantee/ contractor organizations
37CFR 401
Invention policy issues
Invention reporting procedures/forms
Submission of Invention Report records via secure, interactive web-based system 
Production deployment - Oct. ‘97
Single interface to report inventions sponsored by 13 Federal agencies
IEdison url	http://www.iedison.gov

**Didactic content to inform investigators & grantee/ contractor organizations**
**37CFR 401**
**Invention policy issues**
**Invention reporting procedures/forms**
**Submission of Invention Report records via secure, interactive web-based system**
**Production deployment - Oct. ‘97**
**Single interface to report inventions sponsored by 13 Federal agencies**
**IEdison url****	**_**http://www.iedison.gov**_

**Invention Report**

## What’s New in 2003?

- Update on the Transition to Electronic Non-competing Grant Progress Report Notification
-  https://commons.era.nih.gov/commons-demo/
- Just-in-Time requirement for IACUC Review
- Mail Addressed to the NIH
- Product Development Plan, now Commercialization Plan
- All SBIR/STTR recipients register with SBA Tech-Net
***Want to Know More?***
***Subscribe to the NIH Guide:****** ***
_**http://grants1.nih.gov/grants/guide/listserv.htm**__** **_

## Receipt Dates for AIDS or AIDS-Related SBIR and STTR Applications

- Receipt dates for SBIR (R43 and R44) and STTR (R41 and R42) applications that propose AIDS or AIDS-related research are the same as for all other AIDS applications: May 1, September 1, and January 2.
- NIH Guide, March 7, 2002
- _[http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-036.html](http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-036.html)_

- Reminder

**Notes:**
Effective March 2002, the receipt dates for SBIR (R43 and R44) and STTR (R41 and R42) applications that propose AIDS or AIDS-related research will become the same as for all other AIDS applications: May 1, September 1, and January 2. 

## NIH Grants Information Sources

**Notice of Grant Award**** **
**Provides terms of award and agency contacts**
**NIH Grants Policy Statement**
**	**_**http://grants.nih.gov/grants/policy/nihgps_2001/**_** **
**NIH Guide for Grants and Contracts**
**	**_** **__**http://grants1.nih.gov/grants/guide/notice-files/index.html**_
**Frequently Asked Questions**** regarding NIH grants**
**	**_**http://www.grants.nih.gov/grants/funding/giofaq.htm**_
**Grants Information**
**	**_**grantsinfo@nih.gov**_** *****(contact email address)***

## QUESTIONS??

- 		**	****      ****Thank you!**
-              **Lisa Moeller, CRA**
- Grants Management Specialist
- National Institute for Biomedical Imaging and Bioengineering
- National Institutes of Health/DHHS
- (301) 451-4793
- lm236j@nih.gov