Transcript ASSISTING WITH COMPLIANCE Overview and Compliance for NIH SBIR/STTR National Institutes of Health

National Institutes of Health
Overview and Compliance for
NIH SBIR/STTR
ASSISTING WITH COMPLIANCE
Brian Albertini
Chief Grants Management Officer
National Institute of Nursing Research
SBIR/STTR NATIONAL CONFERENCE
OMAHA, NE JUNE 30, 2009
Overview
 Roles and Responsibilities
• Eligibility for SBIR and STTR
–Application Process
• Award Actions
• Post Award Requirements
• Compliance Basics
NIH Staff Roles
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Grants Management Officer (GMO)
Signs awards, ensures compliance and reviews prior
approval requests.
Grants Management Specialist (GMS)
Handles day to day activities and manages a grant
portfolio.
Program Official (PO)
Scientific, and/or technical aspects of grant
Scientific Review Administrator (SRAs)
Manage the activities of Scientific Review Groups
(aka, peer reviewers)
NIH Staff - Responsibilities
• Prior approval items (when required)
GM Staff - review for compliance with policies and
regulations
PO Staff - change in scientific scope
• Noncompetitive applications (Annual progress report)
GM - review for administrative compliance
PO - review scientific progress
• Closeout for projects (Final reports)
GM - all close-out documents
PO - review final scientific progress report
Eligibility: Grantee Institution
The award is made to the institution, not an
individual/PI
The Institution Official (IO):
 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 policies and procedures
Principal Investigator (PI)
 Works with the Institution Official
 Is responsible for the scientific and/or
technical aspects of the grant.
 Handles day-to-day management of the
project.
 Is responsible for the scientific conduct of
the project and must provide the required
progress reports.
SBIR and STTR Overview
See NIH SBIR/STTR website
http://grants1.nih.gov/grants/funding/sbir.htm
• Phase I – Feasibility/design (R43/R41)
– Normally 6 months (SBIR) to 1 year (STTR)
– Normally $100,000 Total Award (Direct costs +
Indirect costs + Fee)
• Phase II – Full R&D continuation of Phase I (R44/R42)
Only Phase I awardees eligible for for Phase II
– Normally Two Years and $750,000 Total Award (Direct
+ Indirect costs + Fee)
• Phase III – Commercialization
– No SBIR or STTR funding
SBIR/STTR Eligibility
• For-profit U.S. business firm
• 51% U.S. owned by individuals* &
independently operated
• Small Business Concern (SBC) located in
the U.S.
• 500 or fewer employees, including
affiliates
*See SBA regulations for SBIR & STTR ownership
SBIR and STTR Eligibility
• Eligibility determined at time of award.
• All project activities should be performed in the United
States.
• “Normally Not-To-Exceed” Funding Levels.
• Project period
– SBIR Phase I - request 12 months budget period if
project has:
• Vertebrate Animals research
• Human subjects involvement
• Third party (consortium/contracts)
SBIR and STTR Application Process
• Electronic Application through Grants.gov
– Use Parent FOA and SF424 R&R forms
• New Applicant Organizations need:
– Tax Identification Number**
– DUNS **
– Human Subjects – FWA for grantee (SBC)
– Animal Assurance for grantee (SBC)
** Required for SF424R&R submission
• Annual Reporting required: Misconduct in Science to
the Office of Research Integrity (ORI)
SBIR Requirements
• P.I. primarily employed by SBC >50%
– Don’t confuse employment w/Time and Effort
– PI employment is rarely negotiable
• Phase I (R43) - third party involvement
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Normally NTE 33% of total award amount
Includes consultants & consortia
Does not include ‘fee for service contracts’
May exceed 33% if requested, justified, and approved
by reviewers and program
– Justify deviations from SBA guidelines in funding
levels & project period in the application
SBIR Requirements Phase II
• Commercialization Plan required for All
Phase II applications and Fast-Track
• Phase II (R44)
– PI employment at least 51% by SBC
– Third party costs normally NTE 50%
– Total amount awarded normally NTE
$750,000 (D.C., F&A + fee) for two years
STTR Phase I (R41) + II (R42)
• Single, partnering Research Institution
Minimum 30% effort/budget
• STTR subaward budget page and
letter from RI required in application
(Small Business Minimum 40%)
• Principal Investigator
– Minimum 10% time & effort
– Must have formal agreement with SBC
• Commercialization Plan for Phase II
Types of Costs For Grants
•
Indirect Costs/F&A Costs:
Not Easily Identified With A Specific Project
– Fringe Benefits, Overhead, Exec. salaries
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Direct Costs
Easily Identified With A Specific Project
– Direct Salaries & Wages
– Materials & Supplies
– Consultants & Subcontracts
• Unallowable Costs -- Government will not
reimburse! http://www.arnet.gov/far/loadmainre.html
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Percentage Calculations
• Work Performance (Research Activities)
– Normally based on total award amount
– Formula for STTR is based on Total Cost
less any requested Fee
– Explain in budget justification for exceptions
• Fee/profit (NTE 7%)
– ONLY for SBIR/STTR grantee (SBC)*
– May be based on total DC + F&A
– Grantee must justify this in the application
*All other mechanisms prohibited from fee/profit on grants
Phase I and Indirect Cost Rates
• If you have a current negotiated ICR
agreement with NIH or another Federal
Agency, request the ICR stated in the
agreement
• PHASE I – If no current negotiated rate
agreement, indirect costs funded cannot
exceed 40% of total direct costs.
NIH does not negotiate rates for Phase I SBIR
or STTR awards.
Phase II - Indirect Cost Rates
• If you have a current negotiated rate agreement; use the
ICR stated in the agreement.
• Per the NIH guide notice dated 01/21/2009
http://grants.nih.gov/grants/guide/notice-files/NOT-OD09-038.html
If you do not have a current negotiated ICR agreement;
and your proposed indirect costs exceed 40% of total
direct costs, rates must be reviewed by NIH/DFAS. The
Awarding IC may elect to restrict indirect cost recovery to
10% of Salaries & Wages until DFAS negotiation is
complete.
• If proposed indirect costs are 40% or less of total direct
costs, you do not need to provide supporting
documentation or negotiate the rate
Questions about Indirect Costs?
NIH Division of Financial Advisory
Services (DFAS)
http://oamp.od.nih.gov/dfas/rates.asp
Raphael Woodruff, Acting Branch Chief
Ph: (301) 496-2444
Attend the IDC Workshop at the Conference!!
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Award Actions
Science with Strings Attached
Notice of Grant Award (NGA)
 A legally binding contract with the government
 Official notice that an award has been made
 NGA includes
 Funding level (amount available for project)
 Periods of support (Project and budget period
 Terms and conditions
(Restrictions/requirements)
 NIH contact information
Grantee Acceptance
The grantee indicates acceptance
of the terms and conditions of the
award by drawing down funds
against the grant from the
Payment Management System.
DHHS Division of Payment Management
http://www.dpm.psc.gov
Expanded Authorities
NIH awards are under EA, which means:
 90 day pre-award cost authority at grantee’s own risk
 Reasonable rebudgeting authority
 > 25% of total award may be unreasonable
Grantee’s under expanded authorities may:
 Change consortium participant
 Extend project period through the NIH Commons for
additional 12 months
No-cost Extensions
 Grantee may extend (without additional
funds) the final budget period of the
project up to 12 months via the NIH
commons up to 90 days prior to the end
date of the award. (one-time only).
Award Elements
Under the Expanded Authorities for select
phase I and all Phase II awards…
 Carryover (Only on for multi year awards)
 The authority to expend funds from the
previous budget period.
 Streamlined Non-competing Award Process
(SNAP uses PHS 2590 forms)
 Eliminates need for annual submission of
budget with progress report and annual
submission of Financial Status Report
(FSR).
Additional Terms and Conditions
 Restrictive/Requirement/Informational Terms:
May specify required action on the part of the
grantee to remove restriction, provide updates,
or restrict efforts or activities. (e.g., IDC rate
negotiation, human subjects etc.)
 Close-out reporting requirements
 Included in the Final year Notice of Grant Award
(NGA)
 Financial, invention and final progress reports
Close Out Requirements
 Due within 90 days of the end of the project
period to the awarding Institute/Commons:
Final Progress Report (no form, format
included in final Notice of Grant Award terms!)
Final Invention Statement - Form HHS 568
Final Financial Status Report – SF 269A or
SF 269
Post Award
These requests should come to NIH in
writing.
Prior NIH Approval Required
 Change of PI and other Key personnel
named in Notice of Grant Award
 Change of Grantee Organization
 Change of Scope
Additional Prior Approval Requirements
Written notification via email should be made if one of
the following occurs:
• Successor-in-interest
• Name change
• Merger or acquisition
Additional Prior Approval Requirements
Any changes involving the Principal Investigator
or other key* personnel should also be promptly
reported if they plan to:
• Withdrawal from the project entirely.
• Are absent three months or more.
• Reduce time devoted to the project by 25% or
more.
*Key personnel named in the NGA Terms of Award
Submitting prior approval
 Requests for project changes that
require NIH approval must be
submitted with the concurrence of
Institutional Official (IO).
• An e-mail request is acceptable
– Sent through the IO to the awarding
institute GMO and Program Official
Compliance
Compliance Basics
Internal Controls
Financial Conflict of Interest
Compliance Basics
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Misuse of funds
Unallowable costs
Allocation of costs
Accelerated expenditures
Large unobligated balances
Cost transfers
Financial Conflict of interest
Compliance Problems
Common Contributors:
 Lack of understanding of roles and
responsibilities of institutional staff
 Inadequate resources
 Outdated or nonexistent policies and
procedures
 Inadequate staff training and education
 Inadequate systems
 Perception that internal control systems are
not necessary
Why is Compliance Important?
• It strengthens the relationship of trust that exists
between federal sponsor and grant recipient
• It suggests a presence of the stewardship
necessary to properly safeguard the Federal
investment in biomedical research
Compliance Program Guidance
for Recipients of NIH Research Grants
http://grants.nih.gov/grants/compliance/compliance.htm
Internal Controls
Are budgetary controls in effect to
preclude incurred expenses/obligations
from exceeding total awarded funds or
budget cost categories?
Is there a separation of duties (record
keeping/ cash receipts/ cash payments)?
Are all accounting entries adequately
documented? (Journal + Chart of
Accounts?)
Internal Controls Capability
The grantee organization must have
• a job cost accounting system,
• an adequate timekeeping system,
• must segregate direct and indirect costs.
• Must have written policies & procedures
Federal Financial and Business Management Systems
- Sample Policies and Procedures
http://www2.niddk.nih.gov/Funding/Grants/ffbms.htm
Who is Accountable?
 The Company is accountable for the
finances and the administration of the grant
 The PI is accountable for the research
 The PI makes budget allocation decisions
 The Company exercises oversight on
budget allocation decisions
NIH Compliance Activities
• Institutional compliance process
– Technical assistance
– Corrective action process
– Settlement process
• Outreach
– Educational seminars
– National and regional meetings
– NIH Regional Seminars
• Proactive Compliance Site Visits
• Targeted Site Reviews (FCOI)
What do Grantees Need to know?
Code of Federal Regulations (CFR)
• 42 CFR Part 52 – Grants for Research Projects
http://www.access.gpo.gov/nara/cfr/waisidx_03/42cfr52_03.html
• 45 CFR Parts 74 and 92 – Public Welfare,
Administrative Requirements
(74) http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr74_04.html
(92) http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr92_04.html
• 45 CFR Part 46 – Public Welfare, Protection of
Human Subjects
http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html
What do Grantees Need to Know?
OMB Circulars http://www.whitehouse.gov.ombcirculars/
Administrative Requirements or Standards:
– A-102: Uniform Administrative Requirements for
Grants and Cooperative Agreements awarded to State
and Local Governments and Indian Tribes
– A-110: Uniform Administrative Requirements for
Grants and Agreements awarded to Universities,
Hospitals, and Other Non-Profit Organizations (& forprofits at NIH)
These include pre-award and post-award requirements
What do Grantees Need to Know?
Cost Principles: Applicable OMB Circulars and CFRs
– A-21: Cost Principles for Educational Institutions
– A-87: Cost Principles for State and Local Governments
and Indian Tribes
– A-122: Cost Principles for Non-Profit Organizations
– 45 CFR Part 74, Appendix E: Principles for
Determining Costs Applicable to Hospitals
– 48 CFR Subpart 31.2 (Federal Acquisition
Regulation) Applicable to For-profit organizations
What do Grantees Need to Know?
Audit Requirements:
Applicable OMB Circular and Regulations
A-133: Audits of States, Local Governments,
and Non-Profit Organizations
45 CFR Part 74.26: Audits of For-Profit and
Foreign Organizations
What do Grantees Need to Know?
• NIH Grants Policy Statement
http://odoerdb2.od.nih.gov/gmac/nihgps_2003/index.htm
• Notice of Grant Award (Read it before you start!)
• NIH Guide to Grants and Contracts
(Stay on top of new requirements)
http://grants.nih.gov/grants/guide/index.html
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 employee contractual agreements
See the NIH Guide:
http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-OO-040.html
**FCOI regulations exclude Phase I SBIR and STTR!
Requirements!
• All SBIR/STTR recipients must register with SBA Tech-Net for
reporting purposes
http://tech-net.sba.gov
• Register NOW with Grants.gov and eRA
http://era.nih.gov/ElectronicReceipt/preparing.htm#4
• REQUIRED PUBLIC ACCESS POLICY
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-071.html
ARRA and SBIR/STTR
• If an application is awarded using ARRA
funding, specific reporting and
transparency requirements must be
complied with:
• Specific Terms and Conditions applied to
ARRA awards are viewable on the link:
http://grants.nih.gov/grants/policy/NIH_HH
S_ARRA_Award_Terms.pdf
NIH Information Sources
For NIH Grantees:
Notice
of Grant Award (read it!)
Provides
terms of award and agency contacts
Frequently
Asked Questions
http://www.grants.nih.gov/grants/funding/giofaq.htm
Grants
Information
[email protected] (contact email address)
NIH
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Grants Policy Information
http://grants1.nih.gov/grants/policy/policy.htm
QUESTIONS??
E-mail: [email protected]
Thank You!