assisting with compliance brian albertini chief grants management officer national institute of...
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ASSISTING WITH COMPLIANCE
Brian Albertini Chief Grants Management Officer
National Institute of Nursing Research
SBIR/STTR NATIONAL CONFERENCE
OMAHA, NE JUNE 30, 2009
Overview and Compliance for NIH SBIR/STTR
National Institutes of Health
Overview
Roles and Responsibilities
• Eligibility for SBIR and STTR–Application Process
• Award Actions
• Post Award Requirements
• Compliance Basics
NIH Staff Roles • 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 InstitutionThe award is made to the institution, not an
individual/PIThe 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 – 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
• 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
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-OD-09-038.htmlIf 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
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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!!
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 ElementsUnder 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
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 Basics
Misuse of funds Unallowable costs Allocation of costs Accelerated expenditures Large unobligated balances Cost transfers Financial Conflict of interest
Compliance Problems
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
Common Contributors:
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 & proceduresFederal Financial and Business Management
Systems - Sample Policies and Procedureshttp://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 Subjectshttp://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 (& for-profits 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 purposeshttp://tech-net.sba.gov
• Register NOW with Grants.gov and eRAhttp://era.nih.gov/ElectronicReceipt/preparing.htm#4
• REQUIRED PUBLIC ACCESS POLICYhttp://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_HHS_ARRA_Award_Terms.pdf
Notice of Grant Award (read it!)Notice of Grant Award (read it!) Provides terms of award and agency contactsProvides terms of award and agency contacts
Frequently Asked Questions Frequently Asked Questions http://www.grants.nih.gov/grants/funding/http://www.grants.nih.gov/grants/funding/giofaq.htmgiofaq.htm
Grants InformationGrants [email protected]@nih.gov (contact email address)(contact email address)
NIH Grants Policy Information NIH Grants Policy Information http://grants1.nih.gov/grants/policy/policy.htmhttp://grants1.nih.gov/grants/policy/policy.htm
NIH Information SourcesFor NIH Grantees: