1 Resolving SBIR/STTR Allegations of Waste, Fraud, and Abuse - NIH Perspective Presented by: Maritza Zeiberg, CPA, Director, Division of Program Integrity, OMA, Office of the NIH Director October 23, 2014
Dec 16, 2015
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Resolving SBIR/STTR Allegations of Waste, Fraud,
and Abuse -NIH Perspective
Presented by: Maritza Zeiberg, CPA,
Director, Division of Program Integrity, OMA, Office of the NIH
DirectorOctober 23, 2014
Presenter
Director, Division of Program Integrity
27 years at HHS; 19 at NIH 1,000+ reviews $40 million recovered $500 million put to better use
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Purpose of Presentation
Describe DPI Roles and responsibilities Process for resolving SBIR/STTR
allegations Actions for SBIR/STTR recipients Discuss current issues and
potential solutions Questions and answers
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DPI Responsibilities
Provide NIH with a centralized review capability for allegations of waste, fraud, abuse, and mismanagement
Review issues referred from OIG NIH Liaison with OIG Office of
Investigations, DOJ, and other law enforcement organizations
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DPI Authority
Misuse of Grant Funds– 45 C.F.R. 74.53 (e) - authority to conduct reviews of NIH grantees’ records and interview grantees’ personnel.
Misuse of Contract Funds– 48 C.F.R. 52.215-2 (FAR) provides the authority to access records of NIH contractors.
Employee Misconduct – Section 402(b)(1) of the PHS Act, 42 U.S.C. 282(b)(1) provides authority to conduct reviews of allegations of improper conduct by NIH employees.
DPI Purview Limitations
Scientific Misconduct
NIH Extramural Research Integrity Liaison Officer, OEROffice of Research Integrity, HHS
Human Subject Issues
Office for Human Research Protections, HHS
Animal Welfare Issues
Office of Laboratory Animal Welfare, NIH
Criminal Activities Office of Inspector General, HHS
Personnel Matters
Office of Human Resources, NIH
Discrimination/Harassment
Office of Equal Opportunity and Diversity Management, NIH
Disputes between Contractors and Subcontractors
NIH does not have a direct contractual or legal relationship with subcontractors
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Impact
Recovered $6.5 per $1 spent in FY13
Provide data for decision making that allows the government to put money to better use
Improve policies and internal controls at NIH and grantee institutions
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FY13 NIH Funding
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Research grants – $20.9 billion Contracts – $4.3 billion SBIR – $617 million STTR – $80 million
Funding Environment
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Twohy, Mike. “Defunding Increases Aggression.” Illustration. The New Yorker, May 9, 2011.
Sources of Allegations
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External35%
Internal 29%
OIG Hot-line26%
OIG Info Requests
5%
OIG OI Re-ferrals for Admin Ac-
tion5%
Review Process
Acknowledge AllegationStress Confidentiality
Prepare Review PlanIdentify Issues, Criteria, Evidence
Notify IC and SBCCoop./Confidentiality Agreement, Request Info
Analyze DataSolicit Expert Opinions, Conduct Interviews
Prepare ReportReport to IC Director and SBC
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What to do if….
…We notify you that we are reviewing your award? Sign cooperation & confidentiality
agreement
Be responsive to our request
Call us if you have questions
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Recommendations
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issues report w/recs
DPIcloses case
implements recs
SBCinforms IC of
actions taken in response to recs
initiate action with SBC
NIH ICinforms DPI of SBC actions
Areas of Concern
Eligibility and general noncompliance
Overlap Inadequate documentation Award transfers
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Findings
Providing false information on applications
Requesting funds for work that is complete
Using funds for other research activities
Overlap of NIH and Non-NIH support
Performing work outside the USA 19
Possible Solutions
Educate staff and raise awareness Define roles and responsibilities Maintain complete financial and
scientific records Disclose sources of support Establish a culture of compliance Provide timely and unrestricted
access to records
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Fraud Indicators
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Missing or incomplete support for award expenditures and scientific progress
Evasiveness/non-responsive/time extension requests to federal staff inquiries
Favors, gifts, money, gratuities to grant/contract to staff at funding agency
Early requests for next SBIR/STTR phase funding
Lax enforcement of award requirements
Multiple complaints
Failure to obtain approval for significant budget or scope changes or for substitutions to key personnel