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
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Presenter
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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
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Describe DPI
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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
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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
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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.
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DPI Purview Limitations
Scientific Misconduct NIH Extramural Research Integrity Liaison Officer, OER
Office 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
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Funding Environment
Twohy, Mike. “Defunding Increases Aggression.” Illustration. The New Yorker,
May 9, 2011.
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Sources of Allegations
OIG Hotline
26%
Internal 29%
OIG Info
Requests
5%
External
35%
OIG OI
Referrals for
Admin Action
5%
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Active Cases
Contracts
12%
Employee
Misconduct
20%
Other
8%
Grants
60%
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Proportion of SBIR/STTR Cases
SBIR/STTR
7%
Other
93%
SBIR/STTR
Other
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Review Process
Acknowledge Allegation
Stress Confidentiality
Prepare Review Plan
Identify Issues, Criteria, Evidence
Notify IC and SBC
Coop./Confidentiality Agreement, Request Info
Analyze Data
Solicit Expert Opinions, Conduct Interviews
Prepare Report
Report 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
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Be responsive to our request
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Call us if you have questions
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Sample Notification
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Collaborative Review Process
DPI
Grants
Contracts
Policy
Scientific
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Recommendations
issues report
w/recs
DPI
initiate action
with SBC
closes case
NIH IC
SBC
informs DPI of
SBC actions
informs IC of
actions taken in
response to recs
implements recs
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Areas of Concern
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Eligibility and general noncompliance
Overlap
Inadequate documentation
Award transfers
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Findings
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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
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Overlap
Budgetary
Commitment
Scientific
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Monetary Rewards for Publishing
~$30,000!
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Possible Solutions
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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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Actions We Take When We Find
Indicators of Possible Criminal Activity
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Fraud Indicators
 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
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Criminal Issues
DPI Contact Information
To report any concerns, please contact us.
Phone:
(301) 496-5586
Web site: http://oma.od.nih.gov
Mail:
National Institutes of Health
Office of Management Assessment
Division of Program Integrity
6011 Executive Boulevard
Suite 601, MSC 7669
Rockville, Maryland 20852
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