1. Presented by: Maritza Zeiberg, CPA,
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

2. 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 

3. 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

4. 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

5. DPI Authority
Misuse of Grant Funds– 45 C.F.R (e) - authority to conduct reviews of NIH grantees’ records and interview grantees’ personnel.
Misuse of Contract Funds– 48 C.F.R (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.

6. 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

7. 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

8. FY13 NIH Funding Research grants – $20.9 billion
Contracts – $4.3 billion
SBIR – $617 million
STTR – $80 million

9. Funding Environment
Twohy, Mike. “Defunding Increases Aggression.” Illustration. The New Yorker, May 9, 2011.

10. Sources of Allegations

11. Active Cases

12. Proportion of SBIR/STTR Cases

13. Review Process Notify IC and SBC Prepare Review Plan
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

14. 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

15. Sample Notification

16. Collaborative Review Process
DPI
Scientific
Grants
Contracts
Policy

17. Recommendations DPI NIH IC SBC initiate action with SBC
issues report w/recs
DPI
closes case
initiate action with SBC
NIH IC
informs DPI of SBC actions
implements recs
SBC
informs IC of actions taken in response to recs

18. Areas of Concern Eligibility and general noncompliance Overlap
Inadequate documentation
Award transfers

19. 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

20. Overlap
Budgetary
Commitment
Scientific

21. Monetary Rewards for Publishing
~$30,000!

22. 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

23. Actions We Take When We Find Indicators of Possible Criminal Activity

24. 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

25. Criminal Issues

26. DPI Contact Information
To report any concerns, please contact us.
Phone: (301)
Web site:
Mail: National Institutes of Health
Office of Management Assessment
Division of Program Integrity
6011 Executive Boulevard
Suite 601, MSC 7669
Rockville, Maryland 20852