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Presented by: Maritza Zeiberg, CPA,

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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

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

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