National Institutes of Health

1
National Institutes of Health

• Small Business Innovative Research Programs
• Kathleen J. Shino, MBA
• Lead SBIR/STTR Grants Management Specialist
• National Cancer Institute
• [phone] or shinok_at_mail.nih.gov

2
Award Mechanisms

• Grants
• Assistance mechanism
• Government is a partner/patron
• Purpose is to support and stimulate

• Contract
• Acquisition instrument
• Government is a purchaser
• Purpose is to acquire goods or services

3
Award Mechanisms

• Grants
• Benefit a public purpose
• Investigator initiated research
• Cost reimbursed

• Contracts
• Benefit the government directly
• Government initiated
• Fixed price contract

4
Roles And Responsibilities

• Institution
• Accepts award made to the organization
• Assumes legal responsibility for project
• Assures compliance with federal regulations,
  policies and procedures
• Assures proper conduct of project
• Oversees administrative and fiscal management of
  project

5
Roles And Responsibilities

• Principal investigator (PI)
• Employee of the small business (SBIR)
• Responsible to the grantee organization
• Responsible for
• Scientific direction of the project
• Fiscal management of the project

6
NIH Staff Roles And Responsibilities

• Program administrator/director
• Monitors programmatic/scientific aspects of the
  project
• Grants management officer
• Monitors fiscal aspects of the project
• Assures compliance with federal regulations,
  policies, procedures and terms of award

7
Preaward Review
8
Financial Management Systems

• Accounting system
• General ledger to track direct and indirect costs
• Project ledger to track direct project costs by
  category
• Time and effort system to track personnel costs
• Financial evaluation information available on NIH
  SBIR website
• http//grants.nih.gov/grants/funding/sbir.htmfine
  val

9
Financial Management Systems

• Financial capability
• Annual financial statements
• Balance sheets
• Income statements
• Audits
• Budgetary controls
• Track expenditures against budget and/or funded
  categorical amounts

10
Financial Management Systems

• Federal Administrative Requirements (45 CFR 74)
  
• NIH Grants Policy Statement
• Internal controls
• One person should not have control over all
  aspects of the accounting system
• Third party contracts should require billing and
  reports prior to payment

11
Notice Of Grant Award

• Legally binding document
• Establishes funding level
• Establishes period of support
• Sets forth terms and conditions of award
• Provides NIH contact information
• Program director
• Grants management specialist

12
Post Award Administration

• Accountability
• Progress report
• End of Phase I or as part of Phase II application
• Invention reporting
• Technical site reviews by NIH
• Program officials to verify resources and
  environment
• Grants managers to assure financial mgmt
  systems

13
Post Award Administration

• Prior approval from NIH required?
• Change of principal investigator
• Change of scope
• Change of grantee organization
• Phase I
• Certain rebudgeting actions
• Extension of project period

14
Post Award Administration

• Phase II
• Expanded authorities
• Grantee may extend project period up to 12 months
  - send letter to NIH before end date
• Automatic carryover of funds from year 02 to 03
  (explain significant carryover to NIH)
• Significant rebudgeting may mean change in scope
  if gt25 of total costs awarded

15
Post Award Administration

• Prior approvals- Phase I and Phase II
• All requests for project changes must be
  submitted in writing and must be signed by the PI
  and business official (send to GMO and PD)
• Change in name of business, mergers or
  successor-in-interest--
• Must notify NIH
  immediately

16
Reporting Requirements

• Phase I - 90 days after end of project period
• Final progress report if Phase II application is
  not submitted
• Financial status report (SF 269A)
• Invention Report http//www.iedison.gov/timeline.h
  tml

17
Reporting Requirements

• PHASE II - must apply for continuation funding
• Streamlined non-competing award process (SNAP)
  PHS form 2590
• Progress report prior to award of second year
• Other information required only if there are
  significant changes

18
Reporting Requirements

• Final reports - end of Phase II
• Due within 90 days of project end date
• Final Financial Status Report (PHS 269A)
• http//www.whitehouse.gov/OMB/grants/sf269a.pdf
• Final progress report
• Final invention statement
• http//www.iedison.gov/timeline.html

19
Electronic Research Administration

• Electronic awards
• Electronic progress reports
• Electronic NIH guide for grants and contracts
• Electronic application submission
• http//www.nih.gov/

20
Conclusion

• NIH - small business
• Partnership
• Keep your NIH partners informed -- let us know
  about your successes!
• Keep those applications coming
• We LIKE innovative ideas