Contracting at a Federally Funded Research
and Development Center (FFRDC)
John Trifone
Director, Contracts & Acquisitions
Leidos Biomedical Research, Inc.
January 30, 2014
DEPARTMENT OF HEALTH AND HUMAN SERVICES • National Institutes of Health • National Cancer Institute
Frederick National Laboratory is a Federally Funded Research and Development Center operated by Leidos Biomedical Research, Inc., for the National Cancer Institute
Discussion Points
• Defining an FFRDC
– What is an FFRDC
– Key FFRDC Characteristics
– How does an FFRDC meet the needs of the Nation?
– Overview of the FNLCR FFRDC
• How does the FNLCR FFRDC differ from other FFRDC’s
• FNLCR Use of Cooperative Research and Development
Agreements (CRADA)
• Subcontracting environment at an FFRDC
– Who does the FFRDC subcontract for
– What challenges does this provide
Frederick National Laboratory for Cancer Research
Overview of a Federally Funded
Research and Development Center
Federally Funded Research and Development Centers
(FFRDC) means activities that are sponsored under a
broad charter by a Government Agency (or agencies) for
the purpose of performing, analyzing, integrating,
supporting, and/or managing basic or applied research
and/or development, and that receive 70% or more of
their financial support from the Government.
(excerpted from FAR 2.101)
Frederick National Laboratory for Cancer Research
Key FFRDC Characteristics
1. A long-term Government/contractor relationship is
contemplated.
2. Most or all of the facilities are owned or funded by the
Government.
3. The contractor has access to
Government data, employees, and
facilities beyond that common in a
typical contractual relationship.
4. Operates in the public interest with
objectivity and free of organizational
conflicts of interest.
Frederick National Laboratory for Cancer Research
Key FFRDC Characteristics (Cont’d)
5. The FFRDC may perform work for other than the
sponsoring agency under the Economy Act or other
applicable legislation.
6. The FFRDC status requires the contractor to meet the
sponsor’s rapidly changing needs by attaining a level of
flexibility, creativity, and responsiveness that cannot be
achieved as effectively by other government
components or through other Government mechanisms.
7. FFRDC’s are operated, managed, and /or administered
by either a university or consortium of universities, other
not-for-profit or non profit organizations, or an industrial
firm, as an autonomous organization or as an
identifiable separate operating unit of a parent
organization.
Frederick National Laboratory for Cancer Research
Key FFRDC Characteristics (Cont’d)
The FFRDC provides the Sponsor a unique structure which facilitates:
–Flexibility – the FFRDC provides for broad latitude in how the work
is performed (in-house vs. subcontracts).
–Rapid Response - new or cutting-edge projects can be
accomplished more expeditiously because of the FFRDC broad
charter and access to Government personnel.
–Increased Efficiency – the FFRDC maintains a staff of highly
trained professionals. New work can be added without incurring
additional indirect costs; infrastructure costs; or fees for contract
administration, management and oversight.
–Accountability – FFRDC is generally a performance-based
contract (i.e. contactor profit is tied directly to performance).
Frederick National Laboratory for Cancer Research
FFRDC Restrictions
• FAR 35.017-1(c)(4): Prohibits the FFRDC from competing with
any non-FFRDC concern in response to a federal agency
request for proposal
• FAR 35.017(a)(2): The FFRDC must operate in the public
interest with objectivity and independence and free of any
organizational conflict of interest
Frederick National Laboratory for Cancer Research
How can the FFRDC more effectively
serve the needs of academic, industry,
and the Small Business Community?
• Improve access to the advanced technologies, including;
– Genomics and next generation sequencing
– Protein chemistry and proteomics
– Imaging (molecular, cellular and small animal)
• Improve access to clinical trials resources, including;
– Biopharmaceutical development/production
– Nanotechnology characterization
– Standardized clinical assays
• Develop a national training program in advanced technologies, biopharmaceuticals
and clinical assays
• Provide a more robust beta-test program for the development of new technologies
• Facilitate the use of public-private partnerships to expedite the development of novel
agents for the prevention, diagnosis and treatment of cancer and AIDS
Frederick National Laboratory for Cancer Research
Examples of How the FNLCR FFRDC is
Meeting the Needs of the Nation
• Nanotechnology Characterization Laboratory (NCL)
• Biopharmaceutical Development Program (BDP)
• Advanced Biomedical Computing Center (ABCC)
• Vaccine Clinical Materials Program (VCMP)
• National Community Cancer Centers Program (NCCCP)
• NCI/NIGMS Beamline Project
• NCI Biospecimen Resources Network (BRN)
• Mouse Models of Human Cancer Consortium (MMHCC)
• Cancer Bioinformatics Grid (caBIG)
• The Cancer Genome Atlas Project (TCGA)
• Therapeutically Applicable Research to Generate Effective
Treatments (TARGET)
Frederick National Laboratory for Cancer Research
Other Examples of How the Frederick
National Laboratory for Cancer Research is
Meeting the Needs of the Nation
• Provided basic and clinical research services to 25 of the 27 NIH ICs
• Provided advanced technology expertise and support to the DHS, DoD, FDA
and USDA
• Executed more than 3,900 material transfer agreements and 30
collaborative research agreements with numerous universities and industry
collaborators
• Filed more than 50% of NCI’s invention reports
• Produced over 60 novel biopharmaceutical products and vaccines through
two cGMP manufacturing programs
• Supported over 350 NCI and NIAID-sponsored clinical trials to test
innovative cancer and AIDS treatments
• Acquired over 1.5 million clinical samples and stored over 2 terabytes of
patient data in support of cancer and AIDS clinical trials worldwide
• Provided advanced biomedical computing expertise and support every year
to >1,800 users as one of the world’s largest computer resources dedicated
to biomedical research
Frederick National Laboratory for Cancer Research
Overview of Frederick National
Laboratory for Cancer Research
• FNLCR is the Federally Funded Research and Development Center
– Established in 1972
– Only FFRDC dedicated to biomedical research
• Proudly operated by Leidos Biomedical Research, Inc. (formerly SAICFrederick, Inc.) on behalf of the National Cancer Institute
• Main campus on 70 acres at Fort Detrick
– Co-located with intramural NCI researchers and other NCI activities
• The FFRDC Contractor maintains several offsite locations including the
Advanced Technology Research Facility (ATRF) off Gas House Pike
(~300,000 sq ft research facility) and the Vaccine Pilot Plant (located off of
Rt 85)
Frederick National Laboratory for Cancer Research
Overview of Frederick National
Laboratory for Cancer Research
Mission:
Provide a unique national resource for the development of new
technologies and the translation of basic science discoveries into
novel agents for the prevention, diagnosis and treatment of cancer
and AIDS.
Frederick National Laboratory for Cancer Research
The FNLCR - A Unique National
Resource
Meeting the most urgent biomedical research
needs of the nation, including:
– The NCI
– Other NIH institutes
– Other government agencies
– Extramural investigators
– NCI corporate partners
Frederick National Laboratory for Cancer Research
Fundamental differences between DOE
FFRDC’s and the FNLCR FFRDC
•
DOE Laboratories and academia provide the science for all DOE’s needs
–
•
DOE Laboratories compete with each other for much of their funding
–
•
FNLCR has no comparable facility use program
DOE Laboratories have access to Congressionally-mandated Lab-directed
Research and Development funds (LDRD) via a 3% to 6% “tax” on all
expenditures
–
•
As the only NIH FFRDC for biomedical research, FNLCR does not directly compete with other
National Laboratories for NIH funding
Many DOE Laboratories offer “Facility Use Agreements” which is functionally
unique, sustainably funded and draws users from the external research
community to the National Laboratory
–
•
The NIH and NCI have robust intramural science programs
No formal “LDRD” at FNLCR (refer to cCRADA program noted later in this presentation)
DOE has received statutory authority to conduct a “Work for Others” program
that allows for extensive collaboration with outside sources (non-federal) and
receipt of funds to cover cost for performance of services
–
NCI does not have the requisite authority but the FFRDC does have CRADA (Cooperative
Research and Development Agreement) authority.
Frederick National Laboratory for Cancer Research
Some examples of how DOE FFRDC
Laboratories operate
•
Lawrence Berkley National Laboratory (University of California –Berkley)
–
$124M in “Work for Others”
–
Supercomputer, Molecular Foundry, Bioenergy
•
–
•
Access is free if you publish, otherwise cost recovery
15,000+ scientific visitors per year
Lawrence Livermore National Laboratory (Joint LLC Bechtel/Univ. of California)
–
High performance computing and laser (500 terawatts) facility are main draw for external resources
•
Extensive use of:
– cCRADA (Contractor Cooperative Research and Development Agreement)
– Work for Others
– Advancing Commercial Technology (ACT)
» Contracts with partner directly and accepts liability and risk for delivery; no government
involvement or reach-in
– Licenses technology to enable startups
•
Sandia National Laboratory (Sandia Corporation – wholly owned subsidiary of Lockheed
Martin)
–
Core missions – ensure nuclear weapon stockpile is safe, secure, and reliable
•
Operates Combustion Laboratory, which provides sustained funding
•
Highly entrepreneurial
Frederick National Laboratory for Cancer Research
Federal Technology Transfer Background
• Federal national laboratories exist to:
– Foster technology development and technology transfer to private sector
– Promote knowledge and resource sharing
– Advance national competitiveness
• Laws and policies enacted supporting federal technology transfer (examples):
– Federal Technology Transfer Act (1986)
 All federal laboratory scientists required to consider TT an individual
responsibility
– Executive Order 12591 (1987)
 Ensure that federal laboratories assist universities and private sector by
transferring technical knowledge…establish industrial extension services…
– National Competitiveness Technology Transfer Act (1989)
 Extends CRADA authority to government-owned, contractor-operated
(GOCO) laboratories
Frederick National Laboratory for Cancer Research
Expanding the Partner Base at the FNLCR
through Contractor Cooperative Research
and Development Agreement (cCRADA)
A Cooperative Research and Development Agreement (CRADA) is a type of
agreement that enables industry, academia and other nonprofit entities to
collaborate with the federal government and/or the federal laboratory in
mutually beneficial joint research and development activities. Although NCI
researchers at FNLCR have been able work with outside entities under a NIH
CRADA, Leidos Biomedical Researchers working at FNLCR have been unable
to do so without the participation of an NCI researcher as lead investigator or in
direct support of NCI research. The approval to allow Leidos Biomedical
Researchers to enter into CRADAs (Contractor CRADA or cCRADA) without
NCI participation in the research is a unique opportunity for Leidos Biomedical
researchers to become engineers in the innovation process by expanding
collaborative opportunities and enhancing the existing technology portfolio.
Frederick National Laboratory for Cancer Research
Contractor CRADAs:
Accelerates Fed Lab Model, Adds Flexibility
• Benchmark: NCI (Government) CRADAs—key elements as a business mechanism
– Partner receives advanced promise to Intellectual Property (IP) resulting from
CRADA work
o However, terms cannot be pre-negotiated
– $$ can flow into NCI for CRADA work
• Contractor CRADA authority offers key advantages:
– Leidos Biomedical Research can establish CRADAs with partners directly (no NCI
investigator involved)
– Partner receives advanced promise to IP resulting from CRADA work
– Leidos Biomedical Research can pre-negotiate IP terms with partner (private sector
+++)
– $$ can flow directly into Leidos Biomedical for CRADA work
– TSAs (simplified Materials-CRADA) enable extramural access to unique services
– Local (FNL) agreement processes will speed-up administrative approvals
Frederick National Laboratory for Cancer Research
Contractor CRADAs:
Accelerates Fed Lab Model, Adds Flexibility
• Enables Leidos Biomedical Research to partner directly with
extramural scientists and organizations for access to our science and
technology know-how
• Use full CRADA authority under CRADA statutes
• c-CRADAs for Research, Development, and Testing collaborations
• “Technical Service Agreement” for tactical evaluation of proprietary partner
materials, AIDS testing kits, etc.
• Intellectual property rights
– Leidos Biomedical is the custodian of joint or sole IP emerging from the CRADA
–
•
•
Streamlined assignment of exclusive commercialization rights
Any royalty streams support FFRDC R&D efforts
Processes
–
Focus on speed
–
Local government review and approval with external input as appropriate
Frederick National Laboratory for Cancer Research
Contractor CRADAs
•
Technical Service Agreement (TSA)
– Pre-approved service
– Requires
• Cost Estimate
• Signed Agreement by the Outside Party and Dr. Heimbrook
• Receipt of Funds Prior to Beginning Work
•
CRADA
– Requires
• Completion of a Concept Approval Form for review by the Strategic Business
Development Team (SBDT)
• Approval by the NCI Program
• Approval by the NCI Management Operations and Support Branch (MOSB)
• Receipt of Funds (Milestone Payment) Prior to Beginning Work
Frederick National Laboratory for Cancer Research
Accelerating progress against Cancer and
AIDS
FNLCR Collaborators
Public Sector
Private Sector
• Federal, state, and
local government
• Academia/Grantees
• Technology incubators
• Pharmaceutical firms
• Top-tier biotech
and IT firms
• SBIR/STTR recipients
• Equipment and device
manufacturers
FNLCR
FFRDC
Partnerships
Frederick National Laboratory for Cancer Research
Accelerating progress against Cancer and
AIDS
We have essential
capabilities…
…integrated into a brand new state-ofthe-art Research Facility
Genetics and
Genomics Proteins
and Proteomics
Integrated in vivo
Services Imaging
and
Nanotechnology
Advanced
Biomedical
Computing
Advanced Technology
Research Facility
Opened June 2012
Frederick National Laboratory for Cancer Research
Subcontracting Environment at the
FNLCR FFRDC
• The FFRDC Contractor supports the entire facility (GOCO) to
include infrastructure support, laboratory operations and
maintenance, supply chain operations, security, operation of
onsite Occupational Health clinic, etc.
• These functional responsibilities include those for other onsite
contractors as well as the on site Government employees
• Subcontracting/outsourcing plays a large role in the day to day
operations of the facility
• Requires:
– Quick reaction
– Reasonable Cost solutions
– Timely delivery of products and services
What does an FFRDC Subcontract for?
• Commercial goods/services (primarily FAR Part 12/13)
– Laboratory equipment and supplies
– Biomedical materials
– Animals and animal supplies
– Testing services
– Maintenance and repair services
– Motor vehicles
– Furniture (office and laboratory)
– Office supplies/general administrative supplies
– Cleaning/Janitorial supplies
Frederick National Laboratory for Cancer Research
What does an FFRDC Subcontract for?
• Research and development services and subcontracts (primarily FAR
Part 15)
– Vaccine development, pharmaceutical development and manufacturing,
R&D services (cGMP)
– IT support services
– Biomedical research services
– Tissue specimens, cell production services, and DNA sequencing
– Consultant services (scientific and administrative)
• Construction services (FAR Part 36)
– General contractor services for new construction and renovation
activities (all trades)
– Architect and engineering services
– Demolition services
Frederick National Laboratory for Cancer Research
What challenges arise for FFRDC
Subcontracts?
• FAR 35.017 (a)(2) states (in part) “An FFRDC...has access,
beyond that which is common to the normal contractual
relationship, to Government and supplier data, including
sensitive and proprietary data..”
– While the FFRDC contractor is responsible for conducting the
acquisitions, the Government may play a large role in the
development and ongoing performance of subsequent awards
– With respect to the NCI FFRDC Contract, Leidos Biomedical
Research operates under a Determination of Exceptional
Circumstances (DEC) from the Bayh-Dole Act which requires all
Intellectual Property “conceived or first reduced to practice” to be
assigned to the NCI unless performed under subcontract by a
small business or academic institution.
Frederick National Laboratory for Cancer Research
What challenges arise for FFRDC
Subcontracts? (Cont’d)
– Many laboratories require product consistency during unique
research experiments which requires specific vendor/products be
provided
– Approval of final subcontract deliverables may not rest solely on
the contractor but with the Government as well
– On site construction/renovation does not follow city/county codes
• Does fall within the NIH Design Requirements Manual
– Defines detailed design requirements and guidance
manual for biomedical research laboratory and animal
research facilities
– Subcontractor design and construction will be required to
fall within these guidelines unless otherwise waived by the
Government
Frederick National Laboratory for Cancer Research
What challenges arise for FFRDC
Subcontracts? (Cont’d)
– Prime contract requires background checks on subcontractor
employees
– The FFRDC Prime Contract does include a Small Business
Subcontracting Plan
• Currently exceeding goal for small business overall
– Challenges include sourcing within the HubZone, Veteran
Owned and Service Disabled Veteran Owned Businesses
• Firms in certain socio-economic categories unable to provide
the unique products or services needed at the FFRDC
• Competing with other small business firms or large
businesses that have acquired distributorships
Frederick National Laboratory for Cancer Research
What challenges arise for FFRDC
Subcontracts? (Cont’d)
– Require quick reaction to proposal requests
– Competitive pricing and delivery
– Innovative ideas/solutions
– ETHICS ARE PARAMOUNT
Frederick National Laboratory for Cancer Research
Conclusion
• FFRDC Contracts are not your standard prime contracts
• Autonomy and Free from Conflicts of Interest
• Contracts not to be viewed as a regular P&L contract but
rather solving a needed mission of the Government
• Provide access to the scientific/technology community to
national resources
QUESTIONS?
Frederick National Laboratory for Cancer Research