FDA Cooperative Research and Development Agreement (CRADA)
Policies and Points to Consider
A CRADA is an agreement between one or more FDA laboratories and one or more
non-Federal parties under which the FDA laboratory provides personnel, services,
facilities, equipment, or other resources toward the conduct of specified research
or development efforts. Such research must be consistent with the mission of
the laboratory. The CRADA partner contributes all of the above and funding to
- CRADAs involve collaborative research which may result in the further development
of government inventions. The Model CRADA (available both in PDF
and Word 97 formats) and Model
Material Transfer Agreement are standard documents which facilitate the
negotiation and approval process.
- In considering a proposed CRADA, FDA must determine if the objectives of
a proposed collaboration warrant the establishment of a CRADA or if its goals
are more appropriately met through a procurement contract, Material Transfer
Agreement, Cooperative Agreement or other contractual mechanism. Also, the
proposed collaborator's scientific and business capabilities will be
- A CRADA is not intended to be a general funding mechanism. CRADA-derived
funds are to be used for costs associated with the project specified in the
CRADA. Laboratories must be prepared to address the impact on the ongoing
research if a CRADA and related financial support is terminated unexpectedly.
- The sole purpose of a CRADA cannot be to support post-doctoral fellows and/or
technicians, to obtain funds, or to purchase equipment and/or supplies. Conversely,
the sole justification of a CRADA cannot be for an FDA laboratory to conduct
research or tests for the collaborator.
- Reasonable confidentiality requirements and brief delays in dissemination
of research results are permitted under a CRADA, as necessary, in order to
protect proprietary materials and intellectual property rights.
- CRADAs are appropriate only with collaborators who will make significant
intellectual contributions to the research project or will contribute essential
research materials or technical resources not otherwise reasonably available
to FDA. CRADAs cannot attempt to direct or restrict research in an FDA laboratory.
Routine, conventional testing, with no collaborative intellectual contribution,
is not appropriate for a CRADA.
- FDA scientists may have conflicts of interest, in that they serve as a project
officer on a contract or have authority over funding decisions in the course
of their research. Any conflict of interest--actual or apparent--must be addressed
in the review and approval of CRADAs along with any other conflict of interest
- FDA will ensure that outside organizations have fair access to collaborative
opportunities, the licensing of federal technologies, and FDA scientific expertise,
while giving special consideration to small business and preference to those
that are located in the U.S., and agree to manufacture in the U.S. products
developed under the CRADA. Fair access to CRADAs is not to be considered as
synonymous with the term "open competition," as defined for contracts
and small purchases. Evidence of fair access or discussion of unique resource
requirements should be part of the official CRADA file.
PDF documents may be read with a free copy of the Adobe
Microsoft Word files can be viewed with that application or with
viewer available free from the Microsoft Web Site.