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 the project.
- CRADAs involve collaborative research which may result in the further development of government inventions. The Model CRADA and Model PHS 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 assessed.
- 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 considerations.
- 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.