FDA laboratories are interested in working with non-Federal parties to collaborate in developing and moving new technologies to market. The CRADA is an essential tool for establishing such collaborations.
FDA advertises opportunities to license or collaborate in developing its technologies. Questions about these collaborative opportunities or the licensing of FDA technologies should be directed to the Technology Transfer Program.
The CRADA is an agreement under which the FDA laboratory contributes personnel, services, facilities, equipment, or other resources--but not funding--toward the conduct of specified research or development efforts. The CRADA partner contributes any necessary funding to the project as well as personnel, services, facilities, equipment, or other resources.
The CRADA provides the non-Federal collaborator with the option to negotiate an exclusive or non-exclusive license to any CRADA Subject Invention that results from the research. The CRADA is the only agreement that permits a license option to intellectual property developed during a collaborative research project.
1. CRADAs are appropriate only with collaborators who will make significant intellectual contributions to the research project or who 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 or research with no collaborative intellectual contribution by both parties is not appropriate for a CRADA.
2. In considering a proposed CRADA, FDA must determine if the objectives of a proposed collaboration warrant the establishing a CRADA or if its goals are more appropriately met through a procurement contract, Material Transfer Agreement, Cooperative Agreement or other contractual mechanism.
3. A CRADA’s sole purpose 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.
4. 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 CRADA research. FDA scientists may have conflicts of interest, in that they are also regulatory reviewers or have authority over regulatory decisions in a product area that overlaps the subject of the CRADA 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.
5. Reasonable confidentiality requirements and brief delays in disseminating research results are permitted under a CRADA, as necessary, to protect proprietary materials and intellectual property rights.
6. FDA takes steps to 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 United States, and agree to manufacture in the United States products developed under the CRADA. Fair access to CRADAs is not considered to mean the same thing as the term "open competition," as defined for contracts and small purchases.