Preparing CRADA Appendices
Components of Appendix A
The Research Plan must accurately reflect the goals and objectives of the participants, including the specific responsibilities of each party in carrying out the research plan. The Research Plan should specifically refer to the particular Institute or Center (IC) involved in the research, rather than making broader reference to "NIH," "PHS," or the "government."
Recommended elements include:
- Goals of the NIH IC, in this case, NIMH, and the collaborator, as well as the scientific importance of the project;
- Contributions of the IC and the collaborator, preferably listed in bullet format;
- An abstract of the Research Plan for public release that discloses no proprietary or confidential information;
- Related CRADAs, M-CRADAs, MTAs, Patent Applications and Patents; and
- A Conflict of Interest disclosure and assurance of "fair access."
This type of specificity in Appendix A provides for a focused research proposal that clearly states objectives, thereby reducing potential future misunderstandings between parties. It also facilitates "fair access" by assuring that research projects do not encompass all of a given laboratory's or investigator's research mission
Components of Appendix B
(Financial and Staffing Contributions of the Parties)
CRADAs need not include a transfer of resources. Nevertheless, it is still important to ensure that each party is willing to provide internal resources (for example, personnel, equipment, funds from the non-governmental collaborator, or space) to carry out the objectives outlined in the Research Plan. Where an exchange of resources does take place, the dollar amount of funds or other resources being transferred to NIMH and their allowable (or categorical) use within the CRADA must be clarified.
Categorical uses include:
- travel, and
* CRADA hires do not count against the NIH FTE ceiling.
Under the Federal Technology Transfer Act (FTTA) of 1986, as amended, the NIMH and its sister institutes are prohibited from transferring funds to the collaborator as a part of its CRADA contribution. Certain funds, namely Small Business Innovative Research (SBIR) funds may be used by a company to perform its part of the collaboration, but they may not be used to support the Federal laboratory portion of the research project by forwarding such funds to the laboratory.
"How to draft a Financial and Staffing Plan" (Appendix B)
Components of Appendix C
(Modifications to the Model CRADA)
Clinical Trial CRADA Terms
There are times when a collaborator will want to propose a modification to the text of the PHS model CRADA, available in full-text at this web site. Any proposed revision to a CRADA clause is presented in Appendix C of the model CRADA. Legal changes are negotiated between the NIMH Technology Transfer Office and a representative of the collaborator. All changes recommended must be within NIH and PHS policy and meet Federal legal requirements.