October 20, 1999

FDA’s Center for Devices and Radiological Health signed a Letter of Intent on October 18, 1999, to formally begin discussions and negotiations on a proposed collaborative project with the Cellular Telecommunications Industry Association (CTIA). Under the proposed collaboration, FDA would provide recommendations on research on the health effects of radiofrequency (RF) energy emissions of the type produced by mobile phones (including cellular phones and PCS phones) and scientific oversight of research based on these recommendations; the research would be administered and funded by CTIA.

The Agreement
On October 18, 1999, FDA and CTIA signed a Letter of Intent to formally begin discussions and negotiations on a collaborative project on the safety of mobile phones. A formal Cooperative Research and Development Agreement (CRADA) may be developed as a result of this effort. The Letter of Intent is not a commitment, however, by either FDA or CTIA to enter into a CRADA. The letter is effective for up to six months from the date it was signed. FDA and CTIA may agree to extend this term provided a formal CRADA is under negotiation.

The research to be planned is to be conducted by organizations other than CTIA, and will address the results of certain as yet unpublished studies previously conducted by the Wireless Technology Research, L.L.C. (WTR) with funding provided by CTIA. Given the potential significance of any research result showing a positive bioeffect finding, FDA and CTIA opted to use a Letter of Intent to allow an informal collaboration to begin even as a formal collaborative agreement is being developed in order to follow up on two of WTR’s studies. The processes to be set forth in the proposed CRADA are intended to ensure that the ensuing research is conducted in a way that promotes quality, scientific independence, integrity and efficiency.

In any resulting collaboration under a CRADA, FDA anticipates providing scientific and technical advice on the studies, and obtaining input from experts in government, industry, and private scientific and technical organizations. FDA expects to propose research questions and protocols for addressing these questions and evaluating the research during the studies and after completion, with the assistance of outside experts as needed. CTIA anticipates administering and funding the research to be conducted under any proposed CRADA, based on recommendations made by FDA and the scientific and technical experts.

Initial Research Under the CRADA
The first study to be conducted would follow up on the findings of studies previously conducted by WTR but not yet published using the micronucleus assay, a test which detects structural effects on genetic material. Research data in the literature from RF exposure studies using the micronucleus assay are conflicting, and warrant follow-up study.

A second portion of the research would follow up on the findings of some epidemiology studies previously funded by WTR. The initial goals are to identify the type of research that may be warranted and to establish the relative priority of those studies. As part of this effort, FDA expects to evaluate the need for participating in a multi-center case control study, such as that being coordinated by International Agency for Research on Cancer.

CRADA as a Mechanism for Collaboration
Established by the Federal Technology Transfer Act of 1986, and continued in subsequent legislation, a CRADA is a cooperative research and development activity under the terms of which the federal government, private sector, academic institutions and others may work collaboratively to meet each organization’s mission and primary goals. A CRADA is required whenever an exchange of material and/or information between the federal agency and the other parties takes place over a period of time for a collaborative purpose. Specifically, a CRADA is required when:

An interchange of ideas, staff, etc. is needed between FDA and the private sector/others. (As part of this interchange, the non-Federal collaborator may contribute money. The Federal agency contributes expertise, other resources, but not funding to the project.)

The collaboration will address an important or controversial issue for the FDA.

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