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Answers to Stakeholders' Questions

SCIENCE

Q. We have heard a great deal about the need to leverage the scientific resources of other government agencies, academia, industry. What specific plans do you have to maximize use of these resources?

A. Leveraging of resources with other government agencies, academia, and industry occurs on several levels and each requires a different approach.

Leveraging with individual scientists--Individual scientists in different government agencies and academia often leverage their resources by sharing experimental samples, reagents, unique equipment, and expertise. FDA is encouraging its scientific staff, both regulatory and research scientists, to participate in more scientific meetings and to develop collaborations with scientists outside the agency. FDA scientists are encouraged to hold adjunct appointments at numerous academic institutions that provide access to the institution's scientific expertise and often results in collaborative research projects, including joint applications for research funding. Academic appointments by FDA scientists often make available graduate students and postdoctoral appointees to supplement the FDA scientific staff.

Leveraging with other government agencies--Leveraging with other government agencies often takes the form of an Interagency Agreement (IAG). FDA will encourage an increased exchange of information with other government agencies by forming information exchange committees to encourage collaboration between agencies and to avoid duplication of effort. FDA will increase its efforts to keep abreast of new products being developed through research in other government agencies to maximize FDA priority setting, training of regulatory scientists, and to allow FDA to maintain the required up-to-date scientific expertise to regulate the emerging technologies. An increase in IAGs between FDA and other agencies to maximize the use of available resources of both agencies will be encouraged. New policies presently are being established to allow more rapid exchange between government agencies of unpublished data to avoid duplication of effort and to insure the availability of all pertinent data for regulatory decisions. FDA is currently developing a shared database with EPA concerning endocrine disrupters and additional shared databases with other agencies as well as industry will be encouraged.

Leveraging with industries--Passage of the Technology Transfer law has made it much easier for FDA to collaborate with private industry to leverage resources to solve problems of mutual interest. FDA will continue to encourage its scientific staff to seek collaborations with industry to provide FDA with additional scientific expertise, experimental equipment and laboratory facilities, as well as financial resources, to develop scientific data needed for regulatory decisions. In addition, FDA will encourage private industry to allow FDA staff much earlier access to information pertaining to development of new products. This will prevent unnecessary or inappropriate testing of products on the part of industry and will allow FDA to process applications for new products much faster and more efficiently by having been kept fully informed during the product development process.

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INSPECTIONS AND ENFORCEMENT

Q. Are there any plans to make all EIRs available on the web?

A. FDA currently does not routinely post EIRs on the Internet. FDA is considering ways to efficiently post EIRs that are "frequently requested" (a provision of the Electronic Freedom of Information Act Amendments of 1996).

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