To: FDADockets@OHRM-MAIL@FDAOC From: Certify: N Subject: Comments for 98N-339N_WC36 Date: Thursday, September 10, 1998 at 9:16:09 am EDT Attached: None Comments: September 9, 1998 Docket Number 98N-0339 Food and Drug Administration Room 1061, Mail Stop HFA-305 5630 Fishers Lane Rockville, MD 20852 To Whom It May Concern: I appreciate the opportunity to submit comments regarding the role of NCTR as part of the FDA Modernization Act of 1997. I served as the consumer representative to the NCTR's Science Advisory Board for 4 years, and served as Chair of a Site Visit Team and member of two other Site Visit Teams to NCTR during that tenure. Therefore, my comments reflect my experiences and knowledge gained of NCTR. 1. I believe strongly that maintenance of a solid basic (and applied) research foundation within FDA is vital for continued science-based support of its regulatory processes. In addition, it keeps the agency current with the needs of the industry and is in the best interests of the public. In-house scientists should continue to strive for a strong, state-of-the-art hypothesis or mechanism-based research program, while maintaining their awareness of key FDA regulatory issues. In my mind, a prime example of this research strategy continues to be the research program at NCTR. 2. A key question that arises in times of dwindling fiscal resources, is whether some current in-house research activities should be discontinued and have the same research contracted through outside laboratories? I have never been in favor of this approach, particularly for a regulatory agency where the potential for conflicts of interest is high. In addition, once in-house research expertise is lost, it is extremely difficult to regain and much time is lost in trying to re-establish any research area. In addition, outside contractors often have their own agendas and the work they perform may not exactly fulfill the needs of the FDA. Therefore, I would favor NCTR trying to maintain its current levels of expertise. 3. Related to item 2 above, I am also not in favor of spreading in-house research activities too thin. Rather, I would favor NCTR working together with its Science Advisory Board and advisors within other FDA centers, to prioritize its research efforts, putting more resources in areas of greatest need to the FDA. These priorities can then be reviewed every 2-3 years as needed, to evolve with the changing needs of the agency. In summary, NCTR is a wonderful resource to the FDA, comprised of many scientists highly respected in their fields. The center should realize that it will not be able to address all areas of research that may be of interest to the FDA. However, by focusing on its core areas of expertise and prioritizing its research efforts, NCTR can continue to help meet the regulatory needs of the FDA. This ultimately benefits industry and the consumer. Sincerely, Michael Dubick, Ph.D. Signature: Dr. Michael Dubick Submitter: USAISR and Univ Texas Health Sci Ctr E-Mail: Michael.Dubick@cs.amedd.army.mil Keywords: I_SciInfra_Research,Q_SciTechExp