RESEARCH

Tuesday, November 13, 2007
4:30 pm
Wolstein Research Building Auditorium, Room 1413

As part of the 5th Annual Inventors Forum, the Technology Transfer Office (TTO) will be presenting its second seminar of the academic year on November 13, 2007. This seminar will focus on patents, how the TTO determines what should be patented, and how patents protect intellectual property.

No registraion is required.

The Office for Human Research Protections is considering modifying the regulations for expedited review by institutional review boards. Specifically, they are seeking to clarify that one category of research eligible for this review "includes research involving materials that were previously collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research." In addition, OHRP is accepting comments on "the entire expedited review list that was last published in the Federal Register on November 9, 1998 (63 FR 60364)". Comments will be accepted until Dec. 26, 2007.

Link: http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-21126.pdf.

• Appendix A lists the chemicals of interest and the screening threshold quantities that trigger the need for compliance with CFATS. The material posted is a pre-publication copy of the final Appendix A for information purposes only. As DHS notes, Appendix A will become effective on the day it is published in the Federal Register. In an informational conference call with the Chemical Security Higher Education Working Group held on November 2, DHS indicated publication in the Federal Register will likely occur on November 16, 2007.
  


• Appendix A has been significantly changed with the deletion of some chemicals – notably acetone, urea, and carbon monoxide – the addition of numeric thresholds for all chemicals, a realignment of the chemical with the nature of the risk, etc. Members of the Campus Safety Health and Environmental Management Association (CSHEMA) are preparing a preliminary, general assessment of the changes in Appendix A to assist colleges and universities in determining how best to proceed.
  


• Inventory of Chemicals - With the publication of Appendix A, an institution will need to determine whether it holds the named chemicals of interest in the quantity, concentrations, and/or in the manner listed in Appendix A. This determination will likely involve an inventory of the institution’s chemical holdings, not only in laboratories but across the operations of the campus.
  
  Identifying and quantifying chemicals on campus will be difficult and time-consuming for those institutions without a current, comprehensive chemical inventory.
  


• Submission of a Top Screen - With the chemical inventory or survey in hand, the institution will need to determine how to represent its chemical holdings – if necessary – to DHS. If the campus holds chemicals of interest that meet DHS’ thresholds, the rule requires submission of the Department’s Top-Screen for each facility within sixty (60) days of Appendix A’s effective date – likely November 16, 2007. A facility is defined by the institution and how a facility is defined will affect the number of Top Screens that it submits.
  


• In the Final Rule, DHS notes that all organizations, including colleges and universities, have flexibility in “defining the boundaries of their facility” and can, “if appropriate, submit a Top-Screen on a building-by-building basis or a campus-wide basis.” (Final Rule, p. 66) A campus may define its facility as it sees fit – the entire campus, building-by-building or at an operational or laboratory, farm, etc., level.
  
  This decision is important. If DHS determines that the facility – as defined by the college or university – is high risk, the institution will be asked to prepare a security plan to minimize the risk for the defined facility. For example, if the chemical(s) of interest determined to be high risk are housed in a single building, the institution may elect to submit a Top Screen for that building as opposed to the entire campus. Thus, the resulting security plan will be prepared for that building rather than the entire campus.
  
  If the institution determines that it has no chemical inventory that exceeds the Top Screen thresholds then it does not need to proceed further and the process is finished. No further action is necessary.
  


• Extension Request - DHS is providing colleges and universities with an option to request an extension of time to complete and submit Top-Screens. A senior official – president, dean, provost, etc. – may request an extension for up to 60 additional calendar days. The Higher Education Working Group has prepared a standard template for an extension request that can be used by the institution. The template will be posted to the COGR website at: http://www.cogr.edu when Appendix A is published.
  
  Without an extension and assuming publication of Appendix A on November 16, 2007, Top-Screens, if necessary, would be due on January 16, 2008. An extension would push the deadline to March 16, 2008. With the rhythms of the academic calendar, institutions may want to request an extension to provide time for a thorough chemical survey or inventory.
  

• Inventory: The Chemical Security Higher Education Working Group with the leadership of CSHEMA will offer a general review and is crafting a survey mechanism for internal institutional use in conducting a preliminary inventory of the Appendix A Chemicals of Interest to assist universities in determining if, where, and in what quantities they hold chemicals listed on Appendix A. It will include Points to Consider to assist universities in determining effective ways for identifying a facility and, thus, organizing the Top Screen submissions.
  


• Alternate Security Plans: DHS believes that the rule’s provision for Alternative Security Programs (§ 27.235) is appropriate for the higher education sector. Because of the limited number of chemicals that will fall under the requirements and the discrete location of the chemicals, the security program may be different from the program described in the rules Site Security Plan section (§ 27.225).
  
  The Working Group is preparing guidance that will offer effective practices with regard to security plans with templates or exemplars that will be reviewed and, if appropriate, endorsed by DHS. Institutions will need to address the challenge of a security plan only after DHS has assessed the Top-Screen and assigned a risk-level to the facility that requires a security plan.