Safety - Frequently Asked Questions

Q. For Safety, I am a small business and will not use etiologic agents or do any laboratory bench work whose role is simply the establishment of a computerized network. Is it still necessary to submit the safety appendix?

A. There are two things to consider when complying with the Facility Safety Plan request. Number one, if your institution has a pre-approved Facility Safety Plan listed on our safety web page listing. Number two, consider the type of research performed at your institution as a whole (not proposal based). As is normally the case with small businesses, depending on the type of research conducted at your institution you may not be required to submit a Facility Safety Plan. Here are the main reasons for safety approval with no laboratory safety research below.

• Research involving medical devices
• Developing an imaging device
• Data collection involving software development
• Medical testing using virtual software
• Merely an administrative review
• Collaborator without research laboratory
• Research being conducted at an approved facility

In both the instances where your institution has a pre-approved Facility Safety Plan listed on our safety web page listing, or your institution has no laboratory safety research for reasons mentioned in the list above, please list the dates of approval (if applicable) and submit only a Principal Investigator Assurance in response to your recommended for funding letter.

Q. If a subcontractor does not handle any etiological agents (see list from 42CFR72.3, http://www.cdc.gov/od/ohs/biosfty/shipregs.htm) do we need to submit a Facility Safety Plan? According to 32CFR626.16(c), we may not have to as a contractor.

A. In order to answer this question,please state if the subcontractor will be doing any laboratory bench work of any kind in association with this upcoming contract, or is the subcontractor's role simply the establishment of a computerized network between your company and a subordinate laboratory to track different strains of biological warfare agents (BWAs)? Specifically, will all the "laboratory bench work" of identifying the BWAs (e.g. anthrax, botulinum toxin, smallpox, etc.) be done at the subordinate laboratory and the computerized networking and strain tracking be done by the subcontractor?

Q. Does a subcontractor need to comply with 32CFR626 & 627 - Biological Defense Safety Program and Technical Requirements, or is this for Military Facilities/Labs?

A. That depends upon your answers to the above mentioned question.