A -- Institutional Review Board Services - Increase Scope of Work

The Environmental Protection Agency (EPA) intends to negotiate on a sole source basis with the University of North Carolina ? Chapel Hill (UNC-CH), Office of Human Research Ethics, Chapel Hill, NC 27599, to expand the scope of contract EP-D-06-101 to provide Institutional Review Board (IRB) services for Human Research for the entire agency. The services required are essential for research experiments involving human subjects. The contractor shall serve as the designated IRB of record; provide review and oversight of EPA's human subject research; coordinate with and establish IRB authorization agreements; provide consultation to EPA staff; and provide training for EPA staff related to ethics and other topics relevant to conducting human research. The remaining period of performance is potentially 3 ? years including optional periods. The vast majority of the Agency's human studies are conducted on the UNC campus, and research protocols for those studies must be reviewed and monitored by a UNC IRB to ensure compliance with UNC policy of on-campus research involving UNC staff. The expansion in scope of contract EPD06101, to include all of EPA's IRB requirements, will not significantly increase the total number of new IRBs required under the existing contract. Unrelated to the expansion issue, there is also a proposed increase in historical volume in the area of IRB modifications, from 30 to 50 annually, to more correctly align the statement of work with more recent actuals encountered during the first 18 months of the existing contract. EPA believes that expanding the existing contract to include all its IRB requirements is in the best interest of the Agency because this action will make the process consistent and cost effective. All interested parties who believe they can provide the required services shall fully explain their capabilities and qualifications in writing within 15 days from the date of this announcement. The North American Industry Classification System (NAICS) Code 541690, which has a small business size standard of $6.5 million, is applicable. The intent of this synopsis is to determine if any source(s) exist, and therefore, no solicitation (RFQ) is available. Consequently, any response(s) failing to provide the aforementioned data but instead choosing to merely submit a routine letter requesting a copy of the RFQ will not be honored. Submit responses via US Mail to the U.S. EPA, Attn: Will Goins (E105-02), RTP Procurement Operations Division, Research Triangle Park, NC 27711. Not telephonic or faxed requests will be honored. Point of Contact WILL GOINS, Contract Specialist, Phone: 919-541-3567, E-Mail: [email protected]; MCDONALD MORRISON, Contracting Officer, Phone: 919-541-4364, E-Mail: [email protected] Email your questions to WILL GOINS at [email protected]