Folic Acid Supplementation and Semen Quality Trial (FASST), Trial Clinical Centers

THIS IS A MODIFICATION TO THE NOTICE PUBLISHED APRIL 20, 2011. THE RFP ISSUE DATE AND THE ANTICIPATED RFP DUE DATE HAVE BEEN CHANGED. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to solicit proposals to award a contract for a clinical trial coordinating center to coordinate and monitor a multi-center, double-blinded, randomized controlled clinical trial to assess the effects of folic acid and zinc sulfate supplementation on semen quality and fertility treatment outcomes among males of couples seeking fertility treatment. It is anticipated that any resultant contract(s) will be a cost reimbursement contract with options with a performance of five years. Further details will be provided in the Request for Proposals (RFP) to inform interested Offerors of an overview of the type of contract to be awarded. NICHD is looking for potential sources that can demonstrate and document experience in recruitment, monitoring, and retention of multi-site clinical trials among couples undergoing fertility treatment. The contractor should have the infrastructure in place to manage and monitor the proposed research study and provide oversight and quality control to recruit approximately 2400 couples over 3.25 years (over 5 years of performance) and data collection at baseline and during follow-up. The Contractor shall serve as a fertility clinic site or subtract with fertility clinic sites with large patient volumes of couples undergoing fertility treatment (at least 800 per year) in order to reach the proposed recruitment schedule. Recruitment will be monitored by phases to ensure that at each phase the recruitment target has been met. The contractor should demonstrate experience in scientific clinical trials management, training, and current in-house capability and capacity to perform the work. Overall, the contractor will be responsible for: supporting development, implementation, recruitment, coordination and monitoring of the trial. The RFP is anticipated to be posted on or about August 30, 2011 on FedBizOpps (FBO) website: http://www.fedbizopps.gov. The due date for submission of proposals in response to the RFP is anticipated to be on or about November 1, 2011. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541712. Any questions concerning this announcement must be submitted in writing to Lynn Salo at ls59u@nih.gov, or Contracting Officer or Elizabeth Osinski, Contracting Officer, at eo43m@nih.gov, or addressed to, NICHD Contracts Management Branch, Office of Acquisitions, NICHD, NIH, 6100 Executive Boulevard, Room 7A-07, MSC 7510, Bethesda, Maryland 20892-7510 (if hand-delivered or sending by delivery service--6100 Executive Boulevard, Suite 7A-07, Rockville, Maryland 20852). No collect calls will be accepted. This is not an RFP and this announcement does not commit the Government to award a contract. The reference number to be used for this announcement is: RFP NIH-NICHD-DESPR-2011-02. All correspondence must cite the reference number as provided.