The purpose of this modification/amendment is to insert item 9 under the list of the Study Centers below which was omitted inadvertently. There are no other changes to this NOTICE OF INTENT by this modification/amendment. THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute of Child Health and Human Development (NICHD) serves as the lead agency for the National Children's Study (NCS or Study), a longitudinal cohort study that will examine the effects of environmental influences on the health and development of approximately 100,000 children. Additional background about the Study is available on the Study's Website (www.nationalchildrensstudy.gov) The NICHD intends to negotiate, on a sole source basis, follow-on contracts with 17 of the current Wave I NCS Study Center contractors identified below for a period of 6 months the purpose of which is to the continue limited NCS activities beyond their September 27, 2012 contract completion dates. The contracts will be awarded under the authority of 41 U.S.C. 253(c) (1), FAR Subpart 6.302-1(a)(2) and HHSAR 306.302-1(a)(2)(iv). WAVE I STUDY CENTER (CONTRACTOR) - LOCATION (COUNTY) 1. University of California, Irvine - San Diego, CA 2. University of New Mexico - Valencia, NM 3. St. Louis University - St Louis, MO 4. University of Hawaii - Honolulu, HI 5. Northwestern University - Cook, IL 6. University of California, Los Angeles - Los Angeles, CA 7. University of Minnesota - Ramsey, MN 8. University of Pittsburgh - Westmorland, PA 9. University of Utah - Cache, UT 10. Brown University - Providence, RI 11. University of California, Davis - Sacramento, CA 12. University of Texas, San Antonio - Bexar, TX 13. Yale University - New Haven, CT 14. Children's Hospital of Philadelphia - Schuylkill, PA 15. Michigan State University - Wayne, MI 16. University of Mississippi - Hinds, MS 17. University of North Carolina - Durham, NC For the period of September 28, 2012 - March 29, 2013 contractors will ensure they have the staff and facilities sufficient to conduct the following activities: - Complete the development and implementation of a Transition Plan that is sufficiently detailed to ensure an efficient and complete transition of Study responsibilities to a possible successor preventing any disruption in Study visits, data collection, data transfer, or other research activities. - Continue Study-related data collections that may take place in the home, in the community, by telephone, other remote setting or in a clinical or specific Study setting. - Transmit Operational and Study data to the NCS-Program Office according to the Study specifications. - Track receipt of self-administered forms and enter this hard copy data into their approved electronic format for transmission to the NCS Vanguard Data Repository (VDR). - Ensure compliance with ongoing quality control procedures described in the Study Protocol and in the study procedural manual. - Comply with all Institutional Review Board (IRB), Office of Management and Budget (OMB) and Health Insurance Portability and Accountability Act (HIPAA) requirements. - Meet via phone and/or face-to-face with the Contracting Officer Representative(s) and other staff to review progress and anticipated or existing problems. - Adhere to the policies of the NCS Publications Committee and the Data Access Committee. Under the existing contracts the Wave I Study Centers in their respective locations (counties) have recruited, tracked, retained and collected data on a cohort of participants. They have conducted home visits to collect biospecimens, environmental samples, and other analytical materials. The primary goal of these follow-on contracts is to retain the current participants; conduct limited data collection, and prepare for the transition of all NCS activities to a successor contractor. Given those objectives, the extent of contractor activities, data rights restrictions, and other pertinent factors, there is no reasonable expectation that another contractor(s) could assume the activities of these centers for a period of 6 months. In addition, transfer of the personally identifiable information (PII) being safeguarded by the existing contractors cannot be released to another prospective contractor without proper authorization, a lengthy process that could result in unacceptable delays to current Study requirements. This is not a request for proposal. However, if any responsible source believes it can perform the above requirements they may submit three (3) copies of their capability statement for consideration by the NICHD to Howard O. Cyrus Jr., Contracting Officer, NICHD Office of Acquisitions, Contract Management Branch, 6100 Executive Blvd., Bethesda, MD 20892-7510. Phone number 301-435-6963; email hc163b@nih.gov All responses must be received in writing and must contain material in sufficient detail to allow the NICHD Contracting Office and the NCS Program Office to make a determination that the party can or cannot perform this requirement. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government.
