A -- Research Registry for Neonatal Lupus

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health, Department of Health and Human Services, intends to negotiate on a sole source basis with the Hospital for Joint Diseases/Orthopaedic Institute (HJD) to extend and expand the scope of their current contract for an additional five (5) years. The HJD was awarded a contract in September 1994, for the project entitled - Research Registry for Neonatal Lupus. The purpose of the contract was to establish a research registry for juvenile neonatal lupus. The registry currently collects only information sufficient to establish the diagnosis of the disease, and information as to the patient's and/or family's willingness to cooperate in basic and clinical research on the disease. There is limited collection of blood specimens; collection of other patient materials for research purposes is not currently part of the registry functions. The overall goal of the registry is to collect sufficient information on individuals and/or families, to allow investigators interested in studying the disease to use the registry data to assist them in obtaining sufficient numbers of patients to pursue their research objectives. The HJD collects information on mothers whose babies are affected with neonatal lupus syndrome. The purpose of this extension is two fold. First, the additional time will allow the incumbent to continue to enroll subjects to expand sample size to assure a robust number of affected children to support genetic analysis of susceptibility and severity factors. Second, the incumbent will pursue a limited expansion of specimen collection to enable genetic studies. The Contractor will maintain a specimen bank for the storage of serum and DNA from all immediate family members (mother and her child/children) with neonatal lupus and unaffected siblings enrolled in the Research Registry. In addition, where feasible, lymphocytes will be obtained from these family members and EBV transformed to maintain a perpetual resource of DNA. A determination for the use of other than full and open competition has been made in accordance with 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1. The Hospital for Joint Diseases/ Orthopaedic Institute (HJD) is determined to be the only responsible source for the following reasons: (1) the HJD leads a unique national effort dedicated to the collection and characterization of neonatal lupus; (2) the HJD has developed and implemented a system for neonatal lupus based on strict enrollment criteria; and (3) the HJD has unique invaluable resources at its disposal such as 312 mothers and 366 children with neonatal lupus and a collection of blood specimens from the mothers and children. Therefore, the HJD has the unique capability to perform this work. This is not an announcement of the availability of a Request for Proposals. Inherent duplication of cost to the Government and unacceptable delays in performance make competition for this additional work unfeasible. All responsible sources may submit a proposal which will be considered by the NIAMS. A determination not to compete the proposed work based upon responses to this notice is solely within the discretion of the Contracting Officer. The North American Industry Classification System (NAICS) Code is 541710. This notice of intent is not an announcement of the availability of a Request for Proposals (RFP), nor is an RFP available. See Numbered Note 22.