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A -- Research Registry for Juvenile Rheumatoid Arthritis

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NIH-NIAMS-04-03Federal

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The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) plans to extend and expand its existing sole source contract with the Children’s Hospital Medical Center (CHMC) in Cincinnati, Ohio, for an additional five years. Originally awarded in 1994 to establish and maintain a research registry for juvenile rheumatoid arthritis (JRA), CHMC has since developed and updated a database focused on multicase families, particularly affected sibling pairs. The registry serves as a national resource to facilitate research by providing ample subject data, improving the understanding of childhood arthritis. The extension aims to support ongoing enrollment of affected sib pairs, include underrepresented JRA subtypes and ethnic groups, and enable pilot studies using novel technologies such as proteomic profiling to explore genetic and clinical disease associations. CHMC is uniquely qualified for this continuation due to its leadership in enrolling and characterizing JRA sibling pairs nationwide, a proven system for strict enrollment, and exclusive access to critical resources like DNA samples, clinical data, and a large cohort of simplex and multiplex families. Because of these factors, competition for this contract extension is considered unfeasible due to potential cost duplication and performance delays. Accordingly, NIAMS intends to negotiate directly with CHMC under a sole source authority, with all responsible parties invited to submit proposals if desired, though the final decision rests with the contracting officer. This notice is not a solicitation or request for proposals, and the project falls under NAICS Code 541710.

General Info

NIAMS extends sole source contract with CHMC to expand juvenile rheumatoid arthritis research registry.

Agency

N/A

NAICS

541710 - Research and Development in the Physical, Engineering, and Life Sciences

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

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Full Description

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The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to negotiate on a sole source basis with the Children's Hospital Medical Center (CHMC), Cincinnati, Ohio, to extend and expand the scope of their current contract for an additional five (5) years. The CHMC was originally awarded a five (5) year contract in September, 1994, for the project entitled - Research Registry for Juvenile Rheumatoid Arthritis. The purpose of the contract was to establish a research registry for juvenile rheumatoid arthritis (JRA). The Contractor developed, maintains, and systematically updates a disease registry for JRA with the focus on multicase families with affected sib pairs. In conjunction with the National Institute of Arthritis and Musculoskeletal and Skin Disease, the CHMC continuously promotes the use of the Registry as a national resource to facilitate research by providing adequate numbers of subjects for study, thus enhancing the national research effort in childhood arthritis. The purpose of this extension is four fold. First, the additional time will allow the incumbent to continue to enroll affected sib pairs to meet its enrollment goals and to follow-up the sib pairs. Second, it will allow for enrollment of multiplex and simplex families to include under-represented JRA subtypes and under-represented ethnicities long-term follow-up of sib pairs with JRA. Third, to carry out pilot studies exploring the relationships of observed genetic linkage or associations with observed clinical features of disease and disease pathogenesis using novel technologies such as proteomic profiling using mass spectrometry. 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 CHMC is determined to be the only responsible source for the following reasons: (1) the CHMC leads a unique national effort dedicated to the collection and characterization of JRA sib pairs and is in a unique position to enroll simplex and multiplex families; (2) the CHMC has developed and implemented a system for sib pair accrual, based on strict enrollment criteria; and (3) the CHMC has unique invaluable resources at its disposal such as 197 sib pairs from 179 families, DNA from 155 families, 425 simplex families, and 69 Hispanic simplex families and comprehensive clinical data, including quantitative trait data on all patients, including therapeutic history. Therefore, the CHMC 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.

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