SOLICITATION NOTICE
A -- Pediatric Hydroxyurea Phase III Clinical Trial (aka BABY-HUG)
- Notice Date
- 7/31/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NHLBI-HB-07-S-02
- Response Due
- 9/13/2007
- Archive Date
- 9/20/2007
- Description
- The National Heart, Lung, and Blood Institute intends to negotiate on a sole source basis with the following organizations to expand the scope of work and extend the periods of performance of their current contracts for an additional three years: Clinical Trials & Surveys Corporation, Children?s Research Institute, Duke University Medical Center, Howard University, Johns Hopkins University, Medical University of South Carolina, St. Jude Children?s Hospital, State University of New York, University of Miami, University of Mississippi, and University of Texas Southwestern. These organizations were originally awarded contracts in September 2000 for a project entitled "Pediatric Hydroxyurea Phase III Clinical Trial (aka BABY-HUG)". The period of performance for all contracts currently expires on December 31, 2009. The purpose of the contracts is to conduct a Phase III, two-year, double-blind randomized placebo-controlled trial of 200 patients to determine if Hydroxyurea can prevent the onset of chronic end organ damage in young children with sickle cell anemia (HbSS). The contractors have successfully enrolled patients into this trial and the final child is expected to enter the BABY-HUG treatment protocol by July 2007 and complete treatment in July 2009. The expanded work scope will add a Follow-Up Study to provide structured follow-up of the children enrolled in the original BABY-HUG treatment study in order to characterize the long-term toxicities and unexpected risks (if any) associated with treatment with Hydroxurea at an early age. In performing the expanded work scope, this unique group of children will be intensively followed for growth, development, and clinical status through puberty or early adulthood to document any alterations in the natural history of sickle cell disease associated with early Hydroxyurea therapy. This three-year extension is the initial installment in that effort and, as such, requires the continuation of care and follow-up at the original institutions, as well as continued data accrual and analysis at the original coordinating center. Pursuant to 41 U.S.C. 253(c)(1) as set forth in FAR 6.302 1, Clinical Trials & Surveys Corporation, Children?s Research Institute, Duke University Medical Center, Howard University, Johns Hopkins University, Medical University of South Carolina, St. Jude Children?s Hospital, State University of New York, University of Miami, University of Mississippi, and University of Texas Southwestern are the only sources capable of performing this requirement due to their prerequisite knowledge and experience in performing preliminary and current work on this trial, as well as their accrual of a unique patient population. Due to the inherent duplication of cost and unacceptable delays in performance, noncompetitive modifications to the current contracts is in the best interest of the Government. Interested parties may identify their interest and capability to respond to the requirements, as described above. All responses must be submitted by September 13, 2007 to the following address: Debi Spillan, Contract Specialist, Office of Acquisitions, NHLBI, 6701 Rockledge Drive, Room 6138, MSC 7902, Bethesda, MD 20892-7902. All responsible sources may submit a response, which if timely received, shall be considered by the agency. A determination not to compete the proposed work based upon responses to this notice is solely within the discretion of the Contracting Officer. 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.
- Record
- SN01357228-W 20070802/070731220602 (fbodaily.com)
- Source
-
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