SOLICITATION NOTICE
B -- Clinical Research Support Services
- Notice Date
- 8/29/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB-(HL)-2006-306-DDC
- Response Due
- 9/7/2006
- Archive Date
- 9/22/2006
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute?s (NHLBI), Office of Acquisitions (OA), intend to negotiate and award a purchase order on a noncompetitive sole source basis to Drexel University, Drexel University College of Medicine, St. Christopher?s Hospital for Children, 3201 Arch Street, Philadelphia, PA., 19104, to provide research support services for the Pilot Trial of Intravenous Nitrite for Sickle Cell Vaso-Occlusive Pain. The sole source determination is based upon the continuation of the on-going collaboration with the National Institutes of Health (NIH), Clinical Center (CC) and the Drexel University, Drexel University College of Medicine, St. Christopher?s Hospital for Children, in the clinical research trial of intravenous sodium nitrite for the treatment of patients with sickle cell disease. The specific objective is to recruit and enroll sufficient number of eligible patients in accordance with the specific protocol provided by the Vascular Medicine Branch of the National Heart, Lung and Blood Institute. The Drexel University, Drexel University College of Medicine, St. Christopher?s Hospital for Children is the only known source that is currently able to assist the NIH, NHLBI, Vascular Medicine Branch in this area of research. An award to any other source would result in a substantial duplication of cost to the Government that is not expected to be recovered through competition. Statement of Work: St. Christopher?s Hospital for Children will act as a collaborator to the NHLBI Vascular Medicine in a pilot clinical trial of intravenous sodium nitrite for the treatment of acute vaso-occlusive pain crisis in patients with sickle cell disease at least 10 years of age. The site will obtain local IRB approval for the study. They will recruit, enroll and complete a target of at least ten patients. They will provide specified clinical research data and research blood specimens from these patients. Summarize the actions to be performed by the contractor and the results that the Government expects, using a broad, non-technical statement of the work to be performed. The contractor is expected to take all measures necessary to obtain local IRB approval for the pilot protocol, recruit eligible patients, and enroll them at the time of an acute pain episode, providing standard hospital treatment supplemented by the study drug. They will collect all required data and blood specimens, and provide these to the Vascular Medicine Branch of the National Heart, Lung and Blood Institute. Contractor Requirements. Tasks to be performed by the vendor. 1) Obtain local IRB approval for the pilot protocol. 2) Assemble an appropriate infrastructure to conduct the trial. 3) Pre-enroll a number of patients as a pool of eligible candidates. 4) Enroll the patients at the time of an acute pain episode, providing standard of care treatment supplemented by a coded intravenous drug, which will later be determined to be either sodium nitrite or placebo, in dosing specified in the protocol. 5) Collect and provide clinical data and research blood specimens as described in the protocol. 6) Completion of the ten studies is targeted to be March 1, 2008. Desired results, functions, or end items required. 1) Provide high quality standard of care treatment to the patients in the study. 2) Provide all clinical trial data and blood specimens as described in the protocol. 3) Provide all these data and specimens to the Vascular Medicine Branch of the National Heart, Lung and Blood Institute. Specify any methodologies to be used and address the applicability of specifications and standards that are critical to performance. Treatment considered to be standard of care at the contracting hospital is to be administered, supplemented by intravenous administration of study drug and recording of clinical trial data exactly in accordance with the specified protocol. Particularly critical is adherence to the specified study endpoint criteria of the protocol. Government Responsibilities. The contractor will be provided with the details of the clinical trial protocol. A member of the NHLBI Vascular Medicine Branch will make a single day site visit at St. Christopher?s Hospital for Children to review applicable records of patients enrolled on this study during the initial three months of the contract and at approximately six month intervals at the discretion of the NHLBI Vascular Medicine Branch. The inspector will provide oral feedback as to acceptability of records. Any items deemed unacceptable by the inspector will be provided to the investigator of St. Christopher?s Hospital for Children in writing within 15 days. Reporting Requirements and Deliverables. 1) The site will provide reports of number of consented and completed patients quarterly, accompanied by clinical data as specified in the protocol. 2) The site will provide adverse event reports as specified in the protocol, adhering to the timeliness requirements in the protocol. The expected period of performance is September 2006 through March 2008. This acquisition is being conducted under simplified acquisition procedures and is exempt from the requirement of Federal Acquisition Regulations (FAR) Part 6, Competition Requirements. The North American Industry Classification System (NAICS) applicable to this requirement is 541990 with a size standard of $6.5 M. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government. Comments to this announcement, referencing synopsis number NHLBI-PB(HL)-2006-306-DDC, may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20892-7902, Attention: Deborah Coulter.
- Place of Performance
- Address: Bethesda, Maryland
- Zip Code: 20892-7902
- Country: UNITED STATES
- Zip Code: 20892-7902
- Record
- SN01128361-W 20060831/060829220339 (fbodaily.com)
- Source
-
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