SPECIAL NOTICE
R -- CLINICAL RESEARCH SUPPORT SERVICES
- Notice Date
- 8/8/2007
- Notice Type
- Special 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NHLBI-PB-(HL)-2007-217-DDC
- Response Due
- 8/20/2007
- Archive Date
- 9/4/2007
- 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), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Howard University, Center for Sickle Cell Disease, 2400 6th NW Room 306, Washington, DC 20059 to provide clinical research support services for the Pilot Trial of Intravenous Nitrite for Sickle Cell Vaso-Occlusive Pain Crisis. The goal of the project is a conduct a pilot clinical trial of systemic intravenous nitrite in sickle cell vaso-occlusive inpatient pain crisis, with the hypothesis that this agent will reduce the duration of vaso-occlusive pain crisis; secondary outcome measures will include amount of opioid analgesic usage during the hospitalization, oxidation of plasma cell free hemoglobin to methemoglobin, and decrease in plasma nitric oxide consumption activity. Additionally, the project aims; i. Determine whether intravenous nitrite therapy reduces the duration of hospitalized vaso-occlusive pain crisis in patients with sickle cell disease. ii. Determine the effect of intravenous nitrite therapy on blood markers of nitric oxide generation, oxidant stress, and proteomic profile. Howard University Hospital 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 year of age. The site will obtain local Institutional Review Board (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. The purpose of the requirement is to assist the National Institutes of Health Clinical Center (CC) in a clinical trial of intravenous sodium nitrite for the treatment of patients with sickle cell disease. The specific objective is to recruit, enroll sufficient number of eligible patients to provide 10 completed evaluable studies, in accordance with the specific protocol provided by the Vascular Medicine Branch of the National Heart, Lung and Blood Institute. Statement of Work: 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. I. Contractor Requirements a. Tasks to be performed by the vendor. i. Obtain local IRB approval for the pilot protocol. ii. Assemble appropriate infrastructure to conduct the trial. iii. Pre-enroll a number of patients as a pool of eligible candidates. iv. 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. v. Collect and provide clinical data and research blood specimens as described in the protocol. vi. Completion of the ten studies is targeted to be March 1, 2009. b. Desired results, functions, or end items required. i. Provide high quality standard of care treatment to the patients in the study. ii. Provide all clinical trial data and blood specimens as described in the protocol. iii. Provide all these data and specimens to the Vascular Medicine Branch of the National Heart, Lung and Blood Institute. c. 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 an adherence to the specified study endpoint criteria of the protocol. II. Government Responsibilities a. List Government-furnished data, property, or facilities to be provided to the vendor. The contractor will be provided with a detailed clinical trial protocol. b. Identify what the Government will do in the way of inspection and acceptance, e.g., state what will be done to review, approve, and accept performance, and identify who will do it and where it will be done. Provide the terms or criteria for acceptance of deliverables and describe how acceptance or rejection of deliverables will be conveyed to the contractor. A member of the NHLBI Vascular Medicine Branch will make a single day site visit at Howard University 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 Howard University in writing within 15 days. III. Reporting Requirements and Deliverables a. Itemize deliverables including reports, if any. i. The site will provide reports of number of consented and completed patients quarterly, accompanied by clinical data as specified in the protocol. ii. The site will provide adverse event reports as specified in the protocol, adhering to the timeliness requirements in the protocol. IV. Program Management and Control Requirements a. Are there to be any internal management and control systems, either specified by the Government or to be developed by the vendor? Only standard university/hospital oversight is accepted. V. Attachments, as applicable a. Reference material, quotations, letters of acceptance. None b. Relevant documents referred to in the statement of work. Protocol: ?Pilot trial of intravenous nitrite for sickle cell vaso-occlusive pain? c. Specifications and standards the vendor must follow. Must indicate in the protocol above. The expected period of performance is September 1, 2007 and completion date is February 28, 2009. The sole source determination is based upon the fact that Howard University, Center for Sickle Cell Disease, 2400 6th NW Room 306, Washington, D.C., is the only known source that is currently able to assist the NIH, NHLBI, Vascular Medicine Branch (VMB)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. 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)-2007-217-DDC, may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20892-7902, Attention: Deborah Coulter. Responses may be submitted electronically to coulterd@nhlbi.nih.gov or hawkinsd@nhlbi.nih.gov and by fax to (301) 480-3345. Responses will only be accepted if dated and signed by an authorized company representative. Point of Contact Deborah Coulter, Contract Specialist, Phone (301) 435-0368, Fax (301) 480-3345, Email dc143b@nih.gov - Debra Hawkins, Chief, Procurement Branch, Phone (301) 435-0367, Fax (301) 480-3345, Email dh41g@nih.gov.
- Record
- SN01365678-W 20070810/070808220659 (fbodaily.com)
- Source
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