SOLICITATION NOTICE
R -- All Other Professional, Scientific and Technical Services
- Notice Date
- 4/15/2008
- Notice Type
- Presolicitation
- 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, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB-{HL}-2008-111-DDC
- Point of Contact
- DeborahCoulter,, Phone: (301) 435-0368, Chris Belt,, Phone: 301.435.6672
- E-Mail Address
-
dc143b@nih.gov, cbelt@nhlbi.nih.gov
- Description
- HE NATIONAL INSTITUTES OF HEALTH (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisition (OA), for the Translational Medicine Branch (TMB) intends to negotiate with Dr. Fayaz Shawl to provide Interventional cardiovascular services for clinical and investigational image-guided cardiovascular intervention to support the following protocol numbers; #07-H-0128, Gadofosveset Imaging of Chronic Total Peripheral Artery Occlusion (CTO), 07-H-0056, Validation of Cardiac MR Perfusion with Cardiac Catherterization Physiological Assessment, 06-H-0203, Catheter-Based Treatment of Cardiovascular Disease in Patients, 05-H-007, Real-Time MRI-Guided Percutaneous Intervention for Aorto-illac and Femoropopliteal, Artery Stenosis, 04-H-0143, Modulation of Vascular Endothelial Growth Factor (VEGF) using an Engineered Zinc-Finger Transcription Factor to treat Lower Limb Intermittent Claudication, 03-H-250, Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging. The primary objective of this requirement is to provide an overview of the work/service to be performed by Dr. Vankatesh Raman, through the Private Practice of Dr. Fayaz Shawl, M.D. in general terms. Background Information: The Translational Medicine Branch is involved in ongoing clinical and laboratory studies whose aim is to develop new understanding and treatments for cardiovascular disease. Within each of these sections a number of basic mechanistic studies and/or translational or clinical protocols are currently underway. The clinical focus includes the use of stem cells in cardiovascular diseases, novel approaches to treat patients with intractable coronary ischemia, application of magnetic resonance imaging (MRI) technology for patients with peripheral vascular disease and new therapeutic approaches for patients with hypertrophic cardiomyopathy. On the basic research side, efforts are underway to better understand cell cycle regulation of vascular smooth muscle cells, the role of reactive oxygen species in signal transduction pathways, cholesterol transport in macrophages and large scale genomic applications in cardiovascular including stress testing (EKG, echo, radionuclide ventriculography), 2-D and 3-D echocardiography, nuclear imaging (left ventricular function studies, myocardial perfusion, myocardial metabolism), electrophysiology testing, pacemaker management, and cardiac catheterization. Scope of Work: The contract will involve and include, but not limited to the following as outlined in the Statement of Work (SOW); Contractor Requirements: 1.Specify tasks to be performed by the Private Practice of Dr. Fayaz Shawl, MD. The Contractor shall execute human research protocols of the Cardiovascular Intervention Program in the Translational Medicine Branch. This includes the practice of interventional cardiovascular medicine as well as conception, design, regulatory filing, enrollment, data analysis and reporting. The contractor also shall execute preclinical research protocols of the Cardiovascular Intervention Program in the Translational Medicine Branch. Includes conception, design, regulatory filing, enrollment, data analysis and reporting. The contractor also shall participate in interventional cardiovascular care of patients and research subjects in the Cardiovascular Intervention Program. 2. Specify the desired results, functions, or end items required. The contractor shall provide experimental data reports deriving from the collaboration. The contractor shall submit (in collaboration) preclinical and clinical manuscripts in peer-reviewed scientific journals. These are long-lead time items. The contractor shall provide safe and effective interventional cardiovascular care of patients and research subjects. The contractor should be successful at recruiting and enrolling research subjects in Laboratory human research protocols. 3. The Contractor shall specify any methodologies to be used and address the applicability of specifications and standards that are critical to performance. The Contractor shall provide clinical care in accordance with the Quality Assurance standards of the Translational Medicine Branch. Successful publication of manuscripts in peer-reviewed manuscripts constitutes successful performance. Government Responsibilities: 1. The Government is required to list Government-furnished data, property, or facilities to be provided to the Private Practice of Dr. Fayaz Shawl, M.D. (medical devices, laptops, etc.) The Contractor will work on campus, using government provided office space and equipment. Free parking on the NIH campus is provided. The Government will also provide a portable computer for offsite work, as well as parking, and transportation expenses to attend research conferences. 2. Inspection and Acceptance: The performance quality and acceptability will be reviewed annually in writing by the Chief, Translational Medicine Branch or designee such as the Principal Investigator of the Cardiovascular Intervention Program. Reporting Requirements and Deliverables: The Contractor is required to itemize deliverables including reports, if any. Describe the results of the service. The contractor will provide clinical care documentation, peer-reviewed manuscripts accepted in scientific journals, and reports of collaborative scientific activity. The reference number for this notice is NHLBI-PB-(HL)-2008-111-DDCThe resultant acquisition will be conducted in accordance with FAR Part 13, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-24. The estimated level effort for this requirement is not expected to exceed 812 hours for a one year period (twelve months). The total estimated amount of this contract is NOT expected to exceed the simplified acquisition threshold of $100,000.00. The intended procurement will be classified under North American Industry Classification System code 541990, with size standard of $6.5million. The Government conducted a Market Research in accordance with the Federal Acquisition Regulations (FAR) Part 10, Market Research, has determined that Dr. Fayaz Shawl, M.D. firms is currently the only company that can provide the Consultant services specified herein. The Cardiovascular Intervention Program within the Translational Branch is developing image-guided transcatheter cardiovascular interventional procedures. This requires development of preclinical animals and early clinical testing. It includes conventional and investigational clinical cardiovascular care. These require subspecialty expertise of physicians who are board specialized in internal medicine, cardiovascular disease, and interventional cardiology, namely Dr. Venkatesh Raman, M.D. who previously worked with the VA and now will be working for the Private Practice of Dr. Fayaz Shawl. The program currently has only one full-time physician with these credentials and requires additional expertise well versed with the complex and specialized research environment of the Translational Medicine Branch. Having the expertise of physicians who are board specialized in internal medicine, cardiovascular disease, and interventional cardiology, requires the assistance of Dr. Raman to participate in management of patients with cardiovascular disease being considered for transcatheter treatment, including outpatients, inpatients, those with coronary artery disease, peripheral artery disease, structural heart disease, and congenital heart disease. Dr. Raman has been successfully conducting this type of work with the Cardiovascular Intervention Program since 2001, first as a clinical research fellow, then via the George Washington University Medical Faculty Associates and, thereafter, through an Inter-Agency Agreement (with 40% effort) with the Department of Veterans Affairs where had a full-time appointment. Dr. Raman is an established world expert in the field with a demonstrated publication record. Dr. Raman has been an integral part of the Cardiovascular Intervention Program in developing the institutional experience with real-time interventional MRI, MR-fusion-guided intervention, non-invasive magnetic resonance angiography with novel contrast agents, and cardiovascular biologics. His particular participation is considered essential to the mission of the Program. Dr. Raman’s ongoing participation provides continuity of experience, institutional memory, and eliminates additional time and resources required for recruitment, training and retention of other individuals with this specialized skill set. The notice of intent is not a request for competitive proposals. The resulting acquisition will be entered into pursuant to the acquisition authority set forth in FAR 6.302-1 and 41 U.S.C. 253©(1) and HHSAR 306-302-1. Only one responsible source and no other supplies or services will satisfy agency requirements. Interested parties may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within 45 days after publication of this synopsis will be considered by the Government. Responses to this notice will be reviewed in accordance with the following criteria: (1) Shall be American Board of Internal Medicine (ABIM ) Board certified in cardiovascular diseases and interventional cardiology. (2) Shall be Licensed or eligible to become a licentiate to practice medicine in the State of Maryland. (3) Shall have knowledge and training in Good Clinical Practice with the understanding of interventional cardiovascular MRI in peer-reviewed journals. (4) Shall be knowledgeable of clinical and research procedures at the NIH Clinical Center and NHBLI Division of Intramural Research. A determination by the Government not to complete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct the competitive procurement. Responses to this announcement, referencing synopsis number NHLBI-PB-(AR)-2008-111-DDC, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition Center, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, Maryland 20892-7902, Attention Deborah Coulter. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=4fae40aeb42d9d7291b36a80dea5ac56&tab=core&_cview=1)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01554449-W 20080417/080415220601-4fae40aeb42d9d7291b36a80dea5ac56 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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