Systemic Lupus Erythematosus (SLE) Consulting Services

Pre-solicitation / Notice of Intent Synopsis R.Q.M. No: Solicitation Number: HHS-NIH-NHLBI-CSB-(AR)-2013-094-CSP Solicitation Type: Sole Source (Non Competitive) Suggested Source: Mariana Kaplan Title: Systemic Lupus Erythematosus (SLE) Consulting Services NAICS: 541690/$14 Million INTRODUCTION 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. This is a pre-solicitation / notice of intent synopsis for a sole source noncompetitive award to Mariana Kaplan for Systemic Lupus Erythematosus (SLE) Consulting Services. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisitions (OA) on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Mariana Kaplan, 173 Wild Ivy Court, Ann Arbor, MI 48109-0600, to provide Systemic Lupus Erythematosus (SLE) Consulting Services. BACKGROUND This is a new requirement. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Intramural Research Program (IRP), is one of the nation's premier research institutions in the area of basic and clinical research efforts in rheumatic, other inflammatory disorders, autoimmune diseases, and has a state of the art clinical research hospital. NIAMS has been in the process over the past few years of reinvigorating the clinical program and has established Systemic Lupus Erythematosus (SLE) as a particular area of emphasis. This field has been a historical strength in the NIAMS, but is presently under-emphasized. In order to promote this effort, NIAMS requires the services of a tenured Senior Investigator. The Senior Investigator will have specific strength in translational focus, which not only examines pathogenesis of human disease, but also applies novel insights to design innovative therapeutic approaches for Lupus and Rheumatoid Arthritis. Dr. Kaplan, of the University of Michigan, been selected by NIAMS as the Senior Investigator to provide these services, and to start the relocation of her lab from the University of Michigan, to the NIH, during this period. PERIOD OF PERFORMANCE The period of performance is February 20, 2013 through July 31, 2013, there are no option periods. The contract type will be a firm fixed-priced purchase order. PROJECT DESCRIPTION The contractor shall supply all labor, materials, facilities, equipment, and supplies to perform or supply the following: The contractor shall act as a senior advisor and will oversee the lab transfer of research and personnel, and provide advice and guidance for projects related to SLE as assigned by the Scientific Director (SD). Comprehensive knowledge of Federal Government policies, procedures, rules, and regulations in all areas of administrative management is required. Contractor Requirements: Responsibilities include: 1) Providing a preliminary detail of research functions that will be relocated from the University of Michigan to the NIH. 2) Provide a project plan with targeted dates when personnel and identified projects will be - up and running in the IRP. 3) Provide the SD advice and expertise in matters related to the research enterprise at the NIH, and in NIAMS on SLE. 4) To provide guidance to the Office of Scientific Director (OSD) management in the establishment of a basic and translational research program as follows: a. Serve to identify appropriate research topics and develop strategies and priorities for research efforts in these areas. b. Utilize existing or develop new research methodologies and databases to provide new insights in lupus and other inflammatory disorders. c. Help develop and/or amend existing protocols to study subjects with lupus or other inflammatory diseases at the NIH Clinical Center. e. Assist clinical staff research efforts to maximize productivity. 5) To augment and/or work to initiate new collaborations that promote productivity and seize upon existing basic and clinical research resources within NIAMS and throughout the NIH. 6) To provide mentorship, research instruction, and advice to NIAMS clinical staff formal and informal discussions, and through fostering and/or developing research opportunities. JUSTIFICATION Dr. Kaplan and her laboratory are currently investigating the path of physiology of premature atherosclerosis in patients with SLE. Dr. Kaplan has identified mechanisms that induce apoptosis in vascular endothelial cells, and is currently studying the activation of these mechanisms in SLE. Pro-apoptotic signaling correlates with abnormal endothelial cell function, promotion of atherosclerosis, and tissue factor generation. Dr. Kaplan is also investigating whether the regenerative capacities of the endothelium are impaired in patients with SLE and other autoimmune diseases (rheumatoid arthritis and scleroderma), and whether this further contributes to premature vascular disease. It is necessary that Dr. Kaplan provide these services to NIAMS, as she is also studying the phenotype and function of specific cell subsets in lupus, including; myeloid dendritic cells and neutrophils, and whether abnormalities in these cells promote abnormal autoimmune responses. In addition, Dr. Kaplan's laboratory is looking into mechanisms of tissue damage in SLE, and whether specific pharmacologic interventions can abrogate/ameliorate these complications in lupus, and potentially in other autoimmune diseases. Dr. Kaplan's extensive knowledge of the role of SLE, and the development of lupus, is indispensable in proceeding with a NIAMS clinical trial, (using Xolair in the treatment of lupus) now being established at the NIH clinical center. Dr. Kaplan's expertise will help NIAMS to gain a better understanding on the role of IgE in lupus and to treat lupus patients with anti-IgE drugs towards ameliorating disease; a disease that is key part of the NIAMS programmatic mission portfolio. REGULATORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth under FAR Part 13.106-1 (b) (1), Soliciting from a single source not exceeding the simplified acquisition threshold, and is exempt from the requirements of FAR Part 6, Competition Requirements. ADDITIONAL INFORMATION The North American Industry Classification Code (NAICS) is 541690, Other Scientific and Technical Consulting Services and the Small Business Size Standard is $14 Million Per Annum. The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-65 (January 29, 2013). The determination by the Government to award a purchase order on a sole source on competitive basis for genetic testing to Mariana Kaplan is based upon the responses to the sources sought synopsis, NHLBI-CSB-AR-2013-080-CSP, published in the FedBizOpps on January 30, 2013, titled Systemic Lupus Erythematosus (SLE) Consulting Services. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. Responses to this notice shall contain sufficient documentation to establish the interested parties bona-fide capabilities for fulfilling the requirement. This notice of intent is not a request for competitive proposals. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. In order to receive an award from NIH/NHLBI, contractors must be registered and have a valid CCR and ORCA on-line at https://www.sam.gov/portal/public/SAM/. If you have any questions, please submit to the National Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6137, Bethesda, Maryland 20892-7902, Attention: Caitlin Palmer. Responses may be submitted electronically to caitlin.palmer@nih.gov. Faxes will not be accepted.