National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

R -- PROFESSIONAL, ADMINISTRATIVE, AND MANAGEMENT SUPPORT SERVICES SOL NHLBI-PS-99-466 DUE 061399 POC Deborah Coulter,Purchasing Agent, (301)435-0368 fax (301)480-3345 The National Heart, Lung, and Blood Institute intends to negotiate on a sole source basis with Mary Hisle, 5517 Brite Drive, Bethesda, MD. 20817, to serve as the Clinical Research Protocol Coordinator for NHLBI's Director of Clinical Research Programs. Ms Hisle, has ten (10) years experience as a Protocol Coordinator with NIH. She is knowledgeable in all aspects of the policy, as well as the legalities necessary in writing and establishing clinical research protocols. She is familiar with all the contracts necessary in each institute as well as the Clinical Center and Medical Executive Committee, NIH. She possess the expertise and experience necessary for teaching new physicians when they come to NIH to conduct clinical research, on the proper way to organize and write a clinical protocol so that it is complete and will be presentable to the Institute's Review Board. Due to Ms. Hisle, knowledge and expertise, an award to any other source would not be advantageous to the government, and would result in a substantial increase of cost to the Government that is not expected to be recovered through competition. STATEMENT OF WORK: The National Heart, Lung, and Blood Institute (NHLBI), Division of Intramural Research (DIR) has a requirement for expertise in the coordination and management of clinical research protocols. The Contractor will serve as the Clinical Researchers Protocol Coordinator who will work closely with the Director, Clinical Research Programs. Specifically, the Clinical Research Protocol Coordinator will serve as the focal point in developing and writing new research protocols related to patient research here in the Clinical Center, NIH by instructing and assisting new physicians and other clinical researchers in the development and writing of their clinical research protocols. Will review all clinical protocols submitted by clinicians and researchers for adherence to DHHS and NIH policy, for format and content, and for completeness on behalf of the Director, Clinical Research Programs, and prior to submission to the Investigational Review Board (IRB). Provides comprehensive support to all clinicians with regard to the clinical protocols by being highly knowledgeable of the Clinical Center policy and procedures as implemented by the NIH Human Subjects Research Advisory Committee (HSRAC), the NIH Protocol Service Center, and other NIH policy as may be relevant to specific protocols. Prepares agenda for IRB; distributes the material for 20 IRB members, and coordinates the bi-weekly (twice monthly) meetings of the IRB. Communicates and works with each Principal Investigator (PI) on each clinical protocol in preparation for presentation before the IRB, as well as afterward if follow-up action is necessary before protocol approval is obtained. Notifies each PI of the IRB's decision regarding their research protocol. Records facts of each IRB and maintains record of each IRB meeting including status of each protocol. Coordinates NHLBI activities with the Protocol Service Center, Clinical Center, to fulfill reporting and filling requirements on behalf of the NHLBI. Processing all necessary documents and obtains Director's, (Clinical Research Programs, NHLBI), approval for filing new clinical protocols as well as amendments to existing protocols. PLACE OF PERFORMANCE: Work will be performed at Building 10, Room 8C103 Center Drive Bethesda, Maryland. PERIOD OF PERFORMANCE: The period of performance is approximately twelve (12) months from date of contract award. DELIVERABLES: Every other week the Protocol Coordinator will file with the Director, Clinical Research Programs, NHLBI, updated copies of clinical research protocols for each principal investigator (PI). The Protocol Coordinator will compile and distribute the 20 copies of each clinical protocol needed for the IRB twice monthly no later than three days prior to the meeting time of the IRB. Summary notes taken from the IRB meetings will also be filed within two weeks after each IRB meeting. The acquisition is being conducted under simplified acquisition procedures and is exempt from the requirements of FAR Part 6. The Standard Industrial Classification (SIC) Code is 8742, and Size Standard is $5.0M. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this requirement. 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. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement. Responses to this announcement, referencing synopsis number NHLBI-PS-99-466 may be submitted to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, Building RKL2, Room 6143, 6701 Rockledge Drive, Bethesda, MD 20892-7902, Attention Deborah Coulter, Purchasing Agent. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Posted 05/27/99 (W-SN336471). (0147)

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