National Library of Medicine, Office of Acquisitions Management, Building 38A, Room B1N17, 8600 Rockville Pike, Bethesda, MD 20894

R -- ADVISORY AND ASSISTANCE SERVICES SOL NLM/97-078/LTN DUE 090297 POC Liem T. Nguyen, Contract Specialist, 301-496-6546 Description of Acquisition or Award: The National Institute of Health, Office for Protection from Research Risks (OPRR) intends to negotiate on a sole-source basis with Sanford L. Leiken, M.D., 5510 Lambeth Road, Bethesda, Maryland 20814, under the authority 41 U.S.C. 253 (c)(1) and FAR 6.302-1(b)(1) for obtaining advisory and assistance services. Advisory and assistance services will be provided for the purpose of expansion of the capabilities of the Division of Human Subject Protections (DHSP) to include the perspective and expertise of an individual with medical, bioethical, and current, first-hand Institutional Review Board (IRB) credentials and experience. Advisory and assistance services will support the programs of the DHSP, OPRR. Support will be provided through expert medico-ethical advice and assistance regarding the methods and procedures established by OPRR/DHSP to require corrective actions under Multiple Project Assurance (MPA) agreements in order to ensure compliance by awardee institutions with the Department's requirements for the protection of human subjects of HHS-supported or conducted research, as set forth in Title 45 Code of Federal Regulations Part 46 (45 CFR 46). Compliance oversight investigations involving findings of noncompliance with human subject protection requirements and resultant corrective actions required by OPRR under MPA agreements will be analyzed by the consultant, who will then provide his opinions, advice, and recommendations regarding established mechanism and/or innovative approaches to resolve problems identified through that review. Emphasis will be placed on the ethical issues raised by the alleged noncompliance, the ethical implications of required corrective actions, effectiveness of required actions, and the regulatory impact of such required actions on MPA renewal. Dr. Leiken has the credentials, specialized experience, expertise, and other qualifications to provide the requested Advisory and Assistance Services. Dr. Leiken formerly served as Director, Office of Ethics, Children's National Medical Center, where he also chaired the Institutional Review Board (IRB) operations. Dr. Leiken currently serves as a volunteer, nonaffiliated member of an IRB devoted to oversight of cutting-edge, clinical, pediatric research. This combination of clinical, administrative, and ethical experience makes Dr. Leiken uniquely qualified to provide the described services. Dr. Leiken is the only individual known to OPRR who has the experience, expertise, and availability to undertake provision of the requested services. The period of performance shall begin on or about September 30, 1997 and extend for one year. This notice of intent is not a Request for Quotations (RFQ) nor is an RFQ available. (0230)

Loren Data Corp. http://www.ld.com (SYN# 0079 19970820\R-0022.SOL)