SOLICITATION NOTICE
B -- Consultant
- Notice Date
- 4/7/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
- ZIP Code
- 20892-7663
- Solicitation Number
- 263-2005-q-DQ-0034
- Response Due
- 4/11/2005
- Description
- Under authority U.S.C. 253(c)(1), FAR 6.302-1(a) (2)The National Institute of Health (NIH), Office of Biotechnology Activities (OBA)intends to negotiate and award, on a sole-source basis, a contract with Lawrence Friedman, 11712 Farmland Drive, Rockville, MD. The NIH has a requirement for a consultant to provide expert advice to the work of the Clinical Trial Design Working Group, of the NIH Recombinant DNA Advisory Committee. The incumbent shall provide but shall not be limited to the following services : ?Shall research, gather information and prepare analyses of current issues being explored by the Crpac program This shall include areas such as adverse event reporting; clinical trial design and clinical monitoring; regulations governing research involving human biological materials; informed consent; third parties, streamlining and standardizing policies and guidelines required for the conduct of clinical research. ?Shall plan and organize a series of workshops and national conferences regarding clinical trial design and clinical trial monitoring issues with initial emphasis on the roles and responsibilities and operating procedures of Data and Safety and Monitoring Boards (DSMB). ?Shall participate in and provide expert advise to the work of the Clinical Trial Design Working Group, of the NIH Recombinant DNA Advisory Committee. ?Shall interact with the senior policy and program staff within the individual NIH IC?s, staff in federal agencies and offices that have responsibilities relative to the oversight of clinical research, including the Office for Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the federal agencies that have adopted the Common Rule, as well as patient advocacy and voluntary organizations and other constituencies with a stake in the conduct of clinical research. ?Shall have at least thirty years of medical experience. ?Shall have experience with this subject in relation to the NIH. An estimated 580 hours will be required for completion of this project. And the work shall begin immediately. This is not a formal solicitation, however, concerns that respond to this notice must furnish concise responses directed specifically to the requirements mentioned above. Sources demonstrating the capability to accomplish the above shall supply pertinent information in sufficient detail to demonstrate their ability to perform. Information furnished shall include enough material to perform a proper evaluation. Respondents will not be notified of the evaluation results.
- Record
- SN00784194-W 20050409/050407211914 (fbodaily.com)
- Source
-
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