SOLICITATION NOTICE
R -- Professional, Scientific and Technical Services
- Notice Date
- 3/23/2005
- Notice Type
- Solicitation Notice
- 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, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PS-2005-074-DDC
- Response Due
- 3/31/2005
- Archive Date
- 4/15/2005
- Small Business Set-Aside
- Total Small Business
- Description
- 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. The National Heart, Lung, and Blood Institute (NHLBI) intends to negotiate and award a purchase order on a noncompetitive basis to Lawrence Friedman, LLC, 11712 Farmland Drive, Rockville, Maryland 20852, to provide consultation services to the Directors of the NHLBI?s Extramural Divisions, the Office of Prevention, Education, & Control, and the Office of Science Policy and Technology. STATEMENT OF WORK: Specifically, the Contractor shall, provide consultation services that 1) Provide scientific review of documents, policies and issues as they relate to clinical study design, clinical study monitoring, and bioethics policies and issues, providing expertise in expertise on study protocol, as well as DSMB and monitoring issues. 2) Review ethics documents such as outside activity requests and conflict of interest forms for data and safety monitoring boards. 3) Provide an update of the Data and Safety Monitoring Board (DSMB) & /Observational Safety Monitoring Board (OSMB) operational guides to improve oversight of clinical trials by updating policy guidelines to facilitate improved interpretation of existing regulations. This project is expected to require 224 man hours during the period of performance, Beginning on April 1, 2005 through October 31, 2005. The sole source determination is based upon the knowledge, skills and expertise of the extramural environments at NIH and the ability to communicate effectively with both areas of science, and research. Also, the successful management of clinical research programs utilizing innovational approaches to complex, difficult, and often high-profile situations. In order to continue the successes gained by the NHLBI in its clinical research programs, it is critical that continuity is maintained and that the work of the Division of Clinical Trials for NHLBI continues without disruption of service. For all these reasons, it is most cost effective to award this contract to Dr. Friedman who has the expertise in the scientific area, the understanding of the NIH environment and the specific knowledge and experience of the Division of Clinical Trials. An award to any other source would affect the NIH?s anticipated outcome based upon Dr. Friedman?s experience, and would not provide any cost savings to the Government. The North American Industry Classification (NAICS) Code is 541990 and the Size Standard is $6.0M. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures. It is noted that FAR Part 6, Competition Requirement is not applicable to simplified acquisition. This notice of Intent is not a request for competitive proposals. Interested parties are requested to review the above requirements, and submit a statement of interest which includes; documented experience in clinical study design and monitoring and in data access issues, particularly related to clinical research data; familiarity with medical-scientific public communications and interactions with other government agencies; documented intimate knowledge of NIH regulations and policies, including NIH cooperative agreements, contracts and grants policies. The consultant must be thoroughly knowledgeable of the clinical trials and observational studies being considered or conducted at NHLBI. The statement of interest must propose a methodology of assuring the achievement of timely and acceptable performance of the work, as well as the proposed method for administration of costs relevant to this contract, and at least three (3) references documenting past performance experiences and completion of the project. The submission will be evaluated on the Offeror?s hourly rate, documented knowledge, skills, abilities, and experiences as reflected in the statement of interest, and past performance. The statement of interest must be submitted on or before March 29, 12:00 noon. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government. Comments to this announcement, referencing synopsis number ?NHLBI-PS-2005-074,? may be submitted to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20814-7902, Attention: Deborah Coulter.
- Place of Performance
- Address: Bethesday Maryland
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN00773930-W 20050325/050323211757 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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