SOLICITATION NOTICE
R -- Medical Officer Services for General Clinical Research Centers (GCRCs) Portfolio Oversight
- Notice Date
- 4/18/2005
- 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-RR-P-05-027A
- Response Due
- 5/20/2005
- Archive Date
- 6/4/2005
- Small Business Set-Aside
- Total Small Business
- Description
- The purpose of this synopsis is to amend previously synopsized synopsis/solicitation number NHLBI-RR-P-05-027 for ?Medical Officer Services for General Clinical Research Centers (GCRCs) Portfolio Oversight,? published December 15, 2004. The National Heart, Lung, and Blood Institute (NHLBI), for the National Center for Research Resources (NCRR), intends to procure the services of a contractor to perform as a medical consultant to guide, assist, and facilitate NCRR in the oversight of a portfolio of sixteen (16) grants for General Clinical Research Centers (GCRCs), and grants for the clinical research resource programs specified below, for the Division for Clinical Research Resources at the NCRR. The assigned portfolio consists of sixteen (16) grants for General Clinical Research Centers (GCRCs) that support clinical research resources, five (5) grants for National Gene Vector Laboratories (NGVLs) that provide gene vectors for gene therapy and gene transfer experiments, ten (10) grants for Islet Cell Resource Centers (ICRCs) that provide transplantation grade islets for basic and clinical research studies, and a grant for the National Disease Research Interchange (NDRI) that supports human specimen collection services. The Statement of Work is as follows: Contractor Requirements: Independently, and not as an agent of the Government, the Contractor shall furnish the materials, equipment, and facilities not otherwise provided by the Government under the terms of the contract. Specifically, the Contractor shall follow the scientific progress and financial status of each of the grants within the assigned portfolio. The Contractor shall consult with grantee organizations, review annual progress reports, attend programmatic site visits, provide recommendations to the Division Director, Division for Clinical Research Resources, on budgetary and administrative matters, which may lead to consolidation and/or the reorganization or significant administrative changes within these clinical research resource programs. The Contractor shall also review policy documents in an effort to facilitate the evaluation of the programs supported by these grants. The National Gene Vector Laboratories (NGVLs) generate Good Manufacturing Practice-grade materials for use in gene transfer protocols at no cost to clinical researchers throughout the United States. The Contractor shall provide oversight management responsibility for the cooperative agreement grants supporting this program. The Contractor shall facilitate expansion of the activity of the NGVLs within the scope of the grants, to include toxicology support. In addition, the Contractor shall facilitate the availability of the NGVL data, as appropriate, to the entire research community through the grantee?s web site, in an effort to decrease reduplication of effort by the National Institutes of Health (NIH) grantees. The Contractor shall also be responsible for monitoring and providing advice to the Associate Director for Clinical Research Resources on the grantees? management of the NGVL repository. The Contractor shall also provide oversight for the cooperative agreement grants that support the Islet Cell Resource Centers (ICRCs) consortium, with funds from the NCRR and the National Institute of Diabetes and Digestive and Kidney Diseases. The mission of the ICRC is to allow optimization and sharing of the procedures necessary for collection of functional human islet cells from cadaveric pancreata and their subsequent transplantation into patients afflicted with type 1 diabetes. Such efforts are critical in view of the limited supply of human pancreata. The ICRC grantees shall continue to develop Good Manufacturing Practice criteria to ensure that the islets generated will be of consistent transplant quality. The Contractor shall also provide oversight and participation in a joint Steering Committee, established to review and approve site-specific protocols for transplantation of cells into eligible patients. The National Disease Research Interchange (NDRI), a not-for-profit organization, is supported by a cooperative agreement grant managed by the NCRR. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Eye Institute (NEI), the National Institute of Allergy and Infectious Diseases (NIAID), and the Office of Rare Diseases also contribute funds through this grant. The mission of the NDRI is to identify, obtain, and distribute human tissues and organs to investigators for use in basic research studies. The Contractor shall provide oversight and make recommendations to the Associate Director for Clinical Research Resources in support of the cooperative agreement. Period of performance: The proposed period of performance for these services will consist of one twelve (12) month basic contract period, and shall include options to renew for four (4) successive twelve (12) month periods. It is anticipated that work, under the proposed contract, will begin on or about July 1, 2005. Level of effort: The level of effort required is based on an hourly rate for the services of a Medical Officer to provide oversight for a portfolio of clinical research resource programs. The number of hours required to perform these services are estimated not-to-exceed 2,080 over a twelve (12) month period. This equates to a full-time work schedule of 40 hours per week. The total effort, in labor hours, will be reported monthly and serve as the basis for payment. A noncompetitive award is contemplated for this requirement to Richard A. Knazek, M.D., 18330 New Cut Road, Mount Airy, Maryland 21771. The noncompetitive determination is based upon FAR Part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. This is a total small business set-aside requirement. Interested parties are requested to review the Statement of Work and submit a response which includes a loaded hourly rate, estimate of travel, and other direct costs, Curriculum Vitae, at least three (3) references documenting similar past performance experiences, and a technical approach of how the work will be performed. Responses to this synopsis will be evaluated based on the following evaluation criteria, which are presented in descending order of importance: 1) Demonstrated expertise and an in-depth understanding of the extramural and intramural environments at the National Institutes of Health (NIH); 2) Knowledge and ability to communicate effectively with both areas of science and research within the NIH environment; 3) Specific knowledge and experience with clinical research resource programs; and 4) Past performance. The offeror must submit at least three (3) references documenting similar past performance experiences. Responses are due not later than May 20, 2005 by 4:30 P.M. Responses must be submitted in writing to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, Rockledge Building 2, Suite 6145, 6701 Rockledge Drive, Bethesda, Maryland 20892-7902, Attention: Mrs. Melissa Lombardo, Contract Specialist. The North American Industry Classification (NAICS) Code is 541990 and the Size Standard is $6.0M. 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 with the discretion of the Government. Any competing firm that believes it is capable of providing the above requirement is invited to provide sufficient documentation to demonstrate that capability to the Contract Specialist. See Numbered Note 22. (0205)
- Record
- SN00790127-W 20050420/050418211607 (fbodaily.com)
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