SOLICITATION NOTICE
Q -- Senior Research Nurse Consultant
- Notice Date
- 4/11/2008
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-80065-NG
- Point of Contact
- MalindaHoldcraft,, Phone: (301) 402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.nih.gov, cr214i@nih.gov
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) and the Surgery Branch (SB), plans to procure on a sole source basis services for a Senior Research Nurse Consultant with Sharon Mavroukakis, 4 Monroe Street No. 610, Rockville Maryland 20850. The supplies and services herein are defined as commercial, as defined in FAR Part 2 and are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13. The North American Industry Classification System code is 541690 and the business size standard is $6.5M. Only one award shall be made as a result of this solicitation. This is a firm fixed price, indefinite delivery indefinite quantity (IDIQ) type contract. Period of Performance: For POB, the period of performance is: Twelve (12) months from date of award with four (4) one year option periods with a minimum of 95 hours and a maximum of 715 hours for the base year and each option. For SB, the period of performance is: Twelve (12) months from date of award with two (2) one year option periods with a minimum of 20 hours and a maximum of 572 hours for the base year and each option. The benefit of this contract is the conduct of biomedical research which is complex and increasingly fraught with complicated regulatory requirements. The Pediatric Oncology Branch (POB) and Surgery Branch (SB) at the NIH NCI have dual functions aimed at improving the management of patients with cancer. Each branch has a major commitment to providing surgical consultative care for patients throughout the Clinical Center and is responsible for clinical care in most surgical subspecialties, including thoracic surgery, gynecological surgery, endocrinology surgery, pediatric surgery, vascular surgery, and vascular access. The Contractor shall provide services to both the NCI-POB and the NCI-SB: 1) Review NCI biomedical research protocols during the development phase and make recommendations in writing; 2) Write informed consent documents with review/input of the Principal Investigator, according to NCI Institutional Review Board (IRB) requirement; 3) Write/coordinate documents for submission and response to stipulations for the Protocol Review and Monitoring Committee (PRMC), IRB, and sponsor(s) according to agency/review body policies and procedures and established POB Protocol Support Office (PSO) procedures, which will be provided to the contractor; 4) Draft Investigational New Drug (IND) submission packages according to CFR 21 Part 312 and coordinate with the NCI CCR submission to the Food and Drug Administration (FDA) according to established procedures, which will be provided to the contractor and; 5) Draft Office of Biotechnology Activities (OBA) applications according to NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH GUIDELINES) for assigned gene therapy research trials and established procedures. Sharon Mavroukakis is the only source known to the NCI that can provide the services required. She has acquired the expertise and knowledge and is recognized as an expert in writing research protocol documents. In addition, she is familiar in working with senior scientific and administrative officials to prepare applications for several regulatory offices which include the Food and Drug Administration (FDA) the Institutional Biosafety Committee, as well as the National Institutes of Health and NCI. She has in depth knowledge of federal regulations that are relevant to the protections of human subjects. Finally, Sharon Mavroukakis has in-depth knowledge of the software systems employed to maintain regulatory compliance in the Protocol Support Office, NCI which is essential for these tasks. This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Contractor shall provide one (1) original and one (1) copy of the capability statement. Capability statements must be received in the contracting office by 11:00 AM ET, on April 21, 2008. All questions must be in writing and can be faxed or emailed to the following: Malinda Holdcraft, Contract Specialist via electronic mail at holdcram@exchange.nih.gov or fax 301-402-4513. It is the contractors responsibility to ensure all questions have been received in the contracting office. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered and have valid certifications in the Central Contractor Registration (CCR) and the Online Representations and Certification Application (ORCA). Please reference NCI-80065-NG on all correspondence.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=3858c4b03fbb2d6025fe8c674a54116a&tab=core&_cview=1)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01552834-W 20080413/080411221905-3858c4b03fbb2d6025fe8c674a54116a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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