SOLICITATION NOTICE
R -- Biomedical Research Protocol Consultation for the Pediatric Oncology Branch
- Notice Date
- 5/17/2007
- 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 Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NCI-70060-NV
- Response Due
- 5/30/2007
- Archive Date
- 6/14/2007
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) proposes to acquire, on a sole source basis with Sharon Mavroukakis, Rockville, Maryland 20850 to provide senior research nurse consultant support. The POB develops new therapies to improve the survival and quality of life for individuals with childhood cancers. The conduct of biomedical research is complex and increasingly fraught with complicated regulatory requirements. The Principal Investigators (PI) of the Pediatric Oncology Branch (POB) are dedicated to the study and treatment of childhood cancer. During the past decade, there has been considerable progress in understanding fundamental processes in the pathogenesis of pediatric cancers. New insights in the cell biology, immunology and molecular genetics of specific cancers have led to new targets for therapy. After extensive laboratory research of potential new cancer treatments, the Principal Investigators in POB must engage in a long regulatory review process prior to the initiation of a clinical research protocol. That review process includes a peer review of the clinical trial plan or research protocol, followed by a scientific review by the Protocol Review and Monitoring Committee (PRMC) of the CCR, NCI. Once that review is completed, additional review, documentation and oversight is required by a sponsor, the Institutional Review Board (NCI IRB) and/or an Investigational New Drug (IND) application is filed with the Food and Drug Administration (FDA ). This lengthy process is extremely time consuming, requiring extensive labor hours, which normally delays the successful and timely completion of research due to conflicting PI priorities. The contractor shall support research protocol writing and revisions, draft standard and ad hoc reports, and assist in the maintenance of office documents and records. On occasion the contractor shall oversee study monitoring and/or data collection. To perform this work a contractor must meet the following minimum qualifications: The contractor shall have a college science degree master?s and a minimum of five (5) years work experience in these areas: 1) writing biomedical research protocol documents including study design and informed consents; 2) preparing applications for the following Regulatory Offices reviewing biomedical research: Office of Biotechnology Activities (OBA), NIH and Institutional Biosafety Committee (IBC), NIH and U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications; 3) preparing documents for NCI Institutional Review Boards (IRB) that comply with FDA and Office of Human Research Protections (OHRP), HHS mandated guidelines and procedures. Tasks 1 -3 require extensive knowledge of and application of the Code of Federal Regulations, Title 45, Public Welfare, PART 46, Protection of Human Subjects; TITLE 21?Food and Drugs, and NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH GUIDELINES). The tasks the contractor will be required to perform are as follows: 1) Review Pediatric Oncology Branch biomedical research protocols during the development phase and make recommendations in writing: a) review formatting and content to meet the NCI IRB requirements (http://home.ccr.cancer.gov/IRB/index.htm); b) 5-10 new protocols per quarter; c ) completion of document review within seven (7) business days, with corrections returned within 2 business days; and d) recommendations will be documented in the protocol file in the Pediatric Oncology Branch Server via remote applications (http://remoteapps.nci.nih.gov/) according to established POBPSO procedures, which will be provided to the contractor; 2) Write informed consent documents with review/input of the Principal Investigator, according to NCI IRB requirements (http://home.ccr.cancer.gov/IRB/index.htm); a) 5-10 informed consent documents per quarter; 3) Write/coordinate documents for submission and response to stipulations for the PRMC, IRB, and sponsor(s) according to agency/review body policies and procedures and established POBPSO procedures, which will be provided to the contractor; a) 10-20 documents, including Response memorandum, copy of protocol document with changes underlined, copy of protocol document with changes accepted, copy of consent document with changes underlined, copy of consent document with changes accepted; and b)Completion of document review within seven (7) business days, with corrections returned within 2 business days; 4) Draft IND submission packages according to CFR 21 Part 312 and coordinate with the Pediatric Oncology Branch Protocol Support Office submission to the FDA according to established POBPSO procedures, which will be provided to the contractor. a) 3-4 IND submission packages per annum, to be completed within 2 weeks of NCI IRB approval of the research protocol according to CFR 21 Part 312; and 5) Draft OBA applications according to NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH GUIDELINES) for assigned gene therapy research trials (http://www4.od.nih.gov/oba/Rdna.htm) and established POBPSO procedures, which will be provided to the contractor. Sharon Mavroukakis is the only known source to the NCI Researcher who possesses the skills and expertise to perform the work as outlined above. Sharon Mavroukakis brings to the POB highly unique expertise in the regulatory requirements for the writing and execution of clinical trials for children with cancer at the NCI. The contractor brings over 20 years of experience in the conduct of translational trials in oncology at the NCI and therefore is able to provide the investigators in the POB with expert support in generating the requirements necessary for regulatory approval of new clinical trials. Specifically, Ms. Mavroukakis aids clinical investigators in the POB in the writing of clinical trials with a focus on ensuring that all specific regulatory requirements for the scientific review committees, institutional review board, Cancer Therapeutic Evaluation Program, NIH Ethics Guidelines and FDA requirements are met. In addition, Ms. Mavroukakis provides expertise in writing of Investigational New Drug Applications for submission for the FDA and provides oversight for adverse event reporting for clinical trials. This expertise allows the investigators of the POB to generate, modify and optimize clinical trials in an expeditious fashion and ensure that we conduct our clinical research meeting all regulatory standards at the highest level possible. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.5 to use simplified procedures for commercial acquisitions. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the entire above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI researcher to determine if it can meet the requirements of this synopsis. An original and one copy of the capability statements must be received in the Contracting Office by 1PM EDT (local Washington, D.C. time) on May 30, 2007. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and may be emailed to Debbie Moore at dm170b@nih.gov or faxed (301) 402-4513. It is the vendor?s responsibility to call (301) 402-4509 and verify that questions were received. A determination by the Government not to compete this proposed contract 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. In order to receive an award from the NCI, contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov in order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. NAICS: 541990; Size Standard is $6.5M .
- Record
- SN01296594-W 20070519/070517220543 (fbodaily.com)
- Source
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