SOLICITATION NOTICE
B -- Special studies and analysis
- Notice Date
- 5/21/2010
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB-(DE)-2010-143-DDC
- Archive Date
- 6/10/2010
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THE NATIONAL INSTITUTES OF HEALTH (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), on behalf of the National Institute of Dental and Craniofacial Research (NIDCR), intends to negotiate with Ms. Sharon Mavroukakis to provide Clinical Trial Support services to support the clinical research efforts of the NIH Bone Marrow Stromal Cell Transplantation (BMSCT) Center. Background Information: The service that is required is in support of the NIH Bone Marrow Stromal Cell Transplantation Center. The mission of the center is to: 1) prepare clinical grade human bone marrow stromal cells to be used by investigators to treat patients with a variety of the diseases, and 2) to provide investigators with assistance in preparing regulatory documents such as a clinical protocol for Institutional Review Board (IRB) approval, and Drug Master Files and Investigation New Drug Applications (INDs) for approval by the Food and Drug Administration (FDA). The work to be accomplished is related to the second part of the NIH Bone Marrow Stromal Cell Transplantation Center’s mission. The contractor shall provide Clinical Trial Support services to support the clinical research efforts of the NIH Bone Marrow Stromal Cell Transplantation (BMSCT) Center. The services will include drafting biomedical research protocols and informed consent documents for NIH BMSCT clinical trials, revising protocols as needed, assisting in writing Drug Master Files (DMFs) and Investigation New Drug Applications (INDs). Purpose and Objectives for the Procurement: The objectives of the proposal are: •Design and write clinical research protocols and informed consent documents to ensure regulatory and guidance specifications are met (i.e., Good Clinical Practices (GCP), IRB, FDA, Office of Human Research Protection (OHRP), Office of Biotechnology Activities (OBA). •Complete continuing reviews/annual reports and protocol amendments, incorporating sponsor, FDA and IRB stipulations and recommendations. •Develop and maintain Drug Master File (DMF) and Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) to include: writing the DMF and IND with all applicable sections, compiling the submission according to FDA guidance, creating IND-Safety Reports, creating mandatory or voluntary MEDWATCH reports, writing FDA annual reports. •Audit and monitor all aspects of clinical trial implementation. Meeting all objectives will result in the submission of a Drug Master File Investigational New Device application to the Food and Drug Administration for their review, and in the submission of clinical protocols to Institutional Review Boards of different institutes for review. Contractor Requirements: 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) Drug Master File (DMF) and Investigational New Drug (IND) applications; 3) preparing documents for NIH Institutional Review Boards (IRB) that comply with FDA and Office of Human Research Protections (OHRP), HHS mandated guidelines and procedures. The tasks listed 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 contractor shall be familiar with the IRB requirements of the participating principal investigators, the protocol subject requirements and other new business presented to the BMSCT Center. The Contractor will submit documents to the participating principal investigators and NIH BMSCT Coordinator. The Contractor will attend BMSCT meetings as needed. The services required involve prolonged periods of up to 25 hours/week of detailed computer work with a variety of software programs, including MSWORD, Acrobat, MS Excel, MS ACCESS, and MS Outlook. Tasks 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 contractor shall provide the tasks described below. 1)Review biomedical research protocols during the development phase and make recommendations in writing. a.Review formatting and content to meet the IRB requirements. b.2-3 new protocols per quarter. c.Completion of document review within seven (7) business days, with corrections returned within 2 business days. d.Recommendations will be documented electronically via remote applications (http://remoteapps.nci.nih.gov/) according to established procedures, which will be provided to the contractor. 2)Write informed consent documents with review/input of the Principal Investigator, according to IRB requirements. a.2-3 informed consent documents per quarter. 3)Write/coordinate documents for submission and response to stipulations for the Scientific Review, IRB, and/or FDA according to agency/review body policies and procedures and established BMSCT procedures, which will be provided to the contractor. a.2-3 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. 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 BMSCT investigator submission to the FDA according to established procedures, which will be provided to the contractor. a.2-3 IND submission packages per annum, to be completed within 2 weeks of IRB approval of the research protocol, according to CFR 21 Part 312. 5)Draft DMF application according to FDA Guidelines for Drug Master Files, specifically CBER requirements. 6) The contractor will evaluate the tasks at hand on a weekly basis, and will coordinate these tasks with appropriate NIH staff. Government Responsibilities: The contractor will be provided with an NIH username and clearance to selected BMSCT data files. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL All Contractor staff that have access to and use of NIH electronic mail (e-mail), and all contractor staff must identify themselves as contractors on all outgoing e-mail messages, including those that are sent in reply or are forwarded to another user. To best comply with this requirement, the contractor staff shall set up an e-mail signature ("AutoSignature") or an electronic business card ("V-card") on each contractor employee's computer system and/or Personal Digital Assistant (PDA) that will automatically display "Contractor" in the signature area of all e-mails sent. Reporting Requirements and Deliverables; The contractor shall provide the tasks described above. The frequency of performing each task shall be determined by the project officer, to be communicated to the contractor through email or written instructions as often as required to perform a task but no less than once a week. Program Management and Control Requirements: The contractor shall carry out quality control procedures for the generated products and shall maintain records for these services, using both hard copy and computer formats in Microsoft Excel or Word that meet standard record keeping and requirements associated with generating products for treating patients enrolled in clinical protocols, and according to established procedures. Records shall be maintained primarily in computer formats using Microsoft Word, Microsoft Excel, but also Acrobat PDF. Inspection and Acceptance Requirements: The contractor shall function with a high level of independence from a list of needs drawn from the tasks noted above and provided by the project officer several times a week. The contractor shall have the responsibility for organizing and carrying out assignments and for quality control of the products generated. Inspection and acceptance of all documents will be performed by the Project Manager either by electronic examination of the prepared documents or by meetings set by the Project Manager. The reference number for this notice is NHLBI-PB-(DE)-2019-143-DDC The resultant acquisition will be conducted in accordance with FAR Part 13, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2005-40. The period of performance shall be from June 1, 2010 through May 31, 2011. The estimated level effort for this requirement is not expected to exceed 572 hours for twelve months. The total estimated amount of this contract is NOT expected to exceed the simplified acquisition threshold of $100,000.00. The intended procurement will be classified under North American Industry Classification System code 541711, with size standard of $7.0million. The sole source basis is determined based on Ms. Sharon Mavroukakis knowledge, experience, and skills needed to accomplish the task with the quality and speed necessary. The services required involve prolonged periods of up to 25 hours/week of detailed computer work with a variety of software programs, including MSWORD, Acrobat, MS Excel, MS ACCESS, and MS Outlook. Ms. Mavroukakis has the require extensive knowledge of the 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). She has the skills for writing biomedical research protocol, and has prepared 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; and prepared documents for NIH Institutional Review Boards (IRB) that comply with FDA and Office of Human Research Protections (OHRP), HHS mandated guidelines and procedures. Ms. Mavroukakis is considered essential to the mission of the NIDCR Program. Ms. Mavroukakis ongoing participation provides continuity of experience. Therefore, Ms. Mavroukakis is the only logical choice based upon all critical factors (i.e., knowledge, skills, abilities, experience) temporal and geographic availability. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by May 26, 2010, 7:30am Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurements. Inquires to this announcement, referencing synopsis number NHLBI-PB-(DE)-2010-143-DDC, may be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, Maryland 20892-7902, Attention: Deborah Coulter. Response may be submitted electronically to coulterd@nhlbi.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-(DE)-2010-143-DDC/listing.html)
- Place of Performance
- Address: NIH, BETHESDA, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02156791-W 20100523/100521235311-a1323997a5a819f16ef498e81180d79b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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