SOLICITATION NOTICE
B -- Consulting Services
- Notice Date
- 9/12/2011
- 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-CSB-(HL)-2011-325-DDC
- Archive Date
- 10/1/2011
- 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
- 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 COAC Services Branch, Office of Acquisitions, DERA, National Heart, Lung, and Blood (NHLB), NIH, for the Division of Intramural Research (DIR), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Ms. Sharon Mavroukakis, to provide Support Services for the Hematology Branch of DIR. The contractor shall provide services to support the clinical research tasks and procedures for the National Heart, Lung and Blood Institute. The contractor shall, with NHLBI Leadership, establish outcomes for a research support infrastructure based on needs of the Branches, assess the competence, expectations and training needs of staff in place, make recommendations for personnel, space and equipment, draft Standard Operating Procedures for research/protocol support activities, provide training and oversight of the support staff to ensure quality, accuracy and timeliness. Provide protocol support activities where needed for the protocol actions, including drafting biomedical research protocols, case report forms and informed consents, revising protocols as needed for response to stipulations from review bodies or amendments, create Instituational Review Board (IRB) submissions, standard and ad hoc reports, and assist in the maintenance of documents and records. The contractor shall upon request draft Food and Drug Administration (FDA) Investigational New Drug (IND) applications, Office of Biotechnology Activities (OBA) and/or Institutional Biosafety Committee (IBC) (applications in conjunction with the NHLBI staff. The contractor shall perform the tasks described below, via e-mail or internet connections. On-site evaluations, assessments, meetings and training to meet the tasks will be performed at a mutually agreed upon time in the facilities located in the NIH Clinical Center. 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. Tasks: 1) Establish outcomes for the support infrastructure based on needs of Branches: a. Meet with NHLBI Leadership to determine the research support needs of each Branch b. Meet individually with each of the staff currently employed, and with the group as a whole to discuss and establish expectations and training needs. 2) Make recommendations to NHLBI leadership for personnel, space and equipment to adequately support the research infrastructure. 3) Draft Standard Operating Procedures for research support activities to ensure accuracy and adherence to applicable regulations and guidelines. 4) Provide training and oversight of the support staff, to ensure quality, accuracy and timeliness, and provide assessments to the supervisors of the support staff. 5) Provide protocol and research support where needed. The research support infrastructure may include, but not limited to the following activities (based on NHLBI Leadership need determination): 1. Maintenance of protocols across the life-cycle: protocol writing, drafting response to stipulations (scientific review, IRB, FDA), consent writing, completing PTMS applications, designing paper protocol case report forms, drafting amendments, drafting continuing reviews and DSMB reports, collecting AIs willingness to participate documentation, maintain electronic files of all protocol actions. 2. Provide IND Sponsor support: draft IND/IDE applications, draft FDA IND/IDE amendments, draft FDA annual reports, and maintain electronic regulatory files of all FDA submissions and correspondence. 3. Central clearing house for regulatory documentation: maintenance of elements of regulatory binders: current CVs, normal lab ranges, CLIA certifications, Certifications of HSP training. 4. Other regulatory applications: draft applications and maintain files and submissions for OBA, IBC, and RSC, if applicable. Government Responsibilities: The contractor will be provided with an NIH username and clearance to selected BMSCT data files. Remote access to National Institutes of Health (NIH) electronic resources requires two-factor authentication and the use of Government-furnished Equipment (GFE). NHLBI will provide a government-owned laptop for use by the contractor for the duration of the contract. The contractor will obtain an NIH PIV identity card that will be used to authenticate to electronic resources. In case the contractor is unable to obtain a PIV card, a separate two-factor authentication method will be provided by NHLBI. The contractor must satisfy all the security training requirements of the NIH prior to obtaining credentials that allow to connect to NIH electronic resources. Reporting Requirements and Deliverables; The delivery point is the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), OCA 10 Center Drive, Building 10-Room 6-5140, Bethesda, Maryland 20892 MSC 1608. The period of performance shall be from September 16th, 2011 through September 15th, 2012. The estimated level effort for this requirement is not expected to exceed 240 hours for ve months. The total estimated amount of this contract is NOT expected to exceed the simplified acquisition threshold of $150,000.00. The intended procurement will be classified under North American Industry Classification System code 541711, with size standard of 500 employees. 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 required 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 NHLBI 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. The notice of intent is not a request for competitive proposals. Only one responsible source and no other supplies or services will satisfy agency requirements. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001) and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-53 (August 4th 2011). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, September 16, 2011by 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 Inquires to this announcement, referencing synopsis number NHLBI-CSB-(HL)-2011-325-DDC, may be submitted to the COAC Services Branch, Office of Acquisitions, DERA, National Heart, Lung and Blood Institute, (NHLBI), 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-CSB-(HL)-2011-325-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02571882-W 20110914/110912235453-4ebea9df5636f52b8614e19d5a87786d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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