MODIFICATION
A -- Acute Respiratory Distress Syndrome Clinical Trials Research Network - Clinical Center
- Notice Date
- 5/28/2013
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- HHS-NIH-NHLBI-RDSS-HR-14-09
- Archive Date
- 12/1/2013
- Point of Contact
- Mary M. Farrell, Phone: 3014350350
- E-Mail Address
-
mary.farrell@NIH.gov
(mary.farrell@NIH.gov)
- Small Business Set-Aside
- N/A
- Description
- Clinical Centers for NHLBI Acute Respiratory Distress Syndrome Clinical Trials Research Network (ARDSnet) Sources Sought Notice RFP HHS-NIH-NHLBI-RDSS-HR-14-09 Contracting Office Address 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 RKL2/6016 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES Introduction This Sources Sought Notice is for interested small and large businesses. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small and large business sources; (2) whether small businesses are classified as HUBZone; service-disabled, veteran-owned; 8(a); veteran-owned; woman-owned; or small disadvantaged; and (3) the size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition for any interested businesses. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code for this acquisition is 541712. Background The NHLBI is seeking Clinical Centers (CCs) for an ongoing program - the NHLBI ARDS Clinical Trials Network (ARDSNet). The ARDSNet is a collection of 12 CCs and one Clinical Coordinating Center (CCC) that conducts definitive clinical trials that can improve the outcomes of patients with ARDS. The CCs are completing enrollment in their fourth and final trial: Statins for Acutely Injured Lungs with Sepsis (SAILS). This study tests the efficacy of rosuvastatin in resolving Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) in patients with ALI/ARDS from an infectious etiology. The NHBLI anticipates that the CCs will be needed for approximately 9 months from December 1, 2013 to August 31, 2014 to recruit the final 200 patients to complete the trial. The ARDSNet is governed by a Steering Committee (SC) composed of Principal Investigators (PI) from the CCs, the CCC, and the NHLBI Contracting Officer's Representative. The CCC oversees all aspects of network functions and governance. NHLBI has a Data and Safety Monitoring Board (DSMB) for advice on participant safety and study continuation in accordance with decision guidelines that are a part of the clinical trial protocol. The PIs from the 12 CCs contribute substantially to the trial's scientific leadership and operational management. CC PIs will participate in SC and other subcommittee meetings. The CCs will work collaboratively with the CCC to complete the SAILS trial. CCs will collect data at the local level in accordance with the trial and manuals of operational procedures, transmit data to the CCC, and manage each participant's treatment. The contractor will be a CC and will be responsible for the Project Requirements as described below. Project Requirements The CC is expected to fulfill the following: In accordance with the ARDSNet Operating Manual the contractor shall: a.Enroll a minimum of 17 patients which reflects appropriate enrollment of women and minorities; obtain informed consent, and collect screening and enrollment data to the CCC in accordance with the protocol and ARDSNet Operating Manual. b.Coordinate with the CCC to train staff in procedures for data collection, entry, transmission and quality control. c.Participate in regular meetings and teleconferences of the PIs and clinical nurses within the CC and the SC to monitor trial progress, identify problems, and develop solutions. Perform quality control and quality assurance activities, including oversight of patient care, adherence to protocols. d.Maintain a record of all adverse events and report serious adverse events in accordance with NHLBI policies found at: http://www.nhlbi.nih.gov/funding/ethics.htm e.Transmit, in a timely manner, patient data to the CCC in accordance with the ARDSNet Operating Manual. f.Procure biological specimens from enrolled patients in accordance with the protocol and ARDSNet Operating Manual. Perform initial specimen processing and send processed biological specimens to the NHLBI Biologic Specimen Repository. g.Participate in the preparation and dissemination of the results and conclusions of the trials via abstracts and manuscripts in accordance with ARDSNet publication procedures. Capability Statement Businesses that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contract Specialist. The capabilities statement must specifically address each project requirement separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 7 single sided or 3.5 double sided pages in length and using a 12-point font size minimum. Interested organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Mary Farrell, Contract Specialist mary.farrell@nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate (1) cost-reimbursement contract using the options contracting method for a period of 9 months from December 1, 2013 - August 31, 2014. Due Date: Friday, June 7, 2013 - 3:00 P. M. Eastern Standard Time.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RDSS-HR-14-09/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr., Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN03072720-W 20130530/130528234616-ed3bf608862a80b9756f14aac3191612 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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