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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 30, 2013 FBO #4205
MODIFICATION

A -- Acute Respiratory Distress Syndrome Clinical Trials Research Network - Clinical Coordinating 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-14-08
 

Archive Date

11/15/2013
 

Point of Contact

Scott A. Bredow, Phone: 301-435-0333
 

E-Mail Address

bredowsa@nhlbi.nih.gov
(bredowsa@nhlbi.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

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 a Clinical Coordinating Center (CCC) for an ongoing program - the NHLBI ARDS Clinical Trials Network (ARDSNet). The ARDSNet is a collection of 12 Clinical Centers (CCs) and one 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 CCC will be needed until August 31, 2014 to achieve recruitment goals of the trial. The ARDSNet is governed by a steering committee (SC) comprised of Principal Investigators from the CCs and the CCC along with the NHLBI Contracting Officer's Representative. The SC selects, designs, and recruits patients into the protocols. The CCC oversees all aspects of network governance and conduct: it manages all committees, maintains public and private websites, provides all needed statistical expertise for design and analysis of studies, provides all support needed to conduct studies including preparation of case report forms, training of all clinical staff, daily assistance with protocols, and safety oversight. NHLBI has a Data and Safety Monitoring Board (DSMB) for advice on study continuation in accordance with decision guidelines that are a part of the clinical trial protocol. The CCC coordinates all SC activities and prepares all reports for the DSMB including communications about safety and planned interim analyses. The CCC prepares all final data reports and plays a major role in the preparation of manuscripts for peer reviewed journals The contractor will be the Clinical Coordinating Center (CCC) and will be responsible for coordination of all aspects of the ARDSNet from October 15, 2013 - August 31, 2014, including oversight and management of the conduct and analysis of the final protocol, SAILS, maintenance of standard operating procedures, public and private web sites, and coordination of all ARDSNet meetings and committees. The CCC will be responsible for the preparation and presentation of interim data reports to the DSMB, analysis of data, and assisting in the preparation of reports and manuscripts for publication of trial results. Project Requirements The CCC is expected to fulfill the following: 1)Experienced and highly competent in the coordination of complex studies utilizing statins in critically ill patients. 2)The Principal Investigator of the CCC will have demonstrated expertise and leadership in biostatistics and clinical trial design and conduct in critically ill patients. 3)The CCC co-investigator will have demonstrated experience in clinical trials and be certified and actively involved in the care and study of pulmonary and critically ill patients with Acute Lung Injury. 4)Ability to prepare final protocols for review by the DSMB. 5)The CCC will continue to oversee: a.randomization of subjects, b.preparation and distribution of protocols, manuals and forms, c.data collection, quality, completeness, confidentiality, and analysis, d.training of the CCC and the CC staff in implementing protocols and data entry, e.audit site data accuracy and quality, f.preparation of data from 750 SAILS patients for the DSMB, g.coordination of drug blinding and distribution, as necessary, h.coordination of collection of biospecimens required by the protocol, i.coordination with NHLBI BIOLINCC to transfer and retrieve ARDSNet biospecimens, j.monitor content of and IRB approval of informed consent forms and protocol modifications, k.perform all required statistical analyses of SAILS and other sub-studies as needed, l.assist in preparation of final manuscripts of SAILS study, m.coordinate communications among the CCs and scheduling conference calls and meetings of trial committees, as needed, n.organize and attend meetings of the SC and DSMB 6)Maintain a randomization system for SAILS to ensure equal and unbiased distribution of patients into treatment groups. 7)Maintain Section 508 compliant Network web sites (public and internal for the network) 8)Plan and coordinate meetings and teleconferences of the SC, DSMB, and subcommittees, as may be necessary. 9)Conduct scientific site visits and data quality/chart review site visits. 10)Provide data sets to the SC for preparation of publications of main trial results. Conduct statistical analyses of main trial results. Capability Statement Businesses that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. 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 Scott Bredow, Contracting Officer, at bredowsa@nhlbi.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 ten and a half (10 ½) months from October 15, 2013 - August 31, 2014.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RDSS-HR-14-08/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, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN03072748-W 20130530/130528234630-c9ac4e3e253cb22c9e2c270b9ef1a8cf (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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