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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 04, 2013 FBO #4240
SOLICITATION NOTICE

A -- linical Center for NHLBI Acute Respiratory Distress Syndrome Clinical Trials Research Network (ARDSNet)

Notice Date

7/2/2013
 

Notice Type

Presolicitation
 

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

NHLBI-HR-14-09
 

Archive Date

10/18/2013
 

Point of Contact

Mary M. Farrell, Phone: 3014350350, Mary M. Farrell, Phone: 3014350350
 

E-Mail Address

mary.farrell@NIH.gov, mary.farrell@NIH.gov
(mary.farrell@NIH.gov, mary.farrell@NIH.gov)
 

Small Business Set-Aside

N/A
 

Description

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI) is planning to negotiate and award an additional option, without providing for full and open competition, to the ARDSNet Clinical Center contractors, Baystate Medical Center, HHSN268200536165C; University of California, San Francisco, HHSN268200536166C; Cleveland Clinic Lerner College of Medicine, HHSN268200536168C; University of Colorado, HHSN268200536167C; Duke University, HHSN268200536169C; Johns Hopkins University, HHSN268200536170C; Intermountain Health Care/LDS Hospital, HHSN268200536171C; Louisiana State University, HHSN268200536172C; Vanderbilt University, HHSN268200536174C; Wake Forest University, HHSN268200536175C; and the University of Washington, HHSN268200536173C to continue as the ARDSNet Clinical Centers (CC). The purpose of this announcement is to provide a Presolicitation Notice as a follow-up to the sources sought synopsis (HHS-NIH-NHLBI-RDSS-HR-14-09), which was posted within FedBizOpps on May 23, 2013. The intended procurements are classified under NAICS code 541712 with a Size Standard of 500 employees. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. Proposals are not being requested and a written solicitation will not be posted to FedBizOpps. The NHLBI is seeking to negotiate a new seven (7) month option with the eleven (11) of the current ARDSNet Clinical Centers (listed above) to continue serving as the ARDSNet CCs for this ongoing program. The ARDSNet is currently a collection of 12 Clinical Centers (CCs) and one CCC that conducts definitive clinical trials that can improve the outcomes of patients with Acute Respiratory Distress Syndrome (ARDS). The CCs are completing enrollment in their final protocol: Statins for Acutely Injured Lungs with Sepsis (SAILS). This study will test the efficacy of rosuvastatin in resolving Acute Lung Injury (ALI) and ARDS in patients with ALI/ARDS from an infectious etiology. The NHBLI anticipates that the CCs will be needed for Phase II of the ARDSNet until June 30, 2014 to achieve the recruitment goals of the trial. The ARDSNet is governed by a steering committee (SC) composed 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 functions; 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 PIs from the CCs contribute substantially to the trial's scientific leadership and operational management. CC PIs participate in SC and other subcommittee meetings. The CCs work collaboratively with the CCC to complete the SAILS trial. CCs 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. Eleven (11) of the ARDSNet CCs will continue to serve as the ARDSNet CCs and will be responsible for the project requirements of the ARDSNet from December 1, 2013 - June 30, 2014. The CCs are expected to fulfill the following in accordance with the ARDSNet Operating Manual: a. Enroll a minimum of 18 patients which reflects appropriate enrollment of women and minorities; obtain informed consent, and collect screening and enrollment data for transmission 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://insider.nhlbi.nih.gov/od_ext_pol/human/ae_tracking.html 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. This synopsis is not a request for competitive proposals and the Government is not committed to award a contract pursuant to this announcement. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." 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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by 3:00 p.m eastern time on July 18, 2013 and must reference number NHLBI-HR-14-09. Responses shall be submitted electronically to Mary Farrell, Contract Specialist at mary.farrell@nhlbi.nih.gov. Fax responses will not be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-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, Office of Acquisitions, 6701 Rockledge Drive, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN03106747-W 20130704/130703000151-8f7ceee6b88857f5560857d2ee26c1b2 (fbodaily.com)
 

Source

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

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