SOLICITATION NOTICE
A -- Title Lung Tissue Research Consortium - Clinical Center
- Notice Date
- 11/19/2014
- 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-16-07
- Archive Date
- 12/16/2015
- Point of Contact
- Sarah Bank, Phone: 301-435-2158, Scott A Bredow, Phone: (301) 435-0333
- E-Mail Address
-
Sarah.bank@nih.gov, bredows@mail.nih.gov
(Sarah.bank@nih.gov, bredows@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Pre-Solicitation Notice NHLBI Lung Tissue Research Consortium (LTRC) Clinical Center(s) The National Heart, Lung, and Blood Institute (NHLBI) is seeking Clinical Centers for a four year program, the NHLBI Lung Tissue Research Consortium (LTRC). The purpose of this announcement is to provide a Presolicitation Notice for the release of Solicitation NHLBI-HR-16-07. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. The NHLBI is seeking three to four organization(s) with the ability to serve as the Clinical Center(s) (CC) during the first three (3) years of the four-year renewal of the NHLBI Lung Tissue Research Consortium (LTRC). The LTRC is a network of centers cooperating to harvest and process lung tissue specimens for use in scientific studies of the etiology and pathogenesis of lung diseases, especially chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis. The LTRC prepares collections of specimens, linked to clinical data describing the donor subjects, for widespread distribution to investigators for use in their research. The CCs will operate in cooperation with a Data Coordinating Center which provides overall management, oversight, and administrative support for the LTRC; a Radiology Center that analyses and archives x-ray CT images; and a Tissue Repository that processes, stores, and distributes biospecimens. It is expected that the CCs will be institutions that routinely perform lung surgical procedures such as lobectomy for suspected cancer. CCs must also have experience and expertise in the enrollment and characterization of human research participants for clinical studies of pulmonary disease. Each CC will enroll donor subjects, perform laboratory and clinical testing according to the LTRC protocol, and harvest surgical waste lung tissues for processing and shipping to the LTRC Tissue Repository. Each CC is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 1. Obtain and maintain Institutional Review Board (IRB) approval for CC activities described in the LTRC Protocol Manual, and any amendments thereto. 2. The Principal Investigator shall have expertise in pulmonary diseases and shall participate fully in the activities of the Steering Committee (SC). 3. Obtain and maintain training of appropriate staff in LTRC protocols and procedures, including: 1) administration of questionnaires, performance of clinical testing, extraction of clinical data from medical records, data entry, and transmission of clinical data to the Data Coordinating Center; 2) imaging procedures and transmission of CT scans to the Radiology Center; and 3) collection, processing, and shipping of specimens to the Tissue Repository. 4. Identify potential donor subjects, obtain their informed consent, and collect screening data necessary to determine eligibility for participation. 5. Procure biological specimens from enrolled donor subjects. Perform initial specimen processing and transmit processed biological specimens to the LTRC Tissue Repository. 6. Acquire CT images according to the LTRC Manual of Operations, de-identify the images, and transmit to the LTRC Radiology Center. 7. Perform quality control and quality assurance activities. 8. Report adverse events and unanticipated problems (consistent with NHLBI/NIH policies). 9. Provide reports of any radiographic or pathological abnormalities noted by the LTRC Radiology Center and/or LTRC Tissue Repository to the donor subjects' primary care physicians. Inform the LTRC Data Coordinating Center when notification is accomplished. 10. Identify any problems with existing LTRC procedures and any difficulties that may interfere with LTRC objectives. 11. Develop detailed plans for the creation of an omics data set based on LTRC biospecimens and phenotypic data. Under this solicitation, the Government anticipates award of three to four (3-4) Indefinite Delivery, Indefinite Quantity (IDIQ) contract(s) with cost reimbursement task orders for a period of approximately three (3) years with an estimated award date of December 16, 2015. This is not a Request for Proposal (RFP) and the Government is not committed to award a contract pursuant to this announcement. The RFP will be available on the FedBizOpps Web page at www.fbo.gov on or about December 18, 2014.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HR-16-07/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 Dr RKL2/6016 MSC 7902, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN03577280-W 20141121/141119234719-60f29ffdef545c2b283a881ec6f39ee0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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