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FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 21, 2014 FBO #4745
SOLICITATION NOTICE

A -- Lung Tissue Research Consortium - Data Coordinating 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-16-04
 

Archive Date

12/16/2015
 

Point of Contact

Scott A Bredow, Phone: (301) 435-0333, Sarah Bank, Phone: (301) 435-2158
 

E-Mail Address

bredows@mail.nih.gov, Sarah.bank@nih.gov
(bredows@mail.nih.gov, Sarah.bank@nih.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Data Coordinating Center (DCC) 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-16-04. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. The NHLBI is seeking a small business with the ability to serve as the Data Coordinating Center (DCC) for a 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 DCC will operate a repository for LTRC data; provide overall management, oversight, and administrative support for the LTRC; and arrange for centralized analyses of selected biospecimens by high throughput methods such as RNAseq. The DCC will operate in cooperation with a Radiology Center that analyses and archives x-ray CT images, with a Tissue Repository that processes, stores, and distributes biospecimens, and with 3-4 Clinical Centers that recruit and characterize human subjects and harvest surgical waste lung tissues. The DCC will train LTRC Clinical Center personnel regarding data forms completion and data entry and will have primary responsibility for data quality control and assessment. The DCC will conduct site visits as needed to assure that LTRC protocol procedures are followed. The DCC will arrange for meetings of LTRC committees and boards and will prepare reports for the committees and boards and the NHLBI summarizing study progress and status. The DCC will implement procedures whereby investigators apply for LTRC resources; the applications are reviewed by the Protocol Review Committee (PRC) and the NHLBI; and tissues and data are granted to applicants whose requests are approved. The DCC 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 DCC activities described in the LTRC Protocol Manual and any amendments thereto. 2. The Principal Investigator shall participate fully in the activities of the Steering Committee (SC). 3. Provide training for LTRC Clinical Center personnel involved in data collection, forms completion, and data entry. 4. Update as needed LTRC data collection forms and informed consent documents for use by the LTRC Clinical Centers and the DCC. Update the LTRC Protocol and Manual of Operations to describe proposed and approved modifications to the LTRC protocol and procedures. 5. Develop and maintain a public and private LTRC web site that meets the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards 6. Develop and/or maintain computer systems and software needed for transfer of clinical data from the LTRC Clinical Centers and External Contributors to the DCC and for the storage, retrieval, and statistical analysis of these data. The computer systems and software shall meet the requirements of Section 508 of the Rehabilitation Act. 7. Assist the LTRC Clinical Centers and External Contributors in transferring clinical and phenotypic data to the DCC. Perform quality control/quality assurance tests and report results to the NHLBI and Observational and Study Monitoring Board (OSMB). 8. Develop and maintain a database of LTRC clinical and phenotypic data, implementing procedures for backup that will minimize possibilities of data loss. The electronic database designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. 9. Serve as the representative of the Steering Committee to convey recommendations for modification of the LTRC Protocol to the PRC and OSMB for review and comment. 10. Coordinate the submission of applications for LTRC resources, review of these applications by the PRC and NHLBI, and delivery of tissues and data to applicants whose requests are approved. 11. Prepare data sets in electronic form for distribution to investigators for approved studies as authorized by the NHLBI, ensuring that study subjects cannot be re-identified using the data provided. 12. Plan, make arrangements for, and provide ongoing support for the meetings and teleconferences of the SC, PRC, and OSMB. Prepare and distribute minutes of the SC meetings. 13. Identify any problems with existing LTRC procedures and any difficulties that may interfere with LTRC objectives. Devise strategies to improve procedures and overcome difficulties. 14. Prepare final limited access data sets. The data sets shall include data with full documentation, prepared in accordance with NHLBI policies available at: http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.htm 15. Transfer all LTRC data to a repository identified by the NHLBI at the end of the contract period, together with the coded information linking the data to tissues and CT images. 16. Develop detailed plans, in collaboration with other LTRC investigators, for the creation of an omics data set based on LTRC biospecimens and phenotypic data. Under this solicitation, the Government anticipates award of one (1) Indefinite Delivery, Indefinite Quantity (IDIQ) contract with cost plus fixed fee task orders for a period of approximately four 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-16-04/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, RKL2/6016 MSC 7902, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN03577582-W 20141121/141119235007-ab0b6914b4206689f974668af708e819 (fbodaily.com)
 

Source

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

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