RFP ANNOUNCEMENT: LUNG TISSUE RESEARCH CONSORTIUM

RELEASE DATE:  March 13, 2003

NOTICE:  NOT-HL-03-009

National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)

The overall objective of the Lung Tissue Resource Consortium (LTRC) is to 
enable better management of lung diseases by increasing understanding of the 
pathogenetic mechanisms of these diseases through molecular histopathological 
studies of human lung tissues with and without disease.  The LTRC will 
facilitate histopathological research of pulmonary diseases by collecting lung 
tissues from donors and preparing and distributing collections of tissue 
specimens to researchers within and outside the Consortium.  Primary emphases 
will be on chronic obstructive pulmonary disease (COPD) and idiopathic 
pulmonary fibrosis.  Collections of specimens will be linked to extensive, 
individual clinical data appropriate to the particular disease.  Donor 
subjects will be recruited for specific enrollment groups that are designed to 
address important research questions.  The consortium will be comprised of 
Clinical Centers, a Tissue Processing and Distribution Center, a Radiology 
Center, and a Data Coordinating Center.  Offerors are strongly encouraged to 
read the RFPs for all of these components of the LTRC to better understand the 
overall structure and function of the Consortium.

Clinical Centers (CC), RFPBNHLBIBHRB04B08, will recruit and enroll specimen 
donors; perform clinical testing of subjects; extract data from the patients' 
medical records; obtain lung tissues and other specimens and perform initial 
processing of these specimens; and transmit clinical data, computed 
tomographic (CT) image data, and biological specimens to appropriate centers 
of the LTRC.  CCs will provide reports of any radiographic or pathological 
abnormalities noted by the Radiology Center and/or Tissue Processing and 
Distribution Center to the donor subjects' primary care physicians.  In 
addition, each CC will perform hypothesis-oriented, tissue-based research, 
using LTRC specimens, that addresses pathogenetic mechanisms of COPD and/or 
idiopathic pulmonary fibrosis and work with other LTRC investigators to 
prepare reports and manuscripts for publication.

The Tissue Processing and Distribution Center (TC), RFPBNHLBIBHRB04B09, will 
prepare protocols for specimen procurement, processing, transport, storage, 
and distribution.  The TC will train Clinical Center personnel regarding 
specimen handling, processing, and shipping to the TC.  The TC will conduct 
site visits to assure that protocols for specimen procurement, processing and 
transport are followed.  The TC will perform diagnostic histopathological 
analysis of lung tissues by a board-certified pathologist; provide a written 
report of any abnormalities seen to the DCC and to the CC for relay to the 
donor subject's primary care physician; obtain quantitative measures of 
disease presence or severity (e.g., mean chord length) in lung tissue 
specimens; establish and maintain a system for tracking specimens received and 
distributed; prepare and distribute specimens and collections of specimens to 
researchers as directed by the DCC, and work with other LTRC investigators to 
prepare reports and manuscripts for publication. 

The Radiology Center (RC), RFPBNHLBIBHRB04B10, will develop protocols related 
to chest CT image acquisition, processing and transmission; train and certify 
CC personnel involved in CT imaging and transmission of images to the RC; 
conduct site visits to CCs to ensure compliance with LTRC protocols; establish 
and maintain a tracking system for the receipt and analysis CT images; 
maintain an archive of CT images; perform diagnostic analysis of each CT image 
by a board-certified radiologist; transmit a written report of any 
abnormalities found to the DCC and to the CC from which the image originated 
and extract quantitative indices of disease severity from the lung images; 
analyze each CT image to obtain quantitative and/or semi-quantitative measures 
of lung disease; transmit anonymized CT images in electronic form to 
researchers as directed by the DCC; work with other LTRC investigators to 
prepare reports and manuscripts for publication.

The Data Coordinating Center (DCC), RFPBNHLBIBHRB04B10, has been set aside for 
small business participation.  The Principle Investigator of the DCC will have 
expertise in biostatistic and clinical research study design and support the 
protocol development, including power and sample size calculations.  The 
Principle Investigator will be responsible for the statistical approaches and 
the overall performance within the DCC.  The DCC will be responsible for the 
statistical approaches and the overall performance within the DCC.  The DCC 
will plan and make all arrangements for meetings and teleconference calls of 
the LTRC; participate and assist the TC in site visits of the CCs by the TC; 
verify that potential subjects are eligible for recruitment into specific 
enrollment groups; coordinate the electronic transfer of clinical data from 
the CCs to the DCC; maintain an electronic repository of clinical data 
collected from LTRC subjects, together with descriptive histopathological 
analyses from the TC and descriptive reports and radiographic measures of lung 
disease from the RC; maintain computer software necessary to process, store, 
and analyze data furnished by the CCs, TC, and RC; maintain a liaison with 
each CC to assist in the solution of operational problems involved in data 
collection and reporting; assist CC staff in data management and 
administrative functions; prepare public use data sets corresponding to tissue 
collections prepared by the TC; direct the TC and the RC to provide specified 
LTRC resources and public use data sets to investigators approved for access; 
perform statistical analyses for investigators for research studies that 
utilize LTRC materials; prepare progress reports of the LTRC; and develop, 
maintain and enhance a LTRC web site.

This announcement is not a request for proposals (RFP).  It is anticipated 
that the RFPs will be available on or about February 24, 2003 through the 
NHLBI Website at: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and 
posted on FedBizOpps at: http://www.fedbizopps.gov.  It is anticipated that 
proposals submitted in response to these RFPs will be due on May 22, 2003.  
This advertisement does not commit the Government to award a contract.  No 
collect calls will be accepted.

Contracting Office Address:

National Institutes of Health
National Heart, Lung, and Blood Institute
Contracts Operations Branch
Rockledge II, Room 6114
6701 ROCKLEDGE DR, MSC-7902
BETHESDA MD 20892-7902

Point of Contact:

Joanne Deshler, Contracting Officer, Phone 301-435-0340, Email jd52g@nih.gov
Fred Ettehadieh, Contract Specialist, Phone 301-435-0340, Email fe19w@nih.gov

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