A -- Gulf South Hurricane Katrina Lung Health Study HHS

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A -- Gulf South Hurricane Katrina Lung Health Study

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General Information

Document Type: Presolicitation Notice Solicitation Number: NIH-ES-06-07

Posted Date: Mar 13, 2006 Original Response Date: Apr 28, 2006 Current

Response Date: Apr 28, 2006 Original Archive Date: May 13, 2006 Current

Archive

Date: May 13, 2006 Classification Code: A -- Research & Development Naics

Code:

541710 -- Research and Development in the Physical, Engineering, and Life

Sciences

Contracting Office Address

Department of Health and Human Services, National Institutes of Health,

National Institute of Environmental Health Sciences, Office of Acquisitions,

Office of Management P.O. Box 12874, 79 T.W. Dr, Bldg 4401, RTP, NC,

27709

Description

The National Institute of Environmental Health Sciences, NIH, intends to

negotiate a sole-source contract with Tulane University, Center for

Bioenvironmental Research , 1430 Tulane Avenue, New Orleans, Louisiana to

conduct a

clinical epidemiology study of patients with chronic airway disease in the Gulf

Coast region near New Orleans. The uniqueness of the gulf coast after

Hurricane Katrina, in particular the high risk of exposure to mold and

microbial

toxins among the clean-up and construction workers and residents, presents an

unprecedented opportunity to uncover the role of gene sequence variants and

environmental exposures in the exacerbation of airway and other forms of

lung disease. The degree to which mold concentrations, mold species, and

mold toxins affect a person?s health is not clearly understood.

Adequately addressing these questions will require prospective data be

collected over

approximately 30 months to define disease status in patients with chronic

airway disease, and to define measures of exposure to mold and microbial toxins

in biological samples of blood, urine and expired air, and from environmental

samples collected in the human breathing zone and in indoor air in the

household and workplace. Blood samples shall also be collected to identify

specific genetic variants for disease exacerbation and progression in future

studies. Some of the biological and environmental samples shall be analyzed

by the contractor; the remainder of the samples will be stored at Tulane?s

own laboratory or shipped to a designated laboratory of analysis.

Specifically Tulane University shall conduct activities in the following areas:

(1)

Recruit and enroll approximately 1000 patients with chronic airway disease

into the study. Provide and modify strategies for recruiting a diverse study

group, including women, persons from lower socioeconomic backgrounds of

particular ethnic or racial groups, older and hard-to-reach groups for study

participation;(2) Conduct baseline and follow-up clinical assessments; analyze

test

results to determine airway disease status (exacerbating or stable). ; (3)

Collect biological specimens of blood, urine, and expired air during clinical

assessment; (4) Conduct environmental sampling of personal or indoor air in

the study participants? residence and/or workplace; (5) Administer a

questionnaire to obtain information on reactive airway disease status and about

potential confounding variables and effect modifiers; (6) Maintain a high

response

rate of 90% during the period following the baseline clinical assessment.

Maintain a secured (patient protected) electronic database of study

information for rapid retrieval and analysis; (7)Maintain a high level of

community

involvement and outreach;(8) Ensure data abstracting, editing, recording,

tracking, and security. All protocols shall be the responsibility of the

Contractor with approval from the Government before implementing. The period of

performance will be for 30 months with a planned award date on or before

September 29, 2006. It is anticipated that this project will require

approximately 13,936 direct labor hours over 30 months. Sole Source

Authority: 41

USC 253©(1), as set forth in FAR 6.302-1--Only One Responsible Source.

Tulane University?s Center for Bioenvironmental Research have extensive

capabilities in conducting complex respiratory epidemiology and clinical

studies.

Tulane investigators have extensive experience conducting both

occupational and community-based health studies in this region, and have

first-hand

knowledge of the medical management infrastructure and level of operation of

individual hospitals and clinics in the region. Tulane has a world-renowned

expert, and recent appointee to the National Academy of Sciences, in the

area of mold and microbial toxins, Dr. Joan . There are only a

handful of such experts in the world, and having Dr. at Tulane is an

advantage. Any other interested sources desiring consideration for this

requirement must fully identify their interests and capabilities to the

Contracting

Officer listed above no later than 4:00 p.m. on April 28, 2006. This notice

of intent is not a request for competitive proposals; no solicitation is

available. See Numbered Note 22 and 26*****

Point of Contact

Velvet Torain, Contracting Officer, Phone 919-541-0400, Fax 919-541-2712,

Email torain@... - Tyre, Procurement Technician, Phone

919-316-4686, Fax 919-541-2712, Email tyre@...