Notice Number: NOT-OD-08-003

Key Dates
Release Date: October 18, 2007

Issued by
National Center for Environmental Health, Centers for Disease Control and Prevention (NCEH/CDC) http://www.cdc.gov/nceh/

This Notice is to inform potential applicants that the National Center for Environmental Health (NCEH) is joining the Parent Small Business Innovation Research (SBIR) Funding Opportunity Announcement (FOA), PA-07-280. Accordingly, applications on research topics within the mission of the NCEH can be submitted for the December 05, 2007 receipt date (January 8, 2008 for AIDS and AIDS-related applications). Note: CDC participates only in the SBIR program; it does not participate in the STTR program.

NCEH Program Description and Research Topics

The National Center for Environmental Health (NCEH) plans, directs, and coordinates a national program to maintain and improve the health of the American people by promoting a healthy environment and by preventing premature death and avoidable illness and disability caused by non-infectious, non-occupational environmental and related factors. The main activities of NCEH is to provide national leadership, through science and service in prevention programs, global health, and the use of human genetic knowledge, and tests.
Examples of potential areas of research pertinent to NCEH’s participation in PA-07-280 include, but are not limited to, those identified below:

A. Environmental Health/Anti-Chemical Terrorism Rapid Field Tests for Human Exposure. There is a need to develop rapid, reliable, field rugged methods for detection and quantitative estimation of human exposure to environmental contaminants and toxic chemical-based weapons of mass destruction or terrorism. Such methods must be able to sense the presence or absence of such substances quickly and reliably, and provide estimations of concentration in human urine, saliva, breath, blood, or transpired through the skin. Minimums of false positives and false negatives are important for such technology to avoid wasting resources and missing actual exposures.

B. Detection of Human Exposure to Aflatoxins and Other Mycotoxins from Food or as Chemical Warfare or Terrorism Agents. Aflatoxins and other mycotoxins are products that naturally occur from fungi on grains and other food materials. They are produced at harmful levels under certain weather conditions or during improper storage. They have the potential to be weaponized as chemical warfare or terrorism agents. There is a need to develop analytical methods for detection of these compounds in urine, saliva, or blood in the field to support epidemiologic investigations or under battlefield conditions. Methods/ instruments must reliably detect and quantify human exposure to these agents, with limits of detection consistent with background levels in populations as well as levels in exposed persons.

C. Rapid Field Tests or Continuous Monitors for Arsenic in Drinking Water. Drinking water with toxic levels of naturally occurring arsenic obtained from shallow wells is a serious problem in many parts of the world. Recently, this problem has become especially acute in rural areas of the under-developed world because of efforts to improve drinking water sources that unfortunately did not fully consider natural sources of arsenic. The solution requires deep wells, or water treatment at the point of use. However, because of uncertainty about the level of arsenic in water from these improved sources, and because of the need to give attention to the most heavily contaminated existing shallow wells first, there is a need to develop rapid, reliable, and cost effective tests or monitors for water arsenic.

D. Rapid Field Tests for Iodine Levels in Urine and Salt. Iodine deficiency is a global problem affecting millions of people, leading to reduced population IQ, cretinism, goiter, and contributing to thyroid cancer. To facilitate efforts to eliminate this problem, rapid, simple, and inexpensive tests are needed that can determine the concentration of iodine in urine for population screening work, and that can determine the concentration of iodine in salt samples for quality control purposes in iodized salt production. While field tests for iodized salt have been developed in recent years, they have proven to be inaccurate and unreliable. Tests for urinary iodine typically have required complicated laboratory procedures. Simple, reliable measures for field use would be a great help.

E. Coronary Heart Disease. The development of a laboratory technology to standardize and improve the quality and reliability of laboratory tests for cholesterol and other metabolically related lipids and lipoproteins that are known risk factors associated with coronary heart disease is an area that needs improvement of diagnostic techniques. Specifically, the contractor should develop and characterize improved serum reference materials that can be used by NCEH to standardize laboratories that conduct epidemiological and lipid research and clinical trials into the causes and prevention of coronary heart disease.

F. Rapid Field Tests for Vitamin A Status. There is a need for the development of rapid, rugged field portable, and economical techniques for determining vitamin A status in finger stick or earlobe blood samples collected by microcapillary techniques or on filter paper. Methods may be based on fluorescence, optical density, or any other technique which reliably estimates vitamin A status in humans, but it should correlate to widely accepted "reference" methods such as high performance liquid chromatography (HPLC). Such methods would be highly valuable in global efforts to eliminate vitamin A deficiency, a high priority for WHO, UNICEF, USAID, and many other international agencies. Vitamin A deficiency is a devastating problem especially in developing countries where it contributes significantly to childhood morbidity and mortality, and is a leading cause of blindness in many parts of the world.

G. Rapid and Reliable Field Tests for Serum Ferritin and Transferrin Receptor. Iron deficiency and iron deficiency anemia are serious problems throughout the developing world and in many high-risk groups in developed countries, including the United States. These problems negatively impact societies by reducing work capacity, impairing mental development and learning, and increasing morbidity and mortality, especially in women of child bearing age and young children. There is a need to develop reliable, easy to operate, and cost effective devices for screening for serum ferritin, and if possible for serum transferring receptor in populations and for managing individuals receiving iron intervention treatments. These devices would have to operate properly in climatic conditions that are not always regulated. Portable devices would be desirable. The use of blood collected through a minimally invasive technique would be preferred.

H. Development of Stable Isotope Labeled Proteins for Quantitation of Protein Biomarkers. Improving the accuracy of measurements of protein levels in humans is an important step toward a better understanding of many diseases. The choice of standards is usually the key for the precision, reproducibility and accuracy of measurements of different compounds. Isotope dilution mass spectrometry is widely used for the quantitation of small molecules in biological specimens. It improves the measurements of low concentrations of chemicals and biomarkers in such samples so that concentrations can be correlated to internal dose. The use of isotope dilution mass spectrometry for the analysis of proteins is less developed due to the difficulties associated with the synthesis of the isotopically labeled proteins used as internal standards in this technique. In order to fulfill this gap, high purity proteins (>95% purity) are needed in which stable isotopes are incorporated into the protein. 13C and 15N are to be incorporated as labeling isotopes instead of 2H or 18O because the later can sometimes be exchanged during sample processing. Enough number of labels should be introduced in the protein so they can be analyzed with a triple quadrupole mass spectrometer and produce meaningful results. We would like to develop a new project for producing high purity labeled hemoglobin, albumin and insulin, which will be used as standards for the quantitation of protein biomarkers.

I. Improved Tests for Zinc Status and Zinc Body Stores in Humans. The essential element zinc has been shown to be extremely important in human health. Recently it has been especially important as a cofactor in efforts to combat iron deficiency and vitamin A deficiency in the developing world. There is a need to develop simple, reliable, easy to operate, and cost effective methods or instruments for screening for zinc deficiency in populations and for managing individuals receiving intervention treatments. There is also a need for improved approaches to assessing zinc body stores.

J. Improving Assessment of Children's Exposure to Toxic Substances. Children tend to be more susceptible to toxic substances than adults because of a variety of differences related to physical and functional characteristics. It is imperative that exposure of children to toxic substances be minimized or eliminated since exposures could result in subtle effects upon children's growth, maturation, and health. Children are generally at greater risk than adults for exposure to environmental pollutants from inhalation because they have a higher respiratory rate; from dermal exposure because they have more exposed surface area; and from ingestion because they have a tendency to play in and eat dirt. In order to address children's exposures, the following rapid response technology is needed:

1. Development of an "environmental sensor" that would detect concentration levels of volatile organic compounds (VOCs) and particulates at threshold levels that would be harmful to small children.
2. Development of a "soil tester" that would determine the concentration level of various trace metals and other environmental pollutants that might concentrate in soil, where children are likely to play.

Inquiries

Inquiries regarding this Notice should be directed to:

SBIR Grants Info
Office of Public Health Research
Office of the Chief Science Officer
Centers for Disease Control and Prevention
Phone: 404-639-4621TTY: 301-451-5936
1600 Clifton Road NE, MS D-72
Atlanta, GA 30333
Telephone: 404-639-4641
Fax: 404-639-4903
Email: [email protected]