B -- Nicotine Exposure and Metabolism in Alaska Native Adults

In accordance with simplified acquisition procedures The National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS), Behavioral Research Program (BRP), Tobacco Control Research Branch (TCRB) plan to procure on a sole source basis with the Alaska Native Tribal Health Consortium (ANTHC), 4000 Ambassador Drive D-DCHS, Anchorage, AK 99508 for a study of nicotine exposure and metabolism in Alaska Native Adults. The primary objectives of the Nicotine Exposure and Metabolism in Alaska Native Adults study (NEAM study) are to 1) describe exposure to nicotine and carcinogens in Alaska Native adults who smoke cigarettes, use commercial chew tobacco, or use a homemade mixture of chew tobacco and ash (Iqmik); 2) characterize nicotine metabolism in Alaska Native adult tobacco users by measuring plasma 3?-hydroxycotinine:cotinine ratio and by genotyping genes related to nicotine metabolism; and 3) quantify the pH, free nicotine content, and carcinogen (tobacco-specific nitrosamine or TSNA) content in commercial chew and Iqmik. The prevalence of cigarette smoking and smokeless tobacco use in American Indians/Alaska Natives is the highest of any group in the United States, and Alaska Natives experience disproportionate rates of tobacco-related deaths. Iqmik is a homemade form of smokeless tobacco in which leaf tobacco is mixed with ash derived from punk fungus, which elevates the pH, raising the amount of free nicotine available for absorption. There is currently little known about the differences in health risks between commercially produced smokeless tobacco such as Copenhagen? and Iqmik. It is believed that differences in nicotine metabolism influence tobacco use patterns, and the rate of an individual?s nicotine metabolism may be an important factor in determining ideal dosing for nicotine replacement therapy. This study will generate information on nicotine and carcinogen exposure in an underserved population with the highest prevalence of tobacco use in the country. Results will be used to generate information for nicotine replacement therapy dosing. This is especially important for Iqmik users as there are currently no treatment guidelines for users of this product. Information on nicotine and carcinogen exposure associated with Iqmik use can be used to generate public health messages for local tobacco control programs, as local tobacco control workers currently have little information on the potential health effects of Iqmik with which to counsel their patients. ANTHC shall conduct a cross-sectional study of Alaska Native adult tobacco users and nonusers living in Bristol Bay, Alaska (an area with high cigarette and smokeless tobacco use). ANTHC shall enroll approximately 400 participants in the full study: 50 in each group of male and female cigarette users, commercial chew users, Iqmik users, and tobacco nonusers. The contractor shall ask each participant to respond to a questionnaire about their tobacco use and general health status, to undergo phlebotomy for blood collection, and to provide a urine specimen. The contractor shall ask commercial chew users and Iqmik users to provide a sample of their tobacco product for testing. The contractor shall invite up to 75 tobacco users who are not eligible for the full study to participate in a product testing study (25 of each, users of roll your own cigarettes, nasal snuff, or commercial chew mixed with ash). ANTHC was formed in December 1997 when statewide health programs and services that were a function of the Indian Health Service (IHS), an operating Division of the US Department of Health and Human Services, were transferred from federal ownership and control to a new set of owner-customers, the Natives of Alaska. Under federal law, all Alaska Natives are simultaneously both the owners and the customers of the Consortium, with their interests represented through their tribal governments and regional nonprofit organizations, whose representatives comprise the ANTHC Board of Directors. The transfer of ownership marked a paradigm shift in thinking about Native health services, as visionary tribal leaders set a bold new direction: a statewide unified Native health system that seeks to achieve the ?highest health status in the world? for Alaska Native people. ANTHC is the largest and most comprehensive Native-owned health services organization in the U.S. and serves 130,682 Alaska Natives statewide, representing 231 federally recognized tribes. ANTHC is at the center of the Alaska Tribal Health System (ATHS), a statewide collaborative network of over 30 different tribally-operated regional hospitals, village-based clinics, and community health programs. Together, ANTHC works to promote Native self-determination, quality health services, and wellness. This experience and expertise is not readily available within the research community. The ANTHC is uniquely qualified to carry out this effort because it is the only organization to have received Bristol Bay Area Health Corporation tribal approval to conduct the NEAM study. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the researcher to determine if the party has the connections and resources to perform this study. An original and one copy of the capability statements must be received in the contracting office by 1:00 p.m. EST, on September 12, 2007. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and can be faxed to (301) 402-4513 or emailed to dm170b@nih.gov. It is the vendor's responsibility to call (301) 402-4509 to verify questions have been received. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov . In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov.No collect call will be accepted. NAICS 541990, Size Standard $6.5M.