SPECIAL NOTICE
A -- POPULATION ASSESSMENT OF TOBACCO AND HEALTH (PATH) STUDY AMONG AMERICAN INDIANS AND ALASKAN NATIVES (AI/ANs)
- Notice Date
- 11/20/2012
- Notice Type
- Special Notice
- 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 Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-RFI-13-033
- Archive Date
- 1/22/2013
- Point of Contact
- Brian H O'Laughlin, Phone: (301) 443-6677
- E-Mail Address
-
olaughlinb@mail.nih.gov
(olaughlinb@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- "This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes." PURPOSE The National Institute on Drug Abuse (NIDA) requests information for a Population Assessment of Tobacco and Health (PATH) Study among American Indians and Alaskan Natives (AI/ANs). BACKGROUND On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (FSPTCA) was signed into law. This act gives broad authority to the Food and Drug Administration (FDA) to enact or facilitate tobacco-product regulations, with the overall goals to (1) prevent Americans - especially youth - from starting to use tobacco; (2) encourage current users to quit; and (3) decrease the harms of tobacco product use. In support of these mandates, the National Institutes of Health (NIH), through NIDA, is partnering with FDA's Center for Tobacco Products (CTP) on a large-scale collaboration, the "Population Assessment of Tobacco and Health" or PATH Study. This landmark effort is aimed at establishing a scientific framework for FDA's development and implementation of near- and long-term tobacco-product regulations. The PATH Study is a nationally representative study of tobacco use and health in the U.S. population. A cohort of approximately 59,000 adults and youth ages 12 years and older will be followed annually to assess attitudes and perceptions related to the use of different tobacco products; patterns and trends in use of existing and emerging tobacco products; knowledge of the contents of tobacco products and of the consequences of their use; and near- and longer-term health outcomes associated with tobacco product use. The study includes the collection of biospecimens (buccal cells, urine, and blood) among adults 18 years of age and older to examine intermediate endpoints and incident health outcomes associated with tobacco use and related disease processes. GOALS AND OBJECTIVES OF A PATH STUDY AMONG AI/ANs Available national and regional data on tobacco product use suggest that rates of tobacco use and tobacco use-related morbidity and mortality are higher for AI/ANs than for any other minority groups in the U.S. These data are limited, however, especially regarding potentially important differences in initiation, prevalence, and consequences of tobacco use within the AI/AN population. Epidemiological data are needed to examine potential within-group differences among AI/ANs and any differences that may exist between AI/ANs and the general U.S. population. These data include geographic, social, and contextual factors (e.g., associated with reservations, or urban or rural areas), types of tobacco products used (e.g., smokeless and pipe tobacco, cigarettes), gender differences in product use, and cultural factors that may influence youth access, initiation behaviors, perceptions of risk, social norms, and attitudes about the use of tobacco. The nationally representative nature of the PATH Study suggests that relatively rare populations such as AI/ANs will only constitute a small percentage of the study cohort. The PATH Study estimates that fewer than 1,000 AI/ANs, including approximately 250 AI/AN tobacco users, will be recruited into the sample. This small number suggests that the national PATH Study will have gaps in its data on tobacco use and health among the AI/AN population. To address these data gaps, NIH, through NIDA, is issuing this request for information (RFI). The RFI solicits information that will help NIDA, with its FDA partner, make meaningful decisions regarding the feasibility, scope, costs, and magnitude of an initiative to address data gaps about the AI/AN population. A PATH Study among AI/ANs is envisioned to be modeled after the nationally representative PATH Study, but tailored specifically to the AI/AN population. At a minimum, such a study should provide longitudinal epidemiological data sufficient for making analytic comparisons among AI/ANs by geographic region, by urban or rural location, including by reservation, and by gender. It should also provide data on youth and adults. For additional information about the PATH Study, see http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201208-0925-002. SPECIFIC INFORMATION REQUESTED: Information in the following areas will aid NIDA, in collaboration with its FDA partner, in evaluating the feasibility of conducting a PATH Study among AI/ANs. NIDA requests that interested organizations respond to the items listed below; information provided in response to this request need not be limited to these points. Respondents are requested to provide up to 3 ranked strategies (or scenarios) for the items below, categorizing these strategies by, for example, "acceptable, satisfactory, optimal," "low, medium, high," or "adequate, good, and the gold standard." Other ranking descriptors may also be used. • Project description and costs. Up to 3 ranked scenarios for conducting a PATH Study among AI/ANs, including its key components, i.e., the study design and the length of time required to develop the study design, sampling approach, and instruments; time for obtaining IRB/OMB approvals; requirements for hiring and training field workers/interviewers; requirements for constituency engagement; the timeline to recruit respondents and conduct the field test and to recruit the cohort for the baseline and at least 3 annual follow-up waves of data collection; plans to achieve high cohort-retention and response rates; and estimated year-by-year costs corresponding to each component for each of the three scenarios. Respondents are also requested to estimate costs (a rough estimate/not detailed) for each scenario to maintain the study cohort over time in the event the follow-up waves are other than annual (e.g., biennial). • Sampling approach, sample size, and population coverage. Estimates of the population sample size/s needed to achieve an average relative standard error of five percent with sufficient power to stratify analyses by 3 major domains (geographic region, urban/rural contexts, gender). These estimates may include other key attributes of interest, such as tobacco-use status (current, former, never), type of tobacco product(s) used, age, and other characteristics. Given that AI/ANs are widely dispersed in the U.S., a major challenge will be to identify and recruit AI/ANs to participate in such a study. This challenge underscores the need for study designs that are highly innovative, efficient, and to the extent possible, evidence-based. This Request for Information (RFI) is for information and planning purposes only, and shall not be construed as a solicitation or as an obligation on the part of either NIDA or its FDA partner. The Government does not intend to award a contract on the basis of responses, nor otherwise pay for the preparation of any information submitted or NIDA's use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of NIDA's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this RFI or the Government's use of such information as either part of the evaluation process or for the development of specifications of a subsequent requirement. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Veteran-owned Small Business, Service-Disabled Veteran-Owned Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization. " Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)." Responses should be identified with as HHS-NIH-NIDA-RFI-13-033 and are due by January 7, 2012. Please submit two copies of your response to: Brian O'Laughlin Contracting Officer NIDA R&D Contracts Management Branch Office of Acquisitions, NIDA 6001 Executive Boulevard, Room 4211, MSC 9559 Bethesda, Maryland 20892-9559* * FedEx/UPS/Courier/Hand Delivery use: Rockville, MD 20852 Phone Number: 301-443-6677 Fax: 301-443-7595 E-mail responses, sent to olaughlinb@nida.nih.gov will also be accepted.
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