Experimental Study on the Subjective, Physiological and Puff Topography Measures of Little Cigars

TITLE: Experimental Study on the Subjective, Physiological and Puff Topography Measures of Little Cigars OPDIV : FDA, Center for Tobacco Products (CTP) Background: This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d). The potential small business will need to demonstrate the capability to perform all facets of the experimental study on the subjective, physiological and puff topography measures from initiation and conduct of the study through the data analyses phase and preparation of the final reports. History: Tobacco products are responsible for more than 440,000 deaths each year. The Centers for Disease Control and Prevention report that every day in the United States, approximately 3,900 young people between these ages of 12 and 17 smoke their first cigarette and approximately 1,000 adolescents become daily smokers. Flavored cigars are a novel class of tobacco products, which resemble cigarettes in size, packing and nicotine levels. Because some of these products taste like candy and are highly flavored, public health officials have raised concerns that flavored cigar tobacco products may be particularly appealing to children and adolescents. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) into law. The Tobacco Control Act granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. FDA is specifically interested in understanding information relating to section 907(a)(3)(B)(i) of the Federal Food, Drug, & Cosmetic Act the following topics: I. the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard; II. the increased or decreased likelihood that existing users of tobacco products will stop using such products; III. the increased or decreased likelihood that those who do not use tobacco products will start using such products. Data on flavored cigars will be critical to the Tobacco Products Scientific Advisory Committee in studying and reporting on their public health impact. FDA is interested in this data for understanding the risks to children and adolescents, how the risks of using these products are perceived by smokers and non-smokers, and how use of these products affects health. Such research may include, but is not limited to the following topics: - puff topography - physiological measures - subjective measures - exploring perceptions The tobacco industry has been charged with introducing flavored cigarettes in an attempt to appeal to new smokers (Connolly, 2004; Lews & Wackowski, 2006). Younger smokers are more open to unique and exotic flavors than their older counterparts (Carpenter et al., 2005). The work of Klein et al. (2008) supports this with data supporting overall use of any of flavored brands in the past 30 days being 11.9% among smokers aged 17-26 years and 6.7% among smokers aged > or =25 years. In addition, high sensation-seeking adolescents have more favorable attitudes and greater intentions of trial for brands with flavor versus more traditional brands (Manning et al., 2009). On September 22, 2009 a ban on cigarettes containing certain characterizing flavors went into effect. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by FDA to reduce smoking in America. FDA's ban on certain characterizing flavored cigarettes highlighted the importance of reducing the number of children who started to smoke, and who became addicted to dangerous tobacco products. FDA is also examining options for flavored tobacco products other than cigarettes. According to section 907(a)(1)(A) of the Act: ...a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. In addition, section 900(3) defines cigarettes as: (3) CIGARETTE.-The term - cigarette'- (A) means a product that- (i) is a tobacco product; and (ii) meets the definition of the term - cigarette' in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and (B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco. The primary objectives of this contract are to conduct a study to assess if flavored little cigars, because of their appearance or type of tobacco used in the filler, are likely to be depicted as and consumed by tobacco users as a cigarette. In order to fulfill these objectives, the Government is seeking a contractor to conduct an experimental study to measure the subjective physiological and puff topography measures, and perception, of flavored little cigars. The FDA shall provide the Contractor a draft protocol and questionnaire to aid the experiment. The Contractor, in collaboration with FDA and through ongoing communication, shall further develop and refine the protocol and questionnaire. The study design should allow for measurement of consumer's ability to perceive differences in tobacco products. 3. SCOPE Contractor tasks shall include, but not be limited to: 2.1.2. Screening The FDA will supply the Contractor with specific recruitment requirements, including a screening questionnaire, to meet the study objectives. The Contractor shall provide the facility, equipment, supplies and recruitment for a total of 48 completed subjects of adult White and African American male and female smokers. The Contractor shall also provide qualified personnel to conduct the screening and study. Experimental sessions will take approximately 90 minutes and the set of four (4) will be conducted at least 24 hours apart after a period of overnight tobacco abstinence. Experimental sessions shall be conducted at IRB approved sites. The experimental sessions will be monitored by the Contractor and the COTR. 2.1.3. Recruitment and Study Population: The Contractor shall provide the required personnel to perform the identified tasks in this scope of work. The Contractor shall provide the required personnel, materials and services, and otherwise meet all requirements for, or incident to, the performance of the work as described below. The Contractor will be responsible for recruiting the subjects. The subjects should include cigarette smokers with no smokeless tobacco or cigar smoking experience during the past year. The subjects should be healthy males & females 18-55 years of age. Women who are pregnant (as verified by a urine pregnancy test) or breastfeeding should be excluded. The subjects should be ethnically diverse, preferably 12 African American males, 12 African American females, 12 White Males and 12 White Females. The estimated sample size is 48 (n=12 per cell) divided into the following subgroups: African American Male African American Female White Male White Female Cigarette Smoker n=12 n=12 n=12 n=12 2.1.4. Data Collection: The contractor shall maintain detailed scientific notes and records from the research study. The contractor shall systematically and comprehensively analyze the data from the research study. The contractor shall analyze the data, synthesize the results, write a report summarizing the analysis, prepare presentation materials, and provide presentations of research results. 2.1.5. Methodology Report and Data Analyses: The Contractor shall provide the FDA with a methodology report including monitoring, sample selection procedures, data collection procedures, data preparation and processing, coding procedures, and any common themes or problems encountered during the execution of the study. The report should also include a summary of the results, including a subgroup analysis of the groups according to age, smoking status, SES, and education level. A preliminary draft of the final report should be sent to the FDA for review and comment prior to submitting the final report. FDA will provide feed back within 14 days. 2.1.6. Information Collection Request (ICR) and Human Subjects Protection: Approval from the Office of Management and Budget (OMB), consistent with the Paperwork Reduction Act, will be needed prior to data collections from ten (10) or more individuals. The FDA Project Officer will be responsible for preparing the OMB package necessary for data collections. The Contractor will be responsible for providing to the FDA Project Officer the necessary information about the Contractor's procedures. Clearance from FDA's Research Involving Human Subjects Committee (RIHSC) must be obtained prior to any data collection (see Special Contract Requirements). The FDA Project Officer will be responsible for preparing the package to obtain this clearance. The Contractor will be responsible for providing to the FDA Project Officer necessary information about the Contractor's procedures. This may include information such as informed consent, confidentiality and record-keeping procedures. The FDA Project Officer must provide written notice of such approval to the Contracting Officer and to the Contractor prior to the Contractor beginning any data collection. NAICS Code: 541990 Contractor Requirements: Contractors must respond to all of the following points, by indicating your experience and capability: 1. Recent experience (including recruitment of suitable participants for research studies, performing data collection as well as methodological analysis of the results of the studies) in conducting research studies comparable to the study outlined herein . 2. To recruit and identify staff (key personnel) with the expertise to perform the tasks in the Statement of Work. 3. Demonstrate capability to select and obtain an appropriate IRB approved research site to perform this study. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email to Ann Argaman, Contract Specialist ann.argaman@fda.hhs.gov. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE. Please address each in order listed above. Teaming Arrangements: All teaming arrangements shall include the above-cited information for each entity on the proposed team. Teaming arrangements are encouraged. Responses must be submitted not later than January 5, 2012. Capability statements will not be returned and will not be accepted after the due date. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates FDA to award a contract. The sole intent of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes. Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the Central Contractor Registration (CCR). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the CCR located at http://www.ccr.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Sources Sought 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. 10. Responders should also include a statement about whether or not they have an approved Federal audited accounting system. If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number). You may submit as an attachment, which will not count towards the overall page limit. All capability statements can be submitted via e-mail, facsimile, or regular mail to the point of contact listed below. Responses shall be limited to 10 pages Responses must be submitted no later than January 5, 2012 Documentation should be sent to: US Food and Drug Administration Office of Acquisition and Grants Services 5630 Fishers Lane, Room 2118 Rockville, Maryland 20857 Attn: Ann Argaman Contract Specialist