Identifying Data Useful in Developing a Tobacco Retailer Compliance Inspection Strategy

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), intends to issue a solicitation to obtain services from a contractor to identify for FDA/CTP, data that may enhance existing methods used in working with States and territories to monitor retailer compliance activities This is not a solicitation for proposals. The purpose of this notice is to obtain capability statements regarding the availability and capability of qualified small business sources for the proposed acquisition. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible. The NAICS Code for this requirement is 541990, All Other Professional, Scientific, and Technical Services. The FDA intends to solicit request for proposals using the Federal Supply Schedule of the General Services Administration. Background Tobacco products are responsible for more than 440,000 deaths each year. The Centers for Disease Control and Prevention (CDC) report that approximately 46 million adults smoke cigarettes in the United States, even though this behavior will result in death or disability for half of all regular users. Paralleling this enormous health burden is the economic burden of tobacco use, which is estimated to total $193 billion annually in medical expenditures and lost productivity. Curbing initiation and increasing cessation are critical public health goals. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111?31: 123Stat. 1776) into law. The Tobacco Control Act grants the Food and Drug Administration (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. The Center for Tobacco Products (CTP) oversees the implementation of the Tobacco Control Act. Since retailers are a key audience of the regulation, it is important to undertake effective and efficient monitoring of retailer compliance rates and ensure efficient direction of resources used in compliance inspections to better understand their potential impact on the public's health. Retailers play a major role in protecting the health of America's youth by not selling, marketing, or advertising cigarettes or smokeless tobacco products to underage children and adolescents. It is critical that FDA gather science?based data to monitor and more fully understand the impact of national, state, and regional data that can be used to determine a tobacco retailer inspection strategy and measure the public health impact in relation to Tobacco Control Act outcomes. Objective The purpose of this procurement is to identify for FDA/CTP, data that may enhance existing methods used in working with States and territories to monitor retailer compliance activities; for example, incorporating a risk?based approach by identifying States whose retailers are considered at higher risk for regulatory violations to more effectively and efficiently direct FDA's compliance efforts. Statement of Work The Contractor shall perform the following tasks: Task 1: Kick?off Meeting Task 1.1. Following communication from the COR of the notice of award of the contract, the Contractor shall meet with the COR and FDA staff to discuss the proposed work plan and proposed progress schedule.. Task 1.2. The Contractor shall prepare and submit a final work plan based on the proposed progress schedule and feedback on the project's clarity, methodology, and expectations. Task 2: Literature Review The Contractor shall utilize the appropriate social science and related databases, to gather and analyze published literature and peer?reviewed studies to explore the issue of monitoring retailer compliance and identifying areas for potential enhanced compliance efforts in order to maximize public health. Task 3: Development of the Algorithm The Contractor will review the existing literature and develop a scientifically?based strategy that can be utilized as part of FDA/CTP's overall compliance inspection strategy with respect to retailer compliance inspections that will be aimed at maximizing the public health impact. Retailer compliance inspections currently examine areas such as youth access (e.g. sales to minors, impersonal modes of sale), retailer?based marketing (e.g. sale of flavored cigarettes or sale of cigarettes in less then packs of 20), and may expand to other areas if CTP issues new regulations. CTP should be able to enter various inputs from existing tobacco compliance monitoring data sources into the model and based on the appropriate succession of yes/no or if/then scenarios, use the model as part of CTP's overall compliance inspection strategy. Factors that may be considered in developing the strategy include, but are not limited to: -Vendor class (or types of retailers) -Demographics (racial/ethnic composition,, age, educational levels) -Population density (rural, urban) -Retailer density -Proximity to schools -Youth smoking rates -Difference across types of tobacco products -State tobacco-tax policies -Previous non-compliance rates in an area (i.e. Synar) -State tobacco laws (i.e. States that issue vending machine licenses vs. States where they are illegal) The Contractor shall develop a predictive algorithm, to be delivered to CTP, which will recommend what additional data could be collected by CTP to enhance the overall compliance inspection strategy. The algorithm will incorporate data generated from the synthesis of studies from the literature review. The Contractor will identify data sources and data collection and analyses necessary for formulating the algorithm. The Contractor will also incorporate the presence of existing State policies into the analyses and algorithm. Task 4: Final Report The Contractor shall provide a report outlining the literature review findings, methods used to develop the algorithm, suggestions for pilot implementation and recommendations for future research. The Contractor shall write this document in MS Word (Office 2003) compatible software. The Contractor shall also provide a MS PowerPoint presentation during the final in?person meeting to present findings to FDA/CTP staff and provide a demo of the algorithm. Task 5: Meetings The Contractor shall meet with the COR on a weekly basis to discuss progress. The Contractor shall prepare minutes of each meeting and submit them to the COR within 2 calendar days of the meeting. Contract Type This is an anticipated firm fixed price type contract. Period of Performance Base Period (12 Months from date of award) CAPABILITY STATEMENT This notice is issued for informational purposes and is not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than 15 days from the date of this announcement. The solicitation will be available on or about May 30, 2012, on the General Services, e-Buy website at https://www.gsaadvantage.gov/advantage/login/eBuyLogin.do. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the Federal Business Opportunities website for the release of the solicitation and amendments. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. Responses and capability statements for this synopsis must be sent via email to: Vivian.Lucas@fda.hhs.gov within 15 days from the date posted of this notice. No phone calls will be accepted.