Policy and Regulatory Analysis

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), intends to issue a solicitation to obtain services for assistance with regulatory and policy analysis of tobacco control regulation or other tobacco control initiatives. 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. Background Tobacco products are responsible for more than 440,000 deaths and $193 billion in medical expenditures and lost productivity annually. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31) into law. The Tobacco Control Act granted the Food and Drug Administration (FDA) important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect Americans from tobacco-related death and disease. This project will assist the Center for Tobacco Products (CTP) with developing and evaluating regulatory and policy options. Objective The objective of this acquisition is for data analysis, preparation of regulatory impact analyses, analysis of regulatory alternatives, drafting a regulatory compliance manual, docket/comment response support, and technical support for seminars/workshops. 1. 1 Description of Work The Food and Drug Administration's Center for Tobacco Products is requesting assistance with regulatory and policy analysis of tobacco control regulation or other tobacco control initiatives. The effort will be performed within the context of the Family Smoking Prevention and Tobacco Control Act and related statutes including the Federal Food, Drug, and Cosmetic Act and the Federal Cigarette Labeling and Advertising Act. The work will also need to consider the Paperwork Reduction Act; the Unfunded Mandates and Regulatory Reform Act (UMRA); the Regulatory Flexibility Act (RFA) as amended by the Small Business Regulatory Fairness Enforcement Act (SBREFA); the Congressional Review Authority and its amendments to the Regulatory Flexibility Act; relevant Executive Orders (EOs); Office of Management and Budget (OMB) analysis guidance such as Circulars and memos issued by OMB (e.g Circular A-4); and international agreements and protocols. As specified in individual calls, the Contractor shall perform work in the following task areas: A. Documentation and Analytical Support 1. Conduct a Literature Review of Economic Studies on Tobacco Control Options, Costs, and Benefits (Sample BPA Call) The Contractor shall conduct a comprehensive literature review of economic studies related to tobacco control options, costs, and benefits. 2. Draft and Revise Policy and Regulatory Analysis Resource Manual The Contractor shall draft the CTP Policy and Regulatory Analysis Resource Manual, which will be used by FDA and Contractors as a guide for performing policy and regulatory impact analyses. B. Support for Policy Analysis and Regulatory Actions FDA estimates that multiple, concurrent analyses will be required. However, FDA anticipates no more than five major concurrent analyses will occur per year. 1. Conduct Tobacco Control Policy Strategy Analysis A policy strategy analysis consists of two stages: 1) methodology development and approval, and 2) conducting and reporting the analysis. Policy strategies for analysis include, but are not limited to, labeling, product standards, advertising restrictions, information disclosure, and innovative regulatory strategies to achieve health protection goals. Impacts to be estimated include costs, changes in initiation, cessation, and product switching. 2. Conduct Cost Analysis of Policy or Regulatory Options A cost analysis consists of three stages: 1) gathering and synthesizing data on affected entities, 2) methodology development and approval, and 3) conducting and reporting the analysis. The Contractor shall also provide a list of reference materials, or copies as requested by FDA, of technical documents, manuals, data sources, and other documentation used to develop the analysis plan. The Contractor shall analyze and report on the economic consequences of regulatory actions and/or programs as those impacts fall on affected industries and the economy as a whole. 3. Conduct Benefit Analysis of Policy or Regulatory Options A benefit analysis consists of two stages: 1) methodology development and approval, and 2) conducting and reporting the analysis. The contractor shall identify, quantify, value, and report on the social benefits expected to result from regulatory actions. Where applicable, the Contractor shall compare the benefits of innovative regulatory strategies to traditional regulatory alternatives. All regulatory alternatives identified by the COR shall be analyzed. 4. Regulatory Impact Analyses The Contractor shall develop, organize, assemble, and edit regulatory impact analysis (RIA) reports for significant regulatory actions. C. Analytics, Data Collection, and Support Projects under C may occur as part of policy and regulatory work described in section B or they may be developed independently based on specific BPA calls. 1. Analysis Methods, Computer Models, and Tools The Contractor shall review, analyze, and report upon economic analysis tools, techniques, and methods that can be applied to defined analysis problems, such as impacts on growth predictions. 2. Information Collection Analyses for Regulatory Impact Analysis and Economic Surveys ( also see C.2) The contractor shall prepare the burden estimates (e.g. monitoring, record keeping, and reporting costs) to government and private entities associated with information collection requirements for regulatory impact analysis or economic surveys. 3. Sensitivity Analysis and Uncertainty/Variability Characterization The Contractor shall support the development and application of methodologies for conducting sensitivity analyses and characterizing uncertainty/variability in cost/benefit assessments.. 4. Prepare Reference Documents Suitable for Docket Inclusion The Contractor shall also assemble, organize, itemize, reproduce, and submit to FDA all background reports, raw data, calculations, memos, models, public documents and other reference materials that were used in preparation and support of work performed by the Contractor. 5. Support for Responses to Public Comments Associated with Regulatory Impact Analyses The Contractor shall review, organize, and summarize public comments received by FDA in response to regulatory notices as needed. The Contractor shall provide technical support in the development of draft responses to comments on regulatory notices, and provide technical analysis as needed to develop such responses. 6. Revise Analyses and Related Documentation The Contractor shall update and revise analyses and reports prepared under this contract to respond to: a) new analysis inputs; b) the considerations and findings of internal FDA reviews and external peer reviews; c) work groups for rulemaking, policies, and guidance; d) the National Academy of Science (NAS), including the Institute of Medicine; e) the Tobacco Products Scientific Advisory Committee (TPSAC); f) Federal Advisory Committee Act (FACA) workgroups; g) CTP clearance, FDA clearance, HHS clearance, and the Office of Management and Budget (OMB) Review; h) requests made during interagency review; i) requests made as a result of Congressional review; j) changes in FDA policy; and k) public comment. 7. Data analysis using Geographic Information Systems As required to support CTP analyses, the Contractor shall perform GIS related activities within a computing hardware/software framework that reflects the current state-of-knowledge in the field of geospatial systems 8. Conduct Economic Surveys. The Contractor shall plan, conduct, and evaluate surveys and/or focus group sessions to provide additional data or methods to evaluate the impacts of CTP policies on specific benefit, cost or economic analysis issues as indentified by the FDA. Office of Management and Budget and Human Subjects Protection Clearances Approval from the Office of Management and Budget (OMB), consistent with the Paperwork Reduction Act, will also be needed prior to data collections from ten (10) or more individuals. The contractor shall also prepare Information Collection Requests for surveys suitable for submission to the Office of Management and Budget. Clearance from FDA's Research Involving Human Subjects Committee (RIHSC) must be obtained prior to any data collection, including pretesting (see Special Contract Requirements). 9. Technical Support for Workshops, Seminars, Meetings, Public Hearings, and Peer Review Panels Related to Economic and Policy Work The contractor shall provide technical support for workshops, seminars, technical meetings, and public hearings related to the areas covered in this Statement of Work. The Contractor shall attend TPSAC, FACA, or IOM meetings, as well as public hearings, site visits, and other related meetings.. As part of the technical development of methodologies and/or analyses completed under this Statement of Work, the Contractor shall attend, participate, and make presentations at workshops, seminars, and conferences. The Contractor shall convene and support panels to conduct peer review of analysis methods that may be used by CTP. 2.1 Project Management The Contractor shall develop technical approaches and specifications to meet the requirements of the contract and shall interact with the COR on a weekly basis, either through personal contact, telephone or e-mail. 2.2 Transition Completion of Project Sixty (60) calendar days prior to completion of this contract the Contractor shall provide a detailed transition plan for contract closure and/or transition to a new contract.. 2.3 Confidentiality The Contractor must sign a Non-Disclosure Agreement we well as a Conflict of Interest Agreement. The Contractor shall submit for review and obtain written approval from the FDA Contacting Officer/Project Officer /Contracting Officer Representative prior to using or disseminating any and all manuals, technical documents, outreach materials (including all training and workshop materials), and computer models that are developed or modified under this contract. ANTICIPATED PERIOD OF PERFORMANCE 5 years for a 60 month ordering period is anticipated. 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 Administration, 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 General Services Administration 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.