FDA Issues Guidance on Tobacco R&D Meetings; Requests Comments on Info Collection
The Food and Drug Administration announced the availability of a guidance for industry entitled “Meeting with Industry and Investigators on the Research and Development of Tobacco Products,” which describes FDA’s current policies and recommendations on FDA meetings with tobacco manufacturers, imports, researchers, and/or investigators relating to their plans to conduct research to inform the regulation of tobacco products, or support the development or marketing of tobacco products. FDA said this guidance does not pertain to other types of meetings or meeting requests with Center for Tobacco Products (CTP) staff. FDA is requesting comments on the guidance, which may be submitted at any time. FDA is also asking for comments, due by July 24, 2012, on two proposed information collections on (i) recommended materials to be included in such a meeting request, and (ii) recommended materials to be included in a meeting information package.
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Guidance on Submissions of Info About Meetings for Tobacco Assistance
The Family Smoking Prevention and Tobacco Control Act offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize marketing a tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market particular products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) where appropriate.
This guidance is intended to assist persons who seek such guidance, and discusses, among other things: (1) what information FDA recommends persons include in such a meeting request; (2) how and when to submit such a request; and (3) what information FDA recommends persons submit prior to such a meeting.
FDA Seeks Comments in Info Collections for Meeting Requests, Submissions
The guidance sets forth FDA’s specific recommendations for materials to be included (i) in a request for a meeting and (ii) in summary information relevant to the product and supplementary information pertaining to any issue raised by the individual or FDA to be discussed at the meeting. FDA estimates that these proposed information collections would (i) be completed by 67 respondents once per year, and average 10 hours per response, for a total of 670 total burden hours and (ii) completed by 67 respondents once per year, and average 18 hours per response, for a total of 1,206 burden hours, respectively.
FDA invites comments on these proposed information collections, on topics including: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, where appropriate, and other forms of information technology.