Request for Extension of Comment Due Date

January 15, 2008 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Request for Extension of Comment Period?Cheese and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; Reopening of the Comment Period [Docket No. 2000P-0586 (Formerly Docket No. 00P-0586)] Dear Sir or Madam: The International Dairy Foods Association (IDFA) respectfully requests, pursuant to 21 C.F.R. ? 10.40(b)(3), that the reopened comment period for the above- captioned Proposed Rule be extended for 60 days until April 11, 2008. As further explained below, the additional time is necessary to compile comprehensive comments to address the issues raised by the Food and Drug Administration in its December 11, 2007 Federal Register notice (the ?Notice?). The comments of IDFA and its individual members will provide significant information to assist the FDA in developing a sound public policy. IDFA is the Washington, D.C.-based organization representing the nation's dairy processing and manufacturing industries and their suppliers. IDFA comprises three constituent organizations: the Milk Industry Foundation (MIF), the National Cheese Institute (NCI), and the International Ice Cream Association (IICA). NCI has 90 member companies that manufacture 80% of the cheese consumed in the U.S. IDFA/NCI member companies will be directly affected by any action FDA takes on this proposed rule. It was on behalf of NCI that IDFA filed comments to the first opening of this docket on January 17, 2006. We appreciate the attention that FDA paid to those comments and recognize that the reopening of this comment period is, in large part, to review the data submitted by IDFA in those comments. Accordingly, we believe it is of utmost importance that sufficient time be granted for IDFA and its member companies to respond to the issues raised by FDA in the Notice. Specifically, FDA?s Notice asks 10 questions that relate to whether ultrafiltered (UF) milk should be subject to specific ingredient labeling in finished cheese products. These questions relate to whether such labeling would be either: (a) impracticable; or (b) misleading to consumers. For example, FDA asks a series of questions regarding the costs for such labeling. FDA noted that IDFA?s original comments did not provide a sufficiently ?detailed or itemized breakdown? of the estimation for these costs. IDFA is more than willing to collect such data and information and provide it to the FDA, and we have already started working with our member companies to do so. However, this new and additional information and data will take some time to collect, and we do not believe we can complete this task with sufficient rigor by February 11th. Because of the nature of the questions, IDFA and its member companies are the only entities who can provide FDA with much of the data and information requested. We appreciate the agency?s interest in moving forward. However, we note that the original comment period closed approximately two years ago, and with the timing of the FDA?s recent Notice?which was published shortly before the holidays on December 11, 2007?this has been a difficult time of year to collect such data and information. Nevertheless, IDFA and its members have been working diligently to collect the requested information. We are committed to participating in this comment period and to contributing to this important issue, which directly, and almost exclusively, affects our members. We believe that an additional 60 days will provide IDFA and its members sufficient time to provide thorough and thoughtful feedback to the Agency. Finally, we note that the subject matter of this notice?ingredient labeling?is strictly a regulatory issue and in no way impacts public health. The public interest, therefore, weighs in favor of allowing the cheese industry sufficient time to provide FDA with a complete response. We appreciate your consideration of our request. Please feel free to contact us with any questions. Sincerely, Best Regards, Clay Hough Group Senior Vice President and General Counsel Cc: Michael Landa Deputy Director for Regulatory Affairs Center for Food Safety and Applied Nutrition Barbara Schneeman, Ph.D. Director Office of Nutritional Products, Labeling and Dietary Supplements Felicia Billingslea Director Food Labeling and Standards Staff The International Dairy Foods Association (IDFA) respectfully requests, pursuant to 21 C.F.R. ? 10.40(b)(3), that the reopened comment period for the above- captioned Proposed Rule be extended for 60 days until April 11, 2008