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 May 14, 1999
The
Society of the Plastics Industry, Inc. Re: FDA Draft User Fees Act Dear Ladies and Gentlemen: In the near future we will be sending you one of our usual letters to update you on recent events of interest; meanwhile, the purpose of this special letter is to bring an important new development to your immediate attention. Enclosed is a copy of a letter the Secretary of Health and Human Services (HHS), Donna Shalala, has now sent to the Honorable J. Dennis Hastert, Speaker of the House of Representatives, to send the House the long-awaited draft bill proposing Food and Drug Administration (FDA) "review fees." Since we just received this document today, we have not had a full opportunity to review it in detail, nor have we engaged in any discussions with FDA on the details of the draft. The purpose of this letter is simply to provide you with a copy of the document so you can review it. As of this writing, we do not know whether any member of Congress has agreed to introduce the legislation. FDA and HHS have been in close touch with Congressman Dingell and perhaps other members of Congress, most of whom, we understand, are unhappy with the FDA proposal for a variety of reasons. Nonetheless, we anticipate that a formal introduction will take place in the near future; the main mystery today is as to who will put the bill in the hopper. When that occurs, we will have a Bill Number or numbers to reference specifically in further correspondence. As you will see, the draft bill is set up into three basic sections. (It is the combining of all the Areview fees@ in one bill that is engendering the most Congressional displeasure.) Title I deals with Medical Device Fees, and Title II deals with fees relating to Food and Color Additive Petitions. We expect that these two Titles will be very controversial on Capitol Hill since there is strong opposition to (a) any fees for medical device application reviews, and (b) anything resembling the proposed food additive manufacturer registrations fees in Title II. Title III, which proposes fees for Food Contact Substance Notifications, probably will be of the most interest to you. These fees essentially are tiered by dietary exposure levels: (1) $5,000 for notifications with uses resulting in a dietary exposure less than 0.5 parts per billion (ppb) or those not requiring review of additional safety data; (2) $20,000 for notifications with uses resulting in a dietary exposure between 0.5 ppb and 50 ppb, inclusive, or those not requiring review of more than one animal toxicity study with a duration of 90 days or more; and (3) $40,000 for notifications not falling under categories (1) and (2), e.g., notifications with a dietary exposure over 50 ppb or those for new food contact materials. We believe that the proposed fee level for the Tier 2 notifications is inordinately high, and suspect that you may feel the same about the other tier levels as well. Nonetheless, we look forward to receiving any of your comments so that we can relate your views to the appropriate regulatory and legislative officials. There also will be an opportunity to discuss the draft bill further at the upcoming June meeting. In the meantime, should you have any questions or comments, please do not hesitate to call. Sincerely yours, Jerome H. Heckman
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