Document jBKgv8wO2Kaq9kE17yRdymg02

JOSEPH E. KELLER JEEOME H HECKMAN CHABLES M MEEHAN WILLIAM H BORGHESANI, JR. ROBERT HTIEBNAN WAYNE V, BLACK DAVID L HILL MARTIN W. BERCOVICI peteb M, nemkov JOSEPH E. HADLEY CAROLE C-HARRIS WILLIAM W, PUGH PETER THOMAS SMITH LAW OFFICES Kelleh and Heckman 1130 irtS STREET, N. W. SUITE lOOO WASHINGTON, D. C. 20036 December 26, 1974 ,W. A. K, DEC 3 0 1974 TELEPHONE 802 200-2700 CABLE ADDRESS KELMaN' Dr. Karl A. Hochschwender American Hoechst Corporation Route 202-206 North Bridgewater Post Office Box 2500 Somerville, New Jersey 08876 Re: FDA "Public Information" RuleMaking, Freedom of Information Act Requirements Dear Karl Without making any pretense whatsoever at having fully read, much less digested, the latest of what have commonly come to be called "Peter's (Hutt) paragraphs," the purpose of this letter is simply to let everyone on The Society of the Plastics Industry's Food, Drug and Cosmetic Packaging Materials Committee know that the Food and Drug Administration has now promulgated its final Regulations under the Freedom of Information Act. We trust you may recall that the original Notice of Proposed Rulemaking on this matter was published in the Federal Register of May 5, 1972. As the Preamble to the final Regulations indicates, FDA has been delaying action on its original draft while it gained "experience under the proposal and because of pending litigation on the scope of the trade secret exemption." In part, this is another way of saying what we have been telling many of you, i.e. even though the Regulations were not final, FDA has been enforcing the proposal, or parts thereof, as if it had adopted the new Regulations long ago. Ordinarily we would be sending all of those re ceiving copies of this letter reproductions of the pages from the Federal Register containing the new Regulations. In this instance, we do not feel that this would be practical because of the voluminous nature of the mate rial and the consequent cost to the Society that reproduc tion and mailing would involve. Thus, we urge that all ASI-PR 0002288 Dr. Karl A. Hochschwender December 26, 1974 Page Two of those interested in the Public Information Rules obtain Part II of Volume 39, No. 248 of the Federal Register, if necessary by ordering the same from the Government Printing Office at the following address: U.S. Government Printing Office Superintendent of Documents Washington, D. C. 20401 This special Part II published on December 2.4, 1974--undoubtedly as some type of late Christmas gift for those of us who must review the document and live by it--is quite lengthy. The beginning page in the Federal Register is 44602 and the final page is 44657. Our cursory review of the material indicates that it at least constitutes a rather careful summary of the history of the public information problem and purports to deal with the substantive Comments filed. It may be that we shall be in a position to comment a little more about the substance of the rulemaking at the Com mittee's meeting on January 22 but, until then, we thought it would be best to simply call the fact of publication to your attention so that everyone else can also be looking the material over and drawing such conclusions as might be applicable to his company's particular interests. I suspect that this matter will give rise to any number of questions for years to come. We shall simply have to do our best to deal with such questions as they come up, and will certainly try to be of help whenever possible. ASI~pp 0002289