SPI - Food, Drug, and
Cosmetic Packaging Materials Committee
May 13, 1998 Newsletter

* * * For Members Only * * *

To: SPI Food Drug and Cosmetic Packaging Materials Committee

RE: Appropriations Subcommittee Draft of Premarket Notification Rulemaking Proposal — Need for Communications with Congressional Committees

Dear Ladies and Gentlemen:

While one of our regular letters will be along shortly to bring you up to date on a number of developments of interest here and abroad, this is a special letter to (1) supply you with a copy of the final version of the draft regulations to implement the Premarket Notification Program along with a copy of a letter of transmittal we sent to the Food and Drug Administration today; and (2) to urge you to call, fax, or write to the members of the House and Senate Appropriations Subcommittees that will be considering a mark-up of the Food and Drug Administration budget within the next few weeks.

We think you will find the letter to FDA and the draft regulations self explanatory since you have previously been supplied with our earlier drafts of the regulations. We are not anticipating any immediate substantive response to our letter from FDA since it is now generally understood in Washington that the Agency, being short of funds for all of its programs, is unlikely to expend any of them on this program unless and until Congress makes the Special Appropriation ordered in the Food and Drug Administration Modernization Act of 1997.

The fact is that while an argument might be made that the Food and Drug Administration should implement the new Section 309 of the 1997 Act — this is the Premarket Notification provision — with or without the Special Appropriation authorized when Congress passed the law, as a practical matter, we do not believe FDA will do so. Thus, it becomes imperative that the appropriate Appropriations Subcommittees (a list of the Senate and House members is attached) not only agree to the appropriation but included it in the budget as a specific line item so that there will be no question about the money having been made available. A great deal of work has already been done in this area by your Washington Representatives and the staff of the Society of the Plastics Industry, Inc., but your help is really needed. Probably the best thing that you can do is to call any of those on the attached lists with whom you have some business relationship. Secondarily, faxes and letters will certainly be helpful. Needless to say, if you send letters or faxes similar to the enclosed (but please do not simply copy them), we would appreciate receiving blind copies.

If you have any questions about any aspect of this matter, please do not hesitate to call or write.

Sincerely yours,

Jerome H. Heckman

(202) 434-4110
heckman@khlaw.com

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