To: FDADockets@OHRM-MAIL@FDAOC From: "Thomas G. Crouthamel Sr" Certify: N Subject: Back to basics, folk. Date: Tuesday, November 24, 1998 at 3:51:42 pm EST Attached: None Re Docket No 98N-0339 I was amazed when I read the FR 11/23/98. Prior to my retirement, in the 23 years that I labored as an FDA Field Investigator, I heard just about every name in the book, except, "Stakeholder". Now, if were "Fat, little, son of Stakeholder", the term would have been at least somewhat familar. I would like very much to be a contributing "Stakeholder". If I remember correctly, the FD & C Act of 1938, as amended, sets the FDA mission as a law enforcement agency. The FDA's mission is to assure that foods, drugs, cosmetics, and medical devices introduced into interstate commerce, during interstate commerce, or held for sale after interstate commerce are not adulterated or misbranded. Kinda simplistic isn't it? Do your job, enforce the law, and that's it. The main point in this is that I do not remember in 98N-0339, anything being said about adequate pay for field investigators and District laboratory analysts. You may not realize the fact that it takes five (5) years of on-the-job training to become a knowlegable, and adequate investigator. Folk that still remember me tell me that the FDA is losing investigators faster than they can be trained. Losing them to industry who are willing to pay adequate salaries. (One factor may be that the old FDA "Perssonel Policy" of "I got mine, to hell with you", may be still in force.) It is shear stupidity to expect any individual to know everything about everything the FDA has jurisdictionm over, therefore there is a drastic need for more and better paid investigators and analysts. If there isn't enough money in the budget for everything Congress wants, just do what will provide the most in consumer protection, and if they complain, ask them to be specific in which consumer protection segment they want to cut. As I read it, the agency's response to the FDAMA, while being a fairly CYA document, the time and money would have been better spent enforcing the Law. (Although I do realize that Congress doesn't really want the Law enforced - some of their biggest contributors might get caught.) THOMAS G. CROUTHAMEL Box 6459 Bradenton, FL 34281 E-mail: crout@flnet.com