Document LKbXxzwdwQ2r5L328L9xEVZBd

July 3} 1907 O. G. Fitahugh, Ph.D. Toxicological Advisor Division of Toxicological Evaluation Department of Health, Education, and Welfare Food and Drug administration Washington, D.C. 20204 Dear Doctor Pitahugh: I enclose herewith the information promised to you in ray letter a June 13. I'm sorry we slipped up on its enclosure in the earlier letter. The memo was being prepared at the time the letter was written, ana in my preoccupation with other matters, I neglected to see that it was enclosed. 1 enclose three items oi information; Cl) The brief protocol indicating the number and sex of the subjects and the bare description of the general procedure; (2) The details of the formulation that is to bo used, ana the type of instructions that are given to the subjects orally, and handed to them in written fora. These items of information are as they were presented to us in writing by the representative* of the sponsors, on our request for his advice. The proposed formulation seeioeu to us to be quite in order, after we had reviewed the various formulations that are marketed. We shall obtain the ingredients and mke our own preparation, and, of course we shall use our own ethyl alcohol instead of any denatured product. We shall not add perfume, but we believe a wetting agent should bo used, if for no other reason than that some such agent as that suggested is used in most of the commercial preparations. We shall use Tween #20 in the suggested concentration; (3) A snemo prepared by me, for the purpose of recording certain details and procedures which seem to be appropriate, g o as to make sure that no matter of significance is overlooked. I believe that this letter and these enclosures will acquaint you with v/hafc we have in mind, but if you require any other information, please lot me know. Cordially yours. ftobort a . Jiohoe, M.D. Professor Emeritus of