Document 5Dk21dGpM5n80g19rDKXr1894

Telephone- 515 26-3241 SALSBURY LABORATORIES Charles City, Iowa, 50616 O. H. Peterson, Ph.D. Vice President September 25, 1967 Dr. William A. Knapp Allied Chemical Corporation P. O. Box 405 Morristown, New Jersey 07960 Dear Doctor Knapp The Proposed Rule Making of FDA which appeared in the Federal Register on August 8, 1967, has been stud ied. The following comments are sent to you as advised by Mr. Morgan W. Hoover. 121.7 (a) (2). A reference is made to sub mitting application for a new drug or anti biotic according to Form FD 356V, We do not know what this form contains as it ap parently has not been released by FDA. We think this form should be available for , study long enough before these Food Addi tives Procedural Regulations become ef fective so that objections, if any, can be considered by FDA. 121.9 (c). We agree that analytical methods should not be considered confidential. But, we maintain that data submitted on toxicology should be considered confidential and en titled to protection as trade secrets. If \ toxicological data becomes public knowledge, /! ' this could enable another company to obtain 1 approval of an NDA, utilizing the toxicologi- 0 cal data submitted. The development of toxicological data is one of the most costly aspects of obtaining an NDA. The crux of ASI 00001846 Dr. William A. Knapp Page 2 September 25, 1967 this proposed rule is the definition of the word "summary." If the information in the summary is sufficient to substantially aid other companies in obtaining an NDA, then this rule should not be allowed to stand as proposed by FDA. 121.50 (c). The requirement for use of 8 x 10-1/2 inch pages in an NDA is unneces sary bureaucratic dictation. We use the standard 8-1/2 x 11 page for our records. If the smaller page is dictated by this pro posed rule, we must either utilize a smaller page for our experimental records or re type everything that goes into our NDA's. To utilize the smaller page for our records would require revision of nearly all of our tabular forms and the splitting of tables, which in most cases is undesirable. We are also opposed to the requirement that all text be double-spaced. In some cases this may be undesirable for the sake of clarity and expediency. Parts of the text are often photocopied from other sources. To double space all of this would require unnecessary typing. The advantages to FDA would not seem to warrant this requirement. 121.50 (g) (f). The same comments given above for 121.9 (c) apply here. Sincerely OHP/mw cc: Hoover Hulse Vincent C , D, Vice president - Kesearch ASI 00001847