COVER SHEET FOR DOCUMENT TRANSMISSION

File: 970101_sep96_decls18_0004.txt
Page: 0004
Total Pages: 5

Subject: COVER SHEET FOR DOCUMENT TRANSMISSION                           

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003205

Folder Title: USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT                                           

Document Number:          3

Folder Seq  #:         13









                The division agrees that all regulations under 21 CFR 312
                dealing with thW performance and responsibilities of 'individual
                investigators' may be waived to the extent that they apply to
                individual investigators because     *individual investigators',
                per se, do not exist in the proposed usage of this product.
                Accordingly, you are waived from the provisions of 21 CPR
                312.53, 21 CPR 312.57, 21 CPR 312.619 21 CFR 312.62, 2i CFR
                312.64l and 21 CPR 312.68.

                Only partial relief can presently be granted from the following
                rmrliilationcil the limitations on these waivers arm also notodi

                       21 CPR 3L2,32 is waived in regard to the 3 and 10 day
                       time limits for the reporting of adverse events; however,
                       DOD I% asked to collect, reviews and make report% of all
                       adverse clinical consequences attributed to the use of
                       Multi-Shiplri Tnriirpil 9kin Prntfprtant. In as timely a
                       manner as conditions permit,

                       21 CPR 312,55 is waived insofar as fhe requirement
                       applies to the delivery of an "Investigator Brochure to
                       individual investigators.   However, a more comprehensive
                       document than the proposed  Doctrinal Statement should be
                       prepared for medical personnel that provides detailed
                       information about the use of the product#       Information
                       at the detail of that provided in the "Inrtructions for
                       Uute" t*tic.Lion of your 0/215i§O submission would be
                       appropriate.   This document should be made available as
                       soon as possible to professional medical personnel who
n of personnel who will
                       be si?lf-administerimg   this product and who may be
                       involved in the management of casualties who have been
                       exposed to mervo agents,

                       21 CPR 312.59 is waived insofar as it applies to the
                       responsibility of individual investigators. Howeverp DOD
                       is urged to make a good faith effort to control supplier.
                       of this drug and disposed in a proper manner,

                       21 CPR 312.60 ire waived insofar as it applies to the
                       behavior of individual investigators; howpvprp        this
                       waiver   does   not   relieve    DOD   for   the   overall
                       responsibility for securing informed consent under 21 CPR
                       312.40 or 21 CPR 30.














                                                                  II. C)6. 90 12:06 PM F

Document 5 f:/Week-36/BX003205/USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT/cover sheet for document transmission:12249609312319
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT
Folder Seq # = 13
Subject = COVER SHEET FOR DOCUMENT TRANSMISSION
Document Seq # = 3
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 24-DEC-1996