USE OF DIAZEPAM AUTOINJECTOR

File: 970101_sep96_decls16_0004.txt
Page: 0004
Total Pages: 5

Subject: USE OF DIAZEPAM AUTOINJECTOR                                    

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003205

Folder Title: USE OF DIAZEPAM AUTO INJECTOR                                                                   

Document Number:          1

Folder Seq  #:         16










                     The diVUlan agree* tUt; SIX
                     P$ct'a     a ad rssponsibilitiser"P'4'tlonm under 91 OM 312 dealing with the
                                                          of , Individual inmtiptors i may bi vai%,sd td
                           ORtOut @t tb$Y IIPPLY to @vidat @nti$ators because o@vidual
                     trxostigators, I par a*, do not exist In the proposed field trial. Accardinglyl
                      = riiquacs senior vai".v And/or :sliaf fr= the pr"inions of
                     ri GIR 312.53, 21 GPI 312.37p 21 CYR 312.61, 21 M 312.62, 91 CYR 312.94, 21
                     GIR 312.68 &re IrAnttd.
                     only li&rti4LI relief Ls panted fr= the folloviris roplations., @ licir4tions
                     an these waivers are alga note4:

                           21      311.32 is waived in regard to the 3 and 10 day t@ @ts for the
                           .4sportiq of adverse 4vents; homor DOD is AAkad to colleat, r@ow, @
                           @ reports of all adverse Clinical cowaquencox attributed to the use
                           of the lutainje@r in " tizely a "anrior as anditions go@t.

                           21 = 312-53 is waived Insofar as the raquirommt applies to @ dsllvtry
                           of am Ilrv&stigator brocb=al to individual investigators gaywor, a more
                           @raboraive doc=ant tbsn the proposed Doetri@ Statooont should be
                           yrsp&rad that provides dit.%Lled infomation about tht ph            okinaties and
                           Amtieowmlsant actions of diazapas delivered by ititrmucular route.
                           ,Tnforution at the detail of that provided witu-n the I DAT4 IVIVI section
                           of your 9/21/90 submission would be appropriat*. @s doe=ant xhould be
                           S&ds svsilablet as soon as possible, to professional taodioal ptratmet vha
t Of Oltousitits vhG h"D best O:CP*std to
                           here# ag@,Ats.
                           21 CYR 312.50 is Waived insofar as It iLprILAs to the responsibility of
                           i@@ -idu&l ir4vostigatars. Xowav*r DOD is urgsd to =U a x@ead faith effort
                           to          supplies of this @g produk%t in view of Its potential for
                           diversion, zigus@i And &bus#,
                           21 On 312.60 is vgivgd jrsof&r as it applies to the b@vior of Individual
                           itmastigaterx; howmtl this v&iv&r do-6x not raliove DOD for the overall
                           responsibLlitT for mac=ing informed consent under 21 CM 312.40 or 21 CYR
                           50.
                                                      Provided thst WD $Xsrcisfis &'PPI:OPTJ&ta diligence
                           21 C7$L 3                                                      ion to ind@d",
                           in the I                                                                         Atd
                           militati                                                                         and
                           p@ne4                                                                             in
                           div*,rai;                                                                         of
                           ragulati
                           ftforoszs                                                                           t
                           of      cc                      or rules eonstz                                tight
                           be iOUghl                       LWMbtigjLrionAl drU$ p'gCdUat.
                           pertain t

Document 5 f:/Week-36/BX003205/USE OF DIAZEPAM AUTO INJECTOR/use of diazepam autoinjector:12249609312217
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = USE OF DIAZEPAM AUTO INJECTOR
Folder Seq # = 16
Subject = USE OF DIAZEPAM AUTOINJECTOR
Document Seq # = 1
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