USE OF DIAZEPAM AUTOINJECTOR

File: 970101_sep96_decls16_0003.txt
Page: 0003
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




                                                                                                              r LTz
                             DIPAIrMn Or BUTS ik HUMM suwcgs                                      Pot hft

                                                                                                 Fmo &-A


                                                                                             SEP 2 8 so

                                        surpon O#Aoral

                                                        and DSVO@T Co==d
                       A6tten                           Uk
                                    SMW-IM Cl@ ,Jag lorlsv & RSSUI&tary Affairs)
                       Part Detrick, Frodsvickt @lozd 21701-3012
                       Dear Mr. larizuk:
                       Raiiiritnaa is rade to y@ twentilittlonal       Now D@ APPIL04ticu (I") su@ttid
                       Purswmt to section 505(i) Of the Fld*L-al foods Drug and Cosutic Act for
                       diuaran *utainjecter, @ to Ye= AUM=nt dated SePtsubar 21, 1990,


                       Tht division bag no abjection to the DOD 'fielding' the di4stPam Autoit*eaeor
                       ear us* in operation Desert a"ld. Your asiortidu that the figldi" of the
                       AUt*@*ator is primarily Intended as * Otraat=ant mod4lityx nowiths                     ng,
                       the proposed plan for @ us* imd rstrfitipsetiva assessment of the consequence
                       of that Use Among casualties &,Iposad to tam giants satisfies FDA'J ra@vary
                       requirements fa@it bons fi0s clinical Lnv*sti$ation. Indotedt V& cannot emotive
                       of a VAlid glti=AtiV& Clinical trial de"9" to SV"U&t& ;hl tfg'e&gy @ Safety
                       of & drul produot intended to som at an antidote to chemical vartate n@a
                       &$into,
                       @&sod an the oAt*rL&la   submitted to the IND and info=tion Available in the
                lpe,sutilie literjt=lk, the division conelud$s that the @nistrgtion Of
                       'ilazop&m, as described LA in* Doctrinal St4ttg=nt (Onclusurs 6 of your           9/21/90
                       submission) Oases no unreasonable or significant risk to ths aaxualtits to wh=
                       it may be administered. wt do, h,,wovsr I ur&t the DOD to institute & Program that
                                          test the G*I%tgats of &,Atoinjouro:!s distributed to troops I,,
                       vill Po-giodicjilly        @ignt temperatures tbat OcOur in the           Saudi desert,
                       Saudi Arabia   Under t@ .        ad degradation.                           cc=anct)'
                       the product ;q

                       vtiv*r requests
                       The division is net 1,11;,novizisd to w&ivli requirements rolilti'tg to the need for
                               Congo-', 001'tlquantly   #ws D&=t respond to yo= raqusst for relief f@oin
                       the vsquir&moutx of 21 cyR 312 40 end 21 CII 50.
                                                                                                      FZOZ t'dlt
                                                              at DOD mAy be granted A W4iV$r
                       Ths division b" been LnfDms'6 th                                      milLtat7 use 'Ltd
                                  of -21 GYR 312.6(s) AtA mAY 012PLOY ths Pll'r&$*                            the
                                               of the    stato=nt ordinarily MaLn"tad for us* On
                       evaluation, in pages           gtig&tional drug produrt.
                       i=ediate PiL@s* Of all ',IV,'

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