REQUEST FOR DETERMINATION INVESTIGATE DRUGS 31 DEC 90

File: 970107_sep96_decls31_0001.txt
Page: 0001
Total Pages: 3

Subject: REQUEST FOR DETERMINATION INVESTIGATE DRUGS   31 DEC 90         

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003202

Folder Title: REQUESTS FOR DETERMINATION - OBTAINING INFORMED CONSENT                                         

Document Number:          1

Folder Seq  #:         26




                                              UNCLASSIFIED


                         THE ASSISTANT SECRETARY OF DEFENSE

                               WASHINGTON. D.C. 20301-1200


                                December 31, 1990


   .EALTH AFFAIRS



        MEMORANDUM TO THE SURGEON GENERAL OF THE ARMY

        SUBJECT: Requests for Determination - Obtaining Informed Consent
                  is not Feasible for Specific Investigational Drugs and
                  Vaccines



            in response to your request of December 28, 1990, regarding
        the subject above, I signed and transmitted the waiver r @ ests
        to the commissioner of the Food and Drug Administration (FDA) on
        December 28, 1990.

            Dr. David Kessler, Commissioner of the Food and Drug Adminis-
        tration approved the requested waiver for obtaining Informed
        Consent for pentavalent botulinum toxoid (ABCDE), BB-IND 3723,
        because of the military combat contingencies in operation Desert
        Shield, on December 31, 1990. The signed waiver and conditions are
        attached at Tab A. The information the Department of Defense has
        agreed to provide verbally, at a minimum, to service persons prior
        to administration, as developed by the U.S. Army Medical Research
        and Development Command and the FDA, is attached at Tab B.

            Please assure that appropriate steps are taken to provide this
        information and the conditions of the waiver approval to personnel
        responsible for immunizations.







        Attachments:
        As Stated


        cc:

        DIR, Joint Staff
        CDR, US@&D



         DECLASSIFIED
         ON: 16 OCT 96
         BY: SEC ARMY (DAMH) UNDER SEC 3.4 EO 12958


                                               CLASSIFIED BY-
                                     N       FIED

                                                            ---------------------


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Document 3 f:/Week-36/BX003202/REQUESTS FOR DETERMINATION - OBTAINING INFORMED CONSENT/request for determination investigate drugs 31:01029715472632
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003202
Unit = OTSG
Parent Organization = HSC
Folder Title = REQUESTS FOR DETERMINATION - OBTAINING INFORMED CONSENT
Folder Seq # = 26
Subject = REQUEST FOR DETERMINATION INVESTIGATE DRUGS 31
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 = 02-JAN-1997