REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0001.txt
Page: 0001
Total Pages: 16

Subject: REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES        

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS                                               

Document Number:       1001

Folder Seq  #:         16






                                      DEPARTMENT OF THE ARMY
                                      OFFICE OF THE SURGEON GENERAL
                                           5109 LEESBURG PIKE                      t
                                        FALLS CHURCH, VA 22041-3258
                  REPLY M
                  A@ENTION OF
                                                                      2 8 D E C 1990
            DASG-ZA (70)


            MEMORANDUM FOR Assistant Secretary of Defense (Health Affairs),
                                 Washington, DC 20301-1200

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


            1. Enclosed are three letters to the Commissioner of The Food
            and Drug Administration requesting determination that compliance
            with their regulations governing informed consent is not feasible
            for selected investigational drug products to be fielded in
            support of Operation Desert Shield. The three products are;
            Multi Shield Topical Skin Protectant, Pyridostigmine 30 mg
            tablets, and BotulinuM ToXoid.

            2. These requests are submitted under the provisions of 21 CFR
            50.23(d)(1) published in the Federal Register on 21 December
            1990. These provisions stipulate that such requests be initiated
            by the Assistant Secretary of Defense (Health Affairs).

            3. Recommend signature.
            3 Encls                                R4     D T. TRAVITS
            as                                     Major General, MC
                                                   Acting The Surgeon General

Document 16 f:/Week-36/BX003201/REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS/req for determination informed consent drug and :12249609312932
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS
Folder Seq # = 16
Subject = REQ FOR DETERMINATION INFORMED CONSENT DRUG AND
Document Seq # = 1001
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