REQUEST FOR DETERMINATION INVESTIGATE DRUGS 31 DEC 90

File: 970107_sep96_decls31_0002.txt
Page: 0002
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






            DEPARTMENT OF HEALTli & liUMM SERVICES                  Publ[c Health Service



                                                                    Food and Drug Admlnlstalion
                                                                    Rockville MD 20857





                                       Decembar 31, 1990





           Enrique Mendez, Jr., M.D.
           Assistant Secretary for Defense, Health Affairs
           Department of Defense
           Washington, D.C. 20301-1220

           Dear Dr. Mendez:

           I have received your request, dated December 28, 1990, and
           submitted pursuant to 21 CPR 50.23(d), for a determination
           that obtaining informed consent is not feasible for the
           investigational agent pentavalent botulinum toxoid vaccine.

           in reviewing the justification for your request, I have
           considered the pertinent factors set forth in the regulation.
           Based upon your assessment of the military operation, I find
           that there is no available satisfactory alternative therapy
           for the prevention of botulism, and I concur with your
           assessment that informed consent is not feasible and that
           withholding treatment would be contrary to the best interests
           of military personnel.

           My determinations expire one year from the date of this
           letter, or when the Department of Defense informs the
           Commissioner of Food and Drugs that the specific military
           operation creating the need for the investigational agent has
           ended, whichever is earlier.

                                       Since   ely,
                                                                   VP
                                           vid A   eas
                                         ommi@
                                              s oner of Food and Drugs

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