REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0006.txt
Page: 0006
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







        Toxoid without informed consent at its meeting of October 17,
        1990. A copy of the pertinent portion of the minutes of the
        meeting is enclosed (Enclosure 2).

        11. Manufacturing Information.

             Pentavalent (ABCDE) Botulinium toxoid is manufactured by the
        Michigan Department of Public Health. The supplier is the U.S.
        Army Research and Development Command, Ft. Detrick, Maryland,
        21702. All manufacturing information concerning the production
        of Pentavalent (ABCDE) Botulinum Toxoid is contained in
        Investigational New Drug Applications BB-IND-161 and BB-IND 3723.
        BB-IND-3723 contains authorization from the CDC for the
        Department of the Army to cross-reference BB-IND 161. A letter
        from the Center for Disease Control authorizing the Office of the
        Surgeon General to cross reference all aspects of BB-IND-161,
        including manufacturing information is enclosed (Attachment 2).

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