REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0008.txt
Page: 0008
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










                                                                         September 5, 1990


           Subject:     BB-IND 161 - Pentavalent Botulinum Toxoid

           Director
           Center for Biologics Evaluation and Research
           Division of Biological Investigational New Drugs (HFB-230)
           Food and Drug Administration
           8800 Rockville Pike
           Bethesda, Maryland 20892

           Dear Sir:


                 We authorize the FDA to cross-reference our Investigational New Dru@
           application BB-IND 161 when reviewing submissions for the same product from the
           Department of the Army, Office of the Surgeon Ceneral (OTSG).

                 We also authorize the Department of the Army, OTSG, to cross-reference BB-
           IND 161.


                                                Sincerely,




                                                Paul A. Blake, M.D., M.P.H.
                                                Chief, Enteric Diseases Branch
                                                Division of Bacterial and Mycotic Diseases
                                                Center for Infectious Diseases

           cc  @. E. Brandt
                 J. Becher
























                                                                  ATTACHTA,ENT 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