COVER SHEET FOR DOCUMENT TRANSMISSION

File: 970101_sep96_decls18_0003.txt
Page: 0003
Total Pages: 5

Subject: COVER SHEET FOR DOCUMENT TRANSMISSION                           

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003205

Folder Title: USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT                                           

Document Number:          3

Folder Seq  #:         13




                   DEPARTMENT OF HEALTH & HUMAN SERVICES                Publ'c Healtt



                                                                        rood and Diug Afttn.'stration
                                                                        Rockville MD 20867





                   IND 35,291       4


                   Office c3f the burgeon  General
                   I)i?partmwnt of the Army
                   U.S. Army Medical Research and Development Command
                   Attn: SSRD-HR
                   Fort Detrick
                   Frederick, MD 21702-5012



                   Dear Mr. gerpzuk:

                   Reference is made to your Investigational New Drug Application
                   (IND) submitted October 49 1990 pursuant to section $05(i) of
                   the Federal Food, Drugs and Cosmetic Act for Multi-Shiwld
                   Topical Skin Protectant.


                   Clin.icall.5afety FssuL*st

                   We are awaiting At this time receipt of the protocol for the
                   rLKtrosppctive study mentioned in your letter of October 2, 1990
                   to the division and receipt of the accompanying approval by the
                   Surgeon   Seneral's )4wman    SLjbjipcts Research   Review    Board.
                   Nonethipless, based on the materials submitted to the IND,
                   including the "Inutructioris for Use of Multishield Skin Cream
                   as a Chemical Warfare Agent Tapir-al Skin Prot6?ctant", the
                   division concludes that the administration of Multi-Sh@ld
                   ,Topicitl-Skin Proti?ctant, as described in the Draft "Instruct'
                   for Use" cited above and the "Doctrinal Statement"        submitted
                   an October 2, poses no unreasonable or sionificant risk to the
                    ndividu,sl to whom it may be administered.


                   The division is not presently authorized to waive requirements
relating to the need for informed consent; consequently, we
                   cannot authorize categorical relief from the requlri?mont@ of 21
                   CFR 312.40 and 21 CFR 50.

                   The division has been Informed that DOD may be granted a waiver
                   from the provisions of 21 CFR 312.6(a) and nay employ the phrase
                   "Wor military use onri Ryaltimtinn" in nlari? of the atatL*ment
                   ordinarily mandated for use on the immediate package of an
                   Investigational drug product.

Document 5 f:/Week-36/BX003205/USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT/cover sheet for document transmission:12249609312319
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = USE OF CHEMICAL WARFARE AGENT TOPICAL SKIL PROTECTANT
Folder Seq # = 13
Subject = COVER SHEET FOR DOCUMENT TRANSMISSION
Document Seq # = 3
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