NSN 6305 01 178 7903 PYRIOSTIGMINE BROMIDE TABLETS 30 MG

File: 121096_sep96_decls13_0002.txt
Page: 0002
Total Pages: 3

Subject: NSN 6305 01 178 7903 PYRIOSTIGMINE BROMIDE TABLETS 30 MG        

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003203

Folder Title: NSN 6505-01-178-7903 PYRIDOSTIGMINE BROMIDE TABLETS                                             

Document Number:          1

Folder Seq  #:        117




               DEIARTMENT OF HEALTH& HUMAN SERVICES                   Public Health S*Nke


                                                                      Food and Drug Adminis
                                                                                     tration
                                                                      Rockville MD 20857





                                           December 5, 1983

               omurphy A. Chesney
               Major General# USArg Mc
               Deputy Surgeon General
               Department of the Air
                                       Force
               Headquarterst United States    AirForce
               Bolling APBE D. C. 20332

               Dear General Chesneyl

               Your July 20, 1983 letter to me requested that the Food
               and Drug Administration (FDA) review a package of data
               relating to the wartime use of pyridostigmine bromide
               tablets as a nerve agent antidote. My October 26,'1983
               letter to you provided the report of FDA's evaluation of
               the data. Members of your staff met with FDA on October
               28, 1983 to discuss the results of IPDA's eval%)@ion. 1
               was unable to attend that meeting because of a prior
               commitment, but Mr. Paul F. Vogel of my staff informed
               me that the dialogue proved very useful# by clarifying
               and satisfying some concerns on the part of both the Air
               Force and FDA that arose from LPI)A'S evaluation of the
               data. Dr. Robert Temple modified one of the conclusions
               contained in his original evaluation report, based on
               discussions with your representatives during this
               meeting.  Mr. Vogel furnished a copy of the modified
               original evaluation report to Major Tom Smogur. I am
               enclosing a copy of Mr. Vogells memorandum of the
               meeting.

     When Colonel Jack Moll and Major Smogur delivered your
               origi'nal letter with accompanying data to me on July 21,
               1983# we briefly discussed the Air Force's plan to
               deploy pyxidostigmine bromide tablets at various
               overseas locations throughout the world for controlled
               storage, to be available in time of war for distribution
               and use by military personnel. our discussion included
               the position FDA might take regarding storage of the
               drug within the United states. i have discussed the
               matter with the Commissioner and the Associate
               commissioner for Regulatory Affairs. The Commissioner
               confirms"that the rDAi-,would-Fnotiobjectmt@cQntr Iled
               t@agf!lof@tbt;@prod!jc                      -uo&,Lby- ilitary
               q_                 - -1 _tdomestically,@for-@        _.m
               pi4Kq-qnnel-unde@.,,the,77oamo-,contingency-,Gituations-.@-asr.yoii
               ar@planning-@,-fpr-.-overs*as.-@,to the extent domestic
               availability might be necessary for national security
               reasons,

Document 3 f:/Week-36/BX003203/NSN 6505-01-178-7903 PYRIDOSTIGMINE BROMIDE TABLETS/nsn 6305 01 178 7903 pyriostigmine bromide table:12069615355114
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = NSN 6505-01-178-7903 PYRIDOSTIGMINE BROMIDE TABLETS
Folder Seq # = 117
Subject = NSN 6305 01 178 7903 PYRIOSTIGMINE BROMIDE TABLE
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 = 06-DEC-1996