SUMMARY IPR J 5 HUMAN MONOCLONAL ANTIBODY

File: 120396_sep96_decls85_0005.txt
Page: 0005
Total Pages: 9

Subject: SUMMARY IPR J 5 HUMAN MONOCLONAL ANTIBODY                       

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: SUMMARY OF CORRESPONDENCE IN-PROCESS REVIEW                                                     

Document Number:          1

Folder SEQ  #:        135








           SGRD-UMB
           Subject: Correspondence Informal In-Process Review (IPR) for the
           J-5 Human Monoclonal (HA-IA) Antibody


           3. The Materiel Developer proposes the following:

               a. Monitor continued development of J-5 Human Monoclonal
           Antibody.

               b. Follow the licensure process as pursued by Centocor.

               c. Adapt a Non-developmental Item approach should the J-5
           Human Monoclonal be granted a Biological Product License by the
           FDA.

           4. Written unconditional concurrence with the Material
           Developer's proposed course of action should be made by the
           agencies shown on enclosure 2 and returned not later than
           27 March 1990.

           5. If an addressee has reservations about the proposed course
           of action, or desires clarification on any issue in the IPR
           package, please contact this Activity.

           6. Point of contact for this Activity is Dr. Michael J. Roy,
           AUTOVON 343-7661, or Commercial (30

           7. USAMMDA - Developing 0                                    S.



           2 Encls
                                       Colonel, MS
                                       Commanding

           CF(w/encls):
           Commander,
           U.S. Army Medical Research and Development Command,
             ATTN: SGRD-PLA (COL Robinson), Fort Detrick, Frederick,
             Maryland 21701-5012
           Naval Medical Command, ATTN: MED-02B (CPT Wood),
             Washington, DC 20372-5120
           U.S. Army Medical Materiel Development Activityp ATTN: SGRD-UKA
             (LTC Montgomery), Fort Detrick, Frederick, Maryland,
             21701-5009
           HQDA(DASG-HCL/KAJ Eng), 5109 Leesburg Pike, Falls Church,
             Virginia 22041-3258

           Director, Walter Reed Army Institute of Research,
             ATTN: SGRD-UWF-A (COL Cross), Washington, DC 20307-5100

, M.D., 244 Great Valley
             Parkway, Malvern, Pennsylvania 19355

                                          2

Document 9 f:/Week-36/BX003203/SUMMARY OF CORRESPONDENCE IN-PROCESS REVIEW/summary ipr j 5 human monoclonal antibody:11259610133425
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = SUMMARY OF CORRESPONDENCE IN-PROCESS REVIEW
Folder Seq # = 135
Subject = SUMMARY IPR J 5 HUMAN MONOCLONAL ANTIBODY
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 = 25-NOV-1996