MOA ON INVESTIGATIONAL USE OF DRUGS ANTIBIOTICS

File: 120396_sep96_decls20_0003.txt
Page: 0003
Total Pages: 5

Subject: MOA ON INVESTIGATIONAL USE OF DRUGS ANTIBIOTICS                 

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003203

Folder Title: MOU BETWEEN THE FOOD AND DRUG ADMINISTRATION AND DOD                                            

Document Number:          1

Folder SEQ  #:        133






                                                3                DoD/FDA MOU-87



                 ordinary requirements of the Investigational   New Drug (IND)
                 and Investigational Device Exemption (IDE) regulations are no
                 longer necessary. Accordingly, the DOD and the FDA agree to
                 the following new procedures concerning investigational use
                 of drugs and devices by the DOD.


                                  111. SUBSTANCE OF AGREEMENT

                 The FDA and the DOD agree that:

                 A.   Clinical testing of investigational drugs, biologics, or
                      medical devices under programs sponsored by the DOD and
                      conducted either by the DOD within its own research
                      facilities, or for the DOD by a contractor or grantee
                      will follow the provisions of 21 CPR 312 or 21 CFR 812
                      governing the investigational use of new drugs and
                      medical devices in human beings, and FDA's informed
                      consent and Institutional Review Board regulations (21
                      CFR 50 and 21 CPR 56).

                 B.   They will continue to cooperate in meeting the
                      requirements of the Federal Food, Drug, and Cosmetic Act
                      and its implementing regulations without jeopardizing
                      the mission of the DOD. To accomplish this goal, they
                      agree that an expeditious review of special DoO
                      requirements to meet national defense considerations
                      will be carried out by FDA. This review would consist
                      of an FDA review of available data on a drug,
                      biological, or device under IND or IDE to determine if
                      stockpiling for future use, or use in an expanded
                      military population is appropriate. When necessary,
     special reporting requirements would also be established-
                      by FDA.

                 C.   It is the general policy of the DOD not to classify
                      medical research and development. However, should It
                      become necessary to classify for reasons of national
                      security the clinical testing of a drug, biologic, or
                      medical device that would normally fall under the
                      provisions of 21 CPR 312 or 812, these studies will be
                      handled under the special provisions of this 140U. The
                      DOD will be solely responsible for determining the
                      security classification of such research projects. If
                      classified studies are required DOD will submit a
                      classified IND or IDE application to be reviewed by

Document 5 f:/Week-36/BX003203/MOU BETWEEN THE FOOD AND DRUG ADMINISTRATION AND DOD/moa on investigational use of drugs antibiotics:11089615090121
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = MOU BETWEEN THE FOOD AND DRUG ADMINISTRATION AND DOD
Folder Seq # = 133
Subject = MOA ON INVESTIGATIONAL USE OF DRUGS ANTIBIOTICS
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 = 08-NOV-1996