MOA ON INVESTIGATIONAL USE OF DRUGS ANTIBIOTICS

File: 120396_sep96_decls20_0002.txt
Page: 0002
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






                                                2               DOD/FDA MOU-87


                  dev.ices at 21 CFR 812 and 813; for protection of human
                  subjects at 21 CFR 50; and for institutional review boards at
                  21 CFR 56. These regulations establish the procedure and
                  prescribe the necessary forms to be filed in order to exempt
                  drugs and devices to be used for investigational purposes
                  from, inter alia, the approval procedures of the Federal
                  Food, Drug, and Cosmetic Act and the biologic licensing
                  provisions of the Public Health Service Act.

                  Pursuant to Title 5, Section 301, of the United States Code,
                  DOD regulations on protection of human subjects in DOD-
                  supported research in 32 CFR Part 219 and DOD Directive
                  3216.2 generally adopt the system of Institutional Review
                  Boards (IRBS) established under 21 CFR 56. However, the
                  functions of research protocol review and approval are
                  separate in the Department of Defense. The function of
                  protocol review remains with the IRB which recommends
                  approval. The function of approval is held by the commander
                  to whom the review committee reports. in addition, the
                  Surgeon General of each Service may require that the final
                  review and approval for use of investigational drugs,
                  biologics, or medical devices, remain within his or her
                  office. The Surgeons General have the authority to-delegate
                  this final review and approval authority to a "Headquarters
                  Review Board" (HRB), or the medical department component
                  holding the IND or IDE. In no case can an approving
                  authority or HRB give final approval to a protocol which has
  been disapproved by a local IRB, nor can an approving
                  authority or HRB reduce safeguards or special conditions
                  imposed by the local IRS

                  A memorandum of Understanding (MOU) on this subject was first
                  executed by the Departments of Defense and Health, Education,-
                  and Welfare in 1964. It was revised in 1974 to state the
                  procedures that would be followed to ensure that the
                  requirements of the Federal Food, Drug, and Cosmetic Act and
                  its implementing regulations are fully met without
                  jeopardizing or impeding the requirements of national
                  security. Experience in operating under these MOUs from 1964
                  to 1987 indicates that the DOD and FDA have a record of
                  cooperation; that human subject concerns have been adequately
                  addressed in DoD-sponsored studies; that the DOD has been
                  able to carry out effectively its responsibilities for
                  national security without compromising the intent of the
                  above-cited statutes and regulations; and that certain
                  exemptions, relieving the DOD from the need to meet the

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