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MOU 225-75-3001

Memorandum of Understanding

Between
The National Institutes of Health 

and

The Food and Drug Administration

 

The Division of Cancer Treatment, National Cancer Institute, as a result of its mission, has a substantial and continuing effort of anticancer drug development, the regulation of which comes under the purview of the Food and Drug Administration, primarily but not exclusively within the Bureau of Drugs. A substantial amount of the information available to the Division of Cancer Treatment and to the Bureau of Drugs, acquired by each in the pursuit of their missions, is of common interest to these organizations. In the past, both have been keenly aware of this community of interest and have had extensive informal and effective interchanges of views and of information on a wide variety of problems. Such informal interchanges should and will continue and both organizations encourage the members of their staff to provide the utmost assistance and cooperation in all appropriate areas. In addition, in order to aid in the maintenance of a harmonious, direct working relationship between these two sister organizations, both charged with responsibilities relating to public health, it is believed that a formal Memorandum of Understanding is desirable. The following specific agreements between the National Cancer Institute and the Food and Drug Administration are made to achieve these objectives:


Commitment of the
National Cancer Institute

 

1. The National Cancer Institute designates the Director, Division of Cancer Treatment as the primary contact on matters of policy relative to anticancer drug development. Members of his/her staff responsible for specific aspects of the Drug Development Program will carry on day-to-day contact with their counterparts at the Food and Drug Administration as appropriate.

 

2. As sponsor of investigational drugs for clinical trial, the Division of Cancer Treatment agrees to comply with all applicable laws, regulations, and any other legal requirements pertaining to such sponsorship.

 

3. The Division of Cancer Treatment will transmit to the Bureau of Drugs pertinent information generated by the activities of the Division of Cancer Treatment. This will include Cancer Treatment Reports and copies of the minutes of pertinent meetings, e.g., the New Drug Liaison Meetings and the Phase I Working Group Meetings. These minutes are not to be considered a substitute for the annual progress reports required for each IND.

 

4. The Division of Cancer will designate a member of its staff as a liaison to FDA's Oncology Advisory Committee and will send members of its staff to other Food and Drug Administration meetings, as appropriate, in order to aid communication between the two organizations.

 

5. The Division of Cancer Treatment will maintain with the Bureau of Drugs a Master File, which will included a detailed description of its overall plan of anticancer drug development, its system of clinical monitoring, its system of drug distribution and data reporting, pertinent information on Division of Cancer Treatment staff, and other background information normally included in individual Notices of Claimed Investigational Exemption for a New Drug (also know as Investigational New Drug Applications).

 

When any portion of the Master File is proposed to be revised in a significant manner, the Division of Cancer Treatment will, prior to such revision, provide a draft copy of the proposed alteration for the Bureau of Drugs' comment. Less substantive revisions will be provided to the Bureau of Drugs in finalized form and such revisions will be sent with reasonable promptness. The Divison of Cancer Treatment agrees to maintain the Master File in a manner which keeps it current, to add information as it believes necessary, or as requested by the Bureau of Drugs, to delete items which are no longer pertinent or active, and to submit to the Bureau of Drugs on or about January 1 of each year a list of the documents it considers to be in the Master File and a certification their currency and accuracy.

Commitment of the
Food and Drug Administration

 

1. The Food and Drug Administration designates the Associate Director for New Drug Evaluation, Bureau of Drugs, as its primary contact for matters of policy regarding anticancer drugs. Members of his/her staff will interact with appropriate Division of Cancer Treatment staff for day-to-day matters.

 

2. The Bureau of Drugs will designate appropriate members of its staff as liaison to the Decision Network, the Phase I Working Group, and the New Drug Liaison meetings and other pertinent meetings of the Division of Cancer Treatment, to aid communication between the Bureau of Drugs and Division of Cancer Treatment.

 

3. In recognition of the position occupied by the Division of Cancer Treatment in antitumor drug development, and in view of the serious nature of the disease, the Bureau of Drugs agrees to cooperate with and assist the Division of Cancer Treatment in the furtherance of its objectives, to the degree permitted by regulation and law.

 

4. The Bureau of Drugs agrees to accept the Master File submission of the Division of Cancer Treatment as applicable to all anticancer investigational drugs sponsored by the Division of Cancer Treatment. Information in the Master File will thus be incorporated by reference into all Notices of Claimed Investigational Exemptions (IND's) for anticancer drugs sponsored by the Division of Cancer Treatment.

 

5. The Bureau of Drugs agrees to bring any deficiencies or problems with the master File to the attention of the Divison of Cancer Treatment as part of its review and approval of that Master File rather than as comments on specific IND's. If, after a reasonable period needed for correction of the Master File, such correction is not forthcoming, the Bureau of Drugs shall inform the Division of Cancer Treatment which of its IND's may be adversely affected and subject to administrative action.

 

Commitment of Both the
National Cancer Institute
and the
Food and Drug Administration

 

If the Director, Division of Cancer Treatment, National Cancer Institute and the Associate Director for New Drug Evaluation, Bureau of Drugs, cannot agree on the appropriate contents of the Master File, or the approvability of the Master File or of any application sponsored by the National Cancer Institute, or on any other matters related to the regulation by the Food and Drug Administration of drugs sponsored by the National Cancer Institute, the matter shall be brought to the attention of the Director of the National Cancer Institute and the Director of the Bureau of Drugs. These persons are then responsible for jointly resolving the matter, either directly or by consultation with, or referral to, the Director of the National Institutes of Health and the Commissioner of Food and Drugs. Absent such resolution, final resolution of the matter rests with the Commissioner of Food and Drugs.

Approved and Accepted
for the National Institutes of Health

Signed by: Donald S. Frederickson
Director
National Institutes of Health

Date: February 5, 1979

Approved and Accepted
for the Food and Drug Administration

Signed by: Donald Kennedy
Commissioner
Food and Drug Administration

Date: January 19, 1979