FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION
AGREEMENTS WITH OTHER GOVERNMENT AGENCIES
ARRANGEMENT WITH FOREIGN GOVERNMENTS: MOUs, CONFIDENTIALITY COMMITTMENTS
FOREIGN MEMORANDUM OF UNDERSTANDING
Transmittal Number 94-25 -- Date: 04/29/1994
This guide establishes areas of responsibility and clearance procedures for the development, formalization,approval and monitoring of Memoranda of Understanding (MOUs) between the Food and Drug Administration (FDA) and foreign government agencies or international organizations.
It is the policy of the FDA to enter into International MOUs that improve consumer protection; help achieve international harmonization; use collective resources more effectively; eliminate duplication of activities by the participating parties; and provide a mechanism for the cooperative exchange of expertise, assistance, and information to help ensure the safety and quality of covered products. Compliance Policy Guide (CPG), Chapter 56, describes Agency policy for developing and negotiating such agreements with foreign countries and international organizations. FDA considers the development and implementation of MOUs to have high priority. This Staff Manual Guide and Compliance Policy Guide, Chapter 56, will help assure that the execution of agreements occurs in a timely manner.
A. Memorandum of Understanding (MOU), as used herein, means any FDA formal agreement including but not limited to ones on information exchange, mutual recognition agreements, and product certification between FDA and one or more foreign governments or international organizations. An Exchange Of Letters (EOL) follows the same clearance procedures but are not considered a formal MOU.
An MOU may not be used to commit the expenditure of manpower, to transfer funds, or to transfer real or personal property. Agreements calling for these actions are considered Interagency Agreements (see Staff Manual Guide 2810.1).
B. Sponsor, as used herein, means the FDA center or office having predominant responsibility for negotiating the proposed agreement.
C. IAS/OHA means the International Affairs Staff, Office of Health Affairs (HFY-50).
D. OP means the International Policy Staff, Office of the Deputy Commissioner for Policy (HF-23).
E. ORA means the Office of Regulatory Affairs (HFC-1).
F. ORM means the Office of Resource Management, ORA (HFC-10).
G. OGC means the Deputy Chief Counsel for Program Review, Office of the Chief Counsel (GCF-1).
H. OCGM means the Office of Contracts and Grants Management, Office of Management (HFA-500).
Any center or office in FDA may identify the possible need or opportunity for a new MOU or for revision of an existing MOU. Before any sponsor begins substantive discussions about developing an MOU with foreign officials, the sponsor informs ORM its interest in pursuing an MOU, along with an explanation of how the MOU is consistent with the agency's criteria (see Attachment A of CPG, Chapter 56). ORM will then consult with other affected units in ORA, IAS/OHA, and OP to allow these offices to determine whether initiation of the MOU would be consistent with the agency's international policy. IAS/OHA will also determine whether additional coordination and reporting are required with the U.S. Department of State (DOS), other agencies, or foreign embassies.
Attachment D sets forth the steps in the processing of MOUs and details the responsibilities of agency components:
1. The sponsor conducts preliminary discussions with foreign officials on the need for an MOU and makes a preliminary assessment on whether a proposed MOU is consistent with agency criteria (see Attachment A to CPG, Chapter 56). If the sponsor believes that MOU discussions should be pursued, the sponsor contacts ORM and provides its assessment on the viability of ORM will assure that all necessary intra-agency coordination is accomplished. (Step 1)
2. Any interested agency unit will inform the sponsor of possible concerns with the MOU. After receiving agency clearance to initiate discussions concerning the MOU, the sponsor makes contact with the foreign party to initiate discussions toward development of the MOU. Discussions should establish whether the foreign party has the technical and administrative infrastructure necessary to carry out its proposed responsibilities under the MOU. If the MOU is to be a mutual recognition agreement, the MOU discussions should determine whether the relevant foreign program is equivalent to FDA's counterpart program. A preliminary draft MOU is developed. (Step 6)
3. If there is to be an informal trial of the MOU, the sponsor describes the design, conduct, and evaluation of the informal trial; whether there are other units in FDA from whom concurrence should be obtained before initiating the trial; and how to assess the completed trial's degree of success. (Step 7)
4. The director of the sponsoring unit sends a written request to ORM for clearance of the draft MOU prior to commencing final discussions with the other party. (Step 8)
5. After reviewing comments from ORM, the sponsor makes revisions as needed.
a. If minor changes were made, the sponsor clears them with the foreign party, prepares two or more copies of the MOU for signature, drafts a transmittal letter to the State Department, and submits all to ORM for coordination with IAS/OHA. (Step 12)
b. If major changes were made to the document during this review, the sponsor returns the draft MOU to ORM for review and clearance (repeats steps 9, 10, and 11).
6. The sponsor performs an assessment of each MOU at least once in the five year period of the agreement. The sponsor initiates appropriate action for continuation, modification, or cancellation of the MOU based on information obtained through these assessments. If the MOU is to be terminated, the sponsor sends a memorandum to this effect to ORM at least two months prior to the termination date. If the MOU is to be continued or modified, the sponsor sends a memorandum to this effect to ORM, together with a copy of the MOU.
b. Office of Regulatory Affairs
Office of Resource Management (HFC-10) (ORM)
1. ORM informs IAS/OHA, OP, and other ORA units that would be involved in implementing the MOU, to ascertain if there is any objection to the proposed MOU. Also ORM, in conjunction with other agency components, reviews each proposed MOU for consistency with agency priorities. (Step
2. If no problems are identified, ORM informs the sponsor to proceed. (Step 5)
3. ORM clears all MOUs through OP, IAS/OHA, OGC, OCGM, other ORA components and other appropriate Offices and Centers. (Step 9)
4. ORM assembles comments on draft MOU and submits them to the sponsor for final negotiation with the foreign party, or for rewrite and reclearance. (Step 11)
5. ORM sends MOUs and draft transmittal letters to IAS so that Circular 175 clearance through the DOS can be initiated. (Step 13)
6. ORM sends original signed MOU to the OCGM for control number and as the repository copy. (Step 16)
7. ORM distributes signed MOU with control number as follows (Step 18):
b. Regulations Policy and Management Staff (HF-26) for publication in the Federal Register;
c. Division of Compliance Policy (HFC-230) for publication in the Compliance Policy Guide Manual; and
d. Offices that had reviewed the MOU and all other appropriate units.
8. ORM maintains, updates and distributes, at least quarterly, a listing of MOUs in process and any Exchange of Letters in effect or in process, with status information.
9. ORM notifies sponsors when it is time to evaluate an existing MOU to determine if it should be continued, modified, or canceled.
10. If a MOU is to be terminated, ORM notifies IAS for coordination with the DOS and others, as appropriate, prior to communications with the foreign government.
c. Office of Policy (OP) (HF-23)
1. Before substantive discussions begin on developing an MOU, OP helps determine if an MOU is consistent with the agency's international priorities and agency policy objectives. (Step 3)
2. OP reviews draft/final MOU and submits comments to ORM. OP receives a copy of Circular 175 clearance package prepared by IAS and, if it has comments, submits them to IAS/OHA. (Step 10).
3. OP, through the Regulations Policy and Management Staff (HF-26), publishes the MOU in the Federal Register. (Step 19).
d. Office of Health Affairs
International Affairs Staff (HFY-50)
1. Before substantive discussions begin on developing MOU, IAS/OHA helps determine if an MOU is consistent with the agency's priorities and international affairs activities. (Step 3)
2. IAS/OHA provides notification to the DOS, foreign embassies, or other U.S. government agencies prior to initiating discussions, as necessary. (Step 4).
3. IAS/OHA reviews draft/final MOUs and submits comments to ORM. (Step 10)
4. IAS/OHA coordinates Circular 175 clearance (this refers to a December 13, 1955, DOS Circular which provides guidelines on negotiations and signature of treaties and other international agreements including MOUs. The actual procedures to obtain this clearance are codified in Volume 11 of the DOS Foreign Manual, Chapter 700.) with the DOS through the PHS Office of International Health and the Office of International Affairs, OS, DHHS, before a foreign MOU may be signed. At the time IAS/OHA sends a copy of the Circular 175 clearance package to the PHS Office of International Health, IAS/OHA will send a copy of the package to OP. (Step 14)
5. After receiving approval from the DOS, IAS/OHA forwards the transmittal letter to the other party notifying it that FDA is now ready to conclude the agreement, arranges for signing of MOU either singly or in a joint ceremony, and sends signed original MOU to ORM. (Step 15)
6. IAS/OHA coordinates with the DOS and others, as appropriate, if an MOU is to be terminated.
e. Office of Chief Counsel (GCF-1)
The Deputy Chief Counsel for Program Review or designee reviews the draft MOU for legal sufficiency and returns the draft MOU with concurrence or comments to ORM. If, after such clearance, significant changes are made in an MOU, reclearance with the Deputy Chief Counsel for Program Review is necessary. (Step 10)
f. Office of Management
Office of Contracts and Grants Management (HFA-500)
1. OCGM reviews draft/final MOUs and submits comments to ORM. (Step 10)
2. OCGM assigns a control number to the MOU after signature by all parties and sends copy of MOU to ORM. (Step 17)
3. OCGM serves as the central FDA repository for all original copies of executed MOUs.
4. OCGM maintains a current listing of all executed MOUs.
All international MOUs shall be reviewed and approved by the appropriate center/offices, ORA, OGC, OCGM, OP, and IAS/OHA prior to final discussions and signature. To facilitate this review process, concurrent clearance is essential. If comments and/or clearances are not received within three weeks, the assumption will be made that the document has concurrence without comments.
A proposed MOU that involves responsibilities of two or more Centers/Offices must have the concurrence of all units involved. The sponsor's documents requesting approval of such MOUs shall indicate that concurrences from other affected Centers/Offices have been obtained.
The format of all MOUs will be in general conformance with the outline in the examples of Attachments A, B and C.
All international MOUs will be signed by the Commissioner or designee.