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ORA FIELD MANAGEMENT DIRECTIVE No. 149

PURPOSE

The purpose of this directive is to establish new procedures for directing and handling requests to the Office of Regulatory Affairs (ORA) to provide foreign government or industry officials or representatives with:

1) short term technical training, either in the U.S. or abroad, and/or

2) site visits to ORA facilities or U.S. firms regulated by FDA.

The International Regulatory Issues Staff (IRIS) is ORA's focal point for international interests and activities. As such, it has the responsibility for coordinating, identifying and selecting ORA personnel to perform technical training or to host a site visit. Decisions to honor requests and select personnel will be based upon agency and ORA strategic plans, expertise needed, current workloads, available resources and other considerations.

Requests from foreign entities (including foreign governments, international organizations, or private sector representatives) to FDA that involve ORA resources to conduct short term technical training or site visits should be forwarded to IRIS. If these requests originate from the Office of International Affairs (OIA) and/or the Office of External Affairs, OIA will immediately notify IRIS and provide assistance or coordination if requested by IRIS. All requests to ORA Headquarters and Field Offices, or other organizational units other than OIA, directly solicited by foreign entities should be forwarded to IRIS, who in turn will notify OIA of the request. The number of foreign visits entertained by ORA will be contingent upon the emerging needs and resources of ORA.

1. Requests from representatives of foreign entities should be clearly and concisely written, and should contain the following information:

a. name and affiliation of foreign official or representative making the request,

b. purpose of visit,

c. tentative dates of the visit,

d. full name, address and telephone number of the foreign official(s) or representative designated as the lead contact(s),

e. dates of previous visits, including the place and purpose,

Note: If the request duplicates, or is similar to, requests honored to the same organization in recent years, the request should identify why the additional request is necessary and why it should be granted, and

f. if travel to a foreign nation is involved in the request, a statement from the requesting foreign entity should be obtained that clarifies any understanding of covering travel, lodging, food and other per diem costs incurred by the ORA official(s) fulfilling the request.

Note: If all of the above information is not provided in the original request, IRIS will follow-up with the requestor to fulfill all of the elements. If the request originates from an office outside of ORA, it is requested that the receiving office use their rapport with the requestor to obtain as much of the needed information as possible before forwarding it to IRIS.

2. Requests should be forwarded to ORA's International Regulatory Issues Staff, HFC-1, Room 14-90, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FAXing the request to the IRIS office in advance of the mail may expedite review of the request (see current directory for FAX number). Each request will be reviewed and discussed with appropriate ORA office(s) in making the decision for the approval or denial.

3. IRIS will prepare a written response to the FDA office that directed the request to IRIS within ten working days of receipt of all pertinent information. All approval letters will specify the most appropriate personnel to perform the technical training or site visit. The forwarding office and IRIS will confer as to who will notify the requestor of the decision and, if approved, which office will be identified as the lead office in carrying out the request.

The criteria listed below should be used to evaluate proposals to provide technical assistance and cooperative activities with foreign entities.

1. ORA should give higher priority to those technical assistance and cooperation initiatives that will further the Agency's domestic public health goals.

2. The public health priorities identified in ORA's current international strategic plan should be given preference. ORA will place high priority on international activities that are directed toward improving the quality, safety, or efficacy of products offered to consumers in the U.S. Thus, ORA should invest its resources in technical assistance or cooperation when: (a) the foreign country exports a significant amount of regulated product to the U.S., (b) the foreign country currently has a violation rate of concern to the agency, (c) the types of products exported to the U.S. pose a high risk of adverse health effects, (d) there is a likelihood that a country will initiate significant export of new products to the U.S., and/or (e) the regulatory system or requesting body in the recipient country has the will and ability to effect positive changes.

3. ORA should also give higher priority to technical assistance/cooperation projects that will result in more efficient use of ORA resources. Where appropriate, ORA should recognize, and support by involvement in, technical assistance projects that are conducted by non-FDA entities, and which objectives will promote FDA=s mission by use of outside experts or resources in place of ORA FTEs. However, this involvement should be restricted to activities that meet the other criteria listed in this document.

4. Requests for assistance of a humanitarian nature (which are designed to improve human health in a foreign country where there is little likelihood for significant export of FDA regulated products to the U.S.) should be considered in terms of FDA's strategic objectives and overall FDA policy.

5. Every effort should be made to assure that the projected costs of any technical assistance/cooperation project are realistic.

6. When considering a proposal from a country with whom ORA has participated in projects in the past, ORA should consider (a) whether the goals of the past projects, even if they were unrelated to the present request, were met; and (b) evaluate, to the extent reasonably possible, conditions in the foreign country to determine whether prospects for success have been heightened or decreased.

7. When there are multiple government organizations in the foreign country, or when a non-governmental organization has made the request, care should be taken to ensure that ORA is working with the most appropriate organization to successfully implement the training provided. The entities to whom ORA provides technical assistance or cooperation should have the necessary authority or alliances, and resources to meet the goals of the technical assistance/cooperation project.

8. When possible, it will be advantageous for the ORA employees selected to do technical training in a foreign country to conversant in the language of the foreign country.

9. Whenever possible, training should be of the train-the-trainer approach whereby adept individuals in the foreign country are themselves trained to train others. Eligibility requirements for trainers-in-training will be coordinated by the IRIS staff in conjunction with appropriate FDA staff and foreign bodies.

DISTRIBUTION:              Regional Food and Drug Directors and District Directors; FDA Headquarters Offices

ISSUED BY:                    ORA/International Regulatory Issues Staff (HFC-1)

AUTHORITY:                   ORA

PUBLICATION DATE:  1/99

This page was last updated on: 05/21/99.

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