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Updated: 2005-11-02

ORA FIELD MANAGEMENT DIRECTIVE No. 37

Subject:
ORA Procedures for Arranging Foreign Visitor Program Activities		 Area:
Operations Management		 Date:
10/30/95 Revised

PURPOSE

To provide ORA headquarters and field offices with procedures for assisting the International Affairs Staff in arranging visits of government or industry representatives from foreign countries.

ORA RESPONSIBILITIES

The regional food and drug director and district director are the official contact persons for the arrangement of agendas for foreign visitors to their respective area.

1. Serve as contact person for Office of International Affairs (OIA) to determine appropriate location for visit and identify appropriate district personnel who will best meet the needs of a foreign visitor while also giving consideration to ORA resource constraints.

2. Develop, with OIA, a tentative agenda for foreign visitors.

3. Notifies OIA contact person when foreign visitors contact ORA district management directly to arrange a visit.

4. If inspections of regulated firms by a foreign visitor are planned, the district should:

a. Select appropriate firms that are believed to be in compliance with FDA regulations.

b. Contact the firm in advance to explain the purpose of the proposed inspection and obtain permission for the non-FDA visitor to accompany the FDA Investigator on the inspection. This pre-inspection notification is designed to eliminate the rare possibility of the firm's management being reluctant to permit a foreign visitor to enter the plant.

IAS RESPONSIBILITIES

The Office of International Affairs contact person for coordination of foreign visitors is Elaine Foster, OIASI/OIP (phone: 301-827-0026). The contact person:

1. Determines and clearly communicates the objectives and purpose of visit by foreign representatives.

2. Explores the feasibility of field locations which meet the needs of a foreign visitor with the appropriate field contact person.

3. Develops and prepares, with the field contact person, a tentative agenda for a foreign visitor.

4. Participates in arranging hotel accommodations and travel arrangements for foreign visitors when necessary.

5. Provides a copy of the foreign visitor's agenda and curriculum vitae to the ORA field contact person, preferably two weeks prior to initiation of agenda activities.

During periods when the OIA contact person is unavailable, OIA will designate an alternative contact.

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

ISSUED BY:                     ORA/ORO/Division of Emergency and Investigational Operations (HFC-130)

AUTHORITY:                  ORA

PUBLICATION DATE:   8/96

This page was last updated on:
2005-11-02: Changed OIASI/OIP Contact name/number
1999-05-21: