U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Inspection References
  4. Field Management Directives
  5. OII Procedures for Arranging Foreign Visitor Program Activities
  1. Field Management Directives

OII Procedures for Arranging Foreign Visitor Program Activities

Subject:
Office of Inspections and Investigations (OII) Procedures for Responding to Foreign Visitor or Information Requests
Area:
Operations Management
Date Revised: October 01, 2024

PURPOSE

To provide OII headquarters and field offices with procedures for assisting in arranging visits of government and industry representatives from foreign countries.

FOREIGN VISITORS

Headquarters Responsibility

The Agency receives numerous requests each year to accommodate visiting international governmental counterparts as well as international industry. The international governmental inquiries include both requests for domestic activities or for activities outside the U.S. Typical governmental requests are site visits to a HQs office, Regional/Division Office or laboratory.

The Agency policy prefers that most international visits take place at HQs. This is to save field resources for only the most critical requests. We also want to make certain that we convey the most current Agency position and coordinate with each other Agency components. There are exceptions to this process depending on the nature of the request as well as the current Agency position at the time of the request.

Any international governmental request relating to FDA activities should officially be submitted to Office of Global Policy and Strategy (OGPS) via the country's respective embassy/consulate to ensure equitable and consistent treatment of international visitors.

Security and policy concerns are important factors that need to be taken into consideration prior to a final Agency decision being made on a specific request. OGPS is FDA's link to the US State Department and other national governments where this security and policy information is made available to them daily. OGPS will work with OII and the various Centers to develop appropriate responses for the Agency. At no time should a headquarters' or field employee agree to an international request without consultation with OII headquarters (specifically the IFE staff) and OGPS.

We would prefer to send an official response within 7-10 business days from the first contact with FDA. The more information we have from the requestor the more efficient we can be in providing a timely response.

Region/Division Responsibility

Requests received to the field for visits from foreign industry or visiting scientists need to be submitted to the OII/IFE Staff. Please submit as much of the following information via email to OII OACII International & Federal Engagement staff (oiioaciiintlandfederal@fda.hhs.gov) with a justification as to why the request should be accommodated:

  • Requestor name(s) — everyone that plans to visit
  • The country each visitor represents
  • Reason for the visit
  • Proposed itinerary
  • Each visitors title, the organization they work for
  • Each visitors business address (street, city, country, zip, etc)
  • Phone and fax numbers
  • Email addresses
  • Time period (specific dates) the visit will take place. Determine if there is any flexibility in dates or schedule
  • Detailed list of questions/issues that our counterparts are in search of or inquiring about
  • If you can gain a CV for all the visitors that would be helpful
  • If the request is to attend a training course, please have the requestor specify which course and basis for the request.

All official international responses to requests will be provided by OGPS via email to the requestor with a cc to all Agency parties involved.

INFORMATION REQUESTS

Headquarters Responsibility

The agency receives requests for information almost on a daily basis. We want to be sure we are delivering the most current information on Agency thinking and policy. Requests received from international contacts for information have to be reviewed by the Freedom of Information Act staff to be sure non-public information is not released.

Examples of information requests can be for inspectional information, an EIR, or import information from a foreign country. It is headquarters responsibility to be sure the information correct.

Division Responsibility

If a division is contacted directly by a foreign country for information related to FDA activities, the division office should contact the OII/IFE staff for help in processing the request. Headquarters will engage with OGPS to facilitate and process the request.

 

Back to Top