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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Procedures for Requesting ORA International Technical Assistance or Site Visits

Subject:
Procedures for Requesting ORA International Technical Assistance or Site Visits
Area:
Operations Management
Date Revised:
March, 25 2010

 

 

 

PURPOSE

 

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

 

  • Short term technical assistance/ training, either in the US or abroad and/or
  • Site inspections, evaluations, or document reviews of foreign facilities producing products regulated by the FDA

 

RESPONSIBILITIES

 

The International Affairs Program (IAP) office, located within the Office of Regional Operations, is the focal point for ORA related foreign interest and activities. Working with the Division of Field Investigations (DFI), the IAP office has the responsibility for processing the request, identifying firms and government contacts, coordinating with DFI who selects ORA personnel to perform technical assistance for the foreign site inspection.  Decisions to approve requests and participate will be based on the current Agency and ORA strategic plans, expertise needed, current workloads, available resources, and other considerations.

 

Requests from foreign entities (including foreign governments, international organizations) to FDA which require ORA expertise will be forwarded to the IAP office.  The IAP office will work in determining if this request will be approved. At no time should field personnel agree to an international request without consulting with the ORA headquarters IAP office or the Director or Deputy Director of DFI.  Security and policy concerns are important factors which are taken into consideration when processing a request.

 

PROCEDURES

 

Requests should be forwarded to the IAP Manager at headquarters (5600 Fishers Lane, PKLN Rm 13-61, HFC-100, Rockville MD 20857). Requests from the foreign entities must be in writing and include the following information:

 

  • Name and affiliation of foreign official or representative making the request
  • Reason for the request
  • Proposed timeframe
  • Business address (street, city, country, zip, etc)
  • Phone and fax numbers
  • Email addresses
  • Dates of previous visits, including the place and purpose

 

All information must be submitted prior to consideration of the request.  Processing of the request will not begin until all information requirements have been satisfied.

 

If the request duplicates or is similar to a previously honored request, by the same organization, the request should identify why the additional request is necessary and why it should be granted.

 

If travel to a foreign country is involved, a statement from the requesting country clarifying any agreement or understanding of cover travel, lodging, food and per diem costs incurred by the ORA official(s) must be included at the time of the request. (Remember the new ORO policy on 348 travel and we should then verify if any of these requests are approved, who will fund the travel.)

 

Each request will be reviewed and discussed at headquarters with the appropriate ORA office(s) to determine approval or denial of the request.

 

If the request comes from a foreign government, a written response will be submitted to the Office of International Programs (OIP) for approval of content and it will be requested the response be sent through official channels at OIP.  If the request is made by a trade organization, private industry, or other non-governmental entity, a written response will be prepared by IAP/DIF and sent to the requesting official either approving or denying the request.

 

CRITERIA & CONSIDERATION

 

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

 

  • ORA should give priority to technical assistance and cooperative initiatives that will align with the Agency’s current policy, objectives, and goals related to our Globalization offices.

 

  • ORA will place a high priority on international activities directed toward improving the quality, safety, and efficacy of products imported into the U.S.  ORA should invest its resources in technical assistance or cooperation when:

 

      • the foreign country exports a significant amount of regulated product to the US,
      • the foreign country currently has a violation rate of concern to the Agency,
      • the products exported to the U.S. pose a high risk of adverse health effects,
      • the likelihood a country will initiate significant export of new products to the U.S.,
      • the recipient country will or can have the ability to effect positive change.

 

  • ORA will give a higher priority to technical assistance or cooperation requests which result in a more efficient use of ORA resources. Where practical, ORA will use outside experts or resources in place of ORA FTE’s but at the same time meeting other listed criteria.

 

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

 

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

 

  • When there are multiple government organizations in the foreign country, or when a non-governmental organization has made the request, ORA should take care to assure we are working with the most appropriate organization to successfully implement the request.  The requestor should have the necessary authority and resources to meet the goals of the request.

 

  • When possible, it will be advantageous for the ORA employees selected to conduct technical training in the language of conversation of the foreign country.

 

  • Whenever possible, training should be of the train-the-trainer approach to allow those individuals to train others. Eligibility requirements for trainers-in-training will be coordinated by ORA in conjunction with the foreign requestor.