Inspections, Compliance, Enforcement, and Criminal Investigations
This Field Management Directive (FMD 13) describes the development, administration, and execution of FDA/ORA's International Travel Plan (ITP). It explains how and upon what basis the ITP is developed and provides procedures that must be followed when ORA personnel are requesting approval and after it has been approved. It demonstrates FDA/ORA's commitment to public health on the international arena, furthering its mission through international inspections, sharing of expertise and knowledge, and allowing FDA personnel to participate in international forums. Refer to FMD 13a (March 16, 2009) for operational directives regarding international inspections.
The Food and Drug Administration encourages person-to-person contact with international scientists and health officials to improve U.S. consumer protection and to raise the standards of food, drugs, medical devices, and biological products throughout the world. However, it is essential that international travel be conducted in full compliance with regulations established by FDA, DHHS, Department of State, and with Executive Orders.
Group travel to visit the same location or to attend the same international meeting should be limited to a minimum number of persons required to accomplish the assignment. Similarly, all international travel should be mission critical and coordinated so as to assure effective use of agency resources.
The DHHS Travel Manual (Section 1.1.4) defines international travel as all travel on official duty time (except change of official duty stations) outside the 50 United States, Guam, American Samoa, Puerto Rico, the U.S. Virgin Islands, the Northern Mariana Islands, and any other territory under U.S. jurisdiction. Trips to the former U.S. Trust Territories in the Pacific, which are now independent (the Federated States of Micronesia, the Republic of Palau, and the Marshall Islands), are considered international travel.
However, some travel to Canada and Mexico are handled as domestic (see page 4).
THE ORA INTERNATIONAL NON-REGULATORY TRAVEL PLAN
The ORA ITP is initiated annually to meet the needs and goals in performing the Agency's mission in foreign countries. The majority of the funds in ORA's International Travel budget are used for inspections, investigations, and bilateral Activities: e.g., Memoranda of Understandings (MOUs). Each year, a certain amount is allocated for ORA personnel to attend and participate in international technical/scientific meetings, conferences, and workshops.
During the fiscal year, ORA units submit requests for international travel for the up coming year to the Director, International Operations Branch (IOB), Division of Field Investigations (DFI), HFC-130. These requests must have the concurrence of the Regional Food and Drug Director, District Director, Laboratory Director or the ORA Office Director. DFI receives each request and seeks the approval from the Office of Regional Operations (ORO), HFC-100. ORO approves the request based on the benefits that participation in the activity requested will have for the agency including goals set by the Commissioner, Agency commitments, regulatory needs, new products approval requirements, Congressional interests, established MOUs, and emerging issues. When more than one traveler participates in the same program, justification is required. Each traveler is to have a different purpose for participating in a program. An example of Programs requested, are listed below.
The requestor will receive notification of the ORO decision (approved, disapproved, or approved with local funding or other modifications):
ORA has established the following priorities for international travel:
- Inspections and Investigations – to assure that international standards for food, drugs, biologics (including blood and blood components), and medical devices intended for import into the U.S. meet the requirements of the FD&C Act. This travel is necessary to provide assurance that products exported to the U.S. comply with Good Manufacturing Practices, and for those products subject to a pending application before the Agency, whether they should be approved or disapproved. This travel may also include extension of domestic investigations to the international arena
- Travel in response to international emergencies where FDA expertise is requested by a foreign government or international health organization. Examples of emergency situations are the contamination of glycerin with diethylene glycol in Haiti and problems with pathogens in imported fruits and vegetables.
- The establishment of new MOUs and Mutual Recognition Agreements (MRA) with foreign countries and the maintenance of existing agreements. These activities relate directly to regulatory issues; and may involve international counterpart agencies that conduct regulatory work for FDA. The Office of International Programs has the lead on the MRA and will coordinate all related foreign travel.
- Participation in technical and scientific meetings, conferences, and workshops. Attendance at a meeting or conference which relates directly to the employee's job responsibilities and has direct benefit to the individual's program, and to furthering one or more of FDA's priority initiatives.
- Assistance to international organizations, such as Food and Agriculture Organization (FAO), Pan American Health Organization (PAHO), and World Health (WHO), etc., where expertise within FDA is requested and necessary for the effective implementation or understanding of a project. The project clearly relates to the employee's job responsibilities and will benefit to both FDA and the international organization. The Office of International Programs should be apprised of all requests for assistance, in order to coordinate on behalf of the Agency, and obtain OC clearance, when warranted.
The contact point for all ORA International Travel is the Director, IOB/DFI, HFC-130. Please refer to the International Operations Branch page of the DFI website for contact number at:
INQUIRIES RELATED TO INTERNATIONAL ASSIGNMENTS
Foreign governments and international organizations requesting FDA assistance should submit a formal written request to the Director, Office of International Programs (OIP), HFG-1.
All ORA headquarters and field personnel contacted by foreign governments and representatives of international organizations regarding FDA assistance will inform the requestor of the proper channels to follow and refer them to OIP. No commitments should be made during these contacts under any circumstances.
The person receiving the inquiry or request will prepare a memo indicating the nature of the request. The memo should be forwarded to the Director of OIP, with copies to ORO and the appropriate District and Regional Directors.
TRAVEL TO CANADA AND MEXICO
When there is no overnight lodging for routine inspections and investigations, travel to Canada and Mexico is handled as domestic rather than international which are typically funded by the center or district. The occasional or recurring meetings of FDA field staff with our counterparts in Canada to discuss matters related to supporting FDA's inspection program has been interpreted by the Deputy Commissioner for Management and Operations to fall within the domestic classification. Therefore, meetings that typically occur on relatively short notice and do not require overnight lodging in Canada and or Mexico will only need to be authorized by the Associate Commissioner for Regulatory Affairs (ACRA) or his/her designee, which includes Regional Food and Drug Directors (RFDD) and/or District Directors (DD).
PERSONAL SAFETY AND SECURITY
Refer to FMD 13a for additional instructions and recommendations regarding health, personal safety, and security. Travelers are encouraged to make every effort to ensure their safety while in international travel status and should provide their office with a copy of the detailed itinerary, received from DFI, so that they can be contacted in an emergency. All travelers are required to electronically register with the US Embassy in the country they are traveling to according to the instructions provided in their itinerary.
Travelers in countries with State Department Warnings should check in with their DFI Trip Coordinator on a weekly basis. ORA personnel who encounter an emergency situation while traveling abroad should immediately contact the DFI personnel provided in their travel itinerary first or FDA/ORA's Prior Notice Center at 1-866-521-2297 or 703-621-7783. International cell phones will be provided to international travelers, so they can be contacted during an emergency.
The following web sites will provide useful information for the international traveler.
- Centers for Disease Control
Information on diseases in specific countries, inoculations and preventive measures.
- CIA Fact Book
Information on climate; population; political parties; and the economy for all countries. There are two ways to access "Fact Book": 1) Click on the "World Fact Book," click on "Country Listing;" 2) Click on "Publications and Reports," click on "World Fact Book," click on "Country Listing."
- State Department Travel Warnings
Click on search and type in Travel Warnings, click on Travel Warnings and Consular Information and Consular Information, click on the letter for the country about which you would like information. The site has information on more than 160 countries and describes entry requirements, travel conditions, available medical facilities, areas of instability and more.
Refer to FMD13a for additional procedures regarding international travel.
- Each request for international activities should be based on the funds requested and approved by ORO pursuant to the annual ORA International Travel Plan. When the request is forwarded it must have the concurrence of the Regional Food and Drug Director or District Director, or the ORA Office Director
- Each request will be given careful scrutiny at all levels within the organization to determine that the trip is necessary. The person making the trip must be qualified for the assignment, as each FDA employee traveling abroad represents the U.S. Food and Drug Administration.
- All FDA foreign travel must be done with an official passport (HHS Travel Manual, Section 188.8.131.52). The Department of State now requires four weeks for processing a request for an official passport. Therefore, a request for issuance or renewal of an official passport must be received by DFI at least eight weeks prior to the travel. Additional time will be needed if one or more visas are required for the country(s) to be visited. Travel to Taiwan requires the assignment to be performed using a personal passport, which also requires four weeks to process. Costs associated to processing of official passport will be reimbursed.
- The Notification of Foreign Travel (NFT) is used to obtain HHS, Department of State and Embassy clearance. The purpose of travel in relation to departmental objectives will be described. In addition, an in-country contact name and telephone number is required. The NFT will be submitted electronically by DFI/IOB personnel to OIP via the Office of Global Health Affairs (OGHA) website: http://184.108.40.206:8080/nft/index.html. This is the first document that needs to be completed and processed. NFTs must be submitted 37 calendar days before the anticipated departure date. Any NFT submitted less than 2 weeks before departure will not be accepted by OIP.
The following are examples of countries that require longer approval time:
Seven weeks: India, China and Russia
Four weeks: Taiwan, Philippines, and all South American Countries
- If this time frame cannot be met a justification must be submitted in the NFT. The justification for late submission for international travel must relate to circumstances outside the control of the traveler and the Agency. Late travel request may be denied unless an emergency or public health crisis exists. If two or more travelers will be participating in a non-inspectional trip, a "Justification for Two or More Travelers" statement is required (SMG 2342.2).
- DFI/IOB will prepare and process the majority of the necessary documents, such as travel reservations, travel orders in GovTrip, obtain signatures on all documents; and will provide a copy of all documents in the travel packet.
- To assure timely processing of travel requests, send pertinent documents and questions of the proposed travel to DFI/IOB.
- If for any reason, the traveler's trip status changes prior to departure, they must notify DFI/IOB immediately. In addition, if changes to the itinerary are made during travel status, the traveler is required to notify DFI/IOB.
- Upon returning from an international trip, the traveler must submit the Travel Voucher (TV) with supporting receipts within five working days, per HHS Travel Manual. The receipts need to be downloaded into the voucher in GovTrip for processing. All foreign TVs are approved by DFI/IOB and not by local management. If the amount of the advance exceeded the expenses incurred, a check or money order made payable to "U.S. Food and Drug Administration" must be attached to the hardcopy of the approved TV and all original receipts when you submit it to OFFAS. The address where the hardcopy voucher needs to be sent will be provided in the travel packet.
*Note: Annual Leave may only be taken during FDA funded trips. For regulatory inspection trips, up to two days of leave can be approved for every five days worked with a total not to exceed five working days for a multi-week trip. For Non-Regulatory trips, only one day of leave per year can be approved. No Annual Leave will be approved for trips funded by outside sources.
FOR TRAVEL FUNDED BY OUTSIDE SOURCES
In addition to the NFT, the following documents are necessary for international travel that is funded by foreign government and/or international organizations and all forms can be found on the OFM Website at: http://inside.fda.gov/Administrative/BudgetFinance/BudgetInformation/UCM013574.html
- Letters of Invitation from outside sources other than FAO, PAHO, WHO, must be submitted to the DFI/IOB Director. This will ensure that FDA can accept travel funds from the organization in accordance to FDA laws and regulations and to assure no conflict of interest.
- Organizations that wish to fund travel must complete and submit a Sponsor Certification Form. This form must be submitted with the letter of invitation.
- A letter of acceptance to the sponsoring organization (for signature of the Director, Office of Resource Management) on FDA/Rockville letterhead.
- Completed General information about FDA Employee Who Attend, Participate in or Speak at Non-Federal Meetings, Conferences and Symposiums document.
All outside sponsor funded travel is processed in GovTrip by DFI/IOB personnel.
The above documentation, must be received by DFI, International Operations Branch, HFC-130, as a package, at least six weeks before departure. A late travel package may be denied.
*Note: No Annual Leave will be approved for trips funded by outside sources.
|Distribution:||Regional Food and Drug Directors, District Directors,|
|Laboratory Directors and Headquarter Office Directors|
|Issued by:||ORA/ORO/Division of Field Investigations (HFC-130)|
|Publication Date:||March 2009|