Inspections, Compliance, Enforcement, and Criminal Investigations
ORA FIELD MANAGEMENT DIRECTIVE No. 13
ORA FIELD MANAGEMENT DIRECTIVE No. 13
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.
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 6-00-00) defines international travel as all official travel outside the United States, Canal Zone, Guam, American Samoa, Wake Island and the Trust Territory of the Pacific Islands, Puerto Rico and the U.S. Virgin Islands, and any other territory under U.S. jurisdiction. However, some travel to Canada and Mexico are considered as domestic (detail see page 3).
THE ORA INTERNATIONAL TRAVEL PLAN
The ORA ITP is developed 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 fourth quarter of each fiscal year, ORA units submit requests for international travel for the up coming year to ORA/ORO/Division of Field Investigations (DFI), HFC-130. DFI reviews and categorizes each request and makes recommendations to ORO, HFC-100. ORO review all requests and develops a plan based on considerations 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.
Each field office will receive a copy of the final plan approved by ORO that shows the status of each request (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 DFI/International Operations Branch (IOB), HFC-130, Telephone:(301) 827-5653.
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 the OIP. No commitments should be made during these contacts under any circumstances.
As required by Staff Manual Guide 2342.2(2), 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 OIA, 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 considered as domestic rather than international by the current HHS Travel Manual (Section 1-20-20). 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 (when there is no overnight lodging). Therefore, meetings that typically occur on relatively short notice and do not require overnight lodging in Canada and or Mexico will need only be authorized on the signature of the Associate Commissioner for Regulatory Affairs (ACRA) or his designee, which includes Regional Food and Drug Directors (RFDD) and/or District Directors (DD). Contact DFI to determine if costs of such trip will come from domestic or international travel funds.
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 detailed itinerary so that they can be contacted in an emergency. Travelers should also check in with their office on a routine basis. ORA personnel who encounter an emergency situation while traveling abroad should immediately contact FDA’s 24-hour emergency number, +1 (301) 443-1240. 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.
For more information, return to the search page and type in “publications.”
- Each request for international activities should be based on the funds requested and approved in the annual ORA International Travel Plan.
- 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.
- 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. Official passports may not be issued for some international activities, such as FAO, WHO, and PAHO consultancies. This type of assignment may be performed using a personal passport, which also requires four weeks to process.
- The Notification of Foreign Travel (NFT) form is used to obtain HHS Department of State and Embassy clearance. This is the first document that needs to be completed and processed. The request should have the concurrence of the Regional Food and Drug Director or District Director, or the ORA Office Director and be forwarded to DFI/International Operations Branch (IOB), HFC-130. The purpose of travel in relation to departmental objectives should be described. In addition, an in-country contact name and telephone number is required.
- The NFT is submitted to the Office of International Programs electronically via website: http://184.108.40.206:8080/nft/index.html. NFTs must be submitted 45 calendars days before the anticipated departure date. The NFT can be submitted by the field office or by IOB personnel. Any NFT received less than 2 weeks before departure will not be accepted.
The following are examples of countries that require longer approval time:
Seven weeks: Peru and India Four weeks: Russia, China, Colombia, Taiwan, Philippines, and all South American counties
- If this time frame cannot be met, Staff Manual Guide 2342.2(2) requires a letter of late justification. 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. An example is shown in Attachment A. If two or more travelers will be participating in a non-inspectional trip, a” Justification for Two or More Travelers” statement is required. An example is shown in Attachment B.
- Travelers from field offices should send the Advance of Funds (SF-1038) and Travel Voucher (SF-1012), if applicable, to the designated Regional Payment Office.
- DFI/IOB will prepare the majority of the necessary documents, such as travel reservations, travel order, obtain signatures on all documents; have accounting data placed on the travel order and return the signed documents to the traveler.
- 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 trip status changes prior to departure, they should notify DFI/IOB immediately.
- Upon returning from an international trip, the traveler must submit the travel Voucher with supporting receipts within five working days per HHS travel Manual. 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 when you submit the travel voucher. Additionally, if the traveler takes annual leave*, the traveler’s timekeeper must verify the leave usage by placing their timekeeper number on the travel voucher, and signing or initialing the travel voucher. The voucher must be submitted directly to the first line supervisor who will review and submit the voucher to the designated international travel voucher auditor in the region. Send travel vouchers for travel paid by outside sources (travel orders designated with a “Z”) to DFI/IOB for processing.
*Note: Annual Leave may only be taken during FDA funded 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. 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 international organizations:
- Letters of Invitation from outside sources other than FAO, PAHO, WHO, must be submitted to Katherine Zink, HFI-1. 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 (Attachment C).
- Organizations that wish to fund travel must complete and submit a Sponsor Certification Form (Attachment F). Form is not necessary for travel funded by FAO, PAHO and WHO. You can access the form via the intranet, Office of Financial Management website, under travel. This form must be submitted with the letter of invitation to Katherine Zink, HFI-1.
- HHS 348 Form, Request and Approval for Acceptance of Payment of Travel Expenses In Cash or In Kind, including the background information on Request for Approval for Acceptance of Payment of Travel Expenses In Cash or In Kind Form. Page two of this form must be signed with an original signature and questions one to eight (1-8) completed, and submitted with your travel package.
The HHS 348 Form can be downloaded and filled in PDF from the website below:
- A letter of acceptance to the sponsoring organization (for signature of Director, Office of Resource Management) on Rockville letterhead stationery (Attachment D).
- General information about FDA Employee Who Attend, Participate in or Speak at Non-Federal Meetings, Conferences and Symposiums (Attachment E).
The above documentation should be prepared by the traveler’s district and must be received by DFI, International Operations Branch, HFC-130, as a package, at least five weeks before departure. A late travel package may be denied. Any request for travel received less than 2 weeks prior to the requested travel date with not be accepted.
|Distribution:||Regional Food and Drug Directors and District Directors|
|FDA Headquarters Offices|
|Issued by:||ORA/ORO/Division of Field Investigations (HFC-130)|
|Publication Date:||November 2002|