ORA FIELD MANAGEMENT DIRECTIVE No. 13
Subject:
International Travel |
Area:
Operations Management |
Date Revised:
October 2002 |
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PURPOSE
This Field Management Directive (FMD 13) describes the development, administration, and
execution of FDA/ORAs 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/ORAs 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.
DEFINITION
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
Agencys mission in foreign countries. The majority of the funds in ORAs
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 employees job
responsibilities and has direct benefit to the individuals program, and to
furthering one or more of FDAs 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 employees 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.
CONTACT POINT
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
FDAs 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 FDAs 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
http://www.cdc.gov
Information on diseases in specific countries, inoculations and preventive measures.
- CIA Fact Book
http://www.odci.gov
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
http://www.state.gov
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.
PROCEDURES
- 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://ogha.psc.gov/ogha/ftform.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 |
Note: In an effort to assure that NFT memos are submitted to IOB on time, we are
encouraging all offices to submit the NFT memo in advance of the other travel documents,
especially if there is the chance of missing the established deadline. NFT memos for
SES individuals require additional clearance.
- 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
travelers 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:
http://forms.cit.nih.gov/adobe/travel/HS348.PDF
- 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 travelers 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 |
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FDA Headquarters Offices |
Issued by: |
ORA/ORO/Division of Field Investigations (HFC-130) |
Authority: |
ORA |
Publication Date: |
November 2002 |
This page was last updated on: 02/20/2003.