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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections

Chapter 2 Administration

 

Chapter 2 Administration

Subchapter 210-220 - TRAVEL, LEAVE

 

CONTENTS

215 TRAVEL VOUCHERS
    215.1 PREPARATION OF TRAVEL VOUCHERS
    215.2 REIMBURSABLE EXPENSES
    215.3 SUPPLEMENTARY EXPENSES - TELEPHONE CALLS
216 ITINERARIES
217 PASSPORT/VISA

Subchapter 220 - LEAVE
    220.1 GENERAL
    220.2 ANNUAL LEAVE
    220.3 SICK LEAVE
    220.4 COMPENSATORY TIME
    220.5 OVERTIME

Subchapter 230 - SAFETY/SECURITY 
    230.1 GENERAL
231 COUNTRIES WITH TRAVEL ALERTS
232 PERSONAL SAFETY
    232.1 TRAVEL DOCUMENTS
    232.2 HEALTH
    232.3 SECURITY CONSIDERATIONS WHEN TRAVELING ABROAD

 215 TRAVEL VOUCHERS

 215.1 PREPARATION OF TRAVEL VOUCHERS

Submit completed travel vouchers to your immediate supervisor for review and forwarding to the regional/district voucher auditor within two weeks after return from international travel and according to district procedures.

Travel vouchers must show departure and arrival dates. A copy of the travel order and subsequent amendments should be attached.

Lodging receipts are required.

All expenses claimed on the travel voucher should be converted to U.S. currency. Include the conversion rate used for your calculations.

Attach receipts for expenses over $75, or if otherwise required (e.g., charges for traveler checks). The travel voucher should state either "receipt attached" or "no receipt available" for each applicable entry on the voucher.

All official telephone calls, FAX's and telexes must be indicated as such. Personal telephone calls initiated by the traveler are reimbursable at an average of $5/day, or not to exceed $5/day for the number of days in travel status (such as $140/28 days). Receipts are required. (Government calling cards should be used whenever possible). Avoid making international calls from the hotel as their rates tend to be more expensive.

Do not delay submission of the travel voucher awaiting a telephone bill as a receipt, especially for telephone calls billed to a personal calling card. Submit the travel voucher, and when all telephone bills are received, submit a separate claim using an SF 1164 (Claim for Reimbursement form). The SF 1164 should be submitted to the regional/district voucher auditor as though it were a normal voucher and a separate reimbursement check will be issued. A copy of the travel order should be attached.

A copy of the completed travel voucher should be retained for personal records and the original plus attachments should be forwarded to the immediate supervisor for review and forwarding to the regional/district voucher auditor for processing. If you have questions regarding how to prepare your travel voucher, you should telephone the regional/district voucher auditor or the FDA Travel Audit Branch (HFA 123) at (301) 827-5008.

If you owe the government money from your travel voucher, make the check payable to "U.S. FDA." The travel order number should be referenced on the check. Checks should be submitted to the Regional or district auditor after the voucher has been audited.

If leave is taken during a trip, include a statement on your travel voucher and have the timekeeper enter the timekeeper number and initial the voucher to show the leave has been recorded.

 215.2 REIMBURSABLE EXPENSES

Excess baggage – receipt or travel voucher must show weight of baggage and points between which moved.

Parking fees – charges for parking automobiles on official business

Currency exchange fees – fees for converting currency in foreign countries

Passports, visas, and inoculations – passports, visa fees, costs of photographs for passports and visas, birth certificates, health and identity and affidavits. Charges for inoculations not obtainable through a Federal dispensary

Postage – postage necessary for official air mail, foreign, or parcel post mail; official registered and special delivery mail; and for express carrier

Transportation used locally while in travel status – taxicab, bus, train, airport limousine used between common carrier or other terminals and home or place of business; and between places of business when a cheaper mode of transportation is not available or is impractical.

Telegrams, cablegrams, fax messages – charges for telegrams, cablegrams, radio grams, and fax messages on official business.

Telephone calls – charges for official local and long distance calls. Charges for telephone calls home, not to exceed $5.00/day average.

Photocopying – charges for copies of records, when necessary on official business.

Shipment (freight or express) – shipment by freight or express of government property not classified as baggage and not admissible to the mails.

Auto rental, - rental charges including gasoline, tools, parking, and extra liability insurance.

Emergency and other miscellaneous expenses – purchase of emergency airline tickets or purchase of emergency supplies.

Porter fees for personal property, briefcases, luggage, etc. and tips to waiters/waitresses, are not allowed. The M&IE allowance is intended to substantially cover the cost of meals and incidental travel expenses such as tips, laundry, and dry cleaning.

Questions regarding reimbursable expenses, should be directed to DFI (301)827-5653 or HFA 123 (301) 827-5008.

 215.3 SUPPLEMENTARY EXPENSES - TELEPHONE CALLS

To keep expenses of phone calls at a minimum, it is very important that ALL travelers have and use government calling cards when placing business calls while in travel status. If you do not have a government issued calling card, you should apply for one immediately!! Use of the calling card will drastically reduce the costs. The cost of direct-dial calls from a hotel room is highly inflated. If for some reason you do not have a government calling card, or you have a problem using it, once you contact the person you need to speak with, explain that you need to discuss an inspection issue and ask the person to call you back right away.

If you use a computer to access the mail system, please check with your local “Computer personnel” so that you are aware of, and employ the most economical means to access the system. (DFI can provide you with instructions to make connection to the internet using the calling card service.) Make sure that after you have downloaded your messages, you get “off-line” while you read the mail. When composing a long message, write it off-line before making the network connection.

 216 ITINERARIES

DFI will provide a detailed itinerary for each traveler. The itinerary will reflect dates, countries, cities, hotels, and the firms to be inspected. The traveler should insure that a completed itinerary is provided prior to departure.

The traveler should keep a copy of the itinerary on his/her person throughout travel status. It is suggested the traveler provide a copy of the completed itinerary to his/her home district.

DFI must be promptly notified, when changes occur in the scheduled itinerary. Use discretion whether to use FAX or telephone to advise of changes. Remember that DFI can be reached 24 hours a day at (301) 443-1240 and FAX at (301) 443-6919 and (301) 827-6685.

Provide DFI with a contact person to be notified in the event of an emergency.

 217 PASSPORT/VISA

DFI has the responsibility of providing the
Traveler with a U.S. Government passport and any travel visas required.

Passport – A U.S. citizen needs a passport to depart or enter the United States and to enter and depart most foreign countries. The passport is your proof of U.S. citizenship.

Visa – An endorsement or stamp placed in your passport by a foreign government that permits you to visit that country for a specified purpose and time period.

DFI will provide the forms or documents necessary for obtaining passports and visas. It is the traveler’s responsibility to complete the visa forms and return them to DFI in a timely manner. Completed passport applications, along with photos and proof of citizenship, must be hand-carried to a local passport office, court-house or post office for swearing-in and processing by the State Department.

DFI has the responsibility of notifying the traveler in advance of an upcoming passport expiration so new passports may be obtained. All expenses involved in obtaining official passports and visas are reimbursable. Certain countries will not permit you to enter and will not place a visa in your passport, within six months of the expiration date.

Official passports are for use while conducting official government business only. Upon return to the U.S., the passport must be returned immediately to DFI, who will have it secured in the designated safe where all official passports for FDA employees are held.

For security reasons a traveler may wish to carry a personal/ tourist passport. The cost of obtaining a tourist passport is not reimbursable. The traveler should remember that a passport that is used to get into a country should also be used to exit the country. If a traveler is carrying a personal passport in addition to the official passport, extreme care should be taken when using the second passport.

a. LOSS OF PASSPORT

It is important that you safeguard your passport. Its loss could cause you unnecessary travel complications.

If your passport is lost or stolen abroad, contact your trip planner. Report the loss immediately to the local police and to the nearest U.S. embassy or consulate. If you can provide the consular officer with the information contained in your passport, it will facilitate issuance of a new passport. It is a good idea to make photocopies of the data page of your passport. Keep copies in a separate place.

 SUBCHAPTER 220 - LEAVE

 220.1 GENERAL

Be guided by the IOM regarding general policy and responsibility concerning leave.

 220.2 ANNUAL LEAVE

Annual leave in conjunction with international travel is discouraged.

Leave must be approved in advance by the traveler's supervisor and ORO/DFI management. Annual leave must be shown on the T.O. Travel vouchers must bear the timekeeper's number and initials to show leave has been posted on the traveler's time card. Travel vouchers must accurately show when official travel starts, pauses, resumes and stops.

 220.3 SICK LEAVE

If a traveler becomes incapacitated during a international trip due to illness and/or injury, notify DFI as soon as possible (via telephone or fax) after seeking and receiving appropriate medical care. Advise DFI of status and anticipated duration of sick leave. DFI will advise subsequent firms, that were due for inspection, of status and changes to itinerary. The traveler should advise DFI of anyone else to be notified if different from the emergency contact.

 220.4 COMPENSATORY TIME

The traveler should use good judgment in claiming compensatory time. If it is believed, due to the extent of time involved that there should be reimbursement, compensatory time should be requested in advance, through district supervisor/manager and subsequently reported by the district timekeeper. DFI must be informed of all requested compensatory time for international work assignments. The information needed is the date, day, firm, nature of extra time worked and hours. Except in rare emergencies, compensatory time cannot be granted for time spent traveling. The actual amount of hours worked must be reported to DFI.

 220.5 OVERTIME

Presently, travelers are allowed to earn up to ten (10) hours overtime per week for international inspection trips. If you anticipate that you will require overtime, submit appropriate paperwork (FDA form 211) to DFI prior to departure. DFI management or trip planners will sign and approve since the money for this eventually comes from the DFI budget.

The traveler is to use good judgment in claiming overtime. The actual hours worked are to be reported to DFI. Overtime earned will be handled as described in Paragraph 220.4 above.

 SUBCHAPTER 230 - SAFETY/SECURITY

 230.1 GENERAL

Take the necessary safeguards to minimize the opportunity for safety problems. Use and/or wear protective gear, follow established procedures in dealing with hazardous materials and situations, and use common sense.

When conducting inspections, be guided by the firm's safety requirements. If the firm requires employees to wear special clothing, use ear protectors, eye protectors, respirators, etc., the investigator should request the firm to provide them with similar protection.

Operations in the radiological area require extra safeguards. Refer to the IOM for further guidance. Additional advice on protective measures may be obtained from Regional Radiological Health Personnel.

 231 COUNTRIES WITH TRAVEL ALERTS

As a routine part of the process of planning any foreign inspection, the DFI trip planners review the current State Department alert list. If a travel warning or advisory issued by the State Department exists for the country in which a non-routine inspection has been requested by a Center, the trip planner will advise the DFI manager.

All requests for inspections in the subject country must be individually approved by the Associate Commissioner for Regulatory Affairs, after which requests for volunteers will issue. Such requests will contain the reference to the State Department Advisory. When and if names of volunteers are submitted, DFI will select two or more members to make up an inspection team for the country subject to the advisory.

There will be no annual leave approved in countries that are referenced in state department advisories or warnings. If no volunteers are forthcoming, DFI will contact the appropriate Center and advise them of the lack of volunteers.

 232 PERSONAL SAFETY

Awareness of your personal safety should be increased when traveling outside the U.S. Extra care should be taken regarding health care, safety and welfare.

 232.1 TRAVEL DOCUMENTS

Travel documents such as airline tickets, train tickets, passports, etc., should be kept in a secure location. These documents should be kept in the immediate proximity of one's person. At motels/hotels security boxes are usually available at no extra charge. Be very careful with travel documents, as well as money. Passports and plane tickets are easily converted into cash by thieves.

Your passport is the most valuable document that you will carry abroad. It confirms your U.S. citizenship. Please guard it carefully. You may need it when your check into hotels or exchange money.

Protect official Agency documents including applications, EIRs, exhibits, computer disks, etc. which may contain confidential or sensitive information and safeguard it to prevent loss or theft. Any such materials should be kept in a secured area. Travelers should not carry the original copy of product applications, DMFs, or any such document.

 232.2 HEALTH

Maintaining good health while traveling abroad is difficult but important. International travelers can improve upon this situation by taking the necessary preventive measures. Contact DFI or local health unit concerning health information tips for international travelers.

The Centers for Disease Control (CDC) publishes a document entitled "Health Information For International Travel" on a yearly basis. This book describes the risks which may be encountered when visiting other countries. It also specifies the vaccinations required by different countries. This information is available on the Internet, http://www.cdc.gov.

The Public Health Service (PHS) Health Unit at Parklawn (301-443 1238) can provide immunization information. With prior notice and a copy of travel order showing international travel, they will provide immunization free of charge while at Parklawn for briefing. The State Department in Washington (202-647 3578) will provide information and free immunizations which are not available at Parklawn. CDC has a Hot-Line for touch-tone phone users regarding immunizations (404-332-4559).

Depending on the destination, in addition to the required immunizations, the traveler may want to consider additional protection in the form of recommended immunizations. For example, both the International Health Care Service, New York, and the Traveler's Clinic, Cleveland, recommend Gamma Globulin for protection against Hepatitis A, a common illness among travelers. Discretion should be used and personal physicians should be consulted regarding immunizations.

It is advisable to maintain an up to date vaccination record. Record cards are usually available through the CDC or local health unit. Required vaccinations (i.e. Yellow Fever, Smallpox) and necessary prophylactic medications (i.e. chloroquinone, pyrimethmine sulfadoxine, etc.) are reimbursable while those recommended are probably not.

It is also advisable to carry necessary medications for commonly encountered health problems such as common colds, constipation, cuts, scratches, minor burns, diarrhea, heartburn, indigestion, insomnia, motion sickness, altitude fever, sore throat, protection against insects, and sun screen.

If prescription medications are necessary, carry enough for the duration of trip, plus extra in case of unexpected extensions of travel. It is also advisable to carry a copy of the prescription to assist clearance through Customs etc.

Review the IOM for further guidance regarding other safety and health concerns.

Travelers who need to wear glasses or contact lenses should consider carrying an extra pair in case of damage or loss of the original pair. Carrying a copy of the prescription is advisable. Soft contact lenses will absorb chemical vapors which could cause injury to the eyes. For this reason, soft contact lenses should not be worn in bulk chemical plants.

Upon becoming ill in a foreign country, contact the American Consulate to obtain direction to an English speaking doctor or an approved medical facility. It is advisable to carry a list of the addresses and phone numbers of consulates/embassies for the countries to be visited.

a. HEALTH CARE FOR COMMISSIONED CORPS OFFICERS

When overseas, officers should follow the same procedure as for domestic emergencies. That is, get the treatment and call the Beneficiary Medical Program (BMP) within 72 hours. Call commercial number 301-594-6424. The officer must pay medical bill and submit to the BMP. BMP also has an e-mail address: bmp@psc.gov

 232.3 SECURITY CONSIDERATIONS WHEN TRAVELING ABROAD

When you are in a foreign country, you are subject to its laws. It helps to learn about local laws and regulations and to obey them. Avoid areas of unrest and disturbance. The internet is an excellent resource for country information.

Deal only with authorized outlets when exchanging money or buying airline tickets and traveler’s checks. Do not deliver a package for anyone, unless you know the person well and you are certain that the package does not contain drugs or other contraband.

The key theme of this document is good common sense. Do NOT go into areas of known hostility. Do NOT interject yourself into riotous situations. "Be careful."