Contents

SUBCHAPTER 100 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS

Definition: the term document applies to official records which are considered to be U.S. Government property regardless of the media e.g. Regulatory notes (electronic and hardcopy), memoranda, inspection reports, e-mails, and official government forms (e.g. SF-71, FDA-482, FDA-483, etc.)

All official FDA documents generated during your routine duties shall be completed in English. This requirement is necessary to facilitate efficiency in the workplace. For instance, many of your work products used in support of FDA’s regulatory process are subject to review and auditing by your supervisor, utilized by your co-workers, and others, including the public, in that they are releasable under the Freedom of Information Act (FOIA). The Agency does not have the resources to assure the accurate and timely English translation of documents written in a non English language in order to facilitate their use in the conduct of official business. English is generally considered to be the common language of the U.S., therefore it is necessary to standardize the language utilized in the production of official FDA documents.

Additionally, FDA imposes English only requirements on the public for information submitted to the Agency. For example 21 Code of Federal Regulations section 803.13(a) (English Reporting Requirement) states that “ All reports required in this part which are submitted in writing or electronic equivalent shall be submitted to FDA in English. “

SUBCHAPTER 110 - TRAVEL

All official travel must be authorized and approved with a valid travel order (T.O.). Emergency travel can be approved and the travel order prepared and authorized after the fact. "After the fact" travel orders (T.O.s) should be utilized on a very limited basis.

The federal travel regulations contained in 41 CFR 301, Department of Health and Human Services (DHHS) Travel Manual, and the Food and Drug Administration (FDA) supplements thereto, govern official travel. Become familiar with these documents. All material contained in the Investigations Operations Manual (IOM) must be used in conjunction with, and subject to, federal travel regulations. Additional travel information can be obtained from the Office of Financial Management (OFM) Intranet home page: http://intranet.fda.gov/ofm/default.htm.

For foreign travel, be aware that there are differences in reporting requirements and reimbursable expenses. See the Guide to International Inspections and Travel, Chapter 1, Subchapter 110 - Travel, for specifics.

Effective March 1, 2000, federal employees must put most official travel-related charges on government-issued credit cards, with exceptions only for expenses that are either relatively minor or inconvenient for credit card usage such as parking, local transportation, tips, phone calls, and certain expenses for which credit cards are not accepted.

FDA selected Carlson-Wagonlit as the Agency-wide Travel Management Center. Carlson-Wagonlit operates from one central reservation center located in San Antonio, Texas. This reservation center has the capability to book airline tickets, hotel reservations, and car rentals via telephone, facsimile (fax), and through their on-line web reservation system. You are encouraged to use the "online" method when making reservations because of the flexibility associated with this service. The system incorporates Federal Government travel policies which include the city pair airfare contract program and Federal Travel Regulations and is structured to require justification if you want to deviate from General Services Administration's (GSA) regulations. A policy has been established with the FDA so that your government-issued credit card will be your primary method of billing and payment when you book flights, make hotel reservations, or reserve a rental car. Additional information can be obtained by contacting your Administrative Officer (AO) or visiting OFM's website: http://intranet.fda.gov/ofm/default.htm.

111 - COMMON CARRIER

Request round-trip tickets when it can be expected you will use them. This reduces paperwork costs, even though there may be no savings on the tickets themselves.

You should cancel reserved tickets if you will not be using them. Failure to do so may result in charges levied by the carrier. Note the date and time of your cancellation, and the name or code number of the agent that you advised. Unused tickets must be returned to your AO or Travel Management Center.

Requirements which authorize you to use cash payments for procurement of common carrier transportation and related expenses, in lieu of your government-issued credit card, or centrally billed account, are specified in 41 CFR 301-72.200 and 301-51.100. Cash payments are generally permitted:

1. To obtain passenger transportation services, in an emergency, for any amount when authorized by your District Director (DD) and documented on your T.O. Otherwise, cash and personal credit cards may not be used for transportation expenses exceeding $100.00.
2. To pay air excess baggage charges up to $15.00 for each leg of a trip.

When cash is used, claim a reimbursement on your travel voucher and submit your ticket stubs or other appropriate receipts. You must also explain the circumstances for using cash on your travel voucher. See IOM 117 for mandatory statements required on a travel voucher.

111.01 - Air

It is FDA's policy to require all travelers to use coach class service for official travel. A contract air carrier must be used unless one of three approved exceptions is met and your District Director approves another carrier. See your fiscal clerk for further information. Justification for use of non-contract carriers must be approved on the Travel Order by the Regional Food and Drug Director (RFDD), DD or Administrative Officer, or on the voucher, if "after the fact." Refer to Federal Travel Regulation (FTR) 301-10.107 and 301-10.108 for the mandatory use of a contract city-pair fare.

Exceptions to using City Pair Program are:

• Contract service is not available in time to accomplish the purpose of your travel
• Use of contract service would require you to incur unnecessary overnight lodging costs that would increase the total cost of the trip
• Contract service is outside normal working hours
• A non-contract carrier offers a lower fare (available to the general public), the use of which will result in a lower total trip cost to the Government
• Cost effective rail service is available and is consistent with mission requirements

The Associate Commissioner for Management must authorize First Class travel. The use of first class travel must be pre-approved, and such approval will not be granted, even for medical reasons, unless business class is not available.

The National Defense Authorization Act for Fiscal Year 2002, Section 1116 specifically states that federal employees may retain for personal use promotion items, including frequent flyer miles, earned on official travel. Normally it is the policy of the Government that employees generally must travel by coach class accommodations. However, you may upgrade your transportation class to premium service e.g. business class/first-class with your personal funds or your frequent flyer miles based on regulations found in FTR 301-10.123 and 301-10.124.

Accommodations other than coach will be approved if in met in accordance with the FTR and the NTEU-MOU for foreign inspections.

Consistent with FTR 301-12.2, you may be reimbursed expenses related to baggage, but you should be prudent and only request reimbursement for reasonable excess baggage authorized and approved in advance on the travel order.

Please see the FTR on the GSA website for additional information.

111.02 - Auto Rental

GSA and the Department of Defense (DOD) both provide employees with a nationwide commercial auto rental program. The Federal Travel Directory, published monthly on floppy diskette, contains a list of vehicle leasing companies participating in this program. Agency policy dictates leasing the least expensive auto to satisfy the transportation requirements.

Commercial auto rental is available when specifically authorized by a special or blanket T.O. You will be reimbursed for rental expense when it is properly vouchered and your receipt is attached to your travel voucher.

Optional Collision Damage Insurance known as CDW will not be reimbursed. Participating rental companies have agreed to settle any claim for damages with the FDA. It is important to note that only damages incident to official travel will be covered by this agreement. If an investigation shows your vehicle damage or personal injury was the result of your unauthorized use of a rental vehicle, you may be personally liable for all related costs. See IOM 112.03 -Liability.

CDW is required for foreign travel and will be reimbursed. See the Guide to International Inspections and Travel, 211.7 - Auto Rental.

Travelers are required to adhere to the same rules and regulations covering government owned vehicles when using a rental car while on official business.

111.03 - Taxi

Reimbursement for the use of taxicabs will only be allowed when authorized on your T.O. Allowable tips are 15% of the reimbursable fare. Receipts are required for fares over $75.00.

You will be reimbursed for the usual cab and/or airport limousine fares plus tip from your home/office to the common carrier terminal on the day you depart on an official overnight trip, and upon your return. In lieu of cab, you may use your personal car at a mileage rate not to exceed the cab fare plus tip. See your administrative personnel for current mileage rates, the maximum allowable taxicab fares, and other pertinent details.

111.04 - Accident Insurance

The government will not pay or reimburse you if you purchase accident insurance. Obtaining accident insurance is at your expense since you are covered while on official business by workmen's compensation insurance. See IOM 111.02 for payment of insurance on rental cars.

Many insurance policies will not cover you if you perform any duties connected with your job while on an interstate transportation carrier. This could affect you if you perform on-board inspections under the Interstate Travel Sanitation Program during a trip.

111.05 - Gainsharing

The Government Employees Incentive Awards Act, 5 USC Paragraphs 4501-4507, authorizes an agency to pay a cash award for "efficiency" or "economy". FDA in conjunction with the National Treasury Employees Union (NTEU) implemented a Gainsharing Travel Savings Program which rewards you if you save the FDA money while you are on temporary travel (TDY). Your participation is optional. The Agency's gainsharing policy as well as filing instructions for gainsharing claims can be found by accessing OFM's website: http://intranet.fda.gov/ofm/default.htm.

112 - GOVERNMENT FURNISHED VEHICLES (GFVs)

GFVs are provided for official purposes only. The term "official purpose" shall be interpreted strictly, and not construed to mean mingling of official business with non-official business. Using a GFV for sightseeing, personal business, personal convenience or preference will be construed as unauthorized use of a GFV. The distance involved in any such misuse is irrelevant. The following is an excerpt from the DHHS Travel Manual Appendix A 1-2.6a., dated May 31, 1988 which further defines official purpose:

"Use of Government-furnished Vehicles."

a. "Use limited to official purposes - When a Government furnished vehicle is used by an employee for official travel, its use shall be limited to official purposes (31 U.S.C. 638a) which include transportation between places where the employee's presence is required incident to official business; between such places and places of temporary lodging when public transportation is unavailable or its use is impractical; and between either of the above places and suitable eating places, drug stores, barber shops, places of worship, cleaning establishments, and similar places necessary for the sustenance, comfort, or health of the employee in order to foster the continued efficient performance of Government business."

You are responsible at all times for the proper care, operation, maintenance, and protection of a GFV. If you willfully or knowingly use or authorize the use of a GFV for other than official purposes, you are subject to suspension or removal.

112.01 - Interagency Motor Pool

GFVs for district operations are furnished by the regional GSA motor pool. Be guided by the district operating procedures in effect for the appropriate regional pool.

Vehicle Operation - You are required to have a valid state, District of Columbia, or commonwealth operator's permit for the type vehicle to be operated, and a valid DHHS identification document (i.e. Agency ID card, credentials, building pass, etc.).

Each district has working arrangements for the repair and maintenance of vehicles, either with GSA contractors or the GSA motor pool. It is your responsibility to adhere to those safety and maintenance checks. Do not operate cars known to be mechanically unsafe. Handle emergency repairs in travel status in accordance with your District and GSA motor pool procedures.

Purchase gas and oil for your GFV with GSA Credit Cards. Make emergency purchases with cash only when the GSA Credit Card is refused. Your receipts are required by the GSA motor pool. Provide for the safe and proper overnight storage of GFVs while you are in travel status, and put the charges on your travel voucher.

You are responsible for all traffic violations, including parking fines, you incur during the use and operation of a GFV. See DHHS Material Management Manual Section 103-38-052.1.

Allowance - While on official business, you may be reimbursed for parking fees or overnight storage charges. Put these charges on your travel voucher. Receipts are required when available.

Bridge, ferry and road tolls may be paid in cash. Put these charges on your travel voucher. Receipts are only required for amounts over $75.00.

112.02 - Accidents

Immediate Action - Render first aid. If you are injured, obtain emergency treatment.

Information to be obtained: (1) description of vehicles involved, including license numbers, (2) name, address and other pertinent information about drivers and owners of other vehicles, (3) names, addresses and signed statements of witnesses, (4) names, official affiliation of investigating police officers, (5) photographs of the scene and the damage, (6) make no statements as to responsibility for the accident, except to your supervisor or investigating official.

Reporting - Report the accident to the police after rendering emergency first aid to the injured. Telephone your supervisor and the chief of the motor pool from which the vehicle is assigned, unless your supervisor advises you the district will handle it.

1. Complete SF 91, Operator's Report of Motor Vehicle Accident. If there are witnesses, prepare SF-94, Statement of Witness. Submit these promptly with a narrative report of all circumstances. Report the actual damage done to all parties, vehicles or property involved.
2. File reports to comply with all local and state laws dealing with accident reporting. Keep copies of all reports made and attach them to the federal accident report.
3. Check with your own insurance carrier for their requirements.
4. Immediately submit to your supervisor any notice, summons, legal paper or claim, which may subsequently arise from the accident.
5. Check with your district safety officer to determine if additional reports or information are needed.

112.03 - Liability

The Federal Drivers Act (28 U.S.C. 2679(a)-(e)) was enacted to protect government drivers from personal liability while driving within the scope of their employment. This means you must be on official business to be covered. It relieves you from the burden of acquiring private automobile liability insurance for driving while on the job.

The government's exclusive liability provided by this Act is predicated on its status as employer, without regard to w hether the vehicle involved is government owned or privately owned.

112.04 - Use of a GFV Between Your Residence and Place of Employment

Use of government owned or leased autos between your residence and place of employment is approved by the Secretary, DHHS, for certain job series as stated in FDA Staff Manual Guide (SMG) 2173.1. The use of a DHHS-16 "Request To Use Government Furnished Vehicle For Transportation Between Domicile and Place of Employment" is no longer required, however, local management may continue to use the form or establish a verbal approval process, if desired. The Daily Log of Government Vehicle (Form FDA-3369) must be maintained by all approved persons using a GFV, assuring that all items indicated on the form are completed for each trip. The DHHS now requires that each person taking a GFV home, in order to perform field work, must indicate in Column 10 on the Form 3369, the location of their residence. The Daily Log must be kept for at least a period of three years and must be available for audit purposes. The use of Form DHHS-17 "Quarterly Report on Use of Government-Owned or Leased Vehicles Between Domicile and Place of Employment" is no longer required.

112.05 - Care & Custody of U.S. Vehicles

GSA has issued instructions on the use and protection of U.S. Government vehicles, Government National Credit Cards, and car keys. The parts of these instructions applicable to you while the car is in your custody are:

1. The car should be locked when parked in public areas, in private lots, or in open government parking areas.
2. The operator is responsible for the keys and the credit card. They should be removed from the vehicle and carried whenever the vehicle is parked.
3. The keys and credit card are returned to the motor pool office when the vehicle is returned. These items should be kept in a safe place at the office if the vehicle is stored at other than a motor pool location.
4. The credit card must be removed when a vehicle is left at a garage or service station and the keys remain with the garage or station attendant.
5. The credit card may only be used to purchase fuel and lubricants or other items listed on the back of the card for the vehicle identified, and not used for other vehicles.
6. Before signing a service ticket, check for accuracy. Be sure the imprinted address is legible, and write the vehicle mileage (odometer reading) on the ticket.
7. The use of tobacco products is prohibited in government-owned or commercial, leased vehicles

113 - PRIVATELY OWNED VEHICLE (POV)

On official business, you may use your POV instead of a GFV, if authorized. However, reimbursement for mileage will not exceed the cost of using a GFV. You should carry a set of government accident reporting forms whenever you use your POV for official business. See IOM 112.02 for accident reporting requirements.

Allowances - In general, the mileage allowance is in lieu of all expenses of operating your POV, except tolls. Unless otherwise authorized, reimbursement is limited to the cost of travel by common carrier. Standard highway guide mileage may be used in lieu of odometer readings for direct travel from one town to another. Explain any extra mileage on your travel voucher.

113.01 - Accidents

The Federal Employee's Compensation Act (Workmen's Compensation) protects employees against losses due to personal injuries received while operating POVs on official business.

Under the Federal Driver's Act [28 U.S.C. 2679(a)-(e)], you are immune from any civil liability to other parties for property damage, personal injury, or death resulting from operation of a vehicle within the scope of your employment. This immunity applies whether the vehicle involved is a GFV or POV. The government would defend any such claim or suit, and would pay any damage award to the injured party.

If an accident was caused by your negligent operation of a vehicle, and your vehicle is damaged, the cost of repairing your vehicle will not be paid for by the government. You should look to your own private insurance carrier for reimbursement, payable under the terms of your own automobile insurance policy. You are protected from liability by the Federal Drivers Act. See IOM 112.03 for further information on this.

If the accident is determined not to have been caused by your negligence, the provisions of the Military Personnel and Civilian Employees Claims Act (31 U.S.C. 240-243) would be applicable. Under this Act, you would be reimbursed for the deductible portion of the repair not covered by your own automobile insurance policy, up to a maximum of $250.00 deductible. (You may also collect from the other party's insurance.) Form DHHS-481, Employee Claim for Loss or Damage to Personal Property, should be obtained from, completed, and submitted to the Personal Property Management Section (HFA-225) Room 9-82, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, with evidence establishing that the use of a POV was authorized for official purposes and that the accident was not caused by your negligence.

Employee Liability - see IOM 112.03.

Reporting - Report vehicle accidents as instructed in IOM 112.02.

114 - PER DIEM AND SUBSISTENCE

Subsistence is the cost of lodging, meals, tips, and the miscellaneous expenses you incur while in travel status. Per Diem is based on the actual cost of lodging, plus a set amount for "Meals and Incidental Expenses" (M&IE), not to exceed the maximum rate for the prescribed city or area. Note: For domestic travel only, report lodging taxes separate from lodging expenses and claim them in the "Other" column on your travel voucher. Foreign travel taxes still remain a part of your lodging expenses.

Lodging expenses should be paid using your government-issued credit card, when possible. The credit card bill will be mailed directly to you. It is your responsibility to pay the bill on time. The FDA will reimburse late charges on your bill only when you can show the late payment was due to late reimbursement of funds by the FDA.

Accurately record all of your expenditures. Document the date of your departure from each point where your duty is performed. Be guided by your district's policy for where to record this information, e.g. in an administrative diary, etc. If your district permits entry of this information in a regulatory diary, be certain that administrative information can be readily distinguished from regulatory entries.

Administrative Notes - Your regulatory notes (See IOM 190) should not contain notes of a purely administrative nature (documentation of travel, expenses [tolls, sample costs, etc.], fiscal data, mileage, etc.) These administrative notes can be documented in some kind of an administrative diary. They do not need to be kept in a permanent record other than the completed Travel Voucher, Claim for Reimbursement for Expenditures on Official Business, Receipt for Samples, etc. Follow your district's requirements for maintaining this information.

114.01 - Per Diem Rates

Consult your supervisor or administrative personnel for specific rates for specific locations or at the OFM website: http://intranet.fda.gov/ofm/travel/authorization/perdiem.htm.

Per Diem commences when you depart your home, office, or other point of departure, and terminates when you return to your home, office, or other point. This applies whether you are traveling by auto or by common carrier. See IOM Exhibit 110-D.

The M&IE Allowance is 3/4 of the daily rate on the first and last day of travel when overnight travel is involved, and the full daily rate for each intervening day.

1. M&IE may apply where there is no overnight lodging. However, M&IE will not be allowed for periods of time less than twelve hours.

Your work time plus your total commute time must be greater than twelve hours for you to be eligible for M&IE.

114.02 - Hospitalized In Travel Status

If, while you are in travel status, you become hospitalized by illness or injury not due to your own misconduct, your per diem continues (even if covered by your health insurance carrier) provided you do not receive hospitalization (or reimbursement therefore) under any Federal statute such as Workmen's Compensation, VA, or military hospital.

Your per diem is calculated on the lodgings-plus system, not to exceed the per diem rate allowed. Check with your district supervisor or administrative personnel.

115 - CHANGE OF OFFICIAL STATION

The complexity of regulations pertaining to allowable expenses, per diem, advance trips to seek housing, etc. necessitate consultation with your supervisor or administrative personnel.

116 - ADVANCE OF FUNDS

You will use your government-issued credit card to obtain a cash advance from an ATM machine, for official government business only. Make sure your T.O. contains a statement that you are authorized to use an ATM to obtain cash advances and the amount authorized. ATM cash advances may be used to purchase samples.  If you do not have a government travel card and are required to travel, please see your administrative officer about receiving a travel advance. 

117 - CLAIMS FOR REIMBURSEMENT

Submit your claim for reimbursement after each trip unless instructed otherwise by your supervisor. Submit expenses for special travel orders promptly (within 5 days) after each trip. If local travel only, submit expenses on an SF 1164, "Claim for Reimbursement for Expenditures on Official Business." Claim expenses for all other travel on an SF 1012, "Travel Voucher." (See IOM Exhibit 110-D.)

Preparation of Claim on Travel Voucher - Clerical procedures vary from district to district, so consult your supervisor or administrative office for instructions. State all items in chronological order. Show your mode of transportation and if accompanied, the names of the other travelers. All vouchers are processed electronically using Travel Manager.

Show your date of departure and return to your official duty station, and when periods of leave commence and end. Show all points where costs are incurred.

Mandatory Statements Required on Travel Voucher - See IOM Exhibit 110-B for allowable expenses, receipts required, etc.

1. Leave Taken in Travel Status - If you take any type of leave while in travel status, include a statement on your travel voucher that you apprised your timekeeper of the amount and type of leave taken. The timekeeper must initial your voucher to show that the leave has been recorded.

Reimbursable Expenses - Explain the necessity for unusual expenditures such as rental equipment, stenographic services and emergency charges (See IOM Exhibit 110-B). The following cash purchases are reimbursable when accompanied by necessary receipts (see Documentation below):

1. Travel costs such as road and bridge tolls, storage and parking for government cars, and handling of official (not personal) baggage.
2. Costs for samples and the necessary casual labor charges for their collection and packing. (See IOM 405.01(d) Official Samples.)
3. Telephone and telegraph expenses. Document that the use was for official purposes. For local telephone calls, show the number of calls only and the total cost each day.
4. Emergency purchases (flashlights, batteries, photographic film, jars, or dry ice for samples, etc.)
5. Coveralls or lab coat laundry while in travel status
6. Personal laundry while in travel status within continental U.S. (CONUS) for four or more consecutive nights

Documentation - Except for samples, all cash payments should be supported by itemized invoices or receipts signed by vendor, if possible. If you are unable to furnish receipts when submitting your voucher, explain that on the voucher.

Receipts for registration fees at meetings are required regardless of the amount. See IOM Exhibit 110-D and IOM 111 for receipts required for cash expenditures for transportation and IOM Exhibit 110-B.

118 - TELEPHONE COMMUNICATIONS

Commercial - Local, official telephone calls are reimbursable. When placing an official call from a non-government phone, use your government-issued calling card, call collect if permitted by your District's policy, or call commercially and claim reimbursement on your travel voucher.

Commercial calls from hotels or motels should be made using your government-issued calling card, whenever possible. If not possible, they should be claimed on your travel voucher and be supported by the phone bill. Calls made using a personal credit card or similar billing arrangement s should be claimed on your travel voucher if a receipt is available at the time of voucher preparation. Otherwise, a follow-up petty cash voucher should be submitted, supported by a copy of your itemized phone bill, and certification the charge was for official government business.

Calls To Residence - FDA has established the following guidelines under which an employee in travel status for more than one night within the U.S. may be reimbursed for telephone calls home:

1. Calls should be made as economically as possible.
2. Calls should be made on the FTS network when possible. If not possible, calls should be made using your government-issued calling card. Telephone calls made with government-issued calling cards are automatically billed to the FDA. You are reimbursed through the voucher system when a surcharge is imposed for credit card calls from the traveler's motel/hotel room. Refer to Staff Manual Guide 2343.2 to determine the maximum allowable reimbursement for telephone calls home.

Districts that have differing union-negotiated agreements regarding telephone calls home while in travel status should be guided by those agreements.

119 - ITINERARIES

Since situations arise which necessitate contacting you while in travel status, provide your supervisor with a travel itinerary listing where and how you can be reached.