FDA Approved Travel Expenses For In-kind Support

Transcription

1 SMG FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION FINANCIAL MANAGEMENT TRAVEL ACCEPTANCE OF PAYMENT FOR TRAVEL EXPENSES FROM NON- FEDERAL SOURCES 1. PURPOSE Effective Date: 09/16/ Purpose 2. Definitions 3. References 4. Policy 5. Responsibilities 6. Procedures 7. Effective Date 8. History This guide defines the policy and procedures of the Food and Drug Administration with respect to acceptance of monetary payment or services in-kind from non-federal sources to defray, in whole or in part, travel or related expenses. It applies to all officers and employees of the FDA, both civilian and commissioned corps. Two types of employee travel are authorized within FDA: travel funded by FDA and travel paid for by a non-federal entity. Travel funded by both the FDA and a non-federal entity is processed in the GovTrip Travel System. 2. DEFINITIONS A. Non-Federal Sources. Refers to any organization, association, corporation, individual, or any governmental unit other than the Federal Government. B. Payment-Is defined as a monetary payment from a non-federal source to a Federal agency for travel, subsistence, related expenses by check or other monetary instrument payable to the Federal agency or payment in kind. SMG (09/16/2008) 1

2 C. Services in-kind. Represents transportation, meals, lodgings, and other items related to travel, or to prepaid tickets or paid bills, including registration fees, for such travel and related expenses provided by a non- Federal source. Payment in kind also includes waiver of any fees that a non-federal source normally collects from meeting attendees (e.g. registration fees). 3. REFERENCES A. Legislative. Acceptance of payment from a non-federal source for travel, subsistence, and travel related expenses is derived from the following legislative authorities U.S.C.1353 provides authority for HHS to accept payment (or authorize an employee to accept such payment on its behalf) from a non-federal source for: a. Travel, subsistence and related travel expenses in connection with attendance at meetings and similar functions relating to the official duties of the employee; b. Acceptance of travel payments for an accompanying spouse in some circumstances: and c. Acceptance of additional expenses when specific conditions are met in accordance with FTR ; Provided that source is not disqualified due to a conflict of interest under FTR U.S.C provides authority for HHS to accept payment from non-federal sources for travel expenses in connection with performing advisory services related to HHS functions or activities U.S.C provides authority for employees and members of an employee s family and household to accept gifts of travel expenses for travel taking place entirely outside of the United States when the donor of the gift is a foreign government (including international and multinational organizations). Acceptance under this authority must be consistent with the interests of the United States, and the appropriate authorizing official must approve the travel, even when the employee travels in his/her private capacity on non-official time. "To the extent and under the conditions provided by regulations of the Secretary, officers (including commissioned officers of the Public Health Service) and employees of the Department of Health and SMG (09/16/2008) 2

3 Human Services may hereafter, in connection with their attendance at meetings, or in performing advisory services concerned with the functions or activities of the Department, be permitted to accept payment, in cash or in kind, from non-federal agencies, organizations, and individuals, for travel and subsistence expenses, to be retained by them to cover the cost thereof or deposited to the credit of the appropriation from which the cost thereof is paid, as may be provided in such regulations." B. Regulatory. DHHS Travel Manual, Chapter 1-70, and Office of Government Ethics Standards of Ethical Conduct 5 CFR 2635 Subpart B. 4. POLICY A. The acceptance of cash or in kind support from outside sources for travel should be the exception and not the rule. The underlying principle of the Department is that if an employee's participation warrants the expenditure of official time, it also warrants the expenditure of DHHS travel funds. Employees shall not solicit the payment of travel expenses from nonfederal sources; indications of solicitation of support may result in denial of an offer of support that might otherwise be acceptable. B. Acceptance of travel funding in cash or in kind will not be accepted in any circumstances where there is the potential for real or perceived conflict of interest. Such circumstances include, but are not limited to, the following: 1. if the proposed sponsor is an FDA regulated firm such as a drug or device manufacturer, food processor or retail grocery chain, or a trade association of such regulated firms. (In the case of foreign firms or trade associations that may represent them, reimbursement may not be accepted, even if the firms do not currently ship regulated products to the U.S.); 2. if the sponsor has submitted a New Drug Application to the Food and Drug Administration; 3. if the non-federal source is engaged in ANY lobbying activities; 4. if the sponsoring organization receives more than 10% of their annual operating income from a corporate source; 5. if the sponsoring organization receives funds from the regulated industry or trade associations: SMG (09/16/2008) 3

4 6. if the sponsoring organization receives federal grant or funds received from a contract or cooperative agreement with the FDA or other DHHS components: 7. if the traveler's Center has a contract, grant, or cooperative agreement with the sponsoring organization; 8. if the employee is an officer, board-member, trustee, or employee of the sponsoring organization; or 9. if any other situation exists that could be perceived as resulting in a conflict of interest. Responsibility for this judgment should be shared initially by the traveler, his or her supervisor, and the travel authorizing authority. Any judgment should be on the side of caution so that even the appearance of any impropriety or potential impropriety is avoided. C. FDA policy allows for the acceptance of in-kind travel support, such as hotel accommodations, meals, or airline tickets. In addition, FDA also allows for the prepayment of travel expenses by the sponsoring organization in the form of a check made payable to the Food and Drug Administration. D. An organization volunteering to pay all or part of an employee's travel cost must assure that it does not put the employee in a difficult situation by contributing to the costs of accommodations other than paying for approved travel expenses in accordance with stated DHHS Travel Regulations.. Sponsors are required to include two standard statements in the letter of invitation as well as in the FDA Sponsor Certification Form. If these assurances are not in these two documents, they must nonetheless be made by the sponsor and documented in some way before the offer can be considered for acceptance. If an employee believes that an organization has attempted to make unapproved contributions to defray travel expenses, the situation should be reported to the employee's supervisor and to the employee s designated Agency Ethics Official. E. Employees who give speeches or participate in conferences in their official capacity are considered to be on duty for those purposes and are prohibited by federal law from accepting any fee or honorarium or anything of monetary value in connection with their participation in the event. F. Employees may not accept travel expenses for a spouse or member of their family to accompany the employee on the travel, or retain cash in excess of actual expenses. G. Acceptance of payment in cash or in-kind services must be authorized in writing in advance by the center/office designee on a properly completed SMG (09/16/2008) 4

5 Form HHS 348. In every possible instance, the prior approval procedures for this type of travel will include a determination of expected costs. (Allowance will be made for any reasonable cost deviations or for any unexpected or unavoidable occurrences or rearrangements beyond the control of the traveler.) H. The restrictions set forth in this section do not include food, refreshments, and materials furnished to all attendees as an integral part of the event. (5 CFR ). 5. RESPONSIBILITIES In FDA the Center/Office Designated Approving Official has the authority to authorize or approve acceptance of cash or services in-kind from non-federal sources. 6. PROCEDURES Acceptance of funding from a non-federal source, after-the-fact, is prohibited by the Food and Drug Administration. A sponsor providing funding or airline tickets in advance of the travel MUST be approved prior to departure. The following documents will be submitted by the employee s Center or Office for review in advance of travel. Please check with your Center/Office for the appropriate time frames for submittal. 1. Form HHS-348 (Request and Approval for Acceptance of Travel Expenses in Cash or in Kind Including Background Information Sheet). Spaces 1 through 10 must be completed on the HHS-348, via the GovTrip Travel System. The Center/Office Designated Approving Official has on-line signature authority in the GovTrip Travel System to approve the HHS-348 form. The Background Information Sheet (now referred to as the Ethics Checklist) must also be completed as part of the HHS-348 approval process and will be completed through GovTrip. Upon return from TDY, the employee will complete section 11 of the HHS-348 Form in GovTrip in order to certify if any expenses were received from the sponsoring organization. 2. Letter of Invitation - from the sponsoring organization offering to fund all or part of the expenses of the employee concerned. The letter of invitation and the FDA Sponsor Certification Form should contain the following standard paragraphs. Our organization does not receive any federal grants or contracts with the Department of Health and Human Services, or from the regulated SMG (09/16/2008) 5

6 industry or trade associations. We are not an FDA regulated industry nor is our organization a Trade Association. Any room charges that are arranged for FDA employees by our organization will not be less that the hotel would normally charge to the traveling public, with the sole exception of volume discounts made available to us by the hotel. Our organization will not otherwise arrange for or make any additional payments to the hotel to defray room costs for FDA employees. 3. Sponsor Certification This form should include the standard paragraphs mentioned above as well as answers to all questions indicated on the form. In addition, the Sponsor Certification Form must be signed and dated by a representative from the non-federal entity. The Sponsor Certification Form does not have to be completed when the sponsoring organization is the World Health Organization (W.H.O.), the Pan American Health Organization (P.A.H.O.), or the Food and Agriculture Organization (F.A.O.). 4. GovTrip Authorization a. The Authorization should indicate what portion of the expenses of the trip are to be paid by the sponsoring organization the estimated costs will be designated on the form. 5. Letter of Acceptance a. A letter of acceptance must be prepared setting forth the terms of agreement for the signature of the center/office designee. In no event will the letter of acceptance be released before the request for payment in cash or kind (HHS-348) has been approved. A letter of acceptance is not required when the sponsoring organization is W.H.O., P.A.H.O. or F.A.O. b. The acceptance letter must always include as an attachment "General Information About FDA Employees Who Attend, Participate In and Speak At Non-Federal Meetings, Conferences and Symposiums". If an honorarium has been offered in the letter of invitation, the letter of acceptance must state the following "Your offer of an honorarium of $ is greatly appreciated, however, agency policy does not allow the acceptance of an honorarium by our employees." c. For additional information pertaining to honorariums, please contact your center/office ethics representative. SMG (09/16/2008) 6

7 Performance of Travel. Travel will be performed in accordance with the Standard Government Travel Regulations (Civilian) or the Joint Travel Regulations (Commissioned Corps), and the DHHS Travel Manual. Leave in Conjuction with Sponsored Travel. FDA employees are not permitted to take annual leave in conjunction with any trips that are sponsored, in whole or in part, by non-federal sources. This includes domestic, non-foreign, and/or foreign travel. Reports. At the conclusion of each trip the traveler shall access the HHS-348 form through the GovTrip Travel System in order to complete the HHS-348 form. Item number 11 on the form must be certified and signed by the traveler. Advances. When requested must be in accordance with applicable GSA/DHHS Travel Regulations. Travel Voucher 1. In accordance with DHHS Travel Regulations, the traveler must always complete and submit a travel voucher via the GovTrip Travel System within five working days of the completion of the trip. If a prepayment check from the sponsoring organization has been deposited by the FDA, then the traveler will be paid by FDA in accordance with applicable travel regulations. 2. In those circumstances when reimbursement of the sponsoring organization is authorized for services in-kind, and no part of the cost is to be paid by FDA, the traveler will submit a no-expense voucher via the GovTrip Travel System. When the payment or service in kind does not include all allowable expenses, an expense voucher will be submitted with appropriate reductions in per diem or other travel expenses depending upon the extent of the reimbursement by the sponsoring organization. 7. EFFECTIVE DATE This issuance is effective September 16, STATUS (I, R, C) 8. Document History -- SMG , Acceptance of Payment for Travel Expenses from Non-Federal Sources DATE APPROVED LOCATION OF CHANGE HISTORY CONTACT APPROVING OFFICIAL Initial 09/16/2008 N/a OC/OM/OFM John P. Gentile, Associate Commissioner for Operations SMG (09/16/2008) 7