Memorandum of Understanding
The United States Department of Health and Human Services
Food and Drug Administration
The Food and Drug Administration Alumni Association, Inc.
Agree to Co-sponsor FDA's 2006 Centennial Observance
According to the Terms Expressed Below:
This agreement is between the U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA), and the Food and Drug Administration Alumni Association, Inc. (FDAAA) -- Taxpayer Identification Number 41-2051166. This agreement sets forth the responsibilities of each party in the cosponsorship of FDA's 2006 Centennial Observance.
FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and help the public get accurate, science-based information they need to use medicines and foods to improve their health.
The FDAAA is an incorporated 501(3)(c) educational public service organization dedicated to supporting the mission of the FDA and to advancing its goals of protecting and promoting the public health.
The FDA and the FDAAA have common interests in collaborating various programs and materials for FDA's 2006 Centennial Observation. Through this collaboration, FDA and FDAAA shall:
1. Broaden public awareness of FDA's services and programs toward increasing public appreciation of FDA's impact on public health and safety by commemorating the first 100 years of contributions to health in America and the worldwide community;
2. Inspire next generation of science, innovation and public health and strengthen FDA capacity to meet future challenges;
3. Salute contributions of FDA employees, legislators, academicians, industry, advocacy groups and public health leaders who support FDA's mission; and
Responsibilities for Developing the Event
FDA and FDAAA agree to collaborate on developing various events in celebration of FDA's 2006 Centennial Observances related to the mission of FDA. FDAAA may independently sponsor portions of the Centennial Observance. FDA appropriations, including staff, shall not be used to develop, promote or support any portion of independently supported events. Official announcements and brochures associated with those events may contain factual references to the schedule of the entire event, including portions supported by private donors.
Registration Fees and Other Charges
FDAAA shall not charge fees that exceed a minimal amount needed to pay the estimated direct costs for portions of FDAAA Centennial Observance commitments. FDAAA intends to sell educational materials about the Centennial. All educational materials, transcript, recordings of the events shall be sold at cost to defray FDAAA's costs of the Centennial Observance.
In all FDAAA solicitations to private donors, FDAAA shall make clear to all private donors that FDA is not asking for any funds in any FDAAA solicitation for funds to cover its share of the Centennial Observance costs. FDAAA shall not imply that FDA endorses any FDAAA fund-raising for the Centennial Observance. FDAAA will make clear to donors that donations shall be applied exclusively toward defraying the expenses of FDAAA's Centennial Observance commitments and not FDA's.
FDAAA shall not use the event mainly as a way to sell or promote products or services. FDAAA shall ensure that any incidental promotions do not imply that FDA endorses FDAAA's private actions or messages. FDAAA shall make reasonable efforts, subject to FDA review, to separate any incidental promotions from the approved Centennial programs, events and materials. Donors who are public officials or candidates for public office will not include political comment as part of their participation. Donors who have a preexisting business relation with FDA shall understand that cosponsoring Centennial Observance and materials create no special consideration by FDA on any other matter. Prospective donors that would provide funding only for an event, as well as prospective donors that do not have a demonstrable substantive interest in the Centennial Observance are excluded.
All Centennial Observance materials bearing the FDA name, logo or HHS Seal must display the authorization number, be approved in advance by FDA and contain the following statements: (1) "FDA's participation in this cosponsorship is not an approval of the views, opinions, products or services of any cosponsor or other person or entity." (2) "All FDA programs or cosponsored programs are extended the public on a nondiscriminatory basis." (3) "Reasonable arrangements for anyone with disabilities shall be made if requested at least 2 weeks in advance."
Centennial Observance material may include publications that contain both information, the income from which is used to defray the cost of production of materials and events. FDAAA is responsible for: 1) soliciting any advertisement, 2) general layout and event preparations, 3) collection of advertising fees, and 4) payment of all production expenses. FDAAA may not receive or benefit from any funds associated with advertisements or production of the Centennial Observance. FDAAA must avoid advertising solicitations from organizations focused on gaming, alcoholic beverage, and tobacco. FDAAA shall not use the FDA name to imply that FDA endorses products or services of any entity. FDA may help compile information, prepare articles and distribute publications.
Event Publicity and Endorsements
FDA requires appropriate recognition for its cosponsorship of Centennial Observance and educational material used or distributed. Within reasonable discretion, FDA retains the right to decide what forms appropriate recognition. FDAAA will not use the name of FDA, except in factual publicity for the Centennial Observance and materials. Factual publicity includes dates, times, locations, purposes, agendas, fees, and speakers involved with the Centennial Observance. Such factual publicity shall not imply FDA's endorsement of any of the opinions, products or services of any donor. There will be no unnecessary promotion of any of the products or services of FDAAA, donor, or contractor involved in FDA's Centennial Observance. Where confusion could result, a disclaimer should clearly state that no endorsement is intended. FDAAA will clear all publicity materials for the event with FDA to ensure compliance with this paragraph.
FDA and FDAAA shall record, account fully and accurately for the 2006 Centennial Observance financial commitments and expenses. Such records shall reflect, at a minimum, the amounts, sources, and uses of all funds. This co-sponsorship agreement, as well as the financial records shall be publicly available.
This agreement can only be amended in writing, and all parties to this agreement who are affected by it must agree to any amendment.
Effect and Termination
This agreement is effective on the date of approval and will continue until close of business on February 28, 2007. Any party may terminate its participation in the cosponsorship on written notice to the other parties. Such termination will not require changes to materials already produced, and will not entitle the terminating party to a return of funds or property contributed. If FDA withdraws from the cosponsorship because of a violation of this agreement by FDAAA or any donor, it reserves the rights to give appropriate notice to the public.
Associate Commissioner for External Relations
Chair, FDA Steering Committee
James S. Benson, Chair
Food and Drug Administration Alumni Association, Inc.
Ad hoc Committee on the FDA Centennial
FDA and FDAAA will comply with the legal memorandum of August 8, 2002, entitled "Co-Sponsorship Guidance," issued by the HHS Designated Agency Ethics Official. See attachment.
Each person approving this agreement is sanctioned to enter this agreement on behalf their respective organization. Except as properly amended, this agreement is the final and complete agreement of the FDA and FDAAA.
Approved and Accepted
Signed by: John Villforth
Date: July 28, 2004
Approved and Accepted
Signed by: Lester M. Crawford, D.V.M., Ph.D.
Date: July 22, 2004