MEMORANDUM OF UNDERSTANDING (MOU)
Public Health Communications, LLC
Food and Drug Administration
This Memorandum of Understanding (MOU) is made and entered into by and among Public Health Communications, LLC, through its operating division Public Health Television (PHTv), and the Food and Drug Administration (FDA).
While not creating any legal rights or legal responsibilities, the purpose of this MOU is to establish a general framework for cooperation between PHTv and FDA, and to set forth the terms and understanding between the parties regarding activities related to improving the health, safety, and well-being of America.
The parties share common priorities and interests, including but not limited to the effective dissemination of information that increases public awareness and understanding of food and medical product safety and the risks of tobacco products. Each organization has unique competencies through which it addresses these goals and, by collaborating, aims to build on these competencies in areas of mutually beneficial interest.
The 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, and by regulating the manufacture, marketing, and distribution of tobacco products.
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 helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health.
PHTv is a private media network that uses Internet Protocol Television (IPTV) technology to reach underserved populations with targeted culturally and linguistically appropriate programming that can advance positive health and social outcomes. PHTv is a digital television service that is delivered via the internet rather than through traditional broadcast and cable formats, allowing programming content to be uniquely targeted and delivered to every screen in the network individually. PHTv will be installed at the point of care, in the reception areas of federally qualified health centers (FQHCs), rural health clinics (RHCs), and critical access hospitals (CABs) nationwide. These providers play a critical role in the health care system by providing affordable, high-quality, and comprehensive primary care services to medically underserved populations. With more than 9,000 facilities nationwide, FQHCs and RHCs are the health care home to more than 25 million people, producing positive results for patients and the communities the centers and clinics serve. PHTv will effectively reach and engage society's most vulnerable and underserved populations with culturally sensitive disease management, wellness, lifestyle, and public awareness programming that can improve outcomes and ultimately reduce health care spending.
FDA has authority to provide information to the public pursuant to section 705(b) and section 1002(d)(2)(D) of the Federal, Food, Drug, and Cosmetic Action, 21 U.S.C. section 375(b) and 393(d)(2)(D).
FDA and PHTv are collaborating to raise awareness and use of science-based information that helps the public make better informed health care decisions.
III. STATEMENT OF MUTUAL INTEREST AND MUTUAL BENEFIT
The overall objective of this agreement is to use the network developed by PHTv to increase access to FDA-produced content by expanding the reach and scope of its delivery channels. It will also measure the reach and effectiveness of the communications. The contributions and intent of all parties is to improve the health of our communities and our Nation.
The parties intend to accomplish their goals through the collaborative activities noted below.
FDA will participate, as deemed appropriate by FDA, in mutually beneficial joint efforts to disseminate culturally sensitive, targeted health education, public awareness, and wellness programming;
PHTv to the extent possible, disseminate FDA printed materials to PHTv sites, and
a. Review and respond to programming plans and other uses of FDA material in a timely and efficient manner.
b. Provide a media delivery mechanism for existing and newly developed FDA consumer health information programming and activities, and
c. Identify FDA as a content dissemination partner on its Web site.
All material developed with FDA and/or containing references to FDA will be submitted to FDA for review and approval before allowing it to be shown through the PHTV network.
As a Federal regulatory agency, FDA cannot appear to endorse or promote any private entity or product. PHTv generally updates its programming across the network on a monthly basis. PHTv will provide FDA with the PHTv programming schedule for the upcoming month no less than ten (10) business days prior to airing to allow FDA to monitor the programming plans for other content that is scheduled to be playing adjacent to FDA related materials so as to avoid implied endorsement of commercial products through proximity placement of taxpayer-funded resources in advertisements, solicitations, or promotions by pharmaceutical companies, device makers, health plans, or other for-profit ventures. FDA will be provided ten (10) business days from the date it receives the monthly PHTv programming schedule to identify any issues in the programming as it relates to any implied endorsement as noted above. Upon notification from FDA PHTv will make modifications to its programming schedule as needed. If notification is not received by PHTv, programming will air as scheduled. If FDA provides notification past the outlined deadlines noted herein, then PHTv will make modifications as soon as practicable and reasonable.
Both organizations, to the extent possible, will include minority, limited-English proficient and disabled populations in the implementation of each of the goals of the collaboration.
IV. MEETINGS AND REPORTING
Upon agreement of both parties, regular quarterly meetings (by conference call) may be held.
Authorized officials of each organization will evaluate and report on the effectiveness and outcomes of this relationship annually. This activity will be based on mutually agreed upon criteria in order to establish the future direction of the collaboration.
PHTv will make clear, in any solicitation or fundraising activities that PHTv, not FDA, is asking for the funds. PHTv will not identify FDA or use its name, logo, website links, or any identifying material in fundraising or solicitation efforts. Nor will PHTv imply that FDA or any related agency endorses any fundraising or solicitation activities. PHTv will make clear to donors that any gift will go solely toward defraying the expenses of PHTv only, without mention of FDA or any related agency.
VI. PUBLICITY AND ENDORSEMENTS
PHTv will not use the name of FDA, or any component centers, offices, or programs, in any marketing, publicity, outreach, products, or other activity without the prior consent and approval of FDA. PHTv cannot imply the involvement or endorsement of FDA in any type of publicity, marketing, products, outreach, or other activities, either virtual or real. PHTv will clear all materials related to the activities of this MOU with FDA to ensure compliance with this paragraph. PHTv will not use the name, logos, or seals of FDA or any of its component centers, offices, or programs without prior written approval from FDA or designated agency contacts to ensure compliance with FDA and its component centers, offices, and programs' trademark and logo use policies.
No funding is attached to this agreement. Each party is expected to bear the costs of its participation in this project. Nothing in this MOU shall be deemed to be a commitment or obligation of Federal funds to any current or future expenditure in advance of the availability of appropriations from Congress or shall obligate FDA or its component centers, offices, or programs to enter into any contract with other obligations.
VIII. INTELLECTUAL PROPERTY
This MOU does not, and is not intended to transfer to either party any rights in any intellectual property of the other party. The parties agree that the material provided by FDA is in the public domain unless otherwise indicated. FDA-developed materials cannot be altered without prior review and approval of the Agency. FDA shall maintain full rights to reuse the content and material that it provides for any and all FDA purposes, and/or to share with other collaborators or requestors. Per mutual agreement between PHTv and FDA, PHTv grants full permission and a royalty-free, nonexclusive, irrevocable license to FDA and its component centers, offices, and programs to use, reproduce, publish, distribute, and exhibit materials that may arise from the activities of this MOU for use in education, training, and other purposes consistent with FDA's mission.
IX. GOVERNING LAW
This MOU shall be governed by applicable Federal law.
This MOU is nonbinding and is not intended to, does not, and may not be relied upon to create a right or benefit, substantive or procedural, enforceable by law by a party against the United States. This MOU in no way restricts PHTv or FDA from participating in similar activities or arrangements with other public, private, or nonprofit entities. Any information shared among the parties pursuant to this MOU will be in the public domain unless exempt from disclosure under the Freedom of Information Act, 5 U.S.C 552, or other applicable Federal statutes or regulations. This MOU shall be publicly available.
This MOU is at-will and may be modified by mutual written consent of authorized officials of the parties. This MOU shall become effective upon the date of the last signatory to this MOU and will remain in effect until modified or terminated by any authorized official from the parties in writing, by mutual written consent of authorized officials from the parties to continue further this collaborative effort, or upon 14-days prior written notice. In the event this MOU is terminated by FDA, all references to FDA will be removed from electronic web sites, notices, e-mails, postings, and any other electronic conveyance within 7 days, and removed from printed materials and any other materials as soon as possible. In the absence of a mutual written agreement by authorized officials from the parties to continue further this MOU, this MOU shall end on
September 1, 2014.
Chief Executive Officer
Public Health Communications, LLC
1801 S. Federal Highway, Suite 210
Delray Beach, FL 33483
Jason D. Brodsky
Consumer Health Information Staff
Office of External Relations
Food and Drug Administration
Building 32, Room 5378
10903 New Hampshire Avenue
Silver Spring, MD 20993
APPROVED AND ACCEPTED FOR PUBLIC HEALTH COMMUNICATIONS
Signed by: Bryan Carmody
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Signed by: Lawrence L. Bachorik, Ph.D.