MEMORANDUM OF UNDERSTANDING
THE FOOD AND DRUG ADMINISTRATION
THE HEALTHCENTRAL NETWORK, INC.
I. PURPOSE, GOALS AND DEFINITIONS
This Memorandum of Understanding (“MOU”) establishes a cooperative public education program between two entities (individually a Party -- collectively the Parties): The Food and Drug Administration (FDA), Office of External Relations (OER), Consumer Health Information Staff and The HealthCentral Network Inc., the operator of a network of health, diet and fitness websites (“HealthCentral”).
The purpose of the cooperative program is to:
- extend the reach of FDA Consumer Health Information; and
- provide consumers with better information and timely content concerning public health and safety topics, including emerging safety issues and product recalls.
The “Program” means a public health education program intended to provide practical wellness and prevention tips and the latest safety information on websites, mobile websites and other electronic means of distribution (including electronic newsletters) but solely to the extent that the FDA Materials are agreed upon by the parties (as provided in Section IV) and delivered to the public under the brands of the FDA and HealthCentral (as provided in Section III, co-branding). The Program includes promotional modules and banners used by HealthCentral to drive traffic to the Program Pages.
“Program Pages” mean electronic newsletters and any web pages that contain FDA and HealthCentral co-branding in the header. For the avoidance of doubt, the parties state that the following are specifically excluded from the definition of Program Pages: any page on which the only FDA Materials are promotional modules that contain an FDA logo.
“FDA Materials” mean the audio and video files, photos or other editorial materials provided by FDA for publication as part of the Program.
This MOU is authorized pursuant to section 903 of the Food, Drug and Cosmetic Act (21 USC 393(d) (2)).
The Parties have entered into this Agreement in mutual recognition of the need to empower consumers with health information they can apply in everyday life.
This MOU meets the requirements set forth in FDA’s policy statement on co-branding of FDA Consumer Health Information, which is available online at www.fda.gov/ForConsumers/ucm126390.htm.
FDA and HealthCentral recognize that this agreement is not intended, and may not be relied on, to create any right or benefit, substantive or procedural, enforceable by law by any party against the United States or against HealthCentral.
IV. PROGRAM COMPONENTS AND ACTIVITIES
The components and activities of the Program are expected to increase FDA’s capacity to disseminate time-sensitive public health information and to engage the public. The cooperative public education program will include the following components:
- An FDA/HealthCentral joint online resource on the Healthcentral.com site which will feature FDA Consumer Health Information including but not limited to articles, videos, photo slideshows and other editorial material. Except as provided in Editorial Control Section below re Direct from the FDA Alert modules, the parties will mutually agree to the type and exact items of content made available through the Program Pages. As a general matter, it is the current expectation of the parties that the Program will feature a minimum of 50 items of FDA content and provide users with access to the agency’s catalog of Consumer Updates. Each Program Page will include a link to a tagline to be agreed upon by the parties, that describes the relationship between the FDA and HealthCentral. For example, and for illustration purposes only, “This special section is published by HealthCentral in coordination with the U.S. Food and Drug Administration as part of a public health education program. Unless otherwise indicated, the content is created by the FDA and selected for publication by the HealthCentral editorial team. The FDA content is not edited by HealthCentral and is under the sole editorial control of the FDA. Content labeled DIRECT FROM THE FDA is both created and selected by the FDA without modification by HealthCentral.”
- An FDA logo module / link to be included in applicable HealthCentral newsletters and index pages which will link to the latest, relevant FDA Consumer Health Information on Program Pages. HealthCentral will also include the logo modules in existing HealthCentral index pages and newsletters as new FDA Consumer Health Information that is relevant to the HealthCentral newsletters and index pages is added to the Program Pages. The text of the logo module will be tailored to the specific FDA Consumer Health Information that is relevant to the topic of the HealthCetnral newsletter and index page in which the module is included.
- In addition, FDA and HealthCentral will work together to extend the reach of FDA Consumer Health Information and to engage the public within the HealthCentral online community and HealthCentral will include links to the Program Pages from relevant pages of the HealthCentral sites. A process for implementing community activities is to be mutually developed and agreed to by both parties.
- Editorial Control. Standard Process. It is the intent of the Parties that the Program will operate as follows: (a) the FDA will provide the FDA Materials to HealthCentral in a format and schedule to be agreed upon by the parties; (b) HealthCentral may, at its discretion, publish or not publish the FDA Materials within the Program after consultation with the FDA as part of a periodic editorial meeting; and (c) when HealthCentral publishes the FDA Materials, it will do so without editing the FDA Materials and will display the FDA Materials in conformance with the co-branding requirements set forth in Section III. Special Process. In the event that HealthCentral elects not to publish certain FDA Materials that the FDA believes are Critical to disseminate to the public, HealthCentral will publish such FDA Materials in a standard size module on the Program landing page. This special process will occur no more than eight times per month; the FDA Materials will consist of teasers that link back to the FDA Website and will meet the technical specifications agreed upon by the parties (e.g., character limitations). “Critical” means issues related to major product recalls or withdrawals, safety issues, a public health emergency/crisis or a major new policy initiative or regulation affecting consumers.
- The parties will make good faith efforts to ensure that the Program is consumer friendly and designed to maximize search engine optimization. The design, look and feel of the Program Pages was developed by HealthCentral and agreed to by the FDA prior to publishing as provided in the Review bullet below.
- Promotion. HealthCentral will promote the Program Pages on HealthCentral’s websites through the use of banners and modules (both alert and promotional).
- Review. The parties have created and completed a process whereby the FDA has reviewed and approved all Program components, activities and program publishing templates (including landing pages, index pages, article pages and modules). For the avoidance of doubt, the parties state that such review has included approval of the program pages publishing template for compliance with Section 508. HealthCentral will publish the Program Pages using only the approved templates in conformance with the process described in the Editorial Control section above. In the event that FDA reviews any Program Page on a post-publication basis and determines that any of the FDA Materials need to corrected or removed, FDA can request changes as provided in Section V(8).
- The parties acknowledge that, based upon the FDA Materials, HealthCentral may deliver email alerts that inform the public of significant public health issues involving food, drug and medical product safety (e.g., major product recalls and public health emergencies). These alerts will be branded with HealthCentral logos and it will be clear to users that any alert is being sent by HealthCentral without association with the FDA (see Section V(1) below). These email alerts may, however, link to Program Pages.
V. TERMS OF THE MOU
1. FDA Materials must be easily distinguishable from non-FDA content within the Program. FDA Materials within the Program should be clearly identified as such. Examples of clearly identifying FDA Materials would be placing this information in a box and/or using a distinct color to distinguish it from non-FDA content, and/or otherwise clearly distinguishing the non-FDA content via an adequate disclaimer statement.
2. FDA Materials that are selected entirely by the FDA and published in modules labeled Direct from the FDA will be distinguished further from the FDA Materials selected by HealthCentral.
3. Printed and online Program Pages must be free of advertisements to avoid implying FDA's endorsement or support for a particular product, service or Web site. For the avoidance of doubt, the parties state that any page which is not a Program Page may contain advertisements.
4. This MOU does not grant exclusivity to either party. Neither party is restricted from participating in similar initiatives with other public or private agencies, organizations or individuals.
5. All activities within the scope of this Agreement must comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 (see HHS policy on Section 508 compliance at http://www.hhs.gov/od/508policy/index.html); and Office of Management and Budget (OMB) policies for protecting private information (see www.usa.gov/webcontent/reqs_bestpractices/laws_regs/privacy.shtml). The parties will cooperate in ensuring compliance with Section 508. All FDA Materials will be provided by the FDA in a manner that is Section 508 ready (e.g., video and audio files will be supplied with closed captions).
6. FDA and HealthCentral will cooperate in the maintenance of each party’s trademarks and logos. Neither party will permit use of its logo for marketing purposes other than to promote the Program. The use of the other party’s names or logos shall not imply any exclusive arrangement. Any use of the other party’s logos must be approved, in advance, by the trademark owner. Use of FDA’s logo must be approved in advance by the FDA’s Consumer Health Information Staff.
7. Both parties agree that the FDA Materials shall be public domain material. FDA shall have full rights to reuse the FDA Materials for all FDA purposes, and the right to share with other collaborators or requestors. Any materials created by HealthCentral based on the FDA Materials will be owned exclusively by HealthCentral. Nothing in this Agreement will prohibit HealthCentral from writing about the FDA or its activities on any page that is not a Program Page and any such writing will not be subject to the approval or review of the FDA.
8. HealthCentral will maintain current FDA Materials within the Program Pages. FDA Materials must be removed from the Program Pages in the following circumstances: (1) within 3 years of the date of its first publication; (2) upon FDA's request in circumstances in which the information becomes outdated; or (3) as soon as commercially practicable after a written request from the FDA for any reason with the expectation that the requested material will be removed within 72 hours after receipt of a written request from FDA, regardless of reason. HealthCentral’s failure to display current FDA Consumer Health Information may result in the termination of this Agreement. In addition, no more than once each quarter, HealthCentral will adhere to any written FDA request to revise FDA Materials published within the Program Pages to the extent that FDA believes such information is now incorrect, inaccurate or misleading. HealthCentral will use reasonable commercial efforts to comply with FDA requests for modifications within five business days.
9. Except for the limited permission to use content and logos discussed herein, this Agreement does not and is not intended to transfer to either party any rights in any technology or intellectual property.
The FDA website will contain links that transport visitors to the Program landing page. It is the intent of the parties that the links from the co-branded modules will link to Program Pages. At its discretion, HealthCentral may link directly to relevant information on the FDA website.
FDA will not provide HealthCentral access to any document or information to the extent that providing such access would place either party in breach of the Trade Secrets Act, codified at 18 U.S.C. sec. 1905; the Privacy Act, codified at 5 U.S.C. sec. 552a; the Food, Drug, and Cosmetic Act, codified at 21 U.S.C. sec. 301, et seq (particularly 21 U.S.C. sec. 331(j)); FDA regulations (21 Code of Federal Regulations (CFR)); or any other Federal law or regulation.
VII. LIAISON OFFICERS
Director, Consumer Health Information Staff
Office of External Relations
U.S. Food and Drug Administration
5600 Fishers Lane, Room 15A-29
Rockville, Maryland 20857
Vice President of Content Development
2300 Wilson Boulevard, Suite 600
Arlington, VA 22201
Each Party shall appoint a representative who shall act as the liaisons between such party and the other party’s representative. A party may update its representative upon written notice to the other party.
VIII. LENGTH OF THE AGREEMENT AND ASSESSMENT MECHANISMS
This MOU will be effective for three years from the date of signature by the later Party to sign it. At the end of each year, and annually thereafter, as long as the Agreement remains in force, the Parties will evaluate the effectiveness of the Agreement in meeting their goals and may amend the Agreement, continue it as written, or dissolve the Agreement by mutual consent. Either party may terminate the MOU with no less than thirty (30) days notice. Upon termination of this MOU for any reason, HealthCentral will remove the Program Pages and all modules with FDA logos from the Site as soon practicable, but in no event later than thirty (30) from the date of any notice of termination. For the avoidance of doubt, the parties state that this paragraph is intended to address use of the FDA Materials on Program Pages and is not intended to alter HealthCentral’s rights to use public domain FDA Materials on any website, mobile website or other medium except for Program Pages.
IX. NO COMMITMENT OF FUNDS
This MOU sets forth principles and guidelines by which the parties intend to engage in a cooperative public education program. Nothing in this MOU shall be construed to obligate either party to make payments to the other. Each party will be responsible for the costs of its performance hereunder.
X. LIMITATIONS ON LIABILITY
IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER UNDER ANY THEORY OF LIABILITY, HOWEVER ARISING, FOR ANY COSTS OF COVER OR FOR DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF THIS AGREEMENT. The provisions of this Section IX shall survive termination, cancellation or expiration of this MOU for any reason whatsoever.
XI. SIGNATURES OF RESPONSIBLE PARTIES
By signing this agreement, the responsible parties agree to the terms and conditions of this MOU, and they further agree to adhere to FDA’s policy statement on co-branding of FDA Consumer Health Information.
APPROVED AND ACCEPTED FOR THE HEALTHCENTRAL NETWORK,INC. Signed by:Alexander D. Baldwin APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION Signed by:Lawrence L. Bachorik, Ph.D.
Executive Vice President and General Counsel
Date:July 11, 2011
Assistant Commissioner for External Relations
Date: July 29, 2011
APPROVED AND ACCEPTED FOR THE HEALTHCENTRAL NETWORK,INC.
Signed by:Alexander D. Baldwin
APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION
Signed by:Lawrence L. Bachorik, Ph.D.