DRAFT MOU FDA -MEDDATA FOUNDATION

MEMORANDUM OF UNDERSTANDING BETWEEN U.S. FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, and MEDDATA Foundation (each a "Party" and collectively the "Parties")

 I. Purpose

 This Memorandum of Understanding (MOU) defines the framework in which the Food and Drug Administration (FDA) will provide publicly available content to be used in health professional informational, educational, and training programs that will be run by MedDATA Foundation on the IRAI platform (the FDA Information Repository for Academic Institutions) and for other public educational purposes.

 MedDATA Foundation is a not for profit foundation which has just completed a contract with FDA to provide an improved platform for browsing and searching all information on the FDA website (http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm455476.htm) and other government website relevant to products regulated by FDA. This collaboration will enhance FDA’s capacity to educate a wide range of stakeholders, and communicate additional information on policies and procedures to assure the safety and efficacy of products FDA regulates.

 II. Background radiation; and tobacco products are labeled and marketed in accordance with applicable statutes and regulations.

 The FDA is also responsible for advancing the public health. FDA’s continued efforts helps the public access the accurate, science-based information they need to use FDA-regulated products to make informed decisions relating to their own health ("FDA Health Information").

 Through IRAI we have made available a better search engine, organized all the information of FDA on www.fda.gov and added text narratives of the Congressional Research Service (CRS) prepared for Congressmen and their staff describing FDA functions; proposed and final legislative amendments; a full copy of 21 USC (the Food Drug and Cosmetic Act); Public Health Statues; relevant NIH regulations and procedures; transcripts of Audio Visual presentations; and provided for additional information from other non-profit organizations relevant to the education prospective and current health professionals in FDA matters. In effect, we are creating an enhanced one stop and shop site on FDA regulatory matters.

 Through this collaboration we will be adding, on a routine basis, additional FDA related information and documents which would otherwise only be available under the Freedom of Information Act and are not on the FDA website, including letters, EIR inspection summary table (if not all EIRs), inspection reports, courseware and other materials already disseminated to others in response to FOIA requests.

 III. Authority

 FDA has authority to provide information to the public pursuant to section 705(b) and section 903(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 3 75(b) and 393(d)(2)(D).

 IV. Substance of Understanding

 FDA and MedDATA will routinely work together, as applicable, depending on the nature of the services being developed, to deliver and share content, to facilitate the dissemination of FDA Health Information. As part of this effort, FDA and MedDATA will identify FDA public health and product alerts, guidance, service descriptions and educational programs for healthcare providers.

 V. General Provisions

 A. This MOU does not grant exclusivity to either Party, nor does it restrict FDA from participating in similar initiatives with other public or private agencies, organizations or individuals.

 B. All materials and programming produced pursuant to this collaboration must be accessible by and free of cost to the general public on a MedDATA website.

 C. All activities within the scope of this MOU must comply with section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998, Pub. L. No. 105-220, Aug. 7, 1998 (see U.S. Department of Health and Human Services policy on section 508 compliance at http://ww.hhs.gov/od/5 08policy/index/html; and Office of Management and Budget policies for protecting private information at www.usa.gov/webcontent/reqsbestpractices/lawsregs/prjvacy/shtml),

 D. Both parties agree that content provided to MedDATA by FDA in connection with the collaboration shall be public domain material and as such, FDA shall have full rights to reuse any and all Agency records for any purpose, including the right to share with other collaborators or requestors.

 E. MedDATA agrees to maintain current FDA Information within IRAI. Information that MedDATA is informed has been superseded or is replaced will be noted as such or placed in an archive file.

 VI. Resource Obligations:

 All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA, and MedDATA must operate.

 FDA under this agreement shall provide on a weekly basis the following items in PDF format with proper document properties:

           The FOI Log weekly.

          Copies of all FOI requests, in redacted form if necessary

          Copies of all documents released under FOI if they are releasable to the general public.

          All refusal or “denial” letters to release requested documents

 All documents provided to MedDATA will be posted within IRAI.

 All documents provided to MedDATA will be free of any fee in accordance with FOIA policy under this special circumstance.

 FDA will review with MedDATA Foundation the content of internal FDA information that may be identified as available under FOI for release. If necessary to conduct such a review, an employee of MedDATA Foundation shall be designated as a Special Employee of FDA and subject to all applicable confidentiality requirements and sanctions.

 FDA and MedDATA shall review previously requested documents under FOIA and MedDATA will request and receive copies of selected documents for inclusion with IRAI.

 MedDATA will remove any document that FDA is required to retract due to error or mishandling.

 VII. CONTACT POINTS

 A. Food and Drug Administration

 B. MedDATA FOUNDATION

 VIII.  LIMITATIONS ON LIABILITY

 In no event will any party hereto be liable to the other under any theory of liability, however arising, for any costs or cover or for indirect, special, incidental, or consequential damages of any kind arising out of this MOU. The provision shall survive termination, cancellation or expiration of this MOU for any reason whatsoever.

 IX. Term,

Termination, and Modification: This MOU, when accepted by all Parties, will have an effective period of performance from the date of the latest signature until terminated. By signing below, the Parties accept the conditions that accurately represent the understanding reached between them.