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MOU 225-07-8008

Memorandum of Understanding

Between
United States Department of Health and Human Services
Food and Drug Aministration
Rockville, Maryland 

and

John Hopkins University
Baltimore, Maryland

 

This Memorandum of Understanding between the U.S. Food and Drug Administration ("FDA")and Johns Hopkins University (the "Parties") is established to develop collaboration in the areas of education, research, and outreach.

 

1. Purpose

The purpose of this Memorandum of Understanding ("MOU") is to establish the framework for a collaborative partnership on mutually agreed activities in the scientific research and education fields.

 

2. Objective

The objectives of this collaborative partnership resulting from this MOU include:

1. Development of a collaborative working relationship between the Parties,
2. Provision of exchange of graduate and undergraduate students, faculty, and personnel, for the purposes of advanced training and outreach,
3. Stimulation of cooperative activities, research, and information exchange in areas such as bioethics,
4. Development of training programs for FDA and potentially other Government agencies and industry in broad scientific areas such as biotechnology and bioethics.
5. Development of a broad-based collaboration in the area of nanotechnology, including, in particular, with the Institute of NanoBioTechnology at the Johns Hopkins University ("INBT": http://inbt.jhu.edu/)

 

3. Program Focus

The MOU is intended as a broad vehicle to promote programmatic interaction in the form of joint collaboration between FDA and Johns Hopkins University researchers, students, and personnel as well as joint development of – projects that are aligned with the respectives missions of the Parties and with benefit to public health.

 

The collaboration may include the following:

Joint exchange programs: These exchanges would include internships, research opportunities, and shadowing opportunities for Johns Hopkins University undergraduate, post-baccalaureate and graduate students at the FDA. Faculty and senior staff of the Parties will be encouraged to participate in tjoint research and training interactions, which may include short or long-term exchanges of staff (e.g. sabbaticals).

Joint research programs: Joint research programs may be formed by scientists from the respective institutions with mutual complementary interests in certain areas such as bioethics.

Joint training activities: Training activities arising from complementary interests may be jointly developed by the Parties.

Joint dissemination of information and outreach: The Parties may disseminate information and enhance the visibility of the work of the collaboration through mutually agreed vehicles including training activities, meetings, and symposia.

Joint programs in nanotechnology: The Parties may explore and develop, to the extent resources permit, programs that may include for example:

 

Joint research projects for development of evaluative tools that will facititate medical product development;

 

Pre-clinical and animal studies, leveraging the extensive animal facilities that exist at the Johns Hopkins University toward the development of predictive models for assessing the fate of nanoparticles in complex biologocal systems;

 

Joint outreach and education programs including scientific workshops to address scientific gaps in the field of nanotechnology.

 

4. Participants

A wide range of faculty, students and resources from various components of Johns Hopkins University may be involved in activities under the terms of this MOU. Participants may include faculty and students from the Schools of Arts and Sciences, Engineering, Medicine, Nursing, and Hygiene and Public Health and their respective departments. Participants from FDA may include Senior Scientists from the Commissioners Office, Centers and Offices of FDA.

This MOU sets forth a framework for collaboration between the Parties and for pursuing specific collaborative projects. The Parties may choose to include additional entities in such collaborative projects. However, such additional entities shall not be involved except as may be permitted by the policies, rules, regulations, and laws under which the Parties operate, and as agreed by both Parties in writing.

5.Coverances

Patents, licenses, and other legal instruments will be prepared in accordance with Federal law and current policies at Johns Hopkins University, and written notice referencing such policies will be provided prior to entering into any of the aforementioned projects with FDA. The Parties may decide to enter into a Cooperatiave Research and Development Agreement (CRADA) at a future time to conduct collaborative research and projects of mutual interest. The terms of such a CRADA will be covered by separate agreement(s) and will address patent and intellectual property rights.

This MOU forms the basis for the initial relations between FDA and Johns Hopkins University for fellowship opportunities, sabbaticals, research, and scientific education. However, as this collaborative effort progresses, it is anticipated that new and wider areas of mutual interest may be included in expansions of this document. In such cases, the scope of this MOU may be expanded by written amendment thereof and/or by separate, written agreement(s) to be negotiated by the Parties.

 

6. Finances and Resources

The Parties agree that this MOU does not commit either to make specific levels of financial or personnel support or to provide specific office or laboratory space for the programs, and that the provision of such support will be based on available resources and provided in accordance with the policies, rules, regulations, and laws under which the Parties operate.

 

7. Citizenship and Security Clearance

Individuals from Johns Hopkins University, who participate in activities covered under the terms and conditions of this MOU will be United States citizens or permanent residents, and all necessary Federal restrictions and laws will apply. Information may be obtained from participants by FDA for security clearance or access to FDA facilities and offices. The information obtained may be re-disclosed to other Federal agencies for the above purposes and in fulfillment of official responsibilities to the extent that such disclosure is permitted by law.

 

8. Protection of Non-Public Information

Residents, fellows, faculty and students appointed to a position at FDA will be required to sign a Commitment to Protect Non-Public Information agreement. Whereas access to proprietary and/or non-public information in the files of the FDA is required in the performance of official duties, the party will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information.

 

9. Conflict of Interest

Individuals must be free of conflict prior to performing their duties. Residents, fellows, faculty and students selected as a fellow or visiting scholar with FDA will be required to sign a Conflict of Interest Clearance agreement. Pursuant to the Ethics in Government Act of 1978, the parties may also be asked to file a financial disclosure report. The person responsible for the participants' assignments will be advised of any potential conflict so that conflicting assignments can be avoided consistent with the agency's needs. If at any time prior to or during the performance of the assigned duties, the program participant believes that a potential or actual conflict exists, the individual must notifiy his or her supervisor and the FDA contact person indicated below on this agreement. A determination will be made by FDA as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. Participants in the program will avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.

 

10. Regulations

This MOU and all associated agreements will be subject to the applicable federal and state laws and regulations.

 

11. Contacts

The individuals to whom all inquiries to FDA should be addressed is:

A. For general questions regarding efforts under this MOU

Norris Alderson, Ph.D.
Associate Commissioner for Science
FDA/HHS
5600 Fishers Lane
HF-32 Rm 14B08
Rockville, MD 20857
Phone: 301-827-3340
Fax: 301-827-3042

 

B. For questions regarding efforts in nanotechnology under this MOU

Wendy R. Sanhai, Ph.D.
Senior Scientific Advisor
Office of the Commissioner, FDA
5600 Fishers Lane, Suite 14-B45
Rockville, MD 20857
Email: wendy.sanhai@oc.fda.gov
Phone: 301-827-7867 (direct)
Assistant: 301-827-7782 (Shauntise Holmes)
Fax: 301-443-9718

The individuals to whom all inquiries to Johns Hopkins University should be addressed is:

 

C. For general questions regarding efforts under this MOU

Theodore O. Poehler
Vice Provost for Research
276 Garland Hall
Johns Hopkins University
3400 North Charles Street
Baltimore, Maryland 21218
410-516-8765

D. For questions regarding efforts in nanotechnology under this MOU

Peter Searson, Ph.D.
Director, INBT
214 Maryland Hall
3400 North Charles Street
Baltimore MD, 21818
Emal: searson@jhu.edu
Phone: 410-516-8774
Fax: 410-516-2355

Approved and Accepted
for John Hopkins University

Signed by: Theodore O. Poehler, Vice Provost for Research

Date: 10/10/07

 

Approved and Accepted
for the Food and Drug Administration

Signed by: Janet Woodcock, M.D.
Deputy Commissioner, Chief Medical Officer

Date: 10/11/07