MEMORANDUM OF UNDERSTANDING
BETWEEN THE FOOD AND DRUG ADMINISTRATION (FDA)
THE NATIONAL CANCER INSTITUTE (NCI)
AND THE NATIONAL INSTITUTE OF STANDARDS AND TEHNOLOGY (NIST)
FOR THE NATIONAL CHARACTERIZATION LABORATORY (NCL)
AND RELATED NANOTECHNOLOGY ACTIVITIES
Whereas extensive cross-sector and multidisciplinary efforts are needed to understand and develop nanotechnology-based platforms and tools for cancer research as well as diagnostic and therapeutic applications;
Whereas the FDA, NCI (NCI is an institute within the National Institutes of Health, component of the Department of Health and Human Services), and NIST, hereafter referred to as the Parties, find that it is in the best interests of the three Parties to continue the partnership that was initiated under THE MEMORANDUM OF UNDERSTANDING (most recent agreement of June 2006; FDA Reference #225-06-8403) and that leverages each Party’s core expertise and resources to facilitate nanotechnology development that will lead to new clinical products;
Whereas FDA, with its unique perspective on research and development activities, regulatory policy, and scientific know-how in reviewing medical products, is interested in facilitating regulatory review and evaluation of new medical products that incorporate nanotechnology devices and tools;
Whereas NCI, with its outstanding cancer biology and oncology knowledge base, research and programmatic infrastructure, both in biology and advanced technologies, seeks to develop approaches to significantly improve the detection, diagnosis, treatment, and prevention of cancer using nanotechnology devices and tools;
Whereas NIST, with its world-class metrology facilities and standardization capabilities and expertise, is interested in developing measurement methods and standards for nanotechnology constructs and in facilitating commercialization of nanotechnology-based products, and enters into this MOU with its authority under 15 USC 15 U.S.C. §§ 272(c); and
Whereas the private sector has expressed interest in further scientific exploration and nanotechnology development for its applications to novel diagnostics and therapeutics;
Now, therefore, the Parties intend to collaborate and develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of facilitating the development of nanotechnologies that constitute novel research tools and safer, more effective cancer diagnostics and therapeutics by establishing a framework for effective risk identification, assessment, and evaluation of emerging products based on nanotechnology. This MOU sets forth the framework for the collaboration among the Parties and for pursuing specific collaborative projects that may involve additional partners and will be implemented through separate agreements, as needed. The Parties intend that this collaboration will be focused primarily on the Nanotechnology Characterization Laboratory (NCL) and directly related activities. The Parties anticipate that concepts developed and activities undertaken under the auspices of this MOU may lead to partnerships that will be implemented through separate agreements.
A. RESPONSIBILITIES OF THE PARTIES
In order to pursue the goals described above and in all cases subject to and only to the extent compliance with applicable statutes, regulations and policies, the Parties intend to work through the process described below:
1. The Parties intend to collaborate on nanotechnology characterization and related development activities primarily in the context of the NCI’s NCL. Through this collaboration, the Parties intend to share best practices and know-how with each other, and to provide access to results regarding the assessment tools for use in FDA’s regulatory evaluation and guidance development to facilitate nanotechnology-based cancer diagnostics and therapeutics. The close collaboration among the Parties, including sharing of material characterization data, characterization approaches, and best practices, is expected to a) support understanding and resolution of potential implications of nanotechnology-based products for clinical applications; b) facilitate the development of measurement methods and standard protocols appropriate to nanotechnologies in medicine; and c) facilitate transfer of developments in cancer research and engineering coupled with the measurement science and standards programs and with regulatory science and evaluation policy development to facilitate safe and effective commercialization of nanotechnology-based cancer diagnostics and therapeutics. None of the data shared between the Parties will include personally identifiable information or will be related to research involving human subjects.
2. Within the framework of this MOU, related collaborations and separate agreements may be developed as appropriate among the Parties, and may include, but may not be limited to the following areas and activities, as time, staff resources, and applicable law and policy permit:
i. Development and refinement of the preclinical and early clinical pathway(s) for nanotechnology-based drugs and diagnostic devices to guide NCI-supported technology development leading to medical products;
ii. Development and validation of standards, risk/benefit analyses and other evaluative tools to identify risks and assess safety and efficacy in newly emerging nanotechnology-based products;
iii. Development of publicly available master files containing data, e.g. protocols, assay cascades and other pre-competitive tools developed collaboratively by the Parties that may guide further development of the field.;
iv. Development, validation and assessment of assays and other appropriate test methods, including close review and input from all Parties prior to standardization of those assays;
v. Development of joint research programs for visiting researchers and trainees to perform research at FDA and NIST in collaboration with FDA and NIST scientists, respectively, as well as potential research collaborations in the NCL by FDA and NIST scientists;
vi. Representation for each agency on the Nanotechnology Characterization Laboratory Scientific Oversight Committee (SOC);
vii. Development of scientific collaborations to capitalize on opportunities generated by NCL activities.
3. Additional concepts or ideas for developing collaborations or activities involving joint projects or integrated approaches to conducting science or technology development may be formally presented by submission of concepts to the designated contact from each Party, as designated in Article C. The Parties intend that these designated contacts will meet as needed, but not more often than once quarterly, to review progress and address new opportunities for collaboration. When necessary, technical and programmatic advisory working groups involving employees from the respective agencies may be assembled to make formal recommendations for collaboration. The designated contacts are expected to obtain appropriate agreement by their respective agency, in writing, on each significant activity to be undertaken pursuant to this MOU, including on the scope of work; tasks, deliverables (if any) and delivery dates; anticipated products and outcomes; periods of performance; levels of funding and resources to be provided for each activity by the Parties; parameters of data sharing in compliance with all applicable statutory and regulatory requirements; and any other appropriate and necessary aspects of mutual activities. The Parties intend that the designated contacts shall seek to resolve any dispute concerning the MOU through good-faith discussions.
4. To the extent that implementation of specific projects involves working with the non-federal government sector, the Parties intend, consistent with all applicable statutory and regulatory requirements, to facilitate dialogue with the appropriate potential collaborators or partners of interest, and formalize agreements with non-federal entities in writing. Such interactions with the non-federal government sector may include a range of stakeholders, such as private non-profit organizations, industry, industry trade organizations, academic institutions, professional organizations, and patient advocacy groups.
5. In addition to nanotechnology characterization activities, the Parties intend to collectively develop and validate standards, nomenclature, assessment tools, and toxicology approaches to facilitate and accelerate the development of, and the evidence base for, new cancer diagnostics and therapeutics within the applicable statutory and regulatory framework. The Parties also intend to develop educational tools to make this information more widely available to patients, clinicians, and researchers.
B. GENERAL PROVISIONS
1. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by and in accordance with appropriate confidentiality disclosure agreements, or to the extent such disclosure is permitted or required by law.
2. It is understood that while the Parties have aligned interest, there may be opportunities for independent collaborations and activities outside the scope of this MOU, but which are under their respective agency missions. As such, the Parties may, as appropriate, enter into independent negotiations and agreements with prospective partners. All such agreements shall be in writing and in compliance with all applicable legal requirements.
3. A member of the NCL Scientific Oversight Committee shall recuse him/herself from any review of data if such member is involved in related activities or agreements with outside partner(s).
4. Materials being analyzed/studied under the terms and conditions of this MOU may be shared among the Parties; such transfers will be carried out under separate, written agreements.
5. NCL data being generated/analyzed under the terms and conditions of this MOU may be shared among the Parties under separate, written agreements. The Parties intend that such arrangements will be in writing and will include parameters of data sharing that comply with applicable statutory and regulatory requirements.
6. Rights to intellectual property developed during the course of research under this MOU will be addressed in separate project-specific implementation agreements.
7. Any notice or other communication required or permitted under this MOU shall be in writing to the contacts listed below, and will be deemed given as of the date it is received and accepted by the receiving Party.
8. This MOU is a statement of intent of the Parties to collaborate as described. Activities contemplated under this MOU are subject to the availability of funds and other necessary resources to the Parties. No funds are obligated or otherwise committed by this MOU.
Notices or formal communications pursuant to this MOU should be sent to:
Frank Weichold, M.D.
Director, Critical Path and Regulatory Science Initiatives
Office of Regulatory Science and Innovation
Office of Chief Scientist
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Piotr Grodzinski, Ph.D.
Director, Office of Cancer Nanotechnology Research
Center for Strategic Scientific Initiatives
Office of the Director
National Cancer Institute
31 Center Drive
Bethesda, MD 2089Telephone 301-451-8983
Debra Kaiser, Ph.D.
Technical Program Director
Material Measurement Laboratory
100 Bureau Drive
Mail Stop 8301
Gaithersburg, MD 20899-8301
D. TERM, TERMINATION AND MODIFICATIONS
1. There are no representations, warranties, agreements or understandings, expressed or implied, written or oral, between or among the Parties hereto relating to the subject matter of this MOU that are not fully expressed herein.
2. No supplements, amendments or modifications to this MOU shall be effective unless executed in writing, with thirty (30) days advance notice, and by mutual consent of the Parties; such modifications are to take the form of amendments.
3. This MOU, when accepted by the Parties, will have an effective date from the date of the last Party to sign, and will remain in effect for five (5) calendar years from the effective date unless modified or terminated in accordance with this Article D.
4. Any Party may terminate its participation in this MOU by thirty (30) days advanced written notice to the other Parties. Should two of the Parties provide such notice of termination, this MOU shall terminate upon the date of receipt of the second of such notices.
SIGNATURES OF RESPONSIBLE PARTIES
APPROVED AND ACCEPTED FOR THE FDA
Stephen Ostroff, M.D.
Food and Drug Administration
January 7, 2015
APPROVED AND ACCEPTED FOR THE NCI
Douglas R. Lowy, M.D.
Deputy Director, National Cancer Institute,
National Institutes of Health
January 20, 2015
APPROVED AND ACCEPTED FOR THE NIST
Laurie E. Locascio, Ph.D.
Director, Material Measurements Laboratory
National Institute of Standards and Technology
January 5, 2015