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MOU 225-00-6000

Memorandum of Understanding

Between
The National Institutes of Health
National Institute of Dental and Craniofacial Research 

and

The Food and Drug Administration
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

I. Purpose

This Memorandum of Understanding hereby establishes a formal collaboration arrangement between the National Institutes of Health's National Institute of Dental and Craniofacial Research (NIDCR) and three of the Food and Drug Administration's (FDA) line organizations: Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research (CBER).

This agreement has been developed to facilitate interactions between the NIDCR and the FDA regarding improvements in the quality and relevance of pre-clinical and clinical research which is directed to the development of products for use in oral health care. The principal goal of this agreement, to reduce the time between the research and development phase of a product's life cycle and its commercial availability, will be achieved by: (1) facilitating the development and market introduction of newly-emerging, safe and effective health care products to enable oral health professional and auxiliaries to provide higher quality services and equip consumers with the tools necessary to improve and sustain their own oral, dental and craniofacial health; and (2) providing complementary support and expertise to enable each agency to better fulfill its public health mission. The goal will be attained by enhancing the quality of product-related research and thus facilitate and improve pre-market evaluations. This agreement also sets forth certain working arrangements between both parties that will enable each to fulfill its respective mission more efficiently and effectively.

II. Background

It is widely accepted that the United States has a world-class health care system. This status is due in part to entrepreneurship and capital investment in the private sector. It is also the result of our nation's longstanding commitment to Federally- funded research into health promotion, disease prevention, diagnosis, etiology and pathogenesis, as well as cost-effective therapeutic approaches for varied and complex health conditions. A third contributing factor is the existence of a vigilant national regulatory system that ensures health professionals and consumers are provided with safe, high quality and clinically viable medical products. Despite the reputation of the U.S. system, however, government agencies with responsibility for the development, promotion and regulatory oversight of new medical products are today, as always, striving to eliminate operational inefficiencies that can act as barriers to the development of new technologies and therapeutics and their timely introduction into the marketplace. Leaders throughout the government sector have intensified efforts to sharpen current modes of business as a means to economize, to insure the expenditure of public funds will yield commensurate public benefits, and to enable the Federal government to better serve the contemporary needs of its constituencies.

Increasingly in recent years, NIDCR and FDA component organizations have harnessed their interdisciplinary skills and professional expertise in a number of areas affecting the public health. Although complementary and beneficial, these interactions have largely been ad hoc and informal. Leaders of both agencies have recognized the added benefits that can accrue from a broader, more formal working arrangement. To this end, this agreement establishes a generalized, cooperative framework with end-goals and categories of activities that, taken together, provide the foundation for a working relationship that is better focused and takes fuller advantages of each organization's strengths and experience.

III. Substance of Agreement

As noted above, this agreement charts a general course of interaction between the NIDCR and three of FDA's product centers that encompasses the following areas:

(A) information exchange; (B) state-of-the-science workshops and conferences; (C) staff development; (D) fellowship sponsorship; (E) policy development; (F) research; and (G) advisory committee and study section review and appointments.

The "Implementation Work Plan" attached to this agreement identifies the range of specific projects and activities that fall within each of the seven categories. The Work Plan also provides a narrative description of the commitments made by each of the signatory agencies and specifies relative priorities and projected implementation timeframes, which are subject to change during the period when this agreement is in effect.

Both parties envisage this agreement and its components to be implemented on an evolutionary and incremental basis in accordance with available organizational resources and mutual determination of the feasibility and anticipated benefit(s) of individual activities. Moreover, both parties have agreed that whenever appropriate and possible, interagency activities - - either on a categorical or individual basis - - should be periodically evaluated to confirm that the putative benefits in relation to administrative costs and other considerations justify continuation or expansion of the activities specified in this agreement.

Evaluation of this pioneering agreement may also serve to establish the basis for similar collaborative arrangements between other NIH Institutes and FDA in the future.

IV. Name and Address of Participating Parties

(1) National Institute of Dental and Craniofacial Research
National Institutes of Health
31 Center Drive, MSC 2290
Building 31, 2C39
Bethesda, MD 20892-2290
Telephone: (301) 496-3571
Fax: (301) 402-2185

(2) Food and Drug Adminstration
5600 Fishers Lane (HF-1)
Rockville, MD 20857
Telephone: (301) 827-3310
Fax: (310) 443-3100
(a) Center for Devices and Radiological Health
9200 Corporate Boulevard (HFZ-1)
Rockville, MD 20850
Telephone: (301) 443-4690
Fax: (301) 594-1320
(b) Center for Drug Evaluation and Research
5600 Fishers Lane (HFD-1)
Rockville, MD 20857
Telephone: (301) 594-6740
Fax: (301) 594-6197
(c) Center for Biologics Evaluation and Research
8800 Rockville Pike (HFM-1)
Bethesda, MD 20892-001
Telephone: (301) 827-0548
Fax: (301) 827-0440

V. Liaison Officers

For the National Institute of Dental and Craniofacial Research:

Dushanka V. Kleinman, D.D.S., M.Sc.D.
Deputy Director
National Institute of Dental and Craniofacial Research
National Institues of Health
31 Center Drive, MSC 2290
Building 31, Room 2C39
Bethesda, MD 20892-2290
Telephone: (301) 496-9469
Fax: (301) 402-2185
E-mail: KLEINMAND@OD31.NIDR.NIH.GOV

Wendy Liffers JD, Alternate Director
Office of Science Policy and Analysis
National Institute of Dental and Craniofacial Research
National Institutes of Health
31 Center Drive, MSC
Building 31, Room 5
Bethesda, MD 20892-2290
Telephone: (301) 435-2007
Fax: (301) 480-0964
E-mail: wendy.lifers@nih.gov

For the Food and Drug Administration:

Bernard A. Schwetz, D.V.M., PhD.
Acting Deputy Commissioner
Office of the Commissioner (HF-1)
Food and Drug Adminstration
5600 Fishers Lane, Room 14-71
Rockville, MD 20857
Telephone: (301) 827-3100
Fax: (301) 827-3310
E-mail: BSCHWETZ@OC.FDA.GOV

Elizabeth D. Jacobson, Ph.D., Alternate
Acting Senior Advisor for Science
Food and Drug Administration
5600 Fishers Lane, Room 14-69
Rockville, MD 20857
Telephone: 914-682-6166
Email: EJacobson@OC.FDA.GOV

VI. Interagency Steering Committee

To assist the Liaison Officers in the management, coordination and oversight of this agreement and the concomitant Implementation Work Plan, an interagency steering committee shall be established. The Committee will be comprised of an equal number of member representatives from the NIDCR and FDA, including the Liaison Officers (or their designees) who shall serve as co-chairs of the Committee.

Member appointments shall be authorized by the signatories to this agreement and shall last for a period of one (1) year, unless renewed by the agreement signatories upon recommendation from the Liaison Officers. The Committee shall meet at least once every six months for the first year of this agreement and then at least once annually thereafter to review the progress of this agreement, resolve any issues and disputes that may arise, re-direct specific activities set forth in the Work Plan, and oversee necessary modifications to the agreement.

As of the date this agreement is approved and accepted, the following persons are designated to serve on the Committee for the initial one-year term.

For the National Institute of Dental and Craniofacial Research:

Dushanka V. Kleinman, D.D.S., M.Sc.D., Co-Chair

Wenday Liffers, JD, Alternate

Henning Birkedal-Hansen, D.D.S., PhD.
Scienfitic Driector
Division of Intramural Research
National Institiute of Dental Research
National Institutes of Health
30 Convent Drive, MSC 4326
Building 30, Room 132
Bethesda, MD 20892-4326
Telephone: (301) 496-1483
Fax: (301) 402-8218E-mail: HBHANSEN@IRP30.NIDR.NIH.GOV

For the Food and Drug Administration:

Bernard A. Schwetz, D.V.M., Ph.D., Co-Chair

Elizabeth D. Jacobson, Ph.D., Alternate

Philip D. Noguchi, M.D.
Director, Division of Cellular and Gene Therapies (HFM-515)
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
8800 Rockville Pike
Building N29B, Room 2NN20
Bethesda, MD 20892-001
Telephone: (301) 827-0680
Fax: (301) 827-0449
E-mail: NOGUCHI@CBER.FDA.GOV

VII. Period of Agreement

Upon acceptance by both parties, this agreement will become effective immediately and remain in effect for a period of five (5) years from the date of signature by authorized officials from both agencies unless extended by the parties. The terms of this agreement may be modified upon mutual written consent, or terminated by either party with a minimum 30-day advance written notice to the other party. Within ninety (90) days prior to expiration of this agreement, a formal written evaluation shall be prepared by both parties and submitted to appropriate officials of both agencies with recommendations regarding the furtherance or discontinuation of the agreement.

VIII. Funding

This MOU will be supported in the budgets of both the NIDCR and the FDA in order to fund related activities. These activities will be planned in advance and budgets projected prior to the fiscal year.

IX. Reporting Requirements

In addition to the evaluation report(s) referenced in section VII. above, reporting responsibilities will be determined on a case-by-case and as required by individual projects and activities. Reports will be provided to all Liaison Officers named in this agreement.

X. Schedules and Milestones

Schedules and milestones for all collaborative projects and activities authorized by this agreement will be developed by mutual agreement on case-by-case basis. Schedules and milestones may be set by interagency working groups established and tasked to implement the specific projects and activities outlined in the Implementation Work Plan appended to this agreement.

XI. Disposition of Data

The plan for each project and activity set forth in the Implementation Work Plan' as appended to this agreement will specify the disposition of data and other information that may result from or be used during the course of a project or activity. Publication or public dissemination of data and information exempt from public disclosure under applicable law shall not occur without prior notification and concurrence of the Liaison Officers of both parties.

XII. Sharing Data and Information

Both parties agree that a free exchange of data and information is vital to the successful executive of this agreement. Therefore, to the extent allowed under 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), 42 U.S.C. § 353g(d), 42 U.S.C. § 263i(e), 21 C.F.R. Part 20, or other applicable law, the parties agree to share data and information as necessary. No exchange of non-public information will occur unless appropriate safeguards are established and set forth in individual work plans and first approved by the agencies' Liaison Officers.

XIII. Disclosure of Data and Information in Response to Requests

If disclosure of data or information received by a party under this agreement is requested under the Freedom of Information Act, a Congressional inquiry or pursuant to other duties and responsibilities of either party to this agreement, the agency that receives the request shall notify the other agency and provide the information. The providing agency will be responsible for making any requisite contact with the submitter of the protected information and will accept full responsibility for evaluating the submitter's comments prior to rendering a disclosure determination.

To preserve maximum control over actual disclosure of their respective records, each party to this agreement shall retain legal authority and the concomitant responsibility regarding disclosure of documents provided to the other agency.

XIV. Government Property/Facilities/Personnel

Both parties to this agreement will make available personnel and facilities as required by individual projects and activities as set forth in the mutually developed work plans. NIDCR personnel enlisted to serve as Federal consultants or liaisons on FDA advisory committees and panels will be subject to the same rights, privileges, obligations and restrictions and all other special government employees who serve on the agency's advisory bodies. Similarly, all FDA employees selected to serve in a consultative capacity on NIDCR research study sections and advisory bodies will be bound by the same rules and allowances that apply to all other consultants appointed by NIDCR.

 

Appendix: Implementation Work Plan

Appendix


IMPLEMENTATION WORK PLAN
FOR
MEMORANDUM OF UNDESTANDING
BETWEEN THE
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
AND THE
FOOD AND DRUG ADMINISTRATION

Introduction

The National Institute of Dental and Craniofacial Research (NIDCR) and the Food and Drug Administration (FDA) have embarked upon a formal collaborative arrangement whose dual aims are to: (1) facilitate the development and market introduction of newly-emerging, safe and effective health care products to enable oral health professionals and auxiliaries to provide higher quality services and quip consumers with the tools necessary to improve and sustain their own oral, dental and craniofacial health; and (2) provide complementary support and expertise to enable each agency to better fulfill its public health mission.

This Implementation Work Plan describes the specific projects and activities that initially constitute the substance of the collaborative arrangement between the two agencies. The information that follows is intended to serve as an overall work plan or framework for NIDCR and FDA personnel assigned individual projects and activities. The specific outcomes, completion timeframes, interaction mechanisms, etc. associated with each project and activity will be defined by those persons designated by each agency to serve on interagency working groups. The relative priority of each project/activity is identified by the use of the letters "I" (immediate — within 3 mos.), "S" (short-term — within 6-12 mos.), and "L" (long-term — beyond 12 mos.).

A. Information Exchange

In this area of collaboration, NIDCR and FDA agree to pursue the following activities:

• Initiation of an ongoing series of introductory meetings and orientation briefings to acquaint NIDCR and FDA personnel with each other's statutory obligations, programs, operational capacities, policies, processes, etc. that are relevant to this agreement. [I]

• Identification of key contact persons at each agency and preparation of a contact/referral directory to facilitate interagency communication and information exchange. [I]

• Establishment of a hyperlink between existing FDA and NIDCR Internet websites to permit continual and instantaneous access to routine and late-breaking information of mutual interest. [I]

• Establishment of an internal exchange forum to enable a periodic two-way sharing of information related to new initiatives by both agencies, market applications for important new products pending with FDA, emerging public health issues and emergencies and policy development. Biomimetics is a case in point and could be used as a case study to identify optional methods for both parties to monitor an issue from the conceptual stage trough research and development .[S]

• Development of the second "Oral, Dental and Craniofacial Forum" in which NIDCR and FDA can interact with leading representatives of the regulated industry, academia, the research community and others on issues relating to technology development and transfer (including regulatory processes for acquiring market clearance), product utilization and treatment outcomes, adverse event reporting, etc. [S]

• Development of the second "Entrepreneurial Venture Fair" in which NIDCR and FDA can present to representatives of the regulated industry new products developed by individual inventors, incubator companies and start ups for the purpose of developing partnerships to bring these products to market. [S]

• Assessment of the viability of NIDCR and/or FDA experts serving as Federal "ombudsmen" to oversee state-of—the-art advances in oral, dental and craniofacial technologies and therapeutics through direct "in the field" interactions with clinical investigators, product developers, scientific researches, etc. The ombudsmen would act as conduits through which regulatory process and research funding information could be funneled to the industrial and research sectors. Information on emerging products, in both the concept and development stage, could in turn be fed back to NIDCR and FDA with the end goal of accelerating the flow of new products that are safe and effective from the R&D arena to the clinical environment.[L]

• This feasibility assessment could also encompass the concept of an ombudsman or independent, non-government expert(s) conducting an evaluation of a sampling of dental products whose basic research costs are underwritten by NIDCR that traces the developmental histories through patent acquisitions and FDA market clearances. The purpose of such evaluations would be to augment the existing patient evaluation study by providing documentation of selected impact(s) of NIDCR-funded research on public health and the "bench-to-chairside" delivery of important new oral care products. [L]

B. Science Transfer & State-of Science Workshops/Conferences

• Participation by FDA regulatory policy-makers and program officials in various conferences in 2001 sponsored by NIDCR or in which NIDCR has a planning/participant role. FDA involvement could entail formal workshops, individual presentations, use of existing videotaped FDA teleconferences on selected regulatory policy and process issues, technology transfer, etc. In addition, NICDR staff will participate in FDA-sponsored workshops and conferences with relevance to oral and dental health care products and services. Collaborative discussions and planning between NIDCR and FDA could serve to focus the form and content of information conducive to each presentation setting and ensure proper coverage by both agencies at key outside conferences and meetings. [I/S]

• Development and joint sponsorship of conferences, symposia and workshops whose foci and outputs will mutually benefit NIDCR and FDA, e.g., in the area of technology transfer. Examples might include the sponsorship of a symposium/display at industry trade shows such as the Biotechnology Industry Association or at professional societies such as the International Association for Dental Research. [S/L]

• Review of the feasibility and utility of live, jointly-produced videotele-conferences using FDA/CDRH and/or NIDCR facilities to communicate to each agency's constituencies on topical areas of interest, fast-moving events, new research and regulatory initiatives, etc. [S]

• Development, pilot testing and nationwide dissemination of a regulatory training module for U.S. dental school instructors, dental students, clinical trial sponsors and investigators to broaden their understanding of FDA's market clearance requirements and product evaluation processes. [L]

C. Staff Development and Collaborations

• Arrange for the temporary exchanges of NIDCR and FDA specialists for pre-set periods of time (e.g., 6-12 months). These cross-appointments, which could include rotation of FDA scientists and clinicians through the NIH Clinical Center where research is performed, could enhance the understanding of each party to the policies and procedures of the other. This cross-fertilization of knowledge and experience could subsequently be shared with in-house colleagues and outside constituent groups in ways that could expedite technology transfer. [S]

• Provide for FDA scientists and regulatory process experts to participate in NIDCR reviews of research applications (e.g., SBIR/STTR) as a means of gaining insights into future research and product development directions, which in turn would enable FDA product reviewers to better anticipate and prepare for scientific and clinical issues associated with future product applications. [S]

• Provide for NIDCR experts to directly participate in premarket evaluation of selected new dental products whose scientific and clinical aspects may be complex or controversial, in addition to submissions seeking FDA authorization to conduct clinical studies involving experimental products. [S]

• Involvement of NIDCR experts in a ground-breaking initiative relating to FDA's review process for medical devices, specifically the Product Development Protocol, a mechanism authorized by Federal law by which FDA and device producers can reach agreement at the front end of the premarket review process on test endpoints that, once satisfied, provide for a higher degree of assurance (but no guarantee) of market clearance. Resident scientific and clinical expertise at NIDCR could be relieved upon as their mechanism is pilot tested and in actual "negotiations" with product manufacturers and study sponsors. [S]

• Development of reference documents describing FDA investigational product and market approval processes for use by NIDCR reviewers in conferring with prospective research grantees and contractors to better assure their clinical studies conform to FDA marketing requirements, which will help spur the clinical availability of valuable new products. Such documents could be adaptations of the regulatory training module discussed in Section B of this document. [S]

• Evaluation of the feasibility of NIDCR requiring prospective research contractors and grantees, as a condition for a funding award, to submit review protocols or criteria that FDA can use in performing premarket reviews of breakthrough products used in the prevention, diagnosis and treatment of oral, dental and craniofacial diseases and conditions. [S]

• Investigation into methods by which NIDCR and FDA can jointly and individually promote the availability and use of FDA's adverse incident reporting systems (e.g. MedWatch) among oral health professionals and other health and dental product user groups. [S]

• Enlistment of NIDCR technical, statistical and clinical experts to assist FDA in the design and content development of guidance documents that FDA product reviewers can use to assess product safety and effectiveness. [L]

D. Fellowship Sponsorship

• Investigation into the merits and legal aspects of establishing non-Federal fellowships in which interested parties from the private sector (e.g. academia, industry, philanthropic organizations) would subsidize individuals (non-federal) with an interest in FDA regulatory processes for one-year residency periods. Under such an arrangement, NIDCR could serve as fiduciary in order to prevent appearances of conflict-of-interest. Fellowship assignments would entail generalized exposure to and experience with FDA regulatory procedures so as to also avoid access to protected, product-specific information that could be used for competitive advantage. Fellows would also be subjected to the controls, rights, privileges and restrictions to which all other FDA-recruited special government employees are subjected. [L]

E. Policy Development

• Continuation of current interchanges and expert consultants on selected policy issues that engender wide-scale interest among consumers and/or oral health professionals, involve products or therapies that pose a known or potential health risk to the general public, relate to research and regulatory processes affecting the pace of technology transfer, etc. [I]

• Reexamination, and if necessary, classification, clarification and coordination, in developing NIDCR Guidelines for Dental, Oral and Craniofacial clinical trials (not to be confused with FDA guidances). Completion of this task has the potential to contribute to achieving the goal of this MOU.

F. Research

• Continuation of ongoing research collaborations, such as those between CDER and NIDCR's Division of Intramural Research.

• Coordination of NIDCR's biological and clinical resources and the CDRH's engineering and life sciences expertise to address a number of diverse issues relating to cleaning, infection and sensitivity reactions to new biomaterials.[S]

• Establishment of one or more patient registries for purposes of monitoring adverse incidents liked to particular dental products in addition to product specific performance trends. Such as activity could be jointly undertaken by FDA and NIDCR, as well as in conjunction with involvement by other organizations and various dental professional and product user organizations. [L]

• Initiation of collaborative research aimed at developing fundamental data and methods needed to assess long-term performance of dental devices and systems. Such research could include the joint development of physical, animal and computer-based models to adequately evaluate long-term clinical performance of marketed and evolving dental devices (e.g., osseous, integration of dental implants, fatigue performance of ceramic porcelains, etc.).[L]

G. Advisory Committee & Study Section Review/Appointments

• Provision of ad hoc or liaison status to FDA officials on the National Advisory Dental and Craniofacial Research Council (including access to closed sessions of the Council on a case-by-case, need-to-know basis), in addition to CSR and other study section/review groups for the purpose of assisting NIDCR in its review of extramural research submissions. [S]

• Expansion of current NIDCR participation as consultants and/or Federal liaisons on dental-related advisory committees and panels managed by FDA (including access to closed sessions on a case-by-case, need-to-know basis) for the purpose of augmenting the scientific and clinical expertise that is brought to bear on product applications and proposed policies on which outside advice is sought by the agency. [S]

• Formal solicitation of advice by each party from the other on candidate nominations for appointment to NIDCR and FDA review and advisory bodies. [S]

Approved and Accepted
for the National Institute of Dental
and Craniofacial Research

Signed by: Harold C. Slavkin, D.D.S.
Director, National Institute of Dental
and Craniofacial Research, NIH
National Institutes of Health

Date: July 13, 2000

Approved and Accepted
for the Food and Drug Administration

Signed by: Jane Henney, M.D.
Commissioner
Food and Drug Administration

Date: December 6, 2000