[Federal Register Volume 63, Number 105 (Tuesday, June 2, 1998)]
[Notices]
[Pages 30002-30005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14462]



[[Page 30002]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Memorandum of Understanding Between the Food and Drug 
Administration and the National Institutes of Health's National 
Institute of Dental Research

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between the National Institutes of 
Health's National Institute of Dental Research (NIDR) and three of 
FDA's line organizations: the Center for Devices and Radiological 
Health, the Center for Drug Evaluation and Research, and the Center for 
Biologics Evaluation and Research. The purpose of the MOU is to 
facilitate interactions between NIDR and FDA regarding improvements in 
the quality and relevance of preclinical and clinical research, which 
is directed to the development of products for use in oral healthcare.

DATES: The agreement became effective August 10, 1997.

FOR FURTHER INFORMATION CONTACT:
    Susan Runner, Center for Devices and Radiological Health (HFZ-410), 
9200 Corporate Blvd., Rockville, MD 20850, 301-443-8879, or
    Norman S. Braveman, National Institute of Dental Research, National 
Institutes of Health, 45 Center Dr., MSC 6400, Bldg. 45, rm. 4AN-24, 
Bethesda, MD 20892-6400, 301-594-2089.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOU's between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: May 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
225-97-6000

Memorandum of Understanding Between the National Institutes of Health, 
National Institute of Dental 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 
collaborative arrangement between the National Institutes of 
Health's National Institute of Dental Research (NIDR) 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 (CDER), and Center for Biologics Evaluation 
and Research (CBER).
    This agreement has been developed to facilitate interactions 
between the NIDR 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 is to reduce the time between 
the research and development phase of a product's life cycle and its 
commercial availability. This goal will be attained by enhancing the 
quality of product-related research and thus facilitate and improve 
premarket 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, NIDR 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 
advantage of each organization's strengths and experience.

III. Substance of Agreement

    As noted above, this agreement charts a general course of 
interaction between the NIDR 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 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 Administration (HF-1), 5600 Fishers Lane, 
Rockville, MD 20857, Telephone: 301-827-3310, FAX: 301-443-3100.
    (a) Center for Devices and Radiological Health (HFZ-1), 9200 
Corporate Boulevard, Rockville, MD 20850, Telephone: 301-443-4690, 
FAX: 301-594-1320.
    (b) Center for Drug Evaluation and Research (HFD-1), 5600 
Fishers Lane, Rockville, MD 20857, Telephone: 301-594-6740, FAX: 
301-594-6197.
    (c) Center for Biologics Evaluation and Research (HFM-1), 8800 
Rockville Pike, Bethesda, MD 20892-001, Telephone: 301-827-0548, 
FAX: 301-827-0440.

V. Liaison Officers

For the National Institute of Dental Research:

    Dushanka V. Kleinman, D.D.S., M.Sc.D., Deputy Director, National 
Institute of Dental Research, National Institutes of Health, 31 
Center Drive, MSC 2290

[[Page 30003]]

Building 31, Room 2C39, Bethesda, MD 20892-2290, Telephone: 301-496-
9469, FAX: 301-402-2185, E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="2d6661686463606c63696d62691e1c036364697f03636465036a627b">[email protected]</a>
    Lois K. Cohen, Ph.D., Alternate Director, Division of Extramural 
Research, National Institute of Dental Research, National Institutes 
of Health, 45 Center Drive, MSC 6400, Building 45, Room 4AN-18, 
Bethesda, MD 20892-6400, Telephone: 301-594-7710, FAX: 301-480-8319, 
E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="4c0f03040902000c08097879620205081e62020504620b031a">[email protected]</a>

For the Food and Drug Administration:

    Bernard A. Schwetz, D.V.M., Ph.D., Interim Chief Scientist, 
Office of the Commissioner (HF-32), Food and Drug Administration, 
5600 Fishers Lane, Room 17-35, Rockville, MD 20857, Telephone: 301-
827-3340, FAX: 301-827-3042, E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="83c1d0c0cbd4c6d7d9c3cdc0d7d1adc5c7c2adc4ccd5">[email protected]</a>
    Elizabeth D. Jacobson, Ph.D., Alternate Deputy Director for 
Science, Center for Devices and Radiological Health (HFZ-2), 9200 
Corporate Boulevard, Room 100G, Rockville, MD 20850, Telephone: 301-
443-4690, FAX: 301-594-1320, E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="b7f2f3fdf7f4f3e5ff99f1f3f699f0f8e1">[email protected]</a>

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 NIDR and FDA, including the Liaison 
Officers 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 Research:

    Dushanka V. Kleinman, D.D.S., M.Sc.D., Co-Chair
    Lois K. Cohen, Ph.D., Alternate
    Norman S. Braveman, Ph.D., Chief, Program Development Branch, 
Division of Extramural Research, National Institute of Dental 
Research, National Institutes of Health, 45 Center Drive, MSC 6400, 
Building 45, Room 4AN-24, Bethesda, MD 20892-6400, Telephone: 301-
594-2089, FAX: 301-480-8318, E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="7d3f2f3c2b38303c33333d39384948533334392f53333435533a322b">[email protected]</a>
    Henning Birkedal-Hansen, D.D.S., Ph.D., Scientific Director, 
Division of Intramural Research, National Institute 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: 301-402-8318, E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="c0888288818e93858e80899290f3f0ee8e898492ee8e8988ee878f96">[email protected]</a>

For the Food and Drug Administration:

    Bernard A. Schwetz, D.V.M., Ph.D., Co-Chair
    Elizabeth D. Jacobson, Ph.D., Alternate
    Michael Weintraub, M.D., Director, Office of Drug Evaluation V 
(HFD-105), Center for Drug Evaluation and Research, 9201 Corporate 
Boulevard, Room S219, Rockville, MD 20850, Telephone: 301-827-2250, 
FAX: 301-827-2317, E-mail: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="e5b2a0acabb1b7a4b0a7a5a6a1a0b7cba3a1a4cba2aab3">[email protected]</a>
    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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="9ed0d1d9cbddd6d7dedddcdbccb0d8dadfb0d9d1c8">[email protected]</a>

VII. Period of Agreement

    Upon acceptance by both parties, this agreement will become 
effective immediately and remain in effect for a period of three (3) 
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. Evaluation of the terms and success of this agreement will be 
made periodically throughout the existence of the interagency 
arrangement. 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

    No funding will be provided or exchanged by either party as part 
of this agreement. NIDR and FDA personnel will collaborate on 
projects of mutual interest. Facilities and equipment of each party 
will be made available to the other on an as needed basis in 
accordance with the individual project and activity plans and 
arrangements.

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 basis 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 a 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 execution 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 CFR 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 agency that provided the 
information. The notified 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. NIDR 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 as 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 NIDR research study sections and advisory bodies will be 
bound by the same rules and allowances that apply to all other 
consultants appointed by NIDR.
    Approved and Accepted for the National Institute of Dental 
Research:
By: Harold C. Slavkin, D.D.S.
Title: Director, National Institutes of Dental Research, NIH
National Institutes of Health

[[Page 30004]]

Date: August 1, 1997
    Approved and Accepted for the Food and Drug Administration:
By: Michael A. Friedman, M.D.
 Title: Lead Deputy Commissioner
Food and Drug Administration
Date: August 10, 1997

Appendix: Implementation Work Plan

Appendix

Implementation Work Plan for Memorandum of Understanding Between the 
National Institute of Dental Research and the Food and Drug 
Administration

Introduction

    The National Institute of Dental Research (NIDR) 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 equip 
consumers with the tools necessary to improve and sustain their own 
oral, dental and cranio-facial 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 NIDR 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, NIDR and FDA agree to pursue the 
following activities:
    <bullet> Initiation of an ongoing series of introductory 
meetings and orientation briefings to acquaint NIDR and FDA 
personnel with each other's statutory obligations, programs, 
operational capacities, policies, processes, etc. that are relevant 
to this agreement. [I]
    <bullet> Identification of key contact persons at each agency 
and preparation of a contact/referral directory to facilitate 
interagency communication and information exchange. [I]
    <bullet> Establishment of a hyperlink between existing FDA and 
NIDR Internet websites to permit continual and instantaneous access 
to routine and late-breaking information of mutual interest. [I]
    <bullet> Establishment of an internal exchange forum to enable a 
periodic two-way sharing of information related to new research 
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 optimal methods for 
both parties to monitor an issue from the conceptual stage through 
research and development. [S]
    <bullet> Creation of a ``Oral, Dental and Cranio-Facial Forum'' 
in which NIDR and FDA can interact periodically 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]
    <bullet> Assessment of the viability of NIDR and/or FDA experts 
serving as Federal ``ombudsmen'' to oversee state-of-the-art 
advances in oral, dental and cranio-facial technologies and 
therapeutics through direct, ``in the field'' interactions with 
clinical investigators, product developers, scientific researchers, 
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 NIDR 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 NIDR 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 
NIDR-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

    <bullet> Participation by FDA regulatory policy-makers and 
program officials in various conferences in 1997-98 sponsored by 
NIDR or in which NIDR has a planning/participant role. FDA 
involvement could entail formal workshops (e.g., FY99 meeting of 
AADR/AADS meeting), individual presentations, use of existing 
videotaped FDA teleconferences on selected regulatory policy and 
process issues, technology transfer, etc. In addition, NIDR 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 NIDR 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]
    <bullet> Development and joint sponsorship of conferences, 
symposia and workshops whose foci and outputs will mutually benefit 
NIDR and FDA, e.g., in the area of technology transfer. [S/L]
    <bullet> Review of the feasibility and utility of live, jointly-
produced videoteleconferences using FDA/CDRH and/or NIDR facilities 
to communicate to each agency's constituencies on topical areas of 
interest, fast-moving events, new research and regulatory 
initiatives, etc. [S]
    <bullet> 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

    <bullet> Arrange for the temporary exchanges of NIDR 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]
    <bullet> Provide for FDA scientists and regulatory process 
experts to participate in NIDR 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]
    <bullet> Provide for NIDR experts to directly participate in 
premarket evaluations 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]
    <bullet> Involvement of NIDR 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 NIDR could be relied upon as 
this mechanism is pilot tested and in actual ``negotiations'' with 
product manufacturers and study sponsors. [S]
    <bullet> Development of reference documents describing FDA 
investigational product and market approval processes for use by 
NIDR 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]
    <bullet> Evaluation of the feasibility of NIDR requiring 
prospective research contractors

[[Page 30005]]

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 cranio-facial diseases and 
conditions. [S]
    <bullet> Investigation into methods by which NIDR 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]
    <bullet> Enlistment of NIDR 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

    <bullet> Investigation into the merits and legal aspects of 
establishing non-Federal fellowships in which interested parties 
from the private sector would subsidize individuals with an interest 
in FDA regulatory processes for one-year residency periods. Under 
such an arrangement, NIDR 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

    <bullet> Continuation of current interchanges and expert 
consultations 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. This activity should 
extend to other matters of major import such as the Surgeon 
General's report on oral health which NIDR has been charged to 
produce and to which FDA can substantively contribute. [I]

F. Research

    <bullet> Continuation of ongoing research collaborations, such 
as those between CBER and NIDR's Division of Intramural Research.
    <bullet> Coordination of NIDR'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]
    <bullet> Establishment of one or more patient registries for 
purposes of monitoring adverse incidents linked to particular dental 
products in addition to product-specific performance trends. Such an 
activity could be jointly undertaken by FDA and NIDR, as well as in 
conjunction with involvement by other organizations such as USP and 
various dental professional and product user organizations. [L]
    <bullet> 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

    <bullet> Provision of ad hoc or liaison status to FDA officials 
on the NIDR National Advisory Dental Research Council (including 
access to closed sessions of the Council on a case-by-case, need-to-
know basis), in addition to DRG and other study sections/review 
groups for the purpose of assisting NIDR in its review of extramural 
research submissions. [S]
    <bullet> Expansion of current NIDR 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]
    <bullet> Formal solicitation of advice by each party from the 
other on candidate nominations for appointment to NIDR and FDA 
review and advisory bodies. [S]
[FR Doc. 98-14462 Filed 6-1-98; 8:45 am]
BILLING CODE 4160-01-F


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