30002 Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices

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.

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
Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices 30003

Building 31, Room 2C39, Bethesda, MD

20892–2290, Telephone: 301–496–9469,

FAX: 301–402–2185, E-mail:

KLEINMAND@OD31.NIDR.NIH.GOV

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:

COHENL@DE45.NIDR.NIH.GOV

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:

BSCHWETZ@NCTR.FDA.GOV

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, Email: EDJ@CDRH.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

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, Email:

BRAVEMANN@DE45.NIDR.NIH.GOV

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:

HBHANSEN@IRP30.NIDR.NIH.GOV

For the Food and Drug Administration:

Bernard A. Schwetz, D.V.M., Ph.D., CoChair

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:

WEINTRAUB@CDER.FDA.GOV

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 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 caseby-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-bycase 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
30004 Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices

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’’ (shortterm—within 6–12 mos.), and ‘‘L’’ (longterm—beyond 12 mos.).

A. Information Exchange

In this area of collaboration, NIDR and

FDA agree to pursue the following activities:

• 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]

• 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 NIDR 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 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]

• Creation of a ‘‘Oral, Dental and CranioFacial 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]

• 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

• Participation by FDA regulatory policymakers 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]

• 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]

• 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]

• 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

NIDR and FDA specialists for pre-set periods

of time (e.g., 6–12 months). These crossappointments, 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 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]

• 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]

• 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]

• 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]

• Evaluation of the feasibility of NIDR

requiring prospective research contractors
Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices 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]

• 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]

• 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

• 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 FDArecruited special government employees are

subjected. [L]

E. Policy Development

• 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

• Continuation of ongoing research

collaborations, such as those between CBER

and NIDR’s Division of Intramural Research.

• 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]

• 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]

• 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 NIDR National Advisory

Dental Research Council (including access to

closed sessions of the Council on a case-bycase, 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]

• 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-toknow 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 NIDR and

FDA review and advisory bodies. [S]

[FR Doc. 98–14462 Filed 6–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collections; Comment

Request: National Institutes of Health

Construction Grants

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

Office of the Director (OD), the National

Institutes of Health (NIH), will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

PROPOSED COLLECTION: Title: National

Institutes of Health Construction Grants

(42 CFR Part 52b). Type of Information

Collection Request: Extension of OMB

No. 0925–0424, expiration date 09/30/

98. Need and Use of Information

Collection: This is a request for OMB

approval for the information collection

and recordkeeping requirements

contained in the final rule 42 CFR Part

52b. The purpose of the regulations is to

govern the awarding and administration

of grants awarded by NIH and its

components for construction of new

buildings and the alteration, renovation,

remodeling, improvement, expansion,

and repair of existing buildings,

including the provision of equipment

necessary to make the building (or

applicable part of the building) suitable

for the purpose for which it was

constructed. In terms of reporting

requirements:

Section 52b.9(b) of the proposed

regulations requires the transferor of a

facility which is sold or transferred, or

the owner of a facility, the use of which

has changed, to provide written notice

of the sale, transfer or change within 30

days. Section 52b.10(f) requires a

grantee to submit an approved copy of

the construction schedule prior to the

start of construction. Section 52b.10(g)

requires a grantee to provide daily

construction logs and monthly status

reports upon request at the job site.

Section 52b.11(b) requires applicants for

a project involving the acquisition of

existing facilities to provide the

estimated costs of the project, cost of the

acquisition of existing facilities, and

cost of remodeling, renovating, or

altering facilities to serve the purposes

for which they are acquired.

In terms of recordkeeping

requirements: Section 52b.10(g) requires

grantees to maintain daily construction

logs and monthly status reports at the

job site. Frequency of Response: On

occasion. Affected Public: Non-profit

organizations and Federal agencies.

Type of Respondents: Grantees. The

estimated respondent burden is as

follows:

Estimated annual reporting and recordkeeping burden

Annual

number of

respondents

Annual frequencyAverage burden perAnnual burden hours

Reporting:

§ 52b.9(b) ............................................................................................................... 1 1 .50 .50