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NAEC Meeting Minutes - September 12, 1996

Department of Health and Human Services
National Institutes of Health

National Eye Institute

September 12, 1996

The National Advisory Eye Council (NAEC) convened for its eighty-fourth meeting at 8:30 a.m. on Thursday, September 12, 1996, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute (NEI), Carl Kupfer, M.D., presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 11:15 a.m., followed by the closed session until adjournment at approximately 5:00 p.m.

Council members present:

Dr. David C. Beebe

Ms. Sue Dauphin

Dr. Jeanette S. Felix

Dr. Marian R. Fisher

Dr. Diane L. Hatchell (Ex Officio)

Dr. Eve J. Higginbotham

Dr. David H. Hubel


Dr. Herbert E. Kaufman

Dr. Millicent L. Knight

Dr. Carl Kupfer (Ex Officio)

Capt. David O. Mazur (Ex Officio)

Dr. Ken Nakayama

Dr. Joseph P. Shovlin

Dr. David S. Zee

Council members absent: Dr. Roy H. Steinberg

Special Council Consultant: Dr. Richard H. Masland

NEI Staff Present:

Ms. Lilyan Atkinson

Ms. Margie Baritz

Dr. Mary Frances Cotch

Mr. Michael Davis

Dr. Peter A. Dudley

Ms. Lois Eggers

Dr. Leon B. Ellwein

Mr. Donald F. Everett

Ms. Carol L. Fivozinsky

Dr. Maria Y. Giovanni

Ms. Carolyn E. Grimes

Dr. Ralph J. Helmsen


Dr. Natalie Kurinij

Dr. Ellen Liberman

Dr. Andrew P. Mariani

Dr. Jack A. McLaughlin

Dr. Loré Anne McNicol

Dr. Carmen P. Moten

Ms. Kathleen Moy

Dr. Michael D. Oberdorfer

Ms. Maria Roos

Ms. Karen Robinson Smith

Ms. Judy Stein

Mr. John Whitaker

Other NIH Staff Present:

Dr. Luigi Giacometti, DRG

Dr. Leonard Jakubczak, DRG

Dr. Carole Jelsema, DRG

Dr. Samuel C. Rawlings, DRG

Dr. Michael Sesma, NIGMS

Ms. Peggy Schnoor, OD

Food and Drug Administration Staff Present:

Dr. Wiley A. Chambers

Dr. A. Ralph Rosenthal

The following members of the general public were present at the open session:

Ms. Joanne G. Angle, Association for Research in Vision and Ophthalmology

Dr. Israel Goldberg, Health Research Associates, Inc.

Mr. Steve Miller, American Academy of Ophthalmology

Mr. Frank Morris, AAO

Dr. Paul J. O’Brien, Health Research Associates, Inc

Dr. John Whitener, American Optometric Association

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Kupfer called the meeting to order and welcomed the Council members
and guests. He thanked Dr. Richard H. Masland who had agreed to
participate in the meeting as a Special Council Consultant. Dr. Masland is
Professor of Neuroscience and Professor of Ophthalmology at the Harvard
Medical School in Boston. Dr. Kupfer thanked the retiring Council members,
Drs. Felix, Kaufman, and Shovlin, for their outstanding service to the Institute.

II. Confidentiality / Avoidance of Conflict of Interest

Dr. Jack A. McLaughlin, Associate Director for Extramural Research, NEI,
and Executive Secretary of the Council, reviewed policies and procedures
regarding confidentiality and avoidance of conflict of interest situations.

III. Consideration of Minutes of Previous Meeting

The minutes of the Council meeting of June 6, 1996, were considered and
approved as submitted.

IV. Future Meeting Dates

The following dates were agreed upon for future Council meetings:

January 23, 1997

June 12, 1997

September 11, 1997

V. Meeting of the National Advisory Council and Board Representatives

Earlier in the year, Dr. Harold Varmus, Director, NIH, had invited
representatives from each of the Institute Advisory Councils and Boards to
meet with him. He indicated that he would like to have a closer working
relationship with the Councils and Boards and that future meetings would
take place on an “as needed” basis. Dr. David C. Beebe
represented the NAEC at the first meeting of this group, held on March 14.
Dr. Diane L. Hatchell attended a second meeting, held on June 18,
following the regular meeting of the Advisory Committee to the Director,
NIH. She presented a summary of the meeting and led an NAEC discussion on
the matter. Four working groups were established to address the role of
Institute Councils and Boards in the following areas: (1) Intramural
Research; (2) Grant Review; (3) Strategic Planning; and, (4) Advocacy. Dr.
Hatchell reviewed the preliminary recommendations of each of the Working
Groups. The NAEC expressed enthusiasm for the various recommendations to
improve and expand NIH outreach and public information efforts. Members
felt that the NAEC’s track record of leading NEI’s long-range planning
activities could be a model for the strategic planning efforts of other
NIH Councils and Boards. Some interest was expressed in receiving more
feedback from NEI staff regarding the NAEC-reviewed applications that were
ultimately funded. Dr. Hatchell finished her presentation by saying that
this had been a very productive meeting and that the National Advisory
Council and Board representatives had demonstrated a high level of energy
and enthusiasm for getting things done. She said that the opportunity to
discuss commonalities and differences in the function of Councils and
Boards across the NIH, one of the goals of these meetings, had been a very
positive experience.

VI. Extramural Research Program

Dr. McLaughlin’s presentation covered the FY 1997 President’s Budget
(P.B.) request for NEI extramural programs and the latest funding
estimates for FY 1996. He said that the P.B. request would allow for a
1.9% increase over the comparable FY 1996 level. This increase is less
than the projected FY 1997 Biomedical Research and Development Price Index
of 3.7%.

Dr. McLaughlin pointed out that the overall distribution of funds among
the various extramural categories of support is similar to previous years,
continuing a long tradition of emphasizing research project grants for
individual investigators. He indicated that the budget for Small Business
Innovation Research Awards and the Small Business Technology Transfer
Grants is scheduled to increase from 2.0% to 2.5% of the extramural budget.

At the P.B. level of support, NEI would be able to fund approximately
the same number of total research project grants in FY 1997 as it will in
FY 1996. However, the underlying assumption in this estimate is that NIH
would provide noncompeting grant increases of 2% on average, rather than
the usual 4% increase to offset the costs of inflation, and that the
average cost of competing grants would increase by no more than 2%. Dr.
McLaughlin indicated that the NEI success rate at the P.B. level would be
comparable to the FY 1996 figure, but to achieve this, NEI program
directors would probably have to make larger cuts from recommended levels
than has been the case in recent years.

VII. “Electronic Council Books”

Dr. Loré Anne McNicol, Program Director, Corneal Diseases,
reported that the NEI had joined several other NIH Institutes in pilot
testing an Internet-based “Electronic Council Book” system that
provides access to summary statements. The hope is that this new system
will simplify and reduce the costs of application-related communications
with NAEC members. A prototype of this system was developed by staff at
the National Institute on Aging and has been in use for about a year. The
NIH Division of Computer Research and Technology has upgraded the system
with a more powerful search engine and modified it for eventual NIH-wide use.

Because of the confidential nature of summary statements, the new system
is access-restricted and password-protected. Council members will be able
to read summary statement text on their computer screens, save text to a
file or disk, and/or print out a hard copy. Summary statements can be
accessed and sorted using a variety of search parameters.

Dr. McNicol concluded her remarks by saying that a demonstration of the
new system would take place during the lunch break at the January 1997
Council meeting. All Council members will be given access to the system
shortly thereafter. As needed, special application materials, staff action
sheets, and letters from applicants will continue to be mailed to Council
members. Complete table books of summary statements and related materials
will continue to be made available to members at Council meetings.

VIII. Report on Rating of Grant Applications

Dr. Andrew P. Mariani, Chief, Scientific Review Branch, presented an
overview of the “Report on Rating Grant Applications.” This
report was prepared by a subcommittee of the NIH Committee on Improving
Peer Review. A summary of this report, the full text, and an update is
available via an NIH Internet site (http://www.nih.gov/grants/peer/rga.htm).
The subcommittee had been charged with the task of examining the process
by which NIH scientific review groups rate grant applications and making
recommendations to improve that process.

Dr. Mariani reviewed the series of recommendations contained in the
report. The Council agreed with the conclusion that the current rating
system works reasonably well. Some members expressed the opinion that most
of the recommendations seemed trivial. There was strong, uniform support
for retaining a reviewer-assigned “global” rating of scientific merit.

IX. Workshop on Neurotrophic Factors

Dr. Maria Y. Giovanni, Program Director, Fundamental Retinal Processes,
presented a brief summary of a June 7 workshop entitled, “The
Potential Therapeutic Use of Neurotrophic Factors for Ocular Diseases.”
Dr. Roy H. Steinberg was instrumental in organizing the workshop, and
several other Council members also participated. The workshop brought
together a group of basic scientists, clinicians, representatives from
biotechnology companies, and NEI and FDA staff scientists to discuss the
latest research on neurotrophic factors, their potential therapeutic use
in various neurodegenerative retinal diseases, drug delivery systems,
clinical trial design and conduct, and regulatory issues.

Dr. Giovanni thanked the NIH Office of Rare Diseases Research for
providing funds to support the travel costs of the individuals who spoke
at the workshop. She said that a summary of the workshop proceedings was
in preparation. The Council members who had attended the workshop spoke
very highly of it, and indicated that although this was a high-risk area
of research, the potential payoff could be great.

X. Eye Care Technology Forum

Dr. Leon B. Ellwein, Special Advisor to the Director, NEI, briefed the
Council on the preparation and tentative agenda for the fourth Eye Care
Technology Forum that would be held on October 10-11, 1996. He related
that the Forum had been established in 1992 to bring together various
parties interested in improving upon the way in which ophthalmic drugs,
devices, and procedures are developed, evaluated, and ultimately brought
to the patient. Forums were held in 1992, 1993, and 1994, with
representatives from industry, government, academia, and eye care provider
organizations. The fourth Forum will address six topics: (1) Eye
Irritation Testing: Issues and Opportunities; (2) Patient Reported Eye
Care Outcomes: Measurement and Importance; (3) Intraocular Delivery of
Therapeutic Molecules; (4) Regulation and Clinical Trials; (5) Off Label
Use of Drugs and Devices: Issues in Aligning Product Labeling with Common
Medical Practices; and, (6) Issues in Facilitating Availability of Safe
and Effective Devices: Lasers for Refractive Surgery. Dr. Ellwein said
that the Forum provides a “no fault” setting for improved
communication among various constituencies along the complex technology
chain linking research with eye care. The hope is that this improved
communication can accelerate and make more efficient the processes of
developing new eye care products and services.

XI. Update: Program Planning

Mr. Michael Davis, NEI Associate Director for Science Policy and
Legislation, informed the Council that it was time to begin work on
development of the next long-range plan for vision research. To that end,
the Vision Research Program Planning Subcommittee of the NAEC has been
reconstituted, and Dr. Beebe has agreed to serve its Chair. Dr.
Higginbotham will also serve on the Subcommittee with additional members
to be appointed at a later date. Mr. Davis invited any interested Council
members to remain for a short meeting of the Subcommittee to plan the
first steps in the development process.

Closed Portion of the Meeting

The next portion of the meeting was closed to the public in accordance
with the determination that it was concerned with matters exempt from
mandatory disclosure under Sections 552b(c)(4)
and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal
Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

Council members absented themselves from the meeting during discussion
of and voting on applications from their own institutions, or other
applications in which there was a potential conflict of interest, real or
apparent. Members signed a statement to this effect.

XII. Consideration of Research and Training Applications

The Council considered 284 research and training applications requesting
$287.9 million in total costs. The Council recommended 263 applications
with a total cost of $179.4 million.

XIII. Adjournment

Dr. Kupfer adjourned the meeting at approximately 5:00 p.m. on September
12, 1996.

XIV. Certification

I hereby certify that, to the best of my knowledge, the foregoing
minutes and attachment(s) are accurate and complete.

Jack A. McLaughlin, Ph.D. (01/03/97)

Executive Secretary

National Advisory Eye Council

Director, Division of Extramural Research

National Eye Institute

Carl Kupfer, M.D. (01/09/97)


National Advisory Eye Council


National Eye Institute

These minutes will be submitted for the approval of the Council at the
next meeting. Any corrections or notations will be incorporated in the
minutes of that meeting.

This version of the Council minutes has been edited. A complete, printed
copy of the official Council minutes, including attachments, may be
obtained from:

Ms. Lois M. DeNinno

National Eye Institute

Executive Plaza South, Suite 350

6120 Executive Blvd MSC 7164

Bethesda, MD 20892-7164

Telephone: (301) 496-9110

FAX: (301) 402-0528

e-mail: lmd@eps.nei.nih.gov