NAEC Meeting Minutes - June 11, 1998

Department of Health and Human Services
National Institutes of Health

National Eye Institute

June 11, 1998

The National Advisory Eye Council (NAEC) convened for its eighty-ninth
meeting at 8:30 a.m. on Thursday, June 11, 1998, 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 11:30 a.m., followed by the closed session for the
review of the intramural research program and grant applications until
adjournment at 4:15 p.m. Attachment A provides a
roster of Council members.

Council members present:

Dr. Anthony J. Adams

Dr. David C. Beebe

Dr. Constance Cepko

Dr. Marian R. Fisher

Lt. Col. William J. Flynn (Ex Officio)

Dr. Diane L. Hatchell (Ex Officio)

Mr. Richard T. Hellner


Dr. Eve J. Higginbotham

Dr. David H. Hubel

Dr. Millicent L. Knight

Dr. Carl Kupfer (Ex Officio)

Dr. Anthony B. Nesburn

Dr. David S. Zee

Council members absent: none

Special Council Consultant: Dr. Dean Bok

NEI Staff Present:

Ms. Margie Baritz

Ms. Cheryl Contreras

Dr. Mary Frances Cotch

Mr. Michael Davis

Ms. Linda Dingle

Dr. Peter A. Dudley

Ms. Lois Eggers

Mr. Donald F. Everett

Ms. Carol 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

Dr. Robert Nussenblatt

Dr. Michael D. Oberdorfer

Ms. Karen Robinson Smith

Ms. Judy Stein

Mr. John Whitaker

Other NIH Staff Present:

Dr. John Bowers, CSR

Dr. Luigi Giacometti, CSR

Dr. Len Jakubczak, CSR

Dr. Carole Jelsema, CSR

Food and Drug Administration Staff Present:

Dr. Ralph Rosenthal

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

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

Ms. Lisa Putman, Blue Sheet

Dr. John C. Whitener, American Optometric Association

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Carl Kupfer, Director, NEI, called the meeting to order and welcomed
the Council members and guests. He introduced a new Council member, Dr.
Constance Cepko. Dr. Cepko is Professor, Department of Genetics and Howard
Hughes Medical Institute, Harvard Medical School. She is a highly-regarded
scientist who is interested in the mechanisms that direct the development
of the central nervous system (CNS). Dr. Cepko has developed innovative
molecular genetic techniques to investigate cell progenitor-progeny
relationships in several areas of the CNS, including the retina. She has
recently initiated a major effort to understand how the cell environment
and other factors interact with retinal progenitors to direct cell fate
decisions. Dr. Cepko has extensive experience in the training of graduate
students and postdoctoral fellows. She has won a number of awards for her
research, including the David O. Cogan Award for Outstanding Young
Investigators from the Association for Research in Vision and
Ophthalmology (ARVO).

Dr. Kupfer next thanked Dr. Dean Bok who had agreed to participate in
the meeting as a Special Council Consultant. Dr. Bok is the Dolly Green
Professor of Ophthalmology, Jules Stein Eye Institute, and Professor of
Neurobiology, Anatomy, and Cell Biology, University of California, Los Angeles.

II. Confidentiality / Avoidance of Conflict of Interest

Dr. Jack A. McLaughlin, Deputy Director, NEI, and Executive Secretary of
the Council, reviewed policies and procedures regarding confidentiality
and avoidance of conflict of interest situations. To avoid conflict of
interest, members of federal advisory committees must not participate in
the discussion of any application or proposal in which they, their spouse,
minor child, close professional associate, or organization has a financial
interest or affiliation. The Council members were later asked to sign a
statement certifying that they were absent during such discussions.

III. Consideration of Minutes of Previous Meeting

The minutes of the January 29,1998 Council meeting were considered next.
The minutes were approved as submitted.

IV. Future Meeting Dates

The following dates were agreed upon for future Council meetings:

September 17-18, 1998 [ subsequently changed to one day - September 17 ]

February 4-5, 1999

June 10-11, 1999

September 16-17, 1999

V. Fiscal Year 1998 Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the
budget situation for Fiscal Years 1998 and 1999 (Attachment B). She said
that NEI had received a Fiscal Year (FY) 1998 budget of $355.7 million, an
increase of 7.3% over the FY 1997 budget. The percentage increase received
by NEI was in line with the increases received by most of the other
Institutes. The NIH received a percentage increase of about 7.1% overall.

Ms. Fivozinsky next reviewed the FY 1999 President’s Budget Request (PB)
for NIH and for NEI. The Administration has requested $384.3 million for
NEI, representing an 8% increase over FY 1998, compared to an 8.4%
increase requested for NIH overall. She said that Dr. Gerald Chader, Chief
Scientific Officer of the Foundation Fighting Blindness, had testified
before the Labor, HHS Appropriations Subcommittee on January 28, on behalf
of ARVO and the Alliance for Eye and Vision Research. His testimony, which
was well-received, included a request that the Subcommittee support a 15%
increase in the FY 1999 NEI budget. The American Optometric Association
had also submitted testimony supporting the 15% increase. Dr. Kupfer
testified before the same Subcommittee on March 18. The Senate
Appropriations Labor, HHS Subcommittee hearings were held on April 1. Ms.
Fivozinsky indicated that considerable enthusiasm had been expressed
recently by prominent members of both the House and Senate for a doubling
of the NIH budget over the next five years. However, she indicated that a
number of factors might preclude such an increase, at least in FY 1999.

VI. Extramural Research Program

Dr. McLaughlin’s presentation covered the latest budget estimates for
the extramural research program for FY 1998 and the estimates associated
with the FY 1999 PB. He pointed out that the overall distribution of funds
among the various extramural categories of support in FY 1998 would be
similar to that of previous years. Dr. McLaughlin said that the success
rate for FY 1998 competing research project grants would be approximately
40%, and that NEI would be able to fund more total grants in FY 1998 than
it did in FY 1997.

With regard to the FY 1999 PB, Dr. McLaughlin estimated that the total
number of research project grants would increase from 984 in FY 1998 est.
to 1005 in FY 1999. The success rate for competing grants should remain
relatively high at about 38%. An important assumption of the FY 1999 PB is
that competing grants, on average, would not be cut from the study section
recommended levels. The overall distribution of funds among the various
extramural categories of support in the FY 1999 PB is similar to FY 1998.

VII. VII. Support Of New Investigators

Dr. McLaughlin then reviewed NIH-wide changes regarding support for new
investigators (NIH Guide, 11/21/97 and 12/19/97). These changes included
the fact that First Independent Research and Transition (FIRST)
applications would no longer be accepted by NIH. He said that individuals
affected were being encouraged to submit regular (R01) research grant
applications clearly identified as being from a new investigator. Dr.
McLaughlin said that there was a very strong commitment by NIH to continue
its support of new investigators. He indicated that NEI staff would be
encouraging new investigators to continue to request five years of support
in their applications if warranted by their project, and that NEI intended
to fund these applications for five years if the study sections made that
recommendation. Dr. McLaughlin said that the peer review criteria would
remain the same, but that the emphasis on some of the criteria would shift
a bit. More emphasis will be put on feasibility than on preliminary
results, on training and research potential than on track record and
number of publications, and on evidence of Institutional commitment of
space and release time.

VIII. New NIH Career Development Awards

Dr. Maria Y. Giovanni, Division of Extramural Research, NEI, reviewed
the recent NIH announcement of three new career development awards
designed to attract talented clinicians to the challenges of clinical
research and to improve the quality of clinical research training. A
detailed description of these awards is available (NIH Guide , 04/06/98).
She said that investigators are being encouraged to contact the NEI
extramural program staff with questions they may have about these awards.
The Council members expressed considerable enthusiasm for these new
awards, and for possibly expanding the program to include other target groups.

K23. The Mentored Patient-Oriented Research Career Development
Award will support clinicians who have finished their clinical training
and need 3 to 5 years of supervised research and study to develop into an
independent investigator in patient-oriented research. The program of
training will consist of a mixture of didactic and supervised research
experiences tailored to the developmental needs of the candidate. As
implemented by NEI, the new K23 award is very similar to the existing
Mentored Clinical Scientist Development Award (K08), but is targeted at
clinicians who directly interact with human subjects in conducting their
research. NEI does not impose any special salary cap on either the K08 or
the new K23 award.

K24. The Mid-Career Investigator Award in Patient-Oriented
Research supports clinical scientists who are within 15 years of their
specialty training to allow them protected time to devote to
patient-oriented research and to serve as a mentors for beginning clinical investigators.

K30. The Clinical Research Curriculum Award supports
institutions as they develop formal curricula designed to impart to new
clinical investigators the fundamental skills, methodology, theories and
conceptualizations necessary to establish an independent career in
clinical research. Institutions with a strong clinical research faculty
who are also committed to establishing a clinical research core curriculum
are invited to apply (only one application per institution) for these 5
year renewable grants. The National Heart, Lung, and Blood Institute will
administer this program for the NIH. The receipt date is October 21, and
it is expected that approximately 20 awards will be made by NIH in FY 1999.

IX. NEI Scholars Award Program

Dr. Giovanni next described progress in developing the NEI Scholars
Award, a new research career development program. The purpose of the NEI
Scholars Award is to provide an opportunity for outstanding new
investigators to receive high quality research training in the NEI
intramural program and to facilitate their successful transition to an
independent research position at an extramural institution. Formal
application and peer review procedures have been established, and an
announcement of the new program is scheduled for this fall. The Council
members expressed strong support for this new program.

X. Inclusion of Children in Research

Dr. Mary Frances Cotch, Ph.D., Division of Extramural Research, NEI,
reviewed the subject of a recent NIH announcement (NIH Guide, 3/6/98). NIH
has published guidelines for including children in research involving
human subjects. Initial applications (Type 1) submitted to NIH on and
after the October 1 receipt date are governed by these guidelines, and
must describe plans for including or excluding children in the study
population of a proposed project. For this policy, a child is defined as “an
individual under the age of 21 years.” The policy states that
children must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific or ethical reasons not
to include them.

XI. Update: Program Planning

Mr. Michael Davis, Associate Director for Science Policy and
Legislation, NEI, informed the Council members that copies of Vision
Research–A National Plan: 1999-2003
and its Executive Summary
had been delivered to their hotel the preceding afternoon. He expressed
his appreciation to the Chairs, Co-chairs, and members of the program
planning panels; to the Co-chairs of Council’s Subcommittee on
Planning, Drs. Beebe and Higginbotham, and its members Dr. Adams and Mr.
Hellner; to the full Council for its timely review of and commentary on
the draft reports; and to the NEI Extramural Program Directors. He said
that without the expertise, dedication, patience, and persistence of these
people, NEI staff would not have been able to follow the ambitious time
schedule that had been set for the plan’s publication.

Dr. Beebe thought that the schedule might have been overly ambitious,
and suggested that in the next iteration, more time should be allowed for
the review phase of the process. He stated that it had been difficult to
adjust his schedule to meet the deadlines and still conduct a thorough review.

Mr. Davis stated that the full shipment of the documents was received
the preceding evening from the printing contractor, and that his office
would begin distribution of the Executive Summary to all grantees and
others involved in the support or conduct of vision research. He also
indicated that the contractor is currently converting both documents so
that they could be posted on NEI’s internet homepage by the end of
the month of June.

XII. Update: Diabetes Research Initiative

Dr. Peter A. Dudley, Division of Extramural Research, NEI, reviewed
several aspects of the NIH diabetes research initiative. Following several
public meetings to develop an integrated plan for diabetes research, NIH
staff released a series of Requests for Applications (RFAs). Of special
relevance to NEI, an RFA was published in the NIH Guide (11/21/97),
entitled “Microvascular Complications of Diabetes Mellitus.” Six
million dollars were set aside in FY 1998 for this one-time solicitation,
and it is expected that approximately 25 awards would be made. He said
that a large number of applications had been submitted by investigators
pursuing vision related projects, and credited ARVO for helping to inform
the vision research community of this funding opportunity. Applications
received in response to this RFA and relevant to the Institute will be
reviewed by the Council at its September meeting.

Dr. Dudley also discussed a related Program Announcement (PA) in which
the NEI was participating, “Therapeutic Modulation of Angiogenesis in
Disease,” released by NIH on July 30, and co-sponsored by the
National Cancer Institute and the National Heart, Lung, and Blood
Institute. The application receipt dates are November 19, 1998, and July
20, 1999. The purpose of this PA is to encourage the translation of basic
knowledge of the angiogenic process into therapeutic applications. He said
that NEI was ideally positioned for the diabetes initiative and the PA on
angiogenesis in that Vision Research–A National Plan: 1999-2003 had just
been prepared and that type of research had been highlighted as important
areas in need of expansion. The Council was very enthusiastic about each
of these initiatives and gratified that the Plan had been put to immediate use.

XIII. Vision Screening & Preschool Children

Dr. Michael D. Oberdorfer, Division of Extramural Research, NEI , said
that early in 1998, the Health Services Research Administration (HRSA) had
informed NEI that it would be organizing an expert panel on vision
screening for the pre-school child and asked for NEI’s assistance.
The purpose of the proposed panel is to evaluate scientific and practical
issues related to early vision screening, particularly those relating to
amblyogenic risk factors. One objective is to promote interdisciplinary
interaction among researchers and clinicians to critique, evaluate, and
plan screening initiatives and to conduct research. The product will be a
working paper describing the type of vision screening program(s) that
should be integrated into the health care system, as well as the optimal
methods for implementing and evaluating these programs. The dates for the
panel meeting are September 10 and 11, and the meeting will be held in the
Bethesda area. The Council members indicated that this effort was
encouraging in that more science would be brought into this difficult area.

XIV. Brain Molecular Anatomy Project (BMAP)

Dr. Oberdorfer then announced that NEI was working with the National
Institute of Neurological Diseases and Stroke, the National Institute of
Mental Health, and other neuroscience-related Institutes, on a trans-NIH
sponsored interdisciplinary project called the Brain Molecular Anatomy
Project (BMAP). BMAP will use state-of-the-art technology and informatics
resources to identify all of the genes expressed in the nervous system,
and to correlate gene expression patterns with changes in nervous system
function. The gene discovery phase will catalog the full repertoire of
genes that are expressed at different times and places in the nervous
system. The analysis phase will quantitatively compare levels of gene
expression in cells as a function of their anatomical location,
developmental stage, and disease processes. The Council will be kept
informed as specific BMAP initiatives emerge.

XV. Review of Applications from Members of Study Sections

Dr. Loré Anne McNicol, Division of Extramural Research, NEI,
presented data regarding the review of applications from members of Center
for Scientific Review study sections. Because of conflict of interest
concerns, applications from members of study sections are reviewed by
review groups other than the study sections on which they serve. Data for
the past five years showed that 77% of the grant applications submitted by
individuals serving on the Visual Sciences A (VISA) study section were
funded. This compares favorably with the overall funding rate of 36%
during the same period. The funding rates were somewhat higher for members
of the Visual Sciences B (VISB) (88%) and Visual Sciences C (VISC) (89%)
study sections. Aggregate data for all applications (from study section
members and from non-members) was also reviewed. The data indicated that
applicants had a “success rate” of 35% for applications reviewed
by one of the three “home” study sections (VISA, VISB, and VISC)
and a “success rate” of 38% for applications reviewed by non-“home”
study sections or other review groups.

During the discussion, Dr. McNicol said that VISA members had submitted
proportionately more applications during their term on study section than
did members of the other two study sections, and that proportionately more
VISA members held more than one NIH R01-type award. Thus, VISA members
were “exposed” to NIH peer review of their applications
relatively more frequently than their counterparts on VISB or VISC. It was
also determined that members of the VISB study section were often
appointed immediately following successful competitive renewal of
their grant awards, thus sparing them the necessity of having to submit a
renewal application during their four year terms. Other discussion related
to the relative merits of review of applications from study section
members by ad hoc “special” review groups vs. review by
standing study sections with overlapping scientific boundaries. Council
members who expressed an opinion favored the practice of review by ad
hoc “special” review groups. Council members also inquired
about the status of the recently reorganized neuroscience study sections,
how the reorganization might affect vision research, and how appropriate
study section members are being identified. Dr. McLaughlin said that Dr.
Ehrenfeld, Director, Center for Scientific Review, had been invited to
attend the September Council meeting and that her attendance would provide
another opportunity to discuss these and other peer review issues.

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).

XVI. Review of Research and Training Applications

The Council considered 346 research and training applications requesting
$378.3 million in total costs. The Council recommended 338 applications
with a total cost of $352.6 million. 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.

XVII. Adjournment

Dr. Kupfer adjourned the meeting at 4:15 p.m. on June 11, 1998.

XVIII. 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.

Executive Secretary

National Advisory Eye Council

Deputy Director

National Eye Institute

Carl Kupfer, M.D.


National Advisory Eye Council


National Eye Institute

These minutes will be submitted for the approval of the Council at the
September 17, 1998, meeting. Any corrections or notations will be
incorporated in the minutes of that meeting. A complete, printed copy of
the 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


Attachment A

National Advisory Eye Council

National Eye Institute

(Terms end 11/30 of the designated year)

Anthony J. Adams, O.D., Ph.D. (00)

Dean and

Professor of Vision Science & Optometry

School of Optometry

University of California, Berkeley

Berkeley, CA

David C. Beebe, Ph.D. (98)

Professor of Ophthalmology & Visual Sciences

Washington University School of Medicine

St. Louis, MO

Constance Cepko, Ph.D. (01)


Department of Genetics

Harvard Medical School

Boston, MA

Marian R. Fisher, Ph.D. (98)

Senior Scientist

Department of Biostatistics

University of Wisconsin

Madison, WI

Mr. Richard T. Hellner (00)

President & CEO

Prevent Blindness America

Schaumburg, IL

Eve J. Higginbotham, M.D. (98)

Professor and Chair

Department of Ophthalmology

School of Medicine

University of Maryland

Baltimore, MD

David H. Hubel, M.D. (99)

John Franklin Enders

Professor of Neurobiology

Harvard Medical School

Boston, MA

Millicent L. Knight, O.D. (99)

North Shore Eye Center

Evanston, IL

Anthony B. Nesburn, M.D. (00)


Ophthalmology Research Laboratories

Cedars-Sinai Medical Center

Los Angeles, CA

David S. Zee, M.D. (99)

Professor of Neurology, Ophthalmology,

Otolaryngology & Neuroscience

Johns Hopkins University

School of Medicine

Baltimore, MD

Special Consultant—June Meeting

Dean Bok, Ph.D.


Jules Stein Eye Institute

University of California, Los Angeles

Los Angeles, CA 90095-1763

Ex Officio Members

Donna E. Shalala, Ph.D.


Department of Health and Human Services

Washington, D.C.

Harold Varmus, M.D.


National Institutes of Health

Bethesda, MD

Carl Kupfer, M.D. (Chair)


National Eye Institute

National Institutes of Health

Bethesda, MD

Department of Veterans Affairs Representative

Diane L. Hatchell, Ph.D.

VA Medical Center

Durham, NC

Department of Defense Representative

Lt. Col. William J. Flynn, USAF, MC

Department of Ophthalmology

Wilford Hall Medical Center

Lackland Air Force Base, TX

Executive Secretary

Jack A. McLaughlin, Ph.D.

Director, Division of Extramural Research

National Eye Institute

National Institutes of Health

Bethesda, MD