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NAEC Meeting Minutes - June 5-6, 2003

Department of Health and Human Services
National Institutes of Health

National Eye Institute

Minutes of Meeting

June 5-6, 2003

One Hundred Fourth Meeting

The National Advisory Eye Council (NAEC) convened for its one hundred third meeting at 8:30
a.m. on Thursday, June 5, 2003, in Conference Room H, Executive Plaza North, National
Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute
(NEI), Paul A. Sieving, M.D., Ph.D., presided as Chair of the Council. The meeting was closed
to the public from 8:30 a.m. until 1:30 p.m. for the review of grant and cooperative agreement
applications and for the review of the NEI Intramural Research Program. The meeting was open
to the public from 1:30 p.m. until adjournment at 3:55 p.m. On Friday, June 6, 2003, the
meeting was open to the public from 8:30 a.m. until 11:30 p.m. Attachment A provides a roster of Council members.

Council Members Present:

Dr. Ruben Adler
Dr. Roy W. Beck
Dr. Suraj P. Bhat
Dr. Martha C. Constantine-Paton
Dr. Mildred M. G. Olivier
Mr. Richard J. Salem

Dr. Lois E. Smith
Dr. J. Wayne Streilein
Dr. Janey L. Wiggs
Dr. Karla Zadnik
Lt. Col. J. Brian Reed (Ex Officio)
Dr. Marco A. Zarbin (Ex Officio)


Council Members Absent:

Dr. Gordon E. Legge
Dr. P. Sarita Soni

NEI Staff Present:

Ms. Louise Amburgey
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Michelle Collins
Dr. Mary Frances Cotch
Mr. William W. Darby
Ms. Chris A. Davis
Mr. Michael Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Mr. Donald F. Everett
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Dr. Ralph J. Helmsen
Ms. Jean Horrigan
Dr. Jeanette Hosseini
Dr. Chyren Hunter
Ms. Rosie Janiszewski
Ms. Tina Jones
Mr. J. Kevin Keating
Dr. Ellen S. Liberman

Ms. Michele Lyles
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Ms. Kathleen Moy
Dr. Michael D. Oberdorfer
Ms. B. Jill Payne
Dr. Samuel Rawlings
Dr. Maryann Redford
Ms. Karen Robinson Smith
Dr. Jean Paul SanGiovanni
Dr. Annie E. Schaffner
Dr. Grace L. Shen
Dr. Paul Sieving
Ms. Judy Stein
Ms. Karen R. Tolson
Dr. Susan Vitale
Ms. Marie Watkins
Ms. Cheryl Wild
Mr. John Whitaker


Other National Institutes of Health (NIH) Staff Present:

Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Mary Custer, CSR
Dr. Christine Melchoir, CSR
Dr. Michael Steinmitz, CSR

Other Federal Government Staff Present:

Dr. Wylie Chambers, Food and Drug Administration


Members of the General Public Present at the Open Session:

Mr. Andrew Brecher, Capitol Associates
Mr. Luke Condra, Salem Saxon, P.A.
Mr. Patrick G. Eddington, American Academy of Ophthalmology
Mr. Thomas Hoglund, Foundation Fighting Blindness (FFB)
Mr. Benjamin Lum, The Blue Sheet
Mr. Edward H. McManus, National Alliance for Vision and Eye Research
Mr. Robert Rupp, Association for Research in Vision and Ophthalmology
Dr. Santa Tumminia, FFB
Dr. John Whitener, American Optometric Association

Thursday, June 5, 2003


Closed Portion of the Meeting

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).


Call to Order and Opening Remarks

Dr. Paul A. Sieving, Director, NEI, and Chair of the Council, called the meeting to order and
welcomed the Council members to the one hundred fourth meeting of the National Advisory Eye
Council. He announced that two members were not able to be present, Drs. Legge and Soni.



Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive
Secretary of the Council introduced Scientific Review Administrators (SRA) from the CSR: Dr.
Michael Chaitin, Visual Sciences C, Dr. Mary Custer, Visual Sciences A, and Dr. Christine
Melchoir, Chief of the Integrative, Functional, and Cognitive Neurosciences Integrated Review
Group. Dr. Melchoir introduced Dr. Michael Steinmetz, who has been appointed as the new
Scientific Review Administrator for the Visual Sciences B Study Section. Dr. Melchoir also
announced a change in the names of the CSR study sections, starting with the October/November
2003 review cycle. Visual Sciences A will become Anterior Eye Diseases. Visual Sciences B
will become Central Visual Processing. And Visual Sciences C will become Disease and Biology of
the Posterior Eye.


Confidentiality / Avoidance of Conflict of Interest

Dr. McNicol 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 signed a statement certifying that they were
absent during such discussions.

Electronic Grant Pilot

Dr. McNicol indicated that the DER staff had been able to mail council members most of the
paper copies of background material two weeks in advance of the meeting. A few pieces of
important late-arriving material were sent by Federal Express. Letters from applicants which
arrived after the two week deadline were made available in the table folders. Dr. Richard S.
Fisher, Director, Corneal Diseases Program, gave an update on the initiative to provide council
review materials on CD. This round he introduced software to provide better file management
for Macintosh users and organized material by program area code. Council members felt that the
pilot was a complete success and asked that future meetings be paperless.


Review of Research and Training Applications

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.

Review of the Intramural Research Program

Dr. Sheldon S. Miller, Scientific Director, presented the report of the NEI Board of Scientific Counselors.


Open Portion of the Metting

Welcome and Call to Order

Dr. Sieving welcomed guests attending the open portion of the meeting.


Dr. McNicol introduced two new members of the DER Program staff.

Dr. Hemin R. Chin is the director of a new program on Ocular Genetics. Dr. Chin received
his Ph.D. in neurobiology from Northwestern University on studies of the regulation of
muscarinic acetylcholine receptors. He then did postdoctoral work in the National Heart Lung
and Blood Institute’s intramural Laboratory of Biochemical Genetics, studying Calcium channel
regulation of parathyroid cell secretion. Dr. Chin was then recruited to the intramural
program of the National Institute of Neurological Disorders and Stroke, where he did
independent research cloning and sequencing genes involved in the structure, function, and
regulation of Calcium channels and opioid receptors in a number of tissues, including Mueller’s
cells in the human retina. He next joined the extramural program of the National Institute of
Mental Health, where he was Chief of the Genetic Basis of Neural Function Program. His duties
included serving as Project Officer on the Brain Molecular Anatomy Project. We are very
pleased to have recruited someone with Hemin’s broad scientific and administrative experience.
He will manage a portfolio of extramural grants and serve a liaison role in integrating and
stimulating intramural/extramural ocular genetics resources.

Dr. Grace L. Shen is the director of a new program on Ocular Immunology, Inflammation, and
Infection. Dr. Shen received her Ph.D. in biochemistry from the St. Louis University in the
field of cancer genetics. She made her initial connection with immunology when she cloned the
myc-IgA translocation in the mouse plasmacytoma. She then worked in the National Cancer
Institute’s intramural Laboratory of Genetics as a postdoctoral fellow and a senior staff
fellow, with a focus on the myb gene and its involvement in myeloid leukemogenesis and
development. Dr. Shen then joined the NCI extramural program as a program director. She
managed a portfolio of grants in cancer immunology, basic cancer genetic research and
functional genomics. Next, Dr. Shen was recruited to serve as Scientific Director for Oncology
Product Development and Pharmacogenomics at Gene Logic Inc., a company focused on the
generation of whole genome expression profile databases. Here she also served as the interim
director for the Inflammation Program. We are very pleased to have recruited someone with
Grace’s strong scientific and administrative experience. She will manage a portfolio of grants
and serve a liaison role in integrating studies of immunology, inflammation, and infection
within the NEI extramural programs.

Consideration of Minutes of Previous Meeting

The minutes of the January 23-24, 2003, NAEC meeting were considered and approved as corrected.


Future Council Meeting Dates

Dr. McNicol indicated that future Council meetings are scheduled for two days, and that
members are asked to free that time on their calendars. The NEI does not always need the
second day, so members will be contacted as soon as the schedule is known.

The following dates were previously agreed upon for future Council meetings:

September 11-12, 2003
February 5-6, 2004
June 10-11, 2004
September 9-10, 2004

Council members were asked to continue to keep these dates reserved as they make future
plans and obligations.


Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the NEI budget. The NIH
FY2003 budget represents the fifth year of a five-year “doubling period”, FY1998 - FY2003. The
NIH budget was $27.0B, which represents a 14.9% increase over the FY2002 level. The NEI FY2003
budget is $633.1M. This represents a 9.2% increase over the FY2002 level.

Ms. Fivozinsky indicated that the NEI FY2003 budget is distributed among the Division of
Extramural Research (87.4%), the Intramural Research Program (9.9%), and Management (2.7%).
Highlights of the FY2003 budget include an increase in the annual salary cap for investigators
to $171,900; an increase in the Program/Evaluation tap from 1.25% to 2.1% (for the NEI this is
an increase from $7 M to $12 M); and an across-the-board rescission of 0.65% ($4 M for the NEI).

The FY2004 President’s budget request calls for a 3.4% increase for the NIH and a 2.4%
increase for the NEI (to $648.3 M). The Citizen Witness hearings endorsed an NEI budget at a
level of $711 M, which would allow the NEI to achieve a doubling of the budget from the FY1998
level. Dr. Zadnik discussed her citizens’ testimony on behalf of the American Optometric
Association, and indicated that she stressed the needs and opportunities for prevention research.


Extramural Budget Trends

Dr. McNicol reviewed the NEI FY2003 extramural research program operating policies. The NEI
has funded non-competitive continuations (Type 5) at the recommended level. Competitive grants
(Types 1 and 2) have been funded at a level determined by staff after a case-by-case review of
the requested budget. The total number of funded research project grants is anticipated to be
1204, a 4.2% increase over the level of FY2002. The research project grant success rate will
be 33.2% for FY2003, compared with 40.6% for FY2002. This decrease in the rate is due to a
large increase in the number of grants submitted, 959 in FY2003 compared with 761 in FY2002 (a
26% increase).

Dr. McNicol reviewed the anticipated funding level of various extramural programs compared
with the FY2002 levels. The center core grant program will have a 3.2% increase in funds. The
Small Business programs will increase from 54 to 59 competitive awards. Collaborative Clinical
Research will increase by 7.7%. And the Loan Repayment Programs will double.

Dr. McNicol discussed the new Vision Research Infrastructure Development Award program which
was initiated this year. Eleven applications were submitted and eight were funded, for a total
investment of $2.5 M.


New NIH Small Grant and Exploratory/Developmental Grant Programs

Dr. Fisher described two new NIH-wide grant programs in which the NEI will participate. The
first is an R03 Small Research Grant program. Its purpose is to provide limited time and funds
to explore a small project, two years and $50,000 annual direct costs. This will be a
non-renewable award, which does not require preliminary data, and which will be reviewed in CSR
study sections. In addition to the NIH R03, the NEI will continue to support both the NEI
Small Grants for Pilot Research program (three years, $100,000 annual direct costs) and the NEI
Small Research Grants for Data Analysis program (two years, $150,000 annual direct costs).
These will be reviewed in study sections convened by the NEI.

Dr. Fisher indicated that the second new NIH program is one for high risk/high impact
research. The NIH R21 Exploratory/Developmental Grant program is designed to provide funds to
assess the feasibility of a novel area of research or a new experimental system; or the
innovative use of existing technology to explore a new area of research. This mechanism will
provide up to $275,000 direct costs over a two year period. The grant is not renewable, no
preliminary data is required, and the application will be reviewed in a CSR study section. In
addition to the NIH R21, the NEI will continue to support both the Clinical Study Planning
Grant program and the Clinical Vision Research Development Award programs.


Concept Clearance: Joint NSF/NIH Program, Collaborative and Innovative Research in Computational Neuroscience

Dr. Michael D. Oberdorfer, Director, Strabismus, Amblyopia, and Visual Processing Program,
described a new initiative which the NEI proposes to support. This will be a reissuance of an
FY2002 Request for Applications, “Joint NSF/NIH Initiative to Support Collaborative Research in
Computational Neuroscience”. That program supported research that focused on integrating
computational models and methods with neuroscience. Over 100 applications were submitted, and
twenty-one were funded (two by the NEI). This year’s program would emphasize both
collaborative and innovative computational neuroscience research. Council was enthusiastic at
the opportunities for continued vision research in this area and endorsed the concept of the
revised program.


Guidelines for Use of Animals in Neuroscience and Behavioral Research

Dr. Oberdorfer informed Council members of NEI participation with seven other NIH Institutes
and the Office of the Director, NIH, in funding a contract to prepare a report, “Guidelines for
Use of Animals in Neuroscience and Behavioral Research”. This document was prepared by the
Institute for Laboratory Animal Research (ILAR), Commission on Life Sciences, the National
Academies. ILAR appointed a committee of experts who held a series of workshops to identify
common research themes in neuroscience and behavioral research, describe methods for
recognizing and minimizing any negative impact the research might have on the health and
welfare of animals, and discuss the innovations and limitations of each method. The committee
has prepared a document which will be available in both print and Cdrom versions. The report
presents a “best practices” approach to behavioral neuroscience research; it will be a valuable
guide to the scientific community and to funding agencies. It replaces NIH Publication No.
94-3207, August, 1994, “Preparation and Maintenance of Higher Mammals during Neuroscience
Experiments”. The NEI will make copies widely available to all interested parties.


Workshop Report: Pathophysiology of the Optic Nerve and Ganglion Cell Degeneration

Dr. Ellen Liberman, Glaucoma Program Director, gave an update on this NEI-sponsored workshop
held on November 12-13, 2002. The workshop examined current hypotheses of glaucoma
pathophysiology, explored whether mechanisms of chronic neurodegeneration are relevant to the
etiology of glaucoma, and discussed the key systems and models that might be explored in
neuroprotection of retinal ganglion cells. The post-meeting report has been posted on a
website for Council members to review.


Healthy Vision 2010 Community Awards Program

Ms. Rosie Janiszewski, Deputy Director, Office of Communication, Health Education, and
Public Liaison (OCHEPL), NEI described this funding program. The NEI is the lead agency for
the vision objectives of Healthy People 2010 (HP 2010), which include such topics as disease
prevention, injury prevention, preschool vision screening, and rehabilitation. The Community
Awards program was first implemented in FY2002. It was designed to provide $10,000 in seed
money for community-based organizations to develop demonstration projects which further the HP
2010 goals. Over 500 hundred applications were submitted and reviewed; they came from all 50
states and covered all HP 2010 objectives. Thirty-four applications were funded. This year
OCHEPL plans to streamline the program and increase its total funding.


Disseminating NEI Research Results

Ms. Judith Stein, Director, OCHEPL, summarized the activities her office undertakes to
publicize the results of NEI-funded clinical research. She indicated that since 1976, her
office has prepared 33 news releases, seven clinical alerts, and seven statements. She
discussed the issues which are considered in planning a dissemination activity and described
the types of products/activities which could be considered. She stressed the collaboration
between the grantee institution, study personnel and NEI staff in the preparation and
distribution of materials. As an example, she demonstrated the types of products that were
prepared for the release of results from the NEI-funded Amblyopia Treatment Study. Key
messages were identified and seven different products were developed. Evaluation results
demonstrated that over 67 million people were exposed to the story, through a combination of
print, internet, radio, and television coverage. Council members indicated their enthusiasm
for the quality and accuracy of the material presented.



Dr. Sieving adjourned the meeting at 3:55 p.m. on June 5, 2003.

Friday, June 6, 2003

Open Portion of the Meeting

Welcome and Call to Order

Dr. Sieving re-convened the open portion of the meeting on Friday, June 6, 2003, at 8:30
a.m. in Conference Room H, Executive Plaza North, National Institutes of Health (NIH),
Rockville, Maryland.

Program Planning

Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, briefly
reviewed the two-step program planning process. Phase I is the preparation of a streamlined
document which identifies recent research progress, overarching programmatic goals, and program
objectives. The second phase involves a continuous process in which workshops, symposia, and
meetings are used to highlight emerging areas of science. These activities would produce
reports to complement and update the document produced in Phase I.

Mr. Davis indicated that Council members are asked to review the Phase I material and send
any comments or suggestions through an internet site. Following incorporation of Council
member suggestions, the draft will be considered by the voluntary/professional/advocacy groups
which make up the National Eye Health Education Partnership. Following incorporation of their
suggestions, the finalized report will be published in both an internet and a print version in
September, 2003.


Presentation of Phase I Program Panel Draft Reports

Dr. McNicol indicated that all six program panels have met and prepared draft documents.
These drafts, along with rosters of the panel members, were sent to Council members in advance
of the meeting.

Each program gave a brief overview of its Phase I report, which was followed by extensive
Council discussion. Members identified topics which should be deleted, added, or expanded, and
they suggested topics for Phase II workshops.



Dr. Sieving adjourned the meeting at 11:30 a.m. on June 6, 2003.


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

Dr. Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute

Paul A. Sieving, M.D., Ph.D.
National Advisory Eye Council
National Eye Institute

These minutes were approved by the Council at the September 11-12, 2003 meeting. A complete,
printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Karen R. Tolson
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: ktolson@nei.nih.gov



Attachment A



(Terms end 11/30 of the designated year)

Ruben Adler, Ph.D. (05)
Department of Ophthalmology
600 N Wolfe St Maumenee 519
Johns Hopkins University School Med.
Baltimore, MD 21287-9257

Roy Beck, M.D., Ph.D. (05)
Jaeb Center for Health Research
Suite 9, 3010 East 138th Avenue
Tampa, FL 33613

Suraj P. Bhat, Ph.D. (06)
Department of Ophthalmology
Jules Stein Eye Institute
100 Stein Plaza, BH623
Los Angeles, CA 90095-7000

Martha C Constantine-Paton, Ph.D. (03)
Professor of Biology
Massachusetts Institute of Technology
Cambridge, MA 02139

Gordon E. Legge, Ph.D. (03)
Department of Psychology
University of Minnesota Twin Cities
75 E River Rd N218 Elliott Hall
Minneapolis, MN 55455-0344

Mildred M. G. Olivier, M.D. (04)
President and CEO
Midwest Glaucoma Center, P.C.
1575 N Barrington Rd, Suite 105
Hoffman Estates, IL 60194

Richard J. Salem, J.D. (04)
Senior Partner
Salem Saxon, P.A.
101 E Kennedy Blvd, suite 3200
Tampa, FL 33602

Lois E. Smith, M.D. (06)
Department of Ophthalmology
Harvard Medical School
300 Longwood Ave
Boston, MA 02115

P. Sarita Soni, O.D. (03)
School of Optometry
Indiana University
800 E Atwater
Bloomington, IN 47405

J. Wayne Streilein, M.D. (04)
President and Director of Research
Schepens Eye Research Institute
20 Staniford St
Boston, MA 02114

Janey Wiggs, M.D., Ph.D. (06)
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
243 Charles St
Boston, MA 02114

Karla Zadnik, O.D., Ph.D. (04)
College of Optometry
Ohio State University
338 West 10th Ave
Columbus OH 43210-1240

Department of Defense Representative

Lt. Col. J. Brian Reed, M.D.
Chief, Vitreoretinal and Uveitis Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Department of Veterans Affairs Representative

Marco Z. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103

Ex Officio Members

Tommy G. Thompson
Department of Health & Human Services
Washington, DC 20201

Elias A. Zerhouni, M.D.
National Institutes of Health
Bethesda, MD 20892


Paul A. Sieving, M.D., Ph.D.
National Eye Institute
National Institutes of Health
Bethesda MD 20892

Executive Secretary

Loré Anne McNicol, Ph.D.
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892