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NAEC Meeting Minutes - November 20, 2001

Department of Health and Human Services
National Institutes of Health

National Eye Institute

Minutes of Meeting
November 20, 2001

The National Advisory Eye Council (NAEC) convened for its ninety-ninth meeting at 8:30 a.m. on Tuesday, November 20, 2001, in Conference Room H, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Deputy Director of the National Eye Institute (NEI), Jack A. McLaughlin, Ph.D., presided as Chair of the Council. The meeting was closed to the public from 8:30 a.m. until 12:00 p.m. for review of the intramural research program and of grant applications. The session was open to the public from 1:15 p.m. until adjournment at 4:10 p.m. Attachment A provides a roster of Council members.

Council members present:

Dr. Dean Bok
Dr. Constance Cepko
Ms. Patricia A. Cleary
Dr. Martha C. Constantine-Paton
Dr. M. Rosario Hernandez
Dr. Gordon E. Legge
Dr. Mildred Olivier
Mr. Richard Salem
Dr. J. Wayne Streilein
Dr. Larry J. Takemoto
Dr. Karla Zadnik
Dr. Marco A. Zarbin (Ex Officio)

Council members absent:

Dr. William Flynn (Ex Officio)
Dr. P. Sarita Soni

NEI staff present:

Ms. Louise M. Amburgey
Ms. Margie E. Baritz
Dr. Rachel Caspi
Dr. Mary Frances Cotch
Mr. William W. Darby
Mr. Michael Davis
Dr. Peter A. Dudley
Ms. Lois J. Eggers
Mr. Donald F. Everett
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Mr. Paul Goldberg
Dr. Ralph J. Helmsen
Dr. Jeanette M. Hosseini
Dr. Chyren Hunter
Dr. Natalie Kurinij
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Paul A. Sieving
Ms. Karen Robinson Smith
Ms. Judy Stein
Ms. Marie E. Watkins
Mr. John Whitaker
Mr. Terry L. Williams
Dr. Robert Wurtz

Other NIH staff present:

Dr. Michael Chaitin, CSR
Dr. Mary Custer, CSR
Dr. Margaret Snyder, OD

FDA staff present:

Dr. Wiley Chambers

Members of the general public present at the open session:

Dr. Israel Goldberg, Health Research Associates
Mr. Edward McManus, National Alliance for Eye and Vision Research
Dr. Santa Tumminia, Foundation Fighting Blindness


The first 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).


Dr. Jack A. McLaughlin, Deputy Director, NEI, and Chairman of the Council, called the meeting to order. Dr. Paul A. Sieving, Director, NEI, welcomed the Council members and guests.


Dr. Loré Anne McNicol, Director, Division of Extramural Research, 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 signed a statement certifying that they were absent during such discussions.


The Council considered 320 research and training applications requesting $447.6 million in total all year costs. The Council recommended 309 applications with a total all year cost of $439.1 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.


As required by the Public Health Service Act, each NIH Institute annually provides its Council a written description of the research reviewed by its Board of Scientific Counselors (BSC), and the results of that review. The Council may make recommendations to the Director, NEI, regarding this research. The Council considered the BSC review and recommendations for the Laboratory of Immunology (LI), Part 2. Dr. Rachel Caspi, Chief, Immunoregulation Section, LI, gave a presentation on her work involving investigations of experimental uveitis as a paradigm to clarify the pathogenesis of immune-mediated disease. Dr. Robert Wurtz, Acting Scientific Director, NEI, was available to present his response to the report and to answer questions regarding implementation of the BSC recommendations.



Dr. Sieving welcomed guests attending the open portion of the meeting. He announced that this was the last Council meeting for Dr. Constance Cepko, and thanked her very gratefully for her service to the NEI during her tenure on the Council.

Dr. McNicol introduced Dr. Maryann Redford, who has joined the NEI as a Program Director in the Collaborative Clinical Research group. Dr. Redford received a B.S. in Biology from Adelphi University, a D.D.S. in Dentistry from Georgetown University, and an M.P.H. in Epidemiology from the Uniformed Services University of the Health Sciences. Following postdoctoral work in clinical trials under Dr. Curtis Meinert at the Johns Hopkins University School of Hygiene and Public Health, she worked as Director of the Clinical Trials Program at the National Institute of Dental and Craniofacial Research. In this position she developed the infrastructure to support clinical trials research and to facilitate the development, submission, and awarding of clinical trial applications.


Dr. McNicol introduced Dr. Margaret Snyder, Director, Office of Scientific Affairs, Office of Extramural Research, Office of the Director, NIH. At the June, 2001, Council meeting, members had expressed concerns with the costs-both in money and time-of compliance with NIH animal welfare regulations. Dr. Snyder presented some perspective on pending legislation in this area, including: rule making at the United States Department of Agriculture on issues involving the use of rats, mice, and birds; Office of Management and Budget (OMB) review of a Federal Register notice of non-policy suggestions regarding primate enrichment from a national workshop; and “puppy mill” regulations which are opposed by the American Kennel Club. Dr. Snyder described the activities of the NIH Regulatory Burden Committee. It seeks to encourage the development of regulations which dictate results rather than process, and to develop collaborative relationships with the research community and interested public groups.


Dr. Peter A. Dudley, Director, Retinal Diseases Program, presented an overview of NEIBank activities. The 1999 NEI Functional Genomics Workshop had recommended development of a website that would present genetic resources as practical and useful tools for the vision research community. The site is now active, and it is located at http://neibank.nei.nih.gov Dr. Dudley indicated that the site is maintained by Dr. Graeme Wistow, Chief, Section on Molecular Structure and Function, NEI, and his staff, in collaboration with an Executive Committee of extramural scientists. Future plans include developing links to proteomics and DNA microarray data. Council members indicated that the site was very useful and urged the NEI to continue expanding the information available.


The minutes of the June meeting were considered and approved.


Dr. McNicol reminded the group that the Council previously established the following meeting dates:

February 14-15, 2002
June 13-14, 2002
September 12-13, 2002

Members were asked to reserve these dates. Council members will be contacted as soon as staff knows whether a one or a two day meeting will be needed this February.


Ms. Carol Fivozinsky, Budget Officer, NEI, summarized details of the FY2001 NEI budget. It marked the third year of a proposed five year doubling of the NIH budget. The actual appropriations have fallen a bit short of that goal, but both the NEI and the NIH have enjoyed double digit increases.

The NIH is presently operating under a continuing resolution. Ms. Fivozinsky reviewed the FY2002 budgets proposed by the President, and recommended by the House and Senate. Proposed appropriations for the NEI range from $571 million to $614 million, compared with $511 million for FY2001 (increases ranging from 12% to 21%).

Mr. Edward McManus, Executive Director, National Alliance for Eye and Vision Research, described the Alliance’s recent advocacy activities. In collaboration with the Foundation Fighting Blindness, Alliance members developed a legislative agenda, visited congressional offices, and sponsored a congressional reception. During these visits, Alliance members were able to present information about national opportunities in vision research.


Dr. McNicol reviewed the FY2001 extramural research budget. Highlights of the year include a 39.7% award rate for research project grants, a 20% increase in the level for P30 Center Core Grants, $2.5 million in funding for ten new DNA Microarray Supplements, and investments in a variety of genomic resources. The initial response to the R03 Small Grants for Pilot Research program was extremely strong, and 31% of the applications were funded. The NEI received approximately $3.6 million in budget transfers from other NIH components to fund multidisciplinary research in areas such as ocular melanoma, bioengineering, gene mapping, and autoimmunity. In addition, budgetary increases have allowed the NEI to participate in a number of new collaborative scientific initiatives including: the enrollment of special populations in several on-going clinical trials; training initiatives in Bioethics, International Bioethics, Interdepartmental Neurosciences, Clinical Research Curriculum Development, and Minority Institution Clinical Research Infrastructure.

Dr. McNicol next described two changes in operating procedures that the staff was proposing for FY2002. In the area of research training, in order to stimulate recruitment of clinician scientists, the staff recommended elimination of the ceiling on the number of postdoctoral positions on T32 Institutional National Service Awards. Rather than allowing a maximum of two postdoctoral positions, applicants would be allowed to request and justify the mix of pre- and post-doctoral positions requested. For P30 Center Core Grants, staff proposed tiered budgets that would permit institutions holding 20 or more eligible NEI grants to request up to $2.5 million in direct costs over a five year period. The budgets for institutions holding fewer than 20 eligible NEI grants would remain at $2 million in direct costs over a five year period. Council members enthusiastically endorsed both recommendations.

Dr. McNicol presented concepts for several new scientific initiatives to be pursed in FY2002:

Program Announcements

Novel Therapeutic and Pathogenetic Studies of Oculomotor Disorders
Molecular Genetic Studies of Craniofacial Muscle Development, Regeneration, & Aging
Novel Approaches for Corneal Tissue Engineering
Vision Research Infrastructure Development Grants

Requests for Applications

Ocular Albinism and the Neuroscience of Retinal Ganglion Cell Axon Guidance
Innovative Strategies and Assistive Technologies for Enhanced Visual Function
Visual System Tissue Engineering Initiative
Development of Innovative Technologies for Vision Research

Council members approved the development of these concepts.


Mr. Michael P. Davis, Associate Director for Science Policy and Legislation, presented the history of NEI program planning activities and the process of preparing five year iterations of “Vision Research: A National Plan” He indicated that the next five year planning cycle would begin in Spring, 2002. Traditionally, these plans have presented an overview of NEI programmatic goals and organization, reviewed recent scientific accomplishments, and presented future research priorities. Since 1999, in response to the Government Performance and Results Act (GPRA), the NEI has submitted annual performance plans and assessments to the OMB and the Congress. Mr. Davis discussed the desirability of integrating preparation of the National Plan with GPRA requirements.


Dr. Chyren Hunter, Training Officer, presented background information regarding the legislative basis of NIH support for research training, and reviewed those funding mechanisms employed by the NEI. She underscored the NEIÕs long-term support for initiatives designed to increase the numbers of clinician scientists engaged in vision research, and reviewed recent trends of increased NEI participation in multidisciplinary training of basic vision scientists.


Dr. McLaughlin adjourned the meeting at 4:10 p.m. on November 20, 2001.


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

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

Jack A. McLaughlin, Ph.D.
National Advisory Eye Council
Deputy Director
National Eye Institute

These minutes will be submitted for the approval of the Council at the February 8, 2001, meeting. Any corrections or notations will be incorporated into the minutes of that meeting. A complete, printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Marie E. Watkins
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-5561
FAX: (301) 402-0528
e-mail: mew@nei.nih.gov


Attachment A

(Terms end 11/30 of the designated year)

Dean Bok, Ph.D. (02)
Professor of Neurobiology, Ophthalmology
University of California, Los Angeles
Los Angeles, CA 90095-1763

Constance Cepko, Ph.D. (01)
Professor of Genetics
Harvard Medical School
Boston, MA 02115

Patricia A. Cleary, M.S. (02)
Senior Research Staff Scientist
The George Washington University
Rockville, MD 20852

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

M. Rosario Hernandez, D.D.S. (02)
Assoc. Professor of Ophthalmology and Visual Sciences
Washington University
St. Louis, MO 63110

Gordon E. Legge, Ph.D. (03)
McKnight Distinguished University Professor of Psychology
University of Minnesota Twin Cities
Minneapolis, MN 55455-0344

Mildred M. G. Olivier, M.D. (04)
President and CEO
Midwest Glaucoma Center, P.C.
Hoffman Estates, IL 60194

Richard J. Salem, J.D. (01)
Senior Partner, Salem Saxon, PA
Tampa, FL 33602
P. Sarita Soni, O.D. (03)
Professor of Optometry and Visual Science
Indiana University
Bloomington, IN 47405

J. Wayne Streilein, M.D. (04)
President and Senior Scientists
Schepens Eye Research Institute
Boston, MA 02114

Larry J. Takemoto, Ph.D. (02)
Professor of Biology
Kansas State University
Manhattan, KS 66506

Karla Zadnik, O.D., Ph.D. (04)
Associate Professor
College of Optometry
Ohio State University
Columbus, OH 43210-1240

Department of Veterans Affairs Representative

Marco Z. Zarbin, M.D., Ph.D.
Professor and Chairman
Department of Ophthalmology
UMDNJ-New Jersey Medical School
Newark, NJ 07103

Department of Defense Representative

Lt. Col. William J. Flynn, USAF, MC, M.D.
Department of Ophthalmology
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Ex Officio Members

Donna E. Shalala, Ph.D.
Department of Health and Human Services
Washington, DC 20201

Ruth L. Kirschstein, M.D.
Principal Deputy Director
National Institutes of Health
Bethesda, MD 20892


Jack A. McLaughlin, Ph.D.
Deputy Director
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