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Home » About NEI » National Advisory Eye Council » NAEC Meeting Minutes February 4, 1999

NAEC Meeting Minutes

Department of Health and Human Services
National Institutes of Health

National Eye Institute

February 4, 1999

The National Advisory Eye Council (NAEC) convened for its ninety-first meeting at 8:30 a.m. on Thursday, February 4, 1999, 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. M. Rosario Hernandez
Dr. Dean Bok Dr. David H. Hubel
Dr. Constance Cepko Dr. Anthony B. Nesburn
Mr. Sanford Cloud, Jr. Dr. Larry J. Takemoto
Lt. Col. William J. Flynn (Ex Officio) Dr. Marco A. Zarbin (Ex Officio)
Mr. Richard T. Hellner Dr. David S. Zee

Council members absent: Ms. Patricia A. Cleary and Dr. Millicent Knight

Special Council Consultant: Dr. Marian R. Fisher

NEI Staff Present:

Ms. Margie Baritz
Dr. Mary Frances Cotch
Mr. Michael Davis
Ms. Linda Dingle
Ms. Judith A. Duff
Ms. Lois Eggers
Mr. Donald F. Everett
Ms. Carol Fivozinsky
Dr. Maria Y. Giovanni
Dr. Ralph J. Helmsen
Ms. Rosemary Janiszewski
Ms. Tina E. Jones
Dr. Natalie Kurinij
Dr. Ellen Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Lore' Anne McNicol
Ms. Kathleen Moy
Dr. Robert B. Nussenblatt
Dr. Michael Oberdorfer
Ms. Karen Robinson Smith
Dr. Robert Sperduto
Ms. Judy Stein
Mr. John Whitaker
Dr. Barbara Wiggert

Other NIH Staff Present:

Dr. Richard Fisher, NIDCD
Dr. Luigi Giacometti, CSR
Dr. Chyren Hunter, NIDCD
Dr. Carole Jelsema, CSR
Mr. David Lisle, OD

Food and Drug Administration Staff Present:
Dr. Wiley Chambers
Dr. Nancy Brogdon

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

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology
Ms. Maggie Donahue, Capitol Associates
Dr. Israel A. Goldberg, Health Research Associates
Ms. Carrie Kovar, American Academy of Ophthalmology
Ms. Fran Marchbank, Association for Research in Vision and Ophthalmology
Dr. Paul O'Brien, Health Research Associates
Dr. Elaine Young, Juvenile Diabetes Foundation International
Dr. John Whitener, American Optometric Association

Open Portion of the Meeting


I. Call to Order and Opening Remarks

Dr. Jack A. McLaughlin, Deputy Director, NEI, called the meeting to order and welcomed the Council members and guests. He introduced four new Council members: Drs. Bok, Hernandez, Takemoto, and Zarbin.

Dean Bok, Ph.D., is Dolly Green Professor, Department of Ophthalmology; Professor, Department of Neurobiology; and Member, Jules Stein Eye Institute, University of California, Los Angeles. He is an internationally recognized authority on the cell and molecular biology of the normal and diseased retina. He has received, among many honors, the Friedenwald Award from the Association for Research in Vision and Ophthalmology, and the MERIT award from NEI. Dr. Bok is a former member and Chair of the NIH Visual Sciences C Study Section, and he also served on NEI's Board of Scientific Counselors. Dr. Bok was Co-Chair of the Retinal Diseases Panel for Vision Research -- A National Plan: 1999-2003.

M. Rosario Hernandez, D.D.S., is Associate Professor, Ophthalmology and Visual Sciences, and Associate Professor, Neurobiology, Washington University, St. Louis, Missouri. She is a highly-regarded scientist and an authority on research aimed at uncovering the underlying cellular and molecular mechanisms involved in glaucomatous optic neuropathy. Dr. Hernandez is a long-time grantee of the NEI and frequently serves as a reviewer on NIH initial review groups. She was a member of the Glaucoma Panel and played an important role in the development of the National Plan.

Larry J. Takemoto, Ph.D., is Professor of Biology, Kansas State University, Manhattan, Kansas. He is known for his outstanding research on the structure and function of proteins from the lens of the eye. The objective of much of his current work is to identify and quantitate modifications in these proteins from aged normal and cataractous human lenses. Dr. Takemoto has served on the NIH Visual Sciences A Study Section and the NEI Board of Scientific Counselors. He served as Chair of the Lens and Cataract Panel for the most recent NEI program planning effort.

Marco A. Zarbin, M.D., Ph.D., is Professor and Chairman, Department of Ophthalmology, and Associate Professor of Neurosciences, New Jersey Medical School, Newark, NJ,. A vitreoretinal surgeon, he holds the position of Staff Physician at the East Orange, New Jersey Veterans Administration Hospital. Dr. Zarbin serves on the Council as the Ex Officio representative of the Veterans Administration, replacing Dr. Hatchell in this capacity. He is a frequent reviewer for NIH study sections, most recently as a member of Visual Sciences C. Dr. Zarbin is a member of the Scientific Advisory Board of the Foundation Fighting Blindness. His major research interests are cellular therapy for ocular disease, including retinal pigment epithelium transplantation, and age-related macular degeneration.

Dr. McLaughlin announced that Dr. Millicent Knight and Ms. Patricia A. Cleary, a new Council member, were not able to attend the meeting. He then introduced and thanked Dr. Marian R. Fisher who had agreed to participate in the meeting as a Special Council Consultant. Dr. Fisher, a former member of the Council, holds the position of Senior Scientist, Department of Biostatistics, University of Wisconsin Medical School, Madison, Wisconsin. Finally, Dr. McLaughlin introduced Ms. Judith Duff who had recently been named Executive Officer, NEI.

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 September 17, 1998 Council meeting were considered next and approved as submitted.

IV. Future Meeting Dates

The following dates were agreed upon for future Council meetings:

June 10, 1999
September 16, 1999
February 10-11, 2000
June 8-9, 2000
September 14-15, 2000

V. Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the budget situation for Fiscal Years 1999 and 2000 (Attachment B). She said that after a series of short-term spending measures, NEI received a Fiscal Year (FY) 1999 budget of $397.0 million, an increase of 11.7% over the FY 1998 budget. The NIH received an increase of about 15% overall.

Ms. Fivozinsky reviewed the FY 2000 President's Budget (PB) request for NIH. She said that the PB proposed a $15.9 billion dollar budget for NIH, an increase of 2.1% over FY 1999. NEI's budget is proposed to increase by $9.5 million (2.4%) to $406.5 million, a percentage increase in line with that proposed for the other Institutes and Centers.

VI. Extramural Research Program

Dr. McLaughlin reviewed the latest budget estimates for the extramural research program for FY 1999. He said that FY 1999 would be a good year for vision research, and that NEI would be able to fund approximately 1,015 research project grants in FY 1999, 28 more that it funded in FY 1998. Dr. McLaughlin said that the success rate for FY 1999 competing research project grants would be approximately 38-40%. He said that competing grants, on average, would not be cut from the levels recommended by study sections. NEI should be able to fund two new Core grants and to increase the average cost of these awards as well. Dr. McLaughlin said that the "Other" research category would also be increased to expand support for clinical career development awards and to fund new cooperative clinical research projects. He said that NIH had increased training stipends by 25%.

VII. NEHEP Low Vision Program

Ms. Rosemary Janiszewski, Director of the National Eye Health Education Program (NEHEP), presented plans for a new Low Vision Public Education Program. She reviewed discussions that had been held with the Ad Hoc Working Group on Low Vision and the NEHEP Partnership, and the concerns expressed by focus groups conducted with middle-aged and older people with self-reported visual impairments. She said that the overall goal of the Program would be to improve the quality of life for individuals who have reduced vision that interferes with their activities of daily living. Program launch is planned for the fall of 1999.

Ms. Janiszewski said that the primary objective of the first phase would be to raise awareness about visual impairment and the benefits of vision rehabilitation. The primary audience would be people aged 65 and older. Secondary audiences would include primary care physicians and other health professionals, managed care organizations, eye care professionals, family and friends, social service and aging networks. Ms. Janiszewski said that for the consumer, she wanted the Program to convey two messages: (1) information and help are available and, (2) people with low vision are not alone. For the health professional, she said that the Program would seek to dispel the perception that nothing can be done to help people with low vision once corrective lenses or medical treatment no longer work.

Ms. Janiszewski said that NEI was planning a multifaceted public health education effort that will include an array of educational materials that are central to increasing public awareness. She said that the Program will also use print, electronic and broadcast media; grassroots outreach; and professional education, and rely heavily on the expertise and experience of the NEHEP Partnership in planning, executing and promoting the program. The Council expressed its approval of this new NEHEP project.

VIII. Vision Screening In The Preschool Child

Dr. Michael D. Oberdorfer, Program Director, Extramural Research Program, and Mr. Hellner discussed the background and proceedings of a September 10-11, 1998, workshop entitled "Vision Screening in the Preschool Child" held in Rockville, Maryland. This workshop was sponsored by the Health Resources and Services Administration with consultation from NEI. The purpose of the workshop was to evaluate issues related to early vision screening. One objective was to promote interdisciplinary interaction among diverse researchers and practitioners required to critique, evaluate, and plan screening initiatives and to conduct research. At the time of the workshop, there did not appear to be consensus on any single approach. Therefore, longer term outcomes of the workshop would be a definition of the research questions that need to be addressed in order to optimally evaluate vision screening programs, and the proposal of specific research protocols for evaluation. It was mentioned that NEI was funding an investigator-initiated pilot study aimed at evaluating a battery of screening tests administered by lay persons to identify children in need of a detailed eye exam.

IX. Healthy People 2010

Ms. Janiszewski and Mr. Hellner discussed planning activities for Healthy People 2010, the Department of Health and Human Service's compilation of health promotion and disease prevention objectives. Healthy People objectives have been specified by Congress as the metric for measuring the progress of the Indian Health Service, the Maternal and Child Health Block Grant, and the Preventive Health and Health Services Block Grant. Healthy People Objectives have also been used in a variety of performance measurement activities. Ms. Janiszewski said that NEI had agreed to accept responsibility as the lead agency for a new focus area on blindness and visual impairment. Mr. Hellner described the interest of his organization, Prevent Blindness America, and that of other organizations in having vision health included in the 2010 objectives. Working with the NEHEP partnership and other groups and individuals, Ms. Janiszewski indicated that NEI had identified 19 new objectives and found a number of related objectives in other sections. The Council strongly encouraged NEI to continue its efforts to develop a coordinated response for DHHS consideration.

X. Modular Grant Applications and Awards

Dr. Loré Anne McNicol, Acting Director, Vision Research Program, NEI, discussed various aspects of the NIH modular grants initiative. The modular grant program was published in the NIH Guide on 12/15/98 and is available on the NIH website at http://www.nih.gov/grants/policy/policy.htm. A modular grant is one in which the budget is not compiled from detailed budget categories, but is instead requested in modules of $25,000. The initiative, which begins on April 1, 1999, applies to investigator-initiated R01, R03, R15, R21, R41, and R43 grants or responses to RFA which request no more than $250,000 direct costs in any one year. The purpose of the modular grants initiative is to streamline the grant application process, reduce administrative burdens, focus the merit review process on science, and emphasize the NIH research project grant as a grant-in-aid mechanism. The modular grant application will present an over-all, modular budget, supported by a narrative which describes personnel positions, roles, and levels of effort; equipment; patient care costs; consortium or contractual arrangements; and alterations and renovations. Initial review groups will evaluate this budget on the basis of a general, expert estimate of total effort and resources needed, recommending any changes in $25,000 modules or in suggested changes in level of effort or elimination of specific aims and/or experiments. NIH staff will evaluate overlap issues and fund awards at or close to the recommended levels with no categorical budgetary breakdown. During post-award management, current rebudgeting requirements will be eliminated, supplements will be permitted, and Financial Status Reports will only be required at the end of a project period.

XI. Trans-NIH Initiatives

Dr. McNicol next discussed a number of NIH initiatives in which NEI was participating. She prefaced her remarks by saying that NEI remains committed to maximizing the funding of individual investigator-initiated research. However, in order to implement both specific NEI program objectives identified in "Vision Research--A National Plan: 1999-2003" as well as multi-disciplinary trans-NIH scientific initiatives, NEI is participating in a number of special research initiatives. These new initiatives are published in the NIH Guide, either as Program Announcements, Notices, or Requests for Applications (RFAs). Information regarding all current funding opportunities is available on the NEI website at http://www.nei.nih.gov.

There are several pending initiatives in the areas of Mouse Genomics, Autoimmunity, and research training. The NEI intends to participate in those multi-disciplinary, NIH initiatives that support vision research objectives. NEI will inform the research community of these programs through the NEI web page. And, whenever special funds are available, the e-mail alert network of the Association for Research in Vision and Ophthalmology will be used to highlight the opportunity.

XII. Report of the Diabetes Working Group

Dr. Peter A. Dudley, Program Director, Extramural Research Program, discussed the status of the broad diabetes research initiative at NIH and specifically the role of the NEI in several RFAs that have been issued. He discussed the involvement of the NEI in an RFA entitled, "Pathogenesis and Therapy of Complications of Diabetes" that was issued in FY 1998. The NEI funded several R01-type projects as a result of applications sent in response to this RFA. Supplemental awards to existing NEI-funded projects were also made during FY 1998. The NEI is also participating in another RFA in FY 1999 entitled, "Pilot Studies for New Therapies for Type 1 Diabetes and Its Complications." Applications in response to this RFA have a receipt date of March 31, 1999, with awards to be made in FY 1999.

XIII. Council Operating Procedures

Dr. McLaughlin reviewed the formal guidelines for Council operations which cover procedures for the Council review of grant and cooperative agreement applications, and for staff negotiations and administrative actions concerning projects recommended previously by the Council. Following a brief discussion, Council voted unanimously to approve a minor change in operating procedures such that ordinarily only applications which have been scored and are within the funding range are presented to Council for special consideration. All applications not identified for special consideration are reviewed en bloc. The approved Council Operating Procedures are presented in Attachment C.

XIV. Inclusion of Women and Minorities in Clinical Research

Dr. Jack McLaughlin summarized the requirement in The NIH Revitalization Act of 1993 that the Advisory Council / Board of each NIH Institute or Center shall prepare biennial reports, for inclusion in the NIH Director's Biennial Report, describing the manner in which the Institute or Center has complied with the provisions of the statute regarding the inclusion of women and minorities as subjects in clinical research. He had previously reviewed with Council policy and procedures adopted by the NIH as implemented by the NEI with regard to the inclusion of women and minorities as subjects in clinical research. Based on this review, the Council had certified NEI compliance with the pertinent provisions of the NIH Revitalization Act of 1993. The Council was satisfied that studies that did not meet the standard were being properly identified by NIH staff, by Study Sections, and by the Council. Appropriate administrative procedures were felt to be in place to resolve any problems that were discovered. The Council was satisfied that these types of issues are being handled in an appropriate manner and unanimously approved a statement to this effect.

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).

XV. Review of Intramural Research Program

The Council considered the Report of the Committee to Review the National Eye Institute Intramural Research Program and the reviews and recommendations of the Board Of Scientific Counselors (BSC) for the Laboratory of Retinal Cell and Molecular Biology and the Division of Biometry and Epidemiology. Drs. Barbara Wiggert and Robert Sperduto were present during the discussions to provide information and answer questions regarding implementation of the BSC recommendations.

XVI. Review of Research and Training Applications

The Council considered 292 research and training applications requesting $333.0 million in total costs. The Council recommended 285 applications with a total cost of $317.0 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 February 4, 1999.

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.
Chair
National Advisory Eye Council
Director
National Eye Institute

These minutes will be submitted for the approval of the Council at the June 10, 1999, 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
e-mail: lmd@nei.nih.gov

05/24/99


Attachment A

National Advisory Eye Council

National Eye Institute

(Terms end 11/30 of the designated year)

Roster

Adams, Anthony J., O.D., Ph.D. (00)
Dean and Professor of Vision Science & Optometry
School of Optometry
University of California, Berkeley
Berkeley, CA 94720

Bok, Dean, Ph.D. (02)
Professor
Jules Stein Eye Institute
University of California, Los Angeles
Los Angeles, CA 90095

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

Cloud, Jr., Sanford (01)
President & CEO
The National Conference
71 Fifth Avenue
New York, NY 10033

Hellner, Richard T. (00)
President & CEO
Prevent Blindness America
Schaumburg, IL 60173

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

Hubel, David H., M.D. (99)
John Franklin Enders
Professor of Neurobiology
Harvard Medical School
Boston, MA 02115

Nesburn, Anthony B., M.D. (00)
Director
Ophthalmology Research Laboratories
Cedars-Sinai Medical Center
Los Angeles, CA 90048

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

Zee, David S., M.D. (99)
Professor of Neurology, Ophthalmology,
  Otolaryngology & Neuroscience
Johns Hopkins University
School of Medicine
Baltimore, MD 21287

Special Council Consultant

Fisher, Marian R., Ph.D.
Senior Scientist
Department of Biostatistics
University of Wisconsin Medical School

Ex Officio Members

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

Varmus, Harold, M.D.
Director
National Institutes of Health
Bethesda, MD 20892

Kupfer, Carl, M.D. (Chair)
Director
National Eye Institute
National Institutes of Health
Bethesda, MD 20892

Department of Veterans Affairs Representative

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

Department of Defense Representative

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

Executive Secretary

McLaughlin, Jack A., Ph.D.
Deputy Director
National Eye Institute
National Institutes of Health
Bethesda, MD 20892

Attachment B

National Eye Institute
(Dollars in thousands)

 

FY 1998
Actuals

FY 1999
Appropriations
FY 1999
Compared to
FY 98 Actuals
FY 2000
Present Budget
FY 2000
Compared to
FY 99 Appropriations
Research Grants $291,627  $323,879  11.1%  $332,048  2.5% 
Training 8,086  10,205  26.2%  10,205   0.0%
R & D Contracts 8,351  11,867  42.1%  12,152  2.4% 
Intramural Research 36,545  39,500  8.1%  40,448  2.4% 
Research Managment & Support 10,787  11,571  7.3%  11,686  1.0% 
           
TOTAL $355,396  $397,022    $406,539   
% Increase over prior
year
    11.7%    2.4% 

National Advisory Eye Council
Operating Procedures

February 1999

Review of Grant and Cooperative Agreement Applications

All applications having undergone initial review shall be reviewed by the Council. Applications not identified for special consideration are reviewed en bloc.

Special Consideration

Ordinarily, only applications which have been scored and are within the funding range are presented to Council for special consideration. However, a member of Council or NEI staff may request that any individual application be discussed. No application requiring special consideration will be funded without Council review.

Applications are routinely presented to the Council for special consideration when:

Options for Council Action

The following options generally are available to Council:

  1. Concurrence with the initial review group (IRG) recommendations;
  2. Deferral for IRG reconsideration of the scientific and technical merit of an application. Council may include in its deferral action the recommendation that the re-review be carried out by a different IRG and/or that a site visit be made in the re-review of the application. If the second IRG review results in a recommendation with which the Council does not agree, the Council may nonconcur with the IRG recommendation without deferral for additional review. Awards may be made, however, only when both an IRG and Council have recommended that an application has significant and substantial merit;
  3. Deferral so that NEI staff can obtain additional information for Council consideration at a subsequent meeting;
  4. Non-concurrence with IRG recommendations based on other than scientific/technical merit considerations (this applies only to policy, procedural or administrative matters);
  5. Designation of an application as having High Program Relevance (HPR). An HPR designation elevates the relative funding position of an application but does not necessarily ensure funding. Staff will give special consideration to an HPR designation and any other Council recommendation on a program relevance issue in making a final funding decision.

Guidelines for Staff Negotiations
and Interim Administrative Actions

Each Institute has guidelines for staff to use in making adjustments in funds or duration of grants and cooperative agreements recommended by its Council, as well as in other terms and conditions. The Council reviews the guidelines annually and recommends necessary modifications. Staff actions related to the guidelines are reported to the Council at each meeting.

It is generally agreed that NEI staff may use administrative discretion to:



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