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Home » About NEI » National Advisory Eye Council » NAEC Meeting Minutes January 23, 1997

NAEC Meeting Minutes

Department of Health and Human Services
National Institutes of Health

National Eye Institute

January 23, 1997

The National Advisory Eye Council (NAEC) convened for its eighty-fifth meeting at 8:30 a.m. on Thursday, January 23, 1997, 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 12 noon, followed by the closed session until adjournment at 4:45 p.m. Attachment A provides a roster of Council members.

Council members present:

Dr. David C. Beebe

Ms. Sue Dauphin

Dr. Marian R. Fisher

Dr. Diane L. Hatchell (Ex Officio)

Dr. Eve J. Higginbotham

Dr. David H. Hubel


Dr. Millicent L. Knight

Dr. Carl Kupfer (Ex Officio)

Dr. Ken Nakayama

Dr. Roy H. Steinberg

Dr. David S. Zee

Council members absent: Capt. David O. Mazur (Ex Officio)

Special Council Consultant: Dr. Paul A. Sieving

NEI Staff Present:

Ms. Margie Baritz

Dr. Mary Frances Cotch

Mr. Michael Davis

Dr. Peter A. Dudley

Ms. Lois Eggers

Mr. Donald F. Everett

Dr. Maria Y. Giovanni

Ms. Carolyn E. Grimes

Dr. Ralph J. Helmsen

Dr. Peter F. Kador

Dr. Natalie Kurinij

Ms. Kim Lien Lam

Dr. Ellen Liberman


Dr. Andrew P. Mariani

Dr. Jack A. McLaughlin

Dr. Loré Anne McNicol

Mr. Edward H. McManus

Dr. Carmen P. Moten

Ms. Kathleen Moy

Dr. Robert B. Nussenblatt

Dr. Michael D. Oberdorfer

Ms. Karen Robinson Smith

Ms. Judy Stein

Mr. John Whitaker

Dr. J. Samuel Zigler, Jr.

Other NIH Staff Present:

Ms. Carol F. Alderson, OD
Dr. Luigi Giacometti, DRG
Dr. Leonard Jakubczak, DRG
Dr. Carole Jelsema, DRG

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. Nielsen Habbs, Blue Sheet
Mr. Steve Miller, American Academy of Ophthalmology
Ms. Lois Schoenburn, American Academy of Optometry
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 Paul A. Sieving, M.D., Ph.D., Professor, Department of Ophthalmology, University of Michigan, for participating in the meeting as a Special Council Consultant. Dr. Sieving is a highly respected and productive clinician-scientist who has established a strong track record of research on the electrophysiology of the retina. In addition, he is also pursuing a new project aimed at understanding the developmental and genetic basis for human X-linked juvenile retinoschisis. Dr. Kupfer said that he was delighted that Dr. Sieving had agreed to also serve as the Co-Chair of the Retinal Diseases Program Planning Panel.

Dr. Kupfer next introduced A. Ralph Rosenthal, M.D., Director, Division of Ophthalmic Devices, Center for Devices and Radiological Health, Food and Drug Administration. From 1978 - 1984, Dr. Rosenthal was the Head, Division of Ophthalmology, Stanford University School of Medicine. In 1984 he was named the Frederick Thorpe Ulverscroft Chair of Ophthalmology, University of Leicester School of Medicine, Leicester, England.

Dr. Rosenthal joined the FDA in July, 1996. Dr. Kupfer pointed out that Dr. Rosenthal is a former trainee and grantee of the NEI. Dr. Rosenthal and Dr. Wiley Chambers, who is also from the FDA, are official Observers to meetings of the Council, and Dr. Kupfer said that he greatly appreciated their participation.

II. Confidentiality / Avoidance of Conflict of Interest

Dr. Jack A. McLaughlin, Director, Division of Extramural Research (DER), 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 September 12, 1996, were considered and approved as submitted.

IV. Future Meeting Dates

The following dates were agreed upon for future Council meetings:

June 12, 1997

September 11, 1997

January 29-30, 1998

June 11-12, 1998

September 17-18, 1998

V. Announcements

Dr. McLaughlin announced that an organizational meeting of the Vision Research Program Planning Subcommittee would be held in Conference Room H, Executive Plaza North, beginning at 8:30 a.m. the next day, Friday, January 24, 1997.

Dr. McLaughlin said that on December 13, 1996, Dr. Hatchell had attended a meeting of the National Advisory Council and Board Representatives. At the meeting, the representatives reviewed and discussed the draft reports of several working groups which had been established earlier. These include the role of Councils in: (1) Intramural Research; (2) Grant Review; (3) Strategic Planning; and, (4) Advocacy. He said that he would send the Council members a copy of the final reports when they became available. Dr. McLaughlin said that Dr. Hatchell had replaced Dr. Beebe as the Council's primary representative to this group, as Dr. Beebe had agreed to serve as the Chair of the Vision Research Program Planning Subcommittee.

VI. Extramural Research Program

Dr. McLaughlin's presentation covered the status of the FY 1997 NEI budget and the corresponding funding estimates. He also presented a more detailed year-end review of funding information for FY 1996.

The NIH received a FY 1997 budget of approximately $12.8 billion, a 6.9% increase over its 1996 budget. The NEI received a budget of $332.6 million, an increase of 6.3%. Most of the Institutes received percentage increases in this range. The exception was the National Human Genome Research Institute, which received an increase of 11.5%. Included in the NIH appropriation is a $90 million "downpayment" on the new hospital which will be called the "Mark O. Hatfield Clinical Research Center." The full costs are expected to be about $310 million, with funding spread over several years. Despite the increases provided for programs, both intramural and extramural, NIH administrative costs were held to the FY 1996 level.

There were no specific earmarks which affect the NEI budget. However, both the House and the Senate reports which accompanied the appropriation bills expressed a great deal of interest in research on Age-Related Macular Degeneration. Dr. McLaughlin indicated that this area of research would likely receive much attention during the FY 1998 budget hearings scheduled to begin the following month.

Dr. McLaughlin said that he had sent a letter in late December to all NEI grantees informing them of the FY 1997 budget and the funding policies that NEI would be following. He said that this letter would also be placed on the newly revamped NEI web site. The overall increase for extramural research will be 6.4% over the FY 1996 level. The 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.

Research Project Grants (RPGs). This category of awards includes NEI's principal mechanisms of support for individual investigator-initiated basic research, the traditional research project award (R01), the MERIT (R37) award for senior, outstanding investigators, and the FIRST (R29) award for newly-independent investigators. NEI will fund approximately 963 RPGs in total (competing and noncompeting) in FY 1997, compared to 951 in FY 1996. Dr. McLaughlin said that NEI will award noncompeting continuation RPGs in FY 1997, in nearly all cases, at the levels committed on the FY 1996 Notices of Grant Award.

Competing RPGs. Dr. McLaughlin said that approximately 263 competing RPGs will be funded in FY 1997, compared to 238 in FY 1996. The success rate (the number of applications funded divided by the number of applications reviewed) will be approximately 39%, compared to 38% in FY 1996. He indicated that the NEI will reduce competing RPG budgets by 5%, on average, from the levels recommended by the study sections. Staff will continue to conduct grant-by-grant reviews of all budget requests and recommendations. Letters of commitment to grantees will include annotated budget pages and an attachment that will provide an explanation for any reductions. Future year commitments will be calculated by using the FY 1997 award level as a base and applying a 3% escalation factor for recurring costs. Appropriate adjustments will be made for non-recurring costs, such as equipment.

The National Institutes of Health (NIH) cost management plan requires that the individual Institutes fund competing RPGs in such a way that the average length of these awards does not exceed four years. To comply with this requirement, NEI plans to continue making approximately equal numbers of three-, four-, and five-year awards. FIRST awards will be funded routinely with a full five-year commitment. However, some grants will be awarded for periods shorter than what was recommended by the study sections.

Dr. McLaughlin emphasized that the authorizing legislation for the Small Business Innovation Research Awards (SBIR) and the Small Business Technology Transfer Research Grants (STTR) mandates an increase for these programs from 2.05% of the extramural budget in FY 1996 to 2.65% in FY 1997. The percentage will then remain at this level for the next few years.

In reviewing NEI funding data from FY 1996, Dr. McLaughlin highlighted the following:

VII. Inclusion of Women and Minorities as Subjects in Clinical Research

Dr. 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.

The NIH Office of Research on Women's Health (ORWH) had prepared a draft report, which was sent to the Council members in advance of the meeting, which describes how the NIH and its review and advisory groups have implemented the policy. The report includes a description of the process utilized across NIH to implement the Act and some aggregate data for FY 1994. Dr. McLaughlin said the Council members had also been sent some aggregate enrollment data for NEI-supported Phase III clinical trials. This data was for FY 1995, but was otherwise comparable to the NIH data presented in the draft report.

The draft NIH report concludes that the policies and procedures for meeting the new requirements have been fully implemented. Studies that do not meet the standard are being properly identified, and administrative procedures allow for timely resolution of problems. There appears to be general acceptance of the goals of the policy by the scientific research community, and the level of compliance is high.

The Council reviewed the 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, with a formal unanimous vote, certified NEI compliance with the pertinent provisions of the NIH Revitalization Act of 1993.

VIII. Council Operating Procedures

Ms. Carolyn E. Grimes, Chief, Grants Management Branch, DER, NEI, 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 by the Council. No substantive changes in operating procedures were proposed by staff. The Council voted unanimously to approve the operating procedures as presented (Attachment B).

IX. Clinical Trial Planning Grants

Dr. Mary Frances Cotch, Collaborative Clinical Research, DER, NEI, provided background information regarding the NEI Clinical Trial Planning Grant and more recent staff experiences using this mechanism of support. This presentation was made in the context of the ongoing long-range program planning activities, as this mechanism of support had been an implementation item in previous planning efforts (italicized text as amended by Council on 6/12/97). The Clinical Trial Planning Grant was initiated in August, 1989. It provided support for the preparation of a Manual of Procedures and for other activities leading to the submission of detailed applications for support of a clinical trial. The application process provided a means for early peer review of the rationale for a clinical trial. The grant provided up to $50,000 in direct costs for one year. Between 1989 and 1995, 20 applications for 18 distinct projects were submitted. Seven of these applications were funded and four ultimately resulted in full-scale clinical trials. The average length of time between funding of the planning grant and the full-scale clinical trial was four years. In 1996, the scope of activities supported by this award was broadened. The mechanism was renamed the NEI Clinical Study Planning Grant and now supports the development of detailed protocols for epidemiologic studies and health services research, in addition to clinical trials.

Council inquired as to what advice the NEI staff give to investigators who approach the NEI with plans for a large-scale clinical study, specifically, the relative merits of submitting a Clinical Study Planning Grant first, versus submitting a detailed application. The advice given by NEI staff depends on a number of factors, including the relevant experience of the investigators, the resources available to them, the complexity of study protocols, and the extent of preliminary data.

Council recommended that outreach to HMOs, private practitioners, and biotechnology companies be improved in order to allow for increased access to these research resources. Council discussed increasing the maximum amount allotted under this mechanism and the length of the grant period beyond one year, but did not make a specific recommendation in this regard.

X. NRSA Training Program

Dr. Maria Y. Giovanni, Research Training Officer, DER, NEI, provided an update on the NEI's training program. Highlights of the training information presented include the following:

XI. Eye Care Technology Forum

Dr. Kupfer commented on the fourth Eye Care Technology Forum that was held on October 10-11, 1996, at the Lister Hill Center on the NIH campus. He said that the Eye Care Technology Forum had been established in 1992 to bring together various parties interested in improving the way ophthalmic drugs, devices, and procedures are developed, evaluated, and ultimately brought to the patient. Forums were also held at the NIH in 1992, 1993, and 1994. The program of the Forum is guided by an Executive Committee. The latest Forum included the participation of more than 100 senior representatives from industry, government, academia, and health care provider organizations, plus practitioners in the field of ophthalmology and optometry. They considered 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; and, (6) issues in facilitating availability of safe and effective devices – lasers for refractive surgery. Dr. Kupfer finished by saying that a transcript of the meeting was being edited and that the proceedings will be published in the spring.

XII. Update: Program Planning

Dr. Beebe, Chair of the Vision Research Program Planning Subcommittee, provided an overview of activities related to the development of the next long-range plan for vision research. He said that there will be six planning panels: Retinal Diseases; Corneal Diseases; Lens and Cataract; Glaucoma; Strabismus, Amblyopia, & Visual Processing; and, Low Vision. In addition, there will be a Health Services Research Working Group. Dr. Beebe summarized the guidance document which charges the Panels with their task, provides outlines and examples of what is required, and lays out the timetable for the project. The target date for completing the project is September, 1997. He said that the interactive internet site for NEI Program Planning was operational and that it could be reached via the NEI home page at: http:\\ Dr. Beebe finished his remarks by saying that the Subcommittee would be meeting with the Panel Chairs and Co-Chairs the following morning and he invited the other Council members to attend the meeting if they were available and wished to do so.

XIII. Intramural Research Program

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 review takes place in the closed session. In addition, NEI intramural scientists also make presentations during the open session, either overviews of the activities of their research groups, or focussed scientific presentations.

Dr. Peter F. Kador, Chief, Laboratory of Ocular Therapeutics (LOT), NEI, presented an overview of projects conducted by scientists working in the Laboratory. The LOT focuses on the development, evaluation, and mechanism of action of new ophthalmic drugs to treat eye diseases. The LOT research team is examining aldose reductase inhibitors (ARI) and anti-cataract agents. In pursuing the development of more effective and less toxic ARIs, a new inhibitor is being developed using biochemical, pharmacological, and computer molecular design techniques. An endogenous ARI has been discovered and efforts are underway to characterize this inhibitor. Studies designed to elucidate the mechanism of how ARIs inhibit diabetic complications are also being conducted. Polyol metabolism in lens cells is being investigated using nuclear magnetic resonance spectroscopy. Magnetic resonance imaging techniques are also being used to measure in vivo ARI efficacy. A study of neutrophils and lymphocytes may link components of the cellular immune system with the function of aldose reductase in preventing ocular complications of diabetes.

Dr. J. Samuel Zigler, Jr., Chief, Laboratory of Mechanisms of Ocular Diseases (LMOD), NEI, provided an overview of research conducted in LMOD. This includes basic and applied research related to determining and manipulating the mechanisms and underlying causes of eye diseases, including cataracts, glaucoma, corneal dysfunction, and retinopathies. The research focuses on the following areas: (1) examining oxidative stress and protein alterations involved in cataract formation; (2) studies of hereditary cataracts and transgenic mouse models; (3) studying alterations in metabolism related to trabecular meshwork dysfunction; (4) investigating the pharmacological, pathological, and biological structure aspects of aldose reductase in causing diabetic ocular complications, including loss of corneal sensitivity, cataracts, and retinopathy; and, (5) defining the alterations in gene expression that are caused by the stress conditions which induce cataracts.

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).

XIV. Consideration of Intramural Research Program

As required by the Public Health Service Act, each NIH Institute annually provides its Council a written description of the research reviewed by its BSC, and the results of that review. The Council may make recommendations to the Director, NEI, regarding this research. During the closed session, the Council considered the BSC reviews and recommendations for the Laboratory of Ocular Therapeutics and the Laboratory of Mechanisms of Ocular Diseases.

XV. Consideration of Research and Training Applications

The Council considered 291 research and training applications requesting $191.5 million in total costs. The Council recommended 274 applications with a total cost of $131.6 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.

XVI. Adjournment

Dr. Kupfer adjourned the meeting at 4:45 p.m. on January 23,1997.

XVII. 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
Director, Division of Extramural Research
National Eye Institute

Carl Kupfer, M.D.
National Advisory Eye Council
National Eye Institute

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
January 23, 1997

BEEBE, David C., Ph.D. (98)*
Department of Ophthalmology
and Visual Science
Washington University
St. Louis, MO 63110

DAUPHIN, Sue (97)
National Sjogren's Syndrome Association
Phoenix, AZ 85080-2207

FISHER, Marian, Ph.D. (98)
Senior Scientist
Department of Biostatistics
University of Wisconsin Medical School
Madison, WI 53706-1532

Department of Ophthalmology
School of Medicine
University of Maryland
Baltimore, MD 21201

HUBEL, David H., M.D. (99)
Department of Neurobiology
Harvard Medical School
Boston, MA 02115

KNIGHT, Millicent L., O.D. (99)
Private Practice
Evanston, IL 60201

NAKAYAMA, Ken, Ph.D. (97)
Department of Psychology
Harvard University
Cambridge, MA 02138

STEINBERG, Roy H., M.D., Ph.D. (98)
Department of Ophthalmology
Beckman Vision Center
University of California
San Francisco, CA 94143

ZEE, David S., M.D. (99)
Department of Neurology
School of Medicine
Johns Hopkins University
Baltimore, MD 21287-6921

Ex Officio Members

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

Harold Varmus, M.D.
Department of Health and Human Services
National Institutes of Health
Bethesda, MD 20892

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

Veteran's Affairs Representative
Diane L. Hatchell, Ph.D.
VA Medical Center
Durham, NC 27705

Department of Defense Representative
Captain David O. Mazur, MC, USN
Department of Ophthalmology
National Naval Medical Center
Bethesda, MD 20889

Special Consultant-January 23, 1997, Meeting
Paul A. Sieving, M.D., Ph.D.
Kellog Eye Center
University of Michigan
Ann Arbor, MI 48105

Executive Secretary
Jack A. McLaughlin, Ph.D.
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892

*Indicates term end date

Attachment B

National Advisory Eye Council
Operating Procedures

January 1997

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 are presented to Council for special consideration. However, a member of Council or NEI staff may request that any individual application be discussed.

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
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:

Department of Health and Human Services NIH, the National Institutes of Health