NAEC Meeting Minutes - January 23, 1997

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

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:

  • the “success rate” was comparable across the five major NEI
    program areas;
  • the “success rate” for new (Type 1) applications was about
    28%, while that for renewal applications (Type 2) was about 50% - this
    is very typical;
  • revised applications and awards based on revised applications account
    for about one third of the total number of applications and awards;
  • the “success rate” of revised and not-revised applications
    was approximately equal;
  • approximately 6% of all awards were made to applications receiving
    the Council designation of “High Program Relevance”; and,
  • awards to foreign institutions comprised only 1% of the total.

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:

  • 3% of the NEI’s extramural budget is used to support NRSA training programs;
  • Overall, using all NRSA grant mechanisms, the NEI supported 145
    predoctoral and 143 postdoctoral positions in FY 1996; and,
  • NRSA-supported fellows at the predoctoral and early postdoctoral
    levels will benefit from a stipend increase beginning in FY 1997;
  • NEI currently supports 33 institutional training grants; the average
    size of an NEI-supported institutional training grant is 4-6 predoctoral
    positions and 1-2 postdoctoral positions;
  • 64% of NEI-supported institutional training grants are located in
    Departments of Ophthalmology, Schools of Optometry, and Vision Research Centers;
  • NEI currently supports 115 individual postdoctoral fellowships and
    receives approximately an equal number of new competing applications
    each year; in FY 1996, the NEI funded approximately 50% of these
    competing applications; and,
  • NEI strongly supports the Mentored Clinical Scientist Award (K08) and
    has broadened its guidelines to include training in epidemiology and
    biostatistics; unlike other NIH awarding components, NEI does not impose
    any special cap on salary requests.

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:

  • The research proposed has been identified by either Council or staff
    as being of particular interest (e.g., consideration of program
    relevance) or concern;
  • The application is for: a core grant or specialized clinical research
    center; an NRSA institutional training program; a collaborative clinical
    research project within the funding range; MERIT candidate or MERIT
    extension award; an NEI-initiated program; or conference grant or
    cooperative agreement within the funding range;
  • The application is from a foreign institution and is within the
    funding range;
  • The adequacy of the initial review or some other aspect of the
    recommendation from the initial review group (IRG) has been questioned
    by either Council or staff;
  • The IRG has expressed a concern about the protection of human
    subjects in the proposed project or has identified an ethical question
    or a potential biohazard;
  • The application describes procedures or conditions that may violate
    policies related to animal care or use;
  • The application is for a clinical research study involving human
    subjects, and there are concerns about the representation of women
    and/or minorities; or,
  • The application, if funded, would be the third or more NIH R01-type
    grant held by an individual principal investigator.

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:

  • Approve the appointment of a new Principal Investigator or Program
    Director to continue an active research or training project at the same institution.
  • Approve the transfer of a project grant when the Principal
    Investigator moves to another institution.
  • Provide funds for the orderly termination of an ongoing project when
    the competing continuation application will not be awarded and sudden
    termination of the grant would cause a serious loss of important
    scientific material or impose a severe hardship to already employed
    personnel. In such cases: (a) the award will usually be made for a three
    month period but will in no case exceed twelve months; (b) careful
    review will be given to needs for salaries and consumable supplies; and
    (c) no funds will be provided for additional animals, equipment, or
    travel, except under the most unusual circumstances.
  • Provide limited interim funding when a recommendation of deferral on
    a competing continuation application would result in a loss of
    continuity of the project.
  • Provide additional funds to a noncompeting application when well
    justified and when NEI resources allow; for example, institution-wide
    salary and fringe benefit increases, and increased costs of supplies.
    These and other increases of an administrative nature may be provided,
    if not related to an expansion of the scope of the project or to a
    significant change in scientific direction.
  • Adjust competitive applications in project period and/or amounts to
    meet the needs of the project and the priorities of the Institute.
    Council recommendations, program relevance, policy, research effort, and
    NEI resources will serve as a guide in making such adjustments.