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Home » About NEI » The National Advisory Eye Council (NAEC), Minutes January 10, 2013

NAEC Meeting Minutes

National Institutes of Health
National Eye Institute
National Advisory Eye Council
One Hundred Thirty-third Meeting
January 10, 2013

The National Advisory Eye Council (NAEC) convened for its one hundred and thirty-third meeting at 8:30 am on Thursday, January 10, 2013, at 5635 Fishers Lane, Rockville, Maryland, 20852. Paul A. Sieving, M.D., Ph.D., the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 08:30 a.m. until 11:45 a.m. The meeting was closed to the public from 11:45 a.m. until adjournment for the review of grant and cooperative agreement applications. Attachment A provides a roster of Council Members.

COUNCIL MEMBERS PRESENT:
Dr. Hollis Cline
Dr. Donald Gagliano
Dr. Bernard Godley
Dr. Jonathan Haines
Dr. John Morrison
Ms. Kathleen Petrillo
Dr. Eric Pierce
Dr. Krishna Sharma
Dr. Sheila West
Dr. Marco Zarbin

COUNCIL MEMBER ABSENT:
Dr. David Copenhagen

NEI STAFF PRESENT:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Ms. Pamela Bobbitt
Ms. Sylvia Braxton
Dr. Deborah Carper
Dr. Preethi Chander
Dr. Hemin Chin
Ms. Monique Clark
Ms. Janet Craigie
Mr. William Darby
Ms. Linda Dingle
Mr. Donald Everett
Dr. Richard Fisher
Dr. Shefa Gordon
Dr. Thomas Greenwell
Ms. Anna Harper
Mr. Dustin Hays
Mr. Thomas Hogland
Ms. Jean Horrigan
Dr. Brian Hoshaw
Ms. Tina Jones
Mr. Kevin Keating
Ms. Marilyn Laurie
Dr. Ellen Liberman
Dr. Andrew Mariani
Dr. George McKie
Dr. Matthew McMahon
Dr. Loré Anne McNicol
Dr. Jennifer Mehren
Dr. Sheldon Miller
Ms. Kathleen Moy
Dr. Lisa Neuhold
Dr. Steven Oversby
Dr. Mary Ann Redford
Ms. Karen Robinson Smith
Dr. Gale Saunders
Dr. Anne Schaffner
Dr. Eleanor Schron
Dr. Grace Shen
Dr. Paul Sieving
Ms. Chantell Stevenson
Dr. Michael Steinmetz
Dr. Santa Tumminia
Ms. Jennifer Wenger
Ms. Keturah Williams
Mr. David Whitmer
Dr. Cheri Wiggs
Dr. Jerome Wujek

OTHER NIH/DHHS STAFF PRESENT:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Paek Lee, CSR
Mr. Christopher Maurer, Office of the Director (OD)
Dr. Kirk Thompson, CSR
Dr. Maqsood Wani, CSR

MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Ms. Shannon Curtis, American Academy of Ophthalmology
Ms. Lauren Finkelstein, Association of Schools and Colleges of Optometry
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Mr. Daniel Molina, Technical Resources International
Dr. Jerry Taylor

OPEN SESSION OF THE MEETING
08:30 am

DIRECTOR'S REPORT AND OPENING REMARKS
Dr. Paul Sieving welcomed all attending the meeting. He reported the retirement of Dr. Natalie Kurinij from the Division of Extramural Research and announced the appointment of Ms. Vicki Buckley as the NEI Deputy Executive Officer. He noted that Dr. Robert Nusssenblatt was the recipient of the Carl Kupfer Visionary Award, and that Ms. Nora Salgado, Dr. Rachel Caspi, and Dr. James Raber received NIH Director's Awards. As part of their duties as Commissioned Officers in the US Public Health Service, Dr. Rachel Bishop and Dr. Steven Oversby were part of the DHHS Relief Efforts for Hurricanes Isaac and Sandy. Dr. Sieving also described recent Institute activities relating to international programs including highlights in the Fogarty International Center's, Global Health Matters. In research news, he announced the recent finding of Drs. Lai Wei and Robert Nussenblatt on the epigenetics of AMD. In NIH news, Dr. Sieving reported on the discussions of the Advisory Committee to the NIH Director (ACD) Working Groups on Biomedical Workforce Implementation, Diversity in the Biomedical Research Workforce Implementation, and Data and Informatics Implementation. He described Diversity in Vision Research and Ophthalmology (DIVRO) as an initiative of the NEI to increase diversity in vision research that is open to high school and college students. Dr. Sieving announced new NIH guidelines for new logos to fortify the NIH identity by requiring consistent logos across all ICs. In NEI specific news, Dr. Sieving reported on the most recent Focus on Fellows program to help research fellows develop their careers and manage work/life issues, the NEIGHBORHOOD investigators meeting to delineate the genetic architecture of primary open-angle glaucoma, the closing of the Audacious Goals challenge with over 500 submissions, January 2013 as Glaucoma Awareness Month, and February 2013 as Low Vision Awareness Month.

CONSIDERATION OF OCTOBER 2012 MINUTES
Dr. Loré Anne McNicol, Executive Secretary of the Council, requested approval of the minutes of the October 2012 Council Meeting. A motion for approval was made and the minutes were accepted.

BUDGET UPDATE
Mr. David Whitmer, Executive officer, NEI, noted that the NIH is operating under a continuing resolution (CR) through March 27, 2013. The American Taxpayer Relief Act was passed on January 1, 2013 and the immediate threat of an 8.2 percent cut in NIH spending for FY 2013 was averted. If no resolution is achieved, a new sequester will be ordered by the President on March 1 and implemented on March 27. The potential reduction to FY 2013 NIH spending would be approximately 6.4 percent. He reported that the Federal debt limit was reached on December 31, 2012 but that with special measures taken by the Department of the Treasury, default would not occur until approximately February 28, unless Congress acts to extend the limit.

Mr. Whitmer stated that the Administration is confident that Congress will agree to replace the sequester with a balanced approach to addressing long-term spending issues and the budget deficit. Meanwhile, NIH will not further ramp down spending in anticipation of the sequester. It will continue to operate cautiously, pursuant to the law as well as general and NIH-specific policies for operating under a CR, until final FY 2013 funding is determined. That includes continuing to fund non-competing grants in FY 2013 at 90% of the approved level.

COUNCIL OPERATING PROCEDURES
Mr. William Darby, Grants Management Officer, NEI, reviewed Council Operating Procedures for CY 2013. These guidelines provide an operating framework for the review of grant and cooperative agreement applications by the National Advisory Eye Council including the handling of appeals and the Special Council Review of Research Applications from PDs/PIs with more than $1.0 M Direct Costs in Annual NIH Support, and options for Council action. Included in the Procedures are guidelines for staff negotiations and interim administrative actions.

UPDATE ON THE AUDACIOUS GOALS INITIATIVE
Dr. Richard Fisher, Director, Office of Program Planning and Analysis, NEI, announced that the Audacious Goals Development Meeting will be February 24 through the 26, 2013 at the Bolger Center in Potomac, MD. Following the meeting, the NAEC will discuss the results of the meeting and make recommendations before final posting of the Goals on the NEI webpage. He reviewed the timeline for the submission and selection of the goals and noted that the Federal judges will be meeting tomorrow, January 11, 2013, and the winners announced on Monday January 14, 2013. He stated that 548 submissions were received and 229 came in on the final deadline day. Dr. Fisher also discussed some of the demographics of the submissions in terms of prior NIH or NEI grant experience, geographic distribution of origin within the United States, and that 13 were received from foreign individuals. He listed the names of the Federal judges and the process for evaluating the 474 “responsive” ideas. Lastly, he raised questions about what would be done with the entries that were not selected and asked if they could be used to develop ideas and inform discussions, and also, what could be done with the suggestions regarding NEI business practices.

Council asked for an explanation of how the scoring was done and had questions about the categorization of the entries, the meaning of the term “NEI Business Practices,” and how the award amount was decided. Council also discussed the format of the AG meeting, how to deal with the non-winning entries and possibly their publication, whether there should be a single audacious goal or several, how much money to invest in the AGs, and the effect of AGs on the Institute's success rate for R01s

CONCEPT CLEARANCE: BEYOND THE COMPETITION
Dr. Loré Anne McNicol noted that although the AG Meeting has not yet been held, it would be important to not lose momentum once the meeting takes place so she presented a concept clearance to issue a funding opportunity announcement to explore directions and details of implementation of the AGs using conference grants. Council responded favorably to the idea with some suggestions. A motion was made, seconded, and unanimously approved for the concept clearance.

BIENNIAL ADVISORY COUNCIL REPORT CERTIFYING COMPLIANCE WITH THE NIH POLICY ON INCLUSION GUIDELINES
Mr. Donald Everett presented the required Biennial Report to Council certifying NEI compliance with the NIH Patient Inclusion Guidelines for Women and Minorities in Clinical Trials. The policy was implemented in 1993 following a mandate by Congress with the passage of PL 103-43. Women and minorities must be included in all clinical research studies. Women and minorities must be included in Phase III clinical trials and the trial must be designed to permit valid analysis. Cost is not allowed as an acceptable reason for exclusion. NIH supports outreach efforts to recruit and retain women, minorities, and their subpopulations in clinical studies. He reviewed the racial and ethnic categories for tracking inclusion and the NEI's strategies to assure compliance and outreach. Mr. Everett detailed the number of patients enrolled, by race and gender, in clinical studies overall and also specifically for phase III clinical trials and stated that the NEI has excellent compliance with the policy.

GENERAL COUNCIL DISCUSSION
Dr. Pierce related how he had reached out to the research community in Boston area and was impressed by research on artificial intelligence, and on low vision rehabilitation with radar devices and smartphones and that he hoped these researchers would participate in the AG initiative. He also mentioned informatics at the Broad Institute as another opportunity the NEI may wish to explore. Dr. Sieving asked about the need. Dr. Pierce replied that large computational centers could enhance genomics research on vision. Dr. Haines agreed and he described the massive computing power at the Oak Ridge National Laboratory of the Department of Energy and mentioned that they are looking for additional uses for their computing power. A discussion on the potential costs and how to implement and integrate informatics into existing NEI grants using supplements ensued. Dr. Sieving called upon Dr. Miller to comment on the status of ClinSeek in the NEI's Intramural Program as a way of understanding clinical phenotypes starting from a genetic analysis.

Council concluded this session with a discussion of big data, cloud computing and crowd sourcing and the opportunities these technologies present.
 
CLOSED SESSION OF THE MEETING — 11:45 a.m.
The meeting was closed to the public at 11:45 a.m. 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. Appendix2).

CONFIDENTIALITY/AVOIDANCE OF CONFLICT OF INTEREST
Dr. Loré Anne McNicol reviewed policies and procedures regarding confidentiality and the 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.

Council members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members signed a statement to this effect.

REVIEW OF RESEARCH, RESEARCH TRAINING, AND COOPERATIVE AGREEMENT APPLICATIONS

ADJOURNMENT
The meeting was adjourned at 01:45 pm


CERTIFICATION
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
National Eye Institute

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

These minutes were submitted for the approval of the Council; all corrections or notations were incorporated. A complete, printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Janet L. Craigie
National Eye Institute
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: craigiej@nei.nih.gov

ATTACHMENT A: NATIONAL ADVISORY EYE COUNCIL MEMBERS

Hollis T. Cline, Ph.D.
Professor
Departments of Molecular and Cellular Neuroscience and Chemical Physiology
The Scripps Research Institute
La Jolla, CA

David R. Copenhagen, Ph.D.
Professor
Departments of Ophthalmology and Physiology
University of California, San Francisco
School of Medicine
San Francisco, CA

Bernard F. Godley, M.D., Ph.D.
Professor and Chair
Department of Ophthalmology and Visual Sciences
University of Texas Medical Branch
Galveston, TX

Jonathan L. Haines, Ph.D.
Professor
Department of Molecular Physiology and Biophysics
Center for Human Genetics Research
Vanderbilt University School of Medicine
Nashville, TN

John C. Morrison, M.D.
Professor
Department of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
Portland, OR

Kathleen M. Petrillo, J.D.
Partner
Senniger Powers, LLP
St. Louis, MO

Pierce, Eric A., Ph.D, M.D.
Director
Ocular Genomics Institute
Massachusetts Eye and Ear Infirmary
Harvard Medical School
Boston, MA

K. Krishna Sharma, Ph.D.
Professor
Departments of Ophthalmology and Biochemistry
Mason Eye Institute
Unviersity of Missouri-Columbia
Columbia, MO

Sheila K. West, Ph.D.
Professor
Department of Ophthalmology
Wilmer Eye Institute
Johns Hopkins University
Baltimore, MD

Ex Officio
Marco A. Zarbin, M.D., Ph.D.
Professor and Chair
Institute of Ophthalmology and Visual Science
UNDNJ-New Jersey Medical School
Newark, NJ

Donald A. Gagliano, M.D. (Colonel)
Director
Vision Center of Excellence
Washington, DC

Last Reviewed: September 2013

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