[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76842-76843]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Food and Drug Administration/American Academy of Ophthalmology 
Workshop on Developing Novel Endpoints for Premium Intraocular Lenses; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``FDA/American Academy of Ophthalmology (AAO) 
Workshop on Developing Novel Endpoints for Premium Intraocular 
Lenses.'' The main topic of this workshop is the current challenges in 
the assessment of innovative intraocular lens (IOL) designs with a 
focus on endpoint methodologies used in evaluating IOL safety and 
effectiveness. Experts in subjects ranging from patient reported 
outcomes to objective measures of accommodation will give talks on the 
latest developments in the field. Participants will then engage in in-
depth discussions of the pros and cons of various methods used to 
assess premium IOLs, and work to devise a plan to further promote 
innovation in this device area. The primary goal of the workshop is to 
improve the regulatory science for evaluating premium IOLs, which in 
turn may enhance the efficiency with which safe and effective premium 
IOLs get to the market. This public workshop is being rescheduled due 
to the government shutdown.
    Date and Time: The public workshop will be held on March 28, 2014, 
from 8:30 a.m. to 5:30 p.m. Materials may be picked up starting at 7:30 
a.m.
    Location: The public workshop will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (rm. 1503), Silver Spring, MD 20993. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact: Michelle Tarver, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-5620, FAX: 301-847-
8126, email: michelle.tarver@fda.hhs.gov.
    Registration: AAO will charge a registration fee to cover its share 
of the expenses associated with the workshop. The registration fee is 
$250 for Academy members and $400 for non-members. Registration is 
available on a first-come, first-served basis. Persons interested in 
attending this public workshop must register online. The deadline for 
online registration is March 27, 2014, at 5 p.m. EDT. There will be no 
onsite registration on the day of the public workshop. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. To register for the public workshop, please visit the AAO 
Web site (http://www.aao.org/meetings/iol_workshop.cfm). Those 
interested in attending but unable to access the electronic 
registration site should fax the PDF form on the AAO Web site (http://www.aao.org/meetings/upload/FDA_iol_workshop_reg.pdf) to 415-561-
8575. Those without Internet access should contact AAO Customer Service 
to register at 415-561-8540 or 866-561-8558 (toll free). Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone number. If there are any 
questions with registration, please contact the AAO administrative 
offices at 415-561-8540. Registrants will receive confirmation after 
they have been accepted. You will be notified if you are on a waiting 
list.
    This public workshop is being rescheduled due to the government 
shutdown. It was originally scheduled for October 11, 2013. Those who 
registered for the original workshop date were contacted by AAO 
individually and offered either a complete refund or the option to have 
those monies applied to the rescheduled date registration. Any 
questions about this process should be addressed to AAO Customer 
Service at 415-561-8540 or 866-561-8558 (toll free).
    Food and beverages will be available for purchase by participants 
during the workshop breaks.
    If you need special accommodations due to a disability, please 
contact Ms. Susan Monahan at susan.monahan@fda.hhs.gov or 301-796-5661 
no later than March 14, 2014.
    For more information on the workshop, please see FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://

[[Page 76843]]

www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.)
    Streaming Webcast of the Public Workshop: The morning session but 
not the afternoon session of this public workshop will also be Webcast. 
Persons interested in viewing the Webcast must register online by 5 
p.m. EDT, March 14, 2014. Early registration is recommended because 
Webcast connections are limited. Organizations are requested to 
register all participants, but to view using one connection per 
location. Webcast participants will be sent technical system 
requirements after registration and will be sent connection access 
information after March 24, 2014. If you have never attended a Connect 
Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get 
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site 
addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcript will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

SUPPLEMENTARY INFORMATION:

I. Background

    Cataract surgery is the most commonly performed elective procedure 
in the United States with over 3 million patients being implanted with 
an IOL. Over the past two decades, IOLs have undergone significant 
design changes allowing them to correct for a spectrum of visual 
distances and refractive errors. As IOL technology evolves, some 
endpoints for the evaluation of the technology are also evolving. 
Endpoints and strategies for assessing the relative safety and 
effectiveness of these innovative lens designs are in various stages of 
development. At this workshop, not only will some of these novel 
endpoints and the challenges with assessments of these endpoints be 
identified, but these endpoints also will be prioritized for further 
discussion, development, and validation. Breakout sessions following 
the didactic portion of the workshop will allow for more in-depth group 
discussions of potential approaches to address these challenges.
    The workshop seeks to involve industry and academia in addressing 
the challenges in the development of novel endpoints for premium IOLs. 
By bringing together all of the relevant stakeholders, which include 
clinicians, researchers, industry representatives, and regulators, to 
this workshop, we hope to facilitate the improvement of regulatory 
science in this rapidly evolving product area.
    FDA and AAO recognize the unique opportunity this workshop provides 
for all stakeholders of the ophthalmic device community and that the 
knowledge and education provided from this workshop will further 
strengthen our mission of protecting the public health.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the public workshop include, but are not 
limited to:
     Safety assessments for premium IOLs and how they could 
differ from those for monofocal IOLs.
     Patient-Reported Outcome (PRO) measures and the need to 
develop and validate them for assessing the safety and effectiveness of 
premium IOLs.
     Objective assessments of accommodation and their 
challenges.
     Subjective assessments of accommodation and Extended Depth 
of Focus (EDF) and their challenges.
    These topics will be presented by experts in the associated area 
and the afternoon will allow for more in-depth discussions of the given 
topics in small breakout sessions.

    Dated: December 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30148 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P