[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44872-44873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16353]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Controlling the Progression of Myopia: Contact Lenses and Future
Medical Devices; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with
the American Academy of Ophthalmology (AAO), American Academy of
Optometry (AAOpt), American Association for Pediatric Ophthalmology and
Strabismus (AAPOS), American Optometric Association (AOA), American
Society of Cataract and Refractive Surgery (ASCRS), and Contact Lens
Association of Ophthalmologists, Inc. (CLAO) is announcing a public
workshop entitled ``Controlling the Progression of Myopia: Contact
Lenses and Future Medical Devices.'' The purpose of this workshop is to
discuss the increasing prevalence of myopia, as well as suggested
clinical trial design attributes for studies using contact lenses or
other medical devices to control the progression of myopia.
DATES: The public workshop will be held on September 30, 2016, from 8
a.m. to 6 p.m. Pickup of materials will begin at 7:30 a.m.
ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 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.
FOR FURTHER INFORMATION CONTACT: Michelle Tarver, Office of Device
Evaluation, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2504, Silver
Spring, MD 20993, 301-796-6884.
SUPPLEMENTARY INFORMATION:
I. Background
The prevalence of myopia in the United States has increased over
the past decade with approximately 24 percent (over 30 million) of
adults over 40 years of age being affected. Recent studies have found
the overall prevalence of myopia to be 1.2 percent among non-Hispanic
White children, 6.6 percent in African Americans, 3.7 percent in
Hispanic, and 3.98 percent in Asian children. Pathologic myopia is the
third most frequent cause of blindness due to retinal detachments or
abnormal blood vessel growth. Given these potentially poor outcomes
with high myopia, researchers have sought ways to prevent its
development by starting interventions in childhood. The literature
suggests that myopia progression is most rapid between 6 and 11 years
of age and manipulating peripheral retinal image quality may be a
treatment strategy to control axial length and therefore the
progression of myopia. The results of studies conducted with
specialized contact lenses, both rigid and soft, have indicated that
this approach may reduce the rate of myopic progression in children. As
research into myopia control is continuing at a rapid pace,
accompanying potential safety and effectiveness questions also have
emerged. To ensure that the studies conducted provide information that
can adequately inform the regulatory review, we are conducting a
workshop to answer questions about the appropriate clinical trial
design and outcomes for these devices.
II. Topics for Discussion at the Public Workshop
Topics to be discussed at the public workshop include, but are not
limited to the following topics:
Myopia Demographics.
Contact Lens Use and Safety in a Pediatric Population.
Contact Lens Behaviors and Hygiene.
Studies Conducted on Myopia Control Devices and Their
Challenges.
Regulation of Contact Lenses (Ref. 1).
Patient/Caregiver Perspectives and the Role in Trial
Design and Conduct (Refs. 2 and 3).
We will also have a panel discussion to address questions related
to the design of these clinical trials.
[[Page 44873]]
Registration: Registration is $250 for members of AAO, AAOpt,
AAPOS, AOA, ASCRS, or CLAO; and $400 for non-members and available on a
first-come, first-served basis. Persons interested in attending this
public workshop must register online. The deadline for online
registration is September 23, 2016, at 4 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.
If you need special accommodations due to a disability, please
contact Ms. Susan Monahan at [email protected] or 301-796-5661
no later than September 16, 2016.
To register for the public workshop, please visit http://www.cfom.info/meetings/myopia/. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, telephone number, and membership in the cosponsoring
organizations. If there are any questions with registration, please
contact Mrs. Bobbi Hahn at [email protected]. Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
Food may be purchased in advance for $45 on the registration Web
site (http://www.cfom.info/meetings/myopia/). Food and beverages will
also be available for purchase by participants during the workshop
breaks.
For more information on the workshop, please see the FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Those
without Internet access should contact Bobbi Hahn to register at 651-
731-7257.
Streaming Webcast of the Public Workshop: The public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by September 23, 2016. 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 September 23, 2016. 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, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.
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. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. 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).
III. References
The following references are on display in the Division of Dockets
Management (see Transcripts) and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
1. Premarket Notification [510(k)] Guidance Document for Class II
Daily Wear Contact Lenses. U.S. Department of Health and Human
Services, Food and Drug Administration. May 1994. http://www.fda.gov/RegulatoryInformation/Guidances/ucm080928.htm.
2. Guidance for Industry: Patient-Reported Outcome Measures: Use in
Medical Product Development to Support Labeling Claims. U.S.
Department of Health and Human Services, Food and Drug
Administration. December 2009. http://www.fda.gov/downloads/Drugs/.../Guidances/UCM193282.pdf.
3. Draft Guidance: Patient Preference Information--Submission,
Review in PMAs, HDE Applications, and De Novo Requests, and
Inclusion in Device Labeling. U.S. Department of Health and Human
Services, Food and Drug Administration. Posted March 2015. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf.
Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16353 Filed 7-8-16; 8:45 am]
BILLING CODE 4164-01-P