81 FR 44872 - Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 132 (July 11, 2016)

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.

[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44872-44873]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16353]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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