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)
Food and Drug Administration
Federal Register Volume 81, Issue 132 (July 11, 2016)
| Page Range | 44872-44873 | |
| FR Document | 2016-16353 |
[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 susan.monahan@fda.hhs.gov 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 bhahn@cfom.info. 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
![44872 Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
4 The reporting requirements under §§ 601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b).
5 The reporting requirements under §§ 601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under
§ 601.12(c).
6 The reporting requirement under § 601.12(a)(2) is included in the estimate under § 601.12(d).
7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (2).
8 The reporting requirement under §§ 601.12(a)(4) and 601.14 is included in the estimate under § 601.12(f)(3).
9 The reporting requirement under § 601.94 is included in the estimate under § 601.45.
10 The numbers in this column have been rounded to the nearest whole number.
Under table 2, the estimated recordkeeping requirements associated
recordkeeping burden of 1 hour is based with the AER system.
on previous estimates for the
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Annual
Number of disclosures Total annual Average burden
21 CFR section Total hours 2
respondents per disclosures per disclosure
respondent
601.6(a) .................................................. 1 20 20 0.33 (20 minutes) ........................ 7
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the nearest whole number.
Dated: July 5, 2016. to 6 p.m. Pickup of materials will begin starting interventions in childhood. The
Leslie Kux, at 7:30 a.m. literature suggests that myopia
Associate Commissioner for Policy. ADDRESSES: The public workshop will progression is most rapid between 6 and
[FR Doc. 2016–16352 Filed 7–8–16; 8:45 am] be held at the FDA White Oak Campus, 11 years of age and manipulating
BILLING CODE 4164–01–P 10903 New Hampshire Ave., Bldg. 31, peripheral retinal image quality may be
Conference Center, the Great Room, a treatment strategy to control axial
(Rm. 1503), Silver Spring, MD, 20993. length and therefore the progression of
DEPARTMENT OF HEALTH AND Entrance for the public workshop myopia. The results of studies
HUMAN SERVICES participants (non-FDA employees) is conducted with specialized contact
through Building 1 where routine lenses, both rigid and soft, have
Food and Drug Administration security check procedures will be indicated that this approach may reduce
performed. For parking and security the rate of myopic progression in
[Docket No. FDA–2016–N–0001] information, please refer to http:// children. As research into myopia
www.fda.gov/AboutFDA/ control is continuing at a rapid pace,
Controlling the Progression of Myopia: accompanying potential safety and
WorkingatFDA/BuildingsandFacilities/
Contact Lenses and Future Medical effectiveness questions also have
WhiteOakCampusInformation/
Devices; Public Workshop emerged. To ensure that the studies
ucm241740.htm.
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
conducted provide information that can
HHS. Michelle Tarver, Office of Device adequately inform the regulatory
ACTION: Notice of public workshop. Evaluation, Center for Devices and review, we are conducting a workshop
Radiological Health, Food and Drug to answer questions about the
SUMMARY: The Food and Drug Administration, 10903 New Hampshire appropriate clinical trial design and
Administration (FDA), in cosponsorship Ave., Bldg. 66, Rm. 2504, Silver Spring, outcomes for these devices.
with the American Academy of MD 20993, 301–796–6884. II. Topics for Discussion at the Public
Ophthalmology (AAO), American SUPPLEMENTARY INFORMATION: Workshop
Academy of Optometry (AAOpt),
American Association for Pediatric I. Background Topics to be discussed at the public
Ophthalmology and Strabismus The prevalence of myopia in the workshop include, but are not limited to
(AAPOS), American Optometric United States has increased over the the following topics:
Association (AOA), American Society of past decade with approximately 24 • Myopia Demographics.
Cataract and Refractive Surgery percent (over 30 million) of adults over • Contact Lens Use and Safety in a
(ASCRS), and Contact Lens Association 40 years of age being affected. Recent Pediatric Population.
of Ophthalmologists, Inc. (CLAO) is studies have found the overall • Contact Lens Behaviors and
announcing a public workshop entitled prevalence of myopia to be 1.2 percent Hygiene.
‘‘Controlling the Progression of Myopia: among non-Hispanic White children, • Studies Conducted on Myopia
Contact Lenses and Future Medical 6.6 percent in African Americans, 3.7 Control Devices and Their Challenges.
Devices.’’ The purpose of this workshop percent in Hispanic, and 3.98 percent in • Regulation of Contact Lenses
sradovich on DSK3GDR082PROD with NOTICES
is to discuss the increasing prevalence Asian children. Pathologic myopia is (Ref. 1).
of myopia, as well as suggested clinical the third most frequent cause of • Patient/Caregiver Perspectives and
trial design attributes for studies using blindness due to retinal detachments or the Role in Trial Design and Conduct
contact lenses or other medical devices abnormal blood vessel growth. Given (Refs. 2 and 3).
to control the progression of myopia. these potentially poor outcomes with We will also have a panel discussion
DATES: The public workshop will be high myopia, researchers have sought to address questions related to the
held on September 30, 2016, from 8 a.m. ways to prevent its development by design of these clinical trials.
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![Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44873
Registration: Registration is $250 for get a quick overview of the Connect Pro Dated: July 6, 2016.
members of AAO, AAOpt, AAPOS, program, visit http://www.adobe.com/ Leslie Kux,
AOA, ASCRS, or CLAO; and $400 for go/connectpro_overview. FDA has Associate Commissioner for Policy.
non-members and available on a first- verified the Web site addresses in this [FR Doc. 2016–16353 Filed 7–8–16; 8:45 am]
come, first-served basis. Persons document, as of the date this document BILLING CODE 4164–01–P
interested in attending this public publishes in the Federal Register, but
workshop must register online. The Web sites are subject to change over
deadline for online registration is time. DEPARTMENT OF HEALTH AND
September 23, 2016, at 4 p.m. EDT. Transcripts: Please be advised that as HUMAN SERVICES
There will be no onsite registration on soon as a transcript is available, it will
the day of the public workshop. Early Food and Drug Administration
be accessible at http://
registration is recommended because www.regulations.gov. It may be viewed [Docket No. FDA–2015–D–3787]
facilities are limited and, therefore, FDA at the Division of Dockets Management,
may limit the number of participants Food and Drug Administration, 5630 Information To Support a Claim of
from each organization. Electromagnetic Compatibility of
Fishers Lane, Rm. 1061, Rockville, MD
If you need special accommodations Electrically-Powered Medical Device;
20852. A transcript will also be
due to a disability, please contact Ms. Guidance for Industry and Food and
Susan Monahan at susan.monahan@ available in either hardcopy or on CD–
ROM, after submission of a Freedom of Drug Administration Staff; Availability
fda.hhs.gov or 301–796–5661 no later
than September 16, 2016. Information request. The Freedom of AGENCY: Food and Drug Administration,
To register for the public workshop, Information office address is available HHS.
please visit http://www.cfom.info/ on the Agency’s Web site at http:// ACTION: Notice of availability.
meetings/myopia/. Please provide www.fda.gov. A link to the transcript
complete contact information for each will also be available approximately 45 SUMMARY: The Food and Drug
attendee, including name, title, days after the public workshop on the Administration (FDA or Agency) is
affiliation, address, email, telephone Internet at http://www.fda.gov/ announcing the availability of the
number, and membership in the MedicalDevices/NewsEvents/ guidance entitled ‘‘Information to
cosponsoring organizations. If there are WorkshopsConferences/default.htm. Support a Claim of Electromagnetic
any questions with registration, please (Select this public workshop from the Compatibility (EMC) of Electrically-
contact Mrs. Bobbi Hahn at bhahn@ posted events list). Powered Medical Device.’’ This
cfom.info. Registrants will receive guidance describes the types of
III. References information that should be provided to
confirmation after they have been
accepted. You will be notified if you are The following references are on support a claim of EMC in a premarket
on a waiting list. display in the Division of Dockets submission for an electrically powered
Food may be purchased in advance Management (see Transcripts) and are medical device. Electromagnetic
for $45 on the registration Web site available for viewing by interested disturbance is electronic product
(http://www.cfom.info/meetings/ persons between 9 a.m. and 4 p.m., radiation that may interfere with the
myopia/). Food and beverages will also Monday through Friday; they are also performance of an electrically powered
be available for purchase by participants available electronically at http:// medical device in its intended
during the workshop breaks. www.regulations.gov. FDA has verified environment (i.e., cause an
For more information on the the Web site addresses, as of the date electromagnetic interference (EMI)).
workshop, please see the FDA’s Medical this document publishes in the Federal EMC assessment helps to ensure that a
Devices News & Events—Workshops & Register, but Web sites are subject to device is able to function in its intended
Conferences calendar at http:// change over time. environment without introducing
www.fda.gov/MedicalDevices/ excessive electromagnetic disturbances
NewsEvents/WorkshopsConferences/ 1. Premarket Notification [510(k)] Guidance that might interfere with other devices.
Document for Class II Daily Wear
default.htm. (Select this public DATES: Submit either electronic or
Contact Lenses. U.S. Department of
workshop from the posted events list.) written comments on this guidance at
Health and Human Services, Food and
Those without Internet access should Drug Administration. May 1994. http:// any time. General comments on Agency
contact Bobbi Hahn to register at 651– www.fda.gov/RegulatoryInformation/ guidance documents are welcome at any
731–7257. Guidances/ucm080928.htm. time.
Streaming Webcast of the Public 2. Guidance for Industry: Patient-Reported ADDRESSES: You may submit comments
Workshop: The public workshop will Outcome Measures: Use in Medical as follows:
also be Webcast. Persons interested in Product Development to Support
viewing the Webcast must register Labeling Claims. U.S. Department of Electronic Submissions
online by September 23, 2016. Early Health and Human Services, Food and Submit electronic comments in the
registration is recommended because Drug Administration. December 2009. following way:
Webcast connections are limited. http://www.fda.gov/downloads/Drugs/.../ • Federal eRulemaking Portal: http://
Organizations are requested to register Guidances/UCM193282.pdf. www.regulations.gov. Follow the
all participants, but to view using one 3. Draft Guidance: Patient Preference instructions for submitting comments.
connection per location. Webcast Information—Submission, Review in Comments submitted electronically,
PMAs, HDE Applications, and De Novo
participants will be sent technical including attachments, to http://
sradovich on DSK3GDR082PROD with NOTICES
Requests, and Inclusion in Device
system requirements after registration Labeling. U.S. Department of Health and
www.regulations.gov will be posted to
and will be sent connection access Human Services, Food and Drug the docket unchanged. Because your
information after September 23, 2016. If Administration. Posted March 2015. comment will be made public, you are
you have never attended a Connect Pro http://www.fda.gov/downloads/ solely responsible for ensuring that your
event before, test your connection at medicaldevices/ comment does not include any
https://collaboration.fda.gov/common/ deviceregulationandguidance/ confidential information that you or a
help/en/support/meeting_test.htm. To guidancedocuments/ucm446680.pdf. third party may not wish to be posted,
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Document Created: 2016-07-09 00:21:40
Document Modified: 2016-07-09 00:21:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 44872 |
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