Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel Endpoints for Premium Intraocular Lenses; Public Workshop, 76842-76843 [2013-30148]

Download as PDF 76842 Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Individual indepth interviews .................................... General public focus group interviews .................... Intercept interviews: Central location ....................... Intercept interviews: Telephone ............................... Self-Administered surveys ....................................... Gatekeeper reviews ................................................. Omnibus surveys ..................................................... 360 144 200 4,000 2,400 400 1,200 1 1 1 1 1 1 1 360 144 200 4,000 2,400 400 1,200 Total (general public) ........................................ 8,704 ........................ Physician focus group interviews ............................ 144 Total (physician) ............................................... Total (overall) .................................................... 1 There [FR Doc. 2013–30149 Filed 12–18–13; 8:45 am] BILLING CODE 4160–01–P 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 Food and Drug Administration, HHS. emcdonald on DSK67QTVN1PROD with NOTICES ACTION: 0.75 1.50 0.25 0.08 0.25 0.50 0.17 Total hours (45 minutes) ...... hours ................. (15 minutes) ...... (5 minutes) ........ (15 minutes) ...... (30 minutes) ...... (10 minutes) ...... 270 216 50 320 600 200 204 ........................ .................................... 1,860 1 144 1.50 hours ................. 216 144 ........................ ........................ .................................... 216 8,848 ........................ ........................ .................................... 2,076 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 11, 2013. Leslie Kux, Assistant Commissioner for Policy. AGENCY: Average burden per response Notice. 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 indepth 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, VerDate Mar<15>2010 16:41 Dec 18, 2013 Jkt 232001 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 https:// 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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 visit the AAO Web site (https:// 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 (https://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 https:// E:\FR\FM\19DEN1.SGM 19DEN1 Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES 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 https://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 https:// 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 https://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 VerDate Mar<15>2010 16:41 Dec 18, 2013 Jkt 232001 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 76843 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Statement of Delegation of Authority Notice is hereby given that I have delegated to the Inspector General, Office of Inspector General, the authority vested in the Secretary of Health and Human Services under section 1116(e)(1) of the Social Security Act (42 U.S.C. 1316(e)(1)) to conduct reconsiderations of disallowances of any item or class of items for which Federal financial participation is claimed under section 1903 of the Social Security Act (42 U.S.C. 1396b) for the establishment or operation of a Medicaid Fraud Control Unit. This authority may be redelegated to the Principal Deputy Inspector General. This delegation excludes the authority to issue regulations. This delegation is effective upon date of signature. Dated: December 12, 2013. Kathleen Sebelius, Secretary. [FR Doc. 2013–30160 Filed 12–18–13; 8:45 am] BILLING CODE 4152–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering (NIBIB) Announcement of Requirements and Registration for the 2014 NIBIB Design by Biomedical Undergraduate Teams (DEBUT) Challenge Authority: 15 U.S.C. 3719. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) DEBUT Challenge is open to teams of undergraduate students working on projects that develop innovative solutions to unmet health and clinical problems. NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The goals of the DEBUT Challenge are (1) to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building and debugging solutions for such open-ended problems; (2) to generate novel, innovative tools to improve healthcare, consistent with NIBIB’s purpose to support research, training, the dissemination of health information, and other programs with respect to SUMMARY: E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[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]


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

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.

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

    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 https://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 (https://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 (https://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 https://

[[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 https://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 https://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 
https://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

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