Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 4578 [2015-01534]
Download as PDF
4578
Federal Register / Vol. 80, No. 18 / Wednesday, January 28, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Joint Meeting of the Dermatologic and
Ophthalmic Drugs Advisory Committee
and Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on DSK4VPTVN1PROD with NOTICES
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Dermatologic and
Ophthalmic Drugs Advisory Committee and
Ophthalmic Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
Agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on February 24, 2015, from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (Rm. 1503), Silver
Spring, MD 20993–0002. Answers to
commonly asked questions including
information regarding special
accommodations due to a disability, visitor
parking, and transportation may be accessed
at: https://www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Moon Hee V. Choi, Center
for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2147, Silver Spring, MD
20993–0002, 301–796–9001, FAX: 301–847–
8533, email: DODAC@fda.hhs.gov, or FDA
Advisory Committee Information Line, 1–
800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly enough
to provide timely notice. Therefore, you
should always check the Agency’s Web site
at https://www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting link,
or call the advisory committee information
line to learn about possible modifications
before coming to the meeting.
Agenda: The committees will discuss new
drug application (NDA) 203324, for
riboflavin ophthalmic solutions with UV–A
irradiation, submitted by Avedro, Inc. The
combination products are used in corneal
collagen cross-linking and proposed to be
indicated for the treatment of progressive
keratoconus or corneal ectasia following
refractive surgery.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
VerDate Sep<11>2014
16:41 Jan 27, 2015
Jkt 235001
Web site prior to the meeting, the background
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee meeting link.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
February 9, 2015. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal oral
presentations should notify the contact
person and submit a brief statement of the
general nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and an
indication of the approximate time requested
to make their presentation on or before
January 30, 2015. Time allotted for each
presentation may be limited. If the number of
registrants requesting to speak is greater than
can be reasonably accommodated during the
scheduled open public hearing session, FDA
may conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by February 2, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Moon Hee
V. Choi at least 7 days in advance of the
meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.htm
for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: January 23, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–01534 Filed 1–27–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Muscular Dystrophy Coordinating
Committee (MDCC).
The meeting will be open to the
public and accessible by live webcast.
Name of Committee: Muscular Dystrophy
Coordinating Committee.
Type of meeting: Open Meeting.
Date: March 17, 2015.
Time: 8:30 a.m. to 4:30 p.m. *Eastern
Time*—Approximate end time.
Agenda: The Muscular Dystrophy
Coordinating Committee (MDCC) is
mandated by the MD–CARE Act to ‘‘develop
a plan for conducting and supporting
research and education on muscular
dystrophy through the national research
institutes, and will periodically review and
revise the plan.’’ The Committee will discuss
the draft 2015 Action Plan for the Muscular
Dystrophies at this meeting. Prior to the
meeting, an agenda will be posted to the
MDCC meeting registration Web site:
https://meetings.ninds.nih.gov/meetings/
MDCC/.
Registration: To register, please go to:
https://meetings.ninds.nih.gov/meetings/
MDCC/.
Webcast Live: For those not able to attend
in person, this meeting will be webcast at:
https://videocast.nih.gov/.
Place: Natcher Conference Center (Building
45), Conference Room D, National Institutes
of Health, 9000 Rockville Pike, Bethesda,
Maryland 20892.
Contact Person: Glen H. Nuckolls, Ph.D.,
Executive Secretary, Muscular Dystrophy
Coordinating Committee, National Institute
of Neurological Disorders and Stroke, NIH,
6001 Executive Boulevard, NSC 2203,
Bethesda, MD 20892, (301) 496–5739,
glen.nuckolls@ninds.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
E:\FR\FM\28JAN1.SGM
28JAN1
Agencies
[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Notices]
[Page 4578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01534]
[[Page 4578]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory
Committee and Ophthalmic Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committees: Dermatologic and Ophthalmic Drugs Advisory
Committee and Ophthalmic Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on February 24, 2015,
from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg.
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Answers to commonly asked questions including
information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Moon Hee V. Choi, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2147, Silver Spring, MD 20993-0002, 301-796-9001, FAX:
301-847-8533, email: DODAC@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the Agency's Web site at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the
advisory committee information line to learn about possible
modifications before coming to the meeting.
Agenda: The committees will discuss new drug application (NDA)
203324, for riboflavin ophthalmic solutions with UV-A irradiation,
submitted by Avedro, Inc. The combination products are used in
corneal collagen cross-linking and proposed to be indicated for the
treatment of progressive keratoconus or corneal ectasia following
refractive surgery.
FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee meeting link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 9, 2015. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
January 30, 2015. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person
will notify interested persons regarding their request to speak by
February 2, 2015.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to
electrical outlets.
FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Moon Hee V. Choi
at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: January 23, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-01534 Filed 1-27-15; 8:45 am]
BILLING CODE 4164-01-P