Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting, 48870-48871 [2015-20051]
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48870
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
Contact Persons: Hilda Scharen,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm 3625, Silver Spring, MD 20993,
301–796–6815, Hilda.Scharen@
fda.hhs.gov; or Jay Gupta, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, Jay.Gupta@fda.hhs.gov, 301–
796–2795.
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by November 6, 2015, at 4 p.m.
Early registration is recommended
because facilities are limited and,
therefore, FDA may limit the number of
participants from each organization. If
time and space permits, onsite
registration on the day of the public
workshop will be provided beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, susan.monahan@fda.hhs.gov
or 301–796–5661 no later than
November 5, 2015.
To register for the public workshop,
please visit FDA’s Medical Devices
Workshops and Conferences calendar at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. Select this meeting/public
workshop from the posted events list.
Please provide complete contact
information for each attendee, including
name, title, affiliation, email, and
telephone number. Those without
Internet access should contact Susan
Monahan to register (see Contact for
special accommodations). Registrants
will receive confirmation after they have
been accepted. You will be notified if
you are on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be available via Webcast. Persons
interested in viewing the Webcast must
register online by 4 p.m., November 6,
2015. 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 November 10,
2015. 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
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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.)
Comments: In order to permit the
widest possible opportunity to obtain
public comment, FDA is soliciting
either electronic or written comments
on all aspects of the public workshop
topics. The deadline for submitting
comments related to this public
workshop is December 5, 2015.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic comments
regarding this document to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. In addition,
when providing comments to the topics
as outlined in section II of this
document, please identify the question
you are addressing. Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
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
(see Comments). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
address of the Division of Freedom of
Information is available on the Agency’s
Web site at https://www.fda.gov. A link
to the transcripts 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
Cognitive assessment medical devices
are intended to provide healthcare
professionals with an evaluation of
cognitive function through non-invasive
measurements. Non-invasive brain
stimulation medical devices are
intended to improve, affect, or
otherwise modify the cognitive function
of a normal individual (i.e., has no
cognitive impairment) by means of noninvasive electrical or electromagnetic
stimulation to the head. These medical
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devices both present important safety
and effectiveness questions as well as
study design and data analysis
challenges.
II. Topics for Discussion at the Public
Workshop
The workshop seeks to involve
industry and academia in addressing
scientific, clinical, and regulatory
considerations associated with medical
devices for assessing and influencing
cognitive function. By bringing together
relevant stakeholders, which include
scientists, patient advocates, clinicians,
researchers, industry representatives,
and regulators, to this workshop, we
hope to facilitate the improvement of
this rapidly evolving product area.
This workshop is aimed to address
scientific, clinical, and regulatory
considerations associated with medical
devices for assessing and influencing
cognitive function; including, but not
limited to, the following topic areas:
• Considerations for clinical study
trial designs, patient populations, and
patient selection methods;
• considerations for clinical study
endpoints, e.g., clinically relevant
outcome measures and related statistical
analyses;
• identification of risks and risk
mitigation strategies; and
• evaluation of prior studies, current
clinical research, and available
scientific and clinical evidence.
Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–19990 Filed 8–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Science Advisory Board to the
National Center for Toxicological
Research 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). At least one portion of the
meeting will be closed to the public.
Name of Committee: Science
Advisory Board (SAB) to the National
Center for Toxicological Research
(NCTR).
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
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 November 3, 2015, from 12:30
p.m. to 5 p.m., and November 4, 2015,
from 8 a.m. to 5 p.m.
Location: NCTR SAB, 3900 NCTR Rd.,
Conference rm. B–12, Jefferson, AR
72079. 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: Donna Mendrick,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
2208, Silver Spring, MD 20993–0002,
301–796–8892; 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: On November 3, 2015, the
SAB Chair will welcome the
participants, and the NCTR Director will
provide a Center-wide update on
scientific initiatives and
accomplishments during the past year.
The SAB will be presented with an
overview of the Division of
Biochemistry Subcommittee and the
Subcommittee Site Visit Report.
Representatives from the Office of the
Chief Scientist and Office of Medical
Products and Tobacco will discuss
research needs and opportunities for
collaborations with NCTR.
On November 4, 2015, the Center for
Drug Evaluation and Research, Center
for Devices and Radiological Health,
Center for Biologics Evaluation and
Research, Center for Tobacco Products,
Center for Veterinary Medicine, and
Office of Regulatory Affairs will each
briefly discuss their Center-specific
research strategic needs. Following the
public session, the SAB will hear an
update from each of NCTR’s research
divisions.
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Following an open discussion of all
the information presented, the open
session of the meeting will close so the
SAB members can discuss personnel
issues at NCTR at the end of each day.
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: On November 3, 2015,
from 12:30 p.m. to 5 p.m., and
November 4, 2015, from 8 a.m. to 4:15
p.m., the meeting is open to the public.
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
October 27, 2015. Oral presentations
from the public will be scheduled
between approximately 11:45 a.m. and
12:45 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 October 19, 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
October 20, 2015.
Closed Committee Deliberations: On
November 4, 2015, from 4:15 p.m. to 5
p.m., the meeting will be closed to
permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). This portion of the meeting
will be closed to permit discussions of
information concerning individuals
associated with the research programs at
NCTR.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
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48871
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 Donna
Mendrick 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: August 10, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–20051 Filed 8–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451; formerly
Docket No. 2004N–0226]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
040
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (FDA Recognized
Consensus Standards). This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 040’’ (Recognition List
Number: 040), will assist manufacturers
who elect to declare conformity with
consensus standards to meet certain
requirements for medical devices.
DATES: Submit electronic or written
comments concerning this document at
any time. See section VII for the
effective date of the recognition of
standards announced in this document.
ADDRESSES: An electronic copy of
Recognition List Number: 040 is
available on the Internet at https://
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48870-48871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Science Advisory Board to the National Center for Toxicological
Research 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Science Advisory Board (SAB) to the National
Center for Toxicological Research (NCTR).
[[Page 48871]]
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 November 3, 2015, from
12:30 p.m. to 5 p.m., and November 4, 2015, from 8 a.m. to 5 p.m.
Location: NCTR SAB, 3900 NCTR Rd., Conference rm. B-12, Jefferson,
AR 72079. 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: Donna Mendrick, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002,
301-796-8892; 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: On November 3, 2015, the SAB Chair will welcome the
participants, and the NCTR Director will provide a Center-wide update
on scientific initiatives and accomplishments during the past year. The
SAB will be presented with an overview of the Division of Biochemistry
Subcommittee and the Subcommittee Site Visit Report. Representatives
from the Office of the Chief Scientist and Office of Medical Products
and Tobacco will discuss research needs and opportunities for
collaborations with NCTR.
On November 4, 2015, the Center for Drug Evaluation and Research,
Center for Devices and Radiological Health, Center for Biologics
Evaluation and Research, Center for Tobacco Products, Center for
Veterinary Medicine, and Office of Regulatory Affairs will each briefly
discuss their Center-specific research strategic needs. Following the
public session, the SAB will hear an update from each of NCTR's
research divisions.
Following an open discussion of all the information presented, the
open session of the meeting will close so the SAB members can discuss
personnel issues at NCTR at the end of each day.
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: On November 3, 2015, from 12:30 p.m. to 5 p.m., and
November 4, 2015, from 8 a.m. to 4:15 p.m., the meeting is open to the
public. 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 October 27,
2015. Oral presentations from the public will be scheduled between
approximately 11:45 a.m. and 12:45 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 October 19, 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 October 20, 2015.
Closed Committee Deliberations: On November 4, 2015, from 4:15 p.m.
to 5 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be
closed to permit discussions of information concerning individuals
associated with the research programs at NCTR.
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 Donna Mendrick 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: August 10, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-20051 Filed 8-13-15; 8:45 am]
BILLING CODE 4164-01-P
