Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting, 77687-77688 [2013-30578]
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Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Notices
of automated collection techniques,
when appropriate, and other forms of
information technology.
FDA Rapid Response Surveys (Generic
Clearance)—(OMB Control Number
0910–0500)—Extension
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355), requires that important
safety information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for
enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C.
360i), FDA is authorized to require
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions to FDA; to require user
facilities to report device-related deaths
directly to FDA and to manufacturers;
and to report serious injuries to the
manufacturer. Section 522 of the FD&C
Act (21 U.S.C. 360l) authorizes FDA to
require manufacturers to conduct
postmarket surveillance of medical
devices. Section 705(b) of the FD&C Act
(21 U.S.C. 375(b)) authorizes FDA to
collect and disseminate information
regarding medical products or cosmetics
in situations involving imminent danger
to health or gross deception of the
consumer. Section 903(d)(2) of the
FD&C Act (21 U.S.C. 393(d)(2))
authorizes the Commissioner of Food
and Drugs to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
These sections of the FD&C Act enable
FDA to enhance consumer protection
from risks associated with medical
products usage that are not foreseen or
apparent during the premarket
notification and review process. FDA’s
regulations governing application for
Agency approval to market a new drug
(21 CFR part 314) and regulations
governing biological products (21 CFR
part 600) implement these statutory
provisions. Currently, FDA monitors
medical product related postmarket
adverse events via both the mandatory
and voluntary MedWatch reporting
systems using FDA Forms 3500 and
3500A (OMB control number 0910–
0291) and the vaccine adverse event
reporting system.
FDA is seeking OMB clearance to
collect vital information via a series of
rapid response surveys. Participation in
these surveys will be voluntary. This
request covers rapid response surveys
77687
for community based health care
professionals, general type medical
facilities, specialized medical facilities
(those known for cardiac surgery,
obstetrics/gynecology services, pediatric
services, etc.), other health care
professionals, patients, consumers, and
risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to quickly
obtain vital information about medical
product risks and interventions to
reduce risks so the Agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
FDA projects six emergency risk
related surveys per year with a sample
of between 50 and 10,000 respondents
per survey. FDA also projects a response
time of 0.5 hours per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
may be able to obtain by working with
health care professional organizations.
The annual number of surveys was
determined by the maximum number of
surveys per year FDA has ever
conducted under this collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
FDA Rapid Response Survey ..............................................
10,000
6
60,000
0.5
30,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30630 Filed 12–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
emcdonald on DSK67QTVN1PROD with NOTICES
Science Advisory Board to the
National Center for Toxicological
Research; 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.
VerDate Mar<15>2010
16:36 Dec 23, 2013
Jkt 232001
Name of Committee: Science
Advisory Board (SAB) to the National
Center for Toxicological Research
(NCTR).
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 January 29, 2014, from 8:45 a.m.
to 5:30 p.m. and on January 30, 2014,
from 8 a.m. to 2 p.m.
Location: NCTR SAB Conference
Room B–12, 3900 NCTR Rd., Jefferson,
AR 72079.
Contact Person: Margaret Miller, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 2208,
Silver Spring, MD 20993–0002, 301–
796–8890, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), to find out further information
regarding FDA advisory committee
information. A notice in the Federal
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 January 29, 2014, the
NCTR Director will welcome the
participants and 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
Microbiology Subcommittee and the
Subcommittee Site Visit Report.
Following the public session, the SAB
will hear an update from each of
NCTR’s research Division’s the Office of
E:\FR\FM\24DEN1.SGM
24DEN1
emcdonald on DSK67QTVN1PROD with NOTICES
77688
Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Notices
Science Coordination, followed by a
report from the National Toxicology
Program of the National Institutes of
Environmental Health Sciences on
current and future collaboration.
On January 30, 2014, the Arkansas
Bioinformatics Consortium will present
concepts and ideas on defining and
meeting NCTR and FDA’s scientific
computing needs and discuss how it can
partner with FDA to foster the
development of collaborative efforts in
this area. To facilitate the discussion
representatives from each of the product
centers will discuss their bioinformatic
needs, how those needs are being
addressed and areas of possible
collaboration.
Following an open discussion of all
the information presented, the open
session of the meeting will close so that
SAB members can discuss personnel
issues at NCTR.
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 January 29, 2014, from
8:45 a.m. to 5 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 January 21, 2014.
Oral presentations from the public will
be scheduled between approximately 12
p.m. to 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
13, 2014. 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
VerDate Mar<15>2010
16:36 Dec 23, 2013
Jkt 232001
notify interested persons regarding their
request to speak by January 14, 2014.
Closed Committee Deliberations: On
January 30, 2014, from 11 a.m. to 2 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 discussion 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 Margaret
Miller 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: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–30578 Filed 12–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
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 Committee: Ophthalmic
Devices Panel of the Medical Devices
Advisory Committee.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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 14, 2014, from 8 a.m.
to 6 p.m.
Location: Gaithersburg Marriott
Washingtonian Center, Salons A, B, C
and D, 9751 Washingtonian Blvd.,
Gaithersburg, MD 20878.
Contact Person: James Swink, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66,
Rm.1609, Silver Spring, MD 20993,
James.Swink@fda.hhs.gov, 301–796–
6313, 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 February 14, 2014, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application for the Visian
Toric Implantable Collamer Lens (TICL)
sponsored by STAAR Surgical
Company. ‘‘Visian TICL proposed
indications for use:
• For adults 21–45 years of age;
• For correction of myopic
astigmatism in adults with spherical
equivalent ranging from ¥3.0D to
≤¥15.0D with cylinder of 1.0D to 4.0D;
• For the reduction of myopic
astigmatism in adults with spherical
equivalent ranging from greater than
¥15.0D to ¥20.0D with cylinder 1.0D
to 4.0D;
• With an anterior chamber depth
(ACD) of 3.0 mm or greater, when
measured from the corneal endothelium
to the anterior surface of the crystalline
lens and a stable refractive history
(within 0.5 Diopter for 1 year prior to
implantation); and
• The Visian TICL is intended for
placement in the posterior chamber
(ciliary sulcus) of the phakic eye.’’
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
E:\FR\FM\24DEN1.SGM
24DEN1
]]>Agencies
[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77687-77688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30578]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Science Advisory Board to the National Center for Toxicological
Research; 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).
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 January 29, 2014, from
8:45 a.m. to 5:30 p.m. and on January 30, 2014, from 8 a.m. to 2 p.m.
Location: NCTR SAB Conference Room B-12, 3900 NCTR Rd., Jefferson,
AR 72079.
Contact Person: Margaret Miller, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 2208, Silver Spring, MD 20993-
0002, 301-796-8890, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), to find out further
information regarding FDA advisory committee information. 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 January 29, 2014, the NCTR Director will welcome the
participants and 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 Microbiology Subcommittee and the
Subcommittee Site Visit Report. Following the public session, the SAB
will hear an update from each of NCTR's research Division's the Office
of
[[Page 77688]]
Science Coordination, followed by a report from the National Toxicology
Program of the National Institutes of Environmental Health Sciences on
current and future collaboration.
On January 30, 2014, the Arkansas Bioinformatics Consortium will
present concepts and ideas on defining and meeting NCTR and FDA's
scientific computing needs and discuss how it can partner with FDA to
foster the development of collaborative efforts in this area. To
facilitate the discussion representatives from each of the product
centers will discuss their bioinformatic needs, how those needs are
being addressed and areas of possible collaboration.
Following an open discussion of all the information presented, the
open session of the meeting will close so that SAB members can discuss
personnel issues at NCTR.
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 January 29, 2014, from 8:45 a.m. to 5 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 January 21, 2014. Oral presentations from the public will be
scheduled between approximately 12 p.m. to 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 13, 2014.
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 January 14, 2014.
Closed Committee Deliberations: On January 30, 2014, from 11 a.m.
to 2 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 discussion 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 Margaret Miller 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: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-30578 Filed 12-23-13; 8:45 am]
BILLING CODE 4160-01-P
