Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 73471-73472 [2012-29650]
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73471
Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Notices
field ‘‘Did the infant/child have an IgMspecific treponemal test?’’ This data
element is no longer required because
treponemal IgM technologies, for the
purpose of identifying CS in an infant,
are highly insensitive. CDC also requests
elimination of infant gender because
gender does not influence the case
definition or define risk. The following
fields have been added: ‘‘Mothers
for presumptive congenital syphilis and,
‘‘Mother’s HIV status during
pregnancy’’.
The congenital syphilis data will
continue to be used to develop
intervention strategies and to evaluate
ongoing control efforts. There is no cost
to respondents other than their time.
The total estimated annual burden
hours are 62.
obstetric history’’, ‘‘Did mother have
treponemal test result: If so, when was
the test performed?’’ ‘‘What stage of
syphilis did mother have?’’, ‘‘Date of
Mother’s treatment’’, ‘‘What was
mother’s treatment?’’ ‘‘What clinical and
what surveillance stage of syphilis did
the mother have during pregnancy’’
‘‘Presumptive has been replaced with
probable,’’ as there is no case definition
ESTIMATE OF ANNUALIZED BURDEN TABLE
Form name
State Health Departments ..............................
Congenital Syphilis (CS) Case Investigation
and Report.
Congenital Syphilis (CS) Case Investigation
and Report.
Congenital Syphilis (CS) Case Investigation
and Report.
Territorial Health Agencies .............................
City and county health departments ...............
Dated: December 4, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012–29723 Filed 12–7–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with
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: Endocrinologic
and Metabolic Drugs 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 January 10, 2013, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
VerDate Mar<15>2010
18:30 Dec 07, 2012
Jkt 229001
be accessed at https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
EMDAC@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 committee will discuss
new drug application (NDA) 204042,
canagliflozin tablets, proposed trade
name INVOCANA, submitted by Janssen
Research and Development, LLC.
Canagliflozin is a member of the
sodium-glucose co-transporter 2
(SGLT2) inhibitors, and was developed
as an adjunct to diet and exercise to
improve glycemic control in adults with
type 2 diabetes mellitus.
FDA intends to make background
material available to the public no later
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Number of
respondents
Types of respondent
Average
burden per
response
(in hours)
10
11
20/60
3
11
20/60
4
11
20/60
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 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 December 27, 2012.
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
December 20, 2012. 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 December 21, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
E:\FR\FM\10DEN1.SGM
10DEN1
73472
Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Notices
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 Caleb Briggs
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 4, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–29650 Filed 12–7–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with
ACTION:
Notice.
This notice announces a forthcoming
teleconference 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: Cellular, Tissue
and Gene Therapies Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The
teleconference meeting will be held on
January 15, 2013 from 2 p.m. to 5:30
p.m., Eastern Time.
Location: National Institutes of Health
(NIH), Building 29B, Conference Room
C, 9000 Rockville Pike, Bethesda, MD
20892. The public is welcome to attend
the meeting at the specified location
where a speakerphone will be provided.
Public participation in the meeting is
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18:30 Dec 07, 2012
Jkt 229001
limited to the use of the speakerphone
in the conference room. Important
information about transportation and
directions to the NIH campus, parking
and security procedures is available on
the internet at https://www.nih.gov/
about/visitor/index.htm. (FDA has
verified the Web site address, but FDA
is not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.) Visitors must show two forms
of identification, one of which must be
a government-issued photo
identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. Detailed
information about security procedures is
located at https://www.nih.gov/about/
visitorsecurity.htm. Due to the limited
available parking, visitors are
encouraged to use public transportation.
Contact Person: Gail Dapolito, Center
for Biologics Evaluation and Research
(HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville MD 20852, 301–827–1289, 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 committees. 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 15, 2013, the
committee will meet in open session to
hear updates of research programs in the
Laboratory of Immunology, Division of
Therapeutic Proteins, Office of
Biotechnology Products, Center for Drug
Evaluation and Research, FDA.
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.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Procedure: On January 15, 2013, from
2 p.m. to 4:30 p.m. (Eastern Time) 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 8, 2013.
Oral presentations from the public will
be scheduled between approximately
3:30 p.m. and 4:30 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 December 31, 2012. 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 2, 2013.
Closed Committee Deliberations: On
January 15, from 4:30 p.m. to 5:30 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)). The committee will discuss
reports of intramural research programs
and make recommendations regarding
personnel staffing decisions.
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 Gail Dapolito
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).
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Notices]
[Pages 73471-73472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29650]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Endocrinologic and Metabolic Drugs 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: Endocrinologic and Metabolic Drugs 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 January 10, 2013, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, email: EMDAC@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 committee will discuss new drug application (NDA)
204042, canagliflozin tablets, proposed trade name INVOCANA, submitted
by Janssen Research and Development, LLC. Canagliflozin is a member of
the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was
developed as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.
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 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
December 27, 2012. 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 December 20, 2012. 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 December 21, 2012.
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 73472]]
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 Caleb Briggs 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 4, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-29650 Filed 12-7-12; 8:45 am]
BILLING CODE 4160-01-P
