Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 61609-61610 [2012-24861]
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Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Notices
the President on bioethical issues
arising from advances in biomedicine
and related areas of science and
technology. The Commission seeks to
identify and promote policies and
practices that ensure scientific research,
health care delivery, and technological
innovation are conducted in a socially
and ethically responsible manner.
The main agenda item for the
Commission’s eleventh meeting is to
continue discussing topics related to the
ethical issues associated with the
development of medical
countermeasures for children.
The draft meeting agenda and other
information about PCSBI, including
information about access to the webcast,
will be available at www.bioethics.gov.
The Commission welcomes input
from anyone wishing to provide public
comment on any issue before it.
Respectful debate of opposing views
and active participation by citizens in
public exchange of ideas enhances
overall public understanding of the
issues at hand and conclusions reached
by the Commission. The Commission is
particularly interested in receiving
comments and questions during the
meeting that are responsive to specific
sessions. Written comments will be
accepted at the registration desk and
comment forms will be provided to
members of the public in order to write
down questions and comments for the
Commission as they arise. To
accommodate as many individuals as
possible, the time for each question or
comment may be limited. If the number
of individuals wishing to pose a
question or make a comment is greater
than can reasonably be accommodated
during the scheduled meeting, the
Commission may make a random
selection.
Anyone planning to attend the
meeting who needs special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify Esther Yoo by telephone
at (202) 233–3960, or email at
Esther.Yoo@bioethics.gov in advance of
the meeting. The Commission will make
every effort to accommodate persons
who need special assistance.
Written comments will also be
accepted in advance of the meeting and
are especially welcome. Please address
written comments by email to
info@bioethics.gov, or by mail to the
following address: Public Commentary,
Presidential Commission for the Study
of Bioethical Issues, 1425 New York
Ave. NW., Suite C–100, Washington, DC
20005. Comments will be publicly
available, including any personally
identifiable or confidential business
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information that they contain. Trade
secrets should not be submitted.
Dated: September 28, 2012.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2012–24911 Filed 10–9–12; 8:45 am]
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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 November 8, 2012, from 8 a.m.
to 5 p.m.
Location: DoubleTree by Hilton Hotel
Washington DC/Silver Spring, The
Ballrooms, 8727 Colesville Rd., Silver
Spring, MD 20910. The hotel’s
telephone number is 301–589–5200.
Contact Person: Paul Tran, 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
the safety and efficacy of new drug
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61609
applications (NDAs) 203313, insulin
degludec/insulin aspart [rDNA origin]
injection and 203314, insulin degludec
[rDNA origin] injection, manufactured
by Novo Nordisk Inc. The proposed
indication (use) for these applications is
for the treatment of Type 1 and 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 October 24, 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 October
16, 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 October 17, 2012.
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 Paul Tran 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/
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61610
Federal Register / Vol. 77, No. 196 / Wednesday, October 10, 2012 / Notices
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: October 3, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–24861 Filed 10–9–12; 8:45 am]
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Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1984.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Maternal and Child
Health Bureau Performance Measures
for Discretionary Grants (OMB No.
0915–0298): Revision
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
The Maternal and Child Health
Bureau (MCHB) intends to continue to
collect performance data for Special
Projects of Regional and National
Significance (SPRANS), Community
Integrated Service Systems (CISS), and
other grant programs administered by
MCHB.
The Health Resources and Services
Administration (HRSA) proposes to
continue using reporting requirements
for SPRANS projects, CISS projects, and
other grant programs administered by
MCHB, including national performance
measures previously approved by OMB,
and in accordance with the
‘‘Government Performance and Results
Act (GPRA) of 1993’’ (Pub. L. 103–62).
This Act requires the establishment of
measurable goals for federal programs
that can be reported as part of the
budgetary process, thus linking funding
decisions with performance.
Performance measures for MCHB
discretionary grants were initially
approved in January 2003. Approval
from OMB is being sought to continue
the use of these measures. Some of these
measures are specific to certain types of
programs and will not apply to all
grantees. Through the experience of
utilizing these measures, we are
enhancing them to better reflect
program goals. Specifically, additional
outcome measures that can be utilized
by grantees that predominantly provide
infrastructure services are being
developed for submission to OMB.
The estimated response burden is as
follows:
Form
Number of
respondents
Responses
per
respondent
Total
responses
Burden hours
per response
Total burden
hours
Grant Report ........................................................................
900
1
900
41
36,900
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806. Please direct all
correspondence to the ‘‘attention of the
desk officer for HRSA.’’
Dated: October 3, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–24889 Filed 10–9–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods Evaluation Report and
Recommendations for Identifying
Chemical Eye Hazards With Fewer
Animals; Availability of Report; Notice
of Transmittal to Federal Agencies
The NTP Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM)
announces availability of an Interagency
Coordinating Committee on the
Validation of Alternative Methods
(ICCVAM) test method evaluation report
(TMER) that provides recommendations
for identifying chemical eye hazards
with fewer animals.
ICCVAM concludes that using a
classification criterion of one or more
positive animals in a three-animal test
to identify chemicals and products that
are eye hazards will maintain hazard
classification equivalent to that
provided by current testing procedures,
while using up to 50% to 83% fewer
animals. ICCVAM recommends
SUMMARY:
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consideration of this classification
criterion together with eye safety testing
procedures that use a maximum of three
animals per test substance. This
recommendation also harmonizes the
number of animals used for eye safety
testing across U.S. regulatory agencies
and international test guidelines.
The report and recommendations
have been transmitted to Federal
agencies for their review and response
to ICCVAM.
FOR FURTHER INFORMATION CONTACT: Dr.
William S. Stokes, Director, NICEATM,
National Institute of Environmental
Health Sciences (NIEHS), P.O. Box
12233, Mail Stop: K2–16, Research
Triangle Park, NC 27709. Phone: 919–
541–2384, Fax: 919–541–0947, Email:
niceatm@niehs.nih.gov. Hand Deliver/
Courier address: NICEATM, NIEHS,
Room 2034, 530 Davis Drive,
Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background: Eye safety testing
procedures vary among U.S. agencies.
Current testing procedures specified in
the U.S. Code of Federal Regulations (16
CFR 1500.42) provide criteria and
procedures for identifying eye hazards
based on rabbit eye test results (CPSC,
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Agencies
[Federal Register Volume 77, Number 196 (Wednesday, October 10, 2012)]
[Notices]
[Pages 61609-61610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24861]
-----------------------------------------------------------------------
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 November 8, 2012, from 8
a.m. to 5 p.m.
Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring,
The Ballrooms, 8727 Colesville Rd., Silver Spring, MD 20910. The
hotel's telephone number is 301-589-5200.
Contact Person: Paul Tran, 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 the safety and efficacy of new
drug applications (NDAs) 203313, insulin degludec/insulin aspart [rDNA
origin] injection and 203314, insulin degludec [rDNA origin] injection,
manufactured by Novo Nordisk Inc. The proposed indication (use) for
these applications is for the treatment of Type 1 and 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
October 24, 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 October 16, 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 October 17, 2012.
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 Paul Tran 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/
[[Page 61610]]
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: October 3, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-24861 Filed 10-9-12; 8:45 am]
BILLING CODE 4160-01-P