Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 14115-14116 [2016-05931]
Download as PDF
<![CDATA[
14115
Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices
• Surveys of parents of a sample of
young children (birth through age eight).
Topics include child health, social
emotional health, school readiness,
parent-child relationships, parent
depression, home environment, and
parental social support.
• Surveys of a sample of kindergarten
teachers. The survey will assess
kindergarten students’ school readiness
in the areas of physical health and
wellbeing; social competence; emotional
maturity; language and cognitive
development; and communication
skills.
• Surveys of elementary school and
ECE administrators. The survey will
assess child suspension and expulsion.
In addition, key informant interviews
will be conducted with local and state
early childhood leaders to gather
contextual information about systems
level activities and change.
Respondents: All Project LAUNCH
grantees for the web-based data
collection; a systematic sample of
parents, teachers, elementary school and
ECE administrators in both LAUNCH
and comparison communities; and key
informants at the local and state levels
in both LAUNCH and comparison
communities.
ANNUAL BURDEN ESTIMATES
[3 Year information collection request]
Number of
respondents
Instrument
Direct Services Survey ........................................................
Systems Activities and Outcomes Survey ...........................
Recruitment of School Districts, Schools, ECEs, and Participants ............................................................................
Parent Survey ......................................................................
Teacher Survey (EDI) ..........................................................
Collection of Student Demographics for Teacher Survey ...
School Survey ......................................................................
Key Informant Interviews on Systems Change ...................
Annual
number of
responses per
respondent
Average
burden
hours per
response
Total
burden hours
Annual
burden hours
31
31
2
1
8.5
8
1,317.5
744
439
248
340
1800
160
20
120
70
1
1
1
1
1
1
1.912
0.5
10
2
1
1
433
600
533
13
80
47
433
600
533
13
80
47
Note, since original Federal Register Notice announcing this study (80 FR 15016), an additional instrument was added: Collection of Student
Demographics for Teacher Survey. This was based on feedback related to the Teacher Survey. We also added burden time for recruitment
efforts.
Estimated Total Annual Burden
Hours: 2,393.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
ADDITIONAL INFORMATION:
Robert Sargis,
ACF Certifying Officer.
[FR Doc. 2016–05861 Filed 3–15–16; 8:45 am]
BILLING CODE 4184–22–P
VerDate Sep<11>2014
18:11 Mar 15, 2016
Jkt 238001
[Docket No. FDA–2016–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 May 24, 2016, 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/
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: LaToya Bonner,
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, 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) 208673 for insulin
glargine and lixisenatide injection, a
fixed ratio drug product consisting of
insulin and a GLP–1 receptor agonist,
and 208471 for lixisenatide injection, a
GLP–1 receptor agonist, submitted by
Sanofi Aventis c/o Sanofi U.S. Services
E:\FR\FM\16MRN1.SGM
16MRN1
mstockstill on DSK4VPTVN1PROD with NOTICES
14116
Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices
Inc., proposed for the treatment of
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 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 May 10, 2016. 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 May 2,
2016. 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 May 3, 2016.
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 disabilities.
If you require accommodations due to a
disability, please contact LaToya Bonner
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/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
VerDate Sep<11>2014
18:11 Mar 15, 2016
Jkt 238001
Notice of this meeting is given under
the Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: March 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–05931 Filed 3–15–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Vaccines and Related Biological
Products 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: Vaccines and
Related Biological Products 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 May 11, 2016, from 1 p.m. to
4:30 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. 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. For those unable to
attend in person, the meeting will also
be Webcast and will be available at
https://collaboration.fda.gov/
vrbpac0516/.
Contact Person: Sujata Vijh or
Rosanna Harvey, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6128,
Silver Spring, MD 20993–0002, 240–
402–7107, sujata.vijh@fda.hhs.gov, or
240–402–8072, rosanna.harvey@
fda.hhs.gov respectively, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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 May 11, 2016, the
committee will participate via
teleconference. In open session, the
committee will hear updates of the
research program in the Laboratory of
Bacterial Polysaccharides, Division of
Bacterial, Parasitic, and Allergenic
Products, Center for Biologics
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.
Procedure: On May 11, 2016, from 1
p.m. to 3:25 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 May 3, 2016. Oral
presentations from the public will be
scheduled between approximately 2:25
p.m. and 3:25 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 April 25,
2016. 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
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Pages 14115-14116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05931]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-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 May 24, 2016, 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: LaToya Bonner, 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, 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) 208673 for insulin glargine and lixisenatide
injection, a fixed ratio drug product consisting of insulin and a GLP-1
receptor agonist, and 208471 for lixisenatide injection, a GLP-1
receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services
[[Page 14116]]
Inc., proposed for the treatment of 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 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 May
10, 2016. 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 May 2, 2016. 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 May 3, 2016.
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
disabilities. If you require accommodations due to a disability, please
contact LaToya Bonner 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: March 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05931 Filed 3-15-16; 8:45 am]
BILLING CODE 4164-01-P
