81_FR_14166 81 FR 14115 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

81 FR 14115 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 51 (March 16, 2016)

Page Range14115-14116
FR Document2016-05931

Federal Register, Volume 81 Issue 51 (Wednesday, March 16, 2016) 
[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Pages 14115-14116]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05931]


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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.

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    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: http://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, [email protected], 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 http://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 http://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 http://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

Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices 14115 • Surveys of parents of a sample of wellbeing; social competence; emotional contextual information about systems young children (birth through age eight). maturity; language and cognitive level activities and change. Topics include child health, social development; and communication Respondents: All Project LAUNCH emotional health, school readiness, skills. grantees for the web-based data parent-child relationships, parent • Surveys of elementary school and collection; a systematic sample of depression, home environment, and parents, teachers, elementary school and ECE administrators. The survey will parental social support. ECE administrators in both LAUNCH assess child suspension and expulsion. • Surveys of a sample of kindergarten and comparison communities; and key teachers. The survey will assess In addition, key informant interviews informants at the local and state levels kindergarten students’ school readiness will be conducted with local and state in both LAUNCH and comparison in the areas of physical health and early childhood leaders to gather communities. ANNUAL BURDEN ESTIMATES [3 Year information collection request] Annual Average Number of number of burden Total Annual Instrument respondents responses per hours per burden hours burden hours respondent response Direct Services Survey ........................................................ 31 2 8.5 1,317.5 439 Systems Activities and Outcomes Survey ........................... 31 1 8 744 248 Recruitment of School Districts, Schools, ECEs, and Par- ticipants ............................................................................ 340 1 1.912 433 433 Parent Survey ...................................................................... 1800 1 0.5 600 600 Teacher Survey (EDI) .......................................................... 160 1 10 533 533 Collection of Student Demographics for Teacher Survey ... 20 1 2 13 13 School Survey ...................................................................... 120 1 1 80 80 Key Informant Interviews on Systems Change ................... 70 1 1 47 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 DEPARTMENT OF HEALTH AND AdvisoryCommittees/ Hours: 2,393. HUMAN SERVICES AboutAdvisoryCommittees/ ucm408555.htm. ADDITIONAL INFORMATION: Copies of the Food and Drug Administration Contact Person: LaToya Bonner, proposed collection may be obtained by [Docket No. FDA–2016–N–0001] Center for Drug Evaluation and writing to the Administration for Research, Food and Drug Children and Families, Office of Administration, 10903 New Hampshire Endocrinologic and Metabolic Drugs Planning, Research and Evaluation, 330 Advisory Committee; Notice of Meeting Ave., Bldg.31, Rm. 2417, Silver Spring, C Street SW., Washington, DC 20201, MD 20993–0002, 301–796–9001, FAX: Attn: OPRE Reports Clearance Officer. AGENCY: Food and Drug Administration, 301–847–8533, EMDAC@fda.hhs.gov, or All requests should be identified by the HHS. FDA Advisory Committee Information title of the information collection. Email ACTION: Notice. Line, 1–800–741–8138 (301–443–0572 address: OPREinfocollection@ in the Washington, DC area). A notice in This notice announces a forthcoming acf.hhs.gov. the Federal Register about last minute meeting of a public advisory committee OMB Comment: OMB is required to of the Food and Drug Administration modifications that impact a previously make a decision concerning the (FDA). The meeting will be open to the announced advisory committee meeting collection of information between 30 public. cannot always be published quickly and 60 days after publication of this Name of Committee: Endocrinologic enough to provide timely notice. document in the Federal Register. and Metabolic Drugs Advisory Therefore, you should always check the Therefore, a comment is best assured of Committee. Agency’s Web site at http:// General Function of the Committee: www.fda.gov/AdvisoryCommittees/ having its full effect if OMB receives it To provide advice and default.htm and scroll down to the within 30 days of publication. Written recommendations to the Agency on appropriate advisory committee meeting comments and recommendations for the FDA’s regulatory issues. link, or call the advisory committee proposed information collection should information line to learn about possible Date and Time: The meeting will be be sent directly to the following: Office modifications before coming to the held on May 24, 2016, from 8 a.m. to 5 of Management and Budget, Paperwork meeting. p.m. Reduction Project, Email: OIRA_ Location: FDA White Oak Campus, Agenda: The committee will discuss SUBMISSION@OMB.EOP.GOV, Attn: mstockstill on DSK4VPTVN1PROD with NOTICES 10903 New Hampshire Ave., Bldg. 31 the safety and efficacy of new drug Desk Officer for the Administration for Conference Center, the Great Room (Rm. applications (NDAs) 208673 for insulin Children and Families. 1503), Silver Spring, MD 20993–0002. glargine and lixisenatide injection, a Robert Sargis, Answers to commonly asked questions fixed ratio drug product consisting of including information regarding special insulin and a GLP–1 receptor agonist, ACF Certifying Officer. accommodations due to a disability, and 208471 for lixisenatide injection, a [FR Doc. 2016–05861 Filed 3–15–16; 8:45 am] visitor parking, and transportation may GLP–1 receptor agonist, submitted by BILLING CODE 4184–22–P be accessed at: http://www.fda.gov/ Sanofi Aventis c/o Sanofi U.S. Services VerDate Sep<11>2014 18:11 Mar 15, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1

14116 Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices Inc., proposed for the treatment of Notice of this meeting is given under Federal Register about last minute adults with type 2 diabetes mellitus. the Federal Advisory Committee Act modifications that impact a previously FDA intends to make background (5 U.S.C. app. 2). announced advisory committee meeting material available to the public no later Dated: March 11, 2016. cannot always be published quickly than 2 business days before the meeting. Jill Hartzler Warner, enough to provide timely notice. If FDA is unable to post the background Associate Commissioner for Special Medical Therefore, you should always check the material on its Web site prior to the Programs. Agency’s Web site at http:// meeting, the background material will [FR Doc. 2016–05931 Filed 3–15–16; 8:45 am] www.fda.gov/AdvisoryCommittees/ be made publicly available at the default.htm and scroll down to the BILLING CODE 4164–01–P location of the advisory committee appropriate advisory committee meeting meeting, and the background material link, or call the advisory committee will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND information line to learn about possible the meeting. Background material is HUMAN SERVICES modifications before coming to the available at http://www.fda.gov/ meeting. AdvisoryCommittees/Calendar/ Food and Drug Administration Agenda: On May 11, 2016, the default.htm. Scroll down to the committee will participate via [Docket No. FDA–2016–N–0001] appropriate advisory committee meeting teleconference. In open session, the link. Vaccines and Related Biological committee will hear updates of the Procedure: Interested persons may Products Advisory Committee; Notice research program in the Laboratory of present data, information, or views, of Meeting Bacterial Polysaccharides, Division of orally or in writing, on issues pending Bacterial, Parasitic, and Allergenic AGENCY: Food and Drug Administration, Products, Center for Biologics before the committee. Written HHS. submissions may be made to the contact Evaluation and Research, FDA. ACTION: Notice. FDA intends to make background person on or before May 10, 2016. Oral presentations from the public will be material available to the public no later This notice announces a forthcoming scheduled between approximately 1 than 2 business days before the meeting. meeting of a public advisory committee p.m. and 2 p.m. Those individuals If FDA is unable to post the background of the Food and Drug Administration interested in making formal oral material on its Web site prior to the (FDA). At least one portion of the presentations should notify the contact meeting, the background material will meeting will be closed to the public. person and submit a brief statement of Name of Committee: Vaccines and be made publicly available at the the general nature of the evidence or Related Biological Products Advisory location of the advisory committee arguments they wish to present, the Committee. meeting, and the background material names and addresses of proposed General Function of the Committee: will be posted on FDA’s Web site after participants, and an indication of the To provide advice and the meeting. Background material is approximate time requested to make recommendations to the Agency on available at http://www.fda.gov/ their presentation on or before May 2, FDA’s regulatory issues. AdvisoryCommittees/Calendar/ 2016. Time allotted for each Date and Time: The meeting will be default.htm. Scroll down to the presentation may be limited. If the held on May 11, 2016, from 1 p.m. to appropriate advisory committee meeting number of registrants requesting to 4:30 p.m. link. speak is greater than can be reasonably Location: FDA White Oak Campus, Procedure: On May 11, 2016, from 1 accommodated during the scheduled 10903 New Hampshire Ave., Building p.m. to 3:25 p.m., the meeting is open open public hearing session, FDA may 31 Conference Center, the Great Room to the public. Interested persons may conduct a lottery to determine the (Rm. 1503), Silver Spring, MD 20993– present data, information, or views, speakers for the scheduled open public 0002. Answers to commonly asked orally or in writing, on issues pending hearing session. The contact person will questions including information before the committee. Written notify interested persons regarding their regarding special accommodations due submissions may be made to the contact request to speak by May 3, 2016. to a disability, visitor parking, and person on or before May 3, 2016. Oral transportation may be accessed at: presentations from the public will be Persons attending FDA’s advisory http://www.fda.gov/ scheduled between approximately 2:25 committee meetings are advised that the AdvisoryCommittees/ p.m. and 3:25 p.m. Those individuals Agency is not responsible for providing AboutAdvisoryCommittees/ interested in making formal oral access to electrical outlets. ucm408555.htm. For those unable to presentations should notify the contact FDA welcomes the attendance of the attend in person, the meeting will also person and submit a brief statement of public at its advisory committee be Webcast and will be available at the general nature of the evidence or meetings and will make every effort to https://collaboration.fda.gov/ arguments they wish to present, the accommodate persons with disabilities. vrbpac0516/. names and addresses of proposed If you require accommodations due to a Contact Person: Sujata Vijh or participants, and an indication of the disability, please contact LaToya Bonner Rosanna Harvey, Center for Biologics approximate time requested to make at least 7 days in advance of the Evaluation and Research, Food and their presentation on or before April 25, meeting. Drug Administration, 10903 New 2016. Time allotted for each mstockstill on DSK4VPTVN1PROD with NOTICES FDA is committed to the orderly Hampshire Ave., Bldg. 71, Rm. 6128, presentation may be limited. If the conduct of its advisory committee Silver Spring, MD 20993–0002, 240– number of registrants requesting to meetings. Please visit our Web site at 402–7107, sujata.vijh@fda.hhs.gov, or speak is greater than can be reasonably http://www.fda.gov/Advisory 240–402–8072, rosanna.harvey@ accommodated during the scheduled Committees/AboutAdvisoryCommittees/ fda.hhs.gov respectively, or FDA open public hearing session, FDA may ucm111462.htm for procedures on Advisory Committee Information Line, conduct a lottery to determine the public conduct during advisory 1–800–741–8138 (301–443–0572 in the speakers for the scheduled open public committee meetings. Washington, DC area). A notice in the hearing session. The contact person will VerDate Sep<11>2014 18:11 Mar 15, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1


Document Created: 2016-03-15 23:43:52
Document Modified: 2016-03-15 23:43:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation81 FR 14115 
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