80 FR 55859 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 180 (September 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 180 (September 17, 2015)
| Page Range | 55859-55859 | |
| FR Document | 2015-23366 |
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)] [Notices] [Page 55859] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23366] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Pediatric Oncology Subcommittee of the Oncologic 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: Pediatric Oncology Subcommittee of the Oncologic 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 19, 2015, from 8 a.m. to 1 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: Lauren D. Tesh, 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: Information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ABT-414, application submitted by AbbVie, Inc., and (2) Lenvatinib, application submitted by Eisai, Inc. 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 subcommittee. Written submissions may be made to the contact person on or before November 4, 2015. Oral presentations from the public will be scheduled between approximately 9:05 a.m. to 9:35 a.m., and 11:30 a.m. to 12 noon. 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 27, 2015. 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 28, 2015. 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 Lauren D. Tesh 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: September 14, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015-23366 Filed 9-16-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices 55859
For purposes of this extension announced advisory committee meeting requesting to speak is greater than can
request, we are retaining our 2012 cannot always be published quickly be reasonably accommodated during the
estimates. The PRA analysis for the enough to provide timely notice. scheduled open public hearing session,
GRAS final rule will take into account Therefore, you should always check the FDA may conduct a lottery to determine
any changes to the GRAS notification Agency’s Web site at http:// the speakers for the scheduled open
procedure as set forth in the final rule www.fda.gov/AdvisoryCommittees/ public hearing session. The contact
and we will revise the collection default.htm and scroll down to the person will notify interested persons
accordingly. appropriate advisory committee meeting regarding their request to speak by
Dated: September 11, 2015. link, or call the advisory committee October 28, 2015.
information line to learn about possible Persons attending FDA’s advisory
Leslie Kux,
modifications before coming to the committee meetings are advised that the
Associate Commissioner for Policy. meeting. Agency is not responsible for providing
[FR Doc. 2015–23334 Filed 9–16–15; 8:45 am] Agenda: Information will be access to electrical outlets.
BILLING CODE 4164–01–P presented to gauge investigator interest FDA welcomes the attendance of the
in exploring potential pediatric public at its advisory committee
development plans for two products in meetings and will make every effort to
DEPARTMENT OF HEALTH AND various stages of development for adult accommodate persons with disabilities.
HUMAN SERVICES cancer indications. The subcommittee If you require accommodations due to a
will consider and discuss issues disability, please contact Lauren D. Tesh
Food and Drug Administration concerning diseases to be studied, at least 7 days in advance of the
[Docket No. FDA–2015–N–0001] patient populations to be included, and meeting.
possible study designs in the FDA is committed to the orderly
Pediatric Oncology Subcommittee of development of these products for conduct of its advisory committee
the Oncologic Drugs Advisory pediatric use. The discussion will also meetings. Please visit our Web site at
Committee; Notice of Meeting provide information to the Agency http://www.fda.gov/
pertinent to the formulation of written AdvisoryCommittees/
AGENCY: Food and Drug Administration, requests for pediatric studies, if
HHS. AboutAdvisoryCommittees/
appropriate. The products under ucm111462.htm for procedures on
ACTION: Notice. consideration are: (1) ABT–414, public conduct during advisory
application submitted by AbbVie, Inc., committee meetings.
This notice announces a forthcoming and (2) Lenvatinib, application
meeting of a public advisory committee Notice of this meeting is given under
submitted by Eisai, Inc. the Federal Advisory Committee Act (5
of the Food and Drug Administration FDA intends to make background
(FDA). The meeting will be open to the U.S.C. app. 2).
material available to the public no later
public. Dated: September 14, 2015.
than 2 business days before the meeting.
Name of Committee: Pediatric If FDA is unable to post the background Jill Hartzler Warner,
Oncology Subcommittee of the material on its Web site prior to the Associate Commissioner for Special Medical
Oncologic Drugs Advisory Committee. meeting, the background material will Programs.
General Function of the Committee: be made publicly available at the [FR Doc. 2015–23366 Filed 9–16–15; 8:45 am]
To provide advice and location of the advisory committee BILLING CODE 4164–01–P
recommendations to the Agency on meeting, and the background material
FDA’s regulatory issues. will be posted on FDA’s Web site after
Date and Time: The meeting will be the meeting. Background material is DEPARTMENT OF HEALTH AND
held on November 19, 2015, from 8 a.m. available at http://www.fda.gov/ HUMAN SERVICES
to 1 p.m. AdvisoryCommittees/Calendar/
Location: FDA White Oak Campus, default.htm. Scroll down to the Health Resources and Services
10903 New Hampshire Ave., Bldg. 31 appropriate advisory committee meeting Administration
Conference Center, the Great Room (Rm. link.
1503), Silver Spring, MD 20993–0002. Alliance for Innovation on Maternal
Procedure: Interested persons may
Answers to commonly asked questions and Child Health Cooperative
present data, information, or views,
including information regarding special Agreement
orally or in writing, on issues pending
accommodations due to a disability, before the subcommittee. Written AGENCY: Health Resources and Services
visitor parking, and transportation may submissions may be made to the contact Administration (HRSA), Department of
be accessed at: http://www.fda.gov/ person on or before November 4, 2015. Health and Human Services (HHS).
AdvisoryCommittees/ Oral presentations from the public will ACTION: Notice of Single-Case Deviation
AboutAdvisoryCommittees/ be scheduled between approximately from Competition Requirement for the
ucm408555.htm. 9:05 a.m. to 9:35 a.m., and 11:30 a.m. to Alliance for Innovation on Maternal and
Contact Person: Lauren D. Tesh, 12 noon. Those individuals interested in Child Health Cooperative Agreement at
Center for Drug Evaluation and making formal oral presentations should the Association of State and Territorial
Research, Food and Drug notify the contact person and submit a Health Officials, Grant Number
Administration, 10903 New Hampshire brief statement of the general nature of UC4MC28036.
Ave., Bldg. 31, Rm. 2417, Silver Spring, the evidence or arguments they wish to
tkelley on DSK3SPTVN1PROD with NOTICES
MD 20993–0002, 301–796–9001, FAX: present, the names and addresses of SUMMARY: HRSA announces the award
301–847–8533, ODAC@fda.hhs.gov, or proposed participants, and an of a program expansion supplement in
FDA Advisory Committee Information indication of the approximate time the amount of $100,000 for the Alliance
Line, 1–800–741–8138 (301–443–0572 requested to make their presentation on for Innovation on Maternal and Child
in the Washington, DC area). A notice in or before October 27, 2015. Time Health (AIM) cooperative agreement.
the Federal Register about last minute allotted for each presentation may be The purpose of the AIM cooperative
modifications that impact a previously limited. If the number of registrants agreement, as stated in the funding
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Document Created: 2015-12-15 09:33:41
Document Modified: 2015-12-15 09:33:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| FR Citation | 80 FR 55859 |
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