Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting, 39274-39275 [2016-14212]

Download as PDF 39274 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 7, subpart C, have been approved under OMB control number 0910–0249. The collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910–0485. The collections of information in 21 CFR part 803, regarding medical device reporting, have been approved under OMB control numbers 0910–0291, 0910–0437, and 0910–0471. The collections of information in 21 CFR part 806 have been approved under OMB control number 0910–0359. The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120. The collections of information in 21 CFR part 810, regarding medical device recall authority, have been approved under OMB control number 0910–0432. The collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078. The collections of information in 21 CFR part 814, subparts B and E, have been approved under OMB control number 0910–0231. The collections of information in 21 CFR part 820, regarding the Quality System regulation, have been approved under OMB control number 0910–0073. The collections of information in 21 CFR part 822, regarding postmarket surveillance of medical devices, have been approved under OMB control number 0910–0449. Dated: June 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–14200 Filed 6–15–16; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] asabaliauskas on DSK3SPTVN1PROD with NOTICES Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs SUMMARY: VerDate Sep<11>2014 18:04 Jun 15, 2016 Jkt 238001 FOR FURTHER INFORMATION CONTACT: 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: ODAC@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. SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P AGENCY: Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on June 28, 2016, from 8 a.m. to 3:15 p.m., and June 29, 2016, from 8 a.m. to 4:15 p.m. ADDRESSES: 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. Agenda: On June 28, 2016, information will be presented to gauge investigator interest in exploring potential pediatric development plans for four 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) VENETOCLAX, application sponsored by AbbVie, Inc.; (2) TAZEMETOSTAT, application sponsored by Epizyme, Inc.; and (3) PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 ATEZOLIZUMAB, application sponsored by Roche/Genentech. On June 29, 2016, during the morning session, 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) LOXO–101, application sponsored by Loxo Oncology, Inc.; and (2) ENTRECTINIB, application sponsored by Ignyta, Inc. During the afternoon session, information will be presented on the current unmet clinical need in the nearly uniformly fatal brain tumor, diffuse intrinsic pontine glioma (DIPG), which occurs predominantly in the pediatric age group. The diagnosis of DIPG is typically based on characteristic radiographic and clinical features in lieu of brain biopsy, and histological confirmation. Recent data has demonstrated that the biology and pathophysiology of these tumors differ. There are no approved drugs for this disease. Clinical investigators seek to exploit precision medicine approaches to DIPG and use potentially predictive information from the genomic signature of tumors at either diagnosis or relapse. This information can be used to select specific molecularly targeted drugs based on the genetic aberrations of an individual patient’s tumor. The Agency will seek the input of the subcommittee, including an assessment of benefit/risk given the potential for an adverse event associated with a surgical intervention in the brainstem. 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, E:\FR\FM\16JNN1.SGM 16JNN1 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person on or before June 21, 2016. Oral presentations from the public will be scheduled between approximately 8:50 a.m. and 9:10 a.m., 11 a.m. and 11:20 a.m., 1:55 p.m. and 2:15 p.m., and 3:50 p.m. and 4:05 p.m. on June 28, 2016, and between approximately 8:50 a.m. and 9:10 a.m., 10:55 a.m. and 11:15 a.m., and 3 p.m. and 3:20 p.m. on June 29, 2016. 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 June 16, 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 June 17, 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 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 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: June 10, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–14212 Filed 6–15–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:04 Jun 15, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Tribal Management Grant Program; Extension of Due Dates AGENCY: ACTION: Indian Health Service, HHS. Notice; extension of due dates. This document extends due dates in the Fiscal Year 2016 Tribal Management Grant Program funding announcement that was published in the Federal Register (81 FR 20396) on April 7, 2016. Several key dates have been extended. SUMMARY: The Application Deadline Date, Signed Tribal Resolutions Due Date, and Proof of Non-Profit Status Due Date are all extended to June 17, 2016. DATES: FOR FURTHER INFORMATION CONTACT: Michelle Eagle Hawk, Deputy Director, Office of Direct Service and Contracting Tribes, Indian Health Service, 5600 Fishers Lane, Mail Stop 08E17, Rockville, MD 20857, telephone (301) 443–1104. (This is not a toll-free number.) Dated: June 9, 2016. Elizabeth A. Fowler, Deputy Director for Management Operations, Indian Health Service. [FR Doc. 2016–14235 Filed 6–15–16; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service; Correction Indian Health Service (IHS), Department of Health and Human Services. AGENCY: ACTION: Notice; correction. The Indian Health Service published a document in the Federal Register on June 3, 2016, for the Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service. The notice contained the incorrect U.S. Code regarding consultation. SUMMARY: FOR FURTHER INFORMATION CONTACT: CAPT Chris Buchanan, Acting Director, Great Plains Area, Indian Health Service, 115 4th Ave. SE., Suite 309, Aberdeen, South Dakota, (605) 226– 7584, Fax (605) 226–7541. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 39275 Correction In the Federal Register of June 3, 2016, in FR Doc. 2016–13135, on page 35787, in the first column, under the heading ‘‘SUPPLEMENTARY INFORMATION: fourth paragraph,’’ delete ‘‘[42 U.S.C. 9835, Section 640(l)(4)(A)],’’ and insert ‘‘2 U.S.C. 1534.’’ Dated: June 9, 2016. Elizabeth A. Fowler, Deputy Director for Management Operations, Indian Health Service. [FR Doc. 2016–14232 Filed 6–15–16; 8:45 am] BILLING CODE 4165–16–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel. Date: July 12, 2016. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, Room 3An.12N, 45 Center Drive, Bethesda, MD 20892. Contact Person: Rebecca H. Johnson, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, Natcher Building, Room 3AN18C, Bethesda, MD 20892, 301–594–2771, johnsonrh@ nigms.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) E:\FR\FM\16JNN1.SGM 16JNN1

Agencies

[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39274-39275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pediatric Oncology 
Subcommittee of the Oncologic Drugs Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public.

DATES: The meeting will be held on June 28, 2016, from 8 a.m. to 3:15 
p.m., and June 29, 2016, from 8 a.m. to 4:15 p.m.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: 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: ODAC@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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On June 28, 2016, information will be presented to gauge 
investigator interest in exploring potential pediatric development 
plans for four 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) 
VENETOCLAX, application sponsored by AbbVie, Inc.; (2) TAZEMETOSTAT, 
application sponsored by Epizyme, Inc.; and (3) ATEZOLIZUMAB, 
application sponsored by Roche/Genentech.
    On June 29, 2016, during the morning session, 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) LOXO-101, application sponsored by Loxo 
Oncology, Inc.; and (2) ENTRECTINIB, application sponsored by Ignyta, 
Inc.
    During the afternoon session, information will be presented on the 
current unmet clinical need in the nearly uniformly fatal brain tumor, 
diffuse intrinsic pontine glioma (DIPG), which occurs predominantly in 
the pediatric age group. The diagnosis of DIPG is typically based on 
characteristic radiographic and clinical features in lieu of brain 
biopsy, and histological confirmation. Recent data has demonstrated 
that the biology and pathophysiology of these tumors differ. There are 
no approved drugs for this disease. Clinical investigators seek to 
exploit precision medicine approaches to DIPG and use potentially 
predictive information from the genomic signature of tumors at either 
diagnosis or relapse. This information can be used to select specific 
molecularly targeted drugs based on the genetic aberrations of an 
individual patient's tumor. The Agency will seek the input of the 
subcommittee, including an assessment of benefit/risk given the 
potential for an adverse event associated with a surgical intervention 
in the brainstem.
    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,

[[Page 39275]]

orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person on or before June 
21, 2016. Oral presentations from the public will be scheduled between 
approximately 8:50 a.m. and 9:10 a.m., 11 a.m. and 11:20 a.m., 1:55 
p.m. and 2:15 p.m., and 3:50 p.m. and 4:05 p.m. on June 28, 2016, and 
between approximately 8:50 a.m. and 9:10 a.m., 10:55 a.m. and 11:15 
a.m., and 3 p.m. and 3:20 p.m. on June 29, 2016. 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 June 16, 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 June 17, 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 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 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: June 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-14212 Filed 6-15-16; 8:45 am]
BILLING CODE 4164-01-P

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