81_FR_49826 81 FR 49681 - Oncologic Drugs Advisory Committee; Notice of Meeting

81 FR 49681 - Oncologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 145 (July 28, 2016)

Page Range49681-49681
FR Document2016-17865

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting 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.

Federal Register, Volume 81 Issue 145 (Thursday, July 28, 2016) 
[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Page 49681]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting 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 September 14, 2016, from 8 a.m. to 1 
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: http://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 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.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss new drug application 208714, 
apaziquone for intravesical instillation, application submitted by 
Spectrum Pharmaceuticals, Inc. The proposed indication (use) for this 
product is for immediate intravesical instillation post-transurethral 
resection of bladder tumors in patients with non-muscle invasive 
bladder cancer.
    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 
August 30, 2016. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:45 a.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 August 22, 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 August 23, 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 special 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: July 25, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-17865 Filed 7-27-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices 49681 Agency is not responsible for providing FOR FURTHER INFORMATION CONTACT: indication of the approximate time access to electrical outlets. Lauren D. Tesh, Center for Drug requested to make their presentation on FDA welcomes the attendance of the Evaluation and Research, Food and or before August 22, 2016. Time allotted public at its advisory committee Drug Administration, 10903 New for each presentation may be limited. If meetings and will make every effort to Hampshire Ave., Bldg. 31, Rm. 2417, the number of registrants requesting to accommodate persons with disabilities. Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably If you require accommodations due to a 796–9001, Fax: 301–847–8533, ODAC@ accommodated during the scheduled disability, please contact Kalyani Bhatt fda.hhs.gov, or FDA Advisory open public hearing session, FDA may at least 7 days in advance of the Committee Information Line, 1–800– conduct a lottery to determine the meeting. 741–8138 (301–443–0572 in the speakers for the scheduled open public FDA is committed to the orderly Washington, DC area). A notice in the hearing session. The contact person will conduct of its advisory committee Federal Register about last minute notify interested persons regarding their meetings. Please visit our Web site at modifications that impact a previously request to speak by August 23, 2016. http://www.fda.gov/ announced advisory committee meeting Persons attending FDA’s advisory AdvisoryCommittees/ cannot always be published quickly committee meetings are advised that the AboutAdvisoryCommittees/ enough to provide timely notice. Agency is not responsible for providing ucm111462.htm for procedures on Therefore, you should always check the access to electrical outlets. public conduct during advisory Agency’s Web site at http:// FDA welcomes the attendance of the committee meetings. www.fda.gov/AdvisoryCommittees/ public at its advisory committee Notice of this meeting is given under default.htm and scroll down to the meetings and will make every effort to the Federal Advisory Committee Act (5 appropriate advisory committee meeting accommodate persons with disabilities. U.S.C. app. 2). link, or call the advisory committee If you require special accommodations information line to learn about possible due to a disability, please contact Dated: July 25, 2016. modifications before coming to the Lauren D. Tesh at least 7 days in Janice M. Soreth, advance of the meeting. meeting. Acting Associate Commissioner, Special FDA is committed to the orderly Medical Programs. SUPPLEMENTARY INFORMATION: conduct of its advisory committee [FR Doc. 2016–17864 Filed 7–27–16; 8:45 am] Agenda: The committee will discuss meetings. Please visit our Web site at BILLING CODE 4164–01–P new drug application 208714, http://www.fda.gov/ apaziquone for intravesical instillation, AdvisoryCommittees/ application submitted by Spectrum AboutAdvisoryCommittees/ DEPARTMENT OF HEALTH AND Pharmaceuticals, Inc. The proposed ucm111462.htm for procedures on HUMAN SERVICES indication (use) for this product is for public conduct during advisory immediate intravesical instillation post- committee meetings. Food and Drug Administration transurethral resection of bladder Notice of this meeting is given under tumors in patients with non-muscle the Federal Advisory Committee Act (5 [Docket No. FDA–2016–N–0001] invasive bladder cancer. U.S.C. app. 2). FDA intends to make background Oncologic Drugs Advisory Committee; material available to the public no later Dated: July 25, 2016. Notice of Meeting than 2 business days before the meeting. Janice M. Soreth, If FDA is unable to post the background Acting Associate Commissioner, Special AGENCY: Food and Drug Administration, Medical Programs. HHS. material on its Web site prior to the meeting, the background material will [FR Doc. 2016–17865 Filed 7–27–16; 8:45 am] ACTION: Notice. be made publicly available at the BILLING CODE 4164–01–P SUMMARY: The Food and Drug location of the advisory committee Administration (FDA) announces a meeting, and the background material will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND forthcoming public advisory committee HUMAN SERVICES meeting of the Oncologic Drugs the meeting. Background material is Advisory Committee. The general available at http://www.fda.gov/ Food and Drug Administration function of the committee is to provide AdvisoryCommittees/Calendar/ default.htm. Scroll down to the [Docket No. FDA–2016–N–0007] advice and recommendations to the Agency on FDA’s regulatory issues. The appropriate advisory committee meeting link. Biosimilar User Fee Rates for Fiscal meeting will be open to the public. Year 2017 Procedure: Interested persons may DATES: The meeting will be held on present data, information, or views, AGENCY: Food and Drug Administration, September 14, 2016, from 8 a.m. to 1 orally or in writing, on issues pending p.m. HHS. before the committee. Written ACTION: Notice. ADDRESSES: FDA White Oak Campus, submissions may be made to the contact 10903 New Hampshire Ave., Bldg. 31 person on or before August 30, 2016. SUMMARY: The Food and Drug Conference Center, the Great Room (Rm. Oral presentations from the public will Administration (FDA) is announcing the 1503), Silver Spring, MD 20993–0002. be scheduled between approximately rates for biosimilar user fees for fiscal Answers to commonly asked questions 10:45 a.m. and 11:45 a.m. Those year (FY) 2017. The Federal Food, Drug, Lhorne on DSK30JT082PROD with NOTICES including information regarding special individuals interested in making formal and Cosmetic Act (the FD&C Act), as accommodations due to a disability, oral presentations should notify the amended by the Biosimilar User Fee Act visitor parking, and transportation may contact person and submit a brief of 2012 (BsUFA), authorizes FDA to be accessed at: http://www.fda.gov/ statement of the general nature of the assess and collect user fees for certain AdvisoryCommittees/ evidence or arguments they wish to activities in connection with biosimilar AboutAdvisoryCommittees/ present, the names and addresses of biological product development, certain ucm408555.htm. proposed participants, and an applications and supplements for VerDate Sep<11>2014 14:44 Jul 27, 2016 Jkt 238001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\28JYN1.SGM 28JYN1


Document Created: 2016-07-28 01:47:56
Document Modified: 2016-07-28 01:47:56
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.
DatesThe meeting will be held on September 14, 2016, from 8 a.m. to 1 p.m.
ContactLauren 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.
FR Citation81 FR 49681 
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