81_FR_7843 81 FR 7813 - Oncologic Drugs Advisory Committee; Notice of Meeting

81 FR 7813 - Oncologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 30 (February 16, 2016)

Page Range7813-7813
FR Document2016-03011

Federal Register, Volume 81 Issue 30 (Tuesday, February 16, 2016) 
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Page 7813]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03011]


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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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    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: 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 April 12, 2016, from 
8:30 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: [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 new drug application (NDA) 
208542, rociletinib tablets, application submitted by Clovis Oncology, 
Inc. The proposed indication (use) for this product is for the 
treatment of patients with mutant epidermal growth factor receptor 
(EGFR) non-small cell lung cancer (NSCLC) who have been previously 
treated with an EGFR-targeted therapy and have the EGFR T790M mutation 
as detected by an FDA approved test.
    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 
March 29, 2016. Oral presentations from the public will be scheduled 
between approximately 11 a.m. and 12 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 March 21, 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 March 22, 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: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03011 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7813 Dated: February 9, 2016. modifications before coming to the due to a disability, please contact Leslie Kux, meeting. Lauren D. Tesh at least 7 days in Associate Commissioner for Policy. Agenda: The committee will discuss advance of the meeting. [FR Doc. 2016–02976 Filed 2–12–16; 8:45 am] new drug application (NDA) 208542, FDA is committed to the orderly BILLING CODE 4164–01–P rociletinib tablets, application conduct of its advisory committee submitted by Clovis Oncology, Inc. The meetings. Please visit our Web site at proposed indication (use) for this http://www.fda.gov/ DEPARTMENT OF HEALTH AND product is for the treatment of patients AdvisoryCommittees/ HUMAN SERVICES with mutant epidermal growth factor AboutAdvisoryCommittees/ receptor (EGFR) non-small cell lung ucm111462.htm for procedures on Food and Drug Administration cancer (NSCLC) who have been public conduct during advisory previously treated with an EGFR- committee meetings. [Docket No. FDA–2016–N–0001] targeted therapy and have the EGFR Notice of this meeting is given under Oncologic Drugs Advisory Committee; T790M mutation as detected by an FDA the Federal Advisory Committee Act (5 Notice of Meeting approved test. U.S.C. app. 2). FDA intends to make background Dated: February 8, 2016. AGENCY: Food and Drug Administration, material available to the public no later HHS. than 2 business days before the meeting. Jill Hartzler Warner, If FDA is unable to post the background Associate Commissioner for Special Medical ACTION: Notice. material on its Web site prior to the Programs. This notice announces a forthcoming meeting, the background material will [FR Doc. 2016–03011 Filed 2–12–16; 8:45 am] meeting of a public advisory committee be made publicly available at the BILLING CODE 4164–01–P of the Food and Drug Administration location of the advisory committee (FDA). The meeting will be open to the meeting, and the background material public. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND Name of Committee: Oncologic Drugs the meeting. Background material is HUMAN SERVICES Advisory Committee. available at http://www.fda.gov/ General Function of the Committee: AdvisoryCommittees/Calendar/ Food and Drug Administration To provide advice and default.htm. Scroll down to the [Docket No. FDA–2016–D–0412] recommendations to the Agency on appropriate advisory committee meeting FDA’s regulatory issues. link. Anthrax: Developing Drugs for Date and Time: The meeting will be Procedure: Interested persons may Prophylaxis of Inhalational Anthrax; held on April 12, 2016, from 8:30 a.m. present data, information, or views, Draft Guidance for Industry; to 1 p.m. orally or in writing, on issues pending Availability Location: FDA White Oak Campus, before the committee. Written 10903 New Hampshire Ave., Bldg. 31 AGENCY: Food and Drug Administration, submissions may be made to the contact Conference Center, the Great Room (Rm. HHS. person on or before March 29, 2016. 1503), Silver Spring, MD 20993–0002. Oral presentations from the public will ACTION: Notice of availability. Answers to commonly asked questions be scheduled between approximately 11 including information regarding special SUMMARY: The Food and Drug a.m. and 12 p.m. Those individuals Administration (FDA or Agency) is accommodations due to a disability, interested in making formal oral visitor parking, and transportation may announcing the availability of a draft presentations should notify the contact guidance for industry entitled ‘‘Anthrax: be accessed at: http://www.fda.gov/ person and submit a brief statement of AdvisoryCommittees/ Developing Drugs for Prophylaxis of the general nature of the evidence or AboutAdvisoryCommittees/ Inhalational Anthrax.’’ The purpose of arguments they wish to present, the ucm408555.htm. this draft guidance is to assist sponsors names and addresses of proposed Contact Person: Lauren D. Tesh, in the development of new drugs for the participants, and an indication of the Center for Drug Evaluation and prophylaxis of inhalational anthrax. approximate time requested to make Research, Food and Drug This draft guidance supersedes the draft their presentation on or before March Administration, 10903 New Hampshire guidance entitled ‘‘Inhalational Anthrax 21, 2016. Time allotted for each Ave., Bldg. 31, Rm. 2417, Silver Spring, (Post-Exposure)—Developing presentation may be limited. If the MD 20993–0002, 301–796–9001, FAX: Antimicrobial Drugs’’ issued in March number of registrants requesting to 301–847–8533, email: ODAC@ 2002. speak is greater than can be reasonably fda.hhs.gov, or FDA Advisory accommodated during the scheduled DATES: Although you can comment on Committee Information Line, 1–800– open public hearing session, FDA may any guidance at any time (see 21 CFR 741–8138 (301–443–0572 in the conduct a lottery to determine the 10.115(g)(5)), to ensure that the Agency Washington, DC area). A notice in the speakers for the scheduled open public considers your comment on this draft Federal Register about last minute hearing session. The contact person will guidance before it begins work on the modifications that impact a previously notify interested persons regarding their final version of the guidance, submit announced advisory committee meeting request to speak by March 22, 2016. either electronic or written comments cannot always be published quickly Persons attending FDA’s advisory on the draft guidance by April 18, 2016. mstockstill on DSK4VPTVN1PROD with NOTICES enough to provide timely notice. committee meetings are advised that the ADDRESSES: You may submit comments Therefore, you should always check the Agency is not responsible for providing as follows: Agency’s Web site at http:// access to electrical outlets. www.fda.gov/AdvisoryCommittees/ FDA welcomes the attendance of the Electronic Submissions default.htm and scroll down to the public at its advisory committee Submit electronic comments in the appropriate advisory committee meeting meetings and will make every effort to following way: link, or call the advisory committee accommodate persons with disabilities. • Federal eRulemaking Portal: http:// information line to learn about possible If you require special accommodations www.regulations.gov. 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Document Created: 2016-02-13 03:13:40
Document Modified: 2016-02-13 03:13:40
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 7813 
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