Joint Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting, 58261 [2015-24541]

Download as PDF Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Joint Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. tkelley on DSK3SPTVN1PROD with NOTICES 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: Cellular, Tissue, and Gene Therapies Advisory Committee and 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 18, 2015, 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 https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. For those unable to attend in person, the meeting will also be available via Webcast. The Webcast will be available at the following link: https://collaboration.fda.gov/ ctgtacodac111815/. Contact Person: Janie Kim or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 301–796–9016 or 240– 402–8072, email: Janie.Kim@fda.hhs.gov or Rosanna.Harvey@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 VerDate Sep<11>2014 17:19 Sep 25, 2015 Jkt 235001 link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committees will discuss the safety and efficacy of Biologics License Application (BLA) 125593, Mycobacterium phlei Cell wall-Nucleic Acid complex (MCNA), submitted by Telesta Therapeutics, Inc. The proposed indication (use) for this product is treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who ´ failed prior Bacillus Calmette-Guerin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCGrelapsing. 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, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 2, 2015. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 12:15 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 October 16, 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 22, 2015. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 58261 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 Janie Kim 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: September 22, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015–24541 Filed 9–25–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0369] M7(R1) Addendum to ICH M7; International Conference on Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ‘‘M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance, an addendum to the ICH M7 guidance of May 28, 2015, provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagens and carcinogens, and that were selected because they are commonly used in pharmaceutical manufacturing or are useful in illustrating the principles for deriving compound-specific intakes as described in ICH M7. The draft SUMMARY: E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Page 58261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24541]



[[Page 58261]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Joint Meeting of the Cellular, Tissue, and Gene Therapies 
Advisory Committee and 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: Cellular, Tissue, and Gene Therapies Advisory 
Committee and 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 18, 2015, 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. For those 
unable to attend in person, the meeting will also be available via 
Webcast. The Webcast will be available at the following link: https://collaboration.fda.gov/ctgtacodac111815/.
    Contact Person: Janie Kim or Rosanna Harvey, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301-796-9016 or 
240-402-8072, email: Janie.Kim@fda.hhs.gov or 
Rosanna.Harvey@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.
    Agenda: The committees will discuss the safety and efficacy of 
Biologics License Application (BLA) 125593, Mycobacterium phlei Cell 
wall-Nucleic Acid complex (MCNA), submitted by Telesta Therapeutics, 
Inc. The proposed indication (use) for this product is treatment of 
non-muscle invasive bladder cancer at high risk of recurrence or 
progression in adult patients who failed prior Bacillus Calmette-
Gu[eacute]rin (BCG) immunotherapy, e.g., in patients who are BCG-
refractory or BCG-relapsing.
    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, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
November 2, 2015. Oral presentations from the public will be scheduled 
between approximately 11:15 a.m. and 12:15 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 October 16, 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 22, 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 Janie Kim 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: September 22, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-24541 Filed 9-25-15; 8:45 am]
BILLING CODE 4164-01-P

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