80 FR 58261 - Joint Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 187 (September 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 187 (September 28, 2015)
| Page Range | 58261-58261 | |
| FR Document | 2015-24541 |
[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)] [Notices] [Page 58261] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24541] [[Page 58261]] ----------------------------------------------------------------------- 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 http://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: [email protected] or [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 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 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 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 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 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
![Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices 58261
DEPARTMENT OF HEALTH AND link, or call the advisory committee FDA welcomes the attendance of the
HUMAN SERVICES information line to learn about possible public at its advisory committee
modifications before coming to the meetings and will make every effort to
Food and Drug Administration meeting. accommodate persons with disabilities.
[Docket No. FDA–2015–N–0001] Agenda: The committees will discuss If you require accommodations due to a
the safety and efficacy of Biologics disability, please contact Janie Kim at
Joint Meeting of the Cellular, Tissue, License Application (BLA) 125593, least 7 days in advance of the meeting.
and Gene Therapies Advisory Mycobacterium phlei Cell wall-Nucleic FDA is committed to the orderly
Committee and the Oncologic Drugs Acid complex (MCNA), submitted by conduct of its advisory committee
Advisory Committee; Notice of Meeting Telesta Therapeutics, Inc. The proposed meetings. Please visit our Web site at
indication (use) for this product is http://www.fda.gov/
AGENCY: Food and Drug Administration, treatment of non-muscle invasive AdvisoryCommittees/
HHS. bladder cancer at high risk of recurrence AboutAdvisoryCommittees/
ACTION: Notice. or progression in adult patients who ucm111462.htm for procedures on
failed prior Bacillus Calmette-Guérin public conduct during advisory
This notice announces a forthcoming committee meetings.
meeting of a public advisory committee (BCG) immunotherapy, e.g., in patients
who are BCG-refractory or BCG- Notice of this meeting is given under
of the Food and Drug Administration the Federal Advisory Committee Act (5
(FDA). The meeting will be open to the relapsing.
FDA intends to make background U.S.C. app. 2).
public.
material available to the public no later Dated: September 22, 2015.
Name of Committee: Cellular, Tissue,
and Gene Therapies Advisory than 2 business days before the meeting. Jill Hartzler Warner,
Committee and the Oncologic Drugs If FDA is unable to post the background Associate Commissioner for Special Medical
material on its Web site prior to the Programs.
Advisory Committee.
General Function of the Committee: meeting, the background material will [FR Doc. 2015–24541 Filed 9–25–15; 8:45 am]
To provide advice and be made publicly available at the BILLING CODE 4164–01–P
recommendations to the Agency on location of the advisory committee
FDA’s regulatory issues. meeting, and the background material
Date and Time: The meeting will be will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
held on November 18, 2015, from 8 a.m. the meeting. Background material is HUMAN SERVICES
to 5 p.m. available at http://www.fda.gov/
AdvisoryCommittees/Calendar/ Food and Drug Administration
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 default.htm. Scroll down to the [Docket No. FDA–2013–D–0369]
Conference Center, the Great Room (rm. appropriate advisory committee meeting
1503), Silver Spring, MD 20993–0002. link. M7(R1) Addendum to ICH M7;
Answers to commonly asked questions Procedure: Interested persons may International Conference on
including information regarding special present data, information, or views, Harmonisation; Draft Guidance for
accommodations due to a disability, orally or in writing, on issues pending Industry; Availability
visitor parking, and transportation may before the committee. Written AGENCY: Food and Drug Administration,
be accessed at http://www.fda.gov/ submissions may be made to the contact HHS.
AdvisoryCommittees/ person on or before November 2, 2015. ACTION: Notice.
AboutAdvisoryCommittees/ Oral presentations from the public will
ucm408555.htm. For those unable to be scheduled between approximately SUMMARY: The Food and Drug
attend in person, the meeting will also 11:15 a.m. and 12:15 p.m. Those Administration (FDA or Agency) is
be available via Webcast. The Webcast individuals interested in making formal announcing the availability of a draft
will be available at the following link: oral presentations should notify the guidance entitled ‘‘M7(R1) Addendum
https://collaboration.fda.gov/ contact person and submit a brief to ICH M7: Assessment and Control of
ctgtacodac111815/. statement of the general nature of the DNA Reactive (Mutagenic) Impurities in
Contact Person: Janie Kim or Rosanna evidence or arguments they wish to Pharmaceuticals to Limit Potential
Harvey, Center for Biologics Evaluation present, the names and addresses of Carcinogenic Risk; Application of the
and Research, Food and Drug proposed participants, and an Principles of the ICH M7 Guidance to
Administration, 10903 New Hampshire indication of the approximate time Calculation of Compound-Specific
Ave., Bldg. 71, Silver Spring, MD requested to make their presentation on Acceptable Intakes.’’ The draft guidance
20993–0002, 301–796–9016 or 240– or before October 16, 2015. Time was prepared under the auspices of the
402–8072, email: Janie.Kim@fda.hhs.gov allotted for each presentation may be International Conference on
or Rosanna.Harvey@fda.hhs.gov, or limited. If the number of registrants Harmonisation of Technical
FDA Advisory Committee Information requesting to speak is greater than can Requirements for Registration of
Line, 1–800–741–8138 (301–443–0572 be reasonably accommodated during the Pharmaceuticals for Human Use (ICH).
in the Washington, DC area). A notice in scheduled open public hearing session, This draft guidance, an addendum to
the Federal Register about last minute FDA may conduct a lottery to determine the ICH M7 guidance of May 28, 2015,
modifications that impact a previously the speakers for the scheduled open provides guidance on acceptable intake
announced advisory committee meeting public hearing session. The contact limits derived for some chemicals that
tkelley on DSK3SPTVN1PROD with NOTICES
cannot always be published quickly person will notify interested persons are considered to be mutagens and
enough to provide timely notice. regarding their request to speak by carcinogens, and that were selected
Therefore, you should always check the October 22, 2015. because they are commonly used in
Agency’s Web site at http:// Persons attending FDA’s advisory pharmaceutical manufacturing or are
www.fda.gov/AdvisoryCommittees/ committee meetings are advised that the useful in illustrating the principles for
default.htm and scroll down to the Agency is not responsible for providing deriving compound-specific intakes as
appropriate advisory committee meeting access to electrical outlets. described in ICH M7. The draft
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Document Created: 2018-02-26 10:21:44
Document Modified: 2018-02-26 10:21:44
| 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 58261 |
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