80_FR_58448 80 FR 58261 - Joint Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting

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)

Page Range58261-58261
FR Document2015-24541

Federal Register, Volume 80 Issue 187 (Monday, September 28, 2015)
[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]]

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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 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
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 Citation80 FR 58261 

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